DEVICE

专利摘要:
surgical instrument with orientation detection. The present invention relates to a surgical instrument comprising a body assembly and an end actuator. the body assembly includes a control module, an orientation sensor coupled in communication to the control module, and a power component. the power component is operable to activate the end actuator in a plurality of power settings. a storage device is coupled in communication to the control module and includes a plurality of gesture profiles and corresponding power settings. the control module is configured to set the power component power setting to the corresponding power setting in response to a correlation between orientation sensor output and a gesture profile. in some versions, the control module modifies the power setting based on the output of a force sensor that measures force at the end actuator. the control module can also lower the power setting in response to an anomalous deceleration or acceleration detected by an accelerometer.
公开号:BR112014030047B1
申请号:R112014030047-0
申请日:2013-05-24
公开日:2021-07-27
发明作者:Donna L. Korvick；Jeffrey D. Messerly；Daniel W. Price；Sora Rhee；Cory G. Kimball；Timothy G. Dietz；Ashvani K. Madan；Foster B. Stulen；Jacqueline C. Aronhalt；William D. Dannaher；John B. Schulte；Danius P. Silkaitus；Stephen J. Balek；Michael R. Lamping；William E. Clem
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

BACKGROUND
[001] In some contexts, endoscopic surgical instruments may be preferred over devices for traditional open surgery, as a smaller incision can reduce recovery time and complications in the postoperative period. Consequently, some endoscopic surgical instruments may be suitable for placing a distal end actuator at a desired surgical site via a trocar cannula. These distal end actuators can secure tissue in a variety of ways to achieve a diagnostic or therapeutic effect (eg, endo-cutter, gripper, cutter, stapler, clip applicator, access device, Drug Order/gene therapy device and device for applying energy using ultrasound, RF, laser, etc.). Endoscopic surgical instruments may comprise a rod between the end actuator and a handle portion, which is manipulated by the physician. Such a rod can allow insertion to a desired depth and rotation around the longitudinal axis of the rod, thus facilitating the positioning of the end actuator within the patient. In some situations, a user may need to use the instrument several times before effectively and efficiently using such devices to perform various procedures. This adaptation time can cause some users to avoid adopting the use of new instruments. Consequently, it can be useful to provide a surgical instrument with various user aids to reduce the learning curve of how to use the instrument.
[002] Examples of such endoscopic surgical instruments that may be adapted to include such user interface aids may include those disclosed in US Patent 6,500,176 entitled "Electrosurgical Systems and Techniques for Sealing Tissue", issued December 31 2002, the description of which is incorporated by reference in this document; U.S. Patent No. 7,416,101 entitled "Motor-Driven Surgical Cutting and Fastening Instrument with Loading Force Feedback", issued August 26, 2008, the description of which is incorporated by reference herein; U.S. Patent No. 7,738,971 entitled "PostSterilization Programming of Surgical Instruments", issued June 15, 2010, the description of which is incorporated by reference herein; U.S. Publication No. 2006/0079874 entitled "Tissue Pad for Use with an Ultrasonic Surgical Instrument", published April 13, 2006, the description of which is incorporated by reference herein; U.S. Publication No. 2007/0191713 entitled "Ultrasonic Device for Cutting and Coagulating", published August 16, 2007, the description of which is incorporated by reference herein; U.S. Publication No. 2007/0282333 entitled "Ultrasonic Waveguide and Blade", published December 6, 2007, the description of which is incorporated by reference herein; U.S. Publication No. 2008/0200940 entitled "Ultrasonic Device for Cutting and Coagulating", published August 21, 2008, the description of which is incorporated by reference herein; U.S. Publication No. 2009/0209990 entitled "Motorized Surgical Cutting and Fastening Instrument Having Handle Based Power Source", published August 20, 2009, the description of which is incorporated by reference herein; and U.S. Patent Publication No. 2010/0069940 entitled "Ultrasonic Device for Fingertip Control", published March 18, 2010, the description of which is incorporated by reference herein; in U.S. Patent Publication No. 2011/0015660 entitled "Rotating Transducer Mount for Ultrasonic Surgical Instruments", published January 20, 2011, the description of which is incorporated by reference herein; and in U.S. Patent Publication No. 2011/0087218 entitled "Surgical Instrument Comprising First and Second Drive Systems Actuatable by a Common Trigger Mechanism", published April 14, 2011, the description of which is incorporated by reference herein. In addition, some of the aforementioned surgical tools may include a wireless transducer such as disclosed in US Patent Publication No. 2009/0143797 entitled "Cordless Handheld Ultrasonic Cautery Cutting Device", published June 4, 2009, the description of which is incorporated in reference title in this document.
[003] Some of the surgical instruments may be used, or adapted for use, in robotic assisted surgery settings as disclosed in US Patent No. 6,783,524 entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument", granted on August 31, 2004.
[004] Although a variety of devices and methods have been created and used for endoscopic surgical procedures, it is believed that none before the inventor(s) created or used the technology described in this document. BRIEF DESCRIPTION OF THE DRAWINGS
[005] Although the specification concludes with claims that specifically indicate and distinctly claim this technology, it is believed that this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which the same numbers references identify the same elements and where:
[006] FIG. 1 depicts a block diagram of an exemplary surgical instrument that has one or more orientation sensors;
[007] FIG. 2 depicts a perspective view of an exemplary surgical instrument;
[008] FIG. 3 depicts a side cross-sectional view of a second exemplary surgical instrument showing an exemplary first orientation sensor assembly;
[009] FIG. 4 depicts a partial side cross-sectional view of an exemplary orientation sensor having a conductive ball disposed within a sensor housing;
[0010] FIG. 5 depicts a side elevation view of the conducting ball of FIG. 4 showing a plurality of conductive sections and a weight;
[0011] FIG. 6 depicts a partial rear cross-sectional perspective view of an alternative orientation sensor;
[0012] FIG. 7 depicts a partial perspective view of an exemplary breakaway end actuator cap;
[0013] FIG. 8 depicts a perspective view of an exemplary surgical instrument showing an exemplary first gesture;
[0014] FIG. 9 depicts a perspective view of an exemplary surgical instrument showing a second exemplary gesture;
[0015] FIG. 10 depicts a perspective view of an exemplary surgical instrument showing a third exemplary gesture;
[0016] FIG. 11 depicts a flowchart of exemplary steps for monitoring movement of an exemplary surgical instrument; and
[0017] FIG. 12 depicts a flowchart of preformed exemplary steps in response to monitoring one or more sensors.
[0018] The drawings are not intended to be limiting in any way, and it is contemplated that various modalities of the technology may be carried out in a variety of other ways, including those not necessarily represented in the drawings. The drawings incorporated in the annex and forming a part of the descriptive report illustrate various aspects of the present technology, and together with the description they serve to explain the principles of the technology; it is understood, however, that this technology is not limited precisely to the provisions shown. DETAILED DESCRIPTION
[0019] The following description of some examples of the technology should not be used to limit its scope. Other examples, elements, aspects, modalities and advantages of the technology will become evident to those skilled in the art with the following description, which is through illustrations, one of the best ways contemplated for carrying out the technology. As will be understood, the technology described here is capable of other different and obvious aspects, all without departing from the technology. Consequently, the drawings and descriptions are to be regarded as illustrative in nature and not restrictive.
[0020] It should therefore be understood that any one or more of the teachings, expressions, modalities, examples, etc. described herein may be combined with any one or more of the teachings, expressions, modalities, examples, etc. that are described in this document. The teachings, expressions, modalities, examples, etc. described below should not be viewed in isolation from one another. Various suitable ways in which the teachings of the present invention may be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. These modifications and variations are intended to be included within the scope of the appended claims. I. Overview
[0021] FIG. 1 depicts an exemplary surgical instrument 10 comprising a handle assembly 12 and a detachable end actuator 90. Of course, it should be understood that, in some versions, the end actuator 90 may be fixedly coupled to the handle assembly 12 or to a rod 22. In the present example, the handle assembly 12 comprises a housing 14 that includes a power component 20, a first sensor 30, a control module 40, a storage device 50, a user interface 60, a source of power 70, a second sensor 80, and a first connector 88. In the present example, the power component 20 is coupled to the power source 70 and is operable to activate the end actuator 90. By way of example only, the component power 20 may comprise an ultrasonic transducer having a rod 22 that is operable to impart ultrasonic motion to an end actuator blade 90 when the end actuator 90 is coupled to the rod. 22 and/or handle assembly 12. An example is described in US Patent Publication No. 2011/0015660 entitled "Rotating Transducer Mount for Ultrasonic Surgical Instruments", published January 20, 2011, the description of which is incorporated by way of reference in this document. In other versions, power component 20 may comprise a motor or other component operable to impart motion to one or more end actuator components 90 via rod 22 and/or otherwise. A merely exemplary motor-driven surgical instrument is disclosed in US Patent No. 7,416,101 entitled "Motor-Driven Surgical Cutting and Fastening Instrument with Loading Force Feedback", granted August 26, 2008, the description of which is incorporated by reference. in this document. Obviously in some versions the power component 20 and/or rod 22 may be omitted in their entirety and the power source 70 may be operable to directly drive one or more end actuator features 90. For example, the power source 70 may be operable to transmit RF energy to the end actuator 90 such as that disclosed in US Patent No. 6,500,176 entitled "Electrosurgical Systems and Techniques for Sealing Tissue", issued December 31, 2002, the description of which is incorporated by way of reference in this document. Although power source 70 is shown in the present example as contained in handle assembly 12 (e.g., as one or more rechargeable batteries), it is to be understood that power source 70 may be external to handle assembly 12, such as the generator 120 shown in FIG. 2. Obviously still additional configurations for the power component 20 and/or the power source 70 will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0022] As shown in FIG. 1, the control module 40 is coupled in communication to the power component 20, the first sensor 30, the storage device 50, the user interface 60, the power source 70, the second sensor 80, and the first connector 88 Obviously it should be understood that any of the aforementioned components may be omitted and/or not be coupled in communication to the control module 40; and that control module 40 may be in communication with a variety of other components in addition to or in place of those described herein. Control module 40 comprises an integrated circuit or a microcontroller configured to receive input from one or more components, such as sensors 30, 80, 98, storage device 50, and/or end actuator storage device 96; and output control instructions to one or more components and/or devices, such as power component 20 and/or user interface 60, although the output is merely optional (e.g., control module 40 may merely be a diagnostic tool for receiving information or components and/or devices can be integrated with control module 40 so that control module 40 can directly enable or disable components and/or devices). In some versions, control module 40 additionally comprises EEPROM for storing data therein. For example, the EEPROM may store machine readable codes to control various components of surgical instrument 10 or the EEPROM may contain one or more operational definitions and/or modes stored in data tables. Obviously other machine readable codes and/or settings for the EEPROM will be evident to a person of ordinary skill in the art in view of the teachings herein. Such code could also be stored in storage device 50, as described below. In the present example, the control module 40 is integrated into the surgical instrument 10 although this is merely optional. In some versions, the control module 40 can be integrated in the generator 120 (shown in FIG. 2) and coupled in communication to instrument 10 via cable 130 or control module 40, it can be an independent device coupled in communication to the instrument 10. Obviously still additional configurations for the control module 40 will be evident to a person of ordinary skill in the art in view of the teachings herein.
[0023] The first sensor 30 of the present example comprises a sensor operable to detect the orientation and/or movement of the instrument 10. By way of example only, first sensor 30 may comprise a gyroscopic sensor, a tilt meter, an accelerometer, and /or any other suitable orientation and/or motion sensor as will be apparent to a person of ordinary skill in the art in view of the teachings herein. As shown in FIG. 1, the first sensor 30 is coupled in communication to the control module 40 and is operable to transmit signals to the control module 40 that indicate the orientation and/or movement of the instrument 10 relative to a baseline orientation and/or movement. . Of course, it should be understood that the first sensor 30 can be configured to provide information in addition to, or as an alternative to, the orientation and/or movement of the instrument 10. Some merely exemplary alternative sensors include heat sensors such as those described in Patent Application No. US Provisional No. 13/277,328, entitled "Surgical Instrument with Sensor and Powered Control", filed October 20, 2011, the description of which is incorporated by reference herein. Obviously the first sensor 30 is merely optional and may be omitted or integrated into other components, such as the control module 40. Still additional sensors 30 will be apparent to a person of ordinary skill in the art in view of the teachings herein.
[0024] The storage device 50 is coupled in communication to the control module 40 and is operable to store or retrieve data to the control module 40. The storage device 50 comprises a computer readable medium that has the ability to store data or instructions in a form in which they can be retrieved or processed by the control module 40. A computer-readable medium should not be limited to any particular type or organization, and should be understood to include distributed and decentralized systems, however, are physically or logically arranged, as well as system storage objects that are located in a defined and/or circumscribed physical and/or logical space. By way of example only, storage device 50 may include hard disks, read-only memory, random access memory, solid-state memory elements, optical disks, and/or registers. As will be described in greater detail below, storage device 50 may include one or more configuration data for instrument 10. Such configuration data may be used with data provided from first sensor 30, second sensor 80, and/ or sensor end actuator 98 by control module 40 to determine if the user is using instrument 10 in accordance with expected usage and/or to adjust the output of power component 20 based on how the user is using instrument 10 Obviously storage device 50 is merely optional and may be omitted or integrated into other components, such as control module 40 and/or generator 120. Still additional configurations for storage device 50 will be apparent to a person of skill common in the art in view of the teachings herein.
[0025] User interface 60 is also communication coupled to control module 40 so that control module 40 can control user interface 60. It should be understood that user interface 60 may comprise a component that communicates only information to a user, is operable to receive input from a user, or both. For example, user interface 60 may include a speaker that is operable to emit audible tones. By way of example only, the control module 40 can be configured to emit varying tones from the speaker in response to whether the user is using the instrument 10 in accordance with an expected usage when compared to configuration data, as will be described in more detail below. Additionally, or alternatively, user interface 60 can include LEDs or other visual components so that control module 40 can operate the LEDs or other visual components. Still additionally, user interface 60 may include a simple screen or a touch-sensitive screen. The screen may be operable to display one or more graphical outputs that indicate whether or not the user is using the instrument 10 in the proper manner. Still additionally, a touchscreen may be operable to select one or more of the configuration data, to select a type of surgical procedure, and/or to select other options or features for the instrument 10. Yet an additional version may include input buttons or other input components so that a user can manage the control module 40 or the other components of the instrument 10. Obviously two or more of the above can be combined for user interface 60. For example, the user interface user 60 can include a speaker and a plurality of LEDs. In another version, user interface 60 may include a speaker and a screen that displays a graphical representation of usage. In yet another version, the user interface 60 may include a speaker and a touchscreen, both of which indicate a graphical representation of usage and are operable to select one or more of the configuration data and/or to select others. options or features for the instrument 10. In addition, additional user interfaces 60 will be apparent to a person of ordinary skill in the art in view of the teachings in this document. Also, in some versions UI 60 may be omitted.
[0026] The second sensor 80 of the present example comprises a sensor operable to detect the orientation of force applied to the end actuator 90 of the instrument 10 or a force vector applied by tissue against the end actuator 90. By way of example only, second sensor 80 may comprise one or more strain gauges coupled to rod 22 that extend between power member 20 and end actuator 90. In some versions, a plurality of strain gauges may be positioned around rod 22 to determine orientation of strength. In addition, second sensor 80 can be used to also determine the magnitude of force applied to end actuator 90. Second sensor 80 can be constructed in accordance with at least some of the teachings of US Patent Application Serial No. [Number of the Lawyer's Dossier END7056USNP.0590477], entitled "Surgical Instrument with Stress Sensor", filed on the same date as this document, the description of which is incorporated by reference in this document. Obviously still additional sensors, as will be evident to a person of ordinary skill in the art in view of the teachings herein. As shown in FIG. 1, the second sensor 80 is coupled in communication to the control module 40 and is operable to transmit signals to the control module 40 which indicate the force applied to the rod 22 and/or end actuator 90 of the instrument 10. Obviously it should. understand that second sensor 80 can be configured to provide information in addition to, or as an alternative to, the force applied to stem 22 and/or end actuator 90. Some merely exemplary alternative sensors include heat sensors such as those described in the patent application US Non-Provisional No. 13/277,328, entitled "Surgical Instrument with Sensor and Powered Control", filed October 20, 2011, the description of which is incorporated by reference herein. Still additional sensors 80 will be apparent to one of ordinary skill in the art in view of the teachings herein. Obviously it should be understood that the second sensor 80 can also be omitted in some versions.
[0027] The first connector 88 is in communication coupled to the control module 40 and is operable to electrically and in communication couple the end actuator 90 to the control module 40. For example, the first connector 88 may comprise a plurality of electrical contacts which are configured to be coupled to a plurality of electrical contacts of the second connector 92 of the end actuator 90. Obviously the first connector 88 may have other configurations (e.g., inductive coupling) that are operable to be electrically coupled and/or in communication to the end actuator 90. In some versions, such as those in which the end actuator 90 is fixedly coupled to the handle assembly 12, the first connector 88 may be omitted in its entirety.
[0028] The end actuator 90 of the present example is releasably coupled to the handle assembly 12 and is coupled to the power component 20 by means of the rod 22. Merely exemplary ways of coupling the end actuator 90 to the handle assembly 12 include clips, clips, snaps, threads, hook and loop connectors, etc. In addition, or as an alternative, end actuator 90 may be constructed in accordance with at least some of the teachings of US Patent Application No. 13/269,870 entitled "Surgical Instrument with Modular Stem and End Actuator", filed at 10 of October 2011, the description of which is incorporated by reference in this document. As with the power component 20 noted above, the end actuator 90 can be configured to secure tissue in a variety of ways to achieve a diagnostic or therapeutic effect (eg, endo-cutter, gripper, cutter, stapler, clip applier, device device, drug/gene therapy delivery device, and energy delivery device using ultrasonic vibrations, RF, laser, etc.). By way of example only, the end actuator 90 may be constructed in accordance with at least some of the teachings of US Patent Publication No. 2011/0015660 entitled "Rotating Transducer Mount for Ultrasonic Surgical Instruments", published January 20, 2011, whose description is incorporated by reference in this document; U.S. Patent No. 7,416,101 entitled "Motor-Driven Surgical Cutting and Fastening Instrument with Loading Force Feedback", issued August 26, 2008, the description of which is incorporated by reference herein; and U.S. Patent No. 6,500,176 entitled "Electrosurgical Systems and Techniques for Sealing Tissue", issued December 31, 2002, the disclosure of which is incorporated by reference herein. Obviously still other configurations for the end actuator 90 will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0029] The end actuator 90 includes the second connector 92, an end actuator storage device 96, and a sensing end actuator 98. As noted above, the second connector 92 comprises a plurality of electrical contacts that are configured to electrically and in communication coupling the end actuator 90 to the control module 40 when the end actuator 90 is attached to the handle assembly 12. The end actuator storage device 96 of the present example comprises a computer readable medium having the ability to store data or instructions in a form in which they can be retrieved or processed by the control module 40. The computer-readable medium should not be limited to any particular type or organization, and should be understood to include distributed systems and decentralized however that are physically or logically arranged as well as the storage objects of systems that are located in a defined and/or circumscribed physical and/or logical space. By way of example only, the storage device of the end actuator 96 may include hard disks, read-only memory, random access memory, solid-state memory elements, optical disks, and/or registers. In the present example, the end actuator storage device 96 comprises a non-volatile memory module that is coupled in communication to the second connector 92 so that the end actuator storage device 96 is coupled in communication to the control module 40 when the end actuator 90 is coupled to the handle assembly 12. Obviously other configurations for the end actuator storage device 96 will be apparent to a person of ordinary skill in the art in view of the teachings herein. Still further, in some versions, the end actuator storage device 96 may be omitted in its entirety.
[0030] The sensor end actuator 98 of the present example comprises a sensor operable to detect the orientation and/or movement of the end actuator 90. By way of example only, the sensor end actuator 98 may comprise a gyro sensor, a meter inclination, an accelerometer, and/or any other suitable orientation and/or motion sensor as will be apparent to a person of ordinary skill in the art in view of the teachings herein. As shown in FIG. 1, the sensing end actuator 98 is coupled in communication to the control module 40 via the interface of the first and second connectors 88, 92, and the sensing end actuator 98 is operable to transmit signals to the control module 40 indicating the orientation and/or movement of the end actuator 90 relative to a baseline orientation and/or movement. Of course it should be understood that sensor end actuator 98 can be configured to provide information in addition to, or as an alternative to, the orientation and/or movement of end actuator 90. For example, sensor end actuator 98 can be configured to detect a force applied to an end actuator blade (not shown) 90 and may be constructed in accordance with at least some of the second sensor 80 teachings described above. In addition, or as an alternative, some other merely exemplary sensors include heat sensors such as those described in US Non-Provisional Patent Application No. 13/277,328 entitled "Surgical Instrument with Sensor and Powered Control", filed October 20, 2011 , the description of which is incorporated by reference in this document. In addition, the additional end actuator sensors 98 will be apparent to a person of ordinary skill in the art in view of the teachings herein. Also, it should be understood that in some versions, the sensing end actuator 98 may be omitted in its entirety. II. Surgical Systems and Exemplary Surgical Instruments
[0031] Although the aforementioned block diagram generally describes a surgical instrument 10 that is attachable to an end actuator 90 and includes a variety of components to provide feedback to the control module 40, various configurations for surgical instrument 10 and/or surgical systems will now be described. A. Elongated ultrasonic surgical instrument with exemplary pistol grip
[0032] FIG. 2 shows an exemplary ultrasonic surgical system 100 that may incorporate one or more of the components described above. In the present example, system 100 comprises an ultrasonic surgical instrument 150, a generator 120, and a cable 130 operable to couple the generator 120 to the surgical instrument 150. A suitable generator 120 is the GEN 300 sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, USA. By way of example only, generator 120 can be constructed in accordance with the teachings of US Patent Publication No. 2011/0087212 entitled "Surgical Generator for Ultrasonic and Electrosurgical Devices", published April 14, 2011, the description of which is incorporated by reference in this document. Generator 120 may include one or more of the control module 40, storage device 50, user interface 60, and/or power supply 70 described above, although they are merely optional. It should be noted that surgical instrument 150 is described in reference to an ultrasonic surgical instrument; However, the technology described below can be used with a variety of surgical instruments, which include, without limitation, endocuters, grippers, cutters, staplers, clip applicators, access devices, drug/gene therapy delivery devices, and devices delivery of energy using ultrasound, RF, laser, etc., and/or any combination thereof as will be apparent to a person of ordinary skill in the art in view of the teachings herein. Furthermore, although the present example is described with reference to a cable-connected surgical instrument 150, it is to be understood that the surgical instrument 150 may be adapted for wireless operation, as disclosed in US Patent Publication No. 2009/0143797 entitled "Cordless Handheld Ultrasonic Cautery Cutting Device", published June 4, 2009, the description of which is incorporated by reference herein. Furthermore, surgical device 150 may also be used, or adapted for use, in robotic assisted surgery settings such as disclosed in US Patent No. 6,783,524 entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument", granted on August 31, 2004.
[0033] The surgical instrument 150 of the present example includes a multi-piece handle assembly 160, an elongated transmission assembly 170, and a transducer 190. It should be understood that the surgical instrument 150 can be viewed as an exemplary version of the instrument surgical procedure 10 described above. Transmission assembly 170 is coupled to multi-piece handle assembly 160 at a proximal end of transmission assembly 170 and extends distally from multi-piece handle assembly 160. In the present example transmission assembly 170 is configured to be an elongated, thin, tubular mount for endoscopic use, but it should be understood that the transmission mount 170 may alternatively be a short mount, such as those shown in Figures 3, 6, and 9 to 11, and/or those disclosed in US Patent Publication No. 2007/0282333, entitled "Ultrasonic Waveguide and Blade", published December 6, 2007, and US Patent Publication No. 2008/0200940 entitled "Ultrasonic Device for Cutting and Coagulating", published 21 of August 2008, the descriptions of which are incorporated by reference herein. The transmission assembly 170 of the present example comprises an outer sheath 172, an inner tubular actuator member (not shown), a waveguide (not shown), and an end actuator 180 located at the distal end of the transmission assembly 170. In the present example, the end actuator 180 comprises a blade 182 coupled to the waveguide, a clamp arm 184 operable to pivot at the proximal end of the transmission assembly 170, and, optionally, one or more clamp blocks 186 attachable to the transmission arm. clamp 184. End actuator 180 may be further configured in accordance with end actuator 90 described above with reference to FIG. 1. It should also be understood that clamp arm 184 may be omitted if desired.
[0034] The waveguide, which is adapted to transmit ultrasonic energy from a transducer 190 to the blade 182, can be flexible, semi-flexible or rigid. In some versions, second sensor 80 can be coupled to the waveguide to detect when force is applied to blade 182 (eg, as blade 182 rests against tissue). Transducer 190 is an exemplary power component 20 that can be used. A merely exemplary 190 ultrasonic transducer is Model No. HP054, sold from Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, USA. It should also be understood that clamp arm 184 and associated features may be constructed and operable in accordance with at least some of the teachings of US Patent No. 5,980,510 entitled "Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Arm Pivot Mount ", issued November 9, 1999, the description of which is incorporated by reference herein. The waveguide can also be configured to amplify mechanical vibrations transmitted through the waveguide to the blade 182 as is well known in the art. The waveguide may additionally have features to control the gain of longitudinal vibration along the waveguide and features to tune the waveguide to the system's resonant frequency.
[0035] In the present example, the distal end of blade 182 is disposed close to an anti-knot in order to tune the acoustic mount to a preferred resonant frequency fo when the acoustic mount is not tissue loaded. When transducer 190 is energized, the distal end of blade 182 is configured to move longitudinally in the range of, for example, approximately 10 to 500 microns from peak to peak, and preferably in the range of about 20 to about 200 microns in a predetermined vibratory frequency fo, for example, 55.5 kHz. When the transducer 190 of the present example is activated, these mechanical oscillations are transmitted through the waveguide to the end actuator 180. In the present example, the blade 182 that is coupled to the waveguide, oscillates at the ultrasonic frequency. Thus, when tissue is trapped between blade 182 and clamp arm 184, the ultrasonic oscillation of blade 182 can simultaneously disrupt tissue and denature proteins in adjacent tissue cells, thus providing a coagulant effect with relatively thermal propagation. small. An electrical current can also be supplied through the blade 182 and the clamp arm 184 to also cauterize the tissue. Although some configurations of transmission assembly 170 and transducer 190 have been described, still other suitable configurations of transmission assembly 170 and transducer 190 will be apparent to one of ordinary skill in the art in view of the teachings herein.
[0036] The multi-piece handle assembly 160 of the present example comprises a mating housing portion 162 and a lower portion 164. The mating housing portion 162 is configured to receive the transducer 190 at a proximal end of the mating housing portion 162 and for receiving the proximal end of the transmission assembly 170 at a distal end of the mating housing portion 162. An opening is provided in the distal end of the mating housing portion 162 for the insertion of a plurality of transmission assemblies 170. A rotation handle 166 is shown in the present example to rotate the transmission assembly 170 and/or the transducer 190, but it is to be understood that the rotation handle 166 is merely optional. The housing portion 162 and/or corresponding transmission assembly 170 may be further constructed in accordance with at least some of the teachings of US Patent Application No. 13/269,870 entitled "Surgical Instrument with Modular Stem and End Actuator", filed on October 10, 2011, the description of which is incorporated by reference herein. The lower portion 164 of the multi-piece handle assembly 160 includes a trigger 168 and is configured to be gripped by a user using a single hand. A merely exemplary alternative configuration of the lower portion 164 is depicted in FIG. 1 of U.S. Patent Publication No. 2011/0015660 entitled "Rotating Transducer Mount for Ultrasonic Surgical Instruments", published January 20, 2011, the description of which is incorporated by reference herein. It should be understood that various components, handle assembly 12 included, may be incorporated into the multi-piece handle assembly 160.
[0037] Furthermore, although the multi-piece handle assembly 160 has been described with reference to two distinct portions 162, 164, it is to be understood that the multi-piece handle assembly 160 may be a unitary assembly with both portions 162, 164 combined. The multi-piece handle assembly 160 may alternatively be divided into multiple discrete components, such as a separate activation portion (operable or by a user's hand or foot) and a separate corresponding housing portion 162. The activation portion may be operable to activate the transducer 190 and may be remote to the corresponding housing portion 162. The multi-piece handle assembly 160 may be constructed of a durable plastic (such as polycarbonate or a liquid crystal polymer), ceramics and/or metals, or any other suitable material as will be apparent to a person of ordinary skill in the art in view of the teachings herein. Still other configurations of the multi-piece handle assembly 160 will be apparent to those of ordinary skill in the art in view of the teachings herein. For example, instrument 150 can be operated as part of a robotic system. Other configurations of the multi-piece handle assembly 160 will also be apparent to those of ordinary skill in the art in view of the teachings herein. By way of example only, surgical instrument 150 can be constructed in accordance with at least some of the teachings of U.S. Patent Publication No. 2006/0079874; in U.S. Patent Publication No. 2007/0191713; in U.S. Patent Publication No. 2007/0282333; in U.S. Patent Publication No. 2008/0200940; in U.S. Patent Publication No. 2011/0015660; U.S. Patent No. 6,969,108; 6,500,176 in U.S. Patent Publication No. 2011/0087218; and/or U.S. Patent Publication No. 2009/0143797. B. Portable ultrasonic surgical instrument with exemplary pencil handle
[0038] FIG. 3 depicts an alternative surgical instrument 200 that is configured to be held in a user's hand similarly to a pen or pencil. The surgical instrument 200 can also be seen as another exemplary version of the surgical instrument 10 described above. As shown in the present example, instrument 200 comprises a housing 202, a rotary transducer 210, an end actuator 220, and an orientation sensor assembly 230. The housing 202 is sized and configured to contain the transducer 210 and the bearing assembly. 230 orientation sensor in it. Housing 202 may be constructed of a durable plastic (such as polycarbonate or a liquid crystal polymer), ceramics and/or metals, or any other suitable material as will be apparent to one of ordinary skill in the art in view of the teachings herein. Transducer 210 is pivotally mounted to housing 202 by means of mounts 204. Transducer 210 is electrically coupled to a generator (not shown), while generator 120 is via wires 214 that extend through a proximal end of the housing 202 and a cable 206. Transducer 210 also includes a waveguide 212 that extends distally to end actuator 220. Transducer 210 may be further constructed in accordance with at least some of the teachings for transducer 190 above and/or of other way.
[0039] End actuator 220 is coupled to a distal end of housing 202 and includes a blade 222 that is coupled to waveguide 212. Consequently, when transducer 210 is energized, the distal end of blade 222 is configured to move longitudinally in the range of, for example, approximately 10 to 500 microns from peak to peak, and preferably in the range of about 20 to about 200 microns at a predetermined vibratory frequency of, for example, 55.5 kHz. Thus, when blade 222 is applied against tissue, the ultrasonic oscillation of blade 222 can simultaneously disrupt tissue and denature proteins in adjacent tissue cells, which thereby provides a coagulant effect with relatively little thermal propagation. In some versions, end actuator 220 is releasably coupled to housing 202 so that multiple end actuators 220 can be used with instrument 200. Obviously other configurations for end actuator 220 will be evident to a person of ordinary skill in the art in view of the teachings of this document.
[0040] The orientation sensor assembly 230 is mounted within the housing 202 and includes one or more sensors 232, 234 configured to sense the orientation and/or movement of the instrument 200. In the present example, the orientation sensor assembly 230 comprises an integrated circuit or a microcontroller having a gyroscope 232 and an accelerometer234. By way of example only, orientation sensor assembly 230 may comprise a MEMS (microelectromechanical system) gyroscope/accelerometer. The orientation sensor assembly 230 is electrically coupled to a control module (not shown) via wires 236. In some versions, the control module can be integrated into the generator while in others the control module can be a separate device. In still other versions, the control module may be integrated with the orientation sensor assembly 230. Of course, it should be understood that one or more components of instrument 10 may also be incorporated into instrument 200. The gyroscope 232 of the present example is operable to provide guidance data relative to a baseline guidance. Merely exemplary baseline orientations may include instrument 200 in a longitudinal orientation as shown in FIG. 3, a vertical orientation perpendicular to that shown in FIG. 3, and/or any other guidance. Accelerometer 234 is operable to provide movement of instrument 200 relative to a stationary position and/or other state of inertia. Consequently, with the gyroscope 232 and accelerometer 234, the orientation and movement of the instrument 200 can be determined. Obviously other configurations for mounting orientation sensor 230 will be apparent to a person of ordinary skill in the art in view of the teachings herein. III. Exemplary Alternative Orientation Sensors
[0041] Although the foregoing describes a first sensor 30 and a gyroscope 232 that are operable to capture the orientation of the aforementioned instruments 10, 150, 200, it should be understood that other orientation sensors can be used with the instruments 10, 150, 200, 400, 500, 600. Also, in some situations, instruments 10, 150, 200, 400, 500, 600 can be configured to be reusable through re-sterilization by an autoclave. In such cases, conventional electronic components may not withstand the resterilization process. Consequently, several alternative orientation sensors that can withstand the resterilization process may be preferred. While some of the example sensors described below may withstand various re-sterilization processes, such functionality need not necessarily be incorporated into all versions of such sensors.
[0042] A merely exemplary alternative orientation sensor 300 is shown in FIGURES 4 to 5. As shown in FIG. 4, sensor 300 comprises a globe 310 and a housing 350. The globe 310 rotates and/or rotates substantially free within the housing 350. Referring to FIG. 5, globe 310 comprises a ball 312 and a plurality of conduction paths 314 disposed on the outer surface of ball 312. In the present example, ball 312 comprises a non-conductive polymer ball having a plurality of copper paths 314 overmolded on the sphere 312. The paths 314 are discrete and electrically isolated from each other. A weight 320 is provided within one end of the ball 312 so that the weight 320 guides the end of the ball 312 down, toward the ground, via gravity. Thus, even if the orientation of an instrument 10, 150, 200 incorporates the orientation sensor 300 is changed, the weight 320 maintains the orientation of the ball 312 with respect to the ground. The paths 314 of the present example are arranged in a variety of orientations on the ball 312 so that the plurality of paths 314 are configured to engage one or more electrodes 354, as will be described in greater detail below. When globe 310 changes position within housing 350, the position of globe 310 can be determined by monitoring a plurality of sensors 356 that are electrically coupled to electrodes 354, as will be described in more detail below.
[0043] Obviously it should be understood that other settings for globe 310 can be used as well. For example, the paths 314 can be additionally arranged around the ball 312 so that each path has a unique start point and an end point relative to the other paths 314. In some versions, a non-conductive material can be placed on the paths 314 to that only the start points and end points of each trajectory 314 are exposed. Consequently, the paths 314 can be arranged in a wide variety of ways (eg, L-shaped paths, V-shaped paths, overlap paths with non-conductive material interposed between the paths, etc.) for the position of the globe 310 can be determined by monitoring sensors 356. In another version, sphere 312 may comprise a conductive sphere with a layer of non-conductive or insulating material in layers on the outside of sphere 312. Paths 314 may be formed by means removing the non-conductive material so that the portions of the conductive sphere 312 are exposed. In a still further configuration, ball 312 may simply comprise a conducting ball, and paths 314 may be omitted. In such a version, the sphere 312 can be sized to contact only a few electrodes 354 so that the electrodes in contact 354 indicate the position of the sphere 312 in relation to the compartment 350. Further configurations for the globe 310 will be evident to a person of ordinary skill in the art in view of the teachings in this document.
[0044] Again with reference to FIG. 4, housing 350 comprises a housing 352 with a plurality of electrodes 354 extending inwardly from housing 352. In the present example, electrodes 354 comprise pogo pins extending inwardly from housing 352 and which are disposed. for electrodes 354 to spherically enclose and contact globe 310. In some versions, electrode tips 354 comprise hemispherically rounded ends. In other versions, electrodes 354 may comprise spring beam electrodes. Obviously any other electrode 354 and/or other electrode 354 geometries may be used as will be apparent to one of ordinary skill in the art in view of the teachings herein. In the present example, globe 310 is sized so that each electrode 354 is in contact with globe 310 to always maintain contact between each electrode 354 and some portion of globe 310, regardless of orientation. Consequently, a plurality of paths 314 can electrically couple a plurality of electrodes 354 together. In some versions, housing 352 may be filled with a non-conductive fluid to facilitate rotation of globe 310 relative to housing 352 and electrodes 354.
[0045] In the present example, two electrodes 354 are coupled to a corresponding sensor 356 so that when the electrodes 354 are electrically coupled via a trajectory 314 of the globe 310, the sensor circuit 356 is closed. Although FIG. 4 depicts five sensors 356 in a plane disposed around globe 310, it is to be understood that sensors 356 and electrodes 354 spherically surround globe 310. Sensors 356 are coupled in communication to control module 40 shown in FIG. 1, so that the control module 40 is operable to read the output of the plurality of sensors 356. Based on the output of the sensors 356, the control module 40 can be configured to determine the orientation of the instrument 10, 150, 200, 400 , 500, 600. By way of example only, a first electrode 354 coupled to a first sensor 356 may have a first voltage applied thereto from a power source, such as power source 70 and/or generator 120 described. above. When trajectory 314 electrically couples this first electrode 354 to a second electrode 354 of sensor 356, sensor 356 issues voltage detection to control module 40. By way of example only, trajectories 314, sensors 356, and electrodes 354 may be arranged so that a single path 314 electrically couples the electrodes 354 of a single sensor 356 for a given orientation. Consequently, the orientation of an instrument 10, 150, 200, 400, 500, 600 can be determined based on which sensor 356 has a closed loop. Sensors 356, electrodes 354, and trajectories 314 can be reduced in size and quantity increased to provide greater resolution to instrument orientation 10, 150, 200, 400, 500, 600. In addition, the rate of change between electrical couplings of electrodes 354 and sensors 356 can be measured to provide data on the speed and direction of movement of the instrument 10, 150, 200, 400, 500, 600.
[0046] Obviously other configurations for compartment 350 will be apparent to a person of ordinary skill in the art in view of the teachings herein. For example, in an alternative version, globe 310 may be smaller in size than the chamber formed by electrodes 354 such that globe 310 contacts only two electrodes 354 in any given orientation. Electrodes 354 can be arranged to alternate between electrodes 354 to which a voltage is applied and electrodes 354 coupled to sensors 356. Consequently, the orientation of the instrument 10, 150, 200, 400, 500, 600 can be determined based on which sensor 356 has a voltage applied to it. It should be understood that, in the present example, only electrodes 354 located near the end of globe 310 with weight 320 will contact globe 310. Still other configurations for alternate orientation sensor 300 will be apparent for a skill element common in the art in view of the teachings herein.
[0047] FIG. 6 depicts another orientation sensor 410 incorporated into a surgical instrument 400. Sensor 410 of the present example comprises an annular channel 420 formed within instrument 400, a plurality of sensors 430 disposed within channel 420, and a ball 450 sized to scroll within channel 420 as the orientation of instrument 400 is changed. Sphere 450 of the present example comprises a metallic sphere that is sized to fit and move within channel 420. Of course, sphere 450 may include a sphere based on durable polymer (such as polycarbonate or a liquid crystal polymer), ceramics and/or any other suitable material as will be apparent to an element of common skill in the art in view of the teachings herein. Channel 420 of the present example is oriented transversely to an end actuator 402 of instrument 400 such that sensor 410 is operable to determine the rotational orientation of instrument 400 about a longitudinal axis 408, although this is merely optional. In some versions, channel 420 can be configured to determine the rotational orientation of instrument 400 around a vertical axis (not shown) and/or a lateral axis (not shown. Obviously, a plurality of channels 420 can be incorporated to instrument 400 and/or channels 420 may have any other orientation, as will be apparent to one of ordinary skill in the art in view of the teachings herein. For example, in some versions, three channels 420 corresponding to the three geometric axes orthogonals can be provided inside the instrument 400.
[0048] A plurality of sensors 430 are disposed within channel 420 and are configured to detect the position of ball 450 within channel 420. In the present example, sensors 430 comprise force and/or contact sensors configured to detect the weight of ball 450 on sensors 430. It should be understood that ball 450 will roll within channel 420 and will align with the lowest point of channel 420. Consequently, sensor 430 that detects ball 450 will approximately indicate the orientation of instrument 400 with respect to longitudinal axis 408. In the present example, sensors 430 are arranged around the circumference of channel 420 such that ball 450 always touches at least one sensor 430 and, in some cases, two sensors 430. Obviously, other sensors 430, such as piezoelectric sensors, strain gauges, tactile sensors, load cells, Hall Effect sensors, etc. may be used as will be apparent to an element of common skill in the art in view of the teachings herein. Also, in some versions, the rate of change of sensors 430 that indicate the presence of ball 450 can be used to determine the movement of instrument 400. Further settings for orientation sensor 410 will be apparent to the common skill element in the art in view of the teachings herein. IV. Exemplary breakaway end actuator that has preloaded gesture data
[0049] FIG. 7 depicts one end of an exemplary surgical instrument 500 and an exemplary detachable end actuator 550. It should be understood that the surgical instrument 500 represents yet another exemplary variation of the surgical instrument 10 described above. In the example shown, instrument 500 comprises a housing 502, a transducer rod 510 extending from housing 502 and a plurality of electrical contacts 520 over housing 502. Transducer rod 510 is configured to threadably engage. to a waveguide 560 of the end actuator 550 so that ultrasonic vibrations from a transducer within the instrument 500 can be transmitted to a blade (not shown) of the end actuator 550. In the example shown, the transducer rod 510 includes a threaded portion 512 starting at a distance d away from a most distal point of the housing 502. The distance d corresponds to a longitudinal length of a key block 570 such that the threaded portion 512 is located within the sleeve. rotation 580 of end actuator 550 when switch block 570 is coupled to housing 502. Consequently, waveguide 560 may be threadably coupled to transducer rod 510 while switch block 570 is engaged with housing 502. Contacts 520 are metallic members that are in a boundary position with complementary contacts (not shown) on end actuator 550 such that one or more components of end actuator 550 are electrically coupled to an instrument 500. In some versions, contacts 520 are additionally electrically coupled to a control module, such as control module 40. Of course, other electrical coupling features between the end actuator 550 and instrument 500 will be apparent to an element of common skill in the art in view of the teachings herein. In the present example, contacts 520 are disposed within a keyway portion 504 of housing 502 such that end actuator 550 can only be coupled to housing 502 in a single orientation. In this way, the switch path portion 504 can ensure that the contacts 520 are aligned with the complementary contacts of the end actuator 550. Further configurations for instrument 500 will be apparent to an element of common skill in the art in view of the teachings in this document.
[0050] The end actuator 550 comprises the waveguide 560, the rotation sleeve 580, the switch block 570 and a module 590. In the present example, the waveguide 560 is coupled to the rotation sleeve 580 in such a way that rotation of rotation sleeve 580 rotates waveguide 560. Waveguide 560 extends distally from rotation sleeve 580 and terminates in a blade (not shown). It should be understood that various features in addition to, or alternative to, the blade may be included distally to the rotation sleeve 580, such as one or more clamp arms. In the example shown, waveguide 560 includes a threaded portion 562 (shown in dashed line) to threadably couple waveguide 560 to transducer rod 510. Thus, when key block 570 is engaged with housing 502 As will be described below, the rotation sleeve 580 is operable to threadably couple the waveguide 560 to the transducer rod 510. Of course, the additional coupling features for the waveguide 560 and the transducer rod 510 will be apparent for an element of common skill in the art in view of the teachings herein. The key block 570 of the present example comprises a key portion 572, a center hole 578 (shown in dashed line), and a module 590 mounted to the key block 570. 510 transducer is inserted through the 570 switch block to engage the 560 waveguide as described above. Key portion 572 is configured to be inserted into key path portion 504 of housing 502 such that key block 570 is pivotally secured with respect to housing 502. provides a mechanical ground for rotation sleeve 580 when switch block 570 is engaged with housing 502. Switch portion 572 additionally includes contacts complementary to contacts 520 described above. Engagement of key portion 572 with key path portion 504 is configured to pivotally align the set of contacts such that when key block 570 is engaged with housing 502 the set of contacts are electrically coupled. The complementary contacts are coupled to module 590 such that module 590 is electrically coupled to contacts 520 when end actuator 550 is coupled to instrument 500.
[0051] In the present example, the module 590 comprises a non-volatile solid state memory module that is operable to store one or more configuration data. For example, module 590 may contain configuration data that has one or more gesture profiles for use by a control module, such as control module 40 described with reference to FIG. 1 of surgical instrument 500 to compare the user's movement of instrument 500 with the expected gesture profiles defined by the configuration data. Such a comparison can be used to provide feedback to the user as the procedure progresses and/or to adjust instrument 500 settings, as will be described in more detail below with reference to Figures 11 through 12. When End Actuator 550 is attached to the instrument 500, module 590 interfaces with instrument control module 500 to provide configuration data to the control module. By way of example only, Figures 8 through 10 depict an instrument 600 with a 650 end actuator that has the configuration data for three different gesture profiles with three different power settings. As shown in FIG. 8, when instrument 600 is used in a manner that indicates a sweeping or excavating motion in accordance with arrow 610 a first power setting may be applied to the transducer of instrument 600. As shown in FIG. 9, when instrument 600 is used in a manner that indicates pressure movement in accordance with arrow 620, a second power setting is applied to instrument 600's transducer. As shown in FIG. 10, when instrument 600 is used in a manner that indicates a sweeping motion in accordance with arrow 630, a third energy setting is applied to instrument 600's transducer. apparent for an element of common skill in the art in view of the teachings herein.
[0052] It should be understood that, in some versions, each end actuator 550 may include configuration data for a single gesture profile and a single corresponding power setting within the 590 module. 550 end provides different configuration data to the control module for power setting and individual gesture profiles. In this way, several end actuators 550 that can be associated with different gestures to be performed can be provided to the user. Such end actuators 550 may include one or more visual indicators to distinguish which end actuator is associated with the various gestures. By way of example only, switch block 570 and/or other portions of end actuator 550 may vary by color. Alternatively, a textual or graphical symbol may be included on end actuator 550 to distinguish end actuators 550. Of course, still other indicators will be apparent to an element of common skill in the art in view of the teachings herein. In some versions, a set of such 550 end actuators may be provided in a kit for a procedure such that a user can readily switch from 550 end actuators to complete a given procedure.
[0053] In some cases, the 590 module may be accessible to a user such that a user can define the configuration data for the 590 module. For example, it may be preferred that a user can define the gesture profiles and settings for the configuration data. Such user-defined configuration data can be modified by a user interface (such as a computer program and interface unit that interfaces with the 590 module, the 60 user interface, etc.) to define the gesture profiles and power settings. In some versions, defining gesture profiles and power settings can be based on monitoring the output of the 500 instrument sensors as the user uses the 500 instrument during a configuration mode where the user establishes the power setting and performs the gesture to be associated with the power setting. In still other versions, module 590 may incorporate other components and/or process data from such other components, such as end actuator sensor 98 and/or accelerometer 234 described above. Still other end actuators 550 and/or modules 590 will be apparent to an element of common skill in the art in view of the teachings herein. V. Exemplary control methods
[0054] As noted above, in some versions it may be preferable to provide feedback to a user and/or adjust the settings of a surgical instrument 10, 150, 200, 400, 500, 600 based on the output of sensors 30, 80, 98 , 232, 234, 300, 410 that interface with a control module 40 and/or based on a comparison between the one or more gesture profiles contained within the configuration data. Such feedback and/or adjustments can reduce the learning curve for a user and/or speed up the performance of procedures by not requiring the user to manually adjust power settings for the surgical instrument 10, 150, 200, 400, 500, 600 for each gesture profile. In addition, if instrument 10, 150, 200, 400, 500, 600 encounters unexpected movement, control module 40 can be configured to adjust instrument settings 10, 150, 200, 400, 500, 600 based on the input from the various sensors 30, 80, 98, 232, 234, 300, 410. Accordingly, an exemplary method for adaptively controlling instrument 10, 150, 200, 400, 500, 600 will now be described.
[0055] FIG. 11 depicts an exemplary method for controlling an instrument, such as instruments 10, 150, 200, 400, 500, 600, with control module 40 based on the way a user uses the instrument 10, 150, 200, 400 , 500, 600 and adjusts power settings based on various predefined gesture profiles, such as those shown in Figures 8 to 10. In the present example, control module 40 receives data from sensors 30, 80, 98, 232 , 234, 300, 410 and compares the sensor data with one or more gesture profiles from the configuration data. The one or more gesture profiles each have a corresponding energy setting that the control module 40 applies to the energy component, such as energy component 20 or transducer 190 of instrument 10, 150, 200, 400, 500 , 600. Configuration data is stored in a storage device such as module 590 and/or storage device 50 and is coupled in communication to control module 40.
[0056] As shown in FIG. 11, the method starts at block 700 by determining which procedure should be performed (eg, plastic surgery, orthopedic surgery, etc.). For example, an end actuator, such as the 550 end actuator, can be configured to include the configuration data for instrument 10, 150, 200, 400, 500, 600 for a specific task or procedure. Consequently, coupling the end actuator to a surgical instrument 10, 150, 200, 400, 500, 600 can determine the procedure simply by receiving, by the control module 40, configuration data when the end actuator is coupled to the instrument 10, 150, 200, 400, 500, 600. In another version, a database of procedures or tasks can be stored on storage device 50 and the various procedures or tasks can be selectable through the user interface, such as as the user interface 60. Such procedures or tasks may have corresponding configuration data that can be loaded into block 710. Still other ways of determining the procedure to be performed will be apparent to an element of common skill in the art in view of the teachings in the this document. Obviously, it should be understood that block 700 can also be omitted.
[0057] In block 710, the configuration data is loaded from a storage device and/or database. In the present example, the configuration data includes one or more gesture profiles, such as those shown in Figures 8 to 10, as well as a corresponding energy configuration for each gesture profile. For example, the transducer can be configured to operate at a first energy level by performing the sweeping motion shown in FIG. 8, while the transducer can be configured to operate at a different second energy level by performing the pressure movement shown in FIG. 9. In addition, or alternatively, the energy levels for the transducer can also be varied based on the procedure to be performed. For example, procedures involving delicate or sensitive tissue areas may include energy settings that limit the transducer to low energy levels while procedures involving thick or thick tissue may include energy settings that employ high energy levels to the transducer. Obviously, it should be understood that such energy settings and gesture profiles are not limited to ultrasonic surgical instruments, but can be applied to other surgical instruments, such as endo-cutters, grippers, cutters, staplers, clip applicators, access devices , drug/gene therapy delivery devices and/or other energy delivery devices using RF, laser, etc. In some versions, configuration data can be loaded from the 550 end actuator module 590 when the 550 end actuator is coupled to the 500 instrument. Alternatively, such configuration data can be preloaded onto a storage device, such as the storage device 50 of the instrument 10, 150, 200, 400, 500, 600, can be loaded from a remote source and/or otherwise.
[0058] With the configuration data loaded, the user starts the procedure in block 720. Just as an example, the procedure can start when the user positions the instrument 10, 150, 200, 400, 500, 600 in a position of initial gesture and/or when a user operates an activation button or other feature, such as a trigger 168. In the case of an initial gesture position, the configuration data may include a plurality of initial orientation positions for the surgical instrument 10 , 150, 200, 400, 500, 600 which correspond to various desired results or procedures. For example, such initial orientation positions may include positions for cutting, coagulating, scraping, pressing, sweeping, etc. Data from sensors 30, 232, 234, 300, 410 that indicate the orientation of the instrument 10, 150, 200, 400, 500, 600 is transmitted to the control module 40 and compared with the various initial orientation positions to determine which initial orientation position is intended by the user. Once an initial orientation position is determined, the energy component, such as energy component 20 or transducer 190, is activated at an energy setting corresponding to that initial orientation position. In addition or alternatively, the activation button or other feature can be provided to selectively activate the instrument 10, 150, 200, 400, 500, 600 once the user positions the instrument 10, 150, 200, 400, 500, 600 at an initial orientation position and/or to activate the instrument 10, 150, 200, 400, 500, 600 at a predetermined initial energy level Regardless of instrument orientation 10, 150, 200, 400, 500, 600. In some versions, the instrument power component 10, 150, 200, 400, 500, 600 may remain inactive even after the activation button is operated by the user and will not activate until the control module 40 determines that one of the gesture profiles of the configuration data has been performed, as will be described below, or, in some versions, until a specific start gesture (for example, a move indicating that the device should be activated) is performed. Obviously, the above is merely optional.
[0059] Once the user starts the procedure, the control module 40 monitors the sensors 30, 80, 98, 232, 234, 300, 410 in block 730. For example, the control module 40 monitors the orientation and/ or movement of the instrument 10, 150, 200, 400, 500, 600 through the output of the first sensor 30, gyroscope 232, accelerometer 234, orientation sensor 300 and/or orientation sensor 410. Consequently, the control module 40 can use the orientation and/or movement data to determine the various gestures and/or the speed of the instrument movements 10, 150, 200, 400, 500, 600 performed by the user. In addition or alternatively, control module 40 monitors force applied to an end actuator via second sensor 80 and/or end actuator sensor 98, as will be discussed in greater detail below with reference to FIG. 12. Obviously, it should be understood that other sensors, such as temperature sensors, Hall Effect sensors, etc., can be monitored by control module 40 such that control module 40 can further adjust the setting of power to the power component or otherwise modify the settings for instrument 10, 150, 200, 400, 500, 600 in real time as instrument 10, 150, 200, 400, 500, 600 is used based on on how the instrument 10, 150, 200, 400, 500, 600 is used.
[0060] In block 740, the sensor data from block 730 is compared to the various gesture profiles of the configuration data. By way of example only, the output of sensors 30, 80, 98, 232, 234, 300, 410 over a predetermined period of time is compared with the expected output of sensors 30, 80, 98, 232, 234, 300, 410 for each of the various gesture profiles. At block 750, control module 40 determines which gesture profile of the configuration data most closely correlates with the output of sensors 30, 80, 98, 232, 234, 300, 410. For example, whether gyroscope 232 indicates that the orientation of instrument 10, 150, 200, 400, 500, 600 remains substantially vertical and accelerometer 234 indicates a downward movement of instrument 10, 150, 200, 400, 500, 600, then control module 40 determines that it occurs. the pressure movement shown in FIG. 9 and the corresponding gesture profile is determined. Similar determinations for a sweep movement FIG. 8 and/or a scraping movement FIG. 10 can be performed using motion and orientation information from sensors 30, 232, 234, 300, 410. With the gesture profile determined, control module 40 applies the power setting corresponding to block 760 such that the output of the energy component is adequate for the given gesture. Control module 40 then returns to monitoring sensors 30, 80, 98, 232, 234, 300, 410 in block 730. The method can continue to adjust power settings according to the various gesture profiles indicated by sensor outputs 30, 80, 98, 232, 234, 300, 410 as the user performs the procedure. Consequently, the user can simply adjust their gestures using the instrument 10, 150, 200, 400, 500, 600 to change energy settings quickly. In some versions, the user can release the activation button or other feature to deactivate the instrument 10, 150, 200, 400, 500, 600, reorient the instrument 10, 150, 200, 400, 500, 600 to a different indicative position from a different power setting and reactivate the instrument 10, 150, 200, 400, 500, 600 to continue the procedure with the new power setting.
[0061] In some versions, a predetermined limit value for an anomalous deceleration or acceleration can be established in the configuration data. While instrument 10, 150, 200, 400, 500, 600 operates according to the gesture profiles, the power setting remains unchanged. If the output of accelerometer 234 indicates that such a limit value for deceleration or anomalous acceleration has occurred, such as during block 730 when control module 40 monitors sensors 30, 80, 98, 232, 234, 300, 410 and/or during block 740 when the output of sensors 30, 80, 98, 232, 234, 300, 410 is compared to the various gesture profiles, then the control module 40 is configured to reduce the power setting or in some versions, to disable the instrument power component 10, 150, 200, 400, 500, 600 fully. Once anomalous deceleration or acceleration ceases and/or sensors 30, 80, 98, 232, 234, 300, 410 indicate a normal gesture profile, the energy component is re-enabled or the energy setting is returned to the value that matches the indicated gesture profile. Thus, if the user inadvertently loses control of the instrument 10, 150, 200, 400, 500, 600 during a procedure or unexpectedly encounters soft or dense tissue, the control module 40 may be operable to reduce or stop the ultrasonic blade oscillation. Obviously, it should be understood that the foregoing is not limited to ultrasonic surgical instruments, but can be applied to other surgical instruments, such as endocutters, grippers, cutters, staplers, clip applicators, access devices, delivery devices. drug/gene therapy and/or other energy delivery devices using RF, laser, etc.
[0062] Although the above has described the application of various energy settings corresponding to various gesture profiles, FIG. 12 depicts a set of alternative power settings that can be determined through the control module 40 in response to monitoring sensors 30, 80, 98, 232, 234, 300, 410 based on the speed of movement of the instrument 10, 150, 200, 400, 500, 600 and the force applied to the end actuator blade. In the present example, the movement of the instrument 10, 150, 200, 400, 500, 600 is measured by an accelerometer, such as accelerometer 234 and the force applied to the blade is measured by a force sensor, such as a second sensor 80 and/or end actuator sensor 98. In block 800, the control module 40 checks the output of sensors 80, 98, 234. If sensors 80, 98, 234 indicate rapid instrument movement 10, 150, 200, 400, 500, 600 with low force or blade pressure, then the energy setting for the energy component is set to a high speed setting for tissue dissection in block 810. If sensors 80, 98, 234 indicate rapid instrument movement 10, 150, 200, 400, 500, 600 with high force or pressure on the blade, so the energy setting for the energy component is set to a medium range setting in block 820 for cut through thick tissue or vessels. If sensors 80, 98, 234 indicate a slow movement of the instrument 10, 150, 200, 400, 500, 600 with low force or pressure on the blade, then the energy setting for the energy component is set to a setting mode of hemostasis in block 830 to seal the vessels. If sensors 80, 98, 234 indicate slow instrument movement 10, 150, 200, 400, 500, 600 with high force or pressure on the blade, then the energy setting for the energy component is set to a setting medium range in block 840 to cut through thick tissue or vessels. The control module 40 can continuously check the sensors in block 800 and determine the proper power setting in blocks 810, 820, 830, 840. It should be further understood that in some versions, the power settings shown in FIG. 12 can be incorporated into the method shown in FIG. 11 to replace blocks 730, 740, 750, 760. Obviously, other definitions based on variable force and/or motion data will be apparent for a common skill element in view of the teachings herein.
[0063] In addition to or alternatively to adjusting power settings, in some versions the instrument 10, 150, 200, 400, 500, 600 can be configured to provide user feedback based on a comparison between user gestures and an expected user gesture profile. For example, if a sweeping motion is expected and the output of sensors 30, 80, 98, 232, 234, 300, 410 indicates that the user performs the sweeping motion, however, it does so very slowly, the control module 40 can be configured to provide audible and/or visual feedback via UI 60 to the user to indicate that the user is too slow. Just as an example, a periodic click can be emitted from a speaker when the instrument 10, 150, 200, 400, 500, 600 operates normally and the periodic click slows down when the user is very slow in relation to gestured movement. If the user is too fast, the periodic click may increase in speed. Obviously, other variations to sonic feedback will be apparent for an element of common skill in the art in view of the teachings herein. In addition or alternatively, a visual indicator can be provided to indicate whether the user is in a preferred operating range for the gesture or is too slow or too fast. For example, an array of LEDs that indicate relative speed can be provided. In addition or alternatively, a continuous or periodic line graphical display may be provided on a screen in a manner similar to an oscilloscope or other graphical display to provide visual feedback to the user about its performance over a preferred operating range. The control module 40 may be further configured in accordance with at least a part of the teachings of US Patent Application No. [Attorney Dossier Number END7056USNP.0590477], entitled "Surgical Instrument with Stress Sensor", filed on the same date as present application, the description of which is incorporated herein by reference. Such audible and/or visual feedback can speed up the user's understanding of preferred operating movements for various gestures, thus reducing the learning curve for the instrument 10, 150, 200, 400, 500, 600. Yet another feedback from user and/or instrument settings 10, 150, 200, 400, 500, 600 will be apparent to an element of common skill in the art in view of the teachings herein. SAW. Miscellaneous
[0064] As noted above, a storage device can be used to store operating parameters, other data and/or control algorithms, etc. associated with the various types of surgical instruments mentioned in this document. Such information may be preloaded and/or updated later; and can dictate the performance characteristics of the surgical instrument. For example, software/firmware/information on the storage device can influence the power delivery from a generator or other power source, which can, in turn, affect the performance of the tip actuator as driven by the power source. In some systems, a generator, power source, control module, and/or other component provides baseline functionality for the surgical instrument; while software/firmware/storage device information provides enhanced functionality (eg active damping, surgeon gesture recognition, enhanced user feedback, etc.). It should be understood that the storage device may take any suitable form, including but not limited to a chip, card or other type of storage medium as will be apparent to those of ordinary skill in the art in light of the teachings herein. document. It should be understood that the storage device can be located in any suitable location within the system. By way of example only, the storage device may be located in a removable cartridge, such as the various removable cartridges described in Patent Application Serial Number US 13/426,760 entitled "Method and Apparatus for Programming Modular Surgical Instrument", filed on March 22, 2012, the description of which is now incorporated by way of reference. As another merely illustrative example, the storage device may be incorporated into a remote online server that is in communication with the surgical instrument and/or generator, etc., such as in the system described in US Patent Application Serial Number 13/ 426,792, entitled "Surgical Instrument Usage Data Management", filed on March 22, 2012, the description of which is now incorporated by way of reference. As yet another merely illustrative example, the storage device may be included either as an integral component or a removable component of the end actuator, rod, handle, handle and/or other part of the surgical instrument. Various other suitable locations for a storage device will be apparent to those of ordinary skill in the art in view of the teachings herein. It should further be understood that the storage device can store surgeon usage data, patient data and/or other types of data as described herein, such that the storage device can receive additional data during the use of the surgical instrument.
[0065] In some versions, a surgical instrument manufacturer or vendor provides the surgical instrument as a single-use instrument, with the appropriate software/firmware/information preloaded on the storage device for single use. In such versions, the software/firmware/information is inaccessible or inoperable after the surgical instrument has been used for a predetermined amount of uses. For example, if the instrument is designed for a specific number of uses, the software/firmware/information may be at least partially erased or disabled at some point after the preset design life is exceeded. In the event that both the manufacturer and another party choose to reprocess/resterilize the device beyond the predefined design life, the reprocessed/resterilized surgical instrument may still be at least partially operable, however, with reduced functionality. For example, a surgeon may still have the ability to properly use the reprocessed/re-sterilized surgical instrument, however, the instrument may not have enhanced functionality (eg, active damping, surgeon gesture recognition, enhanced user feedback, etc.). ) that was otherwise originally provided through the software/firmware/information stored on the storage device. In some versions, the storage device allows the manufacturer or vendor to offer the instrument's performance according to the customer's functional needs. If the customer only needs limited functionality to perform specific surgeries, such as cholecystectomy, then the storage device will be loaded with the appropriate software/firmware/information. If the customer needs enhanced performance for difficult surgeries or to expand the device's potential operating performance if the surgery is more difficult than anticipated, then the storage device can be loaded accordingly. In any case, some versions may allow a manufacturer or vendor to adjust the functionality of the surgical instrument to meet the customer's needs with the customer-defined functionality of the software/firmware/information on the storage device; and to satisfy a different set of customer needs without enhanced functionality.
[0066] Finally, it should be understood that the software/firmware/information in a storage device as described in this document need not necessarily be influenced by any type of sensors in the surgical instrument. For example, the surgical instrument may simply have no sensors; or the storage device may not be communicating with the sensors.
[0067] It should be understood that any one or more of the teachings, expressions, modalities, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, modalities, examples, etc. which are described here. Therefore, the teachings, expressions, modalities, examples, etc. described above should not be viewed in isolation from one another. Various suitable ways in which the teachings of the present invention may be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. These modifications and variations are intended to be included within the scope of the appended claims.
[0068] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings of the present invention can be readily incorporated into robotic surgical systems such as the DAVINCI™ system from Intuitive Surgical, Inc., of Sunnyvale, CA, USA.
[0069] The versions described above may be designed to be discarded after a single use, or they may be designed to be used multiple times. Versions can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps of disassembling the device, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, some versions of the device can be disassembled, in any number of particular parts or parts of the device can be selectively replaced or removed in any combination. With cleaning and/or replacement of particular parts, some versions of the device can be reassembled for subsequent use in a reconditioning facility, or by a user immediately prior to a surgical procedure. Those skilled in the art will understand that reconditioning a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques, and the resulting refurbished device, are all within the scope of this order.
[0070] Just as an example, the versions described here can be sterilized before and/or after a procedure. In a sterilization technique, the device is placed in a closed, sealed container such as a plastic or TYVEK bag. The container and device can then be placed in a radiation field, such as gamma radiation, X-rays or high energy electrons, which can penetrate the container. Radiation can kill bacteria in the device and container. The sterilized device can then be stored in a sterile container for later use. The device may also be sterilized using any other known technique, including, but not limited to, beta or gamma radiation, ethylene oxide, or water vapor.
[0071] In view of the presentation and description of various versions in this disclosure, further adaptations of the methods and systems described in this document can be made through suitable modifications made by an expert in the art, without departing from the scope of the present invention. Several of these possible modifications have been mentioned, and others will be evident to those skilled in the art. For example, the examples, versions, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative only and are not required. Accordingly, the scope of the present invention is to be considered in accordance with the terms of the following claims and it is understood that it is not limited to the details of structure and operation shown and described in the specification and drawings.

权利要求:
Claims (8)
[0001]
1. Apparatus (10, 200, 400), characterized in that it comprises: (a) a body assembly (12, 202) comprising: i. a power component (20, 210) that is operable in a plurality of power configurations, ii. a control module (40) which is operable to establish a power setting for the power component, and iii. an orientation sensor (410), wherein the orientation sensor is coupled to communicate with the control module, wherein the orientation sensor comprises an annular channel (420), a ball (450) and a plurality of force sensors (430) disposed within the channel, wherein the plurality of force sensors are operable to indicate the orientation of the body assembly in response to the position of the ball within the annular channel; (b) an end actuator (90, 220, 402), wherein the end actuator is coupled to the power component; and (c) a storage device (50), wherein the storage device is coupled to communicate with the control module, wherein the storage device comprises configuration data, wherein the configuration data comprises a first gesture profile and a corresponding first energy setting; where the control module is configured to receive configuration data from the storage device; where the control module is configured to receive the output from the orientation sensor; wherein the control module is configured to compare the orientation sensor output with the first gesture profile; and wherein the control module is configured to set the power component power setting to the first corresponding power setting in response to the correlation between the orientation sensor output and the first gesture profile.
[0002]
2. Apparatus according to claim 1, characterized in that the configuration data further comprises a second gesture profile and a corresponding second power configuration, wherein the control module is configured to compare the output of the sensor to orientation with the first gesture profile and the second gesture profile, where the control module is configured to set the power component power setting to the corresponding second power setting in response to a correlation between the sensor output. orientation and the second gesture profile.
[0003]
3. Apparatus according to claim 1, characterized in that the end actuator is detachably coupled to the body assembly.
[0004]
4. Apparatus according to claim 3, characterized in that the storage device is associated with the end actuator.
[0005]
5. Apparatus according to claim 4, characterized in that the storage device is configured to be coupled in selective communication to the control module when the end actuator is coupled to the body assembly.
[0006]
6. Apparatus according to claim 1, characterized in that the power component comprises an ultrasonic transducer, or an RF generator.
[0007]
7. Apparatus according to claim 1, characterized in that it further comprises a user interface, wherein the user interface is coupled in communication to the control module, wherein the storage device comprises a plurality of data from configuration, in which the user interface is operable to select configuration data from the plurality of configuration data.
[0008]
8. Apparatus according to claim 1, characterized in that it further comprises a user interface, in which the user interface is coupled in communication to the control module, in which the user interface is operable to provide audible feedback or visual for a user.

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JP1660087S|2019-10-04|2020-05-25|

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-05-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/05/2013, 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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US13/484,584|US9572592B2|2012-05-31|2012-05-31|Surgical instrument with orientation sensing|

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US13/484,584|2012-05-31|

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PCT/US2013/042664|WO2013181098A2|2012-05-31|2013-05-24|Surgical instrument with orientation sensing|

---