SURGICAL GENERATOR, SURGICAL INSTRUMENT AND SURGICAL INSTRUMENT SYSTEM

专利摘要:
surgical generator for ultrasonic devices and for electrosurgical devices. the present invention relates to a surgical generator (102) that can produce a signal, or signals, for triggering specific voltages, currents, and frequencies, for example, 55,500 cycles per second (hz). the trigger signal, or signals, can be supplied to an ultrasonic surgical device (104), and specifically to a transducer. in one embodiment, the generator can be configured to produce a trigger signal for a specific voltage, current, and / or frequency output signal that can be measured with high resolution, accuracy, and repeatability. in addition, the surgical generator can generate a signal or trigger signals with sufficient output power to perform bipolar electrosurgery using radiofrequency (rf) energy. the trigger signal can be supplied, for example, to the electrodes of the electrosurgical device (106). consequently, the generator can be configured for therapeutic purposes by applying signals to an ultrasonic transducer or electrical energy to the tissue sufficient to treat the tissue (for example, cutting, coagulation, cauterization, tissue welding, etc.).
公开号:BR112012009383B1
申请号:R112012009383-5
申请日:2010-10-07
公开日:2020-03-31
发明作者:Eitan T. Weiner；Jeffrey L. Aldridge；Jeffrey D. Messerly；James R. Giordano；Foster B. Stulen；Matthew C. Miller；Jeffrey P. Wiley；Daniel W. Price；Robert L. Koch；Joseph A. Brotz；John E. Hein；Aaron C. Voegele；Daniel J. Abbott；Scott B. Killinger；Mark A. Davison；David C. Yates；Gavin M. Monson；William E. Clem；Mark E. Tebbe
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

Invention Patent Descriptive Report for SURGICAL GENERATOR, SURGICAL INSTRUMENT AND SURGICAL INSTRUMENT SYSTEM.
CROSS REFERENCE TO RELATED APPLICATION [001] This application claims the benefit under Title 35, United States code § 119 (e), of US provisional patent application No. 61 / 250,217, filed on October 9, 2009 and entitled A DUAL BIPOLAR AND ULTRASONIC GENERATOR FOR ELECTROSURGICAL INSTRUMENTS, which is incorporated herein by reference, in its entirety.
[002] The present application relates to the following US patent applications simultaneously filed, which are incorporated herein by reference, in their entirety:
[003] (1) US patent application serial number 12 / 896,351, entitled
DEVICES AND TECHNIQUES FOR CUTTING AND COAGULATING TISSUE, summary of attorney No. END6427USCIP1 / 080591 CIP;
[004] (2) US patent application serial number 12 / 896,360, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP / 1 00558 [005] (3) US patent application serial number 12 / 896.479, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP1 / 100557;
[006] (4) US patent application serial number 12 / 869,345, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP2 / 100559;
[007] (5) US patent application serial number 12 / 896,384, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP3 / 100560;
[008] (6) US patent application serial number 12 / 896,467, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSUR Petition 870190093148, of 09/18/2019, p. 5/151
2/140
GICAL DEVICES, summary of attorney No. END6673USNP4 / 100562; [009] (7) US patent application serial number 12 / 896,451, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP5 / 100563; and [0010] (8) US patent application serial number 12 / 896,470, entitled
SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, summary of attorney No. END6673USNP6 / 100564. BACKGROUND OF THE INVENTION [0011] Various modalities are related to surgical devices, and generators to supply power to surgical devices, for use in open or minimally invasive surgery environments.
[0012] Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread applications in surgical procedures because of their unique performance characteristics. Depending on specific device settings and operating parameters, ultrasonic surgical devices can offer, substantially simultaneously, tissue transection and coagulation homeostasis, desirably minimizing the patient's trauma. An ultrasonic surgical device may comprise a cable containing an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer having a distally mounted end actuator (for example a blade tip) for cutting and cauterizing tissue. In some cases, the instrument may be permanently attached to the cable. In other cases, the instrument may be separable from the cable, as in the case of a disposable instrument or an instrument that is interchangeable between different cables. The end actuator transmits ultrasonic energy to the tissues placed in contact with it, to perform the cutting and cauterization action. Surgical devices
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3/140 ultrasonic devices of this nature can be configured for use in open, laparoscopic or endoscopic surgical procedures, including robotically assisted procedures.
[0013] Ultrasonic energy cuts and coagulates tissues using temperatures lower than those used in electrosurgical procedures and can be transmitted to the end actuator by an ultrasonic generator in communication with the cable. Vibrating at high frequencies (for example, 55,500 times per second), the ultrasonic blade denatures the protein present in the tissues to form a sticky clot. The pressure exerted on the tissues by the surface of the slide flattens blood vessels and allows the clot to form a hemostatic seal. A surgeon can control the cutting and clotting speed through the force applied to the tissues by the end actuator, the time during which the force is applied and the selected excursion level for the end actuator.
[0014] The ultrasonic transducer can be modeled as an equivalent circuit, comprising a first branch that has a static capacitance and a second movement branch that has serially connected inductance, resistance and capacitance, which defines the electromechanical properties of a resonator. Known ultrasonic generators may include a tuning inductor to cancel static capacitance at a resonant frequency, so that substantially all of the generator's trigger signal current flows into the motion branch. Consequently, using a tuning inductor, the current of the generator's trigger signal represents the current of the motion branch, and the generator is thus able to control its trigger signal to maintain the transducer's resonant frequency. ultrasonic. The tuning inductor can also transform the phase and impedance plotting of the ultrasonic transducer to
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4/140 optimize the frequency locking capabilities of the generator. However, the tuning inductor needs to be combined with the specific static capacitance of an ultrasonic transducer at the operational resonance frequency. In other words, a different ultrasonic transducer having a different static capacitance requires a different tuning inductor.
[0015] Additionally, in some ultrasonic generator architectures, the generator trigger signal displays asymmetric harmonic distortion, which complicates the magnitude and phase measurements of the impedance. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion in current and voltage signals.
[0016] In addition, electromagnetic interference in noisy environments decreases the generator's ability to maintain locking in the resonance frequency of the ultrasonic transducer, increasing the likelihood of invalid inputs from the control algorithm.
[0017] Electrosurgical devices for applying electrical energy to tissues in order to treat and / or destroy said tissues are also finding increasingly widespread applications in surgical procedures. An electrosurgical device can comprise a cable and an instrument having a distally mounted end actuator (for example, one or more electrodes). The end actuator can be positioned against the fabric, so that electric current is introduced into the fabric. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into the tissue and returned from it through the active and return electrodes, respectively, of the end actuator. During monopolar operation, the current is introduced into the tissue by an active electrode of the end actuator and returned through a
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5/140 return electrode (for example, a grounding plate) separately located on the patient's body. The heat generated by the flow of the current through the tissue can form hemostatic seals within the tissue and / or between tissues and, therefore, can be particularly useful for cauterization of blood vessels, for example. The end actuator of an electrosurgical device can also comprise a cutting element that is capable of moving in relation to the tissue and the electrodes, to transect the tissue.
[0018] The electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator in communication with the cable. The electrical energy can be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 300 kHz to 1 MHz. During operation, an electrosurgical device can transmit RF energy at low frequency through the tissue, which causes ionic agitation, or ionic friction, in fact resistive heating, thus increasing the fabric temperature. As a precise boundary can be created between the affected tissue and the surrounding tissue, surgeons can operate with a high level of precision and control, without sacrificing adjacent tissue that is not the target of the operation. The low operating temperatures of RF energy can be useful for removing, shrinking or sculpting soft tissues while blood vessels are simultaneously cauterized. RF energy can work particularly well in connective tissue, which mainly comprises collagen and shrinks when it comes in contact with heat.
[0019] Due to their unique trigger signal, detection and feedback information, ultrasonic and electrosurgical devices generally need different generators. Additionally, in cases where the instrument is disposable or
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6/140 biable with a cable, ultrasonic and electrosurgical generators are limited in their ability to recognize the configuration of the specific instrument being used, and to optimize the control and diagnostic processes as needed. In addition, capacitive coupling between the patient's non-isolated and isolated generator circuits, especially where higher voltages and frequencies are used, can result in a patient's exposure to unacceptable levels of current leakage.
SUMMARY [0020] Various ways of a generator are presented to communicate a trigger signal to a surgical device. In one embodiment, the generator may comprise a power amplifier to receive a time-varying trigger signal waveform. The trigger signal waveform can be generated by a digital to analog conversion of at least a portion of a plurality of trigger signal waveform samples. An output from the power amplifier can be used to generate a drive signal. The trigger signal can comprise one of: a first trigger signal to be communicated to an ultrasonic surgical device, a second trigger signal to be communicated to an electrosurgical device. The generator may also comprise a sampling circuit for generating current and voltage samples from the drive signal when it is communicated to the surgical device. Sample generation can be synchronized with the digital to analog conversion of the trigger signal waveform samples so that, for each digital to analog conversion of a trigger signal waveform sample, the sampling manages a corresponding set of current and voltage samples. The generator may also comprise at least one device designed to
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7/140 turf to, for each trigger signal waveform sample and corresponding set of current and voltage samples, store the current and voltage samples in a memory of at least one device, to associate the stored samples with the sample trigger signal waveform. The at least one device can also be programmed to, when the trigger signal comprises the first trigger signal: determine a current sample from the motion branch of the ultrasonic surgical device, based on the stored current and voltage samples, compare the sample of current from the motion branch to a target sample selected from a plurality of target samples that define a target waveform, the target sample being selected based on the trigger signal waveform sample, to determine an amplitude error between the target sample and the current sample of the motion branch, and modify the trigger signal waveform sample so that a determined amplitude error between the target sample and a current sample of the movement branch is reduced subsequent, based on current and voltage samples associated with the modified trigger signal waveform sample.
[0021] In one embodiment, the generator may comprise a memory and a device coupled to the memory to receive, for each of a plurality of trigger signal waveform samples used to synthesize a trigger signal, a corresponding set of current and voltage samples of the trigger signal. For each trigger signal waveform sample and corresponding set of current and voltage samples, the device can store the samples in a device memory to associate the stored samples with the trigger signal waveform sample. In addition, for each sample of ForPetition 870190093148, of 09/18/2019, p. 11/151
8/140 ma of the trigger signal wave and corresponding set of current and voltage samples, the device can, when the trigger signal comprises a first trigger signal to be communicated to an ultrasonic surgical device, determine a sample of current from the motion branch of the ultrasonic surgical device based on the stored samples, compare the current sample of the motion branch to a target sample selected from a plurality of target samples that define a target waveform, the target sample being selected with based on the trigger signal waveform sample, determine an amplitude error between the target sample and the motion branch current sample, and modify the trigger signal waveform sample so that a amplitude error determined between the target sample and a sample of current from the subsequent movement branch, based on samples current and voltage associated with the modified trigger signal waveform sample.
[0022] Also, modalities of a method for determining the current of the movement branch in an ultrasonic transducer of an ultrasonic surgical device are presented along multiple frequencies of a trigger signal transducer. In one embodiment, the method may comprise, in each of a plurality of frequencies of the transducer driving signal, oversampling a current and voltage of the transducer driving signal, receiving current and voltage samples by means of a processor, and determine by means of the processor the current of the movement branch based on the current and voltage samples, a static capacitance of the ultrasonic transducer and the frequency of the transducer activation signal.
[0023] Also, modalities of a method are presented
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9/140 for control of a waveform of a current of the movement branch in an ultrasonic transducer of a surgical device. In one embodiment, the method may comprise generating a transducer drive signal by selective invocation, using a digital direct synthesis (DDS) algorithm, from stored drive signal waveform samples in a look-up table (LUT), generate current and voltage samples from the transducer drive signal when the transducer drive signal is communicated to the surgical device, determine samples of the movement branch current based on in current and voltage samples, a static capacitance of the ultrasonic transducer and a frequency of the transducer drive signal, compare each sample of the current from the motion branch to a respective target sample of a target waveform to determine an error amplitude , and modify the trigger signal waveform samples stored in the LUT, so that an amplitude error and between subsequent samples of the current of the motion branch and the respective target samples.
[0024] According to various modalities, a surgical generator to supply a trigger signal to a surgical device can comprise a first transformer and a second transformer. The first transformer can comprise a first primary winding and a first secondary winding. The second transformer can comprise a second primary winding and a second secondary winding. The surgical generator can also comprise a generator circuit to generate the trigger signal. The generator circuit can be electrically coupled to the first primary winding to provide the trigger signal through the first primary winding. The surgical generator can comprise
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10/140 also a patient-side circuit, electrically isolated from the generator circuit. The patient-side circuit can be electrically coupled to the first secondary winding. In addition, the patient-side circuit can comprise a first and a second output line to supply the trigger signal to the surgical device. In addition, the surgical generator may comprise a capacitor. The capacitor and the second secondary winding can be electrically coupled in series between the first output line and the ground.
[0025] In addition, according to various modalities, a surgical generator for supplying a trigger signal to a surgical device may comprise a first transformer, a patient-side circuit, and a capacitor. The first transformer can comprise a primary winding, a first secondary winding, and a second secondary winding. A polarity of the first secondary winding in relation to the primary winding can be opposite to the polarity of the second secondary winding. The generator circuit can generate the drive signal and can be electrically coupled to the first primary winding to provide the drive signal. The patient-side circuit can be electrically isolated from the generator circuit and can be electrically coupled to the first secondary winding. In addition, the patient-side circuit may comprise a first and a second output line to supply the trigger signal to the surgical device. The capacitor and the second secondary winding can be electrically coupled in series between the first output line and the ground.
[0026] Additionally, according to various modalities, a surgical generator for supplying a trigger signal to a surgical device may comprise a first transformer, a
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11/140 generator circuit, a patient-side circuit and a capacitor. The first transformer can comprise a primary winding and a secondary winding. The generator circuit can generate the drive signal and can be electrically coupled to the first primary winding to provide the drive signal. The patient-side circuit can be electrically isolated from the generator circuit and can be electrically coupled to the secondary winding. In addition, the patient-side circuit can comprise a first and a second output line to supply the trigger signal to the surgical device. The capacitor can be electrically coupled to the primary winding and the first output line. [0027] According to various modalities, a surgical generator for supplying a trigger signal to a surgical device can comprise a first transformer, a generator circuit, a patient-side circuit, as well as first, second and third capacitors. The first transformer can comprise a primary winding and a secondary winding. The generator circuit can generate the drive signal and can be electrically coupled to the first primary winding to provide the drive signal. The patient-side circuit can be electrically isolated from the generator circuit and can be electrically coupled to the secondary winding. In addition, the patient-side circuit can comprise a first and a second output line to supply the trigger signal to the surgical device. A first electrode of the first capacitor can be electrically coupled to the primary winding. A first electrode of the second capacitor can be electrically coupled to the first output line, and a second electrode of the second capacitor can be electrically coupled to a second electrode of the first capacitor. A first electrode from the third capacitor can be electrically coupled to the second electrode
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12/140 of the first capacitor and the second electrode of the second capacitor. A second electrode from the third capacitor can be electrically coupled to the ground.
[0028] Various modalities of surgical device control circuits are also presented. In one embodiment, the control circuit may comprise a first circuit portion comprising at least a first switch. The first circuit portion can communicate with a surgical generator via a pair of conductors. The control circuit may also comprise a second circuit portion comprising a data circuit element. The data circuit element can be arranged on an instrument of the surgical device and transmit or receive data. The data circuit element can implement data communications with the surgical generator via at least one conductor from the conductor pair.
[0029] In one embodiment, the control circuit may comprise a first circuit portion comprising at least one first switch. The first circuit portion can communicate with a surgical generator through a pair of conductors. The control circuit may also comprise a second circuit portion comprising a data circuit element. The data circuit element can be arranged on an instrument of the surgical device and transmit or receive data. The data circuit element can implement data communications with the surgical generator via at least one conductor from the conductor pair. The first circuit portion can receive a first interrogation signal transmitted from the surgical generator in a first frequency range. The data circuit element can communicate with the surgical generator using an amplitude-modulated communication protocol, transmitted in a second frequency range.
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The second frequency range can be higher than the first frequency range.
[0030] In one embodiment, the control circuit may comprise a first circuit portion comprising at least a first switch. The first circuit portion can receive a first interrogation signal transmitted from a surgical generator through a pair of conductors. The control circuit may also comprise a second circuit portion comprising at least one of a resistive element and an inductive element arranged in an instrument of the device. The second circuit portion can receive a second interrogation signal transmitted from the surgical generator through the pair of conductors. The second circuit portion can be separated by frequency range from the first circuit portion. A feature of the first interrogation signal, when received through the first circuit portion, can be indicative of a state of at least one first key. A characteristic of the second interrogation signal, when received through the second circuit portion, can unequivocally identify the instrument of the device.
[0031] In one embodiment, the control circuit may comprise a first circuit portion comprising a first network of keys and a second network of keys. The first key network may comprise at least one first key, and the second key network may comprise at least one second key. The first circuit portion can communicate with a surgical generator via a pair of conductors. The control circuit may also comprise a second circuit portion comprising a data circuit element. The data circuit element can be arranged on an instrument of the surgical device and can transmit or receive data. The data circuit element
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14/140 can be in data communication with the surgical generator through at least one conductor of the conductor pair.
[0032] According to various modalities, a surgical generator for supplying a trigger signal to a surgical device can comprise a surgical generator body that has an opening. The surgical generator may also comprise a receptacle assembly positioned in the opening. The receptacle assembly may comprise a receptacle body and a flange having an inner and an outer wall. The inner wall can be composed of at least one curved section and at least one linear section. The inner wall can define a cavity. A protruding central portion can be positioned in the cavity and can comprise a plurality of sockets and a magnet. An outer periphery of the protruding central portion may comprise at least one curved section and at least one linear section.
[0033] According to various modalities, a surgical instrument may comprise an electrical connector set. The electrical connector assembly may comprise a flange defining a central cavity and a magnetically compatible pin extending into the central cavity. The electrical connector assembly may comprise a circuit board and a plurality of electrically conductive pins coupled to the circuit board. Each of the plurality of electrically conductive pins can extend into the central cavity. The electrical connector set may also contain a strain relief element and a cover.
[0034] According to various modalities, a surgical instrument system may comprise a surgical generator comprising a receptacle assembly. The receptacle assembly may comprise at least one curved section and at least a linear portion. The surgical instrument system may comprise an ins
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15/140 surgical instrument comprising a connector assembly and an adapter assembly operably coupled to the receptacle assembly and the connector assembly. The adapter assembly may comprise a distal portion in contact with the receptacle assembly. The distal portion may comprise a flange that has at least one curved section and at least one linear portion. The adapter assembly may comprise a proximal portion in contact with the connector assembly. The proximal portion can define a cavity sized to receive at least a portion of the connector assembly. The adapter assembly may also contain a circuit board.
[0035] According to various modalities, methods (for example, in conjunction with surgical instruments) can be used to achieve various surgical objectives. For example, methods for controlling the electrical energy supplied to the tissue via the first and second electrodes may comprise providing a trigger signal to the tissue through the first and second electrodes, and modulating a power supplied to the tissue via the activation based on a detected tissue impedance, according to a first power curve. The first power curve can define, for each of a plurality of possible detected tissue impedances, a corresponding first power. The methods of the present invention may also comprise monitoring the total energy delivered to the tissue through the first and second electrodes. When the total power reaches a first energy limit, the methods of the present invention can comprise determining whether a tissue impedance has reached a first impedance limit. The methods of the present invention can also comprise, conditioned to the fact that the tissue impedance has not reached the first impedance limit, modulate the power
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16/140 supplied to the tissue via the trigger signal based on the detected tissue impedance, according to a second power curve. The second power curve can define, for each of the plurality of possible detected tissue impedances, a corresponding second power.
[0036] According to various modalities, the methods for controlling the electrical energy supplied to the tissue by means of the first and second electrodes may comprise providing a trigger signal to the tissue through the first and second electrodes, and determining a power to be supplied to the fabric. The determination may comprise receiving an indication of a detected tissue impedance; determining a first corresponding power for the tissue impedance detected according to a power curve; and multiply the corresponding power by a multiplier. The power curve can define a corresponding power for each of a plurality of possible detected tissue impedances. The methods of the present invention may further comprise modulating the trigger signal to provide the determined power to the tissue and, subject to the fact that the tissue impedance has not reached the first impedance limit, increasing the multiplier as a function of the total energy supplied to the fabric.
[0037] According to various modalities, the methods for controlling the electrical energy supplied to the tissue through the first and the second electrodes may comprise providing a trigger signal to the tissue through the first and second electrodes, and determine a power to be supplied to the fabric. The determination may comprise receiving an indication of a detected tissue impedance; determining a corresponding first power for the tissue impedance detected according to a power curve; and multiply the corresponding power by a first multiplier of
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17/140 in order to find a specific power. The power curve can define a corresponding power for each of a plurality of possible detected tissue impedances. The methods of the present invention may further comprise modulating the trigger signal to provide the determined power to the tissue, and to monitor the total energy supplied to the tissue through the first and second electrodes. In addition, the methods of the present invention may comprise, when the total energy reaches a first energy limit, determine whether the tissue impedance has reached a first impedance limit and, conditioned on the fact that the tissue impedance has not reached the first limit impedance, increase the first multiplier by a first amount.
[0038] According to various modalities, the methods for controlling the electrical energy supplied to the tissue by means of a surgical device may comprise providing a trigger signal to a surgical device; receive an indication of a tissue impedance; calculate a rate of increase in tissue impedance; and modulating the drive signal to maintain the impedance increase rate greater than or equal to a predetermined constant.
[0039] According to various modalities, the methods for controlling the electrical energy supplied to the tissue by means of a surgical device may comprise the supply of a trigger signal. A power of the trigger signal can be proportional to a power delivered to the tissue through the surgical device. The methods of the present invention may also comprise periodically receiving indications for a tissue impedance, and applying a first compound power curve to the tissue, wherein applying the first compound power curve to the tissue comprises. Applying the first composite power curve to the tissue may comprise modulating a first predetermined number of pulses
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18/140 of the first compound power curve in the drive signal and, for each of the pulses of the first compound power curve, determine a pulse power and pulse width according to a first function of the tissue impedance. The methods of the present invention may also comprise applying a second composite power curve to the tissue. Applying the second compound power curve to the tissue may comprise modulating at least one pulse of the second compound power curve in the trigger signal and, for each of at least one of the pulses of the second compound power curve, determining a pulse power and a pulse width according to a second function of tissue impedance.
FIGURES [0040] The innovative characteristics of the various modalities are presented with particularity in the attached claims. The described modalities, however, both in terms of organization and methods of operation, can be better understood by reference to the description presented below, taken in conjunction with the attached drawings, in which:
[0041] Figure 1 illustrates a modality of a surgical system comprising a generator and several surgical instruments that can be used with it;
[0042] Figure 2 illustrates a modality of an exemplifying ultrasonic device that can be used for transection and / or cauterization;
[0043] Figure 3 illustrates a modality of the end actuator of the example ultrasonic device of Figure 2.
[0044] Figure 4 illustrates a modality of an exemplifying electrosurgical device that can also be used for transection and cauterization;
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19/140 [0045] Figures 5, 6 and 7 illustrate an embodiment of the end actuator shown in Figure 4;
[0046] Figure 8 is a diagram of the surgical system in Figure 1;
[0047] Figure 9 is a model illustrating the current of the movement branch in one mode;
[0048] Figure 10 is a structural view of a generator architecture in one mode;
[0049] Figures 11A to 11C are functional views of a generator architecture in one mode;
[0050] Figure 12 illustrates a controller for monitoring input devices and controlling output devices in one mode;
[0051] Figure 13 illustrates the structural and functional aspects of a generator mode;
[0052] Figures 14 to 32 and 33A to 33C illustrate modalities of control circuits;
[0053] Figures 33D to 33I illustrate cabling modalities and adapter configurations for connecting multiple generators and various surgical instruments;
[0054] Figure 34 illustrates a modality of a circuit 300 for active cancellation of current leakage.
[0055] Figure 35 illustrates a modality of a circuit that can be implemented by the generator of Figure 1 to obtain active cancellation of the current leak;
[0056] Figure 36 illustrates an alternative modality of a circuit that can be implemented by the generator of Figure 1 to obtain active cancellation of the current leak;
[0057] Figure 37 illustrates an alternative modality of a circuit that can be implemented by the generator of Figure 1 to obtain active cancellation of the current leak;
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20/140 [0058] Figure 38 illustrates yet another modality of a circuit that can be implemented by the generator of Figure 1 to obtain active cancellation of the current leak;
[0059] Figure 39 illustrates a modality of a circuit that can be implemented by the generator of Figure 1 to obtain current leak cancellation;
[0060] Figure 40 illustrates another modality of a circuit that can be implemented by the generator of Figure 1 to obtain current leak cancellation;
[0061] Figure 41 illustrates an interface between receptacle and connector in one mode;
[0062] Figure 42 is an exploded side view of the receptacle assembly in one embodiment;
[0063] Figure 43 is an exploded side view of the connector assembly in one embodiment;
[0064] Figure 44 is a perspective view of the receptacle assembly shown in Figure 41;
[0065] Figure 45 is an exploded perspective view of the receptacle assembly in one embodiment;
[0066] Figure 46 is a front elevation view of the receptacle set in one embodiment;
[0067] Figure 47 is a side elevation view of the receptacle assembly in one embodiment;
[0068] Figure 48 is an enlarged view of a socket in one mode;
[0069] Figure 49 is a perspective view of the connector assembly in one embodiment;
[0070] Figure 50 is an exploded perspective view of the connector assembly in one embodiment;
[0071] Figure 51 is a side elevation view of a body of the
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21/140 connector in one mode;
[0072] Figure 52 is a perspective view of the distal end of a connector body in one embodiment;
[0073] Figure 53 is a perspective view of the proximal end of a connector body in one embodiment;
[0074] Figure 54 illustrates a ferrous pin in one embodiment;
[0075] Figure 55 illustrates electrically conductive pins and a circuit board in one mode;
[0076] Figure 56 illustrates a strain relief element in one embodiment;
[0077] Figure 57 illustrates coverage in one mode;
[0078] Figure 58 illustrates two sets of adapter according to various non-limiting modalities;
[0079] Figure 59 illustrates a surgical generator in one mode;
[0080] Figure 60 illustrates a connector set connected to an adapter set in one mode;
[0081] Figure 61 illustrates an adapter set inserted in a receptacle set of a surgical generator in one mode;
[0082] Figure 62 illustrates a connector set connected to an adapter set in one mode;
[0083] Figure 63 illustrates a perspective view of a rear panel of a generator in one mode;
[0084] Figure 64 illustrates a rear panel of a generator in one mode;
[0085] Figures 65 and 66 illustrate different portions of a rear panel of a generator in one embodiment;
[0086] Figure 67 illustrates a neural network for controlling a generator in one mode;
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22/140 [0087] Figure 68 illustrates the measured temperature output versus temperature estimated by a surgical instrument controlled by a generator in one mode;
[0088] Figure 69 illustrates a graph mode showing exemplary power curves;
[0089] Figure 70 illustrates a modality of a process flow for applying one or more power curves to a tissue portion;
[0090] Figure 71 illustrates a modality of a graph showing exemplary power curves that can be used in conjunction with the process flow of Figure 70;
[0091] Figure 72 illustrates a modality of a graph showing exemplary power curves with common format that can be used in conjunction with the process flow of Figure 70;
[0092] Figure 73A illustrates a modality of a routine that can be performed by a digital device of the generator of Figure 1, to act on a new tissue portion;
[0093] Figure 73B illustrates a modality of a routine that can be performed by a digital device of the generator of Figure 1 to monitor the tissue impedance;
[0094] Figure 73C illustrates a modality of a routine that can be performed by a digital device of the generator of Figure 1 to supply one or more power curves to a tissue portion;
[0095] Figure 74 illustrates a modality of a process flow for applying one or more power curves to a tissue portion;
[0096] Figure 75 illustrates a modality of a block diagram describing the selection and application of load curves composed by the generator of Figure 1;
[0097] Figure 76 shows a flow of processes illustrating a
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23/140 modality of the algorithm of Figure 75, as implemented by the generator of Figure 1;
[0098] Figure 77 illustrates a modality of a process flow for generating a first pulse of the composite load curve;
[0099] Figure 78 illustrates a modality of a pulse timing diagram illustrating an exemplary application of the algorithm of Figure 76 by the generator of Figure 1;
[00100] Figure 79 illustrates a graphical representation of the voltage, current and power of the trigger signal, according to an exemplary composite load curve;
[00101] Figures 80 to 85 illustrate a graphical representation of exemplary composite load curves; and [00102] Figure 86 illustrates a modality of a block diagram describing the application of an algorithm for maintaining a constant speed of change in the impedance of the tissue. DESCRIPTION [00103] Before explaining in detail the various modalities of surgical devices and generators, it should be noted that the illustrative modalities are not limited, in their applications or their use, to the details of construction and arrangement of parts illustrated in the drawings and in attached description. The illustrative modalities of the invention can be implemented or incorporated into other modalities, variations and modifications, and can be practiced or carried out in various ways. In addition, except where otherwise indicated, the terms and expressions used in the present invention were chosen for the purpose of describing the illustrative modalities for the convenience of the reader and are not intended to limit them. In addition, it should be considered that one or more of modalities, expressions of modalities and / or examples described below can be combined with any one or more among the others
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24/140 modalities, expressions of modalities and / or examples described below.
[00104] Several modalities refer to ultrasonic surgical devices and improved electrosurgical devices, as well as generators for use with them. The modalities of ultrasonic surgical devices can be configured to transect and / or coagulate tissues during surgical procedures, for example. The modalities of electrosurgical devices can be configured to transect, coagulate, peel, weld and / or dry tissues during surgical procedures, for example.
[00105] The generator modalities use high speed sampling from analog to digital (for example, approximately 200x oversampling, depending on the frequency) of the current and voltage of the generator trigger signal, together with digital signal processing, to obtain numerous advantages and benefits over known generator architectures. In one embodiment, for example, based on current and voltage feedback information, a value of the static capacitance of the ultrasonic transducer, and a value of the frequency of the drive signal, the generator can determine the current of the movement branch of a transducer ultrasonic. This provides the benefit of a virtually tuned system, and simulates the presence of a system that is tuned or resonated to any static capacitance value (for example, C0 in Figure 9) at any frequency. Consequently, the current control of the motion branch can be accomplished by canceling the effects of static capacitance without the need for a tuning inductor. In addition, the elimination of the tuning inductor cannot degrade the frequency locking capabilities of the generator, since the frequency locking can be accomplished by properly processing the
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25/140 current and voltage feedback data.
[00106] High-speed sampling from analog to digital of the current and voltage of the generator trigger signal, together with digital signal processing, can also allow accurate digital filtering of samples. For example, generator modalities can use a digital low-pass filter (for example, a finite impulse response filter (FIR)) that rotates between a fundamental trigger signal frequency and a second harmonic order to reduce asymmetric harmonic distortion and EMI-induced noise in current and voltage feedback reports. The filtered current and voltage feedback samples substantially represent the frequency of the fundamental trigger signal, thus allowing a more accurate measurement of the impedance phase in relation to the frequency of the fundamental trigger signal, as well as an improvement in the capacity of the generator to maintain the locking the resonance frequency. The accuracy of the impedance phase measurement can be further optimized by calculating the average of the phase measurements on the falling edge and rising edge, and by adjusting the phase impedance measured to 0 °.
[00107] Various generator modes can also use high-speed sampling from analog to digital of the current and voltage of the generator trigger signal, along with digital signal processing, to determine actual energy consumption and other quantities with a high degree of accuracy. This can allow the generator to implement numerous useful algorithms, such as to control the amount of power applied to the tissue as the tissue impedance changes, and to control the application of power to maintain a constant rate of increase in the tissue impedance.
[00108] The various generator modes can have a wide range
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26/140 frequency range and increased output power, necessary to drive both ultrasonic surgical devices and electrosurgical devices. The lower voltage and higher current requirement of electrosurgical devices can be met by a dedicated branch in a broadband power transformer, thus eliminating the need for a separate power amplifier and output transformer. In addition, the generator's detection and feedback circuits can support a wide dynamic range that meets the needs of both ultrasonic and electrosurgical applications, with minimal distortion.
[00109] Several modalities can provide a simple and economical way for the generator to read from, and optionally write to, a data circuit (for example, a single wire bus device, such as a 1-wire® protocol EEPROM) arranged on an instrument attached to the cable using existing multi-conductor generator / cable wires. In this way, the generator is able to retrieve and process instrument-specific data from an instrument attached to the cable. This can allow the generator to provide better control and improved diagnostics and error detection. In addition, the generator's ability to record data on the instrument enables new functionality in terms of, for example, tracking instrument usage and capturing operational data. In addition, the use of the frequency range allows for backward compatibility of instruments containing a bus device with existing generators.
[00110] The presented modalities of the generator provide active cancellation of the current leakage caused by the unintentional capacitive coupling between generator circuits not isolated and isolated to the patient. In addition to reducing patient risks, reducing current leakage can also decrease
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27/140 electromagnetic emissions.
[00111] These and other benefits of the modalities of the present invention will be evident from the description presented below.
[00112] It should be recognized that the terms proximal and distal are used in the present invention with reference to a clinician holding a cable. Thus, an end actuator is distal to the most proximal cable. It should be further recognized that, for the sake of convenience and clarity, spatial terms such as top and bottom can also be used in the present invention in relation to the clinician holding the cable. However, surgical devices can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[00113] Figure 1 illustrates a modality of a surgical system 100 comprising a generator 102 configurable for use with surgical devices. According to various modalities, generator 102 can be configurable for use with surgical devices of different types including, for example, ultrasonic surgical device 104 and electrosurgical or RF device 106. Although in Figure 1 the generator 102 is shown separate from the surgical devices 104 and 106, in certain embodiments the generator 102 can be integrally formed with any of the surgical devices 104 and 106, to form a unitary surgical system.
[00114] Figure 2 illustrates a modality of an exemplifying ultrasonic device 104 that can be used for transection and / or cauterization. Device 104 may comprise a cable 116 which may, in turn, comprise an ultrasonic transducer 114. Transducer 114 may be in electrical communication with generator 102, for example, by means of a wire 122 (for example, a multiconductor wire ). Transducer 114 may comprise piezoceramic elements, or other elements or components suitable for converting
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28/140 are the electrical energy of a trigger signal in mechanical vibrations. When activated by generator 102, ultrasonic transducer 114 can cause longitudinal vibration. Vibration can be transmitted through an instrumental portion 124 of device 104 (for example, by means of a waveguide integrated in an outer sheath) to an end actuator 126 of the instrumental portion 124.
[00115] Figure 3 illustrates an embodiment of the end actuator 126 of the exemplary ultrasonic device 104. The end actuator 126 may comprise a blade 151 that can be coupled to the ultrasonic transducer 114 through the waveguide (not shown). When driven by transducer 114, blade 151 can vibrate and, when placed in contact with tissues, can cut and / or coagulate them, as described in the present invention. According to various modalities, and as illustrated in Figure 3, end actuator 126 can also comprise a clamp arm 155 that can be configured for cooperative action with blade 151 of end actuator 126. With blade 151, the arm clamp 155 can comprise a set of claws 140. Clamp arm 155 can be pivotally connected to a distal end of a rod 153 of instrument portion 124. Clamp arm 155 can include a tissue block from the clamp arm 163, which can be formed of TEFLON® or other suitable low-friction material. The block 163 can be mounted for cooperation with the blade 151, with pivoting movement of the clamp arm 155 by positioning the clamp block 163 in a substantially parallel relationship to, and in contact with, the blade 151. For this construction, a tissue portion a clamp can be caught between the tissue block 163 and the blade 151. The tissue block 163 can be provided with a saw-like configuration including a plu
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29/140 ratio of gripping teeth 161 axially spaced and extending proximally to optimize tissue gripping in cooperation with blade 151. Clamp arm 155 can transition from the open position shown in Figures 3 to a closed position (with the clamp arm 155 in contact with or in proximity to blade 151) in any suitable manner. For example, cable 116 may comprise a jaw closure trigger 138. When operated by a clinician, the jaw closure trigger 138 may rotate the clamp arm 155 in any suitable manner.
[00116] Generator 102 can be activated to supply the trigger signal to transducer 114 in any suitable manner. For example, generator 102 may comprise a switch pedal 120 coupled to generator 102 by means of a wire from switch pedal 122 (Figure 8). A clinician can activate transducer 114 and thereby transducer 114 and blade 151 by pressing the switch pedal 120. In addition, or instead of the switch pedal 120, some modalities of device 104 may use one or more keys positioned on cable 116 which, when activated, can cause generator 102 to activate transducer 114. In one embodiment, for example, one or more switches may comprise a pair of toggle buttons 136a and 136b, for example, to determine an operating mode of device 104. When the toggle button 136a is pressed, for example, ultrasonic generator 102 can provide a maximum trigger signal to transducer 114, causing it to produce a maximum output of ultrasonic energy. Pressing the toggle button 136b can cause the ultrasonic generator 102 to provide a user-selectable drive signal to transducer 114, causing it to produce less than the maximum ultrasonic energy output. The additional 104 device or
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30/140 alternatively it can comprise a second key to, for example, indicate a position of a jaw closing trigger 138 to operate the jaws 140 of the end actuator 126. In addition, in some embodiments the ultrasonic generator 102 can be activated based on the position of the jaw closure trigger 138, (for example, as the clinician presses the jaw closure trigger 138 to close the jaws 140, ultrasonic energy can be applied.
[00117] Additionally or alternatively, the one or more keys may comprise a toggle button 136c which, when pressed, causes generator 102 to provide a pulse output. The pulses can be provided at any suitable frequency and grouping, for example. In certain embodiments, the power level of the pulses may consist of the power levels associated with the toggle buttons 136a, b (maximum, less than maximum), for example.
[00118] It should be considered that a device 104 can comprise any combination of toggle buttons 136a, b, c. For example, device 104 could be configured to have only two toggle buttons: a toggle button 136a to produce maximum ultrasonic energy output and a toggle button 136c to produce pulse output, either at the maximum or less than maximum power. Thus, the output configuration of the generator 102 trigger signal could consist of 5 continuous signals and 5 or 4 or 3 or 2 or 1 pulsed signals. In certain embodiments, the specific trigger signal configuration can be controlled based, for example, on the EEPROM settings on generator 102 and / or power level selections by the user.
[00119] In certain embodiments, a two-position key can
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31/140 be offered as an alternative to a toggle button 136c. For example, a device 104 may include a toggle button 136a to produce continuous output at a maximum power level and a two-position toggle button 136b. In a first predetermined position the toggle button 136b can produce a continuous output at a power level less than the maximum, and in a second predetermined position the toggle button 136b can produce a pulse output (for example, at a level of maximum power or less than the maximum, depending on the EEPROM configuration).
[00120] In some embodiments, end actuator 126 may also comprise a pair of electrodes 159 and 157. Electrodes 159 and 157 may be in communication with generator 102, for example via wire 122. Electrodes 159 and 157 may be used, for example, to measure the impedance of a tissue portion present between the clamp arm 155 and the blade 151. Generator 102 can provide a signal (for example, a non-therapeutic signal) to electrodes 159 and 157. A impedance of the tissue portion can be discovered, for example, by monitoring the signal for current, voltage, etc.
[00121] Figure 4 illustrates a modality of an exemplary electrosurgical device 106 that can also be used for transection and cauterization. According to various modalities, the transection and cauterization device 106 may comprise a cable assembly 130, a stem 165 and an end actuator 132. The stem 165 may be rigid (for example for laparoscopic and / or open surgical application) or flexible, as shown (for example for endoscopic application). In various embodiments, the stem 165 may comprise one or more points of articulation. The end actuator 132 may comprise jaws 144 having a first 870190093148, of 09/18/2019, pg. 35/151
32/140 ro jaw element 167 and a second jaw element
169. The first jaw element 167 and the second jaw element 169 can be connected to a shackle 171 which, in turn, can be coupled to stem 165. A translation element 173 can extend inside stem 165, from end actuator 132 to cable 130. On cable 130, stem 165 may be directly or indirectly coupled to a jaw closure trigger 142 (Figure 4).
[00122] The jaw elements 167 and 169 of the end actuator 132 may comprise the respective electrodes 177 and 179. Electrodes 177 and 179 can be connected to generator 102 by means of electrical conductors 187a and 187b (Figure 5) extending from from the end actuator 132, through the stem 165 and the cable 130 and, finally, to the generator 102 (for example, by a multiconductor wire 128). Generator 102 can supply a trigger signal to electrodes 177 and 179 to cause a therapeutic effect on the tissue present between jaw elements 167 and 169. Electrodes 177 and 179 may comprise an active electrode and a return electrode, in which the active electrode and return electrode can be positioned against, or adjacent to, the tissue to be treated, so that current can flow from the active electrode to the return electrode through the tissue. As shown in Figure 4, end actuator 132 is shown with jaw elements 167 and 169 in an open position. A reciprocating blade 175 is illustrated between jaw elements 167 and 169.
[00123] Figures 5, 6 and 7 illustrate an embodiment of the end actuator 132 shown in Figure 4. To close the jaws 144 of the end actuator 132, a clinician can cause the jaw closure trigger 142 to revolve along arrow 183, from a first position to a second position. This can do
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33/140 with the jaws 144 to open and close according to any suitable method. For example, the movement of the jaw closing trigger 142 can, in turn, cause the translation element 173 to move inside a hole 185 of the stem 165. A distal portion of the translation element 173 can be coupled to a reciprocating element 197 so that the distal and proximal movement of the translating element 173 causes the corresponding distal and proximal movement of the reciprocating element. The reciprocating element 197 can have bulkhead portions 191a and 191b, while the jaw elements 167 and 169 can have corresponding cam surfaces 189a and 189b. As the reciprocating element 197 is moved distally from the position shown in Figure 6 to the position shown in Figure 7, the bulkhead portions 191a and 191b may come into contact with the cam surfaces 189a and 189b, causing the jaw elements 167 and 169 transition to the closed position. In addition, in several embodiments, blade 175 can be positioned at a distal end of reciprocating element 197. As the reciprocating element extends to the fully distal position shown in Figure 7, blade 175 can be pushed through any fabric present between the jaw elements 167 and 169, cutting the same during this process.
[00124] During use, a clinician can place the end actuator 132 and close the jaws 144 around a tissue portion to be treated, for example by rotating the jaw closure trigger 142 along arrow 183, as shown described. Once the tissue portion is trapped between jaws 144, the clinician can initiate the delivery of RF or other electrosurgical energy through generator 102 and through electrodes 177 and 179. RF energy can be delivered in any way
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34/140 appropriate. For example, the clinician can activate the switch pedal 120 (Figure 8) of generator 102 to initiate the supply of RF energy. In addition, for example, cable 130 may comprise one or more keys 181 that can be operated by the clinician to cause generator 102 to begin supplying RF energy. Additionally, in some embodiments, RF energy can be delivered based on the position of the jaw closing trigger 142. For example, when trigger 142 is fully depressed (indicating that jaws 144 are closed), RF energy can be be provided. In addition, according to various modalities, the blade 175 can be advanced during the closing of the jaws 144 or can be separately advanced by the clinician after the closing of the jaws 144 (for example, after an RF energy has been applied to the tissue).
[00125] Figure 8 is a diagram of the surgical system 100 of Figure 1. In various embodiments, generator 102 may comprise several separate functional elements, such as modules and / or blocks. Different functional elements or modules can be configured to drive different types of surgical devices 104 and 106. For example, an ultrasonic generator module 108 can drive an ultrasonic device, such as the ultrasonic device 104. A generator module for electrosurgery / RF 110 can drive the device electrosurgical 106. For example, the respective modules 108 and 110 can generate the respective trigger signals to activate surgical devices 104 and 106. In several modalities, each one of the ultrasonic generator module 108 and / or the generator module for electrosurgery / RF 110 can be formed integrally with generator 102. Alternatively, one or more of modules 108 and 110 can be offered as a separate circuit module electrically coupled to generator 102. (Modules 108 and 110 are shown in dashed line
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35/140 to illustrate this option.) In addition, in some embodiments, the generator module for electrosurgery / RF 110 can be formed integrally with the ultrasonic generator module 108, or vice versa.
[00126] According to the described modalities, the ultrasonic generator module 108 can produce one or more activation signals with specific voltages, currents and frequencies, for example 55,500 cycles per second (Hz). The one or more trigger signals can be supplied to the ultrasonic device 104 and specifically to the transducer 114, which can operate, for example, as described above. In one embodiment, generator 102 can be configured to produce a trigger signal for a specific voltage, current, and / or frequency output signal that can be measured with high resolution, accuracy, and repeatability.
[00127] According to the described modalities, the generator module for electrosurgery / RF 110 can generate one or more drive signals with sufficient output power to perform bipolar electrosurgery with the use of radiofrequency (RF) energy. In bipolar electrosurgery applications. The trigger signal can be supplied, for example, to electrodes 177 and 179 of the electrosurgical device 106, for example, as described above. Consequently, generator 102 can be configured for therapeutic purposes by applying sufficient electrical energy to the tissue to treat said tissue (e.g., coagulation, cauterization, tissue welding, etc.).
[00128] Generator 102 can comprise an input device 145 (Figure 1) located, for example, on a front panel of the generator console 102. Input device 145 can comprise any suitable device that generates signals suitable for programming the operation of generator 102. During use, the user can program or otherwise control the operation of the generator
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36/140 generator 102 using input device 145. Input device 145 can comprise any suitable device that generates signals that can be used by the generator (for example, by one or more processors contained in the generator) to control operation generator 102 (for example, the operation of the ultrasonic generator module 108 and / or the generator module for electrosurgery / RF 110). In various embodiments, input device 145 includes one or more of buttons, keys, rotary controls, keyboard, numeric keypad, monitor with touchscreen, pointing device and remote connection to a general purpose or dedicated computer. In other embodiments, the input device 145 may comprise a suitable user interface, such as one or more user interface screens displayed on a touchscreen monitor, for example. Consequently, through the input device 145, the user can adjust or program various operational parameters of the generator, such as current (I), voltage (V), frequency (f), and / or period (T) of one or more signals of drive generated by the ultrasonic generator module 108 and / or by the generator module for electrosurgery / RF 110.
[00129] Generator 102 can also comprise an output device 147 (Figure 1) located, for example, on a front panel of the generator console 102. Output device 147 includes one or more devices to provide the user with sensory feedback . Such devices may comprise, for example, visual feedback devices (for example, a monitor with an LCD screen, LED indicators), hearing feedback devices (for example, a speaker, a bell) or tactile feedback devices ( eg haptic actuators).
[00130] Although certain modules and / or blocks of generator 102 can be described by way of example, it should be considered that it can be
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37/140 use a greater or lesser number of modules and / or blocks and still be within the scope of the modalities. Furthermore, although several modalities can be described in terms of modules and / or blocks to facilitate description, these modules and / or blocks can be implemented by one or more hardware components, for example, processors, digital signal processors ( DSP, from Digital Signal Processors), programmable logic devices (PLD, from Programmable Logic Devices), integrated circuits for specific applications (ASIC, from Application Specific Integrated Circuits), circuits, registers and / or software components, for example, programs, subroutines, logic and / or combinations of hardware and software components.
[00131] In one embodiment, the storage unit module of the ultrasonic generator 108 and the storage unit module for electrosurgery / RF 110 may comprise one or more integrated applications, implemented as firmware, software, hardware or any combination thereof. Modules 108 and 110 can comprise various executable modules, such as software, programs, data, triggers and application program interfaces (APIs), among others. The firmware can be stored in non-volatile memory (NVM), as in read-only memory (ROM) with bit masks, or flash memory. In many implementations, storing firmware in ROM can preserve flash memory. The NVM can comprise other types of memory including, for example, programmable ROM (PROM, programmable ROM), erasable programmable ROM (EPROM, erasable programmable ROM), electrically erasable programmable ROM (EEPROM, electrically erasable programmable ROM), or battery backed random-access memory (RAM) as dynamic RAM
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38/140 (DRAM, of dynamic RAM), DRAM with double data rate (DDRAM, of Double-Data-Rate DRAM), and / or synchronous DRAM (SDRAM, of synchronous DRAM).
[00132] In one embodiment, modules 108 and 110 comprise a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of devices 104 and 106, and generating one or more corresponding output trigger signals for operation of devices 104 and 106. In modalities in which generator 102 is used in conjunction with device 104, the trigger signal can drive ultrasonic transducer 114 in the cutting and / or coagulation operating modes. The electrical characteristics of the device 104 and / or the fabric can be measured and used to control the operational aspects of generator 102 and / or be provided as feedback to the user. In embodiments in which generator 102 is used in conjunction with device 106, the trigger signal can supply electrical energy (e.g., RF energy) to end actuator 132 in the cut, coagulation and / or desiccation modes. The electrical characteristics of the device 106 and / or the fabric can be measured and used to control the operational aspects of generator 102 and / or be provided as feedback to the user. In various modalities, as previously discussed, the hardware components can be implemented as DSP, PLD, ASIC, circuits and / or registers. In one embodiment, the processor can be configured to store and execute computer software program instructions in order to generate the step function output signals for driving various components of devices 104 and 106, such as the ultrasonic transducer 114 and the end actuators 126 and 132.
[00133] Figure 9 illustrates an equivalent circuit 150 of a transdu
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39/140 ultrasonic tor, such as the ultrasonic transducer 114, according to a modality. The circuit 150 comprises a first branch of movement having, serially connected, inductance Ls, resistance Rs and capacitance Cs that define the electromechanical properties of the resonator, and a second capacitive branch having a static capacitance C0. The drive current Ig can be received from a generator at a drive voltage Vg, with the movement current Im flowing through the first branch and the current Ig - Im flowing through the capacitive branch. The control of the electromechanical properties of the ultrasonic transducer can be obtained by properly controlling Ig and Vg. As explained above, known generator architectures can include a Lt tuning inductor (shown in dashed line in Figure 9) to cancel, in a parallel resonance circuit, the static capacitance C0 at a resonance frequency, so that substantially all the current output of the Ig generator flows through the motion branch. In this way, the current control of the movement branch Im is obtained by controlling the current output of the Ig generator. The Lt tuning inductor is specific to the C0 static capacitance of an ultrasonic transducer, however, and a different ultrasonic transducer having a different static capacitance requires a different Lt tuning inductor. Furthermore, how the Lt tuning inductor corresponds to the value rated static capacitance C0 at a single resonance frequency, accurate control of the current of the motion branch Im is guaranteed only at that frequency and, as the frequency drops according to the temperature of the transducer, accurate control of the current of the motion branch is compromised .
[00134] Several types of generator 102 may not have a Lt tuning inductor to monitor the branch current.
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40/140 Im movement. Instead, generator 102 can use the measured value of static capacitance C0 between power applications for a specific ultrasonic surgical device 104 (along with drive signal voltage and current feedback data) to determine the current values of the Im motion branching on a dynamic and continuous basis (for example, in real time). These modalities of generator 102 are therefore capable of providing virtual tuning to simulate a system that is tuned or resonant with any static capacitance value C0 at any frequency, and not just at a single resonance frequency imposed by a nominal capacitance value. static C0.
[00135] Figure 10 is a simplified block diagram of a modality of generator 102, to prove tuning without inductor as described above, among other benefits. Figures 11A to 11C illustrate an architecture of generator 102 of Figure 10, according to an embodiment. Referring to Figure 10, generator 102 may comprise a platform isolated from patient 152 in communication with a non-isolated platform 154 by means of a power transformer 156. A secondary winding 158 of power transformer 156 is contained in the isolated platform 152 and can comprise a bypass configuration (for example, a central bypass or non-central bypass configuration) for defining the trigger signal outputs 160a, 160b and 160c to provide trigger signals to different surgical devices, such as an ultrasonic surgical device 104 and an electrosurgical device 106. In particular, the trigger signal outputs 160a and 160c can provide a trigger signal (for example, a 420V RMS trigger signal) to an ultrasonic surgical device 104, and the trigger signal outputs 160b and 160c can provide a trigger signal (for example, an
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41/140 on 100V RMS) to an electrosurgical device 106, with the output 160b corresponding to the central branch of the power transformer 156. The non-isolated platform 154 may comprise a power amplifier 162 that has an output connected to a primary winding 164 of the power transformer 156. In certain embodiments the power amplifier 162 may comprise a push-pull type amplifier, for example. The non-isolated platform 154 may also contain a programmable logic device 166 for supplying a digital output to a digital to analog converter (DAC) 168 which, in turn, provides an analog signal corresponding to an input of the power amplifier. 162. In certain embodiments, programmable logic device 166 may comprise a field programmable port arrangement (FPGA), for example. The programmable logic device 166, by controlling the input of the power amplifier 162 through the DAC 168, can therefore control any of a number of parameters (for example, frequency, waveform, amplitude of the waveform) of drive signals appearing at the drive signal outputs 160a, 160b and 160c. In certain embodiments and as discussed below, programmable logic device 166, in conjunction with a processor (for example, processor 174 discussed below), can implement a number of control algorithms based on digital signal processing (DSP) and / or other control algorithms for control parameters of the drive signals provided by the generator 102.
[00136] Power can be supplied to a power amplifier feed rail 162 by a switch mode regulator
170. In certain embodiments, the switch mode regulator 170 may comprise an adjustable buck regulator, for example. The non-isolated platform 154 may also contain a processor 174 that,
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42/140 in one embodiment can comprise a DSP processor such as an ADSP-21469 SHARC DSP Analog Devices, available from Analog Devices, Norwood, MA, USA, for example. In certain embodiments, processor 174 can control the operation of the mode power converter of switch 170 which responds to voltage feedback data received from power amplifier 162 by processor 174 via an analog to digital converter (ADC) 176. In one embodiment, for example, processor 174 may receive as input, through the ADC 176, the waveform envelope of a signal (for example, an RF signal) being amplified by power amplifier 162. Processor 174 may, then, control the mode regulator of switch 170 (for example, via a pulse width modulated output (PWM)) so that the voltage from the rail supplied to the power amplifier 162 follows the signal waveform envelope amplified. By dynamically modulating the rail voltage of the power amplifier 162 based on the waveform envelope, the efficiency of the power amplifier 162 can be significantly improved over amplifier schemes with fixed voltage on the rail.
[00137] In certain embodiments and as discussed in further detail in connection with Figure 13, programmable logic device 166, in conjunction with processor 174, can implement a control scheme with direct digital synthesizer (DDS) to control the format of wave, frequency and / or amplitude of the supply of trigger signals by generator 102. In one embodiment, for example, programmable logic device 166 can implement a DDS 268 control algorithm by retrieving stored waveform samples dynamically updated lookup table (LUT), such as a RAM LUT that can be
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43/140 integrated in an FPGA. This control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as the ultrasonic transducer 114, can be driven by a clean sinusoidal current at its resonant frequency. as other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the branching current can correspondingly minimize or reduce the undesirable effects of the resonance. As the waveform of a drive signal output by generator 102 is impacted by various sources of distortion present in the output drive circuit (for example, power transformer 156, power amplifier 162), feedback data over voltage and current based on the trigger signal can be provided to an algorithm, such as an error control algorithm implemented by processor 174, which compensates for the distortion through adequate pre-distortion or modification of the waveform samples stored in the LUT dynamically and continuously (for example, in real time). In one embodiment, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between a current from the computerized motion branch and a desired current waveform, with the error being determined on a sample by sample. In this way, pre-distorted LUT samples, when processed through the drive circuit, can result in a motion branch trigger signal having the desired waveform (for example, sinusoidal) to optimally drive the ultrasonic transducer . In these modalities, the LUT waveform samples will therefore not represent the desired waveform of the trigger signal, but rather the waveform that is necessary to ultimately produce the desired waveform of the trigger signal of the movement branching, when they are leadsPetition 870190093148, of 09/18/2019, p. 47/151
44/140 taking into account the distortion effects.
[00138] The non-isolated platform 154 may further comprise an ADC 178 and an ADC 180 coupled to the output of the power transformer 156 by means of the respective isolation transformers 182 and 184 to respectively take the voltage and current samples of the output of the trigger signals by generator 102. In certain modalities, ADCs 178 and 180 can be configured for sampling at high speeds (for example, 80 Msps) to allow over-sampling of the trigger signals. In one embodiment, for example, the sampling speed of ADCs 178 and 180 may allow an oversampling of approximately 200x (depending on the trigger frequency) of the trigger signals. In certain modalities, the sampling operations of ADCs 178 and 180 can be performed by a single ADC receiving voltage and current input signals through a bidirectional multiplexer. The use of high-speed sampling in generator 102 modes can allow, among other things, calculation of the complex current flowing through the motion branch (which can be used in certain modalities to implement the DDS-based waveform control described above), accurate digital filtering of the sampled signals, and calculation of actual energy consumption with a high degree of accuracy. The output of voltage and current feedback data by ADCs 178 and 180 can be received and processed (for example, FIFO buffering, multiplexing) by programmable logic device 166 and stored in data memory for subsequent retrieval, for example, by processor 174. As noted above, feedback data about voltage and current can be used as an input for a pre-distortion or modification of waveform samples in the LUT, in a dynamic and continuous manner. In certain embodiments, this may
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45/140 want each stored voltage and current feedback data pair to be indexed based on, or otherwise associated with, a corresponding LUT sample that was provided by programmable logic device 166 when the feedback data pair on voltage and current was captured. The synchronization of the LUT samples with the feedback data about voltage and current in this way contributes to the correct timing and stability of the pre-distortion algorithm.
[00139] In certain modalities, voltage and current feedback data can be used to control the frequency and / or amplitude (for example, current amplitude) of the trigger signals. In one mode, for example, feedback data about voltage and current can be used to determine the impedance phase. The frequency of the trigger signal can then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (for example, 0 °), thereby minimizing or reducing the effects of distortion harmonic and, correspondingly, accentuating the accuracy of the impedance phase measurement. The determination of phase impedance and a frequency control signal can be implemented in processor 174, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by programmable logic device 166.
[00140] In another mode, for example, the current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude set point can be specified directly or indirectly determined based on the specified set points for voltage and power amplitude. In certain modalities, the control of the current amplitude
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46/140 can be implemented by the control algorithm, as a proportional-integral-derivative control algorithm (PID), in processor 174. The variables controlled by the control algorithm to properly control the current amplitude of the trigger signal can include, for example, the scaling of the LUT waveform samples stored in programmable logic device 166 and / or the full-scale output voltage of DAC 168 (which provides input to power amplifier 162) via a DAC 186.
[00141] The non-isolated platform 154 may also contain a processor 190 to provide, among other things, the functionality of the user interface (UI). In one embodiment, processor 190 may comprise an Atmel AT91SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, California, USA, for example. Examples of UI functionality supported by the 190 processor may include audible and visual feedback to the user, communication with peripheral devices (for example, via a Universal Serial Bus (USB) interface), communication with the switch pedal 120, communication with a device input 112 (for example, a touchscreen monitor) and communication with an output device 147 (for example, a speaker). Processor 190 can communicate with processor 174 and the programmable logic device (for example, via serial peripheral interface (SPI) buses). Although processor 190 can primarily support UI functionality, it can also coordinate with processor 174 to implement risk mitigation in certain embodiments. For example, processor 190 can be programmed to monitor various aspects of user-supplied inputs and / or other inputs (for example, touchscreen inputs, switch pedal inputs 120, temperature sensor inputs) and can disable drive output
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47/140 of generator 102 when an error condition is detected.
[00142] In certain embodiments, both processor 174 and processor 190 can determine and monitor the operational state of generator 102. For processor 174, the operational state of generator 102 can determine, for example, which control processes and / or diagnostics are implemented by processor 174. For processor 190, the operational state of generator 102 can determine, for example, which elements of a user interface (for example, monitor screens, sounds) are presented to a user. Processors 174 and 190 can independently maintain the current operational state of generator 102, as well as recognize and evaluate possible transitions out of the current operational state. Processor 174 can act as the master in this relationship, and can determine when transitions between operational states should occur. Processor 190 can be aware of valid transitions between operational states, and can confirm that a particular transition is suitable. For example, when processor 174 instructs processor 190 to transition to a specific state, processor 190 may verify that the requested transition is valid. If a requested transition between states is determined to be invalid by processor 190, processor 190 may cause generator 102 to enter a fault mode.
[00143] The non-isolated platform 154 may also contain a controller 196 for monitoring input devices 145 (for example, a capacitive touch sensor used to turn generator 102 on and off, a capacitive touch screen). In certain embodiments, controller 196 may comprise at least one processor and / or another controlling device in communication with processor 190. In one embodiment, for example, controller 196 may comprise a processor (e.g., Me controller)
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48/140 ga168 8 bits available from Atmel) configured to monitor user inputs via one or more capacitive touch sensors. In one embodiment, the 196 controller can comprise a touchscreen controller (for example, a QT5480 touchscreen controller available from Atmel) to control and manage the capture of touch data from a capacitive touchscreen to the touch.
[00144] In certain embodiments, when generator 102 is in an off state, controller 196 can continue to receive operational power (for example, through a line from a generator 102 power supply, such as power supply 211 discussed below). In this way, controller 196 can continue to monitor an input device 145 (for example, a capacitive touch sensor located on a front panel of generator 102) to turn generator 102 on and off. When generator 102 is in the off state, controller 196 can wake up the power supply (for example, allow one or more DC / DC voltage converters 213 of power supply 211 to operate), if activation of the on / off input device 145 by a user is detected . Controller 196 can therefore initiate a sequence for transitioning generator 102 to an on state. On the other hand, controller 196 can initiate a sequence to transition generator 102 to the off state if activation of the on / off input device 145 is detected, when generator 102 is in the on state. In certain embodiments, for example, controller 196 may report the activation of the on / off input device 145 to processor 190 which, in turn, implements the process sequence necessary to transition generator 102 to the off state. In these modalities, controller 196 may not have any independent capacity to cause the removal of power from generator 102, after
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49/140 your connected state has been established.
[00145] In certain modalities, controller 196 may cause generator 102 to offer audible feedback or other sensory feedback to alert the user that an on or off sequence has been initiated. This type of alert can be provided at the beginning of an on or off sequence, and before the start of other processes associated with the sequence.
[00146] In certain embodiments, the isolated platform 152 may comprise an instrument interface circuit 198 for, for example, offering a communication interface between a control circuit of a surgical device (e.g., a control circuit comprising switches cable) and non-isolated platform 154 components, such as programmable logic device 166, processor 174 and / or processor 190. Instrument interface circuit 198 can exchange information with non-isolated platform 154 components via a communication link that maintains an adequate degree of electrical isolation between platforms 152 and 154, like an infrared (IR) communication link. Power can be supplied to the instrument interface circuit 198 using, for example, a low drop voltage regulator powered by an isolation transformer driven from the non-isolated platform 154.
[00147] In one embodiment, the instrument interface circuit 198 can comprise a programmable logic device 200 (e.g., an FPGA) in communication with a signal conditioning circuit 202. The signal conditioning circuit 202 can be configured to receive a periodic signal from programmable logic device 200 (e.g., a 2 kHz square wave) to generate an interrogation signal that has an identical frequency. The question mark can be generated, for example, using a current source
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50/140 bipolar powered by a differential amplifier. The question mark can be communicated to a control circuit of the surgical device (for example, using a conductive pair on a wire that connects generator 102 to the surgical device) and monitored to determine a state or configuration of the control circuit. . As discussed below in connection with Figures 16 to 32, for example, the control circuit may comprise a number of switches, resistors and / or diodes to modify one or more characteristics (for example, amplitude, rectification) of the question mark so that a state or configuration of the control circuit is unambiguously discernible, based on this one or more characteristics. In one embodiment, for example, the signal conditioning circuit 202 may comprise an ADC for generating samples of a voltage signal appearing between inputs of the control circuit, resulting from the passage of the interrogation signal through it. The programmable logic device 200 (or a component of the non-insulated platform 154) can then determine the status or configuration of the control circuit based on the ADC samples.
[00148] In one embodiment, the instrument interface circuit 198 may comprise a first data circuit interface 204 to enable the exchange of information between programmable logic device 200 (or another element of the instrument interface circuit 198) and a first data circuit disposed in, or otherwise associated with, a surgical device. In certain embodiments and with reference to Figures 33E to 33G, for example, a first data circuit 206 may be arranged on a wire integrally attached to a cable of the surgical device, or on an adapter to interface between a type or model specific surgical device and generator 102. In certain embodiments, the first data circuit may comprise a non-storage device
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51/140 volatile, as an electrically erasable programmable read-only memory device (EEPROM). In certain embodiments and again with reference to Figure 10, the first data circuit interface 204 can be implemented separately from the programmable logic device 200 and comprises a suitable circuitry (for example, separate logic devices, a processor) to allow communication between programmable logic device 200 and the first data circuit. In other embodiments, the first data circuit interface 204 may be integral with the programmable logic device 200.
[00149] In certain embodiments, the first data circuit 206 can store information related to the specific surgical device with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical device was used, and / or any other types of information. This information can be read by the instrument interface circuit 198 (for example, by the programmable logic device 200), transferred to a component of the non-isolated platform 154 (for example, to the programmable logic device 166, processor 174 and / or processor 190) for presentation to a user by means of an output device 147 and / or to control a function or operation of generator 102. In addition, any type of information can be communicated to the first data circuit 206 for storage in the same through the first interface of data circuit 204 (for example, using programmable logic device 200). This information may include, for example, an updated number of operations in which the surgical device was used and / or the dates and / or times of its use.
[00150] As discussed earlier, a surgical instrument can be removable from a cable (for example, instrument 124 can
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52/140 be removable from cable 116) to promote interchangeability and / or disposability of the instrument. In such cases, known generators may be limited in their ability to recognize specific instrument configurations being used, as well as to optimize the control and diagnostic processes as needed. The addition of readable data circuits to surgical device instruments to address this issue is problematic from a compatibility point of view, however. For example, designing a surgical device to remain compatible with previous versions of generators lacking the indispensable data reading functionality may be impractical due, for example, to different signaling schemes, design complexity and cost. The instrument modalities discussed below in connection with Figures 16 to 32 address these concerns through the use of data circuits that can be implemented in existing surgical instruments, economically and with minimal design changes to preserve the compatibility of surgical devices with the current generator platforms.
[00151] Additionally, generator 102 modes can enable communication with data circuits based on the instrument, such as those described below in connection with Figures 16 to 32 and Figures 33A to 33C. For example, generator 102 can be configured to communicate with a second data circuit (for example, data circuit 284 in Figure 16) contained in an instrument (for example, instrument 124 or 134) of a surgical device . The instrument interface circuit 198 may comprise a second data circuit interface 210 to enable such communication. In one embodiment, the second data circuit interface 210 may comprise a digital tri-state interface, although other interfaces may also be used. In certain
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53/140 dalities, the second data circuit can generally be any circuit for transmitting and / or receiving data. In one mode, for example, the second data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information. In addition or alternatively, any type of information can be communicated to the second data circuit for storage there via the second data circuit interface 210 (for example, using programmable logic device 200). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use. In certain embodiments, the second data circuit can transmit data captured by one or more sensors (for example, an instrument-based temperature sensor). In certain embodiments, the second data circuit can receive data from generator 102 and provide an indication to the user (for example, an LED indication or other visible indication) based on the received data.
[00152] In certain embodiments, the second data circuit and the second data circuit interface 210 can be configured so that communication between programmable logic device 200 and the second data circuit can be achieved without the need to provide conductors for this purpose (for example, dedicated wire conductors connecting a cable to generator 102). In one mode, for example, information can be communicated to and from the second data circuit using a 1-wire bus communication scheme, implemented in the existing wiring, as one of the conductors used to transmit signal.
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54/140 interrogation from signal conditioning circuit 202 to a control circuit on a cable. In this way, changes or modifications to the design of the surgical device that may otherwise be necessary are minimized or reduced. Furthermore, as discussed in more detail below, in connection with Figures 16 to 32 and Figures 33A to 33C, due to the fact that different types of communication can be implemented over a common physical channel (with or without separation) frequency bands), the presence of a second data circuit may be invisible to generators that do not have the indispensable data reading functionality, thus enabling compatibility with previous versions of the instrument for the surgical device.
[00153] In certain embodiments, the isolated platform 152 may comprise at least one blocking capacitor 296-1 connected to the output of the drive signal 160b, to prevent the passage of direct current to a patient. A single blocking capacitor may be required to comply with medical regulations and standards, for example. Although failures in single-capacitor designs are relatively uncommon, such failures can still have negative consequences. In one embodiment, a second blocking capacitor 296-2 can be placed in series with the blocking capacitor 296-1, with current leakage from one point between the blocking capacitors 296-1 and 296-2 being monitored, for example. example, by an ADC 298 for sampling a voltage induced by current leakage. Samples can be received by programmable logic device 200, for example. Based on changes in current leakage (as indicated by the voltage samples in the form of Figure 10), generator 102 can determine when at least one of the blocking capacitors 296-1 and 296-2 has failed. Consequently, the modality of the Figure
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55/140 can provide a benefit over designs with only one capacitor, having a single point of failure.
[00154] In certain embodiments, the non-insulated platform 154 may comprise a power supply 211 for DC power output with adequate voltage and current. The power supply may comprise, for example, a 400 W power supply to provide a system voltage of 48 VDC. The power supply 211 may further comprise one or more DC / DC voltage converters 213 to receive the power supply output to generate DC outputs at the voltages and currents required by the various components of generator 102. As discussed above in connection with controller 196, one or more of the DC / DC voltage converters 213 can receive input from controller 196 when the activation of the on / off input device 145 by a user is detected by controller 196, to allow the operation of, or wake up, the DC / DC 213 voltage converters.
[00155] Figure 13 illustrates certain functional and structural aspects of a generator 102 mode. The feedback indicating current and voltage output of secondary winding 158 of power transformer 156 is received by ADCs 178 and 180, respectively. As shown, ADCs 178 and 180 can be implemented in the form of a 2-channel ADC and can take feedback signals at high speed (for example, 80 Msps) to enable oversampling (for example, approximately 200x of oversampling) of the trigger signals. Current and voltage feedback signals can be adequately conditioned in the analog domain (for example, amplified, filtered) before processing by ADCs 178 and 180. The samples of current and voltage feedback from ADCs 178 and 180 can be individually recorded ( buffered) and subsequently multi
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56/140 plexed or interleaved in a single data stream within block 212 of programmable logic device 166. In the embodiment of Figure 13, programmable logic device 166 comprises an FPGA.
[00156] The multiplexed voltage and current feedback samples can be received by a parallel data capture port (PDAP) implemented inside block 214 of processor 174. The PDAP can comprise a packaging unit to implement any of the numerous methodologies for correlating multiplexed feedback information with a memory address. In one embodiment, for example, the feedback samples corresponding to a specific LUT sample output by the programmable logic device 166 can be stored in one or more memory addresses that are correlated or indexed to the LUT address in the LUT sample. In another embodiment, the feedback samples corresponding to a specific LUT sample by the programmable logic device 166 can be stored, together with the LUT address of the LUT sample, in a common memory location. Either way, the feedback samples can be stored so that the address of a LUT sample from which a specific set of feedback information originated can be subsequently determined. As discussed above, the synchronization of the addresses of the LUT samples and the feedback data in this way contributes to the correct timing and stability of the pre-distortion algorithm. A direct memory access controller (DMA) implemented in block 216 of processor 174 can store the feedback samples (and any LUT sample address data, where applicable) in a designated memory location 218 of processor 174 (for example,
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57/140 example, internal RAM).
[00157] Block 220 of processor 174 may implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in programmable logic device 166 dynamically and continuously. As discussed above, the pre-distortion of the LUT samples can compensate for various sources of distortion present in the generator output drive circuit 102. The pre-distorted LUT samples, when processed through the drive circuit, will therefore result in a drive signal having the desired waveform (for example, sinusoidal) to optimally drive the ultrasonic transducer.
[00158] In block 222 of the pre-distortion algorithm, the current is determined through the movement branch of the ultrasonic transducer. The current of the movement branch can be determined using the Kirchoff Current Law based, for example, on the current and voltage feedback information stored in memory location 218 (which, when properly sized, can be representative of Ig and Vg in the model of Figure 9, discussed above), a value of the static capacitance of the ultrasonic transducer C0 (measured or known a priori) and a known value of the drive frequency. A sample of current from the motion branch can be determined for each set of stored current and voltage feedback information associated with a LUT sample.
[00159] In block 224 of the pre-distortion algorithm, each current sample of the motion branch determined in block 222 is compared to a sample of a desired current waveform to determine a difference, or error, of the sample amplitude, between the compared samples. For this determination, the sample with the desired current waveform can be provided, by
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58/140 example, of a LUT 226 waveform containing amplitude samples for a cycle of a desired current waveform. The specific LUT 226 current waveform sample used for the comparison can be determined by the LUT sample address associated with the current sample of the motion branch used in the comparison. As needed, the current input from the motion branch in block 224 can be synchronized with the entry of its associated LUT sample address in block 224. LUT samples stored in programmable logic device 166 and LUT samples stored in LUT waveforms 226 can therefore be equal in number. In certain embodiments, the desired current waveform, represented by the LUT samples stored in the 226 waveform LUT, can be a fundamental sine wave. Other waveforms may be desirable. For example, it is contemplated that a fundamental sine wave could be used to trigger the main longitudinal movement of an ultrasonic transducer, superimposed on one or more other trigger signals at other frequencies, such as a third order harmonic to trigger at least two resonances mechanical in order to obtain beneficial vibrations in transverse or other modes.
[00160] Each value of the sample amplitude error determined in block 224 can be transmitted to the LUT of programmable logic device 166 (shown in block 228 in Figure 13) together with an indication of its associated LUT address. Based on the amplitude error sample value and its associated address (and, optionally, the amplitude error sample values for the same LUT address previously received), LUT 228 (or another programmable logic device control block) 166) can pre-predict or modify the value of the LUT sample stored in the en
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59/140 address of LUT, so that the amplitude error sample is reduced or minimized. It should be understood that this pre-distortion or modification of each LUT sample in an iterative way across the LUT address range will cause the waveform of the generator's output current to match or adapt to the waveform of the desired current, represented by the LUT 226 samples of waveforms.
[00161] Current and voltage amplitude measurements, power measurements and impedance measurements can be determined in block 230 of processor 174, based on current and voltage feedback samples stored in memory location 218. Before In determining these quantities, the feedback samples can be properly sized and, in certain modalities, processed through a suitable filter 232 to remove the noise resulting, for example, from the data capture process and the induced harmonic components. The filtered samples of voltage and current can therefore substantially represent the fundamental frequency of the output signal of the generator drive. In certain embodiments, filter 232 can be a finite impulse response filter (FIR) applied in the frequency domain. These modalities can use the fast Fourier transform (FFT) of the current and voltage output signals of the drive signal. In certain embodiments, the resulting frequency spectrum can be used to provide additional functionality to the generator. In a modality, for example, the ratio of the second and / or third order harmonic component to the fundamental frequency component can be used as a diagnostic indicator.
[00162] In block 234, an average square value (RMS) calculation can be applied to a sample size of the feedback samples
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60/140 current formation representing an integral number of cycles of the drive signal, to generate an Irms measurement representing the output current of the drive signal.
[00163] In block 236, an average square value (RMS) calculation can be applied to a sample size of the voltage feedback samples representing an integral number of trigger signal cycles, to determine a Vrms measurement representing the voltage output of the trigger signal.
[00164] In block 238, the current and voltage feedback information can be multiplied point by point, and an average calculation is applied to the samples representing an integral number of cycles of the trigger signal, to determine a Pr measurement of the real power generator output.
[00165] In block 240, the Pa measurement of the apparent output power of the generator can be determined as the product VrmsJrms.
[00166] In block 242, the Zm measurement of the magnitude of the load impedance can be determined as the quotient Vrms / Irms.
[00167] In certain modalities, the quantities Irms, Vrms, Pr, Pa and Zm determined in blocks 234, 236, 238, 240 and 242, can be used by generator 102 to implement any of a number of control processes and / or diagnosis. In certain embodiments, any of these quantities can be communicated to a user through, for example, an output device 147 Integral to generator 102, or an output device 147 connected to generator 102 through a suitable communication interface (for example , a USB interface). The various diagnostic processes can include, without limitation, cable integrity, instrument integrity, instrument fixation integrity, instrument overload, proximity to instrument overload, frequency locking failure, over voltage, over current, over voltage power, failure
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61/140 on the voltage sensor, current sensor failure, audio indication failure, visual indication failure, short circuit, power supply failure and blocking capacitor failure, for example.
[00168] Block 244 of processor 174 may implement a phase control algorithm for determining and controlling the phase of the impedance of an electrical charge (eg, the ultrasonic transducer) conducted by generator 102. As discussed above, when controlling the frequency of the trigger signal to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (eg 0 °), the effects of harmonic distortion can be minimized or reduced, increasing the accuracy in phase measurement.
[00169] The phase control algorithm receives the current and voltage feedback information stored in memory location 218 as input. Before being used in the phase control algorithm, feedback feedback can be appropriately sized and, in certain modalities, processed through a suitable filter 246 (which can be identical to filter 232) to remove the noise resulting from the data capture process and the induced harmonic components, for example. The filtered samples of voltage and current can therefore substantially represent the fundamental frequency of the output signal of the generator drive.
[00170] In block 248 of the phase control algorithm, the current is determined through the movement branch of the ultrasonic transducer. This determination can be identical to that described above in connection with block 222 of the pre-distortion algorithm. Thus, the output of block 248 can be, for each set of stored current and voltage feedback information associated with a LUT sample, a sample of current from the movement branch.
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62/140 [00171] In block 250 of the phase control algorithm, the impedance phase is determined based on the synchronized input of samples from the current of the motion branch determined in block 248 and corresponding to voltage feedback samples. In certain embodiments, the impedance phase is determined as the average between the impedance phase measured at the rising edge of the waveforms and the impedance phase measured at the falling edge of the waveforms.
[00172] In block 252 of the phase control algorithm, the impedance phase value determined in block 222 is compared to the setpoint of phase 254 to determine a difference, or phase error, between the compared values.
[00173] In block 256 of the phase control algorithm, based on a phase error value determined in block 252 and the impedance magnitude determined in block 242, a frequency output is determined to control the frequency of the drive signal . The frequency output value can be continuously adjusted by block 256 and transferred to a DDS control block 268 (discussed below) in order to maintain the impedance phase determined in block 250 of the phase setpoint (for example, zero phase). In certain embodiments, the impedance phase can be set to a phase setpoint of 0 °. In this way, any harmonic distortion will be centered around the crest of the voltage waveform, accentuating the accuracy of the phase impedance determination.
[00174] Block 258 of processor 174 can implement an algorithm for modulating the current amplitude of the drive signal, in order to control the current, voltage and power of the drive signal, according to set points specified by the user , or according to requirements specified by other processes
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63/140 sos or algorithms implemented by generator 102. The control of these quantities can be performed, for example, by dimensioning the LUT samples in LUT 228, and / or by adjusting the full-scale output voltage of DAC 168 ( which supplies the input to the power amplifier 162) through a DAC 186. Block 260 (which can be implemented as a PID controller in certain modes) can receive current feedback samples (which can be properly sized and filtered) ) from memory location 218. Current feedback samples can be compared to the Id current demand value determined by the controlled variable (eg current, voltage or power) to determine whether the drive signal is supplying the current needed. In modes in which the drive signal current is the control variable, the demand for current Id can be specified directly by a current setpoint 262A (Isp). For example, an RMS value of the current feedback data (determined as in block 234) can be compared to the RMS Isp current setpoint specified by the user to determine the appropriate action for the controller. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT dimensioning and / or full-scale output voltage of the DAC 168 can be adjusted by block 260, so that it is the current of the trigger signal is increased. On the other hand, block 260 can adjust a LUT dimensioning and / or the full-scale output voltage of DAC 168 to decrease the drive signal current when the current feedback data indicates a RMS value greater than the set point. current adjustment Isp.
[00175] In modes where the voltage of the trigger signal is the control variable, the demand for current Id can be
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64/140 specified indirectly, for example based on the current required to maintain a required voltage setpoint 262B (Vsp) given the magnitude of the load impedance Zm measured in block 242 (for example Id = Vsp / Zm). Similarly, in modes where the power of the trigger signal is the control variable, the demand for Id current can be specified indirectly, for example based on the current required to maintain a desired power setpoint 262C (Psp) given the voltage Vrms measured in blocks 236 (for example Id = Psp / Vrms).
[00176] Block 268 can implement a DDS control algorithm to control the trigger signal by retrieving LUT samples stored in LUT 228. In certain modalities, the DDS control algorithm is a numerically controlled oscillator (NCO, numerically-controlled oscillator) to generate samples of a waveform at a fixed timing rate using a technique of skipping points (locations in memory). The NCO algorithm can implement a phase accumulator, or frequency to phase converter, which acts as an address pointer for retrieving LUT samples from the LUT 228. In one embodiment, the phase accumulator can be a phase accumulator with size from step D, module N, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in LUT 228. A frequency control value D = 1, for example, can do cause the phase accumulator to point sequentially to each LUT 228 address, resulting in a waveform output that replicates the waveform stored in LUT 228. When D> 1, the phase accumulator can skip addresses in LUT 228, resulting in a waveform output that has a higher frequency. Consequently, the frequency of the waveform generated by the DDS control algorithm
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65/140 can therefore be controlled by varying the frequency control value accordingly. In certain embodiments, the frequency control value can be determined based on the output of the phase control algorithm implemented in block 244. The output of block 268 can provide the input of (DAC) 168 which, in turn, provides a analog signal corresponding to a power amplifier input 162.
[00177] Block 270 of processor 174 can implement a switch mode converter control algorithm to dynamically modulate the voltage on the power amplifier rail 162, based on the signal waveform envelope being amplified, thereby optimizing the efficiency of the power amplifier 162. In certain embodiments, the characteristics of the waveform envelope can be determined by monitoring one or more signals contained in the power amplifier 162. In one embodiment, for example, the characteristics of the format envelope waveform can be determined by monitoring the minimum of a drain voltage (for example, a MOSFET drain voltage) that is modulated according to the amplified signal envelope. A minimum voltage signal can be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal can be sampled by ADC 176, with the output of minimum voltage samples being received in block 272 of the switch mode converter control algorithm. Based on the values of the minimum voltage samples, block 274 can control a PWM output signal by a PWM generator 276 which, in turn, controls the rail voltage supplied to the power amplifier 162 by the mode regulator of the switch 170. In certain modalities, as long as the values of the minimum voltage samples are less than a target input for the minimum 278 in block 262, the
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66/140 voltage on the rail can be modulated according to the waveform envelope, as characterized by the minimum voltage samples. When voltage samples from the minimum indicate low levels of envelope power, for example, block 274 can cause low voltage on the rail to be supplied to the power amplifier 162, with the total rail voltage being supplied only when the voltage samples are minimum voltage indicates maximum envelope power levels. When the voltage samples from the minimum drop below the target to the minimum 278, block 274 can cause the rail voltage to be maintained at an adequate minimum value to ensure the proper operation of the power amplifier 162.
[00178] Figures 33A to 33C illustrate surgical device control circuits according to various modalities. As discussed above in connection with Figure 10, a control circuit can modify characteristics of an interrogation signal transmitted by generator 102. The characteristics of the interrogation signal, which can unequivocally indicate a state or configuration of the control circuit, can distinguished by generator 102 and used to control aspects of its operation. The control circuits can be contained in an ultrasonic surgical device (for example, in the cable 116 of the ultrasonic surgical device 104), or in an electrosurgical device (for example, in the cable 130 of the electrosurgical device 106).
[00179] With reference to the modality of Figure 33A, control circuit 300-1 can be connected to generator 102 to receive an interrogation signal (for example, a bipolar interrogation signal at 2 kHz) from signal conditioning circuit 202 ( for example, from the HS and SR terminals of the generator (Figure 10) by means of a conductive pair of wire 112 or wire 128). The control circuit 300-1 can comprise a first branch that includes diodes connected in series D1 and
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D2, and a SW1 switch connected in parallel with D2. The control circuit 300-1 can also comprise a second branch that includes diodes connected in series D3, D4 and D5, a switch SW2 connected in parallel with D4, and a resistor R1 connected in parallel with D5. In certain embodiments and as shown, D5 can be a Zener diode. The control circuit 300-1 may additionally comprise a data storage element 302 which, together with one or more components of the second branch (for example, D5, R1), defines a data circuit 304. In certain embodiments, the data storage element 302, and possibly other components of the data circuit 304, may be contained within the instrument (e.g. instrument 124, instrument 134) of the surgical device, with other components of the control circuit 300-1 ( for example, SW1, SW2, D1, D2, D3 and D4) being contained in the cable (for example, cable 116, cable 130). In certain embodiments, data storage element 302 can be a single wire bus device (for example, a single wire EEPROM protocol), or another single wire protocol or a local interconnect network protocol device (LIN ). In one embodiment, for example, data storage element 302 may comprise a Maxim DS28EC20 1-Wire ® EEPROM, available from Maxim Integrated Products, Inc., of Sunnyvale, CA, USA. Data storage element 302 is an example of a circuit element that may be contained in data circuit 304. Data circuit 304 may comprise, additionally or alternatively, one or more other circuit elements or components capable of transmitting or receive data. These circuit elements or components can be configured to, for example, transmit data captured by one or more sensors (for example, an instrument-based temperature sensor) and / or receive data from the generator
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68/140 dor 102 and provide an indication to a user (for example, an LED indication or other visible indication) based on the received data.
[00180] During operation, an interrogation signal (for example, a 2 kHz bipolar interrogation signal) from the signal conditioning circuit 202 can be applied through both branches of the control circuit 300-1. In this way, the voltage appearing through the branches can be unequivocally determined by the states of SW1 and SW2. For example, when SW1 is open, the voltage drop across control circuit 300-1 to negative values of the question mark will be the sum of the direct voltage drops across D1 and D2. When SW1 is closed, the voltage drop to negative values of the question mark will be determined by the direct voltage drop only from D1. Thus, for example, with a direct voltage drop of 0.7 volts for each of D1 and D2, the open and closed states of SW1 can correspond to voltage drops of 1.4 volts and 0.7 volts, respectively . Likewise, the voltage drop across the control circuit 300-1 to positive values of the question mark can be unequivocally determined by the state of SW2. For example, when SW2 is open, the voltage drop across control circuit 300-1 will be the sum of the direct voltage drops across D3 and D4 (for example, 1.4 volts) and the breakdown voltage of D5 ( for example, 3.3 volts). When SW2 is closed, the voltage drop across control circuit 300-1 will be the sum of the direct voltage drop across D3 and the breaking voltage of D5. Consequently, the status or configuration of SW1 and SW2 can be distinguished by generator 102 based on the voltage of the interrogation signal appearing through the inputs of the control circuit 300-1 (for example, as measured by a signal conditioning circuit ADC) 202).
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69/140 [00181] In certain embodiments, generator 102 can be configured to communicate with data circuit 304 and, in particular, with data storage element 302, through the second data circuit interface 210 ( Figure 10) and the conductive pair of wire 112 or wire 128. The frequency range of the communication protocol used to communicate with data circuit 304 may be higher than the frequency range of the interrogation signal. In certain embodiments, for example, the frequency of the communication protocol for data storage element 302 can be, for example, 200 kHz or a significantly higher frequency, where the frequency of the question mark used to determine the different SW1 and SW2 states can be, for example, 2 kHz. The D5 diode can limit the voltage supplied to the data storage element 302 to a suitable operating range (for example, 3.3-5V).
[00182] As explained above in connection with Figure 10, data circuit 304 and, in particular, data storage element 302, can store information related to the specific surgical instrument with which they are associated. This information can be retrieved by generator 102 and includes, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other type of information. In addition, any type of information can be communicated from the generator 102 to the data circuit 304 for storage of the data storage element 302. This information can comprise, for example, an updated number of operations in which the surgical instrument was used and / or dates and / or times of use.
[00183] As noted above, data circuit 304 may additionally or alternatively comprise components or elements
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70/140 tos in addition to the data storage element 302 for transmitting or receiving data. These components or elements can be configured to, for example, transmit data captured by one or more sensors (for example, an instrument-based temperature sensor) and / or receive data from generator 102 and provide an indication to a user (for example , an LED indication or other visible indication) based on the data received.
[00184] Control circuit modalities may include additional switches. With reference to the embodiment of Figure 33B, for example, the control circuit 300-2 can comprise a first branch having a first switch SW1 and a second switch SW2 (for a total of three switches), with each combination of states of SW1 and SW2 corresponding to an exclusive voltage drop through the control circuit 300-2 for negative values of the question mark. For example, the open and closed states of SW1 add or remove, respectively, the direct voltage drops of D2 and D3, and the open and closed states of SW2 add or remove, respectively, the direct voltage drop of D4. In the modality of Figure 33C, the first branch of the control circuit 300-3 comprises three switches (for a total of four switches), with the breaking voltage of the Zener D2 diode being used to distinguish changes in the voltage drop resulting from the switching operation. SW1 from voltage changes resulting from the operation of SW2 and SW3.
[00185] Figures 14 and 15 illustrate surgical device control circuits according to various modalities. As discussed above in connection with Figure 10, a control circuit can modify characteristics of an interrogation signal transmitted by generator 102. The characteristics of the interrogation signal, which can unequivocally indicate the status or configuration of the control circuit, can distinguished by generator 102 and used to control
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71/140 control aspects of its functioning. Control circuit 280 in Figure 14 can be contained in an ultrasonic surgical device (for example, in cable 116 of ultrasonic surgical device 104), and control circuit 282 in Figure 15 can be contained in an electrosurgical device (for example, on cable 130 of the electrosurgical device 106).
[00186] With reference to Figure 14, control circuit 280 can be connected to generator 102 to receive an interrogation signal (for example, a 2 kHz bipolar interrogation signal) from signal conditioning circuit 202 (for example, from HS and SR terminals of the generator (Figure 10) using a wire conductor pair 112). Control circuit 280 may comprise a first switch SW1 in series with a first diode D1 to define a first branch, and a second switch SW2 in series with a second diode D2 to define a second branch. The first and second branches can be connected in parallel so that the forward driving direction of D2 is opposite that of D1. The question mark can be applied through both branches. When both SW1 and SW2 are open, control circuit 280 can define an open circuit. When SW1 is closed and SW2 is open, the interrogation signal can undergo a half-wave rectification in a first direction (for example, the positive half of the interrogation signal is blocked). When SW1 is open and SW2 is closed, the interrogation signal may undergo a half-wave rectification in a second direction (for example, the negative half of the interrogation signal is blocked). When both SW1 and SW2 are closed, no rectification can occur. Consequently, based on the different characteristics of the question mark corresponding to the different states of SW1 and SW2, the state or configuration of the control circuit 280 can be distinguished by generator 102 with base 870190093148, from 09/18/2019, p. 75/151
72/140 if on a voltage signal appearing through the control circuit 280 inputs (for example, as measured by a signal conditioning circuit ADC 202).
[00187] In certain embodiments and as shown in Figure 14, wire 112 may comprise a data circuit 206. Data circuit 206 may comprise, for example, a non-volatile storage device, such as an EEPROM device. Generator 102 can exchange information with data circuit 206 through the first data circuit interface 204, as discussed above in connection with Figure 10. This type of information can be specific to a surgical device Integral with, or configured for use com, wire 112, and may comprise, for example, a model number, a serial number, a number of operations in which the surgical device was used, and / or any other types of information. Information can also be communicated from generator 102 to data circuit 206 for storage therein, as discussed above in connection with Figure 10. In certain embodiments and with reference to Figures 33E to 33G, data circuit 206 can be arranged in an adapter to interface between a specific type or model of surgical device and the generator 102.
[00188] With reference to Figure 15, control circuit 282 can be connected to generator 102 to receive an interrogation signal (for example, a bipolar interrogation signal at 2 kHz) from signal conditioning circuit 202 (for example, from HS and SR terminals of the generator (Figure 10) using a wire conductor pair 128). The control circuit 282 can comprise resistors R2, R3 and R4 connected in series, with switches SW1 and SW2 connected through R2 and R4, respectively. The question mark can be applied through at least one of the resistors connected in series to generate a voltage drop through the 282 control circuit.
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73/140 example, when both SW1 and SW2 are open, the voltage drop can be determined by R2, R3 and R4. When SW1 is closed and SW2 is open, the voltage drop can be determined by R3 and R4. When SW1 is open and SW2 is closed, the voltage drop can be determined by R2 and R3. When both SW1 and SW2 are closed, the voltage drop can be determined by R3. Consequently, based on the voltage drop across control circuit 282 (for example, as measured by a signal conditioning circuit ADC 202), the state or configuration of control circuit 282 can be distinguished by generator 102.
[00189] Figure 16 illustrates a modality of a control circuit 280-1 of an ultrasonic surgical device, such as the ultrasonic surgical device 104. Control circuit 280-1, in addition to comprising components of control circuit 280 of Figure 14, may comprise a data circuit 284 having a data storage element 286. In certain embodiments, the data storage element 286, and possibly other components of the data circuit 284, may be contained within the instrument (e.g. example, instrument 124) of the ultrasonic surgical device, with other components of the control circuit 280-1 (for example, SW1, SW2, D1, D2, D3, D4 and C1) being contained within the cable (for example, cable 116 ). In certain embodiments, data storage element 286 may be a single wire bus device (for example, a single wire EEPROM protocol), or another single wire protocol or a local interconnect network protocol device (LIN ). In one embodiment, for example, data storage element 286 may comprise a Maxim DS28EC20 1-Wire® EEPROM, available from Maxim Integrated Products, Inc., of Sunnyvale, CA, USA.
[00190] In certain modalities, generator 102 can be configured
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74/140 to communicate with data circuit 284 and, in particular, with data storage element 286, through the second data circuit interface 210 (Figure 10) and the conductive pair of wire 112. In In particular, the frequency range of the communication protocol used to communicate with data circuit 284 may be higher than the frequency range of the interrogation signal. In certain embodiments, for example, the frequency of the communication protocol for data storage element 286 can be, for example, 200 kHz or a significantly higher frequency, where the frequency of the question mark used to determine the different SW1 and SW2 states can be, for example, 2 kHz. Consequently, the value of capacitor C1 of data circuit 284 can be selected so that data storage element 286 is hidden from the relatively low frequency of the question mark, while allowing generator 102 to communicate with the data storage element 286 at the highest frequency of the communication protocol. A series diode D3 can protect data storage element 286 against negative cycles of the question mark, and a parallel Zener diode D4 can limit the voltage supplied to data storage element 286 to a suitable operating range (for example , 3.3-5V). When in forward driving mode, D4 can also lock the negative cycles of the question mark to the ground.
[00191] As explained above in connection with Figure 10, data circuit 284 and, in particular, data storage element 286, can store information related to the specific surgical instrument with which they are associated. This information can be retrieved by generator 102 and includes, for example, a model number, a serial number, a
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75/140 operations in which the surgical instrument was used, and / or any other type of information. In addition, any type of information can be communicated from the generator 102 to the data circuit 284 for storage of the data storage element 286. This information can comprise, for example, an updated number of operations in which the surgical instrument was used and / or dates and / or times of use. Furthermore, as the different types of communications between the generator 102 and the surgical device can be separated by frequency range, the presence of the data storage element 286 may be invisible to generators that do not have the indispensable data reading functionality. , thus allowing compatibility with previous versions of the surgical device.
[00192] In certain embodiments and as shown in Figure 17, data circuit 284-1 may comprise an inductor L1 to provide isolation of data storage element 286 from the states of SW1 and SW2. The addition of L1 may additionally enable the use of the 284-1 data circuit in electrosurgical devices. Figure 18, for example, illustrates a modality of a control circuit 282-1 that combines control circuit 282 of Figure 15 with data circuit 284-1 of Figure 17.
[00193] In certain embodiments, a data circuit may comprise one or more keys to modify one or more characteristics (for example, amplitude, rectification) of a question mark received by the data circuit, so that a state or configuration of the one or more keys is unmistakably distinguishable based on one or more characteristics. Figure 19, for example, illustrates an embodiment of a control circuit 282-2 in which data circuit 284-2 comprises a switch SW3 connected in parallel with D4. A question mark can be communicated from the generator 102
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76/140 (for example, from signal conditioning circuit 202 of Figure 10) at a frequency sufficient for the interrogation signal to be received by data circuit 284-2 via C1, but blocked from other portions of the control circuit 282-2 by L1. In this way, one or more characteristics of a first interrogation signal (for example, a bipolar interrogation signal at 25 kHz) can be used to distinguish the state of SW3, and one or more characteristics of a second interrogation signal at a frequency lower (for example, a 2 kHz bipolar question mark) can be used to distinguish the states of SW1 and SW2. Although the addition of SW3 is illustrated in connection with the 282-2 control circuit on an electrosurgical device, it should be understood that SW3 can be added to a control circuit of an ultrasonic surgical device, such as the 280-2 control circuit of Figure 17.
[00194] Additionally, it must be understood that the keys in addition to SW3 can be added to a data circuit. As shown in Figures 20 and 21, for example, the data circuit modalities 284-3 and 284-4, respectively, can comprise a second switch SW4. In Figure 20, the voltage values of Zener diodes D5 and D6 can be selected so that their voltage values are sufficiently different to allow reliable discrimination of the interrogation signal in the presence of noise. The sum of the voltage values of D5 and D6 can be equal to or less than the voltage value of D4. In certain embodiments, depending on the voltage values of D5 and D6, it may be possible to eliminate D4 from the modality of data circuit 284-3 illustrated in Figure 20.
[00195] In certain cases, the keys (for example, from SW1 to SW4) can impede the ability of the generator 102 to communicate with the data storage element 286. In one embodiment, this issue can be resolved by declaring a mistake if the
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77/140 switch states are such that they can interfere with the communication between the generator 102 and the data storage element 286. In another embodiment, the generator 102 can only allow communication with the data storage element 286 when determined by the generator 102 that the switch states will not interfere with communication. Since the states of the switches can be to some extent unpredictable, generator 102 can make this determination on a recurring basis. The addition of L1 in certain modalities can avoid interference caused by keys external to the data circuit (for example, SW1 and SW2). For switches contained within the data circuit (for example, SW3 and SW4), the isolation of the switches by separating frequency bands can be done by adding a capacitor C2 having a capacitance value significantly less than C1 (for example , C2 << C1). The modalities of data circuits 284-5, 284-6 and 284-7 comprising C2 are shown in Figures 22 to 24, respectively.
[00196] In any of the modalities of Figures 16 to 24, depending on the characteristics of the frequency response of D4, it may be desirable or necessary to add a fast diode in parallel to D4 and pointing in the same direction.
[00197] Figure 25 illustrates a modality of a 280-5 control circuit in which communication between generator 102 and a data storage element is implemented using an amplitude-modulated communication protocol (for example, protocol Amplitude modulated 1-Wire®, amplitude modulated LIN protocol). Amplitude modulation of the communication protocol on a high frequency carrier (for example, 8 MHz or higher) substantially increases the separation of frequency bands between low frequency interrogation signals (for example, interrogation signals at 2 kHz) and the native base band frequency of the protocol
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78/140 lo of communication used in the modalities of Figures 16 to 24. Control circuit 280-5 can be similar to control circuit 280-1 of Figure 16, with data circuit 288 comprising an additional capacitor C3 and an resistor R5 that, together with D3, demodulate the amplitude-modulated communication protocol for reception by the data storage element 286. As in the embodiment of Figure 16, D3 can protect the data storage element 286 against negative cycles of the data signal interrogation, and D4 can limit the voltage supplied to the data storage element 286 to a suitable operating range (for example, 3.3 to 5V), as well as control negative cycles of the interrogation signal to ground when in the driving forward. The increased frequency separation can allow C1 to be somewhat small in relation to the modalities of Figures 16 to 24. Additionally, the higher frequency of the carrier signal can also optimize noise immunity of communications with the storage element data, as it is additionally removed from the frequency range of electrical noise that can be generated by other surgical devices used in the same room as the operating room. In certain embodiments, the relatively high frequency of the carrier in combination with the characteristics of the frequency response of D4 may make it desirable or necessary to add a fast diode in parallel with D4 and pointing in the same direction.
[00198] With the addition of an L1 inductor to avoid interference with data storage element 286, communications caused by switches external to data circuit 288 (eg SW1 and SW2), data circuit 288 can be used in control circuits of electrosurgical instruments, as shown in the data circuit 288-1 modality in Figure 26.
[00199] With the exception of C2 and R3, and the most likely need
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79/140 through D7, the modalities of Figures 25 and 26 are similar to the baseband modalities of Figures 16 to 24. For example, the way in which keys can be added to the data circuits of Figures 19 to 21 it is directly applicable to the modalities of Figures 25 and 26 (including the possibility of eliminating D4 from the equivalent of the modulated carrier of Figure 20). The modulated carrier equivalents of the data circuits in the modalities of Figures 22 to 24 may simply require the addition of an appropriately sized inductor L2 in series with C2 in order to isolate the interrogation frequency for the additional switches (for example, SW3 and SW4) for an intermediate frequency range, between the carrier frequency and the lowest interrogation frequency for keys external to the data circuit. An embodiment of this type of data circuit 282-7 is shown in Figure 27.
[00200] In the modality of Figure 27, any interference with the capacity of the generator to communicate with the data storage element 286, caused by states of SW1 and SW2, can be resolved as described above in connection with the modalities of the Figures from 19 to 24. For example, generator 102 can declare an error if the states of the keys can prevent communication, or generator 102 can only allow communication when it determines that the states of the keys will not cause interference.
[00201] In certain embodiments, the data circuit may not comprise a data storage element 286 (for example, an EEPROM device) for storing information. Figures 28 to 32 illustrate control circuit modalities that use resistive and / or inductive elements to modify one or more characteristics of a question mark (for example, amplitude, phase) so that a state or configuration of the control circuit be likely to
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80/140 be unmistakably discernible based on one or more characteristics.
[00202] In Figure 28, for example, data circuit 290 may comprise an identification resistor R1, with the value of C1 selected so that R1 is hidden from a first low-frequency question mark (for example, a signal interrogation at 2 kHz) to determine the states of SW1 and SW2. By measuring voltage and / or current (eg amplitude, phase) at the inputs of the control circuit 280-6 resulting from a second question mark within a substantially higher frequency range, generator 102 can measure the value of R1 through C1, in order to determine which of a plurality of identification resistors is contained in the instrument. This information can be used by generator 102 to identify the instrument, or a specific characteristic of the instrument, so that the control and diagnostic processes can be optimized. Any interference with the generator's ability to measure R1, caused by states of SW1 and SW2, can be resolved by declaring an error if the states of the switches can prevent measurement, or by maintaining the voltage of the second question mark, which has a higher frequency, below the activation voltages of D1 and D2. This interference can also be resolved by adding an inductor in series with the switch circuitry (L1 in Figure 29) to block the second interrogation signal, which has a higher frequency, while letting the first interrogation signal pass. which has a lower frequency. The addition of an inductor in this way can also enable the use of data circuit 290 in control circuits of electrosurgical instruments, as shown in the data circuit 290-2 modality in Figure 30.
[00203] In certain modalities, multiple C1 capacitors to allow interrogation at multiple frequencies could be used
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81/140 to differentiate between a larger number of distinct R1 values for a given signal-to-noise ratio, or for a given set of tolerances for components. In such a modality, the inductors can be placed in series with all C1 values except the lowest, in order to create specific pass bands for different interrogation frequencies, as shown in the 290-3 data circuit modality in Figure 31.
[00204] In control circuit modalities based on control circuit 280 of Figure 14, identification resistors can be measured without the need to use frequency range separation. Figure 32 illustrates one of these modalities, with R1 selected to have a relatively high value.
[00205] Figures 33D to 33I illustrate multi-conductor wire modalities and adapters that can be used to establish electrical communication between generator 102 and a cable from a surgical device. In particular, the wires can transmit the trigger signal from the generator to the surgical device and enable control-based communications between the generator 102 and a control circuit of the surgical device. In certain embodiments, the wires can be formed integrally with the surgical device or configured for removable engagement via a suitable connector of the surgical device. Wires 112-1, 112-2 and 112-3 (Figures 33E to 33G, respectively) can be configured for use with an ultrasonic surgical device (for example, ultrasonic surgical device 104), and wire 128-1 (Figure 33D) can be configured for use with an electrosurgical device (for example, electrosurgical device 106). One or more of the wires can be configured for direct connection to generator 102, such as wire 112-1, for example. In these embodiments, the wire may comprise a data circuit (for example, data circuit 206) to store information related to the device
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82/140 specific surgical procedure to which it is associated (for example, a model number, a serial number, a number of operations in which the surgical device was used, and / or any other type of information). In certain embodiments, one or more of the wires can connect to generator 102 via an adapter. For example, wires 112-2 and 112-3 can connect to generator 102 via a first adapter 292 (Figure 33I), and wire 128-1 can connect to generator 102 via a second adapter 294 (Figure 33H). In these embodiments, a data circuit (for example, data circuit 206) can be arranged on the wire (for example, wires 112-2 and 112-3) or on the adapter (for example, second adapter 294).
[00206] In various modalities, generator 102 can be electrically isolated from surgical devices 104 and 106, in order to avoid the presence of unwanted and potentially harmful currents in the patient. For example, if generator 102 and surgical devices 104 and 106 were not electrically isolated, the voltage supplied to devices 104 and 106 via the trigger signal could potentially alter the electrical potential of the patient's tissue being treated by one or more devices 104 and 106 and thus result in unwanted currents in the patient. It should be understood that these concerns may be more acute when using an ultrasonic surgical device 104, which is not intended to pass any current through the tissues. Consequently, the remainder of the description of active current leak cancellation is described in terms of an ultrasonic surgical device 104. It should be considered, however, that the systems and methods described herein may be applicable to electrosurgical devices 106 as well.
[00207] According to various modalities, an isolation transformer, such as isolation transformer 156, can be used to provide electrical insulation between generator 102 and the device
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83/140 surgical 104. For example, transformer 156 can provide insulation between the non-isolated platform 154 and the isolated platform 152 described above. The isolated platform 154 can be in communication with the surgical device 104. The trigger signal can be supplied by the generator 102 (for example, the generator module 108) to the primary winding 164 of the isolation transformer 156, and supplied to the surgical device 104 a secondary winding 158 of the isolation transformer. Considering the non-idealities of real transformers, however, this arrangement may not provide complete electrical insulation. For example, an actual transformer may have stray capacitance between the primary and secondary windings. The parasitic capacitance can prevent complete electrical insulation and allow an electrical potential present in the primary winding to affect the potential of the secondary winding. This can result in current leaks inside the patient.
[00208] Contemporary industry standards, such as the International Electrotechnical Commission (IEC) 60601-1 standard, limit the amount allowed for current leakage in the patient to 10 μΑ or less. Current leakage can be passively reduced by using a leakage capacitor between the secondary winding of the isolation transformer and the ground (for example, ground wire). The leakage capacitor can operate in order to smooth changes in the potential of the patient side coupled by the non-isolated side by means of the parasitic capacitance of the isolation transformer, thus reducing current leakage. As voltage, current, power and / or frequency of the trigger signal provided by generator 102 increase, however, current leakage can also increase. In several modalities, the induced current leakage can increase beyond the capacity of
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84/140 a passive leak capacitor to keep it below 10 μA and / or other current leak patterns.
[00209] Consequently, several modalities are directed to systems and methods to actively cancel the current leak. Figure 34 illustrates a modality of a circuit 800 for active cancellation of current leakage. Circuit 800 can be implemented as part of, or in conjunction with, generator 102. The circuit can comprise an isolation transformer 802 having a primary winding 804 and a secondary winding 806. Drive signal 816 can be provided via the winding primary 804, generating an isolated drive signal via secondary winding 806. In addition to the isolated drive signal, the parasitic capacitance 808 of isolation transformer 802 can couple some component of the drive signal potential in relation to ground 818 to the secondary winding 806 on the patient's side.
[00210] A leakage capacitor 810 and an active cancellation circuit 812 can be used, as shown, connected between secondary winding 806 and earth 818. The active cancellation circuit 812 can generate a reverse trigger signal 814 that can be about 180 ° out of phase with the drive signal 816. The active cancellation circuit 812 can be electrically coupled to the leakage capacitor 810 to lead it to a potential which, in relation to ground 818, is about 180 ° out of phase with the trigger signal 816. Consequently, the electrical charge of the secondary winding on the patient side 806 can reach the ground 818 through leak capacitor 810 instead of through the patient, reducing current leakage. According to various modalities, the leakage capacitor 810 can be designed to meet industry, government and design standards
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85/140 suitable for robustness. For example, leakage capacitor 810 can be a Y-type capacitor according to the IEC 60384-14 standard and / or it can comprise multiple physical capacitors in series.
[00211] Figure 35 illustrates a modality of a circuit 820 that can be implemented by generator 102 to obtain active cancellation of current leakage. Circuit 820 can comprise a generator circuit 824 and a patient-side circuit 822. Generator circuit 824 can generate and / or modulate the drive signal, as described in the present invention. For example, in some embodiments the generator circuit 824 may operate in a manner similar to the non-isolated platform 154 described above. In addition, for example, the patient side circuit 822 may operate in a similar manner to the isolated state 152 described above.
[00212] Electrical insulation between the generator circuit 824 and the patient-side circuit 822 can be provided by an isolation transformer 826. The primary winding 828 of isolation transformer 826 can be coupled to the generator circuit 824. For example, generator circuit 824 can generate the drive signal via primary winding 828. The drive signal can be generated through primary winding 828 according to any suitable method. For example, according to various modalities, primary winding 828 may comprise a central tap 829 that can be maintained at a DC voltage (for example, 48 volts). The generator circuit 824 may comprise output platforms 825 and 827 which are respectively coupled to the other ends of the primary winding 828. Output platforms 825 and 827 can cause currents corresponding to the drive signal to flow in the primary winding 828. For example, positive portions of the trigger signal can be realized when the
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86/140 output 827 brings its output voltage down from the center tap voltage, causing output platform 827 to disperse current through primary winding 828. A corresponding current can be induced in secondary winding 830. Likewise, portions Negative triggering signals can be implemented when the output state 827 brings its output voltage below the voltage of the central tap, causing the output platform 825 to disperse an opposite current through the primary winding 828. This can induce a current corresponding opposite in the secondary winding 830. The patient side circuit 822 can perform various signal conditioning and / or other processing for the isolated drive signal, which can be obtained due to a device 104 via output lines 821, 823.
[00213] An active canceling transformer 832 can have a primary winding 834 and a secondary winding 836. Primary winding 834 can be electrically coupled to the primary winding 828 of isolation transformer 826, so that the trigger signal is provided through the winding 834. For example, primary winding 834 can comprise two windings 843 and 845. A first end 835 of the first winding 845 and a first end 839 of the second winding 843 can be electrically coupled to the central branch 829 of winding 828. A second end 841 of the first winding 845 can be electrically coupled to the output stage 827, while a second end 837 of the second winding 843 can be electrically connected to the output state 825. The secondary winding 836 of the cancellation transformer 832 can be coupled to the ground 818 and to a first electrode of a cancellation capacitor 840. The other electrode of the 840 cancellation capacitor can be coupled to the 823 output line. An optional charge resistor
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838 can also be electrically coupled in parallel, through the secondary winding 836.
[00214] According to various modalities, the secondary winding 836 of the active cancellation transformer can be wound and / or connected by wire to the other components 840, 838 and 818, so that its polarity is opposite to the polarity of the primary winding 834. For example, a reverse drive signal can be induced via secondary winding 836. In relation to ground 818, the reverse drive signal can be 180 ° out of phase with the drive signal provided via primary winding 834 of the cancellation transformer. active 832. In conjunction with load resistor 838, secondary winding 836 can provide the reverse trigger signal on cancellation capacitor 840. Consequently, the load that causes the leakage potential to appear in the patient-side circuit 822 due to the trigger signal can be brought to the cancellation capacitor 840. In this way, capacitor 840, secondary winding 836 and the load resistor 838 can dissipate the current from a possible leak to the ground 818, minimizing the current leakage by the patient.
[00215] According to various modalities, the parameters of components 832, 838 and 840 can be selected to maximize the cancellation of current leakage and, in various modalities, to decrease electromagnetic emissions. For example, the 832 active cancellation transformer can be produced from materials and according to a construction that allows it to match the frequency, temperature, humidity and other characteristics of the 826 isolation transformer. Other parameters of the 832 active transformer (for example , number of turns, ratios between turns, etc.) can be selected in order to achieve a balance between minimizing the current induced by the output, electromagnetic emissions (EM) and
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88/140 current leak due to applied external voltage. For example, circuit 820 can be configured to meet IEC 60601 or other appropriate industry or government standards. The value of the load resistor 838 can be chosen in a similar way. In addition, the parameters of the 840 cancellation capacitor (eg capacitance, etc.) can be selected to match, as much as possible, the characteristics of the parasitic capacitances responsible for inducing current leakage.
[00216] Figure 36 illustrates an alternative modality of circuit 842 that can be implemented by generator 102 to obtain active cancellation of current leakage. Circuit 842 may be similar to circuit 820, however, secondary winding 836 of active cancellation transformer 832 can be electrically coupled to output line 823. Cancellation capacitor 823 can be connected in series between secondary winding 836 and ground 818. Circuit 842 can operate in a similar way to circuit 820. According to several modalities (for example, when the active canceling transformer 832 is a voltage increase transformer), the total working voltage, for example as defined in IEC 60601-1, it can be minimized.
[00217] Figure 37 illustrates an alternative modality of a circuit 844 that can be implemented by generator 102 to obtain active cancellation of current leakage. Circuit 844 can omit active cancellation transformer 832 and replace it with a second secondary winding 846 from isolation transformer 826. Second secondary winding 846 can be connected to output line 823. Cancellation capacitor 840 can be connected in series between the second secondary winding 846 and the ground. The second secondary winding can be wound and / or connected by wire with a polarity opposite to that of the primary winding
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828 and secondary winding 830. Consequently, when the drive signal is present through primary winding 828, the reverse drive signal as described above can be present through secondary winding 846. Consequently, circuit 844 can cancel the current leak similarly to that described above for circuits 820 and 842. Omitting active cancellation transformer 832, as shown on circuit 844, can reduce the number of parts, cost and complexity.
[00218] Figure 38 illustrates yet another modality of a circuit 848 that can be implemented by generator 102 to obtain active cancellation of current leakage. Circuit 848 can be configured to cancel unwanted currents in the patient side circuit 822 due to capacitive coupling, as described above, as well as to other external effects, such as specific effects for certain frequencies (for example, noise at 60 Hz or another frequency , from power sources), trajectory effects, load effects, etc. Instead of being electrically coupled to ground 818, cancellation capacitor 840, as shown in circuit 848, can be coupled to a correction control circuit 851. Circuit 851 can comprise a digital signal processor (PSD) 850 or other processor. The DSP 850 can receive 858 inputs (for example, via an analog to digital converter). Inputs 858 can be values tending to indicate external effects that can cause additional current leakage. Examples of such inputs can be, for example, power supply parameters, load data such as impedance, impedance or other values describing the path of circuit 848 to device 104, etc. Based on inputs 858, DSP 85 can derive a cancellation potential that, when supplied to cancellation capacitor 840, can
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90/140 to cancel the patient side chains due to external effects. The cancellation potential can be supplied, digitally, to the 852 digital-to-analog converter, which can provide an analog version of the cancellation potential to the 840 cancellation capacitor. Consequently, the voltage drop across the 840 cancellation capacitor can be a function of the reverse drive signal, present through the second secondary winding 846, and the cancellation potential found by circuit 851.
[00219] Circuit 848 is shown with active cancellation transformer 832 omitted, and capacitor 840 and second secondary winding 846 in circuit 844 configuration. However, it must be considered that the correction control circuit 851 can be used in any of the configurations described here (for example, 820, 842, 844, etc.). For example, the correction control circuit 851 can be replaced by ground 818 on any of circuits 820, 842 and 844.
[00220] Figure 39 illustrates a modality of a circuit 860 that can be implemented by generator 102 to obtain current leak cancellation. According to circuit 860, cancellation capacitor 840 can be connected between the primary winding 828 of isolation transformer 826 and output line 823 (for example, the common output line). In this way, the inverse of the trigger signal can appear through the cancellation capacitor 840, causing a current leakage cancellation effect similar to those described above.
[00221] Figure 40 illustrates another modality of a circuit 862 that can be implemented by generator 102 to obtain current leak cancellation. Circuit 862 can be similar to circuit 860, with the exception that the cancellation capacitor can be connected between output line 823 (for example, the
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91/140 common output) and two additional capacitors 864 and 866. Capacitor 864 can be connected between cancellation capacitor 840 and primary winding 828 of isolation transformer 826. Capacitor 866 can be connected between cancellation capacitor 840 and o terra 818. The combination of capacitors 864 and 866 can provide a radiofrequency (RF) path to earth that can optimize the RF performance of generator 102 (for example, by decreasing electromagnetic emissions).
[00222] A surgical generator, such as generator 102 schematically illustrated in Figure 10, for example, can be electrically coupled to a variety of surgical instruments. Surgical instruments can include, for example, both RF-based instruments and ultrasound-based devices. Fig. 41 illustrates an interface between receptacle and connector 900 according to a non-limiting mode. In one embodiment, interface 900 comprises a receptacle assembly 902 and a connector assembly 920. The connector assembly 920 can be electrically coupled to the distal end of a wire 921 which is finally connected to a hand-held surgical instrument, for example . Fig. 59 illustrates a surgical generator 1050 according to a non-limiting modality. The surgical generator 1050 may comprise a body of the surgical generator 1052 which generally includes the outer capsule of the generator. Surgical body 1052 can define an opening 1054 for receiving a receptacle assembly, such as receptacle assembly 1058 illustrated in Figure 59. Now with reference to Figures 41 and 59, receptacle assembly 902 may comprise a seal 906 for generally prevent fluid from entering the surgical generator 1050 through opening 1054. In one embodiment, the 906 seal consists of an epoxy seal.
[00223] Figure 42 is an exploded side view of the re-assembly
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92/140 ceptacle 902 according to a non-limiting modality. The receptacle assembly 902 can include a variety of components, such as a magnet 212, for example. The receptacle assembly 902 can also comprise a plurality of sockets 908 which can be arranged in a generally circular formation, or any other suitable formation. Fig. 48 is an enlarged view of a socket 908 according to a non-limiting embodiment. In one embodiment, socket 908 is bifurcated and receptacle assembly 902 includes nine bifurcated sockets 908, while a greater or lesser number of sockets can be used in other embodiments. Each of the sockets 908 can define an internal cavity 910 to receive electrically conductive pins, as discussed in more detail below. In some embodiments, several sockets 908 will be mounted inside the receptacle assembly 902 at different elevations, so that contact is made with certain sockets before other sockets, when a connector assembly is inserted into the receptacle assembly.
[00224] Figure 43 is an exploded side view of the 920 connector assembly according to a non-limiting mode. The connector assembly 920 may comprise, for example, a connector body 922 that includes an insertion portion 924 that is sized to be received by the receptacle assembly 902, as described in more detail below. The connector assembly 920 can comprise a variety of other components, such as a ferrous pin 926, a circuit board 928 and a plurality of electrically conductive pins 930. As shown in Figure 54, ferrous pin 926 can be cylindrical. In other embodiments, the ferrous pin 926 can have other shapes, such as rectangular, for example. The ferrous pin 926 can be of steel, iron or any other magnetically compatible material that is attracted by magnetic fields or that
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93/140 can be magnetizable. The ferrous pin 926 may also have a bulkhead 927, or other type of feature that extends laterally. Now referring to Figure 55, the electrically conductive pins 930 can be attached to, and extending from, circuit board 928. Circuit board 928 may also include a set of circuits for device identification, such as circuits illustrated in Figures 33E to 33G, for example. Thus, in several modalities, the 928 circuit board can contain EEPROM, resistors, or any other electrical components. In some embodiments, the portions of the 928 circuit board may be enclosed in a container or otherwise encapsulated, to optimize the sterility of the surgical device and assist with water resistance.
[00225] Again referring to Figure 43, the connector assembly 920 may also include a strain relief element 932. As shown in Figure 56, the strain relief element 932 generally accepts wire loading to prevent this loading is applied to the circuit board 928 and / or the sockets 908. In some embodiments, the strain relief element 932 may include an alignment notch 934 to assist with assembly. Again with reference to Figure 43, the connector assembly 920 may also include a cover 936 that is coupled to the body of the connector 922. Figure 57 illustrates the cover 936 according to a non-limiting embodiment. The 936 cover can generally serve as a bend relief element for an associated wire, helping to seal the 920 connector assembly. In some embodiments, the 936 cover can be snapped onto the 922 connector body. autoclave, cover 936 can be an overmoulded component. In other modalities, other fixation techniques can be used, such as adhesives or rotational welding, for example.
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94/140 [00226] Figure 44 is a perspective view of receptacle assembly 902 shown in Figure 41. Figure 45 is an exploded perspective view of receptacle assembly 902. Figure 46 is a front elevation view of the assembly receptacle 902. Figure 47 is a side elevation view of receptacle assembly 902. Referring to Figures 44 to 47, receptacle assembly 902 may comprise a flange 950. Flange 950 may have an inner wall 952 and an outer wall 954. Covering inner wall 952 and outer wall 954 is a flange surface 956. Inner wall 952 can include at least one curved portion and at least a linear portion. The inner wall 952 of the flange 950 defines a cavity 960 that has a unique geometry. In one embodiment, cavity 960 is defined by about 270 degrees of a circle and two linear segments that are tangential to the circle and intersect to form an angle Θ. In one embodiment, the angle Θ is about 90 degrees. In one embodiment, a central protruding portion 962 having an outer periphery 964 is positioned in cavity 960. The central protruding portion 962 may have a central surface 966 that defines a recess 968. The magnet 912 (Figure 42) can be positioned adjacent to the recess 968. As illustrated, sockets 908 can be positioned through openings 972 defined by the central surface 966 of the protruding central portion 962. In modalities that use a circular arrangement of sockets 908, magnet 912 can be positioned internally to the circle defined by the sockets . The receptacle body 904 can also define a posterior recess 976 (Figure 47). The rear recess 976 can be dimensioned to receive the 906 seal. The face of the flange 966 can be inclined at an angle β (Figure 47). As shown in Figure 61, a face of body 1052 of surgical generator 1050 can also be tilted at angle β.
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95/140 [00227] Figure 49 is a perspective view of the 920 connector assembly, and Figure 50 is an exploded perspective view of the 920 connector assembly. Figure 51 is a side elevation view of the 922 connector body. with Figures 52 and 53 illustrating perspective views of the distal and proximal ends, respectively, of the connector body 922. Now with reference to Figures 49 to 53, the connector body 922 can have a flange 980. The flange 980 can comprise at least one curved portion and at least one linear portion.
[00228] Adapter assemblies 1002 and 1004 can comprise substantially similar components that are contained by the connector body 922 (Figure 50). For example, each of the adapter assemblies 1002 and 1004 can house a circuit board with circuitry for device identification. Each of the adapter sets 1002 and 1004 can also open one of a ferrous pin and a magnet to help connect to the surgical generator. An outer wall 982 of the flange 980 may have a shape generally similar to that of the inner wall 952 of the receptacle assembly 902 (Figure 46). An inner wall 984 of the flange 980 may be similar in shape to the outer periphery 964 of the protruding central portion 962. The connector body 922 may also have a wall 988 that includes a plurality of openings 990. The openings 990 can be dimensioned to receive electrically conductive pins 930 and ferrous pin 926. In one embodiment, the bulkhead 927 of ferrous pin 926 is dimensioned so that it cannot pass through opening 990. In some embodiments, ferrous pin 926 may be capable of one translation movement in relation to wall 988. When assembled, the shield 927 of the ferrous pin 926 can be positioned between the wall 988 and the circuit board 928. The ferrous pin 926 can be positioned so as to meet the
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96/140 Magnetic field of magnet 912 when connector assembly 920 is inserted into receptacle assembly 902. In some embodiments, a suitable connection will be denoted by an audible click when ferrous pin 926 makes a translation movement in relation to wall 988 and reaches the magnet 912. As is to be understood, several components can be positioned between the ferrous pin 926 and the magnet 912, such as a washer, for example, to reduce the incidental wear of the interface components. Additionally, in some embodiments, the magnet 912 can be attached to the connector assembly 920 and the ferrous pin 926 can be attached to the receptacle assembly 902.
[00229] Figure 58 illustrates two adapter sets 1002 and 1004 according to various non-limiting modalities. Adapter sets 1002 and 1004 allow connector sets having various geometries to be electrically coupled to a receptacle set of a surgical generator. The adapter assembly 1002 is configured to accommodate a surgical instrument that has a connector assembly 1006, and the adapter assembly 1004 is configured to accommodate a surgical instrument that has a connector assembly 1008. In one embodiment, the connector assembly 1006 is associated with an RF-based surgical device by means of a 1060 wire, and the connector assembly 1008 is associated with an ultrasound-based device by means of a 1062 wire. As is to be understood, other modalities of adapter sets can accommodate surgical instruments that have different connector sets than those illustrated in Figure 58. Figure 59 illustrates adapter set 1002 after being inserted into receptacle set 1058 of a surgical generator 1050 according to a non-limiting modality. Figure 60 illustrates the connector assembly 1006 after being inserted into the adapter assembly 1002 and therefore electrically
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97/140 coupled to the surgical generator 1050. Similarly, Figure 61 illustrates the adapter set 1004 after being inserted into the receptacle set 1058 of a surgical generator 1050 according to a non-limiting modality. Figure 62 illustrates the connector assembly 1008 after being inserted into the adapter assembly 1004. Consequently, although each of the connector sets 1006 and 1008 has different geometries, both can be used with the surgical generator 1050.
[00230] With reference to Figures 58 to 62, in one embodiment the adapter assembly 1002 has a distal portion 1010 comprising a flange 1012. The flange 1012 is configured to be inserted into the receptacle assembly 1058 of the surgical instrument 1050 and can be similar to flange 980 shown in Figure 52, for example. Any number of electrically conductive pins, or other connecting components, can be positioned at the distal portion to engage the receptacle assembly 1058. In one embodiment, adapter assembly 1002 also has a proximal portion 1014 that defines a cavity 1016. Cavity 1016 can be configured to accept a specific connector set, such as connector set 1006. As is to be understood, the proximal portion 1014 can be properly configured based on the type of connector set with which it will be used. In one embodiment, adapter assembly 1006 has a distal portion 1020 comprising a flange 1022. Flange 1022 is configured to be inserted into receptacle assembly 1058 of surgical instrument 1050 and may be similar to flange 980 illustrated in Figure 52, for example. example. The adapter assembly 1004 also has a proximal portion 1024 that defines a cavity 1026. In the illustrated embodiment, the central portion 1028 is positioned in the cavity 1026 and is configured to accept the connector assembly 1008.
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98/140 [00231] Figure 63 illustrates a perspective view of a rear panel 1100 of a generator 1102 according to a non-limiting embodiment. The generator 1102 can be similar to the generator 102 illustrated in Figure 10, for example. The back panel 1100 can comprise several input and / or output ports 1104. The back panel 1110 can also comprise an electronic paper display device 1106. The electronic paper display device 1106 can be based on electrophoresis, on which an electromagnetic field is applied to a conductive material so that it has mobility. The microparticles that have conductivity are distributed among flexible substrates of thin type, and positions of the microparticles (or toner particles) are changed due to the alteration of the polarities of an electromagnetic field, so that data is displayed. The technical approach for the realization of electronic paper can be obtained using any suitable technique, such as liquid crystal, organic electroluminescence (EL), reflective film reflection screen, electrophoresis, microspheres (twist ball), or mechanical reflection screen, for example. example. In general, electrophoresis is a phenomenon in which, when the particles are suspended in a medium (ie, a dispersion medium), the particles are electrically charged and, when an electric field is applied to the charged particles, they move through the dispersion medium to an electrode that has an opposite charge. A more detailed discussion of devices with electronic paper screens can be found in US Patent No. 7,751,115, entitled ELECTRONIC PAPER DISPLAY DEVICE, MANUFACTURING METHOD AND DRIVING METHOD THEREOF, the entirety of which is incorporated herein by way of reference.
[00232] Figure 64 illustrates rear panel 1110 shown in Figure 63. Figures 65 and 66 show enlarged views of rear panel 1110. With reference to Figures 64 to 66, the display device
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99/140 tion of electronic paper 1106 can display a variety of information, such as a serial number, part number, patent numbers, warning labels, port identifiers, instructions, supplier information, maintenance information, information about the manufacturer, operational information, or any other type of information. In one embodiment, the information displayed on the electronic paper display device 1106 can be changed or updated by connecting a computing device to a communication port (for example, a USB port) on generator 1102.
[00233] As shown in Figure 66, in some embodiments the back panel 1100 may comprise an interactive portion 1108. In one embodiment, interactive portion 1108 allows a user to provide information to generator 1102 using input devices, such as buttons 1110. Interactive portion 1108 can also display information that is simultaneously displayed on a front panel (not shown) of generator 1102.
[00234] In a surgical procedure using the ultrasonic surgical device, such as the ultrasonic surgical device 104, the end actuator 126 transmits ultrasonic energy to the tissue placed in contact with the end actuator 126, to perform a cutting and cauterization action . The application of ultrasonic energy in this way can cause localized heating of the tissue. Monitoring and control of this heating may be desirable, to minimize the occurrence of unintentional damage to the tissue and / or to optimize the effectiveness of the cutting and cauterization action. Direct measurement of ultrasonic heating requires the presence of temperature sensing devices on or near end actuator 126. Although sensor-based ultrasonic heating measurements are technically feasible, the complexity of the
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100/140 design and other considerations may make direct measurement impractical. Various modalities of generator 102 can solve this problem by generating an estimate of the temperature or heating resulting from an application of ultrasonic energy.
[00235] In particular, a modality of generator 102 can implement an artificial neural network to estimate ultrasonic heating based on a number of input variables 1218. Artificial neural networks are mathematical models that learn complex and non-linear relationships between entrances and exits, based on exposure to known entry and exit patterns, a process commonly called training. An artificial neural network can comprise a network of simple processing units, or nodes, connected to each other to perform data processing tasks. The structure of an artificial neural network can be more or less analogous to the structure of biological neural networks present in the brain. When an artificial neural network is presented with an input data pattern, it produces an output pattern. An artificial neural network can be trained for a specific processing task, by presenting large amounts of data for training. In this way, the artificial neural network can modify its structure by changing the intensity of communication between the nodes, to optimize its performance in terms of training data.
[00236] Figure 67 illustrates a modality of an artificial neural network 1200 for generating an estimated temperature Test resulting from an application of ultrasonic energy using an ultrasonic surgical device, such as the ultrasonic surgical device 104. In certain modalities, the Neural network can be implemented in processor 174 and / or programmable logic device 166 of generator 102. Neural network 1200 can comprise an input layer
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1202, one or more nodes 1204 defining a hidden layer 1206, and one or more nodes 1208 defining an output layer 1210. For the sake of clarity, only a hidden layer 1206 is shown. In certain embodiments, neural network 1200 may comprise one or more additional hidden layers in a cascading arrangement, with each additional hidden layer having a number of nodes 1204 that may be equal to, or different from, the number of nodes 1204 present in the hidden layer 1206.
[00237] Each node 1204 and 1208 in layers 1202 and 1210 can include one or more weight values w 1212, a bias value b 1214, and a transformation function f 1216. In Figure 67, the use of different subscripts for these values and functions are intended to illustrate that each of these values and functions may be different from the other values and functions. Input layer 1202 comprises one or more input variables p 1218, with each node 1204 of hidden layer 1206 receiving as input at least one of the input variables p 1218. As shown in Figure 67, for example, each node 1204 can receive all input variables p 1218. In other modalities, less than all input variables p 1218 can be received by a node 1204. Each input variable p 1218 received by a specific node 1204 is weighed by a corresponding weight value w 1212, and then added to any other input variables p 1218 with similar weight, as well as the bias value b 1214. The transform function f 1216 of node 1204 is then applied to the resulting sum to generate the node's output . In Figure 67, for example, the output of node 1204-1 can be presented as f1 (n1), where n1 = (w1,1-p1 + w1,2-p2 + ... + w1, j-pj) + b1.
[00238] A specific node 1208 of output layer 1210 can receive output from one or more of nodes 1204 of hidden layer 1206 (for example, each node 1208 receives outputs f1 (·), f2 (·), ..., fi (·) of res
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102/140 respective nodes 1204-1, 1204-2, ..., 1204-i in Figure 67), each output being weighed by a corresponding weight value w 1212 and subsequently added to any other outputs received with weight similar, as well as a bias value b 1214. The transformation function f 1216 of node 1208 is then applied to the resulting sum to generate the output of the node, which corresponds to an output of the neural network 1200 (for example, the estimated temperature Test in the modality of Figure 67). Although the mode of neural network 1200 in Figure 67 comprises only one node 1208 in output layer 1210, in other embodiments the neural network 1200 can comprise more than one output, in which case output layer 1210 can comprise multiple nodes 1208.
[00239] In certain embodiments, the transformation function f 1216 of a node 1204 and 1208 can be a nonlinear transfer function. In one embodiment, for example, one or more of the f 1216 transformation functions can be a sigmoid function. In other embodiments, the f 1216 transformation functions may include a tangent sigmoid, a hyperbolic tangent sigmoid, a logarithmic sigmoid, a linear transfer function, a saturated linear transfer function, a radial base transfer function, or some other type transfer function. The transform function f 1216 of a specific node 1204 and 1208 can be the same as, or different from, a transform function f 1216 in another node 1204 and 1208.
[00240] In certain embodiments, the input variables p 1218 received by nodes 1204 of hidden layer 1206 may represent, for example, signals and / or other known quantities or problems or believed to cause an effect on the resulting temperature or heating of an application of ultrasonic energy. These variables can comprise, for example, one or more of:
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103/140 output of the drive voltage by the generator 102, output of the drive current by the generator 102, frequency of the drive of the generator output 102, output of the drive power by the generator 102, output of the drive energy by the generator 102, impedance of the ultrasonic transducer 114, and duration of the time interval during which ultrasonic energy is applied. Additionally, one or more of the input variables p 1218 may not be related to outputs from generator 102 and may comprise, for example, characteristics of end actuator 126 (for example, size, geometry and / or blade tip material) and a particular type of tissue to which ultrasonic energy is directed.
[00241] The neural network 1200 can be trained (for example by changing or varying the weight values w 1212, the bias values b 1214, and the transformation functions f 1216) so that its output (for example, estimated temperature Test in the modality of Figure 67) appropriately approaches a measured dependence of the output for known values of the input variables p 1218. Training can be performed, for example, by providing known sets of input variables p 1218, the comparison the output of the neural network 1200 with measured outputs corresponding to the known sets of input variables p 1218, and the modification of the weight values w 1212, the bias values b 1214, and / or the transformation functions f 1216 until the error between the outputs of the neural network 1200 and the corresponding measured outputs is below a predetermined error level. For example, the neural network 1200 can be trained until the mean square error value is below a predetermined error limit. In certain modalities, aspects of the training process can be implemented by the neural network 1200 (for example, through the propagating errors back through the network 1200 to adaptively adjust the
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104/140 weight values w 1212 and / or bias values b 1214).
[00242] Figure 68 illustrates a comparison between the estimated temperature values Test and the measured temperature values Tm for an implementation of a modality of neural network 1200. The neural network 1200 used to generate Test in Figure 68 comprised six input variables p 1218: switching voltage, switching current, switching frequency, switching power, ultrasonic transducer impedance, and duration of the interval over which the ultrasonic energy was applied. The hidden layer 1206 comprised 25 nodes, and the output layer 1210 comprised a single node 1208. The training data was generated based on 13 applications of ultrasonic energy to carotid arteries. The actual temperature (Tm) was determined based on IR measurements over a range of 250 samples for different values of the input variables p 1218, with estimated temperatures Test being generated by the neural network 1200 based on corresponding values of the variables of entry p 1218. The data shown in Figure 68 was generated in a passage that was excluded from the data for training. Test estimated temperatures demonstrate a reasonably accurate approximation of the measured temperatures Tm in the region of 110190 ° ³ . It is believed that inconsistencies in the estimated Test temperatures appearing in certain regions, such as the region after 110'F, can be minimized or reduced by implementing additional neural networks specific to those regions. In addition, inconsistencies in the data that could distort the trained output of the neural network 1200 can be identified and included in the programming as special cases, to further optimize performance.
[00243] In certain modalities, when the estimated temperature exceeds a temperature limit defined by the user Tth, the generator
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102 can be configured to control the application of ultrasonic energy, so that the estimated temperature Test is maintained at or below the temperature limit Tth. For example, in modalities in which the drive current is an input variable p 1218 for neural network 1200, the drive current can be treated as a control variable, and modulated to minimize or reduce the difference between Test and Tth. These modalities can be implemented using a feedback control algorithm (for example, a PID control algorithm), with Tth being provided to the control algorithm as a setpoint, Test being provided to the algorithm as a variable feedback process, and the drive current corresponding to the controlled output of the algorithm. In cases where the drive current serves as the control variable, the appropriate variations in the drive current value need to be represented in the sets of input variables p 1218 used to train the neural network 1200. In particular, the effectiveness of the current value as a control variable can be reduced if the training data reflects constant values of the drive current, since the neural network 1200 can reduce the weight values w 1212 associated with the drive current due to its apparent lack of effect on the temperature. It should be understood that the input variables p 1218 different from the drive current (for example, drive voltage) can be used to minimize or reduce the difference between Test and Tth.
[00244] According to various modalities, generator 102 can supply power to a tissue portion according to one or more power curves. A power curve can define a relationship between power applied to the tissue and the impedance of the tissue. For example as the tissue impedance changes (for example, it increases)
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106/140 during coagulation, the power supplied by generator 102 can also change (for example, decrease) according to the applied power curve.
[00245] Different power curves may be particularly suitable, or inappropriate, for different types and / or sizes of tissue portions. Aggressive power curves (for example, power curves that require high levels of power) may be suitable for large tissue portions. When applied to smaller tissue portions, such as small blood vessels, more aggressive power curves can lead to external cauterization. External cauterization can reduce the quality of coagulation / weld on the outside and can also prevent complete coagulation of the internal portions of the tissue. Similarly, less aggressive power curves may fail to achieve hemostasis when applied to larger tissue portions (for example, larger bundles).
[00246] Figure 69 illustrates a modality of a graph 1300 showing exemplifying power curves 1306, 1308 and 1310. Graph 1300 comprises an axis of impedance 1302 illustrating increasing potential impedances of the tissue, from left to right. A power axis 1304 illustrates increasing power from the bottom up. Each of the power curves 1306, 1308 and 1310 can define a set of power levels, on the power axis 1304, corresponding to a plurality of potential fabric impedances detected, on the impedance axis 1302. In general, the power curves power can take different shapes, and this is illustrated in Figure 69. The power curve 1306 is shown with a stepped shape, while the power curves 1308 and 1310 are shown with curved shapes. It must be understood that power curves used by various modalities can take any useful continuous or non-continuous format. The rate of application of power or agres
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107/140 sivity of a power curve can be indicated by its position on graph 1300. For example, power curves that provide higher power for a given tissue impedance can be considered more aggressive. Consequently, between two power curves, the curve positioned higher on the power axis 1304 can be the most aggressive. It must be understood that some power curves can overlap.
[00247] The aggressiveness of two power curves can be compared according to any suitable method. For example, a first power curve can be considered more aggressive than a second power curve over a given range of possible fabric impedances, if the first power curve has a higher applied power corresponding to at least half of the range possible fabric impedances. In addition, for example, a first power curve can be considered more aggressive than a second power curve over a given range of possible fabric impedances, if the area under the first curve along said range is greater than the area under the second curve along the strip. Similarly, when the power curves are expressed separately, a first power curve can be considered more aggressive than a second power curve over a given set of possible tissue impedances if the sum of the power values for the first power curve across the set of possible tissue impedances is greater than the sum of the power values for the second power curve across the set of possible tissue impedances.
[00248] According to various modalities, the power curve displacement algorithms described here can be used with any type of surgical device (for example, ultrasonic device 104, electrosurgical device 106). In the modalities that
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108/140 use an ultrasonic device 104, tissue impedance readings can be taken using electrodes 157 and 159. With an electrosurgical device, such as 106, tissue impedance readings can be taken using the first and of the second electrodes 177 and 179.
[00249] In some embodiments, an electrosurgical device 104 may comprise a material with a positive temperature coefficient (PTC) of positive temperature coefficient positioned between one or both electrodes 177 and 179 and the tissue portion. PTC material can have an impedance profile that remains relatively low and relatively constant until it reaches a threshold or trigger temperature, from which point the impedance of PTC material can increase. During use, the material with PTC can be placed in contact with the fabric while the power is applied. The trigger temperature of the material with PTC can be selected to correspond to a temperature of the fabric, indicating the completion of welding or coagulation. Therefore, as the welding or coagulation process is completed, the impedance of the material with PTC may increase, causing a corresponding decrease in the power actually supplied to the fabric.
[00250] It should be understood that, during the coagulation or welding process, the impedance of the tissue can generally increase. In some embodiments, tissue impedance may show a sudden increase, indicating successful clotting. The increase may be due to physiological changes in the tissue, to a material with PTC reaching its trigger limit, etc., and may occur at any point in the coagulation process. The amount of energy that may be needed to cause the sudden increase in impedance may be related to the thermal mass of the fabric being worked. The thermal mass of any given tissue portion, in turn, may be repeated 870190093148, of 09/18/2019, p. 112/151
109/140 related to the type and amount of tissue in said portion.
[00251] Various modalities can use this sudden increase in tissue impedance to select an adequate power curve for a given tissue portion. For example, generator 102 can select and apply successively more aggressive power curves until the tissue impedance reaches an impedance limit indicating that the sudden increase has occurred. For example, reaching the impedance limit may indicate that coagulation is progressing properly with the currently applied power curve. The impedance limit can be a tissue impedance value, a rate of change in tissue impedance and / or a combination of impedance and rate of change. For example, the impedance limit can be reached when a certain impedance value and / or impedance change rate is observed. According to various modalities, different power curves can have different impedance limits, as described in the present invention.
[00252] Figure 70 illustrates a modality of a 1330 process flow for applying one or more power curves to a tissue portion. Any suitable number of power curves can be used. The power curves can be successively applied in order of aggressiveness, until one of the power curves leads the fabric to the impedance limit. In 1332, generator 102 can apply a first power curve. According to various modalities, the first power curve can be selected to provide power at a relatively low rate. For example, the first power curve can be selected in order to avoid cauterization of the tissue with the smallest and most vulnerable tissue portions.
[00253] The first power curve can be applied to the fabric in any suitable way. For example, generator 102 can generate a drive signal by implementing the first power curve.
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The power curve can be implemented by modulating the power of the drive signal. The power of the trigger signal can be modulated in any suitable way. For example, the voltage and / or current of the signal can be modulated. In addition, the activation signal can be pulsed in various modes. For example, generator 102 can modulate the average power by changing the pulse width, duty cycle, etc. of the trigger signal. The drive signal can be supplied to the first and second electrodes 177 and 179 of the electrosurgical device 106. In addition, in some embodiments, the drive signal implementing the first power curve can be supplied to an ultrasonic generator 114 of the ultrasonic device 104 described above.
[00254] During the application of the first power curve, generator 102 can monitor the total energy supplied to the tissue. Tissue impedance can be compared to the impedance limit at one or more energy limits. There can be any suitable number of energy limits, which can be selected according to any suitable methodology. For example, energy limits can be selected to correspond to known points at which different types of tissue reach the impedance limit. In 1334, generator 102 can determine whether the total energy applied to the tissue has reached or exceeded a first energy limit. If the total energy has not yet reached the first energy limit, generator 102 can continue to apply the first power curve in 1332.
[00255] If the total energy has reached the first energy limit, generator 102 can determine whether the impedance limit has been reached (1336). As described above, the impedance limit can be a predetermined rate of change in impedance (for example, increase), a predetermined impedance, or a combination of both. If the impedance limit is reached, generator 102 can
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111/140 continue to apply the first power curve in 1332. For example, reaching the impedance limit on the first power curve may indicate that the aggressiveness of the first power curve is sufficient to cause adequate coagulation or welding.
[00256] If the impedance limit is not reached in 1336, generator 102 can increase to the next and more aggressive power curve in 1338, and apply the power curve as the current power curve in 1332. When the next limit power is reached in 1334, generator 102 can again determine whether the impedance limit has been reached in 1336. If it has not been reached, generator 102 can again increase until the next and more aggressive power curve in 1338, and apply that power curve in 1332.
[00257] Process flow 1330 may continue until terminated. For example, process flow 1330 can be terminated when the impedance limit is reached at 1336. Upon reaching the impedance limit, generator 102 can apply the then current power curve until coagulation or welding is complete. In addition, for example, the 1330 process flow can end up exhausting all available power curves. Any suitable number of power curves can be used. If the more aggressive power curve fails to drive the tissue to the impedance limit, generator 102 may continue to apply the more aggressive power curve until the process is otherwise terminated (for example, terminated by the clinician or upon reaching a limit end of energy).
[00258] According to various modalities, the 1330 process flow can continue until the occurrence of a limit for termination. The termination limit may indicate that coagulation and / or welding is complete. For example, the termination limit may be based on one or more of the tissue impedance, tissue temperature,
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112/140 tissue capacitance, tissue inductance, elapsed time, etc. These can consist of a single limit for termination or, in several modalities, different power curves can have different limits for termination. According to various modalities, different power curves can use different impedance limits. For example, process flow 1330 can transition from a first to a second power curve if the first power curve has failed to drive the fabric to a first tissue impedance limit and can subsequently move from a second for a third power curve if the second power curve has failed to drive the tissue to a second impedance limit. [00259] Figure 71 illustrates a modality of a graph 1380 showing exemplary power curves 1382, 1384, 1386 and 1388 that can be used in conjunction with process flow 1330. Although four power curves 1382, 1384, 1386 are shown and 1388, it should be understood that any suitable number of power curves can be used. The 1382 power curve can represent the least aggressive power curve and can be applied first. If the impedance limit is not reached at the first power limit, then generator 102 can provide the second power curve 1384. The other power curves 1386 and 1388 can be used as needed, for example in the manner described above. [00260] As shown in Figure 71, the power curves 1382, 1384, 1386 and 1388 have different formats. It must be considered, however, that some or all of a set of power curves implemented by the 1330 process flow can have the same shape. Figure 72 illustrates a modality of a graph showing exemplary power curves with common format 1392, 1394, 1396 and 1398, which can be used in conjunction with the process flow of Figure 70. According to various modalities, the
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113/140 power with common format, such as 1392, 1394, 1396 and 1398, can be constant multiple of each other. Consequently, generator 102 can implement common format power curves 1392, 1394, 1396 and 1398 by applying different multiples to a single power curve. For example, curve 1394 can be implemented by multiplying curve 1392 by a first constant multiplier. The 1396 curve can be generated by multiplying the 1392 curve by a second constant multiplier. Similarly, curve 1398 can be generated by multiplying curve 1392 by a third constant multiplier. Consequently, in various modalities, generator 102 can increase even a more aggressive power curve in 1338, by changing the constant multiplier.
[00261] According to various modalities, the 1330 process flow can be implemented by a digital device (for example, a processor, digital signal processor, field programmable logic gate matrix (FPGA), etc.) of the generator 102 Examples of such digital devices include, for example, processor 174, programmable logic device 166, processor 190, etc.). Figures 73A to 73C illustrate process flows describing routines that can be performed by a digital device from generator 102 to generally implement process flow 1330 described above. Fig. 73A illustrates an embodiment of a routine 1340 for preparing generator 102 to act on a new tissue portion. The activation or start of the new tissue portion can begin in 1342. In 1344, the digital device can point to a first power curve. The first power curve, as described above, may be the least aggressive power curve to be implemented as part of the 1330 process flow. Pointing to the first power curve may comprise pointing to a deterministic formula indicating
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114/140 the first power curve, point to a lookup table that represents the first power curve, point to a first power curve multiplier, etc.
[00262] In 1346, the digital device can reset an impedance limit signal. As described below, setting the impedance limit signaling can indicate that the impedance limit has been reached. Consequently, signaling initialization may indicate that the impedance limit has not been reached, as may be appropriate at the beginning of the 1330 process flow. In 1348, the digital device can proceed to the next routine 1350.
[00263] Figure 73B illustrates a modality of a routine 1350 that can be performed by the digital device. to monitor tissue impedance. In 1352, the load or impedance of the tissue can be measured. The impedance of the tissue can be measured according to any suitable method, and using any suitable physical components. For example, according to various modalities, the impedance of the tissue can be calculated according to Ohm's law, using the current and voltage supplied to the tissue. In 1354, the digital device can calculate an impedance change rate. The rate of change in impedance can likewise be calculated according to any suitable way. For example, the digital device can maintain previous tissue impedance values and calculate a rate of change by comparing one or more current tissue impedance values with the previous values. In addition, it should be understood that routine 1350 assumes that the impedance limit is a rate of change. In modalities where the impedance limit is a value, 1354 can be omitted. If the current impedance value of the tissue rate of change (or the impedance itself) is greater than the limit (1356), then the signaling of the impedance limit can be set. The digital device can proceed to the next routine in
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1360.
[00264] Figure 73C illustrates a modality of a routine 1362 that can be performed by the digital device to supply one or more power curves to a tissue portion. In 1364, power can be applied to tissue, for example, as described above in relation to 1334 in Figure 70. The digital device can direct the application of the power curve, for example, by applying the power curve to find a corresponding power for each tissue impedance detected, modulating the corresponding power on a trigger signal provided to the first and second electrodes A20, A22, transducer 114, etc.
[00265] In 1366, the digital device can calculate the total accumulated energy applied to the tissue. For example, the digital device can monitor the total time of application of the power curve, as well as the power applied each time. The total energy can be calculated from these values. In 1368, the digital device can determine whether the total energy is greater than or equal to a next energy limit, for example, similar to the mode described above in relation to 1334 in Figure 70. If the next energy limit is not reached, the current power curve may continue to be applied in 1378 and 1364.
[00266] If the next energy limit is reached in 1368, then in 1370 the digital device can determine whether the signaling of the impedance limit has been set. The status of the impedance limit signaling can indicate whether the impedance limit has been reached. For example, the signaling of the impedance limit may have been set by routine 1350 if the impedance limit has been reached. If the impedance signaling is not defined (for example, the impedance limit has not been reached), then the digital device can determine, in 1372, whether there are still more aggressive power curves to be implemented. If so, the digital device can point the routine
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1362 for the next and more aggressive power curve in 1374. Routine 1362 can continue (1378) to supply power according to the new power curve in 1364. If all available power curves have been applied, then the digital device can disable the calculation and verification of accumulated energy for the rest of the operation on the fabric in 1376.
[00267] If the impedance signal is set to 1370 (for example, the impedance limit has been reached), then the digital device can disable the calculation and verification of energy accumulated by the rest of the operation on the fabric in 1376. understand that, in some modalities, the accumulated energy calculation can be continuous, while 1370, 1372, 1374 and 1376 can be discontinuous. For example, generator 102 and / or the digital device can implement an automated shutdown when the accumulated energy reaches a predetermined value.
[00268] Figure 74 illustrates a modality of a process flow 1400 for applying one or more power curves to a tissue portion. For example, process flow 1400 can be implemented by generator 102 (for example, the digital device of generator 102). In 1402, generator 102 can supply a power curve to the tissue. The power curve can be derived by applying a multiplier to a first power curve. In 1404, generator 102 can determine whether the impedance limit has been reached. If the impedance limit has not been reached, generator 102 can increase the multiplier as a function of the total applied energy. This can have the effect of increasing the aggressiveness of the applied power curve. It should be understood that the multiplier can be increased periodically or continuously. For example, generator 102 can check the impedance limit (1404) and increase the multiplier (1406) at a predetermined periodic interval. In several modalida
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117/140 de, generator 102 can continuously check the impedance limit (1404) and increase the multiplier (1406). The increase of the multiplier as a function of the total applied energy can be carried out in any suitable way. For example, generator 102 can apply a deterministic equation that receives the total energy received as an input and provides a corresponding multiplier value as an output. In addition, for example, generator 102 can store a lookup table that comprises a list of possible values for total applied energy and corresponding multiplier values. According to various modalities, generator 102 can provide a pulsed trigger signal to the tissue (for example, by means of one of the surgical devices 104 and 106). According to various modalities, when the impedance limit is reached, the multiplier can be kept constant. The generator 102 can continue to apply power, for example, until a termination limit is reached. The termination limit can be constant, or it can depend on the final value of the multiplier.
[00269] In some modalities using a pulsed trigger signal, generator 102 can apply one or more load curves composed to the trigger signal and, finally, to the tissue. Compound load curves, like other power curves described here, can define an energy level to be applied to the tissue as a function of one or more measured properties of the tissue (for example, impedance). Composite load curves can additionally define pulse characteristics, such as pulse width, in terms of the measured properties of the tissue.
[00270] Figure 75 illustrates a modality of a block diagram 1450 describing the selection and application of load curves composed by generator 102. It should be understood that the block diagram 1450 can be implemented with any suitable type
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118/140 of generator or surgical device. According to various modalities, the block diagram 1450 can be implemented using an electrosurgical device, such as the device 106 described above in relation to Figures 4 to 7. In addition, in various modalities, the block diagram 1450 can be implemented with an ultrasonic surgical device, such as the surgical device 104 described above in relation to Figures 2 and 3. In some embodiments, block diagram 1450 can be used with a surgical device that has cutting as well as coagulation capabilities. For example, an RF surgical device, such as device 106, may comprise a cutting edge, such as blade 175, to cut tissue before or during clotting.
[00271] Again with reference to Figure 75, an algorithm 1452 can be executed, for example by a digital device of generator 102, to select and apply load curves composed 1456, 1458, 1460 and 1462. The algorithm 1452 can receive an input moment of a 1454 clock and can also receive a loop input 1472 from sensors 1468. Loop input 1472 can represent properties or characteristics of the fabric that can be used in the 1452 algorithm to select and / or apply a load curve composed. Examples of such characteristics may include, for example, current, voltage, temperature, reflectivity, force applied to the tissue, resonance frequency, rate of change in the resonance frequency, etc. The 1468 sensors can be dedicated sensors (for example, thermometers, pressure sensors, etc.) or they can be sensors implemented through software to derive tissue characteristics based on other system values (for example, to observe and / or calculate voltage, current, fabric temperature, etc., based on the trigger signal). The 1452 algorithm can select one of the composite load curves 1456, 1458, 1460 and
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1462 to apply, for example based on loop input 1472 and / or clock time input 1454. Although four compound load curves are shown, it should be understood that any suitable number of compound load curves can be used.
[00272] The 1452 algorithm can apply a selected composite load curve in any suitable way. For example, the 1452 algorithm can use the selected composite load curve to calculate an energy level and one or more pulse characteristics based on the impedance of the tissue (for example, the impedance of the currently measured tissue can be a part, or can be derived, from loop input) or resonant frequency characteristics of an ultrasonic device 104. Examples of pulse characteristics that can be determined based on tissue impedance according to a composite load curve may include pulse width, rise time and off time.
[00273] At setpoint 1464, the derived power and pulse characteristics can be applied to the trigger signal. In several embodiments, a feedback loop 1474 can be implemented to allow more accurate modulation of the drive signal. At the output of setpoint 1464, the trigger signal can be supplied to an amplifier 1466, which can provide adequate amplification. The amplified drive signal can be supplied to a load 1470 (for example, via sensors 1468). Charge 1470 may comprise tissue, surgical device 104 and 106, and / or any wire electrically coupling generator 102 to surgical device 104 and 106 (e.g., wires 112 and 128).
[00274] Figure 76 shows a process flow illustrating a modality of algorithm 1452, as implemented by generator 102 (for example, by a digital device from generator 102). The something
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120/140 rhythm 1452 can be activated in 1476. It must be understood that the 1452 algorithm can be activated in any suitable way. For example, algorithm 1452 can be activated by a clinician when operating the surgical device 104 and 106 (for example, when pulling or otherwise activating a jaw closure trigger 138 and 142, a key, a handle, etc.) .
[00275] According to various modalities, the 1452 algorithm can comprise a plurality of regions 1478, 1480, 1482 and 1484. Each region can represent a different stage of cutting and coagulation of a tissue portion. For example, in the first region 1478, generator 102 can perform an analysis of initial tissue conditions (for example, impedance). In the second region 1480, generator 102 can apply energy to the fabric in order to prepare it for cutting. In the third region, or cutting region 1482, generator 102 can continue to apply energy while surgical device 104 and 106 cuts the tissue (for example, with the electrosurgical device 106, where cutting can be performed by advancing the blade A18). In the fourth region, or completion region 1484, generator 102 can apply energy after cutting to complete coagulation.
[00276] Now with reference to the first region 1478, generator 102 can measure any one or more suitable tissue conditions including, for example, current, voltage, temperature, reflectivity, force applied to the tissue, etc. In several embodiments, an initial tissue impedance can be measured according to any suitable method. For example, generator 102 can modulate the drive signal to supply a known voltage or current to the fabric. The impedance can be derived from the known voltage and the measured current, or vice versa. It should be considered that the impedance of the tissue can, alternatively or additionally, be measured in any other appropriate way. According to algorithm 1452, generator 102
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121/140 can proceed from the first region 1478 to the second region 1480. In several modalities, the clinician can finalize the algorithm 1452 in the first region 1478, for example, by deactivating generator 102 and / or surgical device 104 and 106. If the clinician finalizes the 1542 algorithm, the application of RF (and / or ultrasonic) can also be stopped in 1486.
[00277] In the second region 1480, generator 102 can begin to apply energy to the fabric through the trigger signal to prepare the fabric for cutting. The energy can be applied according to the composite load curves 1456, 1458, 1460 and 1462, as described below. The application of energy according to the second region 1480 may comprise modulation of the pulses on the trigger signal, according to some or all of the composite load curves 1456, 1458, 1460 and 1462. In various modalities, the load curves compounds 1456, 1458, 1460 and 1462 can be applied successively in order of aggressiveness (for example, to accommodate different types of tissue volume trapped between the instrument's jaws).
[00278] The first composite load curve 1456 can be applied first. The generator 102 can apply the first compound load curve 1456 by modulating one or more pulses of the first compound load curve on the drive signal. Each pulse of the first composite load curve can have power and pulse characteristics determined according to the first composite load curve and considering the measured tissue impedance. The tissue impedance measured for the first pulse can be the impedance measured in the first region 1478. In various embodiments, generator 102 can use all or a portion of the pulses from the first composite load curve to take additional measurements of tissue impedance or resonance frequency. Additional measurements can be
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122/140 used to determine the power and other pulse characteristics of one or more subsequent pulses.
[00279] Figure 77 illustrates a modality of a process flow 1488 for generating a first pulse of the composite load curve. Process flow 1488 can be performed by generator 102 (for example, by a digital device from generator 102), for example as part of algorithm 1452. In 1490, generator 102 can calculate a pulse width (Tpw). The pulse width can be determined by considering the most recent measured tissue impedance (Z) and according to the first composite load curve 1456.
[00280] In 1492, generator 102 can gradually increase the power of the trigger signal to a pulse power (PLimit) over a rise time (tsobe), thus applying the pulse to the tissue. The pulse power can again be determined considering the most recent measured tissue impedance (Z) and according to the first composite load curve 1456. The rise time can be determined according to the composite load curve considering the impedance of the tissue, or it can be constant (for example, constant for all pulses of the first composite load curve, constant for all pulses, etc.). The generator 102 can apply the pulse power to the drive signal in any suitable manner including, for example, by modulating a current and / or voltage supplied by the drive signal. According to various modalities, the trigger signal can be an alternating current (AC) signal and, therefore, the pulse itself can comprise multiple cycles of the trigger signal.
[00281] The trigger signal can be maintained at the pulse power during the pulse width in 1494. At the conclusion of the pulse, the trigger signal can be gradually decreased, in 1496, over a fall time (Tdesce). The descent time can be
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123/140 determined according to the first compound load curve considering the impedance of the tissue, or it can be constant (for example, constant for all pulses of the first compound load curve, constant for all pulses, etc.) . It should be understood that, depending on the modality, the rise time and the descent time may or may not be considered part of the pulse width. In 1498, generator 102 can pause for an off time (T off). Like the ramp time and the descent time, the off time can be determined according to the first compound load curve considering the tissue impedance, or it can be constant (for example, constant for all pulses of the first load curve) compound load, constant for all pulses, etc.).
[00282] Upon completion of the off time, generator 102 can repeat process flow 1488, as long as the first compound load curve 1456 is applied. According to various modalities, generator 102 can apply the first compound load curve 1456 for a predetermined period of time. Consequently, process flow 1488 can be repeated until the predetermined time interval has elapsed (for example, as determined based on the time input received from the clock 1454). In addition, in various embodiments, the first composite load curve can be applied over a predetermined number of pulses. As the applied pulse width varies according to the measured tissue impedance, the total time during which the first composite load curve is applied can also vary with the measured tissue impedance. According to various modalities, the first composite load curve 1456 (as well as the other composite load curves 1458, 1460 and 1462) can specify the decrease in pulse widths as the tissue impedance increases. Consequently, a higher initial tissue impedance may take less time
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124/140 being used for the first composite load curve.
[00283] Once the first composite load curve 1456 is completed, generator 102 can successively apply the remaining consolidated load curves 1458, 1460 and 1462 throughout the application of the second region 1480. Each load curve 1458, 1460 and 1462 can be applied in a similar manner to that of the load curve 1456 described above. For example, pulses according to a current load curve can be generated until the completion of that load curve (for example, the expiration of a predetermined interval of time or a predetermined number of pulses). The predetermined number of pulses can be the same for each compound load curve 1456, 1458, 1460 and 1462 or it can be different. According to various modalities, the pulses according to the load curves 1458, 1460 and 1462 can be generated in a similar way to the process flow 1488, except for the fact that the pulse power, the pulse width and, in some modalities, the rise time, the descent time and the off time, can be derived according to the current composite load curve.
[00284] The second region 1480 can be completed after the occurrence of several events. For example, if the total RF application time has exceeded a timeout, then generator 102 can terminate operation on tissues by stopping RF (and / or ultrasonic) application in 1486. In addition, several events can cause generator 102 to transition from the second region 1480 to the third region 1482. For example, generator 102 can transition to the third region 1482 when the tissue impedance (Z) exceeds a tissue impedance limit (Zterm) and the RF energy has been applied for at least more than a minimum time (Tstart). The tissue impedance limit can be an impedance and / or an impedance change rate indicating that the tissue portion is
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125/140 properly prepared to be cut by blade 175.
[00285] According to several modalities, if the final load curve 1462 is completed in the second region 1480, before the completion of the second region 1480, then the final power curve 1462 can be applied continuously, for example, until the tissue impedance limit is reached, the maximum time of the second region is reached and / or the time limit is reached. Furthermore, it should be considered that, with some cuts in the fabric, the second region 1480 can be completed before all the available consolidated load curves 1456, 1458, 1460 and 1462 are executed.
[00286] In the third region 1482, generator 102 can continue to modulate pulses on the trigger signal. In general, the pulses of the third region can be modulated on the trigger signal according to any suitable manner including, for example, that described above with reference to process flow 1488. The power and pulse characteristics of the pulses of the third region they can be determined according to any suitable method and, in various modalities, they can be determined based on the composite load curve that was being executed at the time of the completion of the second region 1480 (the current load curve). According to various modalities, the current load curve can be used to determine the pulse power of the pulses in the third region, while the pulse characteristics (for example, pulse width, rise time, descent time, off time, etc.) can be constant regardless of the compound load curve. In some embodiments, the third region 1482 may use a composite load curve specific to the third region, which may be one of the load curves 1456, 1458, 1460 and 1462 used in the second region 1480, or it may be a composite load curve. different (not shown).
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126/140 [00287] Generator 102 can continue to execute the third region 1482 until it receives an indication that the tissue cut is complete. In modalities in which surgical implements that have a blade, such as 175, are used, the indication can be received when blade 175 reaches its most distal position, as shown in Figure 6. This can trigger a scalpel limit sensor (not shown) indicating that blade 175 has reached the end of its trajectory. Upon receiving the indication that the tissue cut is complete, generator 102 can continue to the fourth region 1484. It should also be considered that, in some modalities, generator 102 can transition from the third region 1482 directly to the RF termination (and / or ultrasonic) in 1486, for example, if the timeout has been reached.
[00288] In the fourth region 1484, generator 102 can provide an energy profile designed to complete the coagulation of the now cut tissue. For example, according to various modalities, generator 102 can provide a predetermined number of pulses. The pulses can be provided in a manner similar to that described above in relation to the 1488 process flow. The power and pulse characteristics of the pulses can be determined in any suitable manner. For example, the power and pulse characteristics of the pulses of the fourth region can be determined based on the current composite load curve, the specific load curve for the third region, or the specific load curve for the fourth region. In some embodiments, power can be determined based on the current composite load curve, while pulse characteristics may be specific to the fourth region. In addition, according to various modalities, the power and pulse characteristics of the pulses of the fourth region can be determined independently of the current composite load curve.
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127/140 [00289] Figure 78 illustrates a modality of a pulse timing diagram 1474 illustrating an exemplary application of algorithm 1452 by generator 102 (for example, by a digital device of generator 102). A pulse from the first region 1502 is shown in the first region 1478. The pulse from the first region 1502 can be used, as described, to measure an initial tissue impedance. At the conclusion of the pulse of the first region (1509), the second region 1480 can begin with the pulses of the second region 1504 applied. The pulses of the second region 1504 can be applied according to the various compound load curves 1456, 1458, 1460 and 1462, for example, as described in the present invention. In the example diagram 1474, the second region 1480 concludes in 1510, when the tissue reaches the impedance limit (Zterm). The third region 1482 is then implemented with pulses from the third region 1506, as described above, applied until a scalpel limit signal is received in 1512. At that point, the fourth region 1484 can begin, with pulses from the fourth region 1508, as described above, applied until the completion of the cycle in 1514.
[00290] According to various modalities, generator 102 can implement a user interface in conjunction with algorithm 1452. For example, the user interface can indicate the current region of the algorithm. The user interface can be implemented visually and / or audibly. For example, generator 102 may comprise a loudspeaker to generate audible tones or other audible indications. At least one audible indication can correspond to the second region 1480. The third and fourth regions 1482 and 1484 may also have audible indications specific to the region. According to various modalities, the first region 1478 may also have an audible indication specific to the region. According to various modalities, the audible indications may comprise pulsed tones
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128/140 generated by generator 102. The frequency of the sounds and / or the tone of the same can indicate the current region. In addition to, or instead of, audible indications, generator 102 may also provide a visual indication of the current region (for example, at output device 147). It should be considered that the clinician can use the described user interface to properly use generator 102 and associated surgical devices 104 and 106. For example, the indication of the second region 1480 can inform the clinician that the treatment of the tissue has started. The indication of the third region 1482 can inform the clinician that the tissue is ready for the cutting operation. The indication of the fourth region 1484 can inform the clinician that the cutting operation is complete. The cessation of the indication and / or a final indication may indicate that the total cutting / coagulation operation is complete.
[00291] Figure 79 illustrates a graphical representation of the voltage, current and power of the drive signal, according to an exemplary load curve 1520. In graphic 1520, the voltage of the drive signal is represented by line 1522, the current of the trigger signal is represented by line 1524 and the power of the trigger signal is represented by line 1526. The pulse width is not indicated in Figure 79. In various modalities, the values for voltage 1522, current 1524 and power 1526 indicated by the graph 1520 can represent possible values within a single pulse. Consequently, the load curve 1520 can be expressed as a load curve composed of the addition of a curve (not shown) indicating a pulse width as a function of tissue impedance or other tissue condition. As shown for load curve 1520, the maximum voltage 1522 is 100 volts in mean square value (RMS), the maximum current is 3 amps RMS and the maximum power is 135 watts RMS.
[00292] Figures 79 to 84 illustrate graphical representations of
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129/140 several exemplary composite load curves 1530, 1532, 1534, 1536, 1538 and 1540. Each of the composite load curves 1530, 1532, 1534, 1536, 1538 and 1540 can indicate both pulse power and pulse width in terms of measured tissue impedance. The composite load curves 1530, 1532, 1534 and 1536 can be implemented either in isolation or as part of a pattern of successively more aggressive composite load curves, as described above in relation to the 1452 algorithm.
[00293] Figure 80 illustrates a graphical representation of a first example composite load curve 1530. The composite load curve 1530 can have a maximum pulse power of 45 watts RMS and a maximum pulse width of 0.35 seconds. In Figure 80, power as a function of tissue impedance is indicated by 1542, while pulse width as a function of tissue impedance is indicated by 1544. Table 1 below illustrates values for the composite load curve 1530 for fabric impedances from 0Ω to 475Ω.
Table 1
Charge, VLim, ILim, P Lim, PW, Ohms RMS RMS W Sec 0-24 85 1.4 45 0.35 25-49 85 1.4 45 0.35 50-74 85 1.4 45 0.3 75-99 85 1.4 45 0.3 100-124 85 1.4 45 0.25 125-149 85 1.4 45 0.25 150-174 85 1.4 45 0.2 175-199 85 1.4 45 0.2 200-224 85 1.4 44 0.15
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Table 1
Charge, VLim, ILim, P Lim, PW, Ohms RMS RMS W Sec 225-249 85 1.4 40 0.15 250-274 85 1.4 36 0.1 275-299 85 0.31 24 0.1 300-324 85 0.28 22 0.1 325-349 85 0.26 20 0.1 350-374 85 0.25 19 0.1 375-399 85 0.22 18 0.1 400-424 85 0.21 17 0.1 425-449 85 0.2 16 0.1 450-475 85 0.19 15 0.1 475+ 85 0.15 14 0.1
[00294] In several modalities, the composite load curve 1530 may be suitable for smaller surgical devices and / or smaller tissue portions.
[00295] Figure 81 illustrates a graphical representation of a second example composite load curve 1532. The composite load curve 1532 can have a maximum pulse power of 45 watts RMS and a maximum pulse width of 0.5 seconds. In Figure 81, power as a function of tissue impedance is indicated by 1546, while pulse width as a function of tissue impedance is indicated by 1548. Table 2 below illustrates values for the composite load curve 1532 for fabric impedances from 0Ω to 475Ω.
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Table 2
Charge, V Lim, I Lim, P Lim, PW, Ohms RMS RMS W Sec 0-24 85 3 45 0.5 25-49 85 2 45 0.5 50-74 85 1.4 45 0.5 75-99 85 1.1 45 0.5 100-124 85 0.9 45 0.5 125-149 85 0.7 45 0.5 150-174 85 0.55 45 0.5 175-199 85 0.48 45 0.5 200-224 85 0.42 32 0.5 225-249 85 0.38 28 0.5 250-274 85 0.33 26 0.3 275-299 85 0.31 24 0.3 300-324 85 0.28 22 0.25 325-349 85 0.26 20 0.25 350-374 85 0.25 19 0.25 375-399 85 0.22 18 0.25 400-424 85 0.21 17 0.25 425-449 85 0.2 16 0.25 450-475 85 0.19 15 0.25 475+ 85 0.15 14 0.25
[00296] The composite load curve 1532 can be indicated for small tissue portions, with a single vessel and, according to several modalities, it can be a first composite power curve applied in region two 1480.
[00297] Figure 82 illustrates a graphical representation of a third example composite load curve 1534. The load curve
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132/140 composite 1534 can have a maximum pulse power of 60 watts RMS and a maximum pulse width of 2 seconds. In Figure 82, power as a function of tissue impedance is indicated by 1550, while pulse width as a function of tissue impedance is indicated by 1552. Table 3 below illustrates values for the composite load curve 1534 for fabric impedances from 0Ω to 475Ω.
Table 3
Charge, V Lim, I Lim, P Lim, PW, Ohms RMS RMS W Sec 0-24 85 3 60 2 25-49 85 3 60 2 50-74 100 3 60 2 75-99 100 3 60 2 100-124 100 3 60 2 125-149 100 3 60 2 150-174 100 3 55 0.5 175-199 100 3 50 0.5 200-224 85 0.42 32 0.3 225-249 85 0.38 28 0.3 250-274 85 0.33 26 0.3 275-299 85 0.31 24 0.3 300-324 85 0.28 22 0.25 325-349 85 0.26 20 0.25 350-374 85 0.25 19 0.25 375-399 85 0.22 18 0.25 400-424 85 0.21 17 0.25 425-449 85 0.2 16 0.25 450-475 85 0.19 15 0.25
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133/140
Table 3
Charge, V Lim, I Lim, P Lim, PW, Ohms RMS RMS W Sec 475+ 85 0.15 14 0.25
[00298] The composite load curve 1534 can be more aggressive than the previous curve 1532 due to its generally higher power. The composite load curve 1534 may also initially have pulse widths greater than the previous curve 1532, although the pulse widths of the composite load curve 1534 may start to decrease at just 150Ω. According to various modalities, the compound load curve 1536 can be used in algorithm 1542 as a load curve implemented sequentially after the compound load curve 1532.
[00299] Figure 83 illustrates a graphical representation of a fourth example composite load curve 1536. The composite load curve 1536 can have a maximum pulse power of 90 watts RMS and a maximum pulse width of 2 seconds. In Figure 83, power as a function of tissue impedance is indicated by 1554, while pulse width as a function of tissue impedance is indicated by 1556. Table 4 below illustrates values for the composite load curve 1536 for fabric impedances from 0Ω to 475Ω.
Table 4
VPCharge, Lim, I Lim, Lim, PW, Ohms RMS RMS W Sec 0-24 85 3 90 2 25-49 85 3 90 2 50-74 100 3 90 2 75-99 100 3 90 2
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Table 4
V P Charge, Lim, I Lim, Lim, PW, Ohms RMS RMS W Sec 100-124 100 3 80 2 125-149 100 3 65 2 150-174 100 3 55 0.5 175-199 100 3 50 0.5 200-224 85 0.42 32 0.3 225-249 85 0.38 28 0.3 250-274 85 0.33 26 0.3 275-299 85 0.31 24 0.3 300-324 85 0.28 22 0.25 325-349 85 0.26 20 0.25 350-374 85 0.25 19 0.25 375-399 85 0.22 18 0.25 400-424 85 0.21 17 0.25 425-449 85 0.2 16 0.25 450-475 85 0.19 15 0.25 475+ 85 0.15 14 0.25
[00300] The composite load curve 1536 can again be more aggressive than the previous curve 1534 and therefore can be implemented sequentially after curve 1534 in algorithm 1452. In addition, according to various modalities, the load curve composite 1536 may be suitable for use with larger fabric bundles.
[00301] Figure 84 illustrates a graphical representation of a fifth example composite load curve 1538. The composite load curve 1538 can have a maximum pulse power of 135 watts RMS and a maximum pulse width of 2 seconds. In Figure 84, power as a function of tissue impedance is indicated by
Petition 870190093148, of 09/18/2019, p. 138/151
135/140
1558, while pulse width as a function of tissue impedance is indicated by 1560. Table 5 below illustrates values for the composite load curve 1538 for tissue impedances from 0Ω to 475Ω.
Table 5
Charge, VLim, ILim, P Lim, PW, Ohms RMS RMS W Sec 0-24 85 3 135 2 25-49 85 3 135 2 50-74 100 3 135 2 75-99 100 3 100 2 100-124 100 3 80 2 125-149 100 3 65 2 150-174 100 3 55 0.5 175-199 100 3 50 0.5 200-224 85 0.42 32 0.3 225-249 85 0.38 28 0.3 250-274 85 0.33 26 0.3 275-299 85 0.31 24 0.3 300-324 85 0.28 22 0.25 325-349 85 0.26 20 0.25 350-374 85 0.25 19 0.25 375-399 85 0.22 18 0.25 400-424 85 0.21 17 0.25 425-449 85 0.2 16 0.25 450-475 85 0.19 15 0.25 475+ 85 0.15 14 0.25
[00302] The composite load curve 1538 can be used sequentially after the previous curve 1536 in algorithm 1452.
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136/140 [00303] Figure 85 illustrates a graphical representation of an exemplary sixth composite load curve 1540. The composite load curve 1540 can have a maximum pulse power of 90 watts RMS and a maximum pulse width of 2 seconds. In Figure 85, power as a function of tissue impedance is indicated by 1562, while pulse width as a function of tissue impedance is indicated by 1564. Table 6 below illustrates values for the composite load curve 1540 for fabric impedances from 0Ω to 475Ω.
Table 6
Charge, VLim, ILim, P Lim, PW, Ohms RMS RMS W Sec 0-24 85 3 90 2 25-49 85 3 90 2 50-74 100 3 90 2 75-99 100 3 90 2 100-124 100 3 80 2 125-149 100 3 65 2 150-174 100 3 55 0.5 175-199 100 3 50 0.5 200-224 85 0.42 32 0.3 225-249 85 0.38 28 0.3 250-274 85 0.33 26 0.3 275-299 85 0.31 24 0.3 300-324 85 0.28 22 0.25 325-349 85 0.26 20 0.25 350-374 85 0.25 19 0.25 375-399 85 0.22 18 0.25
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Table 6
V I PCharge, Lim, Lim, Lim, PW, Ohms RMS RMS W Sec 400-424 85 0.21 17 0.25 425-449 85 0.2 16 0.25 450-475 85 0.19 15 0.25 475+ 85 0.15 14 0.25
[00304] The composite power curve 1540 is less aggressive than the previous power curve 1538. According to several modalities, the composite power curve 1540 can be implemented in algorithm 1452 sequentially after curve 1538. In addition, in some modalities the composite power curve 1540 can be implemented in algorithm 1452 as a third or fourth region specific composite power curve.
[00305] As described above, each of the several composite power curves used in the 1452 algorithm can be implemented for a predetermined number of pulses. Table 7, below, illustrates the number of pulses per compound power curve for an exemplary modality using the power curves 1532, 1534, 1536 and 1540 sequentially in the 1452 algorithm.
Table 7
Compound load curve
1532
1534
1536
1538
Number of pulses
1540 N / A [00306] The last compound power curve 1540 is shown without a corresponding number of pulses. For example, the power curve
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138/140 compound company 1540 can be implemented until the clinician finishes the operation, until the time limit is reached, until the impedance limit of the tissue is reached, etc.
[00307] According to various modalities, generator 102 can supply power to a tissue portion in a way that gives rise to a desired value of other tissue parameters. Fig. 86 illustrates a modality of a block diagram 1570 describing the application of an algorithm 1572 for maintaining a constant rate of change in the impedance of the tissue. The algorithm 1572 can be implemented by generator 102 (for example, by means of a digital device from generator 102). For example, algorithm 1572 can be used by generator 102 to modulate the trigger signal. The 1574 sensors can detect a tissue condition, such as tissue impedance and / or a rate of change in tissue impedance. The 1574 sensors can be sensors based on hardware components or, in several modalities, they can be sensors implemented through software. For example, 1574 sensors can calculate tissue impedance based on the measured current and voltage for the trigger signal. The trigger signal can be supplied by the generator 102 to the cable / implement / load 1576, which can be the electrical combination of the tissue, the surgical device 104 and 106, and a cable 112 and 128 electrically coupling the generator 102 to the device 104 and 106.
[00308] Generator 102, by implementing the 1572 algorithm, can monitor the impedance of the tissue or the load including, for example, the rate of change of the impedance. The generator 102 can modulate one or more of the voltage, current and / or power supplied through the drive signal, to maintain the rate of change of the impedance of the fabric at a predetermined constant value. In addition, according to various modalities, generator 102 can maintain
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139/140 the rate of change in tissue impedance above a minimum impedance change rate.
[00309] It should be understood that the 1572 algorithm can be implemented in conjunction with several other algorithms described here. For example, according to various modalities, generator 102 can sequentially modulate tissue impedance for different, increasingly aggressive rates, similar to what occurs in method 1330 described here with reference to Figure 70 of the present invention. For example, a first impedance change rate can be maintained until the total energy applied to the tissue exceeds a predetermined energy limit. At the energy limit, if the tissue conditions have not reached a predetermined level (for example, a predetermined tissue impedance), then generator 102 can use the trigger signal to drive the tissue to a second impedance change rate, taller. In addition, in various modalities, the rates of change in tissue impedance can be used in a manner similar to that described above in relation to composite load curves. For example, instead of using a plurality of composite load curves, algorithm 1452 of Figure 75 can invoke the application of a plurality of rates of change in tissue impedance. Each rate of change in tissue impedance can be maintained for a predetermined interval of time and / or a predetermined number of pulses. Fees can be applied successively in order of value (for example, fees can be increased successively). In some modalities, however, the conducted impedance change rates can peak and then be reduced.
[00310] Although several modalities of the devices have been described here in connection with certain modalities presented, many modifications and variations can be implemented
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140/140 of these modalities. For example, different types of end effectors can be used. Also, where materials are presented for certain components, other materials can be used. The aforementioned description and the following claims are intended to cover all such modifications and variations.
[00311] Any patent, publication or other description material, in whole or in part, which is said to be incorporated into the present invention as a reference, is incorporated into the present invention only to the extent that the incorporated materials do not come into effect. conflict with existing definitions, statements or other description material presented in this description. Accordingly, and to the extent necessary, the description as explicitly stated herein replaces any conflicting material incorporated herein by way of reference. Any material, or portion thereof, that is deemed to be incorporated by reference in the present invention, but which conflicts with definitions, statements, or other description materials existing herein will be incorporated here only to the extent that no conflict will appear between the embedded material and the existing description material.

权利要求:
Claims (13)
[1]
1. Surgical generator to provide a trigger signal for a surgical device comprising:
a surgical generator body that has an opening; and a receptacle assembly positioned in the opening, the receptacle assembly comprising:
a receptacle body;
a flange having an inner wall and an outer wall, the inner wall comprising at least one curved section and at least one linear section, the inner wall defining a cavity; and a protruding central portion positioned in the cavity, the central projection portion comprising a plurality of sockets;
characterized by the fact that the central portion still comprises a magnet and an outer periphery comprising at least one curved section and at least one linear section.
[2]
2. Surgical generator, according to claim 1, characterized by the fact that at least one curved section of the outer periphery is formed similarly to at least one curved section of the inner wall.
[3]
3. Surgical generator, according to claim 2, characterized by the fact that at least one linear section of the outer periphery is parallel to at least one linear section of the inner wall.
[4]
4. Surgical generator, according to claim 1, characterized by the fact that the protruding central portion defines a central recess, in which the magnet is positioned close to the central recess.
[5]
5. Surgical generator, according to claim 1, ca
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2/3 characterized by the fact that the flange has a flange surface and the protruding central portion has a central surface, where the flange surface is inclined in relation to the central surface.
[6]
6. Surgical generator, according to claim 5, characterized by the fact that the surgical generator body comprises an inclined surface, in which the opening is positioned on the inclined surface, and in which the inclined surface is parallel to the outer surface of the flange .
[7]
7. Surgical instrument comprising:
an electrical connector assembly comprising:
a flange defining a central cavity, wherein the flange comprises at least a curved portion and at least a linear portion;
a circuit board;
a plurality of electrically conductive pins coupled to the circuit board, each of the plurality of electrically conductive pins extends into the central cavity;
a stress-relieving member; and a boot.
characterized by the fact that the connector assembly still comprises a magnetically compatible pin that is attracted to magnetic fields or that is magnetizable and extending into the central cavity, and in which the connector assembly is insertable within a receptacle assembly, so that the magnetically compatible pin is positioned to meet the magnet's magnetic field to assist in connection with the surgical generator when the connector set is inserted from the receptacle set.
[8]
8. Surgical instrument system comprising the genus
Petition 870190093148, of 09/18/2019, p. 146/151
3/3 surgical instrument as defined in claim 1 and the surgical instrument as defined in claim 7, characterized by the fact that:
an outer wall of the surgical instrument flange as defined in claim 7 is shaped similarly to the inner wall of the surgical generator receptacle set as defined in claim 1; and an internal flange wall of the surgical instrument as defined in claim 7 is shaped similarly to the outer periphery of the central protruding portion of the surgical generator as defined in claim 1.
[9]
9. Surgical instrument system, according to claim 105, characterized by the fact that it comprises a surgical instrument identification circuit coupled to the circuit board.
[10]
10. Surgical instrument system, according to claim 9, characterized by the fact that the surgical instrument identification circuit comprises at least one of an EEPROM and a resistor.
[11]
11. Surgical instrument system, according to claim 8, characterized by the fact that in the central protruding portion, the plurality of sockets is arranged in a generally circular formation and the magnet positioned internally to the generally circular formation.
[12]
12. Surgical instrument system, according to claim 11, characterized by the fact that in the connector assembly, the magnetically compatible pin is a ferrous pin.
[13]
13. Surgical instrument system according to claim 12, characterized by the fact that the ferrous pin is cylindrical and comprises a shoulder.

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-01-28| B09A| Decision: intention to grant|

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2020-03-31| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/10/2010, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US25021709P| true| 2009-10-09|2009-10-09|

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US61/250,217|2009-10-09|

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US12/896,467|US9050093B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

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US12/896,384|US8951248B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

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US12/896,467|2010-10-01|

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US12/896,479|2010-10-01|

---

US12/896,451|US9039695B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

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US12/896,345|2010-10-01|

---

US12/896,360|US9060775B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

---

US12/896,470|US9060776B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

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US12/896,384|2010-10-01|

---

US12/896,451|2010-10-01|

---

US12/896,470|2010-10-01|

---

US12/896,345|US8986302B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

---

US12/896,479|US8956349B2|2009-10-09|2010-10-01|Surgical generator for ultrasonic and electrosurgical devices|

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US12/896,360|2010-10-01|

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PCT/US2010/051787|WO2011044338A2|2009-10-09|2010-10-07|Surgical generator for ultrasonic and electrosurgical devices|

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