巴西专利BR112012018797B1 SURGICAL INSTRUMENT

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专利摘要:
surgical cutting instrument that analyzes the thickness of the tissue. the present invention relates to a surgical instrument (10) with an end actuator for fixing tissue (12), in which the actuation of the instrument (10) is locked when the thickness of the tissue fixed to the end actuator (12) does not is within the specified thickness range. the end actuator (12) can comprise a tissue thickness module (60) that detects the thickness of the tissue attached to the end actuator (12). the surgical instrument (10) additionally comprises a control circuit (100) in communication with the tissue thickness module (60). the control circuit (100) prevents the working portion of the end actuator (12) from operating when the thickness of the fabric attached to the end actuator (12) is not within the specified thickness range.
公开号:BR112012018797B1
申请号:R112012018797-0
申请日:2010-12-06
公开日:2021-03-30
发明作者:Brett E. Swensgard；Bret W. Smith；Ryan J. Laurent
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

BACKGROUND OF THE INVENTION
[0001] Surgical staplers are used to make a longitudinal incision in the tissue and simultaneously apply staple lines to opposite sides of the incision. Such instruments commonly include an end actuator having a pair of cooperating claw members which, if the instrument is intended for endoscopic or laparoscopic applications, is capable of passing through a cannula passage. One of the claw members receives a staple cartridge having at least two rows of staples laterally spaced — one on each side of the scalpel channel. The other claw member defines an anvil having staple-forming pockets aligned with the staple rows within the cartridge. The instrument includes a plurality of reciprocating wedges that, when operated distally, pass through the openings in the staple cartridge and engage drivers that support the staples to discharge the staples towards the anvil. Simultaneously, a cutting instrument (or scalpel) is pulled distally along the claw member, so that the fixed tissue is cut and joined (for example, stapled) at the same time.
[0002] An example of a surgical stapler suitable for endoscopic applications is described in the publication of US patent application No. 2004/0232196 A1, entitled "Surgical stapling instrument having separate distinct closing and firing systems", the description of which is incorporated herein, reference title in its entirety. In use, a doctor is able to close the staple's claw members on the fabric to position it before unloading staples. When the doctor determines that the claw members are properly holding the tissue, the doctor can then unload the surgical stapler, thus sectioning and stapling the tissue. The simultaneous sectioning and stapling actions avoid complications that may arise during the performance of these actions in sequence with different surgical instruments that, respectively, only section or staple the tissue.
[0003] Motor-driven endoscopic autosuture instruments are known in the art. In these devices, an electric motor drives the cutting and joining action of the instrument. It is also known to use an onboard battery, located on the instrument's cable, to power the engine. The publication of US patent application No. 2007/0175952 A1, entitled "Motor-driven surgical cutting and fastening instrument with loading force feedback", the description of which is incorporated herein, for reference in its entirety, describes one of these operated surgical instruments per engine. SUMMARY
[0004] In a general aspect, the present invention relates to a surgical instrument with a tissue fixation end actuator, in which the performance of the instrument is blocked when the thickness of the tissue attached to the end actuator is not within the specified thickness range. According to various modalities, the end actuator comprises a tissue thickness module that detects the thickness of the tissue attached to the end actuator. The surgical instrument also comprises a control circuit in communication (for example, wireless communication) with the tissue thickness module. The control circuit prevents the working portion of the end actuator from operating when the thickness of the tissue attached to the end actuator is not within the specified thickness range. In this way, the instrument's performance can be stopped when excess or insufficient tissue is attached to the end actuator. This prevents the instrument from being discharged in situations where it should not be discharged.
[0005] According to various implementations, the end actuator comprises: first and second opposing claw members; and a disposable cartridge (such as a disposable staple cartridge) located on the first jaw member. The fabric thickness module can be part of the disposable cartridge, and can comprise a Hall effect sensor. The second claw member may comprise a magnet, the Hall effect sensor detecting the resistance of the magnet's magnetic field which is indicative of the thickness of the tissue attached to the end actuator. The tissue thickness module communicates data to the control circuit, the data comprising: (i) data indicating the thickness of the tissue attached to the end actuator; and (ii) data indicative of the cartridge type of the disposable cartridge. The control circuit may comprise a processing unit programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge based on data communicated to the control circuit by the tissue thickness module. In this connection, the control circuit may comprise solid state memory that stores thickness range data for one or more types of cartridges. The processing unit can be programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge, based on the data communicated to the control circuit by the tissue thickness module by comparing the indicative data the thickness of the fabric attached to the end actuator with the stored thickness range data for the cartridge type of the disposable end actuator cartridge. FIGURES
[0006] Various modalities of the present invention are described here by way of example, in connection with the figures presented below, in which: Figures 1-2 and 12 are seen in perspective of a surgical instrument according to various modalities of the present invention; figures 3-5 are an exploded view of the end actuator and stem of a surgical instrument in accordance with various embodiments of the present invention; figures 6-7 are views of the end actuator according to various embodiments of the present invention; Figure 8 is a block diagram of the fabric thickness module according to various embodiments of the present invention; figure 9 is a block diagram of the motor control circuit according to various embodiments of the present invention; figure 10 is a block diagram of the radio module according to various embodiments of the present invention; and figure 11 is a flow chart of the process performed by the motor control circuit according to various modalities of the present invention. DESCRIPTION
[0007] Certain embodiments of the present invention will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the devices and methods described here. One or more examples of three modalities are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described and illustrated in the accompanying drawings are exemplary non-limiting modalities, and that the scope of the various modalities is defined only by the claims. The characteristics illustrated or described in relation to one modality can be combined with the characteristics of other modalities. These modifications and variations are intended to be included in the scope of the appended claims.
[0008] In general, the modalities of the present invention are aimed at a surgical instrument that prevents the discharge of the instrument if the thickness of the tissue attached to the instrument's end actuator is outside the acceptable limits (for example, too thick or too thin) . In this way, the instrument can be prevented from being discharged in situations where it should not be activated. If the thickness of the tissue is not within the acceptable limits for the instrument, the operator (for example, doctor) can adjust the thickness of the tissue or change the cartridge, for example.
[0009] The instrument can be a motor driven instrument or a manually driven instrument, according to various modalities. Figures 1 and 2 represent a motor-operated surgical cutting and joining instrument 10, in accordance with various modalities of the present invention. The illustrated modality is a linear endoscopic instrument and, in general, the instrument 10 described here are cutting and joining endoscopic surgical instruments. It should be noted, however, that the invention is not so limited and that, according to other embodiments of the present invention, the instrument can be another type of endoscopic instrument, such as a circular or curved endoscopic autosuture instrument. In addition, the instrument can be a non-endoscopic cutting and joining surgical instrument, such as a laparoscopic or open instrument.
[00010] The surgical instrument 10 shown in figures 1 and 2 comprises a cable 6, a stem 8 and an end actuator 12 connected to the stem 8. In various embodiments, the end actuator 12 can be articulated around a pivot of pivot 14. A pivot control 16 can be provided adjacent to the cable 6 to rotate the end actuator 12 over the pivot pivot 14. In the illustrated embodiment, the end actuator 12 is configured to act as an endoscopic self-suturing instrument. for fixing, sectioning and stapling the tissue, although, in other modalities, different types of end actuators can be used, such as end actuators for other types of surgical devices, such as claws, cutters, clamps, clamp applicators, access devices , drug / gene therapy devices, ultrasound, RF or laser devices, etc. More details regarding RF devices can be found in US patent 5,403,312 and in US patent application serial number 12 / 031,573, entitled "Surgical cutting and fastening instrument having RF electrodes", filed on February 14, 2008, which are hereby incorporated, as a reference in their entirety.
[00011] The cable 6 of the instrument 10 can include a closing trigger 18 and a discharge trigger 20 to drive the end actuator 12. It will be recognized that instruments that have end actuators directed to different surgical tasks can have numbers or types other than triggers or other controls suitable for operating end actuator 12. End actuator 12 is shown separately from cable 6 by a rod 8, preferably elongated. In one embodiment, a physician or instrument operator 10 can articulate the end actuator 12 in relation to the stem 8 by using the articulation control 16, as described in more detail in the publication of US patent application No. 2007/0158385 A1, entitled "Surgical Instrument Having An Articulating End Effector", by Geoffrey C. Hueil et al., incorporated herein, as a reference in its entirety.
[00012] The end actuator 12 includes, in this example, among other things, a clamp channel 22 and an articulably translatable fixing member, such as an anvil 24, which are kept in a spacing that ensures, when the anvil 24 is in its fixed position, effective stapling or sectioning of the tissue attached to the end actuator 12. Cable 6 includes a pistol grip that extends downwards 26 in a direction where a closing trigger 18 is pulled pivoting by the doctor, to cause the anvil 24 to be fixed or closed towards the clip channel 22 of the end actuator 12 to thereby fix the tissue positioned between the anvil 24 and the channel 22. The discharge trigger 20 is further away from the closing trigger 18. Once the closing trigger 18 is locked in the closed position, the discharge trigger 20 can rotate slightly towards the pistol grip 26, so that it can be reached by the operator with the use of one hand. Then, the operator can pull the discharge trigger 20 in an articulated manner towards the pistol grip 12 to cause stapling and sectioning of the tissue attached to the end actuator 12. In other embodiments, different types of limbs can be used. attachment, in addition to the anvil 24. The handle 6 may also include an upper portion 28 which can rest on the top of the user's hand when the user grips the pistol grip portion 26 with his hand.
[00013] It will be recognized that the terms "proximal" and "distal" are used here with reference to the act of holding the handle 6 of an instrument 10 by the physician. Therefore, the end actuator 12 is distal to the most proximal cable 6. It will be further recognized that, for convenience and clarity, the spatial terms such as "vertical" and "horizontal" are used in the present invention in relation to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[00014] In operational use, the closing trigger 18 can be activated first. When satisfied with the positioning of the end actuator 12, the physician can retract the closing trigger 18 to the fully closed and locked position adjacent to the pistol grip 26. Stretching the rear of the closing trigger 18 causes the anvil 24 rotate downwards, securing the fabric between the anvil 24 and the groove 27. The discharge trigger 20 can then be actuated. The actuation of the discharge trigger 20 causes the cutting instrument on the end actuator 12 to section the fixed tissue, and causes the joining elements on the end actuator to join the sectioned tissue. The discharge trigger 20 returns to its open position (shown in figures 1 and 2) when the doctor removes the pressure. A release button 19 on the handle 6, when lowered, can release the locked trigger 18. The release button 19 can be implanted in various ways, for example, as presented in the publication of patent application No. 2007/0175955 , entitled "Surgical cutting and fastening instrument with closure trigger locking mechanism", which is incorporated here, as a reference in its entirety.
[00015] The end actuator 12 may include a cutting instrument, such as a scalpel, to cut the tissue attached to the end actuator 12 when the discharge trigger 20 is retracted by a user. The end actuator 12 may also comprise means for joining the sectioned tissue by the cutting instrument, such as staples, RF electrodes, adhesives, etc. More details regarding possible configurations of end actuator 12 can be found in the following patents and published patent applications, which are incorporated herein, for reference in their entirety: patent no. 5,709,680; patent No. 5,688,270; patent No. 7,000,818; publication no. 2005/0173490 A1; publication No. 2006/0025809 A1; U.S. publication No. 2007/0102453 A1; No. 2007/0102452 A1; publication No. 2009/0206134 A1; and publication No. 2009/0206124 A1.
[00016] The instrument 10 can also comprise a closing system to close (or fix) the end actuator after closing (or retracting) the closing trigger 18. More details regarding the modalities of an exemplary closing system for closing ( or fixation) of the anvil 24 of the end actuator 12 by retracting the closing trigger 18 are provided in the following US patent references, which are incorporated herein by way of reference in their entirety: publication no. 2004/0232196 A1; publication No. 2007/0125956 A1; publication No. 2007/0158385 A1; publication no. 2007/0175962 A1; patent No. 7,464,849; and the references cited in the paragraph above.
[00017] A longitudinally movable or rotating actuating rod located inside the rod 8 of the instrument 10 can drive / drive the cutting instrument and the fixing means in the final actuator 12. An electric motor, located in the pistol grip portion 26 of the cable 6 of instrument 10, can be used to drive, directly or indirectly (by a gear train), the drive rod. In several modalities, the motor can be a DC brush drive motor having a maximum speed of approximately 25,000 RPM. In other embodiments, the motor may include a brushless motor, a wireless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The battery (or "power supply" or "battery"), like a Li ion battery, can be provided in the pistol grip portion 26 of the cable 6 adjacent to the engine. The battery supplies electrical power to the engine through an engine control circuit. According to various modalities, several batteries connected in series can be used as the power source to power the engine. In addition, the power supply can be replaceable and / or rechargeable.
[00018] As described in more detail below, the operation of the motor can be controlled by a processor or control circuit based on a microcontroller, which can be located on handle 6 of the instrument 10, close to the motor and the battery pack. The control circuit can receive input from the end actuator 12 referring to the thickness of the tissue fixed between the opposing jaws (for example, the clamp channel 22 and the anvil 24) from the end actuator 12. The control circuit can be in communication with the tissue thickness sensing module of the wireless end actuator 12 or by a wired connection. If the control circuit determines that the attached tissue is not within acceptable limits (for example, too thick or too thin) based on the input of the tissue thickness detection module, the control circuit may stall the motor operation, thus preventing operation of the instrument. Before describing the control circuit, a description of the end actuator 12 and the tissue thickness detection module is provided.
[00019] Figure 3 is a diagram of end actuator 12 according to various embodiments of the present invention. As shown in the illustrated embodiment, the end actuator 12 may include, in addition to the channel 22 and the anvil 24 previously mentioned, a cutting instrument 32, a rail 33, a staple cartridge 34 which is removably seated in the channel 22, and a helical screw rod 36. The cutting instrument 32 can be, for example, a knife. The anvil 24 can be pivoted open and closed on the pivot pins 25 connected to the adjacent end of the channel 22. The anvil 24 can also include a flap 27 at its adjacent end which is inserted into a component of a mechanical closing system to open and close the anvil 24. When the closing trigger 18 is actuated, that is, it is extracted by a user of the instrument 10, the anvil 24 can pivot around the pivot pins 25 to the fixed or closed position, thus fixing the fabric between the channel 22 and anvil 24. If the fixation of the end actuator 12 is satisfactory, the operator can activate the discharge trigger 20, which causes the scalpel 32 and the rail 33 to run longitudinally along the channel 22, cutting from that mode the fabric fixed inside the end actuator 12. The movement of the sliding support 33 along the channel 22 causes the clips (not shown) of the clip cartridge 34 to be activated through the separate fabric and in in relation to the closed anvil 24, which turns the clips to join the separated tissue. In various embodiments, rail 33 can be an integral component of cartridge 34. US patent No. 6,978,921, entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM", granted to Shelton, IV et al., Which it is incorporated here, as a reference in its entirety, it provides more details on these instruments for cutting and joining two strokes. The rail 33 can be part of the cartridge 34, so that when the knife 32 retracts after the cutting operation, the rail 33 does not retract.
[00020] Figures 4-5 are exploded and figure 6 is a side view of end actuator 12 and stem 8, according to various non-limiting modalities. As shown in the illustrated embodiment, the stem 8 may include an adjacent closing tube 40 and a distal closing tube 42 pivotally connected by pivot connections 44. The distal closing tube 42 includes an opening system 45 within which the flap 27 on anvil 24 is inserted in order to open and close anvil 24, as further described below. Arranged within the closing tubes 40, 42 may be an adjacent structuring tube 46. Arranged within the adjacent structuring tube 46 may be a main (or adjacent) rotational drive shaft 48 that communicates with a secondary (or distal) driving shaft 50 via a bevel gear set 52. The secondary drive shaft 50 is connected to a drive gear 54 that engages an adjacent drive gear 56 of the helical screw rod 36. The vertical bevel gear 52b can rest and pivot in an opening 57 at the distal end of the adjacent structuring tube 46. A distal structuring tube 58 can be used to close the secondary drive shaft 50 and drive gears 54, 56. Collectively, the main drive shaft 48, the secondary drive shaft 50 and the pivot assembly (e.g. bevel gear assembly 52 a - c) are sometimes referred to in the present invention "main drive rod assembly".
[00021] A bearing 38, positioned at a distal end of the clamp groove 22, receives the helical screw 36, allowing the helical screw 36 to rotate freely in relation to the groove 22. The helical screw rod 36 can interconnect a threaded opening ( not shown) of knife 32 so that the rotation of the rod 36 causes the knife 32 to rotate distally or proximally (depending on the direction of rotation) through the clamp groove 22. Consequently, when the main drive shaft 48 is rotated by the actuation of the discharge trigger 20, the set of bevel gears 52a - c causes the secondary drive shaft 50 to rotate, which, in turn, due to the engagement of the drive gears 54, 56, causes the helical screw rod 36 rotates, which causes the knife drive element 32 to run longitudinally along the channel 22 to cut any tissue attached within the end actuator. The track 33 can be produced from, for example, plastic, and can have an inclined distal surface. As the sliding support 33 passes through the channel 22, the sloping front surface can push up or activate the staples on the staple cartridge through the fixed fabric and against the anvil 24. The anvil 24 turns the staples, thus stapling the cut fabric . When the knife 32 is retracted, the scalpel 32 and the rail 33 can be disengaged, thus leaving the rail 33 at the distal end of the channel 22.
[00022] In the illustrated embodiment, the end actuator uses a rotating helical screw rod 36 to drive the cutting instrument 32. This helical screw can be used in modalities in which a rotating drive member is used. In other embodiments, a longitudinally reciprocating drive member can be used to feed the cutting instrument. The end actuator 12 can therefore be modified to suit that longitudinally reciprocating drive member. Further details regarding these end actuators can be found in U.S. Patent Nos. 7,140,528 and No. 7,000,819, which are incorporated herein by reference in their entirety.
[00023] According to various embodiments, the replaceable staple cartridge 34 may comprise a thickness of the tissue detection module that detects the thickness of the tissue attached to the end actuator 12 between the staple channel 22 (including the staple cartridge 34 ) and the anvil 24. According to several non-limiting modalities, as shown in figure 7, the tissue thickness detection module 60 can be located at the distal end 62 of the staple cartridge 34, so that it is away from the staples of the staple. staple cartridge 34 when staples are triggered. Figure 8 is a block diagram of the tissue thickness detection module 60, according to various modalities. As shown in figure 8, the tissue thickness detection module 60 may comprise a tissue thickness sensor 64, a controller 65, a radio module 70 and a power supply 74. Controller 65 may comprise a processing unit (CPU) 66 and a memory unit 68. In various embodiments, the tissue thickness sensor 64 can comprise a Hall effect sensor that detects the thickness of the tissue attached to the end actuator 12 based on the magnetic field of a magnet 78 located, for example, at a distal end 80 of anvil 24, as shown in figure 7. When the doctor closes anvil 24 by retracting the closing trigger 18, magnet 78 rotates downward next to sensor 64, thus varying the magnetic field detected by sensor 64 when the anvil 24 rotates to the closed (or fixed) position. The resistance of the magnetic field of the magnet 78 and detected by the sensor 64 is indicative of the distance between the channel 22 and the anvil 24, which is indicative of the thickness of the tissue fixed between the channel 22 and the anvil 24 when the end actuator 12 is in a closed (or fixed) position.
[00024] The memory unit 68 of the controller 65 may comprise one or more read-only memories in solid state (ROM) and / or random access memory units (RAM). In various embodiments, CPU 66 and memory unit (s) 68 can be integrated with a unit integrated circuit (IC), or multiple ICs. The ROM memory unit (s) may comprise flash memory. The ROM memory unit (s) can store encrypted instructions to be executed by CPU 66 of controller 65. In addition, the ROM memory unit (s) can store data indicative of the cartridge type of cartridge 34. That is, for example, the ROM 68 memory unit (s) can store data indicative of the model type of the staple cartridge 34. As further explained below, the The control motor on the cable 6 of the instrument 10 can use the fabric thickness information and the model type of the staple cartridge 34 to determine whether the fabric attached to the end actuator 12 is too thick or too thin, based on the fabric thickness specified for the specific staple cartridge 34. The radio module 70 can be a low energy two-way radio module that communicates wirelessly, using a wireless communication protocol, with the motor control circuit on cable 6 of the instrument 10. According to several modalities, the radio module 70 can communicate with the motor control circuit using a communication frequency suitable for transmission through human tissue. Communications between the radio module 70 and the motor control circuit may use a MICS (Medial Implant Communication Services) frequency band (402 to 405 MHz), an appropriate industrial, scientific and medical (ISM) radio band (such as the central frequency 433 MHz or central frequency 915 MHz), or any other frequency band that is permeable to human tissue. The power supply 74 may comprise a battery suitable for supplying the components of the tissue thickness detection module 60, such as a lithium ion battery or some other suitable battery cell.
[00025] Figure 9 is a diagram of the motor control circuit 100 according to several non-limiting modalities. The control circuit for motor 100 can be located on cable 6 of instrument 10, close to motor 104 and battery pack 106, and away from the tissue thickness detection module 60 on end actuator 12 by stem 8, for example . Thus, the motor control circuit 100 can communicate wirelessly with the tissue thickness detection module 60 as described in the present invention, although in other embodiments, there may be a wired connection, with wires passing through the stem 8 between the motor control circuit 100 and the tissue thickness detection module 60 to manipulate communications between them.
[00026] As shown in figure 9, the motor control circuit 100 may, according to various modalities, comprise a power switching circuit 101, a controller 108 and a radio module 110. The radio module 110 can be communicate with the radio module 70 of the tissue thickness detection module 60. Therefore, the radio module 100 can be a low-energy module that operates on the same frequency as the radio module 70 and uses the same communication protocol. The radio modules 70, 100, as shown in figure 10, may comprise, according to various modalities, transmit and receive antennas 200, 202, an antenna key 204, a transmit / receive key 206, a modulator / demodulator of RF 208, an encoder / decoder (codec) 210 and a baseband processor 212. The antennas 200, 2002 of the motor control circuit 100 and the fabric thickness detection module 60 can be microfiber antennas, for example.
[00027] The power switching circuit 101 may, according to various modalities, comprise a power switch 103 and a forward / reverse switch 102, which collectively connect the motor 104 and the battery pack 106 in order to connect the supplying battery pack 106 to engine 104. In various modes, the forward / reverse switch 102 may comprise a double pole / double stroke relay which, depending on its polarity, determines whether the rotation of motor 104 will be forward or back. Controller 108 can control the operation of keys 102-103. In various embodiments, controller 108 can be deployed as a microcontroller comprising a processing unit (CPU) 114 and memory 116. Memory 116 may comprise solid-state ROM and / or RAM. The ROM memory unit (s) may comprise an instruction code that is executed by the processing unit 114. The processing unit 114 and memory 116 can be integrated into a single IC, or can be used multiple CIs. Controller 108 and radio module 112 of motor control circuit 100 can be powered by battery pack 106.
[00028] As shown in figure 9, controller 108 can receive several inputs and, based on the processing of these inputs, it can control switches 102-103, in order to properly control the motor 104 of the instrument 10. The Controller inputs 108 can include a discharge input 120, a cutting instrument position input 122, and any other suitable inputs. The discharge input 120 can indicate the state of the discharge trigger 20, such as whether the physician retracted the discharge trigger 20 to initiate a cutting stroke by the scalpel on the end actuator 12 and whether the physician released the discharge trigger 20 to terminate the cutting stroke. The discharge input 120 can be from a sensor, such as a proportional key, responsive to the discharge trigger 20. The input of the position of the cutting instrument 122 can indicate the position of the cutting instrument 34 in the end actuator 12 during the cutting stroke. Controller 108 can use this input to determine the position of the cutting instrument 34 in the cutting stroke, as if the cutting instrument 34 is close to / at the end of the cutting stroke. As the cutting instrument 34 approaches the end of the cutting stroke, controller 108 can reduce the rotation speed of motor 104, and can reverse the rotation of motor 104 when the cutting instrument 34 reaches the end of the cutting stroke. cut. Controller 108 can also reduce the speed of rotation of motor 104 when the cutting instrument is close to its initial resting position, at the end adjacent to the end actuator 12 when the cutting instrument is retracted, and can stop the motor 104, when the cutting instrument is fully retracted More details regarding a proportional discharge trigger key are provided in the following US patent references, which are incorporated herein by reference in their entirety: publication no. 2007/0175957; publication no. 2007/0175958; and publication no. 2007/0175959. Further details regarding instruments with cutting instrument position sensors are provided in the following U.S. patent references, which are incorporated herein by way of reference in their entirety: order no. 12 / 235,782; and order no. 12 / 235,972.
[00029] Of course, controller 108 also receives input data from tissue thickness detection module 60 via radio module 110. Input data from tissue thickness detection module 60 may include: (i) thickness data of the tissue, as detected by sensor 64 of the tissue thickness detection module 60; and (ii) cartridge model data indicative of the model type of staple cartridge 34, which is stored in memory 68 of the tissue thickness detection module 60. Based on this data, controller 108 of the control circuit of the motor 100 can determine whether the fabric attached to end actuator 12 is within the range specified for the specific staple cartridge 34. If the fabric thickness is within the specified range, controller 108 can control keys 102-103 so that power is connected to motor 104 (assuming other input data is adequate). On the other hand, if the thickness of the fabric is not within the specified range, controller 108 can control switch 103 so that the power is not connected to motor 104, thereby blocking motor 104 based on the thickness of the fabric and preventing operation of the instrument 10.
[00030] Figure 11 is a flow chart of a process performed by controller 108, according to several modalities. The process can be performed by the processing unit 114 by executing the code stored in memory 116. The process can be started in step 150, where controller 108 determines whether the thickness of the fabric attached to the end actuator 12 is within the range specified for a specific staple cartridge 34. Controller 108 can perform the determination by comparing the tissue thickness data on sensor 64 with the specified range of a specific staple cartridge 34. Controller 108 can determine the specified thickness range for the staple cartridge using (i) staple cartridge model data transmitted by the tissue thickness detection module 60 and (ii) a look-up table (or other data storage structure) in the controller memory 116, which stores data indicating the specified thickness range for numerous types of staple cartridge models. The specified thickness range can include a minimum thickness and a maximum thickness for each type of model. For example, different types of cartridge models may have staples of different lengths. Longer staples can accommodate more tissue in the end actuator than cartridges with shorter staple lengths. In this way, the upper thickness limit can be higher for cartridges with longer staples, and the lower thickness limit can be lower for cartridges with shorter length staples. If the thickness of the attached fabric is less than the minimum thickness or greater than the maximum thickness for the cartridge model type 34, the fabric thickness is outside the specified range.
[00031] If the thickness of the fabric is outside the specified thickness range for the staple cartridge 34, the process proceeds to step 152, in which controller 108 controls the power switch 103, so that the power switch 103 is open, in a non-conductive state, so that the battery pack 106 power is not coupled to the engine 104. Thus, the engine 104 does not receive power and is kept out of operation, thus preventing the end actuator from starting 12. On the other hand, if the thickness of the fabric is within the specified thickness range for the staple cartridge 34, the process proceeds to step 154, in which controller 108 determines whether the discharge trigger 20 is retracted based on discharge inlet 120. If not, the process proceeds to step 152 so that the battery pack 106 is not coupled to motor 104. If, on the other hand, discharge trigger 20 is retracted, the process proceeds for step 156, in which controller 108 determines the position of the cutting instrument 34 in the cutting stroke based on the position input of the cutting instrument 22. If the position of the cutting instrument is in the advance stroke, the process proceeds to step 158, in which controller 108 generates a control signal for the forward / reverse switch 102 to cause the forward / reverse switch 102 to be in a state that powers the motor 104, so that the motor 104 rotates forward. Conversely, if the position of the cutting instrument in the cutting stroke requires the reverse rotation of motor 104, the process proceeds to step 160, in which controller 108 generates a control signal for the forward / reverse switch 102 to make that the forward / reverse switch 102 is in a state that engages power to engine 104 so that engine 104 rotates backwards. The process can be performed continuously during a surgical procedure involving the instrument 10. Thus, if, for some reason, the thickness of the tissue leaves the band during the procedure, controller 108 can take the appropriate measures in response to the data in question. real tissue thickness time received from tissue thickness module 60.
[00032] Returning to figure 9, controller 108 can also receive feedback from motor 104 regarding the conditions of motor 104, such as rate of rotation, direction of rotation, etc. Controller 108 can use the data to control motor 104. Additionally, controller 108 can release control signals to one or more of the output devices 124. Output devices 124 may comprise visual indicators, such as illuminators (for example, diodes light emitting devices) and / or audible indicators, such as speakers. For example, output devices 124 may comprise several LEDs located outside the instrument cable 6 and visible to the instrument operator 10 when instrument 10 is in use. An LED can be turned on when the thickness of the attached fabric is in the specified thickness range for the staple cartridge; a second LED can be turned on when the thickness of the attached fabric is outside the specified thickness range for the staple cartridge; a third LED can be turned on when motor 104 is turning forward, a fourth LED can be turned on when motor 104 is turning back, etc.
[00033] In addition, in other embodiments, the transmissions of the fabric thickness module 60 can be received by a receiver other than the motor control circuit 100. For example, with reference to figure 12, the transmissions of the thickness module of the motor fabric 60 can be received by a visual display unit 160 and / or by a computer system 170. The visual display unit 160 can comprise an RF radio module 162 for communication with the fabric thickness module 60. Images based in the data of the tissue thickness module 60 can be displayed on the screen 160. In this way, the doctor can consult in real time the data relating to the tissue thickness fixed during the entire procedure involving the instrument 10. The visual display unit 160 can comprise a monitor, such as a CRT monitor, a plasma monitor, an LCD monitor, or any other suitable display monitor. Similarly, computer system 170 may comprise an RF radio module 172 for communication with tissue thickness module 60. Computer system 170 may store data for tissue thickness module 60 in a memory unit ( for example, a ROM or hard drive) and can process the data with a processor.
[00034] The surgical instruments described here can also be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the disassembly steps of the surgical instrument, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, the surgical instrument can be disassembled, and any number of particular parts or parts of the device can be selectively replaced or removed, in any combination. When cleaning and / or replacing specific parts, the surgical instrument can be reassembled for subsequent use in the reconditioning facility, or by a surgical team immediately before a surgical procedure. Those skilled in the art will recognize that the reconditioning of a surgical instrument can use a variety of techniques for disassembly, cleaning / replacement and reassembly. The use of such techniques and the resulting reconditioned surgical instrument are within the scope of the present application.
[00035] Preferably, the surgical instrument described here will be processed before surgery. First, a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK pouch. The container and the instrument are then placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays or high-energy electrons. The radiation kills bacteria on the instrument and the container. The sterile instrument can then be stored in a sterile container. The sterile container keeps the instrument sterile until it is opened at the medical facility.
[00036] In several modalities, some components of the instrument 10 can be part of a replaceable and removable set that can be inserted in the instrument 10 after the instrument 10 has been sterilized. For example, with reference to figure 9, in several embodiments, the battery pack 106, the controller 108 and the radio module 110 can be part of a replaceable and removable set 140 that can be inserted in the cable 6 of the instrument 10 after the instrument has been sterilized. For example, the replaceable and removable assembly 140 can be transferred aseptically to the instrument 10 after the instrument has been sterilized. In such embodiments, the assembly 140 may have external connectors suitable for connection to the motor 104, the switching circuit 101, the inputs 120, 122 and the output devices 124, etc. In such an embodiment, therefore, the set 140 can be reused on multiple instruments 10. The cartridge 34 can be discarded after each use.
[00037] The above modalities have been described in the context of linear endoscopic self-suturing devices with the staple cartridge. It should be noted that the tissue thickness module 60 and the corresponding control circuit 100 can be used in any surgical instrument that has an end actuator used to fix the tissue where the thickness of the attached tissue is an important consideration in the procedure. For example, the tissue thickness module 60 and the corresponding control circuit 100 can be used in circular endoscopic self-suturing devices or in other types of cutting / joining devices, such as laparoscopic devices. In addition, the fabric thickness module 60 and the corresponding control circuit 100 do not need to be used in a device with the use of clamps to join the sectioned fabric, but they can also be used in instruments using other means to join the fabric. sectioned tissue, as noted above. In addition, the fabric thickness module 60 and the corresponding control circuit 100 do not need to be used in instruments that have a motor. In these embodiments, the instrument 10 can employ a mechanical lock to prevent discharge. One such locking mechanism is described in U.S. Patent Application Publication No. 2006/0025811, which is hereby incorporated by reference in its entirety.
[00038] In several embodiments, therefore, the present invention is directed to a surgical instrument 10 comprising an end actuator for fixing tissue 12. In various embodiments, the end actuator 12 comprises a mobile working instrument (for example, a cutting instrument) 34 and a tissue thickness module 60 that detects the thickness of the tissue attached to the end actuator 12. The surgical instrument 10 also comprises a control circuit 100 in communication with the tissue thickness module, where the control circuit prevents the working instrument from acting when the thickness of the tissue attached to the end actuator is not within the specified thickness range. According to various implementations, the end actuator comprises: first and second opposing claw members 22, 24; and a disposable cartridge 34 (such as a disposable staple cartridge) located on the first jaw member 22, the tissue thickness module being part of the disposable cartridge. In addition, the tissue thickness module may comprise a Hall 64 effect sensor, and the second claw member comprises a magnet 78, wherein the Hall effect sensor detects a magnetic field resistance of the magnet, which is indicative of the thickness of the magnet. fabric attached to the end actuator when the end actuator is in the closed (or fixed) position. In addition, the tissue thickness module communicates data to the control circuit, the data comprising: (i) data indicating the tissue thickness attached to the end actuator; and (ii) data indicative of the cartridge type of the disposable cartridge.
[00039] The control circuit may comprise a processing unit 114 programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge, based on data communicated to the control circuit by the thickness module of the fabric, including the data indicating the thickness of the fabric attached to the end actuator and the data indicating the type of cartridge of the disposable cartridge. In addition, the control circuit may comprise solid state memory 116 which stores thickness range data for one or more types of cartridges. The processing unit can be programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge, based on the data communicated to the control circuit by the tissue thickness module by comparing the indicative data the thickness of the fabric attached to the end actuator with the stored thickness range data for the cartridge type of the disposable end actuator cartridge.
[00040] In addition, the surgical instrument may also comprise an electric motor 104 that acts on the drive rod 48, 50, and a set of batteries 106 that supplies electrical energy to the electric motor. The control circuit can prevent the electric motor from operating when the thickness of the fabric attached to the end actuator is not within the specified thickness range.
[00041] Additionally, in several modalities, the tissue thickness module is in wireless communication with the control circuit. The tissue thickness module may comprise a first radio module and the control circuit may comprise a second radio module, in which the first radio module communicates wirelessly with the second radio module. In addition, the tissue thickness module may be communicating with a remote visual display unit or a remote computer system.
[00042] Although this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of the description. It is intended, therefore, that this application will cover any variations, uses or adaptations of the invention with the use of its general principles. In addition, this application is intended to cover such changes to the present description, in accordance with known or customary practice in the technique to which this invention belongs.

权利要求:
Claims (13)
[0001]
1. Surgical instrument (10) characterized by the fact that it comprises: an end actuator (12) for fixing the tissue which comprises: first and second opposing claw members (22, 24); a portion of mobile work; a tissue thickness module (60) that detects the thickness of the tissue attached to the end actuator; and a disposable cartridge (34) located on the first claw member, the tissue thickness module being part of the disposable cartridge; and a control circuit (100) in communication with the tissue thickness module, wherein the tissue thickness module communicates the data to the control circuit, the data comprising: data indicative of the tissue thickness attached to the end actuator; and data indicative of the cartridge type of the disposable cartridge; where the control circuit prevents the action of the mobile working portion when the thickness of the fabric attached to the end actuator is not within the specified thickness range for the disposable cartridge.
[0002]
2. Surgical instrument, according to claim 1, characterized by the fact that: the tissue thickness module comprises a Hall effect sensor (64); and the second claw member comprises a magnet (78), the Hall effect sensor detecting the resistance of the magnet's magnetic field which is indicative of the thickness of the tissue attached to the end actuator.
[0003]
3. Surgical instrument according to claim 1, characterized by the fact that the control circuit comprises a processing unit (114) programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the cartridge disposable based on the data reported to the control circuit by the tissue thickness module, including the data indicating the thickness of the tissue attached to the end actuator and the data indicating the type of cartridge of the disposable cartridge.
[0004]
4. Surgical instrument according to claim 3, characterized by the fact that the control circuit comprises solid-state memory (116) which stores thickness range data for one or more types of cartridge.
[0005]
5. Surgical instrument according to claim 4, characterized by the fact that the processing unit is programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge, based on the reported data to the control circuit by the tissue thickness module by comparing the data indicating the thickness of the tissue attached to the end actuator with the stored thickness range data for the cartridge type of the disposable cartridge in the end actuator.
[0006]
6. Surgical instrument, according to claim 5, characterized by the fact that: the surgical instrument additionally comprises: an actuation rod (48, 50) that activates the mobile working portion; an electric motor (104) that acts on the drive rod; and a battery pack (106) that supplies electrical energy to the electric motor; and the control circuit prevents the electric motor from operating when the thickness of the fabric attached to the end actuator is not within the specified thickness range.
[0007]
7. Surgical instrument, according to claim 6, characterized by the fact that the tissue thickness module is in wireless communication with the control circuit.
[0008]
8. Surgical instrument, according to claim 7, characterized by the fact that the tissue thickness module is in wireless communication with a visual display unit (160).
[0009]
9. Surgical instrument, according to claim 7, characterized by the fact that the tissue thickness module is in wireless communication with a remote computer system (170).
[0010]
10. Surgical instrument, according to claim 7, characterized by the fact that: the tissue thickness module comprises a first radio module (70); and the control circuit comprises a second radio module (110), the first radio module communicating wirelessly with the second radio module.
[0011]
11. Surgical instrument according to claim 1, characterized by the fact that the disposable cartridge comprises a disposable staple cartridge.
[0012]
12. Surgical instrument, according to claim 1, characterized by the fact that the mobile working portion comprises a cutting instrument (32).
[0013]
13. Surgical instrument, according to claim 1, characterized by the fact that the surgical instrument is a cutting and joining instrument, in which the first and second opposing claw members are movable between the open and closed position, and in which the mobile working portion is a mobile cutting instrument that cuts the tissue fixed between the first and second claw members when the claw members are in the closed position, the end actuator further comprises: a magnet at the distal end of the second member claw; and the fabric thickness module comprises a Hall effect sensor that detects a magnetic field resistance of the magnet, the magnetic field resistance being indicative of the thickness of the fabric fixed between the first and the second claw members; and the instrument still comprises: a drive rod that drives the cutting instrument; and the control circuit comprises a processing unit programmed to determine whether the tissue attached to the end actuator is within the specified thickness range for the disposable cartridge, based on data reported to the motor control circuit by the thickness module the control circuit prevents the actuation rod from acting when the thickness of the tissue attached to the end actuator is not within the specified thickness range for the disposable cartridge.

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同族专利:

公开号 | 公开日

US9307987B2|2016-04-12|

AU2010333868A1|2012-05-31|

US20190269407A1|2019-09-05|

US20160183944A1|2016-06-30|

US20110155781A1|2011-06-30|

WO2011078959A1|2011-06-30|

CN102665575B|2015-07-08|

RU2012131566A|2014-01-27|

CA2784307C|2018-10-09|

US8851354B2|2014-10-07|

EP2515769B8|2018-06-06|

BR112012018797A2|2020-09-01|

EP2515769A1|2012-10-31|

CN102665575A|2012-09-12|

JP5770206B2|2015-08-26|

BR112012018797B8|2021-06-22|

US20150038986A1|2015-02-05|

CA2784307A1|2011-06-30|

EP2515769B1|2018-04-25|

JP2013515565A|2013-05-09|

RU2566079C2|2015-10-20|

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