U.S. patent application number 10/243252 was filed with the patent office on 2003-01-16 for skin seal with inflatable membrane.
Invention is credited to Mollenauer, Kenneth H., Monfort, Michelle Y..
Application Number | 20030014076 10/243252 |
Document ID | / |
Family ID | 27409604 |
Filed Date | 2003-01-16 |
United States Patent
Application |
20030014076 |
Kind Code |
A1 |
Mollenauer, Kenneth H. ; et
al. |
January 16, 2003 |
Skin seal with inflatable membrane
Abstract
A skin seal or trocar stabilizer with an inflatable balloon in
the shape of a dumbbell, where the balloon may be stored within a
cannula for easy placement in an incision and inflated to deploy
the balloon inside the body, and a portion of the balloon expands
inside the cannula, whereby medical instruments may be passed
through the skin seal into a laparoscopic workspace while the
balloon is inflated, thereby allowing the use of normal short
surgical instruments during laparoscopic procedures and during
insufflation.
Inventors: |
Mollenauer, Kenneth H.;
(Santa Clara, CA) ; Monfort, Michelle Y.; (Los
Gates, CA) |
Correspondence
Address: |
Douglas E. Denninger, Esq.
United States Surgical, a Division of
Tyco Healthcare Group LP
150 Glover Avenue
Norwalk
CT
06856
US
|
Family ID: |
27409604 |
Appl. No.: |
10/243252 |
Filed: |
September 13, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10243252 |
Sep 13, 2002 |
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09383027 |
Aug 25, 1999 |
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6468292 |
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10243252 |
Sep 13, 2002 |
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08867285 |
Jun 2, 1997 |
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5964781 |
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08867285 |
Jun 2, 1997 |
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08444425 |
May 19, 1995 |
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5634937 |
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Current U.S.
Class: |
606/213 ;
600/207; 606/192 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 2017/00557 20130101; A61B 2017/3419 20130101; A61B 17/3423
20130101; A61B 2017/3486 20130101; A61B 90/40 20160201; A61B
17/3431 20130101 |
Class at
Publication: |
606/213 ;
606/192; 600/207 |
International
Class: |
A61B 017/08; A61M
029/00 |
Claims
What is claimed is:
1. A device for sealing an incision through a layer of body tissue,
said device comprising: a cylindrical balloon having a distal end
and a proximal end and an intermediate portion between the distal
and proximal end, said distal end having a large cross section
compared to the intermediate portion, said cylindrical balloon
having an inner balloon tube and an outer balloon tube, said inner
balloon tube and outer balloon tube being sealed together at the
distal and proximal ends of the balloon to form a closed surface
which can be inflated; a stiffener tube disposed within the closed
surface of the balloon, with the inner balloon tube extending
through the stiffener tube and said outer balloon tube surrounding
the stiffener tube, said stiffener tube being approximately the
same length as the layer of body tissue to be sealed; an inflation
port communicating with the balloon, said inflation port permitting
injection of gas or fluid to inflate the balloon.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of copending U.S.
application Ser. No. 08/867,285, filed on Jun. 2, 1997, which is a
continuation of U.S. application Ser. No. 08/444,425, filed on May
19, 1995, now U.S. Pat. No. 5,634,937. The priority of these prior
applications is expressly claimed and their disclosures are hereby
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] This invention relates to the field of surgical endoscopy,
specifically to improvements in skin seals and cannulas.
BACKGROUND OF THE INVENTION
[0003] Surgical endoscopy is a surgical technique of using small
diameter long-handled tools such as graspers, forceps, scissors,
refractors, dissectors, and clamps specially designed to be
inserted through small incisions in the skin (or other openings in
the body) to perform operations within the body. The surgeon
performing the surgery often cannot see the operation directly and
must watch the procedure on a video monitor fed by an endoscopic
camera or endoscope. Endoscopic surgery replaces open surgery that
requires large incisions, essentially opening the body cavity
completely, in order to perform surgery deep within the body.
Endoscopic techniques have been used for gall stone removal, gall
bladder removal, hernia repair, tumor removal, lymph node removal,
appendectomy, and many other operations. Endoscopic surgery is also
called laparoscopic surgery, video assisted surgery, minimally
invasive surgery, and bandaid surgery, but throughout this
specification the term endoscopic surgery or laparoscopic surgery
will be used.
[0004] To illustrate the background of the inventions described
below, the example of the laparoscopic cholecystectomy, hernia
repair, or lymphadenectomy, as well as the operation for harvesting
a blood vessel, will be used to illustrate both the old
laparoscopic procedures and the new laparoscopic procedures now
possible with the new devices. In the old procedure, a working
space was created in the abdomen using the process called
pneumoperitoneum or insufflation. Insufflation is the process of
injecting gas into the body to blow it up like a balloon, creating
a chamber filled with gas. When performed on the abdomen, the
peritoneum is inflated and the procedure is known as
pneumoperitoneum. The procedure can be used for inflating a space
between the peritoneum and the skin to permit laparoscopic hernia
repair, as illustrated in U.S. Pat. No. 5,496,345, issued to
Kieturakis et al. and entitled "An Expansible Tunneling Apparatus
for Creating an Anatomic Working Space." Insufflation can be used
also to inflate a tunnel shaped working space over a blood vessel,
to facilitate blood vessel harvesting, as described in U.S. patent
application Ser. No. 08/267,484, entitled "Extraluminal Balloon
Dissection Apparatus and Methods," incorporated herein by
reference. While the chamber is filled with gas, the surgeon
inserts long slender laparoscopic tools through trocars and
cannulas that pierce the skin and provide access ports into the
insufflated chamber.
[0005] For abdominal surgery, such as a cholecystectomy, (gall
bladder removal), the insufflation is accomplished by the following
procedure. An incision is made at the lower edge of the belly
button or umbilicus. The surgeon uses his fingers or a blunt
dissection tool, such as a blunt nosed obturator, to uncover the
fascia or abdominal muscles, then a large needle, referred to as a
Verres needle, is inserted into the abdomen or peritoneal cavity.
The Verres needle punctures the fascia and peritoneum that cover
the abdomen. A pressurized gas such as CO.sub.2 is injected into
the abdomen through the needle, in effect inflating the abdomen
like a balloon. After the abdomen is inflated, the Verres needle is
removed. After the needle is removed, trocars and cannulas are
inserted into the space created by the insufflation. Endoscopic
instruments, including an endoscope or laparoscope, scissors,
graspers, etc., are inserted into the abdomen through the cannulas
and manipulated to dissect tissue surrounding the gallbladder,
remove the gall bladder, and stitch the internal wounds.
[0006] To harvest the saphenous vein using laparoscopic procedures,
the surgeon may insufflate a tunnel shaped workspace over a blood
vessel. The tunnel is first created using obturators, tunneling
devices, or balloons inserted through small incisions along or over
the saphenous vein. After the tunnel is created, the surgeon may
insert skin seals and cannulas, and insufflation gas is injected
through one of the trocars. While the tunnel is insufflated, the
cannulas permit the surgeon to insert laparoscopic instruments into
the tunnel to perform surgery on the saphenous vein.
[0007] The cannula used in the procedures described above is a
length of rigid tube. The trocars and cannula are designed to allow
laparoscopic instruments to pass through them and prevent gas from
escaping the abdomen or other insufflated work space. The cannula
may have a flapper valve or a trumpet valve inside that opens to
allow an endoscope, laparoscope, or other instrument to pass
through, and the valve closes when the laparoscope is removed. Some
trocar/cannula devices also contain a duckbill valve to assist in
sealing the trocar. The cannulas are typically about 6 inches or 15
centimeters long, and come in diameters matching various
laparoscopic devices, generally from 2 to 15 mm.
[0008] Some surgeons use bare cannulas, secured only by a tight fit
with the skin and fascia. However, cannulas frequently slip out of
the body during use, disrupting the procedure and possibly
endangering the patient. To prevent this danger, surgeons have
devised a variety of methods to secure the cannula to the body and
prevent it from slipping out of the body. Some cannulas are
provided with threaded sleeves fixed to the cannula. Some cannulas
are provided with a threaded gripper with a smooth inner bore that
matches the size of the cannula, so that the cannula can slide
inside the gripper as shown in FIG. 2. The gripper stabilizes the
cannula so that it will not slip out of the body inadvertently, but
can be easily slipped out when the surgeon wants. The threaded
gripper is simply screwed into the incision in the skin. This
option permits the ready insertion and removal of smooth walled
cannulas by sliding them in and out of the gripper. Other grippers
have been used, such as the gripper with expandable arms, the
gripper with inflatable balloon on the outside, and the Hasson
cannula. These devices are illustrated in Oshinsky, et al.,
Laparoscopic Entry and Exit, reprinted in Urologic Laparoscopy at
91-101 (Das & Crawford ed. 1994). These devices are variously
referred to as threaded skin seals, screw skin seals, skin anchors,
obturators, grippers, trocar stabilizers, or cannula
stabilizers.
[0009] The surgeon usually needs to place several trocars and
cannulas into the abdomen and inserts as many as needed to
accomplish the intended operation. The first cannula placed through
the belly button is used to insert a laparoscope so that the
placement of other trocars and cannulas can be viewed from inside
the abdomen. After several cannulas are in place, the surgeon can
view the procedure through any port and can insert laparoscopic
scissors, cutters and graspers, and other tools through the
cannulas in order to perform the surgery. The typical endoscopic
graspers 3 used for stitching inside the abdomen are shown,
deployed inside the cannulas, in FIG. 2. A bare cannula 4 is used
with endoscopic graspers 3a. Another pair of laparoscopic graspers
3b is inserted into a cannula 4a that is inserted through a
threaded gripper 5. A third cannula 6, shown with a threaded outer
surface, is provided for an endoscope 34 that is inserted into the
workspace to provide the surgeon with a video view of the graspers
3a and 3b and body tissue.
[0010] The arrangement of the cannulas and trocars is required
because the abdomen must be inflated to make room for the surgeon
to work. The small diameter of the cannulas keeps the incisions
small, and the matching diameter of the laparoscopic instruments is
necessary to prevent leakage of the insufflation gas from the
abdomen. Laparoscopic instruments of various designs are available,
and they generally are about 5 to 12 mm in diameter (to match the
inside bore of the cannulas) and about 10 to 40 cm in length. They
are long and therefore difficult to use, and they are usually used
when the surgeon can see them only through the laparoscope. Modern
laparoscopic procedures require the surgeon to view the procedure
on a video monitor. It may take a surgeon a lot of practice before
becoming comfortable and skillful with the laparoscopic graspers,
grippers, and scissors. These tools are more difficult to use than
the surgical tools that every surgeon uses in normal surgery, such
as those shown in FIG. 3, in use during open laparotomy. The normal
graspers are shown in use while the surgeon is tying off a suture.
This normal procedure is familiar to a large number of surgeons.
The normal surgical graspers 7a and 7b are shown in use in FIG. 3,
suturing body tissue 8 with suture 9, and it can readily be
appreciated that the laparoscopic graspers shown in FIG. 2 require
significantly more skill than the normal surgical tools. One of the
drawbacks of the known cannulas and grippers is that they are
adapted to admit only relatively narrow instruments, and are
therefore generally unsuited for use with ordinary open incision
surgical tools.
[0011] It would be advantageous to use normal surgical tools during
laparoscopic procedures, but this is usually not permitted by the
typical construction of the trocars and cannulas that are too
narrow, long, and rigid to permit passage of the normal surgical
tools. Most surgeons are very well trained in using conventional
nonendoscopic instruments, such as the open incision graspers shown
in FIG. 3, and numerous procedures involving the graspers such as
tying off a suture are well known and well practiced. The
endoscopic instruments shown in FIG. 2, on the other hand, are not
well known and well practiced, and generally require significantly
more skill than the more familiar open incision instruments. Thus,
there is a need to provide cannulas and grippers that would
accommodate the instruments used in open incision procedures.
SUMMARY OF THE INVENTION
[0012] In a typical endoscopic or laparoscopic operation, a surgeon
creates a working space inside the body through insufflation. To
create the working space for abdominal surgery, the surgeon makes a
small incision at, for example, the inferior margin of the
umbilicus 1 as shown in FIG. 1, and then uses his fingers or a
dissecting tool, such as a blunt nosed obturator, to prepare a
point of injection. The surgeon then inserts a Verres needle 2 into
the abdominal cavity, and causes a pressurized gas such as CO.sub.2
to flow through the needle and into the abdominal cavity. This
inflates the abdomen, as shown in FIG. 1, and provides a working
space for the surgeon. The needle may then be removed, and a
cannula or trocar/cannula combination may be inserted into the
incision. Additional incisions may also be made, and the first
incision may be used to insert a laparoscope to assist in the
placement of the other incisions. The additional incisions may each
receive a cannula and, once several cannulas are in place, the
surgeon can view the procedure and/or insert laparoscopic scissors,
cutters, graspers, or other tools through any of the cannulas.
[0013] As mentioned above, the trocars and cannulas can be used in
endoscopic blood vessel surgery, laparoscopic cholecystectomy, and
laparoscopic hernia repairs where a workspace is created under the
skin. In the blood vessel harvesting operation where the saphenous
vein is to be removed, a surgeon creates a tunnel between two small
incisions over the saphenous vein. Then a cannula and skin seal are
inserted into each incision. The tunnel is insufflated through one
of the cannulas. In these procedures, the laparoscopic instruments
are also inserted into the working space through the cannulas, and
the surgeon can watch the surgery through a laparoscope inserted
through one of the cannulas.
[0014] The devices presented herein allow for use of normal
surgical tools (such as the forceps and scissors used in open
incision surgery) in laparoscopic procedures. The skin seal is
fitted with one or more balloons on the inner bore. These balloons
can be inflated after the skin seal is inserted into the incision
into the abdomen Placement of the skin seal can be accomplished as
usual, with the aid of a blunt or sharp trocar or cannula placed
within the threaded skin seal. The threaded skin seal can be made
of rigid plastic, as is customary, or preferably it may be made of
soft and pliable material such as latex or silicone rubber. When
the threaded skin seal is in place, the trocar may be removed and
the balloon may be inflated until it expands to fill the inner bore
of the threaded skin seal, thus sealing the bore to maintain the
pressure created inside the abdomen with the insufflation gas. The
balloons are soft and pliable and can conform around the elements
of the instruments as they are moved about during use. Thus, normal
or conventional surgical instruments may be passed between the
balloons. Both normal surgical instruments and laparoscopic
instruments may be inserted into the body through the balloons
without disrupting the seal created by the balloons. The balloon is
soft and pliable so that normal surgical tools may be operated
inside the inflated balloon segments, and the balloon segments will
not hamper the operation of the tool to a significant degree. The
skin seal may be provided with a balloon membrane that expands
outside the lumen of the skin seal to create a dumbbell, dog bone,
or bowtie shaped balloon which pinches the skin and, when
necessary, fills the lumen of the skin seal.
[0015] More than one tool may be inserted through a single skin
seal because the balloons are sufficiently pliable and may be
inflated to a lesser degree. In this manner, normal surgical
instruments may be used in laparoscopic procedures, taking
advantage of the fact that they are easier to use and more surgeons
know how to use them, compared to the long laparoscopic
instruments. The balloon filled skin seal may be used also as a
seal for laparoscopic incisions which are no longer necessary or
which the surgeon desires to plug temporarily while still leaving a
skin seal in place for later use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is an external view of the abdomen of a patient
undergoing insufflation.
[0017] FIG. 2 is a cross section drawing of the insufflated abdomen
of a patient with several trocars, cannulas and laparoscopic
instruments in place for a laparoscopic procedure.
[0018] FIG. 3 is a view of an open laparotomy procedure using
normal surgical forceps.
[0019] FIG. 4 is an exploded view of a cannula with an inflatable
balloon inside.
[0020] FIG. 5 is a cross sectional view of the cannula with the
inflatable balloon inside.
[0021] FIGS. 6, 6a and 6b show cross sectional views of the cannula
with the inflatable balloon shown in its inflated state.
[0022] FIGS. 7 through 7c show end views, from the proximal end, of
the cannula with inflatable balloon inside.
[0023] FIG. 8 shows a pair of skin seals with the balloons inside,
with normal surgical instrument inserted through the balloons,
deployed in the manner of intended use.
[0024] FIG. 9 shows a blunt obturator suited for use with the skin
seal.
[0025] FIG. 10 shows a sharp trocar type obturator suited for use
with the skin seal.
[0026] FIG. 11 shows the blunt obturator inserted in the skin
seal.
[0027] FIG. 12 shows a skin seal with balloons that expand outside
the lumen of the skin seal.
[0028] FIG. 13 shows a cross section of the skin seal with outer
balloon.
[0029] FIG. 14 shows an alternate embodiment of a skin seal with
balloons which expand outside the lumen of the skin seal.
[0030] FIG. 15 shows an exploded view of the skin seal with outer
balloons
[0031] FIG. 16 shows the skin seal with outer balloon prepared for
insertion into a skin incision.
[0032] FIGS. 17 through 17b show the skin seal with outer balloon
inserted into a skin incision.
[0033] FIG. 18 shows an alternate embodiment of the skin seal.
DETAILED DESCRIPTION OF THE DRAWINGS
[0034] The cannulas and grippers described below allow for use of
normal surgical instruments in laparoscopic surgical procedures.
The typical gripper configuration is modified by adding a balloon
or inflatable membrane to the inner bore of the gripper and adding
an inflation port to the wall of the gripper to allow for inflation
of the balloon. When the balloon is inflated, it closes off the
inner bore of the gripper so that it provides an airtight seal
during insufflation. The balloon is pliable so that tools can be
inserted through the inner bore of the balloon, and the balloon
expands around the surgical tool to maintain the seal with little
or no leakage of insufflation gas.
[0035] Referring to FIG. 4, the threaded skin seal 10 is made of a
funnel or tube 11 with a generally conical or frustum outer shape
with screw threads 12 provided on the outer surface 13. The inner
bore 14 is conical or funnel shaped, conforming generally to the
shape of the outer shape. Overall, the skin seal is funnel shaped,
and the proximal end 15 of the threaded skin seal has a large
opening, and the distal or bottom end 16 has a smaller opening. The
distal or bottom portion 16 of the threaded skin seal may have a
straight or cylindrical bore to provide a tight fit with cannulas
that have an outer diameter matching the inner diameter of this
straight bore. The distal or bottom portion of the skin seal may
have a straight or cylindrical outer shape to make it easier to
screw the skin seal into an incision, and this straight section may
be made of variable length to match the different thickness of fat
which will be encountered in different patients. The proximal end
preferably has a conical inner bore to facilitate insertion of
tools into the opening and through the cannula, but the inner bore
may be straight. The proximal end may also be described as flared
and may be gradually flared in relation to the distal end, as
though trumpet shaped, or flared in discrete fashion as in a
typical funnel, with a straight tube at distal end and a conical
segment at the proximal end. The screw threads constitute a
fastening means, and may be replaced with other fastening means
such as a circumferentially ribbed outer contour or a
longitudinally grooved outer contour. As shown, a flange 19 may be
provided on the proximal end of the cannula for ease in handling.
The flange 19 also provides a convenient means for mounting the
bellows onto the cannula. The skin seal is preferably 1 to 3 inches
or about 2 to 8 centimeters long.
[0036] A balloon membrane 20 has a generally conical or frustum
shape matching the inner bore of the threaded skin seal and having
the same overall length of the threaded skin seal. The balloon
membrane fits inside the threaded skin seal and is sealed to the
skin seal funnel at the upper edge and lower edge of the balloon
membrane. The balloon membrane may be shorter than the skin seal,
and may be sealed to the inner surface of the skin seal at points
inside the skin seal, rather than at the immediate distal and
proximal edges of the skin seal. Also, the balloon membrane may be
longer than the skin seal and may be cuffed or folded back around
the outside of the skin seal at the proximal and distal ends and
sealed at the cuffs.
[0037] An inflation port 21 is provided comprising a hole in the
wall 22 of the threaded skin seal. An inflation tube 23 or Luer
fitting connects the inflation port to a suitable pump such as the
syringe 24 shown in FIG. 5 or the squeeze pump 25 shown in FIG. 6.
Where the syringe is used, the membrane may be inflated and
deflated repeatedly by pushing and pulling on the syringe plunger
26, thus forcing air into the bladder and sucking air out of the
bladder. A one-way valve or stopcock may be used to seal the
membrane so that the pump or syringe may be detached from the skin
seal for more convenient use. Alternately, an inflation port can be
provided at the distal tip of the skin seal, comprising an open
airway between the inflatable membrane and the insufflated
workspace. In this manner, the insufflation gas enters the skin
seal from inside the body to pressurize and inflate the inflatable
membrane. In this manner, an automatic seal is created upon
insertion of the skin seal into the insufflated space. This
simplifies placement and use of the skin seal because there is no
need for a separate syringe or pump to inflate the membrane.
[0038] In the preferred embodiment, the bladder 20 is made of
biocompatable elastomeric or elastic material, such as latex,
silicone rubber, or any other suitable compliant material, elastic
material, or inflatable material. The cannula 10 is made of rigid
or flexible material, soft or hard plastic, high density or low
density polyethylene, polypropylene, thick latex, silicone rubber,
or any other suitable material including plastic, elastic, or
nonelastic biocompatable material.
[0039] As shown in FIGS. 4 and 5, the inflatable skin seal may be
constructed by applying an elastic cylindrical or conical balloon
membrane 20 to the inner bore of skin seal cannula 10 and sealing
the distal end of the balloon to the distal end of the cannula and
sealing the proximal end of the balloon to the proximal end of the
cannula, thereby creating an inflatable space between the cannula
and the membrane. Alternatively, a fully formed balloon bladder,
comprising an inner and outer conical membranes sealed to each
other at their distal and proximal ends can be provided and fixed
to the inner bore of the cannula. The overall shape of the balloon
will be conical, funnel shaped, or flared to match the shape of the
inside of the skin seal. While one balloon is depicted in each of
the figures, two or more balloons may be used to guard against the
possibility of rupture and loss of insufflation pressure during an
operation, or to facilitate manufacture, or to facilitate use of
the skin seal with particular tools. A membrane seal may provided
at any cross sectional plane, within the skin seal, to guard
against loss of insufflation pressure.
[0040] FIG. 6 shows the inflatable skin seal with the membrane in
its inflated condition. The squeeze pump 25 is used to force air in
the space between the bladder 20 and the wall of the cannula,
causing the membrane to inflate within the cannula. The inflated
membrane can be inflated until it completely obstructs the inner
bore of the cannula and provides an airtight seal between the
distal and proximal ends of the cannula. The cannula can be
thin-walled and flexible enough to expand, as well, thereby further
improving the seal between the cannula and the skin incision. As
shown in FIG. 6a, the membrane need not extend for the full length
of the cannula, but may instead be sealed to the inner bore at
various points inside the cannula. The cannula in FIG. 6a has a
balloon 20 only in the conical inner bore of the proximal section
of the cannula, and this facilitates use of graspers, scissors, and
other such instruments which might pinch the balloon when operated,
or unnecessarily reduce the internal diameter of the narrowest
portion of the cannula. As shown in FIG. 6b, the wall of the
cannula may be made flexible enough to expand outward when the skin
seal is inflated, so that any gaps or looseness in the seal between
the outside of the skin seal, and the skin incision are closed by
the expansion of the outer wall 22 of the skin seal.
[0041] FIG. 7 shows the view of the inflated membrane viewed from
the proximal end of the cannula. The membrane naturally bulges in
two or more radial sections or segments 27 to fill the lumen of the
cannula. The expansion of the balloon sections need not be
controlled, but may be controlled to facilitate operation of
graspers or other hinged and pinching tools. For example, the
application of restrictors comprised of thickened strips along the
length of the membrane, shown in FIG. 7a, may be applied to the
membrane to inhibit expansion along the strip. Wire bands, plastic
bands, or a line of adhesive gluing the balloon membrane to the
skin seal may also be used to prevent expansion of the membrane
along a longitudinal line of the membrane extending from the
proximal end (or near the proximal end) to the distal end (or near
the distal end) of the funnel. In this manner, a uniform expansion
can be obtained with the membrane expanding from the walls of
cannula to meet along a uniform plane. A pinching tool used in the
cannula can be opened and closed along the plane defined by the
inflated balloons, and the balloon will pliantly close upon the
lumen, but allow the pinching tool to open and close with less
chance of pinching and cutting the balloon. As shown in FIG. 7b,
the inflatable membrane 20 may be placed on the inner bore of the
skin seal in an eccentric manner, covering only a portion of the
inner wall of the skin seal. FIG. 7c shows the eccentric inflatable
membrane in its inflated state.
[0042] FIG. 8 shows the skin seals 28, 29, and 30 with the balloon
membranes inflated.
[0043] Skin seal 28 has the funnel shape described above. A pair of
normal surgical scissors, such as Metzenbaum scissors 31, is
inserted through one skin seal 28 and a pair of normal surgical
graspers 7 (examples include Kelly clamps, Kelly placenta forceps,
and Mayo clamps) is inserted through the skin seal cannula 29 to
perform operations beyond the distal tip of the cannula. The skin
seals are shown screwed into incisions through skin 32 and
subcutaneous fat 33, and they may also extend through the
peritoneum or other tissue when appropriate to the operation. An
endoscope or laparoscope 34 which can be inserted through one skin
seal to provide a view of the procedure is shown in the central
skin seal 30. Because the balloon is pliable and conforms around
any device within the skin seal, the graspers may be manipulated
inside the cannula without breaking the insufflation seal. As the
graspers 7 are manipulated, the membrane conforms around graspers,
but yields to allow the graspers to be opened, closed, twisted,
pushed, and pulled within the skin seal without substantially
degrading the seal created by the membrane. It should be noted that
a perfectly airtight seal is not necessary, and some leakage of
insufflation gas or fluid is acceptable, so long as insufflation
gas or fluid can be injected at a rate sufficient to make up for
any loses. Where the cannula itself is made of a soft pliant
material such as latex rubber or silicone rubber, the forceps may
be manipulated even further, and deformation of the skin seal 28
will permit a wider range of motion for the forceps. Skin seal 28
is shown with a pair of conventional surgical scissors 31 or shears
disposed through the skin seal. The scissors may be opened wide, as
shown, and the distal or proximal end of the skin seal will yield
and flare out to allow operation of the scissors through their full
range of motion and opened through the full throw (the "throw"
referring to the length of arc 35 over which the graspers or
scissors may be opened) of scissors 31 or graspers, as illustrated
by flared distal portion 36 of skin seal 28.
[0044] It will be readily appreciated that such operation would not
be possible using standard cannulas. The normal surgical tools are
much easier to use than the long laparoscopic instruments shown in
FIG. 2. Also, the tools can be much larger and have much larger
operating implements. For example, the cutting edges of scissors 31
are much longer that cutting edges on laparoscopic scissors and can
cut much more quickly. A common method of dissecting tissue with
normal scissors is to pierce connective tissue with the closed
scissors and open the scissors, operating the scissors in backwards
fashion, so that the dull outer edges of the scissors pull
connective tissue apart. This can be done very quickly using the
skin seals 29 and 30, as compared to slow and tedious snipping
required when using long laparoscopic instruments.
[0045] Placement of the skin seals may be facilitated with special
blunt obturators shown in FIGS. 9, 10, and 11. The blunt obturator
37 provides support for the skin seal as it is pushed and screwed
into the incision. The blunt obturator comprises a peg 38 with an
outer contour which matches the inner bore of the skin seal, a
handle 39, a finger gap 40, and a blunt tip 41. The tip may be
blunt and rounded, or it may be sharp and pointed, as illustrated
by the sharp pointed trocar type tip 42 in FIG. 10, in which case
the sharp point 42 can puncture body tissue. The obturator is
placed inside the skin seal as shown in FIG. 11, and the assembly
is screwed into the body as a unit. After the skin seal is in
place, the obturator is removed to allow insertion of other devices
into the skin seal. The finger gap 40 leaves some space for the
surgeon to push against the flange of the skin seal while pulling
the handle 39, thus avoiding the possibility that the skin seal
will be pulled out of the body with the obturator 37. Because the
obturator fits tightly inside the skin seal to give it support
during insertion, it may inadvertently become sealed to the inside
of the skin seal, especially if there is any leakage of body fluids
or water into the skin seal. Any excessive force required to pull
out the obturator could result in pulling the screw skin seal out
of the skin incision. To prevent the need for such excessive force,
the portion of the obturator which fits inside the skin seal may be
provided with vacuum breakers in the form of scored lines or
channels 43, circumferential grooves 44, or a roughened surface to
prevent a vacuum from forming between the skin seal inflatable
membrane. The scoring or roughening may take any form.
[0046] FIG. 12 shows another embodiment of the skin seal in which
the balloon is enlarged so that it expands outside the lumen of the
skin seal. The skin seal 45 shown in FIG. 12 includes a dumbbell
shaped balloon 46. The shape of the balloon may variously be
described dog bone, bowtie, dumbbell, or butterfly shaped. The
balloon 46 has a lumen 47 extending through the balloon and can be
provided with a rigid cannula segment or stiffener tube 48 disposed
within the balloon. The stiffener tube need only be stiff enough to
provide support for the balloon during placement, so it is stiff in
relation to the balloon membrane, but may, in fact, be very
flexible and can be made of any plastic or elastic material or
other materials suitable for the inflatable membrane.
[0047] The balloon may be formed by sealing together an inner
balloon tube 49 and an outer balloon membrane 50. An inflation port
51 is provided on the outer dumbbell portion, but may also be
provided on the waist portion 52 or even the inner dumbbell. When
used during insufflation, an inflation port may be provided on the
inner dumbbell in form of a simple airway provided in the inner
dumbbell that allows insufflation gas to enter the balloon from the
insufflated space. In this manner, the need for a separate source
of inflation gas or fluid is avoided.
[0048] The outer balloon membrane may be made of two or more pieces
to create any desired outer shape. As shown in FIG. 13, the outer
balloon membrane has an oval outer shape when inflated. The balloon
may be provided with any other useful shape and may be round or
toroidal, or oval, as shown. The balloon is formed of two pieces 53
and 54 that are heat sealed or sealed with adhesive along the seam
55. FIG. 13 also illustrates that the inner balloon tube 49 fits
inside the lumen of the stiffener tube 48 while the outer balloon
surrounds the stiffener tube. FIG. 15 shows an exploded view of the
device with butterfly shaped balloon membranes 53 and 54, the
tubular balloon membrane 47 extending across the "wingspan" or
major length of the butterfly shaped membrane, and the stiffener
tube 48 surrounding the tubular balloon membrane 47. With the
tubular balloon membrane and the stiffener tube sandwiched between
the butterfly shaped balloon membranes, the edges of the butterfly
shaped membranes are sealed together, and the ends of the tubular
balloon membrane are sealed to the edge of the butterfly shaped
membranes at the middle of the outer edge of the wings, thereby
forming a single balloon with an overall butterfly shape and a
through hole extending across the wingspan. The balloon can be made
of any suitable material, including polyethylenes, polyamide,
polyurethanes, latex, or silicone rubber. The balloon may be
elastic or nonelastic. The various pieces may be made of different
material, for example the inner balloon tube may be made of an
elastic material, and the outer balloon membranes may be made of
nonelastic material.
[0049] The stiffener tube 48 may be a straight length of tube or it
may be funnel shaped like the screw skin seals described above. The
stiffener tube provides columnar support for the device so that it
can be pushed through an incision in the skin. The stiffener tube
may be made of any suitable material, including any material
previously mentioned above and any material previously used for
cannulas and trocars. The length of the stiffener tube is chosen to
approximate the thickness of the skin and fat layers 32 and 27, and
is preferably slightly shorter than the thickness of the skin and
fat layer. The stiffener tube may be disposed inside the balloon
pieces without being sealed in any way to the balloon pieces, or it
may be sealed to either the inner or outer balloon pieces.
[0050] The inner balloon tube may be sealed along a circumference
of the tube just as the balloon membrane of FIGS. 5 and 6 is sealed
to the threaded skin seal, and it may be sealed to the stiffener
tube along one or more longitudinal lines as shown in FIG. 7a. The
inner balloon may also be provided with thickened longitudinal
portions, metal, or plastic bands, etc., as described in reference
to FIG. 7a to control inflation and encourage inflation toward a
uniform plane in the center of the lumen. Also, the inner balloon
49 may be sealed to the stiffener tube 48 at both ends of the
stiffener tube, as is the balloon membrane of the threaded skin
seal, and inflated through an optional airway 56. The outer balloon
pieces may be sealed to the outside of the stiffener tube, either
by sealing the entire waist portion to the stiffener tube, or by
dispensing with the waist portion and sealing the dumbbell portion
of the balloons to the ends 57 and 58 of the stiffener tube, as
shown in FIG. 14.
[0051] In use, the distal end of the deflated balloon is tucked
into or pulled into the stiffener tube, as shown in FIG. 16. An
obturator, trocar, or cannula 59 is placed inside the stiffener
tube 48 to facilitate insertion of the skin seal into an incision.
The cannula 59 is pushed into the incision along with the skin seal
that rides over the cannula. With the cannula 59 in the incision,
the skin seal 45 can be pushed over the cannula and into the
incision. After the skin seal has been inserted into the incision,
the cannula may be removed leaving the skin seal in place. Then the
balloon can be inflated, as shown in FIG. 17. When the balloon is
inflated, as shown in FIG. 17, the outer dumbbell portion 60 is
inflated while the inner dumbbell portion 61 expands out of the
stiffener tube and into the body and inflates to re-establish the
dumbbell shape. When the balloon is inflated further, the expanding
dumbbells clamp down on skin 32, fat 33, and other tissue trapped
between the inner balloon portion 61 and outer balloon portions 60.
The stiffener tube 48 prevents the inner balloon tube from
collapsing at the waist 52, but the inner balloon may expand to
fill the lumen or through hole 47. The inner balloon tube 49, when
inflated to fill the through hole, acts as a seal for any device
such as the endoscope 34 placed through the lumen, as shown in FIG.
17. A trocar or cannula may be inserted into the body through the
lumen of the skin seal to allow inserting of laparoscopic
instruments through the cannula or laparoscopic instruments, and
normal surgical instruments may be inserted through the skin seal,
as shown in FIGS. 17a and 17b, where the inner balloon tube expands
to conform around the instruments. FIG. 17a shows the same skin
seal with a pair of normal graspers used for open surgery inserted
into the body through the skin seal. FIG. 17b shows the skin seal
inflated so that the inner balloon tube 49 completely fills the
lumen of the skin seal, thus maintaining the insufflation of the
working space below the skin seal.
[0052] In another embodiment, only the inside or distal end of the
balloon expands outside the skin seal. As shown in FIG. 18, the
stiffener tube is provided with a flange 62 on the proximal end.
The inner balloon tube is sealed to the inside of the stiffener
tube at the proximal end of the tube. The outer balloon portion is
sealed to the outside surface of the stiffener tube. The inner or
distal dumbbell portion is expanded inside the body, and inflation
of the distal dumbbell portion clamps the skin and fat between the
flange and the distal balloon. When the central lumen is not
occupied by an instrument, the balloon can be inflated so that the
inner balloon tube expands into the central lumen and establishes a
seal between the insufflated work space and the outside of the
body. The seal can be supplied in a variety of sizes, with
stiffener tubes of various sizes to match commercially available
trocars, cannulas and laparoscopic instruments. The size of the
balloon and the length of the stiffener tube can be varied to fit
incisions of various sizes required by the many different
operations with which the skin seal can be used. The skin seal may
be used for laparoscopic access in any procedure, and can also be
used to compress bleeding incisions and plug unneeded incisions
during laparoscopic surgery.
[0053] The skin seals described above can be used for any
endoscopic or laparoscopic surgery to permit use of normal surgical
instruments, i.e., ordinary open incision surgical instruments.
While the skin seals described above are useful in procedures
requiring insufflation, they may also be used in other endoscopic
or laparoscopic procedures. The use of the skin seal in any
endoscopic or laparoscopic procedures will allow deployment of
normal surgical tools while protecting the area of the incision
from trauma caused by the operation of the surgical instruments.
Where insufflation or flushing is required, the bladder in the skin
seal may be inflated to prevent undesired flow out of the cannula.
Also, although the skin seal described above has been described in
the best known embodiments, fabricated with suitable materials to
the inventors, the particular materials and shapes depicted in the
illustrations may be altered and improved upon without departing
from the inventions as claimed. It is specifically contemplated
that the materials be improved upon. Furthermore, although the
devices have been described in relationship to surgery requiring
insufflation and endoscopic or laparoscopic surgery, the claimed
devices and methods may be used in surgical and nonsurgical
applications wherever the features of these device and methods
prove beneficial.
* * * * *