U.S. patent application number 11/654982 was filed with the patent office on 2007-05-24 for apparatus and method for dissecting tissue layers.
This patent application is currently assigned to General Surgical Innovations, Inc.. Invention is credited to Jan M. Echeverry, Thomas A. Howell, James E. Jervis, Helmut Kayan, Maciej J. Kieturakis, Kenneth H. Mollenauer, Janine C. Robinson.
Application Number | 20070118170 11/654982 |
Document ID | / |
Family ID | 27574531 |
Filed Date | 2007-05-24 |
United States Patent
Application |
20070118170 |
Kind Code |
A1 |
Kieturakis; Maciej J. ; et
al. |
May 24, 2007 |
Apparatus and method for dissecting tissue layers
Abstract
An expansible tunneling apparatus and associated methods for
creating an anatomic working space for a surgical procedure.
Various embodiments of one and two piece apparatus that permit
laparoscopic observation both during tunneling and during
subsequent balloon dissection are disclosed. In a disclosed one
piece embodiment, a tubular member has a bore extending
therethrough and an open distal end. A lip is formed in the distal
end of the tubular member to capture the distal tip of a
laparoscope that is inserted into the tubular member to permit
observation of the procedure both during tunneling to a desired
location and during subsequent balloon inflation. An elongated neck
of the balloon is secured to the tunneling member. The elongated
neck permits the tubular member to be withdrawn slightly from the
balloon after inflation to facilitate observation. After the
balloon has been advanced to the desired location in the body it is
inflated through a balloon inflation lumen to cause the balloon to
dissect tissue and create an operating space. Various balloon
constructions and a reusable design are also disclosed.
Inventors: |
Kieturakis; Maciej J.; (San
Carlos, CA) ; Mollenauer; Kenneth H.; (Los Gatos,
CA) ; Echeverry; Jan M.; (San Jose, CA) ;
Howell; Thomas A.; (Palo Alto, CA) ; Jervis; James
E.; (Atherton, CA) ; Kayan; Helmut; (Redwood
City, CA) ; Robinson; Janine C.; (Haft Moon Bay,
CA) |
Correspondence
Address: |
UNITED STATES SURGICAL,;A DIVISION OF TYCO HEALTHCARE GROUP LP
195 MCDERMOTT ROAD
NORTH HAVEN
CT
06473
US
|
Assignee: |
General Surgical Innovations,
Inc.
|
Family ID: |
27574531 |
Appl. No.: |
11/654982 |
Filed: |
January 17, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10786873 |
Feb 25, 2004 |
7179272 |
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|
11654982 |
Jan 17, 2007 |
|
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|
09252536 |
Feb 18, 1999 |
|
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|
10786873 |
Feb 25, 2004 |
|
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|
09107834 |
Jun 30, 1998 |
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09252536 |
Feb 18, 1999 |
|
|
|
08570766 |
Dec 12, 1995 |
5772680 |
|
|
09107834 |
Jun 30, 1998 |
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|
08403012 |
Mar 10, 1995 |
5540711 |
|
|
08570766 |
Dec 12, 1995 |
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|
08388233 |
Feb 13, 1995 |
5730756 |
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|
08403012 |
Mar 10, 1995 |
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08267488 |
Jun 29, 1994 |
5607443 |
|
|
08388233 |
Feb 13, 1995 |
|
|
|
08124283 |
Sep 20, 1993 |
5836961 |
|
|
08267488 |
Jun 29, 1994 |
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08073737 |
Jun 8, 1993 |
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08124283 |
Sep 20, 1993 |
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07893988 |
Jun 2, 1992 |
6312442 |
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08073737 |
Jun 8, 1993 |
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Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61F 2002/0072 20130101;
A61B 18/08 20130101; A61B 2017/320044 20130101; A61B 2017/320056
20130101; A61B 90/361 20160201; A61F 2/0063 20130101; A61F
2250/0003 20130101; A61B 2017/320048 20130101; A61B 17/320016
20130101; A61M 25/0668 20130101; A61B 90/02 20160201; A61M
2025/1004 20130101; A61B 17/0218 20130101; A61B 17/3439 20130101;
A61B 17/00234 20130101; A61B 17/02 20130101; A61B 2017/00557
20130101; A61B 2090/0813 20160201; A61M 25/1002 20130101; A61B
17/3421 20130101; A61B 2017/0225 20130101; A61M 25/1027 20130101;
A61M 29/02 20130101; A61B 2017/00902 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. (canceled)
2. A method for creating an anatomical working space in tissue in a
body comprising the steps of: inserting a laparoscope into a bore
of a tunneling member, the tunneling member having an open distal
end and a rolled balloon disposed on the distal end, the rolled
balloon formed from a flexible material; introducing the tunneling
member together with the laparoscope and the rolled balloon into an
opening in the body; advancing the tunneling member together with
the laparoscope and the rolled balloon to a desired location within
the body; inflating the balloon with a balloon inflation medium,
thereby causing the balloon to expand and creating the anatomical
working space; and advancing the laparoscope through the open
distal end of the tunneling member to observe dissection as it is
taking place.
3. The method of claim 2, wherein the balloon is formed from a
non-elastomeric material.
4. The method of claim 2, further comprising the step of: deflating
the balloon.
5. The method of claim 4, further comprising the step of: removing
the tunneling member together with the laparoscope and the balloon
through the incision.
6. A surgical introducer device comprising: an elongate tubular
member having a proximal end, a distal end, and a lumen
therebetween, the lumen adapted for receiving a surgical
instrument; an obturator having an open proximal end, a closed
distal end, and a bore therebetween, the obturator being configured
for insertion into the lumen of the elongate tubular member; at
least one baffle disposed in a distal portion of the bore of the
obturator; an inflatable balloon secured to the distal end of the
elongate tubular member, the inflatable balloon including at least
one inflatable compartment, the inflatable balloon fashioned of at
least one sheet that defines at least one wing, the inflatable
balloon including a weakened portion such that an at least
partially removable enclosure concealing the at least one
inflatable compartment is formed, the inflatable balloon being
adapted for fluid tight connection with the distal extremity of the
elongate tubular member; and a source of fluid for inflating the
balloon.
7. The surgical introducer of claim 6, further including a valve
housing including a valve mounted to the proximal extremity.
8. The surgical introducer of claim 6, further including a threaded
skin seal located proximal of the inflatable balloon.
9. The surgical introducer of claim 6, wherein the distal end of
the elongate tubular member is open and at least a portion of the
obturator is positionable therethrough.
10. The surgical introducer of claim 6, wherein an endoscope is
insertable into the obturator.
11. The surgical instrument of claim 10, wherein the at least one
baffle is opaque and inhibits reflections.
12. The surgical instrument of claim 10, wherein the at least one
baffle extends proximally from the distal end of the obturator to
inhibit the endoscope from contacting a transparent portion of the
obturator.
Description
[0001] This is a continuation of co-pending application Ser. No.
09/107,835, filed on Jun. 30, 1998, which is a continuation of
co-pending application Ser. No. 08/570,766, filed on Dec. 12, 1995,
which is a continuation-in-part of application Ser. No. 08/403,012,
filed on Mar. 10, 1995, which is a continuation-in-part of
application Ser. No. 08/388,233, filed on Feb. 13, 1995, which is a
continuation-in-part of application Ser. No. 08/267,488, filed on
Jun. 29, 1994, which is a continuation-in-part of application Ser.
No. 08/124,283, filed Sep. 20, 1993, which is a
continuation-in-part of application Ser. No. 08/073,737, filed on
Jun. 8, 1993, which is a division of application Ser. No.
07/893,988, filed on Jun. 2, 1992. The disclosures of each of these
prior applications are hereby incorporated by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to an apparatus and method
for developing an anatomic space for laparoscopic procedures, and
more specifically, to an apparatus and method that provides for
laparoscopic visualization both during tunneling dissection to the
desired anatomic space as well as during subsequent tissue
dissection during balloon inflation once the desired potential
space has been identified.
[0003] In the past, in developing spaces and potential spaces
within a body, blunt dissectors or soft-tipped dissectors have been
utilized to create a dissected space which is parallel to the plane
in which the dissectors are introduced into the body tissue. This
often may be in an undesired plane, which can lead to bleeding
which may obscure the field and make it difficult to identify the
body structures. In utilizing such apparatus and methods, attempts
have been made to develop anatomic spaces in the anterior,
posterior or lateral to the peritoneum. The same is true for
pleural spaces and other anatomic spaces. Procedures that have been
performed in such spaces include varicocele dissection, lymph node
dissection, sympathectomy and hernia repair. In the past, the
inguinal hernia repair has principally been accomplished by the use
of an open procedure which involves an incision in the groin to
expose the defect in the inguinal floor, removal of the hernial sac
and subsequent suturing the ligaments and fascias together to
reinforce the weakness in the abdominal wall. Recently,
laparoscopic hernia repairs have been attempted by inserting
laparoscopic instruments into the abdominal cavity through the
peritoneum and then placing a mesh patch over the hernia defect.
Hernia repair using this procedure has a number of disadvantages,
principally because the mesh used for the hernia repair is in
direct contact with the structures in the abdominal cavity, as for
example the intestines, there is a tendency for adhesions to form
between these structures. Such adhesions are known to be
responsible for certain occasionally serious complications. Such a
procedure is also undesirable because typically the patch is
stapled to the peritoneum, which is a very thin unstable layer
covering the inner abdomen. Thus, the stapled patch can tear away
from the peritoneum or shift its position. Other laparoscopic
approaches involve cutting away the peritoneum and stapling it
closed. This is time consuming, however, and involves the risk that
important anatomic structures may be inadvertently cut. In
addition, such a procedure is undesirable because it requires the
use of a general anesthesia. There is therefore a need for a new
and improved apparatus and method for developing an anatomic space
and particularly for accomplishing hernia repair by
laparoscopy.
SUMMARY OF THE INVENTION
[0004] In general, it is an object of the present invention to
provide an apparatus and method for developing an anatomic
space.
[0005] Another object of the invention is to provide an apparatus
and method in which such an anatomic space is developed by applying
perpendicular forces to create the anatomic space at the weakest
plane to create a more natural, less traumatic and bloodless region
in which to work.
[0006] Another object of the invention is to provide an apparatus
and method to obtain surgical exposure in the preperitoneal
space.
[0007] Another object of the invention is to provide an apparatus
and method to create preperitoneal working space utilizing a
balloon dissector.
[0008] Another object of the present invention is to provide an
apparatus and method of the above character for developing an
anatomic space for laparoscopic hernia repair through the anatomic
space.
[0009] Another object of the invention is to provide an apparatus
and method for decreasing the time and risk associated with
creating a preperitoneal working space.
[0010] Another object of the invention is to provide an apparatus
and method of the above character for a minimally invasive
procedure.
[0011] Another object of the invention is to provide an apparatus
and method of the above character which can be accomplished without
the use of general anesthesia.
[0012] Another object of the invention is to provide an apparatus
and method of the above character which can be accomplished with a
spinal or epidural anesthesia.
[0013] Another object of the invention is to provide an apparatus
and method of the above character which provides substantially
reduced medical costs and a greatly reduced patient recovery
time.
[0014] Another object of the invention is to provide an apparatus
of the above character which is relatively simple and compact.
[0015] Another object of the invention is to provide an apparatus
and method of the above character which can be readily utilized by
surgeons.
[0016] Another object of the invention is to provide a patch for
use with the apparatus which is firmly secured during the hernia
repair.
[0017] Another object of the invention is to provide a balloon
which has a modified asymmetric manta ray configuration to aid in
providing the desired configuration for the extraperitoneal working
space for hernia repair.
[0018] Another object of the invention is to provide a balloon
dissection apparatus which has a balloon cover detachably secured
to an obturator so that the balloon dissection device is relatively
rigid to permit the balloon dissection apparatus to be grasped by
the handle to operate the same during dissection.
[0019] Another object of the invention is to provide a balloon
dissection apparatus of the above character in which a precise
release mechanism is provided for releasing the balloon cover from
the obturator so that the surgeon can be assured that the balloon
cover has been released before it is removed to release the
balloon.
[0020] Another object of the invention is to provide a balloon
dissection apparatus of the above character in which the guide rod
or obturator remains in place to maintain ready access to the
extraperitoneal working space.
[0021] Another object of the invention is to provide a balloon
dissection apparatus of the above character in which certain of the
parts which are to be moved relative to other parts are color coded
to aid the surgeon in use of the apparatus.
[0022] Another object of the apparatus is to provide a tubular
member which is provided with a tip having an inclined surface.
[0023] Another object of the invention is to provide a balloon
dissection apparatus which is provided with a blunt tip which has a
diameter which is less than the diameter of the cannula tube.
[0024] Another object of the invention is to provide a balloon
dissection apparatus of the above character in which at least a
part of the same can be sterilized and reused.
[0025] Another object of the invention is to provide an apparatus
and method of the above character which has been simplified.
[0026] Another object of the invention is to provide an apparatus
and method of the above character which decreases the number of
steps required to complete a dissection process.
[0027] Another object of the invention is to provide an apparatus
and method which permits a visualization of the insertion of the
balloon into the posterior rectus space at the time of
insertion.
[0028] Another object of the invention is to provide an apparatus
of the above character which makes it possible to utilize
conventional cannulae.
[0029] Another object of the invention is to provide an apparatus
of the above character which makes it possible to utilize a
laparoscope during the surgical procedure to permit viewing of the
dissection as it is occurring.
[0030] Another object of the invention is to provide an apparatus
of the above character in which laparoscopic observation can be
accomplished through the balloon if desired as dissection is taking
place.
[0031] Another object of the invention is to provide an apparatus
of the above character in which a separate removable sheath is not
required for encasing the balloon prior to inflation.
[0032] Another object of the invention is to provide an inflatable
balloon which can be utilized to dissect around obstructions.
[0033] Another object of the invention is to provide a balloon
utilized for dissection which is provided in laterally inwardly
extending folds to aid in dissecting as the balloon is
inflated.
[0034] Another object of the invention is to provide a laparoscopic
apparatus including a tunneling member, channel guide and balloon
assembly into which a conventional laparoscope may be inserted for
visualization of anatomic structures as the tunneling member and
laparoscope are advanced through an incision to the desired
location within the body where dissection of tissue layers is
desired.
[0035] Another object of the invention is to provide a tunneling
member and balloon assembly of the above character wherein the
tunneling member has an open distal end that permits a laparoscope
to be advanced outside the tunneling member into the interior of
the balloon during balloon inflation to permit observation of
tissue dissection through a single balloon layer.
[0036] Another object of the invention is to provide a tunneling
member and balloon assembly of the above character which includes a
U shaped channel guide that remains within the incision site after
the tunneling member and laparoscope are withdrawn to provide
reliable access back to the previously created space.
[0037] Another object of the invention is to provide an apparatus
of the above character in which a separate removable sheath is not
required to cover the balloon prior to inflation.
[0038] Another object of the invention is to provide an apparatus
of the above character which includes an optional endoscope guide
which may be inserted into the incision during tunneling dissection
to preserve access to the created space for subsequent laparoscopic
procedures.
[0039] Additional objects and features of the invention will appear
from the following description in which the preferred embodiments
are set forth in detail in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a side elevational view partially in cross-section
of a laparoscopic apparatus incorporating the present
invention.
[0041] FIG. 2 is a cross-sectional view taken along the 2-2 of FIG.
1.
[0042] FIG. 3 is a side elevational view partially in cross-section
of the tunneling shaft forming a part of the apparatus shown in
FIG. 1 after it has been removed from the apparatus shown in FIG.
1.
[0043] FIG. 4 is a cross-sectional view taken along the line 4-4 of
FIG. 3.
[0044] FIG. 5 is an isometric view of the inflatable balloon
utilized in the apparatus in FIG. 1 secured to the tunneling
rod.
[0045] FIG. 6 is a cross-sectional view taken along the line 6-6 of
FIG. 5, and showing by dotted lines the manner in which the balloon
as it unfolds develops the anatomic space.
[0046] FIG. 7 is a partial plan view of a prone human body, showing
the lower abdomen showing the manner in which the laparoscopic
apparatus of the present invention is utilized for performing a
hernia repair through the preperitoneal space.
[0047] FIG. 8 is a sagittal view of the lower abdominal cavity of
the human being shown in FIG. 7 showing the apparatus of the
present invention introduced into the preperitoneal space.
[0048] FIG. 9 is a view similar to FIG. 8 but showing the sleeve
removed from the apparatus and with the balloon inflated.
[0049] FIG. 10 is a sagittal view similar to FIG. 8 showing the
balloon deflated and being removed.
[0050] FIG. 11 is a sagittal view similar to FIG. 8 showing removal
of the tunnelling shaft.
[0051] FIG. 12 is an isometric view of a patch incorporating the
present invention.
[0052] FIG. 13 is a side elevational view of the patch shown in
FIG. 12.
[0053] FIG. 14 is an isometric view showing the patch in FIGS. 12
and 13 in a rolled-up, generally cylindrical configuration.
[0054] FIG. 15 is a sagittal view showing the hernia sac of hernia
that is to be repaired.
[0055] FIG. 16 is a sagittal view showing the introducer through
which the rolled-up patch in
[0056] FIG. 17 has been introduced into the preperitoneal space by
an introducer rod.
[0057] FIG. 17 is a sagittal view similar to FIG. 16 showing the
attachment of the patch to the hernia sac.
[0058] FIG. 18 is a sagittal view similar to FIG. 17 showing the
dissection of the hernia sac and the unrolling of the patch.
[0059] FIG. 19 is a sagittal view showing the patch in place to
provide the hernia repair.
[0060] FIG. 20 is an isometric view of another embodiment of a
balloon with a patch disposed thereon for use with the apparatus of
the present invention.
[0061] FIG. 21 is a cross-sectional view taken along the line 21-21
of FIG. 20.
[0062] FIG. 22 is an enlarged cross-sectional view taken along the
line 22-22 of FIG. 23.
[0063] FIG. 23 is a sagittal view showing the manner in which the
balloon and patch shown in
[0064] FIG. 20 are disposed in the preperitoneal space.
[0065] FIG. 24 is a sagittal view showing the placement of the
balloon and the patch of FIG. 20, and the inflation of the balloon
in the preperitoneal space.
[0066] FIG. 25 is an isometric view of another embodiment of a
balloon and patch for use with the apparatus of the present
invention.
[0067] FIG. 26 is a rolled-up cross-sectional view of the balloon
and patch shown in FIG. 25.
[0068] FIG. 27 is an isometric view of another embodiment of a
patch for use with the apparatus of the present invention.
[0069] FIG. 28 is an isometric view of the patch shown in FIG. 27
wrapped in an introducer assembly.
[0070] FIG. 29 is a top plan view of another embodiment of a
laparoscopic apparatus incorporating the present invention.
[0071] FIG. 30 is a side elevational view taken along the line
30-30 of FIG. 29.
[0072] FIG. 31 is a cross-sectional view taken along the line 31-31
of FIG. 30.
[0073] FIG. 32 is a cross-sectional view taken along the line 32-32
of FIG. 30.
[0074] FIG. 33 is an enlarged cross-sectional view of the distal
extremity of the laparoscopic apparatus shown in FIG. 29.
[0075] FIG. 34 is a partial plan view showing the balloon after it
has been removed from the laparoscopic apparatus with the obturator
tip shifting its position.
[0076] FIG. 35 is a plan view of the balloon shown in FIG. 34 as it
is being removed from the body of the patient and bringing along
with it the obturator tip.
[0077] FIG. 36 is a side elevational view of another embodiment of
a laparoscopic apparatus incorporating the present invention.
[0078] FIG. 37 is a plan view showing the balloon from the
apparatus shown in FIG. 36 in an inflated condition and showing the
tunneling rod mounted therein being prevented from being advanced
beyond the distal extremity of the balloon.
[0079] FIG. 38 is a plan view showing the manner in which the
balloon is separated from the tunneling rod as it is retracted.
[0080] FIG. 39 is an isometric view of a surgical dissector with a
cannula incorporating the present invention in an assembled
condition.
[0081] FIG. 40 is an isometric exploded view of the components of
the surgical dissector with cannula shown in FIG. 39.
[0082] FIG. 41 is a side elevational view of the assembly shown in
FIG. 39.
[0083] FIG. 42 is a top plan view looking along the line 42-42 of
FIG. 41.
[0084] FIG. 43 is a view partly in cross section taken along the
line 43-43 of FIG. 42.
[0085] FIG. 44 is a view looking along the line 44-44 of FIG.
41.
[0086] FIG. 45 is a partial side elevational view of the assembly
shown in FIG. 1 with the clamping mechanism moved to a release
position.
[0087] FIG. 46 is a view taken along the line 46-46 of FIG. 45.
[0088] FIG. 47 is a partial side elevational view of an assembly
shown in FIG. 41 with the retaining ring moved to a locked
position.
[0089] FIG. 48 is a cross-sectional view taken along the line 48-48
of FIG. 47.
[0090] FIGS. 49A-49G are cartoons showing use of the surgical
dissector shown in FIG. 1 in a laparoscopic hernia procedure.
[0091] FIG. 50 is a cross-sectional view taken along the line 50-50
of FIG. 49C.
[0092] FIG. 51 is a cross-sectional view taken along the line 51-51
of FIG. 52 showing another embodiment of a balloon dissection
apparatus incorporating the present invention.
[0093] FIG. 52 is an end elevational view taken along the line
52-52 of FIG. 51.
[0094] FIG. 53 is an enlarged cross-sectional view taken along the
line 53-53 of FIG. 51.
[0095] FIG. 54 is an enlarged cross-sectional view taken along the
line 54-54 of FIG. 53.
[0096] FIG. 55 is an enlarged cross-sectional view of a portion of
the view shown in FIG. 51 showing the latch members moved to permit
removal of the guide rod.
[0097] FIG. 56 is a side elevational view of another embodiment of
a laparoscopic apparatus incorporating the present invention
showing the balloon in a collapsed condition and packaged in a
roll.
[0098] FIG. 57 is a side elevational view of the obturator shaft
utilized as a part of the laparoscopic apparatus shown in FIG.
56.
[0099] FIG. 57A is an enlarged partial cross-sectional view of the
distal extremity of the obturator shaft shown in FIG. 57.
[0100] FIG. 57B is a view similar to FIG. 57A for use with a
laparoscope having a centrally disposed lens for viewing.
[0101] FIG. 58 is an isometric view of the apparatus shown in FIG.
56 with the balloon inflated but in a rolled out condition.
[0102] FIG. 59 is a cross-sectional view taken along the line 59-59
of FIG. 58.
[0103] FIG. 60 is an isometric view showing the manner in which a
sheet of non-elastomeric material is utilized to form the balloon
of the present invention shown in the embodiments in FIGS. 58 and
59.
[0104] FIG. 61 is an isometric view similar to that shown in FIG.
60 but showing another subsequent step for making the balloon of
the present invention.
[0105] FIG. 62 is another isometric view similar to FIGS. 60 and 61
showing still another step in making the balloon of the present
invention.
[0106] FIG. 63 is a cross-sectional view taken along the line 63-63
of FIG. 56.
[0107] FIG. 64 is a cross-sectional view of a balloon incorporating
the invention showing the balloon provided with laterally and
inwardly extending folds.
[0108] FIG. 65 is a schematic illustration of a balloon dissection
apparatus incorporating the present invention which can be utilized
in connection with dissecting around an obstruction.
[0109] FIG. 66 is a plan view showing the bifurcated balloon in
FIG. 65 partially unrolled.
[0110] FIG. 67 is a plan view illustrating the balloon in FIG. 66
having one of its legs everting around an obstruction.
[0111] FIG. 68 is a plan view illustrating the balloon in FIG. 66
having both legs of the bifurcated balloon everted to create
dissection around the obstruction.
[0112] FIG. 69 is a plan view of another embodiment of a
laparoscopic apparatus incorporating the present invention.
[0113] FIG. 70 is another plan view showing another embodiment of a
laparoscopic apparatus incorporating the present invention.
[0114] FIG. 71 is a plan view showing another embodiment of a
laparoscopic apparatus incorporating the present invention.
[0115] FIG. 72 is a side elevational view taken along the lines
72-72 of FIG. 71.
[0116] FIG. 73 is an enlarged partial cross-sectional view of a
portion of the apparatus shown in FIG. 71.
[0117] FIG. 74 is a plan view partially in cross-section showing
another embodiment of the laparoscopic apparatus incorporating the
present invention.
[0118] FIG. 75 is an isometric view illustrating another embodiment
of a laparoscopic apparatus incorporating the present
invention.
[0119] FIG. 76 is an isometric view of the laparoscopic apparatus
of FIG. 75 with the laparoscope and tunneling member removed and
the balloon opened up to assume a manta ray shape in accordance
with one aspect of the present invention.
[0120] FIG. 77 is a cross-sectional view taken along line 77-77 in
FIG. 76 illustrating the cross section of a balloon with an
integral balloon cover according to aspects of the invention.
[0121] FIGS. 78A-C are plan, side elevational and end views,
respectively, of a channel guide according to the invention.
[0122] FIG. 79 is an isometric view of the tunneling member removed
from the FIG. 75 laparoscopic apparatus illustrating the open
distal end in accordance with the invention.
[0123] FIG. 80 is a side elevational view partially in
cross-section that illustrates the distal end of a conventional
laparoscope extending outside the distal end of the tunneling
member according to one aspect of the invention.
[0124] FIG. 81 is a cross-sectional view taken along line 81-81 in
FIG. 75 that illustrates a rolled up balloon with integral balloon
cover according to the invention.
[0125] FIG. 82 is a cross-sectional view of the proximal end of the
FIG. 75 laparoscopic apparatus.
[0126] FIG. 83 is a cartoon showing the use of the laparoscopic
apparatus shown in FIG. 75 in a laparoscopic hernia repair.
[0127] FIG. 84 is an isometric view of another embodiment of a
laparoscopic apparatus incorporating the present invention.
[0128] FIG. 85 is an isometric view of still another embodiment of
a laparoscopic apparatus incorporating the present invention.
[0129] FIG. 86 is an isometric view of the underside of the
endoscope guide member utilized in the FIG. 84 and 85 embodiments
according to another aspect of the invention illustrating its full
length longitudinal slit.
[0130] FIG. 87 is an isometric view of another embodiment of the
invention that accepts a conventional laparoscope, and permits
unobstructed visualization during laparoscopic surgical procedures
as described herein.
[0131] FIG. 88 is an isometric view of the tunneling member of the
FIG. 87 embodiment according to aspects of the present invention,
illustrating a laparoscope inserted through the central bore of the
member, and illustrating the features associated with the open
ended distal portion of the member.
[0132] FIG. 89 is an isometric view of the FIG. 87 embodiment that
illustrates the insertion of a conventional laparoscope into the
apparatus to permit unobstructed laparoscopic viewing.
[0133] FIG. 90 is an isometric view of the FIG. 87 embodiment of
the invention in partial cut-away, with the balloon unrolled and
laid flat.
[0134] FIG. 91 is an isometric view substantially similar to the
FIG. 90 view illustrating the insertion of a laparoscope into the
apparatus to permit laparoscopic observation during both tunneling
and balloon expansion according to aspects of the present
invention.
[0135] FIG. 92 is a cross-sectional view of the FIG. 87 apparatus,
showing the sealing of the elongate balloon neck between the handle
and an internal instrument body.
[0136] FIG. 93 is yet another embodiment of a laparoscopic
apparatus according to the invention that provides for the
insertion of a conventional laparoscope to permit viewing of
laparoscopic procedures as described herein.
[0137] FIG. 94 is an isometric view of a one-piece tunneling
apparatus according to the invention.
[0138] FIG. 95 is an orthogonal projection of the apparatus
illustrated in FIG. 94.
[0139] FIG. 96 is an orthogonal projection illustrating the handle
and tunneling member portion of the device illustrated in FIGS. 94
and 95.
[0140] FIG. 97 is an isometric view of a clamp that may be utilized
in connection with the device illustrated in FIGS. 94-96.
[0141] FIG. 98 is a plan view illustrating another embodiment of
the apparatus illustrated in FIGS. 94-95 according to aspects of
the present invention.
[0142] FIG. 99 is a partial cross-section of the apparatus
illustrated in FIG. 98.
[0143] FIG. 100 is a plan view illustrating another embodiment of
the device illustrated in FIGS. 94-95.
[0144] FIG. 101 is a cross-sectional view of a tunneling member
having an inflation lumen provided therein according to the
invention.
[0145] FIG. 102 is a plan view illustrating another balloon
construction in accordance with the invention.
[0146] FIG. 103 is a plan view illustrating the balloon illustrated
in FIG. 102 mounted on a handle and tunneling member assembly in
accordance with the invention.
[0147] FIG. 104 is a plan view illustrating a disposable balloon
cartridge according to the invention.
[0148] FIG. 105 is a plan view of a reusable combination handle and
tunneling member assembly for use with the disposable balloon
cartridge illustrated in FIG. 104.
[0149] FIG. 106 is a plan view of yet another balloon formed in
accordance with the invention.
[0150] FIG. 107 is schematic of a preferred arrangement for the
slits or perforations in a balloon cover in accordance with the
parent invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0151] In general, the apparatus of the present invention is used
for insertion into a body to create an anatomic space. In one
embodiment of the invention, the apparatus is comprised of a
tubular introducer member having a bore extending therethrough. A
tunneling shaft is slidably mounted in the bore and has proximal
and distal extremities including a bullet-shaped tip. A rounded
tunneling member is mounted on the distal extremity of the
tunneling shaft. An inflatable balloon is provided. Means is
provided on the balloon for removably securing the balloon to the
tunneling shaft. Means is also provided for forming a balloon
inflation lumen for inflating the balloon. The balloon is wrapped
on the tunneling shaft. A sleeve substantially encloses the balloon
and is carried by the tunneling shaft. The sleeve is provided with
a weakened region extending longitudinally thereof, permitting the
sleeve to be removed whereby the balloon can be unwrapped and
inflated so that it lies generally in a plane. The balloon as it is
being inflated creates forces generally perpendicular to the plane
of the balloon to cause pulling apart of the tissue along a natural
plane to provide the anatomic space.
[0152] More in particular, as shown in the drawings, the apparatus
or device 31 for creating such an anatomic space for use in a
laparoscopic procedure (see FIG. 1) includes an introducer sleeve
32 which consists of a tubular member 33 formed of a suitable
material such as plastic which is provided with a bore 34 extending
throughout the length thereof. A handle section 36 is mounted on
one end of the tubular member 33 and is also formed of a suitable
material such as plastic. It is provided with a bore 37 which is in
communication with the bore 33. A flapper valve 38 is mounted
within the handle section 36 and is movable between a position in
which it closes off the bore 37 and a position out of the way of
the bore 37 by a finger operated actuator 39 mounted on the
exterior of the handle section 36. A stopcock 41 is mounted on the
handle section 36 and is in communication with the passage 37. A
lever 42 is provided for opening and closing the stopcock 41.
[0153] A tunneling shaft assembly 46 is sidably mounted in the
bores 37 and 34 of the introducer sleeve 32. The tunneling shaft
assembly 46 consists of a tunneling shaft or rod 47 formed of a
suitable material such as stainless steel, of a suitable length, as
for example 18 inches, and a suitable diameter of approximately 1/8
inch. The tunneling rod 47 is provided with proximal and distal
extremities 48 and 49.
[0154] An introducer member 51 is slidably mounted on the tunneling
shaft or rod 47 and is formed of a suitable material such as
plastic. The introducer member 51 is substantially hollow as shown
and is provided with a bore 52 through which the tunneling shaft 47
extends. The introducer member 51 is provided with a substantially
hemispherical tip 53 to form a rounded protrusion or first
obturator through which the rod 47 extends. The introducer member
51 has a length such that when it is introduced into the bore 34 of
the introducer sleeve 32, it extends out of the distal extremity of
the introducer sleeve 32, as shown particularly in FIG. 1. This
diameter of the introducer member 51 is sized so that it can be
slidably mounted in the bore 34. The other end of the introducer
member 51 is provided with a chamfer 54.
[0155] A disk-type seal 43 having a central opening is provided in
the handle section 36 in alignment with the bore 37, and is adapted
to permit the introduction of the introducer member 51
therethrough.
[0156] The handle section 36 forms one part of a three-piece handle
56 of the laparoscopic apparatus 31 which is sized so that it is
adapted to be grasped by the human hand. As can be seen
particularly in FIG. 4, the handle 56 is generally rectangular in
cross-section. The handle 56 is provided with an intermediate
section 57 which has a bore 58 extending therethrough in
registration with the bore 37 and has the same general diameter as
the bore 37 so that the introducer member 51 can travel
therethrough. The sections of the handle 56 can be characterized as
having first, second and third sections, in which section 36 is the
first section and intermediate section 57 is the second section. A
latch is provided for interconnecting the intermediate section 57
to the first section 36, and consists of a pair of oppositely
disposed latches 61 pivotally mounted on the pins 62 in the
intermediate section 57. Each of the latches 61 is provided with a
latch portion 63 adapted to engage a protrusion 64 provided on the
first section 36, and is yieldably urged into engagement therewith
by a spring 66. Each of the latches is provided with a cam surface
67 which is adapted to be engaged by the chamfer 54 of the
introducer member 51 to cam the latch portion 63 out of engagement
with the protrusion 64 to release the intermediate section 57 from
the first section 36 for a purpose hereinafter described.
[0157] The handle 56 also consists of another section 71, which can
also be characterized as the third section, which is secured to the
proximal extremity of the tunneling shaft or rod 47. A pair of
latches 72 are provided in the section 71 and are pivotally mounted
on pins 73. The latches 72 are provided with latch portions 74
adapted to engage projections 76 provided in the intermediate
section 57. Means is provided for yieldably retaining the latches
72 in engagement with the projections 76 and consists of a U-shaped
spring 77 mounted within the end section 71 and engaging the
latches 72. The latches 72 are provided with knurled portions 72a
which extend outwardly and which are adapted to be grasped by the
fingers of the hand so that the latch portions 74 can be moved out
of engagement with the projections 76 against the force of the
spring 77.
[0158] The tunneling shaft assembly 46 also includes a tunneling
member or tip 79 which is mounted on the distal extremity of the
tunneling shaft or rod 47. As shown, the tip 79 is substantially
olive-shaped and can also be called a second obturator. It is
provided with a rounded hemispherical surface on its distal
extremity which has a maximum diameter of slightly less than the
diameter of the bores 34 and 37 so that it can pass through the
introducer sleeve 32. The proximal extremity of the tip 79 is of
smaller diameter to provide an annular step 81 in the tip. The
proximal extremity of the tip 79 is also hemispherical, as shown.
The tunneling member or tip 79 can be formed of a suitable material
such as plastic and can be secured to the distal extremity of the
tunneling shaft or rod 47 by suitable means such as an adhesive. As
hereinafter explained, the tunneling shaft or rod 47 is movable so
that the tip 79 can be brought into engagement with the
hemispherical end 53 of the introducer member 51 for a purpose
hereinafter described.
[0159] The laparoscopic apparatus 31 also includes a balloon
assembly 86 which is shown in FIGS. 2, 5 and 6. As shown in FIG. 5,
the balloon assembly 86 consists of a balloon 87 which, when
deflated, has a pear-shaped configuration when viewed in plan. The
balloon 87 is preferably formed of a non-elastomeric, medical-grade
material of a suitable type such as PVC. Thus, the balloon 87 can
be formed of two sheets 88 and 89 of such a material which have
their outer margins bonded together by suitable means such as by a
heat seal 91 extending around the perimeter of the flat balloon 87.
The balloon 87 is provided with a neck 94 into which a flexible
tubular member 96 extends, and is secured therein in a suitable
airtight fashion such as by an adhesive. The tubular member 96 is
provided with a lumen 97 which is in communication with the
interior of the balloon 87 and which can be used for inflating the
balloon 87 through a Luer-type fitting 98 mounted on the free end
of the tubular member 96.
[0160] Means is provided for removably securing the balloon 87 to
the tunneling rod or shaft 47, and consists of a sleeve 101 formed
of the same material as the balloon 87, and which can be formed
integral or separate therefrom and adhered thereto by suitable
means such as an adhesive. The sleeve 101 extends longitudinally of
the balloon 87 and is disposed generally equidistant from the side
margins of the same. The sleeve 101 is provided with a passage 102
extending therethrough which is sized to slidably accommodate the
tunneling shaft or rod 47. Means is provided for permitting
separation of the balloon 87 from the tunneling rod by movement
sidewise from the axis of the passage 102 and takes the form of
longitudinally spaced apart perforations 103 in the sleeve 101
extending longitudinally the length of the sleeve 101. The
perforations 103 are spaced close enough together to form a
weakened region so that the balloon can be readily separated from
the tunneling rod by separating the plastic sleeve 101 by tearing
the plastic between the perforations as hereinafter described.
[0161] As shown in FIG. 6, the sleeve 101 is disposed equidistant
from the side margins of the balloon 87, permitting the balloon 87
to be inflated as hereinafter described and as also shown by the
dotted lines in FIG. 6, to be inflated around the rod 47. When
deflated, the side margins of the balloon 87 can be rolled inwardly
toward the rod 47 as shown by the broken lines in FIG. 6 to permit
the same to be folded into a generally cylindrical configuration as
shown in FIG. 2, and to be enclosed within a removable sleeve 106
carried by the tunneling shaft or rod 47. The removable sleeve 106
is formed of a relatively thin-walled tubular member 107 of a
suitable material such as Teflon which has a weakened region 108 in
its wall extending longitudinally the length thereof This weakened
region 108 can take the form of a slit as shown, or can be a series
of perforations or slots formed in the wall, or a combination
thereof. The proximal extremity of the tubular member 107 is
provided with split-apart or separable end portions 107a and 107b
to which are secured finger rings 109 of a suitable material
such-as plastic and secured thereto by fasteners 111.
[0162] Operation and use of the laparoscopic apparatus in
performing the method for laparoscopic hernia repair through a
preperitoneal space may now be briefly described as follows. Let it
be assumed that the laparoscopic apparatus 31 has been assembled as
shown in FIG. 1. As shown in FIG. 7, let it be assumed that a human
patient 121 is in a prone position and has a hernia 122 in the
lower abdominal area which he wishes to have repaired. The patient
is prepared in an appropriate manner by administering a suitable
anesthesia, as for example a spinal anesthesia, and any other
necessary preparation. The surgeon first makes an infraumbilical
incision 126 in the skin below the navel or umbilicus 127 and
separates the fat 129 and then incises the anterior rectus sheath
or fascia 131 in the midline. Care should be taken not to penetrate
the peritoneum 132 overlying the abdominal cavity 133 (see FIG.
8).
[0163] After the incision 126 has been made in the manner
hereinbefore described, the laparoscopic apparatus 31 is then taken
by one hand of the surgeon, grasping the handle 56 and utilizing
the other hand to facilitate the insertion of the rounded blunt tip
79 into the incision 126.
[0164] The blunt tip 79 is caused to enter the slit in the fascia
131 and pass anterior to the peritoneum 132, in between the rectus
muscles (laterally), and enters the potential preperitoneal space
136.
[0165] The blunt tip 79 is then utilized as a tunneling device by
the surgeon using one hand 56 to advance the blunt end 79 toward
the pubic region of the patient 121 while the surgeon places his
other hand on the abdomen to feel the apparatus or device 31 as it
is being advanced. The advance of the device 31 is continued until
the blunt tip 79 is below the symphysis pubis 137 as shown in FIG.
8, and preferably is disposed between the symphysis pubis 137 and
the bladder 138.
[0166] After the apparatus or device 31 has been properly
positioned as shown in FIG. 8, the removable sleeve or sheath 106
is removed by the surgeon using one hand to engage the finger rings
109 which are exterior of the body of the patient and outside of
the incision 126. At the same time, the other hand of the surgeon
is utilized to stabilize the portion of the device 31 which is
within the preperitoneal space. The sheath 106 can be readily
withdrawn since it is formed of Teflon and is split or weakened
along its length, by pulling it proximally and away from the
longitudinal axis of the tubular member 33. As the sheath 106 opens
and slips off, it exposes the balloon 87 of the balloon assembly
86. When the sheath 106 is completely removed, a sterile saline
solution serving as a balloon inflation medium is introduced into
the balloon 87 through the tubular member 96 by connecting a
conventional syringe 141 to the Luer fitting 98. The balloon 87
typically can be inflated to a suitable size by introducing 500 cc
or less of normal saline solution into the balloon 87 by pressing
on the plunger 142. As the balloon 87 is inflated, the balloon 87
progressively unwraps with its side margins rolling outwardly from
the center while expanding into a plane to cause progressive
separation or dissection of tissue (i.e. 131, 132) along its
weakest points by application of forces generally perpendicular to
the plane of the balloon 87 to create the preperitoneal or anatomic
space. The balloon 87 expands around the tunneling shaft 47 in the
manner shown in broken lines in FIG. 6 to achieve the progressive
separation until complete inflation is achieved. The surgeon can
sense the filling of the balloon 87 by feeling the abdomen of the
patient 121 as the balloon 87 is inflated. The balloon 87 serves to
open up the preperitoneal space 136 to provide a bloodless space
for the procedures hereinafter to be performed. Since the balloon
87 is formed of a non-elastomeric material, it is a volume-limited
balloon to prevent overexpansion. Different sizes of balloons can
be utilized for different patient sizes. With a smaller balloon it
is possible to deflate the balloon and then shift the balloon and
again reinflate it to obtain the desired bloodless preperitoneal
space.
[0167] After the desired bloodless anatomic space or pocket 136 is
formed, the balloon 87 is deflated by withdrawing the normal saline
solution by withdrawal of the plunger 142 of the syringe 141 or via
a hospital vacuum aspirator. After the balloon 87 has been
deflated, the balloon assembly 86 can be removed by grasping the
handle 56 of the laparoscopic apparatus or device 31 with one hand
and using the other hand to grasp the tubular member 96 and the
proximal extremity of the balloon 87 and to remove the same through
the incision 126, as shown in FIG. 10. As the balloon 87 is being
removed, it is progressively separated from the tunneling rod or
shaft 47 by causing the sleeve 101 to split apart along the
longitudinal perforations 103 provided in the sleeve 101. This
makes it possible to separate the balloon 87 from the tunneling rod
47 without the necessity of removing the tunneling rod 47 or the
introducer sleeve 32.
[0168] After the balloon assembly 86 has been removed, the
introducer device 32 can be advanced distally over the tunneling
shaft or rod 47 so it extends well into the preperitoneal space 36
as shown in FIG. 11. The third section 71 of the handle 56 is then
released by depressing the latches 72 by engaging the portions 72a
to disengage the latch portions 74 from the intermediate section 57
of the handle 56. The third section 71 is then withdrawn proximally
as shown in FIG. 11 to bring the olive-shaped tip 79 into
engagement with the distal tip 53 of the introducer member 51 to
cause both the tip 79 and the introducer member 51 to be withdrawn
or retracted. As the introducer member 51 is being withdrawn, its
chamfer 54 will strike the cam surfaces 67 of the latches 61 to
cause them to disengage from the handle section piece 36 to carry
it along with the introducer member 51 and shown in FIG. 2. Thus,
it can be seen that the tunneling shaft assembly 46 can be readily
removed merely by one motion of the surgeon's hand. Thereafter, a
conventional laparoscope 144 (see FIG. 16) can be introduced
through the introducer sleeve 32 to permit the surgeon to view the
dissected preperitoneal space 136.
[0169] The dissected preperitoneal space 136 is then insufflated
with carbon dioxide through the stopcock 41 to a pressure ranging
from 6 to 8 mm of mercury. Thereafter, two additional trocars 146
and 147 are introduced through the abdominal wall into the
dissected preperitoneal space 136 in appropriate locations. Thus,
as shown in FIG. 7, trocar 146 is introduced into the left side of
the abdomen of the patient 121 below the introducer sleeve 32 and
the trocar 147 is introduced into the dissected preperitoneal space
136 immediately above the symphysis pubis 137 and directly below
the introducer sleeve 32. As can be appreciated, the locations of
the trocars 146 and 147 are generally dictated by the location of
the hernia 122 to be repaired.
[0170] A patch 151 of the present invention to be utilized in the
hernia repair procedure is shown in detail in FIGS. 12, 13 and 14.
The patch 151 can be characterized as a hernia patch or graft and
is made of a suitable plastic mesh such as a Prolene mesh
manufactured by Ethicon, Inc. The patch 151 can be of any desired
configuration. For example it can be generally circular as shown,
and consists of a disk 152 of a suitable diameter, as for example 2
inches. A tail 153 is secured to the disk substantially in the
center thereof, in a suitable manner. For example, as shown, the
tail 153 can be provided with split portions 153a and 153b which
are split apart and offset with respect to each other. The split
portions 153a and 153b are secured to a smaller reinforcing disk
154 formed of the same material as disk 152 and secured to the disk
152 by suitable means such as surgical thread (not shown). The tail
153 may be formed of the same material as the disk 152 and 154, or
it can be formed of a different material, such as Goretex. It can
have a size such that it has a width of approximately 1/2 inch and
a length of approximately 11/2 inches. As shown particularly in
FIG. 14, the side margins of the disk 152 can be rolled inwardly
towards the center adjacent the tail 153 to form a cylindrical roll
156 with the tail 153 extending outwardly therefrom. The roll 156
can be maintained in its rolled-up condition by means of sutures
157 disposed adjacent opposite ends of the roll and on opposite
sides of the tail 153.
[0171] Referring now to FIGS. 15 and 16, conventional laparoscopic
instruments, introduced through trocars 146 and 147, are used to
repair the hernia 161 by placement of the patch 151. First, the
laparoscopic instruments are introduced through the introducer
device 32 while being observed through laparoscope 144 to dissect
the hernia 161. The hernia neck 162 may be observed as it is
entering the internal inguinal ring 163. The repair procedure
starts by dissecting the hernia sac 161 from the surrounding tissue
(spermatic duct and vessels) (see FIG. 15). The process is
facilitated by CO.sub.2 pressure impinging on the neck 162 of the
hernia sac 161. As soon as this dissection is completed, the roll
156 is pushed into the trocar 147 and advanced through the same by
suitable means such as a deployment rod 164 (see FIG. 16) to enter
the dissected preperitoneal space 136 as shown in FIG. 16.
Alternatively, the roll 156 can be placed in a tubular member (not
shown) which can be used to position the roll 156 within the trocar
157.
[0172] Thereafter, by the deployment rod 164, the roll 156 can be
pushed out of the tubular member into the dissected preperitoneal
space 136.
[0173] The roll 156, after it is in the preperitoneal space 136, is
then manipulated so that its tail 153 is disposed alongside the
neck 162 of the hernia sac 161 as shown in FIG. 17. With reference
to FIG. 17, a conventional stapling device 166 is then introduced
through the trocar 146 to staple the tail 153 to the neck 162. The
staples 167 serve to divide the neck 162 of the sac 161 into distal
and proximal portions 162a and 162b. As soon as this stapling
operation is completed, the two portions 162a and 162b are
separated from each other because of the pressure of the
insufflation gas to cause the tail 153 of the patch 151 to be
pulled upwardly into the inguinal ring to pull with it the disk
152. The sutures 157 are cut apart to permit the disk 152 to unroll
and to be placed across the inguinal ring 163 which created the
main weakness in the abdominal wall permitting the hernia which is
being repaired to occur. The proximal portion 162b of the neck 162
is stapled together by staples 173 as shown in FIG. 18. The
proximal portion 162 is then permitted to fold back into the
desired anatomical location within the abdomen.
[0174] Thereafter, while observing the procedure under the
laparoscope, the dissected preperitoneal space 136 can be deflated
by permitting the carbon dioxide gas to escape to the atmosphere
through the stopcock 41 in the introducer device 32 by operation of
the stopcock lever arm 42. As deflation is taking place, the
movement of the patch 151 is observed through the laparoscope 144
to ensure that it does not become misplaced. When the deflation is
complete, the patch 151 is in a position over the inguinal ring 163
and serves to provide reenforcement to prevent the occurrence of
another hernia in that area. The tail 153 is disposed within the
inguinal ring 163 and retains the mesh disk 152 so that it
surrounds the inguinal ring 163.
[0175] After deflation is complete, the trocars 146 and 147 as well
as the introducer device 32 can be removed. Small sutures can then
be utilized to close the various small openings which have been
made in the abdominal wall so that upon healing there will be
minimal noticeable scars after healing. The scar in the navel or
umbilicus typically is almost nearly invisible.
[0176] It has been found that the use of the laparoscopic apparatus
31 in accomplishing the method as hereinbefore set forth provides a
procedure in which the pain after the operation is markedly
reduced. This is particularly true since the operation does not
involve suturing of any ligaments which typically produces the
pain. In addition, the recovery time for the patient is greatly
accelerated. In the procedure of the present invention, a patient
can return to work within a matter of 3 to 5 days rather than in a
number of weeks as in a conventional hernia repair procedure. The
procedure also has other advantages. For example, there is a lack
of necessity for a general anesthesia. Another principal advantage
of the procedure is there is no contact of mesh patch 151 with the
intestines of the patient or other intra-abdominal structures, thus
greatly reducing the possibility of adhesion formation. In
addition, the graft which is formed by the patch 151 is more secure
and is positioned in an anatomically correct position. This is
because the hernia sac is in exact alignment with the hernia and
pulls with it the tail 153 of the graft to ensure that the graft
formed by the patch 151 is drawn into the correct position and is
maintained in that position to prevent migration. In addition, the
graft, by having an additional central disk 154, ensures that
additional reinforcement is provided in the proper location in the
center where the weakest region in the abdominal wall has occurred.
In addition, by such proper centering, the mesh construction of the
patch 151 serves to uniformly reinforce the area surrounding the
hernia.
[0177] Another embodiment of the present invention is shown in
FIGS. 20, 21 and 22 with respect to another embodiment of a balloon
assembly 181 and another embodiment of a patch or graft 182. The
balloon assembly 181 consists of a balloon 186 formed of two sheets
187 and 188 which are rectangular in shape, as for example square
as shown in FIG. 20, which are heat-sealed together at their outer
margins as indicated by the broken line 189. A tubular member 191
is provided which has one end sealed into one corner of the balloon
186 as shown in FIG. 20. The tubular member 191 is provided with a
lumen 192 which opens up into the interior space 193 of the
balloon. The sheets 187, 188 are formed from a non-elastomeric
material of the type hereinbefore described. A Luer fitting 194 is
connected into the free end of the tubular member 191 and is
utilized for introducing a saline solution into the balloon 186 for
inflating the same.
[0178] The graft or patch 182 can have a desired configuration, as
for example circular as shown in FIG. 20. It is formed of a
non-absorbable synthetic surgical mesh, as for example from
polypropylene manufactured by Ethicon Inc. As shown, the mesh patch
182 overlies the sheet 187.
[0179] The balloon assembly 181 already made in Ser. No. 324,519
with the patch 182 thereon can be rolled-up into a roll 196 as
shown in FIG. 22 in which the patch or graft 182 is disposed within
the roll 196. The roll can be maintained in the roll configuration
by sutures 197 wrapped about the same. The roll 196 can then be
introduced through a side trocar 146 and introduced into the
dissected preperitoneal space 136 with the tubular member 191
extending through the trocar 146 and having its Luer fitting 194
disposed outside of the trocar. After the roll 196 has been
introduced, the sutures 197 can be removed and the balloon can be
inflated by introducing a saline solution through the fitting 194
by use of a syringe 199. Before the saline solution is introduced
to inflate the balloon 186, the roll 196 is properly positioned so
that when it is inflated and begins to unroll it will unroll in the
proper direction so that the graft or patch 182 carried thereby is
properly positioned as shown in FIG. 23. After the roll 196 has
been completely unrolled, continued inflation of the balloon 186
moves the patch 182 so that it is pressed against the portion of
the fascia through which the hernia has occurred as shown in FIG.
24. As soon as the graft 182 has been properly positioned, the
balloon 186 is deflated. The trocar 146 is then removed, and
thereafter the balloon can be withdrawn through the opening in
which the trocar was present. Thereafter, the gas utilized for
insufflation can be permitted to discharge through another trocar
so that the fascia 131 comes into engagement with the peritoneum
132 with the large-area patch 182 held in place therebetween.
Thereafter, the trocars can be removed in the manner hereinbefore
described to complete the procedure.
[0180] Another embodiment of a balloon assembly for deploying a
large-area patch or graft through a trocar is shown in FIG. 25. The
large-area graft 201 shown in FIG. 25 is formed of a mesh material
of the type hereinbefore described and has a generally oval-shaped
configuration conforming to the general shape of the balloon 202 of
the balloon assembly 203. The balloon 202 is constructed of a
non-elastomeric material in the manner hereinbefore described. A
tubular member 206 is provided for inflating the balloon and has a
Luer fitting 207 on the free end thereof. Means is provided for
retaining the mesh graft 201 on one side of the balloon and
consists of plastic flaps 208 provided on opposite sides of the
balloon 202, and secured thereto by a suitable means such as a heat
seal along the broken line 209. The inner margins of the flaps 208
are free and are adapted to receive the outer margins of the graft
201 as shown particularly in FIG. 25.
[0181] The balloon 202 with the mesh graft 201 thereon can be
rolled-up into a substantially cylindrical roll 211 by rolling the
outer margins of the balloon inwardly on top of the mesh material
to provide two rolls 211 and 212 which are brought in adjacent to
each other as shown in FIG. 26 with the mesh graft 201 being
wrapped up therewith. The two rolls 211 and 212 can then be
inserted into a tubular sheath 214. The sheath 214 can then be
introduced through a trocar in a manner hereinbefore described and
then the rolls 211 and 212 are pushed out of the sheath 214 into
the abdominal cavity. The balloon can then be inflated with a
saline solution to cause the two rolls 211 and 212 to unroll in
opposite directions and then for the balloon to inflate to move the
patch 201 carried thereby into engagement with the portion of the
fascia having the hernia therein. Thereafter, the balloon can be
deflated, the trocar removed, the balloon removed, and the
dissected preperitoneal space deflated so that the large mesh graft
201 is disposed between the fascia and the peritoneum and is
retained in position therebetween.
[0182] Another embodiment of a graft which can be utilized in
connection with the present invention is shown in FIG. 27. The
patch or graft 216 is constructed in a manner similar to the graft
or patch 151 shown in FIGS. 12 and 13, with the exception that it
is constructed in a manner so that it can be utilized with a direct
hernia rather than an indirect inguinal hernia hereinbefore
described. The graft 216 is formed of a sheet of circular mesh in
the form of a disk 217 with a reinforcing central disk 218 which
has a barbed head 219 secured thereto. The barbed head 219 is
formed of a biodegradable material such as polyglycolic acid. The
mesh graft 216 can be folded over a deployment rod 221 and
introduced into a cylindrical sheath 222 (see FIG. 28) which is
sized so that it can be introduced through a conventional trocar,
then deployed from the sheath 22 by pushing on the deployment rod
221. After the graft 216 has been deployed into the dissected
preperitoneal space 136, it can be positioned in an appropriate
manner so that the barb 219 is positioned so that it is in
alignment with the inguinal ring whereby upon deflation of the
preperitoneal space 136, the barb 219 will extend through the
inguinal ring to serve to retain the graft 201 firmly in place.
[0183] Another embodiment of a laparoscopic apparatus incorporating
the present invention is laparoscopic apparatus 231 as shown in
FIGS. 29 through 32. The laparoscopic apparatus 231 includes
introducer sleeve or device 32 identical to that hereinbefore
described. It also includes a tunneling shaft assembly 46 which is
provided with a tunneling shaft or rod 47 and a proximal extremity
49 (see FIG. 32). In the previous embodiment of the laparoscopic
apparatus, the tunneling shaft assembly is provided with an
olive-shaped or bullet-shaped tip 79 which was secured to the
distal extremity 49 of the tunneling shaft 47. In the present
embodiment of the apparatus shown in FIGS. 29 through 32, the
obturator tip 79a is detachably mounted on the distal extremity 49
of the tunneling rod 47. The proximal extremity of the tip 79a is
provided with a slot 236 which extends through one side of the
proximal extremity into the central portion of the proximal
extremity of the tip 79a. The slot 236 is adapted to receive the
rounded extremity 237 provided on the distal extremity 49 of the
tunneling rod 47 (see FIG. 32). A removable sleeve 241 is provided
as a part of a laparoscopic apparatus 231, and is similar in many
respects to the removable sleeve or sheath 106 hereinbefore
described. The removable sleeve 241 is formed of a suitable
material such as Teflon as hereinbefore described and is provided
with a tubular member 242 which is provided with a relatively thin
wall 243 that has a weakened portion extending longitudinally
thereof in the form of a slit 244 (see FIG. 31). The tubular member
242 is provided with a proximal extremity 246 and a distal
extremity 247. The proximal extremity 246 has a thicker
cross-section than the distal extremity 247, as shown in FIGS. 31
and 32. The proximal extremity 246 is provided with a recess 248
formed in the wall which is diametrically opposite the slit 244
that serves as a relief region to permit the movable sleeve 241 to
be split apart when it is removed from the balloon.
[0184] The proximal extremity 246 is provided with wing-like
members 251 and 252 which extend diametrically therefrom, spaced
90.degree. apart from the slit 244. These outstretched wings 251
and 252 serve to help the physician orient the laparoscopic
apparatus 231 as it is being utilized. The proximal extremity 246
is also provided with a handle 256 which is formed integral
therewith and which extends radially from the tubular member 242.
The handle 256 is provided with a finger hole 257 extending
therethrough through which a finger can be inserted to facilitate
pulling the removable sleeve 241 off of the balloon as described in
connection with the previous embodiment.
[0185] As shown in FIG. 33, the tip 79a is detachably mounted in
the proximal extremity of the removable sleeve 241 so that the tip
79 can serve as a second obturator during introduction of the
laparoscopic apparatus 231 as hereinbefore described. Means is
provided for securing the detachable tip 79a to prevent it from
becoming separated from the laparoscopic apparatus 231 and for
permitting its withdrawal after the laparoscopic procedure is being
completed. As shown in FIGS. 33 and 34, such means consists of a
flexible elongate element 261 in the form of a braided string
formed of a suitable fabric such as Nylon, which has one end 262
secured in a slot 263 provided on the distal extremity of the tip
79a by suitable means such as an adhesive (not shown). The flexible
elongate element 261 extends from the distal extremity of the tip
79a in a recess 264 opening through the external surfaces of the
tip 79a. The proximal extremity of the flexible elongate element
261 can be secured directly to the balloon 87 or, alternatively, it
can extend through the perforated sleeve 101 provided in the
balloon along the tunneling shaft so that it extends beyond the
proximal extremity of the tunneling shaft.
[0186] The use of the laparoscopic apparatus 231 in performing a
laparoscopic procedure is substantially identical to that
hereinbefore described with the exception that when the removable
sleeve 241 is removed from the balloon 87, the removable sleeve can
be pushed forwardly to detach the tip 79a from the tunneling shaft
47. The removable sleeve 241 then can be pulled rearwardly to
separate it from the balloon along the slit 244. As soon as this
occurs, the tip 79 becomes free of the sleeve and begins to rotate
in the direction of the arrow 266 shown in FIG. 34. When the
balloon has been inflated and has performed its functions as
hereinbefore described and it is now desired to remove the balloon
87, the balloon 87 can be withdrawn in the manner hereinbefore
described, and since the tip 79a is tethered to the balloon 87
itself or flexible elongate element 261 attached thereto extends
out proximally of the balloon 87, the tip 79a is withdrawn or can
be withdrawn with the balloon 87.
[0187] This laparoscopic apparatus 231 with its detachable
obturator tip 79a will be useful in certain applications of the
present invention. With the previous laparoscopic apparatus
hereinbefore described, there is a possibility that when the
obturator tip 79 is withdrawn, critical structures, as for example
small arteries, may be inadvertently incised between the tip 79 and
the distal extremity of the tubular member 33 of the introducer
device 32. This possibility is eliminated by having the detachable
tip 79a, which is withdrawn when the balloon is withdrawn.
[0188] Still another embodiment of the laparoscopic apparatus
incorporating the present invention is shown in FIGS. 36, 37 and
38, in which the laparoscopic apparatus 271 consists of a balloon
272 of the type hereinbefore described, which is provided with a
perforated sleeve 273 through which the tunneling rod 47 extends.
The distal extremity 274 of the sleeve is closed by an end piece
276. The balloon 272 is wrapped in the manner hereinbefore
described around the tunneling shaft 247. The tunneling shaft or
rod 47 is not provided with a tunneling member or second obturator
of the type hereinbefore described but its end is rounded as shown
by providing a rounded tip 47a.
[0189] The wrapped balloon 272 is enclosed within a removable
sleeve 281 which is similar to those hereinbefore described. It is
provided with a tubular member 282 that has a weakened region in
the form of a slit 283 extending longitudinally the length thereof.
The removable sleeve 281 differs from those hereinbefore described
in that rather than being open at the end as in previous
embodiments, it is provided with a closed-end, bullet-shaped or
olive-shaped tip 286.
[0190] The slit 283 is provided with a curved portion 283a which
extends through the bullet-shaped tip 286 so that the sleeve can be
peeled off of the balloon 272 in the manner hereinbefore described
by pulling on the handle 288 having a finger hole 289 therein.
During the time that the removable sleeve 281 is being peeled off
or separated from the balloon 272, the balloon is held in place by
the tunneling rod 47 which engages the end 276 of the perforated
sleeve 273. The balloon 272 after it is inflated can be separated
from the tunneling rod 47 by pulling on the balloon and causing its
distal extremity to lift up and to break apart at the perforations
and peel away from the rounded extremities 47a of the tunneling
shaft 47 as shown in FIG. 38. Continued pulling on the balloon 272
will cause it to separate from the tunneling rod 47 so that the
balloon 272 can be removed as hereinbefore described. Thus, it can
be seen that there has been provided an embodiment of the
laparoscopic apparatus of the present invention in which the need
for an obturator carried by the distal extremity of the tunneling
rod 47 has been eliminated by providing the second obturator as a
part of the removable sleeve 281. In all other respects, the
operation and use of the laparoscopic apparatus 271 is similar to
that hereinbefore described.
[0191] From the foregoing it can be seen that there has been
provided an apparatus and method for developing an anatomic space
by the use of a wrapped balloon which, as it is inflated, gradually
unwraps to tend to form a plane to cause forces to be created
perpendicular to the plane for pulling apart tissue along a natural
plane to provide an anatomic space, thereby providing a dissection
in the weakest plane creating a more natural, less traumatic and
bloodless region in which to perform various medical procedures.
Such anatomic spaces can be created in various parts of the human
body, for example in the preperitoneal area to provide a space
anterior to the peritoneum for hernia repair and for varocele
dissection. Spaces can also be developed lateral to the peritoneum
and spaces posterior to the peritoneum for performing medical
procedures such as a sympathectomy and a lymph node dissection.
[0192] As hereinbefore explained, the apparatus and method is
particularly appropriate for performing laparoscopic hernia repair,
permitting the use of grafts and patches which can be used for
direct and indirect hernias with minimal pain to the patient and
with the patient being able to return to work within a few
days.
[0193] Another embodiment of a laparoscopic apparatus 301
incorporating the present invention is shown in FIGS. 39-48. The
laparoscopic apparatus 301 can also be described as an assembly in
the form of a surgical dissector with a cannula which serves as a
hand manipulated surgical instrument that can be used during
general surgical laparoscopic procedures to dissect the layers of
fascia between the skin and the peritoneum as described in
conjunction with the previously disclosed embodiments of the
invention. The laparoscopic apparatus 301 consists of a cannula 302
with a tunneling device 303 mounted therein. The tunneling device
303 or guide rod 306 consists of a blunt obturator and an
introducer member 307. The laparoscopic apparatus also includes a
skin seal assembly 311, a balloon assembly 312 and a balloon cover
assembly 316 as shown particularly in FIGS. 39 and 40.
[0194] The cannula 302 consists of a cannula tube 321 formed of a
rigid plastic having proximal and distal extremities 322 and 323. A
flow passage 324 extends from the proximal extremity 322 to the
distal extremity 323. A cannula housing or handle 326 is mounted on
the proximal extremity by suitable means such by molding it
directly thereon. As disclosed in copending application Ser. No.
07/968,201, filed on Oct. 29, 1992, the disclosure of which is
hereby incorporated by reference in its entirety, the handle 326
includes first and second valve members (not shown) in which one
valve member serves as a duck-bill valve and the other valve member
serves as a circular instrument or tool seal. The housing is
provided with a Luer-type fitting 327 which is in communication
with the interior of the housing outside of the duck-bill valve and
is in communication with the passage 324 in the cannula tube
321.
[0195] As described in copending application Ser. No. 07/968,201,
filed on Oct. 29, 1992, the cannula 302 is adapted to receive the
tunneling device or blunt obturator device 303 which is generally
of the type described hereinbefore in the present application. This
device 303 consists of the blunt obturator 306 having a blunt tip
331 which is generally olive-shaped as shown (see FIG. 41) and is
formed of a suitable material such as plastic. The olive-shaped tip
331 is molded on the distal extremity 332 of a rod or a shaft 333
formed of a suitable material such as stainless steel. The blunt
tip 331 is sized so that its outside diameter is slightly less than
the inside diameter of the cannula tube 321. The proximal extremity
334 of the rod or shaft 333 has mounted thereon a handle part 336
of a handle assembly 337 which includes a second handle part 338.
The handle parts 336 and 338 are adapted to mate with each other
and are detachably connected in a manner described in copending
application Ser. No. 07/968,201 filed Oct. 1, 1992, by the use of
latch (not shown) adapted to be actuated by spring-operated latch
members 339 disposed on opposite sides of the handle part 336 and
adapted to be engaged by the fingers of the hand holding the handle
assembly 337. The second handle part 338 forms a part of the
introducer device 307 and is mounted on the proximal extremity 341
of an introducer member. 342 formed of a suitable material such as
plastic. The introducer member 342 is provided with a distal
extremity 343 and has a bore 344 extending from the proximal
extremity to the distal extremity through an end surface 346 (see
FIG. 41) which is inclined at a suitable angle, as for example
approximately 45.degree. proximally from the horizontal axis for
the bore 344. The bore 344 is sized so it can sidably receive the
shaft 333.
[0196] The handle part 338 is provided with latch means (not shown)
which is adapted to releasably connect the handle part 338 to the
cannula housing 326 and includes latch members 349 disposed on
opposite sides of the handle part 338 adapted to be engaged by the
fingers of the hand holding the handle assembly 337 to permit the
handle part 338 to be separated from the cannula housing 326.
[0197] The skin seal assembly 311 generally can be of the type
described in copending application Ser. No. 08/124,333 filed Sep.
20, 1993, and as described therein consists of a screw body 350
formed of a suitable material such as plastic having a helical
thread 351 and a scalloped flange 352. A resilient insert 353 is
disposed in the screw body 351 and is formed of a suitable
resilient material such as silicone. The insert 353 is provided
with a bore 354 extending therethrough. A collet 357 having slots
358 therein surrounds the insert 353 and is engaged by a collar 356
movable axially of the screw body 351 and is adapted to move the
collet to compress the insert 353 to move the insert between a
retaining position for the cannula tube 321 extending through the
bore 354 to retain the cannula 302 in a desired longitudinal
position with respect to the skin seal assembly 311 and a releasing
position in which the cannula 302 can be slidably moved
longitudinally inwardly or outwardly with respect to the skin seal
311. The collar 356 is provided with an annular shoulder 359 having
circumferentially spaced-apart slots 360 therein which are used for
a purpose hereinafter described. As explained in copending
application Ser. No. 08/124,333 filed Sep. 20, 1993, means is
provided to restrain rotation of the collar 356 with respect to the
collet 357 and includes longitudinally extending keys 355 spaced
180.degree. apart.
[0198] The balloon assembly 312 consists of a balloon 361 formed of
a non-elastomeric, medical grade plastic material of a suitable
type such as polyurethane. The balloon 361 can be characterized as
having an asymmetric manta ray configuration when viewed in plan
and is provided with a forwardly extending rounded protuberance 362
which has a width substantially less than that of the balloon 361.
The balloon 361 consists of two sheets of material which can be
identified as a first or upper sheet 363 and a second or lower
sheet 364 which have been die cut to the desired configuration with
their edges bonded together in a suitable manner such as by means
of a heat seal to form a balloon which has a generally flat
configuration when deflated as shown in FIG. 40. The upper or outer
surface of the first or upper sheet 363 has been roughened in areas
365 as shown in FIG. 40 on the outwardly extending lobe portions
361a and 361b for a purpose hereinafter described. The roughening
can be accomplished in any suitable manner such as by embossing the
plastic material with a pattern having raised portions therein.
[0199] Means is provided for inflating the balloon with a suitable
medium, as for example a liquid such as a saline solution and
consists of a flexible tube 366 that extends into the balloon
between the two sheets 363 and 364 and forms a fluid-tight seal
therewith. The interior of the balloon can be inflated and deflated
by introduction of the fluid through the tube 366. The tube 366 is
connected to a Y-adapter 367 which has one leg of the Y connected
to a one-way valve 368 having a Luer fitting and the other leg
connected to a tube 369 which is connected to a tapered fitting
371. A conventional pinch off clamp 372 is mounted on the tube 369.
The tube 366 is adapted to be releasably retained in the slots 360
of the shoulder 359.
[0200] Means is provided for removably securing the balloon 361 to
the tunneling rod or shaft 306 and consists of an elongate tubular
member or sleeve 376 which extends along the length of the balloon
361 and is disposed on one side of the balloon 361 which can be
called the top side generally centrally of the balloon 361. The
tubular member 376 is provided with a passage 377 therein through
which the tunneling or guide rod or shaft 333 extends. As
hereinbefore explained, this tubular member or sleeve 376 can be
formed as a separate member which is bonded to the top sheet 363 or
alternatively can be formed integral with the top sheet 363 with
two heat seals being provided above and below to form the sleeve
376 with the passage 377 therein. The tubular member 376 can be
provided with spaced-apart elongate slits or perforations (not
shown) extending along a line 378 in the tubular member 376 to
facilitate separation of the balloon from the tunneling rod 333 as
hereinafter described. With a such a construction it can be seen
that the tunneling rod or blunt dissector or obturator 306 overlies
the balloon 361 for advantageous features hereinafter
described.
[0201] The balloon cover assembly 316 consists of a semi-rigid tube
381 formed of a suitable material such as plastic and is provided
with proximal and distal extremities 382 and 383. It is provided
with a bore 384 (see FIG. 42) which extends from the proximal
extremity 382 to the distal extremity 383. The tube 381 is provided
with a weakened region in the form of a partial slit 386 extending
from the distal extremity 383 to the proximal extremity 382 of the
tube 381 on the bottom side of the tube 381 as viewed in FIG. 40
(also see FIG. 42). The tube 381 is provided with a proximal end
wall 387 which extends at a suitable angle, as for example
45.degree. proximally with respect to the axis of the bore 384.
[0202] The balloon cover assembly 316 also includes a handle 391
which as shown can be formed as a separate part and is secured to
the proximal extremity 382 of the tube 381 by a metal clip 392. The
handle 391 is provided with a tapered body 393 formed of a suitable
material such as plastic which as shown in FIGS. 42 and 47 is open
on the bottom side to make accessible a longitudinally extending
recess 394 which is semi-circular in cross-section. A pair of
sideways extending wings 396 are formed integral with the body 393
and lie in a plane which is substantially coincident with the axis
of the semi-circular recess 394. As shown, the wings 396 are
disposed at the proximal extremity of the body 393.
[0203] An upwardly extending fin 397 is formed on the body 393
substantially equidistant from the wings 396 in a direction
generally perpendicular to the plane in which the wings 396 lie.
The fin 397 is relatively narrow and is provided with an upper
surface 378 having notches 401 and 402 therein. A vertically
extending wall 406 is formed as a part of the fin 397 and extends
generally in a direction which is perpendicular to the plane of the
wings 396. The wall 406 extends in a direction at right angles to
the fin 397 and has a gradually increasing thickness from the top
to the bottom ends of the wall (see FIG. 46). The body 393 is
provided with a pair of spaced-apart holes 407 spaced approximately
90.degree. apart and 45.degree. from each side of the fin 397. An
elongate slot 408 is formed in the body 393 and is generally in
alignment with the fin 397. A pair of camming slots 411 are
provided on opposite sides of the body 393 in the wings 396
adjacent the distal extremities of the wings adjacent the body. The
camming slots 411 are provided with inclined camming surfaces
412.
[0204] The body 393 is provided with a pair of diametrically
disposed protrusions 413 which extend into the recess 394 and which
are adapted to seat in a pair of diametrically opposed holes 414
provided in the distal extremity of the introducer member 342.
[0205] The balloon cover assembly 316 also includes a clamping
member 416 which is provided with a central body 417 and a pair of
downwardly extending legs 418 and 419 (see FIG. 43) which extend
downwardly into the camming slots 411. As shown, the central body
417 is disposed just distal of the fin 397 and is provided with
semi-circular guides 421 formed integral with the central body 417
and disposed on opposite sides of the fin 397 in a fulcrum region
which is just slightly above the point of commencement of the legs
418 and 419. The central body 417 is provided with longitudinally
extending reinforcing ribs 422 (see FIGS. 43 and 45).
[0206] It is also provided with a proximally extending latch
portion 426 which extends generally at right angles to the central
body 417. The latch portion 426 is provided with a centrally
disposed slot 427 extending substantially the entire length thereof
which receives the upper extremity of the fin 397 so that when the
clamping member 416 is snapped into placed over the body 393, the
latch portion 426 is disposed in the notch 401 and cannot clear the
uppermost portion of the fin 397. The clamping member 416 as
hereinafter described is adapted to be moved between positions in
which it is disposed within the notch 401 or alternatively in the
notch 402. Laterally extending rounded raised portions 428 are
provided on the central body 417 are adapted to be engaged by a
finger of the hand when moving the clamping member 416 from the
notch 401 to the notch 402.
[0207] Operation and use of the surgical balloon dissection
apparatus 301 in performing the method for developing an anatomic
space for laparoscopic hernia repair in connection with the
apparatus shown in FIGS. 39-48 may now be briefly described as
follows in conjunction with the cartoons which are shown in FIGS.
49a through FIG. 49g. The surgeon in connection with the present
method identifies the appropriate fascia layer to be dissected,
either by direct visualization of the tissue and/or by manual
palpation. Let it be assumed that it is desired to perform a hernia
repair on a patient 451 and that it is desired to create an
extraperitoneal working space for performing the surgical repair.
The surgeon makes a small incision 452 in the skin of the patient
in the umbilicus or slightly lateral of the umbilicus. A retractor
(not shown) can then be utilized to open up the incision and to
move it laterally to either side to locate the rectus muscles that
run longitudinally of the body of the patient on both sides of the
umbilicus or navel.
[0208] As soon as the rectus sheath has been located, the incision
is made in the rectus sheath through the incision previously made
midway between the two sets of the rectus muscles. The surgeon then
grasps the laparoscopic or balloon dissection apparatus 301 by
using a hand, as for example his right hand as shown in FIG. 49A to
grasp the handle assembly 337 to introduce the blunt end 331 into
the incision to engage the anterior wall of the posterior rectus
sheath. The balloon dissector 301 is then advanced longitudinally
of the patient's body generally parallel to the two sets of rectus
muscles as shown by the arrow 453 by using the rectus sheath as a
guide to pass the blunt tip 331 to cause separation of tissue and
to pass over the arcuate line and transversal is fascia to the
level of the symphysis pubis. This can be readily accomplished with
the balloon dissector 301 because the balloon cover assembly 316 is
latched to and generally rigidly connected to the distal extremity
of the introducer member 342 of the introducer device 307 by having
the protrusions 413 provided on the tubular cover 381 seated within
the holes 414 provided on the distal extremity of the introducer
member 342. This provides a rigid assembly of the balloon dissector
301 so it can be operated by the surgeon grasping the handle
assembly 337 without the need to have the physician grasp by the
other hand an intermediate part of the balloon dissector to cause a
desired manipulation and steering of the blunt tip 331 as the
dissection of the tissue is accomplished as it is advanced.
[0209] The travel of the blunt tip 331 to the level of the
symphysis pubis can be readily ascertained by the surgeon who can
use his hand to palpate the abdominal region of the patient and
thereby feel the blunt tip 331 as it is advanced until the blunt
tip 331 strikes the symphysis pubis. This can be readily
ascertained by the right hand holding the handle assembly 337
feeling the impact of the tip 331 striking the symphysis pubis 468
(see FIG. 50) which impact is communicated through the rigid
structure of the balloon dissector to the handle assembly 337 where
it can be felt by the hand of the surgeon. The balloon dissector
301 is then advanced a small additional amount so that the blunt
tip 331 drops below the symphysis pubis 468.
[0210] Thereafter, the balloon cover handle 391 is engaged by the
same right hand of the physician as shown in FIG. 49B and the thumb
is used to engage the tranverse rounded protrusions 428 by moving
the upper extremity of the clamping or latching member 416
proximally to cause the latch portion 426 to move into engagement
with the notch 402 carried by the fin 397. As this is occurring,
the legs 418 and 419 carried by the central body 417 are moved from
the position shown in FIG. 42 to the position shown in FIG. 47 and
in doing so engaging the camming surfaces 412 whereby the portions
of the wings 396 secured to the body 393 are cammed outwardly so
that the protrusions 413 are moved out of engagement with the holes
414.
[0211] The direction of movement of the latch or clamping member
416 is indicated by the arrow 454 in FIG. 49B. As soon as the
handle 391 has been released, the handle 391 is moved proximally
with two fingers of the hand grasping the wings 396 to pull them
upwardly and proximally to cause the balloon cover assembly 316 to
be removed. The balloon 361 is held in place by the tunneling shaft
or rod 336 and exits through the slit 386 provided at the bottom of
the tubular cover 381 which serves as a tear away sheath. The
balloon inflation tube 366 is retained in one of the slots 360 in
the shoulders 359 so that it does not become entangled in the wings
396 as the balloon cover assembly 316 is removed. This exposes the
balloon 361 which has its side margins rolled inwardly in rolls 461
with one being rolled in a counterclockwise direction and the other
being rolled in a clockwise direction so that they underlie the
tunneling rod 333 as shown in FIG. 50. Also to provide optimum
dissection as hereinafter described before the rolling up occurs
the forwardly extending protuberance 362 can be folded inwardly
along a fold line 471 and the sidewardly extending lobe portions
also can be folded inwardly along fold lines 472. To inflate the
balloon the pinch off clamp 372 is closed and a conventional 60 cc
syringe 476 containing a saline solution is connected to the
one-way valve 368. The syringe 466 is then operated as shown by the
arrow 477 to introduce the saline solution from the syringe 476
into the tubular member 366 and into the interior of the balloon
361 to gradually inflate the same. The one-way check valve 368
ensures that saline solution cannot exit therefrom when the syringe
466 is removed. The syringe 476 after it has been emptied can be
removed and refilled with a saline solution which is introduced
into the balloon in the same manner to cause the side margins of
the balloon 461 to unwrap in opposite directions as shown in FIG.
50 on opposite sides of the tunneling rod 333 until they become
completely unwrapped. Typically, it may take as many as
approximately ten syringes of saline solution to cause the balloon
361 to completely unwrap and the move into an inflated condition as
shown in FIG. 50. As the balloon is being filled and unwrapping, it
continues to separate or dissect tissue overlying the peritoneum to
provide an extraperitoneal working space between the transversalis
fascia and the rectus muscles.
[0212] As hereinbefore described, the balloon 361 in plan has an
asymmetric manta ray-like configuration to provide the desired
optimum extraperitoneal working space for the hernia repair.
[0213] The forwardly extending protrusion 362 provided on the
balloon 361 as it is inflated dissects distally from the distal
extremity of the blunt tip 331 of the guide rod 333 serves to
provide good dissection of tissue in the area of Cooper's ligaments
and also to dissect laterally around the inguinal rings. By
utilizing an asymmetric manta ray-like construction, it is possible
to provide a balloon 361 with its wide side margins or lobe
portions 361a and 361b which when inflated to cause forward
movement of the balloon 361 to dissect downwardly around the
inguinal rings and to wedge the balloon 361 in place. The forwardly
extending protrusion 362 as it is inflated dissects like a small
balloon down to the Cooper's ligament. In this way, it is possible
to obtain an extraperitoneal working space 478 which exposes all
the desired anatomy at one time before moving off to the hernia sac
and to do the final dissection for the hernia repair. By providing
such a large extraperitoneal working space it is unnecessary to
manually advance the dissection.
[0214] The balloon has also been shaped to properly match the
anatomy in which the procedure is to be formed so as to reduce to a
minimum the amount of manual dissection which may be needed.
[0215] Since the balloon has a particular shape and is formed of a
non-elastomeric material, the dissection will occur in the desired
locations which would not necessarily be the case if the balloon
were formed of an elastomeric material which generally would have a
tendency to follow the path of least resistance. Additional
assurance is provided for ensuring that dissection will occur in
the desired locations with the non-elastomeric balloon of the
present invention because the balloon is held in place by the
tunneling rod 333 underlying the symphysis pubis 468 as shown in
FIG. 50. Also by providing roughened areas 365 these areas
frictionally engage overlying tissue so that the lobe portions 361a
and 361b can serve as anchors to prevent displacement of the
balloon 361 after the balloon 361 as it is being inflated.
[0216] After the amount of desired tissue dissection has taken
place by inflation of the balloon 361 to provide the
extraperitoneal working space, the balloon 361 is deflated by
connecting the evacuation fitting 371 into an evacuation port (not
shown) of an operating room suction system.
[0217] The pinch clamp 372 is released to open the tube 369 to
permit the saline solution which had been introduced into the
balloons 361 to be sucked out to completely deflate the balloon
from the inflated condition as shown in FIG. 49C.
[0218] After the balloon has been deflated, the tubular member 366
can be grasped by the fingers of the hand as shown and the deflated
balloon 361 pulled out through the incision 452 in the direction as
shown by the arrow 481 in FIG. 49D. If necessary, the handle
assembly 337 can be held by the other hand. The balloon 361 as it
is being pulled off has its sleeve 376 separates from the tunneling
or guide rod 331 by breaking through the linear perforations lying
along the line 378. The guide rod 331 remains in place to preserve
an easy entry into the extraperitoneal space which has been
created. The balloon 361 can then be discarded.
[0219] After the balloon 361 has been removed, the left hand is
used to grasp the lower second handle part 38 with the left hand
while the right hand engages the upper or first handle part 336 of
the handle assembly 337. The fingers of the right hand then engage
the latch members 339 on opposite sides by the fingers of the hand
to release the first part 336 from the second part 338 and to
permit the left hand to move the second part 338 in the direction
of the arrow 482 shown in FIG. 49E. The second part 338 carries
with it the cannula 302 attached thereto and the introducer device
307 which extends therethrough with the skin seal assembly 311
mounted on the cannula tube 321. This advancement over the guide
rod 333 is continued until the distal extremity 343 of the
introducer member 342 has been advanced into the desired position.
As soon as this has been accomplished, the skin seal assembly 311
is slidably advanced on the cannula tube 321 until the skin seal
approaches the incision 452. The screw body 351 is then rotated by
the fingers of the hand engaging the flange 352 and/or to the
shoulder 359 to screw it into the incision 452 and to form a gas
tight skin seal with the skin of the patient. As soon as a good
skin seal has been established, the introducer device 307 is
clamped in a fixed position with respect to the skin seal assembly
311 by pushing generally downwardly on the collar 356 to engage the
collet 357 to form a friction grip between the elastomeric insert
353 and the cannula tube 321.
[0220] After the cannula 302 is in a fixed in position, the blunt
obturator 306 can be removed along with the tunneling device or
blunt obturator device 303. This is accomplished merely by
continuing to pull upwardly on the handle part 336 with the hand in
the direction indicated by the arrow 483 as shown in FIG. 49F. As
this pulling motion continues, the blunt tip 331 will engage the
distal extremity 343 of the introducer member 342 causing a
withdrawal force to be applied to the second handle part 338 to
cause it to automatically release from the housing 326. This
permits the blunt obturator device 303 to be removed through the
cannula tube 321. This is possible because the blunt tip 331 has a
diameter which can pass through the interior of the cannula tube
321 and through the valving provided in the housing 326. In
withdrawing the guide rod 333 carrying the obturator tip 331, it
can be seen that it continues to be guided by the introducer member
342 and thus will remain centered with respect to the cannula tube
321 to avoid any pinching action at the distal end 323 of the
cannula tube 321. As soon as the obturator tip 331 strikes the
introducer member 342, the handle part 338 is automatically
disengaged from the cannula handle 326. The latch parts 349 are
substantially buried within the second handle part 338 so they are
relatively inaccessible to the surgeon ensuring that he will
operate the latch parts 339 carried by the first handle 336 which
helps to ensure that the surgeon remove the handle parts 336 and
338 in two stages.
[0221] After this has been accomplished a source of gas such as
carbon dioxide is connected to the stop cock valve 328. The stop
cock valve 328 is opened to permit the carbon dioxide to inflate
the dissected extraperitoneal working space such as indicated by
the dotted lines 476 shown in FIG. 49G. The cannula 302 can then be
utilized for introducing instruments of various types into the
dissected extraperitoneal working space. The inflation gas cannot
escape because of the valving provided in the handle 326 of the
cannula 302.
[0222] Additional cannulae can be introduced in various positions
in the abdomen of the patient through which additional surgical
instruments can be introduced for performing the surgical procedure
to be performed in the extraperitoneal working space. The remainder
of the hernia repair procedure to be accomplished in the
extraperitoneal working space is substantially the same as
hereinbefore described and therefore will not be described in
detail. By way of example, let it be assumed that a hernia sac has
been formed in the patient, as for example by passing down into the
scrotum to form a typical indirect hernia. The hernia sac can be
pulled out and ligated in a manner hereinbefore described.
Thereafter, a piece of mesh as hereinbefore described can be
introduced through another site and rolled out over the region
through which the sac had previously passed. The mesh can then be
stapled in place, as for example along the Cooper's ligament. After
the hernia repair has been completed, the extraperitoneal working
space can be deflated by opening the stop cock valve 328 and
bleeding the CO.sub.2 contained therein to atmosphere to permit the
abdominal wall to return to its normal position to help retain the
mesh which has been placed in the desired position.
[0223] In connection with the formation of the extraperitoneal
working space with the apparatus of the present invention, it has
been found that it is desirable to have the guide rod 333 be in
position in which it overlies the balloon 361 because this helps to
ensure that the balloon dissection will occur in appropriate areas
because the blunt tip 331 underlying the symphysis pubis is
retained in the desired position even during the time that the
balloon is unrolling during inflation. Positioning the guide rod
333 in this manner, ensures that the balloon 361 will roll out in
the opposite directions from the rod and also to help to push the
balloon downwardly during inflation.
[0224] In order to make the apparatus more user friendly, the parts
which are to be moved for operation with respect to other parts
have been color coded, as for example they can be colored black
with the remaining parts being of another color, such as grey or
white. Thus, the clamping or latch member 416 is of a black color
because it must be removed to unlatch the balloon cover assembly
316. Similarly, the collar 356 of the skin seal assembly 311 is of
a black color because it must be moved to clamp the cannula 302 in
a desired position. Similarly, the latch parts 339 and 349 are of
black color because they also must be moved to separate the handle
parts.
[0225] The wings 396 are provided on the balloon cover 316 in
addition to serving as means to facilitate grasping of the balloon
cover assembly 316 when it is desired to remove the same, as serve
to visually indicate the plane in which the balloon 361 of the
balloon dissection apparatus 301 causes dissection. Generally this
dissection plane is in a plane which is parallel to the plane in
which the wings 396 lie.
[0226] As hereinbefore explained, the introducer member 342 is
provided with an obturator end surface or tip which is inclined at
an angle in a direction away from the normal direction of insertion
to inhibit any tendency that the tip might hang up on tissue as it
is being advanced through the tissue during dissection.
[0227] The sizing of the blunt obturator tip 331 so it is smaller
than the inner diameter of the cannula tube 321 helps to ensure
that tissue will not become entrapped or pinched between the tip
331 and the cannula tube 321. In addition, as hereinbefore
described, the obturator tip 331 is tapered in both directions into
a smaller dimension from the center to also minimize the
possibility of any tissue being entrapped between the tip 331 and
the cannula tube 321 and thereby ensuring that a shearing action
will not occur.
[0228] In conjunction with the foregoing disclosure, it has been
assumed that the balloon dissection apparatus hereinbefore
described typically would be disposed of after each use. In the
event it is desired to economize and it is desired to reutilize at
least certain portions of the balloon dissection apparatus after a
use in a laparoscopic procedure, another embodiment of a balloon
dilatation apparatus 501 incorporating the present invention is
shown in FIGS. 51-55.
[0229] As shown therein it consists of a handle assembly 502
similar to the handle assembly 337 hereinbefore described which
includes a handle part 503 similar to the handle part 336. Other
parts of the balloon dissection apparatus 501 are not shown because
they can be identical to those hereinbefore described. The handle
part 503 is provided with two sections 506 and 507 which can be
fastened together in a suitable manner such as by ultrasonic
bonding or an adhesive.
[0230] Latch members 511 and 512 are provided on opposite sides of
the handle part 503 and are provided with finger portions 513 that
are adapted to be engaged by fingers of the hand which extend
outwardly through recesses 514 in the sections 506 and 507. The
latch members 511 and 512 are each provided with a latch 516 which
is yieldably urged in an outward direction by a yieldable spring
member 517 engaging a downwardly depending lip 518 provided within
the sections 506 and 507. The latch members 511 and 512 are
pivotally mounted between the sections 506 and 507 by pivot pins
519 formed integrally on the latch members 511 and 512 and
extending into bosses 521 provided in the sections 506 and 107
which are formed of a suitable material such as plastic.
[0231] First and second inserts 526 and 527 formed of a suitable
material such as plastic are mounted in the sections 506 and 507.
First and second latch members 531 and 532 formed of a suitable
material such as metal are provided which are seated in recesses
533 and 534 provided in the insets 526 and 527. The latch members
531 and 532 are generally U-shaped and are yieldably urged into
engagement with each other to form an elongate slot 536 extending
therethrough. Upstanding legs 538 formed integral with the inserts
526 and 527 are provided in rectangular spaces 539 in the inserts
526 and 527 so that the upper extremities of the legs 538 can be
flexed by movement of the latch members 531 and 532 as shown by
dotted lines in FIG. 54.
[0232] A guide rod 541 is provided which is similar to the guide
rod 333 with the exception that its distal extremity 542 is also
provided with an annular recess 533. The distal extremity 542 is
provided with a chamfer 544 and a pair of opposed flats 546 which
extend through the chamfer 544. The guide rod 541 extends through a
hole 551 provided by semicircular recesses formed in the sections
506 and 507 and by a hole 552 formed by semicircular recesses in
the inserts 526 and 527. A larger hole 553 formed by semicircular
recesses in the inserts 526 and 527 of a larger diameter than the
hole 552 is provided which receives a push-button 556 and extends
through a hole 557 also formed by semicircular recesses provided in
the sections 506 and 507. A dish-shaped or concave recess 558 is
provided in the sections 506 and 507 and facilitates engaging the
push-button 556 by a finger of the hand.
[0233] The pushbutton 556 is provided with a bore 561 which is
sized so that it can receive the distal extremity 542 of the guide
rod 541. The pushbutton is provided with sideways extending skirts
562 extending 180.degree. with respect to each other and which are
provided with distally and inwardly extending camming surfaces 563
which terminate at a tip 564 that is generally V-shaped as shown in
FIG. 51. The tip 564 is formed so that it is adapted to enter into
the slot 536 formed by the U-shaped members 531 and 532. Thus, when
the pushbutton 556 is depressed, the tip 564 will enter the slot
536 in a progressive manner to urge them apart so that the camming
surfaces 563 carried thereby engage the U-shaped latch members 531
and 532 in regions just above and below the guide rod 541 so that
the guide rod 541 is released by the U-shaped latch members 531 and
532 permitting it to be pulled out of the handle part 503.
[0234] Release of the guide rod 541 makes it possible to separate
the guide rod 541 from the remainder of the balloon dissection
apparatus 501 so that the handle assembly 502 and the other parts
carried thereby can be separated from the guide rod. Thereafter,
the guide rod 541, the balloon 361 and the balloon cover assembly
316 can be disposed of. The other parts of the apparatus can be
reutilized after appropriate sterilization. In order to ensure that
the other parts survive sterilization, it may be desirable to form
the plastic reusable parts of a suitable plastic such as a
polysulfone.
[0235] Still another embodiment of the laparoscopic apparatus
incorporating the present invention is shown in FIGS. 56-62. The
laparoscopic apparatus 600 consists of an introducer device 601.
The introducer device consists of a elongate tubular member or
cannula 602 formed of a suitable transparent medical grade plastic
which is provided with proximal and distal extremities 603 and 604
with a bore 606 extending from the proximal extremity 603 to the
distal extremity 604. A valve housing 611 is mounted on the
proximal extremity 603 of the tubular member 602 and is provided
with a valve 612, which may be of the type disclosed in copending
application Ser. No. 08/124,283 filed Sep. 20, 1993, for example.
The valve housing 611 and the valve 612 provided therein can
accommodate relatively large diameter devices which are adapted to
be introduced through the bore 606 of the tubular member 602 and
form a seal with respect thereto.
[0236] An inflatable balloon 616 is provided which is formed of a
sheet 617 (see FIG. 69) of a non-elastomeric plastic material of a
medical grade such as PET-E. The sheet 617 is provided with a
weakened region 618 extending transversely of the sheet, as for
example by providing spaced-apart perforations in the sheet 617
(see FIG. 60). The sheet 617 as shown in FIG. 60 is folded over
onto itself to provide two portions 617a and 617b with a fold line
619 being formed parallel to but spaced from the perforations 618
by a suitable distance, as for example one-quarter of an inch. A
linear heat seal 621 extends across the sheet 617 and bonds the two
portions 617a and 617b to each other along a line parallel to but
spaced apart from the fold line 619 and also from the perforations
618 by a suitable distance, as for example three-quarters of an
inch. This three-quarter inch dimension is dependent upon the size
of the balloon to be formed as hereinafter described. The sheet 617
is cut adjacent its outer margins along the dotted line 622 to
provide the balloon with the desired conformation as for example
the manta ray type shape hereinbefore described having a rounded
distal extremity.
[0237] After the heat seal 621 has been formed, the sheet 617 can
be slit along the fold line 619 by suitable means such as a knife
to provide two additional portions 617c and 617d formed from the
sheet 617. Thus, by use of the heat seal 621 there are provided two
portions 617a and 617b which can be in a plane and two additional
portions 617c and 617d that extend transversely and outwardly of
the plane formed by portions 617a and 617b (see FIG. 62). Also,
these portions 617a-617d can be described as forming an X with the
portions 617a and 617b forming the top side of the inflatable
balloon assembly 616.
[0238] Thereafter, the portions 617a and 617b are unfolded so that
they lie in a plane. They are then placed over another precut sheet
623 (see FIG. 62) of the same non-elastomeric material as the sheet
617 and a suitable seal, as for example a heat seal 624 formed
around the entire outer perimeters of the sheet 623 to bond it to
the outer perimeter of the portions 617a and 617b to form a
fluid-fight enclosure to provide a space 626 within the balloon
627. In order to make it possible to inflate the balloon 627 with
an inflation medium, as for example with a saline solution, one end
of a central portion of the balloon 627 adjacent the portions 617c
and 617d is mounted in an annular recess 628 provided on the distal
extremity 604 of the tubular member 602 (see FIG. 56) is bonded
thereto in such a manner such as by an adhesive tape 629 to form a
fluid-tight connection between the distal extremity 604 of the
tubular member 602 and the space 626 within the balloon 627.
Alternatively, a tube clamp of the type hereinafter described can
be used. The balloon 627 is provided with a rounded protuberance
631 to provide the desired configuration for the dissected anatomic
space to be created by the balloon 627 and also to aid in the
positioning of the balloon 627 during placement of the balloon in
tissue in the body. After the heat seal 624 has been completed, the
outer side margins 632 and 633 of the balloon 627 are rolled
inwardly and downwardly in opposite directions towards the heat
seal 621 to form two rolls 636 and 637 which are immediately
adjacent to each other and generally underlie the heat seal 621.
The two flaps or portions 617c and 617d are then brought downwardly
as shown in FIG. 63 so that they enclose the rolls 636 and 637 and
are bonded together in a suitable manner such as by a heat seal 641
extending transversely of the portions 617c and 617d to form an
enclosure or cover 642 for the compact rolls 636 and 637. The
perforations 618 are within the confines of the cover or enclosure
642 formed for the rolls 636 and 637 within the heat seal 641 so
that the cover or enclosure 642 for the rolls can be made operable
or in other words slit along the weakened region along the
perforations 618 to release the rolls 636 and 637 as hereinafter
described. From the construction hereinbefore described it can be
seen that the balloon 627 forms a part of the inflatable balloon
assembly 616 and is mounted on the distal extremity of the tubular
member 602.
[0239] Means is provided for inflating the balloon 627 and consists
of a Luer-type fitting 646 which is provided on the housing 611 and
opens into the interior of the housing 611 below the valve 612 in
the housing 611 so that it is in communication with the bore 606
and with the interior space 626 within the balloon 627. The fitting
646 is connected by flexible tubing 648 to a male fitting 649 which
can be connected to a suitable fluid source, as for example a
syringe (not shown) containing a saline solution to be utilized for
filling the balloon. A tubing clamp 652 of a conventional type is
provided on the tubing 648.
[0240] A pair of diametrically extending wings 656 and 657 (see
FIG. 58) are formed integral with the housing 611 and lie in a
plane which is parallel to the planes in which the two halves of
the balloon 627 lie. As hereinafter described, these wings 656 and
658 serve as means for ascertaining the orientation of the balloon
627 during dissection as hereinafter described. The wings 656 and
657 are sized so that they are adapted to be engaged by the fingers
of the human hand.
[0241] Means is provided for introducing an insufflation gas into
the anatomic space as it is being dissected and during the time the
laparoscopic apparatus 600 is being utilized. This means consists
of a tubular member 661 which is provided with a lumen 662 (see
FIG. 63) extending between the proximal and distal extremities 663
and 664 of the tubular member 661. The tubular member 661 can be
secured to the balloon 627 by suitable means such as an adhesive
and has its distal extremity 664 extending into the region of the
rounded protuberance 631. The proximal extremity 661 is secured to
a Luer-type fitting 666 and is adapted to be connected to a source
of insufflation gas.
[0242] A skin seal 671 having a helical thread 672 formed thereon
has a cone shaped configuration in which the cone increases in
diameter from the distal extremity towards the proximal extremity.
The skin seal 671 is of the type disclosed in copending application
Ser. No. 08/124,333 filed Sep. 20, 1993 and has a slip-friction fit
on the exterior surface of the tubular member 602. The skin seal
671 has an axially adjustable collar 674 which can be moved into
clamping engagement with the tubular member 602. The skin seal 671
is provided with a large bore 673 so that it can accommodate
various sized cannulae ranging in size from 10-15 millimeters in
diameter. The skin seal 671 is also provided with a conventional
retaining mechanism for retaining a cannula inserted therethrough
at the desired depth.
[0243] The skin seal 671 has a longer length than is typical
because in addition to serving as a skin seal, it is utilized to
preserve access to the dissected space. In other words, it serves
as a guide for directing other cannulae into the dissected
space.
[0244] The laparoscopic apparatus 600 also includes a tunneling
shaft assembly 676 (see FIG. 57) which consists of a tubular member
677 having a bore 678 extending therethrough. The tubular member
677 is formed of a transparent medical grade plastic and is
provided with an outer diameter which is adapted to fit within the
skin seal 671. It can have a suitable length such as 15-30
centimeters.
[0245] The tunneling shaft assembly 676 also consists of a closed
blunt rounded tip 681 formed integral with the tubular member 677.
The tip 681 is also formed of the same transparent medical grade
plastic as the tubular member 677. The tip 681 is provided with a
conical recess 682 of a depth so that the wall thickness is the
same as that of the tubular member 677. It should be appreciated
that if desired, the tip 681 can be formed as a separate part from
the tubular member 677 and secured thereto by suitable means such
as an adhesive. The conical recess 682 is sized so that it can
receive the distal extremity of a laparoscope as hereinafter
described.
[0246] Operation of the laparoscopic apparatus 600 shown in FIGS.
56-63 may now be briefly described as follows. Let it be assumed
that the laparoscopic apparatus 600 is ready to be utilized by a
physician in a laparoscopic procedure to perform a hernia repair.
Typically, the introducer device 602 with the balloon assembly 616
would be shipped by the manufacturer along with the skin seal 671
and the tunneling shaft assembly 676. The tunneling shaft assembly
676 has a bore 678 that can readily accommodate a conventional 10
millimeter laparoscope 686.
[0247] The conventional laparoscope 686 is provided with a shaft
687, an eyepiece 688 and a fitting 689 for introducing light. Such
a laparoscope 686 is inserted into the bore 678 down into the bore
682 in the tip 681 of the tunneling shaft assembly 676. A baffle
683 (see FIG. 57A) is mounted in the bore 682 of the tip 681 and
extends laterally and axially thereof. The baffle 683 is formed of
a suitable material such as plastic and is secured to the tunneling
shaft assembly 676 in a suitable manner such as by an adhesive (not
shown). The baffle 683 is preferably formed of a suitable opaque
material such as a black plastic. Alternatively, it can be provided
with a reflective surface away from the lens of the laparoscope.
Thus the baffle serves to keep reflective light away from the lens
of the laparoscope to improve the viewing capabilities of the
laparoscope without interference from unwanted reflections, as
represented by the ray 689, to provide a glare-free view by the
laparoscope. The baffle 683 is provided where the viewing lens for
the laparoscope 687 is disposed in one semicircular quadrant. Where
the viewing lens for the laparoscope is in the center, a
cylindrical proximally extending opaque baffle 691 (see FIG. 57B)
is mounted in the tip 681 and circumscribes the lens to screen out
unwanted reflections in the field of view for the laparoscope to
provide a glare-free view by the laparoscope.
[0248] The tunneling shaft assembly 676 is then taken and its tip
681 introduced through the valve housing 611 and into the bore 606
of the introducer device 602 and thence into the balloon assembly
616 mounted thereon until the tip 681 is in disposed in the rounded
protuberance 631 of the balloon 627 with the tunneling shaft
assembly 676 disposed in the balloon 637. The tubular member 677 of
the tunneling shaft assembly 676 provides the desired rigidity for
the balloon 637 so that it can be introduced into an incision made
in the appropriate location, as for example in the umbilicus as
described in conjunction with the previous embodiments.
[0249] The tunneling shaft assembly 676 with the balloon carried
thereby is then advanced into the tissue in the manner hereinbefore
described in connection with previous embodiments with the progress
being observed through the laparoscope 686. The laparoscope 686
makes it possible to view the progress of the tip 681 and the
various tissues being encountered, since the tip 681 and the
balloon 627 are transparent.
[0250] Immediately prior to inflation of the balloon 627, the wings
656 and 657 are oriented so they lie in a plane which corresponds
to the plane in which it is desired to have the balloon 627 carry
out the dissection. Thus it can be seen that the wings 656 and 657
help to ensure that the dissection occurs in the appropriate
plane.
[0251] As soon as the tip 681 of the tunneling shaft assembly 676
is located in the desired position, a saline solution can be
introduced through the fitting 649 and into the bore 606 directly
into the space 626 in the balloon 627 to cause inflation of the
balloon. As the balloon 627 begins to inflate, the balloon 627
breaks the cover 642 by causing separation along the perforations
618.
[0252] This permits the rolls 636 and 637 of the balloon 627 to
evert outwardly and gradually unroll and progressively inflate in
two opposite lateral directions in the same plane to cause
dissection of the tissue in a natural plane as hereinbefore
described in connection with the previous embodiments. During the
time this dissection is taking place, the dissection can be viewed
through the laparoscope 686 to visualize anatomic landmarks. The
visualization through the laparoscope 686 is quite effective
because the index or refraction of the saline solution is near to
that of the balloon material so there is very little reflection
compared to a situation in which a visualization is attempted to be
accomplished when the dissection balloon is filled with air.
[0253] Also during the time the balloon is inflated, it is possible
to insert the additional accessory trocars to be utilized during
the laparoscopic procedure into the dissected space to visualize
their entrance into the dissected space and to aid in proper
positioning of the trocars.
[0254] After inflation of the balloon 327 and the desired
dissection has been accomplished, the skin seal 671 can be slid
down on the tubular member 602 into the incision and screwed into
the incision to form a substantially gas-tight seal therewith.
[0255] In connection with the present apparatus during the time
that dissection is being accomplished, it is possible to pass an
insufflation gas into the space as it is being dissected.
[0256] This can be accomplished by introducing a suitable gas, as
for example CO.sub.2 through the tubular member 661 through the
fitting 666. This will provide some inflated dissected space
outside the balloon in the vicinity of the tip 681 to aid in
visualization of the anatomic space being created. Let it now be
assumed that the desired dissection has been accomplished and it is
desired to remove the balloon assembly 616. The skin seal 671 can
be inserted before or after inflation of the balloon 627. The skin
seal 671 can be inserted by exerting a sliding and rotating motion
to the skin seal 671 on the tubular member 602 to cause the distal
extremity of the skin seal 671 to progressively enter the incision
until a substantially fluid-tight seal is formed between the skin
of the patient at the incision and the skin seal 671. Thereafter
the introducer 601 can be grasped by holding the skin seal 671
stationary in one hand and the housing 611 of the introducer 601
with the other hand and pulling the introducer 602 outwardly from
the skin seal and pulling with it the laparoscope 686 if it has not
been previously removed, the tunneling shaft assembly 676 followed
by the balloon assembly 616 secured to the end of the introducer
device 601.
[0257] Thus, it can be seen that the introducer device 601 and the
balloon assembly 616 can be removed through the enlarged bore 673
provided in the skin seal 671. As soon as this has been
accomplished, a conventional trocar cannula can be introduced into
the skin seal and clamped into the skin seal at the desired depth
by operation of the collar 674 in the manner described in copending
application Ser. No. 08/124,333 filed Sep. 20, 1993. Thereafter,
insufflation of the anatomic space can be accomplished by
introducing a gas through the trocar and thereafter the
laparoscopic procedure can be completed in the manner hereinbefore
described in connection with the previous embodiments.
[0258] In connection with the foregoing, it can be seen that by
making minor changes in the construction it is possible to save a
great number of parts of the balloon dissection apparatus for reuse
after sterilization. Only the parts which are most difficult to
clean are disposed of after a one-time use.
[0259] From the foregoing it can be seen that there has been
provided an apparatus and method which is particularly suitable for
developing an anatomic space such as an extraperitoneal working
space between the abdominal wall and the peritoneum by dissecting
tissue with the use of a non-elastomeric balloon. The balloon
dissection apparatus has many features facilitating its use in
developing such an anatomic space and for particularly developing
an extraperitoneal working space for hernia repair.
[0260] In connection with the present embodiment of the invention
it can be seen that visualization is possible through a laparoscope
during the entire dissection procedure. The laparoscopic procedure
has also been simplified that it is unnecessary to remove a balloon
cover as in the previous embodiments. In the present embodiment of
the invention, the balloon can be introduced without a balloon
cover and can be inflated almost immediately. It also can be
readily removed after the desired dissection has been completed by
pulling the balloon out through the skin seal and thereafter
inserting the trocar cannula. The present invention makes it
possible to preserve access to the dissected space without the need
of retaining a obturator in location as with the previous
embodiments.
[0261] In FIG. 64, there is shown a cross-sectional view of the
balloon 627 laterally disposed inwardly extending folded portions
627a and 627b. Thus, in effect the balloon 627 is double-folded
inwardly in a lateral direction before it is wrapped up and both
sides formed into rolls and in the manner hereinbefore described
and as shown particularly in FIG. 63. In addition, the rounded
protuberance 631 can also be folded inwardly in a similar manner
before the balloon is rolled-up and sealed between the portion 617c
and 617d by the heat seal 641. This balloon 627 is folded in the
manner shown in FIG. 64 and then wrapped as shown in FIG. 63 and
can be utilized in the same manner as the embodiment hereinbefore
described. Upon inflation of the space 26 within the balloon, the
balloon begins to inflate in an up and down direction rather than
laterally until sufficient pressure is created within the balloon
to cause the inverted bifolds 627a and 627b to begin to evert
outwardly to aid in forcing the balloon to unroll. This everting
action of the balloon facilitates unrolling of the balloon and aids
in dissection of tissue. This everting motion also avoids dragging
the balloon across the tissue as it fills. When folded in the
manner shown in FIG. 64, the balloon unfurls from within and
progressively lays itself out on the dissected tissue as it
inflates. Similarly, the rounded protuberance 631 will evert and
also unfold in a similar manner to create dissection in a forward
direction.
[0262] It should be appreciated that with the lateral bifolds
provided in the balloon 627 the tubular member 677 can be inside or
outside the balloon and still be provided with the broad bi-folds
in the balloon 627.
[0263] In connection with the present invention it has been found
that in certain surgical procedures there is a need to dissect
around an obstruction as for example a hernia. For this purpose, a
horseshoe-shaped or bifurcated balloon 701 is provided as shown in
FIGS. 65-68.
[0264] The balloon 701 is substantially Y-shaped as shown in FIG.
68 and is provided with a bifurcation 702 which leads into two legs
703 and 704 to provide a U-shaped space 706 therebetween. The
balloon 701 can be constructed in the manner hereinbefore described
for the previous balloons used in accordance with the present
invention.
[0265] The legs 703 and 704 can be inverted into the bifurcation
702 as shown in FIG. 66 and then can be rolled into two rolls
rolled in from opposite sides onto an olive-tipped guide rod 711
shown in FIG. 65 and held in place by a separate balloon cover (not
shown) or by the use of flaps forming a sleeve such as shown in
FIG. 59 to provide an assembly 712. It has been found that in
connection with the present invention to achieve the best
dissection capabilities for the balloon and expansion of the
balloon, the balloon 701 is secured to the guide rod or tunneling
rod 711 so that the guide rod underlies the balloons. The side
margins are rolled inwardly into two rolls so that the two rolls
face downwardly toward the tunneling guide rod 711. They are then
brought into close proximity with each other to form a single roll
and secured to the tunneling guide rod 711 as hereinbefore
described. A tubular member 713 providing a balloon inflation lumen
opening into the interior of the balloon 701 is sealed into the
balloon 701. A Y adapter 714 is secured to the tubular member 713
and carries a male fitting 716 and another tubular member 717 on
which there is mounted a tubing clamp 718 and another male fitting
719.
[0266] Let it be assumed that it is desired to dissect around an
obstruction 720 which by way of example can be ventral hernia or
other obstruction that cannot be readily dissected. Let it also be
assumed that the assembly 712 shown in FIG. 65 has been introduced
into dissected space in the manner hereinbefore described with or
without the laparoscope and an obstruction 720 is encountered and
it is desired to dissect around the obstruction 720. This can be
accomplished by removing the cover or sleeve (not shown) that was
used for enclosing the balloon and securing it to the guide rod
711. As soon as the balloon 701 is released, it can be inflated
through the tubular member 713 to unroll sideways or laterally in a
plane just proximal of the obstruction 720. The balloon 701,
because of the manner in which it was rolled-up, will unroll
downwardly and outwardly away from the tunneling guide rod 711 to
create the desired dissection. Continued inflation of the balloon
will cause one or both the legs 703 and 704 to progressively evert
and advance around the obstruction 720. Thus, as shown in FIG. 67,
the arm 704 everts and passes around one side of the obstruction
720 while accomplishing dissection as it goes, whereas the other
arm 703 can thereafter or simultaneously evert to cause dissection
around the other side of the obstruction 720 until both of the legs
703 and 704 are completely inflated to create a dissection
extending around the obstruction 720. The balloon 701 can then be
deflated and removed through the skin seal in the manner
hereinbefore described. Insufflation and other surgical procedures
in connection with the present invention can thereafter be
performed.
[0267] Where it is desired to utilize a smaller cannula and skin
seal, a construction and method such as that shown in FIG. 69 can
be utilized. The laparoscopic apparatus 21 shown in FIG. 69 for use
for such a purpose consists of a manta ray-shaped balloon 722 of
the type hereinbefore described which is provided with sides or
wings 723 and 724. The balloon 772 is provided with a neck 726
through which a tubular member 731 of the type hereinbefore
described is serving as a scope cover. The neck of the balloon is
secured to the tubular member 731 by suitable means such as a hose
clamp 732 of a conventional type. The tube clamp can be formed of a
suitable material such as plastic and can be of the type
manufactured by Tyton Corporation, 7930 North Faulkner Road,
Milwaukee, Wis. 53223. The tubular member 731 extends through a
skin seal 736 of the type hereinbefore described which is provided
with an axially movable ring or collar 737. In order to be able to
insert the laparoscopic apparatus 721 into an incision, the wings
or sides 723 and 724 can be rolled inwardly and secured to the
distal extremity of the tubular member 731 by suitable means such
as a balloon cover (not shown) of the type hereinbefore described
or, alternatively, by providing two additional flaps on the balloon
of the type hereinbefore described which can be utilized for
securing the rolled balloon to the tubular member.
[0268] A tubular member 741 is sealed within the balloon 722 and
carries a balloon inflation lumen (not shown) which is in
communication with the interior of the balloon 722 through its open
end and through a plurality of longitudinally spaced apart holes
745 in communication with the balloon inflation lumen. Tubular
member 741 carries a Y fitting 742 that carries a male adapter 743.
Tubing 74 is connected to the Y adapter 742 and has mounted thereon
another male fitting 746 and a hose clamp 747, all of the type
hereinbefore described.
[0269] Operation and use of the laparoscopic apparatus 721 as shown
in FIG. 69 may now be briefly described as follows. As in the
previous embodiments, the distal extremity of the apparatus 721 can
be inserted through a cannula or a trocar sleeve 733. As
hereinbefore explained, the distal extremity of the apparatus can
be advanced by the use of the tubular member 731 as an obturator to
advance the balloon to the desired space. As hereinbefore
explained, this procedure can be viewed through a laparoscope (not
shown) inserted into the tubular member 731 permitting viewing
through the distal extremity of the transparent tubular member 731
and the transparent balloon 722. After the desired amount of
dissection has been accomplished to induce the balloon 722 into the
desired location, the balloon cover if utilized can be removed.
[0270] Thereafter, the balloon 722 can be inflated by introducing a
saline solution through the male fitting 743 and through the
tubular member 741 to cause it to unroll in two opposite directions
to cause additional dissection of the tissue to create an anatomic
space below the skin of the patient.
[0271] The balloon is retained on the tubular member or scope cover
731 by the clamp 732 during the time that inflation of the balloon
is taking place.
[0272] After the desired amount of dissection has taken place by
inflation of the balloon 722, the balloon 722 can be deflated by
opening up the clamp 747 and permitting the fluid, as for example
the saline solution, to exit through the male adapter 746. As soon
as the balloon 722 has been deflated, the clamp 732 can be removed
by pressing sideways on the clamp 732.
[0273] The cannula 733 can then be advanced on the scope cover 731
to push the proximal extremity 726 of the balloon 722 through the
incision and so that the cannula 733 extends through the incision.
The skin seal 736 is advanced on the cannula into the incision to
push off of the distal extremity of the cannula 733. Then, while
holding the cannula 733 and the skin seal 736 in place, the tubular
member or scope cover 731 can be retracted and is completely
removed from the balloon 722. As soon as the scope cover 731 has
been removed, the deflated balloon 722 can be withdrawn through the
incision 752 by pulling on the tubular member 741. As soon as the
balloon 722 has been removed, the skin seal 736 can be rotated to
complete insertion of the skin seal to form a fluid-tight seal
between the skin 751 and the skin seal 736. Thereafter, the
anatomic space which has been formed by dissection of tissue by the
use of the balloon 722 can be insufflated in the manner
hereinbefore described and the desired surgical procedures
performed.
[0274] Another embodiment of a laparoscopic apparatus 756
incorporating the present invention is shown in FIG. 70, which is
substantially identical to that shown in FIG. 69 with the exception
that the balloon 722 at the distal extremity of the balloon has
been folded inwardly onto itself onto the distal extremity of the
scope cover 731 as shown by the fold 757. Operation and use of this
embodiment is substantially identical to that hereinbefore
described in connection with the embodiment shown in FIG. 69. Upon
introduction of an inflating fluid through the tubular member 741,
the balloon will expand by everting outwardly to move the fold 757
in the balloon after which the balloon will unroll sidewise in a
manner similar to the balloon 722 as hereinbefore described in FIG.
69 to assume the dotted-line shape shown in FIG. 70. Thereafter,
the balloon 722 can be deflated and removed in the manner
hereinbefore described in connection with FIG. 69.
[0275] A laparoscopic apparatus 761 incorporating another
embodiment of the invention is shown in FIGS. 71 through 73 and as
shown therein consists of a balloon 762 which as shown can have a
manta ray shape of the type hereinbefore described. It is provided
with a narrowed down neck 763 which is adapted to engage an annular
taper 764 (see FIG. 73) carried by the distal extremity of a
cannula 766. The cannula 766 can be substantially identical to the
cannulae hereinbefore described with the exception that it is
provided with an inwardly extending annular taper 764 which can be
engaged by the neck of the balloon. The neck of the balloon is held
in a fluid tight seal with respect to the taper 764 by a tubular
member 771 which is provided with a bore 772 extending therethrough
and which is sized so that it is adapted to receive a conventional
laparoscope 773 of the type hereinbefore described. The tubular
member 771 is provided with an outer tapered distal extremity 776
(see FIG. 74) which is adapted to mate with the inner annular taper
764 provided on the cannula 766 and to retain the neck 763 of the
balloon in a position so as to form a fluid-tight seal to retain
the balloon on the cannula 766 during and after inflation as
hereinafter described. Alternatively, this tapered distal extremity
can be formed in a suitable manner such as by a collar 777 (see
FIG. 73) formed separately or as an integral part of the tubular
member 771 and having a slightly greater outer diameter than the
outer diameter of the tubular member 771 and is spaced a short
distance from the distal extremity of the tubular member 771. This
space has disposed therein an resilient epoxy-like material 778
having an inwardly and forwardly extending taper of decreasing
diameter in a direction towards the distal extremity of the tubular
member 771. This material 778 has a taper which is similar to the
taper provided on the inwardly extending annular taper 764 on the
cannula 776 so that when the tubular member 771 is pushed inwardly
in a distal direction, the tubular member will engage the neck 763
of the balloon and frictionally hold it in place and at the same
time frictionally retain the tubular member 771 therein.
[0276] In the event there is difficulty in seating the neck of the
balloon within the taper 774, the distal extremity of the
laparoscope 773 can be inserted through the bore 772 of the tubular
member 771 and extended a slight distance into the balloon 762
beyond the neck of the balloon. The neck 763 of the balloon 762 can
then be wrapped about the laparoscope and the neck of the balloon
with the laparoscope can be pushed inwardly with the tubular member
771 being retracted out of the way from the taper 764. As soon as
the neck 763 is seated over the inner taper 764, the tubular member
771 can be pushed distally to frictionally engage the neck of the
balloon to firmly clamp it in place to form a sealing engagement
between the balloon 762 and the cannula 766. Thereafter if desired,
the laparoscope 773 can be retracted.
[0277] There are many portions of the apparatus 761 which are very
similar to that hereinbefore described. Thus, a skin seal 784 is
slidably mounted on the cannula 766 and carries an axially movable
collar 782 of the type hereinbefore described for frictionally
retaining the skin seal 784 in a predetermined axial position on
the cannula 771. A valve housing 786 is mounted on the proximal
extremity of the cannula 771 and carries an inlet port 787. A
handle 788 of the type hereinbefore described is detachably mounted
on the valve housing 786 and carries with it the tubular member
771. Another valve housing 791 is mounted on the handle 788 and is
provided with a valve (not shown) to form a fluid tight seal with
respect to the outer surface of the tubular member 771. The
laparoscope 773 extends through the tubular member 771 which
extends through the valve housing 771 and also through the valve
housing 786.
[0278] In the laparoscopic apparatus 771, an additional port is
provided in the balloon 762 for inflating the balloon and consists
of a tubular member 796 which extends into the balloon and is
sealed in the balloon. It is provided with an open end and a
plurality of spaced-apart holes 797 which open into the bore in the
tubular member 796 and can be utilized for inflating the interior
of the balloon 722 in a manner hereinbefore described. A fitting
assembly 799 is mounted on the tubular member 796 and consists of a
wye 801 mounted on tubular member 796. The wye 801 has one leg of
the Y connected to an adapter 802 and has the other leg of the Y
connected to a tube 803 having a tubing clamp 804 mounted thereon
and connected to another male connector 806 of the type
hereinbefore described.
[0279] Operation and use of the laparoscopic apparatus shown in
FIGS. 71-73 may now be briefly described as follows. Let it be
assumed that the apparatus has been shipped in the manner shown in
FIGS. 71-73 with the neck 763 of the balloon retained against the
taper 764 by the tubular member 771. As hereinbefore described, the
balloon 762 can be wrapped up into a roll and enclosed within a
removable balloon cover (not shown) or alternatively it can be
enclosed by an integral balloon cover of the type hereinbefore
described so that the balloon roll with the balloon cover can serve
as an obturator. If necessary, the balloon roll and cover
combination can be aided by the distal extremity of the laparoscope
773 extending to the distal extremity of the balloon 762 to cause
the balloon roll and cover to pass through the incision and do
sufficient dissection of tissue so that the balloon is disposed
below the skin of the patient.
[0280] The balloon cover, if one is present, can then be removed
and the balloon 762 inflated by introducing a saline solution
through the adapter 102 by use of a syringe or other suitable
means.
[0281] As soon as the balloon is inflated and has been unrolled to
create the dissection as hereinbefore described, the balloon can be
deflated by permitting the saline solution to pass through male
adapter 806 upon opening of the tubing clamp 804. The cannula 766
can then be pushed through the incision into the anatomic working
space which has been created by the balloon 762. The laparoscope
773 can then be removed. Thereafter the handle 788 can be released
to bring with it the tubular member 771 with the tapered distal
extremity 776 to release the neck 763 of the balloon 762.
Thereafter the fitting assembly 799 can be grasped and the balloon
762 can be withdrawn through the incision outside the cannula 766.
After the balloon has been retracted, the skin seal 781 can be
advanced into the incision to form a fluid tight seal with respect
to the skin of the patient.
[0282] From the foregoing, it can be seen that with the
laparoscopic apparatus 761 shown, the laparoscope 773 can be
utilized during insertion of the balloon into the incision and
during the time that the balloon is being inflated to dissect
tissue. However, it should be appreciated that if it is unnecessary
to view this procedure, the laparoscope 773 can be eliminated,
because in most instances the wrapped up balloon has sufficient
rigidity to serve as an obturator to permit the balloon to be
pushed through the incision and to create adequate dissection below
the skin of the patient to permit entry of the balloon after which
the balloon can be inflated as hereinbefore described.
[0283] The laparoscopic apparatus 761 and the method for utilizing
the same has the advantage that the balloon 762 can be retracted
without the necessity of pushing the same forwardly or distally of
the cannula 766 before removal.
[0284] Still another laparoscopic apparatus 811 incorporating
another embodiment of the present invention is shown in FIG. 74
which in many respects is similar to the laparoscopic apparatus 761
shown in FIGS. 71-73. Thus, it also includes the balloon 762 which
is provided with a neck 763 seated against the inwardly extending
taper 764 of the cannula 766. The cannula 766 is provided with the
valve housing 786 and the handle 788. The valve housing 791 can be
omitted because of the closed end on the tubular member 816.
[0285] The tubular member 816 has a smaller diameter portion 816a
at the distal extremity and a larger diameter portion 816b at the
proximal extremity with an annular taper 817 adjoining the two
portions 816a and 816b and which is adapted to mate with the
inwardly extending annular taper 764 provided on the cannula 766 so
that the neck 763 of the balloon 762 can be sealingly engaged
therebetween in the same manner as with the tubular member 771 to
permit inflation of the balloon in the same manner as hereinbefore
described for the apparatus 761 shown in FIGS. 71-73. However,
since the tubular member 816 has a closed rounded end, the
inflation medium provided in the balloon cannot escape through the
tubular member 816 and for that reason there is no need for the
additional sealing valve 791 provided in the embodiment of the
laparoscopic apparatus 761. The tubular member 816 serves as a
scope cover as in a number of the previous embodiments of
laparoscopic apparatus incorporating the present invention. It can
be formed of a transparent material so that viewing can be
accomplished through the same and through the balloon 762 in the
manner hereinbefore described.
[0286] Operation and use of the laparoscopic apparatus 811 is very
similar to that hereinbefore described in conjunction with the
apparatus 761 shown in FIGS. 71-73. The proximal extremity or neck
763 can be introduced on to the tapered surface 764 by wrapping it
on to the tubular member 816 and drawing the neck 763 into the
cannula 766 and then advancing the cannula 766 distally so that the
annular taper 817 engages the neck of the balloon 762 and urges it
into sealing engagement with the inwardly extending taper 764.
[0287] With the balloon 762 rolled-up in the manner hereinbefore
described, the balloon 762 can be introduced with the use of the
tubular member 816 as an introducer through the incision in the
skin of the patient and thereafter it can be utilized to dissect
tissue to place the balloon in the dissected tissue so that
thereafter it can be inflated in the manner hereinbefore described.
After the balloon has been deflated after completion of the
dissection, the balloon can be removed by pushing the cannula 766
into the incision and then releasing the neck of the balloon 762 by
removing the tubular member 816. Thereafter, the balloon 762 can be
removed by pulling on the fitting assembly 799 to remove the
balloon 762 through the incision outside the cannula 766. After the
balloon 762 has been removed, the skin seal 781 can be advanced on
the cannula into the incision to form a fluid tight seal with the
skin of the patient. Thereafter, insufflation can be undertaken
followed by the desired surgical procedures as hereinbefore
described.
[0288] In connection with the embodiments of the invention shown in
FIGS. 69 and 74, it should be appreciated that the balloon 722 can
have its proximal extremity pushed forwardly through the incision
752 so that it can be removed outside of the skin seal rather than
retracting it through the skin seal as in previous embodiments to
make possible the use of a smaller cannula and skin seal.
[0289] This can be accomplished in a number of ways, as for example
by utilizing the cannula to push the proximal extremity of the
balloon through the incision or, alternatively, to utilize the skin
seal to push the proximal extremity through the incision.
Alternatively, the scope cover 731 can be pushed in a distal
direction to engage the distal extremity of the balloon to in
effect pull the balloon forwardly through the incision 752. Also,
alternatively, if desired, the balloon can be again partially
inflated after the collar 732 has been released to permit the
proximal extremity of the balloon to be pulled inwardly through the
incision 752.
[0290] Yet another embodiment of the laparoscopic apparatus of the
invention that may be used in conjunction with a conventional
laparoscope to provide laparoscopic visualization during
laparoscopic procedures as described herein is illustrated in FIGS.
75-82. Laparoscopic apparatus 849 differs from previous embodiments
of the invention that provide for laparoscopic visualization during
tunneling and dissection in several ways as will be explained
below.
[0291] Initially, it is to be noted that unlike previous
embodiments, the apparatus 849 does not include a cannula and skin
seal assembly as part of the obturator/balloon assembly 850. In
this embodiment, the cannula and skin seal are supplied as separate
units.
[0292] In FIG. 75, the laparoscopic apparatus 849 is shown
assembled and loaded over the shaft 870 of a conventional
laparoscope 862. The laparoscope has an eyepiece 863 and a fiber
optic light port 897 to permit visualization of images at its
distal end. In a presently preferred embodiment, the apparatus 849
has an elongated U-shaped channel guide 853 (see FIGS. 78A-C) into
which a preferably transparent and substantially rigid tunneling
member 851 (see FIGS. 79 and 80) formed of a suitable material,
such as polycarbonate, is preferably inserted through an instrument
seal (884 in FIG. 82). The tunneling member 851 serves a dual
purpose. First, it functions as a scope cover into which
laparoscope 862 may be inserted for visualization during tunneling
and subsequent dissection. Second, together with the balloon 855
and preferably an integral balloon cover 892, it functions as a
blunt tipped obturator. The U-shaped channel guide 853 is
substantially rigid and is preferably formed of a suitable medical
grade of plastic. As illustrated in FIG. 78B vertical slots 885 may
be cut in the distal end 872 of the channel guide 853 should some
flexibility of the distal end 872 be deemed necessary or
desirable.
[0293] Turning briefly to FIGS. 77 and 81, the presently preferred
transparent non-elastomeric balloon 855 may be formed from die cut
sheets of an appropriate medical grade non-elastomeric plastic
material, for example, and is sealed together along welds 869 such
as by heat sealing.
[0294] The balloon 855 is preferably provided with flaps 868a and
868b (FIG. 77) which are joined together, as shown at 869b. The
right and left balloon wings 891 may be rolled-up, as shown in FIG.
81, so as to form balloon rolls 890. The flaps 869a and 869b may
then be wrapped around the balloon rolls 890 and sealed together to
form an integral balloon cover 892 in the manner previously
described with regard to previous integral balloon cover
embodiments. Thus, the balloon rolls 890 are disposed against the
outer periphery of tunneling member 851 and held in position by the
integral balloon cover 892 as shown in FIG. 81. The laparoscope
shaft 870 can also be seen disposed within the tunneling member 851
in FIG. 81. As best seen in FIG. 75, the balloon cover 892 also
covers part of the distal portion 872 of the channel guide 853 and
the balloon rolls 890 that are disposed therein, along with
portions of the length of the tunneling member 851. The integral
balloon cover 892 thus serves to assemble the balloon 855,
tunneling member 851 and the channel guide 853 into an integral
package. The balloon cover 892 preferably encases all but the
distal tip of the rolled-up balloon, including those portions of
the balloon rolls 890 that lie disposed within the channel guide
853 to either side of the tunneling member 851. The distal tip of
the balloon 855 is preferably provided with a nipple or pocket 867
that mates against the blunt distal end of the tunneling member 851
to help protect against stretching or tearing of the balloon tip
867 during tunneling. The balloon cover 892 is also provided with
slits or perforations 856 that provide a weakened region in the
balloon cover 892 to allow it to break open during balloon 855
inflation as previously described.
[0295] The tunneling member 851 is conveniently provided with a
concentric ring shaped handle 852 for grasping by the surgeon
during introduction of the obturator/balloon assembly 850 through
an incision in the patient, and during tunneling to the desired
location within the body for subsequent balloon tissue dissection
as hereinbefore described. An instrument seal 854 is preferably
provided in the proximal end of the handle 852 to make a
substantially fluid tight seal between the tunneling member 851 and
the laparoscope shaft 870 for reasons that will shortly become
apparent.
[0296] Turning now to FIG. 76, the balloon 855 which as shown may
have a manta ray shape of the type hereinbefore described, is
provided with a narrowed neck 864 through which the tunneling
member 851 is inserted. The neck 864 of the balloon 855 is
preferably disposed between an instrument body 876 (see FIG. 82)
and the interior of the outermost ring end 887 of the channel guide
853. The balloon neck 864 is press fit between the instrument body
876 and the channel guide 853 to provide a substantially fluid
tight seal with the interior of the balloon 855.
[0297] The balloon 855 is also preferably provided with a balloon
inflation lumen 865 that is in communication with the interior
space of the balloon 855. A flexible hollow inflation tube 861 with
an open distal end 866 is inserted into the inflation lumen 865 and
secured in a fluid tight manner as previously described. A wye
adapter 860 is secured to the inflation tube 861 and carries a male
inflation fitting 859 with an integral check valve (not shown) and
another tubular member 888 on which is mounted a pinch clamp 858
and a male evacuation fitting 857, all of the type previously
described.
[0298] Balloon inflation is accomplished by closing the pinch clamp
858 and after connecting the male inflation fitting 859 to a
suitable fluid source, such as a syringe (not shown) for example,
injecting a suitable inflation medium, such as saline, for example,
through the inflation tube 861 into the balloon inflation lumen 865
and into the interior of the balloon. When the balloon 855 is
inflated, the integral balloon cover 892 is designed to separate
along its weakened region (represented by perforations or slits 856
in FIGS. 75 and 76) to allow the balloon 855 to expand as it
unrolls and climbs out of the open distal portion of the channel
guide 853 until it is fully expanded. The balloon 855 may be
deflated by connecting the evacuation fitting 857 to an evacuation
port (not shown) such as an operating room suction system, for
example. The pinch clamp 858 is released to open the tube 888 to
permit the saline solution which had been introduced into the
balloon 855 to be sucked out through the inflation lumen 865 to
completely deflate the balloon 855.
[0299] With reference to FIGS. 79 and 80, in a preferred
embodiment, the hollow tunneling member 851 is provided with an
open distal end 893 so that the distal end 895 of the laparoscope
shaft 870 may be extended through this open end 893 during balloon
855 inflation as illustrated in FIG. 80. By extending the distal
end 895 of the laparoscope 862 outside the tunneling member 851
only a single transparent balloon layer obstructs laparoscopic
visualization and increased resolution over previous embodiments is
possible. As illustrated in FIG. 79, the tunneling member 851 is
provided with spaced apart slits 894 at its distal end. The slits
894 allow the distal open end 893 of the tunneling member 851 to
expand slightly outwardly, thus permitting the distal end 895 of
the laparoscope 862 to be advanced outside the tunneling member
851. Because the end of the tunneling member 851 is open to the
interior of the balloon 851 during inflation, an instrument seal
854 is provided at the proximal end of the tunneling member 851 to
minimize leakage of the inflation medium from the proximal handle
852 portion during inflation. Alternately, or in combination with
instrument seal 854, the tunneling member 851 may have a necked
down portion, as illustrated at 887 in FIG. 82, to form a
substantially fluid tight seal between the tunneling member 851 and
the scope shaft 870 to protect against leakage out the proximal end
of the tunneling member 851.
[0300] The cut-away cross section in FIG. 82 shows the proximal
portion of the laparoscopic apparatus 849. As previously discussed,
the balloon neck 864 is trapped in a fluid tight manner between the
proximal ring 887 of the channel guide 853 and the outer periphery
of cylindrical instrument body 886. Thus, the interior of the
balloon 855 is sealed at the proximal extremity of its elongated
neck 864 by means of a press fit between the proximal ring 887, the
neck 864, and the instrument body 886. A cylindrical shaped
tunneling member seal 884 of the type previously described is
preferably inserted over the proximal end of the instrument body
886 to form a substantially fluid tight seal between the tunneling
member 851 and the channel guide 853. This seal 884 is used to
prevent fluid from coming out the proximal end of the channel guide
853 during balloon 855 inflation.
[0301] Operation and use of the laparoscopic apparatus 849 may now
be briefly described with reference to FIG. 83. After the
laparoscopic apparatus 849 has been readied for use, a conventional
laparoscope is inserted through the instrument seal 854 and into
the hollow lumen of the tunneling member 851 until resistance is
felt and the distal extremity 895 of the laparoscope shaft 870 can
be assumed to rest against the distal extremity of the tunneling
member 851. The surgeon next makes an incision 896 using
conventional techniques at the appropriate location in the body of
the patient. The incision location, of course, depends on the
operation to be performed and is illustrated with regard to hernia
repair in FIG. 83 by way of example only. After making the incision
896, the apparatus 849 is oriented so that the open side of channel
guide 853 faces away from the patient, and the distal extremity of
the apparatus 849 is advanced through the incision. The distal
extremity of the apparatus 849 is then used as an obturator to
tunnel through the appropriate tissue layers until the location of
interest for subsequent balloon inflation and tissue dissection is
found. As the distal extremity of the apparatus 849 is being
advanced through the tissue layers, the progress of the operation
may be observed through the laparoscope 862 to aid the surgeon in
locating important anatomical landmarks. As hereinbefore described
with regard to previous embodiments, during this tunneling stage,
the distal end 895 of the laparoscope 862 looks out through the
open end 893 in the distal extremity of the tunneling member 851
and the distal portion of the balloon 867 which covers it. A
straight tipped scope 862 will give the greatest field of view out
the distal opening 893 during the tunneling process, but an angled
scope 862 (as illustrated in FIG. 80) may be used instead.
[0302] After the desired location in the body has been found,
perhaps with the aid of visual observation and manual palpation in
addition to laparoscopic observation, dissection can proceed to
create an anatomic working space. It should be noted that the
tunneling member 851 should be sized to an appropriate length for
the particular operation being performed so that the channel guide
853 is advanced approximately half of its length through the
incision when tunneling is completed. After the balloon suction
pinch clamp 858 has been closed so as to seal off the suction line,
balloon inflation may proceed through the inflation fitting 859 as
previously explained.
[0303] During inflation the tunneling member 851 and laparoscope
862 may be pulled back slightly from the balloon by grasping the
handle 852 and pulling back with one hand while holding the channel
guide 853 in position with the free hand. The distal portion of the
laparoscope shaft 895 may then be advanced through the open distal
end 893 of the tunneling member 851, forcing open slits 894, to
permit an unobstructed view from inside the balloon 855 of tissue
dissection as the balloon 855 unrolls and inflates as previously
described. If an angular laparoscope is employed, the scope may be
rotated or otherwise manipulated at the proximal end so as to
increase the field of view from within the balloon 855.
[0304] After inflation is complete, the balloon may be deflated by
opening the suction line pinch clamp 858 and applying suction
through male fitting 857 by suitable means such as a syringe or an
operating room suction line as previously described. Once deflated,
the channel guide 853 may be held in position and the tunneling
member 851 and laparoscope 862 completely withdrawn from the
channel guide 853 and balloon 855, either together or sequentially,
leaving the channel guide 853 and deflated balloon 855 within the
incision 896 to provide a path back to the previously dissected
space.
[0305] Next, the tunneling member 851 is discarded and a trocar
with cannula and skin seal assembly of the type hereinbefore
described with reference to FIG. 40, may be slid over the distal
end 895 of laparoscope 862. While holding the channel guide 853 in
place, the distal end 895 of the laparoscope 862 may be inserted
back into the incision 896 site and advanced into the previously
dissected space using the channel guide 853 to guide the scope
shaft 870. While holding the laparoscope 862 together with the
trocar, cannula and skin seal assembly, the channel guide 853 and
the attached deflated balloon 855 may now be removed from the
patient through the incision 896. At this point, the trocar with
cannula and skin seal assembly can be advanced over the laparoscope
shaft 870 into the incision 896 and the skin seal secured in place
as previously described. The operation may now proceed in the
manner appropriate for the particular procedure being
performed.
[0306] Turning now to FIG. 84, yet another embodiment of the
invention is illustrated that adds the use of an endoscope guide
member 880 to the laparoscopic apparatus 849 illustrated in FIG.
75. The apparatus 898 is otherwise identical. Guide member 880
consists of a semi-rigid tube with that may be formed of a suitable
material such as plastic. As illustrated in FIG. 86, guide member
880 is provided with a longitudinal slit 883 running the length of
the tube portion to facilitate its removal from the apparatus 898
in accordance with the laparoscopic procedures described below.
[0307] In a preferred embodiment, the endoscope guide 880 may be
positioned over the channel guide 853, balloon 855, and tunneling
member 851 assembly with its handle 881 oriented in the same
direction as the open portion of the U-shaped channel guide 853
which it partially surrounds. As shown in FIG. 86, the endoscope
guide 880 is provided with a slit 883 that extends longitudinally
along the complete underside of the guide 853. The slit 883 allows
the endoscope guide 880 to separate from the balloon 855, channel
guide 853, and tunneling member 851 assembly as the balloon 855 is
inflated after the tunneling member 851 has been advanced to
dispose the balloon 855 within the desired location.
[0308] In a preferred embodiment, the endoscope guide 880 is also
provided with a rolled over handle 881 secured by appropriate means
such as staple 882 to the guide 880 as illustrated in FIG. 84. The
handle 881 at all times remains outside the incision where it can
be accessed by the surgeon. After balloon deflation, the distal
portion of the endoscope guide 880 remains within the incision to
preserve access to the previously created space and provide a
convenient means for guiding the laparoscope 862 back into the
space.
[0309] Use of the laparoscopic apparatus 898 is substantially
similar to that previously described with regard to the embodiment
shown in FIG. 75. As before, a conventional laparoscope 862 is
inserted into the bore of the tunneling member 851 until its distal
end 895 bottoms against the distal end of the tunneling member 851
bore. After an incision is made in the desired location, the
tunneling member 851 together with the rolled up balloon 855 is
inserted into the incision and advanced as an obturator to the
desired location. Visualization during tunneling dissection is as
described before. The apparatus 898 is sized so that approximately
half of the channel guide 853 and the proximal handle 881 portion
of the endoscope guide 880 remain outside the incision when the
desired location has been reached. The tunneling member 85i
together with the laparoscope 862 may be retracted from against the
distal end 867 of the balloon 855 during inflation so as to provide
the necessary clearance from the interior of the balloon to permit
the distal end 895 of the laparoscope 862 to be advanced outside
the open end 898 of the tunneling member 851. Dissection may then
be viewed through a single balloon layer during inflation as
before.
[0310] The addition of the endoscope guide 880 slightly alters the
procedure after deflation of the balloon 855. After balloon
deflation, the tunneling member 851 and laparoscope 862 are
completely removed from the channel guide 853 and balloon 855, thus
leaving the endoscope guide 880, the channel guide 853, and the
deflated balloon 855 in place within the incision. The next step in
this procedure is while holding the endoscope guide 880 in place,
to remove the channel guide 853 and the attached balloon 855
through the incision. After discarding the tunneling member 851 and
loading a trocar with cannula and skin seal assembly over the
laparoscope 862, the distal end 895 of the scope 862 is inserted
back into the incision using the endoscope guide 880 as a path to
the dissected space. After the space has been located, the
endoscope guide 880 may be removed from the patient and the
cannula/skin seal advanced and secured into the incision as
before.
[0311] Another embodiment of the laparoscope apparatus
incorporating the invention is illustrated in FIG. 85. The
laparoseopic apparatus 899 in this embodiment differs from the
previous FIG. 84 embodiment in that the longitudinally extending
open ended distal portion of the channel guide 853 has been cut
away, leaving only the proximal ring 887 portion and the inner
press fit instrument body 886 to seal the balloon neck 864 as
previously described.
[0312] Use of this apparatus 899 is substantially similar to that
of the previous two embodiments. The apparatus 899 is introduced
into an incision in the body; advanced to the desired location
under laparoscopic observation with the blunt tipped tunneling
member 851 serving as an obturator; the balloon 855 is then
inflated under laparoscopic observation, if desired, to achieve
tissue dissection; and the balloon 855 deflated, all as
hereinbefore described. The tunneling member 851 and laparoscope
862 are then withdrawn from the incision through the ring 887
leaving the deflated balloon 855 and endoscope guide 880 in place.
While holding the endoscope guide 880 in place, the ring 887 and
attached balloon neck 864, which at all times remains outside the
incision, is grasped and pulled away from the patient to withdraw
the deflated balloon 855 from the body through the incision. After
the tunneling member 851 has been discarded, and the trocar with
cannula and skin seal assembly loaded over the laparoscope 862, the
distal tip 895 of the laparoscope 862 is guided into the incision
and the previously created space using the endoscope guide 880 as a
guide as previously described. The remainder of the procedure is
identical to that described with reference to FIG. 84.
[0313] Turning now to FIGS. 87-92, yet another laparoscopic
apparatus that provides for laparoscopic observation during
tunneling and subsequent balloon dissection or retraction is
illustrated. In FIG. 87 the laparoscopic apparatus 900 of this
embodiment is illustrated in a fully assembled state as it would be
prior to insertion through an incision into the human body for the
performance of laparoscopic procedures as explained herein.
[0314] In a preferred embodiment, laparoscopic apparatus 900
includes a tunneling member 913, handle 902, and balloon sleeve 903
together with a balloon (926 in FIGS. 90 and 91) and integral
balloon cover 908. The tunneling member 913 is inserted through the
handle 902 and sleeve 903 into the interior of the balloon 926. In
FIGS. 87 and 89, the balloon 926 is illustrated after it has been
rolled or folded and secured to the distal portion of the tunneling
member 913 by means of an integral balloon cover 908 in the manner
described with regard to prior integral balloon cover embodiments.
The integral balloon cover 908 is provided with slits or
perforations 907 that permit the cover to separate and break away
during balloon expansion as previously described.
[0315] As illustrated in FIGS. 88 and 89, a conventional
laparoscope 909 may be inserted into the tunneling member 913 if
laparoscopic observation is desired. Thus, together with the rolled
or folded balloon 926 and the integral balloon cover 908, the
tunneling member 913 serves as both a blunt tipped obturator and a
laparoscope cover.
[0316] The tunneling member 913, which may be formed of a suitable
medical grade of plastic, such as polycarbonate, comprises an
obturator shaft 915, and an obturator handle 904. Handle 904
facilitates grasping and manipulation by the surgeon during
performance of an operation.
[0317] The obturator shaft 915 is preferably transparent, and
sufficiently rigid to permit tunneling through tissue layers within
the human body. The tunneling member 913 is provided with a hollow
bore extending through its entire longitudinal length from the
proximal handle 904 portion to the distal open ended tip 917 to
accept the insertion of a conventional laparoscope 909 (see FIG.
88).
[0318] In a preferred embodiment, the tunneling member 913 is
removably inserted through the bore (see cross-sectional view in
FIG. 92) provided in handle 902 and balloon sleeve 903, and into
the interior of the rolled or folded balloon 926 (FIGS. 90 and 91).
Like the tunneling member 913, the handle 902 and balloon sleeve
903 may be formed of a suitable medical grade plastic, such as
polycarbonate. As best illustrated in the cross-sectional view in
FIG. 92, the proximal end of balloon sleeve 903 mates against the
distal portion of the handle 902 and is secured in mating
engagement therewith by the elongate balloon neck 927 which
surrounds the sleeve and extends into the handle 902. The balloon
neck 927 is secured between the interior of the handle 902 and the
external periphery of the instrument body 933 by means of a press
fit between the handle 902 and the body 933. The press fit between
the handle 902 and the body 933 traps the balloon neck 927
therebetween and provides a substantially fluid tight seal for the
interior of the balloon 926.
[0319] Because the handle 902 is in communication with the interior
of the balloon 926, seals 932 are inserted at the proximal and
distal ends of the instrument body 933 to provide a substantially
fluid tight seal between the interior bore of the handle 902 and
the obturator shaft 915 which passes through the handle 902. The
seals 932 prevent the balloon inflation medium, typically saline,
from flowing out the proximal end of the handle 902. The seals 932
also add stability to the obturator shaft 915 relative to the
instrument body 933 in the handle 902 that the shaft 915 passes
through.
[0320] The balloon 926 is provided with an inflation lumen 919 in
communication with the interior space of the balloon 926 for
delivering a suitable inflation medium, such as saline solution, to
the interior of the balloon 926. A flexible hollow inflation tube
920 with an open distal end is inserted into the balloon inflation
lumen 919 and secured in a fluid tight manner as previously
described. A wye adapter 921 is secured to the inflation tube 920
and carries a male inflation fitting 922 with an integral check
valve (not shown) and another tubular member on which is mounted a
pinch clamp 923 and a male evacuation fitting 924, all of the type
previously described. The balloon 926 is inflated and deflated in
the same manner as described with regard to prior embodiments.
[0321] When assembled into a complete assemble (as illustrated in
FIG. 87), the obturator shaft 915 of the tunneling member 913
passes through the handle 902 and balloon sleeve 903 bores and
extends into the interior of a rolled balloon 926 (illustrated
unrolled and flattened out without the flaps that preferably
comprise the integral balloon cover 908 in FIGS. 90 and 91) until
the open distal end 917 of the obturator shaft 915 presses against
a nipple 930 provided in the balloon 926. As best illustrated in
FIGS. 90 and 91, showing the apparatus 900 with the balloon 926
unrolled and laid flat, a nipple or pocket 930 is provided in the
balloon 926 to accept the open distal end 917 of the obturator
shaft 915. Use of the nipple 930 helps to prevent stretching or
tearing of the balloon 926 during tunneling when the open distal
end 917 of the obturator shaft 915 presses against the balloon
material of the nipple 930. The balloon 926 may have a manta ray
shape as illustrated in FIGS. 90 and 91, or it may be custom shaped
for the particular procedure to be performed.
[0322] In FIG. 89, a conventional laparoscope 909 is illustrated
after it has been fully inserted into the apparatus 900 to permit
observation through its distal end (not shown) during tunneling and
dissection. The laparoscope 909 includes a shaft 911 that is
inserted through a bore in the tunneling member 913 that extends
from the proximal handle 904 portion to the open ended distal tip
917 (FIG. 88). To prepare for tunneling dissection, the laparoscope
909, which may be a conventional 10 mm laparoscope, for example, is
inserted through the handle portion 904 of the tunneling member 913
and advanced through the tunneling member bore 914 until the distal
extremity 931 of the scope shaft 911 is captured by the lip 918
provided in the obturator shaft 915. The lip 918 in the obturator
shaft 915 thus prevents further advancement of the laparoscope
shaft 911, and retains the distal end 931 of the shaft 911 within
the confines of the obturator shaft 915. The laparoscope 909 is
provided with a fiber optic light port 912 to provide illumination
to the lens (not shown) located at the distal end of the scope
shaft 931. Although an angled scope will provide the best
visualization through the cut-away distal end 917 of the obturator
shaft 913, a straight scope may also be utilized.
[0323] As illustrated in FIG. 92, the distal end 917 of the
obturator shaft 915 is cut away at approximately a 45 degree angle
to provided an open end for unobstructed vision through the
laparoscope 909 during both tunneling and subsequent balloon
dissection. An instrument seal 916, which may comprise a pinched
down region of the obturator shaft 915 as illustrated in FIG. 92,
provides a substantially fluid tight seal between the laparoscope
shaft 911 and the interior of the obturator shaft 915 to prevent
the balloon inflation medium from escaping out the proximal end of
the tunneling member 913 during balloon inflation. As an
alternative to the pinch seal 916, or in addition thereto, an
instrument seal of the type illustrated between the handle 902 and
obturator shaft 915 may be provided in the bore at the proximal end
of the obturator handle 904 as previously described and illustrated
with regard to the FIG. 75 embodiment.
[0324] During surgical use of the apparatus 900 as described
herein, important physical structures and anatomical landmarks may
be observed at the distal end 931 of the scope shaft 915 through
eyepiece 910 (or viewing monitor, not shown) to guide the surgeon
in locating the correct dissection plane. As can be appreciated
from the construction of the apparatus 900 described above, by
providing a cut away distal end 917 in the obturator shaft 915, the
surgeon's vision through the laparoscope 909 during both tunneling
and subsequent balloon 926 expansion is impeded by only a single
balloon 926 layer. After balloon inflation, when the balloon 926
has broken free of its cover 908 and separated from the obturator
shaft 915, the tunneling member 913 together with the laparoscope
909 may be advanced or retracted relative to the stationary handle
902 and balloon sleeve 903 assembly which remain outside the
incision in the patient.
[0325] The surgical procedure for use of apparatus 900 may now be
briefly described. After the laparoscopic apparatus 900 has been
readied for use, a conventional laparoscope 909 is inserted into
the tunneling member 913, and advanced through the pinch seal 916
until the distal extremity 931 of the laparoscope shaft 911 is
captured by lip 918. The surgeon next makes an incision using
conventional techniques at the appropriate location, depending on
the operation to be performed, in the body of the patient. After
making the incision, the apparatus 900 is advanced through the
incision with the distal extremity of the apparatus 900 being used
as an obturator to tunnel through the appropriate tissue layers
until the location of interest is located.
[0326] As the distal extremity of the apparatus 900 is being
advanced through the tissue layers, the progress of the operation
may be observed through the laparoscope 909 to aid the surgeon in
locating important anatomical landmarks. As described with
reference to previous embodiments, during this tunneling stage the
distal end 931 of the laparoscope 909 looks out through the open
(preferably cut at a 45 degree angle) distal end 917 of the
obturator shaft 915 obstructed by only a single and preferably
transparent balloon layer.
[0327] After the desired location in the body has been found,
dissection or retraction, as appropriate for the procedure, may be
performed. It should be noted that the obturator shaft 915 is sized
to an appropriate length for the particular operation being
performed. After the balloon suction pinch clamp 923 has been
closed so as to seal off the suction line, balloon inflation may
proceed through the inflation fitting 922 as previously
explained.
[0328] During inflation the tunneling member 913 and laparoscope
909 may be pulled back slightly from the balloon 926 by grasping
the tunneling member handle 904 and pulling back with one hand
while holding the handle 902 in position with the free hand. The
laparoscope 909 together with the tunneling member 913 may then be
manipulated, and rotated as desired for unobstructed viewing from
inside the balloon 926 of tissue dissection as the balloon 926
unrolls and inflates as previously described.
[0329] After inflation is complete, the balloon 926 may be deflated
by opening the suction line pinch clamp 923 and applying suction
through male fitting 924 by suitable means such as a syringe or an
operating room suction line as previously described. Once deflated,
the laparoscope 909, tunneling member 913 and the handle 902,
balloon guide 903 and secured balloon 926 may be withdrawn, either
together or sequentially through the incision.
[0330] If insufflation is required for the procedure or additional
trocars are needed, a trocar with cannula and skin seal assembly of
the type hereinbefore described with reference to FIG. 40 may be
used. In this case, the trocar with cannula and skin seal is first
loaded over the distal end 931 of the laparoscope 909. The
laparoscope 909 is then inserted back into the incision to access
the previously created space, and the trocar with cannula and skin
seal assembly may be advanced over the laparoscope shaft 911 into
the incision and the skin seal secured in place as previously
described.
[0331] A greatly simplified embodiment that provides for
laparoscopic observation both during tunneling and balloon
dissection after the desired location has been reached is
illustrated in FIG. 93. The laparoscopic apparatus 940 includes a
tunneling member 913 of the type previously described with
reference to the FIG. 87 embodiment, a balloon 926 with an elongate
neck 943, and an inflation lumen 919. The elongate neck 943 may be
folded inwardly and secured to the shaft 915 of the tunneling
member 913 as illustrated at 942. The neck 943 is preferably
secured to the obturator shaft 915 by means of clamping, gluing,
heat sealing or welding as previously described. Additionally, any
one of a number of folding arrangements, including a multiplicity
of folds, may be employed with regard to the balloon neck 943. By
providing this inward folding of the elongate neck 943, the
tunneling member 913 may be retracted from the balloon 926 during
inflation and manipulated to observe dissection as it is occurring
without moving the position of the balloon 926 relative to the
desired location.
[0332] The tunneling member 913 is as previously described with a
handle 904 at its proximal end and a hollow obturator shaft 915
extending distally from the handle 904. The obturator shaft 915 is
sized to accept a conventional laparoscope and is provided with an
open distal end 917 with lip 918 to capture the distal end of the
laparoscope when inserted. The distal end 917 is preferably
cut-away at a 45 degree angle as before to facilitate observation
during tunneling.
[0333] In FIG. 93, the balloon 926 is shown unrolled and flattened
out to illustrate the open distal end 917 of the obturator shaft
915 and the laparoscope shaft 911 that is inserted therein.
[0334] The distal end 931 of the laparoscope is captured by the lip
918 provided in the obturator shaft 915. In practice, the balloon
926 would be rolled or folded and secured relative to the distal
portion of the obturator shaft 915 by means of an integral balloon
cover (not shown) in the manner previously described.
Alternatively, the endoscope guide 880 (illustrated in FIG. 86) may
be used to secure the rolled or folded balloon in place about the
obturator shaft 915. The endoscope guide 880 may be used in place
of, or in addition to, an integral balloon cover. One advantage of
using the endoscope guide 880 is that it may be left within the
incision to preserve access to the dissected space after balloon
deflation and removal as described with reference to the FIGS. 84
and 85 embodiments and further described herein. Use of the
apparatus 940 offers the advantage of permitting greatly simplified
surgical procedures over previous embodiments. As with the FIG. 87
embodiment, a conventional laparoscope 909 is inserted into the
tunneling member 913 and is advanced through pinch seal 916 (see
FIG. 92) until the distal extremity 931 of the laparoscope shaft
911 is captured by lip 918. After an incision is made in the
patient, the apparatus 940 is advanced through the incision with
the distal extremity of the apparatus 940 being used to tunnel
through the appropriate tissue layers until the location of
interest is reached. If the optional endoscope guide 880 is used,
the handle 881 of the guide 880 will remain outside the incision to
facilitate later removal. As before, the progress of the operation
may be observed through the laparoscope 909 during tunneling
dissection. During this tunneling stage, the distal end 931 of the
laparoscope 909 looks out through the open distal end 917 of the
obturator shaft 915 obstructed by only a single and preferably
transparent balloon layer.
[0335] After the desired location in the body has been reached,
dissection or retraction, as appropriate for the procedure, may be
performed. The balloon suction pinch clamp 923 is closed to seal
off the suction line, and the balloon 926 is inflated through the
inflation fitting 922 as previously explained. If the optional
endoscope guide 880 is used, the guide 880 separates from the
rolled up balloon 926 as the balloon 926 inflates to permit the
balloon 926 to freely unroll and expand.
[0336] In a preferred method of use, during inflation the tunneling
member 913 and laparoscope 909 are pulled back slightly from the
nipple 930 of the balloon 926 by grasping the tunneling member
handle 904 and retracting the tunneling member 913 and laparoscope
909. The laparoscope 909 and tunneling member 913 may then be
manipulated and rotated as desired for viewing tissue dissection or
retraction through a single balloon layer from inside the balloon
926.
[0337] After inflation is complete, the balloon 926 may be deflated
by opening the suction line pinch clamp 923 and applying suction
through male fitting 924 by suitable means such as a syringe or an
operating room suction line as previously described. Once deflated,
the laparoscope 909, and tunneling member 913 with the attached
balloon may be withdrawn, either together or sequentially through
the incision. If the endoscope guide 880 is used to retain access
back to the dissected space, the guide 880 is left in place within
the incision.
[0338] If insufflation is required for the procedure or additional
trocars are needed, a trocar with cannula and skin seal assembly of
the type previously described with reference to FIG. 40, for
example, may be loaded over the distal end 931 of laparoscope 909.
The laparoscope 909 is then inserted back into the incision (using
the endoscope guide 880 to find the path back to the space if
utilized) and advanced to the previously created space. After the
space has been reached, the trocar with cannula and skin seal
assembly may be advanced over the laparoscope shaft 911 into the
incision and the skin seal secured in place as previously
described.
[0339] FIGS. 94 through 96 illustrate another embodiment of the
invention that is substantially similar to the embodiment disclosed
with reference to FIG. 93. The tunneling apparatus 950 in this
particular embodiment is a one-piece design that has an elongate
tunneling member 951 having a handle 954 secured thereto by a
suitable fastening system such as a press fit or-bonding using an
appropriate adhesive or solvent, for example. A balloon 952 with an
elongate neck 960 is mounted on the tunneling member 951. The
tunneling member 951 has an internal bore 986 sized to receive a
conventional laparoscope. The bore 986 is in communication with an
opening 956 provided in the handle 954 to provide a continuous
passageway for the laparoscope. The tunneling member 951 thus
serves as a scope cover in addition to serving as a blunt tipped
obturator to tunnel bluntly through tissue in the manner previously
described.
[0340] The tunneling member 951 may be of the same general
construction as the tunneling member 913 described with reference
to FIG. 93. As before, the tunneling member 951 is preferably
fabricated from a suitable medical grade material having sufficient
structural rigidity to tunnel bluntly through tissue in the body. A
medical grade plastic, such as a polycarbonate, for example, has
been found to perform satisfactorily for this purpose. The
tunneling member 951 preferably has an open distal end 980 with a
lip (see FIG. 95) to capture the distal end of the laparoscope. The
open distal end 980 may be cut away at an angle, such as 45
degrees, for example, depending on the type of laparoscope
utilized, to permit unobstructed observation by the laparoscope
through the open distal end 980.
[0341] The elongate neck 960 of the balloon 952 is tucked or folded
inwardly and secured to the tunneling member 951 anywhere along the
length of the tunneling member 951 as shown at reference numeral
958. The neck 960 may be bonded to the tunneling member 951 by any
one of a number of fastening options such as gluing, clamping, or
heat sealing. The tuck 953 in the neck 960 permits the tunneling
member 951 and laparoscope to be retracted from the distal
extremity of the balloon 952 during inflation to provide depth of
field and to allow for manipulation around in the balloon 952
during inflation. If the tuck 953 were not provided, the
laparoscope could be withdrawn slightly to obtain field depth
during inflation, but the tunneling member would remain nested in
the nipple 981. This is less than optimal because the laparoscope
would have to look out through tunneling member material as well as
a balloon layer, rather than through the open distal end 980 of the
tunneling member 951. Because the balloon 952 is preferably formed
of a non-elastomeric material to permit controlled expansion to a
desired shape, as the inelastic balloon 952 inflates the length of
the balloon 952 becomes shorter. The inverted tuck 953 thus also
provides sufficient material such that the distal end 980 of the
tunneling member 951 can remain in a fixed location.
[0342] Any of the balloon and cover constructions previously
disclosed may be utilized in conjunction with the one piece
apparatus 950. In the illustrated integral balloon cover example of
FIG. 94, the apparatus 950 is prepared for use by rolling or folded
the wings of the balloon 952 about the tunneling member 951 in the
manner previously described. Flaps 957a and 957b extend from the
balloon 952 and are utilized to form the integral balloon cover to
secure the balloon 952 to the tunneling member 951 during blunt
tunneling through tissue in the body. One of the flaps is
preferably provided with a series of longitudinally spaced apart
perforations or slits 959. As previously described, this provides a
weakened region so that the flaps 957a and 957b may break apart
when inflation is commenced to permit the balloon 952 to expand to
dissect tissue and form the desired anatomic working space. The
balloon guide 880 illustrated in FIG. 86 or the balloon cover 316
illustrated in FIG. 41 may be used instead of, or in addition to,
an integral balloon cover to retain the balloon 952 in position
relative to the tunneling member 951.
[0343] The handle 954 has an inflation port 955 in communication
with the interior space of the tunneling member 951 and is utilized
to introduce a suitable inflation fluid, such as saline solution,
for example, into the interior space of the balloon 952. The
balloon 952 is inflated by introducing the recommended saline
solution into the inflation port 955. The inflation port 955 is in
communication with the internal bore 986 of the tunneling member
951 which, in turn, is in communication with the interior space of
the balloon 952 through its open distal end 980.
[0344] Because the internal bore 986 of the tunneling member opens
into the interior of the balloon 952 through its open distal end
980, one or more seals 961 are mounted in the handle 954 proximal
of the inflation port 955 to form a seal between the handle 954 and
the laparoscope to prevent the inflation fluid from leaking out the
handle 954. The seals may be of the same type disclosed in
connection with the previous embodiments.
[0345] As illustrated in FIGS. 95, a temporary clamp 962 that
remains outside the incision in the patient may be utilized to
secure the tuck or inversion in the neck 960 of the balloon 952 to
the tunneling member 951 during tunneling dissection when the
apparatus 950 is bluntly advanced to the desired location within
the body. The clamp 962 prevents the balloon neck 960 from coming
unrolled if it is necessary to withdraw the apparatus 950 slightly
during tunneling for reorientation. Once the desired location
within the body has been reached, the clamp 962 may be removed to
permit the tunneling member 951 and laparoscope to be withdrawn
slightly for better visualization as previously described.
[0346] A suitable releasable clamp 962 for this purpose is
illustrated in FIG. 97. Clamp 962 is formed from a pair of
concentric mating rings 963 and 964 that are provided with aligning
holes that are sized to accommodate the diameter of the inverted
tuck 953 in the balloon neck 960 and the tunneling member 951.
Inner clamp ring 964 is inserted into the camming slot 967 provided
in the outer ring 963 and has two leaf springs 965 that extend
outwardly and engage an interior surface of the outer ring 963. The
leaf springs 965 urge the inner and outer rings 964 and 963 apart
causing the tuck 953 and tunneling member 951 to be frictionally
trapped therebetween. A finger grip 966 is provided on each ring to
allow the rings to be more easily squeezed together to align the
holes and release the clamp 962.
[0347] As shown in FIGS. 98 and 99, the elongate neck 960 of the
balloon 952 may also extend into the handle 954. In this particular
variation of the embodiments illustrated in FIGS. 93 and 94, the
neck 960 is tucked inwardly and secured to the handle 954 in
suitable fashion. In FIG. 99, an O-ring 970 is utilized to secure
the neck 960 to the handle 954 and provide a fluid tight seal
therewith. A suitable adhesive or solvent between similar materials
can also be used to secure the balloon neck 960 to the handle 954.
An inflation lumen is provided between the inflation port 955 and
the annular space between the balloon neck 960 and the tunneling
member 951. Inflation fluid delivered through the inflation port
955 passes directly into the interior space of the balloon 952
through the balloon neck 960. Optionally, with the addition of a
transverse hole in the tunneling member 951, inflation could
proceed through the open distal end 980 of the tunneling member 951
as described above.
[0348] A laparoscope seal 961 is mounted in the proximal end of the
handle 954 to form a substantially fluid-tight seal between the
interior space of the tunneling member 951 and the opening in the
handle 956 that the laparoscope is inserted through. This prevents
the inflation fluid from leaking out through the opening 956 when
the balloon 952 is inflated. A seal retainer 971 may be mounted in
the handle 954 to retain the seal 961 in position in the handle
954.
[0349] Alternatively, the seal retainer 971 may be integrally
formed in the handle 954. In FIG. 100, a balloon harness assembly
974, which is substantially similar to the inflation mechanism
described with regard to the previous embodiments, may be utilized
to inflate the balloon 952. The balloon inflation harness 974
includes a pinch clamp 976, a wye adaptor 975, a luer-type fitting
with check valve 978, and an evacuation fitting 977, all of the
type previously described. The balloon 952 is inflated by closing
the pinch clamp 976, and injecting the inflation fluid through the
fitting 978 into the balloon inflation lumen 979 which is in
communication with the interior of the balloon 952.
[0350] A lumen 973 formed in the tunneling member 951, as shown in
FIG. 101, may also be used to inflate the balloon 952. The
inflation lumen 973 is in communication with the inflation port 955
and opens into the interior space of the balloon 952 at some point
along the length of the tunneling member 951 that resides within
the interior space of the balloon 952.
[0351] The method of using the device 950 is substantially similar
to the method of use previously described with reference to FIG.
93.
[0352] Another embodiment of the invention is illustrated in FIGS.
102 and 103. In this embodiment, the balloon 985 has an elongated
neck 960 that is completely sealed. The elongate neck 960 may be
sealed by welding the balloon material all the way around, for
example. The balloon 985 illustrated in FIG. 102 may be of
arbitrary shape and may be utilized in conjunction with the
previously described handle 954 and tunneling member 951 shown in
FIG. 103. In order to mount the balloon 985 on the tunneling member
951, the balloon neck 960 is inverted over the tunneling member
951, and the tunneling member 951 is inserted into the balloon 985
until it abuts the nipple 981 provided in the distal extremity of
the balloon 985. A balloon cover of the types previously described
may be provided for this balloon 985 as well.
[0353] With this particular embodiment, it may also be necessary or
desirable to use a temporary clamp 962, as shown in FIG. 103, to
clamp the inverted balloon neck 960 to the tunneling member 951 to
prevent the tuck in the neck 960 from unrolling if it is necessary
to withdraw or reorient the apparatus during tunneling. The clamp
962 may be of any suitable type, as previously described.
Alternatively, the surgeon may grasp the inverted neck in his or
her hand to prevent the tuck from unrolling. Because the balloon
985 has a sealed neck 960, an inflation harness 974 of the type
previously described is required to inflate the balloon 985. One
benefit of utilizing the balloon 985 is that because the balloon
985 is sealed, it is not necessary to utilize seals in the handle
954 to form a seal between the laparoscope and the tunneling member
951.
[0354] In a preferred method of utilizing any of the one-piece
apparatus illustrated as having inverted tucks in the balloon neck,
the device is inserted through an incision in the body and advanced
bluntly to a desired location where tissue dissection is to occur.
As previously mentioned, during blunt tunneling the temporary clamp
962, if utilized, secures the inverted neck 960 to the tunneling
member 951 to prevent the neck 960 from unrolling if it is
necessary to withdraw the apparatus. During tunneling, the
advancement of the apparatus through tissue layers may be observed
through the laparoscope through the open distal end 980 of the
tunneling member 951.
[0355] After the desired location has been reached, the tunneling
member 951 and laparoscope may be withdrawn slightly by grasping
the handle 954 and withdrawing the handle 954 and laparoscope to
gain clearance from the nipple. 981 of the balloon 985. Before this
is done, however, it is necessary to remove the clamp 962 if one
has been utilized. The balloon 985 is then inflated in the manner
previously described, and tissue dissection can be observed as in
previous embodiments through the laparoscope as the laparoscope
again looks out through the open distal end 980 of the tunneling
member 951. The device and laparoscope are then withdrawn from the
body and additional trocars, as required for the procedure, may be
inserted.
[0356] A reusable version of the expansible tunneling apparatus of
the present invention is shown in FIGS. 104 and 105. In FIG. 104,
the closed neck balloon 985 illustrated in FIGS. 102 and 103 is
illustrated mounted on a tubular member 991. The tubular member 991
is sized to accommodate the insertion of the tunneling member 990
illustrated in FIG. 105. The tunneling member 990 in this
embodiment is preferably a rod, but a tunneling member 990 with an
internal bore sized to receive a laparoscope of the type
illustrated in connection with previous embodiments could be
utilized if laparoscopic visualization is desired. When the
tunneling member 990 is fully inserted into the tubular member 991,
the distal end 995 of the tunneling member 990 preferably extends
beyond the open distal end 996 of the tubular member 991 and mates
with the nipple 981 provided in the balloon 985.
[0357] In this reusable embodiment, the handle 954 and tunneling
member 990 portion of the apparatus are inserted into the tubular
member 991 and removably secured thereto by a suitable fastening
system. One example of a suitable mechanism for fastening the
handle 954 and tunneling member 990 to the tubular member 991 is
illustrated in FIGS. 104 and 105 and comprises a slot 989 in the
tubular member 991 which is aligned with a corresponding groove 986
formed in the tunneling member 990. An O-ring 992 may be placed in
the slot 989 to secure the tubular member 991 to the tunneling
member 990. In this arrangement, the O-ring 992 is placed in shear
and provides a particularly effective temporary attachment
mechanism. A key or tab 988 formed on the tunneling member 990 or,
alternatively, extending from the handle 954, mates with a
corresponding notch 987 in the tubular member 991 to prevent the
tunneling member 990 from rotating with respect to the tubular
member 991 during use of the device. Of course, other suitable
anti-rotation mechanisms may be utilized. Furthermore, an open
necked balloon of the type illustrated in FIG. 94, for example, may
be utilized in conjunction with this reusable embodiment. In this
case, the open balloon neck could be bonded anywhere along the
length of the tubular member 991.
[0358] This reusable embodiment of the tunneling apparatus of the
present invention may be utilized in the same manner as previously
described. After a surgical procedure has been performed with the
device of FIGS. 104 and 105, the handle 954 and the tunneling
member 990 attached thereto may be removed from the remainder of
the apparatus by removing the O-ring 992. The handle 954 and
tunneling member 990 may be reused, after appropriate
sterilization, in further procedures to make the apparatus more
economical to use. Thus, the combination handle 954 and the
tunneling member 990 form a reusable portion, while the balloon 985
and tubular member 991 comprise a disposable cartridge.
[0359] A balloon 1000 preferably formed from a non-elastomeric
material with extending horns 1001 is illustrated in FIG. 106. This
particular balloon shape has been found to be particularly
efficacious for use in connection with bladder neck suspension
procedures. Before inflation, the horns 1001 are everted within the
balloon 1000 as shown by the dashed lines indicated by reference
numeral 1002. This permits the balloon 1000 to be rolled or folded
into a compact arrangement. When the balloon 1000 is inflated, the
horns 1001 extend outwardly when the internal balloon inflation
pressure rises enough to overcome the fold resistance at
reinversion.
[0360] This fairly reliably happens secondarily to inflation of the
main body of the balloon 1000. The balloon 1000 may have an
elongate neck 1003 and may be utilized with any of the previously
disclosed embodiments of the tunneling apparatus of the present
invention.
[0361] FIG. 107 illustrates a presently preferred arrangement for
the slits or perforations in any of the integral balloon cover
embodiments when it is desirable for the distal opening of the
integral cover to separate before proximal separation occurs. When
the balloon cover construction disclosed in FIG. 107 is utilized,
upon inflation of the balloon, the balloon cover separates at the
0.50 inch perforation shown in FIG. 107 and then the cover breaks
apart distally. Thereafter, the cover tears away proximally.
[0362] Although the present invention has been principally
described in conjunction with hernia repair, it should be
appreciated that the various balloon constructions and the methods
hereinbefore described can be utilized in other surgical
procedures. In connection with such procedures, if specialized or
custom-type balloons are required for a specific procedure, it can
be seen that such balloon can be readily constructed in accordance
with the present invention and utilized as hereinbefore described
to perform those procedures. Examples of such procedures which lend
themselves to use of the balloon dissectors and methods disclosed
herein include extraperitoneal endoscopic pelvic lymph node
dissection. Similarly, the balloon dissectors and procedures
described herein may be used in connection with bladder neck
suspension procedures to cure urinary incontinence. Moreover, the
various apparatus and methods can be utilized with little or no
modifications to the shape of the balloon for lymphadenectomies.
The various apparatus and methods can also be used in
retroperitoneal procedures. The horseshoe-shaped balloon described
can be utilized for dissecting around obstructions such as ventral
hernias and median raphes. In all of these procedures, it is
desirable to make them as minimally invasive as possible and, where
feasible, to utilize endoscopic techniques.
[0363] From the foregoing, it can be seen that the apparatus and
methods of the present invention can be utilized in connection with
various laparoscopic surgical procedures. While embodiments and
applications of the disclosed devices and associated methods have
been shown and described, it would be apparent to those skilled in
the art that many more modifications are possible without departing
from the inventive concepts disclosed herein. The invention
therefore is not to be restricted except in the spirit of the
following claims.
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