U.S. patent application number 14/670837 was filed with the patent office on 2015-11-12 for authentication and information system for reusable surgical instruments.
The applicant listed for this patent is Covidien LP. Invention is credited to Ethan Collins, David Durant, John Hryb.
Application Number | 20150324317 14/670837 |
Document ID | / |
Family ID | 53177128 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150324317 |
Kind Code |
A1 |
Collins; Ethan ; et
al. |
November 12, 2015 |
AUTHENTICATION AND INFORMATION SYSTEM FOR REUSABLE SURGICAL
INSTRUMENTS
Abstract
An authentication and information system for use in a surgical
stapling system includes a microprocessor configured to demultiplex
data from a plurality of components in the surgical system. The
authentication and information system can include one wire chips
and a coupling assembly with a communication connection.
Inventors: |
Collins; Ethan; (Naugatuck,
CT) ; Hryb; John; (Southington, CT) ; Durant;
David; (Wallingford, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Family ID: |
53177128 |
Appl. No.: |
14/670837 |
Filed: |
March 27, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61989609 |
May 7, 2014 |
|
|
|
Current U.S.
Class: |
710/106 |
Current CPC
Class: |
G06F 13/4221 20130101;
Y02A 90/10 20180101; A61B 2017/0046 20130101; G16Z 99/00 20190201;
G06F 13/4282 20130101; A61B 2017/00398 20130101; G16H 40/63
20180101; A61B 2090/0814 20160201; A61B 90/98 20160201; A61B
17/07207 20130101; A61B 90/90 20160201; A61B 2017/00017 20130101;
A61B 2090/064 20160201; Y02A 90/26 20180101 |
International
Class: |
G06F 13/42 20060101
G06F013/42; G06F 19/00 20060101 G06F019/00 |
Claims
1. A method of communicating data through a bus, the method
comprising: providing a microprocessor capable of demultiplexing
transmit and receive lines; providing a first microchip and a
second microchip in a surgical system, each of the first and second
microchips configured to provide authentication of a first
component and a second component in the surgical system, each of
the first and second microchips being communicatively-coupled
through a bus to the microprocessor; and controlling a receive mode
and a transmit mode over the bus.
2. The method of claim 1, further comprising: receiving at least
one signal from the first microchip or the second microchip using
the receive mode over the bus.
3. The method of claim 2, wherein receiving at least one signal
includes selecting the receive mode utilizing the
microprocessor.
4. The method of claim 1, further comprising: transmitting at least
one signal to the first microchip or the second microchip using the
transmit mode over the bus.
5. The method of claim 4, wherein transmitting at least one signal
includes selecting the transmit mode utilizing the
microprocessor.
6. The method of claim 1, further comprising providing a third
microchip connected to the microprocessor, the third microchip
having a data wire and a ground wire.
7. The method of claim 6, further comprising receiving at least one
signal from the first microship or the second microchip, including
turning on the ground wire of the first microchip or second
microchip.
8. The method of claim 6, further comprising transmitting at least
one signal from the first microchip or the second microchip,
including turning off the ground wire of the first microchip or
second microchip.
9. A method of communicating data through a bus, the method
comprising: authenticating a surgical component utilizing a
microchip communicatively-coupled through a bus to a microprocessor
capable of demultiplexing transmit and receive lines; and
controlling a receive mode and a transmit mode over the bus.
10. The method of claim 9, wherein authenticating includes
utilizing the microchip.
11. The method of claim 10, wherein authenticating further includes
utilizing a one-wire data interface of the microchip.
12. The method of claim 9, further comprising: receiving at least
one signal from the surgical component using the receive mode over
the bus.
13. The method of claim 12, wherein receiving at least one signal
from the surgical component using the receive mode over the bus
includes turning on the ground wire of the microchip.
14. The method of claim 13, further including utilizing the
microprocessor to select the receive mode.
15. The method of claim 9, further comprising: transmitting at
least one signal to the microprocessor using the transmit mode over
the bus.
16. The method of claim 15, wherein transmitting at least one
signal to the microprocessor using the transmit mode over the bus
includes turning off the ground wire of the microchip.
17. The method of claim 16, wherein transmitting at least one
signal to the microprocessor using the transmit mode over the bus
further includes utilizing the microprocessor to select the
transmit mode.
18. The method of claim 9, wherein the surgical component has a
second microchip.
19. The method of claim 9, wherein the microprocessor is part of a
controller for a surgical system, the surgical component being a
part of the surgical system.
20. A surgical system, comprising: a handle assembly having a
controller, the controller having at least one program; an adapter
assembly; and a loading unit having a tool assembly and at least
one chip assembly having a chip storing data indicating whether the
tool assembly articulates or not, the controller including a
microprocessor configured for de-multiplexing data from said
chip.
21. The surgical system according to claim 20, wherein the
controller reads the data and does not drive an articulation link
in the adapter assembly and/or loading unit if the data indicated
that the loading unit does not articulate.
22. A surgical system, comprising: a handle assembly having a
controller, the controller having at least one program; an adapter
assembly; and a loading unit having a tool assembly and at least
one chip assembly having a chip storing data indicating the maximum
drive force for the loading unit, the controller including a
microprocessor configured for de-multiplexing data from said
chip.
23. The surgical system according to claim 22, wherein the
controller is programmed to read the data, and also read a drive
force from a sensor, wherein the controller does not drive a member
in the adapter assembly and/or loading unit if the drive force
indicates that the maximum drive force has been reached.
24. The surgical system according to claim 21, wherein the
controller is programmed to read the data, and also read a drive
force from a sensor, wherein the controller operates in slow mode
if the drive force indicates that the maximum drive force has been
reached.
25. The surgical system according to any one of the preceding
claims, wherein the chip also stores information about the type of
loading unit.
26. The surgical system according to any one of the preceding
claims, wherein the loading unit includes a removable and
replaceable staple cartridge assembly.
27. The surgical system according to any one of the preceding
claims, wherein the removable and replaceable staple cartridge
assembly includes a chip storing data concerning the staple
cartridge assembly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S.
Provisional Patent Application No. 61/989,609, filed May 7, 2014,
the entire disclosure of which is incorporated by reference
herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to surgical instruments
having a reusable handle and removable and replaceable components,
such as a disposable or replaceable loading unit. The present
disclosure relates to printed circuit boards suitable for use in
surgical devices. More particularly, the present disclosure relates
to a communication protocol for a system in which data is
communicated through a bus, the protocol eliminating the need for
multiple buses for transmitting information from various components
in the system.
[0004] 2. Description of Related Art
[0005] Powered surgical instruments for use in endoscopic
procedures are known. Typically, such instruments include a
reusable handle assembly, and a replaceable and generally
disposable component sometimes referred to as single use loading
unit or SULU. An adapter assembly connects the loading unit, which
can include an end effector for interacting with tissue, to the
handle assembly. In the case of a surgical stapler, the end
effector/tool assembly can include a replaceable cartridge that is
changed after each firing of the surgical stapler. To reduce costs
and shorten procedure times, the handle assemblies are generally
configured for use with a variety of loading units and/or
assemblies of various configurations for use on tissue having
different properties, e.g., thickness and density. For example, the
different loading units may have staples of different sizes and/or
the staples may be arranged in different configurations. To ensure
the handle assembly is programmed to operate with the attached
loading unit, some loading units are provided with an integrated
circuit, also known as a chip, that communicates with the handle
assembly to identify the configuration of the loading unit.
[0006] Printed circuit boards (PCBs), sometimes referred to as
printed wiring boards (PWBs) or etched wiring boards, are widely
used in the assembly of discrete electrical components into
operating circuits. PCBs generally provide a reliable and
economical means of interconnecting electrical signals among system
components. PCBs are available in a variety of different types and
may be classified in a variety of ways.
[0007] PCBs are generally used to mechanically support and
electrically connect electronic components using
electrically-conductive pathways or signal traces that conduct
signals on the PCB. A typical PCB includes one or more layers of
insulating material upon which patterns of electrical conductors
are formed. In addition to a pattern of conductive traces on the
PCB, a patterned array of metal-filled through-holes, or vias, may
be formed to allow for layer-to-layer interconnections among
various conductive features.
[0008] PCBs may be classified as single-sided PCBs, double-sided
PCBs, and multi-layer PCBs, according to the number of circuit
pattern surfaces. PCBs may have circuits that perform a single
function or multiple functions.
[0009] A typical PCB may include a variety of electronic
components. Electronic components form parts of electronic
circuitry and may be classified in a variety of ways. An electronic
component may be classified as active or passive. In general, an
active component is any type of circuit component with the ability
to electrically control the flow of electrons or other
electrically-charged particles. Some examples of active components
are transistors, integrated circuits (ICs), and silicon-controlled
rectifiers (SCRs). Components incapable of controlling current by
means of another electrical signal are generally classified as
passive components. Examples of passive components include
capacitors, resistors, inductors, transformers, and diodes. A PCB
on which electrical components are mounted is sometimes referred to
as a printed circuit assembly (PCA) or a printed circuit board
assembly (PCBA).
[0010] Electrical signals may be used on PCBs for controlling the
operation of a surgical device. For example, electrical signals may
be used on PCBs for controlling the delivery of surgical staples to
tissue, and may be used for indicatory devices, e.g., to provide
feedback to the surgeon relating to various tissue parameters or
conditions. Some surgical systems include a powered hand-held
surgical device, a surgical loading unit (sometimes referred to as
a disposable loading unit or a disposable end effector), and an
adapter for selectively interconnecting the surgical loading unit
and the surgical device. Certain types of adapters enable the
surgical device to drive a multitude of functions of surgical
loading units of various configurations.
[0011] In order for the surgical device to drive the various
functions of the surgical loading unit or assembly so that the
surgical system performs properly, a controller may be associated
with the surgical device and configured to receive various
information, such as information about the type of adapter and/or
the type of loading unit. For example, the different surgical
loading units may have staples of different sizes and/or the
staples may be arranged in different configurations. To ensure the
surgical device is programmed to operate with the attached surgical
loading unit, some reload assemblies are provided with an
integrated circuit, also known as a chip, which communicates with
the surgical device to identify the configuration of the surgical
loading unit.
[0012] To ensure the reliability of the surgical system, it is
desirable to confirm whether the surgical loading unit and the
adapter have been previously used, and, if so, to count how many
times the surgical reload assembly has been used. Data
communications between the surgical loading unit and the surgical
device may pass through a physical connection of an interface
between the adapter and the surgical device.
[0013] It would be desirable to develop a communication protocol
for use in a surgical system for efficiently and effectively
transmitting information from various components in the system.
SUMMARY
[0014] In an aspect of the present disclosure, a method of
communicating data through a bus comprises providing a
microprocessor capable of demultiplexing transmit and receive
lines, providing a first microchip and a second microchip in a
surgical system, each of the first and second microchips configured
to provide authentication of a first component and a second
component in the surgical system, each of the first and second
microchips being communicatively-coupled through a bus to the
microprocessor; and controlling a receive mode and a transmit mode
over the bus.
[0015] The method can further comprise receiving at least one
signal from the first microchip or the second microchip using the
receive mode over the bus. Receiving at least one signal can
include selecting the receive mode utilizing the microprocessor.
The method can further comprise transmitting at least one signal to
the first microchip or the second microchip using the transmit mode
over the bus. Transmitting at least one signal can include
selecting the transmit mode utilizing the microprocessor.
[0016] The method can further comprise providing a third microchip
connected to the microprocessor, the third microchip having a data
wire and a ground wire.
[0017] The method can further comprise receiving at least one
signal from the first microchip or the second microchip, including
turning on the ground wire of the first microchip or second
microchip. The method can further comprise transmitting at least
one signal from the first microchip or the second microchip,
including turning off the ground wire of the first microchip or
second microchip.
[0018] In another aspect, a method of communicating data through a
bus comprises authenticating a surgical component utilizing a
microchip communicatively-coupled through a bus to a microprocessor
capable of demultiplexing transmit and receive lines, and
controlling a receive mode and a transmit mode over the bus.
[0019] Authenticating can include utilizing the microchip.
Authenticating can further include utilizing a one-wire data
interface of the microchip.
[0020] The method can further comprise receiving at least one
signal from the surgical component using the receive mode over the
bus. Receiving at least one signal from the surgical component
using the receive mode over the bus can include turning on the
ground wire of the microchip. The microprocessor can be used to
select the receive mode.
[0021] The method can further comprise transmitting at least one
signal to the microprocessor using the transmit mode over the bus.
Transmitting at least one signal to the microprocessor using the
transmit mode over the bus can include turning off the ground wire
of the microchip. Transmitting at least one signal to the
microprocessor using the transmit mode over the bus can further
include utilizing the microprocessor to select the transmit
mode.
[0022] In certain embodiments, the surgical component has a second
microchip. The microprocessor can be part of a controller for a
surgical system, the surgical component being a part of the
surgical system.
[0023] In another aspect, a surgical system, comprises a handle
assembly having a controller, the controller having at least one
program, an adapter assembly, and a loading unit having a tool
assembly and at least one chip assembly having a chip storing data
indicating whether the tool assembly articulates or not, the
controller including a microprocessor configured for
de-multiplexing data from said chip.
[0024] The controller can read the data and not drive an
articulation link in the adapter assembly and/or loading unit if
the data indicated that the loading unit does not articulate.
[0025] In yet another aspect, a surgical system, comprises a handle
assembly having a controller, the controller having at least one
program, an adapter assembly, and a loading unit having a tool
assembly and at least one chip assembly having a chip storing data
indicating the maximum drive force for the loading unit, the
controller including a microprocessor configured for
de-multiplexing data from said chip.
[0026] The controller can be is programmed to read the data, and
also read a drive force from a sensor, wherein the controller does
not drive a member in the adapter assembly and/or loading unit if
the drive force indicates that the maximum drive force has been
reached.
[0027] The controller can be programmed to read the data, and also
read a drive force from a sensor, wherein the controller operates
in slow mode if the drive force indicates that the maximum drive
force has been reached.
[0028] The chip can also store information about the type of
loading unit. The loading unit can include a removable and
replaceable staple cartridge assembly. The removable and
replaceable staple cartridge assembly can include a chip storing
data concerning the staple cartridge assembly
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The above and other aspects, features, and advantages of the
present disclosure will become more apparent in light of the
following detailed description when taken in conjunction with the
accompanying drawings in which:
[0030] FIG. 1 is a perspective view of a surgical stapling device
for use with a chip assembly according to embodiments of the
present disclosure;
[0031] FIG. 2 is a perspective view of the surgical stapling device
of FIG. 1 showing the handle assembly, adapter assembly, and
loading unit in a separated configuration;
[0032] FIG. 3 is a view of a proximal end of a loading unit and a
distal end of an adapter assembly of the surgical stapling device
shown in FIG. 1;
[0033] FIG. 4 is an enlarged view of the proximal end of the
loading unit and the distal end of the adapter assembly shown in
FIG. 3;
[0034] FIG. 5 is another enlarged view of the proximal end of the
loading unit and the distal end of the adapter assembly shown in
FIG. 3;
[0035] FIG. 6 is an enlarged, exploded view of the proximal end of
the loading unit shown in FIG. 3 with the loading unit and
authentication board separated;
[0036] FIG. 7 is an enlarged, partially-exploded view of the
proximal end of the loading unit shown in FIG. 3 with the
authentication board cover separated from the loading unit;
[0037] FIG. 8 is an enlarged view of the proximal end of the
loading unit shown in FIG. 3;
[0038] FIG. 9 is a perspective view of an authentication board
assembly according to an embodiment of the present disclosure;
[0039] FIG. 10 is a perspective view of an authentication board
contact;
[0040] FIG. 11 is an enlarged, exploded view of the distal end of
the adapter assembly shown in FIG. 3 with the adapter assembly and
adapter board separated;
[0041] FIG. 12 is an enlarged view of the adapter board shown in
FIG. 11;
[0042] FIG. 13 is another enlarged view of the adapter board shown
in FIG. 11;
[0043] FIG. 14 is yet another enlarged view of the adapter board
shown in FIG. 11;
[0044] FIG. 15 is a cross-sectional, side view of the adapter
assembly shown in FIG. 3 showing the adapter assembly separated
from the loading unit;
[0045] FIG. 16 is an enlarged view of the indicated area shown in
FIG. 15 showing the adapter board separated from the authentication
board;
[0046] FIG. 17 is a cross-sectional, side view of the adapter
assembly shown in FIG. 3 showing the adapter assembly engaged with
the loading unit;
[0047] FIG. 18 is an enlarged view of the indicated area shown in
FIG. 17 showing the adapter board engaged with the authentication
board;
[0048] FIG. 19 is a cross-sectional, axial view of the adapter
assembly shown in FIG. 3 showing the adapter assembly separated
from the loading unit;
[0049] FIG. 20 is a cross-sectional, axial view of the adapter
assembly shown in FIG. 3 showing the loading unit inserted into the
adapter assembly;
[0050] FIG. 21 is a cross-sectional, axial view of the adapter
assembly shown in FIG. 3 showing the loading unit engaged with the
adapter assembly;
[0051] FIG. 22 is a perspective view of a surgical stapling device
according to further embodiments of the present disclosure;
[0052] FIG. 23 is a perspective view of a loading unit according to
embodiments of the present disclosure;
[0053] FIG. 24 is the loading unit of FIG. 23 shown with parts
separated;
[0054] FIG. 25 is a detailed perspective view of a board
assembly;
[0055] FIG. 26 is a another detailed perspective view of the board
assembly of FIG. 25;
[0056] FIG. 27 is a detailed perspective view of a chip
assembly;
[0057] FIG. 28 is another detailed perspective view of the chip
assembly of FIG. 27;
[0058] FIG. 29 is a detailed perspective view of a support plate in
accordance with embodiments of the present disclosure;
[0059] FIG. 30 is a perspective view of the chip assembly and board
assembly of FIGS. 25-28;
[0060] FIG. 31 is another perspective view of the chip assembly and
board assembly of FIGS. 25-28;
[0061] FIG. 32 is a top perspective view of a staple cartridge
assembly in accordance with embodiments of the present
disclosure;
[0062] FIG. 33 is a top perspective view of the staple cartridge
assembly of FIG. 32, with a shipping wedge;
[0063] FIG. 34 is a bottom perspective view of the shipping wedge
of FIG. 33;
[0064] FIG. 35 is a detailed perspective view of a lockout assembly
in accordance with embodiments of the present disclosure;
[0065] FIG. 36 is a perspective view of the loading unit of FIG. 23
showing the staple cartridge assembly;
[0066] FIG. 37 is a top view of the loading unit with the anvil and
shipping wedge removed;
[0067] FIG. 38 is a perspective view of the proximal portion of a
support plate of the staple cartridge assembly;
[0068] FIG. 39 is a perspective view of the proximal portion of a
channel of the loading unit;
[0069] FIG. 40 is a cross sectional view of the loading unit;
[0070] FIG. 41 is a perspective view of a chip assembly of the
loading unit with parts separated;
[0071] FIG. 42 is a perspective view of the proximal portion of the
loading unit;
[0072] FIG. 43 is a perspective view of the chip assembly;
[0073] FIG. 44 is a perspective view of the proximal portion of the
loading unit;
[0074] FIG. 45 is another perspective view of the chip
assembly;
[0075] FIG. 46 is a detailed perspective view of a lockout assembly
in accordance with embodiments of the present disclosure;
[0076] FIG. 47 is another detailed perspective view of a lockout
mechanism in accordance with embodiments of the present
disclosure;
[0077] FIG. 48 is a cross sectional view through the drive
beam;
[0078] FIG. 49 is a another detailed perspective view of the
lockout mechanism;
[0079] FIG. 50 is a perspective view with parts separated showing a
latch, sled, and mounting portion;
[0080] FIG. 51 is a perspective view of the latch;
[0081] FIG. 52 is a perspective view of the loading unit with parts
removed showing the lockout mechanism;
[0082] FIG. 53 is a perspective view of the lockout mechanism with
parts separated showing the drive beam;
[0083] FIG. 54 is a cross sectional view taken longitudinally
through the loading unit;
[0084] FIG. 55 is a detailed view of FIG. 54 showing the latch and
dynamic clamping member;
[0085] FIG. 56 is a side view of the drive beam, dynamic clamping
member, and sled;
[0086] FIG. 57 is a side view of the drive beam, dynamic clamping
member, and sled, with the drive beam and dynamic clamping member
advanced; and
[0087] FIG. 58 is a perspective view of a surgical system in
accordance with an embodiment of the present disclosure;
[0088] FIG. 59 a circuit diagram of a printed circuit board (PCB)
in accordance with an embodiment of the present disclosure; and
[0089] FIG. 60 is a circuit diagram of a PCB in accordance with an
embodiment of the present disclosure;
[0090] FIG. 61 is a flowchart illustrating a method of
communicating data through a bus in accordance with an embodiment
of the present disclosure; and
[0091] FIG. 62 is a perspective view of coupling assembly, shown
de-coupled, and showing the rotatable drive connectors and
communication connectors.
DETAILED DESCRIPTION
[0092] Particular embodiments of the present disclosure are
described hereinbelow with reference to the accompanying drawings;
however, it is to be understood that the disclosed embodiments are
merely examples of the disclosure, which may be embodied in various
forms. Well-known and/or repetitive functions and constructions are
not described in detail to avoid obscuring the present disclosure
in unnecessary or redundant detail. Therefore, specific structural
and functional details disclosed herein are not to be interpreted
as limiting, but merely as a basis for the claims and as a
representative basis for teaching one skilled in the art to
variously employ the present disclosure in virtually any
appropriately detailed structure. As is common in the art, the term
"proximal" refers to that part or component closer to the user or
operator, i.e. surgeon or clinician, while the term "distal" refers
to that part or component further away from the user. In addition,
as used herein in the description and in the claims, terms
referencing orientation, e.g., "top", "bottom", "upper", "lower",
"left", "right", and the like, are used with reference to the
figures and features shown and described herein. It is to be
understood that embodiments in accordance with the present
disclosure may be practiced in any orientation without limitation.
In this description, as well as in the drawings, like-referenced
numbers represent elements which may perform the same, similar, or
equivalent functions. Embodiments of the presently disclosed chip
assembly will now be described in detail with reference to the
drawings in which like reference numerals designate identical or
corresponding elements in each of the several views. The word
"exemplary" is used herein to mean "serving as an example,
instance, or illustration." Any embodiment described herein as
"exemplary" is not necessarily to be construed as preferred or
advantageous over other embodiments. The word "example" may be used
interchangeably with the term "exemplary."
[0093] This description may use the phrases "in an embodiment," "in
embodiments," "in some embodiments," or "in other embodiments,"
which may each refer to one or more of the same or different
embodiments in accordance with the present disclosure.
[0094] As it is used in this description, "printed circuit board"
(or "PCB") or "circuit boards" generally refers systems that
provide, among other things, mechanical support to electrical
devices and/or components, electrical connection to and between
these electrical components, combinations thereof, and the like.
For the purposes herein, the term "printed circuit board" is
interchangeable with the term "printed wiring board" and either is
represented herein by the acronym PCB.
[0095] With reference initially to FIGS. 1 and 2, a surgical
stapling instrument including an authentication system according to
the present disclosure is shown generally as stapler 10. Stapler 10
includes a handle assembly 12, an adapter assembly 14 extending
distally from handle assembly 12, and a loading unit 16 selectively
secured to a distal end of adapter assembly 14. A detailed
description of handle assembly 12, adapter assembly 14, and loading
unit 16 is provided in commonly-owned U.S. Patent Appl. Publ. No.
2012/0089131, the contents of which is incorporated herein by
reference in its entirety.
[0096] Handle assembly 12 includes a lower housing portion 17, an
intermediate housing portion 18 extending from and/or supported on
lower housing portion 17, and an upper housing portion 19 extending
from and/or supported on intermediate housing portion 18.
Intermediate housing portion 18 and upper housing portion 19 are
separated into a distal half-section 20a that is integrally formed
with, and extends from, the lower housing portion 17, and a
proximal half-section 20b joined to distal half-section 20a by any
suitable manner of attachment, such as without limitation,
ultrasonic welding and/or a plurality of fasteners. When joined,
distal and proximal half-sections 20a, 20b form a handle housing 21
defining a cavity therein which houses a circuit board that
includes a controller 21a, and a drive mechanism (not shown).
[0097] Lower housing portion 17 includes a door 13 pivotally
connected thereto for accessing a cavity formed in lower housing
portion 17 for retaining a battery (not shown) therein. It is
contemplated that stapler 10 may be powered by any number of power
sources, such as, for example and without limitation, a fuel cell,
a power cord connected to an external power source, and so
forth.
[0098] Adapter assembly 14 includes a drive coupler 22 at a
proximal end thereof and a loading unit coupler 15 at a distal end
thereof. Distal half-section 20a of upper housing portion 19
defines a nose or connecting portion 11 configured to operably
receive drive coupler 22 of adapter assembly 14. Loading unit 16
includes an adapter coupler 27 configured to operably receive
loading unit coupler 15 of adapter assembly 14.
[0099] Upper housing portion 19 of handle housing 21 encloses a
drive mechanism (not shown) configured to drive shafts and/or gear
components (not shown) in order to perform the various operations
of stapler 10. In particular, the drive mechanism is configured to
drive shafts and/or gear components in order to selectively move a
tool assembly or end effector 23 of loading unit 16 relative to a
proximal body portion 24 of loading unit 16, to rotate loading unit
16 about a longitudinal axis "X-X" (FIG. 1) relative to handle
housing 21, to move an anvil assembly 25 relative to cartridge
assembly 26 of loading unit 16, and/or to fire a stapling and
cutting cartridge within cartridge assembly 26 of loading unit
16.
[0100] The loading unit 16 shown in the FIGS. 1-21 is a linear
surgical stapling loading unit. The loading unit includes a
stapling anvil with recesses for forming surgical staples that are
driven against it by operation of the loading unit in the surgical
system. A staple cartridge houses the surgical staples, as well as
the staple firing and/or driving assembly. The staple firing and/or
driving assembly is known. One such assembly is described in U.S.
Pat. Nos. 8,256,656 and 7,044,353, the entire disclosures of which
are hereby incorporated by reference herein. The drive assembly
includes an elongated drive beam having a knife blade. The drive
beam pushes an actuation sled having wedge shaped surfaces for
interacting with pushers. The pushers support the staples and have
camming surfaces that the sled wedge shaped surfaces slide against,
driving the pushers upwardly while the sled is advanced in a
longitudinal fashion through the staple cartridge.
[0101] It is contemplated that the loading unit has jaw members for
supporting the anvil and the staple cartridge respectively. The
anvil jaw member and staple cartridge jaw member can be
approximated to clamp tissue therebetween. It is also contemplated
that the end effector can articulate or pivot off axis from the
longitudinal axis defined by the proximal body portion 24.
[0102] It is contemplated that the loading unit can be a circular
surgical stapling unit, other types of stapling units, or other
types of surgical end effectors, such as electrocautery, ablation,
ultrasonic, etc.
[0103] With reference to FIGS. 3, 4, and 5, loading unit coupler 15
of adapter assembly 14 is configured to operably engage adapter
coupler 27 of loading unit 16 via a push and twist or bayonet-type
arrangement. Adapter coupler 27 includes one or more bayonet lugs
28 that are configured to mate with corresponding one or more
bayonet channels 29 defined in a bayonet collar 48 provided by
loading unit coupler 15 of adapter assembly 14. A short link member
44 and a load link member 45 are longitudinally disposed within
adapter assembly 14 and are configured to translate longitudinally
(e.g., distally and proximally) during operation of stapler 10. A
cam 55 disposed at a distal end of short link member 44 is urged
distally against a bayonet channel 29 by spring 49a. To engage
loading unit 16 with adapter assembly 14, adapter coupler 27 of
loading unit 16 is inserted into loading unit coupler 15 of adapter
assembly 14 and rotated. In turn, bayonet collar 48 rotates
cooperatively with adapter coupler 27. As bayonet collar 48
rotates, cam 55 rides off bayonet channel 29, causing short link
member 44 to translate distally, which, in turn, causes a switch
tab 47 formed in short link member 44 to actuate switch 46. Switch
46 is in operative electrical communication with the controller 21a
and is configured to convey thereto the engagement status between
loading unit 16 and adapter assembly 14.
[0104] Turning now to FIGS. 6-10, adapter coupler 27 of loading
unit 16 includes an authentication board assembly 30 that is
configured to be securely mounted within a recess 31 defined in
adapter coupler 27. Authentication board assembly 30 is positioned
within adapter coupler 27 such that when loading unit 16 is secured
to adapter assembly 14, authentication board assembly 30 engages an
adapter board assembly 50 mounted within loading unit coupler 15 of
the adapter assembly (FIG. 11). In more detail, authentication
board 30 includes a circuit board 37, a pair of contact members
40a, 40b (collectively, contact members 40) and a chip 36. Circuit
board 37 defines a substantially planar elongated member configured
to be securely received within recess 31 defined by adapter coupler
27. Chip 36 is in electrical communication with contact members 40.
A distal end 37a of circuit board 37 supports chip 36, and a
proximal end 37b of circuit board 37 supports contact members 40.
Distal end 37a of circuit board 37 includes an alignment notch 33
defined therein that is configured to engage a corresponding
alignment nub 32 provided at a distal end of recess 31 to ensure
secure and accurate positioning of authentication board assembly 30
within adapter coupler 27.
[0105] Chip 36 includes any chip capable of storing the
specifications of loading unit 16, such as, without limitation,
cartridge size, staple arrangement, staple length, clamp-up
distance, date of manufacture, expiration date, compatibility
characteristics, a unique identifier (e.g., a serial number),
and/or number of uses, and transmitting the specifications to
handle assembly 12. In some embodiments, chip 36 includes an
erasable programmable read only memory ("EPROM") chip. In this
manner, the handle assembly 12 may adjust the firing forces, firing
stroke, and/or other operational characteristics thereof in
accordance with the specifications of loading unit 16 that are
transmitted from chip 36. It is further envisioned that chip 36 may
include write capabilities which allow handle assembly 12 to
communicate to chip 36 that the associated loading unit 16 has been
used, which can prevent reloading or reuse of an expended reload
assembly, or any other unauthorized use.
[0106] In some embodiments, chip 36 includes a secure
authentication chip, such as, without limitation, a DS28E15
DeepCover.TM. Secure Authenticator with 1-Wire SHA-256 and 512-Bit
User EEPROM, manufactured by Maxim Integrated.TM. of San Jose,
Calif. In these embodiments, the contents of chip 36, and the
communications between chip 36 and handle assembly 12, are
encrypted to prevent unauthorized access. In this manner, the use
of low-quality counterfeit, re-manufactured, or "knock-off" loading
units is effectively discouraged, which, in turn, reduces risk to
patients by ensuring that only fresh, authentic loading units 16
are used during surgical procedures. In addition, the likelihood
that medical facilities and/or surgeons may unwittingly use
counterfeit loading units is greatly curtailed, thus reducing the
overall costs to society for delivering medical services. In some
embodiments, chip 36 utilizes a "1-wire" communications interface
whereby a single signal conductor is employed, together with a
ground conductor, for bidirectional serial communications between
chip 36 and handle assembly 12.
[0107] Contact assembly 38 (FIGS. 9, 10) includes a short contact
arm 41 and a long contact arm 42 joined by a contact base 59, and
having a generally elongated u-shaped configuration. Short contact
arm 41 includes a first contact member 40a orthogonally disposed
and fixed to an upper portion of a proximal end thereof. Long
contact arm 42 includes a second contact member 40b orthogonally
disposed and fixed to an upper portion of a proximal end thereof.
Short and long contact arms 41, 42 each include a solder tab 39
orthogonally disposed and fixed to a lower portion of a distal end
thereof. Solder tabs 39 are electromechanically joined to a
proximal end 37b of circuit board 37 by, e.g., soldering,
electrically conductive adhesive, and/or other suitable
technique.
[0108] Adapter coupler 27 includes a raised contact support 34
extending radially from a proximal end thereof and includes a pair
of cradles 35a, 35b defined therein that are configured to receive
first contact member 40a and second contact member 40b,
respectively, when authentication board assembly 30 is positioned
within recess 31 of adapter coupler 27. A cover 43 is configured to
enclose and retain authentication board assembly 30 within recess
31 of adapter coupler 27 (FIGS. 7 and 8).
[0109] In some embodiments, short contact arm 41 and first contact
member 40a are electrically insulated from long contact arm 42 and
second contact member 40b by contact base 59. In these embodiments,
each of short contact arm 41 and long contact arm 42 carries a
separate circuit, e.g., short contact arm 41 carries signal and
long contact arm 42 carries ground. In other embodiments, short
contact arm 41 and first contact member 40a are electrically joined
with long contact arm 42 and second contact member 40b. In these
embodiments, short contact arm 41 and long contact arm 42 operate
in a bifurcated or redundant mode to carry a signal circuit, while
the ground circuit is carried through other electrically conductive
components of loading unit 16, adapter unit 14, and/or handle
assembly 12.
[0110] As mentioned above, authentication board assembly 30 is
configured to engage adapter board assembly 50 mounted within
loading unit coupler 15 when loading unit 16 is secured to adapter
assembly 14. With reference now to FIGS. 11-14, loading unit
coupler 15 includes an adapter board assembly 50 that is configured
to be floatingly mounted within a pocket 60 defined in loading unit
coupler 15. Adapter board assembly 50 is positioned within loading
unit coupler 15 such that when loading unit 16 is secured to
adapter assembly 14, adapter board assembly 50 engages
authentication board assembly 30.
[0111] Adapter board assembly 50 includes a circuit board 51 having
a pair of contact members 55a, 55b (collectively, contact members
55) fixed thereto and in operable communication with handle
assembly 12. In the illustrated embodiment, contact members 55a,
55b are arranged for effective engagement in a transverse
direction, e.g., transverse to the longitudinal axis "X-X" of
stapler 10, to accommodate the rotational coupling of loading unit
16 and adapter assembly 14 as described herein.
[0112] Circuit board 51 includes an upper surface 51a, a lower
surface 51b, a proximal end 51c, and a distal end 51d. Circuit
board 51 defines a substantially planar elongated member configured
to be resiliently or floatingly received within pocket 60 defined
by loading unit coupler 15. A spring clip 52 is fixed to a proximal
end 51c of circuit board 51 and is configured to support adapter
board assembly 50 within pocket 60. Spring clip 52 includes a pair
of spring supports 54 having a wing-like configuration that are
configured prevent spring clip 52 from over-extension and to
provide stiffness thereto. Adapter board assembly 50 includes a
spring 53 having a broad, curvate u-shaped profile disposed on an
upper surface 51a of circuit board 51. In some embodiments, spring
clip 52 and spring 53 may be integrally formed. Spring clip 52
and/or spring 53 may be positively aligned and/or supported by a
notch 62 defined in proximal end 51c of circuit board 51. Circuit
board 51 includes one or more through holes 56 defined therein that
may be utilized to form a conductive pathway between upper surface
51a and lower surface 51b of circuit board 51.
[0113] When adapter board assembly 50 is mounted within pocket 60,
spring 53 bears against outer tube 57 of adapter assembly 14 (FIGS.
15, 16). In use, adapter board 50 is spring-biased towards
authentication board assembly 30 by spring 53 and by side spring
clip 52 such that, upon joining loading unit 16 and adapter
assembly 14, any manufacturing tolerances between loading unit 16
and adapter assembly 14 are compensated for by engagement of the
floating spring mount of adapter board 50 within pocket 60. In this
manner, a reliable connection between contact members 55 of adapter
board 50 and contact members 40 of authentication board assembly 30
is consistently achieved, thus providing a robust communication
link between chip 36 and handle assembly 12. In embodiments,
contact assembly 38, contacts 40, and/or contacts 55 are formed at
least in part from electrically conductive material, such as,
without limitation, beryllium copper.
[0114] Turning now to FIGS. 15-21, the interaction between adapter
board assembly 50 and authentication board assembly 30 is shown. As
seen in FIGS. 15, 16, and 19, adapter board 50 is retained within
loading unit adapter 15 by spring clip 52. Spring 53 bears against
outer tube 57 to bias adapter board 50 inwardly towards bore 61,
such that contact members 55 extend into bore 61. As adapter
coupler 27 is inserted fully into bore 61 of loading unit adapter
15, the initial rotational orientation of adapter coupler 27 and
loading unit coupler 15 is such that contact members 40 of
authentication board 30 and contact members 55 of adapter board 50
are roughly 45.degree. apart (FIG. 20). As loading unit 16 is
rotated with respect to adapter assembly 14, contact members 40 of
authentication board 30 are brought into engagement with contact
members 55 of adapter board 50. Advantageously, contact support 34
of adapter coupler 27 of loading unit 16 provides radial support to
contact members 30 as they engage mating contact members 55 of
adapter board 50. In addition, spring 53 bears against outer tube
57 which enables adapter board 50 to float with respect to
authentication board 30 and loading unit coupler 15, thereby
compensating for manufacturing variations between the various
components and providing a reliable connection between
authentication board 30 and adapter board 50.
[0115] It is contemplated that a loading unit like loading unit 16
could have a removable and replaceable staple cartridge assembly. A
stapling system is shown in FIGS. 22-57, in accordance with an
embodiment of the present disclosure, having a powered handle
assembly 112 similar to the handle assembly 12 discussed above. The
handle assembly is configured as discussed above and has a
controller 121a. The stapling system includes an adapter assembly
114 and a loading unit 116, each of which can be configured as
discussed above. The loading unit is a linear stapling loading
unit, but other types of loading units are contemplated. The
loading unit 116 has a drive assembly for firing staples into
tissue clamped between the anvil jaw member 111 and staple
cartridge jaw member 113, as discussed above.
[0116] Supported in the staple cartridge jaw member 113 is a
removable and replaceable staple cartridge assembly 115. A
removable and replaceable staple cartridge assembly is disclosed in
U.S. patent application Ser. No. 13/280,880, filed Oct. 25, 2011,
and published as US 2013-0098965 A1, the entire disclosure of which
is hereby incorporated by reference herein.
[0117] Loading unit 116 of the present disclosure is configured to
be used more than once. In particular, the loading unit has the
removable staple cartridge assembly 115 that includes the staple
cartridge and drive assembly discussed above. The removable
assembly 116 is configured to be removed and replaced (e.g., after
firing staples or other surgical fasteners therefrom). The loading
unit 116 shown includes a proximal body portion 118 that is
attachable to the adapter assembly 114. However, the features of
the loading units of the present disclosure can be incorporated in
a surgical instrument in which does not include a detachable
portion of the elongated portion of the instrument.
[0118] Loading unit 500 includes a proximal body portion 118
defining a longitudinal axis "A-A". Jaw members include an anvil
jaw member 111 and a cartridge jaw member 113. One of the jaw
members is pivotal in relation to the other to enable the clamping
of tissue between the jaw members. In the illustrated embodiments,
the cartridge jaw member 113 is pivotal in relation to the anvil
jaw member and is movable between an open or unclamped position and
a closed or approximated position. However, the anvil jaw member,
or both the cartridge and anvil jaw member, can be movable. As
discussed in connection with FIGS. 1-21, the anvil jaw member
includes an anvil having a plurality of staple forming
depressions.
[0119] The cartridge jaw member 113 includes a channel or carrier
120 which receives and supports the staple cartridge assembly 115.
The cartridge assembly has a cartridge body 140 and a support plate
111. The cartridge body and support plate are attached to the
channel or carrier 120 by a snap-fit connection, as discussed
below, a detent, latch, or by another type of connection. The
cartridge assembly includes fasteners or staples 141. Cartridge
body 140 defines a plurality of laterally spaced staple retention
slots 142, which are configured as openings (see FIG. 32). Each
slot is configured to receive a fastener or staple therein.
Cartridge assembly also defines a plurality of cam wedge slots
which accommodate staple pushers 146 and which are open on the
bottom to allow the actuation sled 148 to pass longitudinally
therethrough in the firing of the staples as discussed above.
[0120] The removable staple cartridge assembly 115 includes
cartridge body 140 and support plate 111. The removable assembly
115 is removable from channel 120, e.g., after staples have been
fired from the cartridge body 140. Another removable and
replaceable staple cartridge assembly is capable of being loaded
into the channel, such that the loading unit 116 can be actuated
again to fire additional fasteners or staples.
[0121] Channel 120 includes one or a pair of engagement structures
120a (such as slots) for engaging the staple cartridge assembly and
support plate (see FIG. 39), a central slot for the passage of the
drive beam, a pair of proximal holes 150 for connection with the
anvil jaw member, and a ramped surface 152. Proximal holes 150 are
configured to align with/mechanically engage a pair of
corresponding holes or features on the anvil jaw member. The jaw
members can be connected by pins, for example, to facilitate a
pivotal relationship between anvil jaw member 111 and cartridge jaw
member 113.
[0122] The cartridge body 140 includes a central slot 143, and rows
of staple retention slots positioned on each side of slot 143 (see
FIG. 32). Cartridge body also includes a pair of engagement
structures or protrusions which may, in certain embodiments, be
slots or openings adjacent its proximal end for connection with the
support plate 111a and/or channel 120.
[0123] With particular reference to FIG. 29, support plate 111a
includes a base 145, engagement features 147 and 147a (see FIG. 38)
for connection with the cartridge body and/or channel, and a
mounting portion 149 at a proximal end thereof (see FIG. 29). The
support plate 111a is disposed underneath the cartridge body to
support the staple pushers, actuation sled, and staples (or other
surgical fasteners) and prevent those components from falling out
of the staple cartridge assembly.
[0124] The loading unit can include a chip assembly 360 mounted on
a proximal end of the proximal body portion 118, as shown in FIGS.
41-45, for example. The chip assembly is as described above in
connection with the authentication board assembly 30 discussed
above. The chip assembly 360 is mounted for connection with a board
assembly in the coupler on the distal end of the adapter assembly
114, and can be configured as discussed above in connection with
FIGS. 1-21. The chip assembly 360 includes a chip 361 for
authentication and information purposes, and can include a memory
that stores certain information. The information can include the
type of device the loading unit is, the version of the
device/loading unit, the name of the loading unit, the
manufacturing lot number, the serial or other identification
number, the maximum force to which the drive beam of the loading
unit can be driven, the interlock zone (mm), the end zone (mm),
whether or not the loading unit can articulate, and/or a usage
limit (the number of times the loading unit can be used). The
interlock zone is the position of the drive beam, in millimeters,
measured from the start or initial position of the drive beam, when
the drive beam is engaged by a lockout in the loading unit. The end
zone is the position of the drive beam, in millimeters, measured
from the start or initial position of the drive beam, when the
drive beam has reached the end of its travel in the staple
cartridge body 140. Since the staple cartridge assembly 115 can be
removed and replaced, there is an intended limit to the number of
times the loading unit can be reloaded with a fresh unfired staple
cartridge. The information stored on the chip can include the
staple line length and/or length of the staple cartridge.
[0125] The controller 121a in the handle assembly 112 can be
programmed to read the information on the chip 361. This
information is used in the operation of the surgical system.
Desirably, some or all of the information is encrypted, which can
be accomplished as discussed above in connection with FIGS. 1-21.
The controller can be programmed to not provide power to a motor
(not shown) disposed in the handle assembly 112, and not operate
the adapter assembly and loading unit, in the event that the serial
number or other data is not recognized. The maximum force
information is used in conjunction with a load sensor, such as a
strain gauge, disposed in the surgical system. For example, a load
sensor can be disposed in the adapter assembly 114 and/or loading
unit, such as a load sensor on the drive beam. The controller is
programmed to compare the data from the load sensor to the maximum
force data stored on the chip so that, for example, the operation
of the motor (not shown) is interrupted before the maximum force is
exceeded. In another example, the controller can be programmed to
operate in "slow mode" if the measured force reaches a
predetermined level. The predetermined level of force can be the
maximum force discussed above, or another level of force, stored on
a chip in the system, such as chip 361. Slow mode means that the
controller operates the motor (not shown) at a slower rate,
generating more torque, and also delaying the compression of tissue
and/or firing of staples. In thick tissue, slow mode can allow
fluid in the tissue to move away from the site of stapling,
facilitating more compression of the tissue.
[0126] In a similar manner, the operation of the motor can be
stopped or operated in slow mode if the drive beam is disposed in
the interlock zone or the end zone. Furthermore, the controller can
interrupt or prevent the operation of the articulation linkage, bar
or cable if the data on chip 361 indicated that the loading unit
does not articulate.
[0127] It is contemplated that the chip 361 with some or all of the
data discussed above can be provided in any of the embodiments
disclosed herein, including loading units that do not have a
removable and replaceable staple cartridge assembly, and/or loading
units that do not articulate.
[0128] It is contemplated that the information on chip 361 can be
read by the controller in the handle assembly, another chip in the
system, or any other computer component in the surgical system.
[0129] In any of the embodiments disclosed herein, the controller
can write information to the chip on the loading unit. For example,
the maximum force that was used to clamp onto tissue, as measured
by the load sensor discussed above, the maximum force that was used
to fire staples, and/or the position of the drive beam when the
drive beam stops advancing, etc. Other information that can be
written to the chip 361 includes the location of the drive beam
when the device entered into slow mode, the number of times the
loading unit has been fired, whether the loading unit has been
fired, the type of handle assembly, the serial number of the handle
assembly, the type of adapter assembly, and/or the serial number of
the adapter assembly. The maximum force to fire staples can be
saved along with the position of the drive beam, in any of the
embodiments disclosed herein. The information can also be saved in
a memory connected to the controller in the handle assembly, other
chips in the system, or other computer components of the surgical
system.
[0130] It is also envisioned, in any of the embodiments disclosed
herein, that an end effector or tool assembly is arranged for
articulating between a first position where tool assembly is
aligned with longitudinal axis "Y-Y," and a second position where
tool assembly is disposed at an angle with respect to longitudinal
axis "Y-Y." For example, the tool assembly, which includes the
anvil jaw member and the cartridge jaw member, may be mounted so as
to be pivotable with respect to the proximal body portion 118. The
anvil jaw member and cartridge jaw member can be attached to a
mounting assembly 2020 (discussed further below), and the mounting
assembly can be pivotably connected to the proximal body portion
118. The loading unit 116 includes one or more cables or linkages
disposed in the proximal body portion so that when the cable or
linkage is displaced, the tool assembly pivots and articulates with
respect to the instrument. Further details of providing
articulation are described in detail in commonly-owned U.S. Pat.
No. 6,953,139 to Milliman et al., the contents of which are hereby
incorporated by reference in their entirety. The adapter assembly
114 can include a linkage, bar or cable for enabling the
articulation of the tool assembly.
[0131] As seen in FIG. 32, for example, any of the embodiments
disclosed herein can include a cartridge body 140 having a stepped
tissue-contacting surface 1412. In such embodiments, different
sized staples, or all the same sized staples, may be used. Further
details of a staple cartridge having multiple staple sizes are
included in U.S. Pat. No. 7,407,075 to Holsten et al., the entire
contents of which are hereby incorporated by reference herein. The
staple forming recesses of the anvil, or the staple pushers, or
both, can be configured accordingly, to form the staples in the
desired shape and size.
[0132] The removable and replaceable staple cartridge assembly 115
can further include a chip assembly 362. (see FIGS. 27 and 28). A
corresponding board assembly 380 (FIGS. 25 and 26) is disposed on
the tool assembly of the loading unit 116, and may be disposed on
the channel 120. The tool assembly board assembly 380 can be
configured as discussed above in connection with the adapter board
assembly 50 of the adapter coupler 27. The tool assembly board
assembly 380 is configured to be securely mounted on a wall of the
channel 120. This board assembly 380 is positioned such that when
cartridge assembly 140 is secured to the channel 120 of the loading
unit, the chip assembly 362 engages the board assembly 380 mounted
on the channel. (See FIGS. 29-31). FIGS. 27 and 28 show the
relationship between the chip assembly and the staple cartridge
body 140, whereas FIG. 29 shows the relationship between the chip
assembly 362 and the support plate 111a.
[0133] In more detail, chip assembly includes a body 337 and a pair
of contact members 340a, 340b (collectively, contact members 340)
connected to a chip 336 disposed in the body. Body 337 defines a
rectangular member having flexible arms with snap features 337a
thereon. The flexible arms are configured to be securely received
within a recess 331 defined by in the cartridge body. Chip 336 is
in electrical communication with contact members 340.
[0134] Chip 336 includes any chip capable of storing information
concerning the staple cartridge assembly 115. The chip can be the
same as or similar to the chip of authentication board assembly 30.
In any of the embodiments disclosed herein, any of the chips can
store information such as, without limitation, cartridge size,
staple arrangement, staple line length (or cartridge length), date
of manufacture, expiration date, compatibility characteristics, a
unique identifier (e.g., a serial number), and/or number of uses,
as well as whether or not the staple cartridge assembly has been
used. Such information can be transmitted to the controller in the
handle assembly 112, or to another computer component through an
appropriate bus, pin connection, wireless means, etc. In some
embodiments, chip 336 includes an erasable programmable read only
memory ("EPROM") chip. The controller in the handle assembly can
write information to the chip 336. In this manner, the handle
assembly 112 may adjust the firing forces, firing stroke, and/or
other operational characteristics thereof in accordance with the
information concerning the staple cartridge assembly that are
transmitted from chip 336. The handle assembly 112 can communicate
to chip 336 that the staple cartridge assembly has been used, which
can prevent reloading or reuse of an expended reload assembly, or
any other unauthorized use. The information stored in any of the
components in the surgical system can be encrypted using private
keys, public keys, and/or secure hash algorithms.
[0135] The board assembly 380 also has a pair of contacts 380a and
380b and a body 381. The board assembly is mounted for contact with
the chip assembly 362 when the staple cartridge assembly is
properly mounted in the channel 120. The contacts 380a, 380b, 340a,
and 340b have an L-shaped configuration as seen in the figures so
that they may resiliently engage one another. The body 381 can
define a snap feature 382 that is provided to engage a hole 383 in
the channel to securely mount the board assembly. The board
assembly is appropriately connected to a bus, wires, or has a
wireless communicator for transmittal of the information from chip
assembly 362 to the controller in the handle assembly, or any other
computer device.
[0136] In any of the embodiments disclosed herein, a lockout
mechanism 500 is disposed in the loading unit. The loading unit may
be configured as discussed above. Furthermore, the present
disclosure is directed to a removable assembly having the lockout,
or a loading unit having the lockout.
[0137] The lockout mechanism 500 includes a latch 2010 and at least
one spring 2030, and is configured to prevent re-firing of a staple
cartridge assembly 115 or staple cartridge 26, and also prevent
distal translation of a drive beam after the staple cartridge has
been fired and prior to loading of another cartridge assembly 115.
The lockout mechanism 500 is shown alongside the sled 148 and
mounting assembly 2020 in FIG. 50. The at least one spring 2030 is
mounted on a distally facing surface 2031. For example, recesses
are formed in surface 2031 for receiving springs 2030.
Corresponding posts are provided on a proximally facing surface of
the latch 2010. The latch is configured to be pivotable within the
loading unit, and includes at least one prong 2012, a rear portion
2014, and a supporting portion 2016. The latch is configured to
pivot around the supporting portion 2016, shown in FIGS. 50 and 51
as two downwardly depending features, and is biased by the spring
or springs 2030. The sled 148 has a hole or recess for receiving
the at least one prong 2012 when the latch and drive beam are in
their initial positions. (see FIG. 52). The drive beam 2039 can
interact with, or include, a dynamic clamping member 2040 having an
upper flange 2042, lower flange 2044, and knife blade 2046. (see
FIG. 53).
[0138] In the initial position, the latch 2010 is biased in a
forward or distal direction, with the rear portion 2014 in contact
with an edge 2039a on the drive beam 2039, preventing further
rotational movement of the latch. As the drive beam and dynamic
clamping member are moved in a forward or distal direction, the
dynamic clamping member pushes the sled distally. A rear portion
148a of the sled pushes the prong or prongs 2012, tilting the latch
against the bias of the at least one spring 2030. This removes the
rear portion 2014 from the area near the edge 2039a, and allows the
drive beam and dynamic clamping member to move forward. After the
dynamic clamping member passes the latch 2010, the latch rotates
forwardly under the influence of the spring. (see FIG. 57).
[0139] After the dynamic clamping member and sled have fired the
staples from the cartridge 140, the dynamic clamping member is
moved proximally, leaving the sled at the distal end of the
cartridge 140 and cartridge assembly 115. The dynamic clamping
member can move past the latch 2010, as cam surface 2041 moves the
latch out of the path of travel (see FIG. 57). Once the dynamic
clamping member returns to the initial position, the latch 2010
will prevent another forward movement of the dynamic clamping
member 2040. The latch rear portion 2014 is in a position to engage
another edge 2039b of the drive beam. (see FIG. 57). If the loading
unit is of the type that accepts removable and replaceable staple
cartridge assemblies 115, the cartridge assembly 115 can be
configured to return the latch 2010 to the initial position, so
that the drive beam and dynamic clamping member can again be moved
distally to fire another set of staples.
[0140] As discussed above, any of the embodiments disclosed herein
can include a chip assembly 360 on a surgical stapling loading
unit, like loading unit 116, that has information on it concerning
the lockout mechanism, such as the lockout mechanism discussed
above. Furthermore, information can be stored on the chip 361
concerning the lockout mechanism. For example, the fact that the
lockout mechanism was engaged can be recorded in chip assembly 360
and/or chip assembly 362 by the controller in the handle. The
controller in the handle can include a memory for storing
information, including a processor, and other computer components.
The controller can also include a current meter, or ammeter, to
measure the current in the motor of the handle assembly. The
controller can be programmed to record the peak current reached
during use of the loading unit and/or staple cartridge assembly,
and can record that peak current on any of the chips or other
computer components in the system. A peak current reached after the
staples have been fired can be an indication that the loading unit
was attempted to be fired a second time before a fresh staple
cartridge assembly was mounted in the loading unit. Alternatively,
the lockout mechanism can include a sensor such as, for example, on
the latch. It is contemplated that the surgical system can include
loading units that do not have a lockout mechanism like the one
discussed above. The fact that the loading unit does not have a
lockout mechanism can be stored in chip 361.
[0141] The handle assembly can also include an encoder that
determines how many rotations of the motor output shaft have been
made, which can be used to determine a position of drive bars,
linkages, cables, etc., in the adapter assembly, the firing bar in
the loading unit, or other components. Alternatively, other sensors
can be used to determine the position of various components in the
surgical system.
[0142] The adapter assembly disclosed herein, in any of the
embodiments disclosed herein, can be configured as disclosed in
U.S. Published Application No. 2011/0174099 A1, the entire
disclosure of which is hereby incorporated by reference herein. The
motor in the handle assembly provides a rotational output on a
rotating shaft and the adapter is configured to transform that
output to a linearly moving linkage or bar, and can also provide
drive to an articulation linkage in the proximal body portion 118
of the loading unit 116. The handle assembly and/or adapter
assembly can be configured as disclosed in U.S. Published
Application Nos. 2014/0012289 A1 and 2014/0110453 A1, the entire
disclosures of which are hereby incorporated by reference
herein.
[0143] Any of the embodiments described in connection with FIGS. 1
through 57 can include the protocol and/or multiplexor discussed
herein. In any of the embodiment disclosed herein, the motor in the
handle assembly or housing may be any electrical motor configured
to actuate one or more drives (such as rotatable drive connectors).
The motor is coupled to a battery, which may be a DC battery (e.g.,
rechargeable lead-based, nickel-based, lithium-ion based, battery
etc.), an AC/DC transformer, or any other power source suitable for
providing electrical energy to the motor.
[0144] FIG. 58 shows a surgical system 1010 including a surgical
device 1100 that is selectively connectable to an adapter 1200, in
turn, selectively connectable to a surgical loading unit 1300. Such
a system is disclosed in U.S. patent application Ser. No.
14/172,109, the disclosure of which is hereby incorporated herein
by reference in its entirety. It is contemplated that a variety of
surgical reload assemblies 1300 can be used in connection with the
system 1010, including electrosurgical reloads, circular stapling
loading units, linear stapling loading units, suturing devices,
etc.
[0145] Adapter 1200 is configured to connect at least one
configuration of the surgical reload assembly 1300 to the surgical
device 1100, wherein the surgical device 1100 may provide two
rotating drive outputs, which can be converted into different
rotational drives, linear drives, etc., so that different
configurations of the surgical loading units 300 can be operated by
the surgical device 1100. As seen in FIG. 58, the adapter 200
generally includes a proximal coupling assembly 1210 at a proximal
end thereof and a distal coupling assembly 1230 at a distal end
thereof.
[0146] Surgical device 1100, as shown in FIG. 58, includes a handle
housing 1102 having a lower housing portion 1104, an intermediate
housing portion 1106 extending from and/or supported on a lower
housing portion 1104, and an upper housing portion 1108 extending
from and/or supported on an intermediate housing portion 1106.
Handle housing 1102 supports a trigger housing 1107 on a distal
surface or side of intermediate housing portion 1108. Upper housing
portion 1108 defines a connecting portion 1108a configured to
accept a corresponding drive coupling assembly 1210 of adapter
1200. Lower housing portion 1104 of the handle housing 1102
provides a housing in which a battery 1156 is removeably situated.
Battery 1156 is configured to supply power to any of the electrical
components of the surgical device 1100. Lower housing portion 1104
defines a cavity (not shown) into which the battery 1156 is
inserted. Lower housing portion 1104 includes a door 1105 pivotally
connected thereto for closing the cavity of the lower housing
portion 1104 and retaining the battery 1156 therein.
[0147] Surgical loading unit 1300 generally includes a proximal
body portion 1302 and a tool assembly 1304. Proximal body portion
1302 is selectively connectable to the distal coupling assembly
1230 of the adapter 1200, and the tool assembly 304 is pivotally
attached to a distal end of proximal body portion 1302. Tool
assembly 1304 includes an anvil assembly 1306 and a cartridge
assembly 1308. In the illustrative embodiment shown in FIG. 58, the
surgical loading unit 1300 is a linear stapling reload with a
separately removable and replaceable cartridge, and the adapter
1200 is configured to drive the various components of the reload
assembly 1300 in order to clamp tissue, fire staples, and cut the
tissue. An example of a surgical reload assembly having a removable
and replaceable staple cartridge assembly is disclosed in U.S.
patent application Ser. No. 13/280,880, the disclosure of which is
incorporated herein by reference in its entirety.
[0148] Surgical device 1100 includes a controller 1080 that
contains the device software that operates the surgical device
1100, the adapter 1200, and/or the surgical loading unit 1300.
Connections to the various hardware and software interfaces of the
surgical system 1010, and electrical connections relating to the
controller 1080, are described in U.S. patent application Ser. No.
13/331,047, the disclosure of which is hereby incorporated herein
by reference in its entirety.
[0149] The presently-disclosed PCB utilizes a multiplexing scheme
and microprocessor to combine 1-wire data and UART (universal
asynchronous receiver/transmitter) transmit and UART receive onto a
single mechanical pin or other physical connector, so that data can
be read from the chips in the various components of the system in
an efficient manner. In some embodiments, the chips in each
component may be Dallas one wire chips, which have a single data
wire and a ground wire The presently-disclosed PCB embodiments
require two 2 wires (data and ground), for example, as opposed to
four wires required to implement using standard topology. The
presently-disclosed communication protocol may increase reliability
because there are fewer mechanical parts subject to corrosion
and/or failure, particularly where PCB pins may be exposed to
blood. The teachings of the present disclosure may apply to a
variety of surgical devices that include a bus system.
[0150] FIGS. 59 and 60 show a PCB that includes a microprocessor
1020, a microchip 1030, and a bus 1010, which is configured to
receive signals from a signal source 1120, e.g., controller 1080 of
the surgical device 1100. Microchip 1030 is configured to provide
device authentication, and may utilize a one-wire data interface.
Microchip 1030 is communicatively-coupled through the bus 1010 to
the signal source 1120 and communicatively-coupled to the
microprocessor 1020. As shown, the microchip is the DS28E15 chip
from Maxim Integrated, but other chips may be used. Microprocessor
1020 is capable of demultiplexing transmit and receive lines. It is
contemplated that the signal source can be some other computer
component, such as an operating room computer system or robotic
surgical system.
[0151] Based upon communications between microprocessor 1020 and
the signal source 1120, the microprocessor 1020 controls bus
selection. In some embodiments, a receive mode and a transmit mode
over the bus 1010 are controlled by multiplexing on the
microprocessor 1020 utilizing a ground wire 1012 of the microchip
1030. In order to transmit over the bus 1010, the ground wire 1012
is turned off, and the microprocessor 1020 selects the transmit
mode. In order to receive over the bus 1010, the ground wire 1012
is turned on, and the microprocessor 1020 selects the receive
mode.
[0152] Hereinafter, a method of communicating data through a bus in
accordance with the present disclosure is described with reference
to FIG. 60. It is to be understood that the steps of the method
provided herein may be performed in combination and in a different
order than presented herein without departing from the scope of the
disclosure.
[0153] FIG. 61 is a flowchart illustrating a method of
communicating data through a bus in accordance with an embodiment
of the present disclosure. In step 1410, a microprocessor 1020
capable of demultiplexing transmit and receive lines is
provided.
[0154] In step 1420, a microchip 1030 configured to provide device
authentication is provided. Microchip 1030 is
communicatively-coupled through a bus 1010 to a signal source 1120
and communicatively-coupled to the microprocessor 1020. Microchip
1030 may utilize a one-wire data interface. The signal source
transmits to microchip 1030 the combined data from microchips in
the surgical system, such as for example the loading unit, staple
cartridge assembly, and/or adapter.
[0155] In step 1430, a receive mode and a transmit mode over the
bus 1010 are controlled by multiplexing on the microprocessor 1020
utilizing a ground wire 1012 of the microchip 1030.
[0156] In step 1440, at least one signal is received from the
signal source 1120 using the receive mode over the bus 1010. In
some embodiments, receiving at least one signal from the signal
source 1120 using the receive mode over the bus 1010 includes
turning on the ground wire 1012 of the microchip 1030. Receiving at
least one signal from the signal source 1120 using the receive mode
over the bus 1010 may further include selecting the receive mode
utilizing the microprocessor 1020.
[0157] In step 1450, at least one signal is transmitted from the
signal source 1120 using the transmit mode over the bus 1010. In
some embodiments, transmitting at least one signal from the signal
source 1120 using the transmit mode over the bus 10 includes
turning off the ground wire 1012 of the microchip 1030.
Transmitting at least one signal from the signal source 1120 using
the transmit mode over the bus 1010 may further include selecting
the transmit mode utilizing the microprocessor 1020.
[0158] In another embodiment of a method of communicating data
through a bus in accordance with the present disclosure, the method
includes: authenticating a surgical device, or component of a
surgical system utilizing a microchip 1030 communicatively-coupled
through a bus 1010 to a signal source 1120 and
communicatively-coupled to a microprocessor 1020 capable of
demultiplexing transmit and receive lines; and controlling a
receive mode and a transmit mode over the bus 1010 by multiplexing
on the microprocessor 1020 utilizing a ground wire 1012 of the
microchip 1030. Authenticating the surgical device may include
utilizing a one-wire data interface of the microchip 1030.
[0159] Various embodiments of the above-described PCBs utilize a
receive mode and a transmit mode over a bus which is controlled by
multiplexing on a microprocessor utilizing a ground wire of a
microchip configured to provide device authentication.
[0160] It is contemplated that the protocol and/or multiplexor can
be used to reduce the bus to two wires instead of three or four,
from four wires to three, etc., reducing the communication
connectors or pins to two or three, respectively.
[0161] FIG. 62 is an exemplary coupling assembly for the surgical
handle assembly 1100 and adapter assembly 1200, which can be used
in any of the embodiments disclosed herein. A similar coupling
assembly is provided between the adapter assembly and the loading
unit. The connecting portion 2108a of surgical instrument 2100 has
a cylindrical recess 2108b that receives a drive coupling assembly
2210 of adapter assembly 2200 when adapter assembly 2200 is mated
to surgical instrument 2100. Connecting portion 2108a houses three
rotatable drive connectors 2118, 2120, 2122.
[0162] When adapter 2200 is mated to surgical instrument 2100, each
of rotatable drive connectors 2118, 2120, 2122 of surgical
instrument 2100 couples with a corresponding rotatable connector
sleeve 2218, 2220, 2222 of adapter 2200 as shown in FIG. 62. In
this regard, the interface between corresponding first drive
connector 2118 and first connector sleeve 2218, the interface
between corresponding second drive connector 2120 and second
connector sleeve 2220, and the interface between corresponding
third drive connector 2122 and third connector sleeve 2222 are
keyed such that rotation of each of drive connectors 2118, 2120,
2122 of surgical instrument 2100 causes a corresponding rotation of
the corresponding connector sleeve 2218, 2220, 2222 of adapter
assembly 2200.
[0163] The mating of drive connectors 2118, 2120, 2122 of surgical
instrument 2100 with connector sleeves 2218, 2220, 2222 of adapter
assembly 2200 allows rotational forces to be independently
transmitted via each of the three respective connector interfaces.
The drive connectors 2118, 2120, 2122 of surgical instrument 2100
are configured to be independently rotated by drive mechanism 2160.
In this regard, the controller in the instrument or handle assembly
2100 selects which drive connector or connectors 2118, 2120, 2122
of surgical instrument 2100 is to be driven by a drive mechanism in
the handle assembly or surgical instrument.
[0164] Each of drive connectors 2118, 2120, 2122 of surgical
instrument 2100 has a keyed and/or substantially non-rotatable
interface with respective connector sleeves 2218, 2220, 2222. The
selective rotation of drive connector(s) 2118, 2120 and/or 2122 of
surgical instrument 2100 allows surgical instrument 2100 to
selectively actuate different functions of end effector/loading
unit, such as loading unit 1300. Such functions include selective
and independent opening and closing of tool assembly of loading
unit such as loading unit 1300, driving of stapling and/or cutting,
articulation of a tool assembly of a loading unit, and/or rotation
of shaft 1302 and or shaft of the adapter assembly about a
longitudinal axis thereof.
[0165] The coupling assembly also has communication connectors 2501
and 2502, which are shown in a pair in FIG. 62. In embodiments
using the multiplexing scheme and/or multiplexor discussed above,
signals from three chips (e.g., staple cartridge chip, loading unit
chip, and adapter assembly chip) can be combined and communicated
to a microprocessor (such as the one shown in FIG. 60). The
controller of the surgical system can then use the data from such
chips as discussed above. In certain preferred embodiments the
communication connectors are singular connectors instead of the
pair shown. In any of the embodiments disclosed herein, there may
also be force and/or load sensors that connect to the
microprocessor. In any of the embodiments disclosed herein the
microprocessor such as microprocessor 1020 can transmit data to the
one or more chips (staple cartridge chip, loading unit chip, and/or
adapter assembly chip). Such data can include an indication that
the staples have been fired, and/or incrementing a counter for the
number of uses of the particular component. Such data can include
the maximum drive force experienced and/or the position of the
drive assembly/drive beam, etc.
[0166] Although the illustrative embodiments of the present
disclosure have been described herein with reference to the
accompanying drawings, it is to be understood that the disclosure
is not limited to those precise embodiments, and that various other
changes and modifications may be effected therein by one skilled in
the art without departing from the scope or spirit of the
disclosure.
* * * * *