U.S. patent application number 14/633560 was filed with the patent office on 2016-09-01 for surgical charging system that charges and/or conditions one or more batteries.
The applicant listed for this patent is Ethicon Endo-Surgery, LLC. Invention is credited to Chester O. Baxter, III, Andrew T. Beckman, Jerome R. Morgan, Frederick E. Shelton, IV, David C. Yates.
Application Number | 20160249910 14/633560 |
Document ID | / |
Family ID | 59030698 |
Filed Date | 2016-09-01 |
United States Patent
Application |
20160249910 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
September 1, 2016 |
SURGICAL CHARGING SYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE
BATTERIES
Abstract
A combination is disclosed which comprises a handle module that
is attachable to a detachable shaft module for collectively
performing a surgical procedure, a removable, rechargeable battery
pack connectable to the handle module for providing electric power
to the handle module during a surgical procedure, and an
intelligent charging station for charging and discharging the
battery pack when the battery pack is removed from the handle
module and inserted into the charging station. The battery pack
comprises a memory for storing charging and discharging data for
the battery pack. The intelligent charging station charges and
discharges the battery pack based on the charging and discharging
data stored in the memory of the battery pack.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Morgan; Jerome R.; (Cincinnati,
OH) ; Yates; David C.; (West Chester, OH) ;
Baxter, III; Chester O.; (Loveland, OH) ; Beckman;
Andrew T.; (Cincinnati, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, LLC |
Guaynabo |
PR |
US |
|
|
Family ID: |
59030698 |
Appl. No.: |
14/633560 |
Filed: |
February 27, 2015 |
Current U.S.
Class: |
320/112 |
Current CPC
Class: |
A61B 17/105 20130101;
G06F 19/3412 20130101; A61B 2017/07271 20130101; H01M 2/1094
20130101; H02J 7/342 20200101; A61B 2017/00464 20130101; G16H 40/40
20180101; A61B 2017/07285 20130101; H01M 2/1022 20130101; A61B
2017/00725 20130101; H01M 10/46 20130101; H02J 7/0027 20130101;
A61B 90/98 20160201; A61B 2017/00084 20130101; A61B 2017/00716
20130101; A61B 17/07207 20130101; A61B 2017/0003 20130101; H01M
2/1027 20130101; H02J 7/0042 20130101; A61B 17/068 20130101; A61B
2017/00734 20130101; A61B 2017/07214 20130101; H02J 7/0014
20130101; A61B 2090/0813 20160201; A61B 17/1155 20130101; H02J
7/0013 20130101; H02J 2207/40 20200101; A61B 90/70 20160201; A61B
2017/00017 20130101; H02J 7/0047 20130101; A61B 17/1628 20130101;
A61B 50/33 20160201; H02J 7/0045 20130101; G16H 40/20 20180101;
H01M 10/0445 20130101; A61B 2090/0812 20160201; A61B 2017/00402
20130101; A61B 2017/00469 20130101; H01M 2/1055 20130101; A61B
2017/00115 20130101; A61B 2018/1226 20130101; A61B 2017/00473
20130101; A61L 2/26 20130101; H01M 10/4257 20130101; A61B
2017/00221 20130101; A61B 2090/0811 20160201; A61B 2017/0046
20130101; A61B 2017/2925 20130101; H01M 10/6235 20150401; H01M
2220/30 20130101; A61B 2017/00199 20130101; B25F 5/006 20130101;
A61B 17/072 20130101; A61B 2017/00398 20130101; H01M 10/613
20150401; H02J 7/0048 20200101; A61B 17/2909 20130101; A61B
2017/00477 20130101; A61B 2090/0809 20160201; A61B 2090/0814
20160201; A61B 2560/0214 20130101; B25H 3/006 20130101; B25F 3/00
20130101; H02J 7/008 20130101; H01M 10/658 20150401; H02J 7/00
20130101; Y02E 60/10 20130101; H02J 7/00036 20200101; H01M 2/1066
20130101; A61B 2090/0803 20160201; A61L 2/28 20130101; H02J 7/00047
20200101 |
International
Class: |
A61B 17/068 20060101
A61B017/068; A61B 17/072 20060101 A61B017/072; H02J 7/00 20060101
H02J007/00 |
Claims
1. A combination, comprising: a handle module that is attachable to
a detachable shaft module for collectively performing a surgical
procedure; a removable, rechargeable battery pack connectable to
the handle module for providing electric power to the handle module
during a surgical procedure, wherein the battery pack comprises a
memory for storing charging data and discharging data for 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 charging data and
discharging data stored in the memory of the battery pack.
2. The combination of claim 1, 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
discharging data stored in the battery pack memory and based on
rebalancing criteria; 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.
3. The combination of claim 2, wherein the charging station
processor circuit is programmed to determine that the battery cells
should be rebalanced after N charges of the battery pack without
rebalancing, where N is an integer greater than zero.
4. The combination of claim 3, wherein prior to rebalancing the
battery cells, the charging station is configured to top off a
charge of the battery cells.
5. The combination of claim 1, wherein the charging station
comprises a charging station processor circuit that determines
whether the battery pack should be discharged based on the charging
and discharging data stored in the battery pack memory and based on
discharging criteria, and wherein the charging station discharges
the battery pack when the charging station processor circuit
determines that the battery pack should be discharged.
6. The combination of claim 5, wherein the discharging criteria
comprise whether a second battery pack installed in the charging
station is fully charged and ready for use in the handle
module.
7. The combination of claim 5, wherein the charging station is
programmed to charge the battery pack at a time of day based on
surgical procedure schedule data for an organizational user of the
charging station, and wherein the surgical procedure schedule data
is stored in a memory of the charging station.
8. The combination of claim 7, wherein the surgical procedure
schedule data comprises a statistical likelihood that the
organizational user is performing a surgical procedure with the
handle module at the time of day.
9. The combination of claim 1, wherein the charging station
comprises means for automatically securing the battery pack to the
charging station when the battery pack is not ready for use in the
handle module for a surgical procedure.
10. The combination of claim 9, wherein the means for automatically
securing the battery pack to the charging station comprises a screw
that, when actuated by insertion of the battery pack into the
charging station, screws into the battery pack.
11. The combination of claim 10, wherein the means for
automatically securing the battery pack to the charging station
further comprises a linear actuator for actuating the screw.
12. The combination of claim 1, wherein the charging station
comprises a display for displaying charge status information about
the battery pack.
13. The combination of claim 1, wherein the charging station
comprises means for rapidly charging the first battery pack when a
rapid charge user input for the battery pack is received by the
charging station.
14. The combination of claim 13, wherein the charging station
comprises means for automatically securing the battery pack to the
charging station when the battery pack is not ready for use in the
handle module for a surgical procedure.
15. A surgical process, comprising: performing, by a clinician, a
surgical procedure on a patient with a surgical instrument that
comprises a handle module connected to a detachable shaft module,
wherein the handle module is powered during the surgical procedure
by a removable, rechargeable battery pack, and wherein the battery
pack comprises a memory for storing charging data and discharging
data for the battery pack; removing the battery pack from the
handle module after it has been used during the surgical procedure;
following the removing step, placing the battery pack in a charging
station to recharge the battery pack; following the placement step,
downloading by the charging station the charging and discharging
data from the memory of the battery pack; and following the
downloading step, at least one of charging and discharging, by the
charging station, the battery pack based on the charging data and
discharging data stored in the memory of the battery pack.
16. The surgical process of claim 15, wherein the battery pack
comprises a plurality of battery cells, and wherein the process
further comprises: following the downloading step, determining, by
the charging station, whether the battery cells should be
rebalanced based on the charging data and discharging data stored
in the battery pack memory and based on rebalancing criteria; and
upon determining that rebalancing of the battery cells of the
battery pack should be performed, rebalancing the battery cells by
the charging station.
17. The surgical process of claim 15, following the downloading
step, rapidly charging the battery pack in response to receipt of a
rapid charge user input.
18. The surgical process of claim 15, following the placement step,
automatically securing the battery pack to the charging station
when the battery pack is not ready for use in the handle module for
a surgical procedure.
Description
BACKGROUND
[0001] The present invention relates to surgical instruments and,
in various embodiments, to surgical stapling and cutting
instruments and staple cartridges for use therewith.
[0002] A stapling instrument can include a pair of cooperating
elongate jaw members, wherein each jaw member can be adapted to be
inserted into a patient and positioned relative to tissue that is
to be stapled and/or incised. In various embodiments, one of the
jaw members can support a staple cartridge with at least two
laterally spaced rows of staples contained therein, and the other
jaw member can support an anvil with staple-forming pockets aligned
with the rows of staples in the staple cartridge. Generally, the
stapling instrument can further include a pusher bar and a knife
blade which are slidable relative to the jaw members to
sequentially eject the staples from the staple cartridge via
camming surfaces on the pusher bar and/or camming surfaces on a
wedge sled that is pushed by the pusher bar. In at least one
embodiment, the camming surfaces can be configured to activate a
plurality of staple drivers carried by the cartridge and associated
with the staples in order to push the staples against the anvil and
form laterally spaced rows of deformed staples in the tissue
gripped between the jaw members. In at least one embodiment, the
knife blade can trail the camming surfaces and cut the tissue along
a line between the staple rows. Examples of such stapling
instruments are disclosed in U.S. Pat. No. 7,794,475, entitled
SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR
SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE
SAME, the entire disclosure of which is hereby incorporated by
reference herein.
[0003] The foregoing discussion is intended only to illustrate
various aspects of the related art in the field of the invention at
the time, and should not be taken as a disavowal of claim
scope.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] Various features of the embodiments described herein,
together with advantages thereof, may be understood in accordance
with the following description taken in conjunction with the
accompanying drawings as follows:
[0005] FIG. 1 is a perspective view of a modular surgical system
including a motor-driven handle module and three interchangeable
detachable shaft modules;
[0006] FIG. 2 is a side perspective view of the handle module of
FIG. 1 with a portion of the handle housing removed for
clarity;
[0007] FIG. 3 is a partial exploded assembly view of the handle
module of FIG. 1;
[0008] FIG. 4 is another partial exploded assembly view of the
handle module of FIG. 1;
[0009] FIG. 5 is a side elevational view of the handle module of
FIG. 1 with a portion of the handle housing removed;
[0010] FIG. 6 is an exploded assembly view of a mechanical coupling
system for operably coupling the rotary drive systems of the handle
module of FIG. 1 to the drive systems of a detachable shaft
module;
[0011] FIG. 7 is block diagram depicting electrical components of
the handle module of FIG. 1 and the detachable shaft module;
[0012] FIG. 8 is a diagram of a process flow executed by a handle
processor of the handle module of FIG. 1 to determine when the
handle module reaches its end of life;
[0013] FIG. 9 is another diagram of a process flow executed by the
handle processor of the handle module of FIG. 1 to determine when
the handle module reaches its end of life;
[0014] FIG. 10A is a chart showing differences 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 as a function of the stroke of the shaft module;
[0015] FIG. 10B 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 reaches its end of life based on the differences
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;
[0016] 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 reaches its end of life based on the energy
expended by the handle module during use, in aggregate, and the
energy expended by the handle module during each use;
[0017] FIG. 10D is a chart showing an example of the energy
expended by the handle module over a number of device activations,
in aggregate;
[0018] FIG. 10E is a chart showing an example of the power expended
during each activation of the handle module of FIG. 1;
[0019] FIGS. 11A and 11B illustrate a sterilization tray in which a
handle module may be inserted for sterilization;
[0020] FIGS. 11C and 11D illustrate a sterilization tray in which a
handle module and a detachable shaft module may be inserted for
sterilization;
[0021] FIG. 11E illustrates another sterilization tray in which a
handle module may be inserted for sterilization;
[0022] FIGS. 11F, 11G, 11H, and 11I illustrate aspects of the
sterilization tray of FIG. 11E interfacing with a handle
module;
[0023] FIGS. 12A, 12B and 12E illustrate an inspection station for
inspecting a handle module before, during, and/or following a
surgical procedure;
[0024] FIG. 12C is a block diagram of the inspection station and
the handle module;
[0025] FIG. 12D is a diagram of a process flow executed by the
handle processor of the handle module to determine when the handle
module reaches its end of life based on a number of times the
handle module is placed on the inspection station;
[0026] FIG. 13A is a block diagram illustrating aspects of a handle
module and a removable battery pack, where the battery pack
includes an identification emitter so that the handle module can
identify the battery pack;
[0027] FIG. 13B illustrates a process flow executed by the handle
processor of the handle module of FIG. 13A to determine when the
handle module reaches its end of life based on a number of times a
battery pack has been installed in the handle module;
[0028] FIGS. 14A, 14B, and 14C illustrate aspects of a handle
module that detects the attachment of a detachable shaft module
thereto;
[0029] FIG. 14D illustrates a handle module and a detachable shaft
module, where the handle module detects attachment of the
detachable shaft module thereto;
[0030] FIG. 14E illustrates the handle module of FIG. 14D, where
the handle module also detects attachment of a removable battery
pack;
[0031] FIGS. 14F and 14G illustrate a sensor for the handle module
of FIG. 14D to detect the insertion of a removable battery pack
therein;
[0032] FIGS. 15A and 15B illustrate another sensor for the handle
module to detect the insertion of a removable battery pack
therein;
[0033] FIG. 16 illustrates a handle module with multiple power
packs;
[0034] FIGS. 17A and 17B illustrate additional process flows
executed by the handle processor of a handle module to determine
when the handle module reaches its end of life;
[0035] FIGS. 18A, 18B and 18C illustrate a handle module that with
a mechanism that prevents the insertion of a battery pack in
certain circumstances;
[0036] FIGS. 18D and 18E illustrate a mechanism of the handle
module of FIG. 18A that prevents removal of the battery pack from
the handle module in certain circumstances;
[0037] FIGS. 19A, 19B and 19C illustrate a charging station and a
handle module, where the charging station is for charging a battery
pack of the handle module;
[0038] FIGS. 20A and 20B illustrate a handle module with
sterilization covers for covering components of the handle module
during the sterilization thereof;
[0039] FIG. 20C illustrates a sterilization cover for a battery
cavity of the handle module of FIG. 20A;
[0040] FIG. 20D illustrates a removable battery pack for the handle
module of FIG. 20A;
[0041] FIGS. 21A, 21B, 21C and 21D illustrate display
configurations for a surgical instrument comprising a handle module
and a detachable shaft module;
[0042] FIG. 22 illustrates a removable battery pack with an
internal circuit board;
[0043] FIG. 23A illustrates a handle module with a projecting
device that, when projected, prevents insertion of the handle
module into a sterilization tray;
[0044] FIG. 23B illustrates the handle module of FIG. 23A and a
sterilization tray;
[0045] FIGS. 24A and 24B illustrate a handle module inspection
station for applying vacuum pressure to a handle module;
[0046] FIGS. 25A, 25B, 25C and 25D illustrate a handle module
inspection station with one or more fans for drying the handle
module;
[0047] FIG. 25E illustrates an inspection station with a vacuum
port to dry a handle module;
[0048] FIGS. 26A, 26B and 26C illustrate 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;
[0049] FIG. 26D is a cross-sectional view of the load simulation
adapter of FIGS. 26A-26C;
[0050] FIG. 26E is a chart illustrating a sample model of gear
backlash for a handle module as a function of use;
[0051] FIGS. 27A and 27B illustrate an inspection station that can
accommodate both a handle module and a detachable shaft module;
[0052] FIG. 28A illustrates a process flow executed by an
inspection station processor to make service recommendations for a
handle module;
[0053] FIG. 28B illustrates a process flow executed by a handle
module processor to make service recommendations for a handle
module;
[0054] FIG. 29A illustrates a charging station for charging one or
more removable battery packs that can be used in a handle
module;
[0055] FIGS. 29B and 29C illustrate a mechanism of the charging
station for securing a battery pack to the charging station;
[0056] FIG. 29D is a block diagram of the charging station and a
battery pack;
[0057] FIG. 29E illustrates a process flow executed by a handle
module charging station;
[0058] FIGS. 30A and 30B illustrate process flows executed by a
handle module charging station;
[0059] FIGS. 31 and 32 are electrical schematic diagrams of a
charging station;
[0060] FIG. 33A is a top view of a battery pack;
[0061] FIG. 33B is a top view of a charging station showing its
contact configuration for the battery pack of FIG. 33A;
[0062] FIG. 34A is a top view of a battery pack;
[0063] FIG. 34B is a top view of a charging station showing its
contact configuration for the battery pack of FIG. 34A;
[0064] FIG. 35 is a flow chart of a process using an inspection
station;
[0065] FIGS. 36 and 37 are process flow charts illustrating
exemplary steps for sterilizing a handle module and tracking the
number of times it is sterilized;
[0066] FIG. 38 is a perspective view of a battery assembly for use
with a surgical instrument, wherein the battery assembly comprises
a plurality of shock absorbing elements, according to at least one
embodiment;
[0067] FIG. 38A is a detail cross-sectional view of one of the
shock absorbing elements of the battery assembly of FIG. 38;
[0068] FIG. 39 is a partial cross-sectional view of the battery
assembly of FIG. 38;
[0069] FIG. 40 is a perspective view of a battery assembly for use
with a surgical instrument comprising a battery housing configured
to protect one or more battery cells of the battery assembly;
[0070] FIG. 40A is a detail cross-sectional view of the battery
assembly of FIG. 40;
[0071] FIG. 41 illustrates a handle of a surgical instrument system
including a power adapter extending from the handle to a power
source in accordance with at least one embodiment;
[0072] FIG. 42 illustrates the handle of FIG. 41 which is
selectively usable with the power adapter of FIG. 41 or a power
adapter system including a removable battery and a detachable power
cord in accordance with at least one embodiment
[0073] FIG. 43 is a schematic representation of a power adapter in
accordance with at least one embodiment;
[0074] FIG. 44 is a schematic representation of a power adapter in
accordance with at least one embodiment;
[0075] FIG. 45 is a perspective view of a handle of a surgical
instrument system including a battery;
[0076] FIG. 46 is a perspective view of a second battery attached
to the handle of FIG. 45; and
[0077] FIG. 47 is a cross-sectional view of the handle and the
battery of FIG. 45 and the second battery of FIG. 46.
[0078] 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
[0079] Applicant of the present application owns the following
patent applications that were filed on even date herewith and which
are each herein incorporated by reference in their respective
entireties:
[0080] U.S. patent application Ser. No. ______, entitled SURGICAL
APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER; Attorney
Docket No. END7539USNP/140464;
[0081] U.S. patent application Ser. No. ______, entitled SURGICAL
INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION; Attorney Docket
No. END7542USNP/140467;
[0082] U.S. patent application Ser. No. ______, entitled SURGICAL
APPARATUS CONFIGURED TO ASSESS WHETHER A PERFORMANCE PARAMETER OF
THE SURGICAL APPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND;
Attorney Docket No. END7547USNP/140472;
[0083] U.S. patent application Ser. No. ______, entitled CHARGING
SYSTEM THAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY;
Attorney Docket No. END7543USNP/140468;
[0084] U.S. patent application Ser. No. ______, entitled SYSTEM FOR
MONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED;
Attorney Docket No. END7558USNP/140483;
[0085] U.S. patent application Ser. No. ______, entitled REINFORCED
BATTERY FOR A SURGICAL INSTRUMENT; Attorney Docket No.
END7551USNP/140476;
[0086] U.S. patent application Ser. No. ______, entitled POWER
ADAPTER FOR A SURGICAL INSTRUMENT; Attorney Docket No.
END7553USNP/140478;
[0087] U.S. patent application Ser. No. ______, entitled ADAPTABLE
SURGICAL INSTRUMENT HANDLE; Attorney Docket No. END7541USNP/140466;
and
[0088] U.S. patent application Ser. No. ______, entitled MODULAR
STAPLING ASSEMBLY; Attorney Docket No. END7544USNP/140469.
[0089] Applicant of the present application owns the following
patent applications that were filed on Dec. 18, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0090] U.S. patent application Ser. No. 14/574,478, entitled
SURGICAL INSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE END
EFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKE OF A FIRING;
[0091] U.S. patent application Ser. No. 14/574,483, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS;
[0092] U.S. patent application Ser. No. 14/575,139, entitled DRIVE
ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS;
[0093] U.S. patent application Ser. No. 14/575,148, entitled
LOCKING ARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITH
ARTICULATABLE SURGICAL END EFFECTORS;
[0094] 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;
[0095] U.S. patent application Ser. No. 14/575,143, entitled
SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS;
[0096] U.S. patent application Ser. No. 14/575,117, entitled
SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE
FIRING BEAM SUPPORT ARRANGEMENTS;
[0097] U.S. patent application Ser. No. 14/575,154, entitled
SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED
FIRING BEAM SUPPORT ARRANGEMENTS;
[0098] U.S. patent application Ser. No. 14/574,493, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING A FLEXIBLE ARTICULATION
SYSTEM; and
[0099] U.S. patent application Ser. No. 14/574,500, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION
SYSTEM.
[0100] Applicant of the present application owns the following
patent applications that were filed on Mar. 1, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0101] U.S. patent application Ser. No. 13/782,295, entitled
ARTICULATABLE SURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR
SIGNAL COMMUNICATION, now U.S. Patent Application Publication No.
2014/0246471;
[0102] U.S. patent application Ser. No. 13/782,323, entitled ROTARY
POWERED ARTICULATION JOINTS FOR SURGICAL INSTRUMENTS, now U.S.
Patent Application Publication No. 2014/0246472;
[0103] U.S. patent application Ser. No. 13/782,338, entitled
THUMBWHEEL SWITCH ARRANGEMENTS FOR SURGICAL INSTRUMENTS, now U.S.
Patent Application Publication No. 2014/0249557;
[0104] U.S. patent application Ser. No. 13/782,499, entitled
ELECTROMECHANICAL SURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT,
now U.S. Patent Application Publication No. 2014/0246474;
[0105] U.S. patent application Ser. No. 13/782,460, entitled
MULTIPLE PROCESSOR MOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS,
now U.S. Patent Application Publication No. 2014/0246478;
[0106] U.S. patent application Ser. No. 13/782,358, entitled
JOYSTICK SWITCH ASSEMBLIES FOR SURGICAL INSTRUMENTS, now U.S.
Patent Application Publication No. 2014/0246477;
[0107] U.S. patent application Ser. No. 13/782,481, entitled SENSOR
STRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR, now U.S.
Patent Application Publication No. 2014/0246479;
[0108] U.S. patent application Ser. No. 13/782,518, entitled
CONTROL METHODS FOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT
PORTIONS, now U.S. Patent Application Publication No.
2014/0246475;
[0109] U.S. patent application Ser. No. 13/782,375, entitled ROTARY
POWERED SURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM, now
U.S. Patent Application Publication No. 2014/0246473; and
[0110] U.S. patent application Ser. No. 13/782,536, entitled
SURGICAL INSTRUMENT SOFT STOP, now U.S. Patent Application
Publication No. 2014/0246476.
[0111] Applicant of the present application also owns the following
patent applications that were filed on Mar. 14, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0112] U.S. patent application Ser. No. 13/803,097, entitled
ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, now
U.S. Patent Application Publication No. 2014/0263542;
[0113] 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 No. 2014/0263537;
[0114] 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 No.
2014/0263564;
[0115] U.S. patent application Ser. No. 13/803,086, entitled
ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK,
now U.S. Patent Application Publication No. 2014/0263541;
[0116] 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 No.
2014/0263538;
[0117] U.S. patent application Ser. No. 13/803,148, entitled
MULTI-FUNCTION MOTOR FOR A SURGICAL INSTRUMENT, now U.S. Patent
Application Publication No. 2014/0263554;
[0118] U.S. patent application Ser. No. 13/803,066, entitled DRIVE
SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now
U.S. Patent Application Publication No. 2014/0263565;
[0119] U.S. patent application Ser. No. 13/803,117, entitled
ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS,
now U.S. Patent Application Publication No. 2014/0263553;
[0120] U.S. patent application Ser. No. 13/803,130, entitled DRIVE
TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now
U.S. Patent Application Publication No. 2014/0263543; and
[0121] U.S. patent application Ser. No. 13/803,159, entitled METHOD
AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT, now U.S. Patent
Application Publication No. 2014/0277017.
[0122] Applicant of the present application also owns the following
patent application that was filed on Mar. 7, 2014 and is herein
incorporated by reference in its entirety:
[0123] U.S. patent application Ser. No. 14/200,111, entitled
CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS, now U.S. Patent
Application Publication No. 2014/0263539.
[0124] Applicant of the present application also owns the following
patent applications that were filed on Mar. 26, 2014 and are each
herein incorporated by reference in their respective
entireties:
[0125] U.S. patent application Ser. No. 14/226,106, entitled POWER
MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS;
[0126] U.S. patent application Ser. No. 14/226,099, entitled
STERILIZATION VERIFICATION CIRCUIT;
[0127] U.S. patent application Ser. No. 14/226,094, entitled
VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT;
[0128] U.S. patent application Ser. No. 14/226,117, entitled POWER
MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP
CONTROL;
[0129] U.S. patent application Ser. No. 14/226,075, entitled
MODULAR POWERED SURGICAL INSTRUMENT WITH DETACHABLE SHAFT
ASSEMBLIES;
[0130] U.S. patent application Ser. No. 14/226,093, entitled
FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL
INSTRUMENTS;
[0131] U.S. patent application Ser. No. 14/226,116, entitled
SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION;
[0132] U.S. patent application Ser. No. 14/226,071, entitled
SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR;
[0133] U.S. patent application Ser. No. 14/226,097, entitled
SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS;
[0134] U.S. patent application Ser. No. 14/226,126, entitled
INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS;
[0135] U.S. patent application Ser. No. 14/226,133, entitled
MODULAR SURGICAL INSTRUMENT SYSTEM;
[0136] U.S. patent application Ser. No. 14/226,081, entitled
SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT;
[0137] U.S. patent application Ser. No. 14/226,076, entitled POWER
MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE
PROTECTION;
[0138] U.S. patent application Ser. No. 14/226,111, entitled
SURGICAL STAPLING INSTRUMENT SYSTEM; and
[0139] U.S. patent application Ser. No. 14/226,125, entitled
SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT.
[0140] Applicant of the present application also owns the following
patent applications that were filed on Sep. 5, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0141] U.S. patent application Ser. No. 14/479,103, entitled
CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE;
[0142] U.S. patent application Ser. No. 14/479,119, entitled
ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION;
[0143] U.S. patent application Ser. No. 14/478,908, entitled
MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION;
[0144] U.S. patent application Ser. No. 14/478,895, entitled
MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT
OR INTERPRETATION;
[0145] U.S. patent application Ser. No. 14/479,110, entitled USE OF
POLARITY OF HALL MAGNET DETECTION TO DETECT MISLOADED
CARTRIDGE;
[0146] U.S. patent application Ser. No. 14/479,098, entitled SMART
CARTRIDGE WAKE UP OPERATION AND DATA RETENTION;
[0147] U.S. patent application Ser. No. 14/479,115, entitled
MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE; and
[0148] U.S. patent application Ser. No. 14/479,108, entitled LOCAL
DISPLAY OF TISSUE PARAMETER STABILIZATION.
[0149] Applicant of the present application also owns the following
patent applications that were filed on Apr. 9, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0150] 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 No. 2014/0305987;
[0151] 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 No. 2014/0305989;
[0152] U.S. patent application Ser. No. 14/248,595, entitled
SURGICAL INSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLING THE
OPERATION OF THE SURGICAL INSTRUMENT, now U.S. Patent Application
Publication No. 2014/0305988;
[0153] U.S. patent application Ser. No. 14/248,588, entitled
POWERED LINEAR SURGICAL STAPLER, now U.S. Patent Application
Publication No. 2014/0309666;
[0154] U.S. patent application Ser. No. 14/248,591, entitled
TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. Patent
Application Publication No. 2014/0305991;
[0155] U.S. patent application Ser. No. 14/248,584, entitled
MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES
FOR ALIGNING ROTARY DRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS,
now U.S. Patent Application Publication No. 2014/0305994;
[0156] U.S. patent application Ser. No. 14/248,587, entitled
POWERED SURGICAL STAPLER, now U.S. Patent Application Publication
No. 2014/0309665;
[0157] U.S. patent application Ser. No. 14/248,586, entitled DRIVE
SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S.
Patent Application Publication No. 2014/0305990; and
[0158] U.S. patent application Ser. No. 14/248,607, entitled
MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION
ARRANGEMENTS, now U.S. Patent Application Publication No.
2014/0305992.
[0159] Applicant of the present application also owns the following
patent applications that were filed on Apr. 16, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0160] U.S. Provisional Patent Application Ser. No. 61/812,365,
entitled SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A
SINGLE MOTOR;
[0161] U.S. Provisional Patent Application Ser. No. 61/812,376,
entitled LINEAR CUTTER WITH POWER;
[0162] U.S. Provisional Patent Application Ser. No. 61/812,382,
entitled LINEAR CUTTER WITH MOTOR AND PISTOL GRIP;
[0163] U.S. Provisional Patent Application Ser. No. 61/812,385,
entitled SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS
AND MOTOR CONTROL; and
[0164] U.S. Provisional Patent Application Ser. No. 61/812,372,
entitled SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A
SINGLE MOTOR.
[0165] Numerous specific details are set forth to provide a
thorough understanding of the overall structure, function,
manufacture, and use of the embodiments as 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 thus it can be appreciated that the specific
structural and functional details disclosed herein may be
representative and illustrative. Variations and changes thereto may
be made without departing from the scope of the claims.
[0166] The terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "include" (and any form of include, such as
"includes" and "including") and "contain" (and any form of contain,
such as "contains" and "containing") are open-ended linking verbs.
As a result, a surgical system, device, or apparatus that
"comprises," "has," "includes" 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, an element of
a system, device, or apparatus 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.
[0167] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical", "horizontal", "up", and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0168] Various exemplary devices and methods are provided for
performing laparoscopic and minimally invasive surgical procedures.
However, the reader will readily appreciate that the various
methods and devices disclosed herein can be used in numerous
surgical procedures and applications including, for example, in
connection with open surgical procedures. As the present Detailed
Description proceeds, the reader will further appreciate that the
various instruments disclosed herein can be inserted into a body in
any way, such as through a natural orifice, through an incision or
puncture hole formed in tissue, etc. The working portions or end
effector portions of the instruments can be inserted directly into
a patient's body or can be inserted through an access device that
has a working channel through which the end effector and elongated
shaft of a surgical instrument can be advanced.
[0169] A surgical stapling system can comprise a shaft and an end
effector extending from the shaft. The end effector comprises a
first jaw and a second jaw. The first jaw comprises a staple
cartridge. The staple cartridge is insertable into and removable
from the first jaw; however, other embodiments are envisioned in
which a staple cartridge is not removable from, or at least readily
replaceable from, the first jaw. The second jaw comprises 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 envisioned in which first jaw
is pivotable relative to the second jaw. The surgical stapling
system further comprises an articulation joint configured to permit
the end effector to be rotated, or articulated, relative to the
shaft. The end effector is rotatable about an articulation axis
extending through the articulation joint. Other embodiments are
envisioned which do not include an articulation joint.
[0170] The staple cartridge comprises 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 the 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 the tissue against the deck. Thereafter, staples removably
stored in the cartridge body can be deployed into the tissue. The
cartridge body includes staple cavities defined therein wherein
staples are removably stored in the staple cavities. The staple
cavities are arranged in six longitudinal rows. Three rows of
staple cavities are positioned on a first side of a longitudinal
slot and three rows of staple cavities are positioned on a second
side of the longitudinal slot. Other arrangements of staple
cavities and staples may be possible.
[0171] The staples are supported by staple drivers in the cartridge
body. The drivers are movable between a first, or unfired position,
and a second, or fired, position to eject the staples from the
staple cavities. The drivers are retained in the cartridge body by
a retainer which extends around the bottom of the cartridge body
and includes resilient members configured to grip the cartridge
body and hold the retainer to the cartridge body. The drivers are
movable between their unfired positions and their fired positions
by a sled. The sled is movable between a proximal position adjacent
the proximal end and a distal position adjacent the distal end. The
sled comprises a plurality of ramped surfaces configured to slide
under the drivers and lift the drivers, and the staples supported
thereon, toward the anvil.
[0172] Further to the above, the sled is moved distally by a firing
member. The firing member is configured to contact the sled and
push the sled toward the distal end. The longitudinal slot defined
in the cartridge body is configured to receive the firing member.
The anvil also includes a slot configured to receive the firing
member. The firing member further comprises a first cam which
engages the first jaw and a second cam which engages the second
jaw. As the firing member is advanced distally, the first cam and
the second cam can control the distance, or tissue gap, between the
deck of the staple cartridge and the anvil. The firing member also
comprises a knife configured to incise the tissue captured
intermediate the staple cartridge and the anvil. It is desirable
for the knife to be positioned at least partially proximal to the
ramped surfaces such that the staples are ejected ahead of the
knife.
[0173] An end effector can be configured to articulate relative to
the handle and/or shaft of a surgical instrument. For example, the
end effector can be pivotably and/or rotatably coupled to the 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 located intermediate the end effector and the
shaft. In other instances, the shaft can include a proximal
portion, a distal portion, and an articulation joint, which can be
located intermediate the proximal portion and the distal portion of
the shaft, for example.
[0174] FIGS. 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 may be used, and
reused, in connection with one or a variety of different detachable
(and typically reusable) shaft modules (DSM)s. As described in more
detail below, the handle module 10 may include a housing 12 with
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 FIGS. 1 and 5. The
first rotary drive system 20 may be employed, for example, to apply
"closure" motions to a corresponding closure drive shaft assembly
that is operably supported in the DSM and the second rotary drive
system 40 may be employed, for example, to apply "firing" motions
to a corresponding firing drive shaft assembly in the DSM that is
coupled thereto. The various DSMs may be releasably and
interchangeably connected to the housing 12. Three exemplary DSMs
that could be connected to the handle module 10 in various
arrangements are depicted in FIG. 1. The depicted exemplary DSMs
include an open linear stapler DSM 1, a curved cutter stapler DSM
2, and a circular surgical stapler DSM 3. Other DSM types that are
adapted for the drive systems 20, 40 of the handle module 10 could
also be used, including an endocutter DSM, which is described in
more detail in U.S. patent application Ser. No. ______, entitled
MODULAR STAPLING ASSEMBLY, Attorney Docket No. END7544USNP/140469,
which was filed on even date herewith and is incorporated by
reference in its entirety. More details about an exemplary
dual-drive surgical cutting and fastening instrument are provided
in U.S. patent application Ser. No. 14/248,590, entitled MOTOR
DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS, filed
Apr. 9, 2014, hereinafter "the '590 application," which is
incorporated herein by reference in its entirety.
[0175] As shown in FIGS. 1-5, the housing 12 comprises a handle 14
that is configured to be grasped, manipulated and actuated by a
clinician. The handle 14 may comprise a pair of handle housing
segments 16 and 18 that may be interconnected by screws, snap
features, adhesive, etc. In the illustrated arrangement, the handle
housing segments 16, 18 cooperate to form a pistol grip portion 19
that can be gripped and manipulated by the clinician. The handle 14
operably supports the two rotary drive systems 20, 40.
[0176] The first and second rotary drive systems 20, 40 may be
powered by a motor 80 through a "shiftable" transmission assembly
60 that essentially shifts power/motion between two power trains.
The first rotary drive system 20 includes a first rotary drive
shaft 22 that is rotatably supported in the housing 12 of the
handle 14 and defines a first drive shaft axis "FDA-FDA." A first
drive gear 24 is keyed onto or otherwise non-rotatably affixed to
the first rotary drive shaft 22 for rotation therewith about the
first drive shaft axis FDA-FDA. Similarly, the second rotary drive
system 40 includes a second rotary drive shaft 42 that is rotatably
supported in the housing 12 of the handle 14 and defines 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 and
second drive shaft axes are not coaxial. The second rotary drive
shaft 42 has a second drive gear 44 keyed onto or otherwise
non-rotatably affixed to the second drive shaft 42 for rotation
therewith about the second drive shaft axis SDA-SDA. In addition,
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.
[0177] In one form, the motor 80 includes a motor output shaft that
has a motor drive gear 82 attached thereto. The motor drive gear 82
is configured for intermeshing "operable" engagement with the
transmission assembly 60. 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 gears 44 and 46 on
the second rotary drive shaft 42. For example, the transmission
carriage 62 may be slidably journaled on a support shaft 63 that is
mounted within the housing 12 on a shaft mount 61 such that the
line of action of the transmission carriage is perpendicular to the
gear trains of the rotary drive systems. The shaft mount 61 is
configured to be rigidly supported within slots or other features
within the handle module 10. The transmission carriage 62 includes
a carriage gear 64 that is rotatably supported on the support shaft
63 and is configured for selective meshing engagement with gears 44
and 46 while in driving engagement with drive gear 82. In the
arrangement depicted in FIGS. 1-5, the transmission carriage 62 is
attached operably to a shifter or a "means for shifting" 70 that is
configured to shift axially the transmission carriage 62 between a
"first drive position" and a "second drive position." In one form,
for example, the means for shifting 70 includes a shifter solenoid
71 that is supported within the housing 12 of the handle 14. The
shifter solenoid 71 may comprise a bi-stable solenoid or, for
example, may comprise a dual position, spring loaded solenoid. The
illustrated arrangement includes a spring 72 that biases the
transmission carriage 62 in the distal direction "DD" to the first
drive position wherein the carriage gear 64 is in meshing
engagement with the intermediate drive gear 46 while also in
meshing engagement with the drive gear 82. When in that first drive
position, activation of the motor 80 will result in rotation of
gears 82, 46 and 24, which will ultimately result in rotation of
the first drive shaft 22.
[0178] The shifter solenoid 71 may be actuated by a firing trigger
90 that is pivotally supported on the housing 12 of handle 14 as
shown in FIGS. 1-5. In the illustrated embodiment, the firing
trigger 90 is pivotally supported on a firing trigger shaft 92
mounted in the handle 14. The firing trigger 90 is normally biased
in an unactuated position by a firing trigger spring 94, as shown
in FIG. 3. The firing trigger 90 is mounted for operable actuation
of a firing switch 96 that is operably supported on a control
circuit board assembly 100 housed in the housing 12 of the handle
module 10. In the illustrated arrangement, actuation of the firing
trigger 90 results in the actuation of the shifter solenoid 71.
Actuation of the firing trigger 90 results in the shifter solenoid
71 pulling the transmission carriage 62 in the proximal direction
"PD" to thereby move the carriage gear 64 into meshing engagement
with the second drive gear 44. Actuation of motor 80 when the
carriage gear 64 is in meshing engagement with the drive gear 82
and the second drive gear 44 will result in the rotation of the
second drive shaft 42 about the second drive shaft axis "SDA." The
shiftable transmission assembly 60 may also include an indicator
system 74 that includes a pair of switches 75 and 76 that are
operably coupled to the control board 100 as well as a transmission
indicator light 77. The switches 75, 76 serve to detect the
position of the transmission carriage 62, which results in the
control system actuating the indicator light 77 depending upon the
position of the transmission carriage 62. For example, the
indicator light 77 may be energized when the transmission carriage
62 is in the first drive position. This provides the clinician with
an indication that actuation of the motor 80 will result in the
actuation of the first drive system 20.
[0179] The motor 80 may be a DC brushed driving motor having a
maximum rotation of, approximately, 25,000 RPM, for example. In
other arrangements, the motor may include a brushless motor, a
cordless motor, a synchronous motor, a stepper motor, or any other
suitable electric motor, including autoclavable motors. The motor
80 may be powered by a power source 84 that in one form may
comprise 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 a removable cap 17 that is 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 comprise, for example, a Lithium Ion ("LI")
or other suitable battery type. The power pack 86 is configured for
removable operable attachment to the control circuit board assembly
100 of the handle module 10, which is also operably coupled to the
motor 80 and mounted within the handle 14. The power pack 86 may
comprise a number of battery cells connected in series that may
serve as the power source for the surgical instrument. In addition,
the power source 84 may be replaceable and/or rechargeable and, in
at least one instance, can include CR123 batteries, for
example.
[0180] The motor 80 may be actuated by a "rocker-trigger" 110 that
is 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 the first motor switch 112 will result in actuation of
the motor 80 such that the drive gear 82 rotates in a first rotary
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 the second motor switch 114 will result
in actuation of the motor 80 such that the drive gear 82 is rotated
in a second direction. For example, in use, a voltage polarity
provided by the power source 84 can operate the electric motor 80
in a clockwise direction wherein the voltage polarity applied to
the electric motor by the battery can be reversed in order to
operate the electric motor 80 in a counter-clockwise direction. The
handle 14 can also include a sensor that is configured to detect
the directions in which the drive systems are being moved.
[0181] The housing 12 may also comprise a surgical instrument
contact board 30 mounted thereto. Correspondingly, the various DSMs
(e.g., DSMs 1, 2, 3) may include a mating DSM contact board (see
FIGS. 34-60 of the '590 application). The DSM contact board may be
positioned in the DSM such that when the DSM is operably coupled to
the handle module 10, the end effector contact board is
electrically coupled to a handle module contact board 30 mounted in
the handle module 10. In such a manner, data and/or electric power
can be transferred between the handle module 10 and the DSM via the
mating contact boards.
[0182] FIG. 6 illustrates one form of mechanical coupling system 50
that may be employed to facilitate the simultaneous removable and
operable coupling of the two drive systems 20, 40 in the handle
module 10 to the corresponding "driven" shafts in the DSMs. The
coupling system 50 may comprise male couplers that may be attached
to the drive shafts in the handle module 10 and corresponding
female socket couplers that are attached to the driven shafts in
the surgical DSM. Each of the male couplers 51 are configured to be
drivingly received within corresponding female socket couplers 57
that may also be attached to the driven shafts within the DSM.
[0183] Arrangements for driving the drive systems 20, 40 are
disclosed in the '590 application, including that the handle module
10 may include multiple motors.
[0184] FIG. 7 is a block diagram of a modular motor driven surgical
instrument 2100 comprising a handle module 2102 and a DSM 2104. The
handle and DSMs 2102, 2104 comprise respective electrical
subsystems 2106, 2108 electrically coupled by a communications and
power interface 2110. The components of the electrical subsystem
2106 of the handle portion 2102 are supported by, and can be
connected to, the previously described control board 100. The
communications and power interface 2110 is configured such that
electrical signals and/or power can be readily exchanged between
the handle portion 2102 and the shaft portion 2104.
[0185] In the illustrated example, the electrical subsystem 2106 of
the handle module 2102 is coupled electrically to various
electrical elements 2112 and a display 2114. In one instance, the
display 2114 is an organic light emitting diode (OLED) display,
although the display 2114 should not be limited in this context,
and other display technologies could be used. The electrical
subsystem 2108 of the DSM 2104 is electrically coupled to various
electrical elements 2116 of the DSM 2104.
[0186] 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 that may be located either
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 instance, the handle processor 2124
may be a TM4C123BH6ZRB microcontroller from Texas Instruments that
comprises a 32-bit ARM.RTM. Cortex.TM.-M4 80-MHz processor and
on-chip memory, such as 256 KB Flash, 32 KB SRAM, internal ROM for
C Series software, and 2KB EEPROM. The electrical subsystem 2106
could also comprise one or more separate, external memory
chips/circuits (not shown) connected to the handle processor 2124
via a data bus. As used herein, a "processor" or "processor
circuit," such as the handle processor 2124, may be implemented as
a microcontroller, microprocessor, a field programmable gate array
(FPGA), or an application specific integrated circuit (ASIC), that
executes program code, such as firmware and/or software, stored in
associated memory to perform the various functions programmed by
the program code.
[0187] In one aspect, the electrical subsystem 2106 of the handle
module 2102 receives signals from the various electrical components
2112, including a solenoid 2132, a clamp position switch 2134, a
fire position switch 2136, a motor 2138, a battery pack 2140, an
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 indicated whether the fire switch is activated or not).
The motor 2138 may represent motor 80 in FIGS. 2-5.
[0188] In one aspect, the electrical subsystem 2108 of the DSM 2104
comprises 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 are indicative of the status
of the clamp jaws and cutting element in the DSM. In particular,
the electrical subsystem 2108 of the DSM may receive signals from a
clamp opened 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 fire begin
status switch 2154 (which indicates whether the end effector
commenced firing), and a fire end status switch 2156 (which
indicates whether the end effector ended firing), so that the
various switches indicate the states of the clamp and cutting
element.
[0189] 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. The motor
controller/driver 2122 may comprise a three phase brushless DC
(BLDC) controller and MOSFET driver, such as the A3930 motor
controller/driver provided by Allegro, for example. In one aspect,
the modular motor driven surgical instrument 2100 is equipped with
a brushless DC electric motor 2138 (BLDC motor, BL motor), also
known as an electronically commutated motor (ECM, EC motor). One
such motor is the BLDC Motor B0610H4314 provided by Portescap. The
sensor switches 2128 may include one or more unipolar integrated
circuit type Hall Effect sensors. The voltage regulator 2126
regulates the power supplied to the various electrical components
of the handle module 2102 and DSM 2104 from a power source (e.g.,
battery 2140). The battery 2140, which can represent battery pack
86 in FIGS. 1-5, may be, for example, a lithium-ion polymer (LiPo)
battery, polymer lithium ion, and/or lithium polymer batteries, for
example, which (abbreviated Li-poly, Li-Pol, LiPo, LIP, PLi or LiP)
are rechargeable (secondary cell) batteries. The LIPO battery 2140
may comprise several (e.g., four or six) identical secondary cells
in parallel (a "pack"). The OLED interface 2142 is an interface to
the OLED display 2114, which comprises organic light-emitting
diodes.
[0190] In one aspect, the DSM processor 2130 of the electrical
subsystem 2108 of the DSM 2104 may be implemented as an ultra-low
power 16-bit mixed signal MCU, such as the MSP430FR5738 Ultra-low
Power MCU from Texas Instruments. It may comprise, among other
things, internal RAM nonvolatile 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 could also
comprise one or more separate, external memory chips/circuits
connected to the DSM processor 2130 via a data bus.
[0191] More details about exemplary electrical subsystem for the
handle and DSMs 2102, 2104 may be found in the '590 application. In
operation, the electrical subsystem 2106 of the handle module 2102
receives signals from the open switch 2144, close switch 2146, and
fire switch 2148 supported on a housing of the handle module
portion 2102 (e.g., housing 12). When a signal is received from the
close switch 2146 the handle processor 2124 operates the motor 2138
to initiate closing 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 communications
and power interface 2110.
[0192] Once the target tissue has been clamped, the fire switch
2148 may be actuated to generate a signal, which 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 result in the rotation
of a second drive shaft. Once the cutting member is positioned, the
fire begin status switch 2154 located in the end effector sends a
signal indicative of the position of the cutting member to the DSM
processor 2130, which communicates the position back to the handle
processor 2124 through the communications and power interface
2110.
[0193] Actuating the first switch 2148 once again sends a signal to
the handle processor 2138, which in response actuates the second
drive system and the 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 positions in
the surgical staple cartridge, the fire 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 fire switch 2148 may be activated to send a signal to the
handle processor 2124, which operates the motor 2138 in reverse
rotation to return the firing system to its starting position.
[0194] Actuating the open switch 2144 once again sends a signal to
the handle processor 2124, which operates the motor 2138 to open
the clamp. Once open, the clamp opened status switch 2150 located
in the end effector sends a signal to the shaft processor 2130,
which communicates the position of the clamp to the handle
processor 2124. The clamp position switch 2134 and the fire
position switch 2136 provide signals to the handle processor 2124
that indicate the respective positions of the clamp arm and the
cutting member.
[0195] FIG. 8 is a diagram of a process flow that may be executed
by the handle processor 2124 in various instances by executing
software and/or firmware instructions for the handle processor 2124
stored in the internal memory of the processor and/or in an
external memory chip/circuit connected to the handle processor
2124. At step 202, the handle processor 2124 monitors input signals
from sensors of the instrument 2100 for so-called "life events."
The life events are events or actions involving the handle module
2102 and/or the DSM 2104 wherein the handle module 2102 should be
retired (i.e., no longer used) once the threshold number of life
events is reached. The life events could be the clamping of the end
effector, the firing of the end effector, combinations of these
events, and/or other events or actions involving the handle module
2102 and/or DSM 2104 that can be and are 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 opened status switch 2150, the clamp closed status switch
2152, the fire begin 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). A life event may occur and may be
counted when some or all these respective switches are activated,
and/or activated in a particular sequence detected by the handle
processor 2124, depending on the design and application of the
handle module 2102 and instrument 2100. For example, in various
implementations, each detected clamp closure and each detected
firing may count as a life event. Stated another way, 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 a clamp closure followed by firing
may count as one life event. Also, as described above, the handle
processor 2124 can use inputs from the handle sensors 2144, 2146,
2148 and/or the DSM sensors 2150, 2152, 2154, 2156, for example, to
detect life events.
[0196] The handle processor 2124 keeps a count of the life events.
When a life event is detected, the handle processor 2124 increments
the present value of the life event counter in either its internal
or external memory at step 204. The counter may be a count-up
counter, where the count is increased by one count (increment by
+1) when a life event occurs until a pre-established threshold is
met; or the counter may be a count-down counter, where the count is
decreased by one count (incremented by -1) when a life event occurs
until a specific end count (e.g., zero) is reached after starting
at value that is different from the end count by the
pre-established threshold. The pre-established life event count
threshold could be set at any value desired by the manufacturer of
the handle module 2102 in view of the particular sensor events that
count as life events.
[0197] If the life event counter reaches the pre-established life
event threshold at step 206, the handle processor 2124 may initiate
one or more end-of-life actions at step 208, such as causing the
display 2114 of the handle module 2102 or some other display (e.g.,
a mechanical counter visible to the user), for example, in
communication with the handle processor 2124 to indicate that the
handle module 2102 is spent (at end-of-life) and should be retired.
Any suitable visual, tactile, and/or audible indication may be
used. For example, the display 2114 may include an icon and/or text
indicating that the end-of-life for the handle module has been
reached. The display 2114 could also indicate the life event count
on an on-going basis, such as by a numerical display or volume
indicator (full, close to empty, etc.), for example, so that the
user can monitor whether the handle module is nearing the end of
its life cycle. In addition or in lieu of a constant display of the
life event count, the display 2114 may have an icon and/or use text
to show that the handle module is nearing the end of its life
(e.g., "N uses left"). The handle processor 2124 may also initiate
conditions that prevent 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 life count
events until the end-of-life threshold is reached.
[0198] Various implementations of sensors could be used to detect
certain life events. For example, the DSM that is 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), for example. Each
such drive shaft may drive a carriage forward during a clamping or
firing event, respectively. As such, the closure and/or firing
systems may include switches that are triggered when the closure or
firing carriage, as the case may be, contacts them. The switch(es)
may be coupled to the handle processor 2124, and the handle
processor 2124 may register a life event count when it receives a
signal from the switch(es) that it has been triggered. The switches
may be automatically-resettable push button switches that reset
each time they are contacted--and triggered--by the carriage driven
by the drive shaft.
[0199] 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
at FIGS. 34-37 thereof for an open linear stapler, FIGS. 38-41
thereof for a curved cutter stapler, and FIGS. 42-45 thereof for a
circular surgical stapler. Other DSM types that are adapted for the
handle module could also be used, such as endocutters and/or
right-angle staplers, for example. Since different DSMs could be
used with the handle module, the handle module (e.g., the handle
processor 2124) could use more sophisticated algorithms for
tracking handle module usage and remaining life that depend on the
number of times the various types of DSMs are used and fired. For
example, in one instantiation, the handle processor 2124 could
compute a progressively accumulating life event score that weighs
the use by different DSMs differently (depending on how stressful
they are on the handle module, for example) and compares the score
to a predetermined threshold value. When the handle module's score
reaches the threshold value, the handle module is retired (e.g.,
one or more end-of-life actions are taken). For example, the handle
processor 2124 may compute the life event score based on the
following relationship:
Life Event
Score=.SIGMA..sub.i=1.sup.NW.sub.i.SIGMA..sub.j=1.sup.SF.sub.i,j
where i=1, . . . N represents the different DSM types that could be
used with the handle module (e.g., endocutter, liner open,
circular, curved, right-angle stapler, etc.), W.sub.i is a
weighting factor for DSM type i, and is the number of firings for
DSM type i over the j=1, S procedures involving DSM type i. DSM
types that impart less stress in general on the handle module could
have a lower weight W than then DSM types that impart greater
stress in general on the handle module. That way, in various
arrangements, a handle module that is used only for high stress
procedures would expire prior to a handle module that is used only
for less stressful procedures, all other things being equal.
[0200] FIG. 9 illustrates an exemplary process flow that the handle
processor 2124 may execute to compute a life event score and/or
compare the life event score to a threshold score. In such
instances, the handle processor 2124 can execute firmware and/or
software stored in internal and/or external memory, for example.
Assuming that the threshold score of the handle module has not yet
been reached, the process starts at block 250 where the handle
processor 2124 receives inputs for the upcoming procedure. At least
one such input can include an identification of the type of DSM
that is 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 the
process of recognizing 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, circular, etc.)
that is attached to the handle module. Next at step 252, the handle
processor 2124 tracks how many times the handle module is fired
during the surgical procedure. The handle processor 2124 may track
how many times the handle module has been fired by tracking the
number of times the firing trigger has been activated and/or by
tracking feedback from the DSM, such as indications that the end
effector cartridge has been replaced, for example.
[0201] Following 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 for the
just-completed procedure to the prior score. The score for the
just-completed procedure may be based on multiplying the weighting
for the DSM type used in the procedure W.sub.i and the number of
firings in the procedure S. The handle processor 2124 may determine
the weighting for the DSM type W.sub.i by looking up the weighting
in a look-up table (stored in internal and/or external memory)
based on the type identifier received from the DSM at step 250. At
step 256, the handle processor compares the updated life event
score for the handle module to the pre-established threshold score
to determine if the handle module is at the end of its life. If the
threshold has been reached, the process advances to step 258 where
one or more end-of-life actions for the handle module are taken
such as, for example, one or more of the end-of-life actions
described herein. On the other hand, if the threshold has not yet
been reached, the process can advance to step 260 so that the
handle module can be used in at least one more procedure, whereupon
the process of FIG. 9 is repeated.
[0202] The loading conditions experienced by the instrument can be
used to track the usage of both the handle module and the DSM to
assess whether one or both of the handle module and the DSM should
be retired. One such instantiation can involve comparing the force
actually exerted by the instrument to drive the firing member of
the end effector to the force that the instrument was expected to
experience, for example. Similarly, the force actually exerted to
retract the firing member can be compared to the force that the
instrument was expected to experience in order to assess whether
the handle module and/or the DSM should be retired. The handle
module can be rated to a threshold number of firings based on the
force levels that the handle module is expected to experience.
Similarly, the DSM can be rated to a threshold number of firings
based on the force levels that the DSM is expected to experience.
The handle module threshold number and the DSM threshold number can
be the same or different. If the actual forces experienced by the
handle module and/or the DSM meaningfully exceed the expected force
levels, the handle processor and/or the DSM processor, as the case
may be, can determine that the handle module and/or the DSM should
be retired before reaching its expected number of firings.
[0203] In some instances, further to the above, the force exerted
by a handle module and/or DSM may be constant throughout a firing
stroke of the firing member; however, it is quite common for the
force exerted by the handle module and/or DSM to change throughout
the firing stroke. In either event, the force exerted by the handle
module and/or the force expected to be exerted by the handle module
can be a function of the firing member position. Similarly, the
force exerted by the DSM and/or the force expected to be exerted by
the DSM can be a function of the firing member position. A
particular type of DSM can have an expected firing force which is
correlated to the firing stroke of the DSM throughout the entire
length thereof, i.e., the distance between the initial starting
position of the firing member and its end-of-stroke position. The
DSM can also have an expected retraction force which is correlated
to the retraction stroke of the DSM throughout the entire length
thereof, 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 forces as the firing member traverses the
end effector from its starting position to its end-of-stroke
position, and the lower curve 272 shows the expected retraction
forces as the firing member is retracted back to its starting
position. In this particular example, the expected firing forces
are greater than the expected retraction forces.
[0204] For each firing, further to the above, the handle module
and/or DSM processors can track the force exerted per unit distance
increment (e.g., 1 millimeter) of stroke length. Moreover, the
handle module and/or DSM processors can track the force exerted for
each distance increment of stroke length and then compare the
actual forces to the expected forces to see if the actual forces
exerted exceeded the expected forces or not. One way to measure the
force exerted by the instrument during firing and retraction is to
measure the torque output of the motor(s) during the firing and
retraction strokes. In at least one instance, the torque output of
a motor can be determined based on the current drawn by the motor
and the motor speed. In at least one such instance, the voltage
applied to the motor is constant. The current can be measured with
a current sensor; the motor speed can be measured with an encoder,
for example. FIG. 10A shows exemplary force measurements as
departures from the expected firing stroke forces and the expected
retraction stroke forces. In this diagram, for the sake of
simplicity in the illustration, all of the measured forces exceeded
the expected force, and only the difference between the measured
force and the expected force is show by the line segments 274 for
the firing stroke and the by the dotted line segments 276 for the
retraction stroke. The reader should appreciate that one or more
measured forces could be less than their respective expected
force.
[0205] FIG. 10B is a diagram of an exemplary process flow executed
by the handle module processor and/or the 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 can aggregate, i.e., accumulate, the difference
between the measured force and the expected force at each unit
length increment (denoted .DELTA.L below) along the firing stroke
and/or the retraction stroke of the instrument. For example, the
accumulated force difference for a firing stroke and a subsequent
retraction stroke could be computed based on the following
relationship:
Accumulated Force
Difference=.SIGMA..sub..DELTA.L=0.sup.EOS(F.sub.m,f,.DELTA.L-F.sub.e,f,.D-
ELTA.L)+.SIGMA..sub..DELTA.L=EOS.sup.0(F.sub.m,r,.DELTA.L-F.sub.e,r,.DELTA-
.L)
where EOS represents end-of-stroke location; F.sub.m,f,.DELTA.L and
F.sub.e,f,.DELTA.L represent the measured and expected firing
forces, respectively, at position .DELTA.L; and F.sub.m,r,.DELTA.L
and F.sub.e,r,.DELTA.L represent the measured and expected
retraction forces respectively at position .DELTA.L. At step 282,
the processor can then accumulate the force differences by summing
the accumulated force differences per firing for each of the
firings that the handle module and/or DSM has experienced.
[0206] With regard to one particular embodiment, further to the
above, the processor can calculate the accumulated force
differences in real-time. In at least one instance, the processor
can calculate the force differences after each firing and
retraction cycle. In certain instances, the processor can calculate
the force differences after each surgical procedure, which may
include more than one firing and retraction cycle. For example, if
there were seven (7) firings in a particular procedure, then the
processor would sum the result from step 280 for each of the seven
firings. Next, at step 284, the handle can update the total
accumulated force differences for the handle module and/or the DSM,
as the case may be, by adding the accumulated force differences for
the recently-completed procedure to the total prior to the
recently-completed procedure (or zero in the case of the module's
first procedure). At step 286, the processor can then compare the
updated accumulated force difference total to a threshold. If the
threshold has been reached or otherwise satisfied, the process
advances to step 288 where an end-of-life action for 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 yet been
reached, the handle module and/or DSM, as the case may be, can be
used once again.
[0207] Even if the accumulated force difference threshold has not
yet been reached, the handle module and/or the DSM, as the case may
be, may have reached the end of its life according to a different
threshold. For instance, the process of FIG. 10B can advance to
step 289 after step 286 where the processor compares the total
number of procedures involving the handle module and/or the DSM, as
the case may be, to a procedure count threshold. In at least one
example, a handle module can have a procedure count threshold of 20
procedures and a DSM can have a procedure count threshold of 10
procedures. Other examples are possible. In at least one other
example, a handle module and a DSM can have the same procedure
count threshold. If the procedure count threshold has been reached,
the end-of-life action for the handle module and/or DSM, as the
case may be, is initiated at step 288. Conversely, if the procedure
count threshold has not yet been reached, the process advances to
step 290 where the handle module and/or the DSM is prepared for
another procedure. Any of the techniques described herein for
tracking procedure counts may be used to detect the end of a
procedure.
[0208] In various embodiments, the handle processor could perform
the calculations for both the handle module and the DSM and then
communicate the results for the DSM to the DSM processor so that
the DSM processor can initiate the end-of-life actions, if
required. Similarly, the DSM processor could perform the
calculations for both the handle module and the DSM and then
communicate the results for the handle module to the handle
processor so that the handle processor can initiate the end-of-life
actions, if required. In another arrangement, all of the measured
forces for a procedure can be downloaded following a procedure to a
remote processor, such as a processor in an inspection station or
another remote computer-or-processor-based system that is connected
to the handle module following a procedure for post-procedure
processing, for example. Such an inspection station is disclosed
and described in connection with FIGS. 12A-B, for example.
[0209] FIG. 10C illustrates, in conjunction with FIGS. 10D and 10E,
another exemplary process flow that the handle processor could
employ to monitor whether the handle module, for example, has
reached its end of life. The process illustrated in FIG. 10C
determines whether the handle module has reached its end of life
based on the energy used by the handle module over its life, an
exemplary graph of which is shown in FIG. 10D. FIG. 10D depicts the
aggregate, or accumulated, energy spent by a handle module as a
function of the uses, or firings, of the handle module. In addition
to or in lieu of the above, the process illustrated in FIG. 10C can
determine whether the handle module has reached its end of life
based on the power used during each firing of the handle module, an
exemplary graph of which is shown in FIG. 10E. FIG. 10E depicts the
power consumed for each individual firing of the handle module. In
at least one particular embodiment, the processor, in implementing
the exemplary process of FIG. 10C, monitors whether the energy
expended by the handle module, in the aggregate, exceeds various
thresholds (see FIG. 10D) and, concomitantly, whether the handle
module has had a certain number of firings above a threshold power
level (see FIG. 10E). When both of these conditions have been met,
in at least one instance, the handle processor can conclude that
the handle module is at its end of life. In certain instances, the
handle processor could utilize any number of multiple-factor tests,
with thresholds for each test, to determine if a handle module is
at its end of life. In at least one instance, the handle processor
can determine that it has reached its end of life if any test
threshold has been met or exceeded.
[0210] Following a procedure, the handle processor can execute 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 its end of life. At step 290, the handle processor can
compare the accumulated energy of the handle module over its life
to a first threshold energy level, i.e., Energy Level 1 in FIG.
10D. Energy Level 1 can be 40 kJ, for example. The handle module
may include a micro watt or power meter connected to the motor(s)
of the handle module to measure and record the electrical
parameters of the motor(s) so that the energy and power outputs of
the motor(s) can be determined If the first threshold energy level
has been reached or exceeded, i.e., Energy Level 1, the handle
processor can determine at step 291 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, for example.
[0211] If the handle processor determines that first threshold
energy level, i.e., Energy Level 1, has not been met at step 290,
the process advances to step 292 where the handle module determines
if a second, (e.g., lower) energy threshold has been met, i.e.,
Energy Level 2 in FIG. 10D. Energy Level 2 can be 30 kJ, for
example. If the second threshold energy level has been reached or
exceeded (without reaching or exceeding the first threshold energy
level), the process advances to step 293 where the handle processor
determines if the handle module has undergone a certain number of
firings over its life that have exceeded a first power level
threshold, e.g., two firings greater than 55 Watts (see FIG. 10E).
If the second energy level threshold has been met or exceeded and
the power level threshold has been met or exceeded the
predetermined number of times, the handle processor can determine
that the handle module is at its end of life. If, however, the
power level threshold has not been met or exceeded the
predetermined number of times, the handle processor can determine
that the handle module has not yet reached its end of life even
though the second energy level threshold has been met or exceeded.
The dual factors of steps 292 and 293 can be another test on the
handle module's life, and if the handle module fails both tests
(i.e., both thresholds or conditions have been satisfied), the
handle module can be determined to be at its end of life.
[0212] The handle processor can execute any number of such
dual-factor tests. The example of FIG. 10C shows one additional
such dual-factor test. If the dual factors of steps 292 and 293 are
not both satisfied, the process can advance to step 294 where the
handle module determines if a third (e.g., still lower) energy
threshold, i.e., Energy Level 3, has been met. Energy Level 3 can
be 25 kJ, for example. If the third threshold energy level has been
reached or exceeded (without reaching or exceeding the third
threshold energy level), the process advances to step 295 where the
handle processor determines if the handle module has had a certain
number of firings over its life (preferably greater than the number
of such firings checked for at step 293) that exceeded a second
power level threshold (which could be the same or different from
the power level threshold at step 293), e.g., four firings greater
than 55 Watts. The dual factors of steps 294 and 295 can be another
test on the handle module's life, and if the handle module fails
both tests (i.e., the thresholds or conditions have been
satisfied), the handle module can be determined to be at its end of
life. Otherwise, the handle processor can determine that the handle
module is not at its end of life and can be used in a subsequent
procedure.
[0213] It should be apparent that the steps of FIG. 10C can be
performed in various orders while still achieving the same result.
For example, steps 294 and 295 can be performed before step 290,
and so on.
[0214] According to current best practices, a handle module should
be sterilized before it is used to perform a surgical procedure. In
various instances, the handle module is placed in a sterilization
tray which is then placed in a sterilization chamber. In addition
to or in lieu of the above described manners for tracking the end
of life of the handle module, the number of times that the handle
module is placed in a sterilization tray for sterilization could be
used to track the end of life for the handle module. Stated another
way, the number of times that a handle module is sterilized can
serve as a proxy for the number of times that the handle module has
been used. In at least one exemplary embodiment, each handle module
has its own sterilization tray that keeps the sterilization count
for that particular handle module. In such an arrangement, the
sterilization tray may include a counter that is incremented each
time the associated handle module is placed in the tray. The
counter can have visual readout display that can show the number of
times the handle module has been sterilized if a count-up counter
is used or the number of sterilizations remaining, or permitted,
when a count-down counter is used. That way the user can know when
the sterilization limit is reached and, as a result, the user can
retire the handle module and/or take other appropriate end-of-life
measures. In order for the placement of the handle module in a
sterilization tray to be used a proxy for the number of times the
handle module is sterilized and, thus, a proxy for the number of
times the handle module has been used, the handle module should be
sterilized in one and only one sterilization tray. That way, the
counter does not count placements in the tray of other handle
modules. Accordingly, the handle module and sterilization tray
could be provided together, as a kit for example, and they may
include identifiers (e.g., numbers or icons) which show that they
are to be used together. The handle module and DSM could be
sterilized separately or together, for example.
[0215] FIG. 11A depicts an exemplary sterilization tray 300 and a
handle module 302 which is positionable in the sterilization tray
300. The sterilization tray 300 defines an opening, or recess, 304
whose shape matches the shape of handle module 302 to be placed
therein. The recess 304 is configured to closely receive the handle
module 302 such that there is little, if any, relative movement
possible therebetween. The sterilization tray 300 includes a stroke
counter 306 that has a lever arm 308 that extends into the opening
304. The stroke counter 306 further includes a counter visual
readout 310. When the user places the handle module 302 in the
opening 304, the lever arm end 308 is depressed, toggled, or
stroked, which registers as a count, thereby incrementing the stoke
counter 306 by one for a count-up counter (or -1 for a count-down
counter) which is displayed on the readout 310. To reduce false
toggles or strokes of the lever arm 306, in various arrangements,
the lever arm end 308 may include a protrusion 312 configured to
fit into a corresponding opening 314 defined in the handle module
302. FIG. 11B shows the handle module 302 after it is placed in the
sterilization tray 300. The lever end arm 308 is not visible in
FIG. 11B because it is underneath the handle module 302. The
counter readout 310 remains visible to the user when the handle
module 302 is positioned in the opening 304.
[0216] FIGS. 11C and 11D depict a variation where a handle module
302 can be placed in sterilization tray 300 with a DSM 312. Handle
module 302 is similar to handle module 10 in many respects and 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 readout 316. The tray 300 also includes
a DSM opening 324 for receiving the DSM 312, a DSM lever counter
320, and a DSM counter readout 322. In such an arrangement, the
handle module 302 and the 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 The DSM counter 324 shows the number of
times the DSM 312 has been sterilized in the sterilization tray
300, and/or the number of sterilizations remaining The handle
module 302 could be sterilized without the DSM 312, and vice versa,
in which case their respective counts may not be equal.
[0217] FIGS. 11E to 11I illustrate other arrangements for using a
sterilization tray 300 to track uses of a handle module. In FIG.
11E, the sterilization tray 300 includes a protrusion 340 extending
upwardly from the bottom of the opening 304 in the sterilization
tray. The protrusion 340 is positioned to extend into a
corresponding opening 342 defined in the handle module 302 when the
handle module 302 is seated in the opening 304. As shown in FIG.
11F, the handle module 302 may comprise a two-position mechanical
toggle switch 344 having a portion extending into the opening 342
defined by the handle 302 when the switch 344 is in a 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 a second position,
as shown in FIG. 11G. The switch 344 may be in communication with
the handle processor and the handle processor may update an
internal sterilization count (stored in internal and/or external
processor memory of the handle module) when the switch 344 is moved
from the first position (FIG. 11F) to the second position (FIG.
11G). In such an embodiment, the handle module 302 may comprise a
power source as described herein to power the handle processor and
to update the sterilization count during sterilization. Such a
power source can comprise a secondary battery which is not removed
from the handle module even if a primary battery is removed from
the handle module 302. The handle processor may compare the
sterilization count to a predetermined threshold (e.g., 20
sterilizations) and when the sterilization count reaches the
predetermined threshold, the handle processor may implement one or
more of the various end-of-life actions described herein, for
example. The switch 344 may stay in the "triggered" or "activated"
state until it is reset at a later time, such as after the
sterilization process, for example (see FIG. 36). The switch 344
can be biased by a spring, for example, to revert back to its open
position once the handle module 302 is removed from the tray 300
and the protrusion 340 is removed from the opening 342. The handle
module processor could also set an internal flag to indicate that
the handle module 302 was placed in the sterilization tray 300 and
this flag can later be reset after the sterilization process (see
FIG. 37). FIGS. 11H and 11I illustrate a similar embodiment with a
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 the protrusion 340 closes the contact
switch 348, as shown in FIG. 11G, when the handle module 302 is
seated in the opening 304. The contact switch 348 is in
communication with the handle processor to update the sterilization
count of the handle module. The contact switch 348 may be biased to
revert back to its open position (FIG. 11H) by a spring, for
example, when the handle 302 is removed from the tray 300 and
pressure being applied to the contact switch 348 by the inserted
protrusion 340 is removed.
[0218] In addition to or in lieu of the above described manners for
tracking the end of life of a handle module, the end of the life of
a handle module could be tracked through the use of an inspection
station to which the handle module can be connected. The inspection
station could be used at any suitable time to evaluate whether the
handle module can be used to perform a surgical procedure and/or a
subsequent step in a surgical procedure. For instance, an
inspection station could be used before, during, and/or after the
sterilization process of a handle module and/or while preparing the
handle module for reuse. The handle module could be connected to
the inspection station after (i) the post-op cleanup for reusable
components of the handle module following a procedure (usually
involving a manual wipe down of the component or instrument); (ii)
decontamination (e.g., by auto-washer) of the component or
instrument; and/or (iii) cleaning and/or room drying of the
component or instrument, for example. Placement of the handle
module on the inspection station can be a proxy for the number of
times the handle module was used, sterilized, and/or otherwise
processed for reuse. A display on the inspection station (or
elsewhere) may indicate to a user when a threshold number of
placements of the handle module on the inspection station has been
reached or is about to be reached, at which point the user can take
appropriate action with respect to the handle module, such as
retire it, for example. Also, the inspection station could upload
data to the handle processor that prevents further usage of the
handle module (e.g., disables the handle module) when the handle
module has reached the end of its life.
[0219] Further to the above, FIGS. 12A and 12B illustrate an
exemplary inspection station 400 and handle module 402. The handle
module 402 is similar to the handle module 10 in many respects.
FIG. 12A shows the handle module 402 before being placed on the
inspection station 400 and FIG. 12B shows the handle module 402
after being placed into position on the inspection station 400.
Similar to other embodiments disclosed herein, the handle module
402 comprises a battery cavity 403 defined therein which is
configured to receive a battery pack therein. See battery pack 86
in FIGS. 2-5, for example. As also disclosed elsewhere herein, the
battery pack is readily insertable into and removable from the
battery cavity 403. FIG. 12A also shows that the battery pack is
removed from the handle module 402 thereby exposing the battery
cavity 403 prior to the handle module 402 being placed on the
inspection system 400. The inspection station 400 comprises an
insert, or data/power adapter, 404 extending therefrom that is
sized and configured to fit within the battery cavity 403 of the
handle module 402. The data/power adapter 404 is placed in
communication with the processor of the handle module via the power
contacts configured to engage the power terminals of the battery
pack and/or via one or more signal contacts positioned in the
battery cavity 403, as described in greater detail further below.
The handle module 402 may be positioned on the inspection station
400 by sliding the opening 403 over the data/power adapter 404.
[0220] 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
voltage there-across to a voltage regulator 432 of the handle
module 402 in the same or similar manner in which the battery pack
provides voltage to the voltage regulator 432 when the battery pack
is positioned in the opening 403. For instance, if a battery pack
is configured to supply 6V DC to the voltage regulator 432, the
insert 404 can be configured to supply 6V DC to the voltage
regulator 432, for example. The voltage regulator 432 provides
electrical power to the control board 100 (see FIGS. 1-6) of the
handle module 402 to power the components of the control board 100,
including a handle processor 434 and the associated internal and/or
external memory 436, for example. The inspection station 400 may
itself be powered by an AC power source through a power cord 437
utilizing appropriate AC-DC converters. The inspection station 400
includes data ports 438 which come into contact with data ports 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 be
in communication with the inspection station processor 442. As the
reader will appreciate, the inspection station 400 can further
include internal and/or external memory 444 associated with the
inspection station processor 442.
[0221] FIG. 12D is a diagram of a process flow that may be
performed by the handle processor 434 and/or the inspection station
processor 442 when executing software and/or firmware in the handle
memory 436 and/or the inspection station memory 444 to track and
respond to the number of times the handle module 402 is placed on
the inspection station 400. In various arrangements, whenever the
handle module 402 is installed on the inspection device 400 such
that the insert 404 makes data and/or power connections to the
control board 100 of the handle module 402, the handle processor
434 may increment an inspection counter. The inspection counter may
be a count-up counter from zero to a pre-established threshold
number of inspections or a count-down counter from the
pre-established threshold number of inspections 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 (by +1 or -1 as the case may be, depending on the
type of counter) the inspection counter at step 422. At step 424,
the handle processor 434 may compare the inspection count to the
predetermined threshold. If the threshold has not yet been reached,
the handle processor 434 may then output at step 426 the value of
the inspection counter to the inspection station processor 442
while in data communication with the inspection station 400 via the
insert 404.
[0222] Referring to FIG. 12E, the inspection station 400 may
include a visual display 448 that displays visual information
related 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 number (or approximate number) of times remaining that
the handle module 402 should be placed on the inspection station
400 for inspection before the handle module 402 has reached its
end-of-life, for example. However, if the inspection count
threshold has been reached, the process may advance to step 428
where appropriate end-of-life action(s) may be taken. One such
end-of-life action is that the display 448 of the inspection
station 400 may visually display to the user that the handle module
402 should not be used any further. Another end-of-life action that
could be employed in addition to or in lieu of the visual display
is that the inspection station processor 442 sends an instruction
string to the handle processor 434 that causes the handle processor
434 to disable further use of the handle module 402. For example,
the instruction string could instruct the handle processor 434 to
never thereafter actuate the motor of the handle module 402 or some
other disabling action. 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.
[0223] 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
reset when the data/power adapter 404 is removed, or at least
partially removed, from the opening 403. In various aspects, there
could be a timer associated with the inspection station insertion
switch 446 so that the inspection station counter is incremented
(step 422 of FIG. 12D) only if the switch 446 is activated for at
least a threshold period of time (e.g., 30 seconds, etc.). Such a
timer could reduce the number of false positives, i.e., short
placements of the handle module 402 on the inspection station 400
that are likely not associated with post-procedure inspection or
sterilization of the handle module 402.
[0224] In another variation, the inspection station 400 includes a
pressure switch with a counter whose readout is displayed to a
user. The inspection station pressure switch is activated by
placement of the handle module 402 on the inspection station 400.
For example, the inspection station pressure switch could be at the
base on 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 could
be updated (e.g., incremented by one) so that the readout shows the
number of times that the handle module 402 has been installed on
the inspection system 400. Such a counter could be a mechanical
counter and/or an electronic counter, for example. If the limit, or
threshold, is displayed on the inspection station 400, displayed on
the handle module 402, and/or otherwise publicized to the user, the
user can know if the limit has been reached or is being approached.
In at least one instance, the limit could be printed on the
inspection station 400 and/or the handle module 402, for
example.
[0225] The display 448 of the inspection station 400 could also
display other information obtained by the inspection station 400
and/or communicated to the inspection station 400 from the handle
module 402 via the data connection therebetween. For example, the
handle processor memory may store a device type identifier for the
handle module (e.g., a serial number) and that device type
identifier may be downloaded to the inspection station processor
442 for display on the display 448. In addition to or in lieu of
the above, the display 448 may indicate a state of the handle
module, such as how close the handle module is to its end-of-life
and/or whether or not the handle module as been locked out, for
example, based on status data received from the handle processor
434. As described herein, the display 448 could indicate the number
of remaining uses (e.g., procedures) for the handle module and/or
the number of procedures in which the handle module has been used.
As disclosed herein, the inspection station 400 could also be used
to perform post-procedure testing of the handle module 402 to
ensure that the handle module 402 can be used in a subsequent
procedure. This testing can include moisture testing, seal
integrity testing, and/or simulated load testing, for example. The
display could indicate the results of those tests (e.g., passed,
failed, in progress).
[0226] In addition to or in lieu of the above, the display 448 of
the inspection station 400 may indicate the status of the
inspection station itself, such as whether the inspection station
is (i) downloading data from the handle module, (ii) uploading data
and/or software upgrades to the handle module, (iii) processing
data, and/or (iv) performing testing, for example. The display 448
may indicate results from the testing and data processing, such as
whether the handle module is ready to use in another procedure,
whether the handle module needs servicing, whether the warranty of
the handle module has expired because the handle module has reached
its threshold number of uses, for example, and/or other warnings.
The display 448 of the inspection station 400 may be a LED-backlit
LCD display, for example, that is 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 could input
data and/or configuration settings that are stored and used by the
inspection station processor 442. The display 448 could also be a
touch-screen where users could enter data and/or configuration
settings, for example, via the touch-screen. The inspection station
400 may include an external data port 412, such as a USB, micro or
mini USB, for example, for connection to a data cable 414 so that
data can be uploaded from or downloaded to the inspection station
400. For example, procedure data from the handle module 402 could
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 could be downloaded from a remote computer device
via the data port 412 to the inspection station 400 and then
uploaded to the handle module 402, for example.
[0227] FIGS. 13A and 13B depict an arrangement for tracking the use
of a handle module by tracking the installation of power packs in
the handle module. FIG. 13A is a block diagram of a handle module
500. The handle module 500 is similar to the handle module 10 in
many respects. The handle module 500 includes a removable power
pack 502, such as a battery, for example, and a handle processor
504. FIG. 13B illustrates a process flow that may be executed by
the handle processor 504. The process can be executed from firmware
and/or software in memory 506 which is associated with the
processor 504. As illustrated in FIG. 13A, the power pack 502 may
include an identification emitter 508, such as a RFID tag, for
example, that can communicate with an identification receiver 510,
such as a RFID reader, for example, in the handle module 500. The
identification emitter 508 is a wireless signal emitter, for
example; however, any suitable identification emitter could be
used. The identification receiver 510 is a wireless signal receiver
that is in communication with the handle processor 504, for
example; however, any suitable identification receiver could be
used. The identification emitter 508 transmits a unique ID for the
power pack 502 which can be received by the identification receiver
510. The strength of the signal emitted by the identification
emitter 508 can be controlled or limited such that the
identification receiver 510 can only detect the signal emitted from
the identification emitter 508 when the power pack 502 is very
close to the identification receiver 510 (e.g., within 10 cm). In
at least one instance, the identification receiver 510 can be
mounted on the control board 100 (FIGS. 2-4) such that the
identification receiver 510 can only detect the identification
emitter 508 when the power pack 502 has been inserted in the handle
module 500. In various instances, short range RFID tags and readers
could be used such that the identification receiver 510 is less
likely to falsely detect power packs 502 that are not installed in
the handle module 500.
[0228] Referring to the process flow depicted in FIG. 13B, the
identification reader 510 detects an identification emitter 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 for the newly detected power pack 502
to a stored list of power pack IDs that were previously detected by
the identification receiver 510. Such a list of previously-used
power pack IDs are stored in a non-volatile memory of the handle
module 500, for example. If the power pack 502 is not new, i.e.,
its ID is on the stored list of previously used power packs, the
process advances to step 524, where appropriate and pre-established
action(s) is taken. For example, the handle processor 504 can
disable use of the handle module 500 until a new, i.e.,
previously-unrecognized, power pack is installed in the handle
module 500. In at least one such instance, the handle module 500
can disable the motor 80. In addition to or in lieu of the above,
the display of the handle module 500 can display to the user that
the power pack is not new and request installation of a different
power pack, which returns the process to step 520.
[0229] If the power pack 502 is determined to be new by the
processor 504, i.e., the ID of the power pack 502 is not on the
stored list of previously-used power packs, the process advances to
step 526 where the handle processor 504 increments the use count
for the handle module 500. As before, a count-up counter and/or a
count-down counter could be used. At step 528, the handle processor
504 compares the use count to a pre-established threshold value
that represents the number of times that the handle module 500
should be used with a different, unique power pack. Such a use
count can serve as a proxy for the number of times the handle
module 500 has been used in patient procedures. If the use count
threshold has been reached at step 528, a pre-established
end-of-life action(s) can be taken at step 529. For example, the
handle processor 504 may disable the motor, the handle module
display may display to the user that the handle module 500 has no
remaining uses, and/or activate an alarm alerting the user that
there are no remaining uses, for example. If the use 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
illustrated in FIG. 13B could be performed in different orders. For
example, the new power pack ID could be added to the stored list
prior to incrementing the use count. Other techniques for tracking
installation of power packs in the handle module are described
below in connection with FIGS. 14E and 15A-B.
[0230] The embodiment described above in connection with FIGS. 13A
and 13B can be used with rechargeable and/or non-rechargeable
battery packs. That said, battery packs which are used with a
handle module 500, recharged, and then reused with the same handle
module 500 may cause the handle module 500 to go into a lockout
mode. With regard to this particular embodiment, recharged battery
packs would have to be reused with a different handle module. Along
these lines, an embodiment of the handle module 500 is envisioned
in which a recharged battery pack can be reused with the same
handle module 500.
[0231] In at least one instance, the processor 504 can employ logic
which prevents a battery pack 502 from being counted two or more
times for the same use. In at least one instance, the processor 504
may not count a battery pack 502 a second time unless it has been
dis-engaged from and re-engaged with the handle module 500. Even
then, the processor 504 may require an elapsed time between the
first engagement and the subsequent engagement before counting the
subsequent engagement as a second use. Such an elapsed time could
be the time that it takes to recharge the battery pack, for
example.
[0232] In addition to or in lieu of the above, a handle module can
track the number of times that a DSM is connected to and/or
disconnected from the handle module as a proxy for the number of
times that the handle module has been used. The handle module can
display the updated number of uses remaining for the handle module,
the estimated number of uses remaining for the handle module, such
as with a volume indicator that indicates the percentage of life
remaining, for example, and/or the number of times that the handle
module has been used. When the use threshold limit has been
reached, the handle module, via the handle processor, can take one
or more end-of-life actions, such as displaying that the handle
module is spent, disabling further use of the handle module by
disabling the motor, for example, and/or sounding an audible alarm,
for example. FIGS. 14A-G represent different arrangements for
tracking the connection or disconnection of an DSM to a handle
module, as discussed in greater detail further below.
[0233] Turning now to FIG. 14A, a handle module 600, which is
similar to the handle module 10 in many respects, comprises two
rotary drive systems 602, 604. A DSM having two drive systems,
discussed above, can be operably coupled to the rotary drive
systems 602, 604. The DSM can have grooves that are configured to
receive and slide onto bilateral edges 605A, 605B of a tongue
defined in a connection area 608 on the upper portion of the handle
module 600. In such an arrangement, the handle module 600 may
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 (FIGS. 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 depress the switch 612
until the DSM has been fully seated onto the handle module 600. The
switch 612 may be connected to the handle processor wherein the
handle processor may count the number of times the depressible
switch 612 is depressed as a proxy for the number of times that a
DSM has been connected to the handle module 600 and/or as a proxy
for the number of times that the handle module 600 has been used.
Also, the handle processor could require that the depressible
switch 612 be depressed continuously for at least a certain period
of time (e.g., 30 seconds) before incrementing the count to reduce
instances of false positives. When a pre-established threshold
number of uses, or activations of switch 612, has been reached, an
end-of-life action(s) may be performed, as described herein.
[0234] FIGS. 14B and 14C illustrate one arrangement for an
electro-mechanical depressible switch 612. As shown, the
depressible switch 612 includes a head 620 that extends into an
opening 622 defined in the tongue and/or any other suitable
DSM-mating surface of the handle module 600. The head 620 may be at
the end of a spring arm 624 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 edge,
628 defined in the handle module 600 that limits the 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, condition, as illustrated
in FIG. 14B, the spring arm 624 is not in engaged with the contact
630; when the DSM 634 is attached to the handle module 600 and
pushes the head 620 downwardly, as illustrated 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 projection 632
extending therefrom which is configured to contact the head 620.
The switch arm 624 and the contact 630 can be comprised of
electrically conductive materials which can complete a circuit in
communication with the handle processor when the head 620 is
depressed downwardly by the DSM 634, as discussed above.
[0235] Referring now to FIG. 14D, a handle module 700 may include
an electrical contact board 702 that interfaces/mates with and
makes electrical connections to a corresponding electrical contact
board 704 on a DSM 706. In at least one instance, the processor of
the handle module 700 may count the number of times that a DSM,
such as the DSM 706, for example, is assembled to the handle module
700. The processor can increase the DSM-connection count when the
contacts 704 of the DSM 706 engage the contacts 702 of the handle
module 700 and make a working data connection therebetween. The
mating of the contact boards 702, 704 can serve as a proxy for the
number of times that a DSM has been connected to the handle module
700 and as a proxy for the number of times that the handle module
700 has been used. Similar to the above, the handle processor could
require that there be a data connection between the contact boards
702, 704 continuously for at least a certain period of time (e.g.,
30 seconds) before incrementing the count to reduce the instances
of false positives. In another variation, the handle processor and
the DSM processor may exchange data when the DSM 706 is connected
to the handle module 700. In this exchange, the handle processor
can receive identification information for the DSM 706 so that the
handle processor can identify the DSM 706 connected to the handle
module 700 (e.g., the model type for the DSM). In such an
arrangement, the handle processor may increment the DSM-connection
count each time that the handle processor receives identification
information from a DSM that is attached thereto. In any of these
variations, the handle processor compares the DSM connection count
to a pre-established threshold, and if the threshold is reached,
the handle processor takes an end-of-life action(s).
[0236] An alternative arrangement for detecting the connection of a
DSM to a handle module is shown in FIGS. 14E-14G. The illustrated
arrangement uses a Hall Effect sensor to detect the connection of
the DSM 706 to the handle module 700. As shown in FIG. 14E, the
handle module 700 may include a Hall Effector sensor 710 positioned
relative to an upper surface 712 of the handle module 700 to which
the DSM 706 is to be attached. Correspondingly, the DSM 706
includes a magnet 714, such as a permanent magnet, for example,
that is in close proximity to the Hall Effect sensor 710 when the
DSM 706 is fully and properly connected to the handle module 700,
as shown in FIG. 14G. The Hall Effector sensor 710 may be in
communication with the handle processor via a lead wire 716, for
example. The Hall Effect sensor 710 can sense the approaching
magnet 714 of the DSM 706 as the DSM 706 is installed on the handle
module 700. The magnetic field generated by the magnet 714 may be
constant and the handle processor can have access to data regarding
the magnetic field such that the distance between the magnet 714
and the Hall Effect sensor 710 can 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 installed on
the handle module 700, the handle processor can infer that the DSM
706 is fully and properly installed on the handle module 700 and
update the DSM-connection count.
[0237] Similarly, referring again to FIG. 14E, the handle module
700 includes a battery cavity 724 configured to receive a battery
pack 722 therein. The handle module 700 further includes a Hall
Effect sensor 720 configured to detect the insertion of the
removable battery pack 722 into the battery cavity 724. The
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 supply power to the handle module
700 via electrical terminals 726 and it may be desirable to
position the Hall Effect sensor 720 as far away as possible from
the electrical terminals 726 such that any magnetic fields
generated by the current flowing through the terminals 726 do not
substantially disturb the ability of the Hall Effect sensor 720 to
properly detect the insertion of the battery pack 722 into the
handle module 700. The battery pack 722 includes a magnet 730, such
as a permanent magnet, for example, that the Hall Effect sensor 720
senses as the battery pack 722 is inserted into the battery cavity
724. Similar to the DSM Hall Effect sensor 710, the battery pack
Hall Effector sensor 720 is in communication with the handle
processor via a lead wire 732, for example. The Hall Effect sensor
720 can sense the approaching battery pack magnet 730 as the
battery pack 722 is installed into the battery cavity 724. The
magnetic field generated by the magnet 730 may be constant and the
handle processor can have access to data regarding the magnetic
field such that the distance between the magnet 730 and the Hall
Effect sensor 720 can 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 infer that the battery
pack 722 is fully and properly installed in the handle module 700
and update the battery-pack-connection count.
[0238] A handle module can track the number of times that a DSM
and/or a battery pack is connected to and/or disconnected from the
handle module as a proxy for the number of times that the handle
module has been used. The handle module can display the updated
number of uses remaining for the handle module, the estimated
number of uses remaining for the handle module, such as with a
volume indicator that indicates the percentage of life remaining,
for example, and/or the number of times that the handle module has
been used. When the use threshold limit has been reached, the
handle module, via the handle processor, can take one or more
end-of-life actions, such as displaying that the handle module is
spent, disabling further use of the handle module by disabling the
motor, for example, and/or sounding an audible alarm, for
example.
[0239] Turning now to FIGS. 15A and 15B, a handle module 800 can
track the installation of power packs thereto utilizing a pressure
switch that is depressed when a power pack 806, for example, is
completely and properly attached to the handle module 800. The
handle module 800 is similar to the handle module 10 in many
respects. The handle 800 includes an electrically conductive
contact pad 802 that the power pack 806 connects to in order to
supply voltage to the electrical components of the handle module
800. In the illustrated arrangement, a pressure switch 804 is
adjacent to the conductive contact pad 802 and it 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 can increment the power-pack-connection count
until a threshold is reached, at which point an end of life
action(s) can be undertaken. Similar to the above, the handle
processor may require that the pressure switch 804 be actuated
continuously for a period of time (e.g., 30 seconds) before
incrementing the power-pack-connection count to reduce instances of
false positives. In other arrangements, an electro-mechanical
switch could be used, for example.
[0240] In various instances, a processor of a handle module can
increment the use count each time that the handle processor is
powered on. In certain instances, the processor of a handle module
can automatically power down when a battery pack is disengaged from
the handle module. Similarly, the processor can automatically power
up when a battery pack is engaged with the handle module. In at
least one such embodiment, the battery pack is the sole power
source for the handle module and the disconnection of the battery
pack from the handle module may immediately de-power the processor
and the connection of a battery pack to the handle module may
immediately re-power the processor. In certain embodiments, the
handle module can include one or more capacitive elements which can
store power from a battery pack when the battery pack is engaged
with the handle module. When the battery pack is disconnected from
the handle module, the capacitive elements can provide power to the
processor for a period of time and, as a result, the processor may
not power down during a battery pack change. In such instances, the
processor can count a life, or use, event if a battery installation
is detected by a sensor, as described above, and/or if the
processor is powered on after being de-powered.
[0241] In various instances, the handle processor of the handle
module 800 can track how often it receives electrical power via the
conductive contact pad 802 that is used to couple the battery power
pack 806 to the internal electrical components of the handle module
800. For example, the handle module 800 may comprise a micro
voltage and/or current sensor (not shown) connected to the
conductive contact pad 802. The voltage and/or current sensor may
be in communication with the handle processor. When a threshold
input voltage and/or current from the power pack 806 is detected at
the contact pad 802, the handle processor can increment the
battery-pack-connection count. This arrangement may be useful where
the handle processor is powered at times by power sources other
than the power pack, such as by supercapacitors or other
sources.
[0242] Turning now to FIG. 16, a handle module 900 comprises a
plurality of power sources, including a removable battery power
pack 902 and a secondary power source 904, for example. The
removable battery power pack 902 is similar to the removable
battery power packs described herein in many respects. The battery
power pack 902 contains multiple Li ion and/or LiPo battery cells,
for example. 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 regard to this embodiment, the secondary
power source 904 is used for low-power operations of the handle
module 900, such as powering the electronic components on the
control board 910 when the removable battery power pack 902 is
removed from the handle module 900--and not for high-power
operations, such as powering the motor(s) 905 of the handle module
900, for example. In various arrangements, the secondary power
source 904 may comprise rechargeable battery cells and/or
supercapacitors (a/k/a ultracapacitors) that are charged by the
removable battery power pack 902 when it is installed. The
secondary power source 904 can power the electronic components on
the control board 910 in the absence of the primary power source
902 for as long as the secondary power source 904 possesses a
sufficient charge.
[0243] The secondary power source 904 may permit the handle module
900 to track use 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 executable by the processor of the
control board 910, such as handle processor 2124, for example. The
process can be executed from software and/or firmware stored in the
memory of the handle module, for example, in accordance with at
least one embodiment. Prior to performing a surgical procedure, the
power pack 902 is installed in the handle module 900. At step 920
of the process, the handle processor may record a time stamp for
when a DSM is properly connected to the handle module 900. Once the
surgical procedure begins, at step 922, the handle processor may
record time stamps for each firing of the handle module 900 that
occur during the surgical procedure. In addition, the handle
processor can track the time which elapses between the firings. In
at least one instance, the secondary power source 904 can continue
to supply power to the handle processor to track the time following
a firing event even if the removable power pack 902 is removed from
the handle module 900. At step 924, the handle processor can
determine whether the elapsed time since the last firing is greater
than a threshold time period. In at least one instance, the
threshold time period may be on the order of the time required to
substantially process and sterilize the handle module following a
procedure, for example. If the time period between firings is not
greater than the threshold, it can be assumed that the procedure is
ongoing and the process may return to step 922 to record the time
stamp for the next firing. On the other hand, if the time period
between firings is greater than the threshold, it can be assumed
that the procedure has concluded, at which point, at step 926, the
handle processor can increment the use count of the handle module
900. At step 928, the handle processor compares the use count to
the pre-programmed threshold use count for the handle module 900.
If the use count is less than the threshold, the handle module 900
can be used in another procedure and the process can return to step
920 to await connection of a DSM for the next procedure. On the
other hand, if the use count threshold has been reached, the
process advances to step 930, where the end-of-life action(s) for
the handle module 900 can be initiated. As described above, the
end-of-life action(s) can include disabling the handle module such
that the handle module cannot be used in subsequent surgical
procedures. In at least one instance, the motor of the handle
module can be physically and/or electronically disabled. In certain
instances, the end-of-life action(s) include visually indicating
the end of life for the handle module on a display of the handle
module and/or sounding an audible alarm, for example.
[0244] FIG. 17B is a flow chart of another exemplary process that
can be executed by the handle processor and powered at times by the
secondary power source 904 to track uses of the handle module. At
step 950, the handle processor can detect the connection of the
removable battery power pack 902 to the handle module 900. Various
techniques for detecting the insertion of the battery power pack
902 are described elsewhere herein. In various instances, the
insertion of the power pack 902 indicates to the handle processor
that a surgical procedure involving the handle module 900 is about
to commence. As a result, the handle processor can set a process
flag to ON at step 952 when the handle processor detects the
insertion of the power pack 902 into the handle module 900. At step
954, the handle processor can detect the complete and proper
connection of a DSM to the handle module for the procedure. Various
techniques for detecting the attachment of a DSM are described
elsewhere herein. Once the DSM and the battery pack 902 have been
properly attached, the surgical instrument can be used to complete
a surgical procedure. In the event that the battery pack 902 is
removed from the handle module 900, the handle processor can detect
removal of the battery power pack 902 at step 956. Various
techniques for detecting the removal of a power pack are disclosed
elsewhere herein. In various instances, removal of the power pack
is indicative of the conclusion of a surgical procedure and, as a
result, the handle processor, now powered by the secondary power
source 904, can increment the use count for the handle module 900
at step 958. Even if the removal of the power pack does not
constitute the end of a surgical procedure, the insertion of a new
battery pack and/or the re-insertion of a re-charged battery pack
can be viewed as another use. Such reuse of the handle module 900
may be conditioned on a test administered at step 960 to assess
whether the handle module 900 has reached the end of its useful
life. If the end of the handle module's life has been reached, the
handle processor can initiate an appropriate end-of-life action(s)
at step 962. Various end-of-life actions are disclosed elsewhere
herein. It should be appreciated that, with regard to any of the
embodiments disclosed herein, an end-of-life action can be
overridden by the user of the handle module. Such instances can
typically arise when the use threshold count has been reached in
the middle of a surgical procedure, for example.
[0245] FIGS. 18A-18E show end-of-life actions that could be taken
by a handle module that uses a removably battery power pack, for
example, to prevent further use of the handle module. FIG. 18A
illustrates a handle module 1000 which includes an internal
spring-activated lock-out 1002. The lock-out 1002, when released by
the handle module 1000, prevents the complete and proper
installation of a battery power pack 1004, and/or any other
suitable battery pack, into the handle module 1000. In various
instances, the lock-out 1002 can be configured to completely
prevent the power pack 1004 from entering the handle module 1000.
In other instances, the lock-out 1002 can prevent the power pack
1004 from being inserted to a depth in which the battery contacts
make electrical contact with the handle contacts, as illustrated in
FIG. 18A and described in greater detail further below. Owing to
the activation of the lock-out 1002, the power pack 1004 sticks out
of the handle module 1000 by a distance D, as also illustrated in
FIG. 18A. But for the lock-out 1002, the battery pack 1004 could be
seated to a depth in which an end cap 1006 of the battery pack 1004
is flush, or at least substantially flush, with the housing of the
handle module 1000.
[0246] As discussed above, the lock-out 1002 can selectively
prevent the power pack 1004 from supplying power to the handle
module 1000. In the non-locked-out state of the handle module 1000
illustrated in FIG. 18B, an electrical contact pad 1016 of the
handle module 1000 can be in contact with a contact pad 1018 of the
battery pack 1004 so that the internal electrical components of the
handle module 1000 can be powered by the battery power pack 1004.
In the locked-out state of the handle module 1000 illustrated in
FIG. 18C, the lock-out 1002 prevents the contact pad 1018 of the
battery pack 1004 from contacting the contact pad 1016 of the
handle module 1000. In embodiments where the handle module 1000
does not include a secondary power source and/or a means for
storing power, the handle module 1000 will be unusable in its
locked-out condition. In embodiments where the handle module 1000
includes a secondary power source and/or a means for storing power,
the handle module 1000 can utilize the power from these other
sources to run the operating system of the handle module 1000, but
not the drive systems and/or electric motors of the handle module
1000, for example.
[0247] FIG. 18B illustrates the lock-out 1002 in a normal,
operational state where it is not locking out the battery pack 1004
and FIG. 18C illustrates the lock-out 1002 in the locked-out state
where it is locking out the battery pack 1004. The lock-out 1002 is
biased to rotate from its unlocked position (FIG. 18B) to its
locked-out position (FIG. 18C) by a torsion spring 1010 that is
connected to the lock-out 1002. The torsion spring 1010 has a first
end biased against an internal surface 1013 of the handle module
1000 and a second end mounted to the lock-out 1002. The handle
module 1000 further includes a latch 1012 configured to releasably
hold the lock-out 1002 in its unlocked position. The lock-out 1002
includes a lock shoulder 1014 that abuts the latch 1012 when the
latch 1012 is in an extended position and, thus, holds the lock-out
1002 in its unlocked position. When the latch 1012 is retracted, as
illustrated in FIG. 18C, the shoulder 1014 of the lock-out 1002 is
no longer engaged with the latch 1012 and the torsion spring 1010
can bias the lock-out 1002 into its locked-out position.
[0248] When an end-of-life condition of the handle module 1000 has
not yet been reached, a latch actuator of the handle module 1000
can hold the latch 1012 in the position illustrated in FIG. 18B.
When an end-of-life condition is reached, however, the latch
actuator may move the latch 1012 in the direction indicated by
arrow A to move the latch 1012 away from the lock shoulder 1014
thereby allowing the lock-out 1002 to rotate counter-clockwise, as
indicated by the arrow B in FIG. 18C, due to the bias of the spring
1010. In the locked-out state, the lock-out 1002 protrudes into the
battery compartment of the handle module such that, when a battery
pack 1004 is inserted in the handle module 1000, the electrical
contact pad 1016 of the handle module 1000 does not contact the
contact pad 1018 of the battery pack 1004, as discussed above. The
latch actuator can comprise any suitable actuator, such as a
solenoid, for example.
[0249] In addition to or in lieu of the above, FIGS. 18D and 18E
illustrate an embodiment in which, at the determined end-of-life
for the handle module, a battery pack positioned in the handle
module cannot be removed from the handle module, thereby preventing
the insertion of a new (or recharged) battery pack in the handle
module for a subsequent procedure. FIG. 18D illustrates a battery
pack 1004 in a normal, operational state where it can be removed
from the handle module following a procedure and FIG. 18E
illustrates a latch 1040 locking the battery pack 1004 in the
handle module such that the battery pack 1004 cannot be removed
from the handle module. As shown in FIGS. 18D and 18E, the battery
pack 1004 may define an opening 1042 in which a latch head 1044 of
the latch 1040 can be inserted to lock the battery pack 1004 in
position. The latch 1040 is biased downwardly by a compression
spring 1046 mounted on an upper shaft 1048 of the latch 1040. The
latch 1040 also includes an upper shoulder 1050 that, in the normal
operating state of the handle module, shown in FIG. 18D, abuts a
second latch 1052 that is positioned to keep the spring 1046 in a
compressed state and prevent the downward movement of the latch
1040. As also shown in FIGS. 18D and 18E, the latch head 1044
includes a shoulder 1054 that, when the latch 1044 is in its
actuated position as shown in FIG. 18E, locks behind a mating
shoulder 1056 defined by the battery pack 1004.
[0250] 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 out of the way of
the latch 1044. The second latch 1052 may be actuated by any
suitable actuator, such as a solenoid, for example. In the
illustrated embodiment, the second latch 1052 moves left to right
away from the shoulder 1050 of the latch 1040 as indicated by the
arrow A when the latch 1052 is actuated. The removal of the second
latch 1052 away from the shoulder 1050 allows the spring 1046 to
decompress and urge the latch 1044 downward, as indicated by the
arrow B, through an opening 1060 defined in the housing 1013 of the
handle module. As the latch 1040 is moved downwardly by the spring
1046, the latch head 1044 extends into the opening 1042 defined in
the battery pack 1004. The latch shoulder 1054 of the latch head
1044 can slide through the opening 1042 and lock in behind the
mating shoulder 1056 of the battery pack 1004. The downward
movement of the latch head 1044 is limited by the handle module
housing 1013 when the upper shoulder 1050 of the latch 1040
contacts the handle module housing 1013. As a result, the battery
pack 1004 cannot be removed from the handle module, thereby
preventing insertion of a new (or recharged) battery pack into the
handle module for a subsequent procedure.
[0251] Referring now to FIGS. 19A-19C, a handle module 1100
comprises a rechargeable battery pack 1102 (with one or more
rechargeable battery cells 1104) that can be recharged when the
handle module 1100 is docked to a charging station 1106. The handle
module 1100 further includes a slidable door 1108 that slides,
generally 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). A compression spring 1112 is positioned in the
channel 1110 which is configured to bias the slidable door 1108
downwardly into its closed position. When the door 1108 is in its
closed position, the door 1108 can shield the battery charging
terminals 1114, as depicted in FIG. 19B, from being damaged and/or
accidentally coming into contact with a conductive surface in the
surrounding environment, for example. To recharge the battery cells
1104, the handle module 1100 is placed in a receiving area 1120
defined by the charging station 1106 that includes charging
terminals 1122 that mate and contact with the charging terminals
1114 of the handle module 1100 when the handle module 1100 is
inserted fully and properly in the receiving area 1120, as shown in
FIG. 19C. As the handle module 1100 is placed in the received area
1120, the slidable door 1108 engages a shoulder 1124 of the
charging station 1106 which urges the slidable door 1108 upward, as
indicated by the arrow A, compressing the spring 1112, and
unshielding (or revealing) the battery pack charging terminals
1114. At such point, the charging terminals 1114 can connect to and
contact the receiving station charging terminals 1122 to thereby
recharge the battery cells 1104 of the battery pack 1102.
[0252] The charging station 1106 may be powered by an AC power
supply via a power cord 1130. The charging station 1106 may also
include a visual display 1132 that displays information about the
handle module 1100. For example, the charging station 1106 may
include a processor (not shown) that communicates with the handle
processor when the handle module 1100 is installed in the charging
station 1106. For example, the charging terminals 1114, 1122 may
also include data terminals that provide a data path between the
processors. The charging station processor can receive
information/data from the handle processor that can be displayed on
the display 1132. The displayed information can include, for
example, the charge status of the battery pack 1102 (e.g., X %
charged) and/or any information tracked by the handle processor,
such as the life count or remaining uses of the handle module
and/or the number of lifetime firings, for example.
[0253] FIGS. 20A-20B show covers 1201, 1202, 1203 that can be used
with a handle module 1200 during a sterilization process to protect
the internal components of the handle module 1200. The handle
module 1200 includes an attachment portion configured to have a DSM
attached thereto. An end effector connection area cover 1201 can
connect to (e.g., snap-fit) and cover where the DSM connects to the
handle module 1200. The handle module 1200 also includes a
removable trigger assembly which is used to actuate the drive
systems of the handle module 1200. In addition to or in lieu of the
above, a trigger cover 1202 can connect to (e.g., snap-fit) and
cover the opening that is created when the firing trigger assembly
is removed from the handle module 1200. The handle module 1200
further comprises a battery cavity configured to receive a
removable power pack therein. Also in addition to or in lieu of the
above, a battery pack cover 1203 can connect to and cover where the
battery pack is inserted in a pistol grip portion 1206 of the
handle module 1200. These covers 1201, 1202, 1203 are preferably
made of a material that is resistant to the chemicals used to
sterilize the handle module, such as plastic, for example. Further,
the covers 1201, 1202, 1203 can cover electrical contacts of the
handle module 1200 including an end effector contact board 1210,
drive systems 1212, and/or the internal contacts for the battery
pack (not shown), for example.
[0254] The attachment of the covers 1201, 1202, and/or 1203 to the
handle module 1200 can aid in tracking the number of times that 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 can aid in tracking the number of times that the handle
1200 has been used and/or sterilized. At least one of the covers
1201, 1202, 1203 can include 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 operation mode which is optimized to endure a
sterilization procedure. When the handle processor is in a
sterilization operation mode, the handle processor can prevent the
motor(s) of the handle module 1200 from being operated, de-power
certain contacts and/or sensors, power-up certain contacts and/or
sensors, record any data stored in transient memory to a memory
chip, copy the memory of the handle module to a back-up memory,
and/or create a copy the current version of the operating system
software for the handle module, for example. The handle processor
can also increase the use count of the handle module 1200 when one
or more of the covers 1201, 1202, 1203 are attached to 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 on the handle
module 1200 (e.g., a depressible switch, or a contact switch, etc.)
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 instances, the handle processor may update its
sterilization count when actuation of the switch 1222 is detected.
In other arrangements, the trigger 1220 could be on other cover
pieces 1202, 1203 and/or placed in different position on the DSM
connection area cover 1201. In any event, since the battery pack is
ordinarily removed during sterilization, the covers 1201, 1202,
1203 are preferably used in a handle module with 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 the threshold level.
[0255] FIGS. 20C shows a variation of the battery pack cover 1203
and FIG. 20D shows a battery pack 1240 that is interchangeable with
the battery pack cover 1203 in 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 in lieu of one another, the battery pack cover
1203 of FIG. 20C has a shape and configuration that is very similar
to the battery pack 1240 of FIG. 20D. For example, the battery pack
cover 1203 and the battery pack 1240 both include a clip 1244 for
locking to the handle module 1200. Also, the battery pack cover
1203 and the battery pack 1240 both include one or more tubular
vessels 1242. The battery cells 1246 may be inside the vessels 1242
in the battery pack 1240 but not for the cover 1203. The cover
1203, however, also includes a feature(s) that readily
distinguishes it from the battery pack 1240. In the illustrated
arrangement, the cover 1203 includes a relatively thin, long,
easily-graspable tab 1248 at the bottom of the cover 1203 that can
include markings indicating that it is for use in sterilization, as
shown in FIG. 20C.
[0256] As also shown in FIGS. 20C and 20D, each of the cover 1203
and the battery pack 1240 may include a respective tab 1250, 1252
that are located in different relative locations. In the
illustrated arrangement, the tab 1250 of the cover 1203 is on the
right vessel 1242 and the tab 1252 on the battery pack 1240 is on
the left vessel 1242 thereof. When inserted into the handle module
1200, the tabs 1250, 1252 may contact and actuate corresponding and
respective switches in the handle module 1200 to identify the
insertion of the cover 1203 or battery pack 1240, as the case may
be. The switches (not shown) may be in communication with the
handle processor, and the handle processor can use the actuation of
the respective switches to update its use, sterilization, and/or
battery-pack-connection counts, as the case may be. The actuation
of the sterilization switch can place the handle module 1200 in a
sterilization operation mode and the actuation of the battery
switch can place the handle module in a surgical operation mode,
for example. The tabs 1250, 1252 are preferably in two different
locations such that the handle module 1200 may include two
different switches: a battery switch which is only actuated by the
battery pack 1240 and a sterilization switch which is only actuated
by the sterilization cover 1203. In various arrangements, the tabs
1250, 1252 could be located at mirror opposite positions on the
vessels 1242, for example. Both the cover 1203 and battery pack
1240 can include feature(s) so that they can only be inserted in
one orientation, to thereby prevent the battery pack tab 1252 from
actuating the sterilization cover switch and vice versa. In the
illustrated arrangement, for instance, the battery pack cover 1203
and the battery pack 1240 both include a tongue 1254 on only one
side thereof that can fit into a corresponding groove defined in
only one side of the handle module 1200.
[0257] FIGS. 21A-21C show exemplary displays for a handle module
1300 and/or a DSM 1302 that may provide visual information to a
user about 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 one another
or separated from one another. In certain instances, the display
portions 1304A and 1304B can be utilized to display discrete, or
non-overlapping, sets of information. In various instances, the
display portions 1304A and 1304B can be utilized to display
co-ordinated information which may or may not be duplicative. In
certain other instances, the display 1304 could be wholly on the
DSM 1302 as shown in FIG. 21B or, alternatively, the display 1304
could be wholly on the handle module 1300 as shown in FIG. 21C. The
display 1304 may comprise a flat panel display, such as a
LED-backlit LCD flat panel display, for example, 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.
[0258] FIG. 21D shows an exemplary display configuration wherein
the display comprises adjacent handle and end effector portions
1304A, 1304B. As shown in FIG. 21D, the handle portion 1304A
indicators may include indicators related to the handle module,
such as a battery status indicator 1310, an indicator 1312 that
shows that the DSM connected to the handle module is recognized,
and/or a general handle module error indicator 1314. The DSM
display 1304B may include indicators related to the DSM, such as an
indicator 1320 for whether the end effector jaws are closed, an
indicator for whether the staples in the end effector have not yet
been fired, an indicator 1322 for whether the staples have been
properly fired, and/or an indicator 1324 for whether there is an
error related to the staples or staple cartridge, for example. Of
course, in other variations, fewer, more, and/or different icons
could 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 the number of
firings remaining for the battery pack and/or the number of
remaining uses for the handle module, for example. The display may
include buttons and/or a touch screen interface where a
user/clinician could input information to the handle module and/or
DSM processors/memory.
[0259] In various instances, a removable battery pack may be
sterilized and recharged after a procedure so that it can be reused
in a subsequent procedure 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 a proxy for the number of times that the
battery pack 1350 has been used in surgical procedures. The battery
pack 1350 may include a number of battery cells 1352 with 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 pack processor 1360 may
include internal or external memory (such as external memory chip
1364 mounted to the circuit board 1362), and the battery pack
processor 1360 can execute software/firmware stored in the memory.
As such, the batter pack processor, 1360 can implement a battery
management system (BMS) that manages the rechargeable battery. The
BMS can protect the battery from being operated outside its safe
operating area, monitor the state of the battery, calculate
secondary data, report that data, control its environment,
authenticate the battery, and/or balance the cells of the battery,
for example.
[0260] 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 moist or humid environment consistent
with undergoing a sterilization process, for example. The battery
pack processor 1360 may be in communication with the
moisture/humidity sensor 1366 such that, for each instance that the
moisture/humidity sensor 1366 detects a threshold level of moisture
or humidity for a threshold period of time which is consistent with
a typical sterilization process, the battery processor 1360 may
update its sterilization count as a proxy for the number of times
the battery pack 1350 has been used. In various instances, the
battery processor 1360 can be configured to not count aberrational
events that might yield false positives. In any event, once the
threshold sterilization count has been reached, the battery pack
processor 1360 may disable use of the battery pack 1350. For
example, as shown in FIG. 22, the battery pack 1350 may include a
data terminal 1368 that can provide a connection to the handle
processor of the handle module. When the battery pack 1350 is spent
(e.g., reached the sterilization count threshold), the battery pack
processor 1360 may send a signal to the handle processor that the
battery pack 1350 should not be used. The handle processor may then
indicate through its display that there is a problem with the
battery pack 1350.
[0261] In various instances, the battery pack processor 1360 may
update its use count based on data connections to a handle module.
Every time the battery pack processor 1360 detects a data
connection to a handle module, the battery pack processor can
update its use count.
[0262] 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 supply power to a handle
module during a surgical procedure. In such an embodiment, the
low-power battery pack electronic components can remain powered
even when the battery pack 1350 is not installed in a handle
module. Also, as shown in FIG. 22, the battery pack 1350 may
include an end cap 1370 and a latch 1372 for facilitating the
connection of the battery pack 1350 to the handle module.
[0263] FIGS. 23A and 23B illustrate another possible end-of-life
action for a handle module. In the illustrated arrangement, a
handle module 1400 includes a projecting portion 1402 that is
movable between a retracted position and an extended position.
Prior to the end-of-life of the handle module 1400, the projecting
portion 1402 is held in its retracted position. In such a position,
the projecting portion 1402 does not interfere with the handle
module 1400 being positioned in the corresponding opening in its
sterilization tray 1404. Once the handle processor determines that
the handle module 1400 has reached its end-of-life, according to
any suitable algorithm, the projecting portion 1402 is moved into
its extended position. In such a position, the projecting portion
1402 interferes with the proper placement of the handle module 1400
in its corresponding opening in the sterilization tray 1404. In the
illustrated arrangement, the projecting portion 1402 is at the
distal end 1406 of the handle module 1400, but it could be placed
anywhere that is convenient and that, when projected, inhibits
placing the handle module 1400 in the corresponding opening of the
sterilization tray 1404. As mentioned before in connection with
FIG. 11A, the sterilization tray includes an opening whose shape
corresponds to the shape of the handle module so that the handle
module is closely received in the opening. In the arrangement of
FIGS. 23A and 23B, the handle module 1400 fits into the opening in
the sterilization tray 1404 when the projection portion 1402 is
retracted (not projected), but does not fit into the opening when
the projecting portion 1402 is projected outwardly from the handle
module 1400 as shown in FIGS. 23A and 23B. The projecting portion
1402 may be solenoid-driven, for example. When the handle processor
has determined that the end-of-life for the handle module 1400 has
been reached, the coil of the solenoid is energized so that the
solenoid armature is extended outwardly thereby causing the
projecting portion 1402 to extend outwardly from the handle module
1400, for example. The handle module 1400 may also include a
stopper, such as a spring-loaded detent, for example, that prevents
the retraction of the solenoid armature and the projecting portion
1402 once they have been actuated.
[0264] As described in connection with FIGS. 12A-E, a handle module
could be connected to an inspection station before, during, and/or
following a procedure. The inspection station can 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 whether the handle module needs to be conditioned or repaired
before it is suitable for another surgical procedure. As shown in
FIGS. 24A and 24B, an inspection station 1500 includes an extension
1504 configured to be inserted into the empty battery cavity of a
handle module such that the extension 1504 can be placed in
communication with the handle module, similar to the embodiments
described above. A handle module 1501 depicted in FIG. 24B
comprises such a handle module, for example. The inspection station
includes a vacuum coupling 1502 at the upper portion of the
extension 1504 which can mate to a corresponding vacuum coupling
1506 in the internal portion of the handle module 1501. The
inspection station 1500 may be connected to a vacuum pump via a
vacuum port 1508, which is connected to the vacuum coupling 1502 of
the inspection station 1500 via a tube 1510. When the vacuum pump
is turned on, it may draw air from the internal portion of the
handle module 1501 to dry the internal portions of the handle
module 1501. The inspection station 1500 may include pressure
gauges and/or air flow sensors in communication with the tube 1510
that measure how well the handle module 1501 holds the vacuum
pressure. In various instances, such a vacuum test can evaluate 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 areas 1516, and/or seals engaged
with the electrical contact board 1518 that connects to the DSM,
for example. If the various handle module seals are not
satisfactory, and the handle module does not adequately maintain
the vacuum as detected by the vacuum sensors, the inspection
station 1500 can issue a warning via its display indicating that
the handle module 1501 needs to be repaired.
[0265] In addition to or in lieu of the above, an inspection
station could be adapted to dry a handle module following a
surgical procedure and/or sterilization procedure as part of
preparing the handle module for a subsequent procedure. FIG. 25A
illustrates an inspection station 1600 that could be used to dry a
handle module 1602, for example. Similar to the above, the
inspection station 1600 includes a base portion 1610 and, in
addition, an extension 1606 extending from the base portion 1610
that is positionable in the empty battery cavity of the handle
module 1602 in order to place the handle module 1602 in
communication with the inspection station 1600. The inspection
station 1600 includes two fans--a first fan 1604 located at the
upper end of the extension 1606--and a second fan 1608 located at
the front of the base portion 1610. The fans 1604 and 1608 are
electrically powered, such as by an AC power source via a power
adapter 1612, for example. The first fan 1604 can be aimed at the
internal components of the handle module 1602 through an opening in
the battery pack cavity. The upper surface of the extension 1606
can include vent openings through which the air blown by the first
fan 1604 can circulate to the handle module 1602. The second fan
1608 can be aimed at a trigger area 1614 of the handle module 1602
to dry the trigger area 1614 and the surrounding areas of the
handle module 1602. The top, front surface of the base portion 1610
of the inspection station 1600 can include vent openings 1616 for
the second fan 1608 so that air blown from the second fan 1608 can
be circulated to the trigger area 1614. The base portion 1610 may
also include an air intake for the fans 1604 and 1608, such as an
air intake 1618 in the base portion 1610. The inspection station
1600 may also include exhaust vents, such as bilateral exhaust
vents 1620 at the bottom of the extension 1606, to allow exhaust to
escape from the inspection station 1600. The inspection station
1600 could include as many fans, air intakes, and/or air exhausts
as deemed necessary.
[0266] FIGS. 25B, 25C, and 25D illustrate another exemplary
inspection station 1600. The base portion 1610 in FIGS. 25B, 25C,
and 25D is longer front-to-back than the base station in FIG. 25A,
and the lower front fan 1608 in FIGS. 25B, 25C, and 25D is raised
above the base portion 1610 and angled at the trigger area 1614.
The arrangement shown in FIGS. 25B, 25C, and 25D also includes a
cover (or lid) 1630 that attaches to the base portion 1610 of the
inspection 1600 and that covers and envelops the handle module
1602. The cover 1630 may be made of hard, translucent plastic, such
as polycarbonate, for example. In one aspect, the fan 1608 may be
powered by the adapter 1612 for the inspection station 1600, as
shown in FIG. 25C. In another aspect, the fan 1608 may have its own
power adapter 1632, separate from the power adapter 1612 for the
inspection station 1600, as shown in FIG. 25D. The upper surface of
the cover/lid 1630 may include one or more air exhaust vents 1634,
and the cover/lid 1630 may also include air intake vents 1636 near
the fan 1608.
[0267] FIG. 25E illustrates another arrangement for the inspection
station 1600 that uses vacuum flow to dry the handle module 1602.
In such an arrangement, the cover/lid 1630 may define one or more
air intakes 1640 (two of which are illustrated 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 intakes 1640, across the
handle module 1602, and into the vacuum port 1642. Preferably, the
vacuum port 1642 is spaced away from the air intakes 1640 to
increase the air flow across the handle module 1602. In the example
of FIG. 25E, the air intakes 1640 are at the bottom of the
cover/lid 1630 and the vacuum port 1642 is at the top of the
cover/lid 1630; however, any suitable arrangement could be
utilized.
[0268] A handle module, such as handle module 1602, for example,
could also be tested by a simulated load adapter. In various
instances, the handle module 1602 can be tested by a load adapter
1650 when the handle module 1602 is connected to the inspection
station 1600, as shown in the examples of FIGS. 26A-26D. In other
instances, a simulated load adapter can be configured to test a
handle module without a complementing inspection station. In any
event, the simulated load adapter 1650 may include a housing 1651
and opposing load motors 1652, 1654 positioned in the housing 1651.
As described in greater detail further 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 which is operably engageable with a
coupler 1656 driven by the first drive motor of the handle module
1602. The second load motor 1654 is configured to drive a second
mating nut 1662 which is operably engageable with a coupler 1658
driven by the second drive motor of the handle module 1602.
[0269] The simulated load adapter 1650 may comprise a motor control
circuit on a circuit board with at least a processor, memory and a
motor controller for controlling the load motors 1652, 1654, for
example. The motor control circuit may be embodied as one
integrated circuit (e.g., a SOC) or a number of discrete integrated
circuits or other circuitry. The motor control circuit may control
the motors 1652, 1654 to apply an opposing force, under varying
load conditions, to the rotary drive systems of the handle module
1602. The power drawn by the rotary drive systems of the handle
module 1602 to resist and/or overcome the opposing forces can be
monitored by the inspection station 1600 to determine whether the
handle module motor(s) and rotary drive systems are functioning
properly. In various instances, the first motor 1652 of the
simulated load adapter 1650 can be driven in one direction and the
drive motor of the handle module 1602 can drive the first coupler
1656 in an opposite direction. If the drive motor of the handle
module 1602 is unable to resist or overcome the simulated load
applied by the first motor 1652 of the simulated load adapter 1650,
then the simulated load adapter 1650 can instruct the handle module
1602 that the handle module 1602 cannot perform as required. In
various instances, the second motor 1654 of the simulated load
adapter 1650 can be driven in one direction and the drive motor of
the handle module 1602 can drive the second coupler 1658 in an
opposite direction. If the drive motor of the handle module 1602 is
unable to resist or overcome the simulated load applied by the
second motor 1654 of the simulated load adapter 1650, then the
simulated load adapter 1650 can instruct the handle module 1602
that the handle module 1602 cannot perform as required. Such an
assessment can constitute one facet of the overall assessment of
whether the handle module 1602 is suitable for another
procedure.
[0270] In various instances, further to the above, the simulated
load adapter motor control circuit can vary the load imparted by
the simulated load adapter motors 1652, 1654 on the rotary drive
systems of the handle module 1600 from (relatively) low to
(relatively) high in a way that simulates the load that the handle
module rotary drive systems are expected to experience during a
surgical procedure. In at least one instance, the motor control
circuit can be programmed so that it can vary the load profiles of
the motors 1652, 1654 based on the type of DSM to be used in an
upcoming procedure. For example, using the user interface 1672
(e.g., the buttons 1670 and/or a touch screen of the interface
1672), the user could specify the desired simulated load
conditions, such as selecting a pre-programmed simulated load
condition corresponding to the different available DSMs, for
example. The simulated load adapter 1650 may have a data contact
terminal 1674 that mates with the data connection terminal of the
handle module 1602. In such a manner, the user's load profile
selection can be uploaded from the inspection station processor, to
the handle module processor, and to the motor control circuit of
the load simulator 1650. In real-time and/or after the simulation,
the motor control circuit can download to the handle module
processor and/or the inspection station processor time-stamped
power readings for the power (e.g., volt-amps) supplied to the load
simulator motors 1652, 1654 during the simulation. The inspection
station processor and/or the handle module processor can correlate
these readings to time-stamped readings for the power drawn by the
handle module motor(s) to evaluate the efficacy of the handle
module motor(s) and rotary drive systems.
[0271] The simulated load adapter 1650 may be powered by the
inspection station 1600, for example. As shown in the example of
FIG. 26B, electrical power from the inspection station 1600 could
be supplied to the simulated load adapter 1650 via the handle
module 1602 and the electrical contact board 1674. In the example
of FIG. 26C, a separate power cord 1680 extending from the
inspection station 1600 to the simulated load adapter 1650 can
supply electrical power directly to the load simulator adapter
1650, bypassing the handle module 1602. In another arrangement, the
load simulation adapter 1650 could have its own connection to an AC
power source and/or its own battery power supply. In various
instances, the cord 1680 can also place the load simulator 1650 in
direct signal communication with the inspection station 1600.
[0272] The simulated load adapter 1650 could also be used to
monitor backlash in the handle module gears that are part of the
rotary drive systems. When the simulated load adapter 1650 is in a
backlash detection mode, the simulated load adapter motor control
circuit can cause one or both of the simulated load motors 1652,
1654 to rotate, and the processors of either the inspection system
1600 and/or the handle module 1602 can track the rotations by the
corresponding rotary drive systems of the handle module 1602. The
difference in rotation between the simulated load adaptor motors
1652, 1654 and the rotary drive systems of the handle module 1602
is an indication of the backlash in the respective rotary drive
systems of the handle module 1602, which can diminish the life of
the handle module. In other words, an increase in backlash can
decrease the number of uses remaining for the handle module 1602.
Accordingly, at each inspection of a handle module 1602, the
inspection station 1600 and the load simulator 1650 can check the
handle module's backlash and write the result to the handle
module's memory. The handle module memory can store and time-stamp
the backlash readings. The handle processor and/or the inspection
station processor can determine a revised end-of-life threshold for
the handle module, in terms of firings, for example, based on a
model for the effect of backlash on the number of remaining uses. A
sample model is depicted in FIG. 26E. Dashed line 1690 shows a
threshold limit for backlash as a function of the number of firings
of a handle module. Line 1691 depicts the expected backlash for the
handle module as a function of use (e.g., firings). In this
example, the backlash threshold is reached (lines 1690 and 1691
intersect) at about 500 firings. Since the backlash measurements
can be tracked over time (and hence over the number of firings),
the handle processor and/or the inspection processor can compare
the backlash measurements, indicated by the diamonds FIG. 26E, to
determine that the handle module backlash is trending to reach the
threshold at less than 500 firings, in this example about 370
firings. This revised, updated firing threshold could be used in
assessing the remaining life of the handle module. For example, if
the handle module has been fired 220 times, and its revised
end-of-life is 370 firings because of backlash, the processor could
determine that the handle module has 150 firings remaining; or if 7
firings per procedure are assumed, then the handle module has 21
procedures remaining The backlash can be tested for each rotary
drive system of the handle module in this manner and the one with
the least remaining life can dictate the overall remaining life of
the handle module.
[0273] The above being said, if less backlash than expected is
measured, then the firings needed to reach the end-of-life
threshold of the handle module can be revised upwardly, or
increased. In fact, the end-of-life threshold of a handle module
can be increased if any parameter and/or a combination of
parameters indicates that the handle module is experiencing less
wear than expected, for example. Correspondingly, the end-of-life
threshold of a handle module can be decreased if any parameter
and/or a combination of parameters indicates that the handle module
is experiencing more wear than expected, for example. Moreover, the
various parameter thresholds disclosed herein can be fixed or
adaptable. A threshold parameter can be adapted based on intrinsic
and/or extrinsic information. For instance, the control system of a
handle module can evaluate patterns or trends in parameter data and
adapt a 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 that baseline. In some instances, the control system of
a handle module can evaluate patterns or trends in the data
obtained for a first parameter and adjust the threshold of a 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 for
a second parameter relative to that baseline. Moreover, many
thresholds are described herein as comprising two ranges, i.e., a
first range below the threshold and a second range above the
threshold. The threshold itself may be part of the first range or
the second range, depending on the circumstances. That said, a
threshold, as used herein, may comprise three ranges, i.e., 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.
If the sensed data for a parameter is in the first range, the
control system may take a first action and, if the sensed data for
the parameter is in the second range, the control system may take a
second action, which may or may not be the same as the first
action. If the sensed data for the parameter is in the third range,
the control system may take a third action, which could include no
action at all. The minimum value could be part of the first range
or the third range, depending on the circumstances, and the maximum
value could be part of the third range or the second range,
depending on the circumstances. If data is sensed in a first range,
in at least one embodiment, the control system may adapt a
threshold in one direction and, if the data is sensed in a second
range, the control system may adapt the threshold in the opposite
direction while, if the data is sensed in a third range, the
control system may not adapt the threshold, for example.
[0274] In another aspect, as shown in FIGS. 27A and 27B, the
inspection station 1600 could accommodate both a handle module 1602
and one or more DSMs 1680, for example. FIG. 27A illustrates such
an inspection station 1600 by itself; FIG. 27B shows the inspection
station 1600 with both the handle module 1602 and a DSM 1680
connected thereto. The inspection station processor may be in
communication with the handle module processor and/or the DSM
processor in order to download and upload data and information. As
shown in FIG. 27A, an inspection station 1600 that also supports
DSMs may include rotary drives 1682, 1684, configured like the
rotary drives 1656, 1658 of the handle module 1600. The inspection
station 1600 may actuate the inspection station rotary drives 1682,
1684 to test the drive systems of the DSM 1680. In yet other
arrangements, the DSM 1680 may have its own inspection station for
performing the various tests and/or data transfers, for
example.
[0275] In view of the above, an inspection station 1600 could be
used to perform a number of pre-procedure and/or post-procedure
instrument processing tasks for a handle module and/or a DSM, such
as, for example: [0276] Determine and display a device ID (e.g.,
serial number) and/or model, and the state of the device (e.g.,
end-of-life, locked out, etc.); [0277] 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
versions; [0278] Based on the device identification, set and upload
the operation instructions and criteria for the handle module
and/or DSM, which the inspection station can retrieve from memory
based on the device ID; [0279] Perform various electronic tests,
such as modular connection integrity tests, memory version tests,
system electronic checks, transfer rate (read/write) checks,
scheduled maintenance checks, warranty expiration checks,
end-of-life checks, system lockout checks, and/or internal battery
life conditioning tests; [0280] Perform various physical tests,
such motor performance tests (with and/or without simulated loads
as described above), seal integrity tests, etc.; [0281] Performance
testing, such as comparing actual data from a procedure (downloaded
from the handle module and/or DSM memory) to expected procedure
data; [0282] Reset lockouts in the handle module where necessary;
[0283] Dry the device; [0284] Inform users (e.g., via the display)
that the device (handle module and/or DSM) is or is not suitable
for continued use; [0285] Upgrade software of the handle module
and/or DSM; [0286] Write test results to the handle module memory
and/or DSM memory; and/or [0287] Transmit handle and/or DSM
performance and usage data to a remote computer system, via a USB
or wireless (e.g., WiFi) connection, for example. The inspection
station memory may store software and/or firmware that the
inspection station processor executes to perform these various
functions.
[0288] The displays of the inspection station and/or the handle
module may also make maintenance and servicing recommendations
based on the various usage related data for the handle module.
Based on usage data such as the number of procedures, the number of
sterilizations, the number and/or intensity of firings, and/or the
gear backlash, for example, the inspection station and/or handle
module processors can determine whether various maintenance or
servicing tasks should be undertaken or recommended with respect to
the handle module and/or the DSM, and communicate those
recommendations to a user via the displays of either the inspection
station and/or the handle module. The maintenance and servicing
recommendations could be performed and communicated to the user
following a completed procedure, during a procedure, and/or at the
beginning of a procedure.
[0289] FIGS. 28A-28B are exemplary process flows for making
maintenance and/or service recommendations that could be performed
by the handle module processor and/or the inspection station
processor by executing firmware and/or software in the processors'
associated memory. FIG. 28A illustrates an exemplary process flow
for the inspection station processor 442. At step 1800, following a
procedure, the handle module is connected to the inspection station
(see FIG. 19A, for example), whereupon usage and performance data
from the handle module memory is downloaded to the inspection
station. This data may include a count of the number of procedures
for the handle module; various ways to count the number of
procedures are described herein. The data may also include the
number of firings by the handle module, the intensity (e.g., force)
for each firing, the firing force differential between the expected
firing force and the actual firing force, the (accumulated) energy
spent by the handle module over the life of the handle module,
and/or the gear backlash, for example.
[0290] At step 1802, based on the data, the inspection station
processor determines whether service of the handle module is
needed. The inspection station processor may parse the usage and
performance data multiple ways as programmed to determine if
service is needed, and may make one or several service
recommendations at step 1804 if it is determined that service is
required. The service recommendations could be as extensive as
suggesting that the handle module be rebuilt, or as minor as
lubricating certain parts, for example. Also, for example, one
service check that the inspection station processor may perform at
step 1802 is that for every N.sub.1 procedures and/or every S.sub.1
firings, or some combination of procedures and firings (e.g.,
N.sub.2 procedures and S.sub.2 firings), the handle module should
be rebuilt. In such a case, if the inspection station processor
determines that any of those thresholds has been met, at step 1804
the inspection station processor may control the inspection station
display to show that the handle module should be rebuilt. Another
service check that the inspection station processor may perform at
step 1802 is that at every S.sub.3 firings, the rotary drive
systems' gears should be lubricated. Other service checks that the
inspection station can perform and recommend if appropriate
include: electrical integrity checks for electrical contacts of the
handle module; testing of the communication system; extended
diagnostics of electronics of the handle module (e.g., RAM and/or
ROM integrity, processor operation, idle and operating current
draw, operating temperatures of selected components, etc.);
operation of indicators, displays and sensors; and/or battery
issues, such as cycling, balancing and/or testing, for example.
Service checks can be performed on a battery to evaluate the
condition of the battery. For instance, the inspection station can
assess whether the battery is nearing the end of its life, if
rechargeable, or nearing a threshold for less than one firing
remaining for a disposable battery, for example. Yet other services
checks include firing the device (in a diagnostics mode or other
mode that permits firing without a DSM or cartridge) to monitor
abnormalities in a motor parameter (such as voltage or current,
etc.). A damaged gear can cause a change in motor load, detectable
through the monitored motor parameters, that can indicate an
internal problem requiring replacement. Also, a generally higher
motor load can indicate a need for cleaning or lubrication, or
damage within the device.
[0291] At step 1806 the inspection station processor may determine
whether any components of the handle module need to be checked. As
before, the inspection station processor may parse the usage and
performance data multiple ways as programmed to determine if the
checking of various handle module components is needed, and may
make one or several component check recommendations at step 1808 if
it is determined that component checking is required. For example,
if the inspection station processor determines that the gear
backlash is beyond a pre-established threshold at step 1806, the
inspection station processor may display a suggestion at step 1808
that the gears of the rotary drive systems should be checked. Also,
if the inspection station processor determines that the accumulated
energy spent by the handle module is beyond a pre-established
threshold at step 1806, the inspection station processor may
display a suggestion at step 1808 that the motor(s) and/or the
gears of the rotary drive systems should be checked. Similarly, if
the inspection station processor determines that a threshold number
of firings (in the most-recently completed procedure and/or during
the life of the handle module) exceed a pre-established intensity
threshold (e.g., force or electric power) at step 1806, the
inspection station processor may display a suggestion at step 1808
that the motor(s) and/or the gears of the rotary drive systems
should be checked. The inspection station processor, via the
display, could also recommend that the DSM be checked in various
embodiments. For example, if the inspection station processor
determines that a threshold number of firings in the most-recently
completed procedure exceed a pre-established intensity threshold at
step 1806, the inspection station processor may display a
suggestion at step 1808 that the sharpness of the cutting
instrument in the end effector should be checked, since a dull
cutting instrument may necessitate greater force to execute a
cutting stroke.
[0292] The handle module processor may also make service and/or
component checking determinations and recommendations. FIG. 28B
illustrates an exemplary process flow for the handle module
processor 2124. The process of FIG. 28B is similar to that of FIG.
28A, except that, at step 1801, the handle module processor stores
usage and performance data from its procedures and post-procedure
processing so that it can make the determinations at step 1802 and
1806 about whether service and/or component checking is required.
The recommendations and suggestions displayed at steps 1804 and
1808 may be on the handle module's display and/or, in the case when
the handle module is connected to the inspection station and there
is a data connection therebetween, the handle module processor may
communicate the recommendations to the inspection station processor
so that the inspection station display can display the
recommendations, in lieu of or in addition to displaying them on
the handle module display.
[0293] As shown in FIGS. 27A and 27B, a DSM 1680 could also be
connected to an inspection station 1600. In such an arrangement,
the DSM processor and/or the inspection station processor may make
service and component checking determinations and recommendations
based on usage and performance data stored in the DSM memory.
[0294] To that end, FIG. 35 is a flow chart illustrating steps that
can be performed with the inspection stations described herein. At
step 2200, a clinician performs a surgical procedure with the
surgical instrument comprising the handle module and one of the
DSMs. As described herein, the handle module memory can store usage
and procedure data from throughout the procedure, such as motor
energy and power levels, motor torque, and/or time stamps for
actuation of various triggers, for example. Following the
procedure, at step 2202, the clinician can disconnect the DSM from
the handle module and remove the removable battery pack so that the
handle module can be prepared for use in a subsequent procedure by,
at step 2204, connecting the handle module to the inspection
station as shown herein, for example. At step 2206, the inspection
station can download (or read) the procedure and usage data from
the memory of the handle module. The inspection station can also
download the identification data for the handle module, which the
inspection station processor can use to determine the handle module
type and/or configuration at step 2208, which the inspection
station can display on its display.
[0295] At step 2210, the inspection station can set the inspection
programs and inspection criteria for the handle module based on its
type and configuration. For example, the inspection station memory
may store the inspection programs that should be performed for each
handle module type and configuration, as well as the criteria for
the inspections. Based on the handle module type and configuration
ID resolved by the inspection station at step 2208, the inspection
station can call and/or set the appropriate inspection programs and
inspection criteria to be used for the handle module. For example,
at step 2212, the inspection module can dry components of the
handle module, such as described herein in conjunction with FIGS.
25A-25E, for example. Also, at step 2214 the seal integrity tests
can be performed, such as described herein in conjunction with
FIGS. 24A-24B, for example. At step 2216, electronic integrity
tests for the handle module can be performed. These tests can
include testing that electrical connections exist between the
appropriate components, and for data processing components of the
handle module, that the protocols and connections for transmitting
data are functioning. At step 2218, functional and/or physical
tests of the handle module can be performed. For example, the
motor(s) and/or the rotary drive systems can be tested (e.g.,
driven) to make sure that they are functioning properly. At step
2220, the handle module lockouts that need to be reset following a
procedure can be reset. At step 2222, further necessary
conditioning for the handle module can be performed. This
conditioning can include any other conditioning necessary to
prepare the handle module for a subsequent surgical procedure,
and/or performance of any service recommendations identified by the
inspection station. At step 2224, the handle module can be released
from the inspection station, whereupon it can be used in a
subsequent surgical procedure (or sterilized before using in a
subsequent procedure). The inspection station may "release" the
handle module by indicating on the display of the inspection
station that it can be removed, for example.
[0296] As shown in FIGS. 27A and 27B, a DSM could also be connected
to such an inspection station following its use in a surgical
procedure in order to inspect the DSM. A similar process to that
illustrated in FIG. 35 can be used for the DSM connected to the
inspection station to prepare the DSM for a subsequent
procedure.
[0297] Various steps illustrated in FIG. 35 can be performed in
different orders or simultaneously and the steps illustrated in
FIG. 35 do not necessarily need to be performed in the order
illustrated in FIG. 35, although they could be. For example, the
electronic integrity tests (step 2216) could be performed before
the seal integrity test (step 2214), etc.
[0298] FIGS. 36 and 37 are flow charts illustrating exemplary steps
involved in sterilizing a handle module and tracking the number of
times it is used/sterilized. In FIG. 36, the process starts at step
2300 where the handle module (and a DSM) are used in a surgical
procedure. After the procedure, at step 2302, a post-op clean-up of
the handle module can be performed, which can entail a manual wipe
down of the handle module, for example. Thereafter, at step 2304,
the handle module can be decontaminated, such as with an
auto-washer, for example. At step 2306, the handle module can be
dried in a clean room, using heat and/or air, for example. At step
2308, the handle module can be connected to an inspection station,
such as the inspection stations described herein in connection with
FIGS. 12A-12C, 19A, 25A-25E, 26A-26C, and/or 27A-27B, for
example.
[0299] At step 2310, the inspection station can query or
interrogate the handle module to determine if the sterilization
switch (e.g., switch 344, see FIGS. 11E-11I) was activated or
otherwise in the state that indicates its prior placement in a
sterilization tray, such as shown above in FIGS. 11E-11I. If the
sterilization tray switch is in the triggered or actuated state, at
step 2311 the sterilization count is increased and the switch state
reset. Then, at step 2312, the inspection station can determine
whether the threshold sterilization count for the handle module has
been reached, as described herein. If the sterilization count has
been reached, at step 2314, any of the herein-described end-of-life
actions for the handle module can be taken.
[0300] Conversely, if the threshold has not yet been reached, the
process can advance to step 2316 where the handle module is
prepared for sterilization, such as by placing the handle module in
its corresponding sterilization tray (see FIGS. 11E-11I, for
example) and/or placing the sterilization covers on it (see FIGS.
20A-20D, for example), which in either case can activate the
sterilization trigger at step 2318. The handle module can be
sterilized at step 2320, whereupon it can be stored and
subsequently transported to an operating room at step 2322 for use
in a subsequent procedure at step 2300.
[0301] Returning to step 2310, if the sterilization trigger is not
activated or its status changed, the handle module may have to be
physically inspected at step 2324.
[0302] The exemplary process flow of FIG. 37 is similar to that of
FIG. 36, except that following the procedure at step 2300, the
handle module can be powered back on to determine if its
sterilization state flag (set by handle module processor when the
switch 344 is activated, see FIGS. 11E-11I) is set at step 2310. If
so, at step 2311 the sterilization count can be updated and the
sterilization state reset.
[0303] As mentioned above, the handle module battery pack may be
removed from the handle module following a surgical procedure so
that it can be used in the same or another, similarly-configured
handle module in a subsequent procedure, typically after
recharging. FIGS. 29A-D illustrate a charging station 1700 for
recharging battery packs 1702. The battery packs 1702 are inserted
into receptacles 1704 defined in the charging station 1700, shown
in the side-views of FIGS. 29B and 29C, such that, when the battery
packs 1702 are inserted, their respective power terminals 1706
contact corresponding charge terminals 1708 at the bottom of the
receptacles 1704 to charge the respective battery packs 1702. The
illustrated charging station 1700 can simultaneously charge two
battery packs, although in other arrangements a charging station
could have receptacles for storing and charging more or fewer
battery packs.
[0304] The charging station 1700 may include a display 1709 that
displays the status of the battery packs 1702 in terms of the
charging process, such as currently charging or charged/ready to
use, for example. For battery packs currently charging, the display
may show how far along the charging process is and/or how far there
is to go. Text and/or graphics may be used to indicate the charging
status, such as a volume and/or other type of fractional indicator
that indicates how charged the battery pack is (e.g., 40% charged,
50% charged, etc.).
[0305] As shown in FIGS. 29B and 29C, the receptacle 1704 may be
sized so that the end portion of the battery pack 1702 that is
inserted into the receptacle fits in easily (e.g., a zero insertion
force connection). The charging station 1700 may include 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, in
communication with the charging station processor 1722, at the
bottom of the receptacle 1704 that is actuated when the battery
pack 1702 is inserted. Additionally or alternatively, the charging
station processor 1722 may detect the insertion of a battery back
1702 when a charging station data terminal 1712 makes a data
connection with the battery pack data terminal 1710. In any case,
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 so that the battery pack 1702 cannot be removed
prematurely (e.g., prior to charging and/or a complete charging).
In one arrangement, as shown in FIGS. 29B and 29C, this is
accomplished by a screw 1724 at the bottom of the receptacle 1704
of the charging station 1700 that automatically screws into a
corresponding opening 1726 in the bottom of the battery pack 1702
that is sized and threaded for receiving the screw 1724.
[0306] FIG. 29D is a simplified block diagram of the charging
station 1700 and a battery pack 1702 according to various
arrangements. Assuming the charging station 1700 is powered by an
AC power source, the charging station 1700 may include an AC/DC
converter 1730 to convert the AC voltage into DC voltage and a
voltage regulator 1732 for converting the DC voltage to the desired
charging voltage and/or current for charging the battery cells 1734
of the battery pack 1702. The charging station 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 can
be sensed by the sensing circuit 1738 of the charging station 1700.
For example, when charging a battery pack 1702 under normal
charging conditions, the charging 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). Then the charging controller circuit 1736
can hold the cells at that Vpc until the charge current drops to X
% of the initial charge rate (e.g., 10%), at which point the
charging process can terminate. Other charging regimens,
appropriate to the battery technology, can be performed.
[0307] The pressure switch 1720 may detect the insertion of the
battery pack 1702 into the receptacle 1704 of the charging station
1700 and, when activated, send a signal to the charging station
processor 1722. The charging station processor 1722 may send in
response 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 that can power, in addition to the
connection actuator 1740, the other electronic components of the
charging station 1700.
[0308] Further to the above, the battery pack 1702 may include a
data terminal 1710 that, when the battery pack 1702 is inserted
into the receptacle 1704, mates with a corresponding data terminal
1712 of the charging station 1700. The charging station processor
1722 may have internal or external memory 1744 that stores firmware
and/or software to be executed by the charging station processor
1722. By executing the firmware and/or software, the charging
station processor 1722 can (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 pack
electronics may also include memory 1752 that stores firmware
and/or software to be executed by the battery pack processor 1750,
such as a battery management system (BMS). The battery pack 1702
may also comprise sensors 1754 for sensing conditions related to
the battery pack 1702, such as moisture and/or humidity, for
example, as described above. The data terminal 1712 of the charging
station 1700 may also supply low-level power to the battery pack
processor 1750. The charging station 1700 may also include a
wireless module 1755 in communication with the processor 1722 that
can communicate with remote devices via wireless communication
links (e.g., Wi-Fi, Bluetooth, LTE, etc.). As such, the charging
station 1700 could communicate wirelessly to remote computing
systems (e.g., servers, desktops, tablet computer, laptops,
smartphones, etc.) the charge status and other data regarding the
battery packs 1702 installed in the charging station 1700 (e.g.,
impending end-of-life, temperature). The charging station could
also include a port for a wired connection (e.g., USB-type port) so
that charge status and other data regarding the battery packs 1702
can be downloaded from the charging station 1700 to the connected
device. That way, the surgical staff and/or the battery pack
supplier can receive such information.
[0309] In one aspect, to extend battery run time as well as battery
life, for example, the battery cells comprising the battery pack
1702 may be rebalanced from time to time during the life of the
battery pack 1702. FIG. 29E is a diagram of a process flow that can
be performed by the charging station processor 1722 (by executing
firmware/software stored in the memory 1744) to rebalance the
battery cells. At step 1760, the charging station processor 1722
can detect the insertion of a battery pack 1702 into the inspection
station 1700 for charging based on, for example, the signal from
the pressure switch 1720 in the receptacle 1704 and/or by some
other suitable means. At step 1762, the charging station processor
1722 can actuate the connection actuator 1740 to temporarily secure
the battery pack 1702 to the charging station 1700 during the
charging (and/or discharging) session. At step 1764, the charging
station processor 1722 can exchange data with the battery pack
processor 1750. Among other things, the battery pack processor 1750
can exchange a log of the times the battery pack 1702 has been
charged and the times that its cells were balanced. At step 1765,
the charging station 1700 can quickly top-off the charge of the
battery cells in case the battery pack is needed before a complete
charging or discharging cycle can be performed. The top-off charge
at step 1765 could be, for example, to merely charge the battery
cells at a constant current to bring them to the specified Vpc
level or a fraction thereof. At step 1766, the charging station
processor 1722 can determine whether the battery cells should be
balanced again. In various aspects, the cells may be balanced every
N times they are 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 cells, the process advances to step 1768 where the
battery cells are recharged and at step 1770 released for use, such
as by de-actuating the connection actuator 1740 so that the battery
pack 1702 can be removed from the receptacle. On the other hand, at
step 1766, if it is determined that the battery cells need to be
rebalanced, the process can advance to step 1772 where the cells
are discharged before being charged at step 1768. The cells may be
discharged at step 1772 to a suitable (low) voltage level
[0310] As shown in FIG. 29A, the charging station 1700 may include
an emergency release button 1780 for each battery pack charging
receptacle, or just one emergency release button 1780 that releases
only the battery pack 1702 that presently has the most charge (and
thus most suitable for emergency use). In various aspects, the
charging station processor 1722 may initiate one or many actions
when the emergency release button 1780 is depressed for a
particular battery pack 1702 when charging of that battery pack is
in process. For example, the charging station processor 1722 can
signal the connection actuator 1740 to unscrew the battery pack
1702 so that it can be removed. Also, before such mechanical
release of the battery pack 1702, the charging station processor
1722 can instruct the charging controller to take action to
expedite rapid charging of the battery pack 1702. For example, the
charging station processor 1722 can instruct the charging
controller 1736 to use a charging profile that more rapidly charges
the battery cells 1734 for a brief time period, even though such
rapid, short-term charging may not fully charge the battery cells
to their capacity or promote longevity of the battery cells. Common
charge profile stages for charging Li-ion battery cells include (i)
trickle charge, (ii) constant current charge, and (iii) constant
voltage charge. The charging controller circuit 1736 can switch to
one of these profiles (e.g., constant current charge) in the short
duration to provide the battery pack 1702 with as much additional
charge as possible in the short time period. Also, the charging
station processor 1722 can coordinate increasing the charging
voltage available for charging the battery cells by making other
power sources available for charging, such as from other
receptacles and/or charge storing devices (e.g., supercapacitors or
battery cells) in the charging station 1700. Data about such
charging procedures can also be logged in the battery pack
memory.
[0311] FIG. 30A illustrates another exemplary charging/discharging
determination process that the charging station processor 1722 may
undertake, in addition to or in lieu of the process shown in FIG.
29E. The process of FIG. 30A recognizes that discharging of
surgical instrument battery packs often is beneficial to their
longevity, but that the battery packs should not be discharged if
there is insufficient time to discharge them before they will be
needed in a surgical procedure. The process of FIG. 30A starts 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 station memory, which may
include the current remaining battery capacity. Although not shown
in FIG. 30A, the first battery pack could also be secured to the
charging station when it is inserted (see FIGS. 29B-29C, for
example). At step 1784, the charging station 1700 may immediately
charge the first battery pack in case it might be needed in a
currently ongoing or imminent procedure. At step 1786, data about
the charging of the first battery pack at step 1784 is written to
the memory of the first battery pack. This data can include, for
example, time stamps for the beginning and ending of the charging
step, as well as the starting and ending battery capacity.
[0312] At step 1788, the charging station processor checks the
charging/discharging log for the first battery pack and, if the
first battery pack was fully discharged since the last procedure,
the process advances to step 1790 where the first battery pack is
ready for use in a procedure. At this step, the charging station
display may indicate that the first battery pack is ready for use.
On the other hand, if at step 1788 it is determined that the first
battery pack has not been fully discharged since its last
procedure, the process may advance to step 1792 where the charging
station processor can determine if there is at least one other
fully charged battery pack in its charging receptacles. If so, at
step 1794 the first battery pack can be fully discharged to prolong
its longevity and because there is another fully charged battery
pack ready for use if needed. Once the discharge of the first
battery pack is complete, at step 1796 the discharging data (e.g.,
beginning and ending time-stamps, beginning and end capacities) can
be written to the first battery pack memory so that the evaluation
at step 1788 can be performed. Thereafter, the process can advance
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 at step 1794 since the last procedure, from step 1788
the process will advance to step 1790 because another discharge of
the battery cells is not required.
[0313] Modifications to the process of FIG. 30A can be made. For
example, the initial charging step 1784 could be eliminated and/or
moved between steps 1788 and 1790 and/or between steps 1792 and
1790, for example.
[0314] FIG. 30B illustrates another exemplary charging/discharging
determination process that the charging station processor 1722 may
undertake. The process of FIG. 30B is similar to that of FIG. 30A,
except that at step 1783, following step 1782, the charging station
1700 can perform a quick charge top-off of the battery pack (e.g.,
short charge to less than full capacity) and record data about the
top-off charging in the battery pack memory. Then at step 1788, as
in FIG. 30A, the charging station processor can determine if the
battery pack was discharged fully since the last procedure and, if
so, at step 1789, then perform a full charging of the battery pack,
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 was not fully discharged since the
last procedure, the process can advance to step 1792 where the
charging station determines if another battery pack is currently
inserted in one of its receptacles 1704 is ready for use (e.g.,
adequately or fully charged). If not, the first battery pack can be
fully charged at step 1789. However, if another battery pack is
adequately or fully charged and ready for use, at step 1794 the
first battery pack can be discharged (with data about the discharge
being stored in the battery pack memory). After full discharge, the
process can advance to step 1789 so that the first battery pack can
then be charged.
[0315] In various embodiments, the charging station processor 1722
can monitor and store the times at which the various battery cells
are inserted into it, as indications of when procedures are being
performed by the hospital or surgical unit in which the charging
station is located. The charging station processor 1722 can be
programmed to determine times of the day when the hospital or
surgical unit is typically performing procedures involving
instruments that utilize such battery packs and when it is not. In
particular, the charging station processor 1722 can determine a
statistical likelihood that the hospital or surgical unit is
performing a procedure involving instruments that utilize such
battery packs for non-overlapping time increments that span a
24-hour period, such as one-hour increments, for example. Thus, for
the full charging of the battery packs (e.g., at step 1789 of FIG.
30B), the charging station can commence such full charging steps at
times when there is a low likelihood of an ongoing procedure,
especially in instances where there is an already another fully
charged battery pack ready for use. That is, for example, in FIG.
30B, the full charging at step 1789 following discharging at step
1792 need not immediately follow the discharging at step 1792 but
could instead be scheduled for a time that there is a low
likelihood of an ongoing procedure, as determined and scheduled by
the charging station processor 1722. Further, the personnel at the
hospital or surgical unit can input to the charging station 1700,
via the user interface 1709, for example, data about when
procedures are to be performed and/or the types of procedures (or
the amount of charge needed for the procedures) that are to be
performed. This data can be stored in the charging station memory
1744 and used by the charging station processor 1722 to determine
when to charge the battery packs.
[0316] In a system that charges and discharges batteries, there can
be a significant amount of energy wasted in dumping the power from
the cell(s) under maintenance in the form of heat because typically
the charge on a battery cell to be discharged is drained through a
resistive load. Accordingly, the charging station may include fans
and/or heat sinks to help dissipate heat. In other aspects, the
charging station may use the charge on a cell to be discharged to
charge another cell in the charging station or store it in another
charge storing device. FIG. 31 is a simplified diagram of a circuit
1900 for discharging battery cells in such a manner. When charging
the "first" battery cell 1902, the power source/voltage regulator
1904 is connected to the first battery cell 1902 by closing switch
S1, with all other switches (S2, S3, S4 and S5) being open. To
discharge the first battery cell 1902 through the resistor 1906,
switches S2 and S3 are closed and switches S1, S4 and S5 are open.
The diode 1903 controls the direction in which current flows from
the first battery cell 1902. To discharge the first battery cell
1902 to the energy storage device 1908 (e.g., supercapacitor or
another battery cell internal to the charging station and not
ordinarily for use in a surgical instrument), switch S2 is closed
and the rest of the switches S1, S3, S4 and S5 are open. The diode
1903 controls the direction in which current flows to the energy
storage device 1908. To charge the first battery cell 1902 with the
charge on the energy storage device 1908, switch S5 is closed and
the rest of the switches S1, S2, S3, and S4 are open. The diode
1905 controls the direction in which current flows to the first
battery cell 1902. To charge another battery cell 1910 with the
first battery cell 1902, switches S2 and S4 are closed and switches
S1, S3 and S5 are open. The switches S1, S2, S3, S4 and S5 can be
controlled by the charging station processor 1722 and/or the
charging controller 1736.
[0317] FIG. 32 shows a circuit for charging and discharging the
first battery pack 1902 that is similar to that of FIG. 31, except
that the configuration of FIG. 32 includes a set of battery cells
1920 that can be used to charge the first battery cell 1902. In the
illustrated arrangement, the set 1920 includes three battery cells
1922, 1924, 1926, although in other arrangements the set 1920 may
include more or less battery cells. The battery cells 1922, 1924,
and 1926 in the set 1920 may be internal battery cells of the
charging station and/or other battery packs inserted into the
charging station. The cells 1922, 1924, 1926 in the set 1920 may be
used, for example, to rapidly charge the first battery pack 1902,
such as in a situation where a replacement battery pack is needed
in an ongoing procedure. In the illustrated arrangement, the cells
1922, 1924, 1926 in the set 1920 may be connected in series or in
parallel to provide increased voltage (when connected in series) or
increased current (when connected in parallel). To connect the
cells 1922, 1924, 1926 in series, the switches S7 are closed and
the switches S6 are open. To connect the cells 1922, 1924, 1926 in
parallel, the switches S6 are closed and the switches S7 are open.
Each cell may have an associated resistor R1, R2, R3 respectively,
for example, to provide a current source when connected in
parallel.
[0318] In one aspect, referring back to FIG. 29A, if a clinician is
in the midst of a procedure and needs a new battery pack to
complete the procedure, the clinician (or his/her assistant) can
select and remove from the charging station 1700 one of the battery
packs that is fully charged and ready for use, which may be
indicated on the display 1709 of the charging station 1700. If none
of the battery packs 1702 is indicated as ready for use, the
clinician can press the emergency release button 1780, for example,
which may release the battery pack 1702 currently in the charging
station 1700 that has the most charge at the moment, as determined
by the charging controller 1736 and/or the charging station
processor 1722, so that the partially-charged battery pack can be
inserted into the handle module currently being used in the
procedure. The charging station 1700 may also include visual
indicators to indicate which battery pack 1702 is being released in
the emergency so that it is clear which battery pack should be
removed from the charging station for insertion into the surgical
instrument. For charging stations 1700 that include means for
securing the battery pack 1702 to the charging station 1700 during
charging, such as the screw 1724 in the arrangement of FIGS.
29A-29C, activation of the emergency release button 1780 can 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 can take steps to rapidly charge the selected
battery pack 1702 for a short time period, preferably to give it at
least enough charge to complete one or a couple of firings. As
described herein, the charging station processor 1722 may, in
conjunction with the charging controller circuit 1736, change the
charging profile (e.g., constant current or constant voltage
charge), charge the battery pack with a supercapacitor(s) 1908,
and/or charge the battery pack with one or more other battery cells
(which could 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 the
short-term charging charges the battery pack 1702 to a charge level
to a threshold charge that is sufficient to complete one or a
couple of firings.
[0319] In various aspects, the charging station may also be
configured to ease the proper placement of the battery packs into
the charging station for charging and/or to enhance the engagement
between the electrical contacts between the battery pack and the
charge terminals of the charging station to thereby increase the
efficiency of the charging process. For example, the wells (or
receptacles) in the charging station can have multiple sets of
terminals so that no matter which way the battery pack is inserted
into the well/receptacle, the battery pack's charging terminals
contact one set of charging terminals of the charging station.
FIGS. 33A and 33B illustrate top views of a battery pack 2000 and a
charging station 2002, respectively, wherein the battery pack 2000
has a square cross-sectional shape and the wells/receptacles 2004
of the charging station 2002 are sized to the receive such a
square-cross-sectional battery pack 2000. The illustrated charging
station 2002 has two wells/receptacles 2004, but in other
arrangements the charging station 2002 can have one well/receptacle
or more than two wells/receptacles. As shown in FIG. 33A, the
battery pack 2000 has a positive terminal 2006 and a negative
terminal 2008 that the charging station terminals contact in order
to charge the battery packs. 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 could be inserted into
one of square-shaped wells/receptacles 2004 in one of four
configurations (each 90 degree turn, and assuming the side of the
battery pack 2000 with the terminals 2006-2008 is always
face-down), each well/receptacle can have four pairs of charging
terminals 2010 positioned in it so that, no matter which way the
battery pack 2000 is turned when it is inserted into the
well/receptacle 2004, the off-center battery pack terminals
2006-2008 will make contact with one of the charging station
terminal pairs 2010. Each charging station terminal pair 2010 is
connected to the charging circuitry of the charging station, but
only the one pair 2010 that contacts the battery pack terminals
2006-2008 will have a completed circuit so that charging current
can flow to the battery pack 2000. In another arrangement, as shown
in FIGS. 34A and 34B, one of the battery pack terminals could be in
the center of the battery pack 2000. In the illustrated case, the
negative terminal 2008 is in the center with the positive terminal
2006 to one side; however, the opposite arrangement could be
utilized in another embodiment. The wells/receptacle of the
charging station could correspondingly 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 no matter
which way the battery pack 2000 is inserted into the
well/receptacle. For battery packs that have other geometries,
there may need to be a fewer or greater number of terminal pairs in
the well/receptacles (such as two pairs for a rectangular battery
pack).
[0320] As discussed above, a surgical instrument can include a
battery assembly capable of being attached to and/or detached from
the surgical instrument. Such handling of the battery assembly can
increase the chances of damaging the battery assembly. For example,
the battery assembly may be inadvertently dropped while assembling
the battery assembly to the surgical instrument and/or transporting
the battery assembly to a charging station. Discussed in greater
detail further below, the battery assembly can be configured to
protect the housing, battery cells, and/or power supply circuit of
the battery assembly in the event that the battery assembly is
inadvertently dropped.
[0321] Referring now to FIG. 38, a battery assembly, such as
battery assembly 5000, for example, can comprise a battery housing
5010 and a plurality of internal components 5030 including at least
one battery cell 5031 and/or a power supply circuit positioned
within the battery housing 5010. The at least one battery cell 5031
may comprise a lithium-ion battery, for example. The battery
assembly 5000 also comprises one or more electrical contacts 5011
configured to transmit electrical energy provided by the at least
one battery cell 5031 to the surgical instrument. The battery
assembly 5000 further comprises one or more alignment features 5012
configured to assist a user in properly assembling the battery
assembly 5000 to the surgical instrument. The alignment features
5012 comprise slots, for example, which are alignable with
projections extending from the surgical instrument. The alignment
features 5012 are symmetrically arranged around the perimeter of
the battery housing 5010. Although not illustrated, other
embodiments are envisioned in which the alignment features 5012
comprise a non-symmetrical configuration permitting the battery
assembly 5000 to be attached to the surgical instrument in only one
orientation. The battery assembly 5000 further comprises a lock
mechanism 5040 configured to secure the battery assembly 5000 to
the surgical instrument during use. When the battery assembly 5000
is attached the surgical instrument, the battery assembly 5000 can
transmit electrical energy to electrical receiving contacts of the
surgical instrument.
[0322] The battery housing 5010 can act as a container configured
to house the internal components 5030 and/or act as a support
structure configured to support various components thereon.
Functioning as a container and/or a support structure, the battery
housing 5010 may be rigid in order to support the internal
components 5030 positioned therein. The battery housing 5010 may be
comprised of a plastic material, for example. In certain instances,
the inner housing 5010 is comprised of an elastomeric material, for
example. Referring again to FIG. 38, the battery housing 5010
comprises a top face, a bottom face 5016, a plurality of lateral
faces 5015, and a plurality of corners 5014. The bottom face 5016
can be associated with the electrical contacts 5011. The lateral
faces 5015 and the corners 5014 are configured to surround the
internal components 5030.
[0323] Various embodiments discussed herein relate to the
protection of a battery assembly for use with a surgical
instrument. Referring again to FIG. 38, the battery assembly 5000
comprises 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
reinforcement may comprise a shock absorbing layer, for example. In
various instances, the shock absorbing layer may surround the
battery housing 5010 in order to absorb an impact force that is
applied to a lateral face 5015, the bottom face 5016, and/or a
corner 5014 of the battery housing 5010. In addition to or in lieu
of the above, a shock absorbing layer is housed within the battery
housing 5010. Also, in addition to or in lieu of the above, the
battery assembly 5000 may further comprise an outer housing for
added protection. The outer housing can be configured to house the
battery housing 5010 and the shock absorbing layer.
[0324] One means for protecting the battery assembly 5000 is
illustrated in detail in FIG. 38A, for example, comprising a
battery housing, or inner housing 5010, and a shock absorbing layer
5020. As discussed above, the housing 5010 may be comprised of a
rigid material which can support the internal components 5030 of
the battery assembly 5000. The shock absorbing layer 5020 may
contain a lattice structure 5022 comprising a plurality of cells
5024. The cells 5024 can lower the density of the shock absorbing
layer 5020. The cells 5024 can have an open cellular structure
and/or a closed cellular structure. Moreover, the lattice structure
5022 can comprise one or more lattice layers. For instance, the
lattice structure 5022 can include a first, or inner, lattice layer
and a second, or outer, lattice layer.
[0325] The lattice structure 5022 further comprises a plurality of
struts 5025 designed to deflect and/or buckle under pressure. If
the battery assembly 5000 is dropped, an impact force is absorbed
through the compression of the cells 5024 and the buckling and/or
deflection of the struts 5025. Therefore, the shock absorbing layer
5020 can absorb shock and/or vibrational energy rather than relying
on the battery housing 5010 to absorb the energy which could, in
some circumstances, result in the damaging of the internal
components 5030 of the battery assembly 5000. In various instances,
the shock absorbing layer 5020 may comprise a foam-like structure
and/or an elastomeric material, for example.
[0326] In various instances, referring again to FIG. 38, the cells
5024 are arranged in rows, for example, having an inner row of
cells 5026, an intermediate row of cells 5027, and an outer row of
cells 5028. Each cell of 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
with a lateral face 5015 of the battery housing 5010. Each cell of
the outer row of cells 5028 can comprise a planar wall 5028a. The
cells 5028 are oriented such that planar walls 5028a of the cells
5028 are at least substantially parallel with an outer surface 5029
of the shock absorbing layer 5020. Orienting the planar walls
5026a, 5028a of each cell of the inner row 5026 and the outer row
5028 in such a manner can create a more shock resistant shock
absorbing layer 5020. The shock absorbing layer 5020 may comprise
corner portions positioned near the corners 5014 of the battery
housing 5010 that can absorb an impact force directed to a corner
5014 of the battery housing 5010. The corner portions 5020 are not
connected to one another; however, embodiments are envisioned in
which the corner portions 5020 could be connected to one
another.
[0327] In various instances, the battery assembly 5000 comprises 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 instances, an impact force may 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 comprise end portions 5021
which extend beyond a bottom face 5016 of the battery housing 5010
in order to prevent damage to the electrical contacts 5011, for
example, 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 with the
ground, one or more of the end portions 5021 can absorb the impact
force and dissipate the impact energy.
[0328] It may be preferred that a battery assembly be useable after
experiencing an impact force, such as when the battery assembly
5000 is inadvertently dropped. In such instances, the shock
absorbing elements 5020 are configured to allow the battery
assembly 5000 to retain the ability to be properly fitted into the
battery receiving portion of the surgical instrument and still
transmit electrical energy to the electrical receiving contacts of
the surgical instrument even though the battery assembly 5000 has
been dropped. The shock absorbing elements 5020 may comprise
crumple zones configured to deform when an impact force is applied.
In at least one instance, a crumple zone may not permanently
deform, or at least substantially permanently deform, if the impact
force is below a crumple force threshold. In such instances, the
crumple zone may permanently deform only if the impact force meets
or exceeds the crumple force threshold. The crumple zones may limit
the direction of the deformation of the shock absorbing elements
5020 toward the center of the battery assembly 5000. This inward
deformation can preserve 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 acquire a shape that would not fit into
the battery receiving portion of the surgical instrument.
[0329] In various instances, the shock absorbing elements 5020 may
experience an excessive amount of deformation requiring replacement
of the shock absorbing elements 5020. In the event that the shock
absorbing elements 5020 need to be replaced, the battery assembly
5000 can be configured so that the user of the surgical instrument
can remove the damaged shock absorbing elements from the battery
assembly 5000 and then attach useable shock absorbing elements
thereto. Discussed in greater detail below, it may be preferred
that the shock absorbing elements 5020 can be replaced in a timely
fashion. Minimizing the amount of time required to replace the
shock absorbing elements 5020 can be important when introducing
another task to a surgical operation.
[0330] Assembling the shock absorbing elements 5020 to the battery
assembly 5000 may be necessary when the shock absorbing elements
5020 need to be replaced. In various instances, the shock absorbing
elements 5020 comprise one or more protrusions 5023 configured to
slide and/or wedge into corresponding slots 5013 in the battery
housing 5010. The slots 5013 are configured to receive the
protrusions 5023 of new and/or useable shock absorbing elements in
the event that the shock absorbing elements 5020 need to be
replaced. In various instances, the protrusions 5023 and the slots
5013 can comprise a press-fit therebetween which can permit the
protrusions 5023 to be slid within the slots 5013 along the corners
of the housing 5010. In at least one instance, the protrusions 5023
and the slots 5013 can comprise a wedge-fit therebetween. In
various instances, the shock absorbing elements 5020 may be
attached to the battery housing 5010 in a snap-fit fashion. In at
least one instance, the battery housing 5010 may comprise apertures
configured to receive the protrusions 5023 in a snap fit-fashion.
In certain instances, the protrusions 5023 can enter into the slots
5013 radially in a snap-fit manner. In addition to or in lieu of
the above, the shock absorbing elements 5020 may be attached to the
housing 5010 utilizing an adhesive, for example.
[0331] In various instances, the battery assembly 5000 further
comprises a shock absorbing cap 5050. The shock absorbing cap 5050
is positioned at an outer end 5002 of the battery assembly 5000.
The shock absorbing cap comprises a shoulder 5051 configured to
contact the surgical instrument when the battery assembly 5000 is
fully seated in the surgical instrument. The shoulder 5051 can act
as a stop, for example, and can define the fully seated position of
the battery assembly 5000. In various instances, the shoulder 5051
is configured to abut the shock absorbing elements 5020. If the
battery assembly 5000 is attached to the surgical instrument, the
shock absorbing cap 5050 can protect the battery assembly 5000
and/or the surgical instrument if the surgical instrument is
dropped in an orientation such that the top face is at least
substantially parallel with ground upon impact. On the other hand,
if the battery assembly 5000 is not attached to the surgical
instrument the shock absorbing cap 5050 can still protect the
battery assembly 5000 if the battery assembly 5000 is dropped in an
orientation such that the top face is at least substantially
parallel to the ground.
[0332] A partial, cross-sectional view of the battery assembly 5000
is illustrated in FIG. 39. The shock absorbing cap 5050 comprises a
lattice structure, or cellular structure, comprising a plurality of
cells 5052. The shock absorbing cap 5050 can comprise a material
similar to that of the shock absorbing layer 5020. A denser lattice
arrangement 5055 is used near outer edges 5054 of the battery
assembly 5000 which can dissipate a more concentrated impact force.
The shock absorbing cap 5050 comprises a center portion 5053
comprising a columnar lattice arrangement 5056 configured to absorb
an impact energy generated by an impact force applied to the center
portion 5053. In various instances, the column lattice arrangement
5056 is configured to dissipate a broadly-applied impact force.
[0333] In various instances, the shock absorbing cap 5050 may
comprise crumple zones configured to deform when an impact force is
applied. The shock absorbing cap 5050 can be designed to use the
crumple zones to prevent the battery assembly 5000 from bouncing on
the floor, for example, in the event the battery assembly 5000 is
dropped.
[0334] The shock absorbing cap 5050 may be readily replaceable. In
the event that the shock absorbing cap 5050 experiences an
excessive amount of deformation requiring replacement of the shock
absorbing cap 5050, the battery assembly 5000 can be configured so
that the user of the surgical instrument can remove the damaged
shock absorbing cap from the battery assembly 5000 and attach a
useable shock absorbing cap.
[0335] In various instances, the shock absorbing elements 5020 can
be tethered by intermediate portions. The intermediate portions 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 a lateral face 5015 of the battery housing 5010, the stress
generated by the impact force would be less than that if the same
impact force were to be applied to a corner 5014 of the battery
housing 5010 which has a smaller surface area. Stated another way,
the more surface area over which an impact force is distributed,
the lower the stress and the stress concentration will be.
Therefore, it may not be necessary that the intermediate portions
between the shock absorbing elements 5020 be comprised of a
composition which is as substantial as the shock absorbing elements
5020. In at least one instance, as a result, the intermediate
portions may comprise a thinner composition than the shock
absorbing elements 5020; however, various embodiments are
envisioned in which the intermediate portions comprise the same
and/or a thicker composition than the shock absorbing elements
5020.
[0336] Each of the shock absorbing elements 5020 of the battery
assembly 5000 comprise a similar construction; however, other
embodiments are envisioned in which one or more of the shock
absorbing elements 5020 may be different than the others. In at
least one such instance, at least one of the shock absorbing
elements 5020 can comprise an additional weight, such as a metal
weight, for example, positioned therein which can cause the battery
assembly 5000 to fall and land in a specific orientation. Such an
effect could also be achieved by placing one or more weights in the
battery housing 5010, for example.
[0337] A battery assembly 5100, which is similar to the battery
assembly 5000 in many respects, is depicted in FIG. 40. The battery
assembly 5100 can comprise means for protecting the internal
components 5030 of the battery assembly 5100 from damage as a
result of impact shock and/or heat. Various means for protecting
the battery assembly 5100 from impact shock are discussed above.
Heat, which is represented by Q in FIG. 40A, can pass through the
battery housing 5110 and can be absorbed by the battery cells 5031
positioned in the battery housing 5110, for example.
[0338] 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 a high temperature and, as a result, heat flows from a
sterilization chamber into the battery assembly 5100. In some
circumstances, however, the battery assembly 5100 may be improperly
sterilized and may be exposed to an excessive temperature. If at
least one of the battery cells 5031 absorbs and/or retains a
damaging amount of heat Q, the battery cells 5031 may experience a
thermal runaway event and fail.
[0339] Referring now to FIG. 40A, the battery housing 5110
comprises a heat reflective shell, or shield, 5111, a shock
absorbing layer 5112, and a heat sink layer 5113. The reflective
shell 5111 is configured to reflect and/or block the transfer of
heat Q generated by improper sterilization, for example. In various
instances, the reflective shell 5111 may be comprised of a material
with a low thermal conductivity, such as a polymer and/or ceramic
material, for example. A material having a low thermal conductivity
usually has a low thermal expansion rate. A material having a low
thermal conductivity can also perform well as an insulating layer.
In any event, the reflective shell 5111 can comprise a reflective
outer surface which can reflect heat away from the battery assembly
5100. The reflective outer surface can be comprised of a polished
metal, such as polished aluminum, for example.
[0340] Further to the above, the heat sink layer 5113 is configured
to absorb heat that passes through the reflective shell 5111. The
heat sink layer 5113 can also be configured to absorb heat
generated by the battery cells 5031 when the battery cells 5031 are
being re-charged, for example. In some instances, the battery cells
5031 may generate an atypical amount of heat due to the
overcharging and/or overuse thereof. In various instances, the heat
sink layer 5113 can be comprised 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. Moreover, a
material having a high thermal conductivity often has a high
thermal expansion rate.
[0341] Further to the above, the battery cells 5031 can expand as
they are being charged. The expanding battery cells 5031 can push
the heat sink layer 5113 outwardly. Moreover, the heat sink layer
5113 can rapidly expand outwardly due to its high thermal expansion
rate. Such outward movement of the battery cells 5031 and the heat
sink layer 5113 can push the shock absorbing 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,
especially in embodiments where the reflective shell 5111 is
comprised of a material which has a lower thermal expansion rate
than the heat sink layer 5113. In such instances, the heat sink
layer 5113 may 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.
[0342] The shock absorbing layer 5112 is configured to permit
expansion of the battery cells 5031 while preventing damage to the
battery housing 5110. Acting as a degree of freedom for the battery
housing 5110, the shock absorbing layer 5112 may expand and/or
contract in order to manage the expansion and/or contraction of the
battery cells 5031 by allowing the heat sink layer 5113 and the at
least one battery cell 5031 to expand and/or contract due to the
transfer of heat while maintaining the supportive ability of the
battery assembly 5100. In various instances, the expansion and
contraction of the shock absorbing layer 5112 can prevent damage to
the battery housing 5110. The shock absorbing layer 5112 can absorb
thermal shocks as well as impact shocks
[0343] Turning now to FIGS. 41 and 42, a surgical instrument system
5300 includes a handle 5310 which is usable with a shaft assembly
selected from a plurality of shaft assemblies. Further to the
above, one or more of such shaft assemblies can include a staple
cartridge, for example. The handle 5310 comprises a housing 5312, a
first rotatable drive output 5340, and a second rotatable drive
output 5350. The handle 5310 further 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 comprises a battery cavity 5311 configured
to receive a battery therein. The battery can be any suitable
battery, such as a lithium ion battery, for example. In various
instances, the battery is insertable into and removable 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 the complement of an additional and/or tethered power
source, for instance. Such a design can be advantageous for many
reasons. For instance, when the surgical instrument system 5300 is
untethered to a power source, the entirety of the surgical
instrument system 5300 can be present in a sterile field of the
operating suite. Such batteries, however, can only supply a finite
amount of power. In many circumstances, the finite amount of power
that the battery can supply is sufficient to operate the surgical
instrument system 5300. On the other hand, some circumstances can
arise in which the battery cannot supply the surgical instrument
system 5300 with the requisite power.
[0344] 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 supply adapter 5360, for example. The power supply
adapter 5360 comprises a distal plug 5361 positionable in the
battery cavity 5311. The distal plug 5361 comprises a plurality of
electrical contacts 5366 which are engageable with corresponding
electrical contacts 5316 in the handle 5310. In various instances,
the battery and the distal plug 5361 can engage the same electrical
contacts 5316, depending on which one is positioned in the battery
cavity 5311. In such instances, the handle 5310 can be supplied
with power from one set of electrical contacts 5316 regardless of
whether the battery or the power supply adapter 5360 is engaged
with the handle 5310. In other instances, 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
instances, a microprocessor of the handle 5310 can be configured to
identify whether the battery or the power supply adapter 5360 is
coupled to the handle 5310.
[0345] The distal plug 5361 of the power supply adapter 5360 can
comprise any suitable shape so long as the distal plug 5361 is
positionable in the battery cavity 5311. In various instances, the
distal plug 5361 can comprise the same geometry as the battery, for
example. In certain instances, the housing of the distal plug 5361
is analogous or sufficiently similar to the housing of the battery.
In any event, the distal plug 5361 can be configured such that
there is little, if any, relative movement between the distal plug
5361 and the battery cavity 5311 once the distal plug 5361 has been
fully seated in 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 stop 5368 contacts the handle stop datum 5318, the plug 5361
may be fully seated in the battery cavity 5311. The handle 5310
and/or the plug 5361 can comprise a lock configured to hold the
plug 5361 in its fully seated position. For instance, the plug 5361
comprises at least one lock 5362 configured to releasably engage
the housing 5312.
[0346] The power supply adapter 5360 further comprises a cord 5363
extending from the plug 5361. The cord 5363 electrically couples
the plug 5361 with a power source, such as power source 5370, for
example. The power source 5370 can comprise any suitable power
source such as a signal generator that receives power from a 110V,
60 Hz power source and/or a battery, for example. The cord 5363
comprises any suitable number of conductors and insulators to
communicate electrical power from the power source 5370 to the plug
5361. In at least one instance, the cord 5363 comprises a supply
conductor, a return conductor, and a ground conductor, for example,
which are electrically insulated from one another by an insulator
jacket. Each conductor of the cord 5363 can comprise a proximal
terminal contained within a proximal plug 5369, for example. 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 readily detached from the power source
5370.
[0347] In various instances, the power source 5370 can comprise a
direct current (DC) power source, for example. In such instances,
the battery and the power supply adapter 5360 can both supply DC
power to the handle 5310, depending on which one is electrically
coupled to the handle 5310. The power supply adapter 5360 and the
power source 5370 can co-operatively supply electrical power to the
handle 5310 which is equal to and/or in excess of the electrical
power that the battery can supply to the handle 5310. In at least
one instance, a surgeon using the handle 5310 as part of the
surgical instrument system 5300 may determine that the handle 5310
is underpowered, remove the battery from the handle 5310, and
couple the power supply adapter 5360 to the handle 5310. The power
source 5370 can then be operated to supply sufficient power to the
handle 5310 via the power supply adaptor 5360 to operate the
surgical instrument system in the desired manner. In various
instances, the power source 5370 can supply a larger voltage to the
handle 5310, for example.
[0348] In certain instances, the power source 5370 can comprise an
alternating current (AC) power source. In at least one such
instance, the power supply adapter 5360 can include an alternating
current to direct current (AC/DC) power converter configured to
convert the AC power supplied by the power source 5370 to DC power.
In such instances, the battery and the power supply adapter 5360
can both supply DC power to the handle 5310, depending on which one
is electrically coupled to the handle 5310. The AC/DC power
converter can include a transformer, a full-wave bridge rectifier,
and/or a filter capacitor, for example; however, any suitable AC/DC
power converter could be utilized. The AC/DC power converter is
positioned in the plug 5361; however, the AC/DC power converter can
be positioned within the power supply adapter 5360 in any suitable
location, such as the cable 5363, for example.
[0349] In various instances, the handle 5310 includes a AC/DC power
converter in addition to or in lieu of the AC/DC power converter of
the power supply adapter 5360. Such an embodiment could implement
the dual sets of battery contacts 5316 discussed above. In at least
one such embodiment, a battery power supply circuit can comprise,
one, a first circuit segment including the first set of contacts
5316 which are engaged by the battery and, two, a second circuit
segment in parallel to the first circuit segment which includes the
second set of contacts 5316 that are engaged by the power supply
adapter 5360. The second circuit segment includes an AC/DC power
converter configured to convert the AC power supplied by the power
source 5370 to DC power while the first circuit segment does not
include an AC/DC power converter as the battery is already
configured to supply DC power.
[0350] Referring again to FIG. 41, the handle 5310 may be in a
sterile operating field 5301 and the power supply 5370 may be in a
non-sterile field 5302. In such instances, the power supply adapter
5360 can extend between the sterile field 5301 and the non-sterile
field 5302. The sterile field 5301 and the non-sterile field are
separated by a boundary 5303. The boundary 5303 may comprise a
physical boundary, such as a wall, for example, or a virtual
boundary intermediate a sterile operating table and a non-sterile
back table, for example.
[0351] In order to use the power supply adapter 5360, the battery
positioned in the battery cavity 5311 must be removed in order to
install the plug 5361 of the power supply adapter 5360 into the
battery cavity 5311. Alternative embodiments are envisioned in
which the battery can remain in the battery cavity 5311 when a
power supply adapter is operably coupled with the handle 5310.
Turning now to FIG. 42, a battery 5461 is positionable in the
battery cavity 5311. The battery 5461 is readily removable from the
battery cavity 5311 when the lock 5362 is deactivated; however,
embodiments are envisioned in which the battery 5461 is not readily
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 in order 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
comprises an end stop 5468 configured to contact the stop datum
5318 of the handle 5310.
[0352] The battery 5461 comprises one or more lithium ion battery
cells, for example, positioned therein. Similar to the above, the
battery 5461 can supply sufficient power to the handle 5310 to
operate the surgical instrument system in various instances. In the
event that the battery cells of the battery 5461 lack the necessary
power to operate the surgical instrument system, a power supply
adapter 5460 can be coupled to the battery 5461. The power supply
adapter 5460 is similar to the power supply adapter 5360 in many
respects. Similar to the above, the power supply adapter 5460
comprises a cord 5463 including a proximal end 5369 which can be
connected to a power source, such as power source 5370, for
example. The battery 5461 includes an electrical connector 5464
defined therein which is configured to receive a distal connector
5465 of the cord 5463 to electrically couple the power source 5370
to the battery 5461.
[0353] In at least one instance, further to the above, the power
supply adapter 5460 can be placed in series with the cells of the
battery 5461 when the adapter connector 5465 is inserted into the
battery connector 5464. In such instances, the battery 5461 and the
power source 5370 can both supply power to the handle 5310. FIG. 43
depicts such an embodiment. As disclosed in FIG. 43, a battery
5461' comprises a power supply circuit including one or more
battery cells 5470' which are configured to supply DC power to the
handle 5310. When the power supply adapter 5460 is electrically
coupled to the battery 5461', the power source 5370 can, one,
re-charge the battery cells 5470' via re-charging circuit 5471'
and/or, two, supplement the power that the battery cells 5470' are
supplying to the handle 5310. In the instances where the power
source 5370 comprises an AC power source, the battery 5461' can
comprise an AC/DC transformer 5467' which is configured to convert
the AC power supplied by the power source 5370 to DC power before
the power is supplied to the charge circuit 5471' and/or the
battery cells 5470'. The power supply circuit in the battery
comprises the battery connector 5464, the AC/DC transformer 5467',
the charge circuit 5471', the battery cells 5470', and the battery
terminals 5366 which are in series with one another; however, any
suitable arrangement for the power supply circuit can be
utilized.
[0354] In other instances, the insertion of the adapter connector
5465 into the battery connector 5464 can electrically couple the
power source 5370 with the handle 5310 and, concurrently,
electrically decouple the battery cells of the battery 5461 from
the handle 5310. FIG. 44 depicts such an embodiment. As disclosed
in FIG. 44, a battery 5461'' comprises a power supply circuit
including one or more battery cells 5470'' which are configured to
supply DC power to the handle 5310. The battery cells 5470'' are in
electrical communication with the battery contacts 5366 via a first
circuit segment 5472'' and a battery switch 5474'' when the adapter
connector 5465 is not positioned in the battery connector 5464. In
such instances, the battery switch 5474'' is in a first switch
state. The insertion of the adapter connector 5465 into the battery
connector 5464 places the switch 5474'' in a second switch state,
as illustrated in FIG. 44, in which the battery cells 5470'' are no
longer able to supply electrical power to the contacts 5366.
Additionally, the power supply adapter 5460 and the battery
connector 5464 are in electrical communication with the battery
contacts 5366 via a second circuit segment 5473'' and the battery
switch 5474'' when the switch 5474'' is in its second switch state.
In the instances where the power source 5370 comprises an AC power
source, the second circuit segment 5473'' of the battery 5461'' can
comprise an AC/DC transformer 5467'' which is configured to convert
the AC power supplied by the power source 5370 to DC power.
[0355] As discussed above, referring again to FIG. 44, the battery
switch 5474'' can be operated to selectively place the first
parallel circuit segment 5472'' including the battery cells 5470''
in electrical communication with the battery contacts 5366 when the
switch 5474'' is in its first switch state and, alternatively, the
second parallel circuit segment 5473'' including the battery
connector 5464 and the AC/DC transformer 5467'' in electrical
communication with the battery contacts 5366 when the switch 5474''
is in its second switch state. The battery switch 5474'' can
comprise a mechanical switch, an electromechanical switch, and/or
an electronic switch, as described in greater detail further
below.
[0356] A mechanical battery switch 5474'' can comprise a sliding
busbar which is pushed between a first position associated with a
first switch state of the switch 5474'' and a second position
associated with a second switch state of the switch 5474'', for
example. In the first position of the sliding busbar, the busbar
couples the first circuit segment 5472'' with the battery contacts
5366 but does not couple the second circuit segment 5473'' with the
battery contacts 5366. In the second position of the sliding
busbar, the busbar couples the second circuit segment 5473'' with
the battery contacts 5366 but does not couple the first circuit
segment 5472'' with the battery contacts 5366. The battery 5461 can
further comprise a biasing member, such as a spring, for example,
configured to bias the busbar into its first position and, thus,
bias the battery switch 5474'' into its first switch state. Further
to the above, the adapter connector 5465 can contact the busbar of
the switch 5474'' when the adapter connector 5465 is inserted into
the battery connector 5464 and push the busbar from its first
position into its second position and place the switch 5474'' into
its second switch state. When the adapter connector 5465 is removed
from the battery connector 5464, the biasing member can return the
busbar to its first position and electrically re-couple the battery
cells 5470'' with the battery contacts 5366. In certain alternative
embodiments, the insertion of the adapter connector 5465 into the
battery connector 5464 may permanently decouple the battery cells
5470'' from the battery contacts 5466. In at least one such
embodiment, the battery 5461'' can comprise a lock configured to
hold the busbar in its second position once the busbar is pushed
into its second position by the adapter connector 5465. Such an
embodiment can provide a permanent lockout to prevent the battery
5461'' from being used again to supply power from the battery cells
5470'' as it may be undesirable and/or unreliable to reuse and/or
recharge a battery that was unable to provide the handle 5310 with
sufficient power.
[0357] An electromechanical switch 5474'' can comprise a relay, for
example. The relay can be biased into a first relay state when the
adapter connector 5465 is not positioned in the battery connector
5464. The relay can be switched into a second relay state when the
adapter connector 5465 is electrically coupled to the battery
connector 5464. The relay can comprise an electromagnet, which can
include a wire coil and an armature, for example, that is activated
when the contacts of the adapter connector 5465 interface with the
battery connector 5464. In at least one instance, the power supply
adapter 5460 can comprise a relay control circuit in addition to
the power circuits which can provide the coil of the relay with a
sufficient voltage to move the armature of the relay between its
first switch state and its second switch state. In various
instances, the switch 5474'' can comprise a latching relay, for
example. In at least one instance, the switch 5474'' can comprise a
contactor, for example, which can be electronically controlled by a
microprocessor and a control circuit, for example.
[0358] Certain electronic switches may not have any moving
components, such as a solid-state relay, for example. A solid-state
relay can utilize a thyristor, TRIAC and/or any other solid-state
switching device, for example. A solid-state relay can be activated
by a control signal from the power source 5370, for example, to
switch the load being supplied to the battery contacts 5366 from
the battery cells 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, an electronic
switch can comprise a microprocessor and a sensor in signal
communication with the microprocessor which detects whether power
is being supplied to a contact of the battery connector 5464, for
example. In at least one instance, the sensor can be configured to
inductively detect a field that is generated when voltage is
applied to the contacts of the battery connector 5464. In certain
instances, the microprocessor can be responsive to a control signal
received from the power supply 5370, for example, to switch a relay
between a first relay state and a second relay state to control
whether the first parallel circuit segment 5472'' or the second
parallel circuit segment 5473'', respectively, is in electrical
communication with the battery contacts 5366.
[0359] Further to the above, the power supply adapter 5460 can
include an AC/DC power converter. The power supply adapter 5460
includes an AC/DC power transformer 5467 in the cord 5463; however,
an AC/DC power transformer may be placed in any suitable location
in the power supply adapter 5460.
[0360] In various instances, a power adapter supply system can
include a battery, such as the battery 5361, 5461, 5461', and/or
5461'', for example, and a power supply adapter, such as the power
supply adapter 5360 and/or 5460, for example.
[0361] Turning now to FIGS. 45-47, a handle 5510 of a surgical
instrument system comprises a gripping portion, or pistol grip,
5511 and a housing 5512. The handle 5510 further comprises one or
more battery cells, such as battery cells 5470, for example,
positioned in the gripping portion 5511. In many instances, the
battery cells 5470 can provide enough power to the handle 5510 to
operate the surgical instrument system. In other instances, the
battery cells 5470 may not be able to provide enough power to the
handle 5510. In such instances, as described in greater detail
further below, a supplemental battery, such as supplemental battery
5560, for example, can be attached to the handle 5510 to provide
power to the handle 5510.
[0362] Further to the above, referring primarily to FIG. 47, the
battery cells 5470 are arranged in series as part of a battery
power supply circuit 5513. The battery power supply circuit 5513 is
in electrical communication with an electrical connector 5516
defined in the housing 5512. The electrical connector 5516 can
comprise any suitable number of electrical contacts. In at least
one instance, the electrical connector 5516 comprises two
electrical contacts, for example. The electrical connector 5516 is
positioned at the end of the gripping portion 5511; however, the
electrical connector 5516 can be positioned at any suitable
location on the handle 5510.
[0363] The handle 5510 further comprises a connector cover 5517.
The connector cover 5517 is movable between a first position in
which it covers the electrical connector 5516 and a second position
in which the electrical connector 5516 is exposed. The housing 5512
comprises a slot 5518 defined therein configured to slidably
receive and support the connector cover 5517. The handle 5510
further comprises a biasing member, such as spring 5519, for
example, positioned in the slot 5518 intermediate the housing 5512
and the connector cover 5517. The spring 5519 is configured to bias
the connector cover 5517 into its first position to cover the
electrical connector 5516.
[0364] As discussed above, the supplemental battery 5560 is
attachable to the handle 5510. The supplemental battery 5560
comprises a housing 5562 and one or more battery cells, such as
battery cells 5570, for example, positioned therein. The battery
cells 5570 are arranged in series as part of a supplemental 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
comprises the same number of electrical contacts as the electrical
connector 5516 and are configured to form mating pairs with the
electrical contacts of the electrical connector 5516.
[0365] The housing 5562 of the supplemental battery 5560 further
comprises a cavity, or receptacle, 5561 defined therein which is
configured to receive the gripping portion 5511 of the handle 5510.
The cavity 5561 is configured to closely receive the gripping
portion 5511 such that there is little to no relative movement
between the supplemental battery 5560 and the handle 5510 when the
supplemental battery 5560 is fully assembled thereto. As the
supplemental battery 5560 is being assembled to the handle 5510,
the housing 5562 contacts the connector cover 5517 and pushes the
connector cover 5517 into 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 can engage the contacts of the
electrical connector 5516. At such point, the supplemental battery
supply circuit 5563 has been electrically coupled to the battery
power supply circuit 5513.
[0366] The electrical connectors 5516 and 5566 can be positioned
and arranged such that they do not engage one another until the
supplemental battery 5560 has been fully seated onto the gripping
portion 5511. In other embodiments, the electrical connectors 5516
and 5566 can be positioned and arranged such that they engage one
another prior to the supplemental battery 5560 being fully seated
onto the gripping portion 5511. In either event, the housing 5512
of the handle 5510 and/or the housing 5562 of the supplemental
battery 5560 can comprise a lock configured to hold the
supplemental battery 5560 to the housing 5510. The lock is
releasable to allow the supplemental battery 5560 to be readily
removed from the handle 5510; however, embodiments are envisioned
in which the lock does not permit the supplemental battery 5560 to
be readily released from the handle 5510.
[0367] As discussed above, the supplemental battery supply circuit
5563 is electrically coupled to the battery power supply circuit
5513 when the supplemental battery 5560 is assembled to the handle
5510. In various instances, the supplemental battery cells 5570 are
placed in series with the handle battery cells 5470 and can
increase the power available to the handle 5510. Such embodiments
can be useful when the handle battery cells 5470 have become
drained from use, for example. In other instances, the supplemental
battery cells 5570 of the supplemental battery 5560 are placed in
parallel with the battery cells 5470 of the handle 5510. In at
least one such instance, the handle battery cells 5470 can be
electrically decoupled from the handle 5510 when the supplemental
battery cells 5570 are electrically coupled with the handle 5510.
Such embodiments can be useful when a short has occurred in the
handle battery cells 5470. Various embodiments of the handle 5510
can include a switch which can allow the user to selectively place
the supplemental battery cells 5570 in series with or in parallel
with the handle battery cells 5470.
EXAMPLES
Example 1
[0368] A surgical apparatus comprising a handle module comprising
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 for powering the
rotary drive system, and one or more sensors. The handle module
further comprises a handle module processor circuit in
communication with the one or more sensors and the electric motor,
wherein the handle module processor circuit is programmed to
control the electric motor, track an end-of-life parameter for the
handle module based on input from the one or more sensors, and
maintain a count of the end-of-life parameter.
Example 2
[0369] 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 for the end-of-life parameter
reaches a threshold value.
Example 3
[0370] The surgical apparatus of Example 2, wherein the means for
taking the end-of-life action comprises a display that displays to
a user of the surgical apparatus information indicative of the
end-of-life parameter reaching the threshold valve.
Example 4
[0371] The surgical apparatus of Example 3, wherein the display
displays the count.
Example 5
[0372] The surgical apparatus of Examples 3 or 4, wherein the
display displays an indicator that indicates a remaining number of
uses for the handle module before the threshold value is
reached.
Example 6
[0373] The surgical apparatus of Examples 2, 3, 4, or 5, wherein
the means for taking the end-of-life action comprises means for
disabling the handle module for a subsequent surgical
procedure.
Example 7
[0374] The surgical apparatus of Example 6, wherein the means for
disabling the handle module comprises means for disabling the
operation of the electric motor.
Example 8
[0375] The surgical apparatus of Examples 6 or 7, wherein the means
for disabling the handle module comprise means for preventing
installation of a charged battery pack in the handle module.
Example 9
[0376] 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 by the handle module, a number of
surgical procedures involving the handle module, a number of
attachments of a detachable shaft module to the handle module, a
number of sterilizations of the handle module, and a number of
attachments of removable battery packs to the handle module,
wherein the removable battery packs are for supplying electric
power to the handle module during a surgical procedure.
Example 10
[0377] The surgical apparatus of Examples 2, 3, 4, 5, 6, 7, 8, or
9, wherein the end-of-life parameter is computed according to a
function whose inputs include the number of firings by the handle
module and the number of surgical procedures involving the handle
module.
Example 11
[0378] The surgical apparatus of Example 10, wherein the function
computes the end-of-life parameter by using different weighting
coefficients for different detachable shaft modules.
Example 12
[0379] 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 with a firing member that, when fired, traverses a stroke
length, and wherein the end-of-life parameter comprises a usage
parameter for the handle module indicative of differences between
the force that is expected to be exerted by the handle module and
the force actually exerted by the handle module over the stroke
length of the firing member.
Example 13
[0380] The surgical apparatus of Examples 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, or 12, wherein the end-of-life parameter comprises the
number of times the handle module has been sterilized.
Example 14
[0381] The surgical apparatus of Examples 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, 12, or 13, wherein the handle module includes a
sterilization sensor that is in communication with the handle
module processor circuit that is actuated when a protective
sterilization cover is attached to the handle module.
Example 15
[0382] 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
[0383] 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 inspection of the handle module following the surgical
procedure, wherein the inspection station comprises an inspection
station processor circuit that communicates 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 when the handle module is
connected to the inspection station.
Example 17
[0384] A surgical apparatus comprising a handle module that is
attachable to a detachable shaft module for collectively performing
a surgical procedure, wherein the handle module comprises a rotary
drive system which is activatable 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 for the handle module based on the number
of times in which the rotary drive system is activated.
Example 18
[0385] The surgical apparatus of Example 17, wherein the means for
tracking the count of the end-of-life parameter comprises a
processor circuit and memory, wherein the memory stores program
code that is executed by the processor to track the count of the
end-of-life parameter for the handle module.
Example 19
[0386] 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 the count of the end-of-life parameter for
the handle module is further based on a number of times a removable
battery pack is connected to the handle module.
Example 20
[0387] 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
the count of the end-of-life parameter for 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
[0388] An apparatus, comprising a handle module that is 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 for powering the rotary drive
system, and a handle module processor circuit in communication with
the electric motor. The apparatus further comprises an inspection
station for 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 that
communicates 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 handle module connected
to the inspection station.
Example 22
[0389] The apparatus of Example 21, wherein the inspection station
comprises an electric power source for supplying electric power to
the handle module when the handle module is connected to the
inspection station.
Example 23
[0390] 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
[0391] The apparatus of Example 23, wherein the one or more tests
comprises a seal integrity test of the handle module.
Example 25
[0392] The apparatus of Examples 23 or 24, wherein the one or more
tests comprises a gear backlash test for the rotary drive system of
the handle module.
Example 26
[0393] The apparatus of Examples 21, 22, 23, 24, or 25, wherein the
inspection station is configured to perform a conditioning action
to condition the handle module for use in a subsequent surgical
procedure.
Example 27
[0394] The apparatus of Example 26, wherein the conditioning action
comprises drying components of the handle module.
Example 28
[0395] The apparatus of Examples 21, 22, 23, 24, 25, 26, or 27,
wherein the inspection station comprises one or more fans for
blowing air on the components of the handle module.
Example 29
[0396] The apparatus of Examples 21, 22, 23, 24, 25, 26, 27, or 28,
wherein the inspection station comprises a vacuum port for drying
the components of the handle module with vacuum pressure air
flow.
Example 30
[0397] 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
[0398] The apparatus of Example 30, wherein the load simulation
adapter comprises a motor for supplying a simulated load to the
rotary drive system of the handle module.
Example 32
[0399] The apparatus of Examples 21, 22, 23, 24, 25, 26, 27, 28,
29, 30, or 31 wherein the inspection station is further connected
to the detachable shaft module.
Example 33
[0400] A surgical process comprising performing, by a clinician, a
surgical procedure on a patient with a surgical instrument that
comprises a handle module connected to a detachable shaft module,
wherein the handle module includes a memory that stores data about
the handle module and the surgical procedure, while the handle
module is connected to the inspection station, downloading to a
memory of the inspection station data about the surgical procedure
stored in the memory of the handle module, and while the handle
module is connected to the inspection station, visually displaying
on a display of the inspection of station information about the
handle module.
Example 34
[0401] The surgical process of Example 33, further comprising
following the surgical procedure and prior to connecting the handle
module to an inspection station, removing a removable battery pack
from the handle module, wherein the removable battery pack powered
the handle module during the surgical procedure, and while the
handle module is connected to the inspection station, electrically
powering the handle module with electric power from the inspection
station.
Example 35
[0402] The surgical process of Examples 33 or 34, while the handle
module is connected to the inspection station, performing one or
more tests on the handle module to determine the suitability of the
handle module for use in a subsequent surgical procedure.
Example 36
[0403] The surgical process of Example 35, wherein the one or more
tests comprises a seal integrity test of the handle module.
Example 37
[0404] The surgical process of Examples 35 or 36, wherein the one
or more tests comprises a gear backlash test.
Example 38
[0405] The surgical process of Examples 34, 35, 36, or 37, while
the handle module is connected to the inspection station,
performing a conditioning action to condition the handle module for
use in a subsequent surgical procedure.
Example 39
[0406] The surgical process of Example 38, wherein the conditioning
action comprises drying components of the handle module.
Example 40
[0407] A surgical apparatus comprising a handle module that is
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 for powering 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 to monitor 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
[0408] 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 the
acceptable performance band.
Example 42
[0409] The surgical apparatus of Examples 40 or 41, wherein the
handle module further comprises means for taking remedial action
when the handle module processor circuit determines that the
performance parameter is outside the acceptable performance
band.
Example 43
[0410] The surgical apparatus of Examples 40, 41, or 42, wherein
the performance parameter comprises a performance parameter of the
electric motor.
Example 44
[0411] The surgical apparatus of Example 43, wherein the
performance parameter of the electric motor comprises the energy
consumed by the electric motor over the life of the handle
module.
Example 45
[0412] The surgical apparatus of Examples 43 or 44, wherein the
performance parameter of the electric motor comprises the power
consumed by the electric motor for each firing of the handle
module.
Example 46
[0413] The surgical apparatus of Examples 43, 44, or 45, wherein
the performance parameter of the electric motor comprises the
energy consumed by the electric motor over the life of the handle
module and the power consumed by the electric motor for each firing
of the handle module.
Example 47
[0414] The surgical apparatus of Example 46, wherein the handle
module processor circuit is programmed to determine that remedial
action should be taken when at least one of the following
conditions is met the energy consumed by the electric motor over
the life of the handle module exceeds a first energy threshold
value, and the energy consumed by the electric motor over the life
of the handle module exceeds a second energy threshold value, which
is lower than the first energy threshold value, and the handle
module has had a threshold number of device firings above a
threshold power level.
Example 48
[0415] The surgical apparatus of Examples 43, 44, 45, 46, or 47
wherein the performance parameter comprises output torque of the
electric motor.
Example 49
[0416] 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
[0417] The surgical apparatus of Example 49 wherein the performance
parameter of the rotary drive system comprises gear backlash.
Example 51
[0418] 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 condition of the handle
module.
Example 52
[0419] 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 disabling the handle module.
Example 53
[0420] The surgical apparatus of Example 52, wherein the means for
disabling the handle module comprises means for preventing the
insertion of a charged, removable battery pack into the handle
module to power the handle module during a surgical procedure.
Example 54
[0421] The surgical apparatus of Example 53, wherein the means for
preventing the insertion of a charged, removable battery pack
comprises a spring-loaded mechanical lock-out.
Example 55
[0422] The surgical apparatus of Examples 53 or 54, wherein the
means for preventing the insertion of a charged, removable battery
pack comprises a latch that, when actuated, prevents the removal of
a discharged, removable battery pack from the handle module.
Example 56
[0423] 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
for powering 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 upon a
determination that the performance parameter is outside an
acceptable performance band.
Example 57
[0424] The surgical apparatus of Example 56, wherein the
performance parameter comprises the energy consumed by the electric
motor over the life of the handle module.
Example 58
[0425] The surgical apparatus of Examples 56 or 57, wherein the
performance parameter comprises the power consumed by the electric
motor for each firing of the handle module.
Example 59
[0426] The surgical apparatus of Examples 56, 57, or 58, wherein
the performance parameter comprises the output torque of the
electric motor.
Example 60
[0427] The surgical apparatus of Examples 56, 57, 58, or 59,
wherein the means for taking remedial action comprises means for
disabling the handle module.
Example 61
[0428] The surgical apparatus of Example 60, wherein the means for
disabling the handle module comprises means for disabling the
electric motor.
Example 62
[0429] The surgical apparatus of Examples 60 or 61, wherein the
means for disabling the handle module comprises means for
preventing the insertion of a charged, removable battery pack into
the handle module to power the handle module during a surgical
procedure.
Example 63
[0430] A combination, comprising a handle module that is attachable
to a detachable shaft module for collectively performing a surgical
procedure, a removable, rechargeable battery pack connectable to
the handle module for providing electric power to the handle module
during a surgical procedure, wherein the battery pack comprises a
memory for storing charging data and discharging data for 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 charging data and
discharging data stored in the memory of the battery pack.
Example 64
[0431] 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 discharging data stored in the battery pack memory and based on
rebalancing criteria, 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
[0432] The combination of Example 64, wherein the charging station
processor circuit is programmed to determine that the battery cells
should be rebalanced after N charges of the battery pack without
rebalancing, where N is an integer greater than zero.
Example 66
[0433] The combination of Examples 64 or 65, wherein prior to
rebalancing the battery cells, the charging station is configured
to top off a charge of the battery cells.
Example 67
[0434] 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 charging and discharging data stored in the battery pack
memory and based on discharging 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
[0435] The combination of Example 67, wherein the discharging
criteria comprise whether a second battery pack installed in the
charging station is fully charged and ready for use in the handle
module.
Example 69
[0436] The combination of Examples 63, 64, 65, 66, 67, or 68,
wherein the charging station is programmed to charge the battery
pack at a time of day based on surgical procedure schedule data for
an organizational user of the charging station, and wherein the
surgical procedure schedule data is stored in a memory of the
charging station.
Example 70
[0437] The combination of Example 69, wherein the surgical
procedure schedule data comprises a statistical likelihood that the
organizational user is performing a surgical procedure with the
handle module at the time of day.
Example 71
[0438] 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 the handle module for a surgical
procedure.
Example 72
[0439] The combination of Example 71, wherein the means for
automatically securing the battery pack to the charging station
comprises a screw that, when actuated by insertion of the battery
pack into the charging station, screws into the battery pack.
Example 73
[0440] 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
[0441] The combination of Examples 63, 64, 65, 66, 67, 68, 69, 70,
71, 72, or 73, wherein the charging station comprises a display for
displaying charge status information about the battery pack.
Example 75
[0442] The combination of Examples 63, 64, 65, 66, 67, 68, 69, 70,
71, 72, 73, or 74, wherein the charging station comprises means for
rapidly charging the first battery pack when a rapid charge user
input for the battery pack is received by the charging station.
Example 76
[0443] The combination of Example 75, wherein the charging station
comprises means for automatically securing the battery pack to the
charging station when the battery pack is not ready for use in the
handle module for a surgical procedure.
Example 77
[0444] A surgical process comprising performing, by a clinician, a
surgical procedure on a patient with a surgical instrument that
comprises a handle module connected to a detachable shaft module,
wherein the handle module is powered during the surgical procedure
by a removable, rechargeable battery pack, and wherein the battery
pack comprises a memory for storing charging data and discharging
data for the battery pack, removing the battery pack from the
handle module after it has been used during the surgical procedure,
following the removing step, placing the battery pack in a charging
station to recharge the battery pack, following the placement step,
downloading by the charging station the charging and discharging
data from the memory of the battery pack, and following the
downloading step, at least one of charging and discharging, by the
charging station, the battery pack based on the charging data and
discharging data stored in the memory of the battery pack.
Example 78
[0445] The surgical process of Example 77, wherein the battery pack
comprises a plurality of battery cells, and wherein the process
further comprises: following the downloading step, determining, by
the charging station, whether the battery cells should be
rebalanced based on the charging data and discharging data stored
in the battery pack memory and based on rebalancing criteria, and
upon determining that rebalancing of the battery cells of the
battery pack should be performed, rebalancing the battery cells by
the charging station.
Example 79
[0446] The surgical process of Examples 77 or 78, following the
downloading step, rapidly charging the battery pack in response to
receipt of a rapid charge user input.
Example 80
[0447] The surgical process of Examples 77, 78, or 79, following
the placement step, automatically securing the battery pack to the
charging station when the battery pack is not ready for use in the
handle module for a surgical procedure.
Example 81
[0448] A combination, comprising a handle module that is attachable
to a detachable shaft module for collectively performing a surgical
procedure, a removable, rechargeable battery pack connectable to
the handle module for providing electric power to the handle module
during a 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 a rapid charge user input for the battery pack is received by
the charging station.
Example 82
[0449] The combination of Example 81, wherein the charging station
comprises a display for displaying the charge status of the battery
pack.
Example 83
[0450] The combination of Examples 81 or 82, wherein the charging
station comprises a user interface through which a user inputs the
rapid charge user input to the charging station.
Example 84
[0451] The combination of Example 83, wherein the user interface
comprises a button on the charging station which is actuatable to
provide the charging station with the rapid charge user input.
Example 85
[0452] 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 for the battery pack.
Example 86
[0453] The combination of Examples 81, 82, 83, 84, or 85, wherein
the circuitry for changing the charging profile for the battery
pack comprises a voltage regulator connected to the battery pack,
and a charging controller circuit connected to the voltage
regulator.
Example 87
[0454] The combination of Examples 81, 82, 83, 84, 85, or 86
wherein the circuitry for rapidly charging the battery pack
comprises a charge-storing device of the charging station, and
wherein charge stored on the charge-storing device is used to
charge the battery pack.
Example 88
[0455] The combination of Example 87, wherein the charge-storing
device comprises a supercapacitor.
Example 89
[0456] The combination of Example 88, wherein the charging station
further comprises circuitry for discharging the first battery pack
to the supercapacitor.
Example 90
[0457] The combination of Examples 87, 88, or 89, wherein the
charge-storing device comprises one or more battery cells internal
to the charging station.
Example 91
[0458] The combination of Examples 87, 88, or 89, wherein the
charge-storing device comprises a plurality of battery cells
internal to the charging station, and wherein the circuitry for
rapidly charging the battery pack comprises circuitry for charging
the battery pack with the plurality of battery cells.
Example 92
[0459] The combination of Example 91, wherein the plurality of
battery cells are connected in series.
Example 93
[0460] The combination of Examples 91 or 92, wherein the plurality
of battery cells are connected as parallel current sources.
Example 94
[0461] 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
[0462] 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
[0463] 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
[0464] The combination of Examples 95 or 96, wherein the charging
station comprises a display for displaying the charge status of the
first battery pack and the second battery pack.
Example 98
[0465] The 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 the
handle module for a surgical procedure.
Example 99
[0466] 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 electric 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 under two
operating conditions: a first operating condition in which the
battery pack is charged from a primary power source, and a second
operating condition in which the battery pack is charged from the
primary power source and a secondary power source in order to
rapidly charge the battery pack in case the battery pack is
urgently needed in the surgical procedure.
Example 100
[0467] 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
[0468] An apparatus comprising a handle module that is 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 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 for determining one or more service
recommendations for the handle module based on the handle module
usage data stored in the memory of the handle module and based on
service recommendation criteria.
Example 102
[0469] The apparatus of Example 101, wherein the inspection station
further comprises a display that is in communication with the
inspection station processor circuit, and wherein the display is
for displaying information about the one or more service
recommendations.
Example 103
[0470] The apparatus of Examples 101 or 102, wherein the service
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
[0471] 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
the handle module processor circuit is in communication with the
inspection station processor circuit when the handle module is
connected to the inspection station such that usage data from the
handle module memory is downloadable to the inspection station.
Example 105
[0472] The apparatus of Examples 101, 102, 103, or 104, wherein the
handle module usage data comprises data selected from the group
consisting of data regarding a number of surgical procedures
involving the handle module, data regarding a number of device
firings by the handle module, data regarding the power expended
during the device firings of the handle module, data regarding the
forces experienced during the device firings of the handle module,
data regarding energy consumed by an electric motor of the handle
module over the life of the handle module, and data regarding gear
backlash for a rotary drive system of the handle module.
Example 106
[0473] The apparatus of Examples 101, 102, 103, 104, or 105 wherein
the one or more service recommendations comprise a recommendation
that the handle module be rebuilt.
Example 107
[0474] The apparatus of Examples 101, 102, 103, 104, 105, or 106,
wherein the one or more service recommendations comprise a
recommendation that one or more components of the handle module be
lubricated.
Example 108
[0475] The apparatus of Examples 101, 102, 103, 104, 105, 106, or
107 wherein the one or more service recommendations comprise a
recommendation that one or more components of the handle module be
inspected.
Example 109
[0476] An apparatus comprising a handle module that is 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 service recommendations for the handle module based on the
handle module usage data stored in the memory of the handle module
and based on service recommendation criteria.
Example 110
[0477] The apparatus of Example 109, wherein the handle module
further comprises a display that is in communication with the
handle module processor circuit, and wherein the display is for
displaying information about the one or more service
recommendations.
Example 111
[0478] The apparatus of Examples 109 or 110, wherein the handle
module usage data comprises data selected from the group consisting
of data regarding a number of surgical procedures involving the
handle module, data regarding a number of device firings by the
handle module, data regarding the power expended during the device
firings of the handle module, data regarding the forces experienced
during the device firings of the handle module, data regarding
energy consumed by an electric motor of the handle module over the
life of the handle module, and data regarding gear backlash for a
rotary drive system of the handle module.
Example 112
[0479] The apparatus of Examples 109, 110, or 111, wherein the one
or more service recommendations comprise a recommendation that the
handle module be rebuilt.
Example 113
[0480] The apparatus of Examples 109, 110, 111, or 112, wherein the
one or more service recommendations comprise a recommendation that
the handle module be rebuilt.
Example 114
[0481] The apparatus of Examples 109, 110, 111, 112, or 113,
wherein the one or more service recommendations comprise a
recommendation that one or more components of the handle module be
lubricated.
Example 115
[0482] The apparatus of Examples 109, 110, 111, 112, 113, or 114,
wherein the one or more service recommendations comprise a
recommendation that one or more components of the handle module be
inspected.
Example 116
[0483] A surgical instrument system comprising a handle including a
battery cavity and a direct current electrical motor, a battery
removably positionable in the battery cavity, wherein the battery
is configured to supply direct current electrical power to the
direct current electrical motor, and a power adapter including a
plug removably positionable in the battery cavity in lieu of the
battery and a cord extending from the plug, wherein the cord is
configured to transmit power to the plug from a power source. The
surgical instrument system further comprises an alternating current
to direct current power converter configured to convert alternating
current electrical power supplied from the power source to direct
current electrical power.
Example 117
[0484] The surgical instrument system of Example 116, wherein the
alternating current to direct current power converter is positioned
in the plug.
Example 118
[0485] 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
analogous to the plug housing.
Example 119
[0486] 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
[0487] 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
[0488] The surgical instrument system of Examples 116, 117, 118,
119, or 120, wherein the alternating current to direct current
power converter is positioned in the handle and is in electrical
communication with the second set of handle electrical
contacts.
Example 122
[0489] 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
[0490] The surgical instrument system of Example 122, wherein at
least one of the shaft assemblies comprises a stapling
cartridge.
Example 124
[0491] A surgical instrument system comprising a handle including a
battery cavity and a direct current electrical motor, a power
adapter including a battery positioned in the 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 transmit power from a
power source. The surgical instrument system further comprises an
alternating current to direct current power converter configured to
convert alternating current electrical power supplied from the
power source to direct current electrical power and supply direct
current electrical power to the direct current electrical
motor.
Example 125
[0492] The surgical instrument system of Example 124, further
comprising a battery circuit, wherein the at least one battery
cell, the alternating current to direct current 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 direct current electric motor when
the cord is engaged with the electrical connector.
Example 126
[0493] The surgical instrument system of Example 124, further
comprising a first battery circuit segment, wherein the first
battery circuit segment includes the at least one battery cell, a
second battery circuit segment, wherein the second battery circuit
segment includes the alternating current to direct current 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 electrical power to the direct
current electrical motor and the power supply cannot supply
electrical power to the direct current electrical motor, and a
second switch state in which the at least one battery cell cannot
supply electrical power to the direct current electrical motor and
the power supply can supply electrical power to the direct current
electrical motor.
Example 127
[0494] The surgical instrument system of Example 126, wherein the
switch is biased into the first switch state.
Example 128
[0495] The surgical instrument system of Examples 126 or 127,
wherein the insertion of the cord into the battery electrical
connector switches the switch from the first switch state into the
second switch state.
Example 129
[0496] The surgical instrument system of Example 128, further
comprising a biasing member configured to return the switch into
the first switch state.
Example 130
[0497] The surgical instrument system of Examples 126, 127, or 128,
wherein the switch is incapable of being returned to the first
switch state after being placed in the second switch state.
Example 131
[0498] 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
[0499] The surgical instrument system of Example 131, wherein at
least one of the shaft assemblies comprises a stapling
cartridge.
Example 133
[0500] A surgical instrument system comprising a handle including a
handle housing, a handle battery cell positioned in the handle
housing, a handle electrical circuit, wherein the handle battery
cell is configured to supply power to the handle electrical
circuit, and a handle electrical connector in communication with
the handle electrical 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
electrical circuit, a supplemental battery cell positioned in the
battery housing, wherein the supplemental battery cell is
configured to supply power to the battery electrical circuit, and a
battery electrical connector in communication with the battery
electrical 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 electrical circuit in communication with the handle
electrical circuit.
Example 134
[0501] 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
[0502] 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 inhibits
accidental contact with the handle electrical connector and a
second position in which the connector cover permits the battery
electrical connector to engage the handle electrical connector.
Example 136
[0503] 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
[0504] 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
[0505] The surgical instrument system of Example 137, wherein at
least one of the shaft assemblies comprises a stapling
cartridge.
Example 139
[0506] 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 cell
configured to provide electrical energy to the motor and a battery
housing comprising a support housing configured to support the
battery cell, and a shock absorbing element configured to absorb
shock provided by an impact force, wherein the shock absorbing
element is configured to crumple when an impact force is applied to
the shock absorbing element.
Example 140
[0507] The surgical instrument of Example 139, wherein the shock
absorbing element is replaceable.
Example 141
[0508] The surgical instrument of Examples 139 or 140, wherein the
shock absorbing element comprises attachment means configured to
permit the shock absorbing element to be attached to the battery
assembly in a snap-fit fashion.
Example 142
[0509] The surgical instrument of Example 141, wherein the
attachment means comprises an adhesive.
Example 143
[0510] The surgical instrument of Examples 141 or 142, wherein the
battery housing further comprises an aperture, and wherein the
attachment means comprises a protrusion configured to be received
by the aperture in the battery housing in a wedge-fit fashion.
Example 144
[0511] The surgical instrument of Examples 139, 140, 141, 142, or
143, wherein the shock absorbing element comprises a lattice
structure.
Example 145
[0512] The surgical instrument of Examples 139, 140, 141, 142, 143,
or 144 wherein, when the shock absorbing element crumples, the
shock absorbing element deforms in an inward direction which still
permits the attachment of the battery assembly to the housing of
the surgical instrument after the shock absorbing element has been
impacted.
Example 146
[0513] The surgical instrument of Examples 139, 140, 141, 142, 143,
144, or 145, wherein the shock absorbing element crumples when the
impact force is greater than a threshold force.
Example 147
[0514] 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 the shock absorbing elements, and wherein the
plurality of shock absorbing elements are positioned at each
corner.
Example 148
[0515] The surgical instrument of Example 147, wherein the battery
housing comprises an electrical contact configured to transmit
electrical energy from the battery cell to the motor and a bottom
face associated with the electrical contact, wherein each shock
absorbing element comprises an end portion extending beyond the
bottom face of the battery housing to protect the electrical
contact.
Example 149
[0516] The surgical instrument of Examples 148 or 149, wherein each
shock absorbing element comprises a bottom end and a top end, and
wherein the battery assembly further comprises a shock absorbing
cap positioned at the top ends of the shock absorbing elements.
Example 150
[0517] A battery assembly for use with a surgical instrument, the
battery assembly comprising a battery cell, an electrical contact
configured to transmit electrical energy provided by the battery
cell 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 house the
first housing, and a shock absorbing layer positioned between the
first housing and the second housing, wherein the shock absorbing
layer comprises a lattice structure.
Example 151
[0518] The battery assembly of Example 150, wherein the shock
absorbing layer comprises a foam-like material.
Example 152
[0519] The battery assembly of Examples 150 or 151, wherein the
lattice structure comprises a plurality of cells, the plurality of
cells comprising an inner cell comprising an inner planar wall,
wherein the inner planar wall is oriented at least substantially
parallel the first housing and an outer cell comprising an outer
planar wall, wherein the outer planar wall is oriented at least
substantially parallel the second housing.
Example 153
[0520] The battery assembly of Examples 150, 151, or 152, wherein
the battery assembly further comprises a shock absorbing cap, the
shock absorbing cap comprising an outer lattice and an inner
lattice, wherein the outer lattice is more dense than the inner
lattice.
Example 154
[0521] The battery assembly of Examples 150, 151, 152, or 153,
wherein the shock absorbing layer comprises a plurality of
dampening elements.
Example 155
[0522] 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 a housing comprising a heat
reflecting shell, a heat sink layer, and a compressible layer
positioned between the heat sink layer and the heat reflecting
shell, wherein the compressible layer is configured to flex in
response to expansion of the battery cell.
Example 156
[0523] The battery assembly of Example 155, wherein the
compressible layer is further configured to dissipate impact energy
absorbed by the heat reflecting shell.
Example 157
[0524] The battery assembly of Examples 155 or 156, wherein the
compressible layer comprises a lattice structure.
Example 158
[0525] The battery assembly of Example 157, wherein the lattice
structure is a closed lattice structure defined by the heat
reflecting shell and the heat sink layer.
Example 159
[0526] The battery assembly of Examples 155, 156, 157, or 158,
wherein the heat reflecting shell comprises a fist thermal
expansion coefficient, wherein the heat sink layer comprises a
second thermal expansion coefficient, and wherein the first thermal
expansion coefficient is less than the second thermal expansion
coefficient.
[0527] The entire disclosures of the following documents are hereby
incorporated by reference herein in their respective entireties:
[0528] U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC
DEVICE, which issued on Apr. 4, 1995; [0529] U.S. Pat. No.
7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVING SEPARATE
DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21, 2006;
[0530] U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL
CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK,
which issued on Sep. 9, 2008; [0531] U.S. Pat. No. 7,464,849,
entitled ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM
AND ANVIL ALIGNMENT COMPONENTS, which issued on Dec. 16, 2008;
[0532] U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING
AN ARTICULATING END EFFECTOR, which issued on Mar. 2, 2010; [0533]
U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS,
which issued on Jul. 13, 2010; [0534] U.S. Pat. No. 8,393,514,
entitled SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE,
which issued on Mar. 12, 2013; [0535] U.S. patent application Ser.
No. 11/343,803, entitled SURGICAL INSTRUMENT HAVING RECORDING
CAPABILITIES; now U.S. Pat. No. 7,845,537; [0536] U.S. patent
application Ser. No. 12/031,573, entitled SURGICAL CUTTING AND
FASTENING INSTRUMENT HAVING RF ELECTRODES, filed Feb. 14, 2008;
[0537] U.S. patent application Ser. No. 12/031,873, entitled END
EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT, filed
Feb. 15, 2008, now U.S. Pat. No. 7,980,443; [0538] U.S. patent
application Ser. No. 12/235,782, entitled MOTOR-DRIVEN SURGICAL
CUTTING INSTRUMENT, now U.S. Pat. No. 8,210,411; [0539] U.S. patent
application Ser. No. 12/249,117, entitled POWERED SURGICAL CUTTING
AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM, now
U.S. Pat. No. 8,608,045; [0540] U.S. patent application Ser. No.
12/647,100, entitled MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT WITH
ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY, filed Dec. 24,
2009; now U.S. Pat. No. 8,220,688; [0541] U.S. patent application
Ser. No. 12/893,461, entitled STAPLE CARTRIDGE, filed Sep. 29,
2012, now U.S. Pat. No. 8,733,613; [0542] U.S. patent application
Ser. No. 13/036,647, entitled SURGICAL STAPLING INSTRUMENT, filed
Feb. 28, 2011, now U.S. Pat. No. 8,561,870; [0543] U.S. patent
application Ser. No. 13/118,241, entitled SURGICAL STAPLING
INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S.
Patent Application Publication No. 2012/0298719; [0544] U.S. patent
application Ser. No. 13/524,049, entitled ARTICULATABLE SURGICAL
INSTRUMENT COMPRISING A FIRING DRIVE, filed on Jun. 15, 2012; now
U.S. Patent Application Publication No. 2013/0334278; [0545] U.S.
patent application Ser. No. 13/800,025, entitled STAPLE CARTRIDGE
TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013; [0546] U.S.
patent application Ser. No. 13/800,067, entitled STAPLE CARTRIDGE
TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013; [0547] U.S.
Patent Application Publication No. 2007/0175955, entitled SURGICAL
CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING
MECHANISM, filed Jan. 31, 2006; and [0548] U.S. Patent Application
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WITH AN ARTICULATABLE END EFFECTOR, filed Apr. 22, 2010, now U.S.
Pat. No. 8,308,040.
[0549] Although the various embodiments of the devices have been
described herein in connection with certain disclosed embodiments,
many modifications and variations to those embodiments may be
implemented. Also, where materials are disclosed for certain
components, other materials may be used. Furthermore, according to
various embodiments, a single component may be replaced by multiple
components, and multiple components may be replaced by a single
component, to perform a given function or functions. The foregoing
description and following claims are intended to cover all such
modification and variations.
[0550] The devices disclosed herein can be designed to be disposed
of after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces, and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can 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 reconditioning of a
device can utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
[0551] Preferably, the invention described herein will be processed
before surgery. First, a new or used instrument is obtained and if
necessary cleaned. The instrument can 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 on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0552] While this invention has been described as having exemplary
designs, the present invention may be further modified within the
spirit and scope of the disclosure. This application is therefore
intended to cover any variations, uses, or adaptations of the
invention using its general principles.
[0553] 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 materials does not conflict with existing definitions,
statements, or other disclosure material set forth in this
disclosure. As such, 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 will only be incorporated to
the extent that no conflict arises between that incorporated
material and the existing disclosure material.
* * * * *