U.S. patent application number 14/884393 was filed with the patent office on 2016-02-04 for surgical instruments including mems devices.
The applicant listed for this patent is COVIDIEN LP. Invention is credited to Douglas Cuny, Russell Heinrich.
Application Number | 20160030042 14/884393 |
Document ID | / |
Family ID | 29273028 |
Filed Date | 2016-02-04 |
United States Patent
Application |
20160030042 |
Kind Code |
A1 |
Heinrich; Russell ; et
al. |
February 4, 2016 |
SURGICAL INSTRUMENTS INCLUDING MEMS DEVICES
Abstract
Surgical instruments are disclosed that are couplable to or have
an end effector or a disposable loading unit with an end effector,
and at least one micro-electromechanical system (MEMS) device
operatively connected to the surgical instrument for at least one
of sensing a condition, measuring a parameter and controlling the
condition and/or parameter.
Inventors: |
Heinrich; Russell; (Madison,
CT) ; Cuny; Douglas; (Bethel, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COVIDIEN LP |
MANSFIELD |
MA |
US |
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|
Family ID: |
29273028 |
Appl. No.: |
14/884393 |
Filed: |
October 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14338383 |
Jul 23, 2014 |
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14884393 |
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13030434 |
Feb 18, 2011 |
8808311 |
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14338383 |
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10510940 |
Oct 8, 2004 |
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PCT/US03/13056 |
Apr 25, 2003 |
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13030434 |
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60375496 |
Apr 25, 2002 |
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60375495 |
Apr 25, 2002 |
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Current U.S.
Class: |
606/219 |
Current CPC
Class: |
A61B 2034/305 20160201;
A61B 17/0469 20130101; A61B 2017/00022 20130101; A61B 34/30
20160201; A61B 90/06 20160201; A61B 2018/00648 20130101; A61B
2017/07228 20130101; A61B 17/128 20130101; A61B 2034/303 20160201;
A61B 2017/00066 20130101; A61B 17/07207 20130101; A61B 2090/064
20160201; A61B 17/072 20130101; A61B 2018/00702 20130101; A61B
2017/07257 20130101; A61B 17/062 20130101; A61B 17/0686 20130101;
A61B 2017/07214 20130101; A61B 2017/0023 20130101; A61B 2090/061
20160201; A61B 18/1445 20130101; A61B 2017/07271 20130101; A61B
2017/0609 20130101 |
International
Class: |
A61B 17/072 20060101
A61B017/072; A61B 19/00 20060101 A61B019/00; A61B 17/068 20060101
A61B017/068 |
Claims
1. (canceled)
2. A method of performing a surgical procedure, comprising:
positioning tissue between a pair of jaw members of a surgical
instrument, at least one jaw member of the pair of jaw members
having a biosensor; measuring a biological characteristic of the
tissue using the biosensor; and determining, using the measured
biological characteristic of the tissue, whether the tissue is in
condition for stapling.
3. The method according to claim 2, wherein the biological
characteristic of the tissue is indicative of at least one of blood
flow through the tissue, blood flow presence in the tissue, or
blood pressure in the tissue.
4. The method according to claim 3, wherein the tissue is
determined to be in condition for stapling when the measured
biological characteristic through the tissue meets a threshold.
5. The method according to claim 2, further comprising: firing
staples from the surgical instrument into a portion of the tissue
after determining that the tissue is in condition for stapling;
measuring the biological characteristic of the stapled portion of
the tissue after the staples are fired; and determining, using the
biological characteristic of the tissue measured after the staples
are fired, whether the stapled portion of the tissue is healthy or
viable.
6. The method according to claim 5, wherein the biological
characteristic of the tissue is indicative of at least one of blood
flow through the tissue, blood flow presence in the tissue, or
blood pressure in the tissue.
7. The method according to claim 5, wherein the stapled portion of
the tissue is determined to be healthy when a characteristic
measured by the biosensor is above a threshold amount.
8. The method according to claim 2, further comprising providing
feedback to an electronic system for tracking at least one of the
effectiveness of the procedure or proper performance of the
surgical instrument.
9. The method according to claim 2, wherein the surgical instrument
is a surgical stapler.
10. A method of performing a surgical procedure comprising:
providing a surgical instrument having a pair of jaw members, at
least one of the jaw members having a biosensor positioned on a
tissue contacting surface thereof; positioning tissue adjacent the
biosensor; measuring a physiologic parameter of the tissue using
the biosensor; determining, based on the measured physiologic
parameter, whether the tissue is appropriate for a stapling
procedure; and conducting the stapling procedure if the
determination is that the tissue is appropriate.
11. The method according to claim 10 further comprising measuring a
physiologic parameter of the tissue after the stapling procedure
has been completed.
12. A method of performing a surgical procedure comprising:
providing a surgical instrument having a pair of jaw members, at
least one of the jaw members having a biosensor positioned on a
tissue contacting surface thereof; identifying tissue to be
subjected to a stapling procedure; applying staples to the
identified tissue; positioning tissue adjacent the staples in
operative proximity to the biosensor of the surgical instrument;
measuring a biological characteristic of the tissue using the
biosensor; and determining, based on the measured biologic
characteristic, whether the tissue is viable or healthy.
13. The method of claim 12, further comprising measuring a
biological characteristic of the identified tissue prior to
applying staples.
14. A method of performing a surgical procedure, comprising:
positioning tissue between a pair of jaw members of a surgical
instrument, at least one jaw member of the pair of jaw members
having a biosensor; applying at least one surgical fastener to the
tissue; measuring a biological characteristic of the tissue using
the biosensor; and determining, using the measured biological
characteristic of the tissue, whether the tissue is healthy or
viable.
15. The method of claim 14, wherein the surgical fastener is a
surgical staple.
16. The method of claim 14, wherein the surgical instrument is a
circular surgical stapler.
17. A method of performing a surgical procedure, comprising:
positioning tissue between a pair of jaw members of a surgical
instrument, at least one jaw member of the pair of jaw members
having a biosensor; measuring a first biological characteristic of
the tissue using the biosensor indicative of at least one of blood
flow, blood presence, or blood pressure; applying at least one
surgical fastener to the tissue; measuring a second biological
characteristic of the tissue using the biosensor indicative of at
least one of blood flow, blood presence, or blood pressure;
providing feedback to an electronic system for tracking at least
one of the effectiveness of the procedure or proper performance of
the surgical instrument.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of and priority
to U.S. Provisional Application Ser. No. 60/375,495 and U.S.
Provisional Application Ser. No. 60/375,496, both of which were
filed on Apr. 25, 2002, and the entire disclosures of which are
incorporated herein by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to surgical instruments and,
more particularly to mechanical, electro-mechanical and energy
based surgical instruments and systems.
[0004] The present disclosure relates generally to surgical
instruments and systems and, more specifically, to surgical stapler
instruments and systems and energy based instruments and systems,
having micro-electromechanical system (MEMS) devices for sensing,
monitoring, controlling, measuring and/or regulating conditions
and/or parameters associated with the performance of various
surgical procedures.
[0005] 2. Background of Related Art
[0006] Surgical instruments used in open and minimally invasive
surgery are limited in their ability to sense and/or control
conditions and/or parameters and factors critical to effective
operation. For example, conventional surgical instruments cannot
measurably detect the amount of tissue positioned between tissue
contacting surfaces of an end effector of the surgical
instrument.
[0007] Micro-electromechanical systems (MEMS) are integrated micro
devices or systems combining electrical and mechanical components.
They are fabricated using integrated circuitry (i.e., I.C.) batch
processing techniques and can range in size from micrometers to
millimeters. These micro-electromechanical systems sense, control
and/or actuate on the micro scale, and function individually or in
arrays to generate effects on the macro scale.
[0008] In general, MEMS devices are complex systems which
individually include one or more electrical systems and/or one or
more micro-mechanical systems. The micro-mechanical systems are
fabricated using many of the same fabrication techniques that have
miniaturized electronic circuits and made mass production of
silicon integrated circuit chips possible. In particular, MEMS
devices include mechanical micro-structures, micro-sensors,
micro-actuators and electronics integrated in the same environment
(i.e., on a silicon chip) by using micro-fabrication technology.
Micro-fabrication technology enables fabrication of large arrays of
devices, which individually perform simple tasks but in combination
can accomplish complicated functions.
[0009] MEMS devices are advantageous for many reasons. In
particular, MEMS devices can be so small that hundreds can be fit
in the same space, which perform the same or many different
functions, as compared to a single macro-device, which performs a
single function. Moreover, using I.C. batch processing techniques,
hundreds to thousands of these MEMS devices can be fabricated on a
single silicon wafer. This mass production greatly reduces the
price of individual devices. Thus, MEMS devices are relatively less
expensive than their macro-world counterparts. In addition,
cumbersome electrical components are typically not needed with MEMS
devices, since the electronics can be placed directly on the MEMS
device. This integration also has the advantage of picking up less
electrical noise, thus improving the precision and sensitivity of
sensors. As discussed above, MEMS devices provide some of the
functionality of analytical instrumentation, but with vastly
reduced cost, size, and power consumption, and an ability for
real-time, in situ measurement.
[0010] Examples of micro-electromechanical systems are disclosed in
U.S. Pat. No. 6,127,811 to Shenoy et al.; U.S. Pat. No. 6,288,534
to Starkweather et al.; U.S. Pat. No. 6,092,422 to Binnig et al.;
U.S. Patent Application No. US 2001/0020166 PCT filed Apr. 30,
1997; Microtechnology in Modern Health Care by P. Detemple, W.
Ehrfeld, H. Freimuth, R. Pommersheim, and P. Wagler in Medical
Device Technology, November 1998; and Microelectromechanical
Systems (MEMS): Technology, Design and Applications, coordinator:
Lee, Abraham, University of California, Los Angeles, Department of
Engineering, Information Systems and Technical Management, Short
Course Program, Engineering 823.53, May 19-22, 1997, the entire
contents of each of which are incorporated herein by reference.
[0011] Accordingly, a need exists for surgical instruments that can
sense a multitude of parameters and factors, such as, for example,
the distance between the tissue contacting surfaces of the surgical
instrument. Such a surgical instrument can, according to the
conditions sensed and/or measured, utilize, display, record and/or
automatically control the position of the tissue contacting
surfaces of the surgical instrument or alert a surgeon prior to
operation of the surgical instrument.
[0012] In view of the foregoing, the need exists for the use of
micro-electromechanical systems in combination with the surgical
instruments and systems and, in particular in stapling instruments
and energy based surgical instruments for monitoring, controlling
and regulating conditions and/or parameters associated with the
performance of various mechanical, electro-mechanical and
electrosurgical procedures.
SUMMARY
[0013] The present invention is direct to surgical instruments
including an end effector configured and adapted to engage tissue,
and at least one micro-electromechanical system (MEMS) device
operatively connected to the surgical instrument for at least one
of sensing a condition, measuring a parameter and controlling the
condition and/or parameter adjacent the end effector. The at least
one MEMS device is operatively connected to the end effector. The
at least one MEMS device is at least one of a pressure sensor, a
strain sensor, a displacement sensor, an optical sensor, a
biosensor, a temperature sensor, a torque sensor, an accelerometer,
a flow sensor, an electrical sensor and a magnetic sensor for at
least one of sensing, measuring and controlling the associated
condition and/or parameter.
[0014] It is contemplated that the surgical instrument is a
surgical stapler and the end effector includes a staple cartridge
assembly, and an anvil operatively associated with the staple
cartridge, the staple cartridge and the anvil being movably
connected to one another to bring one into juxtaposition relative
to the other. Each of the staple cartridge and the anvil define
tissue contacting surfaces and the at least one MEMS device is
operatively connected to at least one of the tissue contacting
surface of the staple cartridge and the tissue contacting surface
of the anvil. A plurality of MEMS devices are connected to the
surgical instrument, the MEMS devices being configured and adapted
to measure distance between the tissue contacting surface of the
staple cartridge assembly and the tissue contacting surface of the
anvil.
[0015] The MEMS devices can be configured and adapted to measure
the amount of pressure applied to tissue clamped between the tissue
contacting surface of the staple cartridge and the tissue
contacting surface of the anvil. The MEMS devices are configured
and adapted to measure the thickness of the tissue clamped between
the tissue contacting surface of the staple cartridge and the
tissue contacting surface of the anvil.
[0016] It is envisioned that the end effector is configured and
adapted to perform an anastomosis. The surgical instrument can be a
linear stapler that is adapted to perform an endoscopic
gastrointestinal anastomosis. It is further contemplated that the
surgical instrument is an annular stapler that is adapted to
perform an end-to-end anastomosis.
[0017] It is envisioned that the end effector is a jaw mechanism
including a pair of jaw members pivotably coupled to the distal end
of the elongate shaft. It is further envisioned that at least one
MEMS device is provided on at least one of the pair of jaw members.
The MEMS devices are provided at least at one of a proximal end, a
distal end and along a length of each of the pair of jaw
members.
[0018] It is envisioned that the jaw mechanism is configured and
adapted to perform an electrosurgical function. The jaw mechanism
is configured and adapted to deliver electrosurgical energy to a
target surgical site.
[0019] It is further envisioned that the surgical instrument is
operatively couplable to a robotic system, wherein the end effector
is configured and adapted to be remotely operated by the robotic
system.
[0020] It is contemplated that the surgical instrument can include
a loading unit having a proximal end and a distal end, the proximal
end being selectively removably connected to the surgical
instrument, the end effector is operatively connected to and part
of the loading unit, and the loading unit includes the at least one
MEMS device.
[0021] The end effector can be a surgical stapler including a
staple cartridge assembly, and an anvil operatively associated with
the staple cartridge assembly, the staple cartridge assembly and
the anvil being movable and juxstaposable relative to one another.
Each of the staple cartridge assembly and the anvil define tissue
contacting surfaces and wherein at least one MEMS device is
operatively connected to the at least one of the tissue contacting
surface of the staple cartridge assembly and the tissue contacting
surface of the anvil.
[0022] The MEMS devices are configured and adapted to measure
distance between the tissue contacting surface of the staple
cartridge assembly and the tissue contacting surface of the anvil.
The MEMS devices are configured and adapted to measure at least one
of the amount of pressure applied to tissue and the thickness of
tissue clamped between the tissue contacting surface of the staple
cartridge assembly and the tissue contacting surface of the
anvil.
[0023] The loading unit can include an elongate shaft having a
distal end, the end effector being operatively connected to a
distal end of an elongate shaft and the staple cartridge and the
anvil are oriented transversely with respect to the elongate
shaft.
[0024] It is envisioned that the end effector is configured and
adapted to perform an anastomosis. It is further envisioned that
the end effector is a jaw mechanism including a pair of jaw members
pivotably coupled to the distal end of the elongate shaft. The at
least one MEMS device is provided on at least one of the pair of
jaw members. The MEMS devices can be provided at least at one of a
proximal end, a distal end and along a length of each of the pair
of jaw members.
[0025] It is envisioned that the jaw mechanism is configured and
adapted to perform an electrosurgical function. The jaw mechanism
can be configured and adapted to deliver electrosurgical energy to
the target surgical site.
[0026] It is envisioned that each of the plurality of MEMS devices
is electrically connected to a control box via a lead wire
extending from the housing.
[0027] The surgical instrument can further include a control box
electrically connected to each of the plurality of MEMS devices via
at least one wire lead.
[0028] According to another aspect of the present invention, there
is provided a robotic system for performing surgical tasks a frame,
a robotic arm connected to the frame and movable relative to the
frame, an actuation assembly operatively associated with the
robotic arm for controlling operation and movement of the robotic
arm, a loading unit including an elongate shaft operatively
connected to the robotic arm, and an end effector operatively
coupled to a distal end of the elongate shaft and configured to
engage tissue, and at least one micro-electromechanical system
(MEMS) device operatively connected to the loading unit for at
least one of sensing a condition, measuring a parameter and
controlling the condition and/or parameter adjacent the end
effector.
[0029] The at least one MEMS device is at least one of a pressure
sensor, a strain sensor, a displacement sensor, an optical sensor,
a biosensor, a temperature sensor, a torque sensor, an
accelerometer, a flow sensor, an electrical sensor and a magnetic
sensor for at least one of sensing, measuring and controlling an
associated condition and/or parameter.
[0030] In one embodiment the end effector includes a pair of jaw
members movably coupled to the distal end of the elongate shaft. It
is envisioned that a plurality of MEMS devices are provided on each
of the pair of jaw members. Preferably, a plurality of MEMS devices
are provided at least at one of a proximal end, a distal end and
along a length of each of the pair of jaw members.
[0031] The loading unit can be connected to the robotic arm via a
bayonet-type connection.
[0032] In another embodiment, the end effector is configured and
adapted to perform an electrosurgical function. Preferably, the end
effector is configured and adapted to deliver electrosurgical
energy to the target surgical site.
[0033] In yet another embodiment, the robotic system further
includes a controller having a processor and a receiver for
receiving electrical signals transmitted from the actuation
assembly and for controlling the operation and movement of the
loading unit.
[0034] The end effector can be a fastener applier, a surgical
stapler, a vessel clip applier or a vascular suturing assembly.
[0035] As a surgical stapler, the end effector includes a staple
cartridge assembly and an anvil operatively associated with the
staple cartridge assembly and in juxtaposition relative to the
staple cartridge assembly, and wherein at least one MEMS device is
operatively connected to each of the staple cartridge assembly and
the anvil. The staple cartridge assembly defines a tissue
contacting surface and wherein at least one MEMS device is
operatively connected to the tissue contacting surface of the
staple cartridge assembly. The anvil defines a tissue contacting
surface and wherein at least one MEMS device is operatively
connected to the tissue contacting surface of the staple
cartridge.
[0036] The MEMS devices can be configured and adapted to measure
distance between the tissue contacting surface of the staple
cartridge assembly and the tissue contacting surface of the anvil.
Alternatively, the MEMS devices can be are configured and adapted
to measure the amount of pressure applied to tissue clamped between
the tissue contacting surface of the staple cartridge assembly and
the tissue contacting surface of the anvil.
[0037] The staple cartridge assembly and the anvil are desirably
transversely oriented with respect to the elongate shaft. It is
envisioned that the staple cartridge assembly and the anvil are
pivotably connected to the distal end of the elongate shaft.
[0038] As a vessel clip applier, the end effector includes a body
portion having a distal end and a proximal end, wherein the
proximal end is operatively connectable to the robotic arm, and a
jaw assembly operatively connected to the distal end of the body
portion, wherein the jaw assembly includes a first and a second jaw
portion. Each of the first and the second jaw portions includes at
least one MEMS device operatively connected thereto.
[0039] As a vascular suturing assembly, the end effector includes
an elongate body having a distal end and a proximal end, wherein
the proximal end in operatively connectable to the robotic arm, and
a pair of needle receiving jaws pivotably mounted to the distal end
of the elongate body portion, the pair of needle receiving jaws
being configured and adapted to pass a surgical needle and
associated length of suture material therebetween. Preferably, at
least one MEMS component is operatively connected to each of the
pair of needle receiving jaws.
[0040] According to yet another aspect of the present invention a
loading unit for use with a surgical instrument is provided and
includes an elongate tubular shaft having a proximal end and a
distal end, an end effector operably connected to the distal end of
the tubular shaft, a connector for connecting the proximal end of
the tubular shaft to a surgical instrument, and at least one
micro-electromechanical system (MEMS) device operatively connected
to the loading unit for at least one of sensing a condition,
measuring a parameter and controlling the condition and/or
parameter adjacent the end effector.
[0041] It is envisioned that at least one MEMS device is
operatively connected to the end effector. The MEMS device can be
at least one of a pressure sensor, a strain sensor, a displacement
sensor, an optical sensor, a biosensor, a temperature sensor, a
torque sensor, an accelerometer, a flow sensor, an electrical
sensor and a magnetic sensor for at least one of sensing, measuring
and controlling an associated condition and/or parameter.
[0042] It is contemplated that the surgical instrument is a
surgical stapler and the end effector includes a staple cartridge
assembly and an anvil operatively associated with the staple
cartridge, the staple cartridge and the anvil being movably
connected to one another to bring one into juxtaposition relative
to the other. Each of the staple cartridge and the anvil define
tissue contacting surfaces and the at least one MEMS device is
operatively connected to at least one of the tissue contacting
surface of the staple cartridge and the tissue contacting surface
of the anvil.
[0043] It is envisioned that a plurality of MEMS devices connected
to the surgical instrument, the MEMS devices being configured and
adapted to measure distance between the tissue contacting surface
of the staple cartridge assembly and the tissue contacting surface
of the anvil. It is further envisioned that the MEMS devices are
configured and adapted to measure the amount of pressure applied to
tissue clamped between the tissue contacting surface of the staple
cartridge and the tissue contacting surface of the anvil. It is
still further envisioned that the MEMS devices are configured and
adapted to measure the thickness of the tissue clamped between the
tissue contacting surface of the staple cartridge and the tissue
contacting surface of the anvil.
[0044] The end effector can be configured and adapted to perform an
anastomosis. The surgical instrument can be a linear stapler that
is adapted to perform an endoscopic gastrointestinal anastomosis.
The surgical instrument can be an annular stapler that is adapted
to perform an end-to-end anastomosis.
[0045] It is envisioned that the end effector is a jaw mechanism
including a pair of jaw members pivotably coupled to the distal end
of the elongate shaft. At least one MEMS device can be provided on
at least one of the pair of jaw members. The MEMS devices can be
provided at least at one of a proximal end, a distal end and along
a length of each of the pair of jaw members.
[0046] It is contemplated that at least one MEMS device is a
temperature sensing MEMS device. The temperature sensing MEMS
device is positioned on and/or encapsulated in thermally conductive
tips or elements, wherein the conductive tips are semi-rigid wires
made of shape memory metal for a particular application, wherein
the conductive tips are extendable out from the loading unit and
into the tissue adjoining the loading unit in order to monitor
temperature of the tissue adjoining the loading unit.
[0047] According to another aspect of the present invention, a
surgical instrument for use with a loading unit that is operatively
couplable to the surgical instrument and has an end effector with a
pair of juxtaposable jaws for performing a surgical function, the
end effector having at least one micro-electromechanical system
(MEMS) device operatively connected thereto for at least one of
sensing a condition, measuring a parameter and controlling the
condition and/or parameter adjacent the end effector. The surgical
instrument includes a housing, an elongate shaft that extends from
the housing and has a distal end operatively couplable to a loading
unit of the above type, an approximation mechanism for
approximating the pair of jaws, an actuation mechanism for
activating the jaws to perform the surgical function, and at least
one micro-electromechanical system (MEMS) device operatively
connected to the surgical instrument for at least one of sensing a
condition, measuring a parameter and controlling the condition
and/or parameter adjacent the end effector and for cooperative
operation with the at least one MEMS of the end effector.
[0048] It is an object of the present disclosure to provide
mechanical, electro-mechanical and energy based surgical
instruments and systems having micro-electromechanical devices
associated therewith to monitor, control, measure and/or regulate
conditions and parameters associated with the performance and
operation of the surgical instrument.
[0049] It is a further object of the present disclosure to provide
improved mechanical, electro-mechanical and energy based surgical
instruments and systems which are more effective, safer and/or
easier to use than similar conventional surgical instruments and
systems.
[0050] It is another object of the present disclosure to provide
improved mechanical, electro-mechanical and energy based surgical
instruments and systems which better control the effects they have
on target tissue and on the patient.
[0051] These and other objects will be more clearly illustrated
below by the description of the drawings and the detailed
description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the present disclosure and, together with the detailed description
of the embodiments given below, serve to explain the principles of
the disclosure.
[0053] FIG. 1 is a perspective view of a surgical stapling
instrument incorporating micro-electromechanical system devices, in
accordance with the present disclosure;
[0054] FIG. 2 is a partially exploded perspective view of an
alternative surgical stapling instrument incorporating
micro-electromechanical system devices in accordance with the
present disclosure;
[0055] FIG. 3 is a perspective view of yet another surgical
stapling instrument incorporating micro-electromechanical system
devices in accordance with the present disclosure;
[0056] FIG. 3A is an enlarged perspective view of a distal end of
the surgical stapling instrument of FIG. 3;
[0057] FIG. 4 is a perspective view of still another surgical
stapling instrument incorporating micro-electromechanical system
devices in accordance with the present disclosure;
[0058] FIG. 5 is a perspective view of a surgical instrument for
placing clips in laparoscopic or endoscopic procedures
incorporating micro-electromechanical system devices in accordance
with the present disclosure;
[0059] FIG. 5A is an enlarged perspective view of the indicated
region of the surgical instrument depicted in FIG. 5;
[0060] FIG. 6 is a perspective view of an energy-based surgical
instrument incorporating micro-electromechanical system devices in
accordance with the present disclosure;
[0061] FIG. 6A is an enlarged perspective view of the indicated
region of the surgical instrument depicted in FIG. 6;
[0062] FIG. 7 is a perspective view of a robotic system that
employs micro-electromechanical system devices in accordance with
the present disclosure;
[0063] FIG. 8 is a block diagram illustrating the components of a
disposable loading unit in accordance with the present
disclosure;
[0064] FIG. 9 is a perspective view, with portions broken away, of
a robotic system coupled to a loading unit, including an end
effector for applying surgical staples;
[0065] FIG. 10 is a perspective view, with portions broken away, of
a robotic system coupled to a loading unit, including an end
effector for applying electrosurgical energy;
[0066] FIG. 11 is a perspective view, with portions broken away, of
a robotic system coupled to a loading unit, including an end
effector for applying vessel clips; and
[0067] FIG. 12 is a perspective view, with portions broken away, of
a robotic system coupled to a loading unit, including an end
effector for applying a vascular suture.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0068] Preferred embodiments of the presently disclosed surgical
instruments and systems will now be described in detail with
reference to the drawing figures wherein like reference numerals
identify similar or identical elements. As used herein and as is
traditional, the term "distal" will refer to that portion which is
further from the user while the term "proximal" will refer to that
portion which is closer to the user.
[0069] In accordance with the present disclosure, a
micro-electromechanical system (MEMS) is used to provide highly
miniaturized MEMS devices and/or systems capable of performing
various functions, e.g., sensing, monitoring, controlling,
influencing, regulating and/or measuring various conditions and/or
parameters of surgical instruments and systems, such as, for
example, the distance between and/or the pressure applied by the
jaws of an end effector. In the present disclosure, "controlling"
is meant to include influencing and/or regulating. The MEMS devices
and/or systems can also provide feedback for automatic (remote or
manual) control of the operation of the surgical instrument.
[0070] MEMS devices have the required very small size, low power
requirements, and ability to be readily integrated with standard
electrical systems. These characteristics make MEMS devices ideal
for incorporation into and/or on surgical instruments and systems.
As will be described in greater detail below, MEMS devices can be
utilized in conjunction with, and incorporated into and/or on
various portions and structural elements of surgical instruments
and systems.
[0071] MEMS devices and/or systems considered to be within the
scope of the present disclosure, include, for example, MEMS sensors
and/or sensor devices, actuator MEMS devices (motors, hydraulics,
pumps, ultrasonic devices, etc.), fluid moving and mixing
components, heaters, and diagnostic MEMS devices for measuring
physiologic parameters and tissue properties, such as the integrity
of a staple line or of a repaired or joined tissue by measuring
fluid, e.g., blood flow and/or presence, and electrical signals or
pressure within the stapled tissue.
[0072] Also considered within the scope of this disclosure are:
types of MEMS devices and/or systems used to determine and/or
measure distance including capacitive, magnetic (Hall Effect
sensors, for measuring the strength of the magnetic field between
one or more magnets), light or radio frequency (RF)
emitting/receiving, and optical fiber interferometric sensors;
types of MEMS devices and/or systems used to determine and/or
measure the amount of pressure applied to tissue including
capacitive, piezoelectric, piezoresistive, resonant, light or RF
emitting/receiving, and optical fiber interferometric sensors; and
types of MEMS devices and/or systems used to determine and/or
measure tissue thickness, and to determine or measure pressure
and/or to provide pressure data to a processor which correlates the
pressure data with tissue thickness using a look-up table or other
data structure. By knowing the tissue thickness, the surgeon can
then determine the proper size of the staples and/or tissue gap
between the tissue contacting surfaces of the anvil and staple
cartridge before performing the stapling procedure.
[0073] While MEMS devices and/or systems are preferred, it is
within the scope of the present disclosure and envisioned that
other types of devices and/or systems can be used with or without
MEMS devices and/or systems to determine and/or measure various
conditions and/or parameters.
[0074] In a preferred configuration, the surgical instrument can
include one or more transducer MEMS delivery devices and/or systems
capable of being powered by a battery for generating RF or other
types of signals. These transducer MEMS delivery devices are
aligned with transducer MEMS receiving devices capable of receiving
the generated signals. Accordingly, the distance between the
transducer MEMS delivery and receiving devices can be measured by a
processor correlating the transmission time of the generated RF
signals with distance using a data structure. By knowing the
distance, the processor can then compute the thickness of the
tissue clamped by the surgical instrument.
[0075] Further, when the transducer MEMS delivery and/or receiving
devices press upon the tissue clamped by the surgical instrument,
pressure from the tissue is applied to the transducer MEMS delivery
and/or receiving devices and/or systems. The transducer MEMS
delivery and/or receiving devices and/or systems in turn determine
the applied pressure and output signals.
[0076] Alternatively, one or more transducer MEMS delivery and/or
receiving components, capable of generating and receiving signals
reflected off a target, can be provided on the anvil and/or the
staple cartridge in order to determine the distance between the
tissue contacting surfaces of the anvil and the staple cartridge
for determining if the staple cartridge should be fired.
[0077] Preferably, circuitry of the MEMS devices and/or systems
amplifies the signals, before being transmitted to standard
electrical components or to the processor, for analysis using
conventional algorithms implemented as a set of programmable
instructions. The processor analyzes the reading to determine if
the reading is within the desired limits for the surgical
instrument and/or the current application. The processor can use at
least one or more comparators to compare the value of the
determined reading with stored, predetermined values.
[0078] If the determined reading is within the desired limits for
the surgical instrument, then the surgical instrument can be fired
as usual. However, if the reading is outside of the desired limits,
the surgical instrument and/or the operator can: (1) prevent the
firing of the surgical instrument until the reading is within the
desired limits; (2) adjust the components of the surgical
instrument in order to alter the reading as needed; (3) alert the
operator; and/or (4) wait a few moments and then take the reading
again.
[0079] Further, the measured readings received from the MEMS
devices and/or systems can also be used to control the firing of
the surgical instrument. For example, if the tissue thickness is
large, the firing of the surgical instrument can be automatically
or manually adjusted in order for the surgical instrument to be
fired with sufficient power to affect all of the tissue. The
reading of tissue thickness can also be used by a surgeon to
determine whether the power applied by the surgical instrument is
large enough to penetrate and affect all of the tissue.
[0080] The MEMS devices and/or systems are preferably positioned at
opposing or juxtaposed locations when used to measure and/or
determine distances. The MEMS devices are also preferably
positioned on tissue contacting surfaces of the surgical instrument
in order to measure and/or determine a distance between the tissue
contacting surfaces of the surgical instrument as one or more
structural components of the surgical instrument is/are moved
relative to one another. It is further envisioned that MEMS devices
and/or systems are capable of measuring and/or determining a
thickness of tissue clamped between the tissue contacting surfaces
of the surgical instrument.
[0081] Other types of MEMS devices and/or systems that can be used
within the scope of the present disclosure include strain, optical,
flow, electrochemical and bio-sensors. Optical sensors for
fluorescence and absorption for determining, for example, the
presence of blood glucose, and hence, the presence of blood,
require fiber optic connections to photodetectors and/or
photomultiplier tubes that may or may not be miniaturized.
Biosensors can be used to measure tissue characteristics before
and/or after the stapling procedure. That is, bio-sensors can be
used to ensure that the tissue is in condition or acceptable for
stapling, or as a check after the staples have been fired to ensure
that the tissue is healthy (e.g., has good blood flow, is healing
properly, etc).
[0082] Turning now to FIGS. 1-4, specific embodiments of several
representative surgical staplers including MEMS devices "M", in
accordance with the present disclosure, are shown. As seen in FIG.
1, a first embodiment of a surgical stapler, here, a transverse
anastomotic stapler, in accordance with the present disclosure, is
shown generally as 100. Surgical stapler 100 includes a housing 112
including a stationary handle 114, a distally extending body
portion 116 operatively connected to housing 112, and a transverse
body portion 115 operatively connected to distally extending body
portion 116. Transverse body portion 115 is configured and adapted
to operatively receive a support frame 118 in a distal end
thereof.
[0083] Surgical stapler 100 further includes an anvil 120 fastened
to a first leg 124 or distal portion of support frame 118 and
extending transversely across transverse body portion 115. Surgical
stapler 100 further includes a staple cartridge assembly 122
operatively received within transverse body portion 115. Each of
anvil 120 and staple cartridge assembly 122 include juxtaposed
tissue contacting surfaces 120a, 122a, respectively. A trigger
actuator 134 is operatively connected to handle 114 and is
configured and adapted to distally advance staple cartridge
assembly 122 toward anvil 120 in order to fire surgical stapler
100.
[0084] In accordance with the present disclosure, surgical stapler
100 includes a plurality of MEMS devices "M" provided at specific
locations thereon. In particular, by way of example only and in no
way is it to be considered as limiting, as seen in FIG. 1, MEMS
devices "M" can preferably be provided along the length of tissue
contacting surface 120a of anvil 120, along the length of tissue
contacting surface 122a of staple cartridge assembly 122 and/or on
staple cartridge assembly 122 and transverse body portion 115.
[0085] As described above, MEMS devices "M" enable, for example,
the measurement of various parameters of surgical stapler 100, such
as, for example, the distance between tissue contacting surfaces
120a and 122a of surgical stapler 100, as well as the amount of
pressure applied to tissue clamped between tissue contacting
surfaces 120a, 122a. It is further envisioned that MEMS devices "M"
are capable of measuring and/or determining a thickness of the
tissue clamped between tissue contacting surfaces 120a, 122a.
[0086] It is envisioned that MEMS devices "M" may transmit feedback
signals of the measured and/or sensed parameters to a central
processing unit "CPU" (e.g., control box 562 of FIG. 6) or
actuation assembly 612 (see FIG. 7), via wire leads 560 (see FIG.
6) or transmission wires "W" (see FIG. 7), for further processing.
Alternatively, it is contemplated that MEMS devices "M" can
transmit feedback signals of the measured and/or sensed parameters
to the CPU via wireless transmissions.
[0087] Reference is made to commonly assigned U.S. Pat. No.
5,964,394 to Robertson, the entire content of which is incorporated
herein by reference, for a more detailed explanation of the
operation of surgical stapler 100.
[0088] Turning now to FIG. 2, an alternative embodiment of a
surgical stapler, here, an open gastrointestinal anastomotic
stapler, in accordance with the present disclosure, is shown
generally as 200. Surgical stapler 200 includes a cartridge
receiving half-section 212, an anvil half-section 214 operatively
couplable to cartridge receiving half-section 212, a staple
cartridge assembly 216 configured and adapted to be removably
mounted within a distal end of cartridge receiving half-section
212, and an anvil 218 operatively mounted to a distal end of anvil
half-section 214. Staple cartridge assembly 216 includes a tissue
contacting surface 216a and anvil 218 includes a tissue contacting
surface 218a juxtaposed to tissue contacting surface 216a of staple
cartridge assembly 216.
[0089] In accordance with the present disclosure, surgical stapler
200 includes a plurality of MEMS devices "M" provided at specific
locations thereon. In particular, by way of example only and in no
way is it to be considered as limiting, as seen in FIG. 2, MEMS
devices "M" can preferably be provided along the length of or as
shown, at specific locations on tissue contacting surface 218a of
anvil 218, along the length of tissue contacting surface 216a of
staple cartridge assembly 216, on the distal end portions of
cartridge receiving half-section 212 and anvil half-section
214.
[0090] As described above, MEMS devices "M" enable the measurement
of various parameters of surgical stapler 200, such as, for
example, the distance between tissue contacting surfaces 216a and
218a of surgical stapler 200, as well as the amount of pressure
applied to tissue clamped between tissue contacting surfaces 216a,
218a of surgical stapler 200.
[0091] Reference is made to commonly assigned U.S. Pat. No.
6,045,560 to McKean et al., U.S. Pat. No. 6,032,849 to Mastri et
al., and U.S. Pat. No. 5,964,394 to Robertson, the entire contents
of each of which are incorporated herein by reference, for a more
detailed explanation of the operation of surgical stapler 200.
[0092] Turning now to FIGS. 3 and 3A, yet another embodiment of a
surgical stapler, here, an endoscopic gastrointestinal anastomotic
stapler, in accordance with the present disclosure, is shown
generally as 300. Briefly, surgical stapler 300 includes a handle
assembly 312 and an elongated body 314. A disposable loading unit
or DLU 316 is releasably secured to a distal end of elongated body
314. Disposable loading unit 316 includes an end effector 317
having a staple cartridge assembly 318 housing a plurality of
surgical staples (not shown) and an anvil 320 movably secured in
relation to staple cartridge assembly 318. Staple cartridge
assembly 318 includes a tissue contacting surface 318a and anvil
320 includes a tissue contacting surface 320a juxtaposed to tissue
contacting surface 318a of staple cartridge assembly 318.
[0093] Handle assembly 312 includes a stationary handle member 322,
a movable handle member 324 and a barrel portion 326. A rotatable
member 328 is preferably mounted on the forward end of barrel
portion 326 to facilitate rotation of elongated body 314 with
respect to handle assembly 312. An articulation lever 330 is also
preferably mounted on the forward end of barrel portion 326
adjacent rotatable knob 328 to facilitate articulation of end
effector 317.
[0094] In accordance with the present disclosure, surgical stapler
300 includes a plurality of MEMS devices "M" provided at specific
locations thereon. In particular, by way of example only and in no
way is it to be considered as limiting, as seen in FIGS. 3 and 3A,
MEMS devices "M" can be provided preferably along the length of
tissue contacting surface 320a of anvil 320, along the length of
tissue contacting surface 318a of staple cartridge assembly 318, on
disposable loading unit 316, on elongated body 314 and/or on handle
assembly 312.
[0095] As described above, MEMS devices "M" enable the measurement
of various parameters of surgical stapler 300, such as, for
example, the distance between tissue contacting surfaces 318a and
320a of surgical stapler 300, as well as the amount of pressure
applied to tissue clamped between tissue contacting surfaces 318a,
320a of surgical stapler 300.
[0096] In another preferred configuration, as shown in FIGS. 3 and
3A, MEMS devices "M" are positioned in proximity to a pivot point
of anvil 320 and staple cartridge assembly 318 of surgical stapler
300. Other MEMS devices "M" are positioned remotely from the pivot
point. It is envisioned that the MEMS devices "M" positioned on
anvil 320 and staple cartridge assembly 318 can be of the type
capable of emitting light from laser diodes or from a fiber optic
waveguide. In particular, a MEMS device in the form of a MEMS light
producing sensor/device (e.g., bicell or photodiode) is positioned
opposite an aforementioned MEMS device for detecting changes in the
amount of light being received as a result of the changing angle of
rotation between anvil 320 and staple cartridge 318.
[0097] Accordingly, in use, if the amount of light being received
is high, a MEMS light producing device and its corresponding MEMS
light detection device are close to each other. Accordingly, the
distance between anvil 320 and staple cartridge assembly 318 is
small, and, if there is any tissue clamped between anvil 320 and
staple cartridge assembly 318, the thickness of the tissue is also
small. If the amount of light being received is low, the MEMS light
producing device and its corresponding MEMS light detection device
are further from each other. Accordingly, the distance between
anvil 320 and staple cartridge assembly 318 is large, and, if there
is any tissue clamped between anvil 320 and staple cartridge
assembly 318, the thickness of the tissue is also large.
[0098] Distance and tissue thickness can also be determined by
timing the duration until the MEMS light detection device senses
light once the MEMS light producing device is turned on. If the
MEMS light detection device senses light, for example, at time
t.sub.0 after the MEMS light producing device is turned on, then
anvil 320 and staple cartridge assembly 318 are in close proximity
or touching (small tissue thickness). If the MEMS light detection
device senses light, for example, at time t.sub.0+t.sub.1 after the
MEMS light producing device is turned on, then anvil 320 and staple
cartridge assembly 318 are at a predetermined distance from each
other. Also, if there is any tissue clamped between anvil 320 and
staple cartridge assembly 318, then the tissue thickness is a
predetermined tissue thickness. The predetermined distance and
tissue thickness can be determined by a processor accessing one or
more look-up tables or other data structures and correlating the
measured time to distance and, then correlating the distance to
tissue thickness.
[0099] Reference is made to commonly assigned U.S. Pat. Nos.
5,865,361, 6,330,965 and 6,241,139 to Milliman et al., the entire
contents of which are incorporated herein by reference, for a more
detailed explanation of the operation of surgical stapler 300.
[0100] Turning now to FIG. 4, an alternative embodiment of a
surgical stapler, in accordance with the present disclosure, is
shown generally as 400. Briefly, surgical stapler 400 includes a
handle assembly 412 having at least one pivotable actuating handle
member 414 and an advancing member 416 configured and adapted to
open and close surgical stapler 400. Surgical stapler 400 further
includes a tubular body portion 420 extending from handle assembly
412, an annular staple cartridge assembly 422 operatively connected
to a distal end of tubular body portion 420, and an annular anvil
426 positioned opposite staple cartridge assembly 422 and connected
to surgical stapler 400 by a shaft 428. Staple cartridge assembly
422 includes a tissue contacting surface 422a and anvil 426
includes a tissue contacting surface 426a in juxtaposition relative
to tissue contacting surface 422a of staple cartridge assembly
422.
[0101] In accordance with the present disclosure, surgical stapler
400 includes a plurality of MEMS devices "M" provided at specific
locations thereon. In particular, by way of example only and in no
way is it to be considered as limiting, as seen in FIG. 4, at least
one MEMS device "M" can be provided preferably on tissue contacting
surface 426a of anvil 426, tissue contacting surface 422a of staple
cartridge assembly 422, on shaft 428 and/or on handle assembly
412.
[0102] As described above, MEMS devices "M" enable the measurement
of various parameters of surgical stapler 400, such as, for
example, the distance between tissue contacting surfaces 422a and
426a of surgical stapler 400, as well as the amount of pressure
applied to tissue clamped between tissue contacting surfaces 422a,
426a of surgical stapler 400.
[0103] Reference is made to commonly assigned U.S. Pat. No.
5,915,616 to Viola et al., the entire content of which is
incorporated herein by reference, for a more detailed explanation
of the operation of surgical stapler 400.
[0104] While MEMS devices for determining distance and/or pressure
are shown located at certain discrete positions on the structural
elements of the surgical staplers shown in FIGS. 1-4, it is within
the scope of the present disclosure that MEMS devices for
determining distance and/or pressure can be positioned anywhere on
the structural elements of the surgical staplers.
[0105] In FIGS. 1-4, MEMS devices "M" are merely located at
representative positions and are not intended to be indicative of
the only positions where MEMS devices "M" can be provided or the
numbers of MEMS devices "M" that can be provided. It is envisioned
that a staple cartridge holding component of the surgical stapler,
including a staple cartridge, can be automatically or manually
moved away from an anvil if the pressure applied to the clamped
tissue is above a predetermined threshold. The surgical stapler can
also be automatically or manually prevented from being fired in
response to the feedback provided by MEMS devices "M". The feedback
provided by MEMS devices "M" could be in the form of feedback
signals (e.g., audio, visual and/or audiovisual), and/or in the
form of mechanical feedback (e.g., a tactile indication).
[0106] The surgical staplers disclosed herein can be fitted with
different-sized surgical staples (i.e., staples having varying
length legs) and can be adapted to automatically select the proper
sized staples for performing a or the particular surgical procedure
according to information obtained by the MEMS devices "M".
[0107] Turning now to FIGS. 5 and 5A, in which like reference
numerals identify similar or identical elements, a surgical
instrument for placing clips in laparoscopic or endoscopic
procedures employing the novel features of the present disclosure
is generally designated with the reference numeral 450.
[0108] As seen in FIG. 5, surgical instrument 450 includes a handle
portion 452 having pivoting or movable handle 454 and stationary
handle 456. Manipulation of handles 454, 456 actuates a tool
assembly, such as a jaw assembly 458, through elongated body 460
which extends distally from handle portion 452. Elongated body 460
is preferably rotatable with respect to handle portion 452 by
turning knob 459. Jaw assembly 458 includes first and second
juxtaposed jaw portions 462a, 462b, respectively, which are
simultaneously movable between a substantially approximated
position, in which jaw portions 462a and 462b are in relatively
close relation to one another, and a spaced position, in which jaw
portions 462a and 462b are separated at least a sufficient distance
to receive an unformed surgical clip 464 (see FIG. 5A)
therebetween.
[0109] It is envisioned that a plurality of surgical clips 464 are
stored in a loading unit 466 which is releasably mounted to
elongated body 460. In a preferred embodiment, loading unit 466 is
disposable (i.e., in the form of a disposable loading unit or
"DLU") subsequent to depletion of the supply of surgical clips 464
stored therein. The remainder of surgical instrument 450 may be
disassembled, resterilized and reused in combination with another
loading unit containing a supply of surgical clips 464.
[0110] In use, approximation of movable handle 454 toward
stationary handle 456 results in the advancement of a distal-most
surgical clip 464 to a position between jaw portions 462a and 462b.
Further approximation of handles 454, 456 toward one another
results in the approximation of jaw portions 462a and 462b toward
one another to form the surgical clip disposed therebetween.
[0111] In accordance with the present disclosure, surgical
instrument 450 includes a plurality of MEMS devices "M" provided at
specific locations thereon. In particular, by way of example only
and in no way is it to be considered limiting, as seen in FIGS. 5
and 5A, at least one MEMS device "M" can be provided preferably on
the tissue contacting surface of at least one, preferably each, jaw
portion 462a, 462b of jaw assembly 458, on loading unit 466 and/or
elongated body 460, and/or on handle portion 452.
[0112] As described above, MEMS devices "M" enable the measurement
of various parameters of surgical instrument 450, such as, for
example, the distance between the tissue contacting surfaces of jaw
portions 462a, 462b, as well as the amount of pressure applied to
tissue clamped between jaw portions 462a, 462b. It is further
envisioned that MEMS devices "M" are capable of measuring and/or
determining a thickness of the tissue clamped between tissue
contacting surfaces of jaw portions 462a, 462b.
[0113] Reference is made to commonly assigned U.S. Pat. No.
6,059,799 to Aranyi et al., the entire content of which is
incorporated herein by reference, for a more detailed explanation
of the operation of surgical instrument 450.
[0114] Turning now to FIGS. 6 and 6A, in which like reference
numerals identify similar or identical elements, a surgical
instrument employing the novel features of the present disclosure
is generally designated with the reference numeral 500.
[0115] As seen in FIG. 6, surgical instrument 500 includes a
housing 512 having a fixed handle portion 514, a movable handle
portion 516, an elongated shaft 518 extending distally from housing
512, and a jaw mechanism 522 operatively coupled to a distal end of
shaft 518. As seen in detail in FIG. 6A, jaw mechanism 522 includes
a pair of jaw members 580, 582 which are pivotable about pin 519 in
order to provide the opening and closing of jaw mechanism 522.
Surgical instrument 500 is configured and adapted such that, in
operation, manipulation of movable handle portion 516, distally and
proximally, relative to fixed handle portion 514, causes jaw
members 580, 582 of jaw mechanism 522 to open and close. Jaw
members 580, 582 are shown as being configured and adapted to
perform an electrosurgical function, such as, for example,
coagulation, cauterization and the like.
[0116] Jaw mechanism 522 can be configured to grasp, staple, cut,
retract, coagulate and/or cauterize. The above examples are merely
intended to be illustrative of a few of the many functions which
jaw mechanism 522 can be configured to accomplish and in no way is
intended to be an exhaustive listing of all of the possible jaw or
like or pivotable structures.
[0117] As further shown in FIG. 6A, jaw mechanism 522 is provided
with a plurality of micro-electrosurgical system (MEMS) devices "M"
placed at specific desired locations on, in or along the surfaces
of jaw members 580, 582. For example, MEMS devices "M" can be
placed near a proximal end and/or near a distal end of jaw members
580, 582, as well as along the length of jaw members 580, 582.
[0118] In one preferred embodiment of the present disclosure, MEMS
devices "M" offer a solution for controlling the amount of energy
delivered, by radio frequency (e.g., monopolar or bipolar),
ultrasonic, laser, argon beam or other suitable energy systems, to
tissue during treatment with energy based electrosurgical
instruments, for example, electrocautery surgical instruments. In
electrocautery surgical instruments the degree of tissue cutting,
coagulation and damage are influenced by the power setting, the
force applied by the jaw mechanism of the electrocautery surgical
instrument to the tissue, the duration of contact between the jaw
mechanism of the electrocautery surgical instrument and the tissue,
as well as other factors.
[0119] Accordingly, it is contemplated that energy sensing MEMS
devices "M", capable of measuring and/or sensing energy, be used to
monitor, control, measure and/or regulate the amount of energy
delivered by surgical instrument 500 to the tissue. Energy sensing
MEMS devices "M" can provide feedback to electronics within the
electrocautery instrument, for example, to create a more consistent
desired tissue effect. In particular, it is envisioned that
selected MEMS devices "M" are configured and adapted to be force
and/or pressure sensing MEMS devices so that a pressure or a
gripping force applied to the tissue by jaw members 580, 582 can be
sensed and regulated.
[0120] It is further envisioned that selected MEMS devices "M" can
be configured and adapted to measure temperature on or near an
active blade (not shown) of surgical instrument 500 (i.e., an
electrocautery instrument, electrosurgical pencil, etc.). These
temperature sensing MEMS devices "M" can be used to monitor and
control the temperature of the active blade of the electrocautery
instrument, such that the active blade is able to reach and
maintain a specific temperature, for example, by having
intermittent bursts of energy supplied to the active blade or by
controlling the power or energy delivered to the active blade
whenever the temperature of the active blade drops below a certain
threshold level.
[0121] In one embodiment, it is envisioned that these temperature
sensing MEMS devices "M" can be thermocouples positioned directly
on a probe or an instrument and electrically and thermally
insulated from the same for the sensing and/or measuring the
temperature of tissue located adjacent thereto. It is further
contemplated that, due to their relatively smaller size and
sensitivities, temperature sensing MEMS devices "M" can be
positioned on and/or encapsulated in thermally conductive tips or
elements that could be semi-rigid wires or wires made of shape
memory metals for a particular application that could be extended
out from the probe and into the tissue adjoining a treatment probe
in order to monitor the temperature of the tissue adjoining the
treatment probe.
[0122] It is further contemplated that selected MEMS devices "M"
are configured and adapted to be current sensing MEMS devices for
regulating and monitoring electrical current delivered to the
active blade and through the tissue. It is envisioned that the flow
or amount of current could be regulated to stop after delivery of a
specific amount of energy or after reaching a specific current
value.
[0123] In addition, it is contemplated that selected MEMS devices
"M" are configured and adapted to control the energy treatment by
detecting the distance between moveable elements, such as, for
example, jaws having electrodes, in order to maintain the jaws at
an optimal distance for one or more aspects of a given treatment
application. For example, distance sensing MEMS devices "M" can be
employed to use light beams emitted from laser diodes and/or guided
through fiber optics in conjunction with a detecting device, such
as, for example, a bicell or a photo diode positioned directly on
the tip of the probe or at a remote location suitable for measuring
the relative distance between portions of the jaws.
[0124] In an alternative embodiment of the present disclosure, it
is envisioned that MEMS devices "M" are configured and adapted to
be accelerometer MEMS devices "M", which accelerometers detect
frequencies by displacement of a cantilevered or tuned element
associated with MEMS devices "M". Accordingly, when the surgical
instrument is an energy based surgical instrument, for example, of
the cutting or coagulating type (e.g., electrosurgical instrument)
which includes a jaw mechanism 522 as described above, MEMS devices
"M" employing suitable sensors can be employed for measuring the
acceleration and displacement of jaw members 580, 582 in relation
to each other. Accordingly, accelerometer MEMS devices "M" can be
positioned on individual components, such as, for example, each jaw
580, 582, to measure their relative acceleration, on the overall
surgical instrument 500 or on a fixed blade which performs the
coagulating and cutting functions, such as, for example, an
electrosurgical pencil to measure the acceleration of the
instruments a whole, or a combination thereof.
[0125] When accelerometer MEMS devices "M" are employed and
suitably integrated as two or three orthogonal assemblies, they
effectively constitute a two-dimensional or three-dimensional
acceleration measuring device or gyroscope type device when
provided with a known point of origination and appropriately
configured computer system. In this embodiment, MEMS devices "M"
can be advantageously employed as a passive system for tracking the
distance between the jaws, position of the instrument relative to
the target tissue portion and duration of treatment.
[0126] A further application for MEMS devices "M" in surgical
instruments such as electrosurgical cutting or coagulating devices
includes torque sensing. It is contemplated that selected torque
sensing MEMS devices "M" can be properly positioned on each jaw
member 580, 582, on jaw mechanism 522 or on a combination of both.
Torque sensing MEMS devices "M" can be configured and adapted to
employ strain sensors or optical measuring systems, for example. It
is envisioned that, torque sensing MEMS devices "M" can be
configured to detect the deflection at different points along the
element or handle of the instrument relative to one another.
Accordingly, the deflection of portions of the surgical instrument,
at predetermined points and angles of application of torque sensing
MEMS devices "M", could be equated to an applied force or torque.
Strain sensors or fiber optic or integrated waveguide structure in
conjunction with a detection system could be used to detect,
measure and control the degree of force applied to or exerted by
components by monitoring the relative changes in distance or
deflection of portions of the instrument.
[0127] Preferably, as seen in FIG. 6, MEMS devices "M" are
electrically coupled to a control box 562 via wire leads 560
extending from housing 512. It is envisioned that wire leads 560
travel through housing 512 and shaft 518 to MEMS devices "M". In a
preferred embodiment, MEMS devices "M" and control 562 box are
electrically coupled to a feedback circuit (not shown). The
feedback circuit would continually monitor and transmit signals and
parameters between MEMS devices "M" and control box 562.
[0128] MEMS devices "M", such as those described above, may also be
employed individually or in combination with traditional sensor
systems, such as, for example, loss detection circuitry between
elements of the instrument, and can be suitably configured to
provide feedback to an electronic control system (e.g., computer,
microprocessor, programmable logic controller or combination
thereof) for tracking each reported feedback parameter relative to
predefined criteria for the automatic adjustment and control of the
energy delivered by the instrument in order to, e.g., measure,
determine, verify and/or control the effectiveness of the treatment
and proper performance of the surgical instrument. The control
system would preferably also be configured with logic to weight the
inputs of each parameter sensed by a MEMS device "M" and
accommodate the selective manual operation of any parameter. Thus,
parameters of MEMS devices "M" may be integrated into a single
computerized display system or separately monitored, for example,
by the display system or by simple audible, visual or tactile
warning systems. The control system could be integrated at least
partially into the instrument or a separate system connected to the
instrument.
[0129] By way of example only, in accordance with the present
disclosure, it is envisioned that the MEMS devices "M" can include
pressure measuring devices (i.e., capacitive, piezoresistive,
piezoelectric, resonant and/or optical fiber interferometric,
etc.), strain measuring devices (i.e., piezoresistive,
piezoelectric and/or frequency modulation, etc.), displacement
measuring devices (i.e., capacitive, magnetic and/or optical fiber
interferometric), optical (i.e., fluorescence, absorption and/or
optical fiber interferometric), biosensors (for measuring, i.e.,
glucose, neural probes, tactile, pH, blood gases) and/or
immunosensors, temperature sensors, torque sensors, accelerometers,
flow sensors and electrochemical and/or electromagnetic sensors,
and combinations of the above.
[0130] In accordance with the principles of the present disclosure,
as seen in FIGS. 7-12, it is envisioned that the above described
surgical instruments, together with their respective incorporated
MEMS devices "M" can be employed with or interface directly with a
robotic surgical system 600. An exemplary robotic surgical system
is disclosed in commonly assigned U.S. Pat. No. 6,231,565 to Tovey
et al., the entire contents of which is incorporated herein by
reference.
[0131] Generally, robotic surgical systems include surgical
instrument or systems, either powered locally or remotely, having
electronic control systems localized in a console or distributed
within or throughout the surgical instrument or system. The
surgical instrument systems can be powered and controlled
separately from the robotic system or, in the alternative, the
power and control systems can be integrated or interfaced with the
robotic surgical system.
[0132] In particular, as seen in FIG. 7, robotic surgical system
600 includes an actuation assembly 612, a monitor 614, a robot 616
and a loading unit 618 releasably attached to robot 616 and having
at least one surgical instrument 620 for performing at least one
surgical task operatively connected thereto. Robot 616 includes a
trunk 622 extending from a base 624, a shoulder 626 connecting
trunk 622 to an upper arm 628, an elbow 630 connecting upper arm
628 to a lower arm 632, and a wrist 634 attached to lower arm 632
from which extends a mounting flange 636. Preferably, mounting
flange 636 is capable of moving in six degrees of freedom.
[0133] As used herein, "loading unit" is understood to include
disposable loading units (e.g., DLU's) and single use loading units
(e.g., SULU's). SULU's include removable cartridge units, e.g., for
open gastrointestinal anastomosis and transverse anastomosis
staplers and include removable units, e.g., those having a shaft
316, a cartridge assembly 318 and an anvil 317 (see, e.g., FIG. 3
hereof). These latter removable units, which can be modified, are
sometimes referred to as DLU's (e.g., see 618 in FIGS. 7 and 718 in
FIG. 9).
[0134] Disposable loading unit 618 further includes a head portion
640 for housing an electro-mechanical assembly 619 (see FIG. 8)
therein for operating surgical instrument 620 and an attachment
platform 642 for releasably attaching disposable loading unit 618
to robot 616 via mounting flange 636. Mounting flange 636
preferably includes two slots 635 which inter-engage with
protrusions 638 of platform 642 to connect to mounting flange 636
with disposable loading unit 618. It is further contemplated that
an electrical connection 633 (see FIG. 8) be provided between slots
635 and protrusions 638 in order to provide power to
electro-mechanical assembly 619.
[0135] Disposable loading unit 618, which could be a surgical
instrument as contemplated herein, can be removed from mounting
flange 636 and be replaced with another such disposable loading
unit, or surgical instrument, for performing a different surgical
procedure. By way of example only and in no way to be considered as
limiting, potential surgical instruments or systems which can
interface with robotic system 600 include various hand instruments,
e.g., graspers, retractors, specimen retrieval instruments,
endoscopic and laparoscopic instruments, electrosurgical
instruments, stapling or fastener applying instruments, coring
instruments, cutting instruments, hole-punching instruments,
suturing instruments and/or any combination thereof. It is
envisioned that each of these instruments be provided with at least
one, preferably a plurality of MEMS devices "M" as described above,
for providing feedback to the user. It is further contemplated that
MEMS devices "M" can provide feedback directly to robotic system
600 in order for robotic system 600 to respond, e.g., adapt in
response to the feedback and/or provide notification to the user of
robotic system 600. It is further envisioned that a plurality of
sensors can be incorporated into, e.g., provided on an energy based
surgical instrument, which energy based surgical instrument can
also be interfaced with robotic system 600. Accordingly, the energy
provided to the energy based surgical instrument can be delivered
and controlled directly by robotic system 600 for improved user
interfaces and better system integration.
[0136] In operation, the user (e.g., surgeon, nurse, technician,
etc.) controls actuation assembly 612 to control the movement and
operation of robot 616 and disposable loading unit 618. Depending
on the amount of rotation of knobs 644 on actuation assembly 612,
actuation assembly 612 transmits electrical signals to robot 616 to
electro-mechanically operate the moveable parts of robot 616, such
as to rotate robot 616 about vertical trunk 622 or to advance
mounting flange 636. Actuation assembly 612 may include a processor
therein for storing operational commands and for transmitting
digital signals to electro-mechanical assembly 619. Actuation
assembly 612 can also transmit electrical signals to mounting
flange 636 in the form of electrical signals, for example, for
positioning and operating loading unit 618.
[0137] Actuation assembly 612 preferably is adapted to transmit
electrical signals to an electro-mechanical assembly 619 housed
within head portion 640 of loading unit 618 for actuating
electro-mechanical assembly 619 which in turn actuates surgical
instrument 620. Electro-mechanical assembly 619 includes mechanisms
for moving and operating surgical tool instrument 620, such as, for
example, servo motors for harmonically oscillating a scalpel of a
cutting instrument, or rods for pivotally moving a suturing needle
positioned on an axis of a longitudinal casing of a suturing
instrument.
[0138] As seen in FIG. 8, disposable loading unit 618 may further
include integrated circuitry for receiving digital signals from
actuation assembly 612, such as, for example, a receiver 621 and a
processor 623. Receiver 621 and processor 623 are included within
control means 625 electrically connected to electro-mechanical
assembly 619.
[0139] By way of example only, as shown in FIG. 9, a disposable
loading unit 718, hereinafter sometimes referred to as loading unit
718, including an end effector of a surgical stapler, similar to
the end effector of surgical stapler 100 described above, is
operatively connected to robot 616 (see FIG. 7) such that an array
of surgical fasteners (e.g., staples) can be applied to body
tissue. In particular, loading unit 718 includes a distally
extending body portion 716, a transverse body portion 715, and
support frame 719 operatively received in a distal end of
transverse body portion 715. Loading unit 718 further includes an
anvil 720 and a staple cartridge assembly 722 operatively received
within transverse body portion 715. Each of anvil 720 and staple
cartridge assembly 722 include juxtaposed tissue contacting
surfaces 720a, 722a, respectively.
[0140] It is envisioned that loading unit 718 includes an actuator
incorporated within a head portion 792 to perform fast closure and
incremental advancement of staple cartridge assembly 722 with
respect to anvil 720. As described above, relative to surgical
stapler 100, MEMS devices "M" can be provided on anvil 720 and
staple cartridge assembly 722 to provide feedback information to
robot 616.
[0141] Examples of direct information that can be fed back to robot
616 from MEMS devices "M" of loading unit 718 or other MEMS devices
include, for example, whether staples have been fired or, in the
case of an electrosurgical instrument, the amount of energy
delivered. MEMS device "M" can also be used to make indirect
measurements of performance, such as, for example, detecting the
status of staple firing by measuring the position of the assembly
member responsible for pushing the staples out of the cartridge.
Alternatively, MEMS devices "M" can measure an associated member,
such as a displacement of a drive rod or a rotation of a screw rod
to determine whether the staples have been fired or not. In either
instance, robotic system 600 can accept the information from
loading unit 718 and respond accordingly, for example, by either
altering performance, making adjustments, notifying the user,
modifying or stopping operation or any combination thereof.
[0142] Reference is made to commonly assigned U.S. Pat. No.
5,964,394 to Robertson, the entire content of which is incorporated
herein by reference, for a more detailed explanation of the
operation and internal working of the components of the end
effector of the surgical stapler operatively coupled to the distal
end of loading unit 718.
[0143] As seen in FIG. 10, a loading unit including a distal end
portion capable of performing an electrosurgical function, similar
to surgical instrument 500 above, is shown generally as 800. In
particular, loading unit 800 includes a head portion 802 configured
and adapted to be removably coupled to mounting flange 636 of robot
616, an elongate shaft 818 extending distally from head portion
802, and a jaw mechanism 822 operatively coupled to a distal end of
shaft 818. Jaw mechanism 822 includes a pair of jaw members 880,
882 which are pivotable about pin 819 in order to provide the
opening and closing of jaw mechanism 822. Jaw members 880, 882 are
preferably configured and adapted to perform an electrosurgical
function, such as, for example, coagulation, cauterization and the
like.
[0144] Loading unit 800 is preferably further provided with MEMS
devices "M" placed near a proximal end, a distal end, approximately
mid-way and/or all along the length of each jaw member 880, 882 in
order to provide feed back information to robot 616. Accordingly,
in the case of loading unit 800, MEMS devices "M" can feed back, to
robot 616 and actuation assembly 612, information regarding, for
example, the amount of energy delivered, the clamping force being
applied by jaw members 880, 882, the temperature at the target
surgical site and the like.
[0145] Turning now to FIG. 11, a loading unit including a vessel
clip applying end effector, for applying surgical clips to body
tissue, for example, for occluding vessels, is shown generally as
900. Loading unit 900 includes a head portion 902, a body portion
904 extending distally from head portion 902, and a plurality of
surgical clips (not shown) disposed within body portion 904. A jaw
assembly 906 is mounted adjacent a distal end portion 908 of body
portion 904. Jaw assembly 906 includes a first and a second jaw
portion 910a, 910b, respectively, which are movable between a
spaced-apart and approximated position relative to one another.
[0146] A clip pusher (not shown) is provided within body portion
904 to individually distally advance a distal-most surgical clip to
jaw assembly 906 while first and second jaw portions 910a, 910b are
in the spaced-apart position. An actuator 912, disposed within body
portion 904, is longitudinally movable in response to actuation of
electro-mechanical assembly 619 provided within head portion 902. A
jaw closure member 914 is positioned adjacent first and second jaw
portions 910a, 910b to move jaw portions 910a, 910b to the
approximated position. Actuator 912 and jaw closure member 914
define an interlock therebetween to produce simultaneous movement
of actuator 912 and jaw closure member 914 when actuator 912 is
positioned adjacent the distal end portion of body portion 904.
[0147] It is envisioned that loading unit 900 preferably includes
at least one MEMS device "M" operatively connected to each of the
first and second jaw portions 910a, 910b to provide feedback
information to robot 616.
[0148] Reference is made to commonly assigned U.S. Pat. No.
6,059,799 to Aranyi et al., the entire content of which is
incorporated herein by reference, for a more detailed explanation
of the operation and internal working of the components of the
vessel clip applying end effector of loading unit 900.
[0149] Turning now to FIG. 12, a loading unit including a vascular
suture applying end effector, for suturing vascular tissue sections
together, is shown generally as 950. Loading unit 950 includes a
head portion 952 and a body portion 954 extended distally
therefrom. A pair of needle receiving jaws 956, 958 are pivotally
mounted at a distal end of body portion 954 and are configured to
repeatedly pass a surgical needle 960 and associated length of
suture material therebetween. Loading unit 950 further includes
needle holding structure (not shown) mounted within jaws 956 for
reciprocal movement into and out of needle holding recesses 962
formed in jaws 956, 958. During an anastomosis procedure, loading
unit 950 will advantageously respond to movement commands
transmitted from the actuation assembly to apply fasteners to
tissue.
[0150] It is envisioned that loading unit 950 preferably includes
at least one MEMS device "M" operatively connected to each of the
pair of needle receiving jaws 956, 958 to provide feedback
information to robot 616. It is contemplated that MEMS device "M"
can, for example, provide information relating to the position of
jaws 956, 958, whether and in which jaw needle 960 is disposed, and
the force being exerted on needle 960.
[0151] Reference is made to commonly assigned U.S. Pat. No.
5,478,344 to Stone et al., the entire content of which is
incorporated herein by reference, for a more detailed explanation
of the operation and internal working of the components of the
vascular suture applying end effector of loading unit 950.
[0152] An advantage of using MEMS devices in conjunction with
robotic systems, similar to those described above, is that
conditions and forces sensed by the MEMS devices provided on the
end effectors of the loading units can be fed back system to the
robotic systems or transmitted to a user interface.
[0153] Current robotic systems allow little to no tactile
information to reach or be transmitted from the patient back to the
hands of the user (i.e., the surgeon). Accordingly, by using MEMS
devices, in accordance with the present disclosure, in combination
with a feedback and control system, conditions and forces
experienced by the distal end of the end effectors due to the
interaction of the end effector with the tissue of the patient can
be "felt" and/or monitored by the surgeon, thus greatly improving
the surgeon's information and, in turn, ability to perform surgical
procedures.
[0154] In accordance with the present disclosure, it is
contemplated to have feedback of information, data, signals,
conditions and forces, initiated by pressure and/or other
parameters indicative of the surgical task being performed by the
end effector of the disposable loading unit and measured and/or
sensed by MEMS devices provided on the loading unit, and to
transmit this feedback to a control system. This feedback control
system allows the robotic system to be programmed, before the
surgical task is performed, with guidance, pressure, and other
parameters which can be continuously monitored to control the
operation and movement of the loading unit and of the associated
end effector.
[0155] Although the illustrative embodiments of the present
disclosure have been described herein, it is understood that the
disclosure is not limited to those precise embodiments, and that
various other changes and modifications may be affected therein by
one skilled in the art without departing from the scope or spirit
of the disclosure. All such changes and modifications are intended
to be included within the scope of the disclosure.
* * * * *