U.S. patent application number 10/455465 was filed with the patent office on 2003-10-23 for method for treating urinary incontinence in women and implantable device intended to correct urinary incontinence.
This patent application is currently assigned to Mentor Corporation, a Minnesota corporation. Invention is credited to Delorme, Emmanuel, Suslian, Patrice.
Application Number | 20030199732 10/455465 |
Document ID | / |
Family ID | 26212515 |
Filed Date | 2003-10-23 |
United States Patent
Application |
20030199732 |
Kind Code |
A1 |
Suslian, Patrice ; et
al. |
October 23, 2003 |
Method for treating urinary incontinence in women and implantable
device intended to correct urinary incontinence
Abstract
The invention relates to a method and device for treating
urinary incontinence in women.
Inventors: |
Suslian, Patrice; (Gordes,
FR) ; Delorme, Emmanuel; (Chalon Sur Saone,
FR) |
Correspondence
Address: |
FISH & RICHARDSON P.C.
3300 DAIN RAUSCHER PLAZA
60 SOUTH SIXTH STREET
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Mentor Corporation, a Minnesota
corporation
|
Family ID: |
26212515 |
Appl. No.: |
10/455465 |
Filed: |
June 4, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10455465 |
Jun 4, 2003 |
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10092069 |
Mar 5, 2002 |
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10092069 |
Mar 5, 2002 |
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PCT/FR01/02120 |
Jul 3, 2001 |
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10455465 |
Jun 4, 2003 |
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09661620 |
Sep 14, 2000 |
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Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61F 2002/009 20130101;
A61F 2/0045 20130101; A61B 2017/00805 20130101; A61F 2/0036
20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 002/02 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 5, 2000 |
FR |
FR 00.08706 |
Claims
1. Implantable device intended to correct urinary incontinence in
women, characterized in that it is in the form of a tape of which
the central region, intended to be inserted between the Alban
fascia and the periurethral fascias, is coated with a substance
capable of preventing any adhesion of the said fascias to the
tape.
2. Device according to claim 1, characterized in that the substance
is silicone.
3. Device according to claim 1, characterized in that the substance
is made of vegetable or animal growth factors.
4. Device according to on of claims 1 to 3, characterized in that
the tape is coated on both side, advantageously on one side.
5. Device according to claim 1, characterized in that the tape is
made of a material chosen from the group containing polyethylene
and polypropylene.
6. Device according to claim 5, characterized in that the
polypropylene is either meshed, knitted, or alternatively, in the
form of sprayed fibres.
7. Device according to claim 1, characterized in that the tape is
made of absorbable material.
8. Device according to claim 1, characterized in that the central
region of the tape is not as wide as the rest of the tape.
9. Device according to claim 1, characterized in that each of the
ends of the tape has a tapered point intended to be secured in the
groin facing the corresponding obturator foramen.
10. Device according to claim 4, characterized in that the tape has
a length equal to 60 cm and a width equal to 2.5 cm, and has a
central region which is not as wide, being 1 cm wide over a length
equal to 15 mm.
Description
[0001] The invention relates to a method for treating urinary
incontinence in women. It also relates to an implantable device
intended to correct urinary incontinence in women. The said device
is more particularly suited to the treatment of stress urinary
incontinence.
[0002] Various types of device have been proposed for treating
phenomena of urinary incontinence in women.
[0003] Thus, for example, document U.S. Pat. No. 5,899,909
describes a tape of constant width, made of a material of the
meshed or knitted polypropylene type ensuring fibroblast
colonization and thus anchorage into the tissues along its entire
length. Once an incision has been made in the wall of the vagina
this tape is positioned under the urethra, the tape being led
upwards on each side of the bladder to be anchored into the
abdominal wall.
[0004] The method of fitting this tape is relatively tricky.
Specifically, the needles being led vertically up alongside the
bladder may not only pierce the latter, but may above all pierce
the iliac artery or even the small intestine. In consequence, it is
essential that cystoscopy be performed during the intervention.
[0005] Document WO 98/35632 describes a device in the form of a
tape, the central region of which is wider than the body of the
tape, the assembly being made of a biocompatible material,
particularly a woven material, allowing for fibroblast
colonization.
[0006] As before, each of the ends of the tape is led up alongside
the bladder to be secured at the abdominal wall or, more
specifically, in the bone of the pubis. Thus, the same drawbacks as
before may be encountered.
[0007] One of the objects of the invention is to artificially
reconstruct the pelvic fascia by fitting tapes aimed at restoring,
as faithfully as possible, the effective and natural situation of
the endo-pelvic fascia, in its role of fibrous plug obturating the
uro-genital opening, the said fascia resting on either side of the
said opening on the floor of the lifting muscles.
[0008] Another of the stated objects of the present invention lies
in solving the problems associated with subsequent surgical
re-intervention in the region of the urethra; given the fact that
the tapes proposed by the Prior Art are made, along their entire
length, of a material capable of being colonized by fibroblasts,
the problem arises of performing an intervention in this region if
the tape, because of the fibroblast colonization, is anchored to
the periurethral wall. A solution to this new problem is all the
more important now that it has been found that the phenomenon of
urinary incontinence may evolve to the fitting of an artificial
sphincter. A problem such as this is neither disclosed nor
suggested in the Prior Art.
[0009] Furthermore, the literature has described possible phenomena
of the migration of the substance of which the tape is made,
particularly polypropylene, into the viscera
[0010] In order to solve all of these problems, the Applicant is
proposing a method and an implantable device, intended to correct
urinary incontinence in women.
[0011] This method for treating urinary incontinence in women
comprises the following steps:
[0012] making a mediane paraurethral incision, practically in the
middle third of the urethra, measured from the meatus, so as to
allow the passage of a tape between the Alban fascia and the
periurethral fascias;
[0013] extending each of the free ends of the said tape in the
region of the two obturator foramen of the iliac wing and leading
them out into the groin opposite the corresponding foramen so that
they essentially form a V shape, the point of which V passes under
the urethra without changing the position thereof.
[0014] In other words, and contrary to the surgical techniques
employed in the state of the art, the tape is not led up alongside
the bladder to form a U and thus be situated in close proximity to
vital organs, but is on the contrary diverted from the bladder to
form a V. Hence, no risk of damaging the bladder, the iliac artery
or the small intestine is run. In consequence, it is not necessary
to perform cystoscopy during the intervention.
[0015] According to the invention, in order to make it easier to
fit the tape which acts as an implant, a space is made between, on
the one hand, the Alban fascia, the perineal muscular plane and the
anterior insertion of the puborectal muscle and, on the other hand,
the periurethral fascias.
[0016] According to an advantageous version of the invention, the
central region of the tape or implant, which region is intended to
be inserted between the Alban fascia and the periurethral fascias,
is coated with a substance capable of preventing any adhesion of
the said fascias to the tape.
[0017] Thus it becomes possible to avoid any cell growth on the
tape between the wall of the vagina and the wall of the urethra,
hence avoiding any anchorage of the tape in this region and thus to
allow subsequent surgical re-intervention. Furthermore, coating it
with such a substance in the region of the urethra makes it
possible to avoid any migration of polypropylene into the
viscera.
[0018] The device according to the invention is characterized in
that it is in the form of a tape of which the central region,
intended to be inserted between the Alban fascia and the
periurethral fascia, is coated with a substance capable of
preventing any adhesion of the said fascias to the tape.
[0019] In a first embodiment, the substance that prevents adhesion
of the fascias to the tape is silicone.
[0020] In a second embodiment, the substance is made of vegetable
or animal growth factors.
[0021] Of course, any substance capable of avoiding the adhesion of
the fascias to the tape may be envisaged.
[0022] The tape is coated on both side, advantageously on one
side.
[0023] Furthermore, the tape is made of any materials such as those
known to those skilled in the art and, in particular but without
applying any limitation, any material chosen from the group
containing polyethylene and polypropylene.
[0024] According to another feature, when the tape is made of
polypropylene, the polypropylene is either meshed or knitted or
alternatively is in the form of sprayed fibres. Nevetheless, the
tape can also be made of absorbable material.
[0025] In one advantageous embodiment, the central region of the
tape is not as wide as the rest of the tape and this is so as to
limit the area of contact in the region of the Alban fascia and of
the periurethral fascia.
[0026] Furthermore, and according to another feature, each of the
ends of the tape has a tapered point intended to be anchored in the
groin facing the corresponding obturator foramen.
[0027] According to a preferred embodiment, the tape has a length
equal to 60 cm and a width equal to 2.5 cm, and has a central
region which is not as wide, being 1 cm wide over a length equal to
3 cm. Advantageously, the central region has a length equal to 15
mm.
[0028] The invention and its ensuing advantages will emerge better
from the following example in support of the appended figures.
[0029] FIG. 1 is a diagrammatic depiction of the tape of the
invention.
[0030] FIG. 2 is a diagrammatic depiction of the position of the
tape after fitting.
[0031] As shown in FIG. 1, the device of the invention is in the
form of a tape (1) of a length equal to 60 cm and of a width equal
to 2.5 cm. This tape is made, along its entire length, of sprayed
polypropylene fibres.
[0032] According to an advantageous feature, the tape has, at its
centre (2), a narrowing of length equal to 3 cm and of width equal
to 1 cm, this portion being coated on both sides with a
silicone-containing substance. Furthermore, each of its free ends
(3, 4) is tapered.
[0033] Fitting the device requires mini-invasive surgery, the main
steps of which are described hereinafter.
[0034] First of all, a mediane paraurethral incision is made in the
region of the middle third of the urethra.
[0035] One of the two obturator foramen, and more specifically the
lower internal part is then identified by a finger slipped into the
vaginal incision and an incision is made in the perineal skin
opposite it, and so in the groin, so as to form an orifice through
which an Emmet needle is then passed. This needle is introduced
through this cutaneous incision firstly perpendicular to the
perineum for about 15 mm (passing through the internal obturator
muscle as far as just outside the ischiopubic branch), then the
needle is allowed to describe its curvature, guided in this by the
finger introduced opposite the obturator muscle through the vaginal
incision. The pointed end of the tape is then slipped into the eye
of the needle, emerging from the said vaginal incision, then pulled
back through the thickness of muscle, the retractor and the
internal obturator up to the surface of the skin.
[0036] The tape is then placed between the Alban fascia and the
periurethral fascias to position it in such a way that its central
region, coated with silicone as appropriate, faces the said
fascias. The tape is positioned without pulling behind the
urethra.
[0037] An incision is then made in the perineal skin facing the
second obturator foramen, into which incision an Emmet needle is
inserted. The free end of the tape is then slipped into the eye of
the needle which is pulled back in the same way as before.
[0038] The excess tape is then cut off flush with the skin then the
skin is immobilized to disconnect it from the tape. The incision is
finally closed with a stitch of quickly absorbable suture.
[0039] FIG. 2 diagrammatically depicts the position, in cross
section, of the tape after it has been fitted. As shown in this
figure, once in place, the tape adopts the shape of a V, the
branches of which are very far apart.
[0040] Furthermore, it can also be seen that when the tape
according to one of the advantageous embodiments of the invention
is used, the silicone-coated segment of the tape is positioned
between the uterus (5) and the vagina (6), while its ends (3, 4)
are secured in the region of the groin (7, 8) facing the obturator
foramen.
[0041] Thanks to the robustness and texture of the tape, tension
can be strong without there being any risk of rupture. The tape is
positioned under the control of sight without employing cystoscopy.
It is essential that there be no pulling on this tape which has to
be slipped down under the urethra without altering the position
thereof.
[0042] It is apparent from the foregoing that the method according
to the invention for treating urinary incontinence in women differs
from the methods proposed in the state of the art through the
simplicity of fitting of the tape, using mini-invasive surgery.
Furthermore, it provides the urethra with firm suspension while at
the same time maintaining a certain degree of flexibility and, most
of all, keeping the vital organs in the vicinity relatively far
away from the said tape. Furthermore, it plays a part in
reconstructing the endopelvic fascia.
* * * * *