U.S. patent application number 09/873930 was filed with the patent office on 2001-10-11 for extraluminal balloon dissection.
Invention is credited to Echevery, Jan M., Fogarty, Thomas J., Hermann, George D., Mollenauer, Kenneth H..
Application Number | 20010029350 09/873930 |
Document ID | / |
Family ID | 24530279 |
Filed Date | 2001-10-11 |
United States Patent
Application |
20010029350 |
Kind Code |
A1 |
Fogarty, Thomas J. ; et
al. |
October 11, 2001 |
Extraluminal balloon dissection
Abstract
The present invention provides balloon dissection apparatus and
methods of use in which an elongate balloon is utilized to dissect
along a region that follows a naturally existing path alongside a
vessel or structure, such as an artery, a vein, a lymphatic vessel,
the trachea, the esophagus, or even a nerve bundle.
Inventors: |
Fogarty, Thomas J.; (Portola
Valley, CA) ; Hermann, George D.; (Portola Valley,
CA) ; Echevery, Jan M.; (San Jose, CA) ;
Mollenauer, Kenneth H.; (Los Gatos, CA) |
Correspondence
Address: |
United States Surgical, a division of
TYCO HEALTHCARE GROUP LP
150 Glover Avenue
Norwalk
CT
06856
US
|
Family ID: |
24530279 |
Appl. No.: |
09/873930 |
Filed: |
June 4, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09873930 |
Jun 4, 2001 |
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09444420 |
Nov 19, 1999 |
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09444420 |
Nov 19, 1999 |
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09039548 |
Mar 16, 1998 |
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6013090 |
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09039548 |
Mar 16, 1998 |
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08824676 |
Mar 26, 1997 |
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5814060 |
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08824676 |
Mar 26, 1997 |
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08631221 |
Apr 11, 1996 |
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5690668 |
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08631221 |
Apr 11, 1996 |
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08267484 |
Jun 29, 1994 |
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5601589 |
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Current U.S.
Class: |
604/102.02 |
Current CPC
Class: |
A61B 17/0218 20130101;
A61B 2017/320048 20130101; A61M 25/1002 20130101; A61B 2017/00557
20130101; A61B 2017/22062 20130101; A61B 17/00008 20130101; A61B
90/361 20160201; A61M 2025/1081 20130101; A61B 2017/320044
20130101; A61M 25/0194 20130101; A61B 17/3431 20130101; A61M 25/10
20130101; A61M 29/02 20130101; A61B 2017/22061 20130101 |
Class at
Publication: |
604/102.02 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A method of dissecting tissue from an elongate structure in a
body, said method comprising the steps of: (a) providing an
elongate tunneling member having a distal end and an elongate
balloon having a fully inflated length of greater than said
tunneling member, said elongate balloon being folded inwardly to
reduce its length; (b) making an incision in the body adjacent the
elongate structure; (c) introducing said tunneling member and
elongate balloon through said incision; (d) advancing said
tunneling member and said elongate balloon bluntly alongside the
elongate structure in the body until a desired location is reached;
and (e) inflating said elongate balloon to cause said elongate
balloon to expand outwardly and evert distally beyond said
tunneling member to dissect tissue from the elongate structure
along and beyond said distal end of said tunneling member.
2. The method of claim 1 further comprising the steps of: deflating
said elongate balloon; removing said elongate balloon through said
incision; and insufflating a space created alongside the elongate
structure by said inflation step.
3. The method of claim 2 further comprising the step of performing
a surgical procedure in said insufflated space.
4. The method of claim 1 wherein the elongate structure is a
saphenous vein.
5. The method of claim 1 wherein the elongate structure is a
nerve.
6. The method of claim 1 wherein said tunneling member is a
scope.
7. A method of dissecting tissue from an elongate structure in a
body said method comprising the steps of: (a) providing a scope and
an elongate balloon having a fully inflated length substantially
greater than a length of said scope, said elongate balloon being
folded inwardly to reduce its overall length; (b) making an
incision in the body adjacent the elongate structure; (c)
introducing said scope and elongate balloon through said incision;
(d) advancing said scope and said elongate member bluntly alongside
the elongate structure in the body until a desired location is
reached; and (e) while observing through said scope, inflating said
folded elongate balloon to cause said elongate balloon to evert
distally beyond said scope and dissect attached tissue away from
the elongate structure.
8. The method of claim 7 wherein said advancing step is performed
while observing through the scope.
9. The method of claim 7 further comprising the steps of: deflating
said elongate balloon; removing said elongate balloon and said
scope through said incision; and insufflating a space created
alongside the elongate structure by said inflation step.
10. The method of claim 7 further comprising the step of performing
a surgical procedure in said insufflated space.
11. The method of claim 1 wherein the elongate structure is a
saphenous vein.
12. The method of claim 1 wherein the elongate structure is a
nerve.
Description
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 09/039,548; filed on Mar. 16, 1998; which is a
continuation of U.S. pending application Ser. No. 08/824,676, filed
on Mar. 26, 1997, which is a continuation of U.S. application Ser.
No. 08/631,221, filed on Jun. 29, 1994, now U.S. Pat. No.
5,690,668, which is a continuation-in-part of U.S. application Ser.
No. 08/267,484, filed on Jun. 29, 1994, now U.S. Pat. No.
5,601,589, the disclosures of which are hereby incorporated by
reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
extraluminal balloon dissection. More particularly, the present
invention relates to vascular methods and apparatus which can used
for creating an anatomic working space alongside an elongate
structure, such as a vessel or nerve, for example.
BACKGROUND OF THE INVENTION
[0003] In commonly assigned copending application Ser. No.
07/893,988, filed on Jun. 2, 1992, apparatus and methods are
disclosed for developing an anatomic working space for laparoscopic
procedures using balloon dissection. In commonly assigned copending
application Ser. No. 08/570,766, filed on Dec. 12, 1995, further
improvements to the apparatus and methods disclosed in application
Ser. No. 07/893,988 are disclosed. The disclosure of each of these
prior applications is hereby incorporated by reference in its
entirety. The apparatus and methods disclosed in the referenced
prior applications include balloon dissection apparatus with
relatively large surface balloons which expand laterally and are
not particularly well suited for surgical procedures on elongate
structures. There is therefore a need for new and improved balloon
dissection apparatus and associated methods of use for dissecting
or creating space alongside elongate structures in the body.
SUMMARY OF THE INVENTION
[0004] The present invention provides balloon dissection apparatus
and methods of use in which an elongate balloon is utilized to
dissect along a region that follows a naturally existing path
alongside a vessel or structure, such as an artery, a vein, a
lymphatic vessel, the trachea, the esophagus, or even a nerve
bundle.
[0005] The balloon dissection apparatus for use in extraluminal
balloon dissection as described herein may utilize an elongate
balloon with a tunneling shaft assembly of the types described in
any one of copending U.S. application Ser. Nos. 07/893,988,
08/124,283, 08/267,488, 08/388,233, 08/403,012, or 08/570,766, the
disclosure of each of which is hereby incorporated by reference in
its entirety. U.S. Pat. No. 4,271,839 to Fogarty et al. which
discloses a balloon catheter with an inverted balloon is also
expressly incorporated by reference herein.
[0006] In a preferred embodiment, the deflated elongate balloon has
at least a part of its distal extremity folded inwardly to shorten
its predeployment length. The distal portion of the elongate
balloon may be inverted into the proximal portion and folded
inwardly to provide a balloon having a folded length of roughly
one-half the length of the fully distended balloon. Additional
inward folds may be provided to further shorten the balloon.
[0007] In another preferred embodiment, a thumb-shaped balloon
reservoir may be provided as an integral portion of the elongate
balloon. The balloon reservoir generally remains outside the body
and serves to store the distal portion of the inverted, folded
balloon prior to deployment. By storing the bulk of the deflated
balloon outside of the body in the reservoir a longer balloon can
be utilized. Provision is made for laparoscopic observation.
[0008] A bi-directionally expanding balloon is also disclosed which
is useful when anatomical obstructions would cause a balloon
expanding in one direction only to be blocked. The bi-directional
balloon may be utilized either with or without the aid of
laparoscopic observation.
[0009] In a preferred method of performing extraluminal balloon
dissection, a deflated and folded elongate balloon is inserted into
an incision in the body adjacent the elongate structure aided by a
laparoscope, a finger, or other tunneling member. The folded
elongate balloon is then optionally bluntly advanced alongside the
elongate structure until a region where it is desired to perform
balloon dissection is reached. As the balloon is advanced alongside
the elongate structure a laparoscope may be utilized to observe
beyond the distal end of the balloon, either from within or
alongside the balloon. An inflation medium is then introduced into
the balloon to cause the balloon to evert and propagate distally
alongside the elongate structure to dissect the structure along a
natural tissue plane. The laparoscope may also be use to observe
dissection as the balloon propagates alongside the structure if
provided. After the structure has been dissected the balloon may be
deflated and withdrawn through the incision. The anatomic operating
space alongside the vessel created by the dissecting balloon may
then be insufflated and a surgical procedure performed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Reference is made to the accompanying drawings, where like
reference numerals are used on like parts and where illustrative
embodiments of the invention are shown from which one of ordinary
skill in the art will appreciate novel features and advantages of
the present invention.
[0011] In the drawings:
[0012] FIG. 1 is a side elevational view of an extraluminal balloon
dissection apparatus incorporating aspects of the present
invention.
[0013] FIG. 2 is a cross-sectional view taken along line 2-2 in
FIG. 1.
[0014] FIG. 3 is a view of the-human leg illustrating the present
invention being used to create an anatomic working space alongside
a saphenous vein during a saphenous vein bypass procedure.
[0015] FIG. 4 is a cross sectional view taken along line 4-4 in
FIG. 3.
[0016] FIG. 5 is a side elevational view of another embodiment of
an extraluminal balloon dissection apparatus according to the
present invention.
[0017] FIG. 6 is a cross sectional view taken along lines 6-6 in
FIG. 5.
[0018] FIG. 7 is a side elevational view of yet another embodiment
of an apparatus according to the present invention.
[0019] FIG. 8 is a cross sectional view taken along line 8-8 in
FIG. 7.
[0020] FIG. 9 is a cross sectional view showing the balloon of FIG.
8 after it has been inflated.
[0021] FIG. 10 is a plan view of another embodiment of an
extraluminal balloon dissection apparatus according to the
invention illustrating the folding and storage of the elongate
balloon within a thumb-shaped balloon reservoir.
[0022] FIG. 11 is a plan view of the apparatus of FIG. 10 showing
the elongate balloon fully distended after inflation.
[0023] FIG. 12 is plan view of another embodiment of an
extraluminal balloon dissection apparatus according to the
invention utilizing an elongate balloon and a thumb-shaped balloon
reservoir.
[0024] FIG. 13 is a plan view of the apparatus of FIG. 12 showing
the elongate balloon fully distended after inflation.
[0025] FIG. 14 is a plan view of another embodiment of an
extraluminal balloon dissection apparatus according to the
invention utilizing a balloon reservoir and a bulb-shaped
balloon.
[0026] FIG. 15 is a plan view of yet another embodiment of an
extraluminal balloon dissection apparatus according to the
invention utilizing a balloon reservoir and a bulb-shaped
balloon.
[0027] FIG. 16 is a side elevational view of another embodiment of
an extraluminal balloon dissection apparatus according to the
invention having two balloon reservoirs and a bi-directionally
expanding elongate balloon.
[0028] FIG. 17 is a side elevational view of the FIG. 16 embodiment
illustrating the apparatus after the bi-directionally expanding
balloon has been inflated and is fully distended.
[0029] FIG. 18 is a side elevational view of another embodiment of
an extraluminal balloon dissection apparatus according to the
invention which is substantially similar to the embodiment of FIG.
16, which provides for laparoscopic observation.
[0030] FIG. 19 is a side elevational view of the FIG. 18 embodiment
after the bi-directionally expanding balloon has been inflated and
is fully distended.
[0031] FIG. 20 is a plan view of a balloon reinforcing sleeve which
may be utilized with an extraluminal balloon dissection apparatus
in accordance with the invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
[0032] In the exemplary embodiment illustrated in FIG. 1, an
extraluminal balloon dissection apparatus 11 includes a tunneling
shaft assembly 30 substantially similar to the tunneling shaft
assembly disclosed in application Ser. No. 07/893,988, an elongate
balloon 32, a skin seal 21, and a removable balloon cover 51. The
tunneling shaft assembly 30 has a three-piece handle 13.
Alternatively, a hollow tube having either a one or two piece
handle construction as disclosed in Ser. No. 08/570,766 may be
utilized with an elongate balloon according to the invention. The
three-piece handle 13 includes a cannula 18, an obturator 15, and a
tunneling shaft 16, each of which extend from a different section
of the handle 13. The tunneling shaft 16 extends through a bore in
the obturator 15, and the obturator 15 extends through the cannula
18. The tunneling shaft 16 may have an olive-shaped, or other blunt
shaped obturator 17 mounted on its distal end to provide a blunt
distal end for tunneling. A skin seal 21 substantially as described
in Ser. No. 08/124,283 may be utilized if needed for the procedure
to be performed, in which case, the skin seal 21 is slidably
mounted and frictionally retained on the outer surface of the
cannula 18. A moveable collar 26 on the skin seal 21 provides for
adjustment on and locking to the outer surface of the cannula 18.
The outer surface 22 of the skin seal 21 is progressively
cylindrical and tapered and provided with helical screw threads 23
for engaging the skin of the patient to form a seal therewith.
[0033] As shown in FIGS. 1 and 2, an elongate balloon 32 is mounted
on the tunneling shaft 16 which is part of the tunneling shaft
assembly 30. The elongate balloon 32, which may be described as
having a hot dog shape, is generally cylindrical and has a distal
end 34 which extends substantially beyond the distal most point of
the tunneling shaft 16 when fully inflated, as shown by the dashed
extension lines in FIG. 1. The elongate balloon 32 is preferably
formed from a nonelastic material so that its expansion envelope
can be fairly well regulated as is known to those of skill in the
art. The balloon cover 51, which may be formed integrally with the
balloon 32 as disclosed in copending application Ser. No.
08/570,766, for example, or as a separable component as illustrated
in FIG. 1, encloses the deflated balloon 32 and holds it against
the tunneling shaft 16.
[0034] Prior to use, the distal portion 34 of the deflated balloon
32 is folded inwardly to shorten its length so that the distal
portion 34 of the folded balloon 32 does not extend substantially
beyond the distal extremity of the tunneling shaft 16. The distal
portion 34 of the balloon 32 can be folded inwardly by inverting
the distal portion 34 of the balloon 32 into the proximal portion
35 so that approximately one-half of the length of the balloon 32
is folded into the other half of the balloon 32. This reduces the
overall length of the deflated balloon 32 to approximately one-half
of its fully extended length. If a shorter folded balloon 32 is
necessary for the particular procedure contemplated, it is possible
to further shorten the balloon 32 by again folding the distal most
portion of the balloon 32 inwardly so that the deflated balloon 32
is now only approximately one-fourth of its fully extended
length.
[0035] In the embodiment shown in FIGS. 1 through 4, the balloon 32
is releasably secured to the tunneling shaft 16 by a sleeve 36, as
best shown in FIG. 2. The sleeve 36 can be formed from the same
material as the balloon 32 and may be formed as an integral part of
the balloon 32 by bonding the balloon material together as shown at
reference numeral 37 in FIG. 2. Alternatively, the sleeve 36 may be
formed as a separate member of the balloon 32 and bonded to the
balloon 32 by welding, heat sealing, or through the use of a
suitable adhesive, for example. The sleeve 36 extends substantially
along the entire length of the balloon 32 and circumscribes the
tunneling shaft 16. The sleeve 36 is preferably provided with a
weakened region 37 extending the length thereof which can be formed
in a suitable manner, such as by providing axial perforations
extending along the length of the sleeve 36. The weakened region 37
permits the sleeve 36 to be separated from the tunneling shaft 16
when it is desired to separate the balloon 32 from the tunneling
shaft 16, as will be described below.
[0036] In order to inflate the balloon 32, a flexible tubular
member 41 may be utilized as an inflation lumen for the balloon 32.
The distal extremity of the tubular member 41 is inserted into the
balloon 32 so that the lumen in the tubular member 41 opens into
the interior space of the balloon 32. A wye adaptor 42 is secured
to the proximal extremity of the tubular member 41. A hand operated
syringe 43 may be connected to the wye adaptor 42 as shown in FIG.
1 and utilized to inflate the balloon 32 with a suitable fluid,
such as saline solution, for example. The wye adaptor 42 is also
connected to another fitting 44 by tube 46 which has a pinch clamp
47 mounted thereon. A male evacuation fitting 44 terminates the
tube 46 and may be connected to wall suction to evacuate the
balloon 32 after the balloon 32 has been deployed to dissect as
will be described below.
[0037] In FIGS. 1 through 4, a removable balloon cover 51 of the
type described in copending application Ser. Nos. 07/893,988 or
08/124,283 may be utilized in connection with the extraluminal
balloon dissection apparatus 11 disclosed herein. The removable
balloon cover 51 serves to frictionally retain the collapsed
balloon 32 relative to the tunneling shaft 16. The removable
balloon cover 51 preferably has a weakened region 52 (see FIG. 2)
extending along the length thereof to permit the balloon cover 51
to be separated from the balloon 32 and the tunneling shaft 16 when
it is desired to inflate the balloon 32. An integral balloon cover
of the type described in Ser. No. 08/267,488, for example, may be
utilized with the balloon dissection apparatus 11 in lieu of the
removable cover 51. Such an integral balloon cover may be provided
with a weakened region extending along its length so that the
balloon cover separates from the balloon 32 and the tunneling shaft
16 as the balloon 32 is inflated. Alternatively, the balloon 32 can
be packed into the balloon cover 51 without a guide shaft 16.
[0038] Turning now to FIGS. 3 and 4, operation and use of the
extraluminal balloon dissection apparatus 11 will now be described
in connection with an exemplary balloon dissection procedure. One
example of a procedure where the present balloon dissection
apparatus 11 may be used is saphenous vein bypass procedure where
it is desired to improve the circulation of arterial blood in the
leg 61 of a patient having a diseased artery in the leg 61. As
shown in FIG. 3, to perform this procedure, an incision 63 is made
through the skin 67 in the leg 61 immediately adjacent the
saphenous vein 64 selected to serve as the bypass. The distal
extremity defined by the olive-shaped tip 17 of the balloon
dissection apparatus 11 is then introduced through the incision 63
and advanced along the saphenous vein 64 between the vein 64 and
the skin 67 until the tunneling shaft 16 and folded balloon 32 are
disposed within the leg 61 adjacent the saphenous vein 64. It
should be appreciated that, if desired, dissection can be
accomplished along the saphenous vein 64 on the side of the vein 64
away from the skin 67.
[0039] When the tunneling shaft 16 and folded balloon 32 are in the
proper position adjacent the saphenous vein 64, the balloon cover
51 is removed, either by physically removing the balloon cover 51
(facilitated by finger ring 31) and withdrawing the cover 51 from
the incision or, alternatively, in the case where an integral
balloon cover is utilized, by merely inflating the balloon 32 which
causes the integral cover to separate. Once the balloon cover 51
has either been removed (or separated by inflation of the balloon
in the case of an integral cover), the balloon 32 is progressively
inflated by introducing a fluid, such as saline solution, for
example, through the syringe 43 into the interior space of the
balloon 32. As the balloon 32 begins to inflate, the distal portion
34 of the balloon 32 begins to unroll, everting outwardly and
propagating in a distal direction downwardly in the leg 61 toward
and beyond the knee 66 until the distal portion 34 of the balloon
32-is fully extended, as shown by the dashed line in FIG. 3. The
saphenous vein 64 is dissected from adjacent tissue along its
length as the balloon 32 progressively expands and forms a tunnel
alongside the vein 64. Dissection follows a natural tissue plane
immediately adjacent the vessel or elongate structure. The
dissecting balloon 32 propagates along the vessel following a
natural tissue separation plane between the vessel and surrounding
tissue. Thus, dissection occurs as the balloon 32 progressively
inflates and follows the desired natural separation plane alongside
the vessel.
[0040] After the balloon 32 has been completely inflated and has
extended alongside the vein 64 causing the vein 64 to be dissected
from adjacent tissue, the balloon 32 is deflated by opening the
clamp 47 End applying suction to fitting 44. After deflation, the
balloon 32 may be withdrawn through the incision 63 by pulling on
the tubular member 41 to cause the releasable balloon 32 to be
separated from the tunneling shaft 16 along the weakened region 37
of the sleeve 36. The skin seal 21 is then optionally advanced and
threaded into the incision 63 to form a gas-tight seal with the
skin 67 if it is desired to insufflate the dissected space
alongside the saphenous vein 64. An insufflation gas may be
introduced through the fitting 14 on the handle 13 into the
dissected space between the saphenous vein 64 and the skin 67 to
provide an anatomic working space (68 in FIG. 4) extending
lengthwise along the saphenous vein 64. The entire tunneling shaft
assembly 30 can then be removed from the incision 63, leaving the
skin seal 21 and cannula 18 in place to maintain a gas-tight seal
with the leg 61. The cannula 18 may be provided with a duckbill or
flapper valve (not shown) to prevent the insufflation gas from
escaping through the cannula 18 after withdrawal of the tunneling
shaft assembly 30.
[0041] The saphenous vein 64 has side branches 69 which are exposed
within or adjacent to the insufflated anatomic space 68 extending
along saphenous vein 64. Clips (not shown) can be applied to the
side branches 69 in several ways. For example, an incision can be
made at the distal extremity of the insufflated space 68 by the use
of a trocar, for example, and a clip applier can be introduced
through the trocar and hemostats or clips can be applied to the
side branches 69. In order to facilitate this aspect of the
procedure, a laparoscope may be introduced through the skin seal 21
to permit the placement of the clips to be observed. In this
manner, many of the side branches 69 can be clipped utilizing only
one incision in the groin and another incision below the knee 66.
Thus, the procedure of the present invention greatly reduces the
number of incisions required to clip the side branches 69 of the
saphenous vein 64 over traditional open bypass procedures.
[0042] Another method of clipping the side branches 69 involves the
use of an operating endoscope which may be introduced through the
skin seal 21. The operating endoscope has an instrument channel
through which a clip applier can be introduced into the dissected
space adjacent the saphenous vein 68 to clip off the side branches
69 while the procedure is being viewed through the endoscope.
[0043] If it is desired to advance still further down the leg 68
than can be accomplished with the first balloon dissection
apparatus 11, a second similar balloon dissection apparatus 11 can
be introduced through a second incision lower down the leg and the
same procedure utilized to dissect the saphenous vein 64 down to
the ankle of the patient. The same procedure as described above can
be utilized to clip off the side branches 69 of that portion of the
saphenous vein 64 that is dissected by use of the second apparatus
11. After clipping of the side branches 69 has been completed,
valves within the saphenous vein 64 can be removed in a
conventional manner if that is desired. To perform the arterial
bypass procedure, the upper portion of the saphenous vein 64 can
then be connected through the first incision to the artery it is
desired to bypass and reconnected through the lower incision. The
incisions may be closed in a conventional manner.
[0044] By utilizing a balloon dissection apparatus of the present
invention, it is possible to provide working access to the
saphenous vein 64 through only moderate sized incisions made at the
top and bottom of the leg 61 and possibly one additional incision
in the middle of the leg 61. Thus, use of an extraluminal balloon
dissection apparatus eliminates many of the incisions in the leg 61
which have previously been required in order to clip off or occlude
the side branches 69 of the saphenous vein 64. The reduced number
and length of incisions greatly reduces the risk of infections from
multiple and large surface area incisions. From a patient
standpoint, the pain and recovery time in the hospital are greatly
reduced over traditional procedures.
[0045] Balloon dissection apparatus as disclosed herein can also be
used for harvesting the saphenous vein for use in a coronary artery
bypass procedure, for example. In the past, it has been necessary
to make a full length incision all the way down the leg 61 of the
patient to remove the saphenous vein 64 for the bypass procedure.
With a balloon dissection apparatus of the present invention, it is
possible to make a single incision in the groin in the patient and
then utilize the balloon dissection apparatus to create an anatomic
working space adjacent the saphenous vein 64 in the leg 61 through
balloon dissection. This can be accomplished by introducing an
extraluminal balloon dissection apparatus 11 alongside the
saphenous vein 64 and thereafter inflating the balloon 32 to cause
it to evert outwardly and propagate down the leg, in the process
dissecting tissue away from the saphenous vein 64 along
substantially the entire length of the saphenous vein 64 to create
an anatomic working space, as previously described. In this
procedure the inflation pressures for the balloon 32 are generally
below one atmosphere.
[0046] After dissection has occurred, the balloon 32 is removed,
and the anatomic working space 68 created by balloon dissection is
then insufflated and additional trocars, as needed, are inserted
into the insufflated dissected space 68. Side branches 69 of the
saphenous vein 64 may be exposed by additional manual dissection
and are clipped and transected. The saphenous vein 64 is then
dissected free from its surrounding tissue bed and the proximal and
distal ends of the vein 64 are clipped and transected to allow the
saphenous vein 64 to be removed or harvested through the incision
63. This approach drastically reduces the length of the incision 63
which is normally required to harvest the saphenous vein 64. The
saphenous vein 64 can be pulled out through the incision 63 and the
side branches 69 can be closed on the operating table in a standard
procedure. Similarly, as previously described, valves within the
saphenous vein 64 can be removed or disabled in a conventional
fashion if need be.
[0047] In connection with the present invention, it has been found
preferable to utilize a nonelastomeric balloon 32 so that it is
possible to control the shape of the dissected region. By way of
example, for extraluminal procedures involving the saphenous vein,
it is desirable to have a tunneling shaft 16 with a length of
approximately 12 inches and a fully distended balloon 32 having a
axial length of 20 to 30 inches and a maximum diameter when
inflated of approximately 1 to 3 inches. It should be appreciated
that different sizes of balloons can be provided in accordance with
the present invention to provide inflated diameters as great as 3
to 4 inches where that may be necessary or desirable.
Alternatively, the extraluminal dissection balloons can be of a
relatively small diameter, such as 10 millimeters, for example,
when it is desired to tunnel down along the natural plane of an
artery for the purpose of inserting a synthetic graft, for
example.
[0048] In place of a rigid tunneling shaft assembly 30, it should
be appreciated that a semi-rigid tunneling assembly could be
provided to give some flexibility, yet enough rigidity to make
blunt dissection possible to facilitate the advancement of the
balloon 32 to a desired location alongside the vessel of interest.
It should also be appreciated that such a balloon dissection
apparatus 11 could be utilized in conjunction with other vessels in
the human body, as well as with other elongate structures such as
the esophagus, carotid arteries, brain drain shunts, and
nerves.
[0049] Another embodiment of an extraluminal balloon dissection
apparatus 71, according to the invention, is shown in FIGS. 5 and
6. In this embodiment, the apparatus, 71 includes a conventional
endoscope 72 which has a housing 73, a light inlet fitting 74
mounted on the housing 73, and an eye piece 76. The laparoscope 72
has a probe 77 extending from the housing 73. An objective lens
(not shown) mounted in the distal extremity 78 of the probe 77 may
provide a suitable viewing angle, such as a straight viewing angle
parallel to the longitudinal axis of the probe 77 or an angle of 30
degrees with respect to the longitudinal axis, for example. As is
well known to those of the skill in the art, the laparoscope 72 is
provided with optics for receiving a light source at the fitting 74
and directing the light out the distal extremity 78 of the probe 77
so that light is supplied beyond the distal end 78 of the probe 77.
This permits the surgeon to observe beyond the distal end 78 of the
probe 77 through the eyepiece 76 or on a video monitor, if the
laparoscope utilized is capable of providing a video output.
[0050] The balloon dissection apparatus 71 may utilize, as a
tunneling member, an elongate tubular member 81. The tubular member
81, in addition to serving as a scope cover for the laparoscope 72,
also serves as a tunneling member to permit the apparatus 71 to be
advanced bluntly alongside the saphenous vein, following a natural
dissection plane adjacent the vein. The tubular member 81 can be of
the type described in copending application Ser. No. 08/267,488 and
is preferably formed of a suitable transparent material, such as a
clear polycarbonate. The tubular member 81 has a bore extending
therethrough which is sized so that it can readily accommodate the
probe 77 of the laparoscope 72. The tubular member 81 may have
sufficient length to accept the entire length of the probe 77. The
tubular member 81 has a rounded, substantially hemispherical tip 84
at its distal extremity which can be formed integrally therewith as
shown, or alternatively, as a separate piece and bonded to the
tubular member 81 by the use of a suitable adhesive, for example.
The tubular member 81 may also have an open, yet blunt, distal
extremity as disclosed in copending application Ser. No.
08/570,766, to permit observation through the laparoscope 72
through the open distal end. When a closed, rounded tip 84 is
utilized as shown in FIG. 5, the tip 84 is preferably formed from a
transparent material, such as a clear polycarbonate, to facilitate
observation through the distal end 84.
[0051] To further facilitate observation through a closed distal
end, a baffle 86 may be mounted in the bore of the tubular member
81 and extends laterally and axially thereof. The baffle 86 can be
formed integrally with the distal end 84 or, alternatively, can be
formed of a separate material which is then bonded to the distal
end 84 by a suitable adhesive. Assuming that the laparoscope 72 is
of a type in which the light transmitting capabilities are provided
in one semi-circular region of the probe 77, and viewing
capabilities are provided through the other semi-circular region,
the baffle 86 is positioned in such a manner so that it will
inhibit, if not prevent, light emitted from the distal extremity 78
of the probe from bouncing off the inner surface of the distal end
84 and creating a glare which may obscure vision through the eye
piece 76. In order to prevent such a glare, the baffle 86 is
preferably formed of an opaque material, such as a black opaque
material, for example. Alternatively, the baffle 86 may be provided
with one surface which is opaque so that light cannot be
transmitted through the baffle 86 to the lower half of the probe 77
making a clear field of vision possible through the tubular member
81.
[0052] An elongate balloon 92 similar to the balloon 32 in the
previous embodiment may be utilized with the apparatus 71. The
balloon 93 has proximal and distal extremities 93 and 94,
respectively. (See FIG. 6). As in the previous embodiment, the
distal extremity 94 may be folded inwardly into the interior of the
balloon 92 to reduce the overall balloon length by approximately
one-half. As previously described, the balloon 92 may have its
overall length reduced even further by additional inward folding.
As shown in FIG. 6, the balloon 92 has a sleeve 96 extending
axially thereof for at least a portion of its length. The sleeve 96
surrounds the tubular member 81 and secures the balloon 92 to the
tubular member 81. The sleeve 96 is provided with a weakened region
97 extending the length thereof to permit the balloon 92 to be
removed from the tubular member 81. A tubular member 98 of the type
previously described extends into the interior space of the balloon
92 and may be connected to a suitable inflation source, such as a
syringe, for example, to communicate fluid through its internal
lumen into the balloon 92.
[0053] As in the previous embodiment, a removable balloon cover 101
may be utilized in connection with the apparatus 71. Alternatively,
an integral balloon cover, as previously described, may also be
used. The balloon cover 101 surrounds the folded balloon 92 and
retains the balloon 92 in close proximity to the tubular member 81
prior to removal of the cover 101 and deployment of the balloon 92.
The balloon cover 101 has a weakened region 102 (see FIG. 6)
extending the length thereof and may be provided with a finger ring
103 to facilitate removal of the cover 101, as previously
described.
[0054] A skin seal 106 of the type previously described may also be
utilized in connection with the apparatus 71. The skin seal has a
conical surface which is provided with a continuous helical thread
111. An axially movable collar 112 is mounted on the skin seal 106
and is moveable to releasably clamp the skin seal to the scope
cover 81.
[0055] Operation and use of the extraluminal balloon dissection
apparatus 71 is very similar to that of the balloon dissection
apparatus 11 previously described. The principal difference in the
this embodiment is that a laparoscope 72 is continuously available
during the introduction of the apparatus 71 into an incision and
during advancement of the apparatus 71 alongside the elongate
structure or vessel to be dissected free of adjacent tissue. As
before, the apparatus 71 can be tunneled alongside the saphenous
vein, either on the side of the saphenous vein adjacent the skin,
or on the side away from the skin. The balloon 92 is then inflated
to dissect the vein away from adjacent tissue beyond the distal end
84 of the tubular member 81. It has been found preferable to
dissect alongside the saphenous vein on the side of the leg away
from the skin. By utilizing this approach, the light from the
laparoscope 72 makes it possible to visually identify the saphenous
vein location and side branches by forming a silhouette on the
skin. This makes it possible to locate further necessary incisions
and minimize their size.
[0056] After the balloon 92 has been disposed adjacent the
saphenous vein or other elongate structure, the cover 101 is
removed from the folded balloon 92 and tubular member 81, by
separation along its weakened region 102. Removal of the cover 101
is facilitated by finger ring 103. The balloon 92 is then inflated,
and the balloon 92 unrolls and everts in a distal direction to
dissect the saphenous vein from adjacent tissue beyond the distal
end 84 of the tubular member 81. (If an integral cover is utilized
in lieu of the hard cover 101, the integral cover ruptures along
its weakened region during inflation thereby releasing the balloon
92). The balloon 92 can be viewed through the laparoscope 72 as it
unrolls through the laparoscope 72. After the balloon 92 is
completely distended and inflated, it can be deflated as previously
described and stripped off the tubular member 81 along the weakened
region 97, and withdrawn through the incision. Thereafter, the skin
seal 106 may be threaded into the incision to provide a
substantially gas-tight seal therewith if a gas-tight operating
space is desired. The laparoscope 72 and tubular member 81 can then
be removed from the skin seal 106 and a cannula having an
insufflation capability can be introduced through the skin seal 106
to insufflate the dissected anatomic working space adjacent the
vessel. Alternatively, another incision can be made and the desired
surgical procedure can be performed through the other incision
while viewing through the laparoscope 72 already inserted in the
first incision. Thus, the balloon dissection apparatus 71 offers
the advantages obtained with the balloon dissection apparatus 11
previously described, while at the same time making it possible to
view blunt dissection as it occurs adjacent the saphenous vein or
other elongate structure.
[0057] Referring now to FIGS. 7 through 9, another embodiment of a
balloon dissection apparatus 121 according to the present invention
is illustrated. The apparatus 121 is substantially similar to the
apparatus 71 of the previous embodiment, the difference being that
the tubular member 81 is inserted into (rather than being disposed
alongside) the elongate balloon 136. As in the previous embodiment,
the tubular member 81 receives a conventional laparoscope 72 and
serves the dual function of a scope cover and blunt tunneling
member.
[0058] As shown in FIG. 7, the tubular member 81 is inserted inside
the inverted and folded elongate balloon 136 between one of the
inwardly folded layers of the balloon 136 and an outer, proximal
balloon layer. The elongate balloon 136 may have its proximal end
137 secured to the tubular member 81 in a fluid-tight manner, such
as by gluing or other bonding techniques. Alternatively, the
elongate balloon 136 may be completely sealed, and the tubular
member 81 inserted into the proximal end of the elongate balloon
136, inverting the sealed balloon 136 inwardly as the tubular
member 81 is advanced toward the distal most portion of the balloon
136, as disclosed in application Ser. No. 08/570,766.
[0059] In the exemplary embodiment of FIG. 7, the distal portion
139 of the balloon 136 is inverted and folded into the proximal
portion 137 of the balloon 136 such that the distal half of the
balloon 136 resides within the proximal half, as previously
described. The tubular member 81 is inserted through the open
proximal end of the balloon 136 and advanced between the balloon
layers defining the proximal and distal halves of the balloon 136
until its distal extremity is adjacent the approximate midpoint,
now distal, fold in the balloon 136. Because the tubular member 81
and hence, the laparoscope 72, are within the interior space of the
balloon 136, the balloon 136 is preferably formed from a
substantially transparent material so that laparoscopic observation
is still possible. In this case, observation occurs through the
distal extremity of the tubular member 81 and the folded balloon
136. An opaque baffle 86, as previously described, may be utilized
to minimize unwanted reflections of light into the laparoscope 72.
Alternatively, a tubular member 81 having an open distal end
substantially as described in copending application Ser. No.
08/570,166 may be utilized so that laparoscopic observation is
through the open distal end of the tubular member 81.
[0060] A balloon cover 146, having a longitudinally extending and
weakened region 147, may also be utilized in this embodiment. The
balloon cover 146 serves to compress the folded collapsed balloon
136 into a more compact state and to frictionally retain the
balloon 136 on the tubular member 81 during tunneling advancement
of the apparatus 121. It is to be noted that an integral cover, as
previously described, could be utilized in lieu of the removable
balloon cover 146 in this embodiment as well.
[0061] Operation and use of the balloon dissection apparatus 121 is
substantially similar to that of the previous embodiments. Because
the balloon 136 and the distal extremity of the scope cover 81 are
substantially transparent, observation through the laparoscope is
possible during blunt tunneling and subsequent balloon dissection.
After the apparatus 121 has been inserted through an incision
adjacent the elongate structure to be dissected and advanced
bluntly under laparoscopic observation, if desired, to the location
where dissection is to be performed, the balloon cover 146 is
removed and the balloon 136 is inflated through the tubular member
98. The balloon cover 146 is removed by pulling the finger ring 103
proximally to cause the balloon cover 146 to separate from the
tubular member 81 and balloon 136 along its weakened region
147.
[0062] As the balloon 136 is inflated, it everts and propagates
distally following a natural separation plane alongside the
elongate structure in a manner similar to the balloons previously
described. The balloon 136 inflates around the tubular member 81
providing an anatomic working space adjacent the elongate
structure, as shown in cross-section in FIG. 9. After the elongate
structure has been dissected from adjacent tissue by the balloon
136, the balloon 136 is deflated and the apparatus 121 and
laparoscope 72 are withdrawn through the incision, either serially
or together. The remainder of the surgical procedure is then
completed and the incision (or incisions) closed.
[0063] Another embodiment of a balloon dissection apparatus 200
according to the invention is shown in FIGS. 10 and 11. The
apparatus 200 is provided with a laterally extending thumb-shaped
reservoir 201 which is itself part of the elongate balloon 203. A
housing 202 having a tubular balloon sleeve 206 extending therefrom
terminates the balloon 203 and may receive a laparoscope (not
shown) if visualization is required or desirable for the procedure
contemplated. An instrument seal 204, which may be of the type
described in copending application Ser. No. 08/570,766, is mounted
in the housing 202 to provide a fluid-tight seal between the
interior of the handle 202, which is in fluid communication with
the interior of the balloon 202, and a laparoscope. The balloon
sleeve 206 is similar to the balloon sleeve described in copending
application Ser. No. 08/403,012, and may be formed integrally with
the housing 202 or as a separate member.
[0064] The elongate balloon 203 is substantially similar to the
balloons utilized in connection with the previous embodiments and
may be inverted and folded inwardly to reduce its predeployment
length in similar fashion. The proximal end of the balloon 203 is
open and may be terminated in a fluid-tight manner in the housing
202, as shown, or on an outer surface of the balloon sleeve 206.
The open proximal end of the balloon 203 may be secured between the
interior of the housing 202 and the balloon sleeve 206 as described
in application Ser. No. 08/403,012. The balloon 203 is preferably
formed from a substantially transparent material to facilitate
laparoscopic observation through the balloon 203 as described
below.
[0065] Prior to use, the distal portion 205 of the deflated balloon
203 is inverted and folded inwardly to shorten the overall length
of the balloon 203. The distal portion 205 of the inverted, folded
balloon 203 is pushed into the reservoir 201, as shown in FIG. 10.
Additional folds may be provided, as necessary, to further shorten
the deflated balloon 203 and to make it possible to store the
majority of the balloon 203 in the reservoir 201.
[0066] The reservoir 201 provides several advantages over the
previous embodiments. First, the reservoir 201 allows a more
compact design in that a long balloon may be folded and stored in
the reservoir 201 outside the body with only a relatively short
portion of the balloon 203 extending into the incision. This
feature is advantageous because it allows the use of a relatively
short insertion device (i.e., the balloon sleeve 206 or the distal
tip of the laparoscope when the balloon sleeve 206 is not provided,
as shown in later embodiments of the invention, or a finger of
hand) instead of the relatively long tunneling members contemplated
in the previous embodiments. In this regard, it has been found
desirable to utilize the balloon 203, which follows a natural
dissection plane, rather than a blunt tunneling member, which may
not follow the natural plane, to perform as much of the dissection
as possible. Second, because the majority of the balloon 203 is
disposed outside the body, the axial length of the balloon 203 is
not as constrained to the length of the tunneling member as in
previous embodiments.
[0067] An inflation harness 214, also of the type previously
described in Ser. No. 08/570,766, may be utilized to communicate a
suitable inflation medium, such as saline solution, for example, to
the interior of the balloon 203 to inflate the balloon 203. An
inflation lumen 207 extends from the balloon 203 and is connected
to a tubular member 208, which in turn is connected to a wye
fitting 209. Wye fitting 209 may have one port connected to a
luer-type fitting 213 and another port connected to another tubular
member 211. A pinch clamp 210 is mounted on the tubular member 211
and is clamped off during balloon inflation and opened during
deflation. A male fitting 212 terminates the tubular member 211 and
is suitable for connecting to a hospital evacuation source when it
is desired to deflate the balloon 203.
[0068] In a preferred method of use, a laparoscope is inserted
through the instrument seal 204 and advanced through the balloon
sleeve 206 until its distal end reaches the distal end of the
balloon sleeve 206 and the folded balloon 203 which covers the
distal end of the balloon sleeve 206. The apparatus 200 may then be
inserted into the body of a patient through an incision adjacent
the elongate structure to be dissected. Alternatively, the
apparatus 200 may be introduced through the incision into the body
without the aid of the laparoscope if observation is not required
or deemed necessary. Although a laparoscope is preferably utilized
with the apparatus 220, its use is optional in that the balloon
sleeve 206 functions as a separate tunneling member to facilitate
advancement of the apparatus 200 to the desired point adjacent the
elongate structure.
[0069] When a laparoscope is utilized, the apparatus 200 is
advanced alongside the elongate structure using the laparoscope
and/or balloon sleeve 206 as tunneling members until a desired
location for balloon dissection is reached. It is to be noted that
the reservoir 201 does not generally enter the incision and remains
outside the body. When the desired location is reached, the balloon
203 is inflated by connecting a suitable inflation source, such as
a syringe, for example, to the luer fitting 213 and introducing the
inflation medium into the interior of the balloon 203. As the
inflation medium is progressively introduced, the balloon 203
everts outwardly propagating alongside the elongate structure to
dissect adjacent tissue away from the structure, as previously
described. As the balloon 203 is inflated, the distal portion 205
of the balloon 203 stored in the reservoir 201 is gradually
withdrawn from the reservoir by the distal propagation of the
balloon 203. Inflation continues until the distal portion 205 of
the balloon 203 is completely withdrawn from the reservoir 201 and
the balloon 203 is fully distended alongside the structure. (See
FIG. 11) The surgeon can observe the progress of the dissection
procedure through the laparoscope from inside the balloon 203 as
the balloon 203 unrolls and propagates alongside the structure.
[0070] After an operating space adjacent the vessel or structure
has been created by dissection, the elongate balloon 203 is
deflated by opening the pinch clamp 210 and withdrawing the fluid
from the balloon 203 through the male fitting 212. The laparoscope
and apparatus 200 may then be withdrawn from the incision and
additional cannulas or other laparoscopic instruments, as
contemplated by the particular procedure being performed, may be
inserted through the incision into the dissected operating space
and the procedure completed.
[0071] Turning now to FIGS. 12 and 13, another embodiment of an
extraluminal balloon dissection apparatus 225 according to the
invention is disclosed. FIG. 12 illustrates the apparatus 225 as it
would appear prior to use with the elongate balloon 203 inverted,
folded and stored within balloon reservoir 201. FIG. 13 illustrates
the apparatus 225 after the balloon 203 has been inflated and fully
distended. The apparatus 225 is identical to the previous apparatus
200 except that the balloon sleeve 206 has been omitted and the
inflation harness 214 has been relocated from the side of the
balloon 203 to the reservoir 201. In this regard, it should be
noted that the inflation harness 214 in the embodiment of FIGS. 10
and 11 could also extend from the reservoir 201.
[0072] Use of the apparatus 225 is likewise identical to use of the
apparatus 200, with the exception that a laparoscope (not shown) is
preferably utilized to guide the apparatus 225 into the incision
and to advance the apparatus 225 to a point adjacent the elongate
structure to be dissected. The surgeon may also manually insert the
apparatus 225 into the incision adjacent the elongate structure
without the aid of a laparoscope.
[0073] If observation is desired, the laparoscope is inserted
through the seal 204 in the housing 202 and may be advanced
distally into the reservoir 201 following the withdrawal of the
folded balloon 203 from the reservoir 201. As continued inflation
causes the folded balloon 203 to propagate distally, the portion of
the balloon 203 stored in the reservoir 201 is withdrawn and the
laparoscope may be further advanced inside the interior space of
the distended balloon 203 as desired. The flexible apparatus 225
allows the insertion angle of the laparoscope to be easily adjusted
to parallel the structure being dissected.
[0074] In FIG. 14, an extraluminal balloon apparatus 230 has
bulb-shaped balloon 222 with an elongate neck which may be utilized
in place of the elongate hot dog shaped balloon 203 of the
apparatus illustrated in FIGS. 10 and 11. Similarly, FIG. 15
illustrates an apparatus 235 having a bulb-shaped balloon 222 with
an elongate neck 221 in place of the elongate balloon 203 in the
apparatus of FIGS. 12 and 13. Other than the shape of the balloon
222, the embodiments of the invention illustrated in FIGS. 14 and
15 are identical to their counterpart elongate balloon 203
embodiments illustrated in FIGS. 10 and 11 and FIGS. 12 and 13,
respectively.
[0075] The balloon 222 utilized in the FIG. 14 and 15 embodiments
has a wide surface area distal portion which may be shaped as
illustrated, or in any one of the shapes illustrated in application
Ser. No. 08/570,766, for example. An elongate neck 221 extends from
the distal portion of the balloon 222 and may be terminated within
the housing 202 or on the balloon sleeve 206 (if utilized) as
previously described. The deflated balloon 222 may be inverted
inwardly, and the outer margins of the distal portion of the
balloon 222 wrapped or folded together to compact and shorten the
balloon 222. The inwardly folded and wrapped balloon 222 may then
be pushed inside the balloon reservoir 201, as in previous
embodiments.
[0076] When the balloon 222 is inflated, it will evert and
propagate distally in a similar manner to that of the elongate
balloon 203 of the previous embodiments. When the balloon 222 is
essentially fully everted, the side margins of the distal portion
of the balloon 222 will unroll, and the distal portion of the
balloon 222 will fully expand. The balloon 222 may be used either
as a dissector or as a retractor, depending on the application. One
application where the balloon 222 has been found to have particular
utility is in connection with an aortic bifemoral bypass procedure,
where either apparatus 230 or 235 may be inserted into the femoral
canal of the patient and then inflated to cause the balloon 222 to
dissect and retract the peritoneum from the pelvic floor.
[0077] FIGS. 16 and 17 illustrate a bi-directional extraluminal
balloon dissection apparatus 240 which is provided with two
integrally formed balloon reservoirs 201, each of which function to
store approximately one-half of the bi-directionally expanding
elongate balloon 242. The balloon 242 has a left portion 243 and a
right portion 244, as shown packed in the reservoir 201 gird in the
deflated predeployment state in FIG. 16 and in the fully expanded
distended state in FIG. 17. The respective right 244 and left 243
halves of the elongate balloon 242 may be inverted inwardly and
folded in the manner previously described. Each respective half of
the folded elongate balloon 242 is then pushed into the opposite
reservoir 201. A balloon inflation harness 214 of the type utilized
in the previous embodiments may be utilized to inflate the balloon
242 and may be located on either one of the balloon reservoirs 201
or at some other point on the balloon 242.
[0078] The method of using the apparatus 240 is substantially
similar to the methods of use previously described with regard to
the prior embodiments. The apparatus 240 is inserted through an
incision adjacent an elongate structure, and the balloon 242 is
inflated. The right 244 and left 243 halves of the balloon 242 may
be deployed simultaneously or sequentially, as desired. In
practice, the right 244 and left 243 halves of the balloon 242 can
be made to deploy sequentially by manually or otherwise impeding
from unfolding one of balloon halves while the other half is
permitted to unfold. After the first half has unfolded and fully
distended, the manual restraint may be released to deploy the other
half. Each half of the balloon 242 everts and propagates distally
with the folded balloon halves withdrawing from the reservoir 201
as the balloon halves propagate in the manner previously
described.
[0079] A practical use of the apparatus 240 illustrated in FIGS. 16
and 17 is where it is desirable to avoid an anatomical structure
that lies in the desired dissection path if a single entry point
were utilized, or a structure which might impede dissection.
Alternatively, the apparatus 240 may be utilized where it is
desired to make an incision approximately at the midpoint of the
portion of the elongate structure to be dissected and then to
dissect the structure away from adjacent tissue in both axial
directions. One example of a location where it may be desirable to
utilize the bi-directional balloon 242 is the knee, where
anatomical structures within the knee may preclude, or make
difficult, use of an apparatus in which the dissecting balloon only
expands in one direction. The balloon 242 can be inserted through
an incision adjacent a blocking anatomic structure, and inflated to
cause the balloon halves to propagate in opposite axial directions
alongside an elongate structure, thereby avoiding the blocking
structure.
[0080] FIGS. 18 and 19 illustrate a variation on the apparatus 240
illustrated in FIGS. 16 and 17. The extraluminal balloon dissection
apparatus of FIGS. 18 and 19 differs from the apparatus 240, only
in that housings 202 having instrument seals 204 are provided to
receive a laparoscope. The housings 202 and seals 204 are as
previously described and are mounted on the balloon reservoirs 201
which are open-ended in this embodiment. The open-ended balloon
reservoirs 201 may be secured within the housing 202 in a
fluid-tight arrangement, as previously described. The addition of
housings 202 to the apparatus 245 permits a laparoscope (not shown)
to be inserted through the instrument seal 204 and the housing 202
into the interior space of the balloon 242. After the device 245
has been inserted through an incision in the body adjacent the
elongate structure by use of a finger or other aid, the elongate
bi-directional balloon 242 is inflated to dissect tissue adjacent
the elongate structure, starting from the middle of the structure
and thereafter propagating axially in two different directions.
(See FIG. 19) As the balloon 242 is inflated, a laparoscope may be
inserted through the housing 202 having the instrument seal 204 and
advanced following the balloon 242 alongside the structure being
dissected. In order to advance the laparoscope into the balloon
242, it may be necessary to bend the housing 202 and reservoir 201
slightly to align the laparoscope with the axis of the everting
balloon 242 as it dissects alongside the structure.
[0081] FIG. 20 illustrates the use of a reinforcing glove or sheath
250 which may be utilized to reinforce the region of the balloon
203 around the balloon reservoir 201. The reenforcing sleeve 250
may also extend distally of the reservoir 201, as shown in FIG. 20.
Although the use of a reinforcing sleeve 250 is illustrated in FIG.
20 in connection with the extraluminal balloon dissection apparatus
200 previously described with reference to FIGS. 10 and 11, it
should be appreciated that the reinforcing sleeve 250 could be
utilized in connection with any of the embodiments having a balloon
reservoir, or otherwise where it is desired to reinforce a portion
of a balloon. The reinforcing sleeve 250 may be formed of the same
material as the elongate balloon 203 and mounted such that it
surrounds the reservoir 201 and the portion of the elongate balloon
203 into which the balloon sleeve 206 extends. The reinforcing
glove 250 may be formed from a flat sheet or sheets of material and
may optionally be bonded to the reservoir 201. Alternatively, a
reinforced monolithic structure may be used. The function of the
reinforcing sleeve 250 is to reinforce any weak spots on a balloon
that may occur, on the reservoir 201 for example, or alternatively,
to reinforce a weak spot on a balloon that may occur within the
body. Such weak spots may be caused by manufacturing variations in
the balloon or by tissue differences within the body and, without
reinforcement, may be manifested in balloon aneurism behavior.
[0082] From the foregoing, it can be seen that the balloon
dissection apparatus and methods disclosed herein are particularly
suitable for the treatment of elongate structures, such as vessels,
using extraluminal procedures. Extraluminal balloon dissection as
disclosed herein has a wide variety of applications where it is
desired to dissect alongside an elongate structure to create an
anatomic working space exposing the structure. The procedures
contemplated herein are minimally invasive in that small incisions
are utilized and body tissue is minimally disrupted. Because
dissection is along a naturally occurring tissue plane adjacent the
elongate structure, bleeding is minimized and the time required for
healing is reduced. Other patient advantages offered by
extraluminal balloon dissection include marked reductions in
recovery time and post-surgery pain over traditional open
procedures.
[0083] Having thus described an embodiment of the invention, it
will now be appreciated that the objects of the invention have been
fully achieved, and it will be understood by one skilled in the art
that many changes in construction and widely differing embodiments
and applications of the invention will suggest themselves without
departing from the spirit and scope of the invention. Accordingly,
the written description provided herein is purely demonstrative and
is not intended to be in any sense limiting.
* * * * *