U.S. patent application number 13/843295 was filed with the patent office on 2014-05-15 for ultrasonic and electrosurgical devices.
This patent application is currently assigned to ETHICON ENDO-SURGERY, INC.. The applicant listed for this patent is ETHICON ENDO-SURGERY, INC.. Invention is credited to Kevin D. Felder, Jacob S. Gee, Brian E. Keyt, Amy L. Marcotte, Jeffrey D. Messerly, Emily H. Monroe, Daniel W. Price, Patrick J. Scoggins, John A. Weed, III, William B. Weisenburgh, II, John W. Willis.
Application Number | 20140135804 13/843295 |
Document ID | / |
Family ID | 50682415 |
Filed Date | 2014-05-15 |
United States Patent
Application |
20140135804 |
Kind Code |
A1 |
Weisenburgh, II; William B. ;
et al. |
May 15, 2014 |
ULTRASONIC AND ELECTROSURGICAL DEVICES
Abstract
Disclosed are ultrasonic and electrosurgical devices. The
disclosed embodiments include ultrasonic blades comprising various
grasping features, devices configured to prevent ingress of
surgical matter, e.g., fluid and tissue, in the space between an
ultrasonic blade and an inner or outer tube distal of the distal
seal, alternate closure mechanisms for ultrasonic devices,
ultrasonic transducer rotation limiters to limit the rotation of an
ultrasonic transducer, ultrasonic transducer rotation systems to
provide unlimited continuous rotation of an ultrasonic device,
integrated ultrasonic instrument electrically connected to provide
RF spot coagulation with an ultrasonic (RF) generator, and coated
ultrasonic/RF blades.
Inventors: |
Weisenburgh, II; William B.;
(Maineville, OH) ; Willis; John W.; (Cincinnati,
OH) ; Weed, III; John A.; (Monroe, OH) ;
Monroe; Emily H.; (Cincinnati, OH) ; Gee; Jacob
S.; (Cincinnati, OH) ; Messerly; Jeffrey D.;
(Cincinnati, OH) ; Marcotte; Amy L.; (Mason,
OH) ; Felder; Kevin D.; (Cincinnati, OH) ;
Price; Daniel W.; (Loveland, OH) ; Scoggins; Patrick
J.; (Loveland, OH) ; Keyt; Brian E.; (China
Township, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ETHICON ENDO-SURGERY, INC. |
Cincinnati |
OH |
US |
|
|
Assignee: |
ETHICON ENDO-SURGERY, INC.
Cincinnati
OH
|
Family ID: |
50682415 |
Appl. No.: |
13/843295 |
Filed: |
March 15, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61726890 |
Nov 15, 2012 |
|
|
|
Current U.S.
Class: |
606/169 |
Current CPC
Class: |
A61B 17/29 20130101;
A61B 2018/00107 20130101; A61B 2018/00023 20130101; A61B 2018/00958
20130101; A61B 17/320092 20130101; A61B 2018/00916 20130101; A61B
2017/2936 20130101; A61B 2017/320084 20130101; A61B 2018/00083
20130101; A61B 2018/00101 20130101; A61B 2090/0436 20160201; A61B
2018/00922 20130101; A61B 2090/0813 20160201; A61B 2017/2927
20130101; A61B 2017/320074 20170801; A61B 2017/320078 20170801;
A61B 2018/00994 20130101; Y10T 137/2087 20150401; A61B 2017/320094
20170801; A61B 2017/2929 20130101; A61B 2018/00178 20130101; A61B
2217/005 20130101; A61B 18/1445 20130101; A61B 2090/035 20160201;
A61B 2017/005 20130101; A61B 2017/320088 20130101; A61B 2017/320095
20170801; A61B 2017/2939 20130101; A61B 2090/0472 20160201; A61B
18/1206 20130101; F15D 1/0015 20130101; A61B 2017/320093
20170801 |
Class at
Publication: |
606/169 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1-73. (canceled)
74. A surgical instrument, comprising: an ultrasonic waveguide
comprising a proximal end and a distal end, wherein the proximal
end is configured to couple to an ultrasonic transducer; and an
ultrasonic blade coupled to the distal end of the waveguide, the
ultrasonic blade comprising at least one grasping feature.
75. The surgical instrument of claim 74, wherein the grasping
features extend into a body portion of the blade such that the
grasping features are recessed within the body of the blade.
76. The surgical instrument of claim 74, wherein the grasping
features extend from a body portion of the blade such that the
grasping features protrude from the body of the blade.
77. The surgical instrument of claim 74, wherein a plurality of
grasping features is distributed over portions of the blade.
78. The surgical instrument of claim 77, wherein the plurality of
grasping features is distributed over lateral portions of the
blade.
79. The surgical instrument of claim 77, wherein the plurality of
grasping features is distributed longitudinally over the blade.
80. The surgical instrument of claim 77, wherein the plurality of
grasping features is distributed longitudinally over the blade.
81. The surgical instrument of claim 77, wherein the plurality of
grasping features is distributed transversely across the blade.
82. An ultrasonic blade comprising: a body; and at least one
grasping feature projecting from the body.
83. The ultrasonic blade of claim 82, wherein the at least one
grasping feature comprises at least one tooth-like element.
84. The ultrasonic blade of claim 82, wherein the at least one
grasping feature comprises at least one block-like element.
85. The ultrasonic blade of claim 82, wherein the at least one
grasping feature comprises at least one bump-like element.
86. The ultrasonic blade of claim 82, wherein the at least one
grasping feature comprises at least one spike-like element.
87. The ultrasonic blade of claim 82, wherein the at least one
grasping feature comprises at least one transverse bump-like
element.
88. An ultrasonic blade comprising: a body; and at least one
grasping feature recessed into the body.
89. The ultrasonic blade of claim 88, wherein the at least one
grasping feature comprises at least one cavity-like element.
90. The ultrasonic blade of claim 89, wherein the at least one
cavity-like grasping feature comprises at least one cylindrical
cavity-like element extending partially into or all the way through
the body.
91. The ultrasonic blade of claim 89, wherein the at least one
cavity-like grasping feature comprises at least one conical
cavity-like element extending partially into or all the way through
the body.
92. The ultrasonic blade of claim 88, wherein the at least one
grasping feature comprises at least one transverse trench-like
element.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/726,890 filed Nov. 15, 2012 and
entitled "ULTRASONIC AND ELECTROSURGICAL DEVICES," which is hereby
incorporated by reference in its entirety
INTRODUCTION
[0002] The present disclosure is related generally to ultrasonic
and electrical surgical devices. More particularly, the present
disclosure is related to various blade features for ultrasonic
blades to improve tissue grasping, various seals and fluid egress
features to prevent build up and accumulation of tissue and other
bodily materials encountered during surgery on the distal portion
of the tube(s) and the nearby portion of the blade of ultrasonic
surgical devices, clamp closure mechanisms for ultrasonic end
effectors to provide uniform clamp force, rotation mechanisms for
ultrasonic transducers and devices, and combined electrosurgical
and ultrasonic devices to provide tissue cutting and spot
coagulation.
[0003] Ultrasonic surgical devices, such as ultrasonic scalpels,
are used in many applications in surgical procedures by virtue of
their unique performance characteristics. Depending upon specific
device configurations and operational parameters, ultrasonic
surgical devices can provide substantially simultaneous transection
of tissue and hemostasis by coagulation, desirably minimizing
patient trauma. An ultrasonic surgical device comprises a
proximally-positioned ultrasonic transducer and an instrument
coupled to the ultrasonic transducer having a distally-mounted end
effector comprising an ultrasonic blade to cut and seal tissue. The
end effector is typically coupled either to a handle and/or a
robotic surgical implement via a shaft. The blade is acoustically
coupled to the transducer via a waveguide extending through the
shaft. Ultrasonic surgical devices of this nature can be configured
for open surgical use, laparoscopic, or endoscopic surgical
procedures including robotic-assisted procedures.
[0004] Ultrasonic energy cuts and coagulates tissue using
temperatures lower than those used in electrosurgical procedures.
Vibrating at high frequencies (e.g., 55,500 times per second), the
ultrasonic blade denatures protein in the tissue to form a sticky
coagulum. Pressure exerted on tissue by the blade surface in
combination with a clamping mechanism collapses blood vessels and
allows the coagulum to form a hemostatic seal. A surgeon can
control the cutting speed and coagulation by the force applied to
the tissue by the end effector, the time over which the force is
applied and the selected excursion level of the end effector.
[0005] Also used in many surgical applications are electrosurgical
devices. Electrosurgical devices apply electrical energy to tissue
in order to treat tissue. An electrosurgical device may comprise an
instrument having a distally-mounted end effector comprising one or
more electrodes. The end effector can be positioned against tissue
such that electrical current is introduced into the tissue.
Electrosurgical devices can be configured for bipolar or monopolar
operation. During bipolar operation, current is introduced into and
returned from the tissue by active and return electrodes,
respectively, of the end effector. During monopolar operation,
current is introduced into the tissue by an active electrode of the
end effector and returned through a return electrode (e.g., a
grounding pad) separately located on a patient's body. Heat
generated by the current flow through the tissue may form
haemostatic seals within the tissue and/or between tissues and thus
may be particularly useful for sealing blood vessels, for example.
The end effector of an electrosurgical device sometimes also
comprises a cutting member that is movable relative to the tissue
and the electrodes to transect the tissue.
[0006] Electrical energy applied by an electrosurgical device can
be transmitted to the instrument by a generator. The electrical
energy may be in the form of radio frequency ("RF") energy. RF
energy is a form of electrical energy that may be in the frequency
range of 300 kHz to 1 MHz. During its operation, an electrosurgical
device can transmit low frequency RF energy through tissue, which
causes ionic agitation, or friction, in effect resistive heating,
thereby increasing the temperature of the tissue. Because a sharp
boundary may be created between the affected tissue and the
surrounding tissue, surgeons can operate with a high level of
precision and control, without sacrificing adjacent tissues or
critical structures. The low operating temperatures of RF energy
may be useful for removing, shrinking, or sculpting soft tissue
while simultaneously sealing blood vessels. RF energy may work
particularly well on connective tissue, which is primarily
comprised of collagen and shrinks when contacted by heat.
SUMMARY
[0007] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide; a tube
comprising a lumen, wherein the waveguide is located within the
lumen; a clamp arm pivotably connected to the tube; and a tissue
accumulation impedance mechanism configured to prevent tissue from
accumulating in the lumen.
[0008] In another embodiment of the ultrasonic surgical instrument,
the tissue accumulation impedance mechanism comprises a boot
barrier configured to create a seal between the tube and the end
effector.
[0009] In another embodiment of the ultrasonic surgical instrument,
the boot barrier is sealed to the tube using one or more retention
features.
[0010] In another embodiment of the ultrasonic surgical instrument,
the boot barrier comprises a cavity.
[0011] In another embodiment of the ultrasonic surgical instrument,
the cavity is rounded to allow fluid to flow out of the cavity.
[0012] In another embodiment of the ultrasonic surgical instrument,
the boot barrier comprises a plurality of contact points with the
blade.
[0013] In another embodiment of the ultrasonic surgical instrument,
the tissue accumulation impedance mechanism comprises one or more
apertures in the tube.
[0014] In another embodiment of the ultrasonic surgical instrument,
the apertures comprise one or more windows.
[0015] In another embodiment of the ultrasonic surgical instrument
the apertures comprise one or more holes.
[0016] In another embodiment of the ultrasonic surgical instrument,
the distal portion comprises a hemispherical cross section.
[0017] In another embodiment of the ultrasonic surgical instrument,
the tube comprises one or more ribs formed on an inner side of the
tube.
[0018] In another embodiment of the ultrasonic surgical instrument,
the tissue accumulation impedance mechanism comprises a pump
configured to provide a positive pressure flow between the blade
and the tube, wherein the positive pressure flow prevents tissue
ingress into the lumen.
[0019] In another embodiment of the ultrasonic surgical instrument,
the pump or the outlet of the pump is located distally to a
distal-most overmolded seal located within the lumen.
[0020] In another embodiment of the ultrasonic surgical instrument
the tissue accumulation impedance mechanism comprises a slidable
tube disposed within the lumen, the slidable tube slidable from a
first position to a second position, wherein in the first position
the slidable tube is disposed over the blade, and the second
position the blade is exposed.
[0021] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide, the end
effector comprising at least one tissue retention feature; a clamp
arm operatively coupled to the end effector.
[0022] In another embodiment of the ultrasonic surgical instrument,
the at least one tissue retention feature comprises one or more
indentations/grooves/notches/texture formed in the end
effector.
[0023] In another embodiment of the ultrasonic surgical instrument,
the one or more indentations comprise triangular teeth.
[0024] In another embodiment of the ultrasonic surgical instrument,
the one or more indentations comprise holes.
[0025] In another embodiment of the ultrasonic surgical instrument,
the one or more indentations comprise horizontal trenches.
[0026] In another embodiment of the ultrasonic surgical instrument,
the at least on tissue retention feature comprises one or more
projections from the end effector.
[0027] In another embodiment of the ultrasonic surgical instrument,
the one or more projections comprise triangular teeth.
[0028] In another embodiment of the ultrasonic surgical instrument,
the one or more projections comprise blocks.
[0029] In another embodiment of the ultrasonic surgical instrument,
the one or more projections comprise horizontal bumps.
[0030] In another embodiment of the ultrasonic surgical instrument,
the one or more projections comprise circular bumps.
[0031] In another embodiment of the ultrasonic surgical instrument,
the at least one tissue retention feature is disposed over an
entire length of the blade.
[0032] In another embodiment of the ultrasonic surgical instrument,
the at least one tissue retention feature is disposed over a
discrete section of the blade.
[0033] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector operatively coupled to the distal end of the waveguide
guide; a rotation shroud configured to rotate the waveguide; and a
rotation stop mechanism coupled to the rotation shroud prevent
rotation of the rotation knob beyond a predetermined rotation.
[0034] In another embodiment of the ultrasonic surgical instrument,
the shroud comprises at least one channel; at least one boss, the
at least one boss located within the at least one channel, wherein
the at least one boss has a predetermined lateral movement limit,
wherein when the at least one boss reaches the predetermined
lateral movement limit, the at least one boss prevents further
rotation of the rotation knob.
[0035] In another embodiment of the ultrasonic surgical instrument,
the rotation stop comprises a gate comprising a first wing and a
second wing, wherein the first and second wings are disposed at an
angle, wherein the gate is disposed within the shroud and the gate
allows a predetermined angle of rotation of the shroud.
[0036] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide; a clamp
arm operatively coupled to the end effector; a tube disposed over
the waveguide, wherein the tube comprises a counter deflection
element, wherein the counter deflection element is configured to
allow deflection of the blade, wherein the deflection of the blade
counteracts a force placed on the blade by the clamp arm in a
clamped position.
[0037] In one embodiment, a surgical instrument comprises a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a signal source, the signal source
configured to provide an ultrasonic signal and an electrosurgical
signal; an end effector coupled to the waveguide; a clamp arm
operatively coupled to the end effector; and a sealing button,
wherein the sealing button causes the surgical instrument to
deliver the electrosurgical signal to the end effector and/or the
clamp arm for a first period and the sealing button causes the
surgical instrument to deliver the ultrasonic signal to the blade
for a second period, wherein the second period is subsequent to the
first period.
[0038] In another embodiment of the surgical instrument, the
sealing button causes the surgical instrument to deliver the
ultrasonic signal to the end effector prior to transmitting the
electrosurgical signal to the end effector and/or clamp arm.
[0039] In another embodiment of the surgical instrument, the
sealing button causes the surgical instrument to only deliver the
ultrasonic signal to the end effector resulting in haemostatic
transection of tissue. A separate spot coagulation button is
provided on the handle. When the spot coagulation button is
depressed, an electrosurgical signal is provided to either the end
effector or the clamp arm or both to effect spot coagulation of
tissue.
[0040] In another embodiment of the surgical instrument, wherein
the electrosurgical signal is a monopolar RF signal.
[0041] In another embodiment of the surgical instrument, wherein
the electrosurgical signal is a bipolar RF signal.
[0042] In one embodiment, a surgical instrument comprises a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to an ultrasonic transducer; an end
effector coupled to the distal end of the waveguide; a tube
disposed over the waveguide; a cam surface formed on or in an outer
surface of the tube; and a clamp arm, wherein the clamp arm is
operatively coupled to the cam surface.
[0043] In another embodiment of the surgical instrument, a pivot
pin is located within a hole defined by the end effector, the pivot
pin operatively coupled to the clamp arm, wherein the clamp arm
pivots about the pivot pin.
[0044] In another embodiment of the surgical instrument, the pivot
pin is located at the distal most node of the waveguide.
[0045] In another embodiment of the surgical instrument, the tube
is actuatable and the clamp arm is cammed open and closed against
the end effector through relative motion between the tube and the
end effector.
[0046] In one embodiment, a surgical instrument comprises a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to an ultrasonic transducer; an end
effector coupled to the distal end of the waveguide, the end
effector defining a pin hole; a rigid pin disposed within the pin
hole; a clamp arm operatively connected to the outer tube; and a
four-bar linkage; wherein the four-bar linkage is operatively
coupled to the clamp arm and the rigid pin, wherein the four-bar
linkage is actuatable via end effector translation to move the
clamp arm to a clamped position.
[0047] In another embodiment of the surgical instrument, an outer
tube is coupled to the four-bar linkage and the outer-tube actuates
the four-bar linkage from a first position to a second
position.
[0048] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide, wherein
the end effector is partially coated with thermally and
electrically insulative material such that the distal end of the
end effector comprises one or more exposed sections.
[0049] In another embodiment of the ultrasonic surgical instrument
end effector, the one or more exposed areas are symmetrical.
[0050] In another embodiment of the ultrasonic surgical instrument
end effector, the one or more exposed areas are asymmetrical.
[0051] In another embodiment of the ultrasonic surgical instrument
end effector, the one or more exposed sections are separated by one
or more coated sections.
[0052] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide, and a
clamp arm is operatively connected to the end effector, wherein the
clamp arm is partially coated with thermally and electrically
insulative material such that the distal end of the clamp arm
comprises one or more exposed sections.
[0053] In another embodiment of the ultrasonic surgical instrument
clamp arm, the one or more exposed areas are symmetrical.
[0054] In another embodiment of the ultrasonic surgical instrument
clamp arm, the one or more exposed areas are asymmetrical.
[0055] In another embodiment of the ultrasonic surgical instrument
clamp arm, the one or more exposed sections are separated by one or
more coated sections.
[0056] In one embodiment, an ultrasonic surgical instrument
comprises a waveguide comprising a proximal end and a distal end,
wherein the proximal end is coupled to an ultrasonic transducer; an
end effector coupled to the distal end of the waveguide, and a
clamp arm is operatively connected to the end effector, wherein the
end effector and the clamp arm are partially coated with thermally
and electrically insulative material such that the distal end of
the end effector and clamp arm comprise one or more exposed
sections.
[0057] In another embodiment of the ultrasonic surgical instrument,
the one or more exposed areas are symmetrical.
[0058] In another embodiment of the ultrasonic surgical instrument,
the one or more exposed areas are asymmetrical.
[0059] In another embodiment of the ultrasonic surgical instrument,
the one or more exposed sections are separated by one or more
coated sections.
[0060] The foregoing is a summary and thus may contain
simplifications, generalizations, inclusions, and/or omissions of
detail; consequently, those skilled in the art will appreciate that
the summary is illustrative only and is NOT intended to be in any
way limiting. Other aspects, features, and advantages of the
devices and/or processes and/or other subject matter described
herein will become apparent in the teachings set forth herein.
[0061] The foregoing summary is illustrative only and is not
intended to be in any way limiting. In addition to the illustrative
aspects, embodiments, and features described above, further
aspects, embodiments, and features will become apparent by
reference to the drawings and the following detailed
description.
FIGURES
[0062] The novel features of the embodiments described herein are
set forth with particularity in the appended claims. The
embodiments, however, both as to organization and methods of
operation may be better understood by reference to the following
description, taken in conjunction with the accompanying drawings as
follows.
[0063] FIG. 1 illustrates one embodiment of an ultrasonic blade
with tooth-like grasping features formed on a grasping surface of
the blade.
[0064] FIG. 2 illustrates one embodiment of the ultrasonic blade
with tooth-like grasping features formed on a grasping portion of
the blade, where the teeth are machined into the grasping portion
of the blade.
[0065] FIG. 3 illustrates one embodiment of the ultrasonic blade
with tooth-like grasping features formed on a grasping portion of
the blade, where the teeth protrude from the grasping portion of
the blade.
[0066] FIG. 4 illustrates one embodiment of an ultrasonic blade
with protruding block-like grasping features formed on a grasping
portion of the blade.
[0067] FIG. 5 is a side view of the ultrasonic blade shown in FIG.
4, according to one embodiment.
[0068] FIG. 6 illustrates one embodiment of an ultrasonic blade
with protruding bump-like or spike-like grasping features formed on
a grasping portion of the blade.
[0069] FIG. 7A is a side view of the ultrasonic blade shown in FIG.
6, according to one embodiment.
[0070] FIG. 7B shows bump-like protrusions, according to one
embodiment.
[0071] FIG. 7C shows spike-like protrusions, according to one
embodiment.
[0072] FIG. 8 illustrates one embodiment of an ultrasonic blade
with cavity-like grasping features formed on a grasping portion of
the blade.
[0073] FIG. 9A is a side view of the ultrasonic blade shown in FIG.
8 having cylindrical cavity-like grasping features partially formed
into the grasping portion of the blade, according to one
embodiment.
[0074] FIG. 9B is a side view of the ultrasonic blade shown in FIG.
8 having cylindrical cavity-like grasping features formed through
the grasping portion of the blade, according to one embodiment.
[0075] FIG. 9C is a side view of the ultrasonic blade shown in FIG.
8 having conical cavity-like grasping features partially formed
into the grasping portion of the blade, according to one
embodiment.
[0076] FIG. 10 illustrates one embodiment of an ultrasonic blade
with transverse bump-like grasping features formed on a grasping
portion of the blade.
[0077] FIG. 11 is a side view of the ultrasonic blade shown in FIG.
10, according to one embodiment.
[0078] FIG. 12 is a side view of one embodiment of an end effector
assembly comprising medical forceps having a movable jaw member and
an ultrasonic blade having protrusions in the form of tooth-like
grasping features formed on a grasping surface of the blade.
[0079] FIG. 13 is a top view of one embodiment of the medical
forceps shown in FIG. 12 with the movable jaw member drawn in
phantom line to show the ultrasonic blade positioned below the
movable jaw member.
[0080] FIG. 14 is a side view illustrating one embodiment of an
ultrasonic blade comprising tooth-like grasping features having
triangular grooves formed on a grasping surface of the blade.
[0081] FIG. 15 is a top view of the ultrasonic blade shown in FIG.
14, according to one embodiment.
[0082] FIG. 16 is a side view illustrating one embodiment of an
ultrasonic blade comprising tooth-like grasping features including
horizontal trenches having repeated semicircular grooves formed on
a grasping surface of the blade.
[0083] FIG. 17 is a top view of the ultrasonic blade shown in FIG.
16, according to one embodiment.
[0084] FIG. 18 is a top view illustrating one embodiment of an
ultrasonic blade comprising grasping features including cavities
formed on a grasping surface of the blade.
[0085] FIG. 19 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and an ultrasonic blade with a flexible seal positioned over a
proximal portion of the blade and a distal portion of a tube to
seal the blade to an outer diameter of the tube.
[0086] FIG. 20 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and an ultrasonic blade with a flexible seal positioned over a
proximal portion of the blade and within a distal portion of a tube
to seal the blade to an inner diameter of the tube.
[0087] FIG. 21 illustrates one embodiment of a slotted inner tube
to conceal a lengthwise portion of an ultrasonic blade where the
slots provide fluid egress to discharge surgical matter that may
accumulate in a space between the blade and the inner tube.
[0088] FIG. 22 illustrates one embodiment of a perforated mutilated
inner tube to conceal a lengthwise portion of an ultrasonic blade
where the perforations provide fluid egress to discharge surgical
matter that may accumulate in a space between the blade and the
inner tube.
[0089] FIG. 23 illustrates one embodiment of a fluid-directing
ribbed and perforated inner tube to conceal a lengthwise portion of
an ultrasonic blade where the fluid-directing ribs and perforations
provide fluid egress to discharge surgical matter that may
accumulate in a space between the blade and the inner tube.
[0090] FIG. 24 is one embodiment of a fluid-directing ribbed and
perforated inner tube comprising converging ducts
[0091] FIG. 25 illustrates one embodiment of a contoured seal to
seal a space between a portion of an ultrasonic blade and an outer
tube, where the flexible seal having two points of contact and
defining a cavity for collecting surgical matter.
[0092] FIG. 26 illustrates one embodiment of a hybrid system
comprising a contoured seal comprising a flexible membrane that
acts as a pump to force surgical matter out of a distal inner tube
area.
[0093] FIG. 27 illustrates one embodiment of a seal to seal a space
between a portion of an ultrasonic blade and the tube, the flexible
seal multiple points of contact and a low interference point of
contact.
[0094] FIG. 28 illustrates etched areas formed on an outer surface
of an ultrasonic blade to prevent tissue ingress, according to one
embodiment.
[0095] FIG. 29 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and a slidable ultrasonic blade partially retracted within a
tube.
[0096] FIG. 30 illustrates one embodiment of an inner tube having
machined windows formed therein to allow drainage between the inner
and outer tubes.
[0097] FIG. 31 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and an ultrasonic blade where the movable jaw member includes a pad
with a tissue stop to deflect surgical matter where the tissue stop
portion is contoured to the movable jaw member to cover an opening
of the inner tube.
[0098] FIG. 32 illustrates one embodiment of a positive pressure
fluid flow system to apply a positive pressure fluid flow between
an outer tube and an ultrasonic blade at distal end thereof
employing a pump or pump outlet located distal of a distal
node.
[0099] FIG. 33 illustrates a portion of an end effector assembly
comprising an ultrasonic blade including one embodiment of a
flexible seal to seal the ultrasonic blade to a tube at a distal
node, according to one embodiment.
[0100] FIG. 34 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and an ultrasonic blade including a flexible seal positioned distal
to an edge of the movable jaw member and anchored to a tube to
prevent tissue pinching.
[0101] FIG. 35 illustrates one embodiment of a seal positioned
within an inner tube and an ultrasonic blade positioned within the
inner tube.
[0102] FIG. 36 illustrates one embodiment of a seal mechanism for
an ultrasonic blade having a tapered inner tube portion distal to
the last seal where the inner tube necks down to a smaller diameter
at a distal end defining a reduce entry space for surgical
matter.
[0103] FIG. 37 illustrates one embodiment of an overmolded flexible
seal located over an inner tube that an ultrasonic blade punctures
through during assembly.
[0104] FIG. 38 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
and an ultrasonic blade where the movable jaw member comprises a
deflector pad to deflect surgical matter.
[0105] FIG. 39 is a front view of the deflector pad shown in FIG.
38, according to one embodiment.
[0106] FIG. 40 illustrates one embodiment of a seal system for an
ultrasonic blade.
[0107] FIG. 41 illustrates one embodiment of a contoured inner tube
or component that attaches to an inner tube to provide a circuitous
path for fluid.
[0108] FIG. 42 illustrates one embodiment of a molded component
with compliant arms that serve to block the distal opening of a
tube assembly and is attached via the arms going around a pin in
the blade at a node location.
[0109] FIG. 43 illustrates one embodiment of an overmolded silicone
bumper that adheres to the inside of an inner tube.
[0110] FIGS. 44-47 illustrate one embodiment of how a pair of
mandrels can be inserted into an inner tube from both ends to form
the overmolded bumper in FIG. 43.
[0111] FIG. 48 illustrates one embodiment of an overmolded material
affixed to an inner tube that does not seal to the ultrasonic
blade.
[0112] FIG. 49 illustrates one embodiment of a positive fluid
pressure system in which air is pumped down the length of the inner
tube.
[0113] FIG. 50 illustrates one embodiment of an inner tube having a
silicone seal attached thereto at minimal interference with
ultrasonic blade.
[0114] FIG. 51 illustrates one embodiment of seal system for
sealing an ultrasonic blade to a tube.
[0115] FIG. 52 illustrates one embodiment of a flexible seal
located over an inner tube that an ultrasonic blade punctures
through during assembly.
[0116] FIG. 53 illustrates one embodiment of an overmolded flexible
seal attached to an ultrasonic blade distal of a distal seal.
[0117] FIG. 54 illustrates one embodiment of an overmolded flexible
seal attached to an ultrasonic blade distal of a distal seal.
[0118] FIG. 55 illustrates one embodiment of a sealing system
comprising multiple toroidal seals to seal an ultrasonic blade
distal of a distal seal.
[0119] FIG. 56 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
in an open position, an ultrasonic blade, and a slidably movable
inner tube including a wiping seal.
[0120] FIG. 57 illustrates one embodiment of the end effector
assembly shown in FIG. 56 comprising a medical forceps having a
movable jaw member in a closed position.
[0121] FIG. 58 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
in an open position shown in phantom line and a closed position
shown in solid line, an ultrasonic blade, a slidably movable outer
tube, and a fixed inner tube with a flexible seal located over the
blade.
[0122] FIG. 59 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
in an open position, an ultrasonic blade, a slidably movable outer
tube, and a fixed inner tube with a flexible seal overmolded on the
inner tube.
[0123] FIG. 60 is a perspective view of one embodiment of an end
effector assembly comprising a medical forceps having a movable jaw
member and an ultrasonic blade where the movable jaw member is
rotatably attached to a distal node.
[0124] FIG. 61 is a side view of one embodiment of the end effector
assembly shown in FIG. 60 with the movable jaw member in an open
position and shown transparent to show outer tube cam slots to
rotate the movable jaw member upon relative motion between the
blade and the outer tube.
[0125] FIG. 62 illustrates one embodiment of the end effector
assembly shown in FIG. 60 showing the movable jaw member pivot.
[0126] FIG. 63 is a side view of one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
in a closed position and an ultrasonic blade, the end effector
assembly comprising a linkage to open and close the movable jaw
member by employing relative motion between the outer tube and the
blade.
[0127] FIG. 64 is a side view of the end effector assembly shown in
FIG. 63 with the movable jaw member in an open position, according
to one embodiment.
[0128] FIG. 65 is a bottom view of the end effector assembly shown
in FIG. 63 with the movable jaw member in an open position,
according to one embodiment.
[0129] FIG. 66 is a perspective view of the end effector assembly
shown in FIG. 63 with the movable jaw member in an open position,
according to one embodiment.
[0130] FIG. 67 is a perspective view of the end effector assembly
shown in FIG. 63 with the movable jaw member in an open position,
according to one embodiment.
[0131] FIG. 68 is a perspective view of one embodiment of an end
effector assembly comprising a medical forceps having a movable jaw
member and an ultrasonic blade with the movable jaw member shown in
an open position, where an outer tube is translated with respect to
the blade to open and close the movable jaw member.
[0132] FIG. 69 is a perspective view of the inner tube with the
outer tube removed, where the inner tube is operatively coupled to
the end effector assembly shown in FIG. 68, according to one
embodiment.
[0133] FIG. 70 is a perspective view of a notch portion of the
inner tube shown in FIG. 69, according to one embodiment.
[0134] FIG. 71 illustrates one embodiment of an end effector
assembly comprising a medical forceps having a movable jaw member
in a closed position, an ultrasonic blade, and a shaft assembly
configured to counteract deflection of the blade.
[0135] FIG. 72 illustrates one embodiment of an ultrasonic
transducer having a modified flange incorporating external threads
to allow transducer rotation.
[0136] FIG. 73 is a sectional view of one embodiment of an
ultrasonic transducer rotation system comprising a shroud and a
gate fitted into one-half of the shroud.
[0137] FIGS. 74A-74C illustrate the dynamics of the gate
interaction with a rotation knob, according to one embodiment.
[0138] FIG. 74A illustrates the gate in a left-biased position such
that the rotation knob can be rotated approximately 690 degrees
clockwise until a contoured extrusion element on the rotation knob
makes contact with the right wing of the gate so that the left wing
of the gate prevents motion by reacting statically against the
shroud, according to one embodiment.
[0139] FIG. 74B illustrates the rotation knob rotated back
360.degree. until it knocks the right wing of the gate into a
right-biased position, according to one embodiment.
[0140] FIG. 74C illustrates the rotation knob after it knocks the
right wing of the gate into a right-biased position, according to
one embodiment.
[0141] FIG. 75 is a sectional view of one embodiment of an
ultrasonic transducer rotation system comprising a shroud and a
gate fitted into one-half of the shroud, where the rotation system
comprises a tactile feedback element.
[0142] FIGS. 76A-76C illustrate the dynamics of the gate
interaction with a rotation knob, where the rotation knob comprises
a tactile feedback element, according to one embodiment.
[0143] FIG. 76A illustrates the gate in a left-biased position such
that the rotation knob comprising a tactile feedback element can be
rotated approximately 690 degrees clockwise until a contoured
extrusion element on the rotation knob makes contact with the right
wing of the gate so that the left wing of the gate prevents motion
by reacting statically against the shroud, according to one
embodiment.
[0144] FIG. 76B illustrates the rotation knob comprising a tactile
feedback element rotated back 360.degree. until it knocks the right
wing of the gate into a right-biased position, according to one
embodiment.
[0145] FIG. 76C illustrates the rotation knob comprising a tactile
feedback element after it knocks the right wing of the gate into a
right-biased position, according to one embodiment.
[0146] FIG. 77 illustrates one embodiment of an integrated
RF/ultrasonic instrument electrically connected such that the
ultrasonic blade/horn is electrically connected to a positive lead
of an ultrasonic generator coupled to the instrument to provide RF
spot coagulation. The clamp arm and tube are connected to the
return path.
[0147] FIG. 78 illustrates one embodiment of an integrated
RF/ultrasonic instrument comprising four-lead jack connector mated
with a slidable female mating plug electrically connected to a
generator.
[0148] FIG. 79 is a detail view of one embodiment of a four-lead
jack connector mated with a slidable female mating plug coupled to
an ultrasonic transducer where position 1 provides an ultrasonic
signal to the transducer, and where position 2 provides an
electrosurgical signal to the device.
[0149] FIGS. 80-83 illustrate various embodiments of ultrasonic
blades coated with an electrically insulative material to provide
thermal insulation at the tissue contact area to minimize adhesion
of tissue to the blade.
[0150] FIGS. 84-93 illustrate various embodiments of ultrasonic
blades partially coated with an electrically insulative material to
provide thermal insulation at the tissue contact area to minimize
adhesion of tissue to the blade, where the lighter shade regions of
the blade represent the coated portions and the darker shaded
regions of the blade represent exposed surfaces that enable RF
current to flow from the exposed region of the blade, through the
tissue, and the movable jaw member. It is conceivable that this
feature may be employed on the blade, the clamp arm, or both.
[0151] FIGS. 94-95 illustrate embodiments of two ultrasonic blades
with non-symmetrical exposed surface, where the blades are coated
with an electrically insulative material to provide thermal
insulation at the tissue contact area to minimize adhesion of
tissue to the blade, where the lighter shade regions of the blade
represent the coated portions and the darker shaded regions of the
blade represent exposed surfaces that enable RF current to flow
from the exposed region of the blade, through the tissue, and the
movable jaw member. It is conceivable that this feature may be
employed on the blade, the clamp arm, or both.
[0152] FIG. 96 is a perspective view of one embodiment of an
ultrasonic end effector comprising a metal heat shield.
[0153] FIG. 97 is a perspective view of another embodiment of an
ultrasonic end effector comprising a retractable metal heat
shield.
[0154] FIG. 98 is a side view of another embodiment of an
ultrasonic end effector comprising a heat shield shown in
cross-section.
[0155] FIG. 99 is a front view of the ultrasonic end effector shown
in FIG. 98, according to one embodiment.
[0156] FIG. 100 illustrates one embodiment of a clamp arm
comprising a movable jaw member shown in a closed position and a
dual purpose rotatable heat shield located below the ultrasonic
blade.
[0157] FIG. 101 illustrates one embodiment of a movable jaw member
shown in an open position and a dual purpose rotatable heat shield
rotated such that it is interposed between the movable jaw member
and the blade.
[0158] FIG. 102 illustrates an end view of one embodiment of a dual
purpose rotatable heat shield rotated in a first position.
[0159] FIG. 103 illustrates an end view of one embodiment of the
dual purpose rotatable heat shield rotated in a second
position.
[0160] FIG. 104 is a top profile view of one embodiment of a heat
shield showing a tapered portion of the shield.
[0161] FIG. 105 illustrates a conventional rongeur surgical
instrument.
[0162] FIG. 106 illustrates one embodiment of an ultrasonic energy
driven rongeur device.
[0163] FIG. 107 illustrates one embodiment of a surgical system
including a surgical instrument and an ultrasonic generator.
[0164] FIG. 108 illustrates one embodiment of the surgical
instrument shown in FIG. 107.
[0165] FIG. 109 illustrates one embodiment of an ultrasonic end
effector.
[0166] FIG. 110 illustrates another embodiment of an ultrasonic end
effector.
[0167] FIG. 111 illustrates an exploded view of one embodiment of
the surgical instrument shown in FIG. 107.
[0168] FIGS. 112A and 112B illustrate one embodiment of an
unlimited rotation connection for an integrated transducer
[0169] FIGS. 113A-113C illustrate one embodiment of an unlimited
rotation connection for an integrated transducer.
[0170] FIGS. 114A and 114B illustrate one embodiment of an
integrated RF/ultrasonic surgical end effector.
[0171] FIGS. 115A-115I illustrate various electrode arrangements
for the integrated RF/ultrasonic surgical end effector of FIGS.
114A and 114B.
[0172] FIG. 116A illustrates one embodiment of an air cooled
surgical instrument.
[0173] FIG. 116B illustrates one embodiment of a vortex tube.
[0174] FIG. 117 illustrates one embodiment of an integrated
RF/ultrasonic surgical instrument comprising a double pole double
throw switch.
[0175] FIG. 118 illustrates one embodiment of a double pole double
throw switch.
[0176] FIGS. 119A-119E illustrate various embodiments of
combination RF/ultrasonic end effectors.
[0177] FIGS. 120A-120C illustrate various embodiments of bipolar
combination RF/ultrasonic end effectors.
[0178] FIGS. 121A-121C illustrate various embodiments of monopolar
combination RF/ultrasonic end effectors.
DESCRIPTION
[0179] Before explaining the various embodiments of the ultrasonic
and electrical surgical devices in detail, it should be noted that
the various embodiments disclosed herein are not limited in their
application or use to the details of construction and arrangement
of parts illustrated in the accompanying drawings and description.
Rather, the disclosed embodiments are may be positioned or
incorporated in other embodiments, variations and modifications
thereof, and may be practiced or carried out in various ways.
Accordingly, embodiments of the ultrasonic and electrical surgical
devices disclosed herein are illustrative in nature and are not
meant to limit the scope or application thereof. Furthermore,
unless otherwise indicated, the terms and expressions employed
herein have been chosen for the purpose of describing the
embodiments for the convenience of the reader and are not to limit
the scope thereof. In addition, it should be understood that any
one or more of the disclosed embodiments, expressions of
embodiments, and/or examples thereof, can be combined with any one
or more of the other disclosed embodiments, expressions of
embodiments, and/or examples thereof, without limitation.
[0180] In the following description, like reference characters
designate like or corresponding parts throughout the several views.
Also, in the following description, it is to be understood that
terms such as front, back, inside, outside, top, bottom and the
like are words of convenience and are not to be construed as
limiting terms. Terminology used herein is not meant to be limiting
insofar as devices described herein, or portions thereof, may be
attached or utilized in other orientations. The various embodiments
will be described in more detail with reference to the
drawings.
[0181] In various embodiments, the present disclosure is related to
various embodiments of ultrasonic blades comprising various
grasping features. Conventional ultrasonic blades lack grasping
features. Such grasping features may be desirable on a gripping
surface of an ultrasonic blade to provide additional gripping and
to prevent tissue milking during grasping and treatment, which in
some cases may improve hemostasis. Tissue milking occurs when a
tissue section slides, or milks, out of the jaws of a surgical
device during treatment. The present disclosure provides various
blade modification features to prevent tissue milking, as well as
provide better grasping forces.
[0182] In various embodiments, the present disclosure is related to
various embodiments of devices configured to prevent ingress of
surgical matter, e.g., fluid and tissue, in the space between an
ultrasonic blade and an inner or outer tube distal of the distal
seal. Two main categories of embodiments are described. First, a
pressure or energy source attached to the blade-tube subassembly
prevents fluid or tissue ingress into the space between the blade
and the inner tube. Second, a flexible membrane(s) attached to
either the blade or the inner tube prevents fluid or tissue
ingress.
[0183] In various embodiments, the present disclosure also is
related to various embodiments of alternate closure mechanisms for
ultrasonic devices. Present ultrasonic devices utilize a
tube-in-tube (TnT) closure mechanism to enable closure of the clamp
arm, referred to herein as a movable jaw member, against an active
length of the ultrasonic blade. The present embodiments of
alternate closure mechanisms for ultrasonic devices may yield
several advantages. For example, there may be differences among the
drag force of actuating the inner tube against the outer tube
resulting in variation in device clamp force. Additionally, the
pivot location of the clamp arm on the outer tube causes a sharp
angular closure, and results in a non-uniform closure profile.
Furthermore, present device mechanism may be sensitive to variation
in components, as the stackup links the inner and outer tube at the
location of the insulated pin, which currently resides near the
proximal end of the tube assembly.
[0184] In various embodiments, the present disclosure also is
related to various embodiments of shaft assembly/transducer
rotation limiters to limit the rotation of the shaft and ultrasonic
transducer.
[0185] In various embodiments, the present disclosure also is
related to various embodiments of shaft/ultrasonic transducer
rotation systems to provide unlimited continuous rotation of an
ultrasonic device. In various embodiments, tactile feedback may be
provided to the user before a hard stop is hit.
[0186] In various embodiments, the present disclosure also is
related to various embodiments of an integrated RF/ultrasonic
instrument electrically connected to provide RF spot coagulation
energy for pre- or post-ultrasonic treatment of tissues with an
ultrasonic/RF generator. The integrated ultrasonic instrument
enables the touch up of diffuse bleeding (capillary bleeding, cut
site oozing) or pre-treatment of tissue without the need for
coupling pressure and improves the coupling pressure needed for
ultrasonic instruments to couple the blade to tissue such that
friction-based tissue effect is effective. The integrated
ultrasonic instrument reduces (1) difficulty in applying enough
pressure to generate haemostatic effect in loosely supported (i.e.,
un-clamped) tissue or (2) coupling pressure that generates too much
tissue disruption that, in many cases, makes the diffuse bleeding
worse. In one embodiment, a four-lead jack connector is mated with
a slidable female mating plug to electrically isolate a secondary
RF generator from the ultrasonic transducer when switching between
RF energy and ultrasonic energy.
[0187] In various embodiments, the present disclosure is also
directed to ultrasonic blades comprising heat shields. The heat
shields may be fixed, translatable or rotatable. The heat shield
also may be used to conduct RF energy to target tissue.
[0188] In various embodiments, the present disclosure also is
related to coated ultrasonic/RF blades. Ultrasonic blades are
coated with an electrically insulative material to provide thermal
insulation at the tissue contact area to minimize adhesion of
tissue to the blade. Conventional ultrasonic devices utilize one
mode of treatment, which limits versatility. For example,
conventional ultrasonic devices may be used for blood vessel
sealing and transecting tissue. Bipolar or monopolar RF may offer
added benefits such as a method for spot coagulation and
pretreatment of tissue. Incorporating ultrasonic and RF may provide
versatility and increase effectiveness. However, conventional
ultrasonic devices utilize coatings to provide reduced friction and
thermal insulation at the distal end of the blade. These coatings
are electrically insulative, and therefore limit current flow thus
decreasing RF effectiveness. Additionally, current density may
influence effectiveness. In order to incorporate both modes into
one device, a masking or selective coating removal process may be
required. Creating an exposed area on the surface of the blade may
provide a suitable path for current flow. It is conceivable that
the same principles may be applied to the clamping member as
well.
General Surgical Instrument Overview
[0189] Before launching into a description of various embodiments,
the present disclosures turns to the description of FIGS. 107-111,
which describes various embodiments of a surgical system in which
various embodiments of the ultrasonic and electrical surgical
devices described in connection with FIGS. 1-106 may be practiced.
Accordingly, FIG. 107 is a right side view of one embodiment of an
ultrasonic surgical instrument 10. In the illustrated embodiment,
the ultrasonic surgical instrument 10 may be employed in various
surgical procedures including laparoscopic, endoscopic or
traditional open surgical procedures. In one example embodiment,
the ultrasonic surgical instrument 10 comprises a handle assembly
12, an elongated shaft assembly 14, and an ultrasonic transducer
16. The handle assembly 12 comprises a trigger assembly 24, a
distal rotation assembly 13, and an activation switch assembly 28.
The elongated shaft assembly 14 comprises an end effector assembly
26, which comprises elements to dissect tissue or mutually grasp,
cut, and coagulate vessels and/or tissue, and actuating elements to
actuate the end effector assembly 26. The handle assembly 12 is
adapted to receive the ultrasonic transducer 16 at the proximal
end. The ultrasonic transducer 16 is mechanically engaged to the
elongated shaft assembly 14 and portions of the end effector
assembly 26. The ultrasonic transducer 16 is electrically coupled
to a generator 20 via a cable 22. Although the majority of the
drawings depict a multiple end effector assembly 26 for use in
connection with laparoscopic surgical procedures, the ultrasonic
surgical instrument 10 may be employed in more traditional open
surgical procedures and in other embodiments, may be configured for
use in laparoscopic or endoscopic procedures. For the purposes
herein, the ultrasonic surgical instrument 10 is described in terms
of an laparoscopic instrument; however, it is contemplated that an
open and/or endoscopic version of the ultrasonic surgical
instrument 10 also may include the same or similar operating
components and features as described herein.
[0190] In various embodiments, the generator 20 comprises several
functional elements, such as modules and/or blocks. Different
functional elements or modules may be configured for driving
different kinds of surgical devices. For example, an ultrasonic
generator module 21 may drive an ultrasonic device, such as the
ultrasonic surgical instrument 10. In some example embodiments, the
generator 20 also comprises an electrosurgery/RF generator module
23 for driving an electrosurgical device (or an electrosurgical
embodiment of the ultrasonic surgical instrument 10). In various
embodiments, the generator 20 may be formed integrally within the
handle assembly 12. In such implementations, a battery would be
co-located within the handle assembly 12 to act as the energy
source.
[0191] In some embodiments, the electrosurgery/RF generator module
23 may be configured to generate a therapeutic and/or a
sub-therapeutic energy level. In the example embodiment illustrated
in FIG. 107, the generator 20 includes a control system 25 integral
with the generator 20, and a foot switch 29 connected to the
generator via a cable 27. The generator 20 may also comprise a
triggering mechanism for activating a surgical instrument, such as
the instrument 10. The triggering mechanism may include a power
switch (not shown) as well as a foot switch 29. When activated by
the foot switch 29, the generator 20 may provide energy to drive
the acoustic assembly of the surgical instrument 10 and to drive
the end effector 18 at a predetermined excursion level or provide
the therapeutic/sub-therapeutic electromagnetic/RF energy. The
generator 20 drives or excites the acoustic assembly at any
suitable resonant frequency of the acoustic assembly and/or drives
the therapeutic/sub-therapeutic electromagnetic/RF energy.
[0192] In one embodiment, the electrosurgical/RF generator module
23 may be implemented as an electrosurgery unit (ESU) capable of
supplying power sufficient to perform bipolar electrosurgery using
RF energy. In one embodiment, the ESU can be a bipolar ERBE ICC 350
sold by ERBE USA, Inc. of Marietta, Ga. In bipolar electrosurgery
applications, as previously discussed, a surgical instrument having
an active electrode and a return electrode can be utilized, wherein
the active electrode and the return electrode can be positioned
against, or adjacent to, the tissue to be treated such that current
can flow from the active electrode to the return electrode through
the tissue. Accordingly, the electrosurgical/RF module 23 generator
may be configured for therapeutic purposes by applying electrical
energy to the tissue T sufficient for treating the tissue (e.g.,
cauterization).
[0193] In one embodiment, the electrosurgical/RF generator module
23 may be configured to deliver a sub-therapeutic RF signal to
implement a tissue impedance measurement module. In one embodiment,
the electrosurgical/RF generator module 23 comprises a bipolar RF
generator as described in more detail below. In one embodiment, the
electrosurgical/RF generator module 12 may be configured to monitor
electrical impedance Z, of tissue T and to control the
characteristics of time and power level based on the tissue T by
way of a return electrode on provided on a clamp member of the end
effector assembly 26. Accordingly, the electrosurgical/RF generator
module 23 may be configured for sub-therapeutic purposes for
measuring the impedance or other electrical characteristics of the
tissue T. Techniques and circuit configurations for measuring the
impedance or other electrical characteristics of tissue T are
discussed in more detail in commonly assigned U.S. Patent
Publication No. 2011/0015631, titled "Electrosurgical Generator for
Ultrasonic Surgical Instruments," the disclosure of which is herein
incorporated by reference in its entirety.
[0194] A suitable ultrasonic generator module 21 may be configured
to functionally operate in a manner similar to the GEN300 sold by
Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio as is disclosed in
one or more of the following U.S. patents, all of which are
incorporated by reference herein: U.S. Pat. No. 6,480,796 (Method
for Improving the Start Up of an Ultrasonic System Under Zero Load
Conditions); U.S. Pat. No. 6,537,291 (Method for Detecting Blade
Breakage Using Rate and/or Impedance Information); U.S. Pat. No.
6,662,127 (Method for Detecting Presence of a Blade in an
Ultrasonic System); U.S. Pat. No. 6,678,899 (Method for Detecting
Transverse Vibrations in an Ultrasonic Surgical System); U.S. Pat.
No. 6,977,495 (Detection Circuitry for Surgical Handpiece System);
U.S. Pat. No. 7,077,853 (Method for Calculating Transducer
Capacitance to Determine Transducer Temperature); U.S. Pat. No.
7,179,271 (Method for Driving an Ultrasonic System to Improve
Acquisition of Blade Resonance Frequency at Startup); and U.S. Pat.
No. 7,273,483 (Apparatus and Method for Alerting Generator Function
in an Ultrasonic Surgical System).
[0195] It will be appreciated that in various embodiments, the
generator 20 may be configured to operate in several modes. In one
mode, the generator 20 may be configured such that the ultrasonic
generator module 21 and the electrosurgical/RF generator module 23
may be operated independently. Alternatively, the ultrasonic
generator module 21 may be configured to selectively apply either
ultrasonic energy or either therapeutic sub-therapeutic RF energy
to the end effector.
[0196] For example, the ultrasonic generator module 21 may be
activated to apply ultrasonic energy to the end effector assembly
26 and subsequently, either therapeutic sub-therapeutic RF energy
may be applied to the end effector assembly 26 by the
electrosurgical/RF generator module 23. As previously discussed,
the subtherapeutic electrosurgical/RF energy may be applied to
tissue clamped between clamp elements of the end effector assembly
26 to measure tissue impedance to control the activation, or modify
the activation, of the ultrasonic generator module 21. Tissue
impedance feedback from the application of the subtherapeutic
energy also may be employed to activate a therapeutic level of the
electrosurgical/RF generator module 23 to seal the tissue (e.g.,
vessel) clamped between claim elements of the end effector assembly
26.
[0197] In another embodiment, the ultrasonic generator module 21
and the electrosurgical/RF generator module 23 may be activated
simultaneously. In one example, the ultrasonic generator module 21
is simultaneously activated with a sub-therapeutic RF energy level
to measure tissue impedance simultaneously while the ultrasonic
blade of the end effector assembly 26 cuts and coagulates the
tissue (or vessel) clamped between the clamp elements of the end
effector assembly 26. Such feedback may be employed, for example,
to modify the drive output of the ultrasonic generator module 21.
In another example, the ultrasonic generator module 21 may be
driven simultaneously with electrosurgical/RF generator module 23
such that the ultrasonic blade portion of the end effector assembly
26 is employed for cutting the damaged tissue while the
electrosurgical/RF energy is applied to electrode portions of the
end effector clamp assembly 26 for sealing the tissue (or vessel).
Alternatively, the ultrasonic and the electrosurgical/RF energy can
be employed sequentially with a single activation to achieve a
desired tissue effect.
[0198] When the generator 20 is activated via the triggering
mechanism, in one embodiment electrical energy is continuously
applied by the generator 20 to a transducer stack or assembly of
the acoustic assembly. In another embodiment, electrical energy is
intermittently applied (e.g., pulsed) by the generator 20. A
phase-locked loop in the control system of the generator 20 may
monitor feedback from the acoustic assembly. The phase lock loop
adjusts the frequency of the electrical energy sent by the
generator 20 to match the resonant frequency of the selected
longitudinal mode of vibration of the acoustic assembly. In
addition, a second feedback loop in the control system 25 maintains
the electrical current supplied to the acoustic assembly at a
pre-selected constant level in order to achieve substantially
constant excursion at the end effector 18 of the acoustic assembly.
In yet another embodiment, a third feedback loop in the control
system 25 monitors impedance between electrodes located in the end
effector assembly 26. Although FIGS. 107-111 show a manually
operated ultrasonic surgical instrument, it will be appreciated
that ultrasonic surgical instruments may also be used in robotic
applications, for example, as described herein, as well as
combinations of manual and robotic applications.
[0199] In ultrasonic operation mode, the electrical signal supplied
to the acoustic assembly may cause the distal end of the end
effector 18 to vibrate longitudinally in the range of, for example,
approximately 20 kHz to 250 kHz. According to various embodiments,
the blade 22 may vibrate in the range of about 40 kHz to 56 kHz,
for example, at about 50.0 kHz. In other embodiments, the blade 22
may vibrate at other frequencies including, for example, about 31
kHz or about 80 kHz. The excursion of the vibrations at the blade
can be controlled by, for example, controlling the amplitude of the
electrical signal applied to the transducer assembly of the
acoustic assembly by the generator 20. As noted above, the
triggering mechanism of the generator 20 allows a user to activate
the generator 20 so that electrical energy may be continuously or
intermittently supplied to the acoustic assembly. The generator 20
also has a power line for insertion in an electro-surgical unit or
conventional electrical outlet. It is contemplated that the
generator 20 can also be powered by a direct current (DC) source,
such as a battery. The generator 20 can comprise any suitable
generator, such as Model No. GEN04, and/or Model No. GEN11
available from Ethicon Endo-Surgery, Inc.
[0200] FIG. 108 is a left perspective view of one example
embodiment of the ultrasonic surgical instrument 10 showing the
handle assembly 12, the distal rotation assembly 13, the elongated
shaft assembly 14, and the end effector assembly 26. In the
illustrated embodiment the elongated shaft assembly 14 comprises a
distal end 52 dimensioned to mechanically engage the end effector
assembly 26 and a proximal end 50 that mechanically engages the
handle assembly 12 and the distal rotation assembly 13. The
proximal end 50 of the elongated shaft assembly 14 is received
within the handle assembly 12 and the distal rotation assembly 13.
More details relating to the connections between the elongated
shaft assembly 14, the handle assembly 12, and the distal rotation
assembly 13 are provided in the description of FIG. 98.
[0201] In the illustrated embodiment, the trigger assembly 24
comprises a trigger 32 that operates in conjunction with a fixed
handle 34. The fixed handle 34 and the trigger 32 are ergonomically
formed and adapted to interface comfortably with the user. The
fixed handle 34 is integrally associated with the handle assembly
12. The trigger 32 is pivotally movable relative to the fixed
handle 34 as explained in more detail below with respect to the
operation of the ultrasonic surgical instrument 10. The trigger 32
is pivotally movable in direction 33A toward the fixed handle 34
when the user applies a squeezing force against the trigger 32. A
spring element 98 (FIG. 111) causes the trigger 32 to pivotally
move in direction 33B when the user releases the squeezing force
against the trigger 32.
[0202] In one example embodiment, the trigger 32 comprises an
elongated trigger hook 36, which defines an aperture 38 between the
elongated trigger hook 36 and the trigger 32. The aperture 38 is
suitably sized to receive one or multiple fingers of the user
therethrough. The trigger 32 also may comprise a resilient portion
32a molded over the trigger 32 substrate. The overmolded resilient
portion 32a is formed to provide a more comfortable contact surface
for control of the trigger 32 in outward direction 33B. In one
example embodiment, the overmolded resilient portion 32a may be
provided over a portion of the elongated trigger hook 36. The
proximal surface of the elongated trigger hook 32 remains uncoated
or coated with a non-resilient substrate to enable the user to
easily slide their fingers in and out of the aperture 38. In
another embodiment, the geometry of the trigger forms a fully
closed loop which defines an aperture suitably sized to receive one
or multiple fingers of the user therethrough. The fully closed loop
trigger also may comprise a resilient portion molded over the
trigger substrate.
[0203] In one example embodiment, the fixed handle 34 comprises a
proximal contact surface 40 and a grip anchor or saddle surface 42.
The saddle surface 42 rests on the web where the thumb and the
index finger are joined on the hand. The proximal contact surface
40 has a pistol grip contour that receives the palm of the hand in
a normal pistol grip with no rings or apertures. The profile curve
of the proximal contact surface 40 may be contoured to accommodate
or receive the palm of the hand. A stabilization tail 44 is located
towards a more proximal portion of the handle assembly 12. The
stabilization tail 44 may be in contact with the uppermost web
portion of the hand located between the thumb and the index finger
to stabilize the handle assembly 12 and make the handle assembly 12
more controllable.
[0204] In one example embodiment, the switch assembly 28 may
comprise a toggle switch 30. The toggle switch 30 may be
implemented as a single component with a central pivot 304 located
within inside the handle assembly 12 to eliminate the possibility
of simultaneous activation. In one example embodiment, the toggle
switch 30 comprises a first projecting knob 30a and a second
projecting knob 30b to set the power setting of the ultrasonic
transducer 16 between a minimum power level (e.g., MIN) and a
maximum power level (e.g., MAX). In another embodiment, the rocker
switch may pivot between a standard setting and a special setting.
The special setting provides one or more special programs to be
implemented by the device. The toggle switch 30 rotates about the
central pivot as the first projecting knob 30a and the second
projecting knob 30b are actuated. The one or more projecting knobs
30a, 30b are coupled to one or more arms that move through a small
arc and cause electrical contacts to close or open an electric
circuit to electrically energize or de-energize the ultrasonic
transducer 16 in accordance with the activation of the first or
second projecting knobs 30a, 30b. The toggle switch 30 is coupled
to the generator 20 to control the activation of the ultrasonic
transducer 16. The toggle switch 30 comprises one or more
electrical power setting switches to activate the ultrasonic
transducer 16 to set one or more power settings for the ultrasonic
transducer 16. The forces required to activate the toggle switch 30
are directed substantially toward the saddle point 42, thus
avoiding any tendency of the instrument to rotate in the hand when
the toggle switch 30 is activated.
[0205] In one example embodiment, the first and second projecting
knobs 30a, 30b are located on the distal end of the handle assembly
12 such that they can be easily accessible by the user to activate
the power with minimal, or substantially no, repositioning of the
hand grip, making it suitable to maintain control and keep
attention focused on the surgical site (e.g., a monitor in a
laparoscopic procedure) while activating the toggle switch 30. The
projecting knobs 30a, 30b may be configured to wrap around the side
of the handle assembly 12 to some extent to be more easily
accessible by variable finger lengths and to allow greater freedom
of access to activation in awkward positions or for shorter
fingers.
[0206] In the illustrated embodiment, the first projecting knob 30a
comprises a plurality of tactile elements 30c, e.g., textured
projections or "bumps" in the illustrated embodiment, to allow the
user to differentiate the first projecting knob 30a from the second
projecting knob 30b. It will be appreciated by those skilled in the
art that several ergonomic features may be incorporated into the
handle assembly 12. Such ergonomic features are described in U.S.
Pat. App. Pub. No. 2009/055750 entitled "Ergonomic Surgical
Instruments" which is incorporated by reference herein in its
entirety.
[0207] In one example embodiment, the toggle switch 30 may be
operated by the hand of the user. The user may easily access the
first and second projecting knobs 30a, 30b at any point while also
avoiding inadvertent or unintentional activation at any time. The
toggle switch 30 may readily operated with a finger to control the
power to the ultrasonic assembly 16 and/or to the ultrasonic
assembly 16. For example, the index finger may be employed to
activate the first contact portion 30a to turn on the ultrasonic
assembly 16 to a maximum (MAX) power level. The index finger may be
employed to activate the second contact portion 30b to turn on the
ultrasonic assembly 16 to a minimum (MIN) power level. In another
embodiment, the rocker switch may pivot the instrument 10 between a
standard setting and a special setting. The special setting
provides one or more special programs to be implemented by the
instrument 10. The toggle switch 30 may be operated without the
user having to look at the first or second projecting knob 30a,
30b. For example, the first projecting knob 30a or the second
projecting knob 30b may comprise a texture or projections to
tactilely differentiate between the first and second projecting
knobs 30a, 30b without looking.
[0208] In other embodiments, the trigger 32 and/or the toggle
switch 30 may be employed to actuate the electrosurgical/RF
generator module 23 individually or in combination with activation
of the ultrasonic generator module 21.
[0209] In one example embodiment, the distal rotation assembly 13
is rotatable without limitation in either direction about a
longitudinal axis "T." The distal rotation assembly 13 is
mechanically engaged to the elongated shaft assembly 14. The distal
rotation assembly 13 is located on a distal end of the handle
assembly 12. The distal rotation assembly 13 comprises a
cylindrical hub 46 and a rotation knob 48 formed over the hub 46.
The hub 46 mechanically engages the elongated shaft assembly 14.
The rotation knob 48 may comprise fluted polymeric features and may
be engaged by a finger (e.g., an index finger) to rotate the
elongated shaft assembly 14. The hub 46 may comprise a material
molded over the primary structure to form the rotation knob 48. The
rotation knob 48 may be overmolded over the hub 46. The hub 46
comprises an end cap portion 46a that is exposed at the distal end.
The end cap portion 46a of the hub 46 may contact the surface of a
trocar during laparoscopic procedures. The hub 46 may be formed of
a hard durable plastic such as polycarbonate to alleviate any
friction that may occur between the end cap portion 46a and the
trocar. The rotation knob 48 may comprise "scallops" or flutes
formed of raised ribs 48a and concave portions 48b located between
the ribs 48a to provide a more precise rotational grip. In one
example embodiment, the rotation knob 48 may comprise a plurality
of flutes (e.g., three or more flutes). In other embodiments, any
suitable number of flutes may be employed. The rotation knob 48 may
be formed of a softer polymeric material overmolded onto the hard
plastic material. For example, the rotation knob 48 may be formed
of pliable, resilient, flexible polymeric materials including
Versaflex.RTM. TPE alloys made by GLS Corporation, for example.
This softer overmolded material may provide a greater grip and more
precise control of the movement of the rotation knob 48. It will be
appreciated that any materials that provide adequate resistance to
sterilization, are biocompatible, and provide adequate frictional
resistance to surgical gloves may be employed to form the rotation
knob 48.
[0210] In one example embodiment, the handle assembly 12 is formed
from two (2) housing portions or shrouds comprising a first portion
12a and a second portion 12b. From the perspective of a user
viewing the handle assembly 12 from the distal end towards the
proximal end, the first portion 12a is considered the right portion
and the second portion 12b is considered the left portion. Each of
the first and second portions 12a, 12b includes a plurality of
interfaces 69 (FIG. 111) dimensioned to mechanically align and
engage each another to form the handle assembly 12 and enclosing
the internal working components thereof. The fixed handle 34, which
is integrally associated with the handle assembly 12, takes shape
upon the assembly of the first and second portions 12a and 12b of
the handle assembly 12. A plurality of additional interfaces (not
shown) may be disposed at various points around the periphery of
the first and second portions 12a and 12b of the handle assembly 12
for ultrasonic welding purposes, e.g., energy direction/deflection
points. The first and second portions 12a and 12b (as well as the
other components described below) may be assembled together in any
fashion known in the art. For example, alignment pins, snap-like
interfaces, tongue and groove interfaces, locking tabs, adhesive
ports, may all be utilized either alone or in combination for
assembly purposes.
[0211] In one example embodiment, the elongated shaft assembly 14
comprises a proximal end 50 adapted to mechanically engage the
handle assembly 12 and the distal rotation assembly 13; and a
distal end 52 adapted to mechanically engage the end effector
assembly 26. The elongated shaft assembly 14 comprises an outer
tubular sheath 56 and a reciprocating tubular actuating member 58
located within the outer tubular sheath 56. The proximal end of the
tubular reciprocating tubular actuating member 58 is mechanically
engaged to the trigger 32 of the handle assembly 12 to move in
either direction 60A or 60B in response to the actuation and/or
release of the trigger 32. The pivotably moveable trigger 32 may
generate reciprocating motion along the longitudinal axis "T." Such
motion may be used, for example, to actuate the jaws or clamping
mechanism of the end effector assembly 26. A series of linkages
translate the pivotal rotation of the trigger 32 to axial movement
of a yoke coupled to an actuation mechanism, which controls the
opening and closing of the jaws of the clamping mechanism of the
end effector assembly 26. The distal end of the tubular
reciprocating tubular actuating member 58 is mechanically engaged
to the end effector assembly 26. In the illustrated embodiment, the
distal end of the tubular reciprocating tubular actuating member 58
is mechanically engaged to a clamp arm assembly 64, which is
pivotable about a pivot point 70, to open and close the clamp arm
assembly 64 in response to the actuation and/or release of the
trigger 32. For example, in the illustrated embodiment, the clamp
arm assembly 64 is movable in direction 62A from an open position
to a closed position about a pivot point 70 when the trigger 32 is
squeezed in direction 33A. The clamp arm assembly 64 is movable in
direction 62B from a closed position to an open position about the
pivot point 70 when the trigger 32 is released or outwardly
contacted in direction 33B.
[0212] In one example embodiment, the end effector assembly 26 is
attached at the distal end 52 of the elongated shaft assembly 14
and includes a clamp arm assembly 64 and a blade 66. The jaws of
the clamping mechanism of the end effector assembly 26 are formed
by clamp arm assembly 64 and the blade 66. The blade 66 is
ultrasonically actuatable and is acoustically coupled to the
ultrasonic transducer 16. The trigger 32 on the handle assembly 12
is ultimately connected to a drive assembly, which together,
mechanically cooperate to effect movement of the clamp arm assembly
64. Squeezing the trigger 32 in direction 33A moves the clamp arm
assembly 64 in direction 62A from an open position, wherein the
clamp arm assembly 64 and the blade 66 are disposed in a spaced
relation relative to one another, to a clamped or closed position,
wherein the clamp arm assembly 64 and the blade 66 cooperate to
grasp tissue therebetween. The clamp arm assembly 64 may comprise a
clamp pad 69 to engage tissue between the blade 66 and the clamp
arm 64. Releasing the trigger 32 in direction 33B moves the clamp
arm assembly 64 in direction 62B from a closed relationship, to an
open position, wherein the clamp arm assembly 64 and the blade 66
are disposed in a spaced relation relative to one another.
[0213] The proximal portion of the handle assembly 12 comprises a
proximal opening 68 to receive the distal end of the ultrasonic
assembly 16. The ultrasonic assembly 16 is inserted in the proximal
opening 68 and is mechanically engaged to the elongated shaft
assembly 14.
[0214] In one example embodiment, the elongated trigger hook 36
portion of the trigger 32 provides a longer trigger lever with a
shorter span and rotation travel. The longer lever of the elongated
trigger hook 36 allows the user to employ multiple fingers within
the aperture 38 to operate the elongated trigger hook 36 and cause
the trigger 32 to pivot in direction 33B to open the jaws of the
end effector assembly 26. For example, the user may insert three
fingers (e.g., the middle, ring, and little fingers) in the
aperture 38. Multiple fingers allows the surgeon to exert higher
input forces on the trigger 32 and the elongated trigger hook 36 to
activate the end effector assembly 26. The shorter span and
rotation travel creates a more comfortable grip when closing or
squeezing the trigger 32 in direction 33A or when opening the
trigger 32 in the outward opening motion in direction 33B lessening
the need to extend the fingers further outward. This substantially
lessens hand fatigue and strain associated with the outward opening
motion of the trigger 32 in direction 33B. The outward opening
motion of the trigger may be spring-assisted by spring element 98
(FIG. 111) to help alleviate fatigue. The opening spring force is
sufficient to assist the ease of opening, but not strong enough to
adversely impact the tactile feedback of tissue tension during
spreading dissection.
[0215] For example, during a surgical procedure either the index
finger may be used to control the rotation of the elongated shaft
assembly 14 to locate the jaws of the end effector assembly 26 in a
suitable orientation. The middle and/or the other lower fingers may
be used to squeeze the trigger 32 and grasp tissue within the jaws.
Once the jaws are located in the desired position and the jaws are
clamped against the tissue, the index finger can be used to
activate the toggle switch 30 to adjust the power level of the
ultrasonic transducer 16 to treat the tissue. Once the tissue has
been treated, the user the may release the trigger 32 by pushing
outwardly in the distal direction against the elongated trigger
hook 36 with the middle and/or lower fingers to open the jaws of
the end effector assembly 26. This basic procedure may be performed
without the user having to adjust their grip of the handle assembly
12.
[0216] FIGS. 109-110 illustrate the connection of the elongated
shaft assembly 14 relative to the end effector assembly 26. As
previously described, in the illustrated embodiment, the end
effector assembly 26 comprises a clamp arm assembly 64 and a blade
66 to form the jaws of the clamping mechanism. The blade 66 may be
an ultrasonically actuatable blade acoustically coupled to the
ultrasonic transducer 16. The trigger 32 is mechanically connected
to a drive assembly. Together, the trigger 32 and the drive
assembly mechanically cooperate to move the clamp arm assembly 64
to an open position in direction 62A wherein the clamp arm assembly
64 and the blade 66 are disposed in spaced relation relative to one
another, to a clamped or closed position in direction 62B wherein
the clamp arm assembly 64 and the blade 66 cooperate to grasp
tissue therebetween. The clamp arm assembly 64 may comprise a clamp
pad 69 to engage tissue between the blade 66 and the clamp arm 64.
The distal end of the tubular reciprocating tubular actuating
member 58 is mechanically engaged to the end effector assembly 26.
In the illustrated embodiment, the distal end of the tubular
reciprocating tubular actuating member 58 is mechanically engaged
to the clamp arm assembly 64, which is pivotable about the pivot
point 70, to open and close the clamp arm assembly 64 in response
to the actuation and/or release of the trigger 32. For example, in
the illustrated embodiment, the clamp arm assembly 64 is movable
from an open position to a closed position in direction 62B about a
pivot point 70 when the trigger 32 is squeezed in direction 33A.
The clamp arm assembly 64 is movable from a closed position to an
open position in direction 62A about the pivot point 70 when the
trigger 32 is released or outwardly contacted in direction 33B.
[0217] As previously discussed, the clamp arm assembly 64 may
comprise electrodes electrically coupled to the electrosurgical/RF
generator module 23 to receive therapeutic and/or sub-therapeutic
energy, where the electrosurgical/RF energy may be applied to the
electrodes either simultaneously or non-simultaneously with the
ultrasonic energy being applied to the blade 66. Such energy
activations may be applied in any suitable combinations to achieve
a desired tissue effect in cooperation with an algorithm or other
control logic.
[0218] FIG. 111 is an exploded view of the ultrasonic surgical
instrument 10 shown in FIG. 108. In the illustrated embodiment, the
exploded view shows the internal elements of the handle assembly
12, the handle assembly 12, the distal rotation assembly 13, the
switch assembly 28, and the elongated shaft assembly 14. In the
illustrated embodiment, the first and second portions 12a, 12b mate
to form the handle assembly 12. The first and second portions 12a,
12b each comprises a plurality of interfaces 69 dimensioned to
mechanically align and engage one another to form the handle
assembly 12 and enclose the internal working components of the
ultrasonic surgical instrument 10. The rotation knob 48 is
mechanically engaged to the outer tubular sheath 56 so that it may
be rotated in circular direction 54 up to 360.degree.. The outer
tubular sheath 56 is located over the reciprocating tubular
actuating member 58, which is mechanically engaged to and retained
within the handle assembly 12 via a plurality of coupling elements
72. The coupling elements 72 may comprise an O-ring 72a, a tube
collar cap 72b, a distal washer 72c, a proximal washer 72d, and a
thread tube collar 72e. The reciprocating tubular actuating member
58 is located within a reciprocating yoke 84, which is retained
between the first and second portions 12a, 12b of the handle
assembly 12. The yoke 84 is part of a reciprocating yoke assembly
88. A series of linkages translate the pivotal rotation of the
elongated trigger hook 32 to the axial movement of the
reciprocating yoke 84, which controls the opening and closing of
the jaws of the clamping mechanism of the end effector assembly 26
at the distal end of the ultrasonic surgical instrument 10. In one
example embodiment, a four-link design provides mechanical
advantage in a relatively short rotation span, for example.
[0219] In one example embodiment, an ultrasonic transmission
waveguide 78 is disposed inside the reciprocating tubular actuating
member 58. The distal end 52 of the ultrasonic transmission
waveguide 78 is acoustically coupled (e.g., directly or indirectly
mechanically coupled) to the blade 66 and the proximal end 50 of
the ultrasonic transmission waveguide 78 is received within the
handle assembly 12. The proximal end 50 of the ultrasonic
transmission waveguide 78 is adapted to acoustically couple to the
distal end of the ultrasonic transducer 16 as discussed in more
detail below. The ultrasonic transmission waveguide 78 is isolated
from the other elements of the elongated shaft assembly 14 by a
protective sheath 80 and a plurality of isolation elements 82, such
as silicone rings. The outer tubular sheath 56, the reciprocating
tubular actuating member 58, and the ultrasonic transmission
waveguide 78 are mechanically engaged by a pin 74. The switch
assembly 28 comprises the toggle switch 30 and electrical elements
86a, 86b to electrically energize the ultrasonic transducer 16 in
accordance with the activation of the first or second projecting
knobs 30a, 30b.
[0220] In one example embodiment, the outer tubular sheath 56
isolates the user or the patient from the ultrasonic vibrations of
the ultrasonic transmission waveguide 78. The outer tubular sheath
56 generally includes a hub 76. The outer tubular sheath 56 is
threaded onto the distal end of the handle assembly 12. The
ultrasonic transmission waveguide 78 extends through the opening of
the outer tubular sheath 56 and the isolation elements 82 isolate
the ultrasonic transmission waveguide 24 from the outer tubular
sheath 56. The outer tubular sheath 56 may be attached to the
waveguide 78 with the pin 74. The hole to receive the pin 74 in the
waveguide 78 may occur nominally at a displacement node. The
waveguide 78 may screw or snap into the hand piece handle assembly
12 by a stud. Flat portions on the hub 76 enable the assembly to be
torqued to a required level. In one example embodiment, the hub 76
portion of the outer tubular sheath 56 is preferably constructed
from plastic and the tubular elongated portion of the outer tubular
sheath 56 is fabricated from stainless steel. Alternatively, the
ultrasonic transmission waveguide 78 may comprise polymeric
material surrounding it to isolate it from outside contact.
[0221] In one example embodiment, the distal end of the ultrasonic
transmission waveguide 78 may be coupled to the proximal end of the
blade 66 by an internal threaded connection, preferably at or near
an antinode. It is contemplated that the blade 66 may be attached
to the ultrasonic transmission waveguide 78 by any suitable means,
such as a welded joint or the like. Although the blade 66 may be
detachable from the ultrasonic transmission waveguide 78, it is
also contemplated that the single element end effector (e.g., the
blade 66) and the ultrasonic transmission waveguide 78 may be
formed as a single unitary piece.
[0222] In one example embodiment, the trigger 32 is coupled to a
linkage mechanism to translate the rotational motion of the trigger
32 in directions 33A and 33B to the linear motion of the
reciprocating tubular actuating member 58 in corresponding
directions 60A and 60B. The trigger 32 comprises a first set of
flanges 98 with openings formed therein to receive a first yoke pin
92a. The first yoke pin 92a is also located through a set of
openings formed at the distal end of the yoke 84. The trigger 32
also comprises a second set of flanges 96 to receive a first end
92a of a link 92. A trigger pin 90 is received in openings formed
in the link 92 and the second set of flanges 96. The trigger pin 90
is received in the openings formed in the link 92 and the second
set of flanges 96 and is adapted to couple to the first and second
portions 12a, 12b of the handle assembly 12 to form a trigger pivot
point for the trigger 32. A second end 92b of the link 92 is
received in a slot 384 formed in a proximal end of the yoke 84 and
is retained therein by a second yoke pin 94b. As the trigger 32 is
pivotally rotated about the pivot point 190 formed by the trigger
pin 90, the yoke translates horizontally along longitudinal axis
"T" in a direction indicated by arrows 60A, 60B.
Ultrasonic Blades with Various Grasping Features
[0223] FIGS. 1-11 illustrates various embodiments of ultrasonic
blades comprising grasping features. Such grasping features may be
included on a gripping surface of an ultrasonic blade to provide
additional gripping and prevent tissue milking during grasping and
treatment, which in some cases may improve hemostasis. Tissue
milking occurs when a tissue section slides, or milks, out of the
jaws of a surgical device during treatment. Blade modification
features discussed below can prevent tissue milking, as well as
provide better grasping forces.
[0224] A minimum grasping force for an ultrasonic clamp arm in a
medical forceps having a movable jaw member is about 2.25 lb-f when
clamped on a dry chamois while the device is inactive. During
activation, however, the tissue may milk out of the jaws either
proximally or distally. The blade 100 comprising the tooth-like
grasping features 102 for an ultrasonic shears device can help
prevent tissue milking as well as provide better grasping
forces.
[0225] Grasping features may take the form of several shapes as
described in connection with FIGS. 1-11, for example. The grasping
features could be located only on a portion of the blade, such as,
for example, the distal tip, the center of the blade, the proximal
section, or any portion of the blade. In another embodiment, the
grasping features may be located along the entire length or a
portion of the blade. In some embodiments, the features illustrated
and described with respect to FIGS. 1-11 could be located
longitudinally on a portion of the blade, such as, for example,
configured along a center line of the blade, the left side of the
blade, the right side of the blade, or both the right and left side
of the blade. In another embodiment, the grasping features may be
configured along the entire width of the blade. Grasping features
may include, for example, teeth machined into the blade, teeth
protruding from the surface of the blade, protruding blocks,
protruding bumps or spikes, holes formed in the blade, or
protruding elongated bumps. These and other blade grasping features
are described hereinbelow in connection with FIGS. 1-11.
[0226] FIG. 1 illustrates one embodiment of an ultrasonic blade 100
with tooth-like grasping features 102 formed on a grasping surface
104 of the blade 100. In the embodiment illustrated in FIG. 1 the
tooth-like grasping features 102 are formed along lateral portions
106, 108 of the grasping surface 104 of the blade 100, e.g., the
left side of the blade 100 and the right side of the blade 100. In
one embodiment, the tooth-like grasping features 102 may be formed
along the entire active length or a portion of the blade 100.
Elements of the tooth-like grasping features 102 may be uniformly
or variable spaced. In other embodiments, the tooth-like grasping
features 102 could be located only on a portion of the blade 100,
such as, for example, the distal tip 110, the center 112 of the
blade 100, the proximal section 114, or any portion of the blade
100. In another embodiment, the tooth-like grasping features 102
may be located along the entire length or a portion of the blade
100. In some embodiments, the tooth-like grasping features 102
could be located longitudinally on a portion of the blade 100, such
as, for example, configured along a center line 116 of the blade
100, the left side 108 of the blade 100, the right side 106 of the
blade 100, or both the right and left side of the blade 100. In
another embodiment, the tooth-like grasping features 102 may be
configured along the entire width of the blade 100. The tooth-like
grasping features 102 may be configured to trap tissue and prevent
disengagement during activation to prevent tissue milking, as well
as provide better grasping forces. Accordingly, the tooth-like
grasping features 102 formed on the blade 100 improve tissue
grasping. The embodiments, however, are not limited in this
context.
[0227] FIG. 2 illustrates one embodiment of an ultrasonic blade 200
with tooth-like grasping features 202 formed on a grasping portion
204 of the blade 200 where the teeth are machined into the grasping
portion 204 of the blade 200. In the embodiment illustrated in FIG.
2, the blade 200 is part of a medical forceps 206 having a movable
jaw member 208, which is commonly referred to as a clamp arm. The
movable jaw member 208 comprises a clamp pad 210 to engage tissue
between the blade 200 and the movable jaw member 208, e.g., clamp
arm. In one embodiment, the tooth-like grasping features 202 may be
formed along the entire active length or a portion of the blade
200. Elements of the tooth-like grasping features 202 may be
uniformly or variable spaced. Although not shown, the tooth-like
grasping features 202 may be formed across the grasping surface 204
of the blade 200, may be formed as multiple rows along the lateral
portions of the blade 200 as shown in FIG. 1, or may be formed as a
single row along the longitudinal portion of the grasping surface
204 of the blade 200. The tooth-like grasping features 202 may be
configured to trap tissue and prevent disengagement during
activation to prevent tissue milking, as well as provide better
grasping forces. Accordingly, the tooth-like grasping features 202
formed on the blade 200 improve tissue grasping. The embodiments,
however, are not limited in this context.
[0228] FIG. 3 illustrates one embodiment of an ultrasonic blade 300
with tooth-like grasping features 302 formed on a grasping portion
304 of the blade 300, where the teeth 302 protrude from the
grasping portion 304 of the blade 300. In the embodiment
illustrated in FIG. 3, the blade 300 is part of a medical forceps
306 having a movable jaw member 308, which is commonly referred to
as a clamp arm. The movable jaw member 308 comprises a clamp pad
310 to engage tissue between the blade 300 and the movable jaw
member 308, e.g., clamp arm. In one embodiment, the tooth-like
grasping features 302 may be formed along the entire active length
or a portion of the blade 300. Elements of the tooth-like grasping
features 302 may be uniformly or variable spaced. Although not
shown, the tooth-like grasping features 302 may be formed across
the grasping surface 304 of the blade 300, may be formed as
multiple rows along the lateral portions of the blade 300 as shown
in FIG. 1, or may be formed as a single row along the longitudinal
portion of the grasping surface 304 of the blade 300. The
tooth-like grasping features 302 may be configured to trap tissue
and prevent disengagement during activation to prevent tissue
milking, as well as provide better grasping forces. Accordingly,
the tooth-like grasping features 302 formed on the blade 300
improve tissue grasping. The embodiments, however, are not limited
in this context.
[0229] FIG. 4 illustrates one embodiment of an ultrasonic blade 400
with protruding block-like grasping features 402 formed on a
grasping 404 portion of the blade 400. FIG. 5 is a side view of the
ultrasonic blade shown in FIG. 4. In the embodiment illustrated in
FIGS. 4 and 5 the block-like grasping features 402 are formed along
lateral portions 406, 408 of the grasping surface 404 of the blade
400. In one embodiment, the block-like grasping features 402 may be
formed along the entire active length or a portion of the blade
400. Elements of the block-like grasping features 402 may be
uniformly or variable spaced. In other embodiments, the block-like
grasping features 402 could be located only on a portion of the
blade 400, such as, for example, the distal tip 410, the center 412
of the blade 400, the proximal section 414, or any portion of the
blade 400. In another embodiment, the block-like grasping features
402 may be located along the entire length or a portion of the
blade 400. In some embodiments, the block-like grasping features
402 could be located longitudinally on a portion of the blade 400,
such as, for example, configured along a center line 416 of the
blade 400, the left side 408 of the blade 400, the right side 406
of the blade 400, or both the right and left side of the blade 400.
In another embodiment, the block-like grasping features 402 may be
configured along the entire width of the blade 400. The block-like
grasping features 402 may be configured to trap tissue and prevent
disengagement during activation to prevent tissue milking, as well
as provide better grasping forces. Accordingly, the block-like
grasping features 402 formed on the blade 400 improve tissue
grasping. The embodiments, however, are not limited in this
context.
[0230] FIG. 6 illustrates one embodiment of an ultrasonic blade 500
with protruding grasping features 502 formed on a grasping portion
504 of the blade 500. FIG. 7A is a side view of the ultrasonic
blade 500 shown in FIG. 6 and FIG. 7B shows the protruding grasping
features 502 in the form of bump-like protrusions 510 whereas FIG.
7C shows the protruding grasping features 502 in the form of
spike-like protrusions 512. In the embodiment illustrated in FIGS.
6 and 7A the protruding grasping features 502 are formed along
lateral portions 506, 508 of the grasping surface 504 of the blade
500. In one embodiment, the grasping features 502 may be formed
along the entire active length or a portion of the blade 500.
Elements of the grasping features 502 may be uniformly or variable
spaced. In other embodiments, the grasping features 502 could be
located only on a portion of the blade 500, such as, for example,
the distal tip 520, the center 522 of the blade 500, the proximal
section 524, or any portion of the blade 500. In another
embodiment, the grasping features 502 may be located along the
entire length or a portion of the blade 500. In some embodiments,
the grasping features 502 could be located longitudinally on a
portion of the blade 500, such as, for example, configured along a
center line 526 of the blade 500, the left side 508 of the blade
500, the right side 506 of the blade 500, or both the right and
left side of the blade 500. In another embodiment, the grasping
features 502 may be configured along the entire width of the blade
500. The grasping features 502 may be configured to trap tissue and
prevent disengagement during activation to prevent tissue milking,
as well as provide better grasping forces. Accordingly, the
grasping features 502 formed on the blade 500 improve tissue
grasping. The embodiments, however, are not limited in this
context.
[0231] FIG. 8 illustrates one embodiment of an ultrasonic blade 600
with cavity-like grasping features 602 formed on a grasping portion
604 of the blade 600. FIG. 9A is a side view of an ultrasonic blade
600 having cylindrical cavity-like grasping features 611 partially
formed into the grasping portion of the blade 610. FIG. 9B is a
side view of an ultrasonic blade 600 having cylindrical cavity-like
grasping features 613 formed through a grasping portion of the
blade 612. FIG. 9C is a side view of an ultrasonic blade 600 having
conical cavity-like grasping features 615 partially formed into the
grasping portion of the blade 614. In the embodiment illustrated in
FIGS. 8 and 9A-C, the cavity-like grasping features 602 are
distributed along portions of the grasping surface 604 of the blade
600. In one embodiment, the grasping features 602 may be formed
along the entire active length or a portion of the blade 600.
Elements of the grasping features 602 may be uniformly or variable
spaced. In other embodiments, the grasping features 602 could be
located only on a portion of the blade 600, such as, for example,
the distal tip 620, the center 622 of the blade 600, the proximal
section 624, or any portion of the blade 600. In another
embodiment, the grasping features 602 may be located along the
entire length or a portion of the blade 600. In some embodiments,
the grasping features 602 could be located longitudinally on a
portion of the blade 600, such as, for example, configured along a
center line 626 of the blade 600, the left side 608 of the blade
600, the right side 606 of the blade 600, or both the right and
left side of the blade 600. In another embodiment, the grasping
features 602 may be configured along the entire width of the blade
600. The grasping features 602 may be configured to trap tissue and
prevent disengagement during activation to prevent tissue milking,
as well as provide better grasping forces. Accordingly, the
grasping features 602 formed on the blade 600 improve tissue
grasping. The embodiments, however, are not limited in this
context.
[0232] FIG. 10 illustrates one embodiment of an ultrasonic blade
700 with transverse bump-like grasping features 702 formed on a
grasping portion 704 of the blade 700. FIG. 11 is a side view of
the ultrasonic blade 700 shown in FIG. 10. In the embodiment
illustrated in FIGS. 10 and 11, the transverse bump-like grasping
features 702 are distributed transversally along across of the
grasping surface 704 of the blade 700. In one embodiment, the
transverse bump-like grasping features 702 may be formed along the
entire active length or a portion of the blade 700. Elements of the
transverse bump-like grasping features 702 may be uniformly or
variable spaced. In other embodiments, the transverse bump-like
grasping features 702 could be located only on a portion of the
blade 700, such as, for example, the distal tip 720, the center 722
of the blade 700, the proximal section 724, or any portion of the
blade 700. In another embodiment, the transverse bump-like grasping
features 702 may be located along the entire length or a portion of
the blade 700. In some embodiments, the transverse bump-like
grasping features 702 could be located longitudinally on a portion
of the blade 700, such as, for example, configured along a center
line 726 of the blade 700, the left side 708 of the blade 700, the
right side 706 of the blade 700, or both the right and left side of
the blade 700. In another embodiment, the transverse bump-like
grasping features 702 may be configured along the entire width of
the blade 700. The transverse bump-like grasping features 702 may
be configured to trap tissue and prevent disengagement during
activation to prevent tissue milking, as well as provide better
grasping forces. Accordingly, the transverse bump-like grasping
features 702 formed on the blade 700 improve tissue grasping. The
embodiments, however, are not limited in this context.
[0233] FIG. 12 is a side view of one embodiment of an end effector
assembly comprising medical forceps 800 having a movable jaw member
802 and an ultrasonic blade 804 having protrusions 806 in the form
of tooth-like grasping features formed in the grasping surface 808
of the blade 804. FIG. 13 is a top view of one embodiment of the
medical forceps 800 shown in FIG. 12 with the movable jaw member
802 drawn in phantom line to show the ultrasonic blade 804
positioned below the movable jaw member 802.
[0234] In one embodiment, the protrusions 806 (e.g., teeth) may be
defined by several dimensions. A first dimension "a" represents the
height of a protrusion 806 (e.g., tooth). In one embodiment, the
dimension "a" may be about 0.12 mm to 0.18 mm. A second dimension
"b" represents the width of a protrusion 806 (e.g., tooth). In one
embodiment, the dimension "b" may be about 0.2 mm. A third
dimension "c" represents the spacing between each protrusion 806.
In one embodiment, the dimension "c" is about 0.5 mm. The
protrusions 806 may cover, in one embodiment, a distance
represented by dimension "d" which can be as little as 2 mm of the
blade 804 to provide additional grasping strength. The 2 mm of
protrusions 806 may comprise any percentage of the blade 804, such
as, for example, 13% of a 15 mm blade. In one embodiment, the
height of the protrusion 806 near the distal end 810 of the blade
804 may be approximately 2.3 mm. In one embodiment, the protrusions
806 may comprise about 5% of the total height of the blade 804. In
various embodiments, the protrusions 806 may include a pitch of 0.3
mm-1.0 mm, a depth of approximately 0.08 mm-0.8 mm, and an angle of
approximately 5-90 degrees. In various embodiments, the protrusions
806 may be in the form of blocks, bumps, spikes, or speed bumps, as
previously described. These alternate embodiments of the
protrusions 806 would be formed having similar dimensions as the
protrusions 806 described in connection with FIGS. 12 and 13 to
have a similar affect on tissue, e.g., statistically better tissue
grasping forces and preventing tissue milking.
[0235] In one embodiment, the protrusions 806 may mate with
alternating features formed on the clamp arm 802 or tissue pad 812
portion of the medical forceps 800. In another embodiment, this
mating is neither necessary nor required. In one non-mating
embodiment, grasping efficiency may be increased by 64% using three
features in the form of teeth. The presence of the features does
not affect the tissue transection ability of the blade 804. In one
embodiment, the blade 804 may comprise protrusions 806 along the
entire active length of the blade 804. The protrusions 806 may be
configured to trap tissue and prevent disengagement during
activation. Various embodiments of protrusions 806 may include
blade teeth, horizontal trenches, or cavities, as previously
described.
[0236] FIGS. 14-18 illustrate various embodiments of ultrasonic
blades comprising blade features is to address tissue milking. As
previously discussed, tissue milking is defined as the event in
which tissue begins to slip out of the jaws of an ultrasonic
medical forceps having a movable jaw member and an ultrasonic blade
upon device activation. This event increases the difficulty of
manipulating tissue in low accessibility conditions. To address
this and other issues, the present disclosure provides three
embodiments to improve the grasping ability during ultrasonic
activation. At least one embodiment of each of the disclosed
ultrasonic blades employs repeated features across the active
length of the blade. These features are designed to trap tissue and
prevent disengagement during activation. Based on the testing, the
following embodiments have shown between a 30% and 40% improvement
in grasping force during activation over conventional ultrasonic
blades. The three embodiments provide ultrasonic blade teeth
geometries in the form of blade teeth, horizontal trenches, and
holes (e.g., cavities) as described hereinbelow in connection with
FIGS. 14-18 to prevent disengagement of tissue from the blade and
clamp arm upon ultrasonic activation of the device and to improve
tissue grasping ability prior to and during ultrasonic activation.
In various embodiments, the ultrasonic blades comprise tissue
trapping features to improve grasping ability and prevent tissue
disengagement during ultrasonic activation of the blade.
[0237] FIG. 14 is a side view illustrating one embodiment of an
ultrasonic blade 900 comprising tooth-like grasping features 902
having triangular grooves formed on a grasping surface 904 of the
blade 900. FIG. 15 is a top view of the ultrasonic blade 900 shown
in FIG. 14. The blade 900 comprises a proximal end 910 and a distal
end 909. The blade 900 comprises tissue trapping features 902 in
the form of triangular grooves repeated along a portion of or the
entire longitudinal length of the blade 900. A distal side 906
toward the distal end 909 of the blade 900 of each feature 902 may
be a surface perpendicular to the longitudinal axis of the blade
900 followed by an angled surface 908 that tapers off in a proximal
direction 910. In one embodiment, the features 902 may be
characterized by dimensions a, b, c, and d. In one embodiment,
dimension "a" represents the heights of the feature 902, which may
be approximately 0.010'', "b" represents the width of the feature
902, which may be approximately 0.020'', "c" represents the
distance between the features 902, which may be approximately
0.055'', and "d" represents the distance from the most distal
feature 902 to the distal 909 tip of the blade 900, which may be
approximately 0.015''. In one embodiment, the features 902 may be
evenly spaced along the longitudinal length of the blade 900. In
another embodiment, the triangular grooves grasping features 902
may be unevenly spaced along the longitudinal length of the blade
900. In the illustrated embodiment, the blade 900 comprises 12
evenly spaced triangular grooves grasping features 902 along the
longitudinal length of the blade 900.
[0238] FIG. 16 is a side view illustrating one embodiment of an
ultrasonic blade 950 with tooth-like grasping features 952
including horizontal trenches having repeated semicircular grooves
formed on a grasping surface 954 of the blade 950. FIG. 17 is a top
view of the ultrasonic blade 950 shown in FIG. 16. The blade 950
comprises a proximal end 960 and a distal end 959. The blade 950
comprises tissue trapping features 952 in the form of horizontal
trenches having semicircular grooves repeated along the
longitudinal length of the blade 950. In one embodiment, the
features 952 may be characterized by dimensions e, f, g, and h. In
one embodiment, dimension "e" represents the diameter of the
grooves, which may be approximately 0.020'', "f" represents the
distance between each of the features 952, which may be
approximately 0.057'', "g" represents the distance from the most
distal feature 952 to the distal 909 tip of the blade 950, which
may be approximately 0.015'', and "h" represents the depth of the
grooves which may be approximately 0.005''. In one embodiment, the
features 952 may be evenly spaced along the longitudinal length of
the blade 950. In another embodiment, the semicircular groove
grasping features 952 may be unevenly spaced along the longitudinal
length of the blade 950. In the illustrated embodiment, the blade
950 comprises 12 evenly spaced semicircular groove grasping
features 952 along the longitudinal length of the blade 950.
[0239] FIG. 18 is a top view illustrating one embodiment of an
ultrasonic blade 970 comprising grasping features 972 including
cavities or holes formed on a grasping surface 974 of the blade
970. The blade 970 comprises a proximal end 980 and a distal end
979. The blade 970 comprises tissue trapping features 972 in the
form of circular elements repeated along the longitudinal length of
the blade 970. In one embodiment, the features 972 may be
characterized by dimensions i, j, and k. In one embodiment,
dimension "k" represents the diameter of a circular element, which
may be approximately 0.020'', "i" represents the distance between
each of the circular features 972, which may be approximately
0.057'', and "j" represents the distance from the most distal
feature 972' to the distal 979 tip of the blade 970, which may be
approximately 0.015''. In one embodiment, the circular features 972
may be evenly spaced along the longitudinal length of the blade
970. In another embodiment, the circular features 972 may be
unevenly spaced along the longitudinal length of the blade 970. In
the illustrated embodiment, the blade 970 comprises 12 evenly
spaced circular grasping features 972 along the longitudinal length
of the blade 970.
Ingress Prevention
[0240] The present disclosure describes various embodiments of
devices to prevent surgical matter, such as fluid or tissue, for
example, from entering the space between an ultrasonic blade and an
inner tube distal of the blade's distal seal. Two main categories
of embodiments are described. First, a pressure or energy source
attached to the blade-tube subassembly prevents fluid or tissue
ingress into the space between the blade and the inner tube.
Second, a flexible membrane(s) attached to either the blade or the
inner tube prevents fluid or tissue ingress.
[0241] In one embodiment, surgical matter in the form of fluid or
tissue, for example, could be prevented from entering the distal
inner tube area by the application of a constant pressure of a
fluid medium (e.g., air, CO.sub.2 or saline solution) in the distal
direction. FIG. 32 illustrates one embodiment of a positive
pressure fluid flow system 2300 comprising a pump and/or pump
outlet 2306 located distal of the distal seal. In the illustrated
embodiment, the external pump and/or pump outlet 2306 is
fluidically coupled to the device distal of the distal node of an
ultrasonic blade 2304. Air or other fluid medium 2308 is pumped
into the space 2310 between the blade 2304 and the inner tube 2302,
forcing particulates and/or bodily fluids out of that space 2310.
As illustrated in FIG. 32, the pump and/or pump outlet 2306 is
fluidically coupled to the space 2310 between the tube 2302 and the
blade 2304 at a point distal from a distal blade seal 2312, e.g.,
an O-ring or overmolded seal. Thus, the positive pressure fluid
flow 2308 is directed to the distal end of the device to prevent
accumulation of surgical matter in the space 2310.
[0242] FIG. 49 illustrates one embodiment of a positive fluid
pressure system 3500 in which air 3508 is pumped down the length of
the inner tube 3502 through space 3506. The air 3508 prevents
surgical matter from entering the space 3510 between the ultrasonic
blade 3504 and the inner tube 3502. FIG. 49 shows a similar concept
to that shown in FIG. 32, but the distal node does not have a seal
to the inner tube 3502. Rather, air 3508 is pumped down the full
length of the inner tube 3502 to prevent fluid and/or tissue
ingress.
[0243] FIG. 26 illustrates one embodiment of a hybrid system
comprising a contoured seal 1700 comprising a flexible membrane
1701 that acts as a pump to force surgical matter 1714 out of a
distal tube 1706 area. The pressurized flexible membrane 1701
blocks tissue ingress by contact. The flexible membrane 1701 is
attached to the inner tube 1706 and sealed to the ultrasonic blade
1704. Thus, the relative movement between the blade 1704 and the
distal tube 1706 causes the flexible membrane 1701 to act in a
pump-like manner to force fluids, tissue, or other surgical matter
to flow along the contour of the flexible membrane 1701 and out of
the inner tube 1706 area. The contoured seal 1700 seals a space
1702 between a portion of an ultrasonic blade 1704 and a tube 1706.
The contoured seal 1700 has two points of contact 1708, 1710 with
the ultrasonic blade 1704 to minimize friction and interference and
to provide a double seal. A cavity 1712 is defined by the contoured
seal 1700 for collecting surgical matter 1714. In an alternative
embodiment, a separate duct 1718 may be provided to apply a
positive pressure to the flexible membrane of the contoured seal
1700 to expel the surgical matter 1714 from the cavity 1712.
[0244] In various other embodiments, a boot barrier (or seal, for
example) may be added to an end effector portion of an ultrasonic
instrument to prevent the buildup of surgical matter on the end
effector. The boot barrier seals the ultrasonic blade to the distal
ends of one or more tube(s) near to the proximal end of the tissue
effecting portion of the ultrasonic blade. The boot barrier may be
made from any suitable materials including compliant, thermally
robust material that has a relatively low coefficient of friction
in order to minimize the seal load on the blade. Materials suitable
for the boot barrier may include, for example, silicone rubber,
parylene coated silicon rubber,
Tetrafluoroethylene-hexafluoropropylene (FEP), which has similar
properties to those of Polytetrafluoroethylene (PTFE) otherwise
known in the trade as Teflon, shrink tubing, or any similar
material. In another embodiment, the blade may be coated to reduce
power draw of the instrument due to inclusion of the boot
barrier.
[0245] The boot barrier seals to the blade and may provide slight
interference to the blade. Where the boot barrier seals to the
blade, the boot barrier does not provide vertical reaction for
clamping/bending of the blade in order to keep the load on the
blade (from the boot) minimized. The boot barrier may seal to the
outer diameter of the tube(s), the inner diameter of the tube(s) or
both. One or more retention features may be provided on the blade
and/or the tube(s) for retaining the boot to the blade and/or the
tube(s). In one embodiment, the retention features may also be
located on the boot barrier itself.
[0246] Generally, the boot barrier prevents build up and
accumulation of surgical matter such as, for example, tissue,
blood, melted fat, and other related materials encountered during
surgery, between the distal portion of the tube(s) and the nearby
portion of the blade of the ultrasonic surgery device. This build
up and accumulation may result in large and inconsistent mechanical
loads on the system resulting in procedure interruptions due to
high impedance either causing resonance issues or causing the
system to bog down and potentially stop during activation. The
tube(s) are needed to protect tissue and users from the
ultrasonically active blade and, in the case of shears-type device,
to support and/or drive a clamp arm. Ideally, the ultrasonic blade
is as active (ultrasonically) as possible in the proximal portion
of its tissue effecting length. Solutions that maximize this
ultrasonic activity also elongate the portion of the blade between
its most distal node and the proximal end its tissue effecting
length. The result is a relatively large annular volume that
accumulates tissue, blood, fat, etc. with the aforementioned
issues.
[0247] FIG. 19 illustrates one embodiment of an end effector
assembly 1000 comprising a medical forceps having a movable jaw
member 1002 and an ultrasonic blade 1004. The jaw member 1002 is
movable in direction 1016. A flexible boot barrier 1006 is
positioned over a proximal portion 1008 of the blade 1004 and a
distal portion of a tube 1010 to seal the blade 1004 to an outer
diameter 1012 of the tube 1010. A retention feature 1014 may be
provided on the outer diameter 1012 of the tube 1010 to keep the
boot barrier 1006 in place. As previously discussed, the boot
barrier 1006 may be made from silicone rubber or other similar
materials. In one embodiment, the boot barrier 1006 may be coated
with a lubricious material such as parylene, for example, to reduce
friction. In an alternative embodiment, the blade 1104 may be
coated with similar lubricious materials to reduce friction.
Reducing friction between the blade 1004 and the boot barrier 1006
reduces power draw due to the inclusion of the boot barrier
1006.
[0248] FIG. 20 illustrates one embodiment of an end effector
assembly 1100 comprising a medical forceps having a movable jaw
member 1102 and an ultrasonic blade 1104. A flexible seal 1106
positioned over a proximal portion 1108 of the blade 1104 and
within a distal portion 1110 of an inner tube 1112 to seal the
blade 1104 to an inner diameter 1114 of the inner tube 1112. The
inner tube 1112 is slidably movable within an outer tube 1116.
[0249] FIG. 21 illustrates one embodiment of a slotted inner tube
1200 to conceal a lengthwise portion of an ultrasonic blade 1202.
Slots 1204 provide fluid/tissue egress to discharge surgical matter
that may accumulate in a space 1206 between the blade 1202 and the
inner tube 1200. Fluid/tissue egress through the slots 1204 at the
distal end of an ultrasonic device prevents the accumulation of
surgical matter. In ultrasonic laparoscopic shears, for example, an
overmolded silicone distal seal 1208 is provided on or near the
distal node of the blade 1202. A boot barrier may be overmolded,
positioned just distal to the clamp arm edge, which could prevent
tissue pinching, and anchored to the inner tube 1200, or positioned
within the inner tube 1200 and non-visible to the user as shown in
FIG. 22, for example. In these devices, there is approximately 13
mm length of the blade 1202 that is concealed by the outer tube
(not shown) and the inner tube 1200 before the distal seal 1208 is
present. Surgical matter, such as fluid, blood, fat, or other
tissue, can become lodged in that space between the outer diameter
of the blade 1202 and the inner diameter of the inner tube 1200. In
other instruments comprising similar shears, the length of exposed
blade may increase thus increasing the chance of tissue lodging
therein. This could result in increased transection times as the
fluid/tissue becomes a heat sink or in relaxed pressure on the
blade if the fluid/tissue hardens from applied blade heat.
Additionally, if an RF modality is to be added to ultrasonic lap
shears technology, tissue and fluid could cause a short circuit if
the RF energy is allowed to flow from the blade through tissue that
is inside the inner tube, rather than the desired energy path along
the active (exposed) length of the blade. Thus a boot or distal
tissue ingress prevention method or mechanism is provided as
described herein below in connection with FIGS. 21-23 where
surgical matter such as fluid or tissue is expelled from between
the inner tube 1200 and the blade 1202 by slots 1204, windows,
apertures, or perforations formed in the inner tube 1200.
[0250] FIG. 22 illustrates one embodiment of a perforated inner
tube 1300 to conceal a lengthwise portion of an ultrasonic blade
1302. The inner tube 1300 is perforated with holes 1304 to allow
surgical matter such as fluids/tissue to escape. The perforations
1304 provide fluid/tissue egress to discharge surgical matter that
may accumulate in a space 1306 between the blade 1302 and the inner
tube 1300. In the illustrated embodiment, the inner tube 1300
comprises a 180.degree. half circle and is perforated with holes
1304 to allow fluids/tissue to escape. The tube 1300 is located
between the active blade 1302 and the distal most overmold 1310
portion, which is located a distance 1308 from the distal tip of
the blade 1302.
[0251] FIG. 23 illustrates one embodiment of a fluid-directing
ribbed and perforated inner tube 1400 to conceal a lengthwise
portion 1401 of an ultrasonic blade 1402. Fluid-directing ribs 1404
perforations 1406 provide fluid egress to discharge surgical matter
that may accumulate in a space 1410 between the blade 1402 and the
inner tube 1400. The distal most overmold is located at a distance
1408 from the distal tip of the blade 1402. In the illustrated
embodiment, the ribs 1404 radiate inward and comprise holes 1406
located between each rib. The ribs 1404 have a clearance with
respect to the blade 1402. The spacing of the ribs 1404 is such
that only fluids can pass, not solids of appreciable size. The
channeling configuration raises fluid velocity and raises
likelihood of clearing out of holes 1406.
[0252] FIG. 24 is one embodiment of a fluid-directing ribbed and
perforated inner tube 1500 comprising converging ducts 1502. In one
embodiment, the converging ducts 1502 are fluidically coupled to
apertures 1504 to provide fluid egress to discharge surgical
matter.
[0253] FIG. 25 illustrates one embodiment of a contoured seal 1600
to seal a space 1602 between a portion of an ultrasonic blade 1604
distal to the distal seal and a tube 1606. The contoured flexible
seal 1600 has two points of contact 1608, 1610 with the ultrasonic
blade 1604 to minimize friction and interference and to provide a
double seal. A cavity 1612 is defined by the contoured flexible
seal 1600 for collecting surgical matter 1614.
[0254] FIG. 27 illustrates one embodiment of a seal 1800 to seal a
space 1802 between a portion of an ultrasonic blade 1804 distal to
the distal seal and a tube 1806. The flexible seal 1800 has
multiple points of contact 1808 to provide low interference point
of contact between the seal 1800 and the blade 1804. The multiple
points of contact 1808 reduce fluid wicking up the shaft of the
blade 1804. A nose portion 1810 of the seal 1800 and the multiple
points of contact 1808 block surgical matter from entering into the
space 1802 between the blade 1804 and the tube 1806.
[0255] FIG. 28 illustrates etched areas 1902 formed on an outer
surface 1904 of an ultrasonic blade 1900 to prevent fluid/tissue
ingress along the blade due to blade vibration.
[0256] FIG. 29 illustrates one embodiment of an end effector
assembly 2000 comprising a medical forceps having a movable jaw
2002 member and a slidable ultrasonic blade 2004 partially
retracted within a seal 2006. The movable jaw member 2002 comprises
a clamp pad 2014 having a living hinge formed by necked down
regions 2012 at the interface of the clamp pad 2014 and the seal
2006. The blade 2004 is slidable in direction 2010 and is received
within the seal 2006. The seal 2006 is coupled to an inner tube
2008 to seal the blade 2004 to the tube 2008 and prevent
fluid/tissue migration proximally.
[0257] FIG. 30 illustrates one embodiment of an inner tube 2100
having machined windows 2102 formed therein. The windows 2102 allow
drainage between the inner 2100 and an outer tube. This embodiment
may be an alternative to the embodiment show in FIG. 21, for
example.
[0258] FIG. 31 illustrates one embodiment of an end effector
assembly 2200 comprising a medical forceps having a movable jaw
member 2202 and an ultrasonic blade 2204. The movable jaw member
2202 comprises an extended clamp arm pad 2206 that follows the
contour of the movable jaw member 2202 (e.g., clamp arm) into the
space around the blade 2204 to cover the opening of the inner tube
with a tissue stop element 2208. The tissue stop element 2208
deflects surgical matter and prevents it from entering the space
between the blade 2204 and the inner tube 2212. The tissue stop
element 2208 is contoured to the movable jaw member 2202 to cover
an opening 2210 of the inner tube 2212. In one embodiment, the
clamp arm pad 2206 is machined with the tissue stop 2208 element to
provide minimal interference between the blade 2204 and the tube
2212. The pad 2206 and/or the tissue stop element 2208 may be made
of a lubricious material such as Teflon to minimize the load on the
blade 2204.
[0259] FIG. 38 illustrates one embodiment of an end effector
assembly 2900 comprising a medical forceps having a movable jaw
member 2902 and an ultrasonic blade 2904. The movable jaw member
2902 comprises a clamp arm pad 2908 having a deflector pad 2906 to
deflect surgical matter.
[0260] FIG. 39 is a front view of the clamp arm pad 2908 and
deflector pad 2906 shown in FIG. 38. An aperture 2910 is provided
in the deflector pad 2906 to receive the ultrasonic blade 2904
therethrough.
[0261] FIG. 33 illustrates a portion of an end effector assembly
2400 comprising an ultrasonic blade 2404 including one embodiment
of a boot barrier 2402 to seal the ultrasonic blade 2404 to a tube
2406 distal to the distal node 2410 of the blade. In one
embodiment, the boot barrier 2402 seals the blade 2404 to an inner
tube 2406 which is disposed within an outer tube 2408. In the
embodiment illustrate din FIG. 33, the boot barrier 2402 may be
formed of FEP to cover high stress regions of the blade 2404. In
the illustrated embodiment, the outer tube 2408 ends at a blade
distal node 2410.
[0262] FIG. 34 illustrates one embodiment of an end effector
assembly 2500 comprising a medical forceps having a movable jaw
member 2502 and an ultrasonic blade 2504 including a flexible seal
2506 positioned distal to an edge 2508 of the movable jaw member
2502 and anchored to an outer tube 2510 to prevent tissue pinching.
An inner tube 2512 is positioned within the outer tube 2510. The
blade 2504 is positioned within the inner tube 2512.
[0263] FIG. 35 illustrates one embodiment of an end effector
assembly 2600 comprising a seal 2606 positioned within an inner
tube 2602 and an ultrasonic blade 2604 positioned within the inner
tube 2602 such that it is non-visible to the user. The seal 2602
may either be a low friction material to minimize load on the blade
2604 or a small clearance 2608 may be provided between the seal
2606 and the blade 2604 to prevent contact with the blade. The seal
2606 seals the space 2610 defined between the blade 2604 distal to
the distal seal and an inner diameter of the inner tube 2602 to
prevent the accumulation of surgical matter therein.
[0264] FIG. 36 illustrates one embodiment of a seal mechanism 2700
for an ultrasonic blade 2702 having a tapered inner tube 2704
portion distal to the blade distal seal 2716 where the inner tube
2704 necks down 2706 to a smaller diameter at a distal end defining
a reduced entry space 2708 for surgical matter. A conventional
outer tube 2710 is provided over the tapered inner tube 2704. The
diameter of the inner tube portion 2712 proximal to the necked down
region 2706 is greater than the diameter of the inner tube portion
2714 distal to the necked down region 2706. In one embodiment, the
necked down region 2706 coincides with the location just distal to
the distal-most overmold 2716. In one embodiment, the inner tube
2704 may be necked down for a portion distal to the distal-most
seal, to provide less open space for fluids and solids to
enter.
[0265] FIG. 37 illustrates one embodiment of an overmolded flexible
seal 2800 located over an inner tube 2802 that an ultrasonic blade
2804 punctures through during assembly. As shown, as the blade 2804
is moved distally in direction 2806 during device assembly, the
blade 2804 breaks through the overmolded flexible seal 2800 to seal
the space 2808 between the blade 2804 and the inner tube 2802. A
clamp arm pivot hole 2814 in the outer tube distal clevis 2816
enables a movable jaw member to open and close. An outer tube
distal clevis 2816 is located on a distal end of an outer tube. In
one embodiment, the clevis 2816 can be welded on the distal end of
the outer tube.
[0266] FIG. 40 illustrates one embodiment of a seal system 3000 for
an ultrasonic blade 3002. A flexible seal 3004 seals the ultrasonic
blade 3002 distal to a distal seal portion 3008. In one embodiment,
the flexible seal 3004 seals the blade 3002 to the inner diameter
of the inner tube 3006.
[0267] FIG. 41 illustrates one embodiment of a contoured inner tube
3100 or component that attaches to an inner tube 3100 to provide a
circuitous path 3104 for fluid. An area of the inner tube 3100
comprises a locally swaged pair of grooves 3106, 3108 that may be
employed to locate an O-ring that would touch the blade or provide
a circuitous path to prevent ingress of fluids during use.
[0268] FIG. 42 illustrates one embodiment of a molded component
3110 with compliant arms that serves to block the distal opening of
a tube assembly and is attached via arms going around a pin in the
blade at a node location.
[0269] FIG. 43 illustrates one embodiment of an overmolded silicone
bumper 3112 that adheres to the inside of an inner tube. The bumper
3112 prevents fluid ingress and does not nominally touch the blade
so there is no increase in blade loading during use.
[0270] FIGS. 44-47 illustrate one embodiment of how a pair of
mandrels 3120A, 3120B can be inserted into an inner 3122 tube from
both ends. The mandrels 3120A, 3120B combine to form an overmold
channel into which the silicone (or equivalent) bumper 3124
material would be injected. The mandrels would then be removed
leaving just the bumper 3124.
[0271] FIG. 48 illustrates an end view of a seal system 3200
comprising an overmolded bumper 3124 affixed to an inner tube 3202
that does not seal to an ultrasonic blade 3204. In the illustrated
embodiment, the seal system 3200 is an end view of the tube
assembly shown in FIG. 47 with the molded bumper 3124 in place.
[0272] FIG. 50 illustrates one embodiment of an inner tube 3600
comprising having a silicone seal 3602 attached thereto at minimal
interference with an ultrasonic blade.
[0273] FIG. 51 illustrates one embodiment of seal system 3700 for
sealing an ultrasonic blade 3704 to a tube 3706. In the illustrated
embodiment, the sealing system 3700 comprises a funnel 3702 to
prevent ingress of surgical matter in the space 3708 between the
blade 3704 distal to the distal node and the inner tube 3706. The
funnel 3702 deflects surgical matter distally.
[0274] FIG. 52 illustrates one embodiment of a flexible seal 3802
located over an inner tube 3800 that an ultrasonic blade punctures
through and dilates at location 3804 during assembly.
[0275] FIG. 53 illustrates one embodiment of an overmolded flexible
seal 3900 attached to an ultrasonic blade 3902 distal of the distal
node.
[0276] FIG. 54 illustrates one embodiment of an overmolded flexible
seal 4000 attached to an ultrasonic blade 4002 distal of the distal
node. In one embodiment, the overmolded flexible seal 4000 is made
from an FEP material.
[0277] FIG. 55 illustrates one embodiment of a sealing system 4100
comprising multiple toroidal seals 4102, 4104, 4106 to seal an
ultrasonic blade 4108 distal of the distal node. The toroidal seals
4102, 4104, 4106 are suspended by small overmolded features 4110
that do not interfere with the blade 4108.
[0278] FIG. 56 illustrates one embodiment of an end effector
assembly 4200 comprising a medical forceps having a movable jaw
member 4202 in an open position, an ultrasonic blade 4204, and a
slidably movable inner tube 4206 including a wiping seal 4208. As
illustrated in FIG. 56, the slidably movable inner tube 4206 moves
distally in direction 4210 as the jaw member 4212 opens in
direction 4212. The wiping seal 4208 surrounds the blade 4204. As
the jaw member 4202 opens in direction 4212 the wiping seal 4208
moves distally in direction 4210 along with the inner tube 4206 to
wipe surgical matter off the blade 4204.
[0279] FIG. 57 illustrates one embodiment of the end effector
assembly 4200 shown in FIG. 56 comprising a medical forceps having
a movable jaw member 4202 in a closed position. As shown in FIG.
57, as the jaw member 4202 closes in direction 4216, the inner tube
4206 moves proximally in direction 4214 to retract the wiping seal
4208. To wipe the blade 4204 with the wiping seal 4208, the jaw
member 4202 is opened as described in connection with FIG. 56.
[0280] FIG. 58 illustrates one embodiment of an end effector
assembly 4300 comprising a medical forceps having a movable jaw
member 4302 in a closed position shown in solid line and in an open
position shown in phantom line, an ultrasonic blade 4304, a
slidably movable outer tube 4306, and a fixed inner tube 4308 with
an overmolded flexible seal 4310 located on the inner tube 4308
over the blade 4304.
[0281] FIG. 59 illustrates one embodiment of the end effector
assembly 4300 comprising the movable jaw member 4302 in an open
position. As shown in FIG. 59, as the jaw member 4202 is opened the
overmolded flexible seal 4310 seals the throat 4312 of the device
to prevent surgical matter from entering the space 4314 between the
blade 4304 and the inner tube 4308.
Alternate Closure Mechanisms for Ultrasonic Devices
[0282] Present ultrasonic devices utilize a tube-in-tube (TnT)
closure mechanism to enable closure of the clamp arm, referred to
herein as a movable jaw member, against an active length of the
ultrasonic blade. The following embodiments of alternate closure
mechanisms for ultrasonic devices may yield several advantages. For
example, there may be differences among the drag force of actuating
the inner tube against the outer tube results in variation in
device clamp force. Additionally, the pivot location of the clamp
arm on the outer tube causes a sharp angular closure, and magnifies
the impact to a non-uniform closure profile. Furthermore, the
predicate device mechanism may be sensitive to variation in
components, as the stackup links the inner and outer tube at the
location of the insulated pin, which currently sits near the
proximal end of the tube assembly.
[0283] One embodiment of an ultrasonic device comprising an
alternate closure mechanism is described hereinbelow in connection
with FIGS. 60-62. In one embodiment, the ultrasonic device
comprises a vibrating blade with a through hole at distal node, an
actuator mechanism, an outer tube with cam surfaces at a distal
end, and a clamp arm. In another embodiment, the clamp arm is
rotatedly fixed to the vibrating blade. In another embodiment, the
clamp arm is cammed open and closed (against vibrating blade)
through relative motion between the outer tube and vibrating blade.
In yet another embodiment, one or more pivots of the clamp arm are
positioned at a distal node of the vibrating blade. An illustrative
example is discussed hereinbelow.
[0284] FIG. 60 is a perspective view of one embodiment of an end
effector assembly 4400 comprising a medical forceps having a
movable jaw member 4402 and an ultrasonic blade 4404 where the
movable jaw member is rotatably attached to a distal node 4406. The
outer tube 4412 is shown transparent to show the ultrasonic
waveguide 4414 located therein. FIG. 61 is a side view of the end
effector assembly 4400 shown in FIG. 60 with the movable jaw member
4402 in an open position and shown transparent to show outer tube
cam slots 4408, 4410 to rotate the movable jaw member 4402 upon
relative motion between the blade 4404 and the outer tube 4412.
FIG. 62 illustrates one embodiment of the end effector assembly
4400 showing the movable jaw member 4402 pivot 4416.
[0285] With reference now to FIGS. 60-62, in one embodiment, the
movable jaw member 4402 (e.g., clamp arm) is rotatably anchored
directly to the blade 4404. The anchoring is accomplished through
eliminating the inner tube and attaching the movable jaw member
4402 at the most distal node 4406 of the blade 4404 so as not to
interfere with the acoustical train of the device. The attachment
may be made through the use of a through hole and insulated pin
4416 attached to the movable jaw member 4402, although other
attachment means may be used and are contemplated, such as, for
example, pins, screws, snap fits, overmolds or the like.
Additionally, the outer tube 4412 contains a cam surface, which
locates a second pin 4418 attached to the movable jaw member 4402
such that the movable jaw member 4402 rotates about the pivot at
pin 4416 in the blade 4404 when there is relative motion between
the blade 4404 and the outer tube 4412. Furthermore, additional
geometries for the cam surface are contemplated, such as splines,
curves, and the like. As shown in the embodiment of FIG. 62, the
pivot location at pin 4416 is positioned in a more proximal
location than current devices. The benefits of anchoring the
movable jaw member 4402 to the blade 4404 at the distal node 4406
allows for a more parallel closure along the active portion 4420 of
the blade 4404, ultimately creating a more uniform pressure
profile. In one embodiment, the configuration described in
connection with FIGS. 60-62 operates at lower temperatures and can
eliminate the need for a polyimide clamp arm pad within the movable
jaw member 4402. Although not shown in the embodiment of FIG. 62,
the outer tube 4412 may extend longitudinally along the axis of the
blade, to prevent tissue from contacting the non-active blade 4404
surface
[0286] Another embodiment of an ultrasonic device comprising an
alternate closure mechanism is described in connection with FIGS.
63-67 hereinbelow. The current closure mechanism experiences
frictional losses caused by the relative motion of the inner tube
against the outer tube and the inner tube against the blade
overmolds. These frictional losses can be attributed to decreased
tissue feedback experienced by users. In addition, the clamp force
and pressure profile associated with tube-in-tube closure may be
sensitive to component variation. More consistent sealing and
transection ability can be achieved either by tighter tolerances or
decreasing the number of components involved in closure. To address
these and other issues, in one embodiment the ultrasonic device
comprises a vibrating blade with a hole through the distal node, an
outer tube, a clamp arm, and a rigid link. In another embodiment,
the clamp arm is coupled to the vibrating blade with a rigid link
and system of revolute joints. An illustrative example is discussed
hereinbelow.
[0287] FIG. 63 is a side view of one embodiment of an end effector
assembly 4500 comprising a medical forceps having a movable jaw
member 4502 in a closed position and an ultrasonic blade 4504. The
end effector assembly 4500 comprises a linkage 4506 to open and
close the movable jaw member 4502 by employing relative motion
between the outer tube 4508 and the blade 4504. FIG. 64 is a side
view of the end effector assembly 4500 shown in FIG. 63 with the
movable jaw member 4502 in an open position. FIG. 65 is a bottom
view of the end effector assembly 4500 shown in FIG. 63 with the
movable jaw member 4502 in an open position. FIG. 66 is a
perspective view of the end effector assembly 4500 shown in FIG. 63
with the movable jaw member 4502 in an open position. FIG. 67 is a
perspective view of the end effector assembly 4500 shown in FIG. 63
with the movable jaw member 4502 in an open position.
[0288] With reference now to FIGS. 63-67, in one embodiment, the
linkage 4506 may be a four bar linkage configured to actuate the
movable jaw member 4502 (e.g., clamp arm) by utilizing relative
motion between the outer tube 4508 and the blade 4504. The inner
tube may be replaced with the rigid link 4506. The link 4506 may be
pinned to the blade 4504 through the distal node 4510, although
other fastening means are contemplated such as pins, screws, snap
fits, and the like. Locating a pin 4512 at the distal node 4510
minimizes interference to the acoustic train of the ultrasonic
device. The link 4506 is subsequently pinned to a bottom portion
4514 of the movable jaw member 4502 via pin 4516 and a second pivot
of the movable jaw member 4502 is pinned to an end of the outer
tube 4508 via pin 4518. Clamping may be achieved by displacing the
outer tube 4508 forward relative to the blade 4504 in direction
4520. The link 4506 component ensures that the distance between the
distal node 4510 and the lower pivot of the clamp arm remains
constant. The presence of the link 4506 forces the movable jaw
member 4502 to rotate as the outer tube 4508 is displaced in
direction 4520. In one embodiment, the rigid link 4506 may comprise
a small stainless steel component formed from progressive stamping,
although other materials and manufacturing processes are
contemplated, such as metal injection molding (MIM), polymers
formed from plastic injection molding, and the like. The use of a
rigid link 4506 also allows simplification of a trigger assembly.
For example, a trigger assembly for actuating the inner tube may be
removed. The use of a four bar linkage 4506 also reduces frictional
losses in the tube assembly and results in a decrease in
accumulated pressure profile variations.
[0289] Yet another embodiment of an ultrasonic device comprising an
alternate closure mechanism is described in connection with FIGS.
68-70 hereinbelow. The embodiment illustrated in FIGS. 68-70
addresses issues such as tolerance accumulation between the blade,
movable jaw member, inner tube, insulated pin, and rotation knob of
existing ultrasonic devices.
[0290] FIG. 68 is a perspective view of one embodiment of an end
effector assembly 4600 comprising a medical forceps having a
movable jaw member 4602 and an ultrasonic blade 4604 with the
movable jaw member 4602 shown in an open position. An inner tube
4608 is translated with respect to the blade 4604 to open and close
the movable jaw member 4602. FIG. 69 is a perspective view of the
inner tube 4608 with the outer tube 4606 removed. The inner tube
4608 is operatively coupled to the end effector assembly 4600 shown
in FIG. 68. FIG. 70 is a perspective view of a notch portion 4610
of the inner tube 4608 shown in FIG. 69.
[0291] With reference now to FIGS. 68-70, in one embodiment, the
inner tube 4608 is configured to translate with respect to the
blade 4604 to move the movable jaw member 4602 (e.g., clamp arm)
and to generate clamp pressure against the blade 4604. In the
embodiment illustrated in FIGS. 68-70, the movable jaw member 4602
is attached and pivots at pivot 4612 on the inner tube 4608. The
outer tube 4606 translates in direction 4614 to pivot the movable
jaw member 4602. The inner tube 4608 has a notched region 4610 as
shown in FIGS. 69 and 70, that is squeezed inwardly into notches
4616, 4618 formed in the blade 4604 that would be located at the
node location of the blade 4604. In one embodiment, the blade 4604
portion in the notched region 4610 location may be coated with a
thin layer of silicone overmold to provide tight relationship
between the inner tube 4608 and the blade 4604. such tight
relationship provides good movable jaw member 4602 clocking with
respect to the blade 4604 cutting surface 4620 (FIG. 68). As shown
in FIG. 68, in one embodiment, a clamp arm pad 4622 also may be
provided on the inside portion of the movable jaw member 4602.
[0292] FIG. 71 illustrates one embodiment of an end effector
assembly 4700 comprising a medical forceps having an end effector
with a movable jaw member 4702 in a closed position, an ultrasonic
blade 4704, and a shaft assembly 4706 configured to counteract
deflection of the blade 4704. A counter deflection element 4720 is
provided on an inner tube 4710 at one of the blade nodes 4718
proximal to the distal node to counteract deflection of the blade
4704 by the movable jaw member 4702. In one embodiment, a downward
4712 deflection of the blade 4704 by the movable jaw member 4702 is
counteracted by the downward reaction force of counter deflection
element 4720 at the node 4714 proximal to the distal node. In one
embodiment, the counter deflection element 4720 may comprise a
bulge into the inner lumen to provide downward counter force to the
clamping force. In another embodiment, a window 4708 may be cut
into the inner tube 4710 to allow a downward force to deflect the
blade 4704 without making contact with the opposing wall of the
inner tube 4710.
[0293] Any of the inner tubes and/or outer tubes disclosed herein
may be coated with a polymer used as moisture and dielectric
barriers. Among them, parylene C may be selected due to its
combination of barrier properties, cost, and other processing
advantages. Parylene is the trade name for a variety of chemical
vapor deposited poly(p-xylylene), for example. The polymer coating
is used to prevent shorting in the shaft from the blade to adjacent
metal parts. In one embodiment, the just the inner tube (e.g.,
actuator) may be coated to prevent it from shorting to the blade
which is one "pole" in the combined ultrasonic and bipolar (RF)
device, where the other "pole" is the outer tube and the clamp arm.
The inner tube insulation provides a more robust and space
efficient electrical insulating barrier than an intervening plastic
tube, which may be considered an alternative embodiment.
Transducer Support and Limited Rotation with Single Component
[0294] In one embodiment, a shaft rotation limiter comprises a
single piece which interfaces with a transducer flange by a
threaded connection. The rotation limiter provides radial support
through a component fixed in the shroud channels. The amount of
rotation is limited by the allowed lateral motion of the component
in the shroud channels as it is threaded along the transducer. One
example of a shaft rotation limiter is described in connection with
FIG. 72 hereinbelow.
[0295] FIG. 72 illustrates one embodiment of an ultrasonic
transducer 4800 having a modified flange 4802 incorporating
external threads 4804 to allow transducer rotation. In the
illustrated embodiment, the transducer flange 4802 is modified to
incorporate external threads 4804. The external threads 4804 may
mate with a component 4810 having internal threads and at least two
protruding bosses 4806, 4808. The protruding bosses 4806, 4808
engage into channels in the device shroud and limit transducer
rotation. The component 4810 with the threaded inner diameter
interfaces with the transducer 4800 by threaded connection. Since
the component 4810 is limited in transverse travel by the shroud
channels, it provides radial support. The component 4810 with the
threaded inner diameter translates rotational movement of the
transducer 4800 to a lateral motion of the component 4810. Rotation
of the blade or transducer 4800 can be provided by a fixed rotation
knob. Rotating the knob may cause the internally threaded component
4810 to translate laterally and rotation would be limited when the
component 4810 can no longer translate. The lateral movement may be
defined by the length of the channel in the shroud or the length of
the threaded flange 4802 on the transducer. The shroud allows
rotations in excess of 360.degree.. The amount of rotation of the
transducer 4800 is limited by the allowed lateral motion of the
component 4810 in the shroud channels (not shown).
Limited Rotation of Ultrasonic Device with
Rotation>360.degree.
[0296] FIG. 73 is a sectional view of an ultrasonic transducer
rotation system 4900 comprising a shroud 4902 and a gate 4904
fitted into one-half of the shroud 4902. In the illustrated
embodiment, the gate 4904 is L-shaped and has two wings 4906A,
4906B (right and left wings, respectively) extending at a fixed
angle from a central axis 4908 positioned within a portion of the
shroud 4902. One additional component, as well as modifications of
a rotation knob and the right-hand or left-hand shroud 4902, allow
for approximately 690.degree. of rotation--almost two full
rotations. The rotation knob is used by the operator to rotate the
shaft and ultrasonic transducer of the device. The additional
component is referred to herein as the gate 4904. The gate 4904 is
rotationally moveable about axis 4908 within the shroud 4902 to two
positions. The rotation knob will have an additional contoured
extrusion element that extends to make contact with the gate 4904.
Where the gate 4904 is inserted into the shroud 4902 there will be
a minimum amount of frictional contact between the shroud 4902 and
the gate 4904 to keep the gate 4904 in place while it is not in
contact with the rotation knob. The gate 4904 in the shroud 4902 is
constrained by a cylindrical hole 4912 and two bosses 4914, 4916
with a slight undercut. The axis 4908 of the gate 4904 that sits in
the cylindrical hole 4912 would be constrained in part by features
on the rotation knob. The gate 4904 can be made of a rigid metal or
a single stamped metal part or injection molded from plastic. The
gate 4904 can either snap into place in the shroud 4902 or be
ultrasonically welded or heat staked to the shroud 4902 in such a
fashion to allow free rotation of the gate 4904 about axis
4908.
[0297] FIGS. 74A-74C illustrate the dynamics of the gate/rotation
knob interaction. FIG. 74A illustrates the gate 4904 in a
left-biased position such that the rotation knob can be rotated
690.degree. clockwise until a contoured extrusion element 4910 on
the rotation knob makes contact with the right wing 4906A of the
gate 4904 so that the left wing 4906B of the gate 4904 prevents
motion by reacting statically against the shroud 4902. Thus, at the
starting point, the rotation knob contoured extrusion element 4910
is contacting the outside of the right wing 4906A of the gate 4904
and is constrained to only move in a counter-clockwise
direction.
[0298] FIG. 74B illustrates the rotation knob rotated back 360
degrees until it rotates the right wing 4906A of the gate 4904 into
a right-biased position. Upon full 360.degree. rotation the
rotation knob extrusion 4910 contacts the inside of the right wing
4906A of the gate 4904, rotating the gate 4904 to the right as the
knob rotates around.
[0299] FIG. 74C illustrates the rotation knob after it rotates the
right wing 4906A of the gate 4904 into a right-biased position.
Subsequently, the rotation knob can be rotated an additional
330.degree. until the contoured extrusion element 4910 of the
rotation knob contacts the left wing 4906B of the gate 4904 and the
right wing 4906A of the gate 4904 prevents motion by reacting
statically against the shroud 4902. After 690.degree. of rotation
the rotation knob contacts the outside of the left wing 4906B of
the gate 4904. The right wing 4906A of the gate 4904 is contacting
the shroud 4902 and is therefore stopping further rotation of the
rotation knob in the counterclockwise direction. This process can
be reversed to spin the rotation knob clockwise back to its
starting position.
[0300] FIG. 75 is a sectional view of an ultrasonic transducer
rotation system 4920 comprising a shroud 4922 and a gate 4924
fitted into one-half of the shroud 4922, where the rotation system
includes a semi-compliant element. In the illustrated embodiment,
the gate 4924 is L-shaped and has two wings 4926A, 4926B (right and
left wings, respectively) extending at a fixed angle from a central
axis 4928 positioned within a portion of the shroud 4922. One
additional component, as well as modifications of a rotation knob
and the right-hand or left-hand shroud 4922, allow for
approximately 690.degree. of rotation--almost two full rotations.
The rotation knob is used by the operator to rotate the device
shaft and ultrasonic transducer. The additional component is
referred to herein as the gate 4924. The gate 4924 is rotationally
moveable about axis 4928 within the shroud 4922 to two positions.
The rotation knob will have an additional contoured extrusion
element that extends to make contact with the gate 4924. Where the
gate 4924 is inserted into the shroud 4922 there will be a minimum
amount of frictional contact between the shroud 4922 and the gate
4924 to keep the gate 4924 in place while it is not in contact with
the rotation knob. The gate 4924 in the shroud 4922 is constrained
by a cylindrical hole 4932 and two bosses 4934, 4936 with a slight
undercut. The axis 4928 of the gate 4924 that sits in the
cylindrical hole 4932 would be constrained in part by features on
the rotation knob. The gate 4924 can be made of a rigid metal or
injection molded from plastic. The gate 4924 can either snap into
place in the shroud 4922 or be ultrasonically welded or heat staked
to the shroud 4922 in such a fashion to allow free rotation of gate
4924 about axis 4928.
[0301] Unlimited (continuous) rotation of an ultrasonic shear
device with an integrated transducer requires the use of additional
components that may not be cost-effective. One cost-effective
solution is to limit rotation of the shaft of the device, thus
allowing for a direct-wired connection between the transducer and
the hand activation circuit. A tactile benefit is added to the
mechanism that would limit rotation but provide tactile feedback
before a hard stop is hit. This tactile feedback element may enable
the user to change the way they use the device, either through
rotating their wrist to get additional rotation or to choose to
rotate the device back to a neutral position to ensure they have
enough rotation to accomplish the task they need to perform.
[0302] FIGS. 112A and 112B illustrate one embodiment of an
unlimited rotation connection for an integrated transducer 6216. An
unlimited rotation connection may be provided by the ultrasonic
transducer rotation system 6220. The ultrasonic transducer rotation
system 6220 may comprise, for example, a male plug 6222 and a
female receptacle 6224. The male plug 6222 may be configured to
freely rotate within the female receptacle 6224 while maintaining
an electrical connection between the ultrasonic transducer 6216
and, for example, power system 6248. For example, in one
embodiment, the male plug 6222 and the female receptacle 6224 may
comprise a stereo plug and jack. FIG. 112A illustrates the male
plug 6222 and the female receptacle 6224 in an uncoupled, or
unmated, position. FIG. 1128 illustrates the male plug 6222 and the
female receptacle 6224 in a coupled, or mated, position. In the
mated position, the male plug 6222 is able to freely rotate within
the female receptacle while maintaining an electrical connection
between the male plug 6222 and the female receptacle 6224.
[0303] FIGS. 113A-113C illustrate one embodiment of an unlimited
rotation connection 6520. The unlimited rotation connection 6520
comprises a male plug 6522 and a female receptacle 6524. The male
plug 6522 may comprise a plurality of electrodes 6526a-d coupled to
an insulating tube 6528. The male plug 6522 may be coupled to a
shaft/transducer assembly and may rotate in unison with the
shaft/transducer assembly. In some embodiments, the first and
second electrodes 6526a-6526b may be coupled to the transducer. In
some embodiments, the third and fourth electrodes 6526c-6526d may
be coupled to bipolar electrodes located at an end effector. In
some embodiments, such as a monopolar electrode arrangement, the
fourth electrode 6526d may be omitted. The plurality of electrodes
6526 may each be coupled to a wire 6530a-6530d. The female
receptacle 6524 may comprise a plurality of helical contacts
6532a-6532d. The plurality of helical contacts 6532a-6532d may be
positioned such that each of the helical contacts 6532a-6532d is
electrically coupled to a corresponding electrode 6526a-6526d on
the male plug 6522 when the male plug 6522 is inserted into the
female receptacle 6524. FIG. 113B illustrates a cross-sectional
view of the female receptacle 6524 take along line B-B. The female
receptacle 6524 comprises a individual helical contacts 6532a-6532d
separated by insulators 6534a-6534c. FIG. 113C illustrates the
individual helical contact profile of a helical contact 6532a. The
helical contact 6532a may comprise a first metal plate 6536a and a
second metal plate 6536b. A plurality of twisted wires 6538 may be
spirally twisted to assure contact between the male plug 6522 and
the metal plates 6536a, 6536b. In some embodiments, the direction
of the spiral may be alternated to provide increased connectivity
in all directions of rotation. The twisted wires 6538 may comprise
a hyperbolic shape.
[0304] The tactile feedback element is added to the limited
rotation mechanism shown in FIGS. 73-74C, which includes on the
rotation knob an additional contoured extrusion element 4930 that
extends to make contact with the gate 4924 (the mechanism that
limits rotation). In the embodiment illustrated in FIGS. 75-76C, a
contoured extrusion element 4930 (FIGS. 76A-76C) located on the
rotation knob can be made of a semi-compliant material.
Alternatively, portions of contoured extrusion element 4930
indicated by elements 4938, may be comprised of a semi-compliant
material. The semi-compliant material could be made of rubber,
medium to high density rubber, silicone, thermoplastic elastomers,
springy piece of stainless steel, spring steel, copper, shape
memory metals, and the like. Any of these materials can be insert
molded or mechanically connected to the rotation knob.
[0305] The purpose of the contoured extrusion element 4930 (FIGS.
76A-76C) on the rotation knob is to contact the gate 4924 to
provide the motion needed for the gate 4924 to function. Adding
compliance to the contoured extrusion element 4930 rotation knob
feature enables the user to feel that they are approaching the hard
stop a few degrees of rotation before the hard stop is contacted.
This feedback may enable the user to change the way they use the
device, either through rotating their wrist to get additional
rotation or to choose to rotate the device back to a neutral
position to ensure they have enough rotation to accomplish the task
they need to perform.
[0306] FIGS. 76A-76C illustrate the dynamics of the gate
interaction with a rotation knob, where the rotation knob comprises
a tactile feedback element. FIG. 76A illustrates the gate 4924 in a
left-biased position such that the rotation knob can be rotated
690.degree. clockwise until a contoured extrusion element 4930 on
the rotation knob makes contact with the right wing 4906A of the
gate 4924 so that the left wing 4926B of the gate 4924 prevents
motion by reacting statically against the shroud 4922. Thus, at the
starting point, the rotation knob contoured extrusion element 4930
is contacting the outside of the right wing 4926A of the gate 4924
and is constrained to only move in a counter-clockwise direction. A
layer of (insert-molded) semi-compliant material 4938 may be
located on either side or both sides of the contoured extrusion
element 4930. The semi-compliant material 4938 could be made of
rubber, medium to high density rubber, silicone, thermoplastic
elastomers, springy piece of stainless steel, spring steel, copper,
shape memory metals, and the like. Any of these semi-compliant
materials 4938 can be insert molded or mechanically connected to
the rotation knob.
[0307] FIG. 76B illustrates the rotation knob rotated back 360
degrees until it knocks the right wing 4926A of the gate 4924 into
a right-biased position. Upon full 360.degree. rotation the
contoured extrusion element 4930 of the rotation knob contacts the
inside of the right wing 4926A of the gate 4924, rotating the gate
4924 to the right as the knob rotates around. The semi-compliant
material 4938 provides tactile feedback to the user.
[0308] FIG. 76C illustrates the rotation knob after it rotates the
right wing 4926A of the gate 4924 into a right-biased position.
Subsequently, the rotation knob can be rotated an additional
330.degree. until the contoured extrusion element 4930 of the
rotation knob contacts the left wing 4926B of the gate 4924 and the
right wing 4926A of the gate 4924 prevents motion by reacting
statically against the shroud 4922. After 690.degree. of rotation
the rotation knob contacts the outside of the left wing 4926B of
the gate 4924. The right wing 4926A of the gate 4924 is contacting
the shroud 4922 and is therefore stopping further rotation of the
rotation knob in the counterclockwise direction. This process can
be reversed to spin the rotation knob clockwise back to its
starting position. The semi-compliant material 4938 provides
tactile feedback to the user. The semi-compliant material 4938
tactile feedback element mat enable the user to change the way they
use the device, either through rotating their wrist to get
additional rotation or to choose to rotate the device back to a
neutral position to ensure they have enough rotation to accomplish
the task they need to perform.
RF Spot Coagulation with Integrated Ultrasonic/RF Generator
[0309] FIG. 77 illustrates an integrated RF/ultrasonic instrument
5000 electrically connected such that an ultrasonic blade/horn 5002
is electrically connected to a positive lead 5006 of an ultrasonic
generator 5004 and is also coupled to an RF generator to provide
spot coagulation by applying RF energy to tissue 5018. The
integrated RF/ultrasonic instrument 5000 enables the touch up of
diffuse bleeding (capillary bleeding, cut site oozing) without the
need for ultrasonic coupling pressure. Further, the coupling
pressure needed for ultrasonic instruments, to couple the blade to
tissue such that friction-based tissue effect is effective, is
relatively high which results in (1) difficulty in applying enough
pressure to generate hemostatic effect in loosely supported (i.e.,
un-clamped) tissue or (2) coupling pressure that generates too much
tissue disruption that, in many cases, makes the diffuse bleeding
worse.
[0310] In one embodiment, the integrated RF/ultrasonic instrument
5000 is wired such that the horn/blade 5002 is directly connected
to the positive lead 5006 of the generator 5004. Conventional
ultrasonic devices are wired such that the negative/return lead is
connected to the horn/blade. A switch 5010 is provided to enable
two device functionalities (1) ultrasonic and (2) bipolar (RF) to
be performed. The first state of the switch 5010 connects the
negative/return lead 5008 to the piezoelectric transducer (PZT)
stack 5020 such that the generator 5004 drives the PZT stack 5020.
The second state of the switch 5010 isolates the PZT stack 5020 and
connects the negative/return 5008 to the device tube 5016 and a
movable jaw member 5022 (e.g., clamp arm) through an electrical
conductor 5014 and allows the generator 5004 signal to be driven
through tissue 5018 located between the blade 5002 and the clamp
arm 5022. The resistance in the tissue 5018 seals the vessels.
Feedback signals also may be provided back to the generator 5004 to
adjust signal parameters (e.g., amplitude, frequency, pulsing,
modulation, etc.)
[0311] In one embodiment, the integrated RF/ultrasonic instrument
5000 may comprise a sealing button, wherein, when pressed, the
generator 5004 may produce bipolar RF energy through the handpiece
and into the ultrasonic blade 5002 and return through the clamp arm
5022. In one embodiment, the electrical RF current may travel
around the outside of the blade 5002 and create a robust bi-polar
seal. The duration of the bipolar RF energy may be about one
second, after which an algorithm may cause the generator 5004 to
switch to the ultrasonic power curve, wherein the blade 5002 would
be activated and the cut completed in the middle of two RF
seals.
[0312] Ultrasonic cutting also may provide some sealing. The
application of RF energy provides added confidence that there is an
RF seal in place on each side of the blade 5002.
[0313] In one embodiment, the RF/ultrasonic device comprises a
blade or clamp arm or both with the distal end coated with
thermally and electrically insulative material, wherein a distal
end of the blade or clamp arm or both may have varying degrees of
exposed (uncoated) areas that will be application dependent. In
another embodiment, the exposed area on the blade or clamp arm or
both may vary depending on application and may be either
symmetrical or asymmetrical. In another embodiment, the exposed
area on the blade may comprise at least one exposed area/segment
separated by at least one coated segment. In one embodiment, a
process of masking the blade or clamp arm or both to generate
exposed area is provided. Alternatively, coating may be selectively
removed to produce the same desired effect. Specific embodiments of
such coated blades are described hereinbelow in connection with
FIGS. 80-95.
[0314] FIG. 78 illustrates one embodiment of an integrated
RF/ultrasonic instrument 5030 electrically connected to an energy
source such as a generator 5032 comprising four-lead jack connector
5046 is mated with a slidable female mating plug 5048. FIG. 79 is a
detail view of the four-lead jack connector 5046 mated with a
slidable female mating plug 5048 coupled to an ultrasonic
transducer 5034. With reference to FIGS. 78-79, in one embodiment,
the generator 5032 may comprise a first ultrasonic energy source
such as ultrasonic generator 5040 and a second RF energy source
such as an RF generator 5044 either individually or integrated into
the same housing. An ultrasonic transducer 5034 is electrically
connected to positive and negative leads 5036 (H+), 5038 (H-) of
the ultrasonic generator 5040. A monopolar positive lead 5042 (M+)
is coupled to the RF generator 5044. A four-lead jack connector
5046 is mated with a slidable female mating plug 5048 to
electrically engage either 1) connection of the ultrasonic
generator 5040 leads 5036, 5038 to the ultrasonic transducer 5034
or 2) connection of the monopolar RF generator 5044 lead 5042 to
the transducer 5034 to prevent connecting both the ultrasonic
generator 5040 and the monopolar RF generator 5044 to the
transducer 5034 at the same time. In one embodiment, the female
connector may be integrated in the device and the four lead jack
may be mated to a generator.
[0315] A slidable switch 5074 comprises a slidable female connector
5048 configured to receive a rotatable jack connector 5046. The
rotatable jack connector 5046 is used for mating with the slidable
female connector 5048 for providing an electrical connection
between two electrical devices, such as the transducer 5034 and the
generator 5032. Referring particularly to FIG. 79, the rotatable
jack connector 5046 comprises a tip terminal portion 5064 at a
front end thereof, a ground terminal portion 5052 at a rear end
thereof and two intermediate terminal portions 5056, 5060 to the
tip and ground terminal portions 5064, 5052. The terminal portions
5052, 5056, 5060, 5064 are electrically separated from each other
by dielectric insulators 5054. The ground terminal portion 5052
connects with a connecting portion of 5046. Since the structure of
the rotatable mating plug 5046 is well known by those skilled in
the art, detailed description thereof is omitted here. Conductive
terminal portions 1, 2, 3, 4 are electrically connected to terminal
portions 5052, 5056, 5060, 5064. Conductive terminal portions 1 and
2 connected to terminal portions 5052, 5056 and are isolated and
are not coupled to the transducer 5034. Conductive terminal
portions 3 and 4 are electrically connected to terminal portions
5060, 5064 and are electrically connected to the transducer
5034.
[0316] In one embodiment, the slidable female connector 5048 is
slidable between Position 1 and Position 2. Position 1 may be
configured to correspond with ultrasonic mode of operation and
Position 2 may be configured to correspond with monopolar mode of
operation. In Position 1, the monopolar RF lead 5042 (M+) from the
monopolar RF generator 5044 is disconnected physically from the
transducer 5034. The slidable female connector 5048 comprises
contact portions 5066, 5068, 5070, 5072 configured to electrically
engage terminal portions 5052, 5056, 5060, 5064. The slidable
female connector 5048 includes an actuator portion 5074 that
enables the user to slide the slidable female connector 5048
between multiple positions. As shown in particular in FIG. 79, the
slidable female connector 5048 is slidably movable between Position
1 and Position 2, ultrasonic and monopolar RF modes.
[0317] Moving the slidable female connector 5048 into Position 1
places the integrated RF/ultrasonic instrument 5030 in ultrasonic
mode. In this position, the contact portions 5066, 5068 are
electrically engaged with terminal portions 5060, 5064 thereby
electrically coupling positive and negative leads 5036 (H+), 5038
(H-) of the ultrasonic generator 5040 to the transducer 5034
through conductive terminal portions 3 and 4. In position 1, the
monopolar positive lead 5042 (M+) coupled to the RF generator 5044
is physically disconnected from the transducer 5034.
[0318] Moving the slidable female connector 5048 into Position 2
places the integrated RF/ultrasonic instrument 5030 in monopolar RF
mode. In this position, the contact portions 5066, 5068 are
electrically engaged with terminal portions 5052, 5056 thereby
electrically coupling positive and negative leads 5036 (H+), 5038
(H-) of the ultrasonic generator 5040 to isolated conductive
terminal portions 1 and 2, effectively disconnecting the ultrasonic
generator 5040 from the transducer 5034. In position 2, contact
portion 5070 electrically engages terminal portion 5060 thereby
electrically coupling the monopolar positive lead 5042 (M+) of the
RF generator 5044 to the transducer 5034 through conductive
terminal portion 3. Contact portion 5072 electrically engages
terminal tip portion 5064, which is electrically isolated, or
open.
[0319] FIGS. 114A and 114B illustrate one embodiment of an
integrated RF/ultrasonic surgical instrument, for example, the
integrated RF/ultrasonic surgical instrument 5030, comprising an
integrated RF/ultrasonic end effector 6304. The integrated
RF/ultrasonic end effector 6304 may be configured to deliver RF
energy and/or ultrasonic energy to a tissue section. FIG. 114A
illustrates a clamping arm 6364 in an open position. An ultrasonic
blade 6366 is positioned such that the clamping arm 6364 and the
ultrasonic blade 6366 may clamp tissue therebetween. The ultrasonic
blade 6366 is positioned within a heat shield 6322. FIG. 114B
illustrates the integrated RF/ultrasonic end effector 6304 in a
clamped position.
[0320] FIGS. 115A-115I illustrate various embodiments of a
cross-section of the integrated RF/ultrasonic end effector 6304
taken along line A-A. As can be seen in FIGS. 115A-115I, RF
electrodes 6370, 6372 may be located on and/or comprise any
suitable portion of the integrated RF/ultrasonic end effector 6304.
FIGS. 115A-115F illustrates various embodiments of the integrated
RF/ultrasonic end effector 6304 comprising a bipolar electrode
arrangement. For example, FIG. 115A illustrates one embodiment of
the integrated RF/ultrasonic end effector 6304a. Positive
electrodes 6370a, 6372b may be located on the tissue-facing portion
of the clamp pad 6368. The clamp arm 6364a may comprise a return,
or negative, electrode. FIG. 1158 illustrates one embodiment of the
integrated RF/ultrasonic end effector 6304b. The positive
electrodes 6370b, 6372b are located on the heat shield 6322. An
insulator 6374 may be located between the positive electrodes
6370a, 6370b and the heat shield 6322 to insulate heat shield 6322.
The clamp arm 6364 may function as the return electrode. FIG. 115C
is similar to FIG. 115A, with the exception that the clamp arm
6364c extends laterally beyond the insulting clamp pad 6368c. FIG.
115D is similar to FIG. 1158, with the exception that the clamp arm
6364d extends laterally beyond the insulating clamp pad 6368d. In
FIG. 115E, the clamp pad 6368e comprises a positive electrode 6370e
and a negative electrode 6372e. In FIG. 115F, the heat shield 6322f
comprises the positive electrode 6370f and the negative electrode
6372f.
[0321] FIGS. 115G-115I illustrate various embodiments of the
integrated RF/ultrasonic end effector 6304 comprising a monopolar
electrode. In FIG. 115G, the ultrasonic blade 6366g comprises a
monopolar electrode for delivering RF energy to a tissue section.
In FIG. 115H, the clamp arm 6364h comprises the monopolar
electrode. In FIG. 115I, the heat shield 6322i comprises the
monopolar electrode.
[0322] FIGS. 117-118 illustrate one embodiment of an integrated
RF/ultrasonic surgical instrument 6602. The integrated
RF/ultrasonic instrument 6602 may comprise an insulated shaft 6614.
The shaft 6614 and end effector 6604, including the jaw 6664 and
ultrasonic blade 6666, may be energized with monopolar RF energy.
The monopolar RF energy may be controlled by a double pole double
throw (DPDT) selector switch 6620 located, for example, on the
handle 6612 of the integrated RF/ultrasonic instrument 6602. The
DPDT selector switch 6628 may switch the integrated RF/ultrasonic
instrument 6602 from an ultrasonic generator 6620 to a monopolar RF
generator 6622. FIG. 118 illustrates one embodiment of a DPDT
selector switch 6628 which may be configured to switch between the
ultrasonic generator 6620 and the monopolar RF generator 6622. The
DPDT selector switch 6628 may comprise a user toggle 6630.
Coated Ultrasonic/RF Blades
[0323] FIGS. 80-83 illustrate various views of an ultrasonic blade
5100 coated with an electrically insulative material 5102 to
provide thermal insulation at the tissue contact area to minimize
adhesion of tissue to the blade 5100. Conventional ultrasonic
devices utilize one mode of treatment, which limits versatility.
For example, conventional ultrasonic devices may be used for blood
vessel sealing and transecting tissue. Bipolar RF may offer added
benefits such as a method for spot coagulation and pretreatment of
tissue. Incorporating ultrasonic and RF may provide versatility and
increase effectiveness. However, conventional ultrasonic devices
utilize coatings to provide insulation at the distal end of the
blade. These coatings are electrically insulative, and therefore
limit current flow thus decreasing RF effectiveness. Additionally,
current density may influence effectiveness. It may be contemplated
that the entire waveguide of the blade may be coated with such
coating to prevent shorting of the blade to the tube assembly
return path. It is also contemplated that a similar coating and
masking procedure may be employed in the clamp arm in order to
provide a suitable path for current flow. In order to incorporate
both energy modes into one device, a masking process for blade tip
coating or coating removal process may be required. Creating an
exposed area on the surface of the blade may provide a suitable
path for current flow.
[0324] Accordingly, in one embodiment, an ultrasonic blade 5100
comprises a lubricious coating 5102 having properties similar to
Teflon on the distal end of the blade 5100 as shown in FIGS. 80-83.
The use of RF as a mode of treatment requires current to flow from
the blade 5100, through tissue, and to a movable jaw member
generally referred to as a clamp arm. The coating 5102 is used to
provide thermal insulation at the contact area and minimize
adhesion of tissue to blade 5100. However, the coating 5102 also is
electrically insulative, which limits the amount of current flow. A
method of masking the blade 5100 or removing coating selectively
may be used to create exposed surfaces. In other embodiments, the
lubricious coating 5102 provided on the blade 5100 may extend
proximally so as to could coat the whole blade 5100, for example.
In one embodiment, the blade 5100 may be coated back to the distal
node.
[0325] FIGS. 84-93 illustrate various ultrasonic blades partially
coated with an electrically insulative material to provide thermal
and electrical insulation at the tissue contact area to minimize
adhesion of tissue to the blade, where the lighter shade regions
5202 of the blade represent the coated portions and the darker
shaded regions 5204 of the blade represent exposed surfaces that
enable RF current to flow from the exposed region of the blade,
through the tissue, and the movable jaw member. The exposed surface
is symmetrical. The area on the blade that requires and exposed
surface may be application dependent. Therefore, a different
percentage of coating/exposed area has been illustrated is FIGS.
84-93. However, the embodiments are not limited to only the
illustrated coverage. Although the embodiments shown in connection
with FIGS. 84-93 show height-wise variation in electrically
insulative blade coating, the lighter shaded regions 5202, it is
contemplated within the scope of the present disclosure lengthwise
variation in electrically insulative blade coating, the lighter
shaded regions 5202, such that a portion of the distal tip of the
blade exposed. In one example, the distal 1/3 of the sides of the
blade would be exposed.
[0326] FIGS. 94-95 illustrate two ultrasonic blades with
non-symmetrical exposed surfaces, where the blades are coated with
an electrically insulative material to provide thermal insulation
at the tissue contact area to minimize adhesion of tissue to the
blade, where the lighter shade regions 5302 of the blade represent
the coated portions and the darker shaded regions 5304 of the blade
represent exposed surfaces that enable RF current to flow from the
exposed region of the blade, through the tissue, and the movable
jaw member. Current density may impact functionality and may be
controlled by providing different surface areas. The surface areas
do not have to be symmetrical on each side of the blade tip and may
differ depending on performance. In addition, the exposed area may
consist of two or more segments that are separated by at least one
coated segment (not illustrated). Other coated/exposed geometries
are possible as well, such as varying the depth or width of the
exposed area along the axis of the blade.
[0327] In another embodiment, the blade and/or the tube assembly
may be electrically charged to repel surgical matter.
[0328] FIGS. 119A-119E illustrate various embodiments of integrated
RF/ultrasonic surgical end effectors. The clamp arm may comprise,
for example, a circular clamp arm 6764a, 6764b, a hook clamp arm
6764c, a circular clamp arm comprising a cavity 6764d, or a curved
hook clamp arm 6764e. The ultrasonic blade may comprise, for
example, a rectangular ultrasonic blade 6766a, 6766c and/or an
elliptical ultrasonic blade 6766b. FIGS. 120A-120C illustrate
various embodiments of bipolar integrated RF/ultrasonic end
effectors. In one embodiment, the clamp arm 6864a may comprise
first electrode and the ultrasonic blade 6866a may comprise a
second electrode. The clamp arm 6864a or the ultrasonic blade 6866a
may comprise a return electrode. In some embodiments, the clamp arm
6864b may comprise an insulating pad 6868 to separate the clamp arm
6864b from the ultrasonic blade 6866b. In some embodiments, the
clamp arm 6864c may comprise both a first electrode 6870 and a
second electrode 6872. The first and second electrodes 6870, 6872
may be separated by an insulating portion of the clamp arm
6864c.
[0329] FIGS. 121A-121C comprise various embodiment of monopolar
integrated RF/ultrasonic end effectors. In some embodiments, the
entire clamp arm 6964a may comprise a monopolar electrode. In some
embodiments, the clamp arm 6964b may comprise an insulating pad
6968. A portion of the clamp arm 6964b may comprise a monopolar
electrode. In some embodiments, the clamp arm 6964c and an
ultrasonic blade 6966 may comprise a single monopolar
electrode.
Heat Shielded Ultrasonic Blades
[0330] FIG. 96 is a perspective view of one embodiment of an
ultrasonic end effector 5400 comprising a metal heat shield 5402.
The ultrasonic end effector 5400 comprises a clamp arm 5410. The
clamp arm 5410 comprises a movable jaw member 5408 (clamp arm), a
tissue pad 5412, an ultrasonic blade 5404, and a heat shield 5402
provided at a distance from the ultrasonic blade 5404. The heat
shield 5402 is metal and contains apertures 5406 for air flow which
provides cooling to the heat shield 5402 and the ultrasonic blade
5404. The heat shield 5402 is disposed opposite of the movable jaw
member 5408.
[0331] FIG. 97 is a perspective view of another embodiment of an
ultrasonic end effector 5420 comprising a retractable metal heat
shield 5422. The ultrasonic end effector 5420 comprises a clamp arm
5430. The clamp arm 5430 comprises a movable jaw member 5428, a
tissue pad 5432, an ultrasonic blade 5424, and a heat shield 5422
provided at a distance from the ultrasonic blade 5424. In another
embodiment, the metal heat shield 5422 is attachable to the
ultrasonic blade 5424 at the distal most node location. The
attachment means also acts as a heat sink 5422 to remove heat from
the blade 5424. The heat shield 5422 is metal and contains
apertures 5426 for air flow which provides cooling to the heat
shield 5422 and the ultrasonic blade 5424. The heat shield 5422 is
disposed opposite of the movable jaw member 5428.
[0332] FIG. 98 is a side view of another embodiment of an
ultrasonic end effector 5440 comprising a heat shield 5444 shown in
cross-section. The ultrasonic end effector 5440 comprises a clamp
arm 5448. The clamp arm 5448 comprises a movable jaw member 5252,
an ultrasonic blade 5450, and a heat shield 5444 that also acts as
a heat sink 5442. A pad 5452 may be provided on the blade 5450 side
of the movable jaw member 5252 to grasp tissue between the pad 5452
and the blade 5450. The attachment of the heat shield 5444/heat
sink 5442 is at a node location. FIG. 99 is a front view of the
ultrasonic end effector 5440 shown in FIG. 98, according to one
embodiment.
[0333] FIGS. 100-104 illustrate various views of one embodiment of
an ultrasonic end effector 5460 comprising a dual purpose rotatable
heat shield 5462. FIG. 100 illustrates one embodiment of a clamp
arm 5464 comprising a movable jaw member 5464 shown in a closed
position and a dual purpose rotatable heat shield 5462 located
below an ultrasonic blade 5468. The ultrasonic end effector 5460
comprises a clamp arm 5464 having a movable jaw member 5470, an
ultrasonic blade 5468, and the dual purpose rotatable heat shield
5462. In one embodiment, the clamp arm 5464 comprises a movable jaw
member 5470, which is shown in FIG. 100 in a closed position, and
the rotatable heat shield 5462 is located below the ultrasonic
blade 5468. In this embodiment, the heat shield 5462 is dual
purposed and is rotatable about the blade 5468. The blade 5468 in
this example is a straight/non-curved configuration. While the heat
shield 5468 is disposed opposite of the movable jaw member 5470
(shears type end-effector), it acts as a heat shield 5462. After
rotation about the blade 5468, the heat shield 5462 now is disposed
between the blade 5468 and the movable jaw member 5470 providing a
tissue clamping surface, backed by the blade 5468 providing
strength/support for the heat shield 5468. Also, the heat shield
5468 may be configured to provide energy opposite of the energy
that may be provided on the movable jaw member 5470 creating a
bi-polar energy that may effect tissue.
[0334] FIG. 101 illustrates one embodiment of a movable jaw member
5470 shown in an open position and a dual purpose rotatable heat
shield 5462 rotated such that it is interposed between the movable
jaw member 5470 and the blade 5468.
[0335] FIG. 102 illustrates an end view of one embodiment of a dual
purpose rotatable heat shield 5462 rotated in a first position.
FIG. 103 illustrates an end view of one embodiment of the dual
purpose rotatable heat shield 5462 rotated in a second position.
With reference now to FIGS. 102-103, the rotatable heat shield 5462
has purposeful alignment that enables a tapered portion of the
shield 5642 to come in between the top of the blade 5468 surface
and the movable jaw member 5470. This rotation enables "back
cutting" if necessary while still allowing normal activation
shielding. Additionally an inner contour of the shield 5462 may be
configured for contact to "clean" the tip upon rotation if
necessary. Further if the shield 5462 is insulated, rotation of the
shield 5462 from the stage 1 position into the stage 2 position
enables RF energy to be applied for sealing only. Bottom surface of
shield could have grip to assist in grasping as well when rotated
to position 2.
[0336] FIG. 104 is a top profile view of one embodiment of a heat
shield 5462 showing a tapered portion of the shield 5462. As shown,
in one embodiment the heat shield 5462 includes a tapered portion
defined by radius R1 relative to radius R2, where R2>R1.
[0337] FIGS. 116A-116B illustrates one embodiment of a cooling
system for an ultrasonic surgical instrument. Air 6416 may be
forced down an inner tube 6406 of the ultrasonic surgical
instrument 6302 and over an ultrasonic end effector 6404. The air
movement over the ultrasonic end effector 6304 may cool the
ultrasonic end effector 6404. In one embodiment, cold air may be
used to increase the cooling of the end effector 6404. Air 6416 may
be moved in the direction of shown to cool the ultrasonic end
effector 6404 through convection heat transfer from the ultrasonic
end effector 6404 to the air. In some embodiments, a hospital
air-line 6410 may be coupled to the ultrasonic instrument 6302 to
provide compressed air flow through the inner tube 6406. In some
embodiments, a hand pump 6412 and a reservoir 6414 may be located
in the proximal end of the surgical instrument 6402, such as, for
example, in the handle. A clinician may operate the hand pump 6412
to generate air pressure within the reservoir 6414. The hand pump
6412 may comprise, for example, a squeeze bulb. The reservoir 6414
and/or the hospital air-line 6410 may be force air over the
ultrasonic end effector 6404 with each opening and/or closing of
the jaws. In some embodiments, the reservoir 6414 and/or the
hospital air-line 6410 may provide a continuous flow of air over
the ultrasonic end effector. In some embodiments, the inner tube
6406 may comprise a vortex tub, illustrated in FIG. 116B. The
vortex tube may facilitate movement of air 6416 within the inner
tube 6406 to travel distally 6418 through the inner tube 6406, over
the ultrasonic end effector 6404, and return 6420 to the proximal
end of the inner tube 6406 which may be open to release the air.
The distal end of the vortex tube may comprise a splitter to split
the stream of air 6418 to cool the distal end of the ultrasonic end
effector 6404.
Ultrasonic 4-Bar Closure with Application to an Ultrasonic
Rongeur
[0338] FIG. 105 illustrates a conventional rongeur surgical
instrument 6000. Certain orthopedic procedures such as spinal
fusion are used to treat degenerative spinal disk disease. One of
the most commonly used instruments is the rongeur 6000 as shown in
FIG. 105 for the removal of the spinal disk, which is made up of a
nucleus and a tough annulus. The rongeur 6000 uses a 4-bar linkage
in combination with a clamp arm 6002 comprising a movable jaw
member 6004 to take bites of the spinal disk material. Generally
speaking, a number of bites (10 to 20) may be taken for complete
removal of the spinal disk. The multiple use of the rongeur 6000
can be fatiguing.
[0339] Accordingly, FIG. 106 illustrates one embodiment of an
ultrasonic energy driven rongeur device 6100. The ultrasonic energy
driven rongeur device 6100 comprises an ultrasonic transducer 6102
is added to one member of a 4-bar mechanism. The rongeur device
6100 also comprises two elongate horizontal members. As shown in
FIG. 106, only the lower horizontal member 6104 coupled to a handle
6106 is shown. The two elongate horizontal members of the
ultrasonic rongeur device 6100 are each attached to one handle 6106
of the ultrasonic rongeur device 6100. The horizontal members are
connected with a small link at a distal end 6103, and the forward
handle 6106 is the second link. These four members approach
parallel-rules. As can be seen in FIG. 106, the bottom horizontal
member 6104 is basically a straight rod which does not move. In
accordance with one embodiment of the present disclosure, by
placing pivots 6108, 6110 of the lower horizontal member 6104 at
Nodes, the lower horizontal member 6104 may be considered an
ultrasonic waveguide. Accordingly, the rest of the rongeur device
6100 is attached to the lower horizontal arm 6104 at nodes. The
proximal end of the lower horizontal member 6104 can be attached to
an ultrasonic transducer 6102 to produce ultrasonic displacement at
the distal end 6103. The amplitude of the ultrasonic displacement
will aid in cutting the tissue and therefore reduce the force
required by the surgeon. Not shown here is the need to insert some
damping material between the two horizontal members and a sheath on
the lower horizontal member 6104 to avoid contact with intervening
tissue. Advantages of the ultrasonic driven rongeur device 6100
include, without limitation, a novel closure mechanism for
ultrasonic instruments based on a 4-bar linkage, lower force
required to take a bite of spinal disk material, reduce surgeon
fatigue, and novel instrument architecture for additional
applications.
[0340] While various details have been set forth in the foregoing
description, it will be appreciated that the various aspects of the
ultrasonic and electrosurgical devices may be practiced without
these specific details. For example, for conciseness and clarity
selected aspects have been shown in block diagram form rather than
in detail. Some portions of the detailed descriptions provided
herein may be presented in terms of instructions that operate on
data that is stored in a computer memory. Such descriptions and
representations are used by those skilled in the art to describe
and convey the substance of their work to others skilled in the
art. In general, an algorithm refers to a self-consistent sequence
of steps leading to a desired result, where a "step" refers to a
manipulation of physical quantities which may, though need not
necessarily, take the form of electrical or magnetic signals
capable of being stored, transferred, combined, compared, and
otherwise manipulated. It is common usage to refer to these signals
as bits, values, elements, symbols, characters, terms, numbers, or
the like. These and similar terms may be associated with the
appropriate physical quantities and are merely convenient labels
applied to these quantities.
[0341] Unless specifically stated otherwise as apparent from the
foregoing discussion, it is appreciated that, throughout the
foregoing description, discussions using terms such as "processing"
or "computing" or "calculating" or "determining" or "displaying" or
the like, refer to the action and processes of a computer system,
or similar electronic computing device, that manipulates and
transforms data represented as physical (electronic) quantities
within the computer system's registers and memories into other data
similarly represented as physical quantities within the computer
system memories or registers or other such information storage,
transmission or display devices.
[0342] It is worthy to note that any reference to "one aspect," "an
aspect," "one embodiment," or "an embodiment" means that a
particular feature, structure, or characteristic described in
connection with the aspect is included in at least one aspect.
Thus, appearances of the phrases "in one aspect," "in an aspect,"
"in one embodiment," or "in an embodiment" in various places
throughout the specification are not necessarily all referring to
the same aspect. Furthermore, the particular features, structures
or characteristics may be combined in any suitable manner in one or
more aspects.
[0343] Some aspects may be described using the expression "coupled"
and "connected" along with their derivatives. It should be
understood that these terms are not intended as synonyms for each
other. For example, some aspects may be described using the term
"connected" to indicate that two or more elements are in direct
physical or electrical contact with each other. In another example,
some aspects may be described using the term "coupled" to indicate
that two or more elements are in direct physical or electrical
contact. The term "coupled," however, also may mean that two or
more elements are not in direct contact with each other, but yet
still co-operate or interact with each other.
[0344] Although various embodiments have been described herein,
many modifications, variations, substitutions, changes, and
equivalents to those embodiments may be implemented and will occur
to those skilled in the art. Also, where materials are disclosed
for certain components, other materials may be used. It is
therefore to be understood that the foregoing description and the
appended claims are intended to cover all such modifications and
variations as falling within the scope of the disclosed
embodiments. The following claims are intended to cover all such
modification and variations.
[0345] Some or all of the embodiments described herein may
generally comprise technologies for ultrasonic and RF treatment of
tissue, or otherwise according to technologies described herein. In
a general sense, those skilled in the art will recognize that the
various aspects described herein which can be implemented,
individually and/or collectively, by a wide range of hardware,
software, firmware, or any combination thereof can be viewed as
being composed of various types of "electrical circuitry."
Consequently, as used herein "electrical circuitry" includes, but
is not limited to, electrical circuitry having at least one
discrete electrical circuit, electrical circuitry having at least
one integrated circuit, electrical circuitry having at least one
application specific integrated circuit, electrical circuitry
forming a general purpose computing device configured by a computer
program (e.g., a general purpose computer configured by a computer
program which at least partially carries out processes and/or
devices described herein, or a microprocessor configured by a
computer program which at least partially carries out processes
and/or devices described herein), electrical circuitry forming a
memory device (e.g., forms of random access memory), and/or
electrical circuitry forming a communications device (e.g., a
modem, communications switch, or optical-electrical equipment).
Those having skill in the art will recognize that the subject
matter described herein may be implemented in an analog or digital
fashion or some combination thereof.
[0346] The foregoing detailed description has set forth various
embodiments of the devices and/or processes via the use of block
diagrams, flowcharts, and/or examples. Insofar as such block
diagrams, flowcharts, and/or examples contain one or more functions
and/or operations, it will be understood by those within the art
that each function and/or operation within such block diagrams,
flowcharts, or examples can be implemented, individually and/or
collectively, by a wide range of hardware, software, firmware, or
virtually any combination thereof. In one embodiment, several
portions of the subject matter described herein may be implemented
via Application Specific Integrated Circuits (ASICs), Field
Programmable Gate Arrays (FPGAs), digital signal processors (DSPs),
or other integrated formats. However, those skilled in the art will
recognize that some aspects of the embodiments disclosed herein, in
whole or in part, can be equivalently implemented in integrated
circuits, as one or more computer programs running on one or more
computers (e.g., as one or more programs running on one or more
computer systems), as one or more programs running on one or more
processors (e.g., as one or more programs running on one or more
microprocessors), as firmware, or as virtually any combination
thereof, and that designing the circuitry and/or writing the code
for the software and or firmware would be well within the skill of
one of skill in the art in light of this disclosure. In addition,
those skilled in the art will appreciate that the mechanisms of the
subject matter described herein are capable of being distributed as
a program product in a variety of forms, and that an illustrative
embodiment of the subject matter described herein applies
regardless of the particular type of signal bearing medium used to
actually carry out the distribution. Examples of a signal bearing
medium include, but are not limited to, the following: a recordable
type medium such as a floppy disk, a hard disk drive, a Compact
Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer
memory, etc.; and a transmission type medium such as a digital
and/or an analog communication medium (e.g., a fiber optic cable, a
waveguide, a wired communications link, a wireless communication
link (e.g., transmitter, receiver, transmission logic, reception
logic, etc.), etc.).
[0347] All of the above-mentioned U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications, non-patent publications
referred to in this specification and/or listed in any Application
Data Sheet, or any other disclosure material are incorporated
herein by reference, to the extent not inconsistent herewith. As
such, and to the extent necessary, the disclosure as explicitly set
forth herein supersedes any conflicting material incorporated
herein by reference. Any material, or portion thereof, that is said
to be incorporated by reference herein, but which conflicts with
existing definitions, statements, or other disclosure material set
forth herein will only be incorporated to the extent that no
conflict arises between that incorporated material and the existing
disclosure material.
[0348] One skilled in the art will recognize that the herein
described components (e.g., operations), devices, objects, and the
discussion accompanying them are used as examples for the sake of
conceptual clarity and that various configuration modifications are
contemplated. Consequently, as used herein, the specific exemplars
set forth and the accompanying discussion are intended to be
representative of their more general classes. In general, use of
any specific exemplar is intended to be representative of its
class, and the non-inclusion of specific components (e.g.,
operations), devices, and objects should not be taken limiting.
[0349] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations are not expressly set forth
herein for sake of clarity.
[0350] The herein described subject matter sometimes illustrates
different components contained within, or connected with, different
other components. It is to be understood that such depicted
architectures are merely exemplary, and that in fact many other
architectures may be implemented which achieve the same
functionality. In a conceptual sense, any arrangement of components
to achieve the same functionality is effectively "associated" such
that the desired functionality is achieved. Hence, any two
components herein combined to achieve a particular functionality
can be seen as "associated with" each other such that the desired
functionality is achieved, irrespective of architectures or
intermedial components. Likewise, any two components so associated
can also be viewed as being "operably connected," or "operably
coupled," to each other to achieve the desired functionality, and
any two components capable of being so associated can also be
viewed as being "operably couplable," to each other to achieve the
desired functionality. Specific examples of operably couplable
include but are not limited to physically mateable and/or
physically interacting components, and/or wirelessly interactable,
and/or wirelessly interacting components, and/or logically
interacting, and/or logically interactable components.
[0351] In some instances, one or more components may be referred to
herein as "configured to," "configurable to," "operable/operative
to," "adapted/adaptable," "able to," "conformable/conformed to,"
etc. Those skilled in the art will recognize that "configured to"
can generally encompass active-state components and/or
inactive-state components and/or standby-state components, unless
context requires otherwise.
[0352] While particular aspects of the present subject matter
described herein have been shown and described, it will be apparent
to those skilled in the art that, based upon the teachings herein,
changes and modifications may be made without departing from the
subject matter described herein and its broader aspects and,
therefore, the appended claims are to encompass within their scope
all such changes and modifications as are within the true spirit
and scope of the subject matter described herein. It will be
understood by those within the art that, in general, terms used
herein, and especially in the appended claims (e.g., bodies of the
appended claims) are generally intended as "open" terms (e.g., the
term "including" should be interpreted as "including but not
limited to," the term "having" should be interpreted as "having at
least," the term "includes" should be interpreted as "includes but
is not limited to," etc.). It will be further understood by those
within the art that if a specific number of an introduced claim
recitation is intended, such an intent will be explicitly recited
in the claim, and in the absence of such recitation no such intent
is present. For example, as an aid to understanding, the following
appended claims may contain usage of the introductory phrases "at
least one" and "one or more" to introduce claim recitations.
However, the use of such phrases should not be construed to imply
that the introduction of a claim recitation by the indefinite
articles "a" or "an" limits any particular claim containing such
introduced claim recitation to claims containing only one such
recitation, even when the same claim includes the introductory
phrases "one or more" or "at least one" and indefinite articles
such as "a" or "an" (e.g., "a" and/or "an" should typically be
interpreted to mean "at least one" or "one or more"); the same
holds true for the use of definite articles used to introduce claim
recitations.
[0353] In addition, even if a specific number of an introduced
claim recitation is explicitly recited, those skilled in the art
will recognize that such recitation should typically be interpreted
to mean at least the recited number (e.g., the bare recitation of
"two recitations," without other modifiers, typically means at
least two recitations, or two or more recitations). Furthermore, in
those instances where a convention analogous to "at least one of A,
B, and C, etc." is used, in general such a construction is intended
in the sense one having skill in the art would understand the
convention (e.g., "a system having at least one of A, B, and C"
would include but not be limited to systems that have A alone, B
alone, C alone, A and B together, A and C together, B and C
together, and/or A, B, and C together, etc.). In those instances
where a convention analogous to "at least one of A, B, or C, etc."
is used, in general such a construction is intended in the sense
one having skill in the art would understand the convention (e.g.,
"a system having at least one of A, B, or C" would include but not
be limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). It will be further understood by those within the
art that typically a disjunctive word and/or phrase presenting two
or more alternative terms, whether in the description, claims, or
drawings, should be understood to contemplate the possibilities of
including one of the terms, either of the terms, or both terms
unless context dictates otherwise. For example, the phrase "A or B"
will be typically understood to include the possibilities of "A" or
"B" or "A and B."
[0354] With respect to the appended claims, those skilled in the
art will appreciate that recited operations therein may generally
be performed in any order. Also, although various operational flows
are presented in a sequence(s), it should be understood that the
various operations may be performed in other orders than those
which are illustrated, or may be performed concurrently. Examples
of such alternate orderings may include overlapping, interleaved,
interrupted, reordered, incremental, preparatory, supplemental,
simultaneous, reverse, or other variant orderings, unless context
dictates otherwise. Furthermore, terms like "responsive to,"
"related to," or other past-tense adjectives are generally not
intended to exclude such variants, unless context dictates
otherwise.
[0355] In certain cases, use of a system or method may occur in a
territory even if components are located outside the territory. For
example, in a distributed computing context, use of a distributed
computing system may occur in a territory even though parts of the
system may be located outside of the territory (e.g., relay,
server, processor, signal-bearing medium, transmitting computer,
receiving computer, etc. located outside the territory).
[0356] A sale of a system or method may likewise occur in a
territory even if components of the system or method are located
and/or used outside the territory. Further, implementation of at
least part of a system for performing a method in one territory
does not preclude use of the system in another territory.
[0357] Although various embodiments have been described herein,
many modifications, variations, substitutions, changes, and
equivalents to those embodiments may be implemented and will occur
to those skilled in the art. Also, where materials are disclosed
for certain components, other materials may be used. It is
therefore to be understood that the foregoing description and the
appended claims are intended to cover all such modifications and
variations as falling within the scope of the disclosed
embodiments. The following claims are intended to cover all such
modification and variations.
[0358] In summary, numerous benefits have been described which
result from employing the concepts described herein. The foregoing
description of the one or more embodiments has been presented for
purposes of illustration and description. It is not intended to be
exhaustive or limiting to the precise form disclosed. Modifications
or variations are possible in light of the above teachings. The one
or more embodiments were chosen and described in order to
illustrate principles and practical application to thereby enable
one of ordinary skill in the art to utilize the various embodiments
and with various modifications as are suited to the particular use
contemplated. It is intended that the claims submitted herewith
define the overall scope.
[0359] Various aspects of the subject matter described herein are
set out in the following numbered clauses:
[0360] 1. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to an ultrasonic transducer; a tube
defining a lumen, wherein the waveguide is located within the
lumen; an end effector coupled to the distal end of the waveguide,
the end effector comprising an ultrasonic blade and a clamp arm
operatively coupled to the end effector; and a tissue accumulation
impedance mechanism coupled to the end effector, wherein the tissue
accumulation impedance mechanism is configured to prevent tissue
from accumulating within the lumen.
[0361] 2. The surgical instrument of clause 1, wherein the tissue
accumulation impedance mechanism comprises a boot barrier
configured to create a seal between the tube and the end
effector.
[0362] 3. The surgical instrument of clause 2, wherein the boot
barrier is sealed to the tube
[0363] 4. The surgical instrument of clause 2, wherein the boot is
retained by the tube or end effector using one or more retention
features.
[0364] 5. The surgical instrument of clause 2, wherein the boot
barrier is sealed to the ultrasonic blade by way of an interference
fit between the boot barrier and the ultrasonic blade.
[0365] 6. The surgical instrument of clause 2, wherein the boot
barrier comprises a cavity.
[0366] 7. The surgical instrument of clause 6, wherein the cavity
is rounded to allow fluid to flow out of the cavity.
[0367] 8. The surgical instrument of clause 2, wherein the boot
barrier comprises a plurality of contact points with the blade.
[0368] 9. The surgical instrument of claim 1, wherein the tissue
accumulation impedance mechanism comprises one or more apertures in
the tube.
[0369] 10. The surgical instrument of claim 9, wherein the
apertures comprise one or more windows.
[0370] 11. The surgical instrument of claim 9, wherein the
apertures comprises one or more holes.
[0371] 12. The surgical instrument of claim 1, wherein the tube
comprises a distal portion, wherein the distal portion comprises a
half-circle cross section.
[0372] 13. The surgical instrument of claim 1, wherein the tube
comprises one or more ribs formed on an inner side of the tube.
[0373] 14. The surgical instrument of claim 1, wherein the tissue
accumulation impedance mechanism comprises a pump configured to
provide a positive pressure flow between the blade and the tube,
wherein the positive pressure flow prevents tissue ingress into the
lumen.
[0374] 15. The surgical instrument of claim 1, wherein the pump is
located distally to a distal-most overmolded seal located within
the lumen.
[0375] 16. The surgical instrument of claim 1, wherein the tissue
accumulation impedance mechanism comprises a slidable tube disposed
within the lumen, the slidable tube slidable from a first position
to a second position, wherein in the first position the slidable
tube is disposed over the blade, and wherein in the second position
the blade is exposed.
[0376] 17. An ultrasonic surgical instrument comprising: z
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; an end effector coupled to
the distal end of the waveguide, the end effector comprising at
least one tissue retention feature; a clamp arm operatively coupled
to the end effector.
[0377] 18. The surgical instrument of claim 17, wherein the at
least one tissue retention feature comprises one or more
indentations/grooves/notches formed in the end effector.
[0378] 19. The surgical instrument of claim 18, wherein the one or
more indentations comprise triangular teeth.
[0379] 20. The surgical instrument of claim 18, wherein the one or
more indentations comprise holes.
[0380] 21. The surgical instrument of claim 18, wherein the one or
more indentations comprise horizontal trenches.
[0381] 22. The surgical instrument of claim 17, wherein the at
least one tissue retention feature is offset from the tissue
dividing crown of the end effector.
[0382] 23. The surgical instrument of claim 17, wherein the at
least on tissue retention feature comprises one or more projections
from the end effector.
[0383] 24. The surgical instrument of claim 23, wherein the one or
more projections comprise triangular teeth.
[0384] 25. The surgical instrument of claim 23, wherein the one or
more projections comprise blocks.
[0385] 26. The surgical instrument of claim 23, wherein the one or
more projections comprise horizontal bumps.
[0386] 27. The surgical instrument of claim 23, wherein the one or
more projections comprise circular bumps.
[0387] 28. The surgical instrument of claim 17, wherein the at
least one tissue retention feature is disposed over an entire
length of the blade.
[0388] 29. The surgical instrument of claim 17, wherein the at
least one tissue retention feature is disposed over a discrete
section of the blade.
[0389] 30. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; an end effector
operatively coupled to the distal end of the waveguide guide; a
rotation shroud configured to rotate the waveguide; and a rotation
stop mechanism coupled to the rotation shroud prevent rotation of
the rotation knob beyond a predetermined rotation.
[0390] 31. The surgical instrument of claim 30, wherein the shroud
comprises: at least one channel; and at least one boss, the at
least one boss located within the at least one channel, wherein the
at least one boss has a predetermined lateral movement limit,
wherein when the at least one boss reaches the predetermined
lateral movement limit, the at least one boss prevents further
rotation of the rotation knob.
[0391] 32. The surgical instrument of claim 30, wherein the
rotation stop comprises: a gate comprising a first wing and a
second wing, wherein the first and second wings are disposed at an
angle, wherein the gate is disposed within the shroud, and wherein
the gate allows a predetermined angle of rotation of the
shroud.
[0392] 33. The surgical instrument of claim 30, wherein the
rotation stop comprises a contoured extrusion element.
[0393] 34. The surgical instrument of claim 33, wherein the
contoured extrusion element comprises a tactile feedback
element.
[0394] 35. The surgical instrument of claim 34, wherein the tactile
feedback element comprises a semi-compliant material selected from
the group consisting of rubber, medium to high density rubber,
silicone, thermoplastic elastomer, springy piece of stainless
steel, spring steel, copper, shape memory metal, and combinations
of any thereof.
[0395] 36. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; an end effector coupled to
the distal end of the waveguide; a clamp arm operatively coupled to
the end effector; and a tube disposed over the waveguide, wherein
the tube comprises a counter deflection element, wherein the
counter deflection element is configured to allow deflection of the
blade, wherein the deflection of the blade counteracts a force
placed on the blade by the clamp arm when in a clamped
position.
[0396] 37. A surgical instrument comprising: a waveguide comprising
a proximal end and a distal end, wherein the proximal end is
coupled to a signal source, the signal source configured to provide
an ultrasonic signal and an electrosurgical signal; an end effector
coupled to the waveguide; a clamp arm operatively coupled to the
end effector; and a sealing button, wherein the sealing button
causes the surgical instrument to deliver the electrosurgical
signal to the end effector and the clamp arm for a first period,
and wherein the sealing button causes the surgical instrument to
deliver the ultrasonic signal to the blade for a second period,
wherein the second period is subsequent to the first period.
[0397] 38. A surgical instrument, comprising: a waveguide
comprising a proximal end and a distal end, wherein the proximal
end is coupled to a transducer; an end effector coupled to the
distal end of the waveguide; a tube disposed over the waveguide; a
cam surface formed on an outer surface of the tube; and a clamp arm
operatively coupled to the cam surface.
[0398] 39. The surgical instrument of claim 38, comprising: a pivot
pin located within a hole defined by the end effector, the pivot
pin operatively coupled to the clamp arm, wherein the clamp arm
pivots about the pivot pin.
[0399] 40. The surgical instrument of claim 39, wherein the pivot
pin is located at the distal most node of the waveguide.
[0400] 41. The surgical instrument of claim 38, wherein the tube is
actuatable, and wherein the clamp arm is cammed open and closed
against the end effector through relative motion between the tube
and the end effector.
[0401] 42. A surgical instrument, comprising: a waveguide
comprising a proximal end and a distal end, wherein the proximal
end is coupled to a transducer; an end effector coupled to the
distal end of the waveguide, the end effector defining a pin hole;
a rigid pin disposed within the pin hole; a clamp arm; and a
four-bar linkage; wherein the four-bar linkage is operatively
coupled to the clamp arm and the rigid pin, wherein the four-bar
linkage is actuatable to move the clamp arm to a clamped
position.
[0402] 43. The surgical instrument of claim 40, comprising: an
outer tube, wherein the outer tube is coupled to the four-bar
linkage, and wherein the outer-tube actuates the four-bar linkage
from a first position to a second position.
[0403] 44. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; and an end effector
coupled to the distal end of the waveguide, wherein the end
effector is partially coated with thermally and electrically
insulative material such that the distal end of the end effector
comprises one or more exposed sections.
[0404] 45. The ultrasonic surgical instrument of claim 44, wherein
the one or more exposed areas are symmetrical.
[0405] 46. The ultrasonic surgical instrument of claim 44, wherein
the one or more exposed areas are asymmetrical.
[0406] 47. The ultrasonic surgical instrument of claim 44, wherein
the one or more exposed sections are separated by one or more
coated sections.
[0407] 48. The ultrasonic surgical instrument of claim 44, wherein
the waveguide is fully coated with thermally and electrically
insulative material.
[0408] 49. The ultrasonic surgical instrument of claim 44, wherein
the waveguide is partially coated with thermally and electrically
insulative material.
[0409] 50. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; and an end effector
coupled to the distal end of the waveguide, a clamp arm operatively
connected to the end effector wherein the clamp arm is partially
coated with thermally and electrically insulative material such
that the distal end of the clamp arm comprises one or more exposed
sections.
[0410] 51. The ultrasonic surgical instrument of claim 50, wherein
the one or more exposed areas are symmetrical.
[0411] 52. The ultrasonic surgical instrument of claim 50, wherein
the one or more exposed areas are asymmetrical.
[0412] 53. The ultrasonic surgical instrument of claim 50, wherein
the one or more exposed sections are separated by one or more
coated sections.
[0413] 54. The ultrasonic surgical instrument of claim 50, wherein
the waveguide is fully coated with thermally and electrically
insulative material.
[0414] 55. The ultrasonic surgical instrument of claim 50, wherein
the waveguide is fully coated with thermally and electrically
insulative material.
[0415] 56. An ultrasonic surgical instrument, comprising: a
waveguide comprising a proximal end and a distal end, wherein the
proximal end is coupled to a transducer; and an end effector
coupled to the distal end of the waveguide, a clamp arm operatively
connected to the end effector wherein the clamp arm and the end
effector are partially coated with thermally and electrically
insulative material such that the distal end of the end effector
and clamp arm comprise one or more exposed sections.
[0416] 57. The ultrasonic surgical instrument of claim 56, wherein
the one or more exposed areas are symmetrical.
[0417] 58. The ultrasonic surgical instrument of claim 56, wherein
the one or more exposed areas are asymmetrical.
[0418] 59. The ultrasonic surgical instrument of claim 56, wherein
the one or more exposed sections are separated by one or more
coated sections.
[0419] 60. The ultrasonic surgical instrument of claim 56, wherein
the waveguide is fully coated with thermally and electrically
insulative material.
[0420] 61. The ultrasonic surgical instrument of claim 56, wherein
the waveguide is fully coated with thermally and electrically
insulative material.
[0421] 62. An ultrasonic surgical instrument, comprising:
ultrasonic end effector comprising an ultrasonic surgical blade and
a clamp arm; and a heat shield provided at a predetermined distance
from the ultrasonic blade.
[0422] 63. The ultrasonic instrument of claim 62, wherein the heat
shield is rotatable about the ultrasonic blade.
[0423] 64. The ultrasonic instrument of 62, comprising a heat
sink.
[0424] 65. The ultrasonic instrument of 62, wherein the heat shield
comprises a plurality of apertures.
[0425] 66. The ultrasonic instrument of 62, wherein the heat shield
comprises a tapered portion.
[0426] 67. An integrated radio frequency (RF)/ultrasonic surgical
instrument, comprising: an ultrasonic transducer; a jack connector
electrically coupled to the ultrasonic transducer; and a slidable
female mating plug matable with the jack connector; wherein the
slidable female mating plug is slidable in multiple positions to
electrically couple the ultrasonic transducer to either an
ultrasonic energy source or an RF energy source.
[0427] 68. The integrated radio frequency (RF)/ultrasonic surgical
instrument of claim 67, wherein the jack connector is rotatable
with the ultrasonic transducer.
[0428] 69. The integrated radio frequency (RF)/ultrasonic surgical
instrument of claim 67, wherein the jack connector is a four-lead
jack connector.
[0429] 70. The integrated radio frequency (RF)/ultrasonic surgical
instrument of claim 67, wherein the slidable female mating plug in
slidable between a first position and a second position; wherein in
the first position the ultrasonic transducer is electrically
coupled to the ultrasonic energy source and is electrically
isolated from the RF energy source; and wherein in the second
position the ultrasonic transducer is electrically coupled to the
RF energy source and is electrically isolated from the ultrasonic
energy source.
[0430] 71. An ultrasonic energy driven rongeur device, comprising:
at least one elongate member; a linkage connected to a distal end
of the at least one elongate member; an ultrasonic transducer
coupled to the at least one elongate member; and a pivot located at
an ultrasonic node of the at least one elongate member.
[0431] 72. The ultrasonic energy driven rongeur device of claim 71,
comprising: a second linkage connected to a proximal end of the at
least one elongate member; and a second pivot located at a second
ultrasonic of the at least one elongate member.
[0432] 73. The ultrasonic energy driven rongeur device of claim 71,
comprising: a second elongate member above the at least one
elongate member; and a damping material disposed between the least
one elongate member and the second elongate member.
* * * * *