U.S. patent application number 13/346954 was filed with the patent office on 2012-08-23 for controlled tissue compression systems and methods.
This patent application is currently assigned to Tyco Healthcare Group I.P. Invention is credited to David C. Racenet.
Application Number | 20120211542 13/346954 |
Document ID | / |
Family ID | 45656373 |
Filed Date | 2012-08-23 |
United States Patent
Application |
20120211542 |
Kind Code |
A1 |
Racenet; David C. |
August 23, 2012 |
CONTROLLED TISSUE COMPRESSION SYSTEMS AND METHODS
Abstract
A surgical instrument is provided including an end effector
configured to clamp, staple or cut tissue tissue, a motor
configured to drive the end effector and a control system. The
control system is configured to receive information about at least
one tissue property and select a tissue management mode based on
the at least one tissue property. The control system controls the
motor based on the selected tissue management mode.
Inventors: |
Racenet; David C.;
(Middletown, CT) |
Assignee: |
Tyco Healthcare Group I.P
|
Family ID: |
45656373 |
Appl. No.: |
13/346954 |
Filed: |
January 10, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61445700 |
Feb 23, 2011 |
|
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Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 2017/00154
20130101; A61B 2017/00398 20130101; A61B 2090/066 20160201; A61B
17/07207 20130101; A61B 2017/00137 20130101; A61B 2090/061
20160201; A61B 2090/065 20160201; A61B 2017/00022 20130101; A61B
2017/00039 20130101 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical device comprising: an end effector configured to
clamp, staple or cut tissue; a motor configured to drive the end
effector; and a control system configured to: receive information
about at least one tissue property; select a tissue management mode
based on the at least one tissue property; and control the motor
based on the selected tissue management mode.
2. The surgical device according to claim 1, wherein the control
system further comprises an indicator that provides a clinician
with a status of a tissue gap range of the end effector.
3. The surgical device according to claim 1, wherein the control
system further includes a sensor array configured to detect at
least one tissue property.
4. The surgical device according to claim 3, wherein the sensor
array detects a tissue property by measuring a current draw on the
motor.
5. The surgical device according to claim 3, wherein the sensor
array detects a tissue property by measuring a dwell effect at the
end effector.
6. The surgical device according to claim 1, wherein the tissue
management mode is a constant torque profile, a modulated torque
profile, a maximum torque profile or a manual override mode.
7. The surgical device according to claim 6, wherein the control
system applies a constant signal to the motor in the constant
torque profile.
8. The surgical device according to claim 6, wherein the control
system applies a periodic signal to the motor in the modulated
torque profile.
9. The surgical device according to claim 6, wherein the powered
surgical instrument fires at a speed that is faster than the speed
of firing in the constant torque profile, the modulated torque
profile or the manual override mode when the powered surgical
instrument uses the maximum torque profile.
10. The surgical device according to claim 6, wherein a user
manually controls the motor in the manual override mode.
11. A method of applying staples by a powered surgical instrument,
the method comprising the steps of: providing a surgical instrument
having an end effector that is powered by a motor; inputting tissue
type and/or disease type; clamping tissue using the end effector
driven by the motor; detecting at least one tissue property of the
clamped tissue; determining if a desired tissue gap range is
achieved by the end effector; selecting a tissue management mode to
clamp tissue to achieve the desired tissue gap; and firing the
powered surgical instrument in the selected tissue management mode
to apply staples to the clamped tissue.
12. The method according to claim 11 further comprising the step of
providing an indication of a status of a tissue gap range.
13. The method according to claim 11, wherein the step of detecting
at least one tissue property further includes measuring a current
draw on the motor.
14. The method according to claim 11, wherein the step of detecting
at least one tissue property further includes measuring a dwell
effect at the end effector.
15. The method according to claim 11, wherein the step of selecting
the tissue management mode is based on the at least one tissue
property of the clamped tissue detected.
16. The method according to claim 11, wherein the step of selecting
the tissue management mode is performed by a clinician.
17. The method according to claim 11, wherein the tissue management
mode is a constant torque profile, modulated torque profile,
maximum torque profile or a manual override mode.
18. The method according to claim 11, further comprising the step
of the powered surgical instrument suggesting a different reload
when the desired tissue gap range for the end effector is not
achieved.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of and priority
to U.S. Provisional Application Ser. No. 61/445,700, filed on Feb.
23, 2011, the entire contents of which are incorporated herein by
reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates generally to medical devices.
More specifically, the present disclosure relates generally to
systems and methods for controlled tissue compression.
[0004] 2. Background of the Related Art
[0005] Some surgical procedures require the compression, e.g.,
clamping, of a patient's tissue. Such procedures may include, e.g.,
anastomosing, stapling, and resecting of tissue. For example, where
cancerous tissue is identified in a patient's gastrointestinal
tract, the cancerous tissue may need to be surgically removed.
Where, for example, the cancerous tissue is located on the colon
and is accessible by surgical instrumentation, the surgeon may make
an incision in the patient's abdomen to allow access to the bowel.
The surgeon may then use a linear cutting and stapling device, such
as that described in U.S. patent application Ser. No. 12/235,362,
filed Sep. 22, 2008 (U.S. Patent Publication No. 2009/0101692),
which is expressly incorporated herein in its entirety by reference
thereto, to cut and staple the colon tissue on opposite sides of
the cancerous portion to be removed. In this procedure, the colon
is externally clamped (e.g., between opposed jaws) to compress the
tissue. While the tissue is compressed, a cutter and a stapler are
activated to make a linear cut and apply typically two linear rows
of staples in the areas adjacent the cut. The stapling thus closes
both open ends of the portion of the bowel to be removed, as well
as providing a temporary closure of the two cut ends of the bowel.
This closure limits exposure of the surrounding tissue to the
interior of the bowel, thus limiting the risk of infection. After
the cutting and stapling procedure, the cancerous portion of tissue
may be removed from the patient's body.
[0006] After the resection of the cancerous tissue, the surgeon may
employ an anastomosing and stapling device, e.g., a circular
stapler/cutter, such as that described in U.S. patent application
Ser. No. 10/785,682, filed Feb. 24, 2004 (U.S. Pat. No. 7,342,983),
which is expressly incorporated herein in its entirety by reference
thereto. During this procedure a head portion is positioned within
the colon adjacent one of the cut ends and a base or shaft portion
is positioned within the colon adjacent the other cut end. The head
portion and the base portion may be coupled via a shaft and/or
cable that extends out of one cut end and into the other. Via this
coupling, the surgeon is able to actuate the anastomosing and
stapling device to draw the head portion and the base portion
together. After the two cut ends of the colon contact each other,
the actuation continues such that the two portions of the colon are
clamped together at an annular area of contact. While clamped, the
anastomosing and stapling device may be further actuated to apply
an annular ring of staples into the compressed tissue. The device
may also cut excess tissue disposed within the colon. The head
portion and the base portion are then moved apart and the
anastomosing and stapling device removed from the patient.
[0007] To achieve effective stapling in the above procedures, the
tissue must be compressed to the extent that there is an adequately
small tissue gap, e.g., one millimeter, between the faces of the
tool. If the clamping structures of the instrument are exposed to
excessive force, maintaining a uniform target tissue gap across the
length of tissue to be stapled may be difficult or even
impossible.
[0008] Moreover, when performing the compression, a constant
closing rate (e.g., the closing rate between jaws of a linear
stapler or between the head and base portion of a circular
stapler/cutter) may exert a high level of pressure on the clamped
tissue. This high level of pressure may result in excess tissue
trauma. It is thus desirable to limit this trauma, e.g., by
effectively controlling the pressure applied to the tissue.
[0009] Further, it is desirable to determine how the tissue to be
clamped is responding to compression and process this information
to determine clamping pressure. U.S. patent application Ser. No.
09/510,927, filed Feb. 22, 2000 (now U.S. Pat. No. 6,716,233),
which is expressly incorporated herein in its entirety by reference
hereto, describes apparatus and methods of using a tissue sensor to
control operation of a surgical stapler.
SUMMARY
[0010] In an embodiment of the present disclosure, a surgical
device is provided. The surgical device includes an end effector
configured to clamp, staple or cut tissue, a motor configured to
drive the end effector and a control system. The control system
receives information about at least one tissue property and selects
a tissue management mode based on the at least one tissue property.
The control system controls the motor based on the selected tissue
management mode.
[0011] The surgical device may also include an indicator that
provides a clinician with a status of a tissue gap range of the end
effector and a sensor array configured to detect at least one
tissue property. The sensor array may detect at least one tissue
property by measuring the current draw on the motor or the dwell
effect at the end effector. The sensor array may also assess tissue
properties by taking measurements such as pulse oximetry, tissue
oxygen saturation or tissue impedance. The dwell effect occurs as
the jaws remain at a static pressure for a period and fluids escape
from the tissue cells, allowing the tissue to relax.
[0012] The tissue management modes that can be selected by the
surgical device include a constant torque profile, a modulated
torque profile, a maximum torque profile or a manual override mode.
The control system applies a constant signal to the motor in the
constant torque profile or a periodic signal to the motor in the
modulated torque profile. In the maximum torque profile, the
powered surgical instrument fires at a speed that is faster than
the speed of firing in the constant torque profile, the modulated
torque profile or the manual override mode. In the manual override
mode, the user manually controls the motor. Typically, pressure
during tissue clamping will be a function of the motor torque.
[0013] In another embodiment of the present disclosure, a method
for applying a staple by a powered surgical instrument is provided.
The method includes the steps of providing a surgical instrument
having an end effector that is powered by a motor, inputting a
tissue type and/or disease type to determine an initial clamping or
tissue management mode, clamping tissue using the end effector
driven by the motor, detecting at least one tissue property of the
clamped tissue, determining if a desired tissue gap range is
achieved by the end effecter, if necessary, selecting an additional
clamp mode to iteratively adjust clamping to achieve the desired
tissue gap, and firing the powered surgical instrument to apply
staples to the clamped tissue once the desired tissue gap has been
achieved.
[0014] The method may also include the step of providing an
indication of a status of a tissue gap range. The tissue property
may be detected by measuring the current draw on the motor or
measuring a dwell effect at the end effector.
[0015] Selecting the clamping or tissue management mode may be
based on the tissue property of the clamped tissue detected or be
performed by a clinician. The tissue management modes that can be
selected by the surgical device include a constant torque profile,
modulated torque profile or maximum torque profile. A manual
override mode may allow the user to select a tissue management
mode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] 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:
[0017] FIG. 1 is a perspective view of a powered surgical
instrument according to an embodiment of the present
disclosure;
[0018] FIG. 2 is a system block diagram of the powered surgical
instrument according to an embodiment of the present
disclosure;
[0019] FIG. 3 is a flow chart depicting operation of the powered
surgical instrument according to an embodiment of the present
disclosure; and
[0020] FIG. 4 is a flow chart depicting an indicator system
according to an embodiment of the present disclosure.
DETAILED DESCRIPTION
[0021] 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 exemplary of the disclosure and may be embodied in various
forms. Well-known functions or constructions are not described in
detail to avoid obscuring the present disclosure in unnecessary
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.
[0022] Like reference numerals may refer to similar or identical
elements throughout the description of the figures. As shown in the
drawings and described throughout the following description, as is
traditional when referring to relative positioning on a surgical
instrument, the term "proximal" refers to the end of the apparatus
which is closer to the user and the term "distal" refers to the end
of the apparatus which is farther away from the user. The term
"clinician" refers to any medical professional (i.e., doctor,
surgeon, nurse, or the like) performing a medical procedure
involving the use of embodiments described herein.
[0023] A powered surgical instrument, e.g., a surgical stapler, in
accordance with the present disclosure is referred to in the
figures as reference numeral 100. Powered surgical instrument 100
is merely an example of a surgical instrument that utilizes the
embodiments of the present disclosure described herein and
therefore, is not intended to limit the present disclosure to this
one particular embodiment of a surgical instrument.
[0024] Referring initially to FIG. 1, powered surgical instrument
100 includes a housing or handle 110, an endoscopic portion 140
defining a longitudinal axis A-A extending therethrough, and an end
effector 160, defining a longitudinal axis B-B (illustrated
substantially aligned with axis A-A in FIG. 1) extending
therethrough. Endoscopic portion 140 extends distally from housing
110, and clamping mechanism or end effector 160 is disposed
adjacent a distal portion 142 of endoscopic portion 140. End
effector 160 is used to clamp, staple and/or cut tissue disposed
therebetween.
[0025] Powered surgical instrument 100 may include a control system
designated generally as 200 in FIG. 2. Control system 200 may be
integrated in housing 110 of powered surgical instrument 100 or
some of the components may be provide in a stand-alone unit.
Control system 200 includes a processor 202, an input device 204, a
display 206, a memory 208, an indicator 210, a motor 212 and a
sensor array 214.
[0026] Processor 202 may be an integrated circuit or may include
analog and/or logic circuitry that may be used to: execute
instructions according to inputs provided by the input device 204
or sensor array 214; execute instructions according to a program
provided in memory 208; and/or control motor 212 thereby
controlling the end effector 160 to clamp, staple and/or cut tissue
therebetween.
[0027] Input device 204 may include a keyboard, a touchscreen input
device, switches and/or buttons to control operation of the powered
surgical instrument 100. Input device 204 may be used to: select
between tissue management modes; control end effector 160; apply a
staple or clamp; and input tissue properties such as tissue type
and/or disease.
[0028] Display 206 may include a liquid crystal display, a light
emitting diode display or the like. Display 206 may output a status
of the powered surgical instrument, the measured tissue properties,
the number of staples/clips applied, etc.
[0029] Control system 200 may also include an indicator 210 that
may include at least one light emitting diode (LED) to indicate
whether a tissue gap range, between the jaws of end effector 160,
has been met. Indicator 210 may include a single multi-color LED or
separate LEDs for red, yellow and green. The red LED may indicate a
malfunction, a yellow LED may indicate that a tissue gap range has
not been met and a green LED may indicate that the tissue gap range
has been met. Additionally, an LED may be pulsed to indicate
additional information. For instance, a pulsing yellow LED can
indicate that an additional clamping cycle is being performed.
[0030] Sensor array 214 determines tissue properties by detecting
the current draw on motor 212 or a dwell effect at end effector
160. The detected tissue properties are used to determine a
clamping or tissue management mode, a tissue gap range, firing
parameters, a speed of the motor, a modulation/pulse of the motor,
deployment of the staples, etc. The tissue properties are used as
an input to the iterative adjustment of the clamping pressure and
duration for a tissue management mode.
[0031] Memory 208 may be a volatile type memory (e.g., RAM) and/or
non-volatile type memory (e.g., flash media, disk media, etc.) that
stores programs or sets of instructions for the operation of the
powered surgical instrument 100.
[0032] Such programs include a number of tissue management modes
that may be used to clamp tissue in order to apply a staple or clip
to the tissue grasped by end effector 160. The tissue management
modes are selected to apply an atraumatic stress or strain to the
tissue by varying the compression of the tissue. The tissue
management modes include a constant torque profile, a modulated
torque profile, a maximum torque profile and a manual override
mode. The tissue management modes may be automatically selected
based on detected tissue parameters and/or tissue type and disease
type inputted by a clinician or the tissue management mode may be
selected by a clinician.
[0033] When a constant torque profile is selected, the powered
surgical instrument 100 uses controlled tissue compression to apply
constant rate if strain to tissue during the clamp, dwell and
firing stages to optimize tissue gap and staple formation by
applying a constant signal to motor 212 from processor 202. The
parameters used to control the motor 212 and/or end effector 160 in
the constant torque profile may be based on a desired speed of
firing of the surgical instrument 100 or the type of tissue grasped
by end effector 160.
[0034] The modulated torque profile applies pulsating or periodic
strain energy to tissue by applying a periodic signal to motor 212.
More specifically, processor 202 applies a pulse width modulated
signal (PWM) or any other periodic signal to the motor to achieve
an optimized compression profile, i.e., minimum tissue gap (maximum
strain) with minimum tissue trauma (minimum stress). The optimized
compression profile may vary for different tissue types and/or
disease types. The signal from processor 202 may be predetermined
and stored in a memory. Alternatively, the signal outputted by
processor 202 may be determined by performing a current slope
analysis on the current detected from the motor, initial tissue
thickness T.sub.0, initial clamped tissue thickness T.sub.1 and
total strain/energy.
[0035] When the tissue management mode is set for operation in the
maximum torque profile, the surgical instrument 100 fires
relatively faster than the other modes of operation. While in the
maximum torque profile, surgical instrument 100 fires relatively
faster at the beginning and at the end of the stroke where device
stresses are relatively lower. When the tissue management mode is
set to operate in the manual override mode, the clinician can
manually control the motor of surgical instrument 100 to achieve
the desired tissue gap of end effector 100 and to manually fire the
surgical instrument 100.
[0036] Memory 208 may also store correlation tables to correlate
tissue type and disease type to the requisite tissue gap range and
firing parameters that need to be achieved to successfully apply a
staple or clip to tissue.
[0037] FIG. 3 depicts a flow chart describing an operation of the
control system 200 of powered surgical instrument 100. As shown in
FIG. 3, a clinician starts, "powers-up" or "turns on" the powered
surgical instrument 100 in step 300. A clinician enters the tissue
type and/or disease type in step 305 using input device 204. The
clinician then positions end effector 160 onto the desired tissue
and an initial clamping (tissue management) mode is determined.
Then, in step 315, end effector 160 clamps the desired tissue and
determines tissue properties such as initial thickness, density,
initial clamped thickness, etc. in step 320. Processor 202, then,
in step 325, determines if the tissue gap range is met for the
particular tissue type. If the gap range is met, the control system
200 proceeds to step 370.
[0038] In step 325, if the gap range is not met, the tissue gap and
tissue properties are evaluated by processor 202 to determine if
additional clamping is beneficial. If it is, the gap range and
tissue properties are used to determine a new clamping mode in step
327. The iterative clamping and evaluation process then returns to
step 315 and is continued until an optimum gap range is met or it
is determined that the tissue is unsuitable for the selected range
in which instance the powered surgical instrument 100 prompts the
clinician with a suggestion if a different reload or end effector
(loaded with a different sized staple) should be used. If the
clinician selects a different reload or end effector, then the
powered surgical instrument 100 is reloaded in step 340 and
proceeds to step 315 to clamp tissue.
[0039] If the clinician does not select a different reload or end
effector, the clinician may select a manual override mode in step
345. If the user selects the manual override mode, the powered
surgical instrument 100 is placed in the manual override mode in
step 350.
[0040] Alternatively, the process proceeds to step 355 to select a
tissue management mode. The tissue management mode may be
automatically selected by processor 202 based on the inputted
tissue type, disease type, and/or tissue properties or selected by
the clinician. Based on the selection of the tissue management
mode, the powered surgical instrument 100 may enter the constant
torque profile of step 362, modulated torque profile of step 364 or
the maximum torque profile of step 366. Then the control system 200
proceeds to step 370 where a determination is made as to whether a
staple should be applied. This determination may be made by
processor 202 or by the clinician. If the staple should be applied,
then in step 375, the control system 200 controls the powered
surgical instrument 100 to apply the staple. If the staple is not
applied, the control system 200 ends the procedure (step 380) or
restarts to apply a subsequent staple (step 300).
[0041] FIG. 4 depicts a flow chart describing an operation of the
indicator system of the powered surgical instrument 100. The
powered surgical instrument 100 is started in step 400 and the
tissue type and/or disease is entered in step 405. Processor 202
then uses one of the correlating tables stored in memory 208 to
determine the tissue gap range for the red-yellow-green indicator
210. The tissue gap range is measured in step 415. If an error is
determined or the tissue gap range exceeds an upper limit, the
process proceeds to step 430 and the red indictor is illuminated.
If there is no error or the tissue gap range does not exceed an
upper limit, the process proceeds to step 435. If the tissue gap
range is not in the acceptable range but it does not exceed the
upper limit, the yellow indicator is illuminated in step 440. If
the tissue gap range is met, the process proceeds to step 445 and
the green indicator is illuminated.
[0042] It should be understood that the foregoing description is
only illustrative of the present disclosure. Various alternatives
and modifications can be devised by those skilled in the art
without departing from the disclosure. Accordingly, the present
disclosure is intended to embrace all such alternatives,
modifications and variances. The embodiments described with
reference to the attached drawing figs. are presented only to
demonstrate certain examples of the disclosure. Other elements,
steps, methods and techniques that are insubstantially different
from those described above and/or in the appended claims are also
intended to be within the scope of the disclosure.
* * * * *