CN115670557A - Enhanced battery for surgical instrument - Google Patents

Enhanced battery for surgical instrument Download PDF

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Publication number
CN115670557A
CN115670557A CN202211449071.0A CN202211449071A CN115670557A CN 115670557 A CN115670557 A CN 115670557A CN 202211449071 A CN202211449071 A CN 202211449071A CN 115670557 A CN115670557 A CN 115670557A
Authority
CN
China
Prior art keywords
battery
handle module
handle
processor
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202211449071.0A
Other languages
Chinese (zh)
Inventor
F·E·谢尔顿四世
D·C·耶茨
J·S·斯韦兹
J·L·哈里斯
A·T·贝克曼
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery LLC
Original Assignee
Ethicon Endo Surgery LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/633,542 external-priority patent/US9931118B2/en
Application filed by Ethicon Endo Surgery LLC filed Critical Ethicon Endo Surgery LLC
Publication of CN115670557A publication Critical patent/CN115670557A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01MPROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY
    • H01M50/00Constructional details or processes of manufacture of the non-active parts of electrochemical cells other than fuel cells, e.g. hybrid cells
    • H01M50/20Mountings; Secondary casings or frames; Racks, modules or packs; Suspension devices; Shock absorbers; Transport or carrying devices; Holders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00464Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for use with different instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00469Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02EREDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E60/00Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
    • Y02E60/10Energy storage using batteries

Abstract

A battery assembly includes a housing and one or more battery cells positioned in the housing. The battery assembly also includes features configured to absorb impact forces and protect the battery cells. The battery assembly also includes a feature configured to accommodate the thermal expansion of the battery cell.

Description

Enhanced battery for surgical instrument
The present application is a divisional application of international application PCT/US2016/019217 entitled "enhanced battery for surgical instruments" in the chinese country phase of 28/8/2017 and 24/2/2016, and having a chinese application number of 201680012675.5.
Background
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 elongated jaw members, wherein each jaw member is configured to be inserted into a patient and positioned relative to tissue to be stapled and/or incised. In various embodiments, one of the jaw members can support a staple cartridge having at least two laterally spaced rows of staples housed therein, and the other jaw member can support an anvil having staple-forming pockets aligned with the rows of staples in the staple cartridge. In general, the stapling instrument can further include a pusher bar and a knife blade that are slidable relative to the jaw members to sequentially eject staples from the staple cartridge via camming surfaces on the pusher bar and/or camming surfaces on a wedge sled that is urged by the pusher bar. In at least one embodiment, the cam surface can be configured to activate a plurality of staple drivers carried by the cartridge and associated with the staples in order to urge the staples against the anvil and form laterally spaced rows of deformed staples in tissue clamped between the jaw members. In at least one embodiment, the blades can track the cam surface and cut tissue along the path between the rows of staples. An example of such a STAPLING instrument is disclosed in U.S. Pat. No. 7,794,475 entitled "SURGICAL STAPLING INSTRUMENTS FOR STAPLING THE SAME AND STAPLING INSTRUMENTS FOR STAPLING THE SAME," THE entire disclosure of which is hereby incorporated by reference.
The above discussion is intended to be merely illustrative of various aspects of the present invention that are relevant in the field of the invention and should not be taken as a disavowal of the scope of the claims.
Drawings
Various features of the embodiments described herein, together with the advantages thereof, may be understood from the following description taken in conjunction with the accompanying drawings in which:
FIG. 1 is a perspective view of a modular surgical system including a motor driven handle module and three interchangeable detachable 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. 3 is a partially exploded assembly view of the handle module of FIG. 1;
FIG. 4 is another partially exploded assembly view of the handle module of FIG. 1;
FIG. 5 is a side elevational view of the handle module of FIG. 1 with a portion of the handle housing removed;
fig. 6 is an exploded assembly view of a mechanical coupling system for operably coupling the rotary drive system of the handle module of fig. 1 to the drive system of the detachable shaft module;
fig. 7 is a block diagram showing the detachable shaft module and the electronic components of the handle module of fig. 1;
fig. 8 is a diagram of a process flow executed by the handle processor of the handle module of fig. 1 to determine when the handle module has reached the end of its life;
Fig. 9 is another diagram of a process flow performed by the handle processor of the handle module of fig. 1 to determine when the handle module has reached the end of its life;
FIG. 10A is a graph illustrating the difference between expected firing and retraction forces to be applied by the handle module of FIG. 1 and actual firing and retraction forces applied by the handle module as a function of the travel of the shaft module;
FIG. 10B is a schematic view of a process flow performed by the handle processor of the handle module of FIG. 1 for determining when the handle module has reached the end of its life based on the difference between the expected firing and retraction forces to be applied by the handle module of FIG. 1 and the actual firing and retraction forces applied by the handle module;
fig. 10C is a diagram of a process flow executed by the handle processor of the handle module of fig. 1 to determine when the handle module has reached the end of its life based on the energy consumed by the handle module during use, and the energy consumed by the handle module during each use;
fig. 10D is a graph illustrating an example of the total energy consumed by the handle module over multiple device activations;
fig. 10E is a graph showing an example of power consumed during each activation of the handle module of fig. 1;
Fig. 11A and 11B illustrate a sterilization tray into which the handle module may be inserted for sterilization;
11C and 11D illustrate a sterilization tray into which the handle module and detachable shaft module may be inserted for sterilization;
fig. 11E shows another sterilization tray into which the handle module may be inserted for sterilization;
11F, 11G, 11H, and 11I illustrate aspects of the sterilization tray of fig. 11E interfacing with a handle module;
12A, 12B, and 12E illustrate an inspection station for inspecting a handle module before, during, and/or after a surgical procedure;
fig. 12C is a block diagram of an inspection station and handle module;
fig. 12D is a diagram of a process flow executed by the handle processor of the handle module to determine when the handle module has reached the end of its life based on the number of times the handle module is placed on the inspection station;
fig. 13A is a block diagram showing aspects of a handle module and a removable battery pack, where the battery pack includes an identification transmitter so that the handle module can identify the battery pack;
fig. 13B shows a process flow executed by the handle processor of the handle module of fig. 13A to determine when the handle module has reached the end of its life based on the number of times the battery pack has been installed in the handle module;
14A, 14B, and 14C illustrate aspects of a handle module detecting attachment of a detachable shaft module thereto;
FIG. 14D shows a handle module and a detachable shaft module, wherein the handle module detects attachment of the detachable shaft module thereto;
fig. 14E shows the handle module of fig. 14D, wherein the handle module also detects attachment of a removable battery pack;
14F and 14G show sensors for the handle module of fig. 14D to detect insertion of a removable battery pack therein;
15A and 15B illustrate another sensor for the handle module to detect insertion of a removable battery pack therein;
FIG. 16 shows a handle module with multiple power packs;
fig. 17A and 17B illustrate additional process flows performed by the handle processor of the handle module to determine when the handle module has reached the end of its life;
18A, 18B and 18C illustrate a handle module having a mechanism to prevent insertion of a battery pack under certain conditions;
fig. 18D and 18E illustrate a mechanism of the handle module of fig. 18A that prevents removal of the battery pack from the handle module under certain circumstances;
19A, 19B, and 19C illustrate a charging station and handle module, wherein the charging station is used to charge the battery pack of the handle module;
Fig. 20A and 20B illustrate a handle module having a sterile cover for covering components thereof during sterilization of the handle module;
fig. 20C shows a sterile cover for the battery cavity of the handle module of fig. 20A;
fig. 20D shows a removable battery pack for the handle module of fig. 20A;
21A, 21B, 21C, and 21D illustrate display configurations of a surgical instrument that includes a handle module and a detachable shaft module;
fig. 22 shows a removable battery pack with an internal circuit board;
fig. 23A shows a handle module having a protruding means that, when protruding, prevents insertion of the handle module into a sterilization tray;
fig. 23B shows the sterilization tray and handle module of fig. 23A;
fig. 24A and 24B illustrate a handle module inspection station for applying vacuum pressure to the handle module;
25A, 25B, 25C, and 25D illustrate a handle module inspection station having one or more fans for drying the handle module;
fig. 25E shows an inspection station with vacuum ports to dry the handle module;
26A, 26B and 26C show an inspection station, a handle module, and a load simulation adapter for applying a simulated load to the handle module when the handle module is connected to the inspection station;
FIG. 26D is a cross-sectional view of the load simulation adapter of FIGS. 26A-26C;
FIG. 26E is a graph showing a sample model of gear backlash of the handle module as a function of use;
27A and 27B illustrate an inspection station that can house a handle module and a detachable shaft module;
FIG. 28A shows a process flow executed by the inspection station processor to suggest services for the handle module;
fig. 28B shows a process flow executed by the handle module processor to suggest a service for the handle module;
fig. 29A shows a charging station for charging one or more removable battery packs that may be used in the handle module;
fig. 29B and 29C illustrate a mechanism of the charging station for securing the battery pack to the charging station;
FIG. 29D is a block diagram of a charging station and battery pack;
fig. 29E shows a process flow performed by the handle module charging console;
fig. 30A and 30B illustrate a process flow performed by the handle module charging station;
fig. 31 and 32 are electrical schematic views of a charging station;
fig. 33A 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;
fig. 34A is a top view of a battery pack;
FIG. 34B is a top view of a charging station showing the contact configuration of the battery pack of FIG. 34A;
FIG. 35 is a flowchart of a process of using the inspection station;
fig. 36 and 37 are process flow diagrams illustrating exemplary steps for sterilizing a handle module and tracking the number of it sterilized;
FIG. 38 is a perspective view of a battery assembly for use with a surgical instrument, wherein the battery assembly includes a plurality of shock absorbing elements, according to at least one embodiment;
FIG. 38A 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. 40 is a perspective view of a battery assembly for use with the surgical instrument, the battery assembly including a battery housing configured to protect one or more battery cells of the battery assembly;
FIG. 40A is a detailed cross-sectional view of the battery assembly of FIG. 40;
fig. 41 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;
FIG. 42 illustrates the handle of FIG. 41 selectively usable with the power adapter of FIG. 41 or a power adapter system including a removable battery and a removable power cord, in accordance with at least one embodiment;
FIG. 43 is a schematic diagram of a power adapter in accordance with at least one embodiment;
FIG. 44 is a schematic diagram of a power adapter in accordance with at least one embodiment;
FIG. 45 is a perspective view of a handle of a surgical instrument system including a battery;
FIG. 46 is a perspective view of a second battery attached to the handle of FIG. 45; and is
Fig. 47 is a cross-sectional view of the handle and battery of fig. 45 and the second battery of fig. 46.
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate various embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
Detailed Description
The applicant of the present application owns the following patent applications filed on the same day as the present application, each of which is incorporated herein by reference in its entirety:
<xnotran> - "SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER" ___________ ( END7539 USNP/140464); </xnotran>
<xnotran> - "SURGICAL INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION" ___________ ( END7542 USNP/140467); </xnotran>
<xnotran> - "SURGICAL APPARATUS CONFIGURED TO ASSESS WHETHER A PERFORMANCE PARAMETER OF THE SURGICAL APPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND" ___________ ( END7547 USNP/140472); </xnotran>
<xnotran> - "SURGICAL CHARGING SYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE BATTERIES" ___________ ( END7545 USNP/140470); </xnotran>
<xnotran> - "CHARGING SYSTEM THAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY" ___________ ( END7543 USNP/140468); </xnotran>
<xnotran> - "SYSTEM FOR MONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED" ___________ ( END7558 USNP/140483); </xnotran>
<xnotran> - "POWER ADAPTER FOR A SURGICAL INSTRUMENT" ___________ ( END7553 USNP/140478); </xnotran>
<xnotran> - "ADAPTABLE SURGICAL INSTRUMENT HANDLE" ___________ ( END7541 USNP/140466); </xnotran> And
<xnotran> - "MODULAR STAPLING ASSEMBLY" ___________ ( END7544 USNP/140469). </xnotran>
The applicant of the present application owns the following patent applications filed on 12/18/2014 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/574,478 entitled "SURGICAL INSTRUMENT SYSTEM COMPLEMENTS A ARTICULATED END EFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKE OF A FIRING";
U.S. patent application Ser. No. 14/574,483 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS";
U.S. patent application Ser. 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 ASSEMBLIES WITH ARTICULATABLE SURGICAL END EFFECTORS";
U.S. patent application Ser. No. 14/575,130 entitled "SURGICAL INSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCRETE NON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE";
U.S. patent application Ser. No. 14/575,143 entitled "SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS";
U.S. patent application Ser. No. 14/575,117 entitled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FILING BEAM SUPPORT ARRANGEMENTS";
U.S. patent application Ser. No. 14/575,154 entitled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED FIRING BEAM SUPPORT ARRANGEMENTS";
U.S. patent application Ser. No. 14/574,493 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPLEMENTING A FLEXIBLE ARTICULATION SYSTEM"; and
U.S. patent application Ser. No. 14/574,500 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION SYSTEM".
The applicant of the present application owns the following patent applications filed on 2013, 3, month 1 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 13/782,295 entitled "insulating scientific Instruments With reduced Pathways For Signal Communication", now U.S. patent application publication 2014/0246471;
U.S. patent application Ser. No. 13/782,323 entitled "Rotary Power engineering Joints For scientific Instruments," now U.S. patent application publication 2014/0246472;
U.S. patent application Ser. No. 13/782,338 entitled "thumb Switch arrays For Surgical Instruments," now U.S. patent application publication 2014/0249557;
U.S. patent application Ser. No. 13/782,499 entitled "Electrical scientific Device with Signal Relay Arrangement", now U.S. patent application publication 2014/0246474;
U.S. patent application Ser. No. 13/782,460 entitled "Multiple Processor Motor Control for Modular Surgical Instruments," now U.S. patent application publication 2014/0246478;
U.S. patent application Ser. No. 13/782,358 entitled "journal Switch Assemblies For Surgical Instruments", now U.S. patent application publication 2014/0246477;
U.S. patent application Ser. No. 13/782,481 entitled "Sensor straight End Effect or During Removal Through Trocar", now U.S. patent application publication 2014/0246479;
U.S. patent application Ser. No. 13/782,518 entitled "Control Methods for scientific Instruments with Removable implementation procedures", now U.S. patent application publication 2014/0246475;
U.S. patent application Ser. No. 13/782,375 entitled "road Power Surgical Instruments With Multiple details of Freedom," now U.S. patent application publication 2014/0246473; and
U.S. patent application Ser. No. 13/782,536 entitled "Surgical Instrument Soft Stop", now U.S. patent application publication 2014/0246476.
The applicant of the present application also owns the following patent applications filed on 3/14 of 2013 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 13/803,097 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FILING DRIVE", now U.S. patent application publication 2014/0263542;
U.S. patent application Ser. No. 13/803,193, entitled "CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT," now U.S. patent application publication 2014/0263537;
U.S. patent application Ser. No. 13/803,053 entitled "INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT," now U.S. patent application publication 2014/0263564;
U.S. patent application Ser. No. 13/803,086 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPLIMENTING AN ARTICULATION LOCK," now U.S. patent application publication 2014/0263541;
U.S. patent application Ser. No. 13/803,210 entitled "SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS", now U.S. patent application publication 2014/0263538;
U.S. patent application Ser. No. 13/803,148 entitled "Multi-functional Motor FOR A SURGICAL INSTRUMENT," now U.S. patent application publication 2014/0263554;
U.S. patent application Ser. No. 13/803,066 entitled "DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS", now U.S. patent application publication 2014/0263565;
U.S. patent application Ser. No. 13/803,117 entitled "ARTICULATION CONTROL FOR ARTICULATE SURGICAL INSTRUMENTS," now U.S. patent application publication 2014/0263553;
U.S. patent application Ser. No. 13/803,130 entitled "DRIVE TRAIN CONTROL FOR MODULAR SURGICAL INSTRUMENTS", now U.S. patent application publication 2014/0263543; and
U.S. patent application Ser. No. 13/803,159 entitled "METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT," now U.S. patent application publication 2014/0277017.
The applicant of the present application also owns the following patent applications filed on 3/7/2014 and incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 14/200,111 entitled "CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS," now U.S. patent application publication 2014/0263539.
The applicant of the present application also owns the following patent applications filed on 3/26 2014, and each of which is herein incorporated by reference in its entirety:
U.S. patent application Ser. No. 14/226,106 entitled "POWER MANAGEMENT CONTROL SYSTEM FOR SURGICAL INSTRUMENTS";
-U.S. patent application serial No. 14/226,099 entitled "serilization version CIRCUIT";
U.S. patent application Ser. No. 14/226,094 entitled "VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT";
U.S. patent application Ser. No. 14/226,117 entitled "POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL";
U.S. patent application Ser. No. 14/226,075 entitled "MODULAR POWER SURGICAL INSTRUMENTS WITH DETACHABLE SHAFT ASSEMBLIES";
U.S. patent application Ser. No. 14/226,093 entitled "FEEDBACK ALGORITHMS FOR MANUAL BALLOUT SYSTEMS FOR SURGICAL INSTRUMENTS";
U.S. patent application Ser. No. 14/226,116 entitled "SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION";
U.S. patent application Ser. No. 14/226,071 entitled "SURGICAL INSTRUMENT CONTROL CIRCUIT HAVARING A SAFETY PROCESS";
U.S. patent application Ser. No. 14/226,097 entitled "SURGICAL INSTRUMENT COMPLISING INTERACTIVE SYSTEMS";
-U.S. patent application Ser. No. 14/226,126 entitled "INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS";
U.S. patent application Ser. No. 14/226,133 entitled "MODULAR SURGICAL INSTRUMENT SYSTEM";
U.S. patent application Ser. No. 14/226,081 entitled "SYSTEM AND METHODS FOR CONTROLLING A SEGMENTED CICUIT";
U.S. patent application Ser. No. 14/226,076 entitled "POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION";
U.S. patent application Ser. No. 14/226,111 entitled "SURGICAL STAPLING INSTRUMENTS SYSTEM"; and
U.S. patent application Ser. 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 5.9.2014 and each incorporated herein by reference in its entirety:
-U.S. patent application Ser. No. 14/479,103 entitled "CIRCUITRY AND SENSORS FOR POWER MEDICAL DEVICE";
U.S. patent application Ser. No. 14/479,119 entitled "ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION";
U.S. patent application Ser. No. 14/478,908 entitled "MONITORING DEVICE calibration BASED ON measurement EVALUATION";
U.S. patent application Ser. No. 14/478,895 entitled "MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR' S OUTPUT OR INTERPRETATION";
-U.S. patent application Ser. No. 14/479,110 entitled "USE OF POLARITY OF HALL MAGNET DETECTION TO DETECT MISLOADED CARTRIDGE";
U.S. patent application Ser. No. 14/479,098 entitled "SMART CARTRIDGE WAKE UP OPERATION AND DATA RETENTION";
U.S. patent application Ser. No. 14/479,115 entitled "MULTI MOTOR CONTROL FOR POWER MEDICAL DEVICE"; and
U.S. patent application Ser. No. 14/479,108 entitled "LOCAL DISPLAY OF TIMSERE PARAMETER STABILIZATION".
The applicant of the present application also owns the following patent applications filed on 9.4.2014 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/248,590 entitled "MOTOR DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS", now U.S. patent application publication 2014/0305987;
U.S. patent application Ser. No. 14/248,581 entitled "SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROM THE SAME ROTATABLE OUTPUT", now U.S. patent application publication 2014/0305989;
U.S. patent application Ser. No. 14/248,595, entitled "SURGICAL INSTRUMENT SHAFT APPARATUS FOR CONTROLLING THE SAME OPERATION OF THE SURGICAL INSTRUMENT," now U.S. patent application publication 2014/0305988;
-U.S. patent application Ser. No. 14/248,588 entitled "POWER LINEAR SURGICAL STAPLER", now U.S. patent application publication 2014/0309666;
-U.S. patent application Ser. No. 14/248,591 entitled "TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT", now U.S. patent application publication 2014/0305991;
U.S. patent application Ser. No. 14/248,584 entitled "MODULAR MOTOR DRIVE SURGICAL INSTRUMENTS WITH ALIGNMENT DRIVE SHAFT WITH SURGICAL END EFFECTOR SHAFTS", now U.S. patent application publication 2014/0305994;
U.S. patent application Ser. No. 14/248,587 entitled "POWER SURGICAL STAPLER," now U.S. patent application publication 2014/0309665;
U.S. patent application Ser. No. 14/248,586, now U.S. patent application publication 2014/0305990, entitled "DRIVE SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT"; and
U.S. patent application Ser. No. 14/248,607 entitled "MODULAR MOTOR DRIN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS", now U.S. patent application publication 2014/0305992.
The applicant of the present application also owns the following patent applications filed on 2013 on 16.4.2013 and each incorporated herein by reference in its entirety:
U.S. provisional patent application Ser. No. 61/812,365 entitled "SURGICAL INSTRUMENT WITH MULTIPLE FUNCTION PERFORED BY A SINGLE MOTOR";
U.S. provisional patent application Ser. No. 61/812,376 entitled "LINEAR CUTTER WITH POWER";
U.S. provisional patent application Ser. No. 61/812,382 entitled "LINEAR CUTTER WITH MOTOR AND PISTOL GRIP";
U.S. provisional patent application Ser. No. 61/812,385 entitled "SURGICAL INSTRUMENT HANDLE WITH MULTI ACTION MOTORS AND MOTOR CONTROL"; and
U.S. provisional patent application Ser. No. 61/812,372 entitled "SURGICAL INSTRUMENT WITH MULTI FUNCTION BY A SINGLE MOTOR".
Numerous specific details are set forth herein to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the accompanying drawings. Well-known operations, components and elements have not been described in detail so as not to obscure the embodiments described in the specification. The reader will understand that the embodiments described and illustrated herein are non-limiting examples and that specific structural and functional details disclosed herein are representative and illustrative. Variations and changes may be made to these embodiments without departing from the scope of the claims.
The terms "comprises" (and any form of "comprising", such as "comprises" and "comprising)", any form of (and "having", such as "having" and "having)", "comprising" (and "comprising", such as "comprising" and "including)", and any form of "containing" (and "containing", such as "containing" and "containing)", and "containing" (and "containing", such as "containing" and "containing)") are open-ended verbs. Thus, a surgical system, device, or apparatus that "comprises," "has," "contains," or "contains" one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, a system, apparatus, or device that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further appreciated that, for simplicity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in connection with the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Various exemplary devices and methods are provided herein for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices disclosed herein may be used in a number of surgical procedures and applications, including, for example, in conjunction with open surgery. With continued reference to this detailed description, the reader will further appreciate that the various instruments disclosed herein can be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, and the like. The working portion or end effector portion of the instrument may be inserted directly into a patient or may be inserted through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument may be advanced.
A surgical stapling system can 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 includes a staple cartridge. A staple cartridge is insertable into and removable from the first jaw; however, other embodiments are contemplated in which the staple cartridge is not removable or at least not easily replaceable from the first jaw. The second jaw includes an anvil configured to deform staples ejected from the staple cartridge. The second jaw is pivotable relative to the first jaw about a closure axis; however, other embodiments are contemplated in which the first jaw is pivotable relative to the second jaw. The surgical stapling system further comprises an articulation joint configured to allow rotation or articulation of the end effector relative to the shaft. The end effector is rotatable about an articulation shaft extending through the articulation joint. Other embodiments are contemplated that do not include an articulation joint.
The staple cartridge includes a cartridge body. The cartridge body includes a proximal end, a distal end, and a deck extending between the proximal end and the distal end. In use, the staple cartridge is positioned on a first side of tissue to be stapled and the anvil is positioned on a second side of the tissue. The anvil is moved toward the staple cartridge to compress and clamp tissue against the deck. Staples removably stored in the cartridge body can then be deployed into tissue. The cartridge body includes staple cavities defined therein, wherein the staples are removably stored in the staple cavities. The staple cavities are arranged in six longitudinal rows. The three rows of staple cavities are positioned on a first side of the longitudinal slot and the three rows of staple cavities are positioned on a second side of the longitudinal slot. Other arrangements of the staple cavities and staples are possible.
The staples are supported by staple drivers in the cartridge body. The driver is movable between a first, or unfired position and a second, or fired position to eject the staples from the staple cartridge. The driver is retained in the cartridge body by a retainer that extends around a bottom of the cartridge body and includes a resilient member configured to grip the cartridge body and retain the retainer to the cartridge body. The driver is movable between its unfired and fired positions by the sled. The slider is movable between a proximal position adjacent the proximal end and a distal position adjacent the distal end. The sled includes a plurality of ramp surfaces configured to slide under and lift the drivers toward the anvil, and the staples are supported on the drivers.
In addition to the above, the sled can be moved distally by the firing member. The firing member is configured to contact the sled and urge the sled toward the distal end. A longitudinal slot defined in the cartridge body is configured to receive a firing member. The anvil also includes a slot configured to receive the firing member. The firing member also includes a first cam that engages the first jaw and a second cam that engages the second jaw. As the firing member advances distally, the first and second cams may control a distance or tissue gap between a deck of the staple cartridge and the anvil. The firing member also includes a knife blade configured to incise tissue captured intermediate the staple cartridge and the anvil. It is desirable that the blade be positioned at least partially adjacent to the ramp surface so that the staples are ejected prior to the blade.
The end effector can be configured to articulate relative to a handle and/or shaft of the surgical instrument. For example, the end effector can be pivotably and/or rotatably coupled to a shaft of the surgical instrument such that the end effector is configured to pivot relative to the shaft and the handle. In various instances, the end effector can be configured to articulate at an articulation joint intermediate the end effector and the shaft. In other cases, the shaft may include a proximal portion, a distal portion, and an articulation joint that may be located, for example, intermediate the proximal and distal portions of the shaft.
Fig. 1-5 illustrate aspects of a modular surgical cutting and fastening instrument that, in one form, includes a motor-driven reusable handle module 10 that can be used in conjunction with one or a variety of different detachable (and typically reusable) shaft modules (DSMs), as well as being reusable. As described in more detail below, the handle module 10 may include a housing 12 having one or more motor-driven rotary drive systems that generate and apply various control motions to corresponding drive shaft portions of a particular DSM coupled thereto. Two such rotary drive systems 20,40 are shown in the handle module 10 of fig. 1 and 5. The first rotary drive system 20 may be used, for example, to apply a "closing" motion to a corresponding closure drive shaft assembly operably supported in the DSM, and the second rotary drive system 40 may be used, for example, to apply a "firing" motion to a corresponding firing drive shaft assembly in the DSM coupled thereto. The various DSMs may be releasably and interchangeably connected to the housing 12. Three exemplary DSMs that may be connected to the handle module 10 in various arrangements are shown in fig. 1. The exemplary DSMs shown include an open linear stapler DSM 1, a curved cutter stapler DSM 2, and a circular surgical stapler DSM 3. <xnotran> 10 20,40 DSM , DSM, "MODULAR STAPLING ASSEMBLY" ________ ( END7544 USNP/140469) , . </xnotran> More details regarding exemplary DUAL DRIVE SURGICAL cutting and fastening INSTRUMENTS are provided in U.S. patent application Ser. No. 14/248,590 entitled "Motor DRIVE SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS," filed 4, 9, 2014, which is hereinafter referred to as the "590 application," the entire disclosure of which is incorporated herein by reference.
As shown in fig. 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 that may be interconnected by screws, snap features, adhesives, and the like. In the illustrated arrangement, the handle housing sections 16,18 cooperate to form a pistol grip portion 19 that can be grasped and manipulated by a clinician. The handle 14 operably supports two rotary drive systems 20,40.
The first and second rotary drive systems 20,40 may be powered by a motor 80 through a "transferable" transmission assembly 60 that essentially transfers power/motion between the two drive trains. The first rotary drive system 20 includes a first rotary drive shaft 22 rotatably supported in the housing 12 of the handle 14 and defining a first drive shaft axis "FDA-FDA". The first drive gear 24 is keyed to or otherwise non-rotatably attached to the first rotary drive shaft 22 so as to rotate therewith about a first drive shaft axis FDA-FDA. Similarly, the second rotary drive system 40 includes a second rotary drive shaft 42 rotatably supported in the housing 12 of the handle 14 and defining a second drive shaft axis "SDA-SDA". In at least one arrangement, the second drive shaft axis SDA-SDA is offset from and parallel or substantially parallel to the first drive shaft axis FDA-FDA. As used in this context, the term "offset" 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 keyed or otherwise non-rotatably attached to the second drive shaft 42 for rotation therewith about the second drive shaft axis SDA-SDA. Additionally, the second drive shaft 42 has an intermediate drive gear 46 rotatably journaled thereon such that the intermediate drive gear 46 is freely rotatable on the second rotary drive shaft 42 about the second drive shaft axis SDA-SDA.
In one form, the motor 80 includes a motor output shaft having a motor drive gear 82 attached thereto. The motor drive gear 82 is configured for "operable" engagement with the transmission assembly 60 in an intermeshing fashion. In at least one form, the transmission assembly 60 includes a transmission carriage 62 that is supported for axial travel between the drive gear 82 and the gears 44 and 46 on the second rotary drive shaft 42. For example, the transmission bracket 62 is slidably journaled on a support shaft 63 mounted within the housing 12 on the shaft mount 61 such that the line of action of the transmission bracket is perpendicular to the gear train of the rotary drive system. The shaft mount 61 is configured to be rigidly supported within a slot or other feature within the handle module 10. The transmission bracket 62 includes a bracket gear 64 rotatably supported on a support shaft 63 and configured for selective meshing engagement with the gears 44 and 46 when in driving engagement with the drive gear 82. In the arrangement shown in fig. 1-5, the transport carriage 62 is operatively attached to a translator or "means for translating" 70 configured to axially translate the transport carriage 62 between a "first drive position" and a "second drive position". In one form, for example, the means for transferring 70 comprises a translator solenoid 71 supported within the housing 12 of the handle 14. The diverter solenoid 71 may comprise a bi-stable solenoid, or may comprise a two-position, spring-loaded solenoid, for example. The illustrated arrangement includes, for example, a spring 72 that biases the transmission carrier 62 in the distal direction "DD" to a first drive position wherein the carrier gear 64 is in meshing engagement with the idler drive gear 46, while also being in meshing engagement with a drive gear 82. When the motor 80 is in this first drive position, activation thereof will cause rotation of the gears 82,46 and 24, which will ultimately cause rotation of the first drive shaft 22.
The shifter solenoid 71 may be actuated by a firing trigger 90 pivotally supported on the housing 12 of the handle 14, as shown in fig. 1-5. In the illustrated embodiment, the firing trigger 90 is pivotally supported on a firing trigger shaft 92 that is mounted in the handle 14. The firing trigger 90 is vertically biased to an unactuated position, as shown in FIG. 3, by a firing trigger spring 94. The firing trigger 90 is mounted for operative actuation of a firing switch 96 that is operably supported on a control circuit board assembly 100 that is housed in the housing 12 of the handle module 10. In the illustrated configuration, actuation of the firing trigger 90 causes actuation of the shifter solenoid 71. Actuation of the firing trigger 90 causes the shifter solenoid 71 to pull the transport carriage 62 in the proximal direction "PD", thereby moving the carriage gear 64 into meshing engagement with the second drive gear 44. When the carrier gear 64 is in meshing engagement with the drive gear 82 and the second drive gear 44, actuation of the motor 80 will cause the second drive shaft 42 to rotate about the second drive shaft axis "SDA". The transferable transmission assembly 60 can also include an indicator marking system 74 that includes a pair of switches 75 and 76 operably coupled to the control board 100 and the transmission indicator light 77. The switches 75,76 are used to detect the position of the transport carriage 62, which causes the control system to actuate the indicator light 77 based on the position of the transport carriage 62. For example, the indicator light 77 may be energized when the transport carriage 62 is in the first drive position. This provides the clinician with the following indication: actuation of the motor 80 will cause actuation of the first drive system 20.
For example, the motor 80 may be a DC brushed driving motor with a maximum rotation of about 25,000RPM. In other arrangements, the motor may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor, including a thermocompressible motor. The motor 80 may be powered by a power source 84, which in one form may include a power pack 86 that is removably stored in the pistol grip portion 19 of the handle 14. To access the power pack 86, the clinician removes the removable cap 17 attached at the bottom of the pistol grip portion 19. The power pack 86 may operably support a plurality of battery cells (not shown) therein. The battery cells may each include, for example, lithium ion ("LI") or other suitable battery types. The power pack 86 is configured for removable operative attachment to a control circuit board assembly 100 of the handle module 10 that is also operatively coupled to the motor 80 and mounted within the handle 14. The power pack 86 may include a plurality of battery cells connected in series, which may be used as a power source for the surgical instrument. Additionally, for example, power source 84 may be replaceable and/or rechargeable, and in at least one instance may include a CR123 battery.
The motor 80 may be actuated by a "rocker-trigger" 110 pivotally mounted to the pistol grip portion 19 of the handle 14. The rocker trigger 110 is configured to actuate a first motor switch 112 that is operably coupled to the control board 100. The first motor switch 112 may comprise a pressure switch that is actuated by pivoting the rocker trigger 110 into contact therewith. Actuation of first motor switch 112 will cause actuation of motor 80 such that drive gear 82 rotates in a first rotational direction. A second motor switch 114 is also attached to the circuit board 100 and mounted for selective contact by the rocker trigger 110. Actuation of second motor switch 114 will cause actuation of motor 80 such that drive gear 82 rotates in a second direction. For example, in use, the polarity of the voltage provided by the power source 84 may operate the electric motor 80 in a clockwise direction, wherein the polarity of the voltage applied by the battery to the electric motor may be reversed, so as to operate the electric motor 80 in a counterclockwise direction. The handle 14 may also include a sensor configured to detect the direction in which the drive system is moving.
The housing 12 may also include a surgical instrument contact plate 30 mounted thereto. Accordingly, various DSMs (e.g., DSM 1, 2, 3) may include mating DSM contact plates (see fig. 34-60 of the' 590 application). The DSM contact plate may be positioned in the DSM such that when the DSM is operatively coupled to the handle module 10, the end effector contact plate is electrically coupled to the handle module contact plate 30 mounted in the handle module 10. In this manner, data and/or power may be transferred between the handle module 10 and the DSM via the mating contact plate.
Fig. 6 illustrates one form of a mechanical coupling system 50 that may be used to facilitate the simultaneous removable and operable coupling of two drive systems 20,40 in the handle module 10 to corresponding "driven" shafts in the DSM. The coupling system 50 may include a male coupler attachable to a drive shaft in the handle module 10 and a female socket coupler attached to a driven shaft in a surgical DSM. Each of the male couplings 51 is configured to be able to drive a corresponding female socket coupling 57 received within a driven shaft that is also attachable within the DSM.
An arrangement for driving the drive system 20,40 is disclosed in the' 590 application, including that the handle module 10 may include a plurality of motors.
Fig. 7 is a block diagram of a modular motor driven surgical instrument 2100 including a handle module 2102 and a DSM 2104. The handle and DSM 2102,2104 include respective electrical subsystems 2106,2108 that are electrically coupled through a communication and power interface 2110. The components of the electrical subsystem 2106 of the handle portion 2102 are supported by the aforementioned control board 100 and are connectable to the aforementioned control board 100. The communication and power interface 2110 is configured such that electrical signals and/or power may be readily exchanged between the handle portion 2102 and the shaft portion 2104.
In the illustrated embodiment, the electrical subsystem 2106 of the handle module 2102 is electrically coupled to various electrical components 2112 and a display 2114. In one case, the display 2114 is an Organic Light Emitting Diode (OLED) display, but the display 2114 should not be limited in this context and other display technologies may be used. The electrical subsystem 2108 of the DSM 2104 is electrically coupled to the various electrical components 2116 of the DSM 2104.
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, a voltage regulator 2126, and is configured to receive inputs from a plurality of sensor switches 2128 which may be located in the DSM and/or the handle. The handle processor 2124 may be a general-purpose microcontroller suitable for medical and surgical instrument applications. In one case, handle processor 2124 may be a TM4C123BH6ZRB microcontroller from Texas Instruments, which includes a 32-bit, microcontroller
Figure BDA0003950747340000191
Cortex TM An M4-MHz processor and on-chip memory such as 256KB flash, 32KB SRAM, internal ROM for C-series software, and 2KB EEPROM. 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 described herein, a "processor" or "processor circuit," such as the handle processor 2124, may be implemented as a microcontroller, microprocessor, field Programmable Gate Array (FPGA), or Application Specific Integrated Circuit (ASIC) that executes program code (such as firmware and/or software) stored in an associated memory to perform various functions programmed by the program code.
In one aspect, the electrical subsystem 2106 of the handle module 2102 receives signals from various electronic components 2112, including the solenoid 2132, the clamp position switch 2134, the fire position switch 2136, the motor 2138, the battery pack 2140, the OLED interface board 2142 (which drives the display 2114), and various switches, such as an open switch 2144 (which indicates whether the closure trigger is open), a close switch 2146 (which indicates whether the closure trigger is closed), and a fire switch 2148 (which indicates whether the fire switch is activated). Motor 2138 may represent motor 80 of fig. 2-5.
In one aspect, the electrical subsystem 2108 of the DSM 2104 includes a shaft processor 2130. The electrical subsystem 2108 of the DSM is configured to receive signals from various switches and sensors 2116 located in the DSM that indicate the status of the clamping jaws and cutting elements in the DSM. In particular, the electrical subsystem 2108 of the DSM can receive signals from a clamp open status switch 2150 (which indicates whether the end effector clamp is open), a clamp closed status switch 2152 (which indicates whether the end effector clamp is closed), a firing start status switch 2154 (which indicates whether the end effector begins firing), and a firing end status switch 2156 (which indicates whether the end effector ends firing), such that the various switches indicate the status of the clamp and cutting element.
The accelerometer system 2120 may include a MEMS motion sensor that senses 3-axis motion of the handle module 10, such as a LIS331DLM accelerometer from STMicroelectronics. For example, the motor controller/driver 2122 may include a three-phase brushless DC (BLDC) controller and a MOSFET driver, such as the a3930 motor controller/driver provided by Allegro. In one aspect, the modular motor driven surgical instrument 2100 is equipped with a brushless DC electric motor 2138 (BLDC motor, BL motor), also referred to as an electronically commutated motor (ECM, EC motor). One such motor is BLDC motor B0610H4314 provided by Portescap. The sensor switch 2128 may comprise one or more unipolar integrated circuit type hall effect sensors. The voltage regulator 2126 regulates the power supplied from the power source (e.g., battery 2140) to the various electronic components of the handle module 2102 and DSM 2104. The battery 2140, which may represent the battery pack 86 in fig. 1-5, may be, for example, a lithium-ion polymer (LiPo) battery, a polymer lithium-ion and/or lithium polymer battery, for example, which (abbreviated Li-poly, li-Pol, liPo, LIP, PLi, or LIP) are rechargeable (secondary battery) batteries. The LIPO battery 2140 may include several (e.g., four or six) identical secondary batteries ("packs") connected in parallel. The OLED interface 2142 is an interface with an OLED display 2114 including an organic light emitting diode.
In an 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 an MSP430FR5738 ultra-low power MCU from Texas Instruments. It may include, among other things, internal RAM non-volatile memory, a CPU, an a/D converter, a 16-channel comparator, and three enhanced serial channels capable of I2C, SPI, or UART protocols. The subsystem 2108 may also include one or more separate external memory chips/circuits connected to the DSM processor 2130 via a data bus.
More details regarding the handle and exemplary electrical subsystems of DSM 2102,2104 can be found in the' 590 application. In operation, the electrical subsystem 2106 of the handle module 2102 receives signals from an open switch 2144, a close switch 2146, and a fire switch 2148 supported on a housing (e.g., housing 12) of the handle module portion 2102. Upon receiving a signal from the close switch 2146, the handle processor 2124 operates the motor 2138 to initiate closing of the clamp arm. Once the clamp is closed, the clamp closed 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 and power interface 2110.
Once the target tissue has been clamped, the firing switch 2148 may be actuated to generate a signal that is received by the handle processor 2124. In response, the handle processor 2124 actuates the transmission carriage to its second drive position such that actuation of the motor 2138 will cause rotation of the second drive shaft. Once the cutting member is positioned, a fire start status switch 2154 located in the end effector sends a signal to the DSM processor 2130 indicating the position of the cutting member, which the shaft processor communicates back to the handle processor 2124 through the communication and power interface 2110.
Actuating the first switch 2148 again sends a signal to the handle processor 2138 which, in response, actuates the second drive system and firing system in the DSM to drive the tissue cutting member and wedge sled assembly distally through the surgical staple cartridge. Once the tissue cutting member and wedge sled assembly have been driven to their distal most position in the surgical staple cartridge, the firing end switch 2156 sends a signal to the DSM processor 2130, which communicates the position back to the handle processor 2124 through the interface 2110. Now, the firing switch 2148 may be activated to send a signal to the handle processor 2124 which operates the motor 2138 to reverse rotation to return the firing system to its starting position.
Actuating the open switch 2144 again sends a signal to the handle processor 2124 which operates the motor 2138 to open the clamp. Once the clamp is opened, the clamp open status switch 2150 located in the end effector sends a signal to the shaft processor 2130, which communicates the clamp position to the handle processor 2124. The clamp position switch 2134 and the fire position switch 2136 provide signals to the handle processor 2124 indicative of the respective positions of the clamp arm and the cutting member.
Fig. 8 is a diagram of a process flow that may be performed by the handle processor 2124 in various circumstances by: software and/or firmware instructions stored in an internal memory of the processor and/or in an external memory chip/circuit connected to the handle processor 2124 are executed for the handle processor 2124. At step 202, the handle processor 2124 monitors input signals from the sensors of the instrument 2100 for a so-called "life event". A life event is an event or action involving the handle module 2102 and/or the DSM 2104, wherein once a threshold number of life events are reached, the handle module 2102 should be withdrawn (i.e., not used anymore). The life event may be clamping of the end effector, firing of the end effector, a combination of these events, and/or other events or actions involving the handle module 2102 and/or DSM 2104 that may be sensed by the instrument 2100. For example, the open switch 2144, the close switch 2146, and the fire switch 2148 of the handle module 2102 may be coupled to the handle processor 2124. In addition to or in lieu of the above, the clamp open status switch 2150, the clamp closed status switch 2152, the fire start status switch 2154, and the fire end status switch 2156 in the DSM 2104 may be coupled to the handle processor 2124 (via the interface 2110). Depending on the design and application of the handle module 2102 and instrument 2100, a life event may occur and may be counted when some or all of these respective switches are activated, and/or activated in a particular sequence detected by the handle processor 2124. For example, in various implementations, each detected clamp closure and each detected firing may be counted as a life event. In other words, a detected clamp closure can comprise a first life event, and a detected firing can comprise a second or different life event. In other implementations, a sequence of clip closure followed by firing may count as a life event. Additionally, as described above, the handle processor 2124 may use inputs from the handle sensors 2144,2146,2148 and/or the DSM sensors 2150,2152,2154,2156, for example, to detect a life event.
The handle processor 2124 maintains a count of life events. When a life event is detected, at step 204, the handle processor 2124 increments the current value of a life event counter in its internal or external memory. The counter may be an incrementing counter, wherein when a lifetime event occurs until a preset threshold is met, the count is incremented by one count (incremented by + 1); or the counter may be a decrementing counter in which the count is decremented by one count (incremented by-1) when a lifetime event occurs until a particular end count (e.g., zero) is reached after a value different from the preset threshold value from the end count. 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 event as a life event count.
If the life event counter reaches the preset life event threshold at step 206, the handle processor 2124 may initiate one or more end-of-life actions at step 208, such as communicating the display 2114 or some other display (e.g., a user-visible mechanical counter) of the handle module 2102 with the handle processor 2124, for example, to indicate that the handle module 2102 is exhausted (at end-of-life) and should be withdrawn. Any suitable visual, tactile, and/or audible indication may be used. For example, the display 2114 may include icons and/or text indicating that the end of life of the handle module has been reached. The display 2114 may also indicate a life event count on an ongoing basis, such as by a numerical display or volume indicator (full, near empty, etc.), e.g., so that a user can monitor whether the handle module is near the end of its life cycle. In addition to or instead of a constant display of lifetime event counts, the display 2114 may have an icon and/or use text to show that the handle module is nearing the end of its lifetime (e.g., "N use left"). The handle processor 2124 may also initiate a state that prevents further use of the handle module 2102 when the end-of-life count is reached, as described further below. If the end-of-life count has not been reached, the handle processor 2124 continues to monitor the switches and sensors for end-of-life count events until an end-of-life threshold is reached.
Various implementations of sensors may be used to detect certain life events. For example, the DSM used (e.g., DSM 1,2, or 3) may include two drive shafts, one for driving the closure system and one for driving the firing system (each driven by one of the drive systems 20,40, respectively). Each such drive shaft may drive the carriage forward during a clamping or firing event, respectively. Thus, the closure and/or firing system may include a switch that is triggered when the closure or firing carriage (as the case may be) contacts them. The switches may be coupled to the handle processor 2124, and the handle processor 2124 may register the lifetime event counts when it receives a signal from a switch that has been triggered. The switch may be an automatically resettable push button switch that resets each time it is contacted and triggered by a carriage driven by the drive shaft.
Further to the above, the' 590 application describes that the DSMs 1-3 may include a pair of lead screws for driving the closure and firing systems of various different types of DSMs. Examples of such lead screw pairs are shown in the' 590 application for an open linear stapler at its fig. 34-37, a curved cutter stapler at its fig. 38-41, and a circular surgical stapler at its fig. 42-45. Other DSM types suitable for handle modules may also be used, such as endocutters and/or right angle staplers. Since different DSMs may be used with the handle module, the handle module (e.g., the handle processor 2124) may use more complex algorithms to track handle module usage and remaining life, depending on the number of times the various types of DSMs are used and fired. For example, in one illustration, the handle processor 2124 may calculate a progressively cumulative life event score that weights usage differently by different DSMs (e.g., depending on how they are stressed on the handle module) and compare the score to a predetermined threshold. When the score of the handle module reaches a threshold, the handle module is withdrawn (e.g., one or more end-of-life actions are taken). For example, the handle processor 2124 may calculate a life event score based on the following relationship:
Figure BDA0003950747340000231
Where i =1, \8230wheren denotes different DSM types (e.g., endocutter, linear open, circular, curved, right angle stapler, etc.) that may be used with the handle module, W i Is a weighting factor of DSM type i, and F i,j For the number of firings of DSM type i in the S procedure with j =1, \8230jfor DSM type i. DSM types that typically exert less stress on the handle module may have a lower weight W than DSM types that typically exert more stress on the handle module. As such, in various arrangements, all other things being equal, a handle module that is used only for high stress procedures will expire before a handle module that is used only for less stressed procedures.
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 cases, the handle processor 2124 can execute firmware and/or software stored in, for example, internal and/or external memory. Assuming that the threshold score of the handle module has not been reached, processing begins at block 250 with the handle processor 2124 receiving input for the upcoming procedure. At least one of such inputs can include an identification of the type of DSM attached to the handle module, which the handle processor can receive from the DSM processor 2130 when the DSM is connected to the handle module and/or when the handle processor 2124 and the DSM processor 2130 establish a data connection therebetween. In identifying and/or authenticating the DSM, the DSM processor 2130 sends an identifier to the handle processor 2124 that identifies the type of DSM (e.g., endocutter, circle, etc.) that is attached to the handle module. Next at step 252, the handle processor 2124 tracks the number of times the handle module is fired during the surgical procedure. The handle processor 2124 may track the number of times the handle module has been fired, for example, by tracking the number of times the firing trigger has been activated and/or by tracking feedback from the DSM, such as an indication that the end effector cartridge has been replaced.
After the procedure and/or at any other suitable time, referring now to step 254, the handle processor 2124 may update the handle processor's life event score by adding the score of the just completed procedure to the previous score. The score of the just completed program may be based on the program W i The weight of the DSM type used in (a) is multiplied by the number of firings in the program S. The handle processor 2124 may determine the DSM type W by looking up the weights in a lookup table (stored in internal and/or external memory) based on the type identifier received from the DSM at step 250 i The weight of (c). At step 256, the handle processor compares the updated life event score of the handle module to a preset threshold score to determine if the handle module is at the end of its life. If the threshold has been reached, processing advances to step 258 where one or more end-of-life actions for the handle module are taken, such as one or more of the end-of-life actions described herein. On the other hand, if the threshold has not been reached, the process may proceed to step 260 so that the handle module may be used in at least one more procedure, thereby repeating the process of fig. 9.
The loading state experienced by the instrument may be used to track the use of the handle module and DSM to assess whether one or both of the handle module and DSM should be withdrawn. One such instantiation may involve, for example, comparing the force actually applied by the instrument to drive the firing member of the end effector to the force expected to be experienced by the instrument. Similarly, the force actually applied to retract the firing member may be compared to the force expected to be experienced by the instrument in order to assess whether the handle module and/or DSM should be withdrawn. The handle module can be rated to a threshold number of firings based on the level of force that the handle module is expected to experience. Similarly, the DSM may be rated to be a threshold number of firings based on the force level that the DSM is expected to experience. The handle module threshold number and DSM threshold number 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 (as the case may be) may determine that the handle module and/or DSM should be withdrawn before reaching their expected number of firings.
In some cases, further to the above, the force exerted by the handle module and/or DSM may be constant throughout the firing stroke of the firing member; however, it is common for the force applied by the handle module and/or DSM to vary throughout the firing stroke. In either case, the force applied by the handle module and/or the force expected to be applied by the handle module may depend on the firing member position. Similarly, the force applied by the DSM and/or the force expected to be applied by the DSM may be dependent on the firing member position. A particular type of DSM may have an expected firing force that is related to the DSM's firing stroke over its entire length, i.e., the distance between the initial starting position of the firing member and its end-of-stroke position. The DSM may also have an expected retraction force that is related to the DSM's retraction stroke over its entire length, i.e., the distance between the end of stroke position of the firing member and its starting position. Fig. 10A shows an example of expected forces for one type of DSM. The upper curve 270 shows the expected firing force as the firing member traverses the end effector from its starting position to its end of travel position, and the lower curve 272 shows the expected retraction force as the firing member retracts back to its starting position. In this particular embodiment, the expected firing force is greater than the expected retraction force.
For each firing, further to the above, the handle module and/or DSM processor may track the force applied per unit distance increment of the stroke length (e.g., 1 millimeter). Further, the handle module and/or DSM processor may track the force applied for each distance increment of the stroke length and then compare the actual force to the expected force to see if the actual force applied exceeds the expected force. 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 instance, the torque output of the motor may be determined based on the current consumed by the motor and the motor speed. In at least one such case, the voltage applied to the motor is constant. The current may be measured with a current sensor; for example, an encoder may be used to measure motor speed. FIG. 10A illustrates an exemplary force measurement that deviates from the expected firing stroke force and the expected retraction stroke force. In this figure, for simplicity of illustration, all of the measured force exceeds the expected force, and only the difference between the measured force and the expected force is shown by the line segment 274 for the firing stroke and by the dashed line segment 276 for the retraction stroke. The reader should appreciate that one or more measured forces may be less than their corresponding expected forces.
Fig. 10B is a diagram of an exemplary process flow performed by the handle module processor and/or DSM processor by executing firmware and/or software stored in the memory of the handle module and/or DSM (as the case may be). Referring now to step 280, the processor may aggregate (i.e., accumulate) the difference between the measured force and the expected force at each increment of unit length (hereinafter denoted as Δ L) along the firing stroke and/or retraction stroke of the instrument. For example, the cumulative force difference for the firing stroke and the subsequent retraction stroke may be calculated based on the following relationship:
Figure BDA0003950747340000251
wherein EOS represents the end of travel position; f m,f,ΔL And F e,f,ΔL Respectively representing the measured and expected force-to-fire at position al; and F m,r,ΔL And F e,r,ΔL The measured and expected retractive forces at position Δ L are shown separately. At step 282, for each of the firings experienced by the handle module and/or DSM, the processor may then accumulate force difference values by summing the accumulated force difference values for each firing.
As further described above with respect to one embodiment, the processor may calculate the cumulative force difference in real time. In at least one instance, the processor can calculate the force difference after each firing and retraction cycle. In some instances, the processor may calculate the force differential after each surgical procedure, which may include more than one firing and retraction cycle. For example, if there are seven (7) firings in a particular program, the processor will sum the results of step 280 for each of the seven firings. Next, at step 284, the handle may update the total accumulated force difference value of the handle module and/or DSM by adding the accumulated force difference value of the most recently completed procedure to the sum before the most recently completed procedure (or zero in the case of the first procedure of the modules). At step 286, the processor may then compare the updated cumulative force difference sum to a threshold. If the threshold has been reached or otherwise met, processing advances to step 288 where an end-of-life action of the handle module or DSM (as the case may be) is taken. Conversely, if at step 286 the processor determines that the threshold has not been reached, the handle module and/or DSM may be reused (as appropriate).
Even if the cumulative force differential threshold has not been reached, the handle module and/or DSM (as the case may be) may reach their end of life according to different thresholds. For example, the process of fig. 10B may advance to step 289 after step 286, where the processor compares the total number of programs involving the handle module and/or DSM (as appropriate) to a program count threshold. In at least one embodiment, the handle module can have a program count threshold of 20 programs and the DSM can have a program count threshold of 10 programs. Other embodiments are possible. In at least one other embodiment, the handle module and DSM can have the same program count threshold. If the program count threshold has been reached, an end-of-life action of the handle module and/or DSM (as the case may be) is initiated at step 288. Conversely, if the program count threshold has not been reached, the process advances to step 290 where the handle module and/or DSM is prepared for another program. Any of the techniques described herein for tracking program counts may be used to detect the end of a program.
In various embodiments, the handle processor may perform calculations on both the handle module and the DSM, and then communicate the results of the DSM to the DSM processor so that the DSM processor may initiate an end-of-life action when desired. Similarly, the DSM processor may perform calculations for both the handle module and the DSM, and then communicate the results of the handle module to the handle processor so that the handle processor may initiate an end-of-life action when desired. In another arrangement, all of the measured forces of a program may be downloaded to a remote processor after the program, such as a processor in an inspection station, or connected to the handle module after the program is post-processed, for example, to another remote computer or processor based system. Such an inspection station is disclosed, for example, in connection with fig. 12A-12B.
10C in conjunction with fig. 10D and 10E illustrate another exemplary process flow that the handle processor may employ to monitor whether the handle module has reached the end of its life, for example. The process shown in fig. 10C determines whether the handle module has reached the end of its 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 illustrates the accumulated or accumulated energy consumed by the handle module as a function of use or firing of the handle module. In addition to or in lieu of the above, the process shown in fig. 10C may determine whether the handle module has reached the end of its life based on the power used during each firing of the handle module, an exemplary plot of which is shown in fig. 10E. Fig. 10E illustrates the power consumed for each individual firing of the handle module. In at least one specific embodiment, in implementing the exemplary process of fig. 10C, the processor monitors whether the total energy consumed by the handle module exceeds various thresholds (see fig. 10D), and simultaneously monitors whether the handle module has a certain number of firings above a threshold power level (see fig. 10E). When these two conditions have been met, in at least one case, the handle processor can conclude that the handle module is at its end of life. In certain instances, the handle processor may utilize any number of multi-factor tests (each with a threshold) to determine whether the handle module is at the end of its life. In at least one instance, the handle processor may determine that it has reached the end of its life if any of the test thresholds have been met or exceeded.
After the program, the handle processor may perform the process of fig. 10C by executing firmware and/or software stored in internal and/or external memory to determine whether the handle module is at the end of its life. At step 290, the handle processor may compare the energy accumulated by the handle module over its lifetime to a first threshold energy level (i.e., energy level 1 in fig. 10D). For example, the energy level 1 may be 40kJ. The handle module may include a micro watt or power meter connected to one or more motors of the handle module to measure and record electrical parameters of the one or more motors so that the energy and power output of the one or more motors may be determined. For example, if a first threshold energy level (i.e., energy level 1) is reached or exceeded, the handle processor may determine that the handle module is at its end of life and initiate an end-of-life action, such as one or more of the end-of-life actions described herein, at step 291.
If at step 290 the handle processor determines that the first threshold energy level (i.e., energy level 1) has not been met, then the process advances to step 292 where the handle module determines whether a second (e.g., lower) energy threshold has been met, i.e., energy level 2 in FIG. 10D. For example, the energy level 2 may be 30kJ. If the second threshold energy level is reached or exceeded (and the first threshold energy level is not reached or exceeded), then the process advances to step 293 where the handle processor determines whether the handle module has experienced a certain number of firings, e.g., two firings greater than 55 watts, exceeding the first power level threshold during its life (see fig. 10E). The handle processor may determine that the handle module is at the end of its life if the second energy level threshold has been met or exceeded and the power level threshold has been met or exceeded a predetermined number of times. However, if the power level threshold has not been met or exceeded a predetermined number of times, the handle processor may determine that the handle module has not reached the end of its life even though the second energy level threshold has been met or exceeded. The dual factor of steps 292 and 293 may be another test of the life of the handle module, and if the handle module is not capable of performing two tests simultaneously (i.e., both thresholds or conditions have been met), it may be determined that the handle module is at the end of its life.
The handle processor may perform any number of such dual factor tests. The example of fig. 10C illustrates one additional such dual factor test. If neither of the dual factors of steps 292 and 293 are met, processing may proceed to step 294 where the handle module determines whether a third (e.g., still lower) energy threshold, i.e., energy level 3, has been met. For example, the energy level 3 may be 25kJ. If the third threshold energy level has been reached or exceeded (and not reached or exceeded), then processing advances to step 295 where the handle processor determines whether the handle module has a number of firings during its life (preferably, greater than the number of such firings detected at step 293) that exceeds a second power level threshold (which may be the same as or different from the power level threshold at step 293), for example, greater than four firings of 55 watts. The dual factor of steps 294 and 295 may be another test of handle module life, and if the handle module is unable to perform both tests simultaneously (i.e., the threshold or condition has been met), it may be determined that the handle module is at its end of life. Otherwise, the handle processor may determine that the handle module is not at the end of its life and may be used in a subsequent procedure.
It will be apparent that the steps of fig. 10C may be performed in a variety of sequences while still achieving the same results. For example, steps 294 and 295 may be performed before step 290, and so on.
According to the best current practice, the handle module should be sterilized prior to use in performing the surgical procedure. In each case, the handle module is placed in a sterilization tray, which is then placed in a sterilization chamber. In addition to or instead of the above-described means for tracking the end of life of the handle module, the number of times the handle module is placed in the sterilization tray for sterilization may be used to track the end of life of the handle module. In other words, the number of times the handle module is sterilized may be used as a proxy for the number of times the handle module is used. In at least one exemplary embodiment, each handle module has its own sterilization tray that maintains the sterilization count for that particular handle module. In such an arrangement, the sterilization tray may include a counter that increments each time an associated handle module is placed in the tray. The counter may have a visual readout display that may display the number of times the handle module has been sterilized if an incrementing counter is used, or the number of sterilizations remaining or allowed when a decrementing counter is used. In this way, the user may know when the sterilization limit has been reached, and thus, the user may withdraw the handle module and/or take other appropriate end-of-life measures. In order to place the handle module in the sterilization tray for representing the number of times the handle module has been sterilized, and thus representing the number of times the handle module has been used, the handle module should be sterilized in one and only one sterilization tray. In this way, the counter does not count the placement of other handle modules in the tray. Thus, the handle module and the sterilization tray can be disposed together, e.g., as a pill box, and they can include an identifier (e.g., a number or icon) that indicates that they are to be used together. For example, the handle module and DSM can be sterilized separately or together.
Fig. 11A illustrates an exemplary sterilization tray 300 and a handle module 302 that can be positioned in the sterilization tray 300. The sterilization tray 300 defines an opening or recess 304 having a shape that matches the shape of the handle module 302 to be placed therein. The recess 304 is configured to closely receive the handle module 302 such that little, if any, relative movement is possible therebetween. The sterilization tray 300 includes a stroke counter 306 having a lever arm 308 that extends into the opening 304. The travel counter 306 also includes a counter visual reader 310. When the user places handle module 302 in opening 304, lever arm end 308 is depressed, toggled, or stroked, which registers as a count, incrementing stroke counter 306 by 1 for an incrementing counter (or by 1 for a decrementing counter), which is displayed on reader 310. To reduce false switching or travel of lever arm 306, lever arm end 308 may include a protrusion 312 configured to fit into a corresponding opening 314 defined in handle module 302, in various arrangements. Fig. 11B shows handle module 302 after it is placed in sterilization tray 300. Lever arm end 308 is not visible in fig. 11B because it is below handle module 302. When the handle module 302 is positioned in the opening 304, the counter reader 310 remains visible to the user.
Fig. 11C and 11D illustrate variations in which the handle module 302 may be placed in a sterilization tray 300 with DSM 312. The handle module 302 is similar in many respects to the handle module 10, and the DSM 312 represents an exemplary DSM. In such an arrangement, 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 reader 316. Tray 300 also includes a DSM opening 324 for receiving DSM 312, a DSM lever counter 320, and a DSM counter reader 322. In such an arrangement, the handle module 302 and DSM 312 should only be sterilized in a particular sterilization tray 300 so that their respective sterilizations can be accurately tracked. The handle module counter 312 shows the number of times the handle module 302 has been sterilized in the sterilization tray 300 and/or the number of sterilizations remaining. DSM counter 324 shows the number of times DSM 312 has been sterilized in sterilization tray 300 and/or the number of sterilizations remaining. The handle modules 302 may be sterilized without the DSM 312, and vice versa, in which case their respective counts may not be equal.
Fig. 11E-11I illustrate other arrangements for using the sterilization tray 300 to track usage of the handle module. In fig. 11E, the sterilization tray 300 includes a protrusion 340 extending upward from the bottom of the opening 304 in the sterilization tray. When the handle module 302 is seated in the opening 304, the protrusion 340 is positioned to extend into a corresponding opening 342 defined in the handle module 302. As shown in fig. 11F, the handle module 302 may include a two-position mechanical 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. When the handle module 302 is placed in the sterilization tray 300, the opening 342 is aligned with the protrusion 340 such that the protrusion 340 pushes the switch 344 to the second position, as shown in fig. 11G. Switch 344 can be in communication with the handle processor, and when switch 344 is moved from the first position (fig. 11F) to the second position (fig. 11G), the handle processor can update the internal sterilization count (stored in the internal processor memory and/or the external processor memory of the handle module). In such embodiments, the handle module 302 may include a power source as described herein to power the handle processor and update the sterilization count during sterilization. Such a power source may include a secondary battery that is not removed from the handle module, even if the primary battery is removed from the handle module 302. The handle processor can compare the sterilization count to a predetermined threshold (e.g., 20 sterilizations), and when the sterilization count reaches the predetermined threshold, the handle processor can implement one or more of the various end-of-life actions described herein, for example. Switch 344 may remain in a "toggle" or "active" state until it is reset at a later time, such as after a sterilization process, for example (see fig. 36). Once the handle module 302 is removed from the tray 300 and the protrusion 340 is removed from the opening 342, the switch 344 may be spring biased, for example, to return to its open position. The handle module processor may also provide internal indicia to indicate that the handle module 302 is placed in the sterilization tray 300, and that the indicia may be reset later after the sterilization process (see fig. 37). Fig. 11H and 11I show an embodiment similar to contact switch 348. When the handle module 302 is placed in the sterilization tray 300, the opening 342 is aligned with the protrusion 340 such that when the handle module 302 is seated in the opening 304, the protrusion 340 closes the contact switch 348, as shown in fig. 11G. The contact switch 348 communicates with the handle processor to update the sterilization count of the handle module. For example, 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, the contact switch 348 may be biased to return to its open position by a spring (fig. 11H).
In addition to or instead of the above-described means for tracking the end of life of the handle module, the end of life of the handle module may be tracked by using an inspection station to which the handle module is connectable. The inspection station may be used at any suitable time to assess whether the handle module is available to perform the surgical procedure and/or subsequent steps in the surgical procedure. For example, the inspection station may be used before, during, and/or after a sterilization process of the handle module, and/or when preparing the handle module for reuse. The handle module may be connected to the inspection station after, for example, the following steps: (i) Post-treatment cleaning of the reusable components of the handle module after the procedure (typically involving manual wiping of the components or instruments); (ii) Decontamination of the part or instrument (e.g., by an automatic washer); and/or (iii) cleaning and/or in-house drying of the parts or instruments. Placing the handle module on the inspection station may be representative of the number of times the handle module is used, sterilized, and/or otherwise processed for reuse. A display on the inspection station (or elsewhere) may indicate to the user when the threshold number of handle module placements on the inspection station has been reached or is about to be reached, at which point the user may take appropriate action with respect to the handle module, such as causing it to withdraw. In addition, when the handle module has reached the end of its life, the inspection console may upload the data to the handle processor, which prevents further use of the handle module (e.g., disables the handle module).
Further to the above, fig. 12A and 12B illustrate an exemplary inspection station 400 and handle module 402. The handle module 402 is similar in many respects to the handle module 10. Fig. 12A shows handle module 402 prior to being placed on inspection station 400, and fig. 12B shows handle module 402 after being placed into position on 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 therein. See, for example, battery 86 in fig. 2-5. As disclosed elsewhere herein, the battery pack may be easily insertable into the battery cavity 403 and removable from the battery cavity 403. Fig. 12A also shows the battery pack removed from the handle module 402, exposing the battery cavity 403 before the handle module 402 is placed on the inspection system 400. Inspection station 400 includes an insert or data/power adapter 404 extending therefrom that is sized and configured to fit within battery cavity 403 of handle module 402. The data/power adapter 404 is placed in communication with the processor of the handle module via power contacts configured to engage power terminals of the battery pack and/or via one or more signal contacts positioned in the battery cavity 403, as described in further detail below. Handle module 402 may be positioned on inspection station 400 by sliding opening 403 over data/power adapter 404.
Fig. 12C is a block diagram illustrating certain components of the inspection station 400 and the handle module 402. The data/power adapter 404 includes power terminals 430 that provide a cross-over voltage in the same or similar manner to the voltage regulator 432 of the handle module 402, wherein the battery pack provides a voltage to the voltage regulator 432 when the battery pack is positioned in the opening 403. For example, if the battery pack is configured to supply 6V DC to the voltage regulator 432, the insert 404 may be configured to supply 6V DC to the voltage regulator 432, for example. The voltage regulator 432 provides power to the control board 100 (see fig. 1-6) of the handle module 402 to power the components of the control board 100, including, for example, a handle processor 434 and associated internal and/or external memory 436. The inspection station 400 itself may be powered by an AC power source through a power cord 437 using a suitable AC-DC converter. The inspection station 400 includes a data port 438 that contacts a data port 440 of the handle module 402 when the handle module 402 is engaged with the inspection station 400 so that the handle processor 434 can communicate with an inspection station processor 442. As the reader will appreciate, the inspection station 400 may also include internal and/or external memory 444 associated with the inspection station processor 442.
Fig. 12D is a diagram of a process flow performed by handle processor 434 and/or inspection station processor 442 to track and respond to the number of times handle module 402 is placed on inspection station 400 when executing software and/or firmware in handle memory 436 and/or inspection station memory 444. In various arrangements, the handle processor 434 may increment an inspection counter each time the handle module 402 is mounted on the inspection device 400 such that the insert 404 makes a data and/or power connection to the control board 100 of the handle module 402. The check counter may be an incrementing counter from zero to a preset threshold check number or a decrementing counter from a preset threshold check number to zero. In at least one instance, the handle module 402 includes an inspection station insertion switch 446 (fig. 12C) that is triggered when the data/power adapter 404 is fully and properly inserted into the opening 403. This switch 446 may be in communication with the handle processor 434 via the control board 100, and when the switch 446 is triggered at step 420 of fig. 12D, the handle processor 434 may increment the check counter at step 422 (either +1 or-1, as the case may be, depending on the type of counter). At step 424, the handle processor 434 may compare the check count to a predetermined threshold. If the threshold has not been reached, at step 426 handle processor 434 may output the value of the inspection counter to inspection station processor 442 when in data communication with inspection station 400 via insert 404.
Referring to fig. 12E, the inspection station 400 may include a visual display 448 that displays visual information relating to the inspection counter, such as the number of times the handle module 402 has been placed on the inspection station 400 and/or the remaining number of times (or approximate number of times) the handle module 402 should be placed on the inspection station 400 for inspection before the handle module 402 has, for example, reached the end of its life. However, if the check count threshold has been reached, processing may proceed to step 428, where appropriate end-of-life action may be taken. One such end-of-life action is to check that the display 448 of the console 400 can visually indicate to the user that the handle module 402 should not be used any further. Another end-of-life action that may be taken in addition to or in place of the visual display is the inspection console processor 442 sending a string of instructions to the handle processor 434 that disables the handle processor 434 from further use of the handle module 402. For example, the instruction string may instruct the handle processor 434 to never actuate the motor of the handle module 402 or some other disabling action thereafter. For example, the instruction string may instruct the handle processor to set a flag that, when set, prevents the handle processor 434 from actuating the motor.
In various embodiments, the inspection station insertion switch 446 may be a pressure switch that is actuated when the data/power adapter 404 is fully inserted into the opening 403 and is reset when the data/power adapter 404 is removed or at least partially removed from the opening 403. In various aspects, there may be a timer associated with the inspection station insertion switch 446 such that the inspection station counter is incremented only if the switch 446 is activated for at least a threshold period of time (e.g., 30 seconds, etc.) (step 422 of fig. 12D). Such a timer may reduce the number of false positives, i.e., a brief placement of the handle module 402 on the inspection station 400 may not be associated with a post-procedure inspection of the handle module 402.
In another variation, the inspection station 400 includes a pressure switch with a counter whose reading is displayed to the user. The inspection station pressure switch is activated by placing the handle module 402 on the inspection station 400. For example, the inspection station pressure switch may be at the base of the insert 404 of the inspection station 400 such that when the handle module 402 is fully slid onto the insert 404, the inspection station pressure switch is activated. Each time the inspection station pressure switch is activated, the counter may be updated (e.g., incremented by 1) so that the reader shows the number of times the handle module 402 has been installed on the inspection system 400. Such a counter may be, for example, a mechanical counter and/or an electronic counter. If the limits or thresholds are displayed on inspection station 400, displayed on handle module 402, and/or otherwise published to the user, the user may know whether the limits have been reached or are approaching. In at least one instance, the limits can be printed on, for example, the inspection station 400 and/or the handle module 402.
The display 448 of the inspection station 400 may also display other information obtained by the inspection station 400 and/or communicated from the handle module 402 to the inspection station 400 via a data connection therebetween. For example, the handle processor memory may store a device type identifier (e.g., serial number) for the handle module, and the device type identifier may be downloaded to the inspection station processor 442 for display on the display 448. In addition to or instead of the above, the display 448 may indicate the status of the handle module, such as how close the handle module has reached the end of its life and/or whether the handle module has been locked, for example, based on status data received from the handle processor 434. As described herein, the display 448 can indicate the number of remaining uses (e.g., procedures) of the handle module and/or the number of procedures in which the handle module has been used. As disclosed herein, inspection station 400 may also be used to perform post-procedure testing of handle module 402 to ensure that handle module 402 may be used in subsequent procedures. The test may include, for example, a moisture test, a seal integrity test, and/or a simulated load test. The display may indicate the results of these tests (e.g., pass, fail, in progress).
In addition to or instead of the above, the display 448 of the inspection station 400 may indicate the status of the inspection station itself, such as to check whether the station (i) downloads data from the handle module, (ii) uploads data and/or software upgrades to the handle module, (iii) processes the data, and/or (iv) performs a test. The display 448 may indicate results from the testing and data processing, such as whether the handle module is ready for use in another procedure, whether the handle module requires servicing, whether the warranty of the handle module has expired due to, for example, the handle module having reached its threshold number of uses, and/or other warnings. The display 448 of the inspection station 400 may be, for example, an LED backlit LCD display controlled by the inspection station processor 442. The inspection station 400 may also include control buttons 410, as shown in FIG. 12E, where a user may enter data and/or configuration settings for storage and use by the inspection station processor 442. The display 448 may also be a touch screen, where a user may enter data and/or configuration settings, for example, via the touch screen. The inspection station 400 may include, for example, an external data port 412, such as a USB, micro or mini-USB, for connection to a data cable 414 so that data may be uploaded from or downloaded to the inspection station 400. For example, program data from the handle module 402 may be downloaded to the inspection station 400 and then downloaded to a remote computer device via the data port 412. Software and/or firmware upgrades may be downloaded from a remote computer device to inspection station 400 via data port 412 and then uploaded to, for example, handle module 402.
Fig. 13A and 13B show an arrangement for tracking use of a handle module by tracking installation of a power pack in the handle module. Fig. 13A is a block diagram of handle module 500. The handle module 500 is similar in many respects to the handle module 10. The handle module 500 includes, for example, a removable power pack 502 (such as a battery) and a handle processor 504. Fig. 13B illustrates a process flow that may be performed by the handle processor 504. The processing may be performed by firmware and/or software in a memory 506 associated with the processor 504. As shown in fig. 13A, the power pack 502 may include, for example, an identification transmitter 508 (such as an RFID tag) that may communicate with an identification receiver 510 (such as an RFID reader) in the handle module 500. The identification transmitter 508 is, for example, a wireless signal transmitter; however, any suitable identification transmitter may be used. The identification receiver 510 is, for example, a wireless signal receiver in communication with the handle processor 504, however, any suitable identification receiver may be used. The identification transmitter 508 sends a unique ID of the power pack 502 that can be received by the identification receiver 510. The strength of the signal emitted by the identification transmitter 508 may be controlled or limited such that the identification receiver 510 can only detect the signal emitted from the identification transmitter 508 when the power pack 502 is in close proximity (e.g., within 10 cm) to the identification receiver 510. In at least one instance, the identification receiver 510 can be mounted on the control board 100 (fig. 2-4) such that the identification receiver 510 can only detect the identification transmitter 508 when the power pack 502 has been inserted into the handle module 500. In various instances, short range RFID tags and readers may be used so that the identification receiver 510 is less likely to falsely detect a power pack 502 that is not installed in the handle module 500.
Referring to the process flow shown in fig. 13B, identification reader 510 detects an identification transmitter at 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 identification receiver 510. The term "new" in this context means that a particular power pack 502 has not been used with a particular handle module 500. The handle processor 504 may perform this step by comparing the ID of the newly detected power pack 502 to a stored list of power pack IDs previously detected by the identification receiver 510. For example, a list of such previously used power pack IDs is stored in the non-volatile memory of the handle module 500. If the power pack 502 is not new, i.e., its ID is on a stored list of previously used power packs, then processing advances to step 524 where appropriate, and preset actions are taken. For example, the handle processor 504 may disable the handle module 500 until a new, i.e., previously unrecognizable, power pack is installed in the handle module 500. In at least one such instance, the handle module 500 can deactivate the motor 80. In addition to or instead of the above, the display of the handle module 500 may indicate to the user that the power pack is not new and require a different power pack to be installed, which returns the process to step 520.
If the processor 504 determines that the power pack 502 is new, i.e., the ID of the power pack 502 is not on the stored list of previously used power packs, then the process advances to step 526 where the handle processor 504 increments the usage count of the handle module 500. As previously described, an up counter and/or a down counter may be used. At step 528, the handle processor 504 compares the usage count to a preset threshold value that indicates the number of times the handle module 500 should be used with a different unique power pack. Such a usage count may be used as a representative of the number of times the handle module 500 has been used in a patient procedure. If the usage count threshold has been reached at step 528, a preset end-of-life action may be taken at step 529. For example, the handle processor 504 may deactivate the motor, the handle module display may, for example, display to the user that the handle module 500 does not have remaining use, and/or activate an alarm, alerting the user that there is no remaining use. If the usage count threshold has not been reached, the handle processor 504 adds the ID of the new power pack 502 to the stored list of previously used power packs at step 530 so that the new power pack 502 cannot be used after its current use. In other variations, the steps shown in fig. 13B may be performed in a different order. For example, a new power pack ID may be added to the stored list before incrementing the usage count. Other techniques for tracking the installation of a power pack in a handle module are described below in conjunction with fig. 14E and 15A-15B.
The embodiments described above in connection with fig. 13A and 13B may be used with rechargeable and/or non-rechargeable batteries. That is, a battery pack that is used with the handle module 500, recharged, and then reused with the same handle module 500 may cause the handle module 500 to enter a locked mode. With this particular embodiment, the recharged battery pack would have to be reused with a different handle module. Accordingly, embodiments of handle module 500 are contemplated in which a recharged battery pack may be reused with the same handle module 500.
In at least one instance, the processor 504 can employ logic that prevents the battery pack 502 from being counted two or more times for the same purpose. In at least one instance, the processor 504 may not count the battery pack 502 again unless it has been disengaged and re-engaged with the handle module 500. Even so, the processor 504 may require a period of time to elapse between the first bond and the subsequent bond before counting the subsequent bond as a second use. Such elapsed time may be, for example, the time it takes to recharge the battery pack.
In addition to or instead of the above, the handle module can track the number of times the DSM has been connected to and/or disconnected from the handle module as representative of the number of times the handle module has been used. The handle module may display, for example, an updated number of uses remaining for the handle module, an estimated number of uses remaining for the handle module (such as with a volume indicator indicating a percentage of life remaining), and/or a number of times the handle module has been used. When the usage threshold limit has been reached, the handle module may take, for example, one or more end-of-life actions via the handle processor, such as indicating that the handle module is exhausted, further disabling the handle module by disabling the motor, and/or sounding an audible alarm. Fig. 14A-14G represent different arrangements for tracking the connection and disconnection of the DSM to the handle module, as discussed in more detail further below.
Turning now to fig. 14A, a handle module 600, similar in many respects to the handle module 10, includes two rotary drive systems 602,604. A DSM having both drive systems described above may be operably coupled to the rotary drive systems 602,604. The DSM may have a groove configured to receive and slide onto the bilateral edges 605a,605b of the tongue defined in the connection region 608 on the upper portion of the handle module 600. In such an arrangement, the handle module 600 can include a depressible switch 612 on the tongue (as shown in fig. 14A) and/or elsewhere in the connection area 608 such that when a DSM, such as DSM 634 (fig. 14B and 14C), for example, is connected to the handle module 600, the depressible switch 612 is depressed. In at least one instance, the DSM may not press the switch 612 until the DSM has been fully seated onto the handle module 600. The switch 612 may be connected to a handle processor, wherein the handle processor may count the number of times the depressible switch 612 has been depressed as a representation of the number of times the DSM has been connected to the handle module 600 and/or as a representation of the number of times the handle module 600 has been used. In addition, the handle processor may require that the depressible switch 612 be continuously depressed for at least a certain period of time (e.g., 30 seconds) before incrementing the count to reduce instances of false positives. When a preset threshold number of uses or activations of the switch 612 has been reached, an end-of-life action may be performed, as described herein.
Fig. 14B and 14C show one arrangement of an electromechanically depressible switch 612. As shown, the depressible switch 612 includes a head 620 that extends into an opening 622 defined in a 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 configured to bias the position of the head 620 upwardly into the opening 622. The spring arm 624 also includes a shoulder 626 positioned behind an extension or rim 628 defined in the handle module 600 that limits upward movement of the head 620 in the opening 622 to a desired position. The depressible switch 612 also includes a contact 630. When the switch 612 is in an unactuated or open state, as shown in fig. 14B, the spring arm 624 is not engaged with the contact 630; when the DSM 634 is attached to the handle module 600 and pushes the head 620 downward, as shown in fig. 14C, the shoulder 626 of the spring arm 624 engages the contact 630 and closes the switch 612. The DSM 634 includes a protrusion 632 extending therefrom that is configured to contact the head 620. The switch arms 624 and contacts 630 may be constructed of a conductive material that can complete a circuit that communicates with the handle processor when the head 620 is pressed down by the DSM 634, as described above.
Referring now to fig. 14D, the handle module 700 may include electrical contact plates 702 that interface/mate with and make electrical connection with corresponding electrical contact plates 704 on the DSM 706. In at least one instance, the processor of the handle module 700 can count the number of times a DSM (such as DSM 706), for example, is assembled to the handle module 700. When the contacts 704 of the DSM 706 engage the contacts 702 of the handle module 700 and a working data connection is made therebetween, the processor may increase the DSM connection count. The mating of the contact plates 702,704 may serve as a representative of the number of times the DSM has been connected to the handle module 700, and as a representative of the number of times the handle module 700 has been used. Similar to the above, the handle processor may require that the data connection between the contact plates 702,704 be present continuously for at least a certain period of time (e.g., 30 seconds) before incrementing the count to reduce instances of false positives. In another variation, the handle processor and DSM processor may exchange data when the DSM 706 is connected to the handle module 700. In this exchange, the handle processor may receive identification information of the DSM 706 such that the handle processor may identify the DSM 706 (e.g., the model type of the DSM) connected to the handle module 700. In such an arrangement, the handle processor may increment the DSM connection count each time the handle processor receives identification information from the DSM attached thereto. In any of these variations, the handle processor compares the DSM connection count to a preset threshold and if the threshold is reached, the handle processor takes an end-of-life action.
Alternative arrangements for detecting attachment of the DSM to the handle module are shown in fig. 14E-14G. The illustrated arrangement uses hall effect sensors 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 effect sensor 710 positioned relative to an upper surface 712 of the handle module 700 to which the dsm 706 is attached. Accordingly, the DSM 706 includes, for example, a magnet 714, such as a permanent magnet, that is proximate 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. The hall effect sensor 710 may be in communication with the handle processor, for example, via lead 716. The hall effect sensor 710 may sense the proximity magnet 714 of the DSM 706 when the DSM 706 is mounted on 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 such that the distance between the magnet 714 and the hall effect sensor 710 may be determined based on the output of the hall effect sensor 710. Once the distance between the magnet 714 and the hall effect sensor 710 stabilizes to a distance corresponding to the DSM 706 being fully and properly mounted on the handle module 700, the handle processor can conclude that the DSM 706 is fully and properly mounted on the handle module 700 and update the DSM connection count.
Similarly, referring again to fig. 14E, the handle module 700 includes a battery cavity 724 configured to receive the battery pack 722 therein. The handle module 700 also includes a hall effect sensor 720 configured to detect insertion of a removable battery pack 722 into the battery cavity 724. A battery pack hall effect sensor 720 can be positioned at an upper interior surface 723 in the battery cavity 724 in the handle module 700 for the battery pack 722. As the reader will appreciate, the battery pack 722 is configured to be capable of supplying power to the handle module 700 via the electrical terminals 726, and it may be desirable to locate the hall effect sensor 720 as far away from the electrical terminals 726 as possible so that any magnetic field generated by the current flowing through the terminals 726 does not substantially interfere with the ability of the hall effect sensor 720 to properly detect insertion of the battery pack 722 into the handle module 700. The battery pack 722 includes, for example, a magnet 730, such as a permanent magnet, that is sensed by the hall effect sensor 720 when the battery pack 722 is inserted into the battery cavity 724. Similar to the hall effect sensor 710, the battery pack hall effect sensor 720 communicates with the handle processor, for example, via a lead 732. When the battery pack 722 is installed into the battery cavity 724, the hall effect sensor 720 may sense the proximity of the battery pack magnet 730. The magnetic field generated by the magnet 730 may be constant and the handle processor may access data regarding the magnetic field such that the distance between the magnet 730 and the hall effect sensor 720 may be determined based on the output of the hall effect sensor 720. Once the distance between the magnet 730 and the hall effect sensor 720 stabilizes to a distance corresponding to the battery pack 722 being fully and properly installed in the handle module 700, the handle processor can conclude that the battery pack 722 is fully and properly installed in the handle module 700 and update the battery pack connection count.
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 a representative of the number of times the handle module has been used. The handle module may display, for example, an updated number of uses remaining for the handle module, an estimated number of uses remaining for the handle module (such as with a volume indicator indicating a percentage of life remaining), and/or a number of times the handle module has been used. When the usage threshold limit has been reached, the handle module may take, for example, one or more end-of-life actions via the handle processor, such as indicating that the handle module is exhausted, further disabling the handle module by disabling the motor, and/or sounding an audible alarm.
Turning now to fig. 15A and 15B, the handle module 800 may track the installation of the power pack thereto using a pressure switch that is depressed when the power pack 806 is, for example, fully and properly attached to the handle module 800. The handle module 800 is similar in many respects to the handle module 10. The handle 800 comprises conductive contact pads 802 to which a power pack 806 is connected for supplying voltage to the electronic components of the handle module 800. In the illustrated arrangement, the pressure switch 804 is adjacent the conductive contact pad 802 and is in communication with the handle processor. When the power pack 806 is assembled to the handle module 800, referring to fig. 15B, the housing of the power pack 806 depresses and actuates the pressure switch 804. Each time the pressure switch 804 is actuated, the handle processor may increment the power pack connection count until a threshold is reached, at which point an end-of-life action may be taken. Similar to the above, the handle processor may require that the pressure switch 804 be continuously actuated for a certain period of time (e.g., 30 seconds) before incrementing the power pack connection count to reduce instances of false positives. In other arrangements, for example, electromechanical switches may be used.
In various instances, the processor of the handle module may increment the usage count each time the handle processor is powered on. In some instances, the processor of the handle module may be automatically powered off when the battery pack is disengaged from the handle module. Similarly, the processor may power up automatically when the battery pack is engaged with the handle module. In at least one such embodiment, the battery pack is the only power source for the handle module, and disconnection of the battery pack from the handle module can immediately power down the processor, and connection of the battery pack to the handle module can immediately re-power the processor. In certain embodiments, the handle module may include one or more capacitive elements that may store power from the battery pack when the battery pack is engaged with the handle module. The capacitive element may provide power to the processor for a period of time when the battery pack is disconnected from the handle module, and thus, the processor may not be powered down during a battery pack replacement. In such cases, the processor may count the lifetime or usage in the event that the battery installation is detected by the sensor, as described above, and/or the processor is powered on after being powered off.
In various instances, the handle processor of the handle module 800 may track the frequency at which 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 pads 802. The voltage and/or current sensor may be in communication with the handle processor. When a threshold input voltage and/or current from the power pack 806 is detected at the contact pad 802, the handle processor may increment a battery pack connection count. This arrangement may be useful where the handle processor is sometimes powered by a power source other than a power pack, such as by a super capacitor or other source.
Turning now to fig. 16, the handle module 900 includes, for example, a plurality of power sources, including a removable battery power pack 902 and a secondary power source 904. The removable battery power pack 902 is similar in many respects to the removable battery power packs described herein. The battery power pack 902 contains, for example, a plurality of Li-ion and/or LiPo cells. The secondary power source 904 provides a source of power to the handle module 900 even when the removable battery power pack 902 has been removed or otherwise disconnected from the handle module 900. With this embodiment, the secondary power source 904 is used, for example, for low power operation of the handle module 900, such as powering electronic components on the control board 910 when the removable battery power pack 902 is removed from the handle module 900; and not for high power operation, such as powering the motor 905 of the handle module 900. In various arrangements, the secondary power source 904 may include a rechargeable battery cell and/or a super capacitor (a/k/a super capacitor) that is charged by the removable battery power pack 902 when installed. As long as the secondary power source 904 has sufficient charge, the secondary power source 904 can power the electronic components on the control board 910 without the primary power source 902.
The secondary power source 904 may allow the handle module 900 to track usage events and/or take end-of-life actions even when the power pack 902 is not installed in the handle module 900. Fig. 17A is a flow chart of a process that may be performed, for example, by a processor of the control board 910, such as the handle processor 2124. According to at least one embodiment, the processing may be performed by software and/or firmware stored, for example, in the memory of the handle module. Prior to performing a surgical procedure, the power pack 902 is installed in the handle module 900. At process step 920, the handle processor may record a timestamp 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 occurred during the surgical procedure. In addition, the handle processor may track the time elapsed between firings. In at least one instance, the secondary power source 904 may continue to provide power to the handle processor to track the time after the firing event even if the removable power pack 902 is removed from the handle module 900. At step 924, the handle processor may determine whether the elapsed time since the last firing is greater than a threshold time period. In at least one instance, for example, the threshold time period can approximate the time required to substantially process and sterilize the handle module after a procedure. If the time period between firings is not greater than the threshold, then it may be assumed that the procedure is proceeding, and processing may return to step 922 to record the timestamp of the next firing. On the other hand, if the time period between firings is greater than the threshold, then it may be assumed that the procedure has ended, at which point the handle processor may increment the usage count of the handle module 900 at step 926. At step 928, the handle processor compares the usage count to a preprogrammed threshold usage count of the handle module 900. If the usage count is less than the threshold, the handle module 900 may be used in another procedure and the process may return to step 920 to wait for the connection of the DSM of the next procedure. On the other hand, if the usage count threshold has been reached, processing proceeds to step 930, where an end-of-life action of the handle module 900 may be initiated. As described above, the end-of-life action may include deactivating the handle module such that the handle module cannot be used in a subsequent surgical procedure. In at least one instance, the motor of the handle module can be physically and/or electronically deactivated. In some cases, the end-of-life action includes visually indicating the end of life of the handle module, e.g., on a display of the handle module and/or sounding an audible alarm.
Fig. 17B is a flow diagram of another exemplary process that may be performed by the handle processor and sometimes powered by the secondary power source 904 to track usage of the handle module. At step 950, the handle processor may 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 instances, insertion of the power pack 902 indicates to the handle processor that a surgical procedure involving the handle module 900 is about to begin. Thus, when the handle processor detects insertion of the power pack 902 into the handle module 900, the handle processor may set the processing flag to ON at step 952. At step 954, the handle processor may detect for the program a complete and appropriate connection of the DSM to the handle module. Various techniques for detecting attachment of a DSM are described elsewhere herein. Once the DSM and battery pack 902 have been properly attached, the surgical instrument can be used to complete the surgical procedure. With the battery pack 902 removed from the handle module 900, the handle processor may detect the removal of the battery power pack 902 at step 956. Various techniques for detecting removal of a power pack are disclosed elsewhere herein. In various circumstances, removal of the power pack indicates the end of the surgical procedure, and thus, the handle processor, now powered by the secondary power source 904, may 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 another use even if the removal of the power pack does not constitute the end of the surgical procedure. Such reuse of the handle module 900 may be adjusted on the test applied 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 has been reached, the handle processor may initiate an appropriate end-of-life action at step 962. Various end-of-life actions are disclosed elsewhere herein. It should be understood that with respect to any of the embodiments disclosed herein, the end-of-life action may be covered by a user of the handle module. Such a situation typically occurs, for example, when a usage threshold count has been reached in the middle of a surgical procedure.
Fig. 18A-18E illustrate end-of-life actions that may be taken by a handle module that prevents further use of the handle module using, for example, a removable battery power pack. Fig. 18A shows a handle module 1000 that includes an internal spring activated lock 1002. When released by the handle module 1000, the lock 1002 prevents the battery power pack 1004 and/or any other suitable battery pack from being fully and properly installed into the handle module 1000. In various circumstances, the lock 1002 can be configured to completely prevent the power pack 1004 from entering the handle module 1000. In other cases, the lock 1002 may prevent the power pack 1004 from being inserted to the depth where the battery contacts make electrical contact with the handle contacts, as shown in fig. 18A, and described in further detail below. Due to the activation of the lock 1002, the power pack 1004 extends a distance D from the handle module 1000, as also shown in fig. 18A. However, for the lock 1002, the battery pack 1004 may be seated to a depth where the end cap 1006 of the battery pack 1004 is flush, or at least substantially flush, with the housing of the handle module 1000.
As described above, the lock 1002 may selectively prevent the power pack 1004 from supplying power to 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 may be in contact with the contact pads 1018 of the battery pack 1004 so that the internal electronic components of the handle module 1000 may be powered by the battery power pack 1004. In the locked state of the handle module 1000 shown in fig. 18C, the lock 1002 prevents the contact pads 1018 of the battery pack 1004 from contacting the contact pads 1016 of the handle module 1000. In embodiments where the handle module 1000 does not include a secondary power source and/or means for storing power, the handle module 1000 will not be usable in its locked state. In embodiments where the handle module 1000 includes a secondary power source and/or means for storing power, the handle module 1000 may utilize power from these other sources, for example, to run the operating system of the handle module 1000 instead of the drive system and/or electric motor of the handle module 1000.
Fig. 18B shows the lock 1002 in a normal operating state, in which the lock does not lock the battery pack 1004, and fig. 18C shows the lock 1002 in a locked state, in which the lock locks the battery pack 1004. The lock 1002 is biased to rotate from its unlocked position (fig. 18B) to its locked position (fig. 18C) by a torsion spring 1010 connected to the lock 1002. The torsion spring 1010 has a first end biased against the interior surface 1013 of the handle module 1000 and a second end mounted to the lock 1002. The handle module 1000 further comprises a latch 1012 configured to releasably retain the lock 1002 in its unlocked position. The locking member 1002 includes a locking shoulder 1014 that abuts the latch 1012 when the latch 1012 is in the extended position and thus retains the locking member 1002 in its unlocked position. When the latch 1012 is retracted, as shown in fig. 18C, the shoulder 1014 of the locking member 1002 no longer engages the latch 1012 and the torsion spring 1010 can bias the locking member 1002 to its locked position.
When the end-of-life state of the handle module 1000 has not been reached, the latch actuator of the handle module 1000 can hold the latch 1012 in the position shown in fig. 18B. However, when the end-of-life state 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, allowing the locking piece 1002 to rotate counterclockwise due to the bias of the spring 1010, as indicated by arrow B in fig. 18C. In the locked state, the lock 1002 protrudes into the battery compartment of the handle module such that the electrical contact pads 1016 of the handle module 1000 do not contact the contact pads 1018 of the battery pack 1004 when the battery pack 1004 is inserted into the handle module 1000, as described above. The latch actuator may comprise, for example, any suitable actuator, such as a solenoid.
In addition to or in lieu of the foregoing, fig. 18D and 18E illustrate embodiments in which the battery pack positioned in the handle module cannot be removed from the handle module at the determined end of life of the handle module, thereby preventing the insertion of a new (or recharged) battery pack in the handle module for a subsequent procedure. Fig. 18D shows the battery pack 1004 in a normal operating state, where it can be removed from the handle module after a procedure, and fig. 18E shows latch 1040 that locks the battery pack 1004 in the handle module so that the battery pack 1004 cannot be removed from the handle module. As shown in fig. 18D and 18E, the battery pack 1004 may define an opening 1042 into which a latch head 1044 of the latch 1040 may be inserted to lock the battery pack 1004 in place. Latch 1040 is biased downward by a compression spring 1046 mounted on an upper shaft 1048 of latch 1040. Latch 1040 also includes an upper shoulder 1050 that abuts a second latch 1052 positioned to hold spring 1046 in a compressed state and prevent downward movement of latch 1040 in the normal operating state of the handle module shown in fig. 18D. As also shown in fig. 18D and 18E, the latch head 1044 includes a shoulder 1054 that locks behind a mating shoulder 1056 defined by the battery pack 1004 when the latch 1044 is in its actuated position, as shown in fig. 18E.
In operation, when the handle processor determines that the handle module has reached the end of its life (by any of the means described herein), the handle processor may actuate the second latch 1052, causing the second latch 1052 to move away from the latch 1044. The second latch 1052 may be actuated by any suitable actuator, such as a solenoid, for example. In the illustrated embodiment, when latch 1052 is actuated, second latch 1052 moves side-to-side away from shoulder 1050 of latch 1040, as indicated by arrow a. Removing the second latch 1052 from the shoulder 1050 allows the spring 1046 to decompress and push the latch 1044 downward through an opening 1060 defined in the housing 1013 of the handle module, as indicated by arrow B. As the latch 1040 is moved downward by the spring 1046, the latch head 1044 extends into an 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, the downward movement of the latch head 1044 is limited by the handle module housing 1013. Thus, the battery pack 1004 cannot be removed from the handle module, thereby preventing the insertion of a new (or recharged) battery pack into the handle module for a subsequent procedure.
Referring now to fig. 19A-19C, the handle module 1100 includes a rechargeable battery pack 1102 (having one or more rechargeable battery cells 1104) that can be recharged when the handle module 1100 is docked to the charging station 1106. The handle module 1100 further comprises a slidable door 1108 that slides up and down in a channel 1110 defined in the handle module 1100 between an open position (fig. 19C) and a closed position (fig. 19B). The compression spring 1112 is positioned in a channel 1110 configured to bias the slidable door 1108 downward to its closed position. For example, when the door 1108 is in its closed position, the door 1108 may shield the battery charging terminals 1114, as shown in fig. 19B, from damage and/or accidental contact with conductive surfaces in the surrounding environment. To recharge the battery unit 1104, the handle module 1100 is placed in a receiving area 1120 defined by a charging station 1106 that includes charging terminals 1122 that mate with and contact 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. When the handle module 1100 is placed in the receiving area 1120, the slidable door 1108 engages a shoulder 1124 of the charging station 1106, which pushes the slidable door 1108 upward, as indicated by arrow a, thereby compressing the spring 1112 and unshielding (or exposing) the battery pack charging terminals 1114. At this point, the charging terminals 1114 may connect to and contact the receiving console charging terminals 1122 to recharge the battery cells 1104 of the battery pack 1102.
The charging console 1106 may be powered by an AC power source via a power cord 1130. The charging console 1106 can also include a visual display 1132 that displays information about the handle module 1100. For example, the charging station 1106 can include a processor (not shown) in communication with the handle processor when the handle module 1100 is installed in the charging station 1106. For example, the charge terminals 1114,1122 may also include data terminals that provide a data path between the processors. The charging console processor may receive information/data from the handle processor that may be displayed on display 1132. For example, the displayed information may include, for example, the state of charge (e.g., charged X%) of battery pack 1102 and/or any information tracked by the handle processor, such as a life count or remaining usage of the handle module and/or, for example, a number of valid term firings.
Fig. 20A-20B illustrate covers 1201,1202,1203 that may be used with the handle module 1200 to protect the internal components of the handle module 1200 during a sterilization process. The handle module 1200 includes an attachment portion configured to have a DSM attached thereto. The end effector attachment area cap 1201 may attach (e.g., snap fit) to and cover the location where the DSM is attached to the handle module 1200. The handle module 1200 also comprises a removable trigger assembly for actuating the drive system of the handle module 1200. In addition to or in lieu of the above, a trigger cover 1202 can be connected to (e.g., snap fit) and cover an opening created when the firing trigger assembly is removed from the handle module 1200. The handle module 1200 also includes a battery cavity configured to receive a removable power pack therein. Additionally, or in lieu of the above, a battery pack cover 1203 may be connected to and cover the location where the battery pack is inserted into the pistol grip portion 1206 of the handle module 1200. These covers 1201,1202,1203 are preferably made of a material, such as plastic, for example, that is resistant to the chemicals used to sterilize the handle module. Additionally, the covers 1201,1202,1203 may cover the electrical contacts of the handle module 1200, including, for example, the end effector contact plates 1210, the drive system 1212, and/or the internal contacts for the battery pack (not shown).
The attachment of the covers 1201,1202, and/or 1203 to the handle module 1200 may help track the number of times the handle module 1200 has been used and/or sterilized. Similarly, the detachment of the covers 1201,1202, and/or 1203 from the handle module 1200 may 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 a means to trigger a switch on the handle module 1200 indicating that the cover has been installed. When such a switch is triggered, the handle processor can assume that a sterilization procedure is imminent and enter a sterilization mode of operation that is optimized to withstand the sterilization procedure. For example, when the handle processor is in a sterilization mode of operation, the handle processor may prevent the motor of the handle module 1200 from being operated, power down certain contacts and/or sensors, power up certain contacts and/or sensors, record any data stored in the transient memory to the memory chip, copy the memory of the handle module to a backup memory, and/or create a copy of the current version of the operating system software for the handle module. 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 the handle module 1200 or detached from the handle module 1200. In the illustrated arrangement, the DSM connection area cover 1201 includes a protrusion 1220 that contacts and actuates a corresponding switch 1222 (e.g., a depressible switch or a contact switch, etc.) on the handle module 1200 when the cover 1201 is placed on the handle module 1200. The switch 1222 may be in communication with the handle processor, and in various circumstances, the handle processor may update its sterilization count when actuation of the switch 1222 is detected. In other arrangements, the trigger 1220 may be on other covers 1202,1203 and/or placed at different locations on the DSM connection area cover 1201. In any event, since the battery pack is typically removed during sterilization, the covers 1201,1202,1203 are preferably used in handle modules having a secondary power source that powers the handle processor even when the battery pack is removed, as described herein. As described in other arrangements herein, the handle processor may implement one or more of the end-of-life actions described herein when the sterilization count reaches a threshold level.
Fig. 20C shows a modification of battery pack cover 1203, and fig. 20D shows a battery pack 1240 that can be interchanged with battery pack cover 1203 of fig. 20C. Because the battery pack cover 1203 and the battery pack 1240 are both designed to fit into 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. 20C has a shape and configuration very similar to the battery pack 1240 of fig. 20D. For example, battery pack cover 1203 and battery pack 1240 both include a clamp 1244 for locking to handle module 1200. In addition, battery cover 1203 and battery 1240 also include one or more tubular receptacles 1242. Battery cells 1246 may be in receptacles 1242 in battery pack 1240 instead of for lid 1203. However, cover 1203 also includes features that easily distinguish it from battery pack 1240. In the illustrated arrangement, the lid 1203 includes a relatively thin, long, and easily graspable tab 1248 at the bottom of the lid 1203, which may include indicia indicating its use for sterilization, as shown in fig. 20C.
As also shown in fig. 20C and 20D, each of lid 1203 and battery pack 1240 may include respective tabs 1250,1252 located at different relative positions. In the arrangement shown, tab 1250 of lid 1203 is on right receptacle 1242 and tab 1252 on battery pack 1240 is on left receptacle 1242 thereof. When inserted into the handle module 1200, the tabs 1250,1252 can contact and actuate corresponding and corresponding switches in the handle module 1200 to identify the insertion of the cover 1203 or battery pack 1240 (as the case may be). A switch (not shown) may be in communication with the handle processor, and the handle processor may use actuation of the respective switch to update its usage, sterilization, and/or battery pack connection count, as appropriate. For example, actuation of the sterilization switch may place the handle module 1200 in a sterilization mode of operation, and actuation of the battery switch may place the handle module 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 actuated only by the battery pack 1240 and a sterilization switch actuated only by the sterilization lid 1203. In various arrangements, tabs 1250,1252 can be located, for example, at a mirror opposite the location on well 1242. Both the lid 1203 and the battery pack 1240 can include features such that they can only be inserted in one orientation, thereby preventing the battery pack tab 1252 from actuating the sterile lid switch, and vice versa. For example, in the illustrated arrangement, battery pack cover 1203 and battery pack 1240 both include tongues 1254 on only one side thereof that can fit into corresponding grooves defined in only one side of handle module 1200.
Fig. 21A-21C illustrate an exemplary display for the handle module 1300 and/or DSM 1302 that may provide visual information to a user 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 on the handle module 1300 and a display portion 1304B on the DSM. The display portions 1304A and 1304B can be adjacent to each other or separate from each other. In some cases, display portions 1304A and 1304B may be used to display discrete or non-overlapping sets of information. In various instances, display portions 1304A and 1304B may be used to display coordination information, which may or may not be repetitive. In certain other instances, 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. Display 1304 may include, for example, a flat panel display (such as an LED-backlit LCD flat panel display) and/or any other suitable flat panel or non-flat panel display type. The display 1304 may be controlled by the handle processor and/or the DSM processor.
Fig. 21D illustrates an exemplary display configuration, wherein the display includes adjacent handle portion 1304A and end effector portion 1304B. As shown in fig. 21D, the handle portion 1304A indicator can include an indicator associated with the handle module, such as a battery status indicator 1310, an indicator 1312 showing that a DSM connected to the handle module is identified, and/or a handle module error indicator 1314 in general. The DSM display 1304B may include, for example, indicators associated with DSM such as an indicator 1320 of whether the end effector jaws are closed, an indicator 1320 of whether a staple in the end effector has not been fired, an indicator 1322 of whether a staple has been properly fired, and/or an indicator 1324 of 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 as to the status of various components and aspects of the handle module 1300 and/or DSM 1302. For example, the display 1304 may indicate, for example, the number of firings remaining in the battery pack and/or the number of uses remaining in the handle module. The display may include buttons and/or a touch screen interface where a user/clinician may input information to the handle module and/or DSM processor/memory.
In various instances, the removable battery pack may be sterilized and recharged after a procedure such that it may be reused in subsequent procedures in the same handle module and/or a different handle module. Fig. 22 is a diagram of a removable battery pack 1350 that can track the number of times it has been sterilized, which can be representative of the number of times the battery pack 1350 has been used in a surgical procedure. Battery pack 1350 may include a plurality of battery cells 1352 having output voltage terminals 1354. As shown in fig. 22, the battery pack 1350 may also include a battery pack processor 1360 mounted to a battery pack circuit board 1362. The battery processor 1360 may include internal or external memory (such as an external memory chip 1364 mounted to a circuit board 1362), and the battery processor 1360 may execute software/firmware stored in the memory. Accordingly, the battery pack processor 1360 may implement a Battery Management System (BMS) that manages the rechargeable batteries. For example, the BMS may protect the battery from operating outside of its safe operating area, monitor the state of the battery, calculate auxiliary data, report this data, control its environment, authenticate the battery, and/or balance the cells of the battery.
In various arrangements, the battery pack 1350 may also include a micro-moisture or humidity sensor 1366 for sensing when the battery pack 1350 is in a humid or wet environment consistent with undergoing a sterilization process. The battery processor 1360 may be in communication with the moisture/humidity sensor 1366 such that for each instance where the moisture/humidity sensor 1366 detects a threshold level of moisture or humidity within a threshold period of time, the battery processor 1360 may update its sterilization count as representative of the number of times the battery 1350 has been used. In various instances, the battery processor 1360 may be configured to not count anomalous events that may produce false positives. In any event, once the threshold sterilization count has been reached, the battery processor 1360 may disable the battery 1350. For example, as shown in fig. 22, the battery pack 1350 may include data terminals 1368 that provide a connection to the handle processor of the handle module. When the battery 1350 is exhausted (e.g., reaches a sterilization count threshold), the battery processor 1360 may signal to the handle processor that the battery 1350 should not be used. The handle processor may then indicate via its display that a problem exists with the battery pack 1350.
In various instances, the battery pack processor 1360 may update its usage count based on the data connection to the handle module. The battery pack processor 1360 may update its usage count each time it detects a data connection of the handle module.
The battery pack 1350 may include a secondary power source (not shown) that is charged by the battery cells 1352 when the battery cells 1352 are charged and/or that supplies power to the handle module during a surgical procedure. In such embodiments, the low power battery electronics can remain powered even when the battery 1350 is not installed in the handle module. Additionally, as shown in fig. 22, the battery pack 1350 may include an end cap 1370 and a latch 1372 to facilitate connecting the battery pack 1350 to the handle module.
Fig. 23A and 23B illustrate another possible end-of-life action for the handle module. In the illustrated arrangement, the handle module 1400 includes a projection 1402 that is movable between a retracted position and an extended position. The projection 1402 is held in its retracted position until the end of the life of the handle module 1400. In such a position, the projection 1402 does not interfere with the handle module 1400 being positioned in its corresponding opening in the sterilization tray 1404. Once the handle processor determines that the handle module 1400 has reached the end of its life, the projection 1402 moves to its extended position according to any suitable algorithm. In such a position, the projections 1402 interfere with the proper placement of the handle module 1400 in its corresponding opening in the sterilization tray 1404. In the illustrated arrangement, the projection 1402 is at the distal end 1406 of the handle module 1400, but it can be placed anywhere convenient and, when projected, it prevents the handle module 1400 from being placed in a corresponding opening of the sterilization tray 1404. As previously described in connection with fig. 11A, the sterilization tray includes an opening having a shape that corresponds to the shape of the handle module such that the handle module is closely received in the opening. In the arrangement of fig. 23A and 23B, the handle module 1400 fits into an opening in the sterilization tray 1404 when the projection 1402 is retracted (not projected), but does not fit into the opening when the projection 1402 projects outwardly from the handle module 1400, as shown in fig. 23A and 23B. The projection 1402 may be solenoid driven, for example. 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 is energized causing the solenoid armature to extend outward causing the projection 1402 to extend outward from the handle module 1400. The handle module 1400 may also include detents, such as spring-loaded detents, that prevent retraction of the solenoid armature and the projection 1402 once they have been actuated.
As described in connection with fig. 12A-12E, the handle module can be connected to the inspection station before, during, and/or after the procedure. The inspection station may be used to perform tests on the handle module to determine if the handle module is in a condition suitable for another surgical procedure, or if the handle module requires adjustment or repair before being suitable for another surgical procedure. As shown in fig. 24A and 24B, the inspection station 1500 includes an extension 1504 configured to be inserted into an empty battery cavity of the handle module such that the extension 1504 may be placed in communication with the handle module, similar to the embodiments described above. The handle module 1501 shown in fig. 24B includes, for example, such a handle module. The inspection station includes a vacuum coupling 1502 at an upper portion of the extension 1504 that can mate with a corresponding vacuum coupling 1506 in an interior portion of the handle module 1501. Inspection station 1500 may be connected via vacuum port 1508 to a vacuum pump connected via tube 1510 to vacuum coupling 1502 of inspection station 1500. When the vacuum pump is turned on, it may draw air from the interior portion of the handle module 1501 to dry the interior portion of the handle module 1501. Inspection station 1500 may include a pressure gauge and/or air flow sensor in communication with tube 1510 that measures the degree to which handle module 1501 maintains vacuum pressure. In various instances, such vacuum testing may assess the integrity of various seals throughout the handle module 1501, such as seals engaged with the rotary drive outputs 1512,1514, seals engaged with the firing trigger region 1516, and/or seals engaged with the electrical contact plate 1518 connected to the DSM, for example. If the various handle module seals are not satisfactory and the handle module does not adequately maintain a vacuum as detected by the vacuum sensor, inspection station 1500 may issue a warning via its display indicating that handle module 1501 requires repair.
In addition to or in lieu of the above, the inspection station may be capable of drying the handle module after a surgical and/or sterilization procedure as part of preparing the handle module for a subsequent procedure. Fig. 25A shows an inspection station 1600 that can be used, for example, to dry a handle module 1602. Similar to the above, the inspection station 1600 includes a base portion 1610, additionally including an extension 1606 extending from the base portion 1610, which can be positioned in an empty battery cavity of the handle module 1602 in order to place the handle module 1602 in communication with the inspection station 1600. Inspection station 1600 includes two fans: a first fan 1604 at an upper end of the extension 1606, and a second fan 1608 at a front of the base portion 1610. The fans 1604 and 1608 are powered, such as by an AC power source, for example, via a power adapter 1612. The first fan 1604 may be aimed at the internal components of the handle module 1602 through an opening in the battery pack cavity. The upper surface of extension 1606 may include a vent opening through which air blown by first fan 1604 may circulate to handle module 1602. The second fan 1608 can be aimed at the trigger region 1614 of the handle module 1602 to dry the trigger region 1614 and surrounding regions of the handle module 1602. The top front surface of the base portion 1610 of the inspection station 1600 may include vent openings 1616 for the second fan 1608 such that air blown from the second fan 1608 may be circulated to the trigger area 1614. The base portion 1610 may also include air inlets for the fans 1604 and 1608, such as air inlet 1618 in the base portion 1610. The inspection station 1600 may also include exhaust ports, such as bilateral exhaust ports 1620 at the bottom of the extension portion 1606 to allow exhaust gases to escape from the inspection station 1600. The inspection station 1600 may include as many fans, air inlets, and/or air outlets as desired.
Fig. 25B, 25C, and 25D illustrate another exemplary inspection station 1600. The base portion 1610 in fig. 25B, 25C, and 25D is longer from front to back than the base console in fig. 25A, and the lower front fan 1608 in fig. 25B, 25C, and 25D is raised above the base portion 1610 and angled at the trigger region 1614. The arrangement shown in fig. 25B, 25C and 25D further comprises a cover (or cover) 1630 that is attached to the base portion 1610 of the inspection portion 1600 and that covers and encloses the handle module 1602. Cover 1630 may be made of, for example, a hard translucent plastic such as polycarbonate. In an aspect, the fan 1608 may be powered by an adapter 1612 for inspecting the console 1600, as shown in FIG. 25C. In another aspect, the fan 1608 may have its own power adapter 1632 separate from a power adapter 1612 used to inspect the console 1600, as shown in FIG. 25D. The upper surface of the cover/lid 1630 may include one or more exhaust ports 1634, and the cover/lid 1630 may also include an intake port 1636 proximate to the fan 1608.
Fig. 25E shows another arrangement for an inspection station 1600 that uses vacuum flow to dry the handle module 1602. In such an arrangement, the cap/closure 1630 can define one or more air inlets 1640 (two of which are shown in fig. 25E) and have a vacuum port 1642 configured to be placed in communication with a vacuum pump. To dry the handle module 1602, the vacuum pump is turned on to draw air from the air inlet 1640, across the handle module 1602, and into the vacuum port 1642. Preferably, the vacuum port 1642 is spaced from the air inlet 1640 to increase the air flow across the handle module 1602. In the embodiment of FIG. 25E, the air inlet 1640 is at the bottom of the cap/closure 1630 and the vacuum port 1642 is at the top of the cap/closure 1630; however, any suitable arrangement may be used.
Handle modules, such as handle module 1602, for example, may also be tested by the simulated load adapter. In various instances, when the handle module 1602 is connected to the inspection station 1600, the handle module 1602 may be tested by the load adapter 1650, as shown in the embodiment of fig. 26A-26D. In other cases, the mock load adapter may be configured to test the handle module without supplementing the inspection station. In any case, the analog load adapter 1650 may include a housing 1651 and opposing load motors 1652,1654 positioned in the housing 1651. As described in further detail below, the first load motor 1652 is configured to apply a first test load to a first drive motor of the handle module 1602, and the second load motor 1654 is configured to apply a second test load to a second drive motor of the handle module 1602. The first load motor 1652 is configured to drive a first mating nut 1660 that is operably engaged 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 engaged with a coupler 1658 driven by a second drive motor of the handle module 1602.
The analog load adapter 1650 may include motor control circuitry, for example, on a circuit board having at least a processor, memory, and motor controller for controlling the load motors 1652, 1654. The motor control circuit may be embodied as one integrated circuit (e.g., SOC) or multiple discrete integrated circuits or other circuits. The motor control circuitry may control the motors 1652,1654 to apply opposing forces to the rotary drive system of the handle module 1602 under varying load conditions. The power consumed by the rotary drive system of the handle module 1602 to resist and/or overcome the opposing force may be monitored by the inspection station 1600 to determine if the handle module motor and rotary drive system are functioning properly. In various circumstances, the first motor 1652 of the simulated load adapter 1650 can drive in one direction and the drive motor of the handle module 1602 can drive the first coupling 1656 in the opposite direction. If the drive motor of the handle module 1602 cannot resist or overcome the simulated load applied by the first motor 1652 of the simulated load adapter 1650, the simulated load adapter 1650 may indicate to the handle module 1602 that the handle module 1602 cannot perform as desired. In various instances, the second motor 1654 of the simulated load adapter 1650 may drive in one direction and the drive motor of the handle module 1602 may drive the second coupling 1658 in the opposite direction. If the drive motor of the handle module 1602 cannot resist or overcome the mock load applied by the second motor 1654 of the mock load adapter 1650, the mock load adapter 1650 may indicate to the handle module 1602 that the handle module 1602 cannot perform as desired. Such an evaluation may constitute an overall evaluation of whether the handle module 1602 is suitable for one aspect of another procedure.
In various instances, further to the above, the mock load adaptor motor control circuit may vary the load exerted by the mock load adaptor motors 1652,1654 on the rotary drive system of the handle module 1600 from (relatively) low to (relatively) high in a manner that mimics the load that the handle module rotary drive system is expected to experience during a surgical procedure. In at least one instance, the motor control circuit can be programmed such that it can change the load profile of the motors 1652,1654 based on the type of DSM that is to be used in the upcoming program. For example, using the user interface 1672 (e.g., buttons 1670 and/or a touch screen of the interface 1672), the user may specify, for example, a desired simulated load state, such as selecting a preprogrammed simulated load state corresponding to different available DSMs. Analog load adapter 1650 can have data contact terminals 1674 that mate with data connection terminals of handle module 1602. In this manner, 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 simulation and/or after simulation, the motor control circuit can download time-stamped power readings (e.g., volt-amperes) for the power supplied to the load simulator motors 1652,1654 during simulation to the handle module processor and/or the inspection station processor. The inspection station processor and/or the handle module processor may correlate these readings with time-stamped readings of power consumed by the handle module motor to assess the efficacy of the handle module motor and rotary drive system.
The analog load adapter 1650 may be powered by, for example, the inspection station 1600. As shown in the embodiment of fig. 26B, power from the inspection station 1600 may be supplied to the simulated load adapter 1650 via the handle module 1602 and the electrical contact board 1674. In the embodiment of fig. 26C, a separate power cord 1680 extending from the inspection station 1600 to the simulated load adapter 1650 may supply power directly to the load simulator adapter 1650, bypassing the handle module 1602. In another arrangement, the load simulation adapter 1650 may have its own connection to an AC power source and/or its own battery power supply. In various instances, the cord 1680 may also place the load simulator 1650 in direct signal communication with the inspection station 1600.
The dummy load adapter 1650 can also be used to monitor backlash in the handle module gear as part of the rotary drive system. When the mock load adapter 1650 is in the backlash detection mode, the mock load adapter motor control circuit may rotate one or both of the mock load motors 1652,1654, and the processor of either the inspection system 1600 and/or the handle module 1602 may track the rotation by the corresponding rotational drive system of the handle module 1602. The rotational difference between the simulated load adapter motors 1652,1654 and the rotary drive systems of the handle module 1602 is indicative of backlash in the respective rotary drive systems of the handle module 1602, which can reduce the life of the handle module. In other words, the increase in backlash can reduce the number of remaining uses of the handle module 1602. Thus, at each inspection of the handle module 1602, the inspection station 1600 and the load simulator 1650 may inspect the backlash of the handle module and write the results to the memory of the handle module. The handle module memory may store and time stamp the backlash readings. The handle processor and/or the inspection console processor may determine a modified end-of-life threshold for the handle module as a function of firing, for example, based on a model of the effect of backlash on the number of remaining uses. The sample model is shown in fig. 26E. Dashed line 1690 illustrates a threshold limit for backlash as a function of the number of firings performed by the handle module. Line 1691 shows the expected backlash of the handle module as a function of use (e.g., firing). In this embodiment, the side gap threshold is reached ( lines 1690 and 1691 intersect) at about 500 firings. Since the backlash measurement may be tracked over time (and thus within the number of firings), the handle processor and/or the inspection processor may compare the backlash measurement indicated by the diamond shape of fig. 26E to determine that the handle module backlash tends to reach the threshold at less than 500 firings (about 370 firings in this embodiment). The modified updated fire threshold may be used to evaluate the remaining life of the handle module. For example, if the handle module has been fired 220 times and its modified end of life is 370 firings due to backlash, the processor may determine that the handle module has 150 remaining firings; or if it is assumed that there are 7 firings per procedure, the handle module has 21 remaining procedures. In this way, each rotary drive system of the handle module can be tested for backlash, and the one with the shortest remaining life can determine the overall remaining life of the handle module.
As described above, if less backlash is measured than expected, the firing required to reach the end-of-life threshold of the handle module may be modified or increased upwardly. In fact, for example, if any parameter and/or combination of parameters indicates that the handle module is experiencing less wear than expected, the end-of-life threshold of the handle module may be increased. Accordingly, for example, if any parameter and/or combination of parameters indicates that the handle module is experiencing greater than expected wear, the end-of-life threshold of the handle module may be reduced. Further, the various parameter thresholds disclosed herein may be fixed or adaptable. The threshold parameter may be adjusted based on intrinsic information and/or extrinsic information. For example, the control system of the handle module may evaluate a pattern or trend of the parameter data and adapt the parameter threshold relative to the pattern or trend. In at least one instance, the control system can establish a baseline from sensed parameter data and establish a parameter threshold relative to the baseline. In some cases, the control system of the handle module may evaluate a pattern or trend of data obtained for the first parameter and adjust the threshold value of the second parameter based on the evaluation of the first parameter data. In at least one instance, the control system can establish a baseline from sensed data of a first parameter, and establish a threshold of a second parameter relative to the baseline. 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 situation. That is, as described herein, a threshold value may include three ranges, a first range below a minimum value, a second range above a maximum value, and a third range between the minimum value and the maximum value. The control system may take a first action if the sensed data for the parameter is within a first range, and may take a second action if the sensed data for the parameter is within a second range, which may or may not be the same as the first action. If the sensed data of the parameter is within the third range, the control system may take a third action, which may not include any action at all. The minimum value may be part of the first range or the third range, as appropriate, and the maximum value may be part of the third range or the second range, as appropriate. For example, if data is sensed within a first range, in at least one embodiment, the control system may adapt the threshold in one direction, and if data is sensed within a second range, the control system may adapt the threshold in the opposite direction, while if data is sensed within a third range, the control system may not adapt the threshold.
In another aspect, as shown in fig. 27A and 27B, the inspection station 1600 may house, for example, a handle module 1602 and one or more DSMs 1680. Fig. 27A shows such an inspection station 1600 itself; fig. 27B shows an inspection station 1600 having both handle module 1602 and DSM 1680 connected thereto. The inspection station processor may communicate with the handle module processor and/or the DSM processor to download and upload data and information. As shown in fig. 27A, inspection station 1600, which also supports a DSM, may include rotary drives 1682,1684 configured similarly to rotary drives 1656,1658 of handle module 1600. Inspection station 1600 may actuate inspection station rotary drives 1682,1684 to test the drive system of DSM 1680. In other arrangements, for example, DSM 1680 may have its own inspection station for performing various tests and/or data transfers.
In view of the above, a number of pre-program and/or post-program instrument processing tasks for the handle module and/or DSM can be performed using the inspection station 1600, such as:
determine and display device ID (e.g., serial number) and/or model and status of the device (e.g., end of life, locked, etc.);
Read/download data from the memory of the handle module 1602, such as the number of firings/cycles, performance parameters, handle and/or DSM software version;
based on the device identification, setting and uploading operating instructions and criteria for the handle module and/or DSM, which the inspection station may retrieve from memory based on the device ID;
performing various electronic tests, such as a modular connection integrity test, a memory version test, a system electronics check, a transfer rate (read/write) check, a scheduled maintenance check, a warranty expiration check, an end of life check, a system lockout check, and/or an internal battery life adjustment test;
performing various physical tests, such as motor performance tests (with and/or without a simulated load as described above), seal integrity tests, and the like;
performance testing, such as comparing actual data from the program (downloaded from the handle module and/or DSM memory) to expected program data;
resetting the lock in the handle module when necessary;
drying the device;
notify the user (e.g., via a display) that the device (handle module and/or DSM) is or is not suitable for continued use;
Upgrading the software of the shank module and/or the DSM;
writing the test results to the handle module memory and/or the DSM memory; and/or
Communicate handle and/or DSM performance and usage data to a remote computer system via, for example, a USB or wireless (e.g., wiFi) connection.
The inspection station memory may store software and/or firmware that the inspection station processor executes to perform these various functions.
The display of the inspection station and/or the handle module may also suggest maintenance and repair recommendations based on various usage-related data for the handle module. Based on the usage data, such as the number of procedures, number of sterilizations, number and/or intensity of firings, and/or gear backlash, for example, the inspection station and/or handle module processor may determine whether various maintenance or repair tasks should be undertaken or suggested with respect to the handle module and/or DSM, and communicate these suggestions to the user via a display of any of the inspection station and/or handle module. Maintenance and repair recommendations may be performed and communicated to the user after the procedure is completed, during the procedure, and/or at the beginning of the procedure.
28A-28B are exemplary process flows for making maintenance and/or repair recommendations that may be executed by the handle module processor and/or the inspection station processor by executing firmware and/or software in the processor's associated memory. FIG. 28A illustrates an exemplary process flow for inspecting the console processor 442. At step 1800, after the procedure, the handle module is connected to an inspection station (see, e.g., fig. 19A), whereby usage and performance data from the handle module memory is downloaded to the inspection station. The data may include a count of the number of programs of the handle module; various ways to count the number of programs are described herein. The data may also include, for example, the number of firings performed by the handle module, the intensity (e.g., force) of each firing, the firing force differential between the expected firing force and the actual firing force, the (cumulative) energy consumed by the handle module over the life of the handle module, and/or gear backlash.
At step 1802, based on the data, the inspection station processor determines if maintenance of the handle module is required. The inspection station processor can parse the usage and performance data in a variety of ways according to programming to determine if service is needed, and if it determines that service is needed, one or several service recommendations can be made at step 1804. The repair recommendation may be as extensive as, for example, recommending a shank module rebuild, or with lubricating a certainThese components are equally minor. Additionally, for example, one service check that the inspection station processor may perform at step 1802 is for each N 1 Program and/or each S 1 Firing, or procedure and firing (e.g., N) 2 Procedure and S 2 Firing), the handle module should be rebuilt. 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 may control the inspection station display to indicate that the handle module should be rebuilt. Another service check that the inspection station processor may perform at step 1802 is at every S 3 The gears of the rotary drive system should be lubricated during firing. Other maintenance checks that the inspection station may perform and recommend under appropriate circumstances include, for example: an electrical integrity check for electrical contacts of the handle module; testing the communication system; extended diagnostics of electronics of the handle module (e.g., RAM and/or ROM integrity, processor operation, idle and operational current consumption, operating temperature of selected components, etc.); indicating the operation of the markers, display and sensors; and/or battery problems, such as cycling, balancing, and/or testing. Maintenance checks may be performed on the battery to assess the state of the battery. For example, the inspection console may evaluate whether the battery is near the end of its life, rechargeable, or near a threshold that is less than one remaining firing, such as for a disposable battery. Other service checks include firing the device (in a diagnostic mode or other mode that allows firing without the need for a DSM or cartridge) to monitor motor parameters (such as voltage or current, etc.) for abnormal conditions. Damaged gears can cause a change in motor load that can be detected by monitored motor parameters, which can indicate an internal problem requiring replacement. Additionally, a generally higher motor load may indicate a need for cleaning or lubrication, or damage within the device.
At step 1806, the inspection station processor may determine if any components of the handle module need to be inspected. As previously described, the inspection station processor may parse the usage and performance data in a variety of ways according to the programming to determine if various handle module components need to be inspected, and if it is determined that component inspection is needed, one or several component inspection recommendations may be made at step 1808. For example, if the inspection station processor determines at step 1806 that the gear backlash exceeds a preset threshold, the inspection station processor may display a recommendation at step 1808 that the gear of the rotary drive system should be inspected. Additionally, if the inspection station processor determines at step 1806 that the cumulative energy consumed by the handle module exceeds the preset threshold, the inspection station processor may display a recommendation at step 1808 that the motor and/or gears of the rotary drive system should be inspected. Similarly, if the inspection station processor determines at step 1806 that the threshold number of firings (in the most recently completed procedure and/or during the life of the handle module) exceeds a preset intensity threshold (e.g., force or power), the inspection station processor may display at step 1808 a recommendation that the motor and/or gears of the rotary drive system should be inspected. Via the display, the inspection console processor may also suggest inspecting the DSM in various embodiments. For example, if the inspection console processor determines at step 1806 that the threshold number of firings in the most recently completed procedure exceeds the preset intensity threshold, the inspection console processor may display at step 1808 a recommendation that the sharpness of the cutting instrument in the end effector should be inspected, as a blunt cutting instrument may require more force to perform the cutting stroke.
The handle module processor may also make maintenance and/or component inspection determinations and recommendations. Fig. 28B shows an exemplary process flow for the handle module processor 2124. The process of fig. 28B is similar to the process of fig. 28A, except that at step 1801, the handle module processor processes the stored usage and performance data from its program and post-program so that it can make a determination at steps 1802 and 1806 as to whether service and/or component inspection is required. The recommendations and suggestions displayed at steps 1804 and 1808 can be on the display of the handle module, and/or in the event that the handle module is connected to the inspection station and there is a data connection therebetween, the handle module processor can transmit the recommendations to the inspection station processor so that the inspection station display can display the recommendations instead of, or in addition to, displaying them on the handle module display.
As shown in fig. 27A and 27B, DSM 1680 may also be connected to inspection station 1600. In such an arrangement, the DSM processor and/or the inspection station processor may make maintenance and component inspection determinations and recommendations based on the usage and performance data stored in the DSM memory.
To this end, FIG. 35 is a flow chart illustrating steps that may be performed with the inspection station described herein. At step 2200, the clinician performs a surgical procedure with a surgical instrument comprising one of the handle module and the DSM. As described herein, the handle module memory can store, for example, usage and program data throughout the program, such as motor energy and power levels, motor torque, and/or timestamps for actuating various triggers. After the procedure, at step 2202, the clinician may disconnect the DSM from the handle module and remove the removable battery pack, e.g., so that the handle module may be prepared for use in a subsequent procedure by connecting the handle module to an inspection station at step 2204, as shown herein. At step 2206, the inspection station may download (or read) the program and usage data from the memory of the handle module. The inspection station may also download identification data for the handle module, which the inspection station processor may use to determine the handle module type and/or configuration at step 2208, which the inspection station may display on its display.
At step 2210, the inspection station may set inspection procedures and inspection criteria for the handle module based on its type and configuration. For example, the inspection station memory may store inspection programs that should be executed for each handle module type and configuration, as well as criteria for inspection. Based on the handle module type and configuration ID resolved by the inspection station at step 2208, the inspection station can invoke and/or set the appropriate inspection procedures and inspection criteria to be used for the handle module. For example, at step 2212, the inspection module may dry the components of the handle module, such as described herein in connection with fig. 25A-25E. Additionally, at step 2214, a seal integrity test may be performed, such as described herein in connection with fig. 24A-24B. At step 2216, an electronic integrity test for the handle module may be performed. These tests may include testing that electrical connections exist between the appropriate components and that for the data processing components of the handle module, the protocol and connections for sending data are running. 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 (e.g., driven) to ensure that they are functioning properly. At step 2220, the handle module lock that needs to be reset after the procedure can be reset. At step 2222, further necessary adjustments to the handle module may be performed. The adjustment may include any other adjustments needed to prepare the handle module for a subsequent surgical procedure, and/or the performance of any service recommendations identified by the inspection station. At step 2224, the handle module may be released from the inspection station so that it may be used in (or sterilized before) a subsequent surgical procedure. The inspection station may "release" the handle module, for example, by indicating on a display of the inspection station that the handle module may be removed.
As shown in fig. 27A and 27B, after the DSM has been used in a surgical procedure, the DSM may also be connected to such an inspection station in order to inspect the DSM. A process similar to that shown in figure 35 may be used with a DSM connected to the inspection station to prepare the DSM for subsequent procedures.
The various steps shown in fig. 35 may be performed in a different order or simultaneously, and the steps shown in fig. 35 do not necessarily need to be performed in the order shown in fig. 35, but they may also be performed in this order. For example, the electronic integrity test (step 2216) may be performed before the seal integrity test (step 2214), and so on.
Fig. 36 and 37 are process flow diagrams illustrating exemplary steps involved in sterilizing a handle module and tracking the number of uses/sterilizations thereof. In fig. 36, the process begins at step 2300, where the handle module (and DSM) are used in a surgical procedure. After the procedure, at step 2302, a post-treatment cleaning of the handle module may be performed, which may require, for example, manual wiping of the handle module. Thereafter, at step 2304, the handle module may be purged, for example, with an automatic scrubber. 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 may be connected to, for example, an inspection station, such as the inspection station described herein in connection with fig. 12A-12C, 19A, 25A-25E, 26A-26C, and/or 27A-27B.
At step 2310, the inspection station may query or interrogate the handle module to determine whether the sterilization switch (e.g., switch 344, see fig. 11E-11I) is activated or in a state indicating its previous placement in the sterilization tray, such as shown above in fig. 11E-11I. If the sterilization tray switch is in the triggered or actuated state, then at step 2311, the sterilization count is incremented and the switch state is reset. Then, at step 2312, the inspection station may determine whether a threshold sterilization count of the handle module has been reached, as described herein. If the sterilization count has been reached, at step 2314, the end-of-life action for the handle module described herein can be taken.
Conversely, if the threshold has not been reached, the process can proceed to step 2316, where the handle module is prepared for sterilization, such as by: placing the handle module in its corresponding sterilization tray (e.g., see fig. 11E-11I) and/or placing a sterilization lid thereon (e.g., see fig. 20A-20D), which in either case activates the sterilization trigger at step 2318. The handle module can be sterilized at step 2320, whereupon it can be stored at step 2322 and subsequently transported to an operating room for use in subsequent procedures at step 2300.
Returning to step 2310, if the sterilization trigger is not activated or its state changes, the handle module may have to be physically inspected at step 2324.
The exemplary process flow of fig. 37 is similar to fig. 36, except that after the procedure at step 2300, the handle module can be re-energized to determine whether its sterilization status flag is set (set by the handle module processor when switch 344 is activated, see fig. 11E-11I) at step 2310. If so, at step 2311, the sterilization count may be updated and the sterilization status reset.
As noted above, the handle module battery pack may be removed from the handle module after surgery so that it may be used in a subsequent procedure, typically after recharging, in the same or another similarly configured handle module. Fig. 29A-29D illustrate a charging station 1700 for recharging the battery pack 1702. The battery packs 1702 are inserted into receptacles 1704 defined in the charging station 1700, shown in side views in fig. 29B and 29C, such that when a battery pack 1702 is inserted, their respective power terminals 1706 contact corresponding charging terminals 1708 at the bottom of the receptacle 1704 to charge the respective battery pack 1702. The illustrated charging station 1700 may charge two battery packs simultaneously, but in other arrangements, the charging station may have receptacles for storing and charging more or fewer battery packs.
The charging console 1700 may include, for example, a display 1709 that displays the status of the battery pack 1702, such as currently charged or charged/ready for use, according to the charging process. For a battery pack currently being charged, the display may show how long and/or how far the charging process is. Text and/or graphics may be used to indicate the state of charge, such as a volume indicating how much of the battery pack is charged (e.g., 40% charged, 50% charged, etc.) and/or other types of fractional indicators.
As shown in fig. 29B and 29C, the receptacle 1704 may be sized such that the end portion of the battery pack 1702 inserted into the receptacle is easily assembled (e.g., a zero insertion force connection). The charging station 1700 may include a means for detecting when the battery pack 1702 is inserted into the receptacle. For example, as shown in the block diagram of fig. 29D, the charging station 1700 may include a pressure switch 1720 at the bottom of the receptacle 1704 that is actuated upon insertion of the battery pack 1702 in communication with the charging station processor 1722. Additionally or alternatively, the charging console processor 1722 can detect the insertion of the battery pack 1702 when the charging console data terminal 1712 is in data connection with the 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 may temporarily secure the battery pack 1702 to the charging station 1700 such that the battery pack 1702 cannot be removed prematurely (e.g., prior to charging and/or full charging). In one arrangement, as shown in fig. 29B and 29C, this is accomplished by a screw 1724 at the bottom of the receptacle 1704 of the charging station 1700 that automatically threads into a corresponding opening 1726 in the bottom of the battery pack 1702 that is sized and threaded to receive the screw 1724.
Fig. 29D is a simplified block diagram of a charging station 1700 and battery pack 1702 according to various arrangements. Assuming that the charging console 1700 is powered by an AC power source, the charging console 1700 may include an AC/DC converter 1730 to convert AC voltage to DC voltage and a voltage regulator 1732 to convert DC voltage to a desired charging voltage, and/or a current to charge a battery cell 1734 of the battery pack 1702. The charging console 1700 may include a charging controller circuit 1736 for controlling the voltage regulator 1732 based on sensed parameters of the charging operation, such as current, voltage, and/or temperature, which may be sensed by the sensing circuit 1738 of the charging console 1700. For example, when charging the battery pack 1702 in a normal state of charge, the charge controller circuit 1736 may control the voltage regulator 1732 to charge at a constant current until the Li-ion or LiPo battery cells 1734 reach a specified voltage per cell (Vpc). The charge controller circuit 1736 may then maintain the cell at this Vpc until the charge current drops to X% (e.g., 10%) of the initial charge rate, at which point the charging process may terminate. Other charging schemes suitable for battery technology may be implemented.
Pressure switch 1720 can detect insertion of battery pack 1702 into receptacle 1704 of charging station 1700 and, upon activation, send a signal to charging station processor 1722. The charging console processor 1722 may responsively send a control signal to a connection actuator 1740, such as a linear actuator, that drives the screw 1724 into the battery pack screw opening 1726. The connection actuator 1740 may be powered by a second voltage regulator 1742, which may also power other electronic components of the charging station 1700 in addition to the connection actuator 1740.
Further to the above, the battery pack 1702 may include data terminals 1710 that mate with corresponding data terminals 1712 of the charging console 1700 when the battery pack 1702 is inserted into the receptacle 1704. The charging console processor 1722 may have an internal or external memory 1744 that stores firmware and/or software to be executed by the charging console processor 1722. By executing firmware and/or software, the charging console processor 1722 may (i) control the display 1709, (ii) control aspects of the battery cell charging process by communicating with the charging controller 1736, and/or (iii) exchange data with the battery pack processor 1750 via the data terminals 1710, 1712. As described herein, the battery electronics can also include memory 1752 that stores firmware and/or software to be executed by the battery processor 1750, such as a Battery Management System (BMS). The battery pack 1702 may also include a sensor 1754, for example, for sensing a condition associated with the battery pack 1702, such as moisture and/or humidity, as described above. The data terminal 1712 of the charging console 1700 may also supply low levels of power to the battery pack processor 1750. The charging console 1700 may also include a wireless module 1755 in communication with the processor 1722, which may communicate with remote devices via a wireless communication link (e.g., wi-Fi, bluetooth, LTE, etc.). Accordingly, the charging console 1700 may wirelessly transmit the charge status and other data (e.g., upcoming end of life, temperature) regarding the battery pack 1702 installed in the charging console 1700 to a remote computing system (e.g., server, desktop, tablet, laptop, smartphone, etc.). The charging station may also include a port for a wired connection (e.g., a USB-type port) so that the charging status and other data regarding the battery pack 1702 may be downloaded from the charging station 1700 to the connected device. In this way, the surgical personnel and/or the battery pack supplier may receive such information.
In an aspect, for example, to extend battery run time as well as battery life, 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 the charging console processor 1722 (by executing firmware/software stored in memory 1744) to rebalance battery cells. At step 1760, charging station processor 1722 may detect the insertion of battery pack 1702 into inspection station 1700 for charging based on, for example, a signal from pressure switch 1720 in receptacle 1704 and/or by some other suitable means. At step 1762, charging station processor 1722 may actuate linkage actuator 1740 to temporarily secure battery pack 1702 to charging station 1700 during a charging (and/or discharging) period. At step 1764, the charging console processor 1722 may exchange data with the battery pack processor 1750. In addition, the battery pack processor 1750 may exchange the logarithm of the time that the battery pack 1702 has been charged and the time that its cells are balanced. At step 1765, the charging station 1700 may quickly fill the battery pack with charge if needed before a full charge or discharge cycle may be performed. The top-up charge at step 1765 may charge the cells, for example, only at a constant current to bring them to a specified Vpc level or fraction thereof. At step 1766, the charging console processor 1722 may determine whether the battery cells should be rebalanced. In various aspects, the cell may be balanced every N times it is charged, where N is an integer greater than or equal to one, and preferably greater than one. If it is not time to rebalance the battery, the process proceeds to step 1768 where the battery cell is recharged and released for use at step 1770, such as by de-actuating the connection actuator 1740, so that the battery pack 1702 may be removed from the receptacle. On the other hand, at step 1766, if it is determined that the battery cells require rebalancing, the process may proceed to step 1772, where the cells are discharged and then charged at step 1768. The cell may be discharged to the appropriate (low) voltage level at step 1772.
As shown in fig. 29A, the charging console 1700 may include an emergency release button 1780 for each battery pack charging receptacle, or only one emergency release button 1780 that releases only the battery pack 1702 that currently has the most charge (and is therefore best suited for emergency use). In various aspects, when a particular battery pack 1702 is being charged, the charging console processor 1722 may initiate one or many actions when the emergency release button 1780 is pressed for that battery pack. For example, charging console processor 1722 can signal connection actuator 1740 to unscrew battery pack 1702 so that it can be removed. Additionally, prior to such mechanical release of the battery pack 1702, the charging console processor 1722 may instruct the charging controller to take action to expedite the rapid charging of the battery pack 1702. For example, the charging console processor 1722 may instruct the charging controller 1736 to use a charging profile that charges the battery unit 1734 faster in a short period of time, even though such fast short-term charging may not adequately charge the battery unit to its capacity or increase the life of the battery unit. Common charge-pattern phases for charging Li-ion battery cells include (i) trickle charge, (ii) constant current charge, and (iii) constant voltage charge. Charge controller circuit 1736 may switch to one of these profiles (e.g., constant current charging) for a short duration of time to provide as much additional charge as possible for battery pack 1702 in a short period of time. Additionally, the charging console processor 1722 can coordinate the increase in charging voltage available to charge the battery cells by making other power sources available for charging, such as from other outlets and/or charge storage devices (e.g., ultracapacitors or battery cells) in the charging console 1700. Data regarding such charging procedures may also be recorded in the battery pack memory.
Fig. 30A illustrates another exemplary charge/discharge determination process that the charging console processor 1722 may undertake in addition to or instead of the process illustrated in fig. 29E. The process of fig. 30A recognizes that discharging a surgical instrument battery pack is generally beneficial to its life, but that the battery pack should not be discharged if there is insufficient time to discharge the battery pack before surgical needs arise. The process of fig. 30A begins at step 1780, where a "first" rechargeable battery pack is inserted into one of the charging receptacles 1704 of the charging station 1700. At step 1782, battery pack usage data from the first battery pack is downloaded to the charging console memory, which may include the current remaining battery capacity. Although not shown in fig. 30A, the first battery pack may also be fixed to the charging console when it is inserted (see, for example, fig. 29B-29C). At step 1784, the charging station 1700 may immediately charge the first battery pack as may be needed in a procedure that is currently in progress or is about to be performed. At step 1786, data regarding the charging of the first battery pack at step 1784 is written to the memory of the first battery pack. The data may include, for example, time stamps for the beginning and end of the charging step, and the beginning and end battery capacities.
At step 1788, the charging console processor checks the charge/discharge logarithm of the first battery pack, and if the first battery pack has been completely discharged since the last procedure, the process advances to step 1790, where the first battery pack is ready for use in the procedure. At this step, the charging console display may indicate that the first battery pack is ready for use. On the other hand, if it is determined at step 1788 that the first battery pack has not been fully discharged since its last procedure, the process may proceed to step 1792, where the charging console processor may determine whether there is at least one other fully charged battery pack in its charging receptacle. If so, at step 1794, the first battery pack may be fully discharged to extend its life, since there is another fully charged battery pack ready for use, if desired. Once the discharge of the first battery pack is complete, at step 1796, discharge data (e.g., start and end timestamps, start and end capacities) may be written to the first battery pack memory so that an evaluation may be performed at step 1788. Thereafter, the process may proceed to step 1784, where the battery cells of the first battery pack are recharged, and the process repeats. If the first battery pack was discharged since the last procedure at step 1794, then from step 1788, the process will proceed to step 1790 because another discharge of battery cells is not required.
Modifications to the process of fig. 30A may be made. For example, the initial charging step 1784 may be eliminated 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 may be taken by the charging console processor 1722. The process of fig. 30B is similar to fig. 30A, except that at step 1783, after step 1782, the charging station 1700 may perform a fast charge fill of the battery pack (e.g., a brief charge to less than full capacity) and record data regarding the full charge in the battery pack memory. Then at step 1788, as in fig. 30A, the charging console processor may determine if the battery pack has been completely discharged since the last procedure, and if so, at step 1789, a full charge of the battery pack is performed, at which point the battery pack is ready for use (block 1790). On the other hand, at step 1788, if the charging station processor determines that the battery pack has not been fully discharged since the last procedure, the process may proceed to step 1792, where the charging station determines whether another battery pack is currently plugged into one of its receptacles 1704 in preparation for use (e.g., fully or fully charged). If not, the first battery pack may be fully charged at step 1789. However, if the other battery pack is sufficiently or fully charged and ready for use, then at step 1794, the first battery pack may be discharged (with data regarding the discharge being stored in the battery pack memory). After being fully discharged, the process may proceed to step 1789 so that the first battery pack may then be charged.
In various embodiments, the charging station processor 1722 can monitor and store the times at which various battery cells are inserted therein as an indication of when the procedure is performed by the hospital or surgical unit in which the charging station is located. The charging console processor 1722 may be programmed to determine the time of day that the hospital or surgical unit typically performs a procedure involving the use of such battery packs, and the time of day that the hospital or surgical unit does not perform the procedure. In particular, for example, the charging console processor 1722 can determine the statistical likelihood that a hospital or surgical unit is performing a procedure involving instruments using such battery packs that lasts for non-overlapping time increments spanning a 24 hour period, such as one hour increments. Thus, for full charging of the battery pack (e.g., at step 1789 of fig. 30B), the charging station may begin such a full charging step when there is a low likelihood of an ongoing procedure, particularly if there is already another fully charged battery pack ready for use. That is, for example, in fig. 30B, the full charge at step 1789 after the discharge at step 1792 does not have to be immediately after the discharge at step 1792, but instead may be scheduled for a time when there is a low likelihood of an ongoing procedure, as determined and scheduled by the charging console processor 1722. Additionally, the hospital or surgical unit personnel may input data to the charging console 1700 via the user interface 1709, for example, regarding when to execute a procedure and/or the type of procedure to be executed (or the amount of charge required for a procedure). This data may be stored in charging station memory 1744 and used by charging station processor 1722 to determine when to charge the battery pack.
In systems that charge and discharge batteries, bleeding power from the cell under maintenance in the form of heat may waste a significant amount of energy, as the charge on the battery cell to be discharged is typically drained through a resistive load. Accordingly, the charging station may include a fan and/or heat sink to aid in dissipating heat. In other aspects, the charging station may use the charge on the cell to be discharged to charge another cell in the charging station or store it in another charge storage device. Fig. 31 is a simplified diagram of a circuit 1900 for discharging battery cells in such a manner. When charging the "first" cell 1902, the power source/regulator 1904 is connected to the first cell 1902 by closing switch S1, with all other switches (S2, S3, S4 and S5) open. To discharge the first cell 1902 through the resistor 1906, switches S2 and S3 are closed, and switches S1, S4 and S5 are opened. Diode 1903 controls the direction of current flow from first cell 1902. To discharge the first battery cell 1902 to an energy storage device 1908 (e.g., an ultracapacitor or another battery cell inside a charging station, not typically used for surgical instruments), switch S2 is closed and the remainder of switches S1, S3, S4, and S5 are opened. Diode 1903 controls the direction of current flow to energy storage device 1908. To charge the first cell 1902 with charge on the energy storage device 1908, switch S5 is closed, and the remainder of switches S1, S2, S3, and S4 are opened. Diode 1905 controls the direction of current flow to first cell 1902. To charge another cell 1910 with the first cell 1902, switches S2 and S4 are closed, and switches S1, S3, and S5 are opened. Switches S1, S2, S3, S4, and S5 may be controlled by charging console processor 1722 and/or charging controller 1736.
Fig. 32 shows a circuit for charging and discharging a first battery pack 1902 that is similar to the circuit of fig. 31, except that the configuration of fig. 32 includes a cell stack 1920 that can be used to charge a first battery cell 1902. In the illustrated arrangement, the stack 1920 includes three battery cells 1922,1924,1926, but in other arrangements, the stack 1920 may include more or fewer battery cells. The battery cells 1922,1924, and 1926 in pack 1920 may be internal battery cells of the charging station and/or other battery packs that plug into the charging station. The cells 1922,1924,1926 of the bank 1920 may be used, for example, to quickly charge the first battery pack 1902, such as if a replacement battery pack is needed in an ongoing procedure. In the illustrated arrangement, cells 1922,1924,1926 in a group 1920 can be connected in series or in parallel to provide an increased voltage (when connected in series) or an increased current (when connected in parallel). To connect the cells 1922,1924,1926 in series, switch S7 is closed and switch S6 is opened. To connect cells 1922,1924,1926 in parallel, switch S6 is closed and switch S7 is opened. Each cell may have an associated resistor R1, R2, R3, respectively, for example to provide a current source when connected in parallel.
In one aspect, referring back to fig. 29A, if the clinician is in the middle of a procedure and a new battery pack is needed to complete the procedure, the clinician (or his/her assistant) may select and remove a fully charged one of the battery packs from the charging console 1700 and prepare for use, which may be indicated on the display 1709 of the charging console 1700. If none of the battery packs 1702 is indicated as ready for use, the clinician may press, for example, an emergency release button 1780, which may release the battery pack 1702 currently in the charging station 1700, which now has the most charge, as determined by the charging controller 1736 and/or the charging station processor 1722, so that the partially charged battery pack may be inserted into the handle module currently in use during the procedure. The charging station 1700 may also include visual indicators to indicate which battery pack 1702 was released in an emergency, making it clear which battery pack should be removed from the charging station for insertion into a surgical instrument. For the charging console 1700 (which includes means for securing the battery pack 1702 to the charging console 1700 during charging, such as the screws 1724 in the arrangement of fig. 29A-29C), activation of the emergency release button 1780 may cause the connection means to disconnect (or unsecure) the appropriate battery pack 1702 as described herein. At about the same time, the charging station 1722 may take steps to quickly charge the selected battery pack 1702 in a short period of time, preferably giving it at least enough charge to complete one or several firings. As described herein, the charging console processor 1722 can change a charging profile (e.g., constant current or constant voltage charging) in conjunction with the charge controller circuitry 1736, charge the battery pack with the supercapacitor 1908, and/or charge the battery pack with one or more other battery cells (which can be connected in series or in parallel, as described herein). In various arrangements, the battery pack 1702 is not released (e.g., by disconnecting the screw 1724) until a short-term charge charges the battery pack 1702 to a charge level of threshold charge sufficient to complete one or several firings.
In various aspects, the charging station may also be configured to facilitate proper placement of the battery pack into the charging station for charging and/or to enhance engagement between electrical contacts between the battery pack and charging terminals of the charging station, thereby improving the efficiency of the charging process. For example, an aperture (or receptacle) in the charging station may have multiple sets of terminals such that the charging terminals of the battery pack contact a set of charging terminals of the charging station regardless of the manner in which the battery pack is inserted into the slot/receptacle. Fig. 33A and 33B show top views of a battery pack 2000 and a charging station 2002, respectively, where the battery pack 2000 has a square cross-sectional shape and a slot/receptacle 2004 of the charging station 2002 is sized to receive such a square cross-sectional battery pack 2000. The illustrated charging console 2002 has two slots/receptacles 2004, but in other arrangements, the charging console 2002 can have one slot/receptacle or more than two slots/receptacles. As shown in fig. 33A, the battery pack 2000 has a positive terminal 2006 and a negative terminal 2008 which are contacted by the charging console terminal in order to charge the battery pack. In the illustrated arrangement, the terminals 2006,2008 are not centered on the top of the battery pack 2000. Because such a battery pack 2000 may be inserted into one of the square-shaped slots/receptacles 2004 in one of four configurations (each rotated 90 degrees, and assuming that the side of the battery pack 2000 having terminals 2006-2008 is always facing downward), each slot/receptacle may have four pairs of charging terminals 2010 positioned therein such that when the battery pack 2000 is inserted into the slot/receptacle 2004, the off-center battery pack terminals 2006-2008 will make contact with one of the pairs of charging station terminals 2010, regardless of the manner in which the battery pack is rotated. Each charging station terminal pair 2010 is connected to the charging circuitry of the charging station, but only the pair 2010 that contacts battery pack terminals 2006-2008 will have complete circuitry so that charging current can flow to the battery pack 2000. In another arrangement, as shown in fig. 34A and 34B, one of the battery pack terminals may be at the center of the battery pack 2000. In the case shown, the negative terminal 2008 is in the center with the positive terminal 2006 facing one side; however, the opposite arrangement may be used in another embodiment. The slot/receptacle of the charging station may have one terminal 2014 in the center for contacting the negative terminal 2008 of the battery pack 2000 and four terminals 2016 on each side of the center terminal 2014 for contacting the positive terminal 2006, respectively, regardless of the manner in which the battery pack 2000 is inserted into the slot/receptacle. For batteries with other geometries, a fewer or greater number of terminal pairs (such as two pairs for a rectangular battery) may need to be present in the slot/receptacle.
As described above, the surgical instrument may include a battery assembly that is attachable to and/or detachable from the surgical instrument. Such handling of the battery assembly may increase the chance of damaging the battery assembly. For example, the battery assembly may be accidentally dropped while assembling the battery assembly to the surgical instrument and/or transporting the battery assembly to a charging station. As described in further detail below, the battery assembly may be configured to protect the housing, battery cells, and/or power circuitry of the battery assembly in the event the battery assembly is accidentally dropped.
Referring now to fig. 38, a battery assembly, such as battery assembly 5000, for example, can include a battery housing 5010 and a plurality of internal components 5030 that include at least one battery cell 5031 and/or power circuitry positioned within the battery housing 5010. The at least one battery cell 5031 can comprise, for example, a lithium ion battery. The battery assembly 5000 also includes one or more electrical contacts 5011 that are configured to communicate electrical energy provided by the at least one battery cell 5031 to the surgical instrument. The battery assembly 5000 also includes one or more alignment features 5012 that are configured to assist a user in properly assembling the battery assembly 5000 to a surgical instrument. The alignment features 5012 include, for example, slots that can be aligned with protrusions extending from a surgical instrument. The alignment features 5012 are symmetrically disposed about the perimeter of the battery housing 5010. Although not shown, other embodiments are contemplated in which the alignment feature 5012 includes an asymmetric configuration that allows the battery assembly 5000 to be attached to a surgical instrument in only one orientation. The battery assembly 5000 also includes a lock mechanism 5040 configured to secure the battery assembly 5000 to a surgical instrument during use. When the battery assembly 5000 is attached to the surgical instrument, the battery assembly 5000 may transmit electrical energy to the electrical receiving contacts of the surgical instrument.
The battery housing 5010 can serve as a receptacle configured to receive the internal components 5030 and/or as a support structure configured to support various components thereon. As a receptacle and/or support structure, the battery housing 5010 can be rigid to support the internal components 5030 positioned therein. The battery housing 5010 can be constructed of, for example, a plastic material. In some cases, the inner housing 5010 is constructed of an elastomeric material, for example. Referring again to fig. 38, the battery housing 5010 includes a top face, a bottom face 5016, a plurality of lateral faces 5015, and a plurality of corner portions 5014. The bottom faces 5016 can be associated with electrical contacts 5011. The lateral faces 5015 and the corner portions 5014 are configured to surround the inner component 5030.
Various embodiments described herein relate to protection of battery components for use with surgical instruments. Referring again to fig. 38, the battery assembly 5000 includes a radial and/or vertical reinforcement configured to protect the battery housing 5010, the internal components 5030 and/or the electrical contacts 5011. The radial and/or vertical stiffeners may comprise, for example, impact absorbing layers. In various circumstances, an impact absorbing layer can surround the battery housing 5010 in order to absorb impact forces applied to the lateral faces 5015, the bottom faces 5016, and/or the corners 5014 of the battery housing 5010. In addition to or in lieu of the above, an impact absorbing layer is housed within the battery housing 5010. Additionally, the battery assembly 5000 may include an outer housing for additional protection in addition to or in lieu of that described above. The outer housing may be configured to accommodate the battery housing 5010 and the impact absorbing layer.
One means for protecting the battery assembly 5000 is shown in fig. 38A, for example, including a battery housing or inner housing 5010, and a shock absorbing layer 5020. As described above, the housing 5010 can be constructed of a rigid material that can support the internal components 5030 of the battery assembly 5000. The shock absorbing layer 5020 may comprise a lattice structure 5022 having a plurality of cells 5024. The cells 5024 may reduce the density of the impact absorbing layer 5020. The cells 5024 can have an open cell structure and/or a closed cell structure. Further, the lattice structure 5022 can comprise one or more lattice layers. For example, the lattice structure 5022 can include a first or inner lattice layer and a second or outer lattice layer.
The lattice structure 5022 further comprises a plurality of struts 5025 that are designed to deflect and/or bend under pressure. If 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 struts 5025. Thus, the shock absorbing layer 5020 can absorb shock and/or vibrational energy rather than relying on the battery housing 5010 to absorb energy which can in some cases cause damage to the internal components 5030 of the battery assembly 5000. In various instances, the shock absorbing layer 5020 can comprise a foam-like structure and/or an elastomeric material, for example.
In various instances, referring again to fig. 38, the cells 5024 are arranged in rows, such as with an inner row of cells 5026, a middle row of cells 5027, and an outer row of cells 5028. Each cell in the inner row of cells 5026 can comprise a planar wall 5026a. The cells 5026 are oriented such that the planar walls 5026a of the cells 5026 are at least substantially parallel to the lateral face 5015 of the battery housing 5010. Each cell in the outer row of cells 5028 can comprise a planar wall 5028a. The cells 5028 are oriented such that the planar walls 5028a of the cells 5028 are at least substantially parallel to the outer surface 5029 of the shock absorbing layer 5020. Orienting the planar walls 5026a,5028a of each cell in inner row 5026 and outer row 5028 in this manner may produce a more shock-resistant impact-absorbing layer 5020. The shock absorbing layer 5020 can include corner portions positioned near the corners 5014 of the battery housing 5010 that can absorb the impact forces directed toward the corners 5014 of the battery housing 5010. The corner portions 5020 are not connected to each other; however, embodiments are contemplated wherein the corner portions 5020 can be connected to one another.
In various instances, the battery assembly 5000 includes a plurality of shock absorbing elements 5020. The shock absorbing elements 5020 are positioned to protect the corners 5014 of the battery assembly 5000. In various circumstances, the impact forces can be more concentrated at the corners 5014, which can increase the risk of damaging the battery housing 5010 and/or the internal components 5030. The shock absorbing elements 5020 include end portions 5021 that extend beyond the bottom face 5016 of the battery housing 5010 to prevent damage to, for example, the electrical contacts 5011 and to further protect the battery assembly 5000. If the battery assembly 5000 is dropped in an orientation such that the bottom face 5016 is at least substantially parallel to the ground, one or more of the end portions 5021 can absorb impact forces and dissipate impact energy.
It may be preferred that the battery assembly be usable after experiencing an impact force, such as when the battery assembly 5000 is accidentally dropped. In such instances, the shock absorbing elements 5020 are configured to allow the battery assembly 5000 to maintain the ability to fit properly into the battery receiving portion of the surgical instrument and still transmit electrical energy to the electrical receiving contacts of the surgical instrument even if the battery assembly 5000 has been dropped. The shock absorbing elements 5020 can comprise crumple zones configured to deform upon the application of an impact force. In at least one instance, if the impact force is below the crumpling force threshold, the crumpled area may not be permanently deformed, or at least substantially permanently deformed. In such cases, the crumple zone may be permanently deformed only if the impact force reaches or exceeds the crumple force threshold. The crumple zones may limit the direction of deformation of the shock absorbing elements 5020 toward the center of the battery assembly 5000. Such inward deformation may maintain the ability of the battery assembly 5000 to fit into the battery receiving portion of the surgical instrument by preventing outward deformation that would cause the battery assembly 5000 to attain a shape that would not fit into the battery receiving portion of the surgical instrument.
In various circumstances, the impact absorbing elements 5020 may experience excessive deformation that requires replacement of the impact absorbing elements 5020. In the event that the shock absorbing elements 5020 need to be replaced, the battery assembly 5000 can be configured such that a user of the surgical instrument can remove damaged shock absorbing elements from the battery assembly 5000 and then attach usable shock absorbing elements thereto. As described in more detail below, it may be preferable that the shock absorbing elements 5020 can be replaced in a timely manner. When introducing additional tasks into the surgical procedure, it may be important to minimize the amount of time required to replace the shock absorbing elements 5020.
When the shock absorbing elements 5020 need to be replaced, it may be necessary to assemble the shock absorbing elements 5020 to the battery assembly 5000. In various instances, the shock absorbing elements 5020 include one or more protrusions 5023 that are configured to slide/wedge into corresponding slots 5013 in the battery housing 5010. The slots 5013 are configured to receive the protrusions 5023 of new and/or available impact absorbing elements in the event that the impact absorbing elements 5020 need to be replaced. In various instances, the protrusion 5023 and the slot 5013 can include a press fit therebetween, which can allow the protrusion 5023 to slide within the slot 5013 along the corners of the housing 5010. In at least one instance, the protrusion 5023 and the slot 5013 can comprise a wedging fit therebetween. In various circumstances, the shock absorbing elements 5020 can be attached to the battery housing 5010 in a snap-fit manner. In at least one instance, the battery housing 5010 can include an aperture configured to receive the protrusion 5023 in a snap-fit manner. In some cases, the protrusion 5023 can snap fit radially into the slot 5013. In addition to or in lieu of the above, the shock absorbing elements 5020 can be attached to the housing 5010 using, for example, an adhesive.
In various instances, the battery assembly 5000 also includes a shock absorbing cap 5050. An impact absorbing cap 5050 is positioned at the outer end 5002 of the battery assembly 5000. The impact absorbing cover includes a shoulder 5051 configured to contact the surgical instrument when the battery assembly 5000 is fully seated in the surgical instrument. The shoulder 5051 may charge, for example, a stopper and may define a fully seated position of the battery assembly 5000. In various circumstances, the shoulder 5051 is configured to abut the impact absorbing element 5020. If the battery assembly 5000 is attached to a surgical instrument, the impact absorbing cover 5050 may protect the battery assembly 5000 and/or the surgical instrument in the event the surgical instrument falls in a direction such that the top surface is at least substantially parallel to the ground upon impact. On the other hand, if the battery assembly 5000 is not attached to a surgical instrument, the impact absorbing cover 5050 may still protect the battery assembly 5000 in the event that the battery assembly 5000 falls in a direction such that the top surface is at least substantially parallel to the ground.
A partial cross-sectional view of the battery assembly 5000 is shown in fig. 39. The impact absorbing cover 5050 includes a lattice structure or cell structure, which includes a plurality of cells 5052. The impact absorbing cap 5050 may include a material similar to the impact absorbing layer 5020. A denser grid arrangement 5055 is used near the outer edge 5054 of the cell assembly 5000, which can dissipate more concentrated impact forces. The impact absorbing cap 5050 includes a central portion 5053 that includes a columnar lattice arrangement 5056 configured to absorb impact energy generated by impact forces applied to the central portion 5053. In various instances, the column grid arrangement 5056 is configured to dissipate widely applied impact forces.
In various instances, the impact absorbing cap 5050 may include a crumpled region configured to deform upon application of an impact force. The shock absorbing cap 5050 may be designed to prevent the battery assembly 5000 from bouncing on the floor using a crumpled area, for example, in the event the battery assembly 5000 is dropped.
The impact absorbing cap 5050 may be readily replaceable. In the event that the impact-absorbing cap 5050 undergoes excessive deformation requiring replacement of the impact-absorbing cap 5050, the battery assembly 5000 may be configured such that a user of the surgical instrument may remove the damaged impact-absorbing cap from the battery assembly 5000 and then attach the available impact-absorbing cap.
In various circumstances, the shock absorbing elements 5020 can be tethered by the intermediate portion. The middle portion can be configured to protect the lateral faces 5015 and/or the alignment features 5012 of the battery housing 5010. It can be appreciated that if an impact force is applied over the surface area of the lateral faces 5015 of the battery housing 5010, the stress generated by the impact force will be less than if the same impact force were applied to the corners 5014 of the battery housing 5010 having a smaller surface area. In other words, the more surface area the impact force is distributed, the lower the stress and stress concentration. Therefore, it may not be necessary that the intermediate portions between the impact absorbing elements 5020 be made of a composition comparable to that of the impact absorbing elements 5020. In at least one instance, therefore, the intermediate portion can comprise a thinner composition than the impact absorbing elements 5020; however, various embodiments are contemplated wherein the intermediate portion comprises the same and/or thicker composition as the impact absorbing elements 5020.
Each of the shock absorbing elements 5020 of the battery assembly 5000 includes a similar configuration; however, other embodiments are contemplated in which one or more of the impact absorbing elements 5020 may be different from the others. In at least one such case, at least one of the shock absorbing elements 5020 can include additional weights, such as metal weights, for example, positioned therein, which can cause the battery assembly 5000 to fall and fall in a particular orientation. Such an effect can also be achieved, for example, by placing one or more weights in the battery housing 5010.
A battery assembly 5100 that is similar in many respects to battery assembly 5000 is shown in fig. 40. The battery assembly 5100 can include means for protecting the internal components 5030 of the battery assembly 5100 from damage due to impact shock and/or heat. Various means for protecting the battery assembly 5100 from impact shock are discussed above. For example, heat represented by Q in fig. 40A can be transferred through the battery housing 5110 and can be absorbed by the battery cells 5031 positioned in the battery housing 5110.
It should be appreciated that heat flows from a higher temperature environment to a lower temperature environment. Under typical sterilization conditions, the battery assembly 5100 is exposed to high temperatures, and thus heat flows from the sterilization chamber into the battery assembly 5100. In some cases, however, the battery assembly 5100 may be improperly sterilized and may be exposed to excessive temperatures. If at least one of the battery cells 5031 absorbs and/or retains a detrimental amount of heat Q, the battery cells 5031 may experience a thermal runaway event and fail.
Referring now to fig. 40A, a battery housing 5110 includes a heat reflective shell or shield 5111, an impact absorbing layer 5112, and a heat sink layer 5113. For example, the reflective housing 5111 is configured to reflect and/or prevent the transfer of heat Q generated by improper sterilization. In various instances, the reflective housing 5111 can be constructed of a material having a low thermal conductivity (such as a polymer and/or ceramic material), for example. Materials with low thermal conductivity typically have a low rate of thermal expansion. Materials with low thermal conductivity may also perform well as insulating layers. In any case, the reflective housing 5111 can include a reflective outer surface that can reflect heat away from the battery assembly 5100. The reflective outer surface may be constructed, for example, of polished metal, such as polished aluminum.
Further to the above, the heat sink layer 5113 is configured to absorb heat transferred 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 cases, the battery cells 5031 may generate an atypical amount of heat due to their overcharge and/or overuse. In various instances, the heat sink layer 5113 can be constructed of a material having a high thermal conductivity (such as a metal), for example. Any suitable material having a high thermal conductivity can be used to absorb heat generated by the at least one battery cell 5031. In addition, materials with high thermal conductivity typically have a high thermal expansion rate.
As further described above, the battery cells 5031 can expand as they are charged. Expanding the battery cells 5031 can push the heat sink layer 5113 outward. In addition, the heat sink layer 5113 can expand outward rapidly due to its high rate of thermal expansion. Such outward movement of the battery cells 5031 and the heat sink layer 5113 can push the impact absorption layer 5112 toward the reflective shell 5111 and apply pressure to the reflective shell 5111. Such pressure can generate stress within the reflective shell 5111, the heat sink layer 5113, and the battery cells 5031, particularly in embodiments where the reflective shell 5111 is comprised of a material having a lower rate of thermal expansion than the heat sink layer 5113. In such cases, the heat sink layer 5113 can expand more than the reflective shell 5111, thereby creating additional stress in the reflective shell 5111, the heat sink layer 5113, and the battery cells 5031.
The impact absorbing layer 5112 is configured to allow expansion of the battery cells 5031 while preventing damage to the battery housing 5110. As a degree of freedom for the battery housing 5110, the shock absorbing layer 5112 may expand and/or contract to manage the expansion and/or contraction of the battery cells 5031 by allowing the heat sink layer 5113 and at least one battery cell 5031 to expand and/or contract due to heat transfer while maintaining the supporting capability of the battery assembly 5100. In various circumstances, the expansion and contraction of the impact absorbing layer 5112 can prevent damage to the battery case 5110. The impact absorbing layer 5112 can absorb thermal shock and impact shock.
Turning now to fig. 41 and 42, the surgical instrument system 5300 includes a handle 5310 that can be used with a shaft assembly selected from a plurality of shaft assemblies. As further described above, one or more of such shaft assemblies may comprise, for example, a staple cartridge. The handle 5310 comprises a housing 5312, a first rotatable drive output 5340 and a second rotatable drive output 5350. The handle 5310 also includes a first actuator 5314 for operating the first rotatable drive output 5340 and a second actuator 5315 for operating the second rotatable drive output 5350. The handle housing 5312 includes a battery cavity 5311 configured to receive a battery therein. The battery may be, for example, any suitable battery, such as a lithium ion battery. In various circumstances, the battery can be inserted into the battery cavity 5311 and can be removed from the battery cavity 5311. In many instances, such a battery can provide power to the handle 5310 to operate the surgical instrument system 5300 without supplementing an additional and/or tethered power source, for example. Such a design may be advantageous for a number of reasons. For example, when the surgical instrument system 5300 is not tethered to a power source, the entirety of the surgical instrument system 5300 can be present in the sterile field of the operating room. However, such batteries can only provide a limited amount of power. In many cases, the limited amount of power that the battery can supply is sufficient to operate the surgical instrument system 5300. On the other hand, there may be some instances where the battery is unable to supply the necessary power for the surgical instrument system 5300.
Referring again to fig. 41, the battery positioned in the battery cavity 5311 of the handle 5310 can be removed and replaced with a power adapter 5360, for example. The power adapter 5360 includes a distal plug 5361 positioned in the battery cavity 5311. The distal plug 5361 includes a plurality of electrical contacts 5366 engageable with corresponding electrical contacts 5316 in the shank 5310. In various circumstances, the battery and distal plug 5361 can engage the same electrical contacts 5316 depending on which is positioned in the battery cavity 5311. In such cases, the handle 5310 can provide power from a set of electrical contacts 5316, whether or not a battery or power adapter 5360 is engaged with the handle 5310. In other cases, 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 cases, the microprocessor of the handle 5310 can be configured to identify whether the battery or power adapter 5360 is coupled to the handle 5310.
The distal plug 5361 of the power adapter 5360 may comprise any suitable shape as long as the distal plug 5361 is positionable in the battery cavity 5311. In various instances, the distal plug 5361 can include the same geometry as a battery, for example. In some cases, the housing of the distal plug 5361 is similar or sufficiently similar to the housing of a battery. In any event, the distal plug 5361 can be configured such that once the distal plug 5361 has been fully seated in the battery cavity 5311, there is little, if any, relative movement between the distal plug 5361 and the battery cavity 5311. In at least one instance, the distal plug 5361 comprises a stop 5368 configured to contact a stop datum 5318 defined on the handle housing 5312. When the stop plug stops 5368 contact the handle stop datums 5318, the plug 5361 can be fully seated 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 seated position. For example, the plug 5361 includes at least one lock 5362 configured to releasably engage the housing 5312.
The power adapter 5360 also includes a cord 5363 extending from the plug 5361. For example, a cord 5363 electrically couples plug 5361 with a power source (such as power source 5370). Power source 5370 may include, for example, any suitable power source, such as a signal generator, that receives power from, for example, a 110V, 60Hz power source and/or a battery. The cord 5363 includes any suitable number of conductors and insulators to transmit power from the power source 5370 to the plug 5361. In at least one instance, the cord 5363 includes a supply conductor, a return conductor, and a ground conductor that are electrically insulated from one another, such as by an insulator jacket. Each conductor of the cord 5363 can include a proximal terminal, for example, contained within the proximal plug 5369. In various instances, the proximal plug 5369 can be releasably attached to the power source 5370. In certain other instances, the proximal plug may not be easily detachable from the power source 5370.
In various instances, the power source 5370 can comprise a Direct Current (DC) power source, for example. In such cases, the battery and power adapter 5360 can both supply DC power to the handle 5310, depending on which is electrically coupled to the handle 5310. The power adapter 5360 and the power source 5370 can cooperatively supply power to the handle 5310 that equals and/or exceeds the power that the battery can provide to the handle 5310. In at least one instance, a surgeon using the handle 5310 as part of the surgical instrument system 5300 can determine that the handle 5310 is under-powered, remove the battery from the handle 5310, and couple the power adapter 5360 to the handle 5310. The power source 5370 can then be operated to provide sufficient power to the handle 5310 via the power adapter 5360 to operate the surgical instrument system in a desired manner. In various circumstances, the power source 5370 can provide a greater voltage to the handle 5310, for example.
In some cases, power source 5370 comprises an Alternating Current (AC) power source. In at least one such case, the power adapter 5360 can comprise an alternating current to direct current (AC/DC) power converter configured to convert AC power provided by the power source 5370 into DC power. In such cases, the battery and power adapter 5360 can both 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; however, any suitable AC/DC power converter may be used. For example, an AC/DC power converter is positioned in plug 5361; however, the AC/DC power converter can be positioned within the power adapter 5360 in any suitable location, such as the cable 5363.
In various instances, 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 can implement the two sets of battery contacts 5316 described above. In at least one such embodiment, the battery power circuit can include a, first circuit segment including a first set of contacts 5316 engaged by the battery; and two, a second circuit segment in parallel with the first circuit segment, the second circuit segment comprising a second set of contacts 5316 engaged by a power adapter 5360. The second circuit segment includes an AC/DC power converter configured to convert AC power provided by the power source 5370 to DC power, while the first circuit segment does not include an AC/DC power converter because the battery is already configured to provide DC power.
Referring again to fig. 41, the handle 5310 can be in the sterile surgical area 5301 and the power source 5370 can be in the non-sterile area 5302. In such cases, the power adapter 5360 can extend between the sterile area 5301 and the non-sterile area 5302. Sterile area 5301 and non-sterile area are separated by boundary 5303. Boundary 5303 may include, for example, a physical boundary, such as a wall, or a virtual boundary, for example, intermediate a sterile surgical table and a non-sterile back table.
To use the power adapter 5360, the battery positioned in the battery cavity 5311 must be removed in order to install the plug 5361 of the power adapter 5360 into the battery cavity 5311. Alternative embodiments are contemplated wherein a battery can remain in the battery cavity 5311 when the power adapter is operably coupled with the handle 5310. Turning now to fig. 42, a battery 5461 can be positioned in the battery cavity 5311. When the lock 5362 is deactivated, the battery 5461 can be easily removed from the battery cavity 5311; however, embodiments are envisioned in which the batteries 5461 are not easily removable from the battery cavity 5311. Similar to the plug 5361, the battery 5461 can be sized and configured such that the battery 5461 is closely received in the battery cavity 5311 to limit relative movement between the battery 5461 and the battery cavity 5311 when the battery 5461 is fully seated in the battery cavity 5311. Also similar to 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 a variety of circumstances. In the event that the battery unit of battery 5461 lacks the power necessary to operate the surgical instrument system, power adapter 5460 can be coupled to battery 5461. The power adapter 5460 is similar in many respects to the power adapter 5360. Similar to the above, the power adapter 5460 includes, for example, a cord 5463 that includes a proximal end 5369 that is connectable to a power source (such as power source 5370). The battery 5461 includes an electrical connector 5464 defined therein that is configured to receive a distal connector 5465 of the cord 5463 to electrically couple the power source 5370 to the battery 5461.
In at least one instance, further to the above, a power adapter 5460 can be placed in series with a battery 5461 when the adapter connector 5465 is inserted into the battery connector 5464. In such cases, both the battery 5461 and the power source 5370 can supply power to the handle 5310. Fig. 43 shows such an embodiment. As disclosed in fig. 43, the battery 5461 'includes a power 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 source 5370 may, one, recharge the battery unit 5470' via the recharge circuitry 5471', and/or two, supplement the power that the battery unit 5470' is providing to the handle 5310. Where the power source 5370 comprises an AC power source, the battery 5461 'may comprise an AC/DC transformer 5467' configured to convert AC power provided by the power source 5370 to DC power prior to providing power to the charging circuit 5471 'and/or the battery unit 5470'. The power supply circuit in the battery includes a battery connector 5464, an AC/DC transformer 5467', a charging circuit 5471', a battery unit 5470', and a battery terminal 5366 connected in series with each other; however, any suitable arrangement for the power supply circuit may be used.
In other instances, insertion of the adapter connector 5465 into the battery connector 5464 can electrically couple the power source 5370 with the handle 5310 and, at the same time, electrically decouple 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 "includes a power circuit that includes one or more battery cells 5470" configured to provide DC power to the handle 5310. When the adapter connector 5465 is not positioned in the battery connector 5464, the battery unit 5470 "is in electrical communication with the battery contact 5366 via the first circuit section 5472" and the battery switch 5474 ". In such a case, the battery switch 5474 "is in the first switch state. Insertion of the adapter connector 5465 into the battery connector 5464 places the switch 5474 "in a second switch state, as shown in fig. 44, in which the battery unit 5470" is no longer able to supply power to the contacts 5366. Additionally, when the switch 5474 "is in its second switch state, the power adapter 5460 and the battery connector 5464 are in electrical communication with the battery contact 5366 via the second circuit segment 5473" and the battery switch 5474 ". In the case where the power source 5370 includes an AC power source, the second circuit section 5473 "of the battery 5461" may include an AC/DC transformer 5467 "configured to convert AC power provided by the power source 5370 into DC power.
As described above, referring again to fig. 44, the battery switch 5474 "is operable to selectively place the first parallel circuit segment 5472" including the battery cell 5470 "in electrical communication with the battery contact 5366 when the switch 5474" is in its first switch state, and alternatively, to place the second parallel circuit segment 5473 "including the battery connector 5464 and the AC/DC transformer 5467" in electrical communication with the battery contact 5366 when the switch 5474 "is in its second switch state. The battery switches 5474 "may include mechanical switches, electromechanical switches, and/or electronic switches, as described in more detail below.
The mechanical battery switch 5474 "can include, for example, a sliding bus bar that is urged between a first position associated with a first switching state of the switch 5474" and a second position associated with a second switching state of the switch 5474 ". In the first position of the sliding bus bar, the bus bar couples the first circuit section 5472 "with the battery contact 5366, but does not couple the second circuit section 5473" with the battery contact 5366. In the second position of the sliding bus bar, the bus bar couples the second circuit section 5473 "with the battery contact 5366, but does not couple the first circuit section 5472" with the battery contact 5366. The battery 5461 can also include a biasing member, such as a spring, configured to bias the bus bar into its first position, and thus the battery switch 5474 "into its first switch state. Further to the above, when the adapter connector 5465 is inserted into the battery connector 5464, the adapter connector 5465 can contact the bus bar of the switch 5474 "and push the bus bar from its first position to its second position and place the switch 5474" in its second switch state. When the adapter connector 5465 is removed from the battery connector 5464, the biasing member may return the bus bar to its first position and re-electrically couple the battery cell 5470 "with the battery contact 5366. In certain alternative embodiments, insertion of the adapter connector 5465 into the battery connector 5464 can permanently disengage the battery cell 5470 "from the battery contacts 5466. In at least one such embodiment, the battery 5461 "can include a lock configured to retain the bus bar in its second position once pushed to its second position by the adapter connector 5465. Such an embodiment may provide a permanent lock to prevent the battery 5461 "from being reused to supply power from the battery unit 5470" because it may be undesirable and/or unreliable to reuse and/or recharge a battery that is unable to provide sufficient power to the handle 5310.
For example, the electromechanical switch 5474 "may comprise a relay. The relay may be biased to a first relay state when the adapter connector 5465 is not positioned in the battery connector 5464. When the adapter connector 5465 is electrically coupled to the battery connector 5464, the relay may be switched to a second relay state. The relay may include, for example, an electromagnet, which may include a coil and an armature, that is activated when the contacts of the adapter connector 5465 interface with the battery connector 5464. In at least one instance, the power adapter 5460 can include a relay control circuit in addition to the power circuit that can provide sufficient voltage to the coil of the relay to move the armature of the relay between its first and second switch states. In various instances, the switch 5474 "can include, for example, a latching relay. In at least one instance, the switch 5474 "can comprise, for example, a contactor, which can be electronically controlled by, for example, a microprocessor and control circuit.
Some electronic switches may not have, for example, any moving parts, such as solid state relays. The solid state relay may use, for example, thyristors, TRIACs, and/or any other solid state switching devices. The solid state relay may be activated by a control signal from the power source 5370, for example, to switch the load provided to the battery contacts 5366 from the battery cell 5470 "to the power source 5370. In at least one instance, the solid state relay can comprise a contactor solid state relay, for example. In various instances, the electronic switch can include, for example, a microprocessor and a sensor in signal communication with the microprocessor that detects whether power is provided to the contacts of the battery connector 5464. In at least one instance, the sensor can be configured to inductively detect a field generated when a voltage is applied to the contacts of the battery connector 5464. In some cases, the microprocessor may be responsive to a control signal received, for example, from the power source 5370, to switch the relay between a first relay state and a second relay state to control whether the first parallel circuit section 5472 "or the second parallel circuit section 5473" is in electrical communication with the battery contact 5366, respectively.
Further to the above, the power adapter 5460 may include an AC/DC power converter. The power adapter 5460 includes an AC/DC power transformer 5467 in the cord 5463; however, the AC/DC power transformer may be placed in the power adapter 5460 in any suitable location.
In various instances, the power adapter supply system can include, for example, a battery, such as batteries 5361, 5461', and/or 5461", and a power adapter, such as power adapter 5360 and/or 5460.
Turning now to fig. 45-47, the handle 5510 of the surgical instrument system includes a grip portion or pistol grip 5511 and a housing 5512. The handle 5510 also includes one or more battery cells, such as battery cell 5470, positioned in the grip portion 5511, for example. In many cases, the battery unit 5470 can provide sufficient power to the handle 5510 to operate the surgical instrument system. In other cases, the battery unit 5470 may not be able to provide sufficient power to the handle 5510. In such cases, a supplemental battery, such as supplemental battery 5560, for example, can be attached to handle 5510 to provide power to handle 5510, as described in further detail below.
Further to the above, referring primarily to fig. 47, battery cells 5470 are arranged in series as part of a battery power supply circuit 5513. The battery power circuit 5513 is in electrical communication with an electrical connector 5516 defined in the housing 5512. The electrical connector 5516 may include any suitable number of electrical contacts. In at least one instance, the electrical connector 5516 includes, for example, two electrical contacts. The electrical connector 5516 is positioned at an end of the grip portion 5511; however, the electrical connector 5516 may be positioned at any suitable location on the handle 5510.
The handle 5510 further includes a connector cap 5517. The connector cover 5517 is movable between a first position in which the connector cover covers the electrical connector 5516 and a second position in which 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 cap 5517. Handle 5510 also includes a biasing member, such as a spring 5519, positioned in slot 5518, e.g., intermediate housing 5512 and connector cap 5517. The spring 5519 is configured to bias the connector cover 5517 to its first position to cover the electrical connector 5516.
As described above, a supplemental battery 5560 can be attached to the handle 5510. Supplemental battery 5560 includes, for example, a housing 5562 and one or more battery cells, such as battery cell 5570, positioned therein. The battery cells 5570 are arranged in series to supplement a part of the battery supply circuit 5563. The supplemental battery supply circuit 5563 is in electrical communication with an electrical connector 5566 defined in the battery housing 5562. The electrical connector 5566 includes the same number of electrical contacts as the electrical connector 5516 and is configured to mate with the electrical contacts of the electrical connector 5516.
The housing 5562 of the supplemental battery 5560 also includes a cavity or receptacle 5561 defined therein that is configured to receive the grip portion 5511 of the handle 5510. The cavity 5561 is configured to snugly receive the grip portion 5511 such that there is little or no relative movement between the supplemental battery 5560 and the handle 5510 when the supplemental battery 5560 is fully assembled thereto. When the supplemental battery 5560 is assembled to the handle 5510, the housing 5562 contacts the connector cover 5517 and pushes the connector cover 5517 to its second position to expose the electrical connector 5516. Once the contacts of the electrical connector 5516 have been at least partially exposed, the contacts of the electrical connector 5566 may engage the contacts of the electrical connector 5516. At this point, supplemental battery supply circuit 5563 has been electrically coupled to battery power supply circuit 5513.
The electrical connectors 5516 and 5566 may be positioned and arranged such that they do not engage each other until the supplemental battery 5560 has been fully seated onto the grip portion 5511. In other embodiments, electrical connectors 5516 and 5566 may be positioned and arranged such that they engage each other before supplemental battery 5560 is fully seated onto grip portion 5511. In either case, the housing 5512 of the handle 5510 and/or the housing 5562 of the supplemental battery 5560 may include a lock configured to retain the supplemental battery 5560 to the housing 5510. The lock may be released to allow the supplemental battery 5560 to be easily removed from the handle 5510; however, embodiments are contemplated in which the lock does not allow the supplemental battery 5560 to be easily released from the handle 5510.
As described above, when supplemental battery 5560 is assembled to handle 5510, supplemental battery supply circuit 5563 is electrically coupled to battery power circuit 5513. In various instances, a supplemental battery unit 5570 is placed in series with the handle battery unit 5470 and the power available to the handle 5510 may be increased. Such an implementation may be useful, for example, when the handle battery cell 5470 has been depleted from use. In other cases, supplemental battery unit 5570 of supplemental battery 5560 is placed in parallel with battery unit 5470 of handle 5510. In at least one such instance, the handle battery unit 5470 can be electrically disengaged from the handle 5510 when the supplemental battery unit 5570 is electrically coupled with the handle 5510. Such an embodiment may be useful when a short circuit occurs in the handle cell 5470. Various embodiments of the handle 5510 may include a switch that may allow a user to selectively place a supplemental battery unit 5570 in series or in parallel with the handle battery unit 5470.
Examples
Example 1-a surgical apparatus comprising a handle module having an attachment portion, wherein a detachable shaft module is attachable to the attachment portion for collectively performing a surgical procedure, and wherein the handle module comprises a rotary drive system for driving the detachable shaft module, an electric motor coupled to the rotary drive system to power 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, wherein the handle module processor circuit is programmed to control the electric motor, track an end-of-life parameter of the handle module based on input from the one or more sensors, and maintain a count of the end-of-life parameter.
Example 2-the surgical apparatus of example 1, further comprising means, in communication with the handle module processor circuit, for taking an end-of-life action when the handle module processor circuit determines that the count of end-of-life parameters reaches a threshold.
Example 3-the surgical device of example 2, wherein the means for taking the end-of-life action comprises a display that displays to a user surgical device information indicating the end-of-life parameter reaching the threshold.
Example 4-the surgical device of example 3, wherein the display displays a count.
Example 5-the surgical apparatus of examples 3 or 4, wherein the display displays an indicator indicating the number of uses remaining of the handle module before the threshold is reached.
Example 6-the surgical apparatus of examples 2,3,4, or 5, wherein the means for taking an end-of-life action comprises means for deactivating the handle module for a subsequent surgical procedure.
Example 7-the surgical apparatus of example 6, wherein the means for disabling the handle module comprises means for disabling operation of the electric motor.
Example 8-the surgical apparatus of examples 6 or 7, wherein the means for deactivating the handle module comprises means for preventing installation of a charged battery pack in the handle module.
Example 9-the surgical apparatus of examples 2,3,4,5,6,7, or 8, wherein the end-of-life parameter is selected from the group consisting of: a number of firings performed by the handle module, a number of surgical procedures involving the handle module, a number of attachments of the detachable shaft module to the handle module, a number of sterilizations of the handle module, and a number of attachments of a removable battery pack to the handle module, wherein the removable battery pack is used to provide power to the handle module during the surgical procedures.
Example 10-the surgical apparatus of examples 2,3,4,5,6,7,8, or 9, wherein the end-of-life parameter is calculated according to a function, inputs of which include a number of firings performed by the handle module and a number of surgical procedures involving the handle module.
Example 11-the surgical apparatus of example 10, wherein the function calculates the end-of-life parameter by using different weighting coefficients for different detachable shaft modules.
Example 12-the surgical apparatus of examples 2,3,4,5,6,7,8,9,10, or 11, wherein the detachable shaft module comprises an end effector comprising a firing member that traverses a stroke length when fired, and wherein the end-of-life parameter comprises a usage parameter of the handle module that indicates a difference between a force expected to be applied by the handle module and a force actually applied by the handle module over the stroke length of the firing member.
Example 13-the surgical apparatus of examples 2,3,4,5,6,7,8,9,10,11, or 12, wherein the end-of-life parameter comprises a number of times the handle module has been sterilized.
Example 14-the surgical apparatus of examples 2,3,4,5,6,7,8,9,10,11,12, or 13, wherein the handle module comprises a sterilization sensor in circuit communication with the handle module processor that is actuated when the protective sterilization cover is attached to the handle module.
Example 15-the surgical apparatus of example 14, wherein the sterilization sensor comprises a switch that is actuated when the protective sterilization cover is attached to the handle module.
Example 16-the surgical apparatus of examples 2,3,4,5,6,7,8,9,10,11,12,13,14, or 15, further comprising an inspection station, wherein the handle module is connectable to the inspection station for inspecting the handle module after the surgical procedure, wherein the inspection station comprises an inspection station processor circuit in communication with the handle module processor circuit via the data connection when the handle module is connected to the inspection station, and an inspection station display in communication with the inspection station processor circuit, wherein the inspection station display displays information about the handle module when the handle module is connected to the inspection station.
Example 17-a surgical apparatus comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a rotary drive system that can be activated to drive the detachable shaft module, an electric motor coupled to the rotary drive system for powering the rotary drive system, and means for tracking a count of an end-of-life parameter of the handle module based on a number of times the rotary drive system is activated.
Example 18-the surgical apparatus of example 17, wherein the means for tracking a count of the end-of-life parameter comprises a processor circuit and a memory, wherein the memory stores program code executed by the processor to track the count of the end-of-life parameter of the handle module.
Example 19-the surgical apparatus of examples 17 or 18, wherein the handle module is powered by a removable battery pack, and wherein the means for tracking a count of the end-of-life parameter of the handle module is further based on a number of times the removable battery pack is connected to the handle module.
Example 20-the surgical apparatus of examples 17,18, or 19, further comprising a sterilization tray for holding the handle module during a sterilization procedure, wherein the means for tracking a count of the end-of-life parameter of the handle module comprises a counter on the sterilization tray that increments the count when the handle module is placed in the sterilization tray.
Example 21-an apparatus comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a rotary drive system for driving the detachable shaft module, an electric motor coupled to the rotary drive system to power the rotary drive system, and a handle module processor circuit in communication with the electric motor. The apparatus further comprises an inspection station for connection to the handle module when the handle module is not being used in a surgical procedure, wherein the inspection station comprises 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, and an inspection station display in communication with the inspection station processor circuit, wherein the inspection station display displays 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 providing power to the handle module when the handle module is connected to the inspection station.
Example 23-the apparatus of examples 21 or 22, wherein the inspection station is configured to perform one or more tests on the handle module to determine the suitability of the handle module for use in a subsequent surgical procedure.
Example 24-the apparatus of example 23, wherein the one or more tests comprise a seal integrity test of the handle module.
Example 25-the apparatus of examples 23 or 24, wherein the one or more tests comprise a gear backlash test for a rotary drive system of the handle module.
Example 26-the apparatus of examples 21,22,23,24, or 25, wherein the inspection station is configured to perform an adjustment action to adjust the handle module for use in a subsequent surgical procedure.
Example 27-the apparatus of example 26, wherein the adjustment action comprises drying 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 over 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 components of the handle module with a vacuum pressure 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 for providing the 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 coupled to the detachable shaft module.
Example 33-a surgical procedure comprising performing a surgical procedure on a patient by a clinician with a surgical instrument comprising a handle module connected to a detachable shaft module, wherein the handle module comprises a memory storing data about the handle module and the surgical procedure; downloading to the memory, while the handle module is connected to the inspection station, inspection station data regarding the surgical procedure stored in the memory of the handle module; when at the same time the handle module is connected to the inspection station, an inspection of the station information about the handle module is visually displayed on the display.
Example 34-the surgical procedure of example 33, further comprising removing the removable battery pack from the handle module after the surgical procedure and before connecting the handle module to the examination console, wherein the removable battery pack powers the handle module during the surgical procedure; the handle module is powered with power from the inspection station when the handle module is connected to the inspection station at the same time.
Example 35-the surgical procedure of examples 33 or 34, wherein one or more tests are performed on the handle module while the handle module is connected to the inspection station to determine the suitability of the handle module for use in a subsequent surgical procedure.
Example 36-the surgical procedure of example 35, wherein the one or more tests comprise a seal integrity test of the handle module.
Example 37-the surgical procedure of examples 35 or 36, wherein the one or more tests comprise a gear backlash test.
Example 38-the surgical procedure of examples 34,35,36, or 37, when the handle module is connected to the examination console, an adjustment action is performed to adjust the handle module for use in a subsequent surgical procedure.
Example 39-the surgical procedure of example 38, wherein the adjusting act comprises drying components of the handle module.
Example 40-a surgical apparatus comprising a handle module connectable to a detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a rotary drive system for driving the detachable shaft module, an electric motor coupled to the rotary drive system to power the rotary drive system, one or more sensors for sensing data about the electric motor, and a handle module processor circuit in communication with the one or more sensors, wherein the handle module processor circuit is programmed for monitoring a performance parameter of the handle module based on input from the one or more sensors, and wherein the handle module 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 apparatus of example 40, wherein the processor circuit monitors the performance parameter of the handle module by monitoring whether the performance parameter is below or above an acceptable performance band.
Example 42-the surgical apparatus of examples 40 or 41, wherein the handle module further comprises means for taking a remedial action when the handle module processor circuit determines that the performance parameter is outside of an acceptable performance band.
Example 43-the surgical apparatus of examples 40,41, or 42, wherein the performance parameters comprise performance parameters of the electric motor.
Example 44-the surgical apparatus of example 43, wherein the performance parameter of the electric motor comprises energy consumed by the electric motor throughout a life of the handle module.
Example 45-the surgical apparatus of examples 43 or 44, wherein the performance parameter of the electric motor comprises power consumed by the electric motor for each firing of the handle module.
Example 46-the surgical apparatus of examples 43,44, or 45, wherein the performance parameters of the electric motor comprise energy consumed by the electric motor throughout the life of the handle module and power consumed by the electric motor for each firing of the handle module.
Example 47-the surgical apparatus of example 46, wherein the handle module processor circuit is programmed to determine that a remedial action should be taken when at least one of the following conditions is met: the energy consumed by the electric motor throughout the life of the handle module exceeds a first energy threshold, and the energy consumed by the electric motor throughout the life of the handle module exceeds a second energy threshold, the second energy threshold being lower than the first energy threshold, and the handle module having a threshold number of device firings above a threshold power level.
Example 48-the surgical device of examples 43,44,45,46, or 47, wherein the performance parameter comprises an output torque of the electric motor.
Example 49-the surgical apparatus of examples 40,41,42,43,44,45,46,47, or 48, wherein the performance parameter comprises a performance parameter of the rotary drive system.
Example 50-the surgical apparatus of example 49, wherein the performance parameter of the rotary drive system comprises gear backlash.
Example 51-the surgical apparatus of examples 42,43,44,45,46,47,48,49, or 50, wherein the means for taking remedial action comprises a display for displaying a status of the handle module.
Example 52-the surgical apparatus of examples 42,43,44,45,46,47,48,49,50, or 51, wherein the means for taking remedial action comprises means for deactivating the handle module.
Example 53-the surgical apparatus of example 52, wherein the means for deactivating the handle module comprises means for preventing insertion of a charged removable battery pack into the handle module to power the handle module during the surgical procedure.
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 lock.
Example 55-the surgical apparatus of examples 53 or 54, wherein the means for preventing insertion of the charged removable battery pack comprises a latch that, when actuated, prevents removal of the discharged removable battery pack from the handle module.
Example 56-a surgical apparatus comprising a detachable shaft module and a handle module connected to the detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a rotary drive system for driving the detachable shaft module, an electric motor coupled to the rotary drive system to power the rotary drive system, means for monitoring a performance parameter of at least one of the electric motor and the rotary drive system, and means for taking a remedial action when the performance parameter is determined to be outside of an acceptable performance band.
Example 57-the surgical apparatus of example 56, wherein the performance parameter comprises energy consumed by the electric motor throughout a life of the handle module.
Example 58-the surgical apparatus of examples 56 or 57, wherein the performance parameter comprises power consumed by an electric motor for each firing of the handle module.
Example 59-the surgical apparatus of examples 56,57, or 58, wherein the performance parameter comprises an output torque of the electric motor.
Example 60-the surgical apparatus of examples 56,57,58, or 59, wherein the means for taking remedial action comprises means for deactivating the handle module.
Example 61-the surgical apparatus of example 60, wherein the means for deactivating the handle module comprises means for deactivating the electric motor.
Example 62-the surgical apparatus of examples 60 or 61, wherein the means for disabling the handle module comprises means for preventing insertion of a charged removable battery pack into the handle module to power the handle module during the surgical procedure.
Example 63-a combination comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, a removable rechargeable battery pack connectable to the handle module for providing power to the handle module during the surgical procedure, wherein the battery pack comprises a memory for storing charge data and discharge data of the battery pack, and a charging station for at least one of charging and discharging the battery pack when the battery pack is removed from the handle module and inserted into the charging station, wherein the charging station is for at least one of charging and discharging the battery pack based on the charge data and the discharge data stored in the memory of the battery pack.
Example 64-the combination of example 63, wherein the battery pack comprises a plurality of battery cells, the charging station comprises a charging station processor circuit that determines when the battery cells should be rebalanced based on the charging data and the discharging data stored in the battery pack memory and based on a rebalancing criterion, and the charging station rebalances the battery cells of the battery pack when the charging station processor circuit determines that the battery cells should be rebalanced.
Example 65-the combination of example 64, wherein the charging station processor circuit is programmed to determine that the battery cell should be rebalanced after N charges without rebalancing of the battery pack, wherein N is an integer greater than zero.
Example 66-the combination of examples 64 or 65, wherein the charging station is configured to top up the charge of the battery cell prior to rebalancing the battery cell.
Example 67-the combination of examples 63,64,65, or 66, wherein the charging station comprises a charging station processor circuit that determines whether the battery pack should be discharged based on the charge and discharge data stored in the battery pack memory and based on the discharge criteria, and wherein the charging station discharges the battery pack when the charging station processor circuit determines that the battery pack should be discharged.
Example 68-the combination of example 67, wherein the discharge criteria comprises whether a second battery pack installed in the charging station is fully charged and ready for use with the handle module.
Example 69-the combination of examples 63,64,65,66,67, or 68, wherein the charging console is programmed to charge the battery pack at a time of day based on surgical procedure schedule data of an organizational user of the charging console, and wherein the surgical procedure schedule data is stored in a memory of the charging console.
Example 70-the combination of example 69, wherein the surgical procedure schedule data comprises a statistical likelihood of an organization user performing a surgical procedure with the handle module at a time of day.
Example 71-the combination of examples 63,64,65,66,67,68,69, or 70, 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 a surgical handle module.
Example 72-the combination of example 71, wherein the means for automatically securing the battery pack to the charging station comprises a screw that threads into the battery pack when actuated 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 the screw.
Example 74-the combination of examples 63,64,65,66,67,68,69,70,71,72, or 73, wherein the charging station includes a display for displaying charge status information about the battery pack.
Example 75-the combination of examples 63,64,65,66,67,68,69,70,71,72,73, or 74, wherein the charging station includes means for rapidly charging the first battery pack when the charging station receives a rapid charging user input of the battery pack.
Example 76-the combination of example 75, wherein the charging station comprises a means for automatically securing the battery pack to the charging station when the battery pack is not ready for use in a surgical handle module.
Example 77-a surgical procedure comprising performing a surgical procedure on a patient by a clinician with a surgical instrument comprising a handle module connected to a detachable shaft module, wherein the handle module is powered by a removable, charged battery pack during the surgical procedure, and wherein the battery pack comprises a memory for storing charging data and discharging data of the battery pack; removing the battery pack from the handle module after it has been used during surgery; after the removing step, placing the battery pack in a charging station to recharge the battery pack; downloading, by the charging console, charging and discharging data from a memory of the battery pack after the placing step; and at least one of charging and discharging the battery pack by the charging station based on the charging data and the discharging data stored in the memory of the battery pack after the downloading step.
Example 78-the surgical procedure of example 77, wherein the battery pack comprises a plurality of battery cells, and wherein the processing further comprises: after the downloading step, it is determined by the charging station whether the battery cells should be rebalanced based on the charging data and the discharging data stored in the battery pack memory and based on a rebalancing criterion, and upon determining that rebalancing of the battery cells of the battery pack should be performed, the battery cells are rebalanced by the charging station.
Example 79-the surgical procedure of examples 77 or 78, after the downloading step, to rapidly charge the battery pack in response to receipt of a rapid-charge user input.
Example 80-the surgical procedure of examples 77,78, or 79, after the placing step, automatically securing the battery pack to the charging station when the battery pack is not ready for use in the surgical handle module.
Example 81-a combination comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, a removable rechargeable battery pack connectable to the handle module for providing power to the handle module during the surgical procedure, 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, wherein the charging station comprises circuitry for rapidly charging the battery pack when the charging station receives a rapid charging user input for the battery pack.
Example 82-the combination of example 81, wherein the charging station comprises a display for displaying a charging status of the battery pack.
Embodiment 83-the combination of embodiments 81 or 82, wherein the charging station comprises a user interface through which a user inputs the 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 console that is actuatable to provide the quick charge user input to the charging console.
Example 85-the combination of examples 81,82,83, or 84, wherein the circuitry for rapidly charging the battery pack comprises circuitry for changing a charging profile of the battery pack.
Example 86-the combination of examples 81,82,83,84, or 85, wherein the circuit for changing the charging profile of the battery pack comprises a voltage regulator connected to the battery pack, and a charge controller circuit connected to the voltage regulator.
Example 87-the combination of examples 81,82,83,84,85, or 86, wherein the circuitry for rapidly charging the battery pack comprises a charge storage device of the charging station, and wherein the charge stored on the charge storage device is used to charge the battery pack.
The combination of embodiment 88-embodiment 87, wherein the charge 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 the ultracapacitor.
Example 90-the combination of examples 87,88, or 89, wherein the charge storage device comprises one or more battery cells inside the charging station.
Example 91-the combination of examples 87,88, or 89, wherein the charge storage device comprises a plurality of battery cells inside the charging station, and wherein the circuitry for rapidly charging the battery pack comprises circuitry for charging the battery pack having the plurality of battery cells.
Example 92-the combination of example 91, wherein a plurality of battery cells are connected in series.
Example 93-the combination of examples 91 or 92, wherein the plurality of battery cells are connected as a parallel current source.
Example 94-the combination of examples 81,82,83,84,85,86,87,88,89,90,91,92, or 93, wherein the charging station further comprises circuitry for discharging the first battery pack to the internal plurality of battery cells.
Example 95-the combination of examples 81,82,83,84,85,86,87,88,89,90,91,92,93, or 94, wherein the battery pack comprises a first battery pack, wherein the charging station comprises a first charging receptacle for receiving the first battery pack to charge the first battery pack, and a second charging receptacle for receiving a second battery pack to charge the second battery pack, and wherein the circuitry for rapidly charging the first battery pack comprises circuitry for charging the first battery pack with charge stored on the second 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 a charging status of the first battery pack and the second battery pack.
Example 98-a combination of examples 81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96, or 97, 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 a surgical handle module.
Example 99-a surgical instrument system, comprising a handle module for performing a surgical procedure, a removable rechargeable battery pack connectable to the handle module for providing power to the handle module during the surgical procedure, and a charging station for charging the battery pack, wherein the charging station comprises circuitry for charging the handle module in two operating states: a first operational state in which the battery pack is charged from the primary power source, and a second operational state in which the battery pack is charged from both the primary power source and the secondary power source in order to rapidly charge the battery pack in the event that the battery pack is urgently needed during a surgical procedure.
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-an apparatus comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a handle module memory circuit for storing handle module usage data of the handle module, and an inspection console connected to the handle module when the handle module is not in use in the surgical procedure, wherein the inspection console comprises an inspection console processor circuit for determining one or more repair recommendations for the handle module based on the handle module usage data stored in the memory of the handle module and based on repair recommendation criteria.
Example 102-the apparatus of example 101, wherein the inspection station further comprises a display in circuit communication with the inspection station processor, and wherein the display is to display information regarding the one or more repair recommendations.
Embodiment 103-the apparatus of embodiments 101 or 102, wherein the repair recommendation criteria are stored in an inspection station memory of the inspection station, and wherein the inspection station processor circuit is in communication with the inspection station memory.
Example 104-the apparatus of examples 101,102, or 103, wherein the handle module comprises a handle module processor circuit in communication with the handle module memory circuit, and wherein when the handle module is connected to the inspection station, the handle module processor circuit is in communication with the inspection station processor circuit such that the usage data from the handle module memory is downloaded to the inspection station.
Example 105-the apparatus of examples 101,102,103, or 104, wherein the handle module usage data comprises data selected from the group of: data regarding the number of surgical procedures involving the handle module, data regarding the number of device firings by the handle module, data regarding power consumed during device firing of the handle module, data regarding forces experienced during device firing of the handle module, data regarding energy consumed by an electric motor of the handle module throughout the life of the handle module, and data regarding gear backlash of a rotary drive system of the handle module.
Example 106-the apparatus of examples 101,102,103,104, or 105, wherein the one or more service recommendations comprise a recommendation to rebuild the handle module.
Example 107-the apparatus of examples 101,102,103,104,105, or 106, wherein the one or more service recommendations comprise a recommendation to lubricate one or more components of the handle module.
Example 108-the apparatus of examples 101,102,103,104,105,106, or 107, wherein the one or more service recommendations comprise a recommendation to inspect one or more components of the handle module.
Example 109-an apparatus comprising a handle module attachable to a detachable shaft module for collectively performing a surgical procedure, wherein the handle module comprises a handle module memory circuit for storing handle module usage data for the handle module, and a handle module processor circuit for determining one or more repair recommendations for the handle module based on the handle module usage data stored in the memory of the handle module and based on repair recommendation criteria.
Example 110-the apparatus of example 109, wherein the handle module further comprises a display in communication with the handle module processor circuit, and wherein the display is to display information regarding the one or more service recommendations.
Example 111-the apparatus of examples 109 or 110, wherein the handle module usage data comprises a group of data selected from: data regarding the number of surgical procedures involving the handle module, data regarding the number of device firings by the handle module, data regarding power consumed during device firing of the handle module, data regarding forces experienced during device firing of the handle module, data regarding energy consumed by an electric motor of the handle module throughout the life of the handle module, and data regarding gear backlash of a rotary drive system of the handle module.
Example 112-the apparatus of examples 109,110, or 111, wherein the one or more repair recommendations comprise a recommendation to rebuild the handle module.
Example 113-the apparatus of examples 109,110,111, or 112, wherein the one or more repair recommendations comprise a recommendation to rebuild the handle module.
Example 114-the apparatus of examples 109,110,111,112, or 113, wherein the one or more service recommendations comprise a recommendation to lubricate one or more components of the handle module.
Example 115-the apparatus of examples 109,110,111,112,113, or 114, wherein the one or more service recommendations comprise a recommendation to inspect one or more components of the handle module.
Example 116-a surgical instrument system comprising a handle comprising a battery cavity and a dc electric motor, a battery removably positioned in the battery cavity, wherein the battery is configured to provide dc power to the dc electric motor; and a power adapter including a plug removably positioned in the battery cavity, in place of the battery and a cord extending from the plug, wherein the cord is configured to transfer power from the power source to the plug. The surgical instrument system also includes an ac-to-dc power converter configured to convert ac power supplied from the power source to dc power.
Example 117-the surgical instrument system of example 116, wherein the ac to dc power converter is positioned in the plug.
Example 118-the surgical instrument system of examples 116 or 117, wherein the battery comprises a battery housing, wherein the plug comprises a plug housing, and wherein the battery housing is similar to the plug housing.
Example 119-the surgical instrument system of examples 116,117, or 118, wherein the handle comprises a set of handle electrical contacts in the battery cavity, wherein the battery comprises a set of battery electrical contacts configured to engage the handle electrical contacts when the battery is positioned in the battery cavity, and wherein the plug comprises a set of plug electrical contacts configured to engage the handle electrical contacts when the plug is positioned in the battery cavity.
Example 120-the surgical instrument system of examples 116,117,118, or 119, wherein the handle comprises a first set of handle electrical contacts and a second set of handle electrical contacts in the battery cavity, wherein the battery comprises a set of battery electrical contacts configured to engage the first set of handle electrical contacts when the battery is positioned in the battery cavity, and wherein the plug comprises a set of plug electrical contacts configured to engage the second set of handle electrical contacts when the plug is positioned in the battery cavity.
Example 121-the surgical instrument system of examples 116,117,118,119, or 120, wherein the ac-to-dc power converter is positioned in 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, wherein each shaft assembly is selectively engageable with the handle.
Example 123-the surgical instrument system of example 122, wherein the at least one shaft assembly comprises a staple cartridge.
Example 124-a surgical instrument system comprising a handle comprising a battery cavity and a dc electric motor; a power adapter comprising a battery positioned in a battery cavity, wherein the battery comprises at least one battery cell, an electrical connector, and a cord engageable with the electrical connector, wherein the cord is configured to transfer power from a power source. The surgical instrument system also includes an ac-to-dc power converter configured to convert ac power supplied from the power source to dc power and to supply the dc power to the dc electric motor.
Example 125-the surgical instrument system of example 124, further comprising a battery circuit, wherein the at least one battery cell, the ac-to-dc power converter, and the electrical connector are arranged in series in the battery circuit such that the at least one battery cell and the power source can supply power to the dc electric motor when the cord is engaged with the electrical connector.
Example 126-the surgical instrument system of example 124, further comprising a first battery circuit segment, wherein the first battery circuit segment comprises at least one battery cell; a second battery circuit segment, wherein the second battery circuit segment includes an AC-to-DC power converter; and a switch positioned in the battery, wherein the switch is switchable between a first switch state in which the at least one battery cell can supply power to the dc electric motor and the power supply cannot supply power to the dc electric motor, and a second switch state; in the second switching state, the at least one battery cell is unable to supply power to the dc electric motor, and the power supply is able to supply power to the dc electric motor.
Example 127-the surgical instrument system of example 126, wherein the switch is biased to a first switch state.
Example 128-the surgical instrument system of examples 126 or 127, wherein insertion of 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 cannot 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, wherein each shaft assembly is selectively engageable with the handle.
Example 132-the surgical instrument system of example 131, wherein the at least one shaft assembly comprises a staple cartridge.
Example 133-a surgical instrument system comprising a handle housing, a handle battery unit positioned in the handle housing, a handle electronic circuit, wherein the handle battery unit is configured to supply power to the handle electronic circuit; and a handle electrical connector in communication with the handle electronic circuit. The surgical instrument system further comprises a supplemental battery selectively engageable with the handle, wherein the supplemental battery comprises a battery housing engageable with the handle housing, a battery electronic circuit, a supplemental battery cell positioned in the battery housing, wherein the supplemental battery cell is configured to supply power to the battery electronic circuit; and a battery electrical connector in communication with the battery electronic circuit, wherein the battery electrical connector is engageable with the handle electrical connector when the supplemental battery is engaged with the handle to place the battery electronic circuit in communication with the handle electronic circuit.
Example 134-the surgical instrument system of example 133, wherein the handle housing comprises a gripping portion, and wherein the battery housing comprises a receptacle configured to receive the gripping portion.
Example 135-the surgical instrument system of examples 133 or 134, wherein the handle further comprises a connector cover movable between a first position in which the connector cover prevents inadvertent contact with the handle electrical connector and a second position in which the connector cover allows the battery electrical connector to engage the handle electrical connector.
Example 136-the surgical instrument system of example 135, wherein the battery housing is configured to move the connector cover between the first position and the second position when the supplemental battery is engaged with the handle.
Example 137-the surgical instrument system of examples 133,134,135, or 136, further comprising a plurality of shaft assemblies, wherein each shaft assembly is selectively engageable with the handle.
Example 138-the surgical instrument system of example 137, wherein the at least one shaft assembly comprises a staple cartridge.
Example 139-a surgical instrument comprising a housing, a motor, a battery assembly attachable to the housing of the surgical instrument, the battery assembly comprising a battery cell configured to provide electrical energy to the motor, and the battery housing comprising a support housing configured to support the battery cell, and a shock absorbing element configured to absorb a shock provided by an impact force, wherein the shock absorbing element is configured to crumple upon application of the impact force to the shock absorbing element.
Example 140-the surgical instrument of example 139, wherein the impact-absorbing member is replaceable.
Example 141-the surgical instrument of examples 139 or 140, wherein the impact-absorbing element comprises an attachment device configured to allow the impact-absorbing element to be attached to the battery assembly in a snap-fit manner.
Example 142-the surgical instrument of example 141, wherein the attachment means comprises an adhesive.
Example 143-the surgical instrument of examples 141 or 142, wherein the battery housing further comprises an aperture, and wherein the attachment device comprises a protrusion configured to be received by the aperture in the battery housing in a wedge-fit manner.
Example 144-the surgical instrument of examples 139,140,141,142, or 143, wherein the impact-absorbing element comprises a lattice structure.
Example 145-the surgical instrument of examples 139,140,141,142,143, or 144, wherein when the impact-absorbing element is corrugated, the impact-absorbing element deforms in an inward direction that still allows the battery assembly to be attached to the housing of the surgical instrument after the impact-absorbing element has been impacted.
Example 146-the surgical instrument of examples 139,140,141,142,143,144, or 145, wherein the impact-absorbing element crumples when the impact force is greater than the threshold force.
Example 147-the surgical instrument of examples 139,140,141,142,143,144,145, or 146, wherein the battery assembly further comprises a plurality of corners, wherein the battery housing further comprises a plurality of shock absorbing elements, and wherein the plurality of shock absorbing elements are positioned at each corner.
Example 148-the surgical instrument of example 147, wherein the battery housing comprises an electrical contact configured to transfer electrical energy from the battery cell to the motor and a bottom surface associated with the electrical contact, wherein each shock absorbing element comprises an end portion that extends beyond the bottom surface of the battery housing to protect the electrical contact.
Example 149-the surgical instrument of examples 148 or 149, wherein each shock absorbing element comprises a base end and a top end, and wherein the battery assembly further comprises a shock absorbing cap positioned at the top end of the shock absorbing element.
Example 150-a battery assembly for use with a surgical instrument, the battery assembly comprising a battery cell; an electrical contact configured to transfer electrical energy provided by the battery unit to a surgical instrument when the battery assembly is attached to the surgical instrument; a first housing configured to support a battery cell; a second housing configured to accommodate the first housing; and an impact absorbing layer positioned between the first housing and the second housing, wherein the impact absorbing layer comprises a lattice structure.
Example 151-the battery module of example 150, wherein the impact absorbing layer comprises a foam-like material.
Example 152-the battery assembly of examples 150 or 151, wherein the lattice structure comprises a plurality of cells comprising an inner cell having an inner planar wall, wherein the inner planar wall is oriented at least substantially parallel to the first housing; an outer unit having an outer planar wall, wherein the outer planar wall is oriented substantially parallel to the second housing.
Example 153-the battery assembly of examples 150,151, or 152, wherein the battery assembly further comprises an impact absorbing cap comprising an outer grid and an inner grid, wherein the outer grid is denser than the inner grid.
Example 154-the battery assembly of examples 150,151,152, or 153, wherein the shock absorbing layer comprises a plurality of damping elements.
Example 155-a battery assembly for use with a surgical instrument, the battery assembly comprising a battery cell configured to provide power to the surgical instrument; and an outer shell including a thermally reflective shell, a heat spreading layer, and a compressible layer positioned between the heat spreading layer and the thermally reflective shell, wherein the compressible layer is configured to flex in response to expansion of the battery cell.
Example 156-the battery assembly of example 155, wherein the compressible layer is further configured to dissipate absorption of the impact energy by the heat reflective housing.
Example 157-the battery assembly of examples 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 spreading layer.
Example 159-the battery assembly of examples 155,156,157, or 158, wherein the heat reflective shell has a first coefficient of thermal expansion, wherein the heat dissipation layer has a second coefficient of thermal expansion, and wherein the first coefficient of thermal expansion is less than the second coefficient of thermal expansion.
The entire disclosures of each of the following documents are hereby incorporated by reference herein in their entirety:
U.S. Pat. No. 5,403,312, entitled "ELECTROSURURGICAL HEMOSTATIC DEVICE", published 4.4.1995;
U.S. Pat. No. 7,000,818, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCTION CLOSING AND FIRING SYSTEMS", published on 21.2.2006;
U.S. Pat. No. 7,422,139 entitled "MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK", published on 9/2008;
U.S. Pat. No. 7,464,849 entitled "ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS" published on 16/12/2008;
U.S. Pat. No. 7,670,334 entitled "SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR" published on 3, 2.2010;
U.S. Pat. No. 7,753,245 entitled "SURGICAL STAPLING INSTRUMENTS" published on 13/7/2010;
U.S. Pat. No. 8,393,514 entitled "selective organic soluble organic fast carrier vehicle" published on 12.3.2013;
U.S. patent application Ser. No. 11/343,803 entitled "SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES", now U.S. Pat. No. 7,845,537;
U.S. patent application Ser. No. 12/031,573 entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS HAVATING RF ELECTRORDES" filed on 14.2.2008;
U.S. patent application Ser. No. 12/031,873, now U.S. Pat. No. 7,980,443, entitled "END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENTING", filed on 15.2.2008;
U.S. patent application Ser. No. 12/235,782 entitled "MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT", now U.S. Pat. No. 8,210,411;
U.S. patent application Ser. No. 12/249,117 entitled "Power reduced customization AND STAPLING APPATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," now U.S. Pat. No. 8,608,045;
U.S. patent application Ser. No. 12/647,100, now U.S. Pat. No. 8,220,688, entitled "MOTOR-DRIVE SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY", filed 24.12.2009;
U.S. patent application Ser. No. 12/893,461 entitled "STAPLE CARTRIDGE" filed on 9, 29, 2012, now U.S. Pat. No. 8,733,613;
U.S. patent application Ser. No. 13/036,647 entitled "SURGICAL STAPLING INSTRUMENT" filed on 28.2.2011, now U.S. Pat. No. 8,561,870;
U.S. patent application Ser. No. 13/118,241 entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DESYMENT ARRANGEMENTS," now U.S. patent application publication 2012/0298719;
U.S. patent application Ser. No. 13/524,049 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE" filed on 6, 15, 2012, now U.S. patent application publication 2013/0334278;
U.S. patent application Ser. No. 13/800,025 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" filed on 13/3.2013;
U.S. patent application Ser. No. 13/800,067 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" filed on 13.3.2013;
U.S. patent application publication 2007/0175955 entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTT WITH CLOSURE TRIGGER LOCKING MECHANISM" filed on 31.1.2006; and
U.S. patent application publication 2010/0264194 entitled "SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR" filed on 22.4.2010, now U.S. Pat. No. 8,308,040.
While various embodiments of the device have been described herein in connection with certain disclosed embodiments, many modifications and variations to these embodiments may be implemented. Additionally, where materials for certain components are disclosed, other materials may be used. Further, according to various embodiments, a single component may be replaced with multiple components, and multiple components may also be replaced with a single component, to perform a given function or functions. The foregoing detailed description and the following claims are intended to cover all such modifications and variations.
The devices disclosed herein may be designed for disposal after a single use, or they may be designed for multiple uses. In either case, however, the device may be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular components, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the prosthetic device may be disassembled, cleaned/replaced, and reassembled using a variety of techniques. The use of such techniques and the resulting prosthetic devices are within the scope of the present application.
Preferably, the invention described herein will be processed prior to surgery. First, a new or used instrument is obtained and, if necessary, cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria in the instrument and in the container. The sterilized instrument can then be stored in a 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 an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein is only incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Claims (21)

1. A surgical instrument, comprising:
a housing;
a motor; and
a battery assembly attachable to the housing of the surgical instrument, the battery assembly comprising:
a battery unit configured to be able to supply electric power to the motor; and
a battery housing, the battery housing comprising:
a support housing configured to support the battery cell; and
a shock absorbing element configured to absorb a shock provided by an impact force, wherein the shock absorbing element is configured to crumple upon application of an impact force to the shock absorbing element.
2. The surgical instrument of claim 1, wherein the shock absorbing element is replaceable.
3. The surgical instrument of claim 2, wherein the shock absorbing element comprises an attachment device configured to allow the shock absorbing element to be attached to the battery assembly in a snap-fit manner.
4. The surgical instrument of claim 3, wherein the attachment means comprises an adhesive.
5. The surgical instrument of claim 3, wherein the battery housing further comprises an aperture, and wherein the attachment device comprises a protrusion configured to be received by the aperture in the battery housing in a wedge fit.
6. The surgical instrument of claim 1, wherein the shock absorbing element comprises a lattice structure.
7. The surgical instrument of claim 1, wherein when the impact-absorbing element is crumpled, the impact-absorbing element deforms in an inward direction that still allows the battery assembly to attach to the housing of the surgical instrument after the impact-absorbing element has been impacted.
8. The surgical instrument of claim 1, wherein the impact-absorbing element crumples when the impact force is greater than a threshold force.
9. The surgical instrument of claim 1, wherein said battery assembly further comprises a plurality of corners, wherein said battery housing further comprises a plurality of said shock absorbing elements, and wherein said plurality of said shock absorbing elements are positioned at each of said corners.
10. The surgical instrument of claim 9, wherein the battery housing comprises:
an electrical contact configured to transfer electrical energy from the battery cell to the motor; and
a bottom surface associated with the electrical contacts, wherein each of the shock absorbing elements includes an end portion that extends beyond the bottom surface of the battery case to protect the electrical contacts.
11. The surgical instrument of claim 9, wherein each said shock absorbing element comprises a bottom end and a top end, and wherein said battery assembly further comprises a shock absorbing cap positioned at said top end of said shock absorbing element.
12. A battery assembly for use with a surgical instrument, the battery assembly comprising:
a battery cell;
an electrical contact configured to transfer electrical energy provided by the battery unit to the surgical instrument when the battery assembly is attached to the surgical instrument;
a first housing configured to support the battery cell;
a second housing configured to accommodate the first housing; and
an impact absorbing layer positioned between the first housing and the second housing, wherein the impact absorbing layer comprises a lattice structure.
13. The battery module of claim 12 wherein the shock absorbing layer comprises a foam-like material.
14. The battery assembly of claim 12, wherein the lattice structure comprises a plurality of cells comprising:
an inner unit comprising an inner planar wall, wherein the inner planar wall is oriented at least substantially parallel to the first housing; and
An outer unit comprising an outer planar wall, wherein the outer planar wall is oriented at least substantially parallel to the second enclosure.
15. The battery assembly of claim 12, wherein the battery assembly further comprises a shock absorbing cap comprising:
an outer grid; and
an inner grate, wherein the outer grate is denser than the inner grate.
16. The battery assembly of claim 12, wherein the shock absorbing layer comprises a plurality of damping elements.
17. A battery assembly for use with a surgical instrument, the battery assembly comprising:
a battery unit configured to provide electrical energy to the surgical instrument;
a housing, the housing comprising:
a heat reflective housing;
a heat dissipation layer; and
a compressible layer positioned between the heat dissipation layer and the heat reflective housing, wherein the compressible layer is configured to flex in response to expansion of the battery cell.
18. The battery assembly of claim 17, wherein the compressible layer is further configured to dissipate impact energy absorbed by the heat reflective housing.
19. The battery assembly of claim 17, wherein the compressible layer comprises a grid structure.
20. The battery assembly of claim 19, wherein the lattice structure is a closed lattice structure defined by the heat reflective housing and the heat spreading layer.
21. The battery assembly of claim 17, wherein the heat reflective housing has a first coefficient of thermal expansion, wherein the heat spreading layer has a second coefficient of thermal expansion, and wherein the first coefficient of thermal expansion is less than the second coefficient of thermal expansion.
CN202211449071.0A 2015-02-27 2016-02-24 Enhanced battery for surgical instrument Pending CN115670557A (en)

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US14/633,542 US9931118B2 (en) 2015-02-27 2015-02-27 Reinforced battery for a surgical instrument
US14/633,542 2015-02-27
CN201680012675.5A CN107405151A (en) 2015-02-27 2016-02-24 Enhanced battery for surgical instruments
PCT/US2016/019217 WO2016138057A1 (en) 2015-02-27 2016-02-24 Reinforced battery for a surgical instrument

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