JP6724030B2 - Surgical device configured to track end-of-life parameters - Google Patents

Description

The present invention relates to surgical instruments and, in various embodiments, to surgical stapling and cutting instruments and staple cartridges for use therewith.

The stapling instrument can include a pair of cooperating elongate jaw members, each jaw member being adapted to be inserted into a patient and positioned relative to the tissue to be stapled and incised. In various embodiments, one of the jaw members can support a staple cartridge having at least two rows of laterally spaced staples therein and the other jaw member is within the staple cartridge. An anvil having staple forming pockets aligned with the rows of staples can be supported. Generally, the stapling instrument further includes a pusher bar and knife blade slidable relative to the jaw member, via a camming surface on the pusher bar and/or a camming surface on a wedge sled pushed by the pusher bar, The staples can be continuously ejected from the staple cartridge. In at least one embodiment, the cam surface is actuated by a plurality of staple drive elements carried by the cartridge and associated with the staples to urge the staples against the anvil and into the tissue grasped between the jaw members, It can be configured to form rows of deformed staples that are laterally spaced. In at least one embodiment, the knife blade can follow the cam surface to cut tissue along the line between the staple rows. Examples of such stapling devices are "SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR OUR 7 DEPARTMENTS, US Patent No. 7, US Patent No. 7, US Patent No. 7, US Patent No. 7, US Patent No. 7, US Patent No. The disclosure is incorporated herein by reference.

The above discussion is intended only to illustrate various aspects of the related art in the field of the invention at the time, and should not be taken as a negation of the claims.

Various features of the embodiments described herein, as well as their advantages, can be understood by the following description in conjunction with the following accompanying drawings.
1 is a perspective view of a modular surgical system including a motorized handle module and three replaceable removable shaft modules. FIG. 2 is a side perspective view of the handle module of FIG. 1 with a portion of the handle housing removed for clarity. FIG. 2 is a partially exploded view of the handle module of FIG. 1. FIG. 3 is another partially exploded view of the handle module of FIG. 1. FIG. FIG. 3 is a side view of the handle module of FIG. 1 with a portion of the handle housing removed. FIG. 3 is an exploded view of a mechanical coupling system for operatively coupling the rotary drive system of the handle module of FIG. 1 to the drive system of the removable shaft module. 2 is a block diagram showing electronic components of the handle module and the removable shaft module of FIG. 1. FIG. FIG. 3 is a process flow diagram executed by the handle processor of the handle module of FIG. 1 to determine when a handle module reaches its end of life. 3 is another diagram of a process flow executed by the handle processor of the handle module of FIG. 1 to determine when the handle module reaches its end of life. 3 is a graph showing the difference between the expected firing and retraction forces exerted by the handle module of FIG. 1 and the actual firing and retraction forces exerted by the handle module, depending on the stroke of the shaft module. The difference between the expected firing and retraction forces exerted by the handle module of FIG. 1 and the actual firing and retraction forces exerted by the handle module executed by the handle processor of the handle module of FIG. FIG. 6 is a process flow diagram for determining when a handle module reaches its end of life, based on FIG. When executed by the handle processor of the handle module of FIG. 1, the time at which the handle module reaches its end of life is determined by the total amount of energy consumed by the handle module during use and the energy consumed by the handle module during each use. It is a figure of the process flow judged based on. FIG. 6 is a graph showing an example of the total amount of energy consumed by the handle module through multiple activations of the device. 3 is a graph showing an example of power consumed during each activation of the handle module of FIG. 1. Figure 6 shows a sterile tray into which a handle module can be inserted for sterilization. Figure 6 shows a sterile tray into which a handle module can be inserted for sterilization. Figure 6 shows a sterile tray into which a handle module and removable shaft module can be inserted for sterilization. Figure 6 shows a sterile tray into which a handle module and removable shaft module can be inserted for sterilization. Figure 6 shows another sterile tray into which the handle module can be inserted for sterilization. FIG. 11E illustrates an embodiment of the sterile tray of FIG. 11E interfacing with the handle module. FIG. 11E illustrates an embodiment of the sterile tray of FIG. 11E interfacing with the handle module. FIG. 11E illustrates an embodiment of the sterile tray of FIG. 11E interfacing with the handle module. FIG. 11E illustrates an embodiment of the sterile tray of FIG. 11E interfacing with the handle module. 3 illustrates an inspection station for inspecting the handle module prior to, during, and/or subsequent to a surgical procedure. 3 illustrates an inspection station for inspecting the handle module prior to, during, and/or subsequent to a surgical procedure. FIG. 3 is a block diagram of an inspection station and a handle module. 6 is a process flow executed by the handle processor of the handle module to determine when the handle module reaches its end of life based on the number of times the handle module has been placed at the inspection station. 3 illustrates an inspection station for inspecting the handle module prior to, during, and/or subsequent to a surgical procedure. FIG. 3 is a block diagram illustrating aspects of a handle module and a removable battery pack, the battery pack including an ID emitter so that the handle module can identify the battery pack. 13A illustrates a process flow executed by the handle processor of the handle module of FIG. 13A to determine when a handle module reaches its end of life based on the number of times the battery pack has been attached to the handle module. 6 illustrates an aspect of a handle module that detects attachment of a removable shaft module. 6 illustrates an aspect of a handle module that detects attachment of a removable shaft module. 6 illustrates an aspect of a handle module that detects attachment of a removable shaft module. A handle module and a removable shaft module are shown, the handle module detecting the attachment of the removable shaft module. Figure 14D shows the handle module, which also detects the attachment of a removable battery pack. 14D illustrates a sensor of the handle module of FIG. 14D that detects insertion of a removable battery pack. 14D illustrates a sensor of the handle module of FIG. 14D that detects insertion of a removable battery pack. 7 shows another sensor in the handle module that detects insertion of a removable battery pack. 7 shows another sensor in the handle module that detects insertion of a removable battery pack. 3 shows a handle module with multiple power packs. 6 illustrates a further process flow executed by the handle processor of the handle module to determine when the handle module reaches its end of life. 6 illustrates a further process flow executed by the handle processor of the handle module to determine when the handle module reaches its end of life. 6 illustrates a handle module with a mechanism that prevents insertion of a battery pack in a particular environment. 6 illustrates a handle module with a mechanism that prevents insertion of a battery pack in a particular environment. 6 illustrates a handle module with a mechanism that prevents insertion of a battery pack in a particular environment. 18B illustrates the mechanism of the handle module of FIG. 18A that prevents removal of the battery pack from the handle module in certain circumstances. 18B illustrates the mechanism of the handle module of FIG. 18A that prevents removal of the battery pack from the handle module in certain circumstances. Figure 3 shows a charging station and a handle module, which is for charging the battery pack of the handle module. Figure 3 shows a charging station and a handle module, which is for charging the battery pack of the handle module. Figure 3 shows a charging station and a handle module, which is for charging the battery pack of the handle module. Figure 5 shows a handle module with a sterile cover for covering the components of the handle module during sterilization. Figure 5 shows a handle module with a sterile cover for covering the components of the handle module during sterilization. 20B illustrates a sterile cover for the battery cavity of the handle module of FIG. 20A. 20B illustrates a removable battery pack for the handle module of FIG. 20A. 6 illustrates a display configuration for a surgical instrument that includes a handle module and a removable shaft module. 6 illustrates a display configuration for a surgical instrument that includes a handle module and a removable shaft module. 6 illustrates a display configuration for a surgical instrument that includes a handle module and a removable shaft module. 6 illustrates a display configuration for a surgical instrument that includes a handle module and a removable shaft module. 1 shows a removable battery pack with an internal circuit board. Figure 6 shows the handle module with a projecting device that, when projected, prevents insertion of the handle module into the sterile tray. 23B illustrates the handle module and sterilization tray of FIG. 23A. 3 shows a handle module inspection station for applying vacuum pressure to the handle module. 3 shows a handle module inspection station for applying vacuum pressure to the handle module. 1 shows a handle module inspection station with one or more fans for drying the handle module. 1 shows a handle module inspection station with one or more fans for drying the handle module. 1 shows a handle module inspection station with one or more fans for drying the handle module. 1 shows a handle module inspection station with one or more fans for drying the handle module. 3 shows an inspection station with a vacuum port for drying the handle module. 1 illustrates a test station, a handle module, and a load simulation adapter for applying a simulated load to the handle module when the handle module is coupled to the test station. 1 illustrates a test station, a handle module, and a load simulation adapter for applying a simulated load to the handle module when the handle module is coupled to the test station. 1 illustrates a test station, a handle module, and a load simulation adapter for applying a simulated load to the handle module when the handle module is coupled to the test station. FIG. 27A is a cross-sectional view of the load simulation adapter of FIGS. 6 is a graph showing a sample model of the backlash of the gear of the handle module according to the use. 3 illustrates an inspection station that can accommodate both a handle module and a removable shaft module. 3 illustrates an inspection station that can accommodate both a handle module and a removable shaft module. 6 shows a process flow executed by the inspection station processor to provide repair recommendations for the handle module. 6 shows a process flow executed by the handle module processor to provide repair recommendations for the handle module. 3 illustrates a charging station for charging one or more removable battery packs that can be used with the handle module. 2 shows a mechanism of a charging station for fixing a battery pack to the charging station. 2 shows a mechanism of a charging station for fixing a battery pack to the charging station. It is a block diagram of a charging station and a battery pack. 6 illustrates a process flow performed by the handle module charging station. 6 illustrates a process flow performed by the handle module charging station. 6 illustrates a process flow performed by the handle module charging station. It is an electrical connection diagram of a charging station. It is an electrical connection diagram of a charging station. It is a top view of a battery pack. FIG. 33B is a top view of the charging station showing the contact configuration of the battery pack of FIG. 33A. It is a top view of a battery pack. FIG. 34B is a top view of the charging station showing the contact configuration of the battery pack of FIG. 34A. FIG. 6 is a flow diagram of a process using an inspection station. 3 is a process flow chart showing exemplary steps for sterilizing the handle module and tracking the number of sterilizations. 3 is a process flow chart showing exemplary steps for sterilizing the handle module and tracking the number of sterilizations. 1 is a perspective view of a battery assembly for use with a surgical instrument, the battery assembly comprising a plurality of shock absorbing elements according to at least one embodiment. FIG. 39 is a detailed cross-sectional view of one of the shock absorbing elements of the battery assembly of FIG. 38. FIG. 39 is a partial cross-sectional view of the battery assembly of FIG. 38. FIG. 3 is a perspective view of a battery assembly for use with a surgical instrument that includes a battery housing configured to protect one or more battery cells of the battery assembly. FIG. 41 is a detailed cross-sectional view of the battery assembly of FIG. 40. 6 illustrates a handle of a surgical instrument system including a power adapter extending from the handle to a power source, according to at least one embodiment. 41 shows the handle of FIG. 41 optionally usable with the power adapter of FIG. 41, or a power adapter system including a removable battery and a removable power cord, according to at least one embodiment. FIG. 3 is a schematic diagram of a power adapter according to at least one embodiment. FIG. 3 is a schematic diagram of a power adapter according to at least one embodiment. FIG. 6 is a perspective view of a handle of a surgical instrument system including a battery. FIG. 47 is a perspective view of a second battery attached to the handle of FIG. 45. FIG. 47 is a cross-sectional view of the handle, the battery of FIG. 45, and the second battery of FIG. 46.

Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations provided herein are illustrative of various embodiments of the invention in one form, and such illustrations should not be construed as limiting the scope of the invention in any way. Absent.

The applicant of the present application owns the following patent applications filed on the same date as the present application, which are hereby incorporated by reference in their entirety:
-U.S. Patent Application No. _____________, Name "SURGICAL INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION", Attorney Docket END7542USNP/140467;
-U.S. Patent Application No. ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________-US Patent Application No.
-U.S. Patent Application No. ________________, entitled "SURGICAL CHARGING SYSTEM THE THAT CHARGES AND/OR CONDITIONS ONE OR MORE BATTERIES", Attorney Docket END7545USNP/140470;
-U.S. Patent Application No. ________________, entitled "CHARGING SYSTEM THE NAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY", Attorney Docket No. END7543USNP/140468;
-U.S. Patent Application No. ______________, entitled "SYSTEM FOR MONITORING WHETER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED", Attorney Docket END7558USNP/140483;
-U.S. Patent Application No. ___________, title "REINFOCED BATTERY FOR A SURGICAL INSTRUMENT", attorney docket no.
-U.S. Patent Application No. _________, title "POWER ADAPTER FOR A SURGICAL INSTRUMENT", Attorney Docket END7553USNP/140478;
-U.S. Patent Application No. ________________, Name "ADAPTABLE SURGICAL INSTRUMENT HANDLE", Attorney Docket No. END7541USNP/140466;

The applicant of the present application owns the following patent applications filed on December 18, 2014, which are hereby incorporated by reference in their entirety:
-US Patent Application No. 14/574,478, entitled "SURGICAL INSTRUMENT SYSTEM COMPRISING AN ARTICULATABLE END EFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKING OF;
-US Patent Application No. 14/574,483, entitled "SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS";
-U.S. Patent Application No. 14/575,139, entitled "DRIVE ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS";
-U.S. patent application Ser. No. 14/575,148, entitled "LOCKING ARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLEIES WITH ARTICULATABLE SURGICAL END EFFECTORS";
-U.S. patent application Ser. No. 14/575,130, entitled "SURGICAL INSTRUMENT WANT AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCREATE NON-MOVABLE AXIS RELATEIVE TO ATRADE CHARCALE.
-U.S. Patent Application No. 14/575,143, entitled "SURGICAL INSTRUMENTS WITH IMPROVED CLOSEURE ARRANGEMENTS";
-U.S. Patent Application No. 14/575,117, entitled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FIRING BEAM SUPPPORT ARRANGENEMENTS";
-U.S. Patent Application No. 14/575,154, entitled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED FIRING BEAM SUPPPORT ARRANGENEMENTS";
-US Patent Application No. 14/574,493, name "SURGICAL INSTRUMENT ASSEMBLE COMPRISING A FLEXIBLE ARTICULATION SYSTEM"; and-US Patent Application No. 14/574,500, name "SURGICAL INSTRUMENTAL SUMMER SUMMER ADDRESS BUSINESS INFORMATION.

The applicant of the present application owns the following patent applications filed March 1, 2013, which are incorporated herein by reference in their entirety:
-U.S. Patent Application No. 13/782,295, entitled "ARTICULATABLE SURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR SIGNAL COMMUNICATION" (Current U.S. Patent Application Publication No. 2014/0246471);
-U.S. Patent Application No. 13/782,323, entitled "ROTARY POWERED ARTICULATION JOINTS FOR SURGICAL INSTRUMENTS" (Current U.S. Patent Application Publication No. 2014/0246472);
-US Patent Application No. 13/782,338, entitled "THUMBWHEEEL SWITCH ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (Current US Patent Application Publication No. 2014/0249557);
-U.S. Patent Application No. 13/782,499, entitled "ELECTROME CHANICAL SURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT" (current U.S. Patent Application Publication No. 2014/0246474);
-U.S. Patent Application No. 13/782,460, entitled "MULTIPLE PROCESS MOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS" (current U.S. Patent Application Publication No. 2014/0246478);
-U.S. Patent Application No. 13/782,358, entitled "JOYSTICK SWITCH ASSEMBLIES FOR SURGICAL INSTRUMENTS" (Current U.S. Patent Application Publication No. 2014/0246477);
-U.S. Patent Application No. 13/782,481, entitled "SENSOR STRAIGHTTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR" (current U.S. Patent Application Publication No. 2014/0246479);
-U.S. Patent Application No. 13/782,518, entitled "CONTROL METHODS FOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT PORTIONS" (current U.S. Patent Application Publication No. 2014/0246475);
-US Patent Application No. 13/782,375, entitled "ROTARY POWERED SURGICAL INSTRUMENTS WITH MULTIPLEGE DEGREES OF FREEDOM" (Current US Patent Application Publication No. 2014/0246473); and-US Patent Application No. 13/782,536. , "SURGICAL INSTRUMENT SOFT STOP" (current US Patent Application Publication No. 2014/0246476).

Applicant also owns the following patent applications filed March 14, 2013, which are incorporated herein by reference in their entirety:
-U.S. Patent Application No. 13/803,097, titled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE" (current U.S. Patent Application Publication No. 2014/0263542);
-U.S. Patent Application No. 13/803,193, entitled "CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT" (Current U.S. Patent Application Publication No. 2014/0263537);
-U.S. Patent Application No. 13/803,053, entitled "INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT" (Current U.S. Patent Application Publication No. 2014/0263564);
-U.S. Patent Application No. 13/803,086, titled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK" (current U.S. Patent Application Publication No. 2014/0263541);
-U.S. Patent Application No. 13/803,210, titled "SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONINGING SYSTEM FOR SURGICAL INSTRUMENTS" (current U.S. Patent Application Publication No. 2014/0263538);
-U.S. Patent Application No. 13/803,148, entitled "MULTI-FUNCTION MOTOR FOR A SURGICAL INSTRUMENT" (current U.S. Patent Application Publication No. 2014/0263554);
-U.S. Patent Application No. 13/803,066, entitled "DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (Current US Patent Application Publication No. 2014/0263565);
-U.S. Patent Application No. 13/803,117, entitled "ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS" (current U.S. Patent Application Publication No. 2014/0263553);
-U.S. Patent Application No. 13/803,130, entitled "DRIVE TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (Current U.S. Patent Application Publication No. 2014/0263543); and-US Patent Application No. 13/803,159, The name "METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT" (current US Patent Application Publication No. 2014/0277017).

The applicant of the present application also owns the following patent applications, filed March 7, 2014, which are incorporated herein by reference in their entirety:
-U.S. Patent Application No. 14/200,111, entitled "CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS" (Current US Patent Application Publication No. 2014/0263539).

Applicant of the present application also owns the following patent applications filed March 26, 2014, which are hereby incorporated by reference in their entirety:
-U.S. Patent Application No. 14/226,106, entitled "POWER MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS";
-U.S. patent application Ser. No. 14/226,099, entitled "STERILIZATION VERIFICATION CIRCUIT";
-U.S. Patent Application No. 14/226,094, entitled "VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT";
-U.S. Patent Application No. 14/226,117, entitled "POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL";
-U.S. Patent Application No. 14/226,075, titled "MODULAR POWERED SURGICAL INSTRUMENT WITH WITH DETACHABLE SHAFT ASSEMBLIES";
-U.S. patent application Ser. No. 14/226,093, name "FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS";
-US Patent Application No. 14/226,116, entitled "SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION";
-U.S. Patent Application No. 14/226,071, entitled "SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR";
-U.S. Patent Application No. 14/226,097, entitled "SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS";
-U.S. Patent Application No. 14/226,126, entitled "INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS";
-US Patent Application No. 14/226,133, entitled "MODULAR SURGICAL INSTRUMENT SYSTEM";
-US Patent Application No. 14/226,081, name "SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT";
-U.S. Patent Application No. 14/226,076, entitled "POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION";
-US Patent Application No. 14/226,111, entitled "SURGICAL STAPLING INSTRUMENT SYSTEM"; and-US Patent Application No. 14/226,125, entitled "SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT".

The applicant of the present application also owns the following patent applications filed on September 5, 2014, which are hereby incorporated by reference in their entirety:
-U.S. Patent Application No. 14/479,103, entitled "CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE";
-U.S. Patent Application No. 14/479,119, entitled "ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION";
-U.S. Patent Application No. 14/478,908, entitled "MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION";
-U.S. Patent Application No. 14/478,895, entitled "MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT OR INTERPRETATION";
-U.S. Patent Application No. 14/479,110, entitled "USE OF POLARITY OF HALL MAGNET DETECTION TO DETECT MISLOADED CARTRIDGE";
-U.S. Patent Application No. 14/479,098, entitled "SMART CARTRIDGE WAKE UP OPERATION AND DATA RETENTION":
-US Patent Application No. 14/479,115, entitled "MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE";

The applicant of the present application also owns the following patent applications filed on April 9, 2014, which are hereby incorporated by reference in their entirety:
-U.S. Patent Application No. 14/248,590, entitled "MOTOR DRIVEN SURGICAL INSTRUMENTS WITH LOCKLOCKABLE DUAL DRIVE SHAFTS" (current U.S. Patent Application Publication No. 2014/0305987);
-U.S. Patent Application No. 14/248,581, entitled "SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROM THE SAME ROTATABLE OUTPUT" (Current US Patent Application No. 30/59) No. 009/2014.
-U.S. Patent Application No. 14/248,595, entitled "SURGICAL INSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLING THE OPERATION OF THE SURGICAL INSTRUMENT";
-U.S. Patent Application No. 14/248,588, entitled "POWERED LINEAR SURGICAL STAPLER" (current U.S. Patent Application Publication No. 2014/03096666);
-U.S. Patent Application No. 14/248,591, titled "TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT" (current U.S. Patent Application Publication No. 2014/03030591);
-US Patent Application No. 14/248,584, entitled "MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH WHICH ALIGNING FEATURES FOR ALIGNING ROTARY DRIVE SHAFTS WHITES AFAT 04 US/WHITE SURFFIC 20 HOURS SURGENIC".
-U.S. Patent Application No. 14/248,587, entitled "POWERED SURGICAL STAPLER" (current U.S. Patent Application Publication No. 2014/0309665);
-US Patent Application No. 14/248,586, Name "DRIVE SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT" (Current US Patent Application Publication No. 2014/0305990); and-US Patent Application No. 14/248,607. The name "MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS" (current US Patent Application Publication No. 2014/03055992).

The applicant of the present application also owns the following patent applications filed on April 16, 2013, which are hereby incorporated by reference in their entirety:
-U.S. Provisional Patent Application No. 61/812,365, entitled "SURGICAL INSTRUMENT WITH MULTIPLELE FUNCTIONS PERFORMED BY A SINGLE MOTOR";
-U.S. Provisional Patent Application No. 61/812,376, entitled "LINEAR CUTTER WITH POWER";
-US Provisional Patent Application No. 61/812,382, entitled "LINEAR CUTTER WITH MOTOR AND PISTOL GRIP";
-U.S. Provisional Patent Application No. 61/812,385, Name "SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTION MOTORS AND MOTOR CONTROL"; A SINGLE MOTOR".

Many specific details are set forth in order to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described herein and shown in the accompanying drawings. Well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described herein. It will be appreciated by the reader that the embodiments described and shown herein are non-limiting examples, and therefore, the specific structural and functional details disclosed herein may be representative. It should be understood that this may be exemplary and exemplary. Modifications and changes thereto may be made without departing from the scope of the claims.

The terms "comprise" (any form of rise, such as "comprises" and "comprising"), "have" (any form of have, such as "has" and "having"), "include ( "include" (any word of include, such as "includes" and "including"), "contain" (any word of contain, such as "contains" and "containing") is an open concatenation It is a verb. As a result, a surgical system, device, or apparatus "comprising," "having," "containing," or "containing" one or more elements is one or more of those Although it has elements, it is not limited to having only one or more of those elements. Similarly, an element of a system, device, or apparatus "comprising," "having," "including," or "containing" one or more features is one or more of those features. , But is not limited to having only one or more of those features.

The terms "proximal" and "distal" are used herein with reference to the clinician operating the handle portion of the surgical instrument. The term "proximal" refers to the portion that is closest to the clinician, and the term "distal" refers to the portion that is located far from the clinician. It is further understood that spatial terms such as “vertical”, “horizontal”, “top”, and “bottom” may be used herein for the drawings, for convenience and clarity. Let's do it. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Various representative devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, it will be readily apparent to the reader that the various methods and devices disclosed herein may be used in numerous surgical procedures and applications, including, for example, those associated with open surgical procedures. You will understand. In reading the "Modes for Carrying Out the Invention" herein, the reader will be informed that the various devices disclosed herein may be used to make incisions or punctures made in tissue, for example, through natural openings. It will be further appreciated that it can be inserted into the body in any way, such as through a hole. The working or end effector portion of these instruments may be inserted directly into the patient's body, or an access device such as a trocar having a working passage through which the end effector and elongated shaft of the surgical instrument may be advanced. It can also be inserted through.

The surgical stapling system may include a shaft and an end effector extending from the shaft. The end effector includes a first jaw and a second jaw. The first jaw comprises a staple cartridge. The staple cartridge is insertable into and removable from the first jaw, but the staple cartridge is not removable from the first jaw, or at least not easily replaceable. Examples are also envisioned. The second jaw comprises an anvil configured to deform staples ejected from the staple cartridge. Another embodiment in which the second jaw is pivotable about the closure axis relative to the first jaw, but the first jaw is pivotable relative to the second jaw. Is also envisioned. The surgical stapling system further comprises an articulation joint configured to allow the end effector to rotate or articulate relative to the shaft. The end effector is rotatable about an articulation axis that extends through the articulation joint. Other embodiments are also envisioned that do not include articulation joints.

The staple cartridge includes a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal and distal ends. In use, the staple cartridge is positioned on the first side of the tissue to be stapled and the anvil is positioned on the second side of the tissue. The anvil is moved towards the staple cartridge to compress and clamp the tissue against the deck. Subsequently, staples that are removably stored within the cartridge body can be deployed into the tissue. The cartridge body includes a staple cavity defined therein, the staple being removably stored within the staple cavity. The staple cavities are arranged in six longitudinal rows. Three rows of staple cavities are located on the first side of the longitudinal slot and three rows of staple cavities are located on the second side of the longitudinal slot. Other arrangements of staple cavities and staples may be possible.

The staples are supported by staple drive elements within the cartridge body. The drive element is moveable between a first or unfired position and a second or fired position that ejects staples from the staple cavity. The drive element is retained within the cartridge body by a retaining element that extends around the bottom of the cartridge body, and is also an elastic member configured to grip the cartridge body and retain the retaining element relative to the cartridge body. including. The drive element is movable by the sled between its unfired position and its fired position. The sled is moveable between a proximal position adjacent the proximal end and a distal position adjacent the distal end. The sled comprises a plurality of ramped surfaces configured to slide under the drive element to raise the drive element and staples supported thereon and toward the anvil.

In addition to the above, the sled is moved distally by the firing member. The firing member is configured to contact the thread and push the thread toward the distal end. A longitudinal slot defined in the cartridge body is configured to receive the firing member. The anvil also includes a slot configured to receive the firing member. The firing member further comprises a first cam that engages the first jaw and a second cam that engages the second jaw. When the firing member is advanced distally, the first cam and the second cam can control the distance between the staple cartridge deck and the anvil, or tissue gap. The firing member also includes a knife that is configured to dissect the trapped tissue intermediate the staple cartridge and the anvil. It is desirable for the knife to be positioned at least partially proximal to the ramp so that the staples are ejected in front of the knife.

The end effector can be configured to articulate with respect to the handle and/or shaft of the surgical instrument. For example, the end effector can be pivotally and/or rotatably coupled to a shaft of a surgical instrument, whereby the end effector is configured to pivot with respect to the shaft and handle. In various examples, the end effector can be configured to articulate at an articulation joint located intermediate the end effector and the shaft. In other examples, the shaft can include a proximal portion, a distal portion, and an articulation joint, which can be located, for example, intermediate the proximal and distal portions of the shaft.

1-5, in one form, may be used and reused in connection with one or a variety of different removable (and typically reusable) shaft modules (DSMs), motor drives 1 illustrates an aspect of a modular surgical cutting and fastening instrument including the reusable handle module 10 of FIG. As will be described in more detail below, the handle module 10 produces one or more motorized motions to impart various control motions and apply these control motions to corresponding drive shaft portions of the particular DSM to be coupled. It may include a housing 12 with a rotary drive system. Two such rotary drive systems 20, 40 are shown in the handle module 10 of FIGS. 1 and 5. The first rotary drive system 20 may be used, for example, to apply a "closed" motion to a corresponding closed drive shaft assembly operably supported within the DSM, and the second rotary drive system 40 may be used, for example. , May be used to apply a "fire" motion to the corresponding fire drive shaft assembly in the DSM being coupled. Various DSMs may be releasably and interchangeably connected to housing 12. FIG. 1 shows three exemplary DSMs that may be connected to the handle module 10 in various configurations. The exemplary DSMs shown include an open linear stapler DSM1, a curved cutter stapler DSM2, and a surgical circular stapler DSM3. An end cutter, described in further detail in U.S. Patent Application No. _________, entitled "MODULAR STAPLING ASSEMBLY", attorney docket no. Other types of DSM suitable for the drive system 20, 40 of the handle module 10, such as a DSM, can also be used. Further details regarding an exemplary dual drive surgical cutting and fastening instrument can be found in US patent application Ser. No. 14/248,590, filed Apr. 9, 2014, which is hereby incorporated by reference in its entirety. It is provided under the name "MOTOR DRIVER SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS" (hereinafter "'590 application").

As shown in FIGS. 1-5, the housing 12 includes a handle 14 configured to be grasped, manipulated, and actuated by a clinician. The handle 14 may include a pair of handle housing segments 16 and 18, which may be interconnected with screws, snap mechanisms, adhesives, or the like. In the configuration shown, the handle housing segments 16, 18 cooperate to form a pistol grip portion 19 that can be grasped and manipulated by a clinician. The handle 14 operably supports the two rotary drive systems 20, 40.

The first rotary drive system 20 and the second rotary drive system 40 may be powered by a motor 80 through a “shift” transmission assembly 60 that effectively shifts power/motion between two power trains. .. The first rotary drive system 20 includes a first rotary drive shaft 22, which is rotatably supported within the housing 12 of the handle 14 and has a first drive shaft axis "FDA-FDA. Is defined. The first drive gear 24 is keyed to the first rotary drive shaft 22 or otherwise keyed to rotate with the first rotary drive shaft 22 about the first drive shaft axis FDA-FDA. It is fixed so that it cannot rotate. Similarly, the second rotary drive system 40 includes a second rotary drive shaft 42, which is rotatably supported within the housing 12 of the handle 14 and has a second drive shaft axis ". SDA-SDA". In at least one device configuration, the second drive shaft axis SDA-SDA is offset from the first drive shaft axis FDA-FDA and is parallel to the first drive shaft axis FDA-FDA. Or are substantially parallel. As used in this context, the term "deviation" means that the first drive shaft axis and the second drive shaft axis are not coaxial. The second rotary drive shaft 42 has a second drive gear 44, which is adapted to rotate with the second rotary drive shaft 42 about a second drive shaft axis SDA-SDA. , Keyed to the second rotary drive shaft 42 or otherwise fixed non-rotatably. In addition, the second drive shaft 42 has an intermediate drive gear 46, which is rotatably supported on the second rotary drive shaft 42, so that the intermediate drive gear 46 is It is freely rotatable on the second rotary drive shaft 42 about the second drive shaft axis SDA-SDA.

In one form, the motor 80 has a motor output shaft, which has a motor drive gear 82 attached to the motor output shaft. Motor drive gear 82 is configured to make a meshing “operable” engagement with transmission assembly 60. In at least one form, the transmission assembly 60 includes a transmission carriage 62, which is supported for axial movement between a drive gear 82 and gears 44 and 46 on the second rotary drive shaft 42. Has been done. For example, the transmission carriage 62 may be slidably mounted on a support shaft 63, which is within the housing 12 such that the line of action of the transmission carriage is perpendicular to the gear train of the rotary drive system. It is mounted on the shaft mount 61. The shaft mount 61 is configured to be rigidly supported within a slot or other mechanism within the handle module 10. The transmission carriage 62 has a carriage gear 64, and the carriage gear 64 is rotatably supported on the support shaft 63. The carriage gear 64 makes a driving engagement with the driving gear 82 and selectively has the gears 44 and 46. Is configured to be in meshing engagement with. 1-5, the transmission carriage 62 is operably attached to a shifter, or "means for shifting" 70, which means 70 for shifting is referred to as "first drive position". And the “second drive position”, the transmission carriage 62 is axially shifted. In one form, for example, the means 70 for shifting comprises a shifter solenoid 71 supported within the housing 12 of the handle 14. The shifter solenoid 71 may include a bistable solenoid, or may include, for example, a two-stage spring loaded solenoid. The illustrated apparatus configuration includes a spring 72 that biases the transmission carriage 62 distally "DD" to a first drive position, with the carriage gear 64 in mesh engagement with the intermediate drive gear 46. Thus, the drive gear 82 also meshes with the drive gear 82. When in the first drive position, actuation of the motor 80 results in rotation of the gears 82, 46, and 24, which ultimately results in rotation of the first drive shaft 22. become.

The shifter solenoid 71 may be actuated by a firing trigger 90, which is pivotally supported on the housing 12 of the handle 14, as shown in FIGS. In the illustrated embodiment, the firing trigger 90 is pivotally supported on a firing trigger shaft 92 mounted within the handle 14. The firing trigger 90 is normally biased by a firing trigger spring 94 in the inoperative position, as shown in FIG. Firing trigger 90 is mounted to operably activate firing switch 96, which is operably supported on control circuit board assembly 100 housed within housing 12 of handle module 10. ing. In the illustrated device configuration, actuation of the firing trigger 90 results in actuation of the shifter solenoid 71. As a result of firing trigger 90, shifter solenoid 71 pulls transmission carriage 62 in the proximal direction "PD", thereby moving carriage gear 64 into meshing engagement with second drive gear 44. The operation of the motor 80 while the carriage gear 64 is in meshing engagement with the drive gear 82 and the second drive gear 44 results in the second drive shaft 42 being driven by the second drive shaft axis "SDA." It will rotate around. The shift transmission assembly 60 may also include a display system 74, which includes a pair of switches 75 and 76 operably coupled to the control board 100 and a transmission indicator light 77. The switches 75, 76 function to detect the position of the transmission carriage 62 so that the control system will activate the indicator light 77 in response to the position of the transmission carriage 62. For example, the indicator light 77 may be energized when the transmission carriage 62 is in the first drive position. This provides the clinician with an indication that the first drive system 20 should be activated as a result of the motor 80 being activated.

Motor 80 may be, for example, a brushed DC drive motor having a maximum speed of about 25,000 RPM. In other configurations, the motor can include any other suitable electric motor, such as a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or a pressure sterilizable motor. The motor 80 may be powered by a power source 84, which in one form may comprise a power pack 86 that is removably stored within the pistol grip portion 19 of the handle 14. To access the power pack 86, the clinician removes the removable cap 17 attached to the bottom of the pistol grip portion 19. The power pack 86 may operably support a plurality of battery cells (not shown) therein. Each battery cell may include, for example, lithium ion (“LI”) or other suitable battery type. The power pack 86 is configured to be removably and operably attached to the control circuit board assembly 100 of the handle module 10, the control circuit board assembly 100 also being operably coupled to the motor 80 and within the handle 14. It is installed. Power pack 86 may include a number of battery cells connected in series that may function as a power source for a surgical instrument. In addition, the power supply 84 may be replaceable and/or rechargeable and may include, in at least one example, a CR123 battery, for example.

The motor 80 may be actuated by a “rocker trigger” 110, which is pivotally mounted to the pistol grip portion 19 of the handle 14. Rocker trigger 110 is configured to actuate a first motor switch 112 operably coupled to control board 100. The first motor switch 112 may include a pressure switch that is activated by pivoting the rocker trigger 110 into contact. The actuation of the first motor switch 112 results in the actuation of the motor 80 such that the drive gear 82 rotates in the first rotational direction. A second motor switch 114 is attached to the circuit board 100 and is attached so as to be selectively contacted by the rocker trigger 110. The actuation of second motor switch 114 results in actuation of motor 80 such that drive gear 82 rotates in the second direction of rotation. For example, in use, the voltage polarity provided by the power supply 84 may cause the electric motor 80 to operate clockwise, while the voltage polarity applied to the electric motor by the battery may cause the electric motor 80 to operate counterclockwise. It can be inverted to allow it. The handle 14 may also have a sensor configured to detect the direction in which the drive system is being moved.

The housing 12 may also include a surgical instrument contact substrate 30 mounted to the housing 12. Accordingly, various DSMs (eg, DSM 1, 2, 3) may include mating DSM contact substrates (see FIGS. 34-60 of the '590 application). The DSM contact board is configured such that the end effector contact board is electrically coupled to the handle module contact board 30 mounted within the handle module 10 when the DSM is operably coupled to the handle module 10. May be located within. In this way, data and/or power can be exchanged between the handle module 10 and the DSM via the mating contact substrate.

FIG. 6 is a mechanical coupling system that may be used to facilitate releasably and operably coupling two drive systems 20, 40 in the handle module 10 to corresponding “driven” shafts in the DSM simultaneously. One form of 50 is shown. Coupling system 50 may include a male coupler that may be attached to a drive shaft within handle module 10 and a corresponding female socket coupler that may be attached to a driven shaft within a surgical DSM. Each of the male couplers 51 is configured to be drivingly received in a corresponding female socket coupler 57, which may also be mounted on a driven shaft in the DSM.

The '590 application discloses a configuration for driving the drive systems 20, 40, such as the handle module 10 may include multiple motors.

FIG. 7 is a block diagram of a modular powered surgical instrument 2100 that includes a handle module 2102 and a DSM 2104. The handle and DSM 2102, 2104 each include an electrical subsystem 2106, 2108 electrically coupled by a communication power interface 2110. The components of the electrical subsystem 2106 of the handle portion 2102 may be supported by and connected to the control board 100 described above. Communication power interface 2110 is configured such that electrical signals and/or power can be easily exchanged between handle portion 2102 and shaft portion 2104.

In the illustrated example, the electrical subsystem 2106 of the handle portion 2102 is electrically coupled to various electrical elements 2112 and display 2114. In one example, display 2114 is an organic light emitting diode (OLED) display, but display 2114 should not be limited to this situation, and other display technologies may be used. The electrical subsystem 2108 of the DSM 2104 is electrically coupled to various electrical components 2116 of the DSM.

In one aspect, the electrical subsystem 2106 of the handle module 2102 comprises a solenoid driver 2118, an accelerometer system 2120, a motor controller/driver 2122, a handle processor 2124, and a voltage regulator 2126, and the DSM and/or handle. Is configured to receive inputs from a plurality of sensor switches 2128, which may be located anywhere in the. The handle processor 2124 may be a general purpose microcontroller suitable for medical and surgical instrument applications. In one example, the handle processor 2124 comprises a 32-bit ARM® Cortex™-M4 80-MHz processor, as well as 256KB Flash, 32KB SRAM, internal ROM for C-series software, and on-chip memory such as 2KB EEPROM. It may be a TM4C123BH6ZRB microcontroller from Texas Instruments. The electrical subsystem 2106 may also include one or more separate external memory chips/circuits (not shown) connected to the handle processor 2124 via a data bus. As used herein, a “processor” or “processor circuit”, such as handle processor 2124, is programmed with program code, such as firmware and/or software, stored in associated memory to execute program code. It may be implemented as a microcontroller, microprocessor, field programmable gate array (FPGA), or application specific integrated circuit (ASIC) that performs various functions.

In one aspect, the electrical subsystem 2106 of the handle module 2102 includes a solenoid 2132, a clamp position switch 2134, a firing position switch 2136, a motor 2138, a battery pack 2140, an OLED interface board 2142 (which drives the display 2114), and an open switch 2144. Various electronic components including various switches (indicating whether the closing trigger is open), closing switch 2146 (indicating whether the closing trigger is closing), firing switch 2148 (indicating whether the firing switch is activated), etc. A signal is received from 2112. In FIGS. 2-5, motor 2138 may represent motor 80.

In one aspect, the electrical subsystem 2108 of the DSM 2104 may include a shaft processor 2130. The DSM electrical subsystem 2108 is configured to receive signals from various switches and sensors 2116 located on the DAM, the signals being indicative of the status of the DSM clamp jaws and cutting elements. .. Specifically, the DSM electrical subsystem 2108 has a clamp open status switch 2150 (indicating whether the end effector clamp is open), a clamp closed status, as various switches indicate the status of the clamp and disconnect elements. Switch 2152 (indicates whether the end effector clamp is closed), fire start status switch 2154 (indicates whether the end effector has started firing), and end fire status switch 2156 (whether the end effector has finished firing). Signal).

Accelerometer system 2120 may include a MEMS motion sensor that senses 3-axis motion of handle module 10, such as a LIS331DLM accelerometer from STMicroelectronics. The motor controller/driver 2122 can include, for example, a three-phase brushless DC (BLDC) controller and a MOSFET driver, such as the A3930 motor controller/driver provided by Allegro. In one aspect, modular electric surgical instrument 2100 is equipped with a brushless DC electric motor 2138 (BLDC motor, BL motor), also known as electronic commutation motor (ECM, EC motor). One such motor is the BLDC Motor B0610H4314 provided by Portescap. The sensor switch 2128 may include one or more unipolar integrating circuit Hall effect sensors. The voltage regulator 2126 regulates the power provided by the power supply (eg, battery 2140) to the various electronic components of the handle module 2102 and DSM 2104. The batteries 2140 that may represent the battery pack 86 of FIGS. 1-5 may be, for example, lithium ion polymer (LiPo) batteries, polymer lithium ion batteries, and/or lithium polymer batteries, such as (abbreviated Li- poly, Li-Pol, LiPo, LIP, PLi, or LiP) rechargeable battery (secondary battery). The LIPO battery 2140 may include multiple (eg, 4 or 6) identical secondary batteries (“packs”) connected in parallel. OLED interface 2142 is an interface to an OLED display 2114 that includes organic light emitting diodes.

In one aspect, the DSM processor 2130 of the electrical subsystem 2108 of the DSM 2104 may be implemented as an ultra-low power 16-bit mixed signal MCU, such as the MSP430FR5738 Ultra-low Power MCU provided by Texas Instruments. It may comprise, inter alia, an internal RAM non-volatile memory, a CPU, an A/D converter, a 16 channel comparator and three extended serial channels capable of supporting I2C, SPI or UART protocols. Subsystem 2108 may also include one or more separate external memory chips/circuits connected to DSM processor 2130 via a data bus.

Further details regarding the handle and an exemplary electrical subsystem for the DSM 2102, 2104 can be found in the '590 application. In operation, the electrical subsystem 2106 of the handle module 2102 receives signals from the open switch 2144, the close switch 2146, and the fire switch 2148 supported on the housing (eg, housing 12) of the handle module portion 2102. When a signal is received from the close switch 2146, the handle processor 2124 actuates the motor 2138 to begin closing the clamp arm. When the clamp is closed, the clamp closure status switch 2152 in the end effector sends a signal to the shaft processor 2130, which communicates the status of the clamp arm to the handle processor 2124 through the communication power interface 2110.

When the target tissue is clamped, firing switch 2148 may be activated to generate a signal received by handle processor 2124. In response, the handle processor 2124 actuates the transmission carriage to the second drive position, which causes actuation of the motor 2138 resulting in rotation of the second drive shaft. When the cutting member is positioned, the firing start status switch 2154 located in the end effector sends a signal to the DSM processor 2130 indicating the position of the cutting member, and the DSM processor 7030 again handles through the communication power interface 2110 the handle processor 2124. Communicate position to.

Actuating the first switch 2148 again causes a signal to be sent to the handle processor 2138, which in turn actuates the second drive system and firing system in the DSM to remove the tissue cutting member and The wedge sled assembly is driven distally through the surgical staple cartridge. When the tissue cutting member and wedge sled assembly is driven to the most distal position within the surgical staple cartridge, the end-of-fire switch 2156 sends a signal to the DSM processor 2130, which again handles the handle processor 2124 through the interface 2110. Communicate position to. The firing switch 2148 can now be actuated to send a signal to the handle processor 2124, which causes the motor 2138 to operate in reverse rotation to return the firing system to the starting position.

By activating the open switch 2144 again, a signal is sent to the handle processor 2124, which operates the motor 2138 to open the clamp. Once released, the clamp release status switch 2150 located in the end effector sends a signal to the shaft processor 2130, which communicates the position of the clamp to the handle processor 2124. Clamp position switch 2134 and fire position switch 2136 provide signals to handle processor 2124 indicating the respective positions of the clamp arm and cutting member.

FIG. 8 illustrates the handle processor in various examples by executing software and/or firmware instructions relating to the handle processor 2124 stored in an internal memory of the processor and/or an external memory chip/circuitry connected to the handle processor 2124. 2124 is a diagram of a process flow that may be performed by 2124. FIG. At step 202, the handle processor 2124 monitors the input signal from the sensor of the instrument 2100 for so-called "life events". A life event is an event or action that requires the handle module 2102 and/or the DSM 2104, and the handle module 2102 should be retired (ie, no longer used) once the threshold number of life events is reached. A life event may be a clamp on the end effector, a firing of the end effector, a combination of these events, and/or other that requires the handle module 2102 and/or DSM 2104 to be or be sensed by the instrument 2100. It can be an event or an action. For example, open switch 2144, close switch 2146, and fire switch 2148 of handle module 2102 may be coupled to handle processor 2124. In addition or in the alternative, clamp open status switch 2150, clamp close status switch 2152, start fire status switch 2154, and end fire status switch 2156 in DSM 2104 may be connected to handle processor 2124 (via interface 2110). May be combined. Life events are triggered when some or all of their respective switches are activated and/or in a particular order detected by the handle processor 2124, depending on the design and application of the handle module 2102 and instrument 2100. May occur and be counted. For example, in various implementations, each detected closure of the clamp and each detected firing may be counted as a life event. In other words, the detected clamp closure may include a first life event and the detected firing may include a second or another life event. In other implementations, a series of clamp closures and subsequent firings may be counted as one life event. Also, as described above, the handle processor 2124 can use inputs from the handle sensors 2144, 2146, 2148 and/or the DSM sensors 2150, 2152, 2154, 2156 to detect, for example, life events.

The handle processor 2124 holds the number of life events. When a life event is detected, the handle processor 2124 increments the current value of the life event counter in either its internal or external memory at step 204. The counter may be an increment counter that increments by one (increments by +1) when a life event occurs, until the preset threshold is met, or the counter may be an end count when a life event occurs. May be a subtraction counter starting from a different preset threshold value and decrementing by one count (incrementing by -1) until a particular ending count (eg zero) is reached. The preset life event count threshold may be set to any value desired by the manufacturer of the handle module 2102, taking into account the particular sensor events that it counts as life events.

When the life event counter reaches the preset life event threshold in step 206, the handle processor 2124 determines in step 208 the display 2114 of the handle module 2102, or any other display (eg, in communication with the handle processor 2124). For example, one or more end-of-life operations may be initiated, such as having a user-visible mechanical counter indicate that the handle module 2102 has been used (end of life) and should be retired. Good. Any suitable visual, tactile, and/or audible display may be used. For example, the display 2114 may include an icon and/or text that indicates the end of life of the handle module has been reached. The display 2114 also provides a continuous life event count, such as by a numerical display or volume indicator (full, near empty, etc.), to allow the user to monitor whether the handle module is nearing the end of its life cycle. Can be shown. In addition to, or instead of, the constant display of life event count, the display 2114 may have an icon that indicates that the handle module is approaching its end of life and/or may use text. (For example, "remaining used N times"). The handle processor 2124 may also initiate a condition that prevents further use of the handle module 2102 when the end-of-life count is reached, as described in detail below. If the end of life count has not been reached, the handle processor 2124 monitors the switches and sensors for life event counts until the end of life threshold is reached.

Various implementations of the sensor can be used to detect a particular life event. For example, the DSMs used (eg DSM 1, 2, 3) are, for example, two drive shafts (a shaft for driving the closure system and a shaft for driving the firing system, (each drive system 20 , 40))). Each such drive shaft may drive the carriage forward during a clamping or firing event, respectively. Accordingly, the closure system and/or the firing system may optionally include a switch that is triggered upon contact of the closure carriage or the firing carriage. The switch may be coupled to the handle processor 2124, which may record the life event count upon receiving a signal from the triggered switch. The switch may be a self-resetting pushbutton switch that is reset each time it is contacted (triggered) by a carriage driven by a drive shaft.

In addition to the above, the '590 application describes that DSM1-3 can include a pair of lead screws to drive the closure and firing systems of various different types of DSMs. Examples of such lead screw pairs are illustrated in Figures 34-37 (open linear stapler) of the '590 application, Figures 38-41 (curved cutter stapler) of the '590 application, and Figures 42-45 (surgical circular stapler) of the '590 application. ) In the '590 application. Other DSM types suitable for handle modules such as end cutters and/or right angle staplers can also be used. Because different DSMs can be used in the handle module, the handle module (eg, handle processor 2124) is more sophisticated to track the usage and remaining life of the handle module based on the number of uses and firings of various types of DSMs. Various algorithms can be used. For example, in one example, the handle processor 2124 calculates a gradual cumulative life event score that weights usage by different DSMs differently (eg, in response to stress on the handle module) and sets the score to a predetermined threshold. You can compare. When the handle module score reaches a threshold, the handle module is retired (eg, one or more end of life operations are performed). For example, the handle processor 2124 may calculate the life event score based on the following relationship.

式中、ｉ＝１、．．．Ｎは、ハンドルモジュール（例えば、エンドカッター、リニアオープン、円形、湾曲、直角ステープラなど）で使用できる、異なるＤＳＭタイプを示し、Ｗ_ｉは、ＤＳＭタイプｉの重み係数であり、Ｆ_ｉ，ｊは、ＤＳＭタイプｉを必要とする、ｊ＝１，．．．Ｓ処置中のＤＳＭタイプｉの発射回数である。ハンドルモジュールに対して概してより少ない応力を加えるＤＳＭタイプは、ハンドルモジュールに対して概してより多くの応力を加えるＤＳＭタイプより低い重みＷを有し得る。このようにして、様々な構成において、高応力処置のみに使用されるハンドルモジュールは、他のすべての条件が同一であるならば、より低応力処置にのみ使用されるハンドルモジュールよりも前に有効期限が切れるであろう。

Where i=1,. ． ． N indicates the different DSM types that can be used with the handle module (eg end cutter, linear open, circular, curved, right angle stapler, etc.), W _i is the weighting factor for DSM type i, and F _i,j is , DSM type i, j=1,. ． ． S is the number of firings of DSM type i during treatment. A DSM type that stresses the handle module generally less may have a lower weight W than a DSM type that stresses the handle module generally more. In this way, in various configurations, a handle module used only for high stress procedures will be more effective than a handle module used only for lower stress procedures if all other conditions are the same. It will expire.

FIG. 9 illustrates an exemplary process flow that the handle processor 2124 may execute to calculate a life event score and/or compare the life event score to a threshold score. In such an example, the handle processor 2124 may execute firmware and/or software stored in, for example, internal and/or external memory. Assuming the handle module threshold score has not been reached, the process begins at block 250 where the handle processor 2124 receives input for the next procedure. At least one such input may include a DSM type ID attached to the handle module, which may be when the DSM is connected to the handle module and/or between the handle processor 2124 and the DSM processor 2130. The handle processor may receive from the DSM processor 2130 when establishing data communication. In the process of recognizing and/or authenticating the DSM, the DSM processor 2130 sends an ID to the handle processor 2124 that identifies the type of DSM (eg, end cutter, circle, etc.) attached to the handle module. .. Next, at step 252, the handle processor 2124 tracks the number of firings of the handle module during the surgical procedure. The handle processor 2124 tracks the number of firings of the handle module by tracking the number of firing trigger activations and/or by tracking the feedback from the DSM, eg, an indication that the end effector cartridge has been replaced. You may

Referring now to step 254, following the procedure, and/or at any other suitable time, the handle processor 2124 may add a score for the procedure just completed to the previous score to add a score for the handle processor. The life event score may be updated. The score for the just completed procedure may be based on multiplying the DSM type weight W _i used in the procedure and the number of firings S in the procedure. The handle processor 2124 may determine the DSM type weight W _i by looking up the weight in a look-up table (stored in internal and/or external memory) based on the type ID received from the DSM in step 250. .. At step 256, the handle processor compares the updated life event score of the handle module with a preset threshold score to determine if the handle module is at the end of its life. If the threshold has been reached, the process proceeds to step 258 where one or more end-of-life operations for the handle module are performed, eg, one or more end-of-life operations described herein. .. On the other hand, if the threshold has not been reached, then the process may proceed to step 260 so that the handle module may be used in at least one or more procedures, whereupon the process of FIG. 9 is repeated.

The loading conditions experienced by the instrument can be used to track usage of both the handle module and DSM to assess whether one or both of the handle module and DSM should retire. One such illustration includes, for example, comparing the force actually applied by the instrument to drive the firing member of the end effector with the force the instrument is expected to experience. Similarly, the force actually applied to retract the firing member can be compared to the force the instrument is expected to experience to assess whether the handle module and/or DSM should retire. The handle module may be evaluated for a threshold number of firings based on the force level the handle module is expected to experience. Similarly, the DSM may be evaluated for a threshold number of firings based on the force level the DSM is expected to experience. The handle module threshold count and the DSM threshold count may be the same or different. If the actual force experienced by the handle module and/or DSM significantly exceeds the expected force level, the handle processor and/or DSM processor may, in some cases, cause the handle module and/or DSM to reach its expected firing. It may be decided whether to retire before the number is reached.

In some examples, in addition to the above, the force applied by the handle module and/or DSM may be constant over the firing stroke of the firing member, while the force exerted by the handle module and/or DSM may be It is quite common for it to change throughout the stroke. In any case, the force exerted by the handle module and/or the force expected to be exerted by the handle module may depend on the position of the firing member. Similarly, the force exerted by the DSM and/or the force expected to be exerted by the DSM may depend on the position of the firing member. A particular DSM type may have an expected firing force that is correlated with the firing stroke of the DSM over its entire length, the distance between the initial start position of the firing member and its stroke end position. The DSM may also have an expected retract force, which is correlated with the retract stroke of the DSM over its entire length, ie, the distance between the firing member stroke end position and its start position. FIG. 10A shows an example of the expected force for one DSM type. The upper curve 270 shows the expected firing force as the firing member traverses the end effector from its starting position to its stroke end position, and the lower curve 272 retracts the firing member back to its starting position. Indicates the expected retractive force at time. In this particular example, the expected launch force is greater than the expected retract force.

For each firing, in addition to the above, the handle module and/or DSM processor can track the force applied per unit distance increment of stroke length (eg, 1 millimeter). Further, the handle module and/or DSM processor tracks the applied force for each distance increment of stroke length, and then compares the actual force to the expected force to predict the actual applied force. You can check whether you have exceeded your power. One way to measure the force exerted by the instrument during firing and retraction is to measure the torque output of the motor during the firing and retraction strokes. In at least one example, the torque output of the motor can be measured based on the current drawn by the motor and the motor speed. In at least one such example, the voltage applied to the motor is constant. For example, current may be measured with a current sensor and motor speed may be measured with an encoder. FIG. 10A shows exemplary force measurements as deviations from the expected launch stroke force and the expected retract stroke force. In this figure, for simplicity of explanation, all measured forces exceed the expected force, and only the difference between the measured force and the expected force is shown in line 274 for the firing stroke. The reverse stroke is shown by the dotted line segment 276. The reader should understand that the one or more measured forces may be below their respective expected forces.

FIG. 10B is a diagram of an exemplary process flow optionally performed by the handle module processor and/or DSM processor by executing firmware and/or software stored in the handle module and/or DSM memory. .. Referring now to step 280, the processor sums the force difference (denoted by ΔL below) between the measured and expected forces at each unit length increment along the instrument's firing and/or retraction strokes. Can, that is, can be accumulated. For example, the cumulative force difference between the firing stroke and the subsequent retract stroke can be calculated based on the following relationship.

式中、ＥＯＳはストローク終了位置を示し、Ｆ_{ｍ，ｆ，ΔＬ}及びＦ_{ｅ，ｆ，ΔＬ}は、位置ΔＬにおける測定された発射力及び予期される発射力をそれぞれ示し、Ｆ_{ｍ，ｒ，ΔＬ}及びＦ_{ｅ，ｒ，ΔＬ}は、位置ΔＬにおける測定された後退力及び予期される後退力をそれぞれ示す。工程２８２において、次いでプロセッサは、ハンドルモジュール及び／又はＤＳＭが経験した各発射について発射あたりの累積力差を合計することによって力差を累積できる。

Where EOS is the end-of-stroke position, F _{m,f, ΔL} and F _{e,f, ΔL} are the measured and expected firing forces at position ΔL, respectively, and F _{m,r, ΔL} And F _e,r,ΔL indicate the measured and expected retractive force at position ΔL, respectively. At step 282, the processor may then accumulate the force difference by summing the accumulated force difference per firing for each firing experienced by the handle module and/or the DSM.

For certain embodiments, in addition to the above, the processor may calculate the cumulative force difference in real time. In at least one example, the processor can calculate the force difference after each firing and retract cycle. In a particular example, the processor can calculate the force difference after each surgical procedure, which may include two or more firing and retracting cycles. For example, if there were seven shots in a particular procedure, the processor would sum the results of step 280 for each of the seven shots. Then, in step 284, the handle optionally adds the cumulative force difference of the most recently calculated procedure to the sum prior to the most recently calculated procedure (or zero for the module's first procedure). , The handle module and/or the total cumulative force difference of the DSM can be updated. At step 286, the processor can then compare the updated total cumulative force difference to a threshold. If the threshold is reached or otherwise met, the process optionally proceeds to step 288 where end-of-life operation of the handle module or DSM occurs. Conversely, in step 286, if the processor determines that the threshold has not been reached yet, then in some cases the handle module and/or DSM may be used again.

In some cases, the handle module and/or DSM may have reached end of life according to another threshold even if the cumulative force difference threshold has not been reached. For example, the process of FIG. 10B may proceed to step 289 after step 286 where the processor optionally compares the total number of procedures requiring a handle module and/or DSM to a procedure count threshold. In at least one example, the handle module may have a treatment count threshold of 20 treatments and the DSM may have a treatment count threshold of 10 treatments. Other examples are possible. In at least one other example, the handle module and the DSM may have the same treatment count threshold. Once the treatment count threshold is reached, at step 288, end-of-life operation of the handle module and/or DSM is optionally initiated. Conversely, if the treatment count threshold is not yet reached, the process proceeds to step 290 where the handle module and/or DSM is prepared for another treatment. Any of the techniques described herein for tracking treatment counts may be used to detect the end of treatment.

In various embodiments, the handle processor can perform calculations on both the handle module and the DSM, and then communicate the DSM results to the DSM processor so that the DSM processor can initiate end-of-life operation as needed. .. Similarly, the DSM processor can perform both the handle module and DSM calculations, and then communicates the handle module results to the handle processor so that the handle processor can initiate end-of-life operation as needed. In another configuration, all forces measured with respect to the procedure are connected to a handle after the procedure, for example, a remote processor such as a processor in an inspection station, or a procedure for post-procedure processing, and another remote computer. Alternatively, it may be downloaded to a processor-based system. Such inspection stations are disclosed and described, for example, in connection with Figures 12A-B.

FIG. 10C, in conjunction with FIGS. 10D and 10E, illustrates another exemplary process flow in which the handle processor can be used to monitor, for example, whether a handle module has reached its end of life. The process shown in FIG. 10C determines if the handle module has reached its end of life based on the energy used by the handle module during its life (an exemplary graph of which is shown in FIG. 10D). FIG. 10D shows the total or cumulative energy consumption by the handle module in response to use or firing of the handle module. In addition to, or in the alternative to, the process illustrated in FIG. 10C may determine whether the handle module has reached its end of life based on the power used during each firing of the handle module (an exemplary thereof). A graph is shown in FIG. 10E). FIG. 10E shows the power consumed for each firing of the handle module. In at least one particular embodiment, the processor determines whether cumulative energy consumed by the handle module exceeds various thresholds in performing the exemplary process of FIG. 10C (see FIG. 10D). And at the same time, it monitors whether the handle module had a certain number of shots above the threshold power level (see FIG. 10E). When both of these conditions are met, in at least one example, the handle processor can conclude that the handle module is at the end of its life. In a particular example, the handle processor can use any number of multi-factor tests (thresholding each test) to determine if the handle module is at the end of its life. In at least one example, the handle processor can determine that its end of life has been reached when either test threshold is met or exceeded.

Following the procedure, the handle processor can perform the process of FIG. 10C by executing firmware and/or software stored in internal and/or external memory to determine if the handle module is at the end of its life. .. At step 290, the handle processor may compare the cumulative energy during the life of the handle module to a first threshold energy level, namely energy level 1 in FIG. 10D. Energy level 1 may be, for example, 40 kJ. The handle module may include a microwatt or power meter connected to the motor of the handle module to measure and record electrical parameters of the motor so that the energy and power output of the motor can be determined. If the first threshold energy level, ie, energy level 1, is reached or exceeded, the handle processor determines in step 291 that the handle module is at the end of its life, eg, as described herein. An end-of-life operation can be initiated, such as one or more end-of-life operations described.

If the handle processor determines in step 290 that the first threshold energy level, ie, energy level 1, has not been reached, the process causes the handle module to move to a second (eg, lower) energy threshold, ie, FIG. 10D. Then, the process proceeds to step 292, in which it is determined whether the energy level 2 has been satisfied. Energy level 2 may be, for example, 30 kJ. If the second threshold energy level is reached or exceeded (without reaching or exceeding the first threshold energy level), the process causes the handle module to move to the first power level threshold. , A handle processor determines 293 if it has undergone two or more firings (see FIG. 10E) over its lifetime, eg, more than 55 watts. If the second energy level threshold is met or exceeded and the power level threshold is met or exceeded a predetermined number of times, the handle processor can determine that the handle module is at the end of its life. However, if the power level threshold has not been met or exceeded a predetermined number of times, the handle processor may have met or exceeded the second energy level threshold, but the handle module is still at end of life. It can be determined that it has not reached. The dual factor of steps 292 and 293 can be another test for the life of the handle module, and if the handle module fails both tests (ie, both thresholds or conditions are met), the handle module will , It can be determined that it is at the end of its life.

The handle processor can perform any number of such dual factor tests. The example of FIG. 10C shows one further such dual factor test. If neither of the dual factors of steps 292 and 293 is satisfied, the process determines if the handle module has satisfied a third (eg, even lower) energy threshold, ie, energy level 3, step 294. You can proceed to. Energy level 3 may be, for example, 25 kJ. If the third threshold energy level is reached or exceeded (without reaching or exceeding the third threshold energy level), the process is A number of firings greater than a second power level threshold (which may be the same as or different from the power level threshold in step 293) (preferably more than the number of such firings identified for step 293), eg , Go to step 295 to determine if four shots over 55 watts have passed during its life. The dual factor of steps 294 and 295 can be another test for the life of the handle module, and if the handle module fails both tests (ie, a threshold or condition is met), the handle module will It can be determined that it is at the end of life. Otherwise, the handle processor can determine that the handle module is not at the end of its life and can be used in subsequent actions.

Obviously, the steps of FIG. 10C can be performed in various orders while achieving the same result. For example, steps 294 and 295 can be performed before step 290, and so on.

Current best practice requires that the handle module be sterilized prior to performing a surgical procedure. In various examples, the handle module is then placed in a sterile tray that is then placed in the sterilization chamber. In addition to or instead of the above method for tracking the end-of-life of a handle module, the number of times the handle module is placed in a sterile tray for sterilization can be used to track the end-of-life of the handle module. In other words, the number of times of sterilization of the handle module functions as a substitute for the number of times of use of the handle module. In at least one exemplary embodiment, each handle module has its own sterilization tray that holds the sterilization number for a particular handle module. In such a configuration, the sterile tray may include a counter that increments each time the associated handle module is placed in the tray. The counter has a visual readout display that can indicate the number of times the handle module has been sterilized when the increment counter is used, or the number of remaining sterilizations, that is, the number of sterilizations allowed, if the subtraction counter is used. Can have. In this way, the user can know when the sterilization limit has been reached so that the user can retract the handle module and/or take other suitable end-of-life measures. You can To use the placing of the handle module in the sterile tray as an alternative to the number of times the handle module is sterilized, and thus the number of times the handle module is used, the handle modules are sterilized in one and only one sterile tray. Need to In this way, the counter does not count the placement of other handle modules on the tray. Thus, the handle module and sterilization tray may be provided together, eg, as a kit, and may include an ID (eg, number or icon) indicating that they are to be used together. The handle module and DSM can be sterilized separately or together, for example.

FIG. 11A shows an exemplary sterile tray 300 and a handle module 302 that may be positioned within the sterile tray 300. The sterilization tray 300 defines an opening, or recess 304, the shape of which matches the shape of the handle module 302 disposed therein. The recess 304 is configured to tightly receive the handle module 302, and thus the relative movement, if any, between them is negligible. The sterilization tray 300 includes a stroke counter 306 having a lever arm 308 that extends into the opening 304. The stroke counter 306 further includes a counter visual readout 310. When the user places the handle module 302 in the opening 304, the lever arm end 308 is depressed, toggled, or stroked. This causes the stroke counter 306 displayed on the reading device 310 to be incremented by 1 (or by 1 in the case of a subtraction counter) and thus recorded as a count. To reduce false switching or stroke of the lever arm 306, in various configurations, the lever arm end 308 includes a protrusion 312 that is configured to fit into a corresponding opening 314 defined in the handle module 302. May be included. FIG. 11B shows the handle module 302 after it has been placed on the sterile tray 300. In FIG. 11B, the lever arm end 308 is not visible because it is below the handle module 302. The counter reader 310 remains visible to the user even though the handle module 302 is positioned within the opening 304.

11C and 11D show variations in which the handle module 302 can be placed on the sterile tray 300 with the DSM 312. Handle module 302 is similar to handle module 10 in many respects, and DSM 312 represents an exemplary DSM. In such a configuration, the sterilization tray 300 includes a handle module opening 318 for receiving the handle module 302, a handle module lever counter 314, and a handle module counter readout device 316. The tray 300 also includes a DSM opening 324 for receiving the DSM 312, a DSM lever counter 320, and a DSM counter reader 322. In such a configuration, the handle module 302 and DSM 312 should only be sterilized in a particular sterilization tray 300 so that their sterilization can be accurately tracked. The handle module counter 312 indicates the number of times the handle module 302 in the sterilization tray 300 has been sterilized and/or the number of remaining sterilizations. The DSM counter 324 indicates the number of times the DSM 312 has been sterilized in the sterilization tray 300 and/or the number of remaining sterilizations. The handle module 302 can be sterilized without the DSM 312 and vice versa. In this case, the respective counts may not be equal.

11E-11I show another configuration for tracking the use of the handle module using the sterile tray 300. In FIG. 11E, the sterilization tray 300 includes a protrusion 340 that extends upwardly from the bottom of the sterilization tray opening 304. The protrusions 340 are positioned to extend into corresponding openings 342 defined in the handle module 302 when the handle module 302 is secured in the opening 304. As shown in FIG. 11F, the handle module 302 includes a mechanical two-position toggle switch 344 having a portion that extends into the opening 342 defined by the handle 302 when the switch 344 is in the first position. You may be prepared. When the handle module 302 is placed in the sterile tray 300, the opening 342 is aligned with the protrusion 340 so that the protrusion 340 pushes the switch 344 to the second position, as shown in FIG. 11G. The switch 344 may be in communication with the handle processor, and when the switch 344 is moved from the first position (FIG. 11F) to the second position (FIG. 11G), the handle processor (the internal and/or external processor of the handle module The internal sterilization count (stored in memory) may be updated. In such an embodiment, the handle module 302 may be equipped with a power source as described herein to power the handle processor and update the sterilization count during sterilization. Such a power source may comprise a secondary battery that does not remove from the handle module if the primary battery does. The handle processor may compare the sterilization count to a predetermined threshold (eg, 20 sterilizations), and when the sterilization count reaches the predetermined threshold, the handle processor may, for example, perform one or two of the methods described herein. One or more various end-of-life operations may be performed. The switch 344 may remain in a "trigger" or "activated" state until reset later, eg, after the sterilization process (see FIG. 36). The switch 344 may return to its open position when the handle module 302 is removed from the tray 300 and the protrusion 340 is removed from the opening 342, eg, biased by a spring. The handle module processor also sets an internal flag to indicate that the handle module 302 has been placed in the sterilization tray 300, which can be reset later after the sterilization process (see Figure 37). 11H and 11I show a similar embodiment with a contact switch 348. When the handle module 302 is placed in the sterile tray 300, the opening 342 causes the protrusion 340 to close the contact switch 348 when the handle module 302 is secured to the opening 304, as shown in FIG. 11G. And is aligned with the protrusion 340. The contact switch 348 is in communication with the handle processor and updates the sterilization count of the handle module. The contact switch 348 returns to its open position when the handle 302 is removed from the tray 300 and the pressure applied to the contact switch 348 by the inserted protrusion 340 is removed, eg, biased by a spring. To obtain (FIG. 11H).

In addition to or instead of the above method for tracking the end of life of the handle module, the end of life of the handle module can be tracked by using an inspection station to which the handle module can be connected. The inspection station can be used at any suitable time to evaluate whether the handle module can be used to perform a surgical procedure and/or subsequent steps of the surgical procedure. For example, the inspection station may be used before, during, and/or after the handle module sterilization process and/or during preparation of the handle module for reuse. The handle module may include, for example, (i) post-operative cleaning of reusable components of the handle module following treatment (usually including manual wiping of the component or instrument), (ii) decontamination of the component or instrument. It can be connected to an inspection station (e.g., by an automatic washer), and/or (iii) after cleaning of components or equipment and/or room drying. Placing the handle module at the inspection station may replace the number of uses of the handle module, the number of sterilizations, and/or the number of treatments for other reuse. A display at the inspection station (or elsewhere) has reached or is likely to reach a threshold number of placements of the handle module at the inspection station, at which point the user can perform appropriate actions with respect to the handle module, such as retracting. You may show it to the user at any time. The inspection station can also upload data to the handle processor that prevents further use of the handle module (eg, disables the handle module) once the handle module reaches the end of life.

In addition to the above, FIGS. 12A and 12B show an exemplary inspection station 400 and handle module 402. The handle module 402 is similar in many respects to the handle module 10. 12A shows the handle module 402 before it is placed in the inspection station 400, and FIG. 12B shows the handle module 402 after it has been placed in the inspection station 400. Similar to other embodiments disclosed herein, the handle module 402 includes a battery cavity 403 defined therein that is configured to receive a battery pack. See, for example, the battery pack 86 of FIGS. As disclosed elsewhere herein, the battery pack can be easily inserted into and removed from the battery cavity 403. FIG. 12A also shows that the battery pack has been removed from the handle module 402, thus exposing the battery cavity 403 before the handle module 402 is placed in the inspection system 400. The inspection station 400 comprises an insert or data/power adapter 404 extending from the inspection station 400 that is sized and configured to fit within the battery cavity 403 of the handle module 402. As will be described in further detail below, the data/power adapter 404 may be one or two positioned with a power contact configured to engage the power terminals of the battery pack and/or positioned within the battery cavity 403. One or more signal contacts are arranged to communicate with the processor of the handle module. The handle module 402 may be positioned at the inspection station 400 by sliding the opening 403 over the data/power adapter 404.

FIG. 12C is a block diagram showing certain components of inspection station 400 and handle module 402. The data/power adapter 404 provides voltage to the voltage regulator 432 of the handle module 402 in the same or similar manner as the battery pack provides voltage to the voltage regulator 432 when the battery pack is positioned within the opening 403. The power supply terminal 430 for providing For example, if the battery pack is configured to provide 6V DC to voltage regulator 432, insert 404 may be configured to provide 6V DC to voltage regulator 432, for example. The voltage regulator 432 powers the control board 100 (see FIGS. 1-6) of the handle module 402, eg, of the control board 100, including the handle processor 434 and associated internal and/or external memory 436. Power components. The inspection station 400 itself may be powered by an AC power source through the power cord 437 using a suitable AC-DC converter. Inspection station 400 includes a data port 438 that contacts handle module 402 data port 440 when handle module 402 engages inspection station 400 so that handle processor 434 can communicate with inspection station processor 442. As will be appreciated by a reader, inspection station 400 may further include internal and/or external memory 444 associated with inspection station processor 442.

12D is executed by the handle processor 434 and/or the inspection station processor 442 during execution of software and/or firmware in the handle memory 436 and/or inspection station memory 444 to place the handle module 402 in the inspection station 400. FIG. 7 is a diagram of a process flow that can track and respond to the number of times an attempt has been made. In various configurations, the handle processor 434, such that the insert 404 makes a data and/or power connection to the control board 100 of the handle module 402 whenever the handle module 402 is installed in the inspection device 400. The check counter may be incremented. The check counter may be an increment counter from zero to a preset threshold check count, or may be a subtraction counter from a preset threshold check count to zero. In at least one example, the handle module 402 includes a test station insert switch 446 (FIG. 12C) that is triggered when the data/power adapter 404 is fully and properly inserted into the opening 403. The switch 446 may be in communication with the handle processor 434 via the control board 100, and when the switch 446 is triggered in step 420 of FIG. 12D, the handle processor 434 increments the test counter in step 422. Good (possibly +1 or -1 depending on counter type). At step 424, the handle processor 434 may compare the test count to a predetermined threshold. If the threshold is not yet reached, then in step 426 the handle processor 434 may output the value of the test counter to the test station processor 442 during communication with the test station 400 via the insert 404. ..

Referring to FIG. 12E, the inspection station 400 may be inspected for inspection by, for example, the number of times the handle module 402 has been placed in the inspection station 400 and/or before the handle module 402 reaches its end of life. A visual display 448 may be included to display visual information related to the inspection counter, such as the number of remaining (or approximate) numbers to be placed at station 400. However, if the inspection count threshold is reached, the process may proceed to step 428, which may take appropriate end-of-life operation. One such end-of-life operation is that the display 448 of the inspection station 400 provides a visual indication to the user that the handle module 402 should no longer be used. Another end-of-life operation that may be used in addition to, or instead of, a visual indication is that the inspection station processor 442 issues a sequence of instructions to the handle processor 434 that causes the handle processor 434 to disable further use of the handle module 402. Is to send. For example, the sequence of instructions may instruct the handle processor 434 to never activate the motor of the handle module 402 thereafter, or any other disabling operation. For example, the instruction sequence, when set, may instruct the handle processor 434 to set a flag that disables the motor.

In various embodiments, the inspection station insertion switch 446 is activated when the data/power adapter 404 is fully inserted into the opening 403 and the data/power adapter 404 is removed from the opening 403 or at least partially. It may be a pressure switch that resets when taken out. In various aspects, the inspection station insertion switch 446 is configured such that the inspection station counter is incremented (step 422 of FIG. 12D) only if switch 446 has been activated for at least a threshold time (eg, 30 seconds, etc.). There may be an associated timer. Such a timer may reduce the number of false positives (ie, short-term placement of the handle module 402 at the inspection station 400 that is less likely to be associated with post-procedure inspection or sterilization of the handle module 402).

In another variation, the inspection station 400 includes a pressure switch with a counter whose readout is displayed to the user. The inspection station pressure switch operates by placing the handle module 402 on the inspection station 400. For example, the test station pressure switch may be located at the base of the insert 404 of the test station 400 so that the test station pressure switch is activated when the handle module 402 slides completely over the insert 404. Good. The counter may be updated (e.g., incremented by 1) each time the inspection station pressure switch is activated, as indicated by the number of times the handle module 402 has been installed in the inspection system 400. Such counters can be, for example, mechanical counters and/or electronic counters. If the upper limit, or threshold, is displayed on the inspection station 400, displayed on the handle module 402, and/or otherwise informed to the user, the user may determine whether the upper limit has been reached or is approaching. I can know. In at least one example, the upper limit may be displayed on the inspection station 400 and/or the handle module 402, for example.

Display 448 of inspection station 400 may also display other information obtained by inspection station 400 and/or transmitted from handle module 402 to inspection station 400 via a data connection therebetween. For example, the handle processor memory may store a handle module device type ID (eg, a serial number), which may be downloaded to the inspection station processor 442 for display on the display 448. In addition to or in the alternative, the display 448 may, based on status data received from the handle processor 434, indicate, for example, how far the handle module is approaching its end of life and/or whether the handle module has been locked out. It may indicate the status of the handle module, such as. As described herein, the display 448 may indicate the number of remaining uses of the handle module (eg, the number of treatments) and/or the number of treatments the handle module has been used. As disclosed herein, the inspection station 400 may also be used to perform post-procedure testing of the handle module 402 to ensure subsequent use of the handle module 402. This test may include, for example, a moisture content test, a seal integrity test, and/or a simulated load test. The display can show the results of these tests (eg, pass, fail, in progress).

In addition or in the alternative, the display 448 of the inspection station 400 may indicate the status of the inspection station itself, eg, whether the inspection station is (i) downloading data from the handle module, (ii) data and/or It may indicate whether a software upgrade is being uploaded to the handle module, (iii) is processing data, and/or (iv) is being tested. The display 448 may indicate, for example, whether the handle module is ready for use in another procedure, whether the handle module needs repair, whether the handle module has expired because its handle has reached its threshold number of uses. Results of tests and data processing, such as, and/or other alerts may be indicated. Display 448 of inspection station 400 may be, for example, an LED backlit LCD display controlled by inspection station processor 442. Inspection station 400 may also include control buttons 410, as shown in FIG. 12E, to allow a user to enter data and/or settings stored and used by inspection station processor 442. Display 448 may also be a touch screen, through which the user may enter, for example, data and/or settings. The inspection station 400 may include an external data port 412, such as a USB, micro USB or mini USB for connecting to a data cable 414 so that data can be uploaded to or downloaded from the inspection station 400. For example, treatment data from handle module 402 may be downloaded to inspection station 400 and then to a remote computing device via data port 412. Software and/or firmware upgrades may be downloaded to the inspection station 400 from a remote computing device via data port 412 and then uploaded to the handle module 402, for example.

13A and 13B show an arrangement for tracking the use of the handle module by tracking the mounting of the power pack on the handle module. FIG. 13A is a block diagram of the handle module 500. The handle module 500 is similar in many respects to the handle module 10. The handle module 500 includes a removable power pack 502, such as a battery, and a handle processor 504, for example. FIG. 13B illustrates a process flow that may be executed by the handle processor 504. This process may be performed from firmware and/or software in memory 506 associated with processor 504. As shown in FIG. 13A, the power pack 502 may include an ID emitter 508, eg, an RFID tag, in communication with an ID receiver 510, eg, an RFID reader, in the handle module 500. ID emitter 508 is, for example, a radio signal emitter, but any suitable ID emitter can be used. The ID receiver 510 is, for example, a wireless signal receiver in communication with the handle processor 504, but any suitable ID receiver can be used. The ID emitter 508 transmits a unique ID of the power pack 502, which can be received by the ID receiver 510. The strength of the signal emitted by the ID emitter 508 is such that when the power pack 502 is in close proximity to the ID receiver 510 (eg, within 10 cm), the ID receiver 510 will only emit the signal emitted from the ID emitter 508. Can be controlled or can be restricted. In at least one example, the ID receiver 510 can be mounted on the control board 100 such that the ID receiver 510 can only detect the ID emitter 508 when the power pack 502 is inserted into the handle module 500 (FIG. 2-4). In various examples, short range RFID tags and readers may be used so that the ID receiver 510 is less likely to falsely detect a power pack 502 that is not attached to the handle module 500.

Referring to the process flow shown in FIG. 13B, the ID reader 510 detects the ID emitter in step 520. At step 522, the handle processor 504 determines whether the power pack 502 is a new power pack based on its ID received by the ID receiver 510. The term “new” in this context means that the particular power pack 502 is not in use with the particular handle module 500. The handle processor 504 may perform this step by comparing the newly detected ID of the power pack 502 with the stored list of power pack IDs already detected at the ID receiver 510. The list of such used power pack IDs is stored in the non-volatile memory of the handle module 500, for example. If the power pack 502 is not new, that is, its ID is listed in the stored used power packs, the process proceeds to step 524 with appropriate preconfigured actions. For example, the handle processor 504 can disable the handle module 500 until a new, previously unrecognized power pack is attached to the handle module 500. In at least one such example, the handle module 500 can disable the motor 80. In addition to, or in the alternative to, the display of the handle module 500 may indicate to the user that the power pack is not new and request the installation of another power pack (return process to step 520).

If the processor 504 determines that the power pack 502 is new, that is, the ID of the power pack 502 is not listed in the stored used power packs, the process causes the handle processor 504 to handle the module 500. Proceed to step 526 of incrementing the usage count of. As mentioned above, an addition counter and/or a subtraction counter can be used. At step 528, the handle processor 504 compares the usage count with a preset threshold that indicates the number of times the handle module 500 should be used with a different, unique power pack. Such a usage count can serve as a surrogate for the number of times the handle module 500 is used in treating a patient. If the usage count threshold is reached at step 528, then preset end-of-life operation may be performed at step 529. For example, the handle processor 504 may deactivate the motor, the handle module display may indicate to the user that the handle module 500 has no remaining usage count, and/or, for example, that there is no remaining usage count. An alert may be activated to alert the user. If the usage count threshold has not been reached, the handle processor 504 determines in step 530 the ID of the new power pack 502 in the stored list of used power packs so that the new power pack 502 cannot be used after the current usage. To add. In other variations, the steps shown in Figure 13B may be performed in a different order. For example, the new power pack ID may be added to the stored list before incrementing the usage count. Other techniques for tracking the mounting of the power pack on the handle module are described below in connection with Figures 14E and 15A-B.

The embodiments described above in connection with FIGS. 13A and 13B can be used with rechargeable and/or non-rechargeable battery packs. That said, a battery pack used in the handle module 500, recharged, and then reused in the same handle module 500 may cause the handle module 500 to enter the lockout mode. For this particular embodiment, the recharged battery pack needs to be reused with another handle module. Along this line, embodiments of the handle module 500 are envisioned in which the recharged battery pack is reusable with the same handle module 500.

In at least one example, processor 504 can employ logic that prevents battery pack 502 from being counted more than once, or more than twice for the same use. In at least one example, processor 504 may not count battery pack 502 a second time if it is disengaged from handle module 500 and not re-engaged with it. Also in that case, the processor 504 may request the elapsed time between the first engagement and the subsequent engagements before counting the subsequent engagements as the second use. Such elapsed time may be, for example, the time required to recharge the battery pack.

In addition to or in the alternative, the handle module may track the number of times the DSM is connected to and/or disconnected from the handle module, as an alternative to the number of times the handle module has been used. The handle module uses the updated number of remaining uses of the handle module, for example, a volume indicator indicating a ratio of remaining life, to predict the number of remaining uses of the handle module and/or the number of times the handle module has been used. Can be displayed. Upon reaching the upper limit of the usage threshold, the handle module, via the handle processor, indicates, for example, that the handle module has been used, disables further use of the handle module by disabling the motor, and For example, one or more end-of-life operations, such as sounding an alarm, can be performed. 14A-G show different configurations for tracking DSM connection or disconnection to a handle module, as discussed in more detail below.

Referring now to FIG. 14A, handle module 600, which in many respects is similar to handle module 10, comprises two rotary drive systems 602, 604. A DSM having the two drive systems described above can be operably coupled to rotary drive systems 602, 604. The DSM may have a groove configured to receive and slide on the tongue's opposite side edges 605A, 605B defined in the connection area 608 on the top of the handle module 600. In such a configuration, the handle module 600 may be configured such that when a DSM, such as DSM 634 (FIGS. 14B and 14C), is connected to the handle module 600, the depressible switch 612 is depressed, as shown in FIG. 14A. A pushable switch 612 may be included on the top and/or other portions of the connection area 608. In at least one example, the DSM may not depress the switch 612 until the DSM is fully secured to the handle module 600. The switch 612 may be connected to a handle processor, the handle processor pressing the depressible switch 612 as a substitute for the number of times the DSM is connected to the handle module 600 and/or as a substitute for the number of times the handle module 600 has been used. You may count the number of times. The handle processor can also request that the depressible switch 612 be continuously depressed for at least a specific period of time (eg, 30 seconds) before incrementing the count, reducing the number of false positives. .. Once the preset threshold number of uses or threshold number of actuations of the switch 612 is reached, end-of-life operation may occur, as described herein.

14B and 14C show one configuration of electromechanically depressible switch 612. As shown, the depressible switch 612 includes a head 620 that extends into an opening 622 defined in the tongue and/or any other suitable DSM mating surface of the handle module 600. The head 620 may be at the end of a spring arm 624 that is configured to bias the position of the head 620 upward into the opening 622. The spring arm 624 also limits the upward movement of the head 620 within the opening 622 to the desired position, an extension defined within the handle module 600, or a shoulder positioned behind the edge 628. 626 is included. Pushable switch 612 also includes contacts 630. As shown in FIG. 14B, when the switch 612 is in the non-actuated or open state, the spring arm 624 is not engaged with the contact 630. As shown in FIG. 14C, when the DSM 634 is attached to the handle module 600 and the head 620 is depressed, the shoulder 626 of the spring arm 624 engages the contact 630 and closes the switch 612. DSM 634 includes a protrusion 632 extending from DSM 634 configured to contact head 620. The switch arm 624 and contacts 630 may be constructed of a conductive material capable of completing a circuit in communication with the handle processor when the head 620 is pressed downward by the DSM 634, as described above.

Referring now to FIG. 14D, the handle module 700 may include an electrical contact board 702 that interfaces/mates with and makes electrical connection with a corresponding electrical contact board 704 on the DSM 706. In at least one example, the processor of handle module 700 may count the number of times a DSM, such as DSM 706, is assembled to handle module 700. The processor may increase the DSM connection count when the contacts 704 of the DSM 706 engage the contacts 702 of the handle module 700 to form a working data connection therebetween. The engagement of the contact boards 702, 704 can function as a substitute for the number of times the DSM has been connected to the handle module 700 and as a substitute for the number of times the handle module 700 has been used. Similar to the above, the handle processor requires that the data connection between the contact boards 702, 704 exist continuously for at least a certain period of time (eg, 30 seconds) before incrementing the count, resulting in false detection examples. Can be reduced. In another variation, the handle processor and DSM processor may exchange data upon connection of the DSM 706 to the handle module 700. In this exchange, the handle processor can receive the ID information of the DSM 706 (eg, DSM model type) so that the handle processor can identify the DSM 706 connected to the handle module 700. In such a configuration, the handle processor may increment the DSM connection count each time the handle processor receives ID information for an attached DSM. In any of these variations, the handle processor compares the DSM connection count with a preset threshold, and when the threshold is reached, the handle processor performs end-of-life operation.

14E-14G, another configuration for detecting the connection of the DSM to the handle module is shown. The illustrated configuration uses a Hall effect sensor to detect the connection of the DSM 706 to the handle module 700. As shown in FIG. 14E, the handle module 700 may include a Hall Effector sensor 710 positioned with respect to an upper surface 712 of the handle module 700, to which the DSM 706 is attached. Accordingly, the DSM 706 includes a magnet 714, such as a permanent magnet, in close proximity to the Hall effect sensor 710 when the DSM 706 is fully and properly connected to the handle module 700, as shown in FIG. 14G. Hall effect sensor 710 may be in communication with the handle processor via lead 716, for example. The Hall effect sensor 710 can sense the magnet 714 of the approaching DSM 706 when the DSM 706 is attached to the handle module 700. The magnetic field generated by the magnet 714 may be constant and the handle processor may access data regarding the magnetic field so that the distance between the magnet 714 and the Hall effect sensor 710 can be measured based on the output of the Hall effect sensor 710. .. When the distance between the magnet 714 and the Hall effect sensor 710 stabilizes at a distance corresponding to the DSM 706 fully and properly attached to the handle module 700, the handle processor causes the DSM 706 to be fully and properly attached to the handle module 700. It is possible to update the DSM connection count.

Similarly, referring again to FIG. 14E, the handle module 700 includes a battery cavity 72 configured to receive a battery pack 722 therein. The handle module 700 further includes a Hall effect sensor 720 configured to detect insertion of the removable battery pack 722 into the battery cavity 724. The battery pack Hall effect sensor 720 can be positioned on the upper inner surface 723 of the battery cavity 724 in the handle module 700 for the battery pack 722. As will be appreciated by the reader, the battery pack 722 is configured to power the handle module 700 via electrical terminals 726, and any magnetic field generated by the current flowing through the terminals 726. It is desirable to position the Hall effect sensor 720 as far as possible from the electrical terminals 726 so as not to substantially interfere with the Hall effect sensor 720's ability to accurately detect insertion of the battery pack 722 into the handle module 700. is there. The battery pack 722 includes a magnet 730, such as a permanent magnet, that the Hall effect sensor 720 senses when the battery pack 722 is inserted into the battery cavity 724. Similar to the DSM Hall effect sensor 710, the battery pack Hall effect sensor 720 is in communication with the steering wheel processor, eg, via lead wire 732. The Hall effect sensor 720 can sense the approaching battery pack magnet 730 when the battery pack 722 is installed in the battery cavity 724. The magnetic field generated by the magnet 730 may be constant and the handle processor may access data regarding the magnetic field so that the distance between the magnet 730 and the Hall effect sensor 720 can be measured based on the output of the Hall effect sensor 720. .. When the distance between the magnet 730 and the Hall effect sensor 720 stabilizes at a distance corresponding to the battery pack 722 fully and properly attached to the handle module 700, the handle processor causes the battery pack 722 to be completely attached to the handle module 700. It can be assumed that it has been properly installed, and the battery pack connection count can be updated.

The handle module can track the number of times the DSM and/or battery pack is connected to and/or disconnected from the handle module as an alternative to the number of times the handle module has been used. The handle module uses the updated number of remaining uses of the handle module, for example, a volume indicator indicating a ratio of remaining life, to predict the number of remaining uses of the handle module and/or the number of times the handle module has been used. Can be displayed. Upon reaching the upper limit of the usage threshold, the handle module, via the handle processor, indicates, for example, that the handle module has been used, disables further use of the handle module by disabling the motor, and For example, one or more end-of-life operations, such as sounding an alarm, can be performed.

Referring now to FIGS. 15A and 15B, the handle module 800 tracks power pack attachment, for example, using a pressure switch that is depressed when the power pack 806 is fully and properly attached to the handle module 800. it can. The handle module 800 is similar in many respects to the handle module 10. The handle 800 includes conductive contact pads 802 that connect the power pack 806 to supply voltage to the electronic components of the handle module 800. In the illustrated configuration, the pressure switch 804 is in close proximity to the conductive contact pad 802 and is in communication with the handle processor. Referring to FIG. 15B, when the power pack 806 is assembled to the handle module 800, the housing of the power pack 806 presses the pressure switch 804 to activate it. Each time the pressure switch 804 is activated, the handle processor can increment the power pack connection count until a threshold is reached at which point end-of-life operation can occur. Similar to the above, the handle processor may require the pressure switch 804 to operate continuously for a period of time (eg, 30 seconds) before incrementing the power pack connection count, reducing the number of false positives. .. In other configurations, for example, electromechanical switches may be used.

In various examples, the handle module processor may increment the usage count each time the handle processor is powered on. In a particular example, the processor of the handle module may be automatically powered down when the battery pack is disengaged from the handle module. Similarly, the processor may be automatically powered on when the battery pack engages the handle module. In at least one such embodiment, the battery pack is the sole power source for the handle module, and the processor may be powered down immediately upon disconnecting the battery pack from the handle module, and immediately upon connecting the battery pack to the handle module. The processor may be power cycled. In certain embodiments, the handle module may include one or more capacitive elements capable of storing power from the battery pack when the battery pack engages the handle module. When the battery pack is removed from the handle module, the capacitive element can power the processor for a predetermined period of time, so that the processor may not be powered off during battery pack replacement. In such an example, as described above, the processor can count life events or usage events even if battery attachment is detected by the sensor and/or the processor is powered up after power down.

In various examples, the handle processor of the handle module 800 can track the number of times it receives power via the conductive contact pads 802 used to couple the battery power pack 806 to the internal electronics of the handle module 800. For example, the handle module 800 may include a micro voltage and/or current sensor (not shown) connected to the conductive contact pad 802. The voltage and/or current sensor may be in communication with the handle processor. When a threshold input voltage and/or current from power pack 806 is detected at contact pad 802, the handle processor can increment the battery pack connection count. This configuration may be useful when the handle processor is sometimes powered by a power source other than a power pack, such as a supercapacitor or other power source.

Referring now to FIG. 16, the handle module 900 includes multiple power sources, such as a removable battery power pack 902 and a secondary power source 904. The removable battery power pack 902 is in many respects similar to the removable battery power packs described herein. The battery power pack 902 includes, for example, a large number of Li-ion and/or LiPo battery cells. The secondary power source 904 provides power to the handle module 900 even when the removable battery power pack 902 is removed or otherwise disconnected from the handle module 900. For this embodiment, the secondary power source 904 provides low power operation of the handle module 900, such as powering the electronic components on the control board 910 when the removable battery power pack 902 is removed from the handle module 900. It is used and not used for high power operation, such as powering the motor 905 of the handle module 900. In various configurations, the secondary power source 904 is a rechargeable battery cell and/or supercapacitor (a/k/a ultracapacitor) that is charged by the removable battery power pack 902 when installed. ) May be provided. The secondary power source 904 can power the electronic components on the control board 910 as long as the secondary power source 904 has sufficient charge in the absence of the primary power source 902.

The secondary power source 904 may allow the handle module 900 to track usage events and/or perform end-of-life operation even when the power pack 902 is not attached to the handle module 900. FIG. 17A is a flow chart of a process that may be performed by a processor of control board 910, such as handle processor 2124, for example. This process may be performed, for example, from software and/or firmware stored in the memory of the handle module, according to at least one embodiment. The power pack 902 is attached to the handle module 900 prior to performing the surgical procedure. At step 920 of the process, the handle processor may record a time stamp when the DSM was properly connected to the handle module 900. Once the surgical procedure is initiated, at step 922, the handle processor may record a timestamp for each firing of the handle module 900 that occurs during the surgical procedure. In addition, the handle processor can track the time elapsed between firings. In at least one example, the secondary power source 904 can continue to power the handle processor even if the removable power pack 902 is removed from the handle module 900 to track the time after the firing event. At step 924, the handle processor can determine if the elapsed time since the last firing is greater than a threshold period. In at least one example, the threshold period may be about the same as the time required to substantially treat and sterilize the handle module following treatment, for example. If the period between shots is not greater than the threshold, then it may be inferred that the procedure is currently in progress and the process may return to step 922 to record the time stamp of the next shot. On the other hand, if the time period between firings is greater than the threshold, then the procedure is complete and at this point, it can be estimated that in step 926, the handle processor can increment the usage count of the handle module 900. At step 928, the handle processor compares the usage count with the pre-programmed threshold usage count of the handle module 900. If the usage count is below the threshold, the handle module 900 can be used in another procedure and the process can return to step 920 to wait for the DSM to connect for the next procedure. On the other hand, if the usage count threshold has been reached, the process proceeds to step 930, where end-of-life operation of the handle module 900 may be initiated. As noted above, end of life operation may include disabling the handle module so that it cannot be used in subsequent surgical procedures. In at least one example, the handle module motors may be physically and/or electrically disabled. In certain examples, end-of-life operation includes, for example, visually indicating the end-of-life of the handle module on a display of the handle module and/or sounding an alarm.

FIG. 17B is a flow chart of another exemplary process executed by the handle processor and sometimes powered by the secondary power source 904 to track the use of the handle module. At step 950, the handle processor can detect the connection of the removable battery power pack 902 to the handle module 900. Various techniques for detecting insertion of the battery power pack 902 are described elsewhere herein. In various examples, insertion of power pack 902 indicates to the handle processor that a surgical procedure requiring handle module 900 is about to begin. As a result, the handle processor can set the process flag on at step 952 when the handle processor detects insertion of the power pack 902 into the handle module 900. At step 954, the handle processor can detect that the DSM has fully and properly connected to the handle module for treatment. Various techniques for detecting DSM attachment are described elsewhere in this specification. With the DSM and battery pack 902 properly attached, surgical instruments can be used to complete the surgical procedure. If the battery pack 902 is removed from the handle module 900, the handle processor can detect removal of the battery power pack 902 in step 956. Various techniques for detecting power pack removal are described elsewhere herein. In various examples, removal of the power pack indicates completion of the surgical procedure, and as a result, the handle processor currently powered by the secondary power source 904 can increment the usage count of the handle module 900 at step 958. The insertion of a new battery pack and/or the reinsertion of a recharged battery pack may be considered as a separate use, even if removal of the power pack is not a component of termination of the surgical procedure. Such reuse of the handle module 900 may be adjusted in a test performed at step 960 to assess whether the handle module 900 has reached the end of its useful life. If the end-of-life of the handle module is reached, the handle processor can initiate appropriate end-of-life operation at step 962. Various end-of-life operations are disclosed elsewhere in this specification. Of course, for any of the embodiments disclosed herein, end-of-life operation may be disabled by the user of the handle module. Such an example can typically occur, for example, when the usage threshold count is reached in the middle of a surgical procedure.

18A-18E illustrate end-of-life operation that can be performed by the handle module that prevents further use of the handle module, for example, using a removable battery power pack. FIG. 18A shows a handle module 1000 including an internal spring actuated lockout 1002. Lockout 1002, when released by handle module 1000, prevents complete and proper attachment of battery power pack 1004, and/or any other suitable battery pack to handle module 1000. In various examples, lockout 1002 may be configured to completely prevent power pack 1004 from entering handle module 1000. In another example, the lockout 1002 may prevent the power pack 1004 from being inserted to a depth where the battery contacts make electrical contact with the handle contacts, as shown in FIG. 18A and described in further detail below. As also shown in FIG. 18A, actuation of lockout 1002 causes power pack 1004 to project a distance D from handle module 1000. Without the lockout 1002, the battery pack 1004 may be secured at a depth where the end caps 1006 of the battery pack 1004 are flush with, or at least substantially flush with, the housing of the handle module 1000.

As mentioned above, the lockout 1002 can selectively prevent the power pack 1004 from powering the handle module 1000. In the unlocked state of the handle module 1000 shown in FIG. 18B, the electrical contact pads 1016 of the handle module 1000 contact the battery pack 1004 so that the internal electronics of the handle module 1000 can be powered by the battery power pack 1004. The pad 1018 can be contacted. In the locked out state of the handle module 1000 shown in FIG. 18C, the lockout 1002 prevents the contact pad 1018 of the battery pack 1004 from contacting the contact pad 1016 of the handle module 1000. In embodiments where the handle module 1000 does not include a secondary power source and/or storage means, the handle module 1000 cannot be used in this lockout condition. In embodiments where the handle module 1000 includes a secondary power source and/or storage means, the handle module 1000 can use power from these other sources to, for example, run the operating system of the handle module 1000. Drive systems and/or electric motors cannot be run.

FIG. 18B shows the lockout 1002 in a normal operation state in which the battery pack 1004 is not locked out, and FIG. 18C shows the lockout 1002 in a lockout state in which the battery pack 1004 is locked out. The lockout 1002 is biased by a torsion screw 1010 connected to the lockout 1002 to rotate from its unlocked position (FIG. 18B) to the lockout position (FIG. 18C). The torsion screw 1010 has a first end that is biased against the inner surface 1013 of the handle module 1000 and a second end that is attached to the lockout 1002. The handle module 1000 further includes a latch 1012 configured to releasably retain the lockout 1002 in its unlocked position. Lockout 1002 includes a lock shoulder 1014 that abuts latch 1012 when latch 1012 is in the extended position, thus holding lockout 1002 in its unlocked position. As shown in FIG. 18C, when the latch 1012 retracts, the shoulder 1014 of the lockout 1002 disengages from the latch 1012 and the torsion screw 1010 can bias the lockout 1002 to its lockout position.

When the end of life state of the handle module 1000 has not yet been reached, the latch actuator of the handle module 1000 can hold the latch 1012 in the position shown in Figure 18B. However, when the end-of-life condition is reached, the latch actuator may move the latch 1012 in the direction indicated by arrow A to move the latch 1012 away from the locking shoulder 1014, and thus the biasing of the spring 1010. , Lockout 1002 can be rotated counterclockwise, as indicated by arrow B in FIG. 18C. In the lockout state, as described above, when the battery pack 1004 is inserted into the handle module 1000, the lockout is performed so that the electrical contact pad 1016 of the handle module 1000 does not contact the contact pad 1018 of the battery pack 1004. 1002 projects into the battery compartment of the handle module. The latch actuator may comprise any actuator, such as a solenoid.

18D and 18E, in addition or in the alternative, do not remove the battery pack positioned within the handle module from the handle module at the time the handle module is determined to be at end-of-life. 7 illustrates an embodiment that prevents insertion of a new (or recharged) battery pack into a handle module for a procedure. FIG. 18D shows the battery pack 1004 in a normal operating condition that can be removed from the handle module following treatment, and FIG. 18E shows the battery pack in the handle module so that the battery pack 1004 cannot be removed from the handle module. Shown is a latch 1040 locking 1004. As shown in FIGS. 18D and 18E, the battery pack 1004 may define an opening 1042 into which the latch head 1044 of the latch 1040 may be inserted to lock the battery pack 1004 in place. The latch 1040 is biased downward by a compression spring 1046 mounted on the upper shaft 1048 of the latch 1040. The latch 1040 also contacts the second latch 1052, which is positioned to keep the spring 1046 in compression and prevent downward movement of the latch 1040 in the normal operating state of the handle module, as shown in FIG. 18D. Including 1050. 18D and 18E, the latch head 1044 has a shoulder that locks behind the mating shoulder 1056 defined by the battery pack 1004 when the latch 1044 is in the actuated position as shown in FIG. 18E. The unit 1054 is included.

During operation, when the handle processor determines that the handle module has reached its end of life (by any means described herein), the handle processor actuates the second latch 1052 to move the latch 1044 out of the way. The second latch 1052 is removed. The second latch 1052 may be actuated by any suitable actuator, such as a solenoid. In the illustrated embodiment, the second latch 1052 moves from left to right away from the shoulder 1050 of the latch 1040 when the latch 1052 is actuated. When the second latch 1052 is removed from the shoulder 1050, the spring 1046 reduces pressure and moves the latch 1044 downward through the opening 1060 defined in the handle module housing 1013, as indicated by arrow B. Can be made As the latch 1040 is moved downward by the spring 1046, the latch head 1044 extends into the opening 1042 defined in the battery pack 1004. The latch shoulder 1054 of the latch head 1044 can slide through the opening 1042 and lock behind the mating shoulder 1056 of the battery pack 1004. When the upper shoulder 1050 of the latch 1040 contacts the handle module housing 1013, downward movement of the latch head 1044 is limited by the handle module housing 1013. As a result, the battery pack 1004 cannot be removed from the handle module, thus preventing insertion of a new (or recharged) battery pack into the handle module for subsequent procedures.

Referring now to FIGS. 19A-19C, the handle module 1100 includes a rechargeable battery pack 1102 (one or more rechargeable battery packs 1102 that can be recharged when the handle module 1100 is docked to the charging station 1106. The battery cell 1104 is included). The handle module 1100 further includes a slidable door 1108 that slides a channel 1110 defined in the handle module 1100 generally up and down between an open position (FIG. 19C) and a closed position (FIG. 19B). The compression spring 1112 is positioned within the channel 1110 configured to bias the slidable door 1108 downward into a closed position. When the door 1108 is in its closed position, the door 1108 can shield the battery charging terminals 1114 from, for example, damage and/or accidental contact with conductive surfaces in the surrounding environment, as shown in FIG. 19B. To recharge the battery cells 1104, the handle module 1100 mates with the charging terminals 1114 of the handle module 1100 when the handle module 1100 is fully and properly inserted into the receiving area 1120 as shown in FIG. 19C. Located in the receiving area 1120 defined by the charging station 1106, including the charging terminals 1122 that contact it. When the handle module 1100 is placed in the receiving area 1120, the slidable door 1108 engages the shoulder 1124 of the charging station 1106 and moves the slidable door 1108 upward as indicated by arrow A. , The spring 1112 is compressed, and the shielding of the battery pack charging terminal 1114 is released (that is, exposed). In such a position, the charging terminal 1114 can connect and contact the charging terminal 1122 of the receiving station and thus recharge the battery cells 1104 of the battery pack 1102.

Charging station 1106 may be powered by an AC power source via power cord 1130. Charging station 1106 may also include a visual display 1132 that displays information about handle module 1100. For example, charging station 1106 may include a processor (not shown) that communicates with the handle processor when handle module 1100 is attached to charging station 1106. For example, charging terminals 1114, 1122 may also include data terminals that provide a data path between the processors. The charging station processor can receive information/data from the handle processor that can be displayed on the display 1132. The displayed information is tracked by the handle processor, eg, the charge status of the battery pack 1102 (eg, X% charged), and/or the lifetime count or remaining usage of the handle module, and/or the number of lifetime firings, for example. Any information can be mentioned.

20A-20B show covers 1201, 1202, 1203 that can be used with the handle module 1200 during the sterilization process to protect the internal components of the handle module 1200. The handle module 1200 includes a mount configured to mount the DSM. The end effector connection area cover 1201 can connect (eg, snap fit) to the portion where the DSM connects to the handle module 1200 and cover that portion. The handle module 1200 also includes a removable trigger assembly used to activate the drive system of the handle module 1200. In addition to, or in the alternative, the trigger cover 1202 can connect (eg, snap fit) to an opening formed when the firing trigger assembly is removed from the handle module 1200 and cover that portion. The handle module 1200 further comprises a battery cavity configured to receive a removable power pack therein. Also, in addition to or in lieu of the above, the battery pack cover 1203 may connect to and cover a portion of the handle module 1200 where the battery pack is inserted into the pistol grip portion 1206. These covers 1201, 1202, 1203 are preferably made of a material that is resistant to the chemicals used to sterilize the handle module, such as plastic. Further, the covers 1201, 1202, 1203 can cover electrical contacts of the handle module 1200, such as, for example, the end effector contact substrate 1210, the drive system 1212, and/or battery pack internal contacts (not shown).

Attachment of the covers 1201, 1202, and/or 1203 to the handle module 1200 can help track the number of times the handle module 1200 has been used and/or sterilized. Similarly, removal of the covers 1201, 1202, and/or 1203 from the handle module 1200 can help track the number of times the handle 1200 has been used and/or sterilized. At least one of the covers 1201, 1202, 1203 may include means for triggering a switch on the handle module 1200 that indicates that the cover is installed. When such a switch is triggered, the handle processor can assume that a sterilization procedure is about to occur and enter a sterilization mode of operation that is optimized to withstand the sterilization procedure. When the handle processor is in the sterilization mode of operation, the handle processor may, for example, deactivate the motor of the handle module 1200, power off certain contacts and/or sensors, or power certain contacts and/or sensors. Can be loaded, any data stored in the temporary memory can be recorded in the memory chip, the memory of the handle module can be copied to the backup memory, and/or a copy of the current version of the operating system software of the handle module can be made. The handle processor may also increase the usage count of the handle module 1200 when one or more of the covers 1201, 1202, 1203 are attached to or removed from the handle module 1200. In the illustrated embodiment, the DSM connection area cover 1201 contacts a corresponding switch 1222 (eg, a depressible switch, or a contact switch, etc.) on the handle module 1200 when the cover 1201 is placed on the handle module 1200. , Including a protrusion 1220 for actuating it. The switch 1222 may be in communication with the handle processor, and in various examples, the handle processor may update its sterilization count upon detection of actuation of the switch 1222. In other configurations, the trigger 1220 may be on the other cover piece 1202, 1203 and/or may be located at another location on the DSM connection area cover 1201. In any case, since the battery pack is typically removed during sterilization, the covers 1201, 1202, 1203 preferably power the handle processor even when the battery pack is removed, as described herein. Used in handle module with secondary power supply. As described in other configurations herein, the handle processor may perform one or more of the end of life operations described herein when the sterilization count reaches a threshold level.

20C shows a modified example of the battery pack cover 1203, and FIG. 20D shows a battery pack 1240 that can be replaced with the battery pack cover 1203 of FIG. 20C. Since both the battery pack cover 1203 and the battery pack 1240 are designed to fit in the battery pack opening in the pistol grip portion 1206 of the handle module 1200 instead of each other, the battery pack cover 1203 of FIG. It has a shape and configuration very similar to the battery pack 1240 of FIG. 20D. For example, the battery pack cover 1203 and the battery pack 1240 both include a clip 1244 for locking the handle module 1200. Further, both the battery pack cover 1203 and the battery pack 1240 also include one or more tubular containers 1242. The battery cells 1246 may be in the container 1242 of the battery pack 1240, but the cover 1203 is not. However, the cover 1203 also includes a mechanism to easily distinguish itself from the battery pack 1240. In the configuration shown, the cover 1203 includes a relatively thin, long, easily grippable tab 1248 on the bottom of the cover 1203 that is marked for sterilization, as shown in FIG. 20C. May be included.

As also shown in FIGS. 20C and 20D, each of cover 1203 and battery pack 1240 may include respective tabs 1250, 1252 located in different relative positions. In the illustrated configuration, the tab 1250 of the cover 1203 is on the right side container 1242 and the tab 1252 of the battery pack 1240 is on the left side container 1242. When inserted into the handle module 1200, the tabs 1250, 1252 contact and actuate corresponding respective switches in the handle module 1200 to activate and optionally identify insertion of the cover 1203 or battery pack 1240. You may A switch (not shown) may be in communication with the handle processor, and the handle processor may use the actuation of the respective switch to optionally update the use, sterilization, and/or battery pack connection count. For example, when the sterilization switch is activated, the handle module 1200 can be in a sterilization mode of operation, and when the battery switch is activated, the handle module can be in a surgical mode. The tabs 1250, 1252 are preferably in two different positions so that the handle module 1200 can include two different switches: a battery switch that operates only by the battery pack 1240 and a sterilization switch that operates only by the sterilization cover 1203. In various configurations, the tabs 1250, 1252 can be located, for example, in mirror opposite positions on the container 1242. Both cover 1203 and battery pack 1240 include features that are inserted only in one direction, thus preventing battery pack tabs 1252 from activating the sterile cover switch and vice versa. In the illustrated configuration, for example, both the battery pack cover 1203 and the battery pack 1240 include a tongue 1254 on only one side that can fit into a corresponding groove defined on only one side of the handle module 1200.

21A-21C illustrate exemplary displays of the handle module 1300 and/or DSM 1302 that may provide a user with visual information regarding the status of the handle module 1300 and/or DSM 1302. As shown in FIG. 21A, the display may include a display portion 1304A of the handle module 1300 and a display portion 1304B of the DSM. Display port portions 1304A and 1304B can be in close proximity to each other or can be separated from each other. In particular examples, display portions 1304A and 1304B may be used to display separate or non-overlapping sets of information. In various examples, display portions 1304A and 1304B may be used to display tailored information that may or may not overlap. In certain other examples, the display 1304 may be entirely on the DSM 1302, as shown in FIG. 21B, or the display 1304 may be entirely on the handle module 1300, as shown in FIG. 21C. The display 1304 may comprise, for example, a flat panel display such as a LED backlit LCD flat panel display, and/or any other flat panel or non-flat panel display scheme. The display 1304 may be controlled by the handle processor and/or the DSM processor.

FIG. 21D shows an exemplary display configuration, which includes proximal handles and end effector portions 1304A, 1304B. As shown in FIG. 21D, the handle portion 1304A indicators include a battery status indicator 1310, an indicator 1312 indicating that the DSM connected to the handle module is recognized, and/or a general handle module error indicator 1314. An indicator associated with the handle module may be included. The DSM display 1304B may include, for example, an indicator 1320 regarding whether the end effector jaws are closed, an indicator regarding whether staples within the end effector have not been fired, an indicator 1322 regarding whether staples have been fired properly, and/or Or it may include an indicator associated with the DSM, such as indicator 1324 regarding whether there is an error associated with the staple or staple cartridge. Of course, in other variations, fewer, more, and/or different icons may be used to alert the user/clinician regarding the status of various components and aspects of the handle module 1300 and/or DSM 1302. .. For example, the display 1304 may show, for example, the number of remaining firings of the battery pack and/or the number of remaining uses of the handle module. The display may include buttons, and/or a touch screen interface, and the user/clinician may enter information into the handle module and/or DSM processor/memory.

In various examples, the removable battery pack may be sterilized and recharged after the procedure for use in subsequent procedures on the same handle module and/or another handle module. FIG. 22 is a diagram of a removable battery pack 1350 that can track the number of times the battery pack 1350 has been sterilized, which can replace the number of times the removable battery pack 1350 is used in a surgical procedure. Battery pack 1350 may include a number of battery cells 1352 with an output voltage terminal 1354. As shown in FIG. 22, the battery pack 1350 may also include a battery pack processor 1360 mounted on the battery pack circuit board 1362. The battery pack processor 1360 may include internal or external memory (such as an external memory chip 1364 mounted on the circuit board 1362), and the battery pack processor 1360 can execute software/firmware stored in the memory. Accordingly, the battery pack processor 1360 can execute a battery management system (BMS) that manages rechargeable batteries. The BMS may, for example, protect the battery from operating outside the safe operating area, monitor the condition of the battery, calculate secondary data, report that data, control its environment, Authentication of the battery and/or balancing of the cells of the battery can be performed.

In various configurations, the battery pack 1350 also includes, for example, a micro-humidity sensor 1366 for sensing when the battery pack 1350 is in a humid environment suitable for undergoing a sterilization process. The battery pack processor 1360 updates its sterilization count in lieu of the number of times the battery pack 1350 has been used, whenever the humidity sensor 1366 detects a threshold humidity level for a threshold period suitable for a typical sterilization process. May be in communication with the humidity sensor 1366. In various examples, battery processor 1360 may be configured to not count anomalous events that may result in false positives. In any case, the battery pack processor 1360 may disable the battery pack 1350 when the threshold sterilization count is reached. For example, as shown in FIG. 22, the battery pack 1350 may include a data terminal 1368 that may provide a connection for the handle module to the handle processor. If the battery pack 1350 has been used (eg, the sterilization count threshold has been reached), the battery pack processor 1360 may send a signal to the handle processor to indicate that the battery pack 1350 should not be used. The handle processor may then indicate through its display that there is a problem with the battery pack 1350.

In various examples, the battery pack processor 1360 may update its usage count based on the data connection to the handle module. Each time the battery pack processor 1360 detects a data connection to the handle module, the battery pack processor can update its usage count.

Battery pack 1350 may include a secondary power source (not shown) that is charged by battery cell 1352 as battery cell 1352 is charged and/or that powers the handle module during a surgical procedure. In such an embodiment, the low power battery pack electronic component can remain powered on even though the battery pack 1350 is not attached to the handle module. Also, as shown in FIG. 22, the battery pack 1350 may include an end cap 1370 and a latch 1372 to facilitate connection of the battery pack 1350 to the handle module.

23A and 23B show another possible end-of-life operation of the handle module. In the configuration shown, the handle module 1400 includes a protrusion 1402 movable between a retracted position and an extended position. Prior to the end of life of the handle module 1400, the protrusion 1402 is held in its retracted position. In such a position, the protrusion 1402 does not prevent the handle module 1400 from being positioned within the corresponding opening of its sterile tray 1404. When the handle processor determines that the handle module 1400 has reached end of life, the protrusion 1402 is moved to its extended position according to any suitable algorithm. In such a position, the protrusion 1402 prevents the handle module 1400 from being properly positioned in the corresponding opening of its sterilization tray 1404. In the illustrated configuration, the protrusion 1402 is at the distal end 1406 of the handle module 1400, but is convenient and any that, when extended, will prevent placement of the handle module 1400 into a corresponding opening in the sterile tray 1404. Can be placed in the position. As described above in connection with FIG. 11A, the sterile tray includes an opening whose shape corresponds to that of the handle module so as to tightly receive the handle module in the opening. In the configuration of FIGS. 23A and 23B, the handle module 1400 fits into the opening of the sterile tray 1404 when the protrusion 1402 is retracted (not protruding), but as shown in FIGS. 23A and 23B. When 1402 projects outward from the handle module 1400, it does not fit into the opening. The protrusion 1402 may be solenoid driven, for example. When the handle processor determines that the end of life of the handle module 1400 has been reached, the coil of the solenoid, for example, causes the solenoid armature to extend outward, thus causing the protrusion 1402 to extend outward from the handle module 1400. Then, a voltage is applied. The handle module 1400 may also include a stop, such as a spring-loaded detent, that when actuated prevents the solenoid armature and protrusion 1402 from retracting.

As described in connection with Figures 12A-E, the handle module can be connected to the inspection station prior to, during, and/or subsequent to the procedure. A test station is used to perform a test on the handle module to determine if the handle module is in a condition suitable for another surgical procedure, or if the handle module is adjusted or repaired before being suitable for another surgical procedure. You can determine if you need to receive it. As shown in FIGS. 24A and 24B, the inspection station 1500 may be inserted into an empty battery cavity of the handle module such that the extension 1504 may be positioned to communicate with a handle module similar to the above embodiments. The expansion unit 1504 configured as described above is included. The handle module 1501 shown in FIG. 24B includes, for example, a handle module. The inspection station includes a vacuum connection 1502 on top of the extension 1504 that can mate with a corresponding vacuum connection 1506 inside the handle module 1501. Inspection station 1500 may be connected to a vacuum pump via vacuum port 1508, which is connected by tube 1510 to vacuum connection 1502 of inspection station 1500. When the vacuum pump is turned on, air may be sucked from the inside of the handle module 1501 to dry the inside of the handle module 1501. The inspection station 1500 may include a pressure gauge and/or airflow sensor that communicates with the tube 1510 and measures the extent to which the handle module 1501 holds a vacuum pressure. In various examples, such a vacuum test may include, for example, a seal engaging the rotary drive outputs 1512, 1514, a seal engaging the firing trigger region 1516, and/or an electrical contact substrate 1518 connecting to the DSM. The sealability of various seals, such as the seals that engage with, can be evaluated across the handle module 1501. If the various handle module encapsulations are not sufficient and the handle module does not maintain sufficient vacuum detected by the vacuum sensor, the inspection station 1500 will indicate through its display that the handle module 1501 needs repair. An alert can be issued to indicate.

In addition to, or in the alternative, the inspection station may be configured to dry the handle module following surgical and/or sterilization procedures as part of preparing the handle module for subsequent procedures. FIG. 25A shows an inspection station 1600 that can be used to dry the handle module 1602, for example. Similar to the above, the inspection station 1600 can be positioned within the empty battery cavity of the handle module 1602 to position the base 1610 and, in addition, the handle module 1602 in communication with the inspection station 1600. An extension 1606 extending from the base 1610. The inspection station 1600 includes two fans, a first fan 1604 located at the upper end of the extension 1606 and a second fan 1608 located in front of the base 1610. The fans 1604 and 1608 are powered by, for example, an AC power source via a power adapter 1612. The first fan 1604 may target internal components of the handle module 1602 through the opening of the battery pack cavity. The upper surface of the extension 1606 may have a ventilation opening through which the air blown by the first fan 1604 can circulate through the handle module 1602. The second fan 1608 may target the trigger area 1614 of the handle module 1602 to dry the trigger area 1614 and the surrounding area of the handle module 1602. The upper front surface of the base 1610 of the inspection station 1600 may include a vent 1616 for the second fan 1608 to allow air blown from the second fan 1608 to circulate through the trigger area 1614. Base 1610 may also include air intakes for fans 1604 and 1608, such as air intake 1618 of base 1610. The inspection station 1600 may also include an exhaust, such as a double sided exhaust 1620 at the bottom of the extension 1606, to allow exhaust to escape from the inspection station 1600. The inspection station 1600 may include as many fans, air intakes, and/or exhausts as are deemed necessary.

25B, 25C, and 25D show another exemplary inspection station 1600. The base 1610 of FIGS. 25B, 25C, and 25D is not in the anterior-posterior direction as in the base of FIG. 25A, the lower front fan 1608 of FIGS. 25B, 25C, and 25D is higher than the base 1610, and the trigger area 1614 is Is inclined to. The configurations shown in FIGS. 25B, 25C, and 25D also include a cover (or lid) 1630 attached to the base 1610 of the test 1600 and covering and enclosing the handle module 1602. Cover 1630 may be made of a rigid translucent plastic, such as polycarbonate. In one aspect, the fan 1608 may be powered by an adapter 1612 for the inspection station 1600, as shown in Figure 25C. In another aspect, the fan 1608 may have its own power adapter 1632, separate from the power adapter 1612 for the inspection station 1600, as shown in FIG. 25D. The top surface of cover/lid 1630 may include one or more vents 1634, and cover/lid 1630 may also include an air intake 1636 near fan 1608.

FIG. 25E shows another configuration of the inspection station 1600 that uses a vacuum flow to dry the handle module 1602. In such a configuration, the cover/lid 1630 may define one or more air intakes 1640 (two of which are shown in FIG. 25E), such that they are placed in communication with the vacuum pump. It has a vacuum port 1642 configured. To dry the handle module 1602, the vacuum pump is turned on to draw air across the handle module 1602 from the air intake 1640 to the vacuum port 1642. Preferably, vacuum port 1642 is spaced from air intake 1640 to increase airflow across handle module 1602. In the example of FIG. 25E, the air intake 1640 is at the bottom of the cover/lid 1630 and the vacuum port 1642 is at the top of the cover/lid 1630, although any suitable configuration can be used.

For example, handle modules such as handle module 1602 may also be tested by a simulated load adapter. In various examples, as shown in the examples of FIGS. 26A-26D, when the handle module 1602 is connected to the inspection station 1600, the handle module 1602 can be tested by the load adapter 1650. In another example, the simulated load adapter can be configured to test the handle module without supplementing the inspection station. In any case, the simulated load adapter 1650 may include a housing 1651 and opposed load motors 1652, 1654 positioned within the housing 1651. As further detailed below, the first load motor 1652 is configured to apply a first test load to the first drive motor of the handle module 1602, and the second load motor 1654 is It is configured to apply a second test load to the second drive motor of module 1602. The first load motor 1652 is configured to drive a first mating nut 1660 that is operably engageable with a coupler 1656 driven by a first drive motor of the handle module 1602. The second load motor 1654 is configured to drive a second mating nut 1662 that is operably engageable with a coupler 1658 driven by a second drive motor of the handle module 1602.

The simulated load adapter 1650 may include, for example, a motor control circuit having at least a processor for controlling the load motors 1652, 1654, a memory, and a motor controller on a circuit board. The motor control circuit may be integrated as one integrated circuit (eg, SOC) or as a number of separate integrated circuits or other circuits. Motor control circuitry may control the motors 1652, 1654 to apply opposing forces to the rotary drive system of the handle module 1602 under various load conditions. The power drawn by the rotary drive system of the handle module 1602 to counteract and/or overcome the opposing forces is monitored by the inspection station 1600 to ensure that the handle module motor and rotary drive system function properly. It can be determined whether or not. In various examples, the first motor 1652 of the simulated load adapter 1650 can be driven in one direction and the drive motor of the handle module 1602 can drive the first coupler 1656 in the opposite direction. If the drive motor of the handle module 1602 cannot or cannot overcome the simulated load applied by the first motor 1652 of the simulated load adapter 1650, the simulated load adapter 1650 will provide the handle module 1602 with the required performance. It is possible to inform the handle module 1602 that the work cannot be performed. In various examples, the second motor 1654 of the simulated load adapter 1650 can be driven in one direction and the drive motor of the handle module 1602 can drive the second coupler 1658 in the opposite direction. If the drive motor of the handle module 1602 cannot or cannot overcome the simulated load applied by the second motor 1654 of the simulated load adapter 1650, the simulated load adapter 1650 will provide the handle module 1602 with the required performance. It is possible to inform the handle module 1602 that the work cannot be performed. Such an assessment may form an aspect of an overall assessment of whether the handle module 1602 is suitable for another procedure.

In various examples, in addition to the above, the simulated load adapter motor control circuit, in a manner that mimics the load the handle module rotary drive system is expected to experience during a surgical procedure, the rotary drive system of the handle module 1600. The load applied by the above simulated load adapter motors 1652, 1654 can be varied from (relatively) low load to (relatively) high load. In at least one example, the motor control circuitry can be programmed to change the load profile of the motors 1652, 1654 based on the DSM type used in the next procedure. For example, the user may use a user interface 1672 (eg, buttons 1670 and/or a touch screen 1672 of the interface), such as selecting a pre-programmed simulated load condition that corresponds to different available DSMs, for example. You can specify the desired simulated load. The simulated load adapter 1650 may have data contact terminals 1674 that mate with the data connection terminals of the handle module 1602. In this way, the user's load profile selections can be uploaded from the inspection station processor to the handle module processor and to the motor control circuitry of the load simulator 1650. In real time and/or after simulation, the motor control circuitry may provide a time stamped power reading (eg, volt amps) of the power supplied to the load simulator motors 1652, 1654 during simulation to the handle module processor and/or inspection station. It can be downloaded to the processor. The inspection station processor and/or the handle module processor can correlate these readings with the time stamped readings of the power drawn by the handle module motor to evaluate the effectiveness of the handle module motor and the rotary drive system.

The simulated load adapter 1650 may be powered by the inspection station 1600, for example. As shown in the example of FIG. 26B, power from the inspection station 1600 can be supplied to the simulated load adapter 1650 via the handle module 1602 and the electrical contact board 1674. In the example of FIG. 26C, a separate power cord 1680 extending from the inspection station 1600 to the simulated load adapter 1650 can bypass the handle module 1602 and power the load simulator adapter 1650 directly. In another configuration, the load simulation adapter 1650 may have its own connection to an AC power source and/or its own battery power source. In various examples, the code 1680 may also place a load simulator 1650 in direct signal communication with the inspection station 1600.

The simulated load adapter 1650 can also be used to monitor backlash in handle module gears that are part of the rotary drive system. When the simulated load adapter 1650 is in backlash detection mode, the simulated load adapter motor control circuit can rotate one or both of the simulated load motors 1652, 1654 and either the inspection system 1600 and/or the handle module 1602. Processor can track rotation by the corresponding rotary drive system of the handle module 1602. The rotational difference between the simulated load adapter motors 1652, 1654 and the rotary drive system of the handle module 1602 is indicative of backlash in the corresponding rotary drive system of the handle module 1602, which can shorten the life of the handle module. In other words, the increased backlash may reduce the number of remaining uses of the handle module 1602. Therefore, in each inspection of the handle module 1602, the inspection station 1600 and the load simulator 1650 can check the backlash of the handle module and write the result in the memory of the handle module. The handle module memory can store and time stamp backlash readings. The handle processor and/or inspection station processor can determine a modified end-of-life threshold of the handle module for firing, for example, based on a model of the effect of backflush on the number of lives. A sample model is shown in FIG. 26E. A broken line 1690 indicates the upper limit of the backlash threshold depending on the number of firings of the handle module. Line 1691 shows the expected backlash of the handle module in response to use (eg, firing). In this example, the backlash threshold is reached after about 500 shots (at the intersection of lines 1690 and 1691). Since the backlash measurements can be tracked over a long period of time (and thus over a large number of shots), the handle processor and/or inspection processor compares the backlash measurements shown by the diamonds in Figure 26E to determine the handle module backlash. Can be determined to tend to reach the threshold with less than 500 shots (about 370 shots in this example). This modified and updated firing threshold can be used to assess the remaining life of the handle module. For example, if the handle module has fired 220 times, the end-of-life corrected for backlash is 370 shots and the processor has 150 shots left on the handle module or a treatment. Assuming that 7 shots are fired each time, it can be determined that 21 treatments remain in the handle module. Backlash can be tested in this manner for each rotary drive system of the handle module and the one with the lowest remaining life can determine the overall remaining life of the handle module.

That being said, if less than the expected number of backlashes is measured, the firing required to reach the end-of-life threshold of the handle module may be upwardly modified, i.e. increased. In fact, for example, the end-of-life threshold of the handle module may be increased if any parameter and/or combination of parameters indicate that the handle module is experiencing less wear than expected. Accordingly, the end-of-life threshold of the handle module may be reduced, for example, if any parameter and/or combination of parameters indicate that the handle module is experiencing more wear than expected. Further, the various parameter thresholds disclosed herein can be modified or adapted. The threshold parameter can be adapted based on unique information and/or external information. For example, the handle module control system can evaluate patterns or trends in the parameter data and adapt parameter thresholds to the patterns or trends. In at least one example, the control system can determine a reference value from the detected parameter data and set a parameter threshold value with respect to the reference value. In some examples, the control system of the handle module can evaluate the pattern or trend of the data obtained for the first parameter and adjust the threshold of the second parameter based on the evaluation of the first parameter data. In at least one example, the control system can determine a reference value from the detection data of the first parameter and determine a threshold value of the second parameter with respect to the reference value. Further, many thresholds are described herein as including two ranges, a first range below the threshold and a second range above the threshold. The threshold itself may be part of the first range or the second range, depending on the circumstances. That being said, as used herein, the threshold is between three ranges: a first range below the minimum value, a second range above the maximum value, and between the minimum and maximum values. A third range may be included. The control system may perform a first operation when the detected data of the parameter is in the first range, and the control system may perform a second operation when the detected data of the parameter is in the second range. The second operation may or may not be the same as the first operation. When the detection data of the parameter is in the third range, the control system may perform the third operation, and the third operation may include no operation. The minimum value may be part of the first range or the third range depending on the situation, and the maximum value may be part of the third range or the second range depending on the situation. For example, in at least one embodiment, if the data is detected in the first range, the control system may adapt the threshold in one direction, and if the data is detected in the second range, the control system may adjust the threshold. May be fitted in the opposite direction and if the data is detected in the third range, the control system may not fit the threshold.

In another aspect, as shown in FIGS. 27A and 27B, the inspection station 1600 can house, for example, both a handle module 1602 and one or more DSM 1680. 27A shows such an inspection station 1600 alone, and FIG. 27B shows an inspection station 1600 with both a handle module 1602 and a DSM 1680 connected thereto. The inspection station processor may be in communication with the handle module processor and/or the DSM processor for downloading and uploading data and information. As shown in FIG. 27A, the inspection station 1600, which also supports the DSM, may include rotary drives 1682, 1684 configured like the rotary drives 1656, 1658 of the handle module 1600. Inspection station 1600 may activate inspection station rotary drives 1682, 1684 to test the drive system of DSM1680. In yet other configurations, the DSM 1680 may have its own test station, for example, for performing various tests and/or data transfers.

From this, the inspection station 1600 can be used to perform a number of pretreatment and/or posttreatment instrument processing tasks for handle modules and/or DSMs, for example:
Determine and display the device ID (eg, serial number) and/or model, and device status (eg, end of life, lockout, etc.).
Read/download data from the memory of the handle module 1602, such as number of shots/cycles, performance parameters, handle and/or DSM software version.
Set and upload the operating instructions and criteria of the handle module and/or DSM that the inspection station can obtain from the memory based on the device ID based on the device ID.
Modular connection integrity test, memory version test, electronic system check, transfer rate (read/write) check, periodic maintenance check, warranty expiration check, end of life check, system lockout check, and/or internal battery life Perform various electronic tests such as conditioning tests.
Perform various physical tests such as motor performance tests (with and/or without simulated load above), seal integrity tests.
Perform tests such as comparing the actual data from the procedure (downloaded from the handle module and/or DSM memory) with the expected procedure data.
-Reset the lockout on the handle module if necessary.
-Dry the device.
Notify the user (eg via a display) that the device (handle module and/or DSM) is or is not suitable for continuous use.
-Upgrade the handle module and/or DSM software.
-Write test results to handle module memory and/or DSM memory. And/or
-Send handle and/or DSM performance and usage data to a remote computer system, eg, via a USB or wireless (eg, WiFi) connection.

The inspection station memory may store software and/or firmware that the inspection station processor executes to perform various functions.

The display of the inspection station and/or handle module may also provide maintenance and repair recommendations based on various usage related data of the handle module. For example, based on usage data such as number of procedures, number of sterilizations, number of firings and/or integrity, and/or gear backlash, the inspection station and/or handle module processor may perform various maintenance or repair tasks. It can be determined whether to be recommended or recommended to the handle module and/or DSM and these recommendations can be communicated to the user via the display on either the inspection station and/or the handle module. Maintenance and repair recommendations may be performed and communicated to the user after the completion of the procedure, during the procedure, and/or at the beginning of the procedure.

28A-28B are exemplary for making maintenance and/or repair recommendations that may be performed by the handle module processor and/or inspection station processor by executing firmware and/or software in the processor's associated memory. It is a process flow. FIG. 28A illustrates an exemplary process flow for inspection station processor 442. At step 1800, following certain procedures, the handle module is connected to the inspection station (see, eg, FIG. 19A), whereupon usage and performance data from the handle module memory is downloaded to the inspection station. This data may include a count of the number of treatments of the handle module, and various methods of counting the number of treatments are described herein. The data also includes, for example, the number of firings by the handle module, the intensity (eg, force) of each firing, the difference in firing power between expected and actual firing forces, consumed by the handle module over the life of the handle module. (Cumulative) energy, and/or gear backlash.

At step 1802, the inspection station processor determines based on the data whether the handle module needs repair. The inspection station processor may analyze the usage and performance data in a number of ways as programmed to determine if repair is required, and if so, then in step 1804, one may be used. Or, multiple repair recommendations may be provided. Repair recommendations can be gross, for example, suggesting that the handle module needs to be rebuilt, or trivial, such as lubricating certain parts. Also, for example, one repair check that the inspection station processor may perform at step 1802 is _once every N ₁ procedure and/or every S ₁ firing, or treatment and firing (eg, N ₂ treatment and S ₂ firing). ) Is for rebuilding the handle module for some combination of. In such a case, if the inspection station processor determines that any of these thresholds have been met, then at step 1804 the inspection station processor controls the inspection station display to indicate that a handle module rebuild is required. You can do it. Another repair check that the inspection station processor may perform at step 1802 is that the gears of the rotary drive system need to be lubricated after every S ₃ shot. Other repair checks that the inspection station can perform and can recommend when appropriate include, for example, electrical integrity checks of the handle module electrical contacts, testing of communication systems, extended diagnostics of the handle module electronics (eg, RAM). And/or ROM integrity, processor operation, idle and operating current draw, operating temperature of selected components, etc.), indicator, display, and sensor operation and/or cycle, balance, and/or test Battery problems such as. A repair check may be performed on the battery to assess the condition of the battery. For example, the inspection station can evaluate, for example, if the battery is nearing its end of life if rechargeable, or if it is nearing a threshold of less than one remaining shot for disposable batteries. Other repair checks include firing the device (in diagnostic mode or other modes that can be fired without using the DSM or cartridge) to monitor for anomalies in motor parameters (such as voltage or current). Damaged gears can cause changes in motor load that can be detected through monitored motor parameters, which can indicate an internal problem that requires replacement. Also, generally higher motor loads may indicate a need for cleaning or lubrication, or damage within the device.

At step 1806, the inspection station processor may determine if any component of the handle module requires a check. As previously mentioned, the inspection station processor may analyze the usage and performance data in a number of ways as programmed to determine if various handle module component checks are required. If it is determined that is required, then one or more component check recommendations may be made at step 1808. For example, if in step 1806 the inspection station processor determines that the gear backlash is above a preset threshold, then in step 1808 the inspection station processor should check the gears of the rotary drive system. A suggestion may be displayed indicating that Also, at step 1806, if the inspection station processor determines that the accumulated energy consumed by the handle module exceeds a preset threshold, then at step 1808 the inspection station processor determines that the rotary drive system motor and And/or a suggestion may be displayed indicating that a gear check should be performed. Similarly, in step 1806, the inspection station processor causes the threshold number of firings (at the most recently completed procedure and/or during the life of the handle module) to exceed a preset intensity threshold (eg, force or power). If so, then at step 1808 the inspection station processor may display a suggestion that a motor and/or gear check of the rotary drive system should be performed. The inspection station processor may also display, via the display, a suggestion indicating that a DSM check should be performed in various embodiments. For example, if in step 1806 the inspection station processor determines that the threshold number of firings for the most recently completed procedure exceeds a preset intensity threshold, then the blunt cutting instrument may force the cutting stroke to perform more. Since, at step 1808, the inspection station processor may also display a suggestion that a sharpness check of the cutting instrument within the end effector should be performed.

The handle module processor may also make repairs and/or component check decisions and recommendations. FIG. 28B shows an exemplary process flow for the handle module processor 2124. The process of FIG. 28B, in steps 1802 and 1806, allows the handle module processor to use and performance data from its treatment and post-treatment processes in step 1801 so that it can determine whether repair and/or component checks are needed. Is similar to the process of FIG. 28A, except that The recommendations and suggestions displayed in steps 1804 and 1808 may relate to the display of the handle module and/or if the handle module is connected to an inspection station and a data connection exists between them. The module processor may communicate the recommendations to the inspection station processor so that the inspection station display can display the recommendations instead of, or in addition to, displaying the recommendations on the handle module display.

As shown in FIGS. 27A and 27B, DSM 1680 may also be connected to inspection station 1600. In such an arrangement, the DSM processor and/or inspection station processor may make repair and component check decisions and recommendations based on the usage and performance data stored in the DSM memory.

To this end, FIG. 35 is a flow chart showing steps that may be performed using the inspection station described herein. At step 2200, the clinician performs a surgical procedure using a surgical instrument that includes a handle module and one of the DSMs. As described herein, the handle module memory can store usage and treatment data from any treatment, such as motor energy and power levels, motor torque, and/or time stamps for actuation of various triggers. Following the procedure, the clinician may, in step 2202, prepare the handle module for use in subsequent procedures, for example, by connecting the handle module to the testing station provided herein, in step 2204. You can disconnect the DSM from the handle module and remove the removable battery pack. In step 2206, the inspection station can download (or read) treatment and usage data from the handle module memory. The inspection station can also download handle module ID data, which the inspection station processor uses in step 2208 to determine which handle module types and/or configurations the inspection station can display on its display.

At step 2210, the inspection station can set an inspection program and inspection criteria for the handle module based on the type and configuration of the handle module. For example, the inspection station memory may store inspection programs and inspection criteria to be executed for each handle module type and configuration. Based on the handle module type and configuration ID determined by the inspection station in step 2208, the inspection station can call and/or set the appropriate inspection program and inspection criteria to use for the handle module. For example, in step 2212, the inspection module can dry the components of the handle module, eg, as described herein in connection with FIGS. Also, at step 2214, a seal integrity test may be performed, such as those described herein in connection with Figures 24A-24B. At step 2216, a handle module electrical integrity test may be performed. These tests include the existence of electrical connections between the appropriate components and, for the data processing components of the handle module, the testing of protocols and connections for data transmission. Can be done. At step 2218, functional and/or physical testing of the handle module may be performed. For example, the motor and/or rotary drive system may be tested (eg, driven) to confirm that it is functioning properly. At step 2220, the lockout of the handle module that requires a reset following the procedure may be reset. At step 2222, further adjustments necessary for the handle module may be performed. This adjustment may include any other adjustments necessary to prepare the handle module for performance of subsequent surgical procedures and/or any repair recommendations identified by the inspection station. At step 2224, the handle module may be released from the examination station and used immediately in subsequent surgical procedures (or sterilized prior to use in subsequent procedures). The inspection station may "release" the handle module, for example, by indicating on the display of the inspection station that the handle module is removable.

As shown in FIGS. 27A and 27B, the DSM may also be connected to such an inspection station following use in a surgical procedure to inspect the DSM. A process similar to that shown in Figure 35 can be used with a DSM connected to an inspection station to prepare the DSM for subsequent treatment.

The various steps shown in FIG. 35 may be performed in different orders or simultaneously, and the steps shown in FIG. 35 may be as in FIG. 35, but are not necessarily performed in the order shown in FIG. 35. For example, the electrical integrity test (step 2216) may be performed prior to the seal integrity test (step 2214), and so on.

36 and 37 are flow charts illustrating exemplary steps involved in sterilizing the handle module and tracking use/sterilization times. In FIG. 36, the process begins at step 2300 where the handle module (and DSM) is used in a surgical procedure. After treatment, post-procedure cleaning of the handle module may be performed in step 2302, which may involve, for example, manually wiping the handle module. Thereafter, in step 2304, the handle module can be cleaned, for example, using an automatic washer or the like. At step 2306, the handle module may be dried in a clean room using, for example, heat and/or air. At step 2308, the handle module is connected to an inspection station, such as, for example, the inspection station described herein in connection with FIGS. 12A-12C, 19A, 25A-25E, 26A-26C, and/or 27A-27B. obtain.

At step 2310, the inspection station may interrogate or interrogate the handle module to activate the sterilization switch (eg, switch 344, see FIGS. 11E-11I) or otherwise, see FIGS. 11E-11I above. It is determined whether or not it is in a state before being placed on the sterilization tray such as the one shown in. If the sterilization tray switch has been triggered or activated, then in step 2311 the sterilization count is incremented and the switch state is reset. Then, in step 2312, the inspection station may determine if the threshold sterilization count of the handle module has been reached, as described herein. If the sterilization count is reached, then at step 2314, end-of-life operation of the handle module, as described herein, may be performed.

Conversely, if the threshold is not yet reached, the process places the handle module on the corresponding sterile tray (see, eg, FIGS. 11E-11I) and/or places the sterile cover on the handle module (eg, on the handle module). , FIGS. 20A-20D), etc. (in any case, the sterilization trigger may be activated at step 2318) and the process may proceed to step 2316 where the handle module is prepared for sterilization. The handle module may be sterilized in step 2320 and immediately stored in step 2322 for use in subsequent procedures in step 2300 and subsequently transferred to the operating room.

Returning to step 2310, if the sterilization trigger has not fired or its status has not changed, the handle module may need to be physically inspected in step 2324.

The exemplary process flow of FIG. 37 follows the procedure at step 2300, where the handle module is power cycled at step 2310 and its sterility flag (set by the handle module processor upon activation of switch 344, It is similar to the process flow of FIG. 36, except that it can be determined whether (see FIGS. 11E-11I) is set. If so, in step 2311 the sterilization count may be updated and the sterilization status may be reset.

As noted above, the handle module battery pack may be used following surgical procedures to allow the handle module to be used in subsequent procedures, typically the same or another similarly configured handle module after recharging. It may be removed from the module. 29A-D show a charging station 1700 for recharging a battery pack 1702. The battery pack 1702 is charged so that when the battery pack 1702 is inserted, the corresponding power supply terminal 1706 contacts the corresponding charging terminal 1708 on the side of the receptacle 1704 to charge the corresponding battery pack 1702. It is inserted into a receptacle 1704 (shown in side views in Figures 29B and 29C) defined in station 1700. The illustrated charging station 1700 can charge two battery packs at the same time. However, in other configurations, the charging station may have receptacles for storing and charging more or less battery packs.

The charging station 1700 may include, for example, a display 1709 that displays the status of the battery pack 1702 regarding the charging process such as currently charging or charged/ready to use. For battery packs that are currently being charged, the display may show the progress of the charging process and/or the extent of the charging process that has not been completed. Use text and/or graphics to show other types of fractional indicators (eg, 40% charged, 50% charged, etc.) that indicate the charging status, such as amount, and/or the degree to which the battery pack is charged. Good.

As shown in FIGS. 29B and 29C, the receptacle 1704 may be dimensioned to easily fit the end of the battery pack 1702 that is inserted into the receptacle (eg, zero insertion force connection). The charging station 1700 may include means for detecting when the battery pack 1702 is inserted in the receptacle. For example, as shown in the block diagram of FIG. 29D, charging station 1700 may include a pressure switch 1720 in communication with charging station processor 1722 at the bottom of receptacle 1704 that is activated when battery pack 1702 is inserted. Additionally or alternatively, charging station processor 1722 may detect insertion of a battery back 1702 when charging station data terminal 1712 makes a data connection with battery pack data terminal 1710. In any event, when the battery pack 1702 is inserted into the receptacle 1704 of the charging station 1700 for charging, the charging station 1700 will prematurely charge the battery pack 1702 (eg, prior to charging and/or completion of charging). The battery pack 1702 may be temporarily secured to the charging station 1700 so that it cannot be removed. As shown in FIGS. 29B and 29C, in one configuration, this is sized to receive a screw 1724 and is therefore automatically threaded into a corresponding opening 1726 in the bottom of the battery pack 1702. This is accomplished by a screw 1724 on the bottom of the receptacle 1704 of the charging station 1700 that screws in.

FIG. 29D is a simplified block diagram of charging station 1700 and battery pack 1702 according to various configurations. Assuming that charging station 1700 is powered by an AC power source, charging station 1700 may include an AC/DC converter 1730 that converts AC voltage to DC voltage and a desired charging for charging battery cells 1734 of battery pack 1702. A voltage regulator 1732 that converts the DC voltage into a voltage and/or current. The charging station 1700 includes a charging control circuit 1736 for controlling the voltage regulator 1732 based on the detected parameters of the charging operation, such as current, voltage, and/or temperature that can be detected by the detection circuit 1738 of the charging station 1700. Good. For example, when charging the battery pack 1702 under normal charging conditions, the charge control circuit 1736 controls the voltage regulator 1732 until the Li-ion or LiPo battery cells 1734 reach a specified voltage (Vpc) per cell. It may be charged with a constant current. The charge control circuit 1736 can then hold the cell at its Vpc until the charge current drops to X% (eg, 10%) of the initial charge rate at which the charging process can end. Other charging regimes suitable for battery technology can be implemented.

Pressure switch 1720 may detect insertion of battery pack 1702 into receptacle 1704 of charging station 1700 and, when activated, sends a signal to charging station processor 1722. The charging station processor 1722 may in response send a control signal to a connecting actuator 1740, such as a linear actuator, which pushes a screw 1724 into the battery pack screw opening 1726. The connection actuator 1740 may be powered by a second voltage regulator 1742, which may power other electronic components of the charging station 1700 in addition to the connection actuator 1740.

In addition to the above, the battery pack 1702 may include a data terminal 1710 that mates with a corresponding data terminal 1712 of the charging station 1700 when the battery pack 1702 is inserted into the receptacle 1704. Charging station processor 1722 may have internal or external memory 1744 that stores firmware and/or software executed by charging station processor 1722. By executing firmware and/or software, the charging station processor 1722 can (i) control the display 1709, (ii) communicate with a charging controller 1736 to control aspects of the battery cell charging process, and/or Alternatively, (iii) data can be exchanged with the battery pack processor 1750 via the data terminals 1710, 1712. As described herein, the battery pack electronics may also include a memory 1752 that stores firmware and/or software executed by a battery pack processor 1750, such as a battery management system (BMS). Battery pack 1702 may also include a sensor 1754 for detecting conditions associated with battery pack 1702, such as, for example, humidity and/or humidity, as described above. The data terminal 1712 of the charging station 1700 may also provide low level power to the battery pack processor 1750. The charging station 1700 may also include a wireless module 1755 in communication with a processor 1722 that may communicate with remote devices via a wireless communication link (eg, Wi-Fi, Bluetooth, LTE, etc.). Accordingly, the charging station 1700 may be configured for a remote computing system (eg, server, desktop, tablet computer, laptop, smartphone, etc.), charging status, and other data regarding the battery pack 1702 attached to the charging station 1700 ( For example, it is possible to wirelessly communicate the end of life, temperature, which is approaching. The charging station may also include a wired connection port (eg, USB-type port) to allow the charging station 1700 to download charging status and other data regarding the battery pack 1702 to the connected device. In this way, the surgical staff and/or the battery pack supplier can receive such information.

In one aspect, to extend battery run time and battery life, for example, the battery cells comprising the battery pack 1702 may be rebalanced from time to time during the life of the battery pack 1702. FIG. 29E is a diagram of a process flow that may be performed by charging station processor 1722 (by executing firmware/software stored in memory 1744) to rebalance the battery cells. At step 1760, charging station processor 1722 causes insertion of battery pack 1702 into charging station 1700 for charging based on, for example, a signal from pressure switch 1720 of receptacle 1704 and/or some other suitable means. Can be detected. In step 1762, charging station processor 1722 may activate connection actuator 1740 to temporarily secure battery pack 1702 to charging station 1700 during a charging (and/or discharging) session. At step 1764, the charging station processor 1722 can exchange data with the battery pack processor 1750. Among other things, the battery pack processor 1750 can exchange a log of the time that the battery pack 1702 has been charged and the number of times the cell has been balanced. In step 1765, the charging station 1700 can quickly bring the battery cells to full charge if a battery pack is needed before a full charge or discharge cycle can be performed. The highest level of charging in step 1765 may be, for example, simply charging the battery cells in constant flow to a specified Vpc level, or fraction thereof. At step 1766, charging station processor 1722 may determine whether to rebalance the battery cells. In various aspects, the cells may be balanced every Nth charge, where N is an integer greater than or equal to 1, preferably greater than 1. If it is not time to rebalance the cells, the process proceeds to step 1768, where the battery cells are recharged, and in step 1770, such as by stopping the connection actuator 1740 so that the battery pack 1702 can be removed from the receptacle. By releasing the battery cell for use. On the other hand, if at step 1766 it is determined that the battery cells need to be rebalanced, then the process may proceed to step 1772 where the cells are discharged before being charged at step 1768. At step 1772, the cell may be discharged to a suitable (low) voltage level.

As shown in FIG. 29A, the charging station 1700 may include an emergency release button 1780 on each battery pack charging receptacle, or is currently the most charged (and therefore most suitable for emergency use) battery pack 1702. Only one emergency release button 1780, which releases only one, may be included. In various aspects, the charging station processor 1722 may initiate one or more actions when the emergency release button 1780 is pressed for a particular battery pack 1702 and charging of that battery pack is in progress. For example, the charging station processor 1722 may send a signal to the connection actuator 1740 to unscrew the battery pack 1702 so that the battery pack 1702 can be removed. Also, prior to such mechanical release of the battery pack 1702, the charging station processor 1722 can instruct the charge controller to take action to facilitate rapid charging of the battery pack 1702. For example, the charging station processor 1722 may instruct the charge controller 1736 to use a charging profile that charges the battery cell 1734 more quickly in a short period of time, but such a short period of charge will also fill the battery cell to its full capacity. It may not be fully charged or may not promote the long life of the battery cell. Common charge profile stages for charging Li-ion battery cells include (i) trickle charge, (ii) constant flow charge, and (iii) constant pressure charge. The charge control circuit 1736 can switch to one of these profiles (eg, constant current charge) in a short period of time to provide as much additional charge to the battery pack 1702 as possible in a short period of time. The charging station processor 1722 may also allow other power sources to be used for charging, such as from other receptacles and/or power storage devices (eg, supercapacitors or battery cells) within the charging station 1700. It can be adjusted to increase the charging voltage available for charging. Data regarding charging procedures and the like can also be recorded in the battery pack memory.

FIG. 30A illustrates another exemplary charge/discharge determination process that charging station processor 1722 may undertake in addition to or in place of the process shown in FIG. 29E. The process of FIG. 30A shows that discharging the battery pack of a surgical instrument is often beneficial for its longevity, but the battery pack has sufficient time to discharge before it is needed in a surgical procedure. If not, admit that it should not be discharged. The process of FIG. 30A begins at step 1780 when a “first” rechargeable battery pack is inserted into one of the charging receptacles 1704 of charging station 1700. At step 1782, battery pack usage data from the first battery pack is downloaded to the charging station memory, which may include the current remaining battery capacity. Although not shown in FIG. 30A, the first battery pack may also be secured to the charging station upon insertion (see, eg, FIGS. 29B-29C). At step 1784, the charging station 1700 may immediately charge the first battery pack if required by the ongoing or immediate procedure. At step 1786, the data regarding the charging of the first battery pack at step 1784 is written to the memory of the first battery pack. This data may include, for example, time stamps at the beginning and end of the charging process, and battery capacity at the beginning and end.

In step 1788, the charging station processor confirms charging/discharging of the first battery pack, and if the first battery pack has been fully discharged since the last treatment, the process proceeds to the first battery pack treatment. Step 1790 ready for use. In this step, the charging station display may show that the first battery pack is ready for use. On the other hand, if in step 1788 it is determined that the first battery pack has not been fully discharged since the last procedure, the process indicates that the charging station processor has at least one other fully charged battery in the charging receptacle. Proceed to step 1792, where it can be determined if a battery pack is present. In such a case, at step 1794, the first battery pack may be completely discharged, extending its life. This is because another fully charged battery pack is ready for use as needed. Upon completion of discharging the first battery pack, the discharge data (eg, start and end time stamps, start capacity and end capacity) is stored in the first battery pack memory in step 1796 so that the evaluation can be performed in step 1788. Can be written in. The process may then proceed to step 1784 where the battery cells of the first battery pack are recharged and the process is repeated. In step 1794, if the first battery pack has been discharged since the last treatment, then another discharge of the battery cells is not required, so the process proceeds from step 1788 to step 1790.

The process of FIG. 30A can be modified. For example, the initial charging step 1784 may be omitted and/or moved between steps 1788 and 1790 and/or between steps 1792 and 1790, for example.

FIG. 30B illustrates another exemplary charge/discharge determination process that the charging station processor 1722 may undertake. The process of FIG. 30B is the step 1782 following the step 1782, where the charging station 1700 performs the highest level of fast charging of the battery pack (eg, a short-time charge less than full charge) and the highest level of charging of the battery pack memory. 30A is similar, except that data for can be recorded. Then, in step 1788, as in FIG. 30A, the charging station processor may determine if the battery pack has been completely discharged since the last procedure, and if so, in step 1789, the battery pack's A full charge has been performed and the battery pack is ready for use at this point (block 1790). On the other hand, if in step 1788 the charging station processor determines that the battery pack has not been completely discharged since the last procedure, the process is that the charging station is currently inserted in one of the receptacles 1704. Proceed to step 1792 to determine if another battery pack is ready for use (eg, fully or fully charged). If not, the first battery pack may be fully charged at step 1789. However, if another battery pack is fully or fully charged and ready for use, the first battery pack may be discharged at step 1794 (data regarding discharge is stored in battery pack memory). ). After a complete discharge, the process may then proceed to step 1789 so that the first battery pack can be charged.

In various embodiments, the charging station processor 1722 can monitor and store the time that various battery cells are inserted as an indication of the time that the procedure is performed by the hospital or operating room where the charging station is located. Charging station processor 1722 may be programmed to determine when a hospital or operating room typically performs and does not perform procedures that require instruments using such battery packs. Specifically, the charging station processor 1722 performs statistical procedures to perform procedures requiring non-overlapping time increments, such as 1 hour increments, over a 24-hour period in a hospital or operating room requiring such a battery pack-based instrument. The tendency can be determined. Therefore, for a full charge of a battery pack (eg, in step 1789 of FIG. 30B), the charging station is currently in progress, especially if there is another fully charged battery pack ready for use. Can be initiated for a time-consuming full charge process. That is, for example, in FIG. 30B, the full charge in step 1789 following the discharge in step 1792 need not be immediately after the discharge in step 1792, but instead, determined and scheduled by the charging station processor 1722. As such, treatments currently in progress may be scheduled for times when there is less tendency to exist. In addition, the hospital or operating room personnel may provide data via the user interface 1709 to the charging station 1700, for example, the duration of the procedure and/or the type of procedure being performed (or the amount of charge required for the procedure). You can enter. This data is stored in charging station memory 1744 and can be used by charging station processor 1722 to determine when to charge the battery pack.

In systems that charge and discharge batteries, the discharged battery cell charge is usually drained through a load resistor, thus wasting a significant amount of energy and dissipating the power from the servicing cell in the form of heat. To be Therefore, the charging station may include a fan and/or heat sink to facilitate heat dissipation. In another aspect, the charging station may use the charge of the discharged cell to charge another cell in the charging station or store it in another power storage device. FIG. 31 is a simplified diagram of a circuit 1900 for discharging a battery cell in such a manner. When charging the "first" battery cell 1902, the power/voltage regulator 1904 is connected to the first battery cell 1902 by closing switch S1 (all other switches (S2, S3, S4, and S5) is open). To discharge the first battery cell 1902 via register 1906, switches S2 and S3 are closed and switches S1, S4 and S5 are open. The diode 1903 controls the direction in which current flows from the first battery cell 1902. To discharge the first battery cell 1902 to an energy storage device 1908 (eg, a supercapacitor, or another battery cell inside a charging station and not normally used in surgical instruments), switch S2 is closed. , The remaining switches S1, S3, S4, and S5 are open. The diode 1903 controls the direction of current flow to the energy storage device 1908. To use the charge of the energy storage device 1908 to charge the first battery cell 1902, switch S5 is closed and the remaining switches S1, S2, S3, and S4 are open. The diode 1905 controls the direction in which the current flows to the first battery cell 1902. To charge another battery cell 1910 using the first battery cell 1902, switches S2 and S4 are closed and switches S1, S3 and S5 are open. Switches S1, S2, S3, S4, and S5 may be controlled by charging station processor 1722 and/or charging controller 1736.

FIG. 32 is similar to FIG. 31 except that the configuration of FIG. 32 includes a battery cell set 1920 that can be used to charge the first battery cells 1902 to charge and discharge the first battery pack 1902. Shows a circuit for. In the illustrated configuration, the battery cell set 1920 includes three battery cells 1922, 1924, 1926. However, in other configurations, the battery cell set 1920 may include more or less than three battery cells. The battery cells 1922, 1924, and 1926 in the battery cell set 1920 may be internal battery cells of the charging station and/or other battery packs inserted in the charging station. The cells 1922, 1924, 1926 in the battery cell set 1920 may be used to quickly charge the first battery pack 1902, for example, in situations where a replacement battery pack is required by the ongoing procedure. .. In the illustrated configuration, the cells 1922, 1924, 1926 in the battery cell set 1920 are connected in series or in parallel to provide increased voltage (for series connection) or increased current (for parallel connection). Good. To connect cells 1922, 1924, 1926 in series, switch S7 is closed and switch S6 is open. To connect cells 1922, 1924, 1926 in parallel, switch S6 is closed and switch S7 is opened. Each cell may have an associated register, eg, R1, R2, R3, respectively, to provide a current source when connected in parallel.

In one aspect, referring again to FIG. 29A, if the clinician is in the middle of a procedure and needs a new battery pack to complete the procedure, the clinician (or his assistant) is fully charged. , Select one of the available battery packs and remove it from charging station 1700. This battery pack may be shown on the display 1709 of the charging station 1700. If none of the battery packs 1702 are shown to be ready for use, the clinician may, for example, charge controller 1736 and/or charge controller 1736 so that a partially charged battery pack may be inserted into the handle module currently in use in the procedure. Alternatively, the emergency release button 1780, as determined by the charging station processor 1722, which may release the most charged battery pack 1702 currently in the charging station 1700, may be pressed. Charging station 1700 may also include a visual indicator showing battery pack 1702 released in an emergency to identify the battery pack to remove from the charging station for insertion into a surgical instrument. For a charging station 1700 that includes means for securing battery pack 1702 to charging station 1700 during charging, such as screw 1724 in the configuration of FIGS. 29A-29C, actuation of emergency release button 1780 as described herein. As described above, the connection means can disconnect (or release fixing) the appropriate battery pack 1702. At about the same time, the charging station 1722 may perform the steps of rapidly charging the selected battery pack 1702 in a short period of time, preferably providing sufficient charging to complete one or several shots. As described herein, the charging station processor 1722, along with the charging control circuit 1736, changes the charging profile (eg, constant current or constant voltage charging), charges the battery pack using the supercapacitor 1908, and/or Charging of a battery pack comprising one or more other battery cells (which may be series connection or parallel connection as described herein) may be performed. In various configurations, the battery pack 1702 (e.g., screws 1724's) is charged until the battery pack 1702 is charged to a charge level equal to a threshold charge that is sufficient to complete one or more shots with a short charge. Not released (by disconnecting).

In various aspects, the charging station also facilitates proper placement of the battery pack in the charging station for charging and/or enhances the engagement between the electrical contacts of the battery pack and the charging terminals of the charging station. And therefore may be configured to increase the efficiency of the charging process. For example, a well (or receptacle) in a charging station may be configured such that no matter how the battery pack is inserted into the well/receptacle, the charging terminals of the battery pack will contact one of the charging terminal sets of the charging station. It is possible to have multiple terminal sets. 33A and 33B show top views of the battery pack 2000 and the charging station 2002, respectively, wherein the battery pack 2000 has a rectangular cross-sectional shape and the well/receptacle 2004 of the charging station 2002 has such a rectangular cross-sectional shape. Is a dimension for receiving. The illustrated charging station 2002 has two wells/receptacles 2004, but in other configurations, the charging station 2002 may have one well/receptacle or more than two wells/receptacles. As shown in FIG. 33A, the battery pack 2000 has a positive terminal 2006 with which a charging station terminal contacts to charge the battery pack, and a negative terminal 2008. In the illustrated configuration, the terminals 2006, 2008 are not in the center of the top of the battery pack 2000. Such a battery pack 2000 is one of the square-shaped well/receptacles 2004 in one of four configurations (assuming that the sides of the battery pack 2000 having terminals 2006 to 2008 each rotate 90 degrees and are always facing downward). Since each well/receptacle is inserted into the well/receptacle 2004 regardless of the insertion direction of the battery pack 2000 when inserted into the well/receptacle 2004, the off-center battery pack terminals 2006 to 2008 are connected to the charging station terminal pair. There may be four pairs of charging terminals 2010 positioned within each well/receptacle thereof for contact with one of 2010. Each charging station terminal pair 2010 is connected to the charging circuit of the charging station, but only one charging station terminal pair 2010 is in contact with the battery pack terminals 2006 to 2008 so that the charging current can flow to the battery pack 2000. It has a completed circuit. In another configuration, one of the battery pack terminals can be central to the battery pack 2000, as shown in FIGS. 34A and 34B. In this illustrated example, the negative terminal 2008 is in the center and the positive terminal 2006 is on one side. However, in another embodiment, the opposite configuration may be used. The well/receptacle of the charging station accordingly has one terminal 2014 in the center for contacting the negative terminal 2008 of the battery pack 2000 and no matter which direction the battery pack 2000 is inserted into the well/receptacle. Four terminals 2016 on each side of the center terminal 2014 for contacting the positive terminal 2006. For battery packs with other geometries, the well/receptacle may require fewer or many terminal pairs (such as two for a triangular battery pack).

As mentioned above, the surgical instrument may include a battery assembly that is attachable to and/or removable from the surgical instrument. Such handling of the battery assembly may increase the chances of damaging the battery assembly. For example, the battery assembly may be inadvertently dropped during assembly of the battery assembly into a surgical instrument and/or transfer of the battery assembly to a charging station. As discussed in more detail below, the battery assembly may be configured to protect the housing, the battery cells, and/or the power circuit of the battery assembly should the battery assembly be inadvertently dropped.

Referring now to FIG. 38, a battery assembly, such as battery assembly 5000, includes a battery housing 5010 and a plurality of internal components 5030, such as at least one battery cell 5031 and/or a power circuit positioned within the battery housing 5010. Can be provided. At least one battery cell 5031 may comprise, for example, a lithium-ion battery. Battery assembly 5000 also includes one or more electrical contacts 5011 configured to transfer the electrical energy provided by at least one battery cell 5031 to the surgical instrument. Battery assembly 5000 further comprises one or more alignment features 5012 configured to help a user properly assemble battery assembly 5000 into a surgical instrument. Alignment mechanism 5012 includes, for example, a slot that can be aligned with a protrusion extending from the surgical instrument. The alignment mechanism 5012 is symmetrically arranged on the outer peripheral portion of the battery housing 5010. Although not shown, other embodiments are envisioned where the alignment mechanism 5012 has an asymmetrical configuration to allow the battery assembly 5000 to be attached to the surgical instrument in only one orientation. The battery assembly 5000 further comprises a locking mechanism 5040 configured to secure the battery assembly 5000 to a surgical instrument during use. When the battery assembly 5000 is attached to a surgical instrument, the battery assembly 5000 can transfer electrical energy to the power receiving contacts of the surgical instrument.

The battery housing 5010 can act as a container configured to house the internal component 5030 and/or can act as a support structure configured to support various components thereon. The battery housing 5010, which functions as a container and/or support structure, may be rigid to support an internal component 5030 positioned in its middle. The battery housing 5010 may be made of a plastic material, for example. In a particular example, the inner housing 5010 is constructed of, for example, an elastomeric material. Referring back to FIG. 38, the battery housing 5010 includes a top surface, a bottom surface 5016, a plurality of side surfaces 5015, and a plurality of corner portions 5014. Bottom surface 5016 may be associated with electrical contact 5011. The side surface 5015 and the corner portion 5014 are configured to surround the internal component 5030.

Various embodiments described herein relate to protection of battery assemblies for use with surgical instruments. Referring again to FIG. 38, the battery assembly 5000 comprises radial and/or longitudinal stiffeners configured to protect the battery housing 5010, internal components 5030, and/or electrical contacts 5011. The radial and/or vertical reinforcements may include, for example, a shock absorbing layer. In various examples, a shock absorbing layer may surround the battery housing 5010 to absorb shock forces applied to the side surfaces 5015, bottom surface 5016, and/or corners 5014 of the battery housing 5010. In addition to or in the alternative, the shock absorbing layer may be contained within the battery housing 5010. Also, in addition to or in the alternative, the battery assembly 5000 may further comprise an outer housing for additional protection. The outer housing may be configured to house the battery housing 5010 and the shock absorbing layer.

One means for protecting the battery assembly 5000 is detailed in FIG. 38A, which includes, for example, a battery housing or inner housing 5010 and a shock absorbing layer 5020. As mentioned above, the housing 5010 may be constructed of a rigid material capable of supporting the internal components 5030 of the battery assembly 5000. The shock absorbing layer 5020 may include a lattice structure 5022 having a plurality of cells 5024. The cells 5024 can reduce the density of the shock absorbing layer 5020. The cell 5024 may have an open cell structure and/or a closed cell structure. Further, the grid structure 5022 may comprise one or more grid layers. For example, the lattice structure 5022 may include a first or inner lattice layer and a second or outer lattice layer.

The lattice structure 5022 further comprises a plurality of braces 5025 designed to deflect and/or flex under pressure. When the battery assembly 5000 is dropped, the impact force is absorbed by the compression of the cells 5024 and the bending and/or deflection of the brace 5025. Thus, the shock absorbing layer 5020, depending on the battery housing 5010, absorbs shock and/or vibration energy in some circumstances, rather than absorbing energy that could damage the internal components 5030 of the battery assembly 5000. it can. In various examples, the shock absorbing layer 5020 may include, for example, a foam-like structure and/or an elastomeric material.

In various examples, referring again to FIG. 38, cells 5024 are arranged, for example, in rows, with cells 5026 in the inner row, cells 5027 in the middle row, and cells 5028 in the outer row. Each cell in the inner row of cells 5026 may comprise a planar wall 5026a. The cell 5026 is oriented such that the planar wall 5026a of the cell 5026 is at least substantially parallel to the side surface 5015 of the battery housing 5010. Each cell in the outer row of cells 5028 may comprise a planar wall 5028a. The cell 5028 is oriented such that the planar wall 5028a of the cell 5028 is at least substantially parallel to the outer surface 5029 of the shock absorbing layer 5020. By orienting the planar walls 5026a, 5028a of each cell of the inner row 5026 and outer row 5028 in this manner, a more impact resistant shock absorbing layer 5020 can be formed. The shock absorbing layer 5020 may include a corner located near the corner 5014 of the battery housing 5010 that can absorb the impact force directed at the corner 5014 of the battery housing 5010. Although the corners 5020 are not connected to each other, embodiments are contemplated in which the corners 5020 may be connected to each other.

In various examples, the battery assembly 5000 comprises a plurality of shock absorbing elements 5020. The shock absorbing element 5020 is positioned to protect the corner 5014 of the battery assembly 5000. In various examples, the impact force is more concentrated in the corners 5014, which may increase the risk of damaging the battery housing 5010 and/or the internal components 5030. The shock absorbing element 5020 comprises an end 5021 that extends beyond the bottom surface 5016 of the battery housing 5010 to prevent damage to the electrical contacts 5011 and further protect the battery assembly 5000, for example. When the battery assembly 5000 is dropped in a direction such that the bottom surface 5016 is at least substantially parallel to the ground, one or more of the ends 5021 may absorb impact forces and dissipate impact energy. ..

It may be desirable for the battery assembly to be usable after undergoing an impact force, such as when the battery assembly 5000 is inadvertently dropped. In such an example, the shock absorbing element 5020 can retain the ability of the battery assembly 5000 to properly fit into the battery receptacle of the surgical instrument, and even if the battery assembly 5000 is dropped, electrical energy is still available to the surgical instrument. It is configured so that it can be transmitted to the power receiving contact. The shock absorbing element 5020 may include a crumple zone configured to deform when an impact force is applied. In at least one example, the crumple zone may not permanently deform, or at least substantially not permanently deform, when the impact force falls below the crumple force threshold. In such an example, the crumple zone may only permanently deform if the impact force meets or exceeds the crumple force threshold. The crumple zone may limit the direction of deformation of the shock absorbing element 5020 toward the center of the battery assembly 5000. This inward deformation causes the battery assembly 5000 to acquire a shape that does not fit into the battery receptacle of the surgical instrument, thereby allowing the battery assembly 5000 to fit into the battery receptacle of the surgical instrument. Can be maintained.

In various examples, shock absorbing element 5020 may experience excessive deformation that requires replacement of shock absorbing element 5020. If the shock absorbing element 5020 needs to be replaced, the battery assembly 5000 allows the user of the surgical instrument to remove the damaged shock absorbing element from the battery assembly 5000 and then attach a usable shock absorbing element thereto. Can be configured as follows. As will be discussed in more detail below, it may be preferable for the shock absorbing element 5020 to be timely replaceable. Minimizing the time required to replace the shock absorbing element 5020 can be important when performing other tasks in surgery.

Assembling the shock absorbing element 5020 into the battery assembly 5000 may be necessary when the shock absorbing element 5020 needs to be replaced. In various examples, the shock absorbing element 5020 includes one or more protrusions 5023 configured to slide into and/or plug into a corresponding slot 5013 in the battery housing 5010. Prepare The slot 5013 is configured to receive a new and/or usable shock absorbing element protrusion 5023 if the shock absorbing element 5020 needs to be replaced. In various examples, the protrusion 5023 and the slot 5013 can include a press fit therebetween that allows the protrusion 5023 to slide within the slot 5013 along a corner of the housing 5010. In at least one example, the protrusion 5023 and the slot 5013 can include a push fit between them. In various examples, shock absorbing element 5020 may be snap-fit mounted to battery housing 5010. In at least one example, the battery housing 5010 may include an opening configured to snap-fit to receive the protrusion 5023. In a particular example, the protrusion 5023 can snap into the slot 5013 radially. In addition to or in the alternative, the shock absorbing element 5020 may be attached to the housing 5010 using, for example, an adhesive.

In various examples, the battery assembly 5000 further comprises a shock absorbing cap 5050. The shock absorbing cap 5050 is positioned on the outer end 5002 of the battery assembly 5000. The shock absorbing cap comprises a shoulder 5051 configured to contact the surgical instrument when the battery assembly 5000 is fully secured to the surgical instrument. Shoulder 5051 may act as a stop, for example, and may define a fully fixed position for battery assembly 5000. In various examples, shoulder 5051 is configured to abut shock absorbing element 5020. When the battery assembly 5000 is attached to a surgical instrument, the shock-absorbing cap 5050 may provide the battery assembly 5000 and/or the surgical instrument when the surgical instrument is dropped in a direction such that the top surface is at least substantially parallel to the ground during impact. Can protect equipment. On the other hand, if the battery assembly 5000 is not attached to a surgical instrument and the battery assembly 5000 is dropped in a direction such that the top surface is at least substantially parallel to the ground, the shock absorbing cap 5050 still protects the battery assembly 5000. To do.

A partial cross-sectional view of the battery assembly 5000 is shown in FIG. The shock absorbing cap 5050 may include a lattice structure or a cell structure, and includes a plurality of cells 5052. The shock absorbing cap 5050 can be made of a material similar to that of the shock absorbing layer 5020. A denser grid configuration 5055 is used near the outer edge 5054 of the battery assembly 5000, which may dissipate more concentrated impact forces. The shock absorbing cap 5050 comprises a central portion 5053 with a columnar grid arrangement 5056 configured to absorb the impact energy generated by the impact force applied to the central portion 5053. In various examples, the columnar grid configuration 5056 is configured to dissipate widely applied impact forces.

In various examples, the shock absorbing cap 5050 may include a crumple zone that is configured to deform when an impact force is applied. The shock-absorbing cap 5050 can be designed using the crumple zone to prevent the battery assembly 5000 from bouncing on the floor when the battery assembly 5000 is dropped, for example.

The shock absorbing cap 5050 may be easily replaceable. If the shock absorbing cap 5050 experiences excessive deformation that requires replacement of the shock absorbing cap 5050, the battery assembly 5000 can be used by a surgical instrument user to remove a damaged shock absorbing cap from the battery assembly 5000. It may be configured such that a shock absorbing cap can be attached.

In various examples, shock absorbing element 5020 can be coupled to the middle with a tether. The middle portion may be configured to protect the side surface 5015 of the battery housing 5010 and/or the alignment feature 5012. Of course, if the impact force is applied to the entire surface area of the side surface 5015 of the battery housing 5010, if the same impact force is applied to the corner 5014 of the battery housing 5010 having a smaller surface area, the stress caused by the impact force will be It will be smaller than this. In other words, the greater the surface area over which the impact force is distributed, the lower the stress and stress concentration. Therefore, the intermediate portion between the shock absorbing elements 5020 may not have to have the same structure as the shock absorbing element 5020. In at least one example, as a result, the middle portion may be thinner than shock absorbing element 5020, but the middle portion may have the same and/or thicker construction as shock absorbing element 5020. Various embodiments are also envisioned.

Each of the shock absorbing elements 5020 of the battery assembly 5000 has a similar structure, but other embodiments are contemplated in which one or more of the shock absorbing elements 5020 may be different from the others. In at least one such example, at least one of the shock absorbing elements 5020 is an additional weight, such as a metal weight, positioned therein that can cause the battery assembly 5000 to drop and land in a particular direction. Can be provided. Such effects may also be achieved, for example, by placing one or more weights in the battery housing 5010.

A battery assembly 5100, which in many respects is similar to battery assembly 5000, is shown in FIG. Battery assembly 5100 may include means for protecting internal components 5030 of battery assembly 5100 from shock and/or heat damage. Various means for protecting the battery assembly 5100 from shock are described above. Heat shown by Q in FIG. 40A may pass through the battery housing 5110 and be absorbed by, for example, battery cells 5031 located in the battery housing 5110.

Of course, heat flows from a hot environment to a cool environment. Under typical sterilization conditions, the battery assembly 5100 is exposed to high temperatures. As a result, heat flows from the sterilization chamber into the battery assembly 5100. However, in some circumstances, the battery assembly 5100 may be improperly sterilized and exposed to excessive temperatures. If at least one of the battery cells 5031 absorbs and/or retains a damaging amount of heat Q, the battery cell 5031 may experience thermal runaway events and failures.

Referring now to FIG. 40A, the battery housing 5110 comprises a heat reflective shell or shield 5111, a shock absorbing layer 5112, and a heat sink layer 5113. The reflective shell 5111 is configured, for example, to reflect and/or block the transfer of heat Q caused by improper sterilization. In various examples, the reflective shell 5111 may be constructed of a material with low thermal conductivity, such as, for example, a polymer and/or ceramic material. Materials with low thermal conductivity typically have low coefficients of thermal expansion. Materials with low thermal conductivity also work well as insulating layers. In any case, the reflective shell 5111 may include a reflective outer surface that may reflect heat away from the battery assembly 5100. The reflective outer surface can be constructed of, for example, a polished metal such as polished aluminum.

In addition to the above, the heat sink layer 5113 is configured to absorb heat passing through the reflective shell 5111. The heat sink layer 5113 can also be configured to absorb heat generated by the battery cells 5031, for example, when the battery cells 5031 are recharged. In some examples, the battery cell 5031 may generate an atypical amount of heat due to its overcharge and/or overuse. In various examples, the heat sink layer 5113 can be composed of a material having a high thermal conductivity, such as a metal. Any suitable material having a high thermal conductivity can be used to absorb the heat generated by the at least one battery cell 5031. Furthermore, materials with high thermal conductivity typically have high coefficients of thermal expansion.

In addition to the above, the battery cells 5031 may expand as they are charged. The expanding battery cell 5031 can push the heat sink layer 5113 outward. Moreover, the heat sink layer 5113 can expand outward rapidly due to its high coefficient of thermal expansion. Such outward movement of the battery cells 5031 and heat sink layer 5113 may push the shock absorbing layer 5112 toward the reflective shell 5111 and apply pressure to the reflective shell 5111. Such stress may cause stress in the reflective shell 5111, the heat sink layer 5113, and the battery cell 5031, especially in embodiments where the reflective shell 5111 is constructed of a material having a lower coefficient of thermal expansion than the heat sink layer 5113. .. In such an example, the heat sink layer 5113 may expand more than the reflective shell 5111, thus creating additional stress in the reflective shell 5111, the heat sink layer 5113, and the battery cell 5031.

The shock absorbing layer 5112 is configured to allow the battery cell 5031 to expand while preventing damage to the battery housing 5110. The shock absorbing layer 5112 acts as a degree of freedom for the battery housing 5110 so that the heat sink layer 5113 and the at least one battery cell 5031 can expand and/or contract due to heat transfer while maintaining the supporting ability of the battery assembly 5100. By doing so, it may be expanded and/or contracted in order to manage the expansion and/or contraction of the battery cell 5031. In various examples, the expansion and contraction of shock absorbing layer 5112 can prevent damage to battery housing 5110. The shock absorption layer 5112 can absorb thermal shock and shock.

41 and 42, the surgical instrument system 5300 includes a handle 5310 usable with a shaft assembly selected from a plurality of shaft assemblies. In addition to the above, one or more of such shaft assemblies may include, for example, staple cartridges. The handle 5310 includes a housing 5312, a first rotatable drive output section 5340, and a second rotatable drive output section 5350. The handle 5310 further includes a first actuator 5314 for actuating the first rotatable drive output 5340 and a second actuator 5315 for actuating the second rotatable drive output 5350. The handle housing 5312 includes a battery cavity 5311 configured to receive a battery therein. The battery can be any suitable battery such as, for example, a lithium ion battery. In various examples, the battery can be inserted into and removed from the battery cavity 5311. In many examples, such a battery can provide power to the handle 5310 to operate the surgical instrument system 5300 without being supplemented with, for example, an additional power source and/or a tethered power source. Such a design can be advantageous for many reasons. For example, if the surgical instrument system 5300 is not tethered to a power source, the entire surgical instrument system 5300 may reside in a sterile compartment of the operating room. However, such batteries can only supply a finite amount of power. In many instances, the finite amount of power the battery can provide is sufficient for the surgical instrument system 5300 to operate. On the other hand, it may be the case that the battery is unable to provide the necessary power to the surgical instrument system 5300.

Referring again to FIG. 41, the battery located in the battery cavity 5311 of the handle 5310 can be removed and replaced, eg, with the power adapter 5360. The power adapter 5360 comprises a distal plug 5361 that can be positioned within the battery cavity 5311. Distal plug 5361 comprises a plurality of electrical contacts 5366 that are engageable with corresponding electrical contacts 5316 in handle 5310. In various examples, the battery and distal plug 5361 can engage the same electrical contact 5316, depending on the electrical contact located in the battery cavity 5311. In such an example, the handle 5310 may be powered from a set of electrical contacts 5316 regardless of whether a battery or power adapter 5360 engages the handle 5310. In another example, the battery engages a first set of electrical contacts 5316 and the distal plug 5361 engages a different set of electrical contacts 5316. In such an example, the microprocessor of handle 5310 may be configured to identify whether a battery or power adapter 5360 is associated with handle 5310.

The distal plug 5361 of the power adapter 5360 can comprise any suitable shape as long as the distal plug 5361 can be positioned within the battery cavity 5311. In various examples, the distal plug 5361 can have the same geometry as, for example, a battery. In a particular example, the housing of the distal plug 5361 is similar, or sufficiently similar, to the battery housing. In any case, the distal plug 5361 has almost no relative movement between the distal plug 5361 and the battery cavity 5311, if any, once the distal plug 5361 is fully secured in the battery cavity 5311. Can be configured to not. In at least one example, the distal plug 5361 comprises a stop 5368 configured to contact a stop datum 5318 defined on the handle housing 5312. When the stop portion 5368 of the stop plug contacts the handle stop datum 5318, the plug 5361 may be fully secured in the battery cavity 5311. The handle 5310 and/or the plug 5361 may include a lock configured to hold the plug 5361 in its fully locked position. For example, the plug 5361 comprises at least one lock 5362 configured to releasably engage the housing 5312.

The power adapter 5360 further includes a cord 5363 extending from the plug 5361. The cord 5363 electrically connects the power source such as the power source 5370 and the plug 5361, for example. The power supply 5370 may comprise any suitable power supply, such as a signal generator, which receives power from a 110 V, 60 Hz power supply and/or battery, for example. Cord 5363 comprises any suitable number of conductors and insulators to transfer power from power supply 5370 to plug 5361. In at least one example, the cord 5363 comprises a supply conductor, a return conductor, and a ground conductor, which are electrically insulated from each other, for example, by an insulating jacket. Each conductor of cord 5363 may comprise, for example, a proximal terminal contained within proximal plug 5369. In various examples, the proximal plug 5369 can be releasably attached to the power source 5370. In certain other examples, the proximal plug may not be easily removed from the power source 5370.

In various examples, the power supply 5370 can comprise, for example, a direct current (DC) power supply. In such an example, both the battery and power adapter 5360 can supply DC power to the handle 5310 depending on whether it is electrically coupled to the handle 5310. The power adapter 5360 and the power supply 5370 can cooperate with the handle 5310 to provide power equal to and/or greater than the power that the battery can provide to the handle 5310. In at least one example, a surgeon using the handle 5310 as part of the surgical instrument system 5300 determines that the handle 5310 is underpowered, removes the battery from the handle 5310, and connects the power adapter 5360 to the handle 5310. You may The power supply 5370 can then operate to provide sufficient power to the handle 5310 via the power adapter 5360 to operate the surgical instrument system in the desired manner. In various examples, the power supply 5370 can provide a greater voltage to the handle 5310, for example.

In a particular example, power supply 5370 may comprise an alternating current (AC) power supply. In at least one such example, power adapter 5360 may include an alternating current to direct current (AC/DC) power converter configured to convert the AC power provided by power supply 5370 to DC power. In such an example, both the battery and power adapter 5360 can provide DC power to the handle 5310 depending on which is electrically coupled to the handle 5310. The AC/DC power converter may include, for example, a transformer, a full wave bridge rectifier, and/or a filter capacitor, although any suitable AC/DC power converter may be used. The AC/DC power converter is located within the plug 5361, but the AC/DC power converter can be located within the power adapter 5360 at any suitable location, such as the cable 5363.

In various examples, the handle 5310 includes an AC/DC power converter in addition to or in place of the AC/DC power converter of the power adapter 5360. Such an embodiment may implement the double set of battery contacts 5316 described above. In at least one such embodiment, the battery power circuit includes (1) a first circuit segment including a first set of contacts 5316 engaged by a battery, and (2) a first circuit segment engaged by a power adapter 5360. A second circuit segment that is parallel to the first circuit segment and includes two sets of contacts 5316. The second circuit segment includes an AC/DC power converter configured to convert the AC power provided by power supply 5370 to DC power, and the first circuit segment includes a battery to provide DC power. It does not include an AC/DC power converter as it is already configured in.

Referring again to FIG. 41, the handle 5310 can be in the sterile surgical compartment 5301 and the power source 5370 can be in the non-sterile compartment 5302. In such an example, power adapter 5360 may extend between sterile compartment 5301 and non-sterile compartment 5302. The sterile compartment 5301 and the non-sterile compartment are separated by a boundary 5303. Boundary 5303 may be, for example, a physical boundary, such as a wall, or a virtual boundary, such as, for example, between a sterile operating table and a non-sterile back table.

In order to use the power adapter 5360, the battery located in the battery cavity 5311 needs to be removed to install the plug 5361 of the power adapter 5360 into the battery cavity 5311. Another embodiment is also envisioned in which the battery can remain in the battery cavity 5311 when the power adapter is operably coupled to the handle 5310. Referring now to FIG. 42, battery 5461 can be positioned within battery cavity 5311. With the lock 5362 disabled, the battery 5461 can be easily removed from the battery cavity 5311, but embodiments are also envisioned where the battery 5461 cannot be easily removed from the battery cavity 5311. Similar to the plug 5361, the battery 5461 fits tightly into the battery cavity 5311 to limit relative movement between the battery 5461 and the battery cavity 5311 when the battery 5461 is fully secured in the battery cavity 5311. Acceptable dimensions and may be so configured. Also, like the plug 5361, the battery 5461 includes an end stop 5468 configured to contact the stop datum 5318 of the handle 5310.

Battery 5461 includes, for example, one or more lithium-ion battery cells positioned therein. Similar to the above, the battery 5461 can provide sufficient power to the handle 5310 to operate the surgical instrument system in various examples. The power adapter 5460 may be coupled to the battery 5461 if the battery cells of the battery 5461 lack the power needed to operate the surgical instrument system. Power adapter 5460 is similar in many respects to power adapter 5360. Similar to the above, the power adapter 5460 comprises a cord 5463 that includes a proximal end 5369 that may be connected to a power source, such as power source 5370, for example. Battery 5461 includes an electrical connector 5464 defined therein configured to receive distal connector 5465 of cord 5463 and electrically couple power supply 5370 to battery 5461.

In at least one example, in addition to the above, the power adapter 5460 may be placed in series with the cells of the battery 5461 when the adapter connector 5465 is inserted into the battery connector 5464. In such an example, both battery 5461 and power supply 5370 can supply power to handle 5310. FIG. 43 shows such an embodiment. As disclosed in FIG. 43, the battery 5461' comprises a power supply circuit that includes one or more battery cells 5470' configured to provide DC power to the handle 5310. When the power adapter 5460 is electrically coupled to the battery 5461', the power supply 5370 can (1) recharge the battery cell 5470' via the recharge circuit 5471' and/or (2) the battery cell 5470. 'Can supplement the power supplied to the handle 5310. In the example where the power source 5370 comprises an AC power source, the battery 5461' converts the AC power provided by the power source 5370 into DC power before power is provided to the charging circuit 5471' and/or the battery cells 5470'. AC/DC transformer 5467' configured as described above. The power supply circuit in the battery includes a battery connector 5464, an AC/DC transformer 5467′, a charging circuit 5471′, a battery cell 5470′, and a battery terminal 5366, which are in series with each other, but any configuration suitable for the power supply circuit can be used. Can be used.

In another example, insertion of the adapter connector 5465 into the battery connector 5464 can electrically couple the power source 5370 to the handle 5310, while at the same time electrically disconnecting the battery cells of the battery 5461 from the handle 5310. FIG. 44 shows such an embodiment. As disclosed in FIG. 44, the battery 5461 ″ comprises a power supply circuit that includes one or more battery cells 5470 ″ configured to provide DC power to the handle 5310. The battery cell 5470" is in electrical communication with the battery contacts 5366 via the first circuit segment 5472" and the battery switch 5474" when the adapter connector 5465 is not positioned within the battery connector 5464. In such an example, the battery switch 5474'' is in the first switch state. Inserting the adapter connector 5465 into the battery connector 5464 puts the switch 5474" in the second switch state, as shown in FIG. 44, and the battery cell 5470" can no longer supply power to the contact 5366. In addition, the power adapter 5460 and battery connector 5464 electrically connect to the battery contacts 5366 through the second circuit segment 5473'' and battery switch 5474'' when the battery switch 5474'' is in its second switch state. Communicate with each other. In the example where the power source 5370 comprises an AC power source, the second circuit segment 5473″ of the battery 5461″ is configured to convert the AC power provided by the power source 5370 into DC power. 5467''.

As described above, referring again to FIG. 44, the battery switch 5474″ includes a first parallel circuit segment 5472′ that includes battery cells 5470″ when the switch 5474″ is in its first first switch state. 'Selectively in electrical communication with the battery contacts 5366, or alternatively, when the switch 5474'' is in its second switch state, a second battery connector 5464 and an AC/DC transformer 5467'' are included. The parallel circuit segment 5473 ″ is selectively operable to be in electrical communication with the battery contacts 5366. Battery switch 5474" may comprise a mechanical switch, an electromechanical switch, and/or an electronic switch, as described in further detail below.

Mechanical battery switch 5474″ may be, for example, between a first position associated with a first switch state of switch 5474″ and a second position associated with a second switch state of switch 5474″. A sliding bus bar that can be pushed into. In the first position of the sliding bus bar, the bus bar couples the first circuit segment 5472 ″ with the battery contact 5366 but not the second circuit segment 5473 ″ with the battery contact 5366. In the second position of the sliding bus bar, the bus bar couples the second circuit segment 5473 ″ with the battery contact 5366, but not the first circuit segment 5472 ″ with the battery contact 5366. The battery 5461 may further include a biasing member, such as a spring, which biases the bus bar to its first position, thus causing the battery switch 5474'' to move to its first switch state. It is configured to bias to. In addition to the above, the adapter connector 5465 inserts the adapter connector 5465 into the battery connector 5464 and pushes the bus bar from its first position to its second position to bring the switch 5474'' to its second switch state. When contacting, the bus bar of the switch 5474'' may be contacted. When the adapter connector 5465 is removed from the battery connector 5464, the biasing member can return the busbar to its first position to electrically re-engage the battery cell 5470" with the battery contact 5366. In certain other embodiments, insertion of adapter connector 5465 into battery connector 5464 may permanently separate battery cell 5470 ″ from battery contact 5466. In at least one such embodiment, the battery 5461 ″ may include a lock configured to hold the busbar in its second position when the busbar is pushed into its second position by the adapter connector 5465. .. Such an embodiment may reuse the battery 5461 ″ to provide a permanent lockout such that it cannot be powered by the battery cell 5470 ″. This is because it may be undesirable and/or unreliable to recycle and/or recharge batteries that were unable to provide sufficient power to the handle 5310.

The electromechanical switch 5474" may comprise, for example, a relay. The relay may be biased into the first relay state when the adapter connector 5465 is not positioned within the battery connector 5464. When the adapter connector 5465 is electrically coupled to the battery connector 5464, the relay can be switched to the second relay state. The relay may include an electromagnet that may include a wire coil and an armature that operates when the contacts of the adapter connector 5465 interface, for example, with the battery connector 5464. In at least one example, the power supply adapter 5460 provides sufficient voltage to the relay's coil to move the relay's armature between its first switch state and its second switch state. In addition to the circuitry, relay control circuitry may be included. In various examples, the switch 5474'' may comprise, for example, a latch relay. In at least one example, the switch 5474" may comprise, for example, a contactor, which may be electronically controlled by, for example, a microprocessor and control circuitry.

A particular electronic switch may have any moving parts, such as a solid state relay, for example. Solid state relays may use, for example, thyristors, triacs, and/or any other solid state switching device. The solid-state relay can operate, for example, with a control signal from the power supply 5370 to switch the load supplied to the battery contact 5366 from the battery cell 5470″ to the power supply 5370. In at least one example, the solid-state relay can include, for example, a contactor solid-state relay. In various examples, the electronic switch includes, for example, a microprocessor and a sensor in signal communication with the microprocessor that detects whether the contacts of the battery connector 5464 are powered. In at least one example, the sensor can be configured to inductively detect a field that occurs when a voltage is applied to the contacts of the battery connector 5464. In a particular example, the microprocessor switches the relay between a first relay state and a second relay state in response to a control signal received from, for example, a power supply 5370 to provide a first parallel circuit segment 5472'. 'Or second parallel circuit segment 5473'' may each control whether or not it is in electrical communication with battery contact 5366.

In addition to the above, power adapter 5460 may include an AC/DC power converter. Power adapter 5460 includes an AC/DC power transformer 5467 at cord 5463, but the AC/DC power transformer may be located at any suitable location on power adapter 5460.

In various examples, the power adapter supply system may include batteries, such as batteries 5361, 5461, 5461′, and/or 5461″, and power adapters, such as power adapters 5360 and/or 5460, for example. ..

45-47, the handle 5510 of the surgical instrument system includes a grip or pistol grip 5511 and a housing 5512. The handle 5510 further comprises one or more batteries positioned within the grip 5511, such as, for example, battery cells 5470. In many examples, the battery cell 5470 may provide sufficient power to the handle 5510 to operate the surgical instrument system. In other examples, battery cells 5470 may not be able to provide sufficient power to handle 5510. In such an example, as described in more detail below, an auxiliary battery, such as auxiliary battery 5560, may be attached to handle 5510 to power handle 5510.

In addition to the above, referring mainly to FIG. 47, the battery cells 5470 are arranged in series as a part of the battery power supply circuit 5513. Battery power circuit 5513 is in electrical communication with electrical connector 5516 defined in housing 5512. Electrical connector 5516 may include any suitable number of electrical contacts. In at least one example, electrical connector 5516 comprises, for example, two electrical contacts. Although the electrical connector 5516 is located at the end of the grip 5511, the electrical connector 5516 may be located at any suitable location on the handle 5510.

The handle 5510 further includes a connector cover 5517. The connector cover 5517 is movable between a first position that covers the electrical connector 5516 and a second position where the electrical connector 5516 is exposed. The housing 5512 includes a slot 5518 defined therein that is configured to slidably receive and support the connector cover 551. The handle 5510 further comprises a biasing member, such as a spring 5519, positioned in the slot 5518 intermediate the housing 5512 and the connector cover 5517. The spring 5519 is configured to bias the connector cover 5517 to the first position and cover the electrical connector 5516.

As mentioned above, the auxiliary battery 5560 can be attached to the handle 5510. Auxiliary battery 5560 includes a housing 5562 and one or more battery cells positioned therein, such as battery cell 5570, for example. The battery cells 5570 are arranged in series as a part of the auxiliary battery supply circuit 5563. Auxiliary battery supply circuit 5563 is in electrical communication with electrical connector 5566 defined in battery housing 5562. The electrical connector 5566 includes the same number of electrical contacts as the electrical connector 5516 and is configured to form a mating pair with the electrical contacts of the electrical connector 5516.

The housing 5562 of the auxiliary battery 5560 further comprises a cavity or receptacle 5561 defined therein, the cavity being configured to receive the grip portion 5511 of the handle 5510. Cavity 5561 is configured to tightly receive grip 5511 such that when auxiliary battery 5560 is fully assembled therein, there is little or no relative movement between auxiliary battery 5560 and handle 5510. Has been done. Since the auxiliary battery 5560 is assembled to the handle 5510, the housing 5562 contacts the connector cover 5517 and pushes the connector cover 5517 into its second position, exposing the electrical connector 5516. When the contacts of electrical connector 5516 are at least partially exposed, the contacts of electrical connector 5566 can engage the contacts of electrical connector 5516. At this time, the auxiliary battery supply circuit 5563 is electrically connected to the battery power supply circuit 5513.

The electrical connectors 5516 and 5566 can be positioned and arranged so that the auxiliary battery 5560 does not engage each other until fully secured on the grip 5511. In other embodiments, electrical connectors 5516 and 5566 may be positioned and arranged to engage each other before auxiliary battery 5560 is fully secured with grip 5511. In any case, the housing 5512 of the handle 5510 and/or the housing 5562 of the auxiliary battery 5560 may comprise a lock configured to retain the auxiliary battery 5560 in the housing 5510. The lock is releasable so that the auxiliary battery 5560 can be easily removed from the handle 5510, but embodiments are contemplated where the lock prevents the auxiliary battery 5560 from being easily removed from the handle 5510.

As described above, when the auxiliary battery 5560 is assembled to the handle 5510, the auxiliary battery supply circuit 5563 is electrically coupled to the battery power supply circuit 5513. In various examples, the auxiliary battery cell 5570 may be placed in series with the handle battery cell 5470 to increase the power available to the handle 5510. Such an embodiment may be useful, for example, when the handle battery cell 5470 is exhausted by use. In another example, the auxiliary battery cell 5570 of the auxiliary battery 5560 is arranged in parallel with the battery cell 5470 of the handle 5510. In at least one such example, the handle battery cell 5470 can be electrically isolated from the handle 5510 when the auxiliary battery cell 5570 is electrically coupled to the handle 5510. Such an embodiment may be useful when a short circuit occurs in the handle battery cell 5470. Various embodiments of the handle 5510 may include a switch that allows a user to selectively place the auxiliary battery cell 5570 in series or in parallel with the handle battery cell 5470.

Example 1-Surgical device comprising a handle module with a mounting portion, the removable shaft module being attachable to the mounting portion for performing a surgical procedure in bulk, the handle module being detachable A surgical apparatus comprising a rotary drive system for driving a possible shaft module, an electric motor coupled to the rotary drive system for powering the rotary drive system, and one or more sensors. The handle module further comprises a handle module processor circuit in communication with the one or more sensors and the electric motor, the handle module processor circuit controlling the electric motor, an input from the one or more sensors. Is programmed to track end-of-life parameters of the handle module and maintain counts of end-of-life parameters.

Example 2-The surgical example of Example 1 further comprising means for communicating with a handle module processor circuit for performing end-of-life operation when the handle module processor circuit determines that the end-of-life parameter count has reached a threshold value. apparatus.

Example 3-The surgical device of Example 2 wherein the means for performing end-of-life operation comprises a display that displays to the user of the surgical device information indicating that end-of-life parameters have reached a threshold.

Example 4-The surgical device of Example 3 wherein the display shows counts.

Example 5-The surgical device of Example 3 or 4, wherein the display displays an indicator of the number of remaining uses of the handle module before the threshold is reached.

Example 6-The surgical device of Examples 2, 3, 4, or 5 wherein the means for performing end-of-life operations includes means for disabling the handle module for subsequent surgical procedures.

Example 7-The surgical device of Example 6, wherein the means for disabling the handle module comprises means for disabling operation of the electric motor.

Example 8-The surgical device of Examples 6 or 7, wherein the means for disabling the handle module includes means for preventing attachment of a charged battery pack to the handle module.

Example 9-End-of-life parameters are the number of firings by the handle module, the number of surgical procedures requiring the handle module, the number of times the removable shaft module is attached to the handle module, the number of times the handle module is sterilized, and the removable battery. A removable battery pack selected from the group consisting of the number of times the pack is attached to the handle module is for powering the handle module during a surgical procedure, Examples 2, 3, 4, 5,. 6, 7 or 8 surgical devices.

Example 10-Examples End-of-Life Parameters are calculated according to a function whose inputs include the number of firings of the handle module and the number of surgical procedures requiring the handle module, Examples 2, 3, 4, 5, 6, 7. , 8 or 9 surgical devices.

Example 11-The surgical device of Example 10, the function calculating end-of-life parameters by using different weighting factors for different removable shaft modules.

Example 12-A removable shaft module comprises an end effector having a firing member that traverses the stroke length upon firing, and end-of-life parameters are expected to be exerted by the handle module over the stroke length of the firing member and the handle. The surgical device of Examples 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 including the use parameters of the handle module indicating the difference from the force actually applied by the module.

Example 13-The surgical device of Examples 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 wherein the end-of-life parameter comprises the number of sterilized handle modules.

Example 14-The handle module includes a sterilization sensor in communication with a handle module processor circuit that operates when the protective sterilization cover is attached to the handle module. Examples 2, 3, 4, 5, 6, 7 , 8, 9, 10, 11, 12, or 13 surgical device.

Example 15-The surgical device of Example 14, wherein the sterilization sensor comprises a switch that is activated when the protective sterilization cover is attached to the handle module.

Example 16-Further comprising an inspection station, the handle module being connectable to the inspection station for inspecting the handle module following a surgical procedure, the inspection station when the handle module is connected to the inspection station. An inspection station display in communication with the handle module processor circuit and the inspection station processor circuit via a data connection, the inspection station display displaying information about the handle module when the handle module is connected to the inspection station. A station display. The surgical device of any of Examples 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15.

Example 17-Surgical device, a handle module attachable to a removable shaft module for performing a surgical procedure in bulk, actuatable to drive the removable shaft module. A rotary drive system, an electric motor coupled to the rotary drive system for powering the rotary drive system, and means for tracking the end-of-life parameter counts of the handle module based on the number of starts of the rotary drive system; A surgical module comprising: a handle module;

Example 18-Means for tracking end of life parameter counts comprises processor circuitry and memory, the memory being executed by a processor to provide program code for tracking end of life parameter counts of a handle module. The surgical device of Example 17, containing.

Example 19-The handle module is powered by a removable battery pack and the means for tracking the count of end-of-life parameters of the handle module is further based on the number of connections of the removable battery pack to the handle module. The surgical device of Example 17 or 18, wherein

Example 20-Further comprising a sterile tray for holding the handle module during the sterilization procedure, the means for tracking the count of end-of-life parameters of the handle module counting when the handle module is placed in the sterile tray. The surgical device of example 17, 18, or 19 comprising a counter on a sterile tray that increments.

Example 21-A device comprising a handle module attachable to a removable shaft module for performing a surgical procedure in a lump, the handle module comprising a rotary drive system for driving the removable shaft module. And an electric motor coupled to the rotary drive system for powering the rotary drive system, and a handle module processor circuit in communication with the electric motor. The apparatus further comprises an inspection station for connecting to the handle module when the handle module is not being used in a surgical procedure, the inspection station providing a data connection when the handle module is connected to the inspection station. An inspection station processor circuit in communication with the handle module processor circuit and an inspection station display in communication with the inspection station processor circuit, the inspection station display displaying information about the handle module connected to the inspection station. ..

Example 22-The apparatus of Example 21, wherein the inspection station comprises a power source for powering the handle module when the handle module is connected to the inspection station.

Example 23-Examination station is configured to perform one or more tests on a handle module to determine suitability of the handle module for use in subsequent surgical procedures. The apparatus of Example 21 or 22.

Example 24-The apparatus of Example 23, wherein the one or more tests include a seal integrity test of the handle module.

Example 25-The apparatus of Example 23 or 24, wherein the one or more tests include a backlash test of the gears of the rotary drive system of the handle module.

Example 26-The apparatus of Examples 21, 22, 23, 24, or 25, wherein the examination station is configured to perform an adjustment operation to adjust the handle module for use in subsequent surgical procedures. ..

Example 27-The apparatus of Example 26, wherein the conditioning operation comprises drying the components of the handle module.

Example 28-The apparatus of Examples 21, 22, 23, 24, 25, 26, or 27, wherein the inspection station comprises one or more fans for blowing air into the components of the handle module.

Example 29-The apparatus of Examples 21, 22, 23, 24, 25, 26, 27, or 28, wherein the inspection station comprises a vacuum port for drying the components of the handle module with a vacuum air stream.

Example 30-The apparatus of Examples 21, 22, 23, 24, 25, 26, 27, 28, or 29 wherein the inspection station further comprises a load simulation adapter connectable to the rotary drive system of the handle module.

Example 31-The apparatus of Example 30, wherein the load simulation adapter comprises a motor to provide a simulated load to the rotary drive system of the handle module.

Example 32-The apparatus of Examples 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or 31 wherein the inspection station is further connected to the removable shaft module.

Example 33-Surgical process wherein a clinician performs a surgical procedure on a patient using a surgical instrument comprising a handle module connected to a removable shaft module, the handle module comprising: An operating station, including a handle module and a memory storing data relating to a surgical procedure, and performing the operating station data stored in the memory of the handle module, while the handle module is connected to the examining station. A memory of the handle module and visually displaying information about the handle module on a display of the inspection station while the handle module is connected to the inspection station.

Example 34-Removing a removable battery pack from a handle module following a surgical procedure and prior to connecting the handle module to an inspection station, wherein the removable battery pack is during the surgical procedure. Powering the handle module, and further comprising powering the handle module with power from the inspection station while the handle module is connected to the inspection station. Surgical process.

Example 35-Compatibility of a handle module for use in subsequent surgical procedures by performing one or more tests on the handle module while the handle module is connected to the inspection station. The surgical process of Example 33 or 34, wherein

Example 36-The surgical process of Example 35, wherein the one or more tests include a seal integrity test of the handle module.

Example 37-Surgical process of Example 35 or 36 wherein one or more tests include a gear backlash test.

Example 38-Surgical of Examples 34, 35, 36, or 37 that performs an adjusting action to adjust the handle module for use in subsequent surgical procedures while the handle module is connected to the examination station. process.

Example 39-The surgical process of Example 38, wherein the adjusting operation comprises drying the components of the handle module.

Example 40-Surgical device comprising a handle module attachable to a removable shaft module for performing a surgical procedure in bulk, the handle module rotating for driving the removable shaft module. A drive system, an electric motor coupled to the rotary drive system for powering the rotary drive system, one or more sensors for detecting data regarding the electric motor, one or more A handle module processor circuit in communication with the sensor, the handle module processor circuit programmed to monitor a performance parameter of the handle module based on inputs from one or more sensors, A surgical device, wherein the processor circuit monitors the performance parameter of the handle module by monitoring whether the performance parameter is outside an acceptable performance band.

Example 41-The surgical device of Example 40, wherein the processor circuitry monitors the performance parameters of the handle module by monitoring whether the performance parameters are below or above an acceptable performance band.

Example 42-The surgical device of Example 40 or 41, wherein the handle module further comprises means for performing corrective action when the handle module processor circuit determines that the performance parameter is outside the acceptable performance band.

Example 43-The surgical device of Examples 40, 41, or 42, wherein the performance parameters include electric motor performance parameters.

Example 44-The surgical device of Example 43, wherein the performance parameters of the electric motor include energy consumed by the electric motor over the life of the handle module.

Example 45-The surgical device of Example 43 or 44, wherein the electric motor performance parameters include the power consumed by the electric motor for each firing of the handle module.

Example 46-Example 43, 44, or wherein the performance parameters of the electric motor include energy consumed by the electric motor over the life of the handle module and power consumed by the electric motor for each firing of the handle module. 45 surgical devices.

Example 47-The handle module processor circuit determines that the energy consumed by the electric motor over the life of the handle module exceeds a first energy threshold and the energy consumed by the electric motor over the life of the handle module is the first energy. It is determined that corrective action should be taken when at least one of a second energy threshold below the threshold and a handle module having a threshold device firing count above a threshold power level is met. The surgical device of Example 46, which is programmed as follows.

Example 48-The surgical device of Examples 43, 44, 45, 46, or 47, wherein the performance parameter comprises the output torque of the electric motor.

Example 49-The surgical device of Examples 40, 41, 42, 43, 44, 45, 46, 47, or 48, wherein the performance parameters include rotary drive system performance parameters.

Example 50-The surgical device of Example 49, wherein the rotary drive system performance parameters include gear backlash.

Example 51-The surgical device of Examples 42, 43, 44, 45, 46, 47, 48, 49, or 50, wherein the means for performing the corrective action comprises a display for displaying the status of the handle module. ..

Example 52-Surgical of Examples 42, 43, 44, 45, 46, 47, 48, 49, 50, or 51, wherein the means for performing the corrective action comprises means for disabling the handle module. apparatus.

Example 53-To Means for Disabling the Handle Module Prevent Insertion of a Charged, Removable Battery Pack into the Handle Module and Prevent Power Supply to the Handle Module During Surgical Procedure The surgical device of Example 52 including the means of.

Example 54-The surgical device of Example 53, wherein the means for preventing insertion of the charged, removable battery pack comprises a spring loaded mechanical lockout.

Example 55-Example wherein the means for preventing insertion of a charged, removable battery pack comprises a latch which, upon actuation, prevents removal of a discharged, removable battery pack from the handle module 53 or 54 surgical device.

Example 56-Surgical device comprising a removable shaft module and a handle module connected to the removable shaft module for performing a surgical procedure in bulk, the handle module comprising a removable shaft. A rotary drive system for driving the module; an electric motor coupled to the rotary drive system for powering the rotary drive system; and a performance parameter of at least one of the electric motor and the rotary drive system A surgical device comprising: means and a means for performing a corrective action upon determining that the performance parameter is outside an acceptable performance band.

Example 57-The surgical device of Example 56, wherein the performance parameters include energy consumed by the electric motor over the life of the handle module.

Example 58-The surgical device of Example 56 or 57, wherein the performance parameter comprises the power consumed by the electric motor for each firing of the handle module.

Example 59-The surgical device of Example 56, 57, or 58, wherein the performance parameter comprises the output torque of the electric motor.

Example 60-The surgical device of Examples 56, 57, 58, or 59, wherein the means for performing the corrective action includes means for disabling the handle module.

Example 61-The surgical device of Example 60, wherein the means for disabling the handle module comprises means for disabling the electric motor.

Example 62-Means for Disabling the Handle Module To Prevent Insertion Of A Charged, Removable Battery Pack Into The Handle Module To Prevent The Handle Module From Powering During A Surgical Procedure The surgical device of example 60 or 61 including the means of.

Example 63-A combination, a handle module attachable to a removable shaft module for performing a surgical procedure in bulk, and a handle module for powering the handle module during a surgical procedure. A removable rechargeable battery pack that is connectable to the battery pack, the battery pack having a memory for storing charge data and discharge data of the battery pack, and the battery pack being detached from the handle module and charged. A charging station for charging and/or discharging a battery pack when it is inserted into the station, and charging and discharging the battery pack based on charging data and discharging data stored in a memory of the battery pack. And a charging station for performing at least one of discharging.

Example 64-A battery pack comprises a plurality of battery cells, and when the charging station should rebalance the battery cells based on the charge and discharge data stored in the battery pack memory and based on the rebalance criteria. The combination of example 63 comprising a charging station processor circuit for determining, and the charging station rebalancing the battery cells of the battery pack when the charging station processor circuit determines that the battery cells should be rebalanced.

Example 65-A charging station processor circuit is programmed to determine that a battery cell should be rebalanced after charging the battery pack N times without rebalancing, where N is an integer greater than 0. A combination of Example 64.

Example 66-The combination of Examples 64 or 65 wherein the charging station is configured to bring the charging of the battery cells to the highest level prior to rebalancing the battery cells.

Example 67-The charging station comprises a charging station processor circuit that determines whether to discharge the battery pack based on the charge and discharge data stored in the battery pack memory and based on the discharge criteria. The combination of embodiments 63, 64, 65, or 66 in which the charging station discharges the battery pack when the processor circuit determines that the battery pack should be discharged.

Example 68-The discharge standard includes the combination of Example 67, including whether the second battery pack attached to the charging station is fully charged and ready for use in the handle module.

Example 69-A charging station is programmed to charge a battery pack at a time based on surgical schedule data for an organizational user of the charging station, the surgical schedule data stored in a memory of the charging station. The combination of Examples 63, 64, 65, 66, 67, or 68.

Example 70-The combination of Example 69, wherein the surgical procedure schedule data includes the statistical likelihood that the tissue user will perform the surgical procedure using the handle module at that time.

Example 71-The charging station comprises means for automatically securing the battery pack to the charging station when the battery pack is not ready for use in the handle module for a surgical procedure. Examples 63, 64 , 65, 66, 67, 68, 69, or 70 combinations.

Example 72-The combination of Example 71, wherein the means for automatically securing the battery pack to the charging station comprises a screw that is screwed into the battery pack when activated by insertion of the battery pack into the charging station. ..

Example 73-The combination of Examples 71 or 72, wherein the means for automatically securing the battery pack to the charging station further comprises a linear actuator for actuating a screw.

Example 74-A combination of Examples 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, or 73, wherein the charging station comprises a display for displaying charging status information regarding the battery pack.

Example 75-The charging station comprises means for rapidly charging the first battery pack when a fast charging user input to the battery pack is received at the charging station, Examples 63, 64, 65, 66. , 67, 68, 69, 70, 71, 72, 73, or 74 combination.

Example 76-The combination of Example 75, wherein the charging station comprises means for automatically securing the battery pack to the charging station when the battery pack is not ready for use in the handle module for a surgical procedure. ..

Example 77-Surgical process wherein a clinician performs a surgical procedure on a patient using a surgical instrument comprising a handle module connected to a removable shaft module, the removal A possible rechargeable battery pack powers the handle module during a surgical procedure and the battery pack comprises a memory for storing the charging and discharging data of the battery pack, the steps and during the surgical procedure. The step of removing the battery pack from the handle module after use, the step of placing the battery pack in the charging station to recharge the battery pack after the removing step, and the step of placing the battery pack by the charging station Of the charging and discharging data of the battery pack by the charging station based on the charging and discharging data stored in the memory of the battery pack, following the steps of downloading the charging data and discharging data from the memory of Performing at least one.

Example 78-A battery pack comprises a plurality of battery cells, and the process includes a step of downloading the battery cells based on charge and discharge data stored in the battery pack memory and based on a rebalancing criterion. An embodiment further comprising the steps of determining by the charging station whether to rebalance, and rebalancing the battery cells by the charging station when it is determined that rebalancing of the battery cells of the battery pack should be performed. 77 surgical processes.

Example 79-The surgical process of Example 77 or 78, in which, following the downloading step, the battery pack is rapidly charged in response to receiving the quick charge user input.

Example 80-Examples 77, 78, or following the step of deploying, automatically securing the battery pack to a charging station when the battery pack is not ready for use in a handle module for a surgical procedure. 79 surgical processes.

Example 81-A combination, a handle module attachable to a removable shaft module for performing a surgical procedure in bulk, and a handle module for powering the handle module during a surgical procedure. A removable rechargeable battery pack that can be connected to the battery pack and a charging station for charging the battery pack when the battery pack is removed from the handle module and inserted into the charging station, Fast charging, the charging station comprising circuitry for rapidly charging the battery pack when user input is received at the charging station.

Example 82-The combination of Example 81, wherein the charging station comprises a display for displaying the charging status of the battery pack.

Example 83-The combination of Examples 81 or 82, wherein the charging station comprises a user interface for the user to enter fast charge user input to the charging station.

Example 84-The combination of Example 83, wherein the user interface comprises a button on the charging station that is operable to provide fast charging user input to the charging station.

Example 85-A combination of Examples 81, 82, 83, or 84, wherein the circuit for rapidly charging the battery pack comprises a circuit for altering the charging profile of the battery pack.

Example 86-Examples 81, 82, 83, 84 in which the circuit for modifying the charge profile of the battery pack comprises a voltage regulator connected to the battery pack and a charge control circuit connected to the voltage regulator. Or 85 combinations.

Example 87-Examples 81, 82, 83, wherein a circuit for rapidly charging a battery pack comprises a power storage device of a charging station and the charge stored in the power storage device is used to charge the battery pack. A combination of 84, 85, or 86.

Example 88-The combination of Example 87, wherein the power storage device comprises a supercapacitor.

Example 89-The combination of Example 88, wherein the charging station further comprises circuitry for discharging the first battery pack to a supercapacitor.

Example 90-The combination of Examples 87, 88, or 89, wherein the power storage device comprises one or more battery cells inside the charging station.

Example 91-A power storage device includes a plurality of battery cells inside a charging station, and a circuit for rapidly charging a battery pack includes a circuit for charging the battery pack using the plurality of battery cells. , The combination of Examples 87, 88, or 89.

Example 92-A combination of Example 91, where multiple battery cells are connected in series.

Example 93-A combination of Examples 91 or 92, where multiple battery cells are connected as a parallel current source.

Example 94-Examples 81, 82, 83, 84, 85, 86, 87, 88, 89, wherein the charging station further comprises circuitry for discharging the first battery pack into a plurality of battery cells therein. A combination of 90, 91, 92, or 93.

Example 95-Battery pack comprises a first battery pack, and a charging station has a first charging receptacle for receiving the first battery pack and charging the first battery pack, and a second battery pack. And a second charging receptacle for charging the second battery pack by receiving the charge, and a circuit for rapidly charging the first battery pack with a charge accumulated in the second battery pack. A combination of Examples 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, or 94, comprising a circuit for charging the first battery pack.

Example 96-The combination of Example 95, wherein the charging station further comprises circuitry for discharging the first battery pack to the second battery pack.

Example 97-The combination of Examples 95 or 96, wherein the charging station comprises a display for displaying the charging status of the first battery pack and the second battery pack.

Example 98-The charging station comprises means for automatically securing the battery pack to the charging station when the battery pack is not ready for use in the handle module for a surgical procedure. Examples 81, 82 , 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, or 97 combinations.

Example 99-Surgical Instrument System, Detachable, Handle Module for Performing a Surgical Procedure, and Connectable to the Handle Module for Powering the Handle Module During a Surgical Procedure A rechargeable battery pack and a charging station for charging the battery pack, the first operating condition in which the battery pack is charged from a primary power source, and the battery pack being urgently needed in a surgical procedure In order to rapidly charge the battery pack, the battery pack is provided with a circuit for charging the handle module under two operating conditions: a second operating condition in which the battery pack is charged from a primary power source and a secondary power source. A surgical instrument system comprising: a station.

Example 100-The surgical instrument system of Example 99, wherein the secondary power source comprises a second removable, rechargeable battery pack connectable to the handle module.

Example 101-A device, a handle module attachable to a removable shaft module for performing a surgical procedure in a lump, the handle module memory for storing handle module usage data of the handle module. A handle module comprising a circuit and an inspection station for connecting to the handle module when the handle module is not in use in a surgical procedure, the handle module based on handle module usage data stored in a memory of the handle module, And a test station comprising a test station processor circuit for determining one or more repair recommendations for the handle module based on the repair recommendation criteria.

Example 102-The apparatus of Example 101, wherein the inspection station further comprises a display in communication with the inspection station processor circuitry, the display being for displaying information regarding one or more repair recommendations. ..

Example 103-The apparatus of Example 101 or 102, wherein the repair advisory criteria is stored in the inspection station memory of the inspection station and the inspection station processor circuitry is in communication with the inspection station memory.

Example 104-The handle module comprises a handle module processor circuit in communication with a handle module memory circuit, the handle module processor circuit testing the handle module so that usage data from the handle module memory can be downloaded to a test station. The apparatus of example 101, 102, or 103 in communication with an inspection station processor circuit when connected to a station.

Example 105-Handle Module Usage Data is data regarding the number of surgical procedures requiring the handle module, data regarding the number of device firings by the handle module, data regarding power consumed during the device firing of the handle module, handle module Data selected from the group consisting of data on forces experienced during launch of the device, data on energy consumed by the electric motor of the handle module over the life of the handle module, and data on backlash of gears of the rotary drive system of the handle module. The apparatus of any of Examples 101, 102, 103, or 104, including.

Example 106-The apparatus of Example 101, 102, 103, 104, or 105, wherein the one or more repair recommendations include a recommendation that the handle module be rebuilt.

Example 107-Examples 101, 102, 103, 104, including one or more repair recommendations including a recommendation that one or more components of the handle module should be lubricated. 105 or 106 devices.

Example 108-Examples 101, 102, 103, 104, 105, including one or more repair recommendations including recommendations that one or more components of the handle module should be inspected. 106, or 107 devices.

Example 109-A device, a handle module that can be attached to a removable shaft module to perform a surgical procedure in a lump, the handle module memory for storing handle module usage data of the handle module. A circuit and a handle module processor circuit for determining one or more repair recommendations for the handle module based on handle module usage data stored in a memory of the handle module and based on repair recommendation criteria; An apparatus comprising a handle module comprising.

Example 110-The apparatus of Example 109, wherein the handle module further comprises a display in communication with the handle module processor circuitry, the display being for displaying information regarding one or more repair recommendations. ..

Example 111-Handle module usage data includes data regarding the number of surgical procedures requiring the handle module, data regarding the number of device firings by the handle module, data regarding power consumed during the device firing of the handle module, handle module data. Data selected from the group consisting of data on forces experienced during launch of the device, data on energy consumed by the electric motor of the handle module over the life of the handle module, and data on backlash of gears of the rotary drive system of the handle module. The device of example 109 or 110, comprising:

Example 112-The apparatus of Example 109, 110, or 111, wherein the one or more repair recommendations include a recommendation that the handle module be rebuilt.

Example 113-The apparatus of Examples 109, 110, 111, or 112, wherein the one or more repair recommendations include a recommendation that the handle module be rebuilt.

Example 114-Examples 109, 110, 111, 112, including one or more repair recommendations, including recommendations for lubricating one or more components of the handle module. Or the device of 113.

Example 115-Examples 109, 110, 111, 112, 113, in which one or more repair recommendations include recommendations that one or more components of the handle module should be inspected. Or 114 devices.

Example 116-Surgical Instrument System, a Handle Comprising a Battery Cavity and a DC Electric Motor, and a Battery Removably Positionable within the Battery Cavity for DC Powering the DC Electric Motor A battery, a power adapter that includes a plug that can be removably positioned in the battery cavity instead of the battery, and a cord that extends from the plug to transfer power from the power source to the plug. A surgical instrument system comprising: a cord configured; The surgical instrument system further comprises an AC-to-DC power converter configured to convert AC power supplied from the power source into DC power.

Example 117-The surgical instrument system of Example 116, wherein the AC to DC power converter is positioned within the plug.

Example 118-The surgical instrument system of Example 116 or 117, wherein the battery comprises a battery housing, the plug comprises a plug, and the battery housing is similar to the plug housing.

Example 119-The handle comprises a handle electrical contact set within the battery cavity, and the battery comprises a battery electrical contact set configured to engage the handle electrical contact when the battery is positioned within the battery cavity. , The plug comprises a set of plug electrical contacts configured to engage the handle electrical contacts when the plug is positioned within the battery cavity, the surgical instrument system of any of Examples 116, 117, or 118.

Example 120-The handle comprises a first handle electrical contact set and a second handle electrical contact set within the battery cavity, the battery comprising a first handle electrical contact when the battery is positioned within the battery cavity. A battery electrical contact set configured to engage the contact set, the plug configured to engage the second handle electrical contact set when the plug is positioned within the battery cavity. The surgical instrument system of any of Examples 116, 117, 118, or 119, comprising a set of plug electrical contacts.

Example 121-The surgical instrument system of Examples 116, 117, 118, 119, or 120, wherein an AC-DC power converter is positioned within the handle and is in electrical communication with the second set of handle electrical contacts.

Example 122-The surgical instrument system of Examples 116, 117, 118, 119, 120, or 121, further comprising a plurality of shaft assemblies, each of the shaft assemblies being selectively engageable with a handle.

Example 123-The surgical instrument system of Example 122, wherein at least one of the shaft assemblies comprises a staple cartridge.

Example 124-Surgical Instrument System, a battery including a battery cavity and a direct current electric motor, a battery positioned within the battery cavity, the battery including at least one battery cell; and an electrical connector; A surgical instrument system comprising: a cord engageable with an electrical connector, the cord configured to transmit power from a power source; and a power adapter. The surgical instrument system further comprises an AC-DC power converter configured to convert AC power supplied from a power source into DC power and supply DC power to the DC electric motor.

Example 125-At least one battery cell, AC-DC, further comprising a battery circuit so that the at least one battery cell and the power supply can power the DC electric motor when the cord is engaged with the electrical connector. The surgical instrument system of Example 124, wherein the power converter and electrical connector are arranged in series within the battery circuit.

Example 126-First Battery Circuit Segment, a first battery circuit segment including at least one battery cell, and a second battery circuit segment including an AC to DC power converter, the second. A battery circuit segment and a switch positioned within the battery, wherein at least one battery cell is capable of supplying power to the DC electric motor and the power source is not capable of supplying power to the DC electric motor. A switch that is switchable between a second switch state in which at least one battery cell cannot power the direct current electric motor and the power source can power the direct current electric motor. The surgical instrument system of Example 124.

Example 127-The surgical instrument system of Example 126, wherein the switch is biased to the first switch state.

Example 128-The surgical instrument system of example 126 or 127, wherein inserting the cord into the battery electrical connector switches the switch from the first switch state to the second switch state.

Example 129-The surgical instrument system of Example 128, further comprising a biasing member configured to return the switch to the first switch state.

Example 130-The surgical instrument system of Examples 126, 127, or 128, wherein the switch is unable to return to the first switch state after being placed in the second switch state.

Example 131-The surgical instrument system of Examples 124, 125, 126, 127, 128, 129, or 130 further comprising a plurality of shaft assemblies, each of the shaft assemblies being selectively engageable with a handle. ..

Example 132-The surgical instrument system of Example 131, wherein at least one of the shaft assemblies comprises a staple cartridge.

Example 133-Handle housing, handle battery cell positioned within the handle housing, and handle electrical circuit, wherein the handle battery cell is configured to power the handle electrical circuit. And a handle electrical connector in communication with the handle electrical circuit, the surgical instrument system comprising a handle. The surgical instrument system includes an auxiliary battery selectively engageable with the handle, a battery housing engageable with the handle housing, a battery electrical circuit, and an auxiliary battery cell positioned within the battery housing. And an auxiliary battery cell configured to supply power to the battery electrical circuit and a battery electrical connector in communication with the battery electrical circuit, the auxiliary battery engaging the handle to provide the battery electrical circuit. A battery electrical connector engageable with the handle electrical connector when in communication with the handle electrical circuit.

Example 134-The surgical instrument system of Example 133, wherein the handle housing comprises a grip and the battery housing comprises a receptacle configured to receive the grip.

Example 135-The handle further comprises a connector cover, the connector cover engaging the battery electrical connector with the handle electrical connector in a first position where the connector cover prevents accidental contact with the handle electrical connector. The surgical instrument system of example 133 or 134 movable to and from a second position that allows for mating.

Example 136-The battery housing of Example 135 is configured to move the connector cover between the first position and the second position when the auxiliary battery is engaged with the handle. Surgical instrument system.

Example 137-The surgical instrument system of Examples 133, 134, 135, or 136 further comprising a plurality of shaft assemblies, each of the shaft assemblies being selectively engageable with a handle.

Example 138-The surgical instrument system of Example 137, wherein at least one of the shaft assemblies comprises a staple cartridge.

Example 139-A surgical instrument, a housing, a motor, and a battery assembly attachable to the housing of the surgical instrument, the battery cell configured to provide electrical energy to the motor. A battery housing, comprising: a support housing configured to support the battery cells; and a shock absorbing element configured to absorb a shock caused by a shock force. A battery assembly, the shock absorbing element being configured to collapse when an impact force is applied to the shock absorbing element.

Example 140-The surgical instrument of Example 139, wherein the shock absorbing element is replaceable.

Example 141-The surgical instrument of Example 139 or 140, wherein the shock absorbing element comprises attachment means configured such that the shock absorbing element can be snap fit and attached to the battery assembly.

Example 142-The surgical instrument of Example 141, wherein the attachment means comprises an adhesive.

Example 143-The surgical instrument of Example 141 or 142, wherein the battery housing further comprises an opening and the attachment means comprises a protrusion configured to be push-fitted to be received in the opening of the battery housing. ..

Example 144-The surgical instrument of Examples 139, 140, 141, 142, or 143, wherein the shock absorbing element comprises a lattice structure.

Example 145-When the shock-absorbing element collapses, the shock-absorbing element deforms inwardly, but still allows for attachment of the battery assembly to the surgical instrument housing after impact with the shock-absorbing element. The surgical instrument of Examples 139, 140, 141, 142, 143, or 144.

Example 146-The surgical instrument of Examples 139, 140, 141, 142, 143, 144, or 145 wherein the shock absorbing element collapses when the shock force is greater than a threshold force.

Example 147-Examples 139, 140, 141, wherein the battery assembly further comprises a plurality of corners, the battery housing further comprises a plurality of shock absorbing elements, the plurality of shock absorbing elements positioned at each of the corners. , 142, 143, 144, 145, or 146 surgical instrument.

Example 148-A battery housing comprises electrical contacts configured to transfer electrical energy from battery cells to a motor and a bottom surface associated with the electrical contacts, each of the shock absorbing elements being a battery housing. 147. The surgical instrument of Example 147, comprising ends extending beyond the bottom of the to protect the electrical contacts.

Example 149-The surgical instrument of Example 148 or 149, wherein each of the shock absorbing elements comprises a lower end and an upper end, and the battery assembly further comprises a shock absorbing cap positioned at the upper end of the shock absorbing element.

Example 150-Battery assembly for use with a surgical instrument that transfers a battery cell and electrical energy provided by the battery cell to the surgical instrument when the battery assembly is attached to the surgical instrument. An electrical contact configured as described above, a first housing configured to support a battery cell, a second housing configured to house the first housing, and a first housing And a shock absorbing layer positioned between the second housing and the second housing, the shock absorbing layer comprising a lattice structure.

Example 151-The battery assembly of Example 150, wherein the shock absorbing layer is comprised of a foam material.

Example 152-The lattice structure includes a plurality of cells, the plurality of cells being inner cells with inner planar walls, the inner planar walls being oriented at least substantially parallel to the first housing, The battery of example 150 or 151, comprising an inner cell and an outer cell comprising an outer planar wall, the outer planar wall being oriented at least substantially parallel to the second housing. assembly.

Example 153-The battery assembly further comprises a shock-absorbing cap, the shock-absorbing cap comprising an outer grid and an inner grid, the outer grid being more dense than the inner grid, of Examples 150, 151, or 152. Battery assembly.

Example 154-The battery assembly of Example 150, 151, 152 or 153 wherein the shock absorbing layer comprises a plurality of cushioning elements.

Example 155-A battery assembly for use with a surgical instrument, wherein the battery cell is configured to power the surgical instrument, the housing is a heat reflective shell, a heat sink layer, A housing comprising a compressible layer positioned between the heat sink layer and the heat-reflecting cell, the compressible layer configured to flex in response to expansion of the battery cell, the battery assembly.

Example 156-The battery assembly of Example 155 wherein the compressible layer is further configured to dissipate the impact energy absorbed by the heat reflective shell.

Example 157-The battery assembly of Example 155 or 156, wherein the compressible layer comprises a lattice structure.

Example 158-The battery assembly of Example 157 wherein the lattice structure is a closed lattice structure defined by a heat reflective shell and a heat sink layer.

Example 159-The heat reflective shell comprises a first fist thermal expansion coefficient, the heat sink layer comprises a second coefficient of thermal expansion, the first coefficient of thermal expansion being greater than the second coefficient of thermal expansion. The smaller cell assembly of Examples 155, 156, 157, or 158.

The entire disclosures of the following documents are each incorporated herein by reference in their entirety.
US Pat. No. 5,403,312, issued April 4, 1995, entitled “ELECTROSURGICAL HEMOSTATIC DEVICE”;
U.S. Patent No. 7,000,818, issued on February 21, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISCINTING CLOSES AND FIRING SYSTEMS";
-U.S. Patent No. 7,422,139, issued on September 9, 2008, entitled "MOTOR-DRIVER SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK";
-U.S. Patent No. 7,464,849, issued December 16, 2008, entitled "ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSE SYSTEM SYSTEM AND ANVIL ALIGNMENT COMPONENTS";
US Pat. No. 7,670,334, issued March 2, 2010, entitled “SURGICAL INSTRUMENT HAVING AN ARTICULTING END EFFECTOR”;
US Pat. No. 7,753,245, issued July 13, 2010, entitled “SURGICAL STAPLING INSTRUMENTS”;
US Pat. No. 8,393,514, issued March 12, 2013, entitled "SELECTIVERY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE";
U.S. Patent Application No. 11/343,803, entitled "SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES" (current US Pat. No. 7,845,537),
-U.S. Patent Application No. 12/031,573, filed February 14, 2008, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES";
-U.S. Patent Application No. 12/031,873, filed on February 15, 2008, entitled "END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT" (current U.S. Patent No. 7,980,443);
U.S. Patent Application No. 12/235,782, entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT" (current U.S. Patent No. 8,210,411);
U.S. Patent Application No. 12/249,117, entitled "POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM" (current U.S. Patent No. 8,608,045);
-U.S. Patent Application No. 12/647,100, filed December 24, 2009, entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUALATOR DIRECTIONAL CONTROL ASSEMBLY" (current US Patent No. 8,220, 220,8). ),
-U.S. Patent Application No. 12/893,461, filed September 29, 2012, titled "STAPLE CARTRIDGE" (current U.S. Patent No. 8,733,613);
-U.S. Patent Application No. 13/036,647, filed February 28, 2011, entitled "SURGICAL STAPLING INSTRUMENT" (current U.S. Patent No. 8,561,870);
US Patent Application No. 13/118,241, name "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS" (current US Patent Application Publication No. 2012/0298719);
U.S. Patent Application No. 13/524,049, filed June 15, 2012, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE" (current US Patent Application Publication No. 2013/0334278);
-U.S. Patent Application No. 13/800,025, filed March 13, 2013, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM";
-U.S. Patent Application No. 13/800,067, filed March 13, 2013, titled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM";
-U.S. Patent Application Publication No. 2007/0175955, filed January 31, 2006, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSE CLOSER TRIGGER LOCKING MECHANISM," and-April 22, 2010. Patent Application Publication No. 2010/0264194, name “SURGICAL STAPLING INSTRUMENT WITH AN AN ARTICULATABLE END EFFECTOR” (current US Pat. No. 8,308,040).

Although various embodiments of an apparatus have been described herein with respect to particular disclosed embodiments, many modifications and changes can be made to those embodiments. Also, while materials have been disclosed for particular components, other materials may be used. Further, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or multiple functions. May be. The above description and the following claims are intended to cover all such modifications and variations.

The devices disclosed herein may be designed to be disposed of after a single use, or may be designed to be used multiple times. However, in any case, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of a disassembly process of the device, followed by a cleaning or replacement process of certain parts, and a subsequent reassembly process. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Once a particular part has been cleaned and/or replaced, the device can be reassembled for later use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present invention.

Preferably, the invention described herein will be processed before surgery. First, obtain new or used equipment and clean it if necessary. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and instrument are then placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, and high energy electrons. The radiation kills bacteria on the device or in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

While this invention has been described as having a representative design, the present invention may be further modified within the spirit and scope of this disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present invention using its general principles.

Any patents, publications, or other disclosures, incorporated in this specification by whole or in part, are hereby incorporated by reference to the present definition, description, or other disclosure in this disclosure. Incorporated herein only to the extent not inconsistent with the disclosure of As such, and to the extent necessary, the disclosure expressly set forth herein supersedes any contradictory statements incorporated herein by reference. Any document, or part thereof, which is hereby incorporated by reference but is inconsistent with an existing definition, description, or other disclosed document mentioned herein, is hereby incorporated by reference. It is incorporated only to the extent that it does not conflict with the content.

Embodiments
(1) A surgical device,
A handle module comprising a mounting portion, the removable shaft module can be mounted to the mounting portion for performing a surgical procedure in a lump, the handle module comprising:
A rotary drive system for driving the removable shaft module;
An electric motor coupled to the rotary drive system for powering the rotary drive system;
One or more sensors,
A handle module processor circuit in communication with the one or more sensors and the electric motor,
Control of the electric motor,
A handle module processor circuit programmed to track end-of-life parameters of the handle module and maintain counts of end-of-life parameters based on inputs from the one or more sensors; A surgical device comprising:
(2) Embodiment 1 further comprising means for communicating with the handle module processor circuit for performing an end of life operation when the handle module processor circuit determines that the count of the end of life parameter has reached a threshold. The surgical device according to.
(3) The means for performing the end of life operation comprises a display for displaying to a user of the surgical device information indicating that the end of life parameter has reached the threshold. Surgical device.
(4) The surgical device according to embodiment 3, wherein the display displays the count.
(5) The surgical apparatus according to embodiment 3, wherein the display displays an indicator of the number of remaining uses of the handle module before the threshold is reached.

(6) The surgical apparatus according to embodiment 2, wherein the means for performing the end of life operation includes means for disabling the handle module for subsequent surgical procedures.
(7) The surgical apparatus according to embodiment 6, wherein the means for disabling the handle module includes means for disabling operation of the electric motor.
(8) The surgical device according to embodiment 6, wherein the means for disabling the handle module includes means for preventing attachment of a charged battery pack to the handle module.
(9) The end of life is
The number of firings by the handle module,
The number of surgical procedures requiring the handle module,
The number of times the removable shaft module is attached to the handle module,
Selected from the group consisting of the number of times the handle module is sterilized and the number of times a removable battery pack is attached to the handle module, the removable battery pack powering the handle module during a surgical procedure The surgical device according to embodiment 2, which is for.
(10) The surgical device of embodiment 9, wherein the end-of-life parameter is calculated according to a function whose inputs include the number of firings by the handle module and the number of surgical procedures requiring the handle module.

(11) The surgical device according to embodiment 10, wherein the function calculates the end-of-life parameter by using different weighting factors for different removable shaft modules.
(12) It is expected that the removable shaft module comprises an end effector having a firing member that traverses a stroke length upon firing and the end-of-life parameter is applied by the handle module over the stroke length of the firing member. The surgical device according to embodiment 2, including a use parameter of the handle module indicating a difference between the force applied by the handle module and the force actually applied by the handle module.
(13) The surgical device according to embodiment 2, wherein the end-of-life parameter includes the number of times the handle module has been sterilized.
(14) The surgical device of embodiment 13, wherein the handle module includes a sterilization sensor in communication with the handle module processor circuit that operates when a protective sterilization cover is attached to the handle module.
(15) The surgical apparatus according to embodiment 14, wherein the sterilization sensor includes a switch that is activated when the protective sterilization cover is attached to the handle module.

(16) An inspection station may be further included, wherein the handle module is connectable to the inspection station for inspecting the handle module following the surgical procedure.
An inspection station processor circuit in communication with the handle module processor circuit via a data connection when the handle module is connected to the inspection station;
An inspection station display in communication with the inspection station processor circuit, the inspection station display displaying information about the handle module when the handle module is connected to the inspection station. 2. The surgical device according to 2.
(17) A surgical device,
A handle module attachable to a removable shaft module for performing a surgical procedure in bulk, comprising:
A rotary drive system activatable to drive the removable shaft module;
An electric motor coupled to the rotary drive system for powering the rotary drive system;
Means for tracking a count of end-of-life parameters of the handle module based on the number of activations of the rotary drive system.
(18) The means for tracking the count of the end-of-life parameter comprises a processor circuit and a memory, the memory being executed by the processor to provide the end-of-life parameter of the handle module. The surgical device according to embodiment 17, wherein the surgical code stores a program code that tracks counts.
(19) The handle module is powered by a removable battery pack, and the means for tracking the count of the end-of-life parameter of the handle module includes connecting a removable battery pack to the handle module. The surgical device according to embodiment 17, further based on a count.
(20) further comprising a sterile tray for holding the handle module during a sterilization procedure, the means for tracking the count of the end-of-life parameter of the handle module disposed by the handle module on the sterile tray. The surgical apparatus according to embodiment 17, comprising a counter on the sterile tray that increments the count when being operated.

Claims (13)

A surgical device,
A handle module comprising a mounting portion, the removable shaft module can be mounted to the mounting portion for performing a surgical procedure in a lump, the handle module comprising:
A rotary drive system for driving the removable shaft module;
An electric motor coupled to the rotary drive system for powering the rotary drive system;
One or more sensors,
A handle module processor circuit in communication with the one or more sensors and the electric motor,
Control of the electric motor, and
A handle module processor circuit programmed to count end-of-life parameters of the handle module based on inputs from the one or more sensors .
Further comprising means for communicating with the handle module processor circuit for performing an operation that inhibits use of the handle module when the handle module processor circuit determines that the count of the end-of-life parameter has reached a threshold value,
The end-of-life parameter is
The number of firings by the handle module,
The number of surgical procedures requiring the handle module,
The number of times the removable shaft module is attached to the handle module,
The number of sterilization of the handle module, and
The number of times a removable battery pack is attached to the handle module, the removable battery pack for powering the handle module during a surgical procedure,
The surgical device wherein the end-of-life parameter is calculated according to a function whose inputs include the number of firings by the handle module and the number of surgical procedures requiring the handle module . It said means for communicating with the handle module processor circuit includes a display for displaying information indicating that the end of life parameter has reached the threshold value to the user of the surgical device The surgical device of claim 1. The surgical device according to claim 2 , wherein the display displays the count. The surgical apparatus of claim 2 , wherein the display displays an indicator of the number of remaining uses of the handle module before the threshold is reached. Means for communicating with the handle module processor circuit includes means for disabling the handle module for subsequent surgical procedure, the surgical device according to claim 1. The surgical apparatus according to claim 5 , wherein the means for disabling the handle module comprises means for disabling operation of the electric motor. The surgical apparatus of claim 5 , wherein the means for disabling the handle module includes means for preventing attachment of a charged battery pack to the handle module. The surgical device of claim 1 , wherein the function calculates the end-of-life parameter by using different weighting factors for different removable shaft modules. A surgical device,
A handle module comprising a mounting portion, the removable shaft module can be mounted to the mounting portion for performing a surgical procedure in a lump, the handle module comprising:
A rotary drive system for driving the removable shaft module;
An electric motor coupled to the rotary drive system for powering the rotary drive system;
One or more sensors,
A handle module processor circuit in communication with the one or more sensors and the electric motor,
Control of the electric motor, and
A handle module processor circuit programmed to count end-of-life parameters of the handle module based on inputs from the one or more sensors.
Further comprising means for communicating with the handle module processor circuit for performing an operation that inhibits use of the handle module when the handle module processor circuit determines that the count of the end-of-life parameter has reached a threshold value,
The removable shaft module comprises an end effector having a firing member that traverses a stroke length upon firing, wherein the end-of-life parameter is expected to be exerted by the handle module over the stroke length of the firing member; A surgical device , including use parameters of the handle module, which indicate a difference from the force actually applied by the handle module. The surgical device of claim 1 or 9 , wherein the end-of-life parameter comprises the number of times the handle module has been sterilized. 11. The surgical device of claim 10 , wherein the handle module includes a sterilization sensor in communication with the handle module processor circuit that operates when a protective sterilization cover is attached to the handle module. The surgical device of claim 11 , wherein the sterilization sensor comprises a switch that is activated when the protective sterilization cover is attached to the handle module. An inspection station is further provided, the handle module being connectable to the inspection station for inspecting the handle module following the surgical procedure, the inspection station comprising:
An inspection station processor circuit in communication with the handle module processor circuit via a data connection when the handle module is connected to the inspection station;
An inspection station display in communication with the inspection station processor circuit, the inspection station display displaying information about the handle module when the handle module is connected to the inspection station. The surgical device according to 1 or 9 .

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