U.S. patent application number 12/516373 was filed with the patent office on 2010-03-18 for device especially useful for hernia repair surgeries and methods thereof.
This patent application is currently assigned to Surgical Structure Ltd.. Invention is credited to Ibrahim Matter, Mordehai Sholev, Amir Szold, Ziv Tamir.
Application Number | 20100069947 12/516373 |
Document ID | / |
Family ID | 39267754 |
Filed Date | 2010-03-18 |
United States Patent
Application |
20100069947 |
Kind Code |
A1 |
Sholev; Mordehai ; et
al. |
March 18, 2010 |
DEVICE ESPECIALLY USEFUL FOR HERNIA REPAIR SURGERIES AND METHODS
THEREOF
Abstract
An elongate open-bored applicator (EOBP) adapted to deploy a
mesh comprising (a) at least one inflatable contour-balloon; (b) at
least one inflatable dissection balloon. The inflatable
contour-balloon and the inflatable dissection balloon are
adjustable and located at the distal portion; and, (c) at least one
actuating means located at the proximal portion. The actuating
means is in communication with the inflatable contour-balloon and
the inflatable dissection balloon. The actuating means is adapted
to provide the inflatable contour-balloon and the inflatable
dissection balloon with independent activation and/or
de-activation.
Inventors: |
Sholev; Mordehai; (Doar-Na
Alona, IL) ; Szold; Amir; (Tel-Aviv, IL) ;
Matter; Ibrahim; (Haifa, IL) ; Tamir; Ziv;
(Modiln, IL) |
Correspondence
Address: |
MARTIN D. MOYNIHAN d/b/a PRTSI, INC.
P.O. BOX 16446
ARLINGTON
VA
22215
US
|
Assignee: |
Surgical Structure Ltd.
Kiryat-Shmona
IL
|
Family ID: |
39267754 |
Appl. No.: |
12/516373 |
Filed: |
November 27, 2007 |
PCT Filed: |
November 27, 2007 |
PCT NO: |
PCT/IL07/01463 |
371 Date: |
May 27, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60861095 |
Nov 27, 2006 |
|
|
|
Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61F 2250/0003 20130101;
A61F 2/0063 20130101; A61F 2002/0072 20130101; A61B 17/00234
20130101; A61B 17/0057 20130101; A61B 17/0218 20130101; A61B
2017/00557 20130101; A61B 2017/0225 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1.-63. (canceled)
64. A hernia repair device, comprising: an inflatable balloon
having a flexible inflation tube; and a mesh removably attached to
said balloon such that, when the device is in a deployed state, the
mesh is situated only on one side of said balloon, wherein the
inflation tube passes through the mesh.
65. A hernia repair device according to claim 64, wherein the
balloon when inflated has a smaller extent in one direction than
the respective extents in the two directions perpendicular to the
one direction wherein the tube is attached to the balloon at a
central region of a surface formed in the directions of the two
larger extents.
66. A hernia repair device according to claim 64 wherein the inside
of said inflatable balloon comprises inflation fluid only.
67. A hernia repair device according to claim 64, wherein the
extent of the mesh is larger than any extent of the balloon.
68. A hernia repair device according to claim 64, wherein said
balloon comprises a plurality of interconnected inflatable
parts.
69. A hernia repair device according to claim 64, wherein the
balloon has a generally flat structure.
70. A hernia repair device according to claim 64, wherein said
balloon is made of a shape memory material.
71. A hernia repair device according to claim 64, wherein said
balloon has a substantially non-symmetrical shape.
72. A hernia repair device, comprising: an inflatable balloon
having a plurality of connected portions separated by open areas,
the open areas comprising more than 50% of the extent of the
balloon; and a mesh attached to and supported by said balloon such
that the mesh is situated only on one side of said balloon, wherein
the balloon comprises an inflation tube which passes through said
mesh.
73. A hernia repair device according to claim 72, wherein the
inside of said balloon comprises inflation fluid only.
74. A hernia repair device according to claim 72, wherein the area
of the balloon is less than 50% of the area of the mesh.
75. A hernia repair device according to claim 72, wherein the open
areas of the balloon are covered by the mesh when the balloon is
attached to the mesh.
76. A hernia repair device according to claim 72 wherein the
largest extent of the balloon is no larger than the largest extent
of the mesh.
77. A hernia repair device according to claim 72, wherein the
balloon has a generally flat structure.
78. A hernia repair device according to claim 72, wherein said mesh
is removably attached to said balloon.
79. A hernia repair device according to claim 72, wherein said mesh
and said balloon comprise extensions, the extensions of the balloon
adapted to be inserted into the extensions of the mesh.
80. A hernia repair device according to claim 72, wherein said
balloon further comprises a centering element for adjusting the
center of the balloon to the center of the hernia.
81. A hernia repair device according to claim 72, wherein said
balloon has a substantially non-symmetrical shape.
82. A method of positioning a hernia, the method comprising:
inserting a balloon and a mesh into an abdominal cavity of a
subject, the balloon having a flexible inflation tube which passes
through the mesh; inflating the balloon, thereby deploying the mesh
in the abdominal cavity, such that the mesh is situated on one side
of the balloon only; deflating the balloon; and extracting the
balloon from the abdominal cavity.
83. A method according to claim 82, further comprising: directing
the right side of said mesh to said abdominal cavity.
84. A method according to claim 82, further comprising: attaching
said mesh to said balloon before inserting the balloon and mesh
into the abdominal cavity.
85. A method according to claim 82, further comprising: fitting the
center of said balloon to the center of said hernia.
86. A method according to claim 82, further comprising: fastening
the mesh to the abdominal wall.
Description
FILED OF THE INVENTION
[0001] The present invention generally related to a device
especially useful in hernia repair and a method of using the
same.
BACKGROUND OF THE INVENTION
[0002] This invention generally relates to a device, especially
useful for hernia repair surgery.
[0003] Hernia, denoted hereinafter for umbilical hernia, ventral
hernia, postoperative ventral hernia epigastric hernia, spiegelian
hernia inguinal hernia, etc. is a common medical condition in which
an organ protrudes through an opening in its surrounding walls
(especially in the abdominal region). Hernia is sometimes treated
in a tension free repair, such as implementation of meshes, patches
etc. This procedure requires the insertion of a wide mesh via a
relatively small aperture such that the mesh is located in a
posterior layer parallel to the abdominal wall. The insertion of
the mesh implants to the abdominal wall by means of laparoscopic
technique or similar medical procedures requires more than one
aperture and thus the abdominal wall is punctured several times.
Those procedures require anesthesia and usually demand a relatively
long healing time.
[0004] One of the major problems of the above procedure is the
unrolling or spreading and the positioning or deploying of the mesh
inside the abdominal or the pre-peritoneal cavity. The step of
unrolling the mesh, directing the right side of the mesh,
positioning and fixating the mesh and positioning it in the right
place usually adds significantly to the time required for carrying
out the procedure. Moreover, inserting the mesh/patch into the body
without a trocar may expose the mesh/patch to infections.
[0005] Some techniques suggested in the literature disclose
mesh-like for treating hernia. Those techniques fail to guarantee
even, complete and smooth deployment of the mesh, without formation
of wrinkles, and cannot ensure full anchoring of the implant to the
abdominal wall. U.S. Pat. No. 5,824,082 ('082) relates to a
prosthetic hernia repair patch that can be rolled into a tube for
laparoscopic delivery through a trocar and which deploys to a
generally planar form when ejected from the trocar into the
abdominal cavity. The deployment of the prosthetic is done by
embedding a wire frame made of shape memory alloys into the
prosthetic. When the prosthetic is inserted into the body it is
heated thus, activated--i.e. it springs into its functional,
predetermined configuration and deploys the patch. However,
embedding a wire frame in a prosthetic is complicated.
[0006] Thus, there is still a long felt need for a device that is
simple, will shorten the time required for the spreading and the
positioning of the mesh inside the body and will be inserted via a
single small-bore opening.
SUMMARY OF THE INVENTION
[0007] It is one object of the invention to disclose an inflatable
contour-balloon useful in minimal invasive and/or open surgery;
wherein at least a portion of said inflatable contour-balloon is
positioned in the contour of a mesh and/or a patch and/or a net;
further wherein said inflatable contour-balloon is adapted to
spread and/or deploy said mesh and/or said patch and/or said net in
the abdominal cavity and/or pre-peritoneal and/or space and/or
hollow body organs and/or natural and/or artificial orifices and/or
spaces and/or post operative spaces.
[0008] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is especially adapted for use in hernia repair
surgery.
[0009] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon additionally comprising means adapted to adjust the
center of said inflatable contour-balloon to the center of said
hernia.
[0010] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon additionally comprising means adapted to ensure the
right side of said mesh or said patch or said net is directed to
said abdominal cavity and/or said pre-peritoneal and/or said space
and/or said hollow body organs and/or said natural and/or said
artificial orifices and/or said spaces and/or said post operative
spaces.
[0011] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is provided with means enabling coupling of
inflating means to said inflatable contour-balloon.
[0012] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said means is
selected from a group comprising at least one radial tube, non
radial tubes.
[0013] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflating
means is selected from a group consisting manually inflating pump,
motorized inflating pump.
[0014] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is provided with means enabling threading of said
mesh and/or said patch to said inflatable contour-balloon.
[0015] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said means is
selected from a group comprising at least one slit.
[0016] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is glued to said mesh and/or said patch and/or said
net.
[0017] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is provided with means enabling sewing of said
inflatable contour-balloon to said mesh and/or patch and/or said
net.
[0018] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon is made of a group comprising biocompatible
materials, self-dissolving materials and shape memory
materials.
[0019] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein the shape of
said inflatable contour-balloon is selected from a group comprising
a polygonal shape, a curved shape, a symmetrical, a non-symmetrical
shape, a linear shape, continues, non-continues, a concave shape, a
irregular shape, a square-like shape, a rectangular shape, an oval
shape, a U-like shape, a grid-like shape, a flat structure, a 3D
structure and a rake-like shape or any combination thereof.
[0020] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein said inflatable
contour-balloon comprises at least two independent parts.
[0021] It is another object of the invention to disclose the
inflatable contour-balloon as define above, wherein the
configuration is as described in any of FIG. 13 to FIG. 17.
[0022] It is another object of the invention to disclose a method
for spreading and/or deploying a mesh and/or a patch, useful in
minimal invasive and/or open surgery. The method comprises step
selected inter alia from (a) obtaining an inflatable
contour-balloon as define above; (b) attaching said inflatable
contour-balloon to said mesh and/or to said patch; (c) coupling
said inflating means to said inflatable contour-balloon; (d)
adjusting said inflatable contour-balloon; (e) inserting said
adjusted inflatable contour-balloon into abdominal cavity and/or
pre-peritoneal and/or hollow body organs and/or natural and/or
artificial orifices and/or spaces and/or post operative spaces;
and, (f) inflating at least a portion of said inflatable
contour-balloon via said inflating means; thereby spreading and/or
deploying said mesh and/or said patch in said abdominal cavity
and/or said pre-peritoneal and/or said hollow body organs and/or
said natural and/or said artificial orifices and/or said spaces
and/or said post operative spaces.
[0023] It is another object of the invention to disclose the method
as define above, additionally comprising the step of uncoupling
said inflating means from said inflatable contour-balloon.
[0024] It is another object of the invention to disclose the method
as define above, additionally comprising the step of extracting
said inflatable contour-balloon from said abdominal cavity and/or
said pre-peritoneal and/or said hollow body organs and/or said
natural and/or said artificial orifices and/or said spaces and/or
said post operative spaces.
[0025] It is another object of the invention to disclose the method
as define above, additionally comprising the step of deflating said
inflatable contour-balloon. It is another object of the invention
to disclose the method as define above, especially in hernia repair
surgery.
[0026] It is another object of the invention to disclose the method
as define above, additionally comprising the step of fitting the
center of said inflatable contour-balloon to the center of said
hernia.
[0027] It is another object of the invention to disclose the method
as define above, additionally comprising the step of ensuring the
right side of said mesh or said patch or said net is directed to
said abdominal cavity and/or said pre-peritoneal and/or said space
and/or said hollow body organs and/or said natural and/or said
artificial orifices and/or said spaces and/or said post operative
spaces.
[0028] It is another object of the invention to disclose the method
as define above, additionally comprising the step of threading said
mesh or/and said patch or/and said net to said inflatable
contour-balloon.
[0029] It is another object of the invention to disclose the method
as define above, additionally comprising the step of gluing said
mesh or/and said patch or/and said net to said inflatable
contour-balloon.
[0030] It is another object of the invention to disclose the method
as define above, additionally comprising the step of selecting said
inflatable contour-balloon from a group comprising biocompatible
materials, self-dissolving materials, shape memory materials.
[0031] It is another object of the invention to disclose the method
as define above, additionally comprising the step of selecting the
shape of said inflatable contour-balloon from a group comprising a
polygonal shape, a curved shape, a symmetrical, a non-symmetrical
shape, a linear shape, continues, non-continues, a concave shape, a
irregular shape, a square-like shape, a rectangular shape, an oval
shape, a U-like shape, a grid-like shape, a flat structure, a 3D
structure and a rake-like shape or any combination thereof.
[0032] It is another object of the invention to disclose the method
as define above, additionally comprising the step of continuing
inflating said inflatable contour-balloon according to a
predetermined medical need.
[0033] It is another object of the invention to disclose an
elongate open-bored applicator (EOBP) useful in minimal invasive
surgery; said EOBP having a distal portion that is insertable into
the abdominal cavity and/or pre-peritoneal and/or space and/or
hollow body organs and/or natural and/or artificial orifices and/or
spaces and/or post operative spaces; and a proximal portion that
remains outside said body. The EOBP comprising:
[0034] a. at least one inflatable contour-balloon as defined
above;
[0035] b. at least one inflatable dissection balloon; said
inflatable contour-balloon and said inflatable dissection balloon
are adjustable and located at said distal portion; and,
[0036] c. at least one actuating means located at said proximal
portion; said actuating means is in communication with said
inflatable contour-balloon and said inflatable dissection balloon;
said actuating means is adapted to provide said inflatable
contour-balloon and said inflatable dissection balloon with
independent activation and/or de-activation;
[0037] wherein said device is adapted to spread and/or deploy a
mesh and/or a patch and/or a net in said abdominal cavity and/or in
said pre-peritoneal and/or in said space and/or hollow body organs
and/or in said natural and/or artificial orifices and/or said
spaces and/or said post operative spaces.
[0038] It is another object of the invention to disclose the EOBP
as defined above, wherein said actuating means additionally
comprises inflating means used to inflate said at least one
inflatable dissection balloon and said at least one inflatable
contour-balloon.
[0039] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP is especially adapted for use
in hernia repair surgery.
[0040] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP additionally comprising means
adapted to adjust the center of said inflatable contour-balloon to
the center of said hernia.
[0041] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP additionally comprising means
adapted to ensure the right side of said mesh or said patch or said
net is directed to said abdominal cavity and/or said pre-peritoneal
and/or said space and/or said hollow body organs and/or said
natural and/or said artificial orifices and/or said spaces and/or
said post operative spaces.
[0042] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP is provided with means enabling
coupling of inflating means to said inflatable contour-balloon; and
the coupling of inflating means to said inflatable dissection
balloon.
[0043] It is another object of the invention to disclose the EOBP
as defined above, wherein said means is selected from a group
comprising at least one radial tube, non radial tubes.
[0044] It is another object of the invention to disclose the EOBP
as defined above, wherein said inflating means is selected from a
group comprising manually inflating pump, motorized inflating
pump.
[0045] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP is provided with means enabling
threading of said mesh and/or said patch to said inflatable
contour-balloon.
[0046] It is another object of the invention to disclose the EOBP
as defined above, wherein said means is selected from a group
comprising at least one slit.
[0047] It is another object of the invention to disclose the EOBP
as defined above, wherein said inflatable contour-balloon is glued
to the edges of said mesh and/or said patch and/or said net.
[0048] It is another object of the invention to disclose the EOBP
as defined above, wherein said EOBP is provided with means enabling
sewing of said inflatable contour-balloon to said mesh and/or patch
and/or said net.
[0049] It is another object of the invention to disclose the EOBP
as defined above, wherein said inflatable contour-balloon and/or
said dissection balloon is made of a group comprising biocompatible
materials, self-dissolving materials and shape memory
materials.
[0050] It is another object of the invention to disclose the EOBP
as defined above, wherein the shape of said inflatable
contour-balloon and/or said inflatable dissection balloon is
selected from a group comprising a polygonal shape, a curved shape,
a symmetrical, a non- symmetrical shape, a linear shape, continues,
non-continues, a concave shape, a irregular shape, a square-like
shape, a rectangular shape, an oval shape, a U-like shape, a
grid-like shape, a flat structure, a 3D structure and a rake-like
shape or any combination thereof.
[0051] It is another object of the invention to disclose the EOBP
as defined above, wherein said inflatable contour-balloon comprises
at least two independent parts. It is another object of the
invention to disclose the EOBP as defined above, configured as
described in any of FIG. 13 to FIG. 17.
[0052] It is another object of the invention to disclose the EOBP
as defined above, configured as described in any of FIG. 10a to
FIG. 10g.
[0053] It is another object of the invention to disclose a method
for spreading and/or deploying a mesh and/or a patch, useful in
minimal invasive and/or open surgery. The step comprises step
selected inter alia from (a) obtaining an EOBP as defined above;
(b) attaching said inflatable contour-balloon to said mesh and/or
to said patch; (c) coupling said inflating means to said inflatable
contour-balloon and said inflatable dissection balloon; (d)
adjusting said inflatable contour-balloon and said inflatable
dissection balloon; (e) introducing said device into abdominal
cavity and/or pre-peritoneal and/or hollow body organs and/or
natural and/or artificial orifices and/or spaces and/or post
operative spaces; and, (f) inflating at least a portion of said
inflatable contour-balloon via said inflating means; thereby
spreading and/or deploying said mesh and/or said patch in said
abdominal cavity and/or said pre-peritoneal and/or said hollow body
organs and/or said natural and/or said artificial orifices and/or
said spaces and/or said post operative spaces.
[0054] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of inflating at
least a portion of said inflatable dissection balloon via said
inflating means.
[0055] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of uncoupling
said inflating means from said inflatable contour-balloon.
[0056] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of uncoupling
said inflating means from said inflatable dissection balloon.
[0057] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of deflating
said inflatable contour-balloon.
[0058] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of deflating
said inflatable dissection balloon.
[0059] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of extracting
said inflatable contour-balloon from said abdominal cavity and/or
said pre-peritoneal and/or said hollow body organs and/or said
natural and/or said artificial orifices and/or said spaces and/or
said post operative spaces.
[0060] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of extracting
said inflatable dissection balloon from said abdominal cavity
and/or said pre-peritoneal and/or said hollow body organs and/or
said natural and/or said artificial orifices and/or said spaces
and/or said post operative spaces.
[0061] It is another object of the invention to disclose the method
as defined above, especially in hernia repair surgery.
[0062] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of fitting the
center of said inflatable contour-balloon to the center of said
hernia.
[0063] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of ensuring the
right side of said mesh or said patch or said net is directed to
said abdominal cavity and/or said pre-peritoneal and/or said space
and/or said hollow body organs and/or said natural and/or said
artificial orifices and/or said spaces and/or said post operative
spaces.
[0064] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of threading
said mesh or/and said patch or/and said net to said inflatable
contour-balloon.
[0065] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of gluing said
mesh or/and said patch or/and said net to said inflatable
contour-balloon.
[0066] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of selecting
said inflatable contour-balloon and/or said inflatable dissection
balloon from a group comprising biocompatible materials,
self-dissolving materials, shape memory materials.
[0067] It is another object of the invention to disclose the method
as defined above, additionally comprising the step of selecting the
shape of said inflatable contour-balloon and/or said inflatable
dissection balloon from a group comprising a polygonal shape, a
curved shape, a symmetrical, a non-symmetrical shape, a linear
shape, continues, non-continues, a concave shape, a irregular
shape, a square-like shape, a rectangular shape, an oval shape, a
U-like shape, a grid-like shape, a flat structure, a 3D structure
and a rake-like shape or any combination thereof.
[0068] It is another object of the invention to disclose the EOBP
as defined above, wherein said actuating means are adapted to
extract said inflatable contour-balloon and/or said inflatable
dissection balloon from said abdominal cavity and/or in said
pre-peritoneal and/or in said space and/or hollow body organs
and/or in said natural and/or artificial orifices and/or said
spaces and/or said post operative spaces.
[0069] It is another object of the invention to disclose the EOBP
as defined above, additionally comprising means adapted to anchor
said EOBP in said abdominal cavity and/or in said pre-peritoneal
and/or in said space and/or hollow body organs and/or in said
natural and/or artificial orifices and/or said spaces and/or said
post operative spaces.
[0070] It is still an object of the invention to disclose the
method as defined above, additionally comprising the step of
continuing inflating said inflatable dissection balloon according
to a predetermined medical need.
[0071] It is lastly an object of the invention to disclose the
method as defined above, additionally comprising the step of
continuing inflating said inflatable contour-balloon according to a
predetermined medical need.
BRIEF DESCRIPTION OF THE FIGURES
[0072] In order to understand the invention and to see how it may
be implemented in practice, a plurality of preferred embodiments
will now be described, by way of non-limiting example only, with
reference to the accompanying drawings, in which
[0073] FIG. 1 schematically present general view of the of the
elongate open-bored applicator.
[0074] FIGS. 1a-1d schematically display wings-like means adapted
to anchor the elongate open-bored applicator 100 within the tissue
and to thrust the tissue.
[0075] FIG. 2 schematically display the elongate open-bored
applicator once the posterior portion is inside the body.
[0076] FIGS. 2-2d schematically present general view of the
applicator, the inflatable dissection balloon, the inflatable
contour-balloon and the mesh.
[0077] FIG. 3 schematically presents cut view of the in the middle
of the applicator.
[0078] FIG. 4a and FIG. 4b displaying an applicator according to
another embodiment of the present invention.
[0079] FIG. 5 schematically presents the applicator according to
another embodiment of the present invention.
[0080] FIG. 6a presents a cut view in the middle of the applicator
100 according to the embodiment described in FIG. 5.
[0081] FIG. 6b displays the applicator according to another
embodiment of the present invention.
[0082] FIGS. 7a to 7e schematically present the mesh implanting
process according to one embodiment of the present invention.
[0083] FIGS. 8a to 8e schematically present the mesh implanting
process according to another embodiment of the present
invention.
[0084] FIGS. 9a to 9g present possible solutions or means for
centering the mesh with respect to the inflatable dissection
balloon.
[0085] FIGS. 10a-10g present possible designs of the inflatable
dissection balloon and possible coupling options between said
inflatable balloon and the mesh.
[0086] FIGS. 11a-11d present possible valve designs for sealing the
airway of the inflatable contour-balloon.
[0087] FIG. 12 presents a possible design a handle which is also
used as an air pump.
[0088] FIGS. 13-13o schematically displays a different design of
the inflatable contour-balloon; furthermore FIGS. 13-13o display
different options for connecting the mesh/net/patch to the
balloons.
[0089] FIGS. 14, 15 and 16 schematically display different
rectangle shapes of the inflatable contour-balloon and the
mesh.
[0090] FIG. 17 schematically represents the inflatable
contour-balloon and the mesh according to another embodiment of the
present invention.
[0091] FIG. 18 displays an option of attaching the mesh to the
inflatable contour-balloon.
[0092] FIG. 19 displays the inflatable contour-balloon with the
mesh threaded inside the slits.
[0093] FIGS. 20a and 20b display a more detail look of the
same.
[0094] FIGS. 20c-20e display a different way to couple the
inflatable contour-balloon and the mesh.
[0095] FIG. 20f displays another design of the inflatable
contour-balloon and the mesh.
[0096] FIGS. 20g and 20h display another option to couple the
inflatable contour-balloon and the mesh.
[0097] FIG. 20i-20i display different designs of the inflatable
contour-balloon.
DETAIL DESCRIPTION OF THE INVENTION
[0098] The following description is provided, alongside all
chapters of the present invention, so as to enable any person
skilled in the art to make use of said invention and sets forth the
best modes contemplated by the inventor of carrying out this
invention. Various modifications, however, is adapted to remain
apparent to those skilled in the art, since the generic principles
of the present invention have been defined specifically to provide
an inflatable contour-balloon useful in minimal invasive and/or
open surgery. The inflatable contour-balloon positioned in the
contour of a mesh and/or a patch and/or a net. The inflatable
contour-balloon is adapted to spread and/or deploy a mesh and/or a
patch and/or a net in the abdominal cavity and/or pre-peritoneal
and/or space and/or hollow body organs and/or natural and/or
artificial orifices and/or spaces and/or post operative spaces.
[0099] The present invention also provides a method for spreading
and/or deploying a mesh and/or a patch, useful in minimal invasive
and/or open surgery. The method comprises step selected inter alia
from (a) obtaining an inflatable contour-balloon; (b) attaching the
inflatable contour-balloon to the mesh and/or to the patch; (c)
coupling the inflating means to the inflatable contour-balloon; (d)
adjusting the inflatable contour-balloon; (e) inserting the
adjusted inflatable contour-balloon into abdominal cavity and/or
pre-peritoneal and/or hollow body organs and/or natural and/or
artificial orifices and/or spaces and/or post operative spaces; and
(f) inflating at least a portion of the inflatable contour-balloon
via the inflating pump; thereby spreading and/or deploying said
mesh and/or the patch in the abdominal cavity and/or the
pre-peritoneal and/or the hollow body organs and/or the natural
and/or the artificial orifices and/or the spaces and/or the post
operative spaces.
[0100] The present invention also provides a device adapted to
spread and/or deploy a mesh and/or a patch, useful in minimal
invasive and/or open surgery. The device comprising: (a) at least
one inflatable contour-balloon; (b) one inflatable dissection
balloon; (c) at least one actuating means. The device is adapted to
spread and/or deploy a mesh and/or a patch and/or a net in the
abdominal cavity and/or pre-peritoneal and/or space and/or hollow
body organs and/or natural and/or artificial orifices and/or spaces
and/or post operative spaces.
[0101] The present invention also provides a method for spreading
and/or deploying a mesh and/or a patch, useful in minimal invasive
and/or open surgery. The method comprises step selected inter alia
from (a) obtaining a device; (b) attaching the inflatable
contour-balloon to the mesh and/or to the patch; (c) coupling the
inflating means to the inflatable contour-balloon and the
inflatable dissection balloon; (d) adjusting the inflatable
contour-balloon and the inflatable dissection balloon; (e)
introducing the device into abdominal cavity and/or pre-peritoneal
and/or hollow body organs and/or natural and/or artificial orifices
and/or spaces and/or post operative spaces; (f) inflating at least
a portion of the inflatable dissection balloon via the inflating
means; and, (g) at least a portion of inflating the inflatable
contour-balloon via the inflating means; thereby spreading and/or
deploying the mesh and/or the patch in the abdominal cavity and/or
the pre-peritoneal and/or the hollow body organs and/or the natural
and/or the artificial orifices and/or the spaces and/or the post
operative spaces.
[0102] The methods can comprise steps selected inter alia from
extracting the inflatable contour-balloon and/or the inflatable
dissection balloon from the abdominal cavity and/or the
pre-peritoneal and/or the hollow body organs and/or the natural
and/or the artificial orifices and/or the spaces and/or the post
operative spaces; continuing inflating the inflatable
contour-balloon and/or the inflatable dissection balloon according
to a predetermined medical need; deflating the inflatable
contour-balloon and/or the inflatable dissection balloon.
[0103] The term "balloon" refers hereinafter to any flexible bag
which can inflates or expands. The balloon can be made from
materials such as rubber, latex, silicone, polyurethane,
chloroprene or a nylon fabric or any thermoelastomeric materials.
The balloon can be made of biocompatible materials, self-dissolving
materials or shape memory materials.
[0104] The term "Hernia" refers hereinafter for umbilical hernia,
hiatal hernia, ventral hernia, postoperative hernia, epigastric
hernia, spiegelian hernia, inguinal hernia and femoral hernia,
generally any abdominal wall related hernia.
[0105] The term "minimally invasive surgery" refers hereinafter to
a procedure that is carried out by entering the body through the
skin or through a body cavity or anatomical opening, but with the
smallest damage possible.
[0106] The term "Biocompatible materials" refers hereinafter to
materials that have the ability to perform with an appropriate host
response in a specific application. Biocompatible materials have
the quality of not having toxic or injurious effects on biological
systems.
[0107] The term "self-dissolving materials" refers hereinafter to
materials that are degraded by the body's enzymatic and/or
hydrolytic pathways through a reaction against "foreign" material.
Some urologists may prefer self-dissolving materials in catheter
simply because then they don't have to go necessarily through the
procedure of removing them afterwards. Examples of self-dissolving
polymers are Polydioxanone (PDO), Polycaprolactone (PCL),
Polylactic acid (PLA), Polyglycolic acid (PGA), Adipic acid, PEG
and glutamic acid.
[0108] The term "shape memory materials" refers hereinafter to
materials which can "remember" there original geometry. After a
sample of shape memory materials has been deformed from its
original geometry, it regains its original geometry by itself
during heating (one-way effect) or, at higher ambient temperatures,
simply during unloading (pseudo-elasticity or superelasticity). The
thermally induced shape-memory effect has been described for
different material classes: polymers, such as polyurethanes,
poly(styrene-block-butadiene), Polydioxanone and polynorbornene,
metallic alloys, such as copper-zinc-aluminium-nickel,
copper-aluminium-nickel, and nickel-titanium (NiTi) alloys.
[0109] The term "adjusting" or "adjustable" refers hereinafter to
rolling, bending, twisting, folding and winding.
[0110] The term "activation" refers hereinafter to the act of
inflating a balloon.
[0111] The term "de-activation" refers hereinafter to the act of
deflating the balloon (i.e. extracting the air out of the
balloon).
[0112] The term "contour" refers hereinafter to any section (and
not only to the outer edge) of the mesh and/or patch and/or
net.
[0113] Reference is now FIGS. 1-2d, which schematically present a
general view of the elongate open-bored applicator 100 according to
the present invention. The elongate open-bored applicator 100 has
an anterior portion 11 terminated outside the body and a posterior
portion 12 terminated with an orifice 13 insertable into the
abdominal cavity abdominal cavity and/or pre-peritoneal and/or
space and/or hollow body organs and/or natural and/or artificial
orifices and/or spaces and/or post operative spaces. The elongate
open-bored applicator 100 comprises at least one inflatable
contour-balloon 30, which is attached to the contours of mesh 20
(the different ways of attaching the inflatable contour-balloon 30
to mesh 20 will be discussed later on in the detail description).
The elongate open-bored applicator 100 may additionally comprises a
second inflatable balloon (refers herein after as inflatable
dissection balloon) 10. The mesh and the inflatable contour-balloon
are adjusted to fit inside the applicator 100. Mesh 20 is adapted
to deploy when injected outside the applicator inside the body
cavity. The elongate open-bored applicator 100 additionally
comprises actuating means 14 adapted to push mesh 20 throughout the
applicator via said posterior orifice 13. The actuating means 14
can comprises a maneuverable pistol and/or handles operating the
same (denotes as 14 in FIG. 1) or inflating pumps for inflating the
inflatable dissection balloon 10 and the inflatable contour-balloon
30 (denotes as 14 in FIG. 2).
[0114] Reference is now made to figures la-lb, which schematically
display wings-like means 77 adapted to anchor the elongate
open-bored applicator 100 within the tissue and to thrust the
tissue. The wings-like means 77 are positioned in the posterior
portion 12. FIG. 1a represent the wings-like means 77 in a semi
open configuration and FIG. 1b represents the wings-like means 77
in a fully open configuration. Activation means 78 are also
provided for activating (i.e. opening and closing) the wings-like
means 77. The activation or de-activation of the wings-like means
77 by the activation means 78 can be performed by sliding the
activation means 78 towards and away from the posterior portion
12.
[0115] The wings-like means 77 can have the configuration as shown
in FIGS. 1c-1d. In those figures the wings-like means 77 are fixed
in their positions. Reference is now made to FIG. 2 which
schematically display the elongate open-bored applicator 100 once
the posterior portion 12 is inside the body. As can be seen from
FIG. 2, both the inflatable dissection balloon 10 and the
inflatable contour-balloon 30 are inflated so as mesh 20 is in
parallel to the wall of the abdominal cavity.
[0116] The modus in which both the balloon are inflated can include
different timing. For example, the inflatable contour-balloon 30 is
inflated to about 50% of its volume, then the inflatable dissection
balloon 10 is inflated to about 70% of its volume, and then the
inflation of the inflatable contour-balloon 30 is completed.
[0117] The actuating means 14 are represented in FIG. 2 as two
pumps 14 used for inflating balloons 10 and 30. It should be
pointed out that the present invention is not limited to the use of
two pumps. One pump can be used to inflate both balloons 10 and 20
(as seen in FIG. 2a).
[0118] Reference is now made to FIGS. 2a and 2b schematically
present general view of the applicator, the inflatable
contour-balloon 30 and mesh 20. According to FIG. 2a the applicator
100 comprises only the inflatable contour-balloon 30. FIG. 2b is an
enclose view of the inflatable contour-balloon 30 and mesh 20.
[0119] Reference is now made to FIGS. 2c and 2d schematically
present general view of the applicator, the inflatable dissection
balloon 10, the inflatable contour-balloon 30 and mesh 20. As can
be seen in FIG. 2c, the applicator 100 comprises the inflatable
contour-balloon 30 and inflatable dissection balloon 10. FIG. 2d is
an enclose view of the inflatable contour-balloon 30, the
inflatable dissection balloon 10 and mesh 20.
[0120] Those figures (FIGS. 2a-2d) also display the actuating means
14 (which are handles is in those figures) enabling the surgeon to
control and to pump air into the inflatable contour-balloon 30 and
to the inflatable dissection balloon 10.
[0121] The elongate open-bored applicator is activated as follows:
applicator 100 is introduced into the wall of the abdominal cavity.
Next, at least a portion of the inflatable dissection balloon 10 is
inflated, hence thrusting. Then the inflatable contour-balloon 30
which is attached to mesh 20 is inflated to a predetermined size,
such that said mesh is laying in parallel to said wall. Next, the
inflatable dissection balloon 10 is deflated and evacuated
throughout said applicator 100. Finally, applicator 100 is removed
and mesh 20 is fastened to the posterior abdominal wall.
[0122] Contour-balloon 30 and/or the inflatable dissection balloon
10 can be made of a group comprising bio compatible materials,
self-dissolving materials such that after a period of time only
mesh 20 stays connected to the tissue. Inflatable contour-balloon
30 can be made of shape memory materials.
[0123] Inflatable contour-balloon 30 may be covered with mesh 20
all-around. Furthermore, inflatable contour-balloon 30 can be
removed out of the body when mesh 20 is fully spread.
[0124] The shape of the inflatable contour-balloon 30 and/or the
inflatable dissection balloon 10 can be a polygonal shape, a curved
shape, a symmetrical, a non-symmetrical shape, a linear shape,
continues, non-continues, a concave shape, a irregular shape, a
square-like shape, a U-like shape, a grid-like shape and a
rake-like shape or any combination thereof.
[0125] Mesh 20 is attached to the inflatable contour-balloon 30 by
means of gluing, sewing, or threading the mesh into the inflatable
contour-balloon 30. Another option to couple the mesh to the
balloon is by velcro. The mesh can be attached to the inflatable
contour-balloon 30 by means of gluing the balloon to the mesh such
that the balloon remains in the body. Another option is to glue the
mesh to the inflatable contour-balloon 30 such that the balloon can
be separated from the mesh and extracted from the body. I.e., only
the mesh remains in the body. The actuating means 14 can be used
for extracting the inflatable contour-balloon 30 and/or the
inflatable dissection balloon 10.
[0126] Another option is to use the mesh as bedding for building
the inflatable contour-balloon 30. A proofing material is spread on
the mesh's fibers. The inflatable contour-balloon 30 will be
created by folding the edges of mesh.
[0127] Both the balloons (30 or 10) can be inflated by air, CO2,
saline etc.
[0128] Reference is now made to FIG. 3, which schematically
presents cut view of the middle of the applicator 100 showing mesh
20, inflatable contour-balloon 30, inflatable dissection balloon 10
and the relation between them.
[0129] Reference is now made to FIGS. 4a and FIG. 4b displaying an
applicator according to another embodiment of the present
invention. According to this embodiment, the applicator
additionally comprising a cover 52 and means 51 enabling the
surgeon to pull aside the cover 52 from the balloons system.
[0130] Reference is now made to FIG. 5, displays the applicator
according to another embodiment of the present invention. According
to this embodiment, the inflatable contour-balloon 30 is positioned
above the inflatable dissection balloon 10.
[0131] FIG. 6a schematically presents a cut view in the middle of
the applicator 100 according to the embodiment described in FIG.
5.
[0132] FIG. 6b displays the applicator according to another
embodiment of the present invention. According to this embodiment,
the inflatable contour-balloon 30 comprises two independent parts
(as seen clearly from FIG. 20i or 20j which display a balloon
comprising several independent parts). Furthermore, the applicator
according to this embodiment comprises three handles: one for the
inflatable dissection balloon 10 and two for the inflatable
contour-balloon (one for each part).
[0133] Reference is now made to FIGS. 7a to 7e, which schematically
present the mesh implanting process according to one embodiment of
the present invention. According to this embodiment, the mesh is
spread by using the inflatable contour-balloon 30 only (without the
inflatable dissection balloon 10).
[0134] According to this embodiment, the applicator 100 comprises
mesh 20 and the inflatable contour-balloon 30.
[0135] FIG. 7a schematically shows the surgeon check the hernia
area through the incision made by the surgeon.
[0136] FIG. 7b schematically displays the placement of applicator
100 in the incision made by the surgeon.
[0137] In FIG. 7c the inflatable contour-balloon 30 is inflated
(thus producing a cavity in which the mesh will be placed) and mesh
20 is spread in its anterior part.
[0138] FIG. 7d shows the surgeon insuring, through the incision,
that mesh 20 is fully spread.
[0139] FIG. 7e shows the incision closed with stitches.
[0140] Reference is now made to FIGS. 8a to 8e, which schematically
present the mesh implanting process according to another embodiment
of the present invention:
[0141] According to this embodiment, the applicator 100 comprises
mesh 20, the inflatable contour-balloon 30 and the inflatable
dissection balloon 10.
[0142] FIG. 8a represents the first step in which the applicator
100 is placed in the incision made by the surgeon.
[0143] FIG. 8b represents the second step in which the inflatable
dissection balloon 10 is semi inflated starting to produce a cavity
in which mesh 20 will be spread in.
[0144] FIG. 8c represents the next step in which the inflatable
dissection balloon 10 is inflated and the inflatable
contour-balloon 30 is inflated thus mesh 20 is spread in its
anterior part.
[0145] FIG. 8d represents the next step in which the inflatable
dissection balloon 10 is emptied and drawn out from the incision
while mesh 20 stays spread around the incision and lying in
parallel to abdominal wall.
[0146] FIG. 8e represents the last step in which the incision is
closed with stitches. Reference is now made to FIGS. 9a, 9b and 9c
presenting a possible solutions or means for centering mesh 20 with
respect to the inflatable dissection balloon 10.
[0147] In FIG. 9a, centralization of mesh 20 may be realized with
wires 91 stretching from the posterior side of the inflatable
dissection balloon 10 to mesh 20.
[0148] Centralization of mesh 20 is realized by using Velcro and/or
double sided masking tape and/or small Silicon tubes 92 that hold
the mesh until the inflatable dissection balloon 10 is inflated
enough to tear the connection. FIG. 9b displays the inflatable
dissection balloon 10 with Velcro and/or double sided masking tape
and/or small Silicon tubes 92. FIG. 9c displays the inflatable
dissection balloon 10 with Velcro and/or double sided masking tape
and/or small Silicon tubes 92, attached/combined/adjusted with the
inflatable contour-balloon 30 and mesh 20. FIG. 9d displays the
Velcro and/or double sided masking tape and/or small Silicon tubes
92 after the inflatable dissection balloon 10 is inflated enough
such that the connection between the inflatable dissection balloon
10 and mesh 20 is torn apart.
[0149] In FIGS. 9e-9f centralization of mesh 20 is made by a ribbon
90 that surrounds the balloon and holds the mesh tight to the
dissection balloon. When the inflatable dissection balloon 10 is
inflated, the ribbon expands until mesh 20 is relapsed. FIG. 9e
displays the inflatable dissection balloon 10 is inflated such that
mesh 20 is relapsed. FIG. 9f displays the inflatable dissection
balloon 10 prior to the inflation.
[0150] In FIG. 9g, rigid but flexible stripes 91 are leaning on the
inflatable contour-balloon 30. just like the mechanism of an
umbrella, when the stripes 91 are pushed they stretch mesh 20. The
inflatable dissection balloon 10 makes room in between the tissues
and strengths the central part of the mesh 20.
[0151] Reference is now made to FIGS. 10a-10g presenting possible
designs of the inflatable dissection balloon 10 and possible
coupling options between said inflatable balloon 10 and the mesh
20. As can be seen from the figures tube 101 is used to inflate the
inflatable dissection balloon 10 and tube 102 is used to inflate
the inflatable contour-balloon 30.
[0152] As can be seen from FIGS. 10a and 10b the inflatable
dissection balloon 10 surrounds mesh 20 and the inflatable
contour-balloon 30.
[0153] In FIGS. 10a-10b mesh 20 and the inflatable contour-balloon
30 are positioned in the internal portion of the inflatable
dissection balloon 10. FIG. 10a is a cut view of the same.
[0154] In FIG. 10c mesh 20 and the inflatable contour-balloon 30
are positioned in the internal portion of the inflatable dissection
balloon 10. FIG. 10d is a cut view of the same. The difference
between FIGS. 10a and 10c is the location of the two balloon with
respect to each other. In FIGS. 10a and 10b the inflatable
dissection balloon 10 surrounds mesh 20 and the inflatable
contour-balloon 30 from bellow and in FIGS. 10c and 10d the
inflatable dissection balloon 10 surrounds mesh 20 and the
inflatable contour-balloon 30 from above.
[0155] In FIG. 10e mesh 20 and the inflatable contour-balloon 30
are positioned in the inner portion 103 of the inflatable
dissection balloon 10.
[0156] In FIG. 10f mesh 20 and the inflatable contour-balloon 30
are incorporated within inflatable dissection balloon 10. FIG. 10g
is a cut view of the same. Reference is now made to FIGS. 11a-11d
presenting possible valve designs for sealing the airway of the
inflatable contour-balloon 30:
[0157] FIG. 11a displays a possible valve design according to one
embodiment of the present invention. According to this embodiment,
a rigid tube 110 in inserted into the flexible inflating tube 102.
The inside portion of the tube 102 is covered with glue 111. When
the rigid tube 110 is drawn out of the flexible inflating tube 102,
the inside portion of said tube 102 stick together and do not allow
air to escape.
[0158] FIG. 11b displays another possible design of a valve. In
this embodiment, the valve is made of a rigid tube 113. The rigid
tube 113 is positioned inside the flexible inflating tube 102. In
the inside of the flexible inflating tube 102 there are leafs 114
covered with glue. When the rigid tube 113 is drawn out of the
flexible inflating tube 102, leafs 114 inside the inflating tube
102 expand and stick to each other and thus do not allow air to
escape.
[0159] FIGS. 11c and 11d display a rubber band 115 positioned
around the rigid tube 116. When the rigid tube 116 is drawn out of
the flexible inflating tube 102 (see FIG. 11d), the rubber band 116
applies force on the flexible inflating tube 102 and thus do not
allow air to escape.
[0160] Reference is now made to FIG. 12, which presents a possible
design a handle which is also used as an air pump. The air pump can
be used either to pump air or to empty the air out of the
inflatable contour-balloon 30.
[0161] Reference is now made to FIG. 13, which schematically
displays different designs of the inflatable contour-balloon
30.
[0162] The inflatable contour-balloon 30 may have a flat structure
as displays in FIGS. 13a, 13b, 13c, or a 3D structure as displays
in FIGS. 13d, 13e and 13f.
[0163] The inflatable contour-balloon 30 may not have a complete
closed shape as can be seen in FIGS. 13g and 13h. The different
parts of the inflatable balloon may be connected to each other with
glue, wire, scotch Etc.
[0164] The inflating tube 102 may be flexible (FIG. 13), or rigid
(FIG. 13j). Moreover, the inflating tube 102 may not be connected
to the center of the balloon 30. FIG. 13k represents a different
design for the inflatable contour-balloon 30. According to this
design, inflatable contour-balloon 30 has two parts. An internal
part 31 and an external part 32. Mesh 20 is positioned in between
the internal part 31 and the external part 32. An inflating tube
102 is coupled to a tube 34, which passes through both the internal
part 31 and the external part 32. FIG. 13l is a cross section area
of the same.
[0165] In another embodiment of the invention the 2 balloons may be
inflated with different pumps allowing the use of sequenced
pumping.
[0166] FIG. 13m represent another different design for the
inflatable contour balloon 30. According to this design, the
inflatable contour-balloon 30 encapsulate an internal balloon 40
shaped as an o-ring. Mesh 20 is captured in between the inflatable
contour-balloon 30 and the internal balloon 40. FIG. 13n is a cut
and an enlarge view of the same. FIG. 13o displays the inflatable
contour-balloon 30 and the internal balloon 40 according to this
design.
[0167] Reference is now made to FIGS. 14, 15 and 16, which
schematically display different rectangle shapes of the inflatable
contour-balloon 30 and mesh 20.
[0168] As can be seen from FIG. 14, the shape of the inflatable
contour-balloon 30 is a rectangle shape having two oppositely faced
curves. The two curves can be fused one to the other in a common
section. Additionally, according to this embodiment mesh 20 is
threaded in slits 7 which are positioned in two oppositely sides
ribs on the rectangle. Inflating tube 102 is connected to
inflatable contour-balloon 30. An inflating pump 14 is connected to
the inflating tube 102.
[0169] Reference is now made to FIG. 15, which schematically
represents the inflatable contour-balloon 30 and the mesh 20
according to another embodiment of the present invention. According
to this embodiment mesh 20 extends beyond the inflatable
contour-balloon 30.
[0170] Reference is now made to FIG. 16, which schematically
represents the inflatable contour-balloon 30 and the mesh 20
according to another embodiment of the present invention.
[0171] Reference is now made to FIG. 17, which schematically
represents the inflatable contour-balloon 30 and mesh 20 according
to another embodiment of the present invention. According to this
embodiment, the inflatable contour-balloon 30 additionally
comprises two arcs 10 that may replace the function of the
dissection balloon. The inflatable contour-balloon 30 is fixed to
its position by creating pressure on the mesh/patch towards the
abdominal wall.
[0172] Reference is now made to FIG. 18, which displays an option
of attaching mesh 20 to the inflatable contour-balloon 30.
According to that embodiment, the inflatable contour-balloon 30
additionally comprises at least one slit 7 into which the edges of
mesh 20 are threaded. FIG. 19 displays the inflatable
contour-balloon 30 with mesh 20 threaded inside the slits. FIG. 20a
and FIG. 20b display a more detail look of the same.
[0173] Another way of coupling between the inflatable
contour-balloon 30 and the mesh is by making specials cuts in the
mesh such that those cute surround the balloon as can be seen from
FIGS. 20c and 20d.
[0174] Another way to attach the inflatable contour-balloon 30 to
the mesh is by double-sided adhesive material as displayed in FIG.
20e. FIG. 20f displays another design of the inflatable
contour-balloon 30 and mesh 20.
[0175] Another option to couple the inflatable contour-balloon 30
and mesh 20 is by using special extensions 11 as can be seen in
FIGS. 20g and 20h. The special extensions 11 are insertable into
extension 18 in the mesh 20. The inflatable contour-balloon 30 can
additionally comprise means 25 (such as bulge, lines, signs and
symbols) adapted to adjust the center of said inflatable balloon to
the center of the hernia.
[0176] Reference is now made to FIG. 20i, which schematically
displays the inflatable contour-balloon 30, which comprises several
independent parts 40 and several inflating tubes 102 (which will be
couple to the inflating means). As can be seen from FIG. 20i tubes
102 are not positioned in the center of the balloon.
[0177] Reference is now made to FIG. 20j, which schematically
displays the inflatable contour-balloon 30 comprising several
independent parts 40 and several inflating tubes. As can be seen
from FIG. 20i tubes 102 are not radial. I.e., tubes 102 are
positioned in the perimeter of the inflatable balloon.
* * * * *