U.S. patent application number 13/304067 was filed with the patent office on 2012-03-22 for implantable sling having bladder support.
Invention is credited to Red Alinsod, Bryon Merade.
Application Number | 20120071708 13/304067 |
Document ID | / |
Family ID | 34423036 |
Filed Date | 2012-03-22 |
United States Patent
Application |
20120071708 |
Kind Code |
A1 |
Merade; Bryon ; et
al. |
March 22, 2012 |
Implantable Sling Having Bladder Support
Abstract
Surgical implants operative to simultaneously function as a
pubovaginal sling for the treatment of incontinence and as a
support member to effectuate cystocele repair. The implant
comprises a first sling portion operative to be positioned beneath
the urethra, per conventional pubovaginal sling surgery. The
implant further includes a second bladder support portion extending
from the sling support portion that is oriented to extend beneath
and be surgically attached to a portion of the bladder to thus
enable the same to be supported to a degree necessary to effectuate
cystocele repair. The implant may be fabricated from a unitary
piece of harvested tissue, synthetic material or combinations
thereof. Preferably, the sling portion of the implant is fabricated
from a synthetic material whereas the bladder support portion of
the implant comprises a segment of harvested tissue sewn to the
sling portion.
Inventors: |
Merade; Bryon; (Thousand
Oaks, CA) ; Alinsod; Red; (Glendale, CA) |
Family ID: |
34423036 |
Appl. No.: |
13/304067 |
Filed: |
November 23, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12145417 |
Jun 24, 2008 |
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13304067 |
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10684861 |
Oct 14, 2003 |
7393319 |
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12145417 |
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Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61F 2/0045
20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. An implant for concomitantly treating incontinence and
effectuating cystocele repair in a female patient in need thereof
comprising: a. a sling portion operatively positionable beneath the
urethra of said patient; and b. a bladder support portion connected
to and extending from said sling portion, said bladder support
portion being operatively positionable against the bladder of said
patient to substantially prevent said bladder from pushing against
the vagina of said patient.
2. The implant of claim 1 wherein said sling portion comprises an
elongate segment defining opposed ends.
3. The implant of claim 2 wherein said sling portion has a
generally rectangular shape.
4. The implant of claim 1 wherein said sling portion is fabricated
from a substance selected from the group consisting of harvested
tissue and synthetic material.
5. The implant of claim 1 wherein said sling portion and said
bladder support portion are integrally formed with one another.
6. The implant of claim 5 wherein said implant is fabricated from a
substance selected from the group of harvested segment of tissue
and a synthetic material.
7. The implant of claim 1 wherein said sling portion and said
bladder support portion are fastened to one another.
8. The implant of claim 7 wherein said sling portion defines a
continuous peripheral edge and said bladder support portion defines
a continuous peripheral edge, said sling portion and said bladder
support portion being interconnected to one another by a segment of
stitching whereby a portion of said peripheral edge of said sling
portion stitched to a portion of said peripheral edge of said
bladder support portion.
9. The implant of claim 7 wherein said sling material is fabricated
from a synthetic material and said bladder support portion is
fabricated from harvested tissue.
10. The implant of claim 7 wherein said sling material is
fabricated from a harvested tissue and said bladder support portion
is fabricated from a synthetic material.
11. The implant of claim 1 wherein said sling portion and said
bladder support portion cooperates to define a generally
T-shape.
12. A method for concomitantly treating a female patient afflicted
with urinary incontinence and effectuating cystocele repair via a
single surgical procedure comprising the steps: a. providing an
implant comprising: i. a sling portion operatively positionable
beneath the urethra of said patient; and ii. a bladder support
portion connected to and extending from said sling portion, said
bladder support portion being operatively positionable against said
bladder of said patient to substantially prevent said bladder from
pushing against the vagina of said patient; b. forming an incision
within the vagina of said patient; c. transvaginally implanting
said implant provided in step (a) through incision made in step (b)
such that said sling portion of said implant is operatively
positioned beneath the urethra of said patient and said bladder
support portion of said implant is operatively positioned against
the bladder of said patient.
13. The method of claim 12 wherein in step (a) said sling portion
of said implant is fabricated from a synthetic material and said
bladder support portion of said implant is fabricated from a
segment of harvested tissue.
14. A method for concomitantly treating a female patient afflicted
with urinary incontinence and effectuating cystocele repair via a
single surgical procedure comprising the steps: a. providing an
implant comprising: i. a sling portion operatively positionable
beneath the urethra of said patient; and ii. a bladder support
portion connected to and extending from said sling portion, said
bladder support portion being operatively positionable against said
bladder of said patient to substantially prevent said bladder from
pushing against the vagina of said patient; b. forming an incision
within the abdomen of said patient; c. implanting said implant
provided in step (a) through incision made in step (b) such that
said sling portion of said implant is operatively positioned
beneath the urethra of said patient and said bladder support
portion of said implant is operatively positioned against the
bladder of said patient.
15. The method of claim 14 wherein in step (a) said sling portion
of said implant is fabricated from a synthetic material and said
bladder support portion of said implant is fabricated from a
segment of harvested tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Not Applicable
STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
[0002] Not Applicable
BACKGROUND OF THE INVENTION
[0003] Concomitant cystocele repair and placement of a pubovaginal
sling for the treatment of urinary incontinence by means of a
transvaginal approach is known in the art. In this regard, a high
correlation exists between such medical conditions and it is
frequently desirable to address both via a single surgical
procedure. Specifically, such procedure seeks to accomplish both
goals of lifting and tightening the tissue around the bladder so
that it no longer pushes against weakened tissue in the front wall
of the vagina (i.e., cystocele) and positioning a sling beneath the
urethra in order to provide structural support thereto such that
accidental leakage of urine is eliminated or substantially reduced,
particularly during provocative events such as coughing and the
like.
[0004] The specifics regarding suburethral sling surgical
procedures are described in detail in the references of Blaivas,
Jerry G., Successful Pubovaginal Sling Surgery, Contemporary
Urology, July, 1993; Blaivas, Jerry, G. Treatment of Female
Incontinence Secondary To Urethral Damage Or Loss, Urologic Clinics
of North America, Vol. 18, No. 2, May, 1991; Raz, Schlomo, Surgical
Therapy For Urinary Incontinence, Atlas Of Transvaginal Surgery, W.
B. Saunders, 1992, Loughlin, K. R., The Endoscopic Fascial Sling
Treatment of Female Urinary Stress Incontinence, J. Urol, 1996,
A.P.R.; 155 (4): 1265-7; and Staskin, D. R., et al., The Gore-Tex
Sling Procedure For Female Sphincteric Incontinence: Indications,
Technique And Results, J. Urol, 1997; 15(5): 295-9, the teachings
of which are expressly incorporated herein by reference.
[0005] With respect to the simultaneous repair of the cystocele and
placement of a pubovaginal sling, such procedure is disclosed by
Kobashi et al., in the reference A New Technique for Cystocele
Repair and Transvaginal Sling: the Cadaveric Prolapse Repair and
Sling (CaPS), Urology, 2000 Dec. 4:56 (Suppl. 1): 9-14 and by Chung
et al., in the reference Technique of Combined Pubovaginal Sling
and Cystocele Repair Using a Single Piece of Cadaveric Dermal
Graft, Urology. 2002 April; 59 (4): 538-41, the teachings of each
of which are expressly incorporated herein by reference.
[0006] Despite the optimal opportunity to concurrently perform
cystocele repair and pubovaginal sling surgery via a transvaginal
approach, there has not to date been any type of implantable
support material/tissue that is readily sized and configured to be
surgically affixed into position such that both the bladder is
properly supported (i.e., so that it no longer pushes against the
vagina), and that the urethra is provided with a suburethral sling
optimally positioned to treat the related condition of
incontinence. In this respect, to the extent concurrent cystocele
repair and pubovaginal sling surgery are performed, the prior art
teaches the use of a harvested piece of tissue derived from a
cadaver that must be surgically fashioned for implantation within a
particular patient. To derive such implantable material, however,
is exceptionally problematic due to the requirement that cadaveric
tissue be available. Moreover, even to the extent a source of
cadaveric tissue is available, the same must necessarily be excised
to near precise dimensions and thereafter implanted with great
care. In this respect, to the extent the harvested tissue is
improperly sized or is otherwise torn or damaged during
implantation, such supportive material will be rendered useless and
require that at least one additional segment of material be
harvested. As a consequence, substantial time, expense, and
potential patient discomfort associated with such surgical
procedure can frequently occur.
[0007] Accordingly, there is a substantial need in the art for a
surgical implant operative to serve both as a suburethral sling for
the treatment of incontinence, as well as provide structural
support necessary to effectuate cystocele repair. There is
additionally a need in the art for such an implant that can be
readily fabricated from known implantable materials, and
specifically sized and configured for immediate surgical
implantation in procedures involving both the placement of a
suburethral sling and supportive tissue to effectuate cystocele
repair. There is still a further need in the art for such an
implant that may be fabricated from materials possessing desirable
properties, such as biocompatibility, material strength, and
adaptability for use in surgical procedures. There is yet a further
need in the art for such an implant that is of exceedingly simple
construction, low cost to manufacture, and is capable of being
readily deployed using known surgical techniques.
BRIEF SUMMARY OF THE INVENTION
[0008] The present invention specifically addresses and alleviates
the above-identified deficiencies in the art. In this regard, the
present invention is direct to an implant operative to
simultaneously function as a suburethral sling for the treatment of
incontinence, as well as provide lift and support about the bladder
so that it no longer pushes against the vagina and thus effectuate
cystocele repair. According to a preferred embodiment, the implant
comprises a first sling portion sized and configured as per
conventional suburethral slings for positioning and placement
beneath the urethra to provide a sufficient degree of urethral
support. Such implant includes a second bladder support portion
affixed to or formed as part of the sling portion that is operative
to be surgically interconnected about a portion of the bladder to
enable the latter to be lifted and supported to a degree necessary
to effectuate cystocele repair. Preferably, the implant will
possess a generally T-shape with the first sling portion defining
an elongate strip having opposed ends, a front portion and a rear
portion. The second implant portion will be affixed medially about
a portion of the rear peripheral edge of the first sling portion
and extend rearwardly therefrom. The implant may be fabricated such
that both sling and bladder support portions are integrally formed
from a single piece of harvested tissue. Alternatively, the sling
and bladder support portions will be integrally formed from a
unitary piece of synthetic material. Still further, the implant may
be fabricated such that a respective one of the sling portion or
bladder support portion is fabricated from a synthetic material
with the respective other portion being fabricated from a piece of
harvested tissue and coupled to the respective other piece via
stitching or any other means known in the art to couple the two
implant portions to one another. In a most highly preferred
embodiment, the sling portion of the implant will be comprised from
a synthetic material, which may be selected from a variety of
well-known materials in the art, and the bladder support portion
will comprise a graft harvested from a donor, which may comprise a
cadaver, another human subject, an animal, such as a pig, and even
the patient herself.
[0009] Advantageously, by providing a pre-formed implant operative
to provide both suburethral support concomitantly with the bladder
support necessary to perform cystocele repair, both conditions
(i.e., incontinence and cystocele) can be treated via a single
surgical procedure. Moreover, by providing a readily-fabricated
implant, there is thus eliminated the need to surgically fashion
such a support from cadaverous tissue, thus tremendously reducing
the time necessary to perform such procedure, as well as
eliminating the need to have a source of cadaverous tissue
available. Furthermore, in those embodiments where the implant is
comprised of a sling portion fabricated from a synthetic material
and a bladder support portion formed from a graft or harvested
tissue, such embodiment allows for rapid fabrication that further
enables the implant to possess exceptional durability with respect
to the sling component thereof and optimal biocompatibility with
respect to the bladder support portion thereof.
[0010] With respect to the surgical implantation of the implants of
the present invention, the same may be deployed through any known
procedure in the art. Along these lines, such implant may be
secured in position pursuant to those procedures disclosed by
Kobashi et al., in the reference A New Technique for Cystocele
Repair and Transvaginal Sling: the Cadaveric Prolapse Repair and
Sling, referred to above.
[0011] It is therefore an object of the present invention to
provide an implantable sling having bladder support that enables
pubovaginal sling surgery and cystocele repair to be performed via
a single surgical procedure.
[0012] Another object of the present invention is to provide an
implantable sling having bladder support that enables pubovaginal
sling surgery and cystocele repair to be performed in a manner that
eliminates the need to surgically fashion an implant operative to
simultaneously impart suburethral support for the treatment of
incontinence and also impart a sufficient degree of support to the
bladder to effectuate cystocele repair.
[0013] Another object of the present invention is to provide an
implantable sling having bladder support that enables pubovaginal
sling surgery and cystocele repair to be performed in a manner that
eliminates any dependency on a readily accessible source of
cadaverous tissue during such surgical procedure.
[0014] Another object of the present invention is to provide an
implantable sling having bladder support that may be easily and
readily fabricated from known implantable materials, is of simple
construction, is easy to surgically manipulate, is exceptional
durable in functioning as an implant, and is of relatively low
cost.
[0015] Still further objects of the present invention are to
provide methods for using the implants of the present invention to
thus simultaneously effectuate cystocele repair and urinary
incontinence that is substantially more time efficient, easier to
perform, and more cost effective than prior art techniques.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] These as well as other features of the present invention
will become more apparent upon reference to the drawings
[0017] FIG. 1 is a perspective view of an implant comprised of a
suburethral sling having a bladder support portion for use in
performing cystocele repair.
[0018] FIG. 2 is a top view of the implant depicted in FIG. 1
illustrating a first sling portion and a second bladder support
portion.
DETAILED DESCRIPTION OF THE INVENTION
[0019] The detailed description set forth below is intended as a
description of the presently preferred embodiment of the invention,
and is not intended to represent the only form in which the present
invention may be constructed or utilized. The description sets
forth the functions and sequences of steps for constructing and
operating the invention. It is to be understood, however, that the
same or equivalent functions and sequences may be accomplished by
different embodiments and that they are also intended to be
encompassed within the scope of the invention.
[0020] Referring now to the Figures, and initially to FIG. 1, there
is shown an implant 10 for use in concomitantly functioning as a
pubovaginal sling for use in the treatment of incontinence, as well
as providing support necessary to effectuate cystocele repair. In
this respect, the implant 10 is operative to simultaneously impart
support to the urethra 12 and a portion of the bladder 14 when
implanted via a single surgical procedure. As discussed in the
background, it is well-known in the art that cystocele and
incontinence are frequently related conditions that, for
appropriate patients, warrants that both conditions be treated,
preferably via a single surgical procedure.
[0021] To that end, the implant 10 is specifically fashioned and
configured to address both such conditions. According to the
preferred embodiment shown, the implant 10 comprises a first sling
portion 16 that is operatively positioned beneath a portion of the
urethra 12. As per conventional sling procedures, the sling portion
16 is fashioned as an elongate strip having opposed ends 16a, 16b,
that are secured into position via a variety of techniques
well-known to those skilled in the art. In this regard, such
opposed ends 16a, 16b, may be secured to the pubic bone 22, fascia
24, or other structures, such as Cooper's ligament (not shown), or
any other method well-known to those skilled in the art. In this
regard, it is contemplated that such methods for securing the
opposed ends 16a, 16b, into position such that the sling portion 16
is positioned beneath the urethra may take any of those types of
procedures described in U.S. Pat. No. 6,200,330 to Benderev, et
al., entitled SYSTEMS FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE
TO BONE AND PERIOSTEUM, issued Mar. 13, 2001, the teachings of
which are expressly incorporated herein by reference.
[0022] Alternatively, such sling portion 16 may be configured per
well-known and commercially available slings currently in use,
including the TVT tension-free vaginal tape produced by Johnson and
Johnson of Summerville, N.J. or the SPARC sling system for curing
female stress urinary incontinence produced by American Medical
Systems of Minneapolis, Minn. The structure related to such
commercially-available products is expressly incorporated herein by
reference. In this regard, such sling systems are operatively
positioned such that a portion of the sling extends beneath the
urethra with the opposed free ends of the sling remaining as free
ends that are not secured to any type of anatomical structure. In
this respect, it is expressly contemplated that the sling portion
16 of the implant 10 of the present invention may be operatively
fashioned according to such slings embodying such principles.
[0023] In addition to the sling portion 16, the implant 10 is
further provided with a bladder support portion 18. As illustrated,
the bladder support portion 18 is operative to extend rearwardly
from a portion of the peripheral edge of the sling portion 16, and
extend at least partially about the underside of bladder 14, as
shown. As will be appreciated by those skilled in the art, such
bladder support portion 18 will be operative to lift and support
the bladder 14 to a degree sufficient to effectuate cystocele
repair. In this regard, it is contemplated that bladder support
portion 18 will be specifically configured and fashioned per
conventional implantable tissue masses or synthetic materials
utilized in cystocele repair necessary to support the bladder 14
via the introduction of such tissue portion 18 between the vagina
and the bladder 14.
[0024] In order to more clearly illustrate the construction of the
implant 10 of the present invention, there is shown in FIG. 2 a
frontal plan view thereof. As illustrated, the sling portion 16
will be constructed as per conventional slings having a generally
elongate strip preferably formed to have a generally rectangular
configuration defining opposed ends 16a, 16b and a continuous
peripheral edge. Formed upon a portion of the peripheral edge
defining sling portion 16 is bladder support portion 18. As
illustrated, bladder support portion 18 is connected upon a portion
of the rear or distal peripheral edge of the sling portion 16
generally upon the medial portion thereof. In the embodiment shown,
the sling portion 16 is connected to bladder support portion 18 via
stitching 20 to thus enable the two pieces to remain
interconnected. As will be readily appreciated by those skilled in
the art, it should be understood that the implant 10, as opposed to
being fabricated from two separate portions 16, 18, may be
fabricated from a unitary piece of material. Along these lines, it
is contemplated that the implant 10 may be fabricated from a single
piece of harvested tissue that is precut and preformed to have the
configuration as shown. Alternatively, the implant 10 may be
fabricated from a unitary piece of synthetic material, such as
surgical mesh and the like, that defines both sling portions 16 and
bladder support portion 18.
[0025] In an alternative, more highly preferred embodiment, the
sling portion 16 and bladder support portion 18 will be fabricated
from dissimilar materials whereby one portion is fabricated from
either tissue or synthetic material and the respective other
portion is formed from a dissimilar type of material. Preferably,
the implant will be fabricated such that sling portion 16 is formed
from a synthetic material, and thus operative to provide durable
support to the urethra 12 once positioned there underneath, and the
bladder support portion 18 will be fabricated from a graft or
section of harvested tissue. With respect to the latter, it is
well-known in the art that by utilizing tissue as a material to
provide bladder support provides substantially enhanced
biocompatibility and generally provides for more favorable surgical
outcome. Implants constructed in accordance to the aforementioned
embodiment are presently being commercialized by Caldera Medical,
Inc. of Thousand Oaks, Calif.
[0026] With respect to the surgical implantation of the implants of
the present invention, the same may be performed utilizing any of a
variety of known techniques in the art. At the present time,
however, it is expressly contemplated that the implants of the
present invention will be deployed transvaginally via an incision
made to the vaginal wall. By utilizing a transvaginal route, access
to the urethra, for placement of the sling portion 16, as well as
the site of bladder prolapse will be provided via a single surgical
site. Exemplary of such surgical procedures ideally suited for the
placement of the present invention include those discussed by
Kobashi, et al., discussed above.
[0027] Alternatively, the implants of the present invention may be
secured into position via a transobturator route via known
procedures in the art. In this regard, such transobturator route
likewise requires the formation of an incision in the vagina
through which the implant will be positioned against the urethra
and bladder, respectively. To achieve that end, it is contemplated
that the opposed ends of the sling portion 16 will be disposed
within the obturator foramen and either secured thereto via a
conventional anchoring means or otherwise remain as non-attached
free ends suspended therein. As should be appreciated by those
skilled in the art, however, although a transvaginal deployment is
considered most ideally suited as the preferred route for
surgically implanting the implants of the present invention, any
type of procedure by which the bladder and the urethra can be
accessed in order to surgically position the implants of the
present invention should be deemed to fall within the scope of the
present invention. Along these lines, it is contemplated that
although possibly less efficient, the implants of the present
invention may be implanted via an alternative route, such as
through an incision made in the patient's abdomen (i.e., suprapubic
route), the top surface of which being depicted as 26 in FIG. 1.
Accordingly, all known surgical procedures capable of deploying the
implants of the present invention should be deemed to fall within
the scope of the present invention.
[0028] Additional modifications and improvements of the present
invention may also be apparent to those of ordinary skill in the
art. Thus, the particular combination of parts and steps described
and illustrated herein is intended to represent only certain
embodiments of the present invention, and is not intended to serve
as limitations of alternative devices and methods within the spirit
and scope of the invention. Along these lines, it is expressly
contemplated that the sling portion 16 may be fabricated to have
any dimensions that are operative to enable the same to adequately
support the urethra, as well as be adequately secured into
position. Likewise, the bladder support portion may be fabricated
to have any shape or dimensions that may be necessary to impart the
degree of support necessary to effectuate cystocele repair. Still
further, it is contemplated that the implants of the present
invention can readily be utilized in related surgical procedures,
such as rectocele and enterocele repair, through surgical
techniques that will be readily known to those skilled in the art.
In such applications, it will be readily understood that the
bladder support portion 18 will be utilized to provide support to
the source of herniation and, where appropriate, may be sized and
configured to specifically support a target organ or tissue mass
sought to be supported while at the same time providing suburethral
sling support via sling portion 16. Accordingly, although depicted
as generally rectangular portions, the sling portion and bladder
support portion may have alternative shapes and configurations that
will be readily understood by those skilled in the art.
* * * * *