U.S. patent application number 13/185218 was filed with the patent office on 2012-01-19 for methods and systems for minimally invasive endoscopic surgeries.
Invention is credited to Debra A. King.
Application Number | 20120016203 13/185218 |
Document ID | / |
Family ID | 45467466 |
Filed Date | 2012-01-19 |
United States Patent
Application |
20120016203 |
Kind Code |
A1 |
King; Debra A. |
January 19, 2012 |
METHODS AND SYSTEMS FOR MINIMALLY INVASIVE ENDOSCOPIC SURGERIES
Abstract
The present invention provides systems and methods for minimally
invasive endoscopic surgical procedures. In certain embodiments,
the minimally invasive endoscopic surgical systems comprise a
harvesting cannula having a cylindrical body sized to receive an
endoscope and having a length of about 20 cm to about 26 cm, a
bisector/bipolar device having finger grooves and/or other
ergonomic/non-slip features, and/or a suction device to clear a
visual field of the endoscope, as well as methods for using such
systems.
Inventors: |
King; Debra A.; (New York,
NY) |
Family ID: |
45467466 |
Appl. No.: |
13/185218 |
Filed: |
July 18, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61365319 |
Jul 17, 2010 |
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61420092 |
Dec 6, 2010 |
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Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 2017/1107 20130101;
A61B 2017/22067 20130101; A61B 2217/007 20130101; A61M 1/3655
20130101; A61B 17/0218 20130101; A61B 18/14 20130101; A61B
2018/00404 20130101; A61B 1/00137 20130101; A61B 17/00008 20130101;
A61B 2018/00595 20130101; A61B 17/3423 20130101; A61B 2017/320056
20130101; A61B 1/00135 20130101; A61B 2017/320044 20130101; A61B
2217/005 20130101; A61B 17/11 20130101; A61B 1/313 20130101 |
Class at
Publication: |
600/204 |
International
Class: |
A61B 1/313 20060101
A61B001/313; A61M 1/00 20060101 A61M001/00 |
Claims
1. A minimally invasive endoscopic surgical system, comprising: a
blunt tip trocar (BTT); a cannula having a handle at a proximal
end, at least one port at the proximal end, and a cylindrical body
extending from the handle to a distal end, the body having a length
of about 20 cm to about 26 cm; an endoscope; and a bisector/bipolar
device, comprising at least one blade and a cautery, and having a
handle at a proximal end, wherein the cannula is sized to receive
the endoscope, the BTT is for insertion into an incision site and
is sized to receive the cannula, and the at least one port is sized
to receive the bisector/bipolar device.
2. The system of claim 1, wherein the body of the cannula has a
length of about 23 cm.
3. The system of claim 1, wherein the handle of the
bisector/bipolar device has finger grooves.
4. The system of claim 1, wherein the handle of the
bisector/bipolar device is contoured to fit within a user's
hand.
5. The system of claim 1, wherein the handle of the
bisector/bipolar device includes a textured surface.
6. The system of claim 1, wherein the handle of the
bisector/bipolar device has a length of about 11 to about 12
cm.
7. The system of claim 1, wherein the handle of the
bisector/bipolar device has a length of about 12 cm.
8. The system of claim 1, further comprising: a suction device
having a handle at a proximal end, a valve at the proximal end for
controlling air flow, and a body extending from the handle to a
distal end, wherein the at least one port is sized to receive the
bisector/bipolar device or the suction device.
9. The system of claim 8, wherein the body of the suction device
has a length of about 29 to about 35 cm.
10. The system of claim 8, wherein the body of the suction device
has a length of about 32 cm.
11. An endoscopic suction device for use with a minimally invasive
endoscopic surgical system comprising an endoscope and a cannula
sized to receive the endoscope and having a port, the suction
device comprising: a connector for connecting to a source of
suction; a handle at a proximal end, the handle having a valve in
fluid communication with the connector to control suction to be
applied by the suction device; and an elongated body having a
proximal end coupled to the handle and a distal end, the elongated
body including a channel in fluid communication with the valve and
connector, wherein the body is sized to be received within the
port.
12. The suction device of claim 11, wherein the body is
approximately 29 to 35 cm in length.
13. The suction device of claim 12, wherein the body is
approximately 32 cm in length.
14. The suction device of claim 11, wherein the body is
approximately 43 cm in length.
15. The suction device of claim 11, wherein the handle is contoured
to fit within a user's hand.
16. The suction device of claim 11, wherein the handle includes a
textured surface.
17. The suction device of claim 11, wherein the distal end of the
body is fenestrated.
18. The suction device of claim 11, wherein the valve is adjustable
for controlling a level of suction.
19. A method of performing a surgical procedure on a patient with a
minimally invasive endoscopic surgical system, the procedure
comprising: creating an incision of about 2 cm in the patient;
introducing a blunt tip trocar (BTT) into the incision; introducing
a cannula through the BTT, the cannula having a distal end inserted
into the BTT and an opening at the distal end for CO.sub.2
insufflation; introducing an endoscope into the cannula, the
endoscope having a tip; insufflating with low pressure CO.sub.2 to
create a visual field at the tip of the endoscope; introducing a
suction device into the cannula, the suction device having a distal
end proximate the visual field; and providing suction through the
suction device, clearing the visual field.
20. The method of claim 19, further comprising: spraying irrigation
fluid from the distal end of the cannula to wash the tip of the
endoscope, wherein providing suction through the suction device
includes suctioning the irrigation fluid to clear the visual
field.
21. An endoscopic surgical system for use in an extremity of a
patient through an incision, the device comprising: means for
providing suction; means for dissecting tissue; means for viewing;
means for bisecting a vein or fascia; means for introducing the
means for suction, means for bisecting, means for viewing and means
for dissecting into the patient through the incision, the means for
introducing having a distal end; and means for creating a sealed
tunnel at the incision and receiving the means for introducing,
wherein the means for providing suction is further for providing
suction at the distal end of the means for introducing to remove
debris without removing the means for introducing.
22. The endoscopic surgical system of claim 21, wherein the suction
means has a length of about 32 cm.
23. The endoscopic surgical system of claim 21, wherein the suction
means includes a fenestrated distal end.
24. The endoscopic surgical system of claim 21, wherein the means
for viewing is an endoscope and the means for dissecting is the
endoscope having a dissecting tip.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of, and priority to,
U.S. Provisional Application No. 61/365,319, filed Jul. 17, 2010,
entitled "Minimally Invasive Endoscopic Surgical Approach: Arterial
Venous Fistula Ligation--Excision and Arterial Venous Fistula
Creation with Simultaneous Transposition" and U.S. Provisional
Application No. 61/420,092, filed Dec. 6, 2010, entitled "Methods
and Systems for Minimally Invasive Endoscopic Surgeries," both of
which are incorporated herein by reference in their entirety.
BACKGROUND
[0002] Minimally invasive surgery is the desired approach to reduce
scarring, improve cosmesis, lessen postoperative pain, limit
potential for infection, and promote faster recovery. Minimally
invasive approaches have become the standard of care since
laparoscopic cholecystectomy was introduced in the 1990s.
[0003] Traditional open techniques for certain surgical procedures,
such as vascular access via arteriovenous fistulas for dialysis
and/or fasciotomy, create long and/or multiple incisions and
disfiguring scars. These open techniques place patients at high
risk for infections, bleeding, painful surgical sites, poor wound
healing, and/or functional impairment.
[0004] Thus, improved, minimally invasive endoscopic methods for
arteriovenous fistula and/or fasciotomy surgeries, and improved
surgical instrumentation for performance of those and other
minimally invasive procedures, are needed.
SUMMARY
[0005] Embodiments of the present invention provide methods for
minimally invasive endoscopic surgeries, including minimally
invasive endoscopic arteriovenous (AV) fistula creation with
simultaneous or staged transposition, minimally invasive endoscopic
ligation and excision of aneurysmal AV fistulas, and minimally
invasive endoscopic fasciotomy. Benefits of the methods described
herein relative to traditional open techniques may include, for
example, reduction in unsightly and disfiguring scarring at a long
incision site, faster wound healing, reduced pain, lower infection
risk, and elimination of a subsequent surgery.
[0006] Embodiments of the present invention also provide an
improved surgical system designed to perform the surgical methods
described herein and other minimally invasive endoscopic
procedures, particularly useful for the upper extremities and
smaller parts of the lower extremities. Benefits of the systems
described herein relative to existing surgical instrumentation may
include, for example, ease of use, reduced slippage, improved
precision and results, and smaller surgical incisions.
[0007] Certain embodiments of the invention provide a minimally
invasive endoscopic surgical system, comprising a blunt tip trocar
(BTT); a cannula having a handle at a proximal end, at least one
port at the proximal end, and a cylindrical body extending from the
handle to a distal end, the body having a length of about 20 cm to
about 26 cm; an endoscope; and a bisector/bipolar device,
comprising at least one blade and a cautery, and having a handle at
a proximal end. The cannula is sized to receive the endoscope, the
BTT is for insertion into an incision site and is sized to receive
the cannula, and the at least one port is sized to receive the
bisector/bipolar device. In some embodiments, the body of the
cannula has a length of about 23 cm.
[0008] In various embodiments, the handle of the bisector/bipolar
device has finger grooves, is contoured to fit within a user's
hand, and/or includes a textured surface.
[0009] In some embodiments, the handle of the bisector/bipolar
device has a length of about 11 to about 12 cm. In certain
embodiments, the handle of the bisector/bipolar device is 12 cm
long.
[0010] In some embodiments, the endoscopic surgical system further
comprises a suction device having a handle at a proximal end, a
valve at the proximal end for controlling air flow, and a body
extending from the handle to a distal end, and the at least one
port is sized to receive the bisector/bipolar device or the suction
device.
[0011] In some embodiments, the body of the suction device has a
length of about 29 to about 35 cm. In certain embodiments, the body
of the suction device is about 32 cm long. In other embodiments,
the body of the suction device is about 43 cm long.
[0012] Certain other embodiments of the invention provide an
endoscopic suction device for use with a minimally invasive
endoscopic surgical system comprising an endoscope and a cannula
sized to receive the endoscope and having a port, the suction
device comprising a connector for connecting to a source of
suction; a handle at a proximal end, the handle having a valve in
fluid communication with the connector to control suction to be
applied by the suction device; and an elongated body having a
proximal end coupled to the handle and a distal end, the elongated
body including a channel in fluid communication with the valve and
connector, wherein the body is sized to be received within the
port.
[0013] In some embodiments, the body is approximately 29 to 35 cm,
or approximately 32 cm, in length. In other embodiments, the body
is approximately 43 cm in length.
[0014] In various embodiments, the handle is contoured to fit
within a user's hand and/or includes a textured surface.
[0015] In some embodiments, the distal end of the body is
fenestrated.
[0016] In some embodiments, the valve is adjustable for controlling
a level of suction.
[0017] Certain embodiments of the invention provide a method of
performing a surgical procedure on a patient with a minimally
invasive endoscopic surgical system, the procedure comprising
creating an incision of about 2 cm in the patient; introducing a
blunt tip trocar (BTT) into the incision; introducing a cannula
through the BTT, the cannula having a distal end inserted into the
BTT and an opening at the distal end for CO.sub.2 insufflation;
introducing an endoscope into the cannula, the endoscope having a
tip; insufflating with low pressure CO.sub.2 to create a visual
field at the tip of the endoscope; introducing a suction device
into the cannula, the suction device having a distal end proximate
the visual field; and providing suction through the suction device,
clearing the visual field.
[0018] In some embodiments, the method further comprises spraying
irrigation fluid from the distal end of the cannula to wash the tip
of the endoscope, wherein providing suction through the suction
device includes suctioning the irrigation fluid to clear the visual
field.
[0019] Additional features and advantages of embodiments of the
present invention are described further below. This summary section
is meant merely to illustrate certain features of embodiments of
the inventions, and is not meant to limit the scope of the
invention in any way. The failure to include, or the inclusion of,
a specific feature or embodiment of any invention in this summary
section should not be construed to limit any invention as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The foregoing summary, as well as the following detailed
description of the embodiments, will be better understood when read
in conjunction with the appended drawings. For the purposes of
illustrating the methods and systems of the present application,
there are shown in the drawings preferred embodiments. It should be
understood, however, that the application is not limited to the
precise arrangements and instrumentalities shown. In the
drawings:
[0021] FIG. 1 shows an endoscopic system according to an embodiment
of the invention. FIG. 1A shows a blunt tip trocar, FIG. 1B an
endoscope, FIG. 1C a harvesting cannula, and FIG. 1D a
bisector/bipolar device.
[0022] FIG. 2 shows a suction device according to an embodiment of
the invention. FIG. 2A shows the suction device alone and FIG. 2B
shows the suction device inserted into the harvesting cannula of
FIG. 1C.
[0023] FIG. 3 shows a detailed view of the blunt tip trocar of FIG.
1A.
[0024] FIG. 4 shows a detailed view of the endoscope of FIG.
1B.
[0025] FIG. 5 shows a detailed view of the harvesting cannula of
FIG. 1C with the bisector/bipolar device of FIG. 1D inserted.
[0026] FIG. 6 shows a detailed view of the bisector/bipolar device
of FIG. 1D, with an enlarged view of the handle.
DETAILED DESCRIPTION OF EMBODIMENTS
Endoscopic Surgical Systems
[0027] Existing endoscopic vein harvesting systems were developed
for harvesting of the saphenous vein or radial artery as conduits
for coronary artery bypass graft surgery. However, these and other
endoscopic devices have been applied to limited types of
procedures. In addition, the existing devices are large and
cumbersome to maneuver, even for their intended
cardiovascular-related uses.
[0028] The anatomy of the upper extremity, and nerve--vein
differentiation, large peripheral vein branches, and less
CO.sub.2/less pressure in the upper extremity, are of particular
technical consideration in the endoscopic AV fistula surgical
procedures described herein. Minimizing damage to the intimal vein
wall in transposition cases is of great importance. Thus, improved
endoscopic devices, suitable for these and other minimally invasive
applications, are needed.
[0029] An improved endoscopic system, which is smaller, more
precise, and easier to use, as compared to existing endoscopic
systems, is presented. Moreover, the improved endoscopic system
described herein is particularly well-suited for minimally invasive
endoscopic procedures in the upper extremity and/or smaller parts
of the lower extremity, including, but not limited to, the novel
minimally invasive endoscopic AV fistula, cardiovascular, and
fasciotomy surgical methods described herein.
[0030] In some embodiments, the invention provides an endoscopic
system 100 comprising a blunt tip trocar (BTT) introducer 110, an
endoscope 120, a harvesting cannula 130, and a bisector/bipolar
device 140, as shown in FIG. 1A-D. In some embodiments, the
endoscopic system of the present invention includes a suction
device 200, as shown in FIG. 2A-B.
[0031] As shown in FIG. 1A, the BTT 110 may include an inflatable
occlusion balloon 114, a balloon inflation port 116 (which may be
attached to a syringe or other device for filling with air), a
CO.sub.2 port 118 (to access a constant low flow of CO.sub.2, e.g.,
8-10 mm Hg), and an endoscope/cannula seal 112 to create a sealed
tunnel. FIG. 3 shows a detailed view of this element, according to
some embodiments, with like features having similar numbering, and
arrow indicating the insertion direction of the
endoscope/cannula.
[0032] In some embodiments, a standard endoscope 120 may be used in
the endoscopic system. An exemplary currently-available endoscope
is a Storz endoscope. As shown in FIG. 1B, the Storz scope is
preferably a 0.degree. endoscope having a length 126 of about 26 cm
to about 32 cm, preferably about 29 cm and a diameter/width of
about 5 mm. The endoscope may include an attachable clear conical
tip 128 for dissection at a distal end and a site for attachment of
a camera head 122 at a proximal end. Other features of the
endoscope may include, for example, an illumination port 124 and a
light source and/or a camera. Another view of the endoscope is
shown in FIG. 4, with like features having similar numbering. As
shown in FIG. 1B-C, the endoscope may be inserted into the
harvesting cannula through opening 131 at the proximal end. These
two elements (endoscope and cannula) together are referred to
herein as the endoscopic device.
[0033] Referring to FIG. 1C, the harvesting cannula 130 of the
endoscopic system of the present embodiment preferably has a shaft
137 with a length equal to, or preferably less than, the length of
the endoscope. For example, for use with an endoscope of length
about 29 cm, as shown in FIG. 1B and FIG. 4, the cannula preferably
has a shaft 137 length of about 20 cm to about 26 cm, preferably
about 23 cm. In some embodiments, as shown in FIG. 1C, the cannula
includes at its distal end (i.e., the end inserted into the
incision site through the BTT) a C-ring 138 and one or more
openings 139 for irrigation and/or CO.sub.2 insufflation. At a
proximal (non-inserted) end of the cannula, there is a handheld
portion 135, which may, for example, have an adjustable slider 136
coupled to the C-ring for extending/retracting the C-ring, at least
one port/opening 132 for inserting the bisector or the suction
device, and/or one or more syringe attachments (e.g., for saline
irrigation 133 and/or CO.sub.2 insufflation 134). In some
embodiments, the handheld portion 135 is about 14 cm in length.
Other handle lengths and/or features for comfort, reduced slippage
(e.g., for more stable use with wet gloves), and/or ease of use are
contemplated. Preferably, the handheld portion 135 is ergonomically
correct. FIG. 5 shows a view of the cannula 130 with
bisector/bipolar device 140 inserted, according to an embodiment of
the invention, with like features having similar numbering.
[0034] Referring to FIG. 1D, in some embodiments, a
bisector/bipolar device 140 (also referred to herein as the
bisector) is used in the endoscopic system and can, for example, be
inserted into the harvesting cannula through opening/port 132 as
shown in FIG. 1C. The length 148 of the bisector/bipolar device is
preferably related to, and may vary with, the length of the cannula
used. The bisector/bipolar device is preferably longer than the
harvesting cannula (e.g., long enough to extend through the distal
end of the cannula to cut tissue, and sufficient on the proximal
end to ensure that the handle does not dangle and bend, or come too
close to the port 132). As shown in FIG. 1D, the bisector/bipolar
device 140 is about 40 cm to about 46 cm, preferably about 43 cm,
in shaft 148 length, when used with cannula 130. The
bisector/bipolar device 140 may include a blade 150 and/or a
cautery 152 at its distal end. The bisector/bipolar device 140 may
also include at its proximal end a handle 144 with moveable slider
146 for actuating the scissors/cutting. The bisector handle
preferably includes an electrical connector 142. In some
embodiments, the bisector handle 144 is between about 11 cm and
about 12 cm in length. As shown in FIG. 6, in certain embodiments,
the bisector handle 644 may include, for example, three grooves 645
for fingers. Other handle lengths and/or features for comfort,
reduced slippage (e.g., with wet gloves), ergonomic correctness,
and/or ease of use are contemplated. For example, as shown in FIGS.
5 and 6, in some embodiments, the finger grooves 545/645 may be
textured (e.g., with small raised semi-spherical bumps) and/or
comprise a non-slip material (e.g., a rubber, silicone, or other
grip material). Such a handle can prevent the slipping and spinning
that can easily occur during surgical procedures using an existing,
smooth-handled bisector/bipolar device.
[0035] Referring to FIG. 2A-B, in some embodiments, a suction
device 200 is used in the endoscopic system, and can, for example,
be inserted into the harvesting cannula 230 through a port 232, as
shown in FIG. 2B. In some embodiments, the port 232 for the suction
device is the same port 132 that is used for the bisector device.
The length 268 of the suction device is preferably related to, and
may vary with, the length of the cannula used. For example, the
length of the suction device should be sufficient to extend through
the harvesting cannula and out the distal end to suction out
contents, and be sufficient on the proximal end for ease and safety
of use (e.g., not too long/dangling around or too short/hugging the
endoscopic device). The suction device 200 is about 29 cm to about
35 cm, preferably about 32 cm, in shaft 268 length, when used with
cannula 130. In some embodiments, however, the suction device may
be the same length as the bisector device (e.g., about 43 cm), for
example so that it may be used in conjunction with an existing
cannula, which is larger than cannula 130. The suction device 200
may include a handle 264 at its proximal end. In some embodiments,
the suction device handle 264 is about 5 cm. In some embodiments,
the suction device 200 is optionally fenestrated at its distal end
270 (e.g., the distal 2 cm). In some embodiments, the suction
device 200 includes a proximal-end connector 262 to wall suction
tubing, which connects off the sterile field to a suction canister.
A thumb hole or other controllable valve/opening 266 (e.g., a screw
valve) may be provided at the proximal end to turn on/off and/or
vary the amount of suction. Suction device 200 allows the
endoscopic field of vision to be cleared (e.g., of blood, debris,
and/or fluid used to wash the endoscope) by suction, without
deflating the BTT 110 and removing the endoscopic device, as is
traditionally done in the types of endoscopic surgeries discussed
herein.
[0036] Endoscopic surgical systems discussed herein have a number
of advantages over existing saphenous vein-harvesting systems. For
example, existing saphenous vein-harvesting systems do not include
any suction functionality to clear the field of vision. If the
field of view becomes covered with blood or debris, it needs to be
removed. In some existing instruments, the field of vision may be
cleared, for example, by irrigating the distal end by spraying
liquid toward the endoscope (similar to windshield wiper fluid).
However, the liquid pools in the extremity, potentially
blocking/blurring the visual field.
[0037] Thus, with current systems, when there is bleeding or a pool
of irrigation liquid (water, dirty saline, etc.) or debris (strands
of tissue, adipose tissue, small blood clot, etc.) obstructing the
visual field, the BTT must be deflated and removed and the entire
endoscopic system needs to be removed from the extremity. The wound
is irrigated from the incision site, blindly squirting irrigation
solution into the wound. Then the contents (blood, debris,
irrigation solution, etc.) are "milked" or rolled out by
sequentially applying pressure externally (meaning on the skin from
the outside), from the location of the distal end of the endoscope
to the incision site (e.g., with a rolled up lap pad). The debris
and liquid are expelled out through the incision site. If there is
internal bleeding, for example, from a side branch of the vein, or
a small artery is injured and bleeding, external pressure is held
for a couple minutes to control hemostasis. Meanwhile, there is no
direct vision as the endoscope has been removed. Time is spent
removing and re-inserting the endoscopic device, and each time it
is re-inserted, it goes back to a slightly different position.
Thus, still more time is needed to re-situate/re-orient the device
after re-insertion. In addition, even when anatomical landmarks are
noted to mark the initial placement of the endoscopic device (e.g.,
vein branches, adipose tissue, a bifurcation of the vein, a
narrowed area, a tissue bulge, obvious bleeding, artery branch
protruding), when re-inserting the device, the wrong plane could be
opened, which may cause tissue damage and open areas for fluid to
accumulate, leading to seromas, hematomas, and poor wound
healing.
[0038] With the suction device of the present invention as part of
the endoscopic system, the operative field can be cleared quicker
and a source of bleeding can be more easily
identified/recognized/located. One can irrigate, suction, and then
cauterize the bleeder by simply exchanging the suction device and
the bisector device, all while keeping the endoscope and cannula in
situ and maintaining direct visualization at all times.
[0039] Thus, it should be appreciated by those skilled in the art
that having suction functionality in an endoscopic system makes
minimally invasive endoscopic surgical procedures more time
efficient, safer, and saves blood loss (e.g., loss of blood due to
removing and re-inserting the instrumentation, the time it would
take to irrigate then re-insert the endoscope, cannula, and
bisector and find the previous area and the source of the
bleeding). It further allows for continuous stability of the
operative site. With suction, the irrigation liquid can be easily
removed and not be a cause of visual obstruction.
[0040] Suction may be used with the smaller cannulas described
above in connection with FIGS. 1C, 2B, and 5. Suction may also be
used with existing and future endoscopic systems, such as an
existing saphenous-vein harvesting system having a larger cannula,
to augment/improve the functionality and solve the problem of
blood/fluid obstruction in those systems as well. In such
embodiments the suction device may be sized to extend the length of
the cannula (e.g., 43 cm).
[0041] Another advantage of the endoscopic surgical systems
discussed herein is maneuverability. Existing saphenous
vein-harvesting systems can be unnecessarily large/cumbersome and
awkward for certain cardiovascular harvesting procedures, such as
radial artery harvesting (upper extremity; forearm/arm) and
harvesting smaller saphenous vein segments (partial extremity).
[0042] Radial artery harvesting is used as a conduit for coronary
artery bypass surgery. The radial artery is harvested from the
distal area (wrist) to the antecubital (inside of elbow) proximal
end. Once the radial artery is confirmed as a useable conduit,
without compromising the arterial blood flow to the hand, the
initial dissection is performed, identifying the radial artery with
direct vision. The dissector (endoscope with the dissector tip) is
introduced, separating the tissue surrounding the radial artery
with bilateral vein attachments (small veins). The radial artery is
separated anteriorly, posteriorly, laterally, and medially.
Branches are isolated. The dissector is then exchanged for the
endoscopic device (harvesting cannula and endoscope without
dissector tip) with the bisector/bipolar device attachment.
Branches are cauterized and cut. Any possible bleeding causes the
field of vision to be covered very quickly as the arterial flow is
pulsatile and under pressure. Suction allows for the blood to be
removed. The bleeding is controlled and removed with harvesting
cannula in situ. The suction is exchanged with the bisector. Once
the radial artery and subsequent vein are free from surrounding
tissue a separate stab site is made at the proximal end and the
radial artery is ligated ahead of the brachial junction. The radial
artery is then prepared by flushing with heparinized saline and all
branches are secured. As described in detail below, the smaller
device allows for more appropriate size suitability. The harvesting
cannula with suction can be re-introduced and the prior radial
artery donor site is inspected for any possible bleeders. The
suction device allows for removal of irrigation solution to secure
a hemostatic environment and then closure of the site distally. The
proximal site can be closed prior to final inspection to allow for
a CO.sub.2 seal.
[0043] Typically, when harvesting a right radial artery the cardiac
surgeon is standing at the right side of the patient's chest (the
patient is lying on his/her back with arms straight out on arm
boards in standard cardiac surgical procedures). The existing
saphenous vein-harvesting cannula that may be used is long, and the
radial artery from wrist to antecubital space (inside of elbow) is
a much shorter distance. The larger cannula is hard to manage and
difficult to balance with a narrow arm board. The smaller cannula
described herein is more appropriately sized and can eliminate
contamination and obstruction from close surroundings (e.g., a
surgeon hitting instrumentation with his/her left arm; if the
surgeon is harvesting the internal mammary artery at the same time
the radial artery is being harvested, it is often the surgeon's
back and left arm that are in the radial artery operative field
with a high incident of hitting/contaminating). In some operating
rooms, the cardio-pulmonary bypass machine (perfusion machine),
which is bulky (bigger than the patient), is also at the patient's
right side. Thus, there may be very little room on the patient's
right side for the surgeon/harvester to access a right radial
artery. The harvester may be in the surgeon's way; the surgeon may
be in the harvester's way; inches away from both the surgeon and
the person harvesting the radial artery is the cardio-pulmonary
bypass machine, which is the life line to the patient. A
shorter/smaller cannula device is more manageable and can help
prevent/minimize the contamination that occurs when using a larger
endoscopic device, and is therefore preferable for radial artery
harvesting.
[0044] The smaller cannula described herein may be preferable in
certain cases even for saphenous vein-harvesting, for which the
larger endoscopic systems were designed. For example, sometimes the
cardiac surgery only needs one or two pieces of saphenous vein,
which can be taken from the lower leg or just a segment from the
upper leg. If only a small segment is needed, then the smaller
cannula would be better suited to use for harvesting (whereas if
4-5 segments are needed for bypass, an existing, larger cannula may
be better suited). For example, when harvesting a segment of
saphenous vein in the lower leg (e.g., the knee down), the
endoscopic harvesting device often ends up resting in the chest
area. Thus, a smaller device is more manageable. The patient might
be a "re-op," meaning they had cardiac surgery before and are now
returning for another cardiac bypass surgery and all that remains
is the lower leg or only the upper thigh, so again the smaller
cannula would be the better option. Another example is if a lesser
saphenous vein is being harvested. Lesser saphenous veins are
difficult to harvest with the large endoscopic system. The lesser
saphenous veins are anatomically on the back side of the lower leg.
The smaller cannula would be a better, more manageable option for
this case as well.
[0045] The saphenous vein in the lower extremities can be harvested
and used as a conduit for coronary artery bypass grafting. Once the
saphenous vein is identified at the medial aspect of the knee area,
the dissector (endoscope with dissector tip) is introduced through
the blunt tip trocar (BTT). All tissue is separated from the vein,
anteriorly, posteriorly, laterally and medially, isolating all
branches. The dissector is then exchanged for the endoscopic device
(harvesting cannula and endoscope without dissector tip) with the
bisector/bipolar device attachment. Branches are cauterized and cut
with the bisector. The grooves on the bisector handle allow for
better handling and grip. A slight slip of the bisector while
bovieing (cauterizing) can easily damage the donor saphenous vein,
compromising the integrity of the vein. Any possible bleeding,
irrigation fluid, and/or debris can be removed by the added suction
device. Once all branches are isolated the vein can be removed at
the proximal end through a separate stab incision. The vein is
ligated under and removed. The stab site can be closed. The
harvesting cannula can be re-introduced and the donor site of the
saphenous vein is irrigated and the contents suctioned out. Any
bleeding can be cauterized by exchanging the suction with the
bisector. Once hemostasis is confirmed the endoscopic device is
removed and the site is closed.
[0046] If more vein is required prior to ligating, the endoscope
with dissector tip is flipped around and the knee (now considered
the proximal end) is harvested down to the ankle. The same
procedure is performed.
[0047] If only a lower leg segment is required, there is the option
to start at the ankle and work most distally (ankle, medial fossa)
to proximally (the medial aspect of the knee).
[0048] In harvesting from the knee to the ankle, the large
endoscopic device and attachments/cords (camera, light source,
bovie cord--the cauterizer, CO.sub.2) all extend out the end of the
harvesting device and can drape into the abdominal area and often
fall in the chest area. This causes difficulty for the surgeon at
the chest and cardio-pulmonary artery and venous lines. The
operating area is cluttered, leading to increased chance of
contamination. Thus for this case in particular, a smaller device
of the embodiments described herein is more appropriate.
[0049] In harvesting both the radial artery and the saphenous vein,
any incidental injury caused by the cauterizing because of slippage
of the handle can damage the conduit, compromising the entire
bypass surgery. The conduits become the blood flow to the heart,
from the aorta to the distal aspect of the stenosis, bypassing the
stenotic area. Thus, the non-slip features of the bisector/bipolar
device handle 144, 544, 644 described herein, are of particular
importance for these procedures.
[0050] Suction and irrigation allow for better visual comprehension
and less chance of error.
[0051] Both conduits, a segment of saphenous vein and/or the radial
artery(ies) used for coronary artery bypass surgery, should be in
the best presentation in terms of integrity and structure. A
smaller device allows for better manageability, and suction
prevents the removal and re-insertion of the device, thus limiting
the possibility of error and more dissection down a false plane
looking for the original site.
[0052] These are exemplary benefits and uses of the endoscopic
surgical devices/systems described herein, and should not be
construed as limiting; other advantageous applications may easily
be recognized by those of ordinary skill in the art.
Endoscopic AV Fistula Surgeries
[0053] The incidence and prevalence of end-stage renal disease
continues to increase. Patients with end-stage renal disease
require vascular access for dialysis. Some of these patients
require temporary access while awaiting a kidney transplant
(assuming they are an acceptable candidate), while others (e.g.,
those who are not transplant candidates) may require dialysis for
the rest of their lives. Decisions about the type of dialysis and
the best method of access for dialysis require collaboration among
the patient, nephrologist, and access surgery team.
[0054] Primary autogenous arteriovenous (AV) fistulas are the
preferred means of vascular access for hemodialysis. In patients
who choose hemodialysis, an AV fistula is often created
preemptively, allowing time for the fistula to mature pending
usage. Indeed, the National Kidney Foundation Kidney Disease
Outcomes Quality Initiative guidelines support a "fistula first"
doctrine.
[0055] Traditional venous transpositions use an open technique
generally as follows. If the anatomy permits, surgically created
vascular access starts distally on the upper extremity. The
radial-cephalic path is the most distal access option. In the upper
arm, the brachial artery is anastomosed to either the basilic or
cephalic veins. Initially, a deep cephalic-vein-to-brachial-artery
fistula is created through a horizontal incision (e.g., 3 to 5 cm)
near the antecubital fossa.
[0056] In many patients, the cephalic vein in the upper arm is
superficial enough for direct cannulation for hemodialysis. After a
period of maturation (e.g., four to six weeks), the AV fistula is
assessed for palpable thrill, audible bruit, and the ability of the
vein to be accessed through the skin for dialysis, which are
indicators of a successful AV fistula. If necessary, ultrasound may
be used to assess fistula size and depth.
[0057] If the vein (whether cephalic or basilic) remains too deep,
the patient is scheduled for a second surgery for transposition.
Vein transposition is also referred to as superficialization, as
the vein is dissected from the deep tissue and embossed directly
under the skin to allow easier access of the hemodialysis
catheters. This is done through a separate vertical incision
(referred to as the conventional open incision) from the
antecubital fossa to the axillary area. Patients with deep veins or
extensive adipose tissue typically require this two-stage surgery:
the first stage completes artery and vein anastomosis (the
fistula), and the second completes the transpositioning of the
vein.
[0058] An open AV fistula transposition surgical incision is long
(about 20 to 25 cm in length, from the antecubital space to the
axillary area) and unsightly. Patients who undergo this
conventional procedure are at risk for infections, bleeding, and
painful surgical sites. Each surgical procedure lends itself to
scarring and potential deformities. Many of these patients also
have comorbidities, such as diabetes, predisposing them to poor
wound healing. Renal-failure patients are at particularly high risk
for complications from any surgery, and immunosuppressant therapy
places kidney transplant recipients at even greater surgical
risk.
[0059] Over time, chronic-renal-failure patients may require
revisions or develop painful aneurysmal fistulas that necessitate
removal of the AV fistula. An AV fistula may fail for various
reasons, including low or poor blood flow, failure to mature,
excessive pain (e.g., due to repeated dialysis needling), a
sclerotic vein, and/or a thrombotic vein. Failure can be
disheartening to a patient who realizes that another surgery is
required. In addition, patients with functioning renal allografts
(post-renal transplant) frequently request fistula removal, as
these fistulas can be painful, disfiguring, and a reminder of the
patient's experience on hemodialysis. Traditionally, these
ligations and excisions are completed through incisions that extend
the length of the aneurysmal fistula, which also carry a risk of
infection, bleeding, painful surgical sites, and scarring.
[0060] The minimally invasive endoscopic methods and systems
described here provide an alternative approach for AV fistula
creation/transposition and ligation/excision.
[0061] The novel minimally invasive endoscopic surgical methods
discussed herein include: (i) harvesting of a deep basilic or
cephalic vein for creation of a brachial-basilic or
brachial-cephalic AV fistula, with simultaneous transpositioning;
(ii) harvesting of a deep basilic or cephalic vein for
transposition of an existing brachial-basilic or brachial-cephalic
AV fistula; and (iii) ligating and excising an aneurysmal
radial-cephalic, brachial-cephalic, or brachial-basilic AV fistula
from the upper or lower arm. As will be appreciated by those of
skill in the art, although surgical procedures may be performed
with any number of endoscopic devices, the devices and systems
disclosed herein with regard to FIGS. 1-6 are particularly well
suited for performing such procedures.
[0062] In certain embodiments, the harvested vein is
transpositioned to directly under the skin, then anastomosed to the
brachial artery, creating an AV fistula accessible for
hemodialysis. This replaces the traditional two-stage surgery with
a single-stage surgery and eliminates the long vertical incision
associated with a conventional open AV fistula transposition.
[0063] In other embodiments, an aneurysmal AV fistula is ligated
and excised endoscopically, thereby minimizing incisions.
[0064] As compared to traditional open AV fistula surgeries, these
procedures reduce body disfigurement, scarring, post-operative
pain, and potential for infection. Following the procedure
disclosed herein to harvest a deep upper-arm cephalic vein, for
example, the patient is left with only two small scars. This
procedure also eliminates repeated or staged surgery and promotes
faster recovery and improved wound healing and patient body image.
These procedures are described in greater detail below.
[0065] I. Primary creation with simultaneous endoscopic
transposition of upper extremity basilic or cephalic vein for
arterial venous fistula. In some embodiments, an exemplary method
for primary AV fistula creation with simultaneous endoscopic
transposition of an upper extremity basilic or cephalic vein is as
follows. A 2-cm incision is made at the antecubital area. The
artery and intended vein are identified. A blunt tip trocar (BTT)
is introduced to the incision. A balloon on the BTT is inflated to
create a seal, and low pressure CO.sub.2 insufflation is started.
An endoscopic device (endoscope and cannula) is introduced through
the BTT. The endoscope is advanced with a conical tip for
dissection. The vein is passed superiorly, inferiorly, medially,
and laterally, and vein branches are isolated. The C-ring at the
end of the cannula is exchanged for (e.g., retracted) and replaced
with a bisector/bipolar device, which is advanced through the
cannula. The vein branches are cauterized and cut/bisected. A 1-cm
stab site is made at a proximal end of the vein (axillary area).
The vein is grasped and pulled out through the stab site. The
bisector/bipolar device is removed, and the vein is cannulated and
flushed with heparanized saline. The cauterized side branches of
the transpositioned vein are tied off/reinforced (e.g., with 4-0
silk ties). A tunneler device is passed from the distal to the
proximal incision. The vein is loaded into the tunneler. The
tunneler is passed with the vein from the proximal to the distal
incision. Vascular clamps are applied. The vein is anastomosed to
the artery end. Vascular clamps are removed. The resulting AV
fistula is assessed for thrill, which indicates a successful AV
fistula creation. The incision sites are closed.
[0066] II. Endoscopic staged transposition of upper extremity
cephalic vein for arterial venous fistula. In some embodiments, an
exemplary method for endoscopic staged transposition of an upper
extremity cephalic vein for an AV fistula is as follows. A 2-cm
incision is made through the primary incision (made when the AV
fistula was initially created) at the antecubital area. The AV
fistula is identified and isolated. A vascular clamp is placed
above the anastomosis on the vein. A cut is made on the vein side
and the vein edge is secured with silk tie. The silk ties are
clamped or tacked to a drape so as not to drag the vein into the
wound. A BTT is introduced to the incision. A balloon on the BTT is
inflated to create a seal, and low pressure CO.sub.2 insufflation
is started. An endoscopic device is introduced through the BTT. The
endoscope is advanced with a conical tip for dissection. The vein,
which may be within deep layers of adipose tissue, is passed
superiorly, inferiorly, medially, and laterally, and vein branches
are isolated. The C-ring is exchanged for (e.g., refracted) and
replaced with a bisector/bipolar device, which is advanced through
the cannula. The vein branches are cauterized and cut/bisected. A
1-cm stab site is made at a proximal end of the vein (axillary
area). The vein is grasped and pulled out through the stab site.
The bisector is removed and the vein is cannulated and flushed with
heparanized saline. The cauterized side branches of the
transpositioned vein are tied off/reinforced (e.g., with 4-0 silk
ties). A tunneler device is passed from the distal to the proximal
incision. The vein is loaded into the tunneler. The tunneler is
passed with the vein from the proximal to the distal incision.
Vascular clamps are applied. The vein is re-anastomosed, vein to
vein--artery (AV fistula site) end to end. Vascular clamps are
removed. The resulting AV fistula is assessed for thrill, which
indicates a successful AV fistula creation. The incision sites are
closed.
[0067] III. Endoscopic excision of an aneurysmal arterial venous
fistula in the upper extremity (radial-cephalic, brachial-cephalic,
or brachial-basilic). In some embodiments, an exemplary method for
endoscopic excision of an aneurysmal AV fistula in the upper
extremity (radial-cephalic, brachial-cephalic, or brachial-basilic)
is as follows. A 2-cm incision is made through an existing scar
from the initial creation of the AV fistula. The anastomosis of the
artery and vein is identified and isolated. A vascular clamp is
placed on the vein side of the anastomosis. The vein is divided
from the anastomosis. The arterial stub is over-sewn. The first
couple of centimeters of vein are dissected out. Blood is expressed
from the vein lumen. The vein edge is tied, preferably twice, with
2-0 silk tie. The silk ties are tacked to a drape so as not to drag
the vein into the wound. A BTT is introduced to the incision. A
balloon on the BTT is inflated and low pressure CO.sub.2
insufflation is started. An endoscopic device is introduced through
the BTT. The endoscope is advanced with a conical tip for
dissection. The vein is passed superiorly, inferiorly, medially,
and laterally, and vein branches are isolated. The C-ring is
exchanged for (e.g., retracted) and replaced with a bisector, which
is advanced through the cannula. A 1-cm stab site is made at a
proximal end of the aneurysmal vein. The vein is grasped and a
vascular clamp is placed around the vein. The vein is excised and
the vein specimen is removed. The proximal vein stub is over-sewn,
and the proximal clamp is removed. The wound is irrigated with
antibiotic solution. Incisions are closed (e.g., with 3-0 vicryl
then 4-0 biosyn). Dressings are applied and the extremity is
wrapped (e.g., with ACE.TM. wrap). The wrap is preferably left on
for 24 hours unless the patient has finger numbness, pain, or
finger swelling, and the extremity is preferably kept elevated.
Heavy lifting is not recommended.
[0068] As will be appreciated by those of skill in the art, the
foregoing procedures are exemplary, and procedures including fewer
or additional steps, or performing such steps in a modified order,
or other variations are also within the scope of the present
invention. For example, for each of the above procedures, a block
with Monitored Anesthesia Care (MAC) may be used unless the patient
is under general anesthesia. Also, in some embodiments,
transpositioning does not include a second stab--grab incision.
[0069] In some embodiments, a tunnel is created through adipose
tissue with the cannula, eliminating any use of a separate tunneler
device. After the vein is pulled out at the proximal end, flushed
with heparinized saline, and inspected/examined for leaks, the
branches are tied off. Then, instead of using the tunneler device,
the endoscope with dissector tip is passed through, distal to
proximal (in the same fashion that tunneling is performed with the
tunneler device), just under the skin, making a tunnel. Then the
endoscope with dissector tip is withdrawn and replaced with the
endoscopic device (harvesting cannula and endoscope with dissector
tip removed) with bisector/bipolar device attachment. The bisector
is advanced through from distal to proximal following the same
subcutaneous path. Once the bisector is through to the proximal
end, there is a tiny opening on the C-ring to thread a suture. The
end of the suture is tied to the vein, then pulled through the
endoscopic device, carefully advancing the vein through under the
skin. Preferably there are no clips, just suture ties used on the
vein. These embodiments eliminate the use of a separate tunneler
instrument for transpositioning, making the procedures entirely
endoscopic except for the anastomosis (sewing the vein end to the
side of the artery), which is typically performed under direct
vision at the incision site.
Endoscopic Fasciotomy Surgeries
[0070] Compartment syndrome is a limb threatening condition which
can be found wherever a compartment can be anatomically present.
This includes, for example, the hand, forearm, upper arm, abdomen,
buttock, and lower extremities (both upper and lower legs as well
as the feet). Compartment syndrome can occur when the muscle
compartment exceeds the perfusion pressure of the tissue. The
fascia covering creates a restrictive element, thereby inhibiting
any expansion of the affected anatomical area. Compartment syndrome
is the compression of underlying tissue, vascular compression
and/or occlusion, nerve damage, muscle compression and restriction,
leading to tissue ischemia and necrosis.
[0071] Compartment syndrome can be caused, for example, by long
bone fractures, burns (chemical, thermal, and/or electrical),
bleeding in enclosed spaces, external or crush injuries/events,
envenomation from snake bites, thrombotic or embolic events (e.g.,
deep vein thrombosis), traumatic injuries, exercise, prolonged
extremity immobilization, vascular injury, massive fluid
resuscitation in burn or trauma victims, and/or morbid obesity.
Compartment syndrome can be chronic in certain athletes from
exercise-induced or repetitive impact injuries.
[0072] A fasciotomy is the treatment for compartment syndrome. The
fasciotomy is performed to relieve underlying tissue pressure, and
enable better perfusion and blood flow. A fasciotomy is performed
to prevent tissue death. The fascia tissue can vary in terms of
density, thickness, and elasticity.
[0073] Traditional fasciotomies are open fasciotomies that involve
long incisions made longitudinally from proximal to distal through
the skin and tissue to the internal fascia of the affected area.
Thus, an open fasciotomy can be a source of morbidity and lead to
potential infections due to exposed underlying tissue, poor wound
healing, skin grafts, disfigurement and extensive scarring, and
decreased and/or permanent functional impairment.
[0074] Such issues with traditional fasciotomies due to compartment
syndrome have left orthopedic surgeons looking for a better method
to decompress the tissue without making large incisions. Other
current methods include "semi-blind" passage of long scissors to
cut the fascia and the use of army-navy retractors, in chronic
compartment syndrome patients. Nothing is known to have been
attempted on acute compartment syndrome patients. Problems with the
existing semi-blind techniques include potential risk for
incomplete fascia division, nerve injury/impingement, and/or
unrecognized fascial defects.
[0075] In addition, because there is no "designated" device or
appropriate instrument to use for fasciotomy procedures, orthopedic
surgeons have attempted various alternative techniques. For
example, some have used a gynecological speculum (the instrument
that is used for obtaining a PAP smear for women), whereas others
have used a shoulder arthroscope (a scope for the shoulder). Use of
various instruments intended for other procedures demonstrate that
there is a need and a setting for improved methods and devices for
performing fasciotomies.
[0076] Once a fasciotomy has been determined to be the surgical
intervention, the option of performing the procedure endoscopically
can be considered. Embodiments of the present invention provide
endoscopic fasciotomy procedures that may be easily completed for
preventing or treating compartment syndrome. Instead of opening a
leg or arm through the traditional open incision, such procedures
can be performed through a smaller incision, while providing
complete visualization. Endoscopic fasciotomy may be useful, for
example, in situations where transport to a higher level of trauma
facility may be needed and endoscopic fasciotomy could provide an
initial intervention. More generally, the endoscopic fasciotomy
approach of the present invention may be useful in situations in
which there is a need for space for swelling, but an open technique
would increase morbidity.
[0077] Thus, embodiments of the minimally invasive endoscopic
surgical methods of the invention further include, for example:
(iv) endoscopic leg fasciotomy and (v) endoscopic arm fasciotomy.
These procedures are described in greater detail below.
[0078] Fundamental knowledge of the anatomy and the underlying
tissue, as well as the anatomical landmarks and structures, is
assumed for these procedures (including the fascia and muscles, as
well as the nerves and vascular tissue). Briefly, each lower leg
has four muscle compartments (anterior, lateral, superficial
posterior, deep posterior). The thigh has four compartments
(anterior, medical, lateral and posterior). The buttock is composed
of three major muscles, each within its own compartment, the
gluteus maximus muscle, gluteus medius muscle, and the gluteus
minimus muscle. The upper arm has two compartments, anterior and
posterior. The forearm has two compartments, anterior and
posterior.
[0079] IV. Endoscopic leg fasciotomy. In some embodiments, an
exemplary method for endoscopic leg fasciotomy is as follows. An
initial incision is made approximately 2 cm above the most proximal
site. The tissue is then dissected down to the fascia. Once enough
space is created then the endoscopic device is inserted. Once
identifying tissue is clearly visualized, then the endoscopic
dissector (endoscope with dissector tip) is advanced longitudinally
to the desired distal site. Once enough space has been created
(e.g., tissue plane dissected) then the dissector tip is removed
(e.g., unscrewed) and the endoscopic device (harvesting cannula and
endoscope without dissector tip) with the bisector/bipolar device
attachment is inserted. Appropriate landmarks (such as muscles,
nerves, and connective tissue of the fascia) should be identified.
The bisector/bipolar device penetrates the fascia, cauterizing
enough to make an initial opening of approximately 3 mm. The C-ring
cups or grasps the edge of the fascia, which is preferably lifted
off of the underlying tissue, vascular structures, muscle, and
nerves. As the C-ring creates a counter tension at the crotch of
the fascia opening, the bisector/bipolar device is advanced,
cauterizing and cutting the fascia. As the bisector/bipolar device
is advanced, care is taken to maintain hemostasis. Suction can be
applied by exchanging the bisector/bipolar device with the suction
device, as described herein.
[0080] Once the fascia is opened, then the endoscopic device is
retracted to the insertion site and slowly advanced for inspection
and then to separate individual muscle groups as needed. The
procedure is repeated for as many compartments of fascia as are
necessary to be opened.
[0081] In performing a fasciotomy of the thigh/upper leg, for
example, the 2-cm incision may be at a site near the buttock with
the endoscopic fasciotomy proceeding along the femur toward the
knee. In the lower leg, the 2 cm incision may, for example, be at a
site near the knee (lateral or medial) with the endoscopic
fasciotomy proceeding along the tibia/fibula toward the
lateral/medial malleolus.
[0082] V. Endoscopic arm fasciotomy. In some embodiments, an
exemplary method for endoscopic arm fasciotomy is as follows. An
initial incision is made approximately 2 cm in length at the most
proximal area. Dissection to the fascia is obtained. The endoscopic
device is inserted into the incision and the dissector tip creates
an open plane as it is advanced to the distal site. The dissector
tip is then removed and the endoscopic device (harvesting cannula
and endoscope without dissector tip) with the bisector/bipolar
device attachment is inserted. Once the fascia is clearly
identified, a small opening, approximately 3 mm (enough to open the
fascia for the bisector to be advanced) is created. As with the leg
fasciotomy, the fascia is cupped by or grasped with the C-ring,
creating counter tension. Then the bisector/bipolar device is
advanced in synchrony with the harvesting cannula, cauterizing the
fascia while cutting it open. Once the distal area is reached, then
the bisector/bipolar device is withdrawn. If further areas of the
fascia need to be cut, then the endoscopic device is retracted to
the insertion site and the same procedure is applied.
[0083] Each of the above fasciotomy procedures is typically
performed in the operating room; however, if properly prepared and
if equipment is available, fasciotomies can be performed in the
emergency room. These endoscopic procedures can be performed under
a regional block anesthesia or general anesthesia, taking into
consideration the presenting situation.
[0084] Each fasciotomy allows room for swelling and expansion of
the underlying tissue. Assessment of the tissue for perfusion,
pallor, pain, pulses, and/or paresthesia is preferably performed.
If more extensive expansion is required then the endoscopic
fasciotomy may be converted to an open fasciotomy, or an open
fasciotomy may be performed following the endoscopic
fasciotomy.
[0085] An appropriately sized endoscopic system with suction, such
as that described herein, is preferred for these minimally invasive
endoscopic fasciotomy surgeries, allowing for complete
visualization, minimizing potential internal damage, and permitting
the best possible outcomes. However, an existing endoscopic device,
such as a saphenous vein-harvesting device, may also be used for
the fasciotomy procedures as described above.
[0086] Additional uses of the minimally invasive approach described
herein are also contemplated, particularly for any endoscopic
surgical procedures in which small incisions are desirable. The
smaller endoscopic system described herein may be more
appropriately sized, easier for the harvester to use, and may
minimize error.
EXAMPLES
[0087] The invented surgical methods presented herein are further
described in the following examples, which do not limit the scope
of the invention set forth in the claims. The following examples
describe clinical cases that have been treated according to some
embodiments of the invented methods. The surgeries described in the
examples were performed using an existing saphenous vein-harvesting
system. However, in some embodiments (such as those in the upper
extremities), an improved endoscopic system such as that described
above, which is smaller, more precise, and easier to use, is
preferred for these surgical methods.
Example 1
[0088] Transposition and creation of brachial-cephalic AV fistula
with endoscopic vein harvesting. The initial antecubital fossa
incision was about 2 cm in length. Once the brachial artery and the
cephalic vein were identified, an endoscopic device was introduced
through the same incision and utilized to harvest the cephalic vein
from the most distal to proximal end.
[0089] The endoscopic device was equipped with in-line tools. With
the conical tip attached to a 7-mm scope, the cephalic vein was
followed on a level plane. Insufflation with low-pressure CO.sub.2
created a visual field that enabled the identification of vein
branches. The branches were cauterized with a bisector tip
providing hemostatic control. Harvesting included dissection of
adipose tissue from the vein and avoidance of the nerve as it was
visualized. The concave shape of the endoscope's C-ring basined the
vein, allowing the surgeon to run the vein from its proximal to
distal end while inspecting for any further dissection. This also
allowed for careful assessment to ensure all branches had been
ligated and divided.
[0090] A 2-cm counter-stab incision was then made at the proximal
end to allow for the vein to be reined out. The vein was inspected
and flushed with heparinized saline. Divided venous-side branches
were reinforced with 4-0 silk ties. The patency of the vein was
evident. A standard AV graft tunneling device was used to tunnel
the vein from the proximal to the distal incision in the
subcutaneous plane. The harvested vein was placed in the inner
aspect of the tunneler and passed back through from the proximal
end to the distal incision. The transpositioned vein was then
anastomised to the side of the brachial artery. Venous and arterial
clamps were removed; a palpable thrill was appreciated. Hemostasis
was obtained, and the incisions were closed using absorbable
sutures. The need for a second surgery was eliminated. At eight
weeks, the fistula was mature and able to be cannulated for
hemodialysis.
Example 2
[0091] Transposition of brachial-basilic AV fistula with endoscopic
vein harvesting. The patient presented with a brachial-basilic AV
fistula in situ that, while adequate in size, was too deep for
hemodialysis needle puncture access. The patient was morbidly
obese, had comorbidities that would delay wound healing, and was at
risk for complications. The minimally invasive approach to
endoscopic harvesting of the basilic vein ensued.
[0092] The antecubital incision from the creation of the AV fistula
was opened and the anastomosis site identified. The arterial flow
was clamped on the venous side. An endoscopic device was introduced
and the undistended deep basilic vein harvested. A 2-cm
counterincision was made about 17 cm from the insertion site at the
proximal side. The basilic vein was reined out and all branches
were ligated. After patency had been established, the basilic vein
was tunneled back through the subcutaneous plane. The
transpositioned vein was re-anastomised back to the original AV
fistula site. Venous and arterial clamps were removed; a palpable
thrill was appreciated.
[0093] When the patient returned for a two-week post-operative
follow up, the vein was palpable throughout with a thrill and the
incisions were well-healed. The patient was instructed to return in
four weeks for AV fistula anastomosis maturation assessment.
Example 3
[0094] Radial-cephalic AV fistula ligation and excision. The
patient had a renal transplant and complained of an unsightly and
painful radial-cephalic AV fistula. A 2-cm incision was made
through the original fistula-creation scar. The radial-cephalic AV
fistula anastomosis was dissected and ligated, halting the arterial
blood supply. An endoscopic device was introduced through the same
incision. The conical tip was used to separate the thickened
fistulous vein from surrounding tissue. Insufflation with CO.sub.2
was used to create a visual field. All identifiable branches were
cauterized and bisected. A 2-cm stab incision was made
approximately 15 cm from the distal incision. The aneurysmal vein
was reined out through the stab-site incision and tied off. The
incisions were irrigated and closed. An ACE.TM. wrap was placed
over the site for 24 hours with instructions to remove if any
numbness or tingling in the fingers occurred.
[0095] The patient returned approximately one week later. There was
no report of any numbness or tingling in the fingers and no
swelling. Distal pulses were intact, as was distal perfusion.
Example 4
[0096] Brachial-cephalic AV fistula ligation and excision. The
patient had a renal transplant and complained of an unsightly and
painful brachial-cephalic AV fistula. As in Example 2, the incision
was established through the original creation-site scar at the
antecubital fossa. The cephalic vein was ligated near the arterial
anastomosis and the aneurysmal cephalic vein harvested
endoscopically. A counterincision was made at the proximal end
approximately 15 cm from the distal site. The vein was reined out
through a 1-cm incision, tied off, and excised. The wound was
irrigated and closed. An ACE.TM. wrap was applied. Two weeks later,
the patient had minimal swelling and no complaints of any pain or
discomfort. Distal pulses and perfusion were intact.
[0097] While there have been shown and described fundamental novel
features of the invention as applied to the preferred and exemplary
embodiments thereof, it will be understood that omissions and
substitutions and changes in the form and details of the disclosed
methods, devices, and systems may be made by those skilled in the
art without departing from the spirit of the invention. Moreover,
as is readily apparent, numerous modifications and changes may
readily occur to those skilled in the art. Hence, it is not desired
to limit the invention to the exact construction, procedures, and
operations shown and described and, accordingly, all suitable
modification equivalents may be resorted to falling within the
scope of the invention as claimed. It is the intention, therefore,
to be limited only as indicated by the scope of the claims appended
hereto.
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