U.S. patent application number 09/891068 was filed with the patent office on 2002-09-12 for surgical instrument and method for treating female urinary incontinence.
Invention is credited to Kammerer, Gene W., Ulmsten, Ulf.
Application Number | 20020128670 09/891068 |
Document ID | / |
Family ID | 26942438 |
Filed Date | 2002-09-12 |
United States Patent
Application |
20020128670 |
Kind Code |
A1 |
Ulmsten, Ulf ; et
al. |
September 12, 2002 |
Surgical instrument and method for treating female urinary
incontinence
Abstract
The invention relates to a surgical instrument and a method for
treating female urinary incontinence. A tape or mesh is permanently
implanted into the body as a support for the urethra. In one
embodiment, portions of the tape comprise tissue growth factors and
adhesive bonding means for attaching portions of the tape to the
pubic bone. In a further embodiment, portions of the tape comprise
attachment means for fastening portions of the tape to fascia
within the pelvic cavity. In both embodiments the tape is implanted
with a single incision through the vaginal wall.
Inventors: |
Ulmsten, Ulf; (Danderyd,
SE) ; Kammerer, Gene W.; (East Brunswick,
NJ) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
26942438 |
Appl. No.: |
09/891068 |
Filed: |
June 25, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60252561 |
Nov 22, 2000 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/00491 20130101;
A61F 2/0045 20130101; A61B 2017/00805 20130101; A61B 2017/0419
20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 017/08 |
Claims
We claim:
1. A method for treating female urinary incontinence comprising the
steps of: creating an access way from the vagina to the pelvic
cavity; passing a tape having a first end and a second end into the
body via the access way to form a loop around the urethra, the loop
located between the urethra and the vaginal wall, and via the
access way, attaching the ends of the tape within the pelvic
cavity.
2. A method for treating female urinary incontinence comprising the
steps of: passing a tape having a first end and a second end into
the body via the vagina to form a loop around the urethra, the loop
located between the urethra and the vaginal wall, and bonding the
ends of the tape to tissue within the the pubic bone.
3. A method for treating female urinary incontinence comprising the
steps of: passing a tape having a first end and a second end into
the body via the vagina to form a loop around the urethra, the loop
located between the urethra and the vaginal wall, and imbedding the
first and second ends of the tape to fascia within the pelvic
cavity.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of earlier-filed U.S.
provisional patent application serial No. 60/252,561, filed on Nov.
22, 2000, which is incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a surgical instrument and a method
for treating female urinary incontinence, i.e. the incapacity of
controlling the discharge of urine.
BACKGROUND OF THE INVENTION
[0003] Women account for more than 11 million of incontinence
cases. Moreover, a majority of women with incontinence suffer from
stress urinary incontinence (SUI). Women with SUI involuntarily
lose urine during normal daily activities and movements, such as
laughing, coughing, sneezing and regular exercise.
[0004] SUI may be caused by a functional defect of the tissue or
ligaments connecting the vaginal wall with the pelvic muscles and
pubic bone. Common causes include repetitive straining of the
pelvic muscles, childbirth, loss of pelvic muscle tone, and
estrogen loss. Such a defect results in an improperly functioning
urethra. Unlike other types of incontinence, SUI is not a problem
of the bladder.
[0005] Normally, the urethra, when properly supported by strong
pelvic floor muscles and healthy connective tissue, maintains a
tight seal to prevent involuntary loss of urine. When a woman
suffers from the most common form of SUI, however, weakened muscle
and pelvic tissues are unable to adequately support the urethra in
its correct position. As a result, during normal movements when
pressure is exerted on the bladder from the diaphragm, the urethra
cannot retain its seal, permitting urine to escape. Because SUI is
both embarrassing and unpredictable, many women with SUI avoid an
active lifestyle, shying away from social situations.
[0006] U.S. Pat. No. 5,899,909 discloses a surgical instrument
comprising a shank having a handle at one end and connecting means
at the other end to receive, one at a time, two curved needle-like
elements which are connected at one end to one end of a tape
intended to be implanted into the body. In practice, the tape is
passed into the body via the vagina first at one end and then at
the other end at one side and the other, respectively, of the
urethra to form a loop around the urethra, located between the
urethra and vaginal wall. The tape is extended over the pubis and
through the abdominal wall and is tightened. The tape ends are cut
at the abdominal wall, and the tape is left implanted in the body.
U.S. Pat. No. 5,899,909 is hereby incorporated by reference in its
entirety herein.
[0007] This invention simplifies the apparatus and method of the
instrument and method prior art and provides for a safe and
effective method of placing a tape mesh in a sling relationship
with the urethra.
SUMMARY OF THE INVENTION
[0008] The object of the invention is to provide an improved and
simplified surgery to restore urinary continence.
[0009] For this purpose the invention provides a surgical
instrument for treating female urinary incontinence of the kind
referred to above, comprising a tape or mesh (hereinafter
collectively referred to as "tape") to be permanently implanted
into the body as a support for the urethra. In one embodiment,
portions of the tape comprise tissue growth factors and adhesive
bonding means for attaching portions of the tape to the pubic bone.
In a further embodiment, portions of the tape comprise attachment
means for fastening portions of the tape to fascia within the
pelvic cavity.
[0010] The invention also provides for a method for treating female
urinary incontinence comprising the steps of creating an access way
to the pelvic cavity via the vagina; passing a tape into the body
via the access way first passing one end of the tape on one side of
the urethra; passing the second end of the tape on the opposite
side of the urethra to form a loop around the urethra, the tape
located between urethra and the vaginal wall; and attaching the
ends of the tape to the pubic bone or surrounding fascia.
Preferably, in each embodiment the tape is left permanently in the
body to provide, as an artificial ligament, the reinforcement of
the tissue required in order to restore the urinary continence,
and/or to provide said reinforcement by the development of fibrous
tissue.
[0011] The object of the invention is to provide a surgical
instrument and method for implanting a mesh to treat incontinence
that does not require penetration of the abdomen.
[0012] An advantage of the invention is that it reduces the risk of
perforating unintended body structures when carrying out the
procedure.
[0013] These and other features and advantages of the present
invention will become apparent from the following more detailed
description, when taken in conjunction with the accompanying
drawings which illustrate, by way of example, the principles of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIGS. 1a-c are alternate embodiments of the tape;
[0015] FIG. 2 is a cut-away elevation view of the tape of FIG.
1;
[0016] FIGS. 3a-f illustrate diagrammatically one embodiment of
several surgical steps of the method for inserting a tape according
to the invention
[0017] FIG. 4 illustrates a fastener in combination with a tape for
use in inserting the tape in accordance with an alternate
embodiment of the invention;
[0018] FIG. 5 illustrates an apparatus for fastening the tape into
fascia in the lower abdomen;
[0019] FIGS. 6a-e illustrate diagrammatically an alternate
embodiment of several surgical steps of the method for inserting a
tape according to the invention; and
[0020] FIG. 7 illustrates exemplary tissues within the lower
abdomen to which the tape is fastened.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0021] Before explaining the present invention in detail, it should
be noted that the invention is not limited in its application or
use to the details of construction and arrangement of parts
illustrated in the accompanying drawings and description, because
the illustrative embodiments of the invention may be implemented or
incorporated in other embodiments, variations and modifications,
and may be practiced or carried out in various ways. Furthermore,
unless otherwise indicated, the terms and expressions employed
herein have been chosen for the purpose of describing the
illustrative embodiments of the present invention for the
convenience of the reader and are not for the purpose of limiting
the invention.
[0022] The invention discloses an apparatus and method for treating
SUI. A tape is passed through pelvic tissue and positioned
underneath the urethra, creating a supportive sling. The tape
provides a structure means for tissue ingrowth and thereby provides
a newly created body tissue supporting means for the urethra. When
pressure is exerted upon the lower abdomen, such as during a cough
or sneeze, the tape provides support to the urethra, allowing it to
keep its seal and prevent the unwanted discharge of urine.
[0023] Referring to FIGS. 1a-c and 2, tape 12 comprises any
tissue-compatible synthetic material, or any natural material,
including, but not limited to, autologous, allograft, xenograft, a
tissue engineered matrix, or a combination thereof. An exemplary
synthetic material is PROLENE.RTM. polypropylene mesh, a mesh
having a thickness of 0.7 mm and openings of about 1 mm
manufactured by Ethicon, Inc., a Johnson & Johnson company
located at Somerville, N.J., U.S.A. This material is approved by
the U.S. Food and Drug Administration for implantation into the
human body. A still further embodiment of the tape 12 is a
combination of a synthetic material 11 and a natural material 13
centered between the synthetic material 11. A still further
embodiment of the tape 12 includes a combination of synthetic
material 11 and natural material 13, whereby the natural material
is placed over or incorporated within a generally central portion
of the synthetic material 11. One advantage of the tape
configurations is that natural material 13 is along the center
region of tape 12 so that after installation of tape 12, natural
material 13 is positioned below the urethra and eliminates possible
erosion issues at the interface of the urethra and tape. Natural
material 13 may be connected to the synthetic material 11 by means
of sewing, a bio-compatible glue, cell culturing techniques or
other known means.
[0024] Tape 12 may be of any convenient shape that suits the
intended purpose of the invention. An exemplary width is about 1 cm
and the length would be dependent upon the size of the female
undergoing the procedure. Tape 12 may be single or double ply,
generally planar in structure, or tubular to provide additional
supporting strength and more surface area on which tissue fibers
may attach. Moreover, tape 12 may consist of different types of
material, such as a bioabsorbable and non-bioabsorbable material.
Tape 12 may also be coated with an antimicrobial additive to
prevent or minimize infection and a lubricous coating, for example,
a bioabsorbable hydrogel, to facilitate the tape passing through
the tissue as discussed below.
[0025] In one embodiment the tape comprises growth factors for
stimulating cell growth at the interface of the tape and pubic
bone. Growth factors may include natural or recombinant proteins
(TGF-.beta..sub.1, TGF-.beta..sub.2, TGF-.beta..sub.3, BMP-2,
BMP-4, BMP-7, pleiotrophin, bone sialoprotein, osteopontin,
endothelin, PTH, sonic hedgehog), mixtures (autologous growth
factors, Emdogain, demineralized bone matrix, BMP extracts),
transcription factors (cbfa-1), small molecures (PGE.sub.1,
PGE.sub.2, peptide analogs of growth factors, P15, PTH, PTH 1-34,
Chrysalin) or plasmids containing genes for any of the above
molecules. Bone formation at the interface of the pubic bone and
tape may also be induced by adding bone marrow cells, mesenchymal
stem cells, osteoblasts or microvascular tissues or engineered cell
lines or primary cells.
[0026] There are many methods of attaching the growth factors to
the tape, which must be chosen with a specific growth factor in
mind, as is well known to those skilled in the art. Attachment
methods include: covalent attachment with or without a linker or
spacer molecule; attachment via an affinity ligand; physical
adsorption to the tape; encapsulation on the surface via ploymers,
liposomes or gels; lyophilization onto the mesh (with
co-precipitates such as mannose or albumin); or wetting the tape at
the time of surgery with a solution, gel or slurry containing the
growth factor.
[0027] Referring to FIG. 2, the ends of the tape 12 may be modified
to include an easily breakable pouch 14, 16 (not shown) containing
an adhesive for bonding the tape to the pubic bone. This allows the
surgeon to manipulate the tape within the body and once in place,
burst the pouch to free the adhesive and bond the tape to the pubic
bone as described in more detail below. Examples of bonding
adhesives include fibrin glues; di isocyanates; glutaraldehyde;
cyano acrylates; thiolactones; carbodiimides; mussel adhesive
protein; poly amino acid adhesives; photo crosslinked acrylates;
PMMA (bone cement); and bis-GMA (dental cement).
[0028] The surgical procedure for implanting tape 12 is shown in
FIGS. 3a-e utilizing the tape embodiment of FIG. 2. In the figures
the relevant parts of the female lower abdomen are disclosed, the
vagina being 50, the uterus 52, the urethra 54, the pubic bone 56,
the urinary bladder 58 and the abdominal wall 60.
[0029] The surgeon first prepares an incision in the vaginal wall,
creating a tissue flap. The surgeon performs a blunt dissection of
the tissue on one side of the urethra to create a channel from the
vaginal incision to the pubic bone. At this point the surgeon is
able to guide a finger from the vaginal incision, around the
urethra and to the backside of the pubic bone. Preliminary
measurements may be made to determine the length of tape required
for the procedure. Preferably, multiple lengths of tape are
available, each with adhesive pouches 14,16 at both ends of the
tape. For an average-sized female, tape 12 is about 10 cm long. The
surgeon passes the first end of tape 12 through the incision and
positions the tape end at approximately the mid-line at the back
side of the pubic bone 56 and attaches the tape to the pubic bone
by bursting the adhesive-containing pouch 14, simply by pressing
the pouch against the pubic bone, FIGS. 3a-c.
[0030] The surgeon then performs a blunt dissection of the tissue
on the opposite side of the urethra and passes the second end of
tape 12 through the incision in the vaginal wall and through the
soft tissue, on the opposite side of the urethra than the previous
end of tape 12. The surgeon may hold the tape in place while a
urodynamic test is performed to check the integrity of the urethra
to ensure the proper position of the tape. The position of the
second end of tape 12 at the pubic bone may be adjusted according
to the results of the urodynamic test. Once the proper position of
the second end of tape 12 is established in relation to the pubic
bone, the surgeon again bursts pouch 16 thereby releasing the bone
adhesive, FIGS. 3d-f. Tape 12 may further comprise means for
post-operative adjustment as is described in pending U.S. patent
application Ser. No. 09/589,242 filed on Jun. 7, 2000, entitled
Method and Apparatus for Adjusting Flexible Areal Polymer Implants,
which is hereby incorporated herein by reference in its
entirety.
[0031] Table 1, below, provides the average attachment force of
BIOGLUE and DERMABOND when used to attached a PROLENE mesh tape to
the pelvic bone in an animal study.
1TABLE 1 AVERAGE ATTACHMENT FORCE (lbs.) Time Period BioGlue
DERMABOND 0 day 1.36 2.83 2 week 2.04 1.93 3 week 2.40 9.2 4 week
2.32 2.49 6 week 2.76 3.11
[0032] In an alternate embodiment, the ends of tape 12 are secured
within fascia surrounding the pubic bone 56 using an applicator 110
(FIG. 5). This embodiment takes advantage of the Mitek Men iscal
Repair System, as disclosed in U.S. Pat. No. 5,941,439, and sold by
Mitek, a business unit of Ethicon, Inc., a Johnson & Johnson
company. A preferred applicator is product code 228000 with a 340
needle, product code 228218.
[0033] As shown in FIG. 4, an "H" fastener 20, 10 mm long with 4 mm
legs, is attached to both ends of a tape 12. The fastener may be
made biodegradeable material, such as PDS suture material or a
non-biodegradeable material, such as polypropolene. One leg passes
completely through one end of the tape 12, and the other leg loads
into the Mitek applicator, as shown in FIG. 5.
[0034] The surgical procedure for implanting tape 12 is shown in
FIGS. 6a-e utilizing the tape embodiment of FIG. 4. Using the same
preparatory procedures stated above, the sugeon guides the
applicator through the dissected area on the right side of the
urethra, FIG. 6a. The needle and tape are brought in contact with
the cooper's ligament 70 at the inferior lateral aspect of the
pubic bone, FIG. 6b. The fastener is deployed into the tissue where
the legs are released into and captured by the tissue, FIG. 6c. The
mesh is placed beneath the urethra and the second end of the tape
is attached to similar tissue on the left side of the urethra,
FIGS. 6d-e. Adjustments to the length of the tape may be made by
simply placing the fastener at shorter or longer lengths along the
tape. Further, adjustments to the length may be made after initial
deployment by deploying a third fastener through the mesh and into
the tissue at some shorter tape length. Again, post-operative
adjustments may be accomplished via the means disclosed in U.S.
patent application Ser. No. 09/589,242.
[0035] Although the preferred embodiment for the fastener is an
H-shaped device, other configurations can be utilized. Exemplary
shapes may include a hooked-shaped device, arrow-shaped fasteners,
and T-shaped fasteners. Further, the fastener may be a large mass,
such as a knot, which is held within the tissue. Still further,
more than one fastener may be attached to each end of tape 12 to
increase the amount of tissue captured by each fastener.
[0036] As would be appreciated by those skilled in the art, there
exist multiple tissue areas within the pelvic area in which to
attach the mesh. Referring to FIG. 7, examples include the
obturator foramen 80, the pubourethral ligaments 90 and the levator
ani muscle 100.
[0037] In still a further embodiment, a guide system or cannula may
be employed to guide the applicator through the tissue so that less
blunt dissection is required. The cannula may be pre-dimensioned
and act as a template to effectively position the application.
Preferably, the cannula has graduations or dimension marks so the
surgeon is able to accurately determine the depth of penetration of
the cannula and applicator.
[0038] A still further embodiment includes a combination of the two
previous methods and apparatus. For example, the surgeon may attach
the first end of the tape to the pubic bone using an adhesive as
previously described and attaching the second end of the tape to
tissue. One advantage of this technique is that the second
attachment using a fastener allows for adjustment if the tape is
too loose as previously discussed.
[0039] An additional embodiment includes combining the growth
factors and the fastener on both ends of the tape. The fasteners
work as the primary attachment modes and the growth factors work as
the final attachment modes. In this case fast absorbing materials,
such as collegen or regenerated cellulose can be use as the
fasteners. The advantage being that the solid fasteners do not
remain in the uro/genital area for any significant length of
time.
[0040] It will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. Accordingly, it is not
intended that the invention be limited, except as by the appended
claims.
* * * * *