U.S. patent application number 17/071315 was filed with the patent office on 2022-04-21 for ultrasonic surgical instrument.
The applicant listed for this patent is Covidien LP. Invention is credited to Michael J. Brown, Jason L. Craig, Weng-Kai Lee, Kenneth E. Netzel, Christopher T. Tschudy.
Application Number | 20220117623 17/071315 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-21 |
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United States Patent
Application |
20220117623 |
Kind Code |
A1 |
Craig; Jason L. ; et
al. |
April 21, 2022 |
ULTRASONIC SURGICAL INSTRUMENT
Abstract
An ultrasonic surgical instrument includes a housing, a
waveguide extending from the housing to a blade, a clamp jaw
pivotable relative to the blade to clamp tissue, a drive member
extending from the housing to the end effector and operably coupled
to the clamp jaw such that translation of the drive member pivots
the clamp jaw to exert a jaw force on the clamped tissue, a rigid
slider operably coupled to the drive member such that translation
of the rigid slider results in corresponding translation of the
drive member, and a clamp lever. The clamp lever is actuatably
coupled to the housing and operably coupled to the rigid slider
such that a full actuation of the clamp lever translates the rigid
slider and the drive member to thereby pivot the clamp jaw from the
open position towards the clamping position with substantially no
dampening of the jaw force.
Inventors: |
Craig; Jason L.; (Loveland,
CO) ; Netzel; Kenneth E.; (Loveland, CO) ;
Brown; Michael J.; (Superior, CO) ; Tschudy;
Christopher T.; (Arvada, CO) ; Lee; Weng-Kai;
(Longmont, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Appl. No.: |
17/071315 |
Filed: |
October 15, 2020 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. An ultrasonic surgical instrument, comprising: a housing; a
waveguide extending distally from the housing and having a blade at
a distal end thereof, the waveguide configured to transmit
ultrasonic energy to the blade; an end effector including the blade
and a clamp jaw, wherein the clamp jaw is pivotable relative to the
blade from an open position towards a clamping position to clamp
tissue therebetween; a drive member extending from the housing to
the end effector and operably coupled to the clamp jaw such that
translation of the drive member pivots the clamp jaw from the open
position towards the clamping position to exert a jaw force on the
clamped tissue; a rigid slider operably coupled to a proximal end
portion of the drive member such that translation of the rigid
slider results in corresponding translation of the drive member;
and a clamp lever having an initial position and an actuated
position, the clamp lever actuatably coupled to the housing and
operably coupled to the rigid slider such that a full actuation of
the clamp lever from the initial position to the actuated position
translates the rigid slider and the drive member to thereby pivot
the clamp jaw from the open position towards the clamping position
with substantially no dampening of the jaw force.
2. The ultrasonic surgical instrument according to claim 1, further
comprising an ultrasonic transducer mounted on the housing, the
ultrasonic transducer coupled to the waveguide and configured to
generate ultrasonic energy for transmission along the waveguide to
the blade.
3. The ultrasonic surgical instrument according to claim 1, wherein
the clamp lever is pivotably coupled to the housing on a first side
of a longitudinal axis of the drive member, wherein the clamp lever
is actuatable via a grasping portion disposed on a second, opposite
side of the longitudinal axis, and wherein the rigid slider is
substantially aligned on the longitudinal axis.
4. The ultrasonic surgical instrument according to claim 3, wherein
actuation of the clamp lever translates the rigid slider proximally
to thereby move the drive member proximally to pivot the clamp jaw
towards the clamping position.
5. The ultrasonic surgical instrument according to claim 4, wherein
the clamp lever includes a proximal contact surface configured to
urge the rigid slider proximally in response to actuation of the
clamp lever.
6. The ultrasonic surgical instrument according to claim 4, further
comprising a linkage coupled between the rigid slider and the clamp
lever, wherein actuation of the clamp lever urges the linkage
proximally to thereby urge the rigid slider proximally.
7. The ultrasonic surgical instrument according to claim 1, wherein
a hard stop is defined at the actuated position of the clamp
lever.
8. The ultrasonic surgical instrument according to claim 7, wherein
the hard stop is defined by contact of a portion of the clamp lever
with a portion of the housing.
9. The ultrasonic surgical instrument according to claim 1, wherein
the rigid slider includes an inner retainer longitudinally fixed
relative to the proximal end portion of the drive member and an
outer slider slidably disposed about the inner retainer, and
wherein actuation of the clamp lever urges the outer slider to
translate, thereby correspondingly translating the inner retainer
and, in turn, correspondingly translating the drive member.
10. The ultrasonic surgical instrument according to claim 9,
wherein the rigid slider is rotatable relative to the drive
member.
11. The ultrasonic surgical instrument according to claim 9,
wherein the inner retainer is rotationally fixed relative to the
drive member and wherein the outer slider is rotatable relative to
the inner retainer and the drive member.
12. A method of manufacturing an ultrasonic surgical instrument,
comprising: assembling an ultrasonic surgical instrument to include
a clamp lever operably coupled to a clamp jaw via a rigid slider
and a drive member such that actuation of the clamp lever
translates the rigid slider and the drive member together to
thereby pivot the clamp jaw; measuring a lever force required to
fully actuate the clamp lever; determining whether the measured
lever force is within a lever force setting range; measuring a jaw
force applied by the clamp jaw in response to full actuation of the
clamp lever; and determining whether the measured jaw force is
within a jaw force setting range.
13. The method according to claim 12, wherein the lever force is
measured at a midpoint of the clamp lever and the lever force
setting range is from about 1 lbf to about 10 lbf.
14. The method according to claim 12, wherein the jaw force is
measured at about 0.192 inches from a distal end of the jaw member
and the jaw force setting range is from about 1 lbf to about 8
lbf.
15. The method according to claim 12, further comprising: in a case
where the measured lever force is within the lever force setting
range and the measured jaw force is within the jaw force setting
range, accepting the ultrasonic surgical instrument.
16. The method according to claim 12, further comprising: in a case
where the measured lever force is outside of the lever force
setting range or the measured jaw force is outside of the jaw force
setting range, rejecting the ultrasonic surgical instrument.
17. The method according to claim 12, wherein measuring the jaw
force includes positioning the ultrasonic surgical instrument in a
first testing assembly and actuating the clamp lever to clamp the
clamp jaw against a sensor of the first testing assembly to measure
the force applied by the clamp jaw.
18. The method according to claim 12, wherein measuring the lever
force includes positioning the ultrasonic surgical instrument in a
second testing assembly, fully actuating the clamp lever using the
second testing assembly, and measuring a force applied by the
second testing assembly to fully actuate the clamp lever.
19. The method according to claim 12, wherein assembling the
ultrasonic surgical instrument further includes engaging a contact
surface of the clamp lever with a contact surface of the rigid
slider such that actuation of the clamp lever translates the rigid
slider.
20. The method according to claim 12, wherein assembling the
ultrasonic surgical instrument further includes coupling a linkage
between the clamp lever and the rigid slider such that actuation of
the clamp lever translates the linkage to thereby translate the
rigid slider.
Description
BACKGROUND
Technical Field
[0001] The present disclosure relates to surgical instruments and,
more particularly, to an ultrasonic surgical instrument configured
to treat tissue with ultrasonic energy.
Background of Related Art
[0002] Ultrasonic surgical instruments utilize ultrasonic energy,
i.e., ultrasonic vibrations, to treat tissue. More specifically,
ultrasonic surgical instruments utilize mechanical vibration energy
transmitted at ultrasonic frequencies to coagulate, cauterize,
fuse, seal, cut, desiccate, fulgurate, or otherwise treat
tissue.
[0003] Typically, an ultrasonic surgical instrument is configured
to transmit ultrasonic energy produced by a generator and
transducer assembly along a waveguide to an end effector that is
spaced-apart from the generator and transducer assembly. With
respect to cordless ultrasonic instruments, for example, a portable
power source, e.g., a battery, and the generator and transducer
assembly are mounted on the handheld instrument itself, while the
waveguide interconnects the generator and transducer assembly with
the end effector. Tethered ultrasonic instruments operate in
similar fashion except that, rather than having the generator and
power source mounted on the handheld instrument itself, the
handheld instrument is configured to connect to a standalone power
supply and/or generator via a corded connection.
SUMMARY
[0004] As used herein, the term "distal" refers to the portion that
is being described which is further from an operator (whether a
human surgeon or a surgical robot), while the term "proximal"
refers to the portion that is being described which is closer to
the operator. Terms including "generally," "about,"
"substantially," and the like, as utilized herein, are meant to
encompass variations, e.g., manufacturing tolerances, material
tolerances, use and environmental tolerances, measurement
variations, and/or other variations, up to and including plus or
minus 10 percent. Further, any or all of the aspects described
herein, to the extent consistent, may be used in conjunction with
any or all of the other aspects described herein.
[0005] Provided in accordance with aspects of the present
disclosure is a surgical instrument including a housing, an end
effector including a clamp jaw pivotable from an open position
towards a clamping position, a drive member extending distally from
the housing, and a clamp lever pivotably coupled to the housing.
The drive member is operably coupled to the clamp jaw such that
translation of the drive member pivots the clamp jaw from the open
position towards the clamping position. The clamp lever is operably
coupled to the drive member via a rigid slider. The clamp jaw is
configured to provide a jaw force to tissue clamped between the
clamp jaw and an opposing structure, measured at about 0.192 inches
from a distal end of the clamp jaw, of from about 1 lbf to about 8
lbf in response to a full actuation of the clamp lever.
[0006] In an aspect of the present disclosure, a lever force,
measured at a midpoint of the clamp lever, of from about 1 lbf to
about 10 lbf is required to fully actuate the clamp lever.
[0007] In another aspect of the present disclosure, the surgical
instrument further includes a waveguide extending distally from the
housing and having a blade at a distal end thereof. The blade
defines the opposing structure. The waveguide is configured to
transmit ultrasonic energy to the blade. The clamp jaw is
configured to oppose the blade in the clamping position
thereof.
[0008] In another aspect of the present disclosure, an ultrasonic
transducer is mounted on the housing and coupled to the waveguide.
The ultrasonic transducer is configured to generate ultrasonic
energy for transmission along the waveguide to the blade.
[0009] In yet another aspect of the present disclosure, the clamp
lever is pivotably coupled to the housing on a first side of a
longitudinal axis of the drive member, the clamp lever is
actuatable via a grasping portion disposed on a second, opposite
side of the longitudinal axis, and the rigid slider is
substantially aligned on the longitudinal axis. In such aspects,
actuation of the clamp lever may translate the rigid slider
proximally to thereby move the drive member proximally to pivot the
clamp jaw towards the clamping position. Additionally or
alternatively, the clamp lever includes a proximal contact surface
configured to urge the rigid slider proximally in response to
actuation of the clamp lever.
[0010] In still another aspect of the present disclosure, a linkage
is coupled between the rigid slider and the clamp lever. In such
aspects, actuation of the clamp lever urges the linkage proximally
to thereby urge the rigid slider proximally.
[0011] In still yet another aspect of the present disclosure, the
full actuation of the clamp lever includes moving the clamp lever
from an initial position to a hard stop. The hard stop may be
defined by contact of a portion of the clamp lever with a portion
of the housing.
[0012] Another surgical instrument provided in accordance with
aspects of the present disclosure includes a housing, a waveguide
extending distally from the housing and having a blade at a distal
end thereof, drive and support members extending distally from the
housing, a clamp jaw pivotably supported at a distal end portion of
the support member and operably coupled to a distal end portion of
the drive member such that translation of the drive member relative
to the support member pivots the clamp jaw relative to the blade
from an open position towards a clamping position, a clamp lever
pivotably coupled to the housing, and a drive assembly. The clamp
jaw includes a tissue-contacting surface configured to oppose the
blade in the clamping position of the clamp jaw. The
tissue-contacting surface defines a tissue-contacting surface area.
The drive assembly includes a rigid slider operably coupling the
clamp lever with the drive member. The clamp jaw, in response to a
full actuation of the clamp lever, imparts an average jaw pressure
of from about 35 psi to about 285 psi to tissue clamped between the
tissue-contacting surface of the clamp jaw and the blade.
[0013] In an aspect of the present disclosure, a lever force,
measured at a midpoint of the clamp lever, of from about 1 lbf to
about 10 lbf is required to fully actuate the clamp lever.
[0014] In another aspect of the present disclosure, the surgical
instrument further includes an ultrasonic transducer mounted on the
housing, coupled to the waveguide, and configured to generate
ultrasonic energy for transmission along the waveguide to the
blade.
[0015] In still another aspect of the present disclosure, the clamp
lever is pivotably coupled to the housing on a first side of a
longitudinal axis of the drive member, the clamp lever is
actuatable via a grasping portion disposed on a second, opposite
side of the longitudinal axis, and the rigid slider is
substantially aligned on the longitudinal axis. In such aspects,
actuation of the clamp lever may translate the rigid slider
proximally to thereby move the drive member proximally to pivot the
clamp jaw towards the clamping position. Alternatively or
additionally, the clamp lever includes a proximal contact surface
configured to urge the rigid slider proximally in response to
actuation of the clamp lever.
[0016] In yet another aspect of the present disclosure, a linkage
is coupled between the rigid slider and the clamp lever. Actuation
of the clamp lever urges the linkage proximally to thereby urge the
rigid slider proximally.
[0017] In still yet another aspect of the present disclosure, the
full actuation of the clamp lever includes moving the clamp lever
from an initial position to a hard stop. The hard stop may be
defined by contact of a portion of the clamp lever with a portion
of the housing.
[0018] In another aspect of the present disclosure, the clamp lever
is pivotably coupled to the housing on a first side of a
longitudinal axis of the drive member, the clamp lever is
actuatable via a grasping portion disposed on the first side of the
longitudinal axis, and the rigid slider is substantially aligned on
the longitudinal axis.
[0019] An ultrasonic surgical instrument provided in accordance
with aspects of the present disclosure includes a housing, a
waveguide extending distally from the housing and having a blade at
a distal end thereof, an end effector including the blade and a
clamp jaw, a drive member extending from the housing to the end
effector and operably coupled to the clamp jaw, a rigid slider
operably coupled to a proximal end portion of the drive member, and
a clamp lever having an initial position and an actuated position.
The waveguide is configured to transmit ultrasonic energy to the
blade. The clamp jaw is pivotable relative to the blade from an
open position towards a clamping position to clamp tissue
therebetween. Translation of the drive member pivots the clamp jaw
from the open position towards the clamping position to exert a jaw
force on the clamped tissue. Translation of the rigid slider
results in corresponding translation of the drive member. The clamp
lever is actuatably coupled to the housing and operably coupled to
the rigid slider such that a full actuation of the clamp lever from
the initial position to the actuated position translates the rigid
slider and the drive member to thereby pivot the clamp jaw from the
open position towards the clamping position with substantially no
dampening of the jaw force.
[0020] In an aspect of the present disclosure, an ultrasonic
transducer is mounted on the housing and coupled to the waveguide
to generate ultrasonic energy for transmission along the waveguide
to the blade.
[0021] In another aspect of the present disclosure, the clamp lever
is pivotably coupled to the housing on a first side of a
longitudinal axis of the drive member, the clamp lever is
actuatable via a grasping portion disposed on a second, opposite
side of the longitudinal axis, and the rigid slider is
substantially aligned on the longitudinal axis.
[0022] In another aspect of the present disclosure, actuation of
the clamp lever translates the rigid slider proximally to thereby
move the drive member proximally to pivot the clamp jaw towards the
clamping position.
[0023] In yet another aspect of the present disclosure, the clamp
lever includes a proximal contact surface configured to urge the
rigid slider proximally in response to actuation of the clamp
lever.
[0024] In still another aspect of the present disclosure, a linkage
is coupled between the rigid slider and the clamp lever. In such
aspects, actuation of the clamp lever urges the linkage proximally
to thereby urge the rigid slider proximally.
[0025] In still yet another aspect of the present disclosure, a
hard stop is defined at the actuated position of the clamp lever.
The hard stop may be defined by contact of a portion of the clamp
lever with a portion of the housing.
[0026] In another aspect of the present disclosure, the rigid
slider includes an inner retainer longitudinally fixed relative to
the proximal end portion of the drive member and an outer slider
slidably disposed about the inner retainer. In such aspects,
actuation of the clamp lever urges the outer slider to translate,
thereby correspondingly translating the inner retainer and, in
turn, correspondingly translating the drive member.
[0027] In yet another aspect of the present disclosure, the rigid
slider is rotatable relative to the drive member.
[0028] In still another aspect of the present disclosure, the inner
retainer is rotationally fixed relative to the drive member and the
outer slider is rotatable relative to the inner retainer and the
drive member.
[0029] A method of manufacturing an ultrasonic surgical instrument
in accordance with aspects of the present disclosure includes
assembling an ultrasonic surgical instrument to include a clamp
lever operably coupled to a clamp jaw via a rigid slider and a
drive member such that actuation of the clamp lever translates the
rigid slider and the drive member together to thereby pivot the
clamp jaw, measuring a lever force required to fully actuate the
clamp lever, determining whether the measured lever force is within
a lever force setting range, measuring a jaw force applied by the
clamp jaw in response to full actuation of the clamp lever, and
determining whether the measured jaw force is within a jaw force
setting range.
[0030] In an aspect of the present disclosure, the lever force is
measured at a midpoint of the clamp lever and the lever force
setting range is from about 1 lbf to about 10 lbf.
[0031] In another aspect of the present disclosure, the jaw force
is measured at about 0.192 inches from a distal end of the jaw
member and the jaw force setting range is from about 1 lbf to about
8 lbf.
[0032] In yet another aspect of the present disclosure, in a case
where the measured lever force is within the lever force setting
range and the measured jaw force is within the jaw force setting
range, the method further includes accepting the ultrasonic
surgical instrument.
[0033] In still another aspect of the present disclosure, in a case
where the measured lever force is outside of the lever force
setting range or the measured jaw force is outside of the jaw force
setting range, the method further includes rejecting the ultrasonic
surgical instrument.
[0034] In still yet another aspect of the present disclosure,
measuring the jaw force includes positioning the ultrasonic
surgical instrument in a first testing assembly and actuating the
clamp lever to clamp the clamp jaw against a sensor of the first
testing assembly to measure the force applied by the clamp jaw.
[0035] In another aspect of the present disclosure, measuring the
lever force includes positioning the ultrasonic surgical instrument
in a second testing assembly, fully actuating the clamp lever using
the second testing assembly, and measuring a force applied by the
second testing assembly to fully actuate the clamp lever.
[0036] In still another aspect of the present disclosure,
assembling the ultrasonic surgical instrument further includes
engaging a contact surface of the clamp lever with a contact
surface of the rigid slider such that actuation of the clamp lever
translates the rigid slider.
[0037] In yet another aspect of the present disclosure, assembling
the ultrasonic surgical instrument further includes coupling a
linkage between the clamp lever and the rigid slider such that
actuation of the clamp lever translates the linkage to thereby
translate the rigid slider.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The above and other aspects and features of the present
disclosure will become more apparent in view of the following
detailed description when taken in conjunction with the
accompanying drawings wherein like reference numerals identify
similar or identical elements.
[0039] FIG. 1 is a perspective view of an ultrasonic surgical
instrument provided in accordance with the present disclosure;
[0040] FIG. 2 is a perspective view of the ultrasonic surgical
instrument of FIG. 1 with a handle assembly of the ultrasonic
instrument separated from an elongated assembly of the ultrasonic
surgical instrument;
[0041] FIG. 3 is an exploded, perspective view of the elongated
assembly of the ultrasonic surgical instrument of FIG. 1;
[0042] FIG. 4 is an enlarged, longitudinal, cross-sectional view of
a proximal portion of the ultrasonic surgical instrument of FIG.
1;
[0043] FIG. 5 is a side view of a proximal portion of the
ultrasonic surgical instrument of FIG. 1 wherein an outer housing
portion, an ultrasonic transducer and generator assembly, a battery
assembly, and additional internal component are removed to
unobstructively illustrate the operable coupling between a clamp
lever and drive assembly of the ultrasonic surgical instrument;
[0044] FIG. 6 is an enlarged, perspective view of an end effector
of the ultrasonic surgical instrument of FIG. 1 operably coupled to
a jaw force test fixture;
[0045] FIG. 7 is an enlarged, perspective view of a portion of the
ultrasonic surgical instrument of FIG. 1 including the fixed handle
portion and clamp lever operably coupled to a lever force test
fixture;
[0046] FIGS. 8A and 8B are experimental result graphs of lever
force versus length and jaw force versus length, respectively, in
accordance with the present disclosure;
[0047] FIG. 9A is an experimental result graph of lever force
versus lever displacement for prior art devices and devices in
accordance with the present disclosure;
[0048] FIGS. 9B and 9C are experimental result graphs of clamp
lever force and jaw force as a function of clamp jaw displacement
for prior art devices and devices in accordance with the present
disclosure, respectively;
[0049] FIG. 10 is a side view of the ultrasonic surgical instrument
of FIG. 1 as illustrated in FIG. 5, including another clamp lever
in accordance with the present disclosure;
[0050] FIG. 11 is a side view of the ultrasonic surgical instrument
of FIG. 1 as illustrated in FIG. 5, including another clamp lever
and drive assembly in accordance with the present disclosure;
[0051] FIG. 12 is a side, perspective view of the ultrasonic
surgical instrument of FIG. 1 as illustrated in FIG. 5, including
another clamp lever and drive assembly in accordance with the
present disclosure; and
[0052] FIG. 13 is a schematic illustration of a robotic surgical
system configured for use in accordance with the present
disclosure.
DETAILED DESCRIPTION
[0053] Referring generally to FIGS. 1-5, an ultrasonic surgical
instrument provided in accordance with the aspects and features of
the present disclosure is shown generally identified by reference
numeral 10. Ultrasonic surgical instrument 10 generally includes a
handle assembly 100 and an elongated assembly 200 engaged with
handle assembly 100. Handle assembly 100 includes a housing 110
defining a body portion 112 configured to support an ultrasonic
transducer and generator assembly ("TAG") 300, and a fixed handle
portion 114 defining a compartment 116 configured to receive a
battery assembly 400. Handle assembly 100 further includes an
activation button 120 operably positioned to electrically couple
between TAG 300 and battery assembly 400 when TAG 300 is mounted on
body portion 112 of housing 110 and battery assembly 400 is engaged
within compartment 116 of housing 110.
[0054] A clamp lever 130 extends from housing 110 of handle
assembly 100 adjacent fixed handle portion 114 of housing 110.
Clamp lever 130 includes a grasping portion 131 extending from body
portion 112 of housing 110, a bifurcated drive portion 132
extending into body portion 112 of housing 110, and a connector
portion 133 interconnecting grasping portion 131 and bifurcated
drive portion 132. Bifurcated drive portion 132 is selectively
movable relative to housing 110 to actuate ultrasonic surgical
instrument 10, as detailed below. Bifurcated drive portion 132 of
clamp lever 130 is pivotably connected to body portion 112 of
housing 110 about a pivot axis 134 via one or more pivotable
engagements, e.g., pivot bosses and corresponding recesses, a pivot
pin, etc. Bifurcated drive portion 132 further includes a proximal
contact surface 136 and a distal contact surface 138. Proximal and
distal contact surfaces 136, 138 may be similarly configured or
differently configured and may define linear configuration, angled
configurations, curved configurations, protruding portion(s),
recessed portion(s), or any other suitable configuration. Connector
portion 133 of clamp lever 130 interfaces with a return spring 139a
disposed about a return spring shaft 139b. Return spring 139a
biases connector portion 133 of clamp lever 130 distally and, thus,
biases clamp lever 130 towards an initial or un-actuated position,
wherein clamp lever 130 is distally spaced-apart from fixed handle
portion 114 of housing 110.
[0055] TAG 300 and battery assembly 400 are each removable from
handle assembly 100 to facilitate disposal of handle assembly 100
after a single use or to enable sterilization of handle assembly
100 for subsequent use. TAG 300 may be configured to withstand
sterilization such that TAG 300 may be sterilized for repeated use.
Battery assembly 400, on the other hand, is configured to be
aseptically transferred and retained within compartment 116 of
fixed handle portion 114 of housing 110 of handle assembly 100 such
that battery assembly 400 may be repeatedly used without requiring
sterilization thereof, although other configurations are also
contemplated. As an alternative to the cordless, battery-powered
configuration shown and described herein, ultrasonic surgical
instrument 10 may be configured as a tethered device wherein the
generator and power source are remotely disposed and connected to
the transducer (which is supported on body portion 112 of housing
110) by way of a cable.
[0056] An electrical connector 140 disposed within housing 110 of
handle assembly 100 includes TAG contacts 142, battery assembly
contacts 144, and an activation button connector 146. Electrical
connector 140 electrically couples to activation button 120 via
activation button connector 146, is configured to electrically
couple to TAG 300 via TAG contacts 142 upon engagement of TAG 300
with body portion 112 of housing 110 of handle assembly 100, and is
configured to electrically couple to battery assembly 400 via
battery assembly contacts 144 upon engagement of battery assembly
400 within compartment 116 of fixed handle portion 114 of housing
110 of handle assembly 100. As such, in use, when activation button
120 is activated in an appropriate manner, an underlying two-mode
switch assembly 122 is activated to supply power from battery
assembly 400 to TAG 300 in either a "LOW" power mode or a "HIGH"
power mode, depending upon the manner of activation of activation
button 120. However, other suitable activation configurations
employing different and/or multiple buttons, switches, modes, etc.,
are also contemplated.
[0057] With particular reference to FIG. 4, TAG 300 includes a
generator 310 and an ultrasonic transducer 320. Generator 310
includes a housing 312 configured to house the internal electronics
of generator 310, and a cradle 314 configured to rotatably support
ultrasonic transducer 320. Ultrasonic transducer 320 includes a
piezoelectric stack 322 and a distally-extending horn 324. Horn 324
defines a female receiver 326, e.g., defining internal threading,
at the free distal end thereof. A set of connectors 330, 332 and
corresponding rotational contacts 334, 336 associated with
generator 310 and ultrasonic transducer 320, respectively, enable
drive signals to be communicated from generator 310 to
piezoelectric stack 322 to drive ultrasonic transducer 320. More
specifically, piezoelectric stack 322 of ultrasonic transducer 320
converts a high voltage AC signal received from generator 310 into
mechanical motion that is output from horn 324 to elongated
assembly 200. Ultrasonic transducer 320 further includes a rotation
knob 328 (FIG. 1) disposed at a proximal end thereof to enable
rotation of ultrasonic transducer 320 relative to generator
310.
[0058] Referring again to FIGS. 1-5, elongated assembly 200
includes a drive member and a support member such as, for example,
an outer drive sleeve 210 and an inner support sleeve 220 disposed
within outer drive sleeve 210 (although this configuration may be
reversed, e.g., wherein the outer sleeve is the fixed support
sleeve and the inner sleeve is the movable drive sleeve and/or
other suitable drive and support structures, e.g., cables, bars,
etc. may be utilized). Elongated assembly 200 further includes a
waveguide 230 extending through inner support sleeve 220, a torque
adapter 240 engaged about waveguide 230, a drive assembly 250
disposed about outer drive sleeve 210 and operably coupled between
outer drive sleeve 210 and bifurcated drive portion 132 of clamp
lever 130, a torque housing 260 disposed about outer drive sleeve
210 and operably coupled to waveguide 230, a rotation knob 270
operably disposed about torque housing 260, and an end effector 280
disposed at the distal end of inner support sleeve 220. Elongated
assembly 200 is operably engaged with handle assembly 100 such that
mechanical motion output from horn 324 of ultrasonic transducer 320
is transmitted along waveguide 230 to end effector 280 for treating
tissue therewith, such that clamp lever 130 is selectively
actuatable to manipulate end effector 280, and such that rotation
knob 270 is selectively rotatable to rotate elongated assembly 200
relative to handle assembly 100.
[0059] Outer drive sleeve 210, as noted above, is slidably disposed
about inner support sleeve 220. Sleeves 210, 220 may be
concentrically arranged about one another and/or waveguide 230.
Outer drive sleeve 210 includes drive tube 252 of drive assembly
250 fixedly engaged thereabout. Outer drive sleeve 210 and inner
support sleeve 220 are each operably coupled to clamp jaw 282 of
end effector 280 at the distal end thereof. More specifically,
clamp jaw 282 includes a pair of jaw flanges 284 that are pivotably
mounted at the distal end of inner support sleeve 220 to pivotably
couple clamp jaw 282 to inner support sleeve 220, and a jaw foot
286 extending through an aperture 214 defined within outer drive
sleeve 210 at the distal end thereof such that proximal translation
of outer drive sleeve 210 about inner support sleeve 220 and
relative to end effector 280 pivots clamp jaw 282 from an open
position to a clamping position. Clamp jaw 282 includes a
structural body 288 (FIG. 6) supporting a more-compliant jaw liner
290 (FIG. 6) formed from, for example, PTFE. The jaw liner 290
(FIG. 6) of clamp jaw 282 is configured to oppose blade 234 to
enable clamping of tissue therebetween.
[0060] Waveguide 230, as noted above, extends through inner support
sleeve 220. Waveguide 230 defines a body 232, a blade 234 extending
from the distal end of body 232, and a proximal connector 239
extending from the proximal end of body 232. Blade 234 extends
distally from inner support sleeve 220 and forms part of end
effector 280 in that blade 234 is positioned to oppose clamp jaw
282 such that pivoting of clamp jaw 282 from the open position to
the clamping position enables clamping of tissue between clamp jaw
282 and blade 234. Blade 234 defines a curved configuration wherein
the directions of movement of clamp jaw 282 between the open and
clamping positions are perpendicular to the direction of curvature
of blade 234. However, it is also contemplated that blade 234
define a straight configuration or that blade 234 curve towards or
away from clamp jaw 282, that is, where the directions of movement
of clamp jaw 282 between the open and clamping positions are
coaxial or parallel to the direction of curvature of blade 234.
Multiple curves and/or angles of blade 234 in similar or different
directions and/or planes are also contemplated.
[0061] Proximal connector 239 of waveguide 230 is configured to
enable engagement of waveguide 230 with horn 324 of ultrasonic
transducer 320 such that mechanical motion produced by ultrasonic
transducer 320 is capable of being transmitted along waveguide 230
to blade 234 for treating tissue clamping between blade 234 and
clamp jaw 282 or positioned adjacent to blade 234. To this end,
proximal connector 239 includes, for example, a threaded male
shaft, that is configured for engagement, e.g., threaded
engagement, within female receiver 326 of horn 324 of ultrasonic
transducer 320, although other suitable engagement configurations
for operably coupling horn 324 and waveguide 230 with one another
are also contemplated.
[0062] Continuing with reference to FIGS. 1-5, torque adapter 240,
as noted above, is engaged about waveguide 230. Torque adapter 240
enables rotational locking of waveguide 230 relative to outer drive
sleeve 210, inner support sleeve 220, drive assembly 250, torque
housing 260, and rotation knob 270 such that these components
rotate together relative to handle assembly 100 upon manipulation
of rotation knob 270. Torque housing 260 is configured for
engagement about drive tube 252 and functions as an integrated
torque-wrench that ensures appropriate application of torque to
sufficiently engage waveguide 230 and ultrasonic transducer 320 to
one another during assembly, e.g., upon rotation of rotation knob
270 relative to ultrasonic transducer 320, while inhibiting
over-tightening of the engagement between waveguide 230 and
ultrasonic transducer 320, e.g., despite further rotation of
rotation knob 270 relative to ultrasonic transducer 320.
[0063] Drive assembly 250 of elongated assembly 200 is disposed
about outer drive sleeve 210 and operably coupled between outer
drive sleeve 210 and bifurcated drive portion 132 of clamp lever
130. Drive assembly 250 includes a drive tube 252 and a rigid
slider 256. Drive tube 252 is fixedly engaged about outer drive
sleeve 210 and includes a distal collar 253a and a proximal body
253b. Rigid slider 256 includes an inner retainer 254 fixedly
engaged with proximal body 253b of drive tube 252 at a proximal end
portion thereof and an outer slider 258 slidably disposed about a
distal body 259b of inner retainer 254 between a proximal rim 259a
of inner retainer 254 and distal collar 253a of drive tube 252.
Alternatively or additionally, distal body 259b of inner retainer
254 may be omitted or shortened such that outer slider 258 is
slidably disposed proximal body 253b of drive tube 252.
[0064] In some configurations, rather than outer slider 258 of
rigid slider 256 being slidable relative to inner retainer 254,
outer slider 258 and inner retainer 254 may be fixed relative to
one another, e.g., via a fixed engagement (such as by welding,
snap-fitting, interference fitting, keyed engagement, adhesion,
etc.), or via monolithically forming as a single component. In some
configurations, rigid slider 256 (or a portion thereof) is
monolithically formed with drive tube 252. In still other
configurations, drive tube 252 is omitted and rigid slider 256 is
directly coupled about a proximal end portion of outer drive sleeve
210. In configurations where rigid slider 256 is directly coupled
about outer drive sleeve 210, inner retainer 254 may be fixed about
outer drive sleeve 210, e.g., via welding, snap-fitting,
interference fitting, keyed engagement, adhesion, etc., or via
monolithic formation, while outer slider 258 is slidable relative
to both inner retainer 254 and outer drive sleeve 210, or both
inner retainer 254 and outer slider 258 may be fixed relative to
outer drive sleeve 210.
[0065] Inner retainer 254 and outer slider 258 of rigid slider 256
may be formed from any (similar or different) substantially rigid
material or materials such that rigid slider 256 is not configured
to compress, extend, or otherwise deflect during normal operation.
Further, rigid slider 256 is configured to provide a 1:1 force
ratio; that is, a force input to rigid slider 256 is substantially
equal to a force output from rigid slider 256 (due to the lack of
compression, extension, etc. thereof). Thus, rigid slider 256 is
configured to transfer force without itself limiting or otherwise
modifying force.
[0066] An annular gap 255 (FIG. 5) is defined about distal body
259b of inner retainer 254 or, in configurations where distal body
259b is omitted or shortened, about proximal body 253b of drive
tube 252. Annular gap 255 is defined longitudinally between the
distal end of outer slider 258 of rigid slider 256 and distal
collar 253a of drive tube 252 and is configured to receive
bifurcated drive portion 132 of clamp lever 130 on either side
thereof such that actuation of clamp lever 130 urges rigid slider
256. More specifically, proximal and distal contact surfaces 136,
138 of clamp lever 130 are configured for positioning within
annular gap 255 adjacent the distal end of outer slider 258 of
rigid slider 256 and distal collar 253a of drive tube 252,
respectively, such that proximal actuation of clamp lever 130 urges
proximal contact surface 136 into the distal end of outer slider
258 to thereby urge outer slider 258 proximally. Outer slider 258,
in turn, whether by fixed engagement or by sliding contact, urges
inner retainer 254 proximally to thereby urge drive tube 252 and
outer drive sleeve 210 proximally. Of course, where drive tube 252
is omitted, the proximal movement of inner retainer 254 directly
urges outer drive sleeve 210 proximally. In either configuration,
proximal movement of outer drive sleeve 210, as noted above, pivots
clamp jaw 282 from the open position towards the clamping position
for clamping tissue between clamp jaw 282 and blade 234. Distal
return of clamp lever 130, on the other hand, urges distal contact
surface 138 into contact with raised collar 253a of drive tube 252
(or other feature associated with rigid slider 256 or outer drive
sleeve 210) to thereby urge outer drive sleeve 210 distally to
return clamp jaw 282 back towards the open position.
[0067] The longitudinal length of annular gap 255, e.g., the
distance between the distal end of outer slider 258 of rigid slider
256 and distal collar 253a of drive tube 252 substantially
approximates the distance between proximal and distal contact
surfaces 136, 138 to substantially eliminate any play therebetween
while permitting bifurcated drive portion 132 of clamp lever 130 to
pivot within annular gap 255 as clamp lever 130 is pivoted relative
to body portion 112 of housing 110 about pivot axis 134.
[0068] As an alternative to the above-detailed configuration,
wherein proximal translation of outer drive sleeve 210 in response
to proximal pivoting of bifurcated drive portion 132 of clamp lever
130 pivots clamp jaw 282 from the open position to the clamping
position, the opposite configuration may be provided, such as
detailed below with respect to FIG. 11.
[0069] Continuing with reference to FIGS. 1-5, as noted above,
clamp lever 130 and drive assembly 250 are designed such that the
force imparted to clamp lever 130 is proportional to the
longitudinal motion of outer drive sleeve 210 to pivot clamp jaw
282 from the open position towards the clamping position for
clamping tissue between clamp jaw 282 and blade 234 under a
clamping force and, thus, such that the lever force imparted to
clamp lever 130 is proportional to the jaw force applied by clamp
jaw 282 (and the jaw pressure applied by clamp jaw 282). Although
there is necessarily some dampening and/or loss from connections,
friction, material properties, etc., associated with clamp lever
130, waveguide 230, and drive assembly 250, neither clamp lever
130, waveguide 230, nor drive assembly 250 is designed to
incorporate any specific force-dampening features such as, for
example: increased flexibility or a spring incorporated into a
portion(s) of clamp lever 130, one or more springs associated with
drive assembly 250, increased flexibility or a spring incorporated
into a portion(s) of drive sleeve 210, increased flexibility or a
spring incorporated into a portion(s) of waveguide 230, other
flexible connections specifically designed to dampen force,
etc.
[0070] Rather than using one or more springs, flexible portions,
flexible connections, and/or other suitable dampening feature(s) to
regulate the jaw force (and jaw pressure) applied by clamp jaw 282,
ultrasonic instrument 10 (FIG. 1) as a whole and, more
specifically, clamp lever 130 and drive assembly 250 thereof, are
design to provide substantially no dampening between clamp lever
130 and clamp jaw 282, and are tuned to provide a jaw force
(defined herein as a numerical jaw force or jaw force within a
numerical range), to require a lever force (defined herein as a
numerical lever force or lever force within a numerical range),
and/or to provide a jaw pressure (defined herein as a numerical jaw
pressure or jaw pressure within a numerical range). As detailed
below, the jaw force and/or lever force may be based on
fully-actuating clamp lever 130, e.g., wherein grasping portion 131
of clamp lever 130 contacts fixed handle portion 114 of housing 110
(or at another hard stop), while clamp jaw 282 is clamped against a
test device (and is not in contact with blade 234). However, other
suitable bases for determining the jaw force and lever force are
also contemplated. It is noted that the jaw force and lever force
to which ultrasonic instrument 10 (FIG. 1) is turned are not
necessarily the forces applied during use but, rather, are set
points based upon which ultrasonic instrument 10 (FIG. 1) is
designed and based upon which ultrasonic instrument 10 (FIG. 1) can
be tested during manufacturing to ensure compliance. Further, the
values of such forces are not universal but, rather, are relative
to the manner in which the forces are measured. As such, the
present disclosure is not limited to particular set point forces or
manners of determining the same but, rather, is inclusive of any
suitable forces and/or manners of determining the same to which an
ultrasonic surgical instrument can be readily tuned. Further, an
acceptable tolerance level may be built into the forces to allow
for acceptable variation, e.g., due to manufacturing tolerances,
material tolerances, use and environmental tolerances, measurement
variations, and/or other variations, in the design and
manufacturing of ultrasonic surgical instrument 10 (FIG. 1). An
acceptable tolerance may include, for example, plus or minus 10% of
the force(s), although other acceptable tolerances are also
contemplated.
[0071] Jaw pressure may correspond to the pressure applied by clamp
jaw 282 to tissue, e.g., a blood vessel, clamped between clamp jaw
282 and blade 234 during use and/or in testing, and may be based on
fully-actuating clamp lever 130, e.g., wherein grasping portion 131
of clamp lever 130 contacts fixed handle portion 114 of housing 110
(or at another hard stop). Further, with respect to testing, a
tissue-approximating structure such as, for example, a rubber pad,
a foam pad, an elastic tube, etc., may be utilized in place of
actual tissue. Jaw pressure is calculated as jaw force divided by
clamping surface area. The jaw force may be an average jaw force
applied to tissue (or a tissue-approximating structure) clamped
between clamp jaw 282 and blade 234, e.g., an average of plural
measurements taken at plural locations along the tissue-contacting
length of blade 234 such as, for example, at a proximal heal
location, a distal tip location, and an intermediate location, thus
yielding an average jaw pressure. Alternatively, the jaw force may
be measured at a single, pre-defined location, e.g., at a
midpoint.
[0072] As pressure is force per unit area, for the same force
applied, the pressure applied to tissue that contacts the entire
clamping surface area is less than the pressure applied to tissue
that contacts only a portion of the clamping surface area. The
pressures detailed herein are based on tissue contacting the entire
clamping surface area. The clamping surface area is defined as the
tissue-contacting surface area of jaw liner 290 (FIG. 6) that
clamps tissue against the blade 234 in the clamping position, e.g.,
a length of the tissue-contacting surface of jaw liner 290 (FIG. 6)
that extends along the blade 234 multiplied by a width of the
tissue-contacting surface of jaw liner 290 (FIG. 6) that extends
across the blade 234. Jaw pressure may alternatively be calculated
by dividing the set-point jaw force, e.g., as detailed herein
(instead of measuring a jaw force applied to clamped tissue), by
the clamping surface area. The clamping surface area may be, in
aspects, from about 0.020 in.sup.2 to about 0.040 in.sup.2; in
other aspects, from about 0.025 in.sup.2 to about 0.035 in.sup.2;
and, in still other aspects, about 0.028 in.sup.2, although other
clamping surface areas are also contemplated depending, for
example, upon the tissue effect desired, the waveguide
configuration, the blade configuration, the operating parameters,
etc.
[0073] Referring to FIGS. 6 and 7, exemplary set-ups for measuring
the set point jaw force and lever force, respectively, are shown,
although other suitable configurations are also contemplated. With
initial reference to FIG. 6, end effector 280 of ultrasonic
surgical instrument 10 is shown disposed within a testing assembly
500. Testing assembly 500 generally includes a fixture 510 and a
sensor 520 coupled to fixture 510. Fixture 510 defines a
longitudinal channel extending from a proximal end portion 510a to
a distal end portion 510b of fixture 510 to enable receipt and
retention of blade 234 of end effector 280 therein. End effector
280, more specifically, is positioned relative to fixture 510 such
that sensor 520 is disposed adjacent a notch 296 defined within
structural body 288 of clamp jaw 282. As a result of this
configuration, as clamp jaw 282 is approximated relative to blade
234, sensor 520 is received within notch 296, wherein sensor 520
measures the jaw force applied by clamp jaw 282. Sensor 520 may be,
for example, a force sensor, e.g., a load cell, or any other
suitable sensor capable of measuring and providing feedback with
respect to the jaw force applied by clamp jaw 282 of end effector
280. It is noted that sensor 520 is received within notch 296 and
measures the jaw force when clamp lever 130 is in the fully
actuated position (without jaw liner 290 contacting blade 234),
although other configurations are also contemplated such as, for
example the omission of notch 296. Whether notch 296 is provided or
not, sensor 520 is configured to obtain a jaw force measurement
provided by structural body 288 at a known longitudinal position
such as, for example, a distance of about 0.192 inches from a
distal end of clamp jaw 282. In aspects, jaw force is measured at
multiple locations, e.g., at a proximal end portion of clamp jaw
282, a distal end portion of clamp jaw 282, and an intermediate
position therebetween, to enable determination of an average jaw
force along the length of structural body 288. Further, as another
alternative to providing a notch 296, sensor 520, another sensor
(not shown), or a manual measurement may utilized to measure a
distance from the measurement point to the pivot location of clamp
jaw 282 and/or to the distal end of clamp jaw 282 to enable
normalization of the jaw force measurement across different device
configurations. With respect to measuring jaw force in use or in
testing to simulate use on tissue, sensor 520 may be incorporated
into tissue or a tissue-approximating structure that is clamped
between clamp jaw 282 and blade 284 in order to enable measurement
of the jaw force applied thereto, e.g., at one or more locations.
Regardless of the manner in which the jaw force measurement taken,
jaw pressure may be determined based thereon by dividing the jaw
force by the clamping surface area. Where multiple jaw force
measurements are used to determine an average jaw force, an average
jaw pressure may thus be determined.
[0074] Turning to FIG. 7, fixed handle portion 114 of ultrasonic
surgical instrument 10 is shown disposed within a testing assembly
600. Testing assembly 600 generally includes a fixture 610, a
piston 620, and a sensor 630 configured to measure a force applied
by piston 620. Fixture 610 is configured to retain a portion of
fixed handle portion 114 therein and operably supports piston 620
thereon. Piston 620 is positioned distally adjacent grasping
portion 131 of clamp lever 130 and is configured, upon activation,
to actuate clamp lever 130, e.g., urging clamp lever 130
proximally. Sensor 630 is configured to measure the force required
to urge clamp lever 130 to a fully-actuated position, e.g., wherein
at least a portion of grasping portion 131 of clamp lever 130 abuts
fixed handle portion 114, although the fully-actuated position need
not require such contact and/or other reference positions for
determining lever force may also be utilized. Piston 620 is
positioned to contact clamp lever 130 at about a midpoint along the
height of grasping portion 131 of clamp lever 130, adjacent the
free end of the hook portion of clamp lever 130, although other
configurations are also contemplated.
[0075] Referring generally to FIGS. 1-5, utilizing a rigid
configuration wherein clamp lever 130 and drive assembly 250 are
tuned to achieve a lever force, jaw force, and/or jaw pressure is
advantageous at least because such a configuration enables more
precise tuning, reduces cost and complexity, and also provides
increased tactility in that it enables the user to feel the amount
of jaw force applied. The use of a spring(s) or other dampening
feature(s), on the other hand, dampens the tactility between the
user and tissue, can be challenging for manufacturing, and adds
additional cost and complexity to the mechanical system.
[0076] Altering the configuration of one or more components of
ultrasonic instrument 10 enables ultrasonic instrument 10 (FIG. 1)
and, more specifically, clamp lever 130 and drive assembly 250, to
be tuned to achieve the desired lever force, jaw force, and/or jaw
pressure. For example, moving the position of proximal contact
surface 136 proximally or distally (along a longitudinal axis
defined through outer drive sleeve 210) alters the jaw force (and,
thus, the jaw pressure). More specifically, moving proximal contact
surface 136 proximally reduces the jaw force while moving the
proximal contact surface 136 distally increases the jaw force.
Proximal contact surface 136 may be moved by modifying a width of
bifurcated drive portion 132 at proximal contact surface 136 or in
any other suitable manner. Modifying the position of proximal
contact surface 136 may also require further modification of
bifurcated drive portion 132 and, more specifically, the
longitudinal position of distal contact surface 138, to maintain
bifurcated drive portion 132 within annular gap 255 to
substantially eliminate any play therebetween.
[0077] As another example, instead of or in addition to modifying a
width of bifurcated drive portion 132 at proximal contact surface
136, the longitudinal length of outer slider 258 of rigid slider
256 may be modified. More specifically, increasing the length of
outer slider 258 increases the jaw force (and, thus, the jaw
pressure) and the lever force, while decreasing the length of outer
slider 258 decreases the jaw force (and, thus, the jaw pressure)
and the lever force. Experimental results illustrating the same are
shown in FIGS. 8A and 8B. By way of example, and as illustrated in
the graphs of FIGS. 8A and 8B, the length of outer slider 258
(and/or configurations of other components) may be tuned to achieve
a lever force of about 3.8 lbf and/or a jaw force of about 3.2 lbf,
although outer suitable forces (including force ranges) are also
contemplated. For example, the lever force may be from about 1 lbf
to about 10 lbf; in other aspects, from about 2 lbf to about 5 lbf.
The jaw force may be from about 1 lbf to about 8 lbf; in other
aspects, from about 2 lbf to about 5 lbf; in still other aspects
from about 2.5 lbf to about 4.5 lbf. The jaw pressure may be from
about 35 psi to about 285 psi; in other aspects, from about 70 psi
to about 180 psi; and in other aspects from about 90 psi to about
160 psi.
[0078] Turning to FIG. 9A, experimental results illustrating clamp
lever force as a function of clamp lever displacement, e.g., from
the un-actuated position towards the actuated position, are shown
for a prior art device including a force-dampening spring ("PA")
and for a device employing a rigid configuration in accordance with
the present disclosure ("PD"). The clamp lever force measurements
were obtained using a structure clamped between the jaw and blade
that approximates tissue, e.g., a rubber pad, and has a sufficient
thickness to approximate a substantially full grasp of tissue
between the jaw and blade. Further, it is noted that the plotted
lines are offset for clarity, e.g., the "PA" and "PD" lines do not
start at zero force/displacement.
[0079] With respect to the plotted lines indicative of the prior
art "PA," the slope between points "A" and "B" is defined by
waveguide deflection, tissue compression, and a relatively minor
influence of the force-dampening spring. Between points "B" and
"C," the slope is defined by the compression of the dampening
spring with relatively minor influence from tissue compression and
system tolerances. At point "C," the clamp lever is disposed in the
fully actuated position, e.g., at least partially contacting the
fixed handle.
[0080] With respect to the plotted lines indicative of the present
disclosure "PD," the slope between point "D" and point "E" is
substantially zero (with any slope attributed thereto being an
artifact of the experimental set up). The slope between point "E"
and point "F" is defined by waveguide deflection, tissue
compression, and a relatively minor influence from system
tolerances. The slope from point "F" to point "G" is defined by
properties of the tissue, e.g., stiffness, thickness, etc., with
minor influence from system tolerances. At point "G," the clamp
lever is disposed in the fully actuated position, e.g., at least
partially contacting the fixed handle.
[0081] Comparing the slope between points "B" and "C" on the
plotted lines indicative of the prior art "PA" with the slope
between points "E" and "G" on the plotted lines indicative of the
present disclosure "PD," it can be seen that the slope between "B"
and "C" approaches zero, providing little to no "feel" to the user,
while the slope between points "E" and "G" is angled and, thus,
provides the user with a near real "feel" of force input (by the
clamp lever) to force applied (to tissue). From this "feel," the
user gains knowledge of the thickness, hardness, etc. of tissue
being clamped between the jaw and blade. Further, due to the
effects of the dampening spring in the prior art devices, the slope
between "B" and "C" remains substantially consistent, approaching
zero, regardless of tissue thickness, hardness, etc., thus
providing little to no feedback relating to these tissue
properties. The slope between points "E" and "G" varies between a
shallower angle and a steeper angle depending upon the tissue
properties (thickness, hardness, etc.), thus providing the feedback
regarding the same, e.g., in the form of "feel" to the user.
[0082] With reference to FIGS. 9B and 9C, experimental results
illustrating clamp lever force and jaw force as a function of clamp
jaw displacement, e.g., from the open position towards the clamping
position, are shown for prior art devices including force-dampening
springs (FIG. 9B) and for c in accordance with the present
disclosure (FIG. 9C). On the graphs, zero displacement corresponds
to the open position of the clamp jaw, with displacement increasing
as the clamp jaw is pivoted towards the clamping position. The drop
offs in jaw force indicated on the far right of the graphs
correspond to the fully clamped position, at approximately 0.325
inches of jaw displacement. These experimental results were
obtained by initially clamping the clamp jaw on a first load cell
in a fully open position with the clamp lever disposed in a fully
actuated position. A second load cell constrained the lever in the
fully actuated position. The clamp jaw was then incrementally moved
from the fully open position to the fully clamped position. Data
was collected off both load cells are the various incremental
positions of the clamp jaw between the fully open position and the
fully clamped position to obtain the jaw force and lever force data
shown in FIGS. 9B and 9C.
[0083] As shown in FIG. 9B, due to the force-dampening springs
utilized in the prior art devices, the jaw force and lever force
remain substantially constant as the clamp jaw is pivoted towards
the fully clamped position. In contrast, as shown in FIG. 9C, with
respect to the devices of the present disclosure employing a rigid
configuration, both the jaw force and the lever force varied (e.g.,
decreased substantially linearly) as the clamp jaw was pivoted
towards the fully clamped position. Thus, the devices of the
present disclosure provide feedback to the user, as varying lever
force, as to position of the clamp jaw and/or the jaw force applied
thereby. No such feedback is provided by the prior art devices.
[0084] Returning to FIGS. 1-5, as still another example, the radial
distance between pivot axis 134 and proximal contact surface 136
may be varied to modify the requisite lever force required to fully
actuate clamp lever 130 (e.g., to achieve the jaw force (and, thus,
the jaw pressure)). More specifically, decreasing the distance
between pivot axis 134 and proximal contact surface 136 decreases
the lever force while increasing the distance increases the lever
force.
[0085] With reference to FIG. 10, another clamp lever 1130 provided
in accordance with the present disclosure is shown wherein
bifurcated drive portion 1132 includes a proximally-extending
protrusion 1135 defining proximal contact surface 1136 and a
distally-extending protrusion 1137 defining distal contact surface
1138. The amounts proximally and distally-extending protrusions
1135, 1137 protrude may be varied as detailed above to achieve
lever force and the jaw force. Alternatively or additionally,
proximally-extending protrusion 1135 may be moved towards pivot
axis 1134 or away from pivot axis 134 (to thereby move proximal
contact surface 1136) to achieve the lever force.
[0086] Turning to FIG. 11, in the above-detailed configurations of
clamp levers (e.g., clamp levers 130, 1130 (FIGS. 5 and 10,
respectively)), lever force and jaw force are positively correlated
with respect to modifications to longitudinal positioning of the
proximal contact surface and/or length of the rigid slider. That
is, the lever force and jaw force are moved in the same direction,
e.g., increased or decreased, in response to modifying the
longitudinal positioning of the proximal contact surface and/or
length of the rigid slider. FIG. 11 illustrates another
configuration of clamp lever 2130 and drive assembly 2250 in
accordance with the present disclosure wherein the lever force and
jaw force are inversely correlated. More specifically, clamp lever
2130 includes a grasping portion 2131 extending from body portion
112 of housing 110, a bifurcated drive portion 2132 extending into
body portion 112 of housing 110, and a connector portion 2133
interconnecting grasping portion 2131 and bifurcated drive portion
2132. Clamp lever 2130 is pivotably connected to housing 110 about
a pivot axis 2134 that is disposed at connector portion 2133 of
clamp lever 2130 between grasping portion 2131 and bifurcated drive
portion 2132 and, thus, below a longitudinal axis of outer drive
sleeve 210. In this manner, actuation of clamp lever 2130 moves
bifurcated drive portion 2132 distally. As such, rigid slider 2256
is positioned distally of bifurcated drive portion 2132 and is
oppositely oriented compared to rigid slider 256 (FIG. 5) but may
otherwise be configured similarly as rigid slider 256 (FIG. 5).
Thus, actuation of clamp lever 2130 translates outer drive sleeve
210 distally to move clamp jaw 282 (FIG. 1) towards the clamping
position and to apply the jaw force. The operability of proximal
and distal contact surfaces 2136, 2138 of clamp lever 2130 are
opposite of those detailed above with respect to configurations
wherein the pivot location is above the longitudinal axis and the
rigid slider is positioned proximally of the clamp lever. Further,
the operable coupling of clamp jaw 282 (FIG. 1) with outer drive
sleeve 210 may be modified to accommodate the clamping of clamp jaw
282 (FIG. 1) in response to distal movement of outer drive sleeve
210, e.g., via positioning jaw foot 286 (FIG. 4) on the opposite
side of the jaw pivot, utilizing a cam-slot engagement, camming
outer drive sleeve 210 about clamp jaw 282 (FIG. 1) to act as a
closure tube, or in any other suitable manner.
[0087] The above-detailed configuration illustrated in FIG. 11
provides for an inverse correlation between lever force and jaw
force with respect to modifications to longitudinal positioning of
the distal contact surface and/or length of the rigid slider. That
is, in the configuration of clamp lever 2130 and drive assembly
2250 in FIG. 11, as the longitudinal positioning of the proximal
contact surface and/or length of the rigid slider is altered, lever
force is modified in one direction while jaw force is modified in
the opposite direction.
[0088] With reference to FIG. 12, another configuration of clamp
lever 3130 and drive assembly 3250 in accordance with the present
disclosure is shown wherein, rather than including contact surfaces
on clamp lever 3130 to directly interact with drive assembly 3250,
first and second linkages 3160 operably couple clamp lever 3130
with rigid slider 3256 of drive assembly 3250. More specifically,
clamp lever 3130 includes a grasping portion (not shown) extending
from body portion 112 of housing 110, a bifurcated drive portion
3132 extending into body portion 112 of housing 110, and a
connector portion 3133 interconnecting the grasping portion (not
shown) and bifurcated drive portion 3132. Clamp lever 3130 is
pivotably connected to housing 110 via pivots 3134 that are
disposed at a free end of bifurcated drive portion 3132 of clamp
lever 3130, above a longitudinal axis of outer drive sleeve
210.
[0089] Linkages 3160 are disposed on either side of rigid slider
3256 and within bifurcated drive portion 3132, although linkages
3160 may alternatively be disposed outside of bifurcated drive
portion 3132 or in any other suitable position. Further, in some
aspects, only one linkage 3160 is provided. Linkages 3160 are
pivotably coupled, towards distal end portions thereof, to
bifurcated drive portion 3132 via pivots 3162. In aspects, pivots
3162 are disposed above the longitudinal axis of outer drive sleeve
210. Linkages 3160 are further pivotably coupled, towards proximal
end portions thereof, to rigid slider 3256 via pivots 3164. Rigid
slider 3256 may be longitudinally fixed but rotatably coupled to
outer drive sleeve 210 to enable rotation, or may include an inner
retainer fixedly engaged with outer drive sleeve 210 and an outer
slider longitudinally fixed but rotatably coupled to the inner
retainer to likewise enable rotation. Rigid slider 3256 may be
similar to the configurations detailed above or may be provided in
any other suitable manner.
[0090] As a result of the above-detailed configuration, actuation
of clamp lever 3130 moves bifurcated drive portion 3132 proximally
which, in turn, urges linkages 3160 proximally to thereby urge
rigid slider 3256 proximally to translate outer drive sleeve 210
proximally to move clamp jaw 282 (FIG. 1) towards the clamping
position and to apply the jaw force. Further, the above-detailed
configuration illustrated in FIG. 12 provides for an increased
mechanical advantage in that it enables positioning of the force
transfer pivot axis, e.g., the pivot axis about which the distal
end portion of linkage 3160 is connected to bifurcated drive
portion 3132, closer to the pivot axis about which clamp lever 3130
is pivotably connected to housing 110. Thus, with the increased
mechanical advantage, a relatively smaller lever force is required
to achieve the same jaw force (and jaw pressure) or, put another
way, the same lever force achieves a relatively greater jaw force
(and jaw pressure). The location of the force transfer pivot axis
may be selected to achieve a desired mechanical advantage and,
thus, a desired resultant jaw force in response to an input lever
force.
[0091] Referring to FIG. 13, a robotic surgical system in
accordance with the aspects and features of the present disclosure
is shown generally identified by reference numeral 1000. For the
purposes herein, robotic surgical system 1000 is generally
described. Aspects and features of robotic surgical system 1000 not
germane to the understanding of the present disclosure are omitted
to avoid obscuring the aspects and features of the present
disclosure in unnecessary detail.
[0092] Robotic surgical system 1000 generally includes a plurality
of robot arms 1002, 1003; a control device 1004; and an operating
console 1005 coupled with control device 1004. Operating console
1005 may include a display device 1006, which may be set up in
particular to display three-dimensional images; and manual input
devices 1007, 1008, by means of which a person (not shown), for
example a surgeon, may be able to telemanipulate robot arms 1002,
1003 in a first operating mode. Robotic surgical system 1000 may be
configured for use on a patient 1013 lying on a patient table 1012
to be treated in a minimally invasive manner. Robotic surgical
system 1000 may further include a database 1014, in particular
coupled to control device 1004, in which are stored, for example,
pre-operative data from patient 1013 and/or anatomical atlases.
[0093] Each of the robot arms 1002, 1003 may include a plurality of
members, which are connected through joints, and an attaching
device 1009, 1011, to which may be attached, for example, a
surgical tool "ST" supporting an end effector 1050, 1060. One of
the surgical tools "ST" may be ultrasonic surgical instrument 10
(FIG. 1), wherein manual actuation features thereof, e.g., clamp
lever 130 (FIG. 1), are replaced with robotic inputs. The other
surgical tool "ST" may include any other suitable surgical
instrument, e.g., an endoscopic camera, other surgical tool, etc.
Robot arms 1002, 1003 may be driven by electric drives, e.g.,
motors, that are connected to control device 1004. Control device
1004 (e.g., a computer) may be configured to activate the motors,
in particular by means of a computer program, in such a way that
robot arms 1002, 1003, their attaching devices 1009, 1011, and,
thus, the surgical tools "ST" execute a desired movement and/or
function according to a corresponding input from manual input
devices 1007, 1008, respectively. Control device 1004 may also be
configured in such a way that it regulates the movement of robot
arms 1002, 1003 and/or of the motors.
[0094] With respect to robotic implementations, although the clamp
lever is removed and replaced with a robotic input, the ultrasonic
surgical instrument may still include a rigid slider configuration
wherein the instrument is tuned to provide a jaw force (and jaw
pressure) and a input force (in place of the lever force). The
input force may be tuned to requirements of the robotic arm 1002 or
in any other suitable manner. Further, due to the use of a rigid
slider configuration without any dampening features, the robotic
arm 1002 may be configured to sense the jaw force applied (based on
a torque, displacement, and/or current of the driving motor)
without the need for sensing equipment within the attachable
ultrasonic surgical instrument. The determined jaw force may be
displayed to the operator and/or utilized to provide corresponding
tactile feedback to the operator at manual input device(s) 1007,
1008.
[0095] While several configurations of the disclosure have been
shown in the drawings, it is not intended that the disclosure be
limited thereto, as it is intended that the disclosure be as broad
in scope as the art will allow and that the specification be read
likewise. Therefore, the above description should not be construed
as limiting, but merely as exemplifications of particular
configurations. Those skilled in the art will envision other
modifications within the scope and spirit of the claims appended
hereto.
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