U.S. patent application number 11/324028 was filed with the patent office on 2006-09-14 for apparatus and method for treating female urinary incontinence.
This patent application is currently assigned to Gyne Ideas Limited. Invention is credited to James Browning.
Application Number | 20060205995 11/324028 |
Document ID | / |
Family ID | 46323515 |
Filed Date | 2006-09-14 |
United States Patent
Application |
20060205995 |
Kind Code |
A1 |
Browning; James |
September 14, 2006 |
Apparatus and method for treating female urinary incontinence
Abstract
The present invention provides a surgical implant and method for
supporting the urethra where the implant includes a suburethral
support suspended between two soft tissue anchors. The surgical
implant is introduced into at least one incision made on the upper
wall of a vagina with the first soft tissue anchor inserted on a
first side of the urethra behind the pubic bone, and the second
soft tissue anchor inserted on a second side of the urethra behind
the pubic bone, such that the suburethral support is suspended from
the soft tissue anchors and supports the urethra. Each of the first
and second soft tissue anchors are inserted in, and fix in, the
soft tissue of the perineum without penetrating the obturator
foramen.
Inventors: |
Browning; James; (Glasgow,
GB) |
Correspondence
Address: |
KUDIRKA & JOBSE, LLP
ONE STATE STREET
SUITE 800
BOSTON
MA
02109
US
|
Assignee: |
Gyne Ideas Limited
Glasgow
GB
|
Family ID: |
46323515 |
Appl. No.: |
11/324028 |
Filed: |
December 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10510488 |
Mar 28, 2005 |
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PCT/GB03/01573 |
Apr 11, 2003 |
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11324028 |
Dec 30, 2005 |
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11199061 |
Aug 8, 2005 |
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11324028 |
Dec 30, 2005 |
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10398992 |
Apr 11, 2003 |
6960160 |
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PCT/GB01/04554 |
Oct 12, 2001 |
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11324028 |
Dec 30, 2005 |
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60393969 |
Jul 5, 2002 |
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Current U.S.
Class: |
600/29 |
Current CPC
Class: |
A61B 90/39 20160201;
A61B 2017/00805 20130101; A61B 17/0401 20130101; A61B 2017/0427
20130101; A61F 2/0045 20130101; A61B 2017/0464 20130101; A61F
2002/0072 20130101; A61B 17/3468 20130101; A61F 2250/0051 20130101;
Y10T 29/49826 20150115; A61B 2017/0412 20130101; A61B 2017/0409
20130101; A61F 2250/0031 20130101; A61B 17/06066 20130101; A61B
17/0469 20130101; A61B 17/00491 20130101; A61F 2220/0016 20130101;
A61B 2017/0417 20130101; A61B 17/06109 20130101; A61F 2/0063
20130101 |
Class at
Publication: |
600/029 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 12, 2000 |
GB |
0025068.8 |
Claims
1. A method of supporting a urethra comprising the steps of
introducing a surgical implant comprising first and second soft
tissue anchors and a suburethral support portion therebetween into
at least one incision made on the upper wall of a vagina, inserting
the first soft tissue anchor on a first side of the urethra behind
the pubic bone, and inserting the second soft tissue anchor on a
second side of the urethra behind the pubic bone, such that the
suburethral support is suspended from the soft tissue anchor and
supports the urethra, wherein each of the first and second soft
tissue anchors are inserted in and fix in the soft tissue of the
perineum without penetrating the obturator foramen.
2. The method as recited in claim 1 wherein at least one of the
first and second tissue anchors comprises a central portion and
retaining means wherein the retaining means comprise a plurality of
projections, the projections extending radially from the central
portion along a substantial portion of the length of the central
portion allowing fixation of the anchor at a plurality of layers
within the soft tissue of the perineum.
3. The method as recited in claim 1 wherein at least one of the
first and second tissue anchors comprises biocompatible glue.
4. The method as recited in claim 1 wherein the first soft tissue
anchor is inserted on a first side on the urethra behind the pubic
bone in a lateral direction away from the urethra and positioned in
the soft tissue of the perineum, and the second soft tissue anchor
is inserted on a second side of the urethra in an opposite lateral
direction from the first soft tissue anchor and away from the
urethra and positioned in the soft tissue of the perineum, such
that the suburethral support is suspended from the first and second
soft tissue anchors and supports the urethra.
5. The method as recited in claim 1 wherein the surgical implant
does not penetrate the endopelvic fascia.
6. The method as recited in claim 1 further comprising providing at
least one of the first and second soft tissue anchors with portions
to grip the soft tissue of the perineum at multiple layers.
7. The method as recited in claim 1 wherein the surgical implant
comprises polymer tape.
8. The method as recited in claim 1 wherein the surgical implant
comprises bioabsorbable material.
9. A method of supporting a urethra comprising the steps:
introducing a surgical implant into at least one incision made on
the upper wall of a vagina the surgical implant comprising first
and second ends and a suburethral support section therebetween;
inserting a first end of the surgical implant on a first side of
the urethra and positioning the first end into soft tissue of the
perineum without penetrating the obturator foramen; and inserting a
second end of the surgical implant on a second side of the urethra
and positioning the second end into the soft tissue of the perineum
without penetrating the obturator foramen such that the suburethral
support section is positioned under the urethra and provides
support thereto.
10. The method of claim 9 wherein the surgical implant does not
penetrate the endopelvic fascia.
11. A method of supporting a urethra, comprising: mechanically
coupling, with a surgical implant, a first soft tissue portion of a
perineum on a first side of the urethra to a second soft tissue
portion of the perineum on a second side of the urethra, wherein
the urethra is positioned between the first and second tissue
portion, and orientating a portion of the surgical implant
underneath the urethra to provide support thereto, wherein the
obturator foramen is not penetrated.
12. The method as recited in claim 11, further comprising causing a
portion of the surgical implant to grip at least one of the first
and second tissue portions.
13. The method as recited in claim 11 wherein the surgical implant
does not penetrate the endopelvic fascia.
14. A method of supporting a urethra comprising: positioning a
surgical implant in a perineum to mechanically couple a first
tissue portion of the perineum on a first side of the urethra to a
second tissue portion of the perineum on a second side of the
urethra, wherein the urethra is positioned between the first and
second tissue portions; and positioning a portion of the surgical
implant underneath the urethra to provide support thereto, wherein
substantially all of the mechanical coupling is provided by
interaction of the first and second tissue portions with respective
portions of the surgical implant.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of co-pending
U.S. patent application Ser. No. 10/510,488 filed Mar. 28, 2005,
entitled "Apparatus And Method For Treating Female Urinary
Incontinence," and a continuation-in-part of co-pending U.S. patent
application Ser. No. 11/199,061, filed Aug. 8, 2005, entitled
"Apparatus And Method For Treating Female Urinary Incontinence,"
which is a continuation of U.S. patent application Ser. No.
10/398,992, filed Apr. 11, 2003, entitled "Apparatus And Method For
Treating Female Urinary Incontinence," and which issued as U.S.
Pat. No. 6,960,160 on Nov. 1, 2005, the entire contents of each of
which are incorporated herein in their entireties.
FIELD OF THE INVENTION
[0002] This invention relates to an apparatus and method for
treating female urinary incontinence and, in particular, to a
surgical implant having a sling that passes under the urethra in
use and supports the urethra to alleviate incontinence, along with
related apparatus and methods for inserting the surgical implant in
the body.
BACKGROUND OF THE INVENTION
[0003] Urinary incontinence affects a large number of women and,
consequently, various approaches have been developed to treat
female urinary incontinence. Those skilled in the art will be
familiar with approaches ranging from pelvic floor exercises to
surgical techniques such as Burch colposuspension and Stamey type
endoscopic procedures in which the sutures are placed so as to
elevate the bladder neck.
[0004] One known procedure positions a sling loosely under the
urethra. It is generally understood that this treatment alleviates
urinary incontinence by occluding the mid-urethra (for example at a
time of raised abdominal pressure by coughing or the like).
[0005] As is known, a sling is provided in the body using two large
curved needles which are provided at each end of the sling, where
the sling comprises a long mesh or tape. Each of the needles is
carried on an insertion tool (which is basically a handle
facilitating manipulation of the needles). The mesh or tape is
usually made of knitted polypropylene (such as Prolene.RTM.). The
mesh or tape is generally covered with a plastics sleeve or
polythene envelope to aid smooth insertion, the mesh or tape having
rough surfaces to aid retention in the body.
[0006] An incision is made in the anterior vaginal wall and the
first of the needles is passed through the incision, past one side
of the urethra, behind the pubic bone, through the rectus sheath
and out through the lower anterior abdominal wall. Likewise, the
second needle is passed through the incision, past the other side
of the urethra, behind the pubic bone, through the rectus sheath
and out through the lower abdominal wall. The needles are separated
from their respective insertion tools and also from the mesh or
tape such that only the tape and its plastics sleeve are left in
the body, passing from a first exit point in the lower abdominal
wall, through the rectus sheath, behind the pubic bone, under the
urethra, back behind the pubic bone, back through the rectus sheath
and out through a second exit point in the lower abdominal
wall.
[0007] The plastics sleeve is then removed from the tape and the
tape adjusted to a suitable tension (such that the tape provides a
sling that passes loosely under the urethra, as described above) by
maneuvering the free ends of the tape outside the exit points in
the lower abdominal wall whilst the urethra is held using a rigid
catheter inserted therein. The tape is then cut such that it just
falls short of protruding from the exit points in the lower
abdominal wall. The exit points and the incision in the upper
vaginal wall are then closed by sutures. The tape is held in
position by virtue of friction between the tape's rough edges and
the surrounding body tissue (such as the rectus sheath and the body
tissue behind the pubic bone) and subsequent natural adhesion of
the tape with the body tissue as it re-grows around the mesh
material.
[0008] Whilst highly effective in treating urinary incontinence,
this procedure has a number of problems. One such problem is that
the needles used for inserting the tape are comparatively large,
with the needles having, for example, a diameter of around 5-6 mm
and a length of around 200 mm. As well as causing concern for
patients viewing such needles before or during the procedure (which
is carried out under local anesthetic), this can also lead to a
high vascular injury rate.
[0009] Similarly, the requirement that the needles exit the lower
abdominal wall is disadvantageous due to the trauma to the patient
in this area and pain of such abdominal wounds. A further
disadvantage is that the tape comprises a relatively large foreign
body mass to be retained within the patient and this can lead to
related inflammation, infection translocation, erosion, fistula and
such like.
[0010] Similarly, the nature of the large needles and tape, along
with the tools required to insert these in the body, lead to the
procedure having a relatively high cost.
[0011] In another known procedure which may be used to correct
urinary incontinence, as shown in FIGS. 24 and 25, an incision is
made in the perineal skin over a patient's first obturator foramen
134 and an incision 117 is made in the wall of the patient's vagina
116, a surgical instrument is inserted through the cutaneous
incision, over the first obturator foramen 134 and passed through
the obturator foramen (134) at a "safe" zone (138) close to the
inferior pubic ramus (140), through the obturator muscle, and
through the vaginal incision. A surgical implant is attached to the
surgical instrument and the surgical instrument with the implant
attached is retracted such that one end of the implant is pulled
out of the body via the incision over the obturator foramen. A
second incision is provided over the patient's second obturator
foramen and the procedure repeated such that the implant is
provided under the urethra 118 with a first end of the implant
extending out of the first incision made over the first obturator
foramen and a second end of the implant extending out of the second
incision made over the second obturator foramen.
[0012] The requirement that the needles exit the body over the
obturator foramen is disadvantageous due to the trauma to the
patient in this area and pain of such wounds. A further
disadvantage is that the implant comprises a relatively large
foreign body mass to be retained within the patient and this can
lead to related inflammation, infection translocation, erosion,
fistula and such like. Furthermore, anatomical damage to nerves and
blood vessels may occur during procedures which penetrate the
obturator foramen.
SUMMARY OF THE INVENTION
[0013] According to one aspect of the present invention there is
provided a surgical implant for supporting the urethra, the implant
comprising: a suburethral support suspended between at least two
soft tissue anchors attached at either side of the suburethral
support, each soft tissue anchor having retaining means for
retaining each anchor in tissue and suspending means for suspending
each side of the suburethral support from a soft tissue anchor such
that the suburethral support passes under the urethra in use.
[0014] In one embodiment, a method of supporting a urethra
comprises the steps of: introducing a surgical implant comprising
first and second soft tissue anchors and a suburethral support
portion therebetween into at least one incision made on the upper
wall of a vagina; inserting the first soft tissue anchor on a first
side of the urethra behind the pubic bone, and inserting the second
soft tissue anchor on a second side of the urethra behind the pubic
bone, such that the suburethral support is suspended from the soft
tissue anchor and supports the urethra. Each of the first and
second soft tissue anchors are inserted in and fix in the soft
tissue of the perineum without penetrating the obturator
foramen.
[0015] In another embodiment, a method of supporting a urethra
comprises the steps of: introducing a surgical implant into at
least one incision made on the upper wall of a vagina the surgical
implant comprising first and second ends and a suburethral support
section therebetween; inserting a first end of the surgical implant
on a first side of the urethra and positioning the first end into
soft tissue of the perineum without penetrating the obturator
foramen; and inserting a second end of the surgical implant on a
second side of the urethra and positioning the second end into the
soft tissue of the perineum without penetrating the obturator
foramen such that the suburethral support section is positioned
under the urethra and provides support thereto.
[0016] In another embodiment, a method of supporting a urethra
comprises: mechanically coupling, with a surgical implant, a first
soft tissue portion of a perineum on a first side of the urethra to
a second soft tissue portion of the perineum on a second side of
the urethra, wherein the urethra is positioned between the first
and second tissue portion, and orientating a portion of the
surgical implant underneath the urethra to provide support thereto,
wherein the obturator foramen is not penetrated.
[0017] In an embodiment of the surgical implant of the present
invention the soft tissue anchor is capable of anchoring in the
soft tissue of the perineum.
[0018] Preferably the soft tissue anchors comprise soft tissue
anchors capable of anchoring in tissue of the retropubic space
and/or tissue of the perineum at multiple points via a Christmas
tree type configuration of deflectable wings.
[0019] A soft tissue anchor according to these embodiments
comprises a central portion and the retaining means includes a
plurality of projections the projections extending radially from
the central portion along a substantial portion of the length of
the central portion allowing fixation at a plurality of layers.
[0020] Preferably the projections extend radially from the central
portion at an angle inclined toward the second end of the central
portion.
[0021] Preferably the projections are of a shape that they are able
to provide additive traction to the soft tissue anchor and allow it
to grip fibro-fatty soft tissue and blood vessels of the
para-uretheral tunnel below the level of the rectus sheath and/or
the soft tissue of the perineum.
[0022] In a preferred embodiment of the surgical implant the
retaining means are moveable from an inserting position to a
retaining position.
[0023] It is preferable if at least one of the retaining means of
the implant is moveable from a collapsed position to an extended
position as it enables the retaining means to actively move into
tissue in at least one layer of the tissue following suitable
location of the implant. The movement of the retaining means from a
collapsed position to an extended position allows the means to move
into and be retained in tissue which has been undisturbed or which
has not been disrupted during placement of the implant. The
collapsed position of the implant can be achieved by rolling up,
folding, bending, or enclosing the implant in a restrained
position.
[0024] It is more preferable if the retaining means can be moved
from a collapsed position to an extended position at two or more
layers in the tissue as this provides for gripping of the tissue by
the implant at multiple sites which may require increased force to
be used to dislodge the soft tissue anchors of the implant from the
anchored positions in the fibro-fatty soft tissue of the retropubic
space or from the soft tissue of the perineum.
[0025] Suitably the retaining means may be at least one projection
which can project from the implant into the tissues of the
retropubic space or the soft tissue of the perineum in at least one
plane the projection being moveable from a collapsed position to an
extended position.
[0026] In particular embodiments of the implant the retaining means
comprise a plurality of projections extending laterally from the
longitudinal axis of the implant.
[0027] Suitably the projections may extend from the longitudinal
axis of the implant such that they point away from the bladder when
the implant is positioned such that the suburethral support passes
under the urethra.
[0028] In particular embodiments of the implant the projections may
be curved such that they point away from bladder when the implant
is positioned such that the suburethral support passes under the
urethra.
[0029] In particular embodiments of the implant, the implant may be
curved such that the longitudinal edges of the soft tissue anchors
of the implant and thus the retaining means in use are directed
away from the bladder.
[0030] In embodiments of the surgical implant wherein the retaining
means are mechanical in nature in an inserting position the
mechanical means are collapsed and in a retaining position the
mechanical retaining means are in an extended position.
[0031] In embodiments of the surgical implant wherein the retaining
means are chemical in nature, for example glue, in an inserting
position the glue is in a state which minimizes its adhesion to the
surrounding tissue and in a retaining position the glue is in a
state which allows the glue to adhere to the surrounding
fibro-fatty tissue in the retropubic space or in the soft tissue of
the perineum. Thus in moving from an inserting position to a
retaining position the presentation or the nature of the glue is
changed to cause the glue to adhere the implant to the surrounding
tissue.
[0032] The glue may be encapsulated (inserting position) within a
capsule such that the glue cannot interact with the tissue during
placement of the implant. When the implant is suitably located, the
capsule of glue may be burst (retaining position) to release the
glue and allow the implant to be fixed to the surrounding
tissue.
[0033] In particular embodiments the glue is held in a releasable
container. The glue containing releasable container may prevent the
glue interacting with surrounding tissues until an appropriate
point in the surgical procedure. At this point the surgeon may use
means, for example a point on the introducing tool to release the
glue from the container, for example by puncturing the container
and enabling the glue to adhere the implant to the surrounding
tissue.
[0034] Alternatively in particular embodiments of the implant the
glue may be activated by some means, for example heat, light, cold
or ultrasound. The implant may be moved into the fibro-fatty tissue
of the retropubic space or the soft tissue of the perineum without
the glue adhering the implant to the surrounding tissue (inserting
position) then following the activation of the glue or change in
state of the glue by some means, not limited to heat, light, cold
or ultrasound, the glue will adhere the implant to the surrounding
tissues (retaining position).
[0035] It is preferable if the implant has minimal mass to reduce
the likelihood of inflammation or rejection of the implant when it
is located in the body. Further, it is preferable that the implant
comprises as little material as allows support of the urethra
during periods of increased intra-abdominal pressure to minimize
the abrasion or the urethra and the likelihood of adhesions forming
at the urethra.
[0036] In addition, it is advantageous if the tissue anchors and
the suburethral support are integral with each other as it allows
easier manufacture of the implant. As the distance from the
supporting region under the urethra to the fixing points in the
fibro-fatty tissue of the retropubic space and/or in the soft
tissue of perineum are relatively short in comparison to the
distances between the suburethral support and the fixing points
described in the implants of the prior art, the overall size of the
implant of the present invention can be reduced.
[0037] The production of an implant from a portion of tape material
is advantageous as it allows easier manufacture than implants
comprising multiple portions comprising of different materials
which have to be fixed together. This design minimizes the risk of
failure of the implant due to the simplicity of the implant and
provides for easier packaging and sterilization of the implant.
[0038] The soft tissue anchors of the implant must be anchored in
the tissues of the retropubic space or the tissue of the perineum
with adequate tensile strength to counter dislodging by coughing
until suitable integration of tissue occurs with the implant.
[0039] At least two forces are exerted on the surgical implant
portion which extends under the urethra. A first force is the force
exerted by the urethra during increased intra-abdominal pressure.
The surgical implant has to be secured in the fibro-fatty tissue of
the retropubic space or the soft tissue of the perineum such that
it is capable of supporting the urethra and occluding the urethra
at periods of increased intra-abdominal pressure, to minimize
incontinence.
[0040] A second force is the force exerted on the surgical implant
during periods of increased intra-abdominal pressure which acts in
a direction opposite to the direction in which the anchors are
inserted into the retropubic space or the soft tissue of the
perineum. This force can be considered to be a force of
dislodgement.
[0041] Suitably the implant is anchored in the fibro-fatty tissues
of the retropubic space and/or the soft tissue of the perineum such
that the implant can resist forces of dislodgement created during
periods of increased intra-abdominal pressure.
[0042] Coughing and other causes of increased abdominal pressure
typically cause increased pressures of around 200-400 cm water.
This has been determined by the Applicant to be equivalent to
around a force of 3.75 N through each tape arm.
[0043] Suitably the implant is anchored in the fibro-fatty tissues
of the retropubic space or soft tissue of the perineum such that
the implant can resist forces of dislodgement created during
periods of increased intra-abdominal pressure of up to 3 N.
[0044] In particular embodiments, the implant may be anchored in
the fibro-fatty tissues of the retropubic space or soft tissue of
the perineum such that the implant can resist forces of
dislodgement of up to 5 N.
[0045] In further embodiments the implant may be anchored in the
fibro-fatty tissues of the retropubic space or soft tissue of the
perineum such that it can resist forces of dislodgement of up to 10
N.
[0046] In embodiments of the implant a soft tissue anchor may
comprise a plurality of retaining means.
[0047] In embodiments of the implant a soft tissue anchor may be
tapered.
[0048] Curvature of the longitudinal edges of the soft tissue
anchor such that they are directed away from the bladder minimizes
medial presentation of the retaining means such as projections to
the bladder minimizing erosion of the bladder.
[0049] In a particular embodiment of the implant a soft tissue
anchor may be shaped as a serrated arrowhead wherein the base
portion of the arrowhead is conjoined to the suburethral
support.
[0050] The serrated arrowhead may be provided by cutting a flat
tape such that the serration's of the arrowhead exist in two
dimensions only.
[0051] Suitably the soft tissue anchor may have a pointed end at a
first end, a base portion at a second end, wherein the longitudinal
edges extend between the pointed end and the base and the
longitudinal edges are notched to provide a row of projections
extending outward from the longitudinal edges.
[0052] In other words the anchor may have a pointed tip at a first
end and a base portion at a second end, the first end being the end
of the anchor furthest from the suburethral support and the base
portion being conjoined to the suburethral support. The
longitudinal edges of the anchor extend from the pointed tip to the
base wherein the longitudinal edges are notched to from a row of
tooth like projections extending from the longitudinal edge.
[0053] In yet a further embodiment the soft tissue anchor may
comprise a substantially flat head the bottom surface nearest the
suspending means of the flat head providing the retaining means
which, in use is held in the rectus sheath.
[0054] In a further embodiment the soft tissue anchor may comprise
a sharp point allowing it to pierce or penetrate the rectus sheath,
and retaining means comprising a surface or protrusion directed
rearwardly with respect to the sharp point which does not cause the
soft tissue to part and thus prevents the soft tissue anchor from
being pulled back out through the rectus sheath soft tissue in the
direction opposite to that in which it is inserted into the soft
tissue.
[0055] Preferably the sharp point is provided by the apex of a
conical head portion and retaining means are provided by a
substantially flat base of the conical head.
[0056] Suitably a soft tissue anchor as described herein for
anchoring into the fibro-fatty tissues of the retropubic space may
be used to anchor in the soft tissue of the perineum.
[0057] In any embodiment the soft tissue anchor may be comprised of
plastics material.
[0058] Typically the soft tissue anchor may be comprised of
polypropylene.
[0059] Alternatively the soft tissue anchor is comprised of
absorbable material so as to form temporary fixation in soft
tissue.
[0060] The soft tissue anchor may comprise a point formed of
absorbable material including polyglactin, the sharp point thus
capable of facilitating insertion of the anchor, yet being absorbed
by the body later.
[0061] Preferably the soft tissue anchor may be integral with the
suspending means.
[0062] More preferably the soft tissue anchor is integrally formed
from polypropylene or other polymeric material the attachment
between the anchor and the suspending means being formed as a
single unit.
[0063] An integral construction of the soft tissue anchor and
suspending means has the advantage of simplifying the construction
of the soft tissue anchor and suspending means, which can reduce
the possibility of defective manufacture etc. and reduce costs and
the chance of the soft tissue anchor and suspending means becoming
detached once implanted in the body.
[0064] Alternatively the soft tissue anchor is attached to the
suspending means by a thin metal tube crimped or otherwise attached
around the suspending means and central portion of the soft tissue
anchor.
[0065] The suburethral support of the first aspect of the invention
passes under the urethra, loosely supporting the urethra, the
suburethral support being held in position by suspending means
attached to each of its free ends on either side of the urethra,
the suspending means being attached at the opposite end to at least
one soft tissue anchor.
[0066] Preferably the suburethral support is comprised of flat
polymer tape.
[0067] Preferably the suburethral support has dimensions sufficient
only to pass around the urethra.
[0068] More preferably the suburethral support has dimensions of
length 15-35 mm, width 5-15 mm and thickness 50-350 mm.
[0069] In one embodiment the suburethral support has dimensions of
length 25 mm, width 10 mm and thickness 100 mm.
[0070] Preferably the suburethral support has at least two
junctions to attach the suburethral support to the suspending
means.
[0071] Preferably the distance between the soft tissue anchor(s)
and the suburethral support is adjustable.
[0072] The surgical implant is preferably of a length in the range
12 cm to 16 cm.
[0073] More preferably the soft tissue anchor (or anchors) can be
positioned first and the suburethral support then positioned by
adjusting the length of the suspending means.
[0074] Preferably the suburethral support is provided with at least
one attachment tab to which suspending means are releasably or
permanently attached.
[0075] In particular embodiments of the surgical implant the
suburethral support is provided by a mesh. Advantageously when the
suburethral support is provided by a mesh, the mesh is resilient to
such an extent that it mimics the physiological elasticity of the
tissues which would normally support the urethra.
[0076] In embodiments of the implant wherein the suburethral
support is formed from mesh the strands of the mesh may be spaced
apart to form spaces of 1 to 10 mm. Suitably the strands may have a
diameter of less than 600 mm. Suitably the strands of the mesh may
be arranged to form a warp knit diamond or hexagonal net mesh.
[0077] In particular embodiments of the implant the suburethral
support may be formed from polyester or polypropylene.
Alternatively, the suburethral support may be formed from
absorbable material or may be encapsulated by an absorbable
coating. In particular embodiments, such a coating may be applied
to only one side of the implant.
[0078] In further embodiments the suburethral support may be formed
from biocomponent microfibres comprising a core and surface
material. For example, the surface material may be readily
absorbable by the body while the core material may remain in the
body for a longer period of time. Suitably the surface material may
be polylactic acid and the core material may be polypropylene.
[0079] The suburethral support of the implant may be absorbable at
a different rate than the soft tissue anchors of the implant, for
example the soft tissue anchors may be absorbed within six weeks of
implantation, while the soft tissue anchors may remain for 9
months.
[0080] Preferably the suburethral support comprises an attachment
tab comprising a tunneled element and an aperture, the tunneled
element being located at each of the free ends of the suburethral
support on either side of the urethra at a position that the
suspending means are capable of being introduced through, the
tunneled element co-operating with the aperture such that
suspending means can be passed through the tunneled element and
then through the aperture, the aperture being present on the
opposite surface of the suburethral support to that which contacts
the urethra the aperture having an edge capable of co-operating
with a ring element and the ring element being capable of being
fitted around the aperture trapping the suspending means between
the ring element and the edge of the aperture such that the
suspending means remain fixed in an adjusted position wherein the
suburethral support hangs loosely under the urethra.
[0081] Alternatively the attachment tab comprises at least one slot
through which suspending means can be passed, the suspending means
being permanently attached to the slot by tying.
[0082] Alternatively the attachment tab comprises jamming slots
that the suspending means can be permanently attached by being
threaded through the jamming slots such that the suspending means
are held in an adjusted position.
[0083] Alternatively the suburethral support is capable of being
suitably positioned under the urethra by altering the position of
the soft tissue anchors within the body such that at least one soft
tissue anchor is secured in the soft tissue or in the rectus sheath
and a subsequent anchor is inserted into the soft tissue or rectus
sheath to a suitable depth such that the suburethral support hangs
loosely under the urethra.
[0084] Alternatively the suspending means may be attached to the
suburethral support by heating such that the suburethral support
and/or suspending means melt and form a join.
[0085] Alternatively the attachment tabs may have closure means for
gripping the suspending means.
[0086] The suspending means may be any means suitable for
connecting each end of the suburethral support to the soft tissue
anchor (or respective soft tissue anchors).
[0087] Preferably the suspending means comprises a plastics
strip.
[0088] Preferably the plastics strip has smooth edges.
[0089] Preferably the plastics strip comprises material such as
polypropylene or other suitable non-absorbable or absorbable
polymer tape.
[0090] Preferably the plastics strip is 3-5 mm in width.
[0091] Preferably the plastics material comprises pores which
extend through the plastics material from a first surface of the
plastics material to a second opposite surface of the plastics
material said pores ranging in width across the surface of the
plastics material from 50 mm to 200 mm, the pores allowing tissue
in-growth to secure the strip in the body.
[0092] Alternatively the plastics material may comprise pits, that
indent but do not extend through the plastics material, on at least
one of the surfaces of the plastics material, the pits ranging in
width from 50 mm to 200 mm, the pits allowing tissue in-growth to
secure the strip in the body.
[0093] Preferably the plastics material comprises pits or pores
ranging in width across the surface of the plastics material from
100 mm to 150 mm.
[0094] Preferably the pits or pores are distributed across the
complete surface of the plastics material.
[0095] Alternatively the pits or pores are distributed only in a
particular portion of the surface of the plastics material.
[0096] Preferably the pits or pores are created by post synthesis
modification of the plastics material.
[0097] More preferably the pits or pores are created by post
synthesis treatment of the plastics material by a laser.
[0098] Alternatively the pits or pores of between 50-200 mm are
created during synthesis of the plastics material by spaces between
the waft and weave of mono-filament or multi-filament yarns when
the filaments are woven to form a mesh.
[0099] Alternatively pits or pores formed during the synthesis of
plastics material are formed by the inter-filament spaces created
when mono-filaments are twisted to create multi-filaments, the
multi-filaments then being woven to form a mesh.
[0100] In an embodiment the suspending means is provided with a
plurality of microgrooves of width between 0.5-7 .mu.m and of depth
0.25-7 .mu.m on at least one surface of the plastics strip.
[0101] Preferably the microgrooves are 5 .mu.m in width and 5 .mu.m
in depth.
[0102] Preferably the plurality of microgrooves are aligned such
that they are substantially parallel with each other.
[0103] Preferably the plurality of microgrooves are aligned such
that they are separated by ridges which range in size between 1-5
.mu.m in width.
[0104] More preferably the microgrooves are separated by ridges of
5 .mu.m in width.
[0105] Preferably the ridges are formed by square pillars and the
base of the microgroove is substantially perpendicular to the
square pillars.
[0106] Alternatively the ridges are formed by square pillars and
the base of the microgroove is beveled in relation to the
pillars.
[0107] Preferably the microgrooves are present on at least one
surface of the suspending means.
[0108] More preferably the microgrooves are present on a plurality
of surfaces of the suspending means.
[0109] These microgrooves act to orientate and align the
proliferating fibroblasts on the surface of the plastics material
and cause axial alignment of collagen fibres and formation of at
least one strong ordered neoligament.
[0110] The orientation and alignment of the proliferating cells is
capable of adding mechanical strength to the tissue which forms
around the plastics material such that it is more able to support
the urethra.
[0111] Preferably the suburethral support of the present invention
has neither pores, pits or grooves to discourage the formation of
peri-urethral adhesions.
[0112] Suitably the implant may be comprised of non-absorbable
material. Alternatively the implant may be comprised of absorbable
material. In particular embodiments of the implant, the implant is
comprised of polypropylene.
[0113] Preferably the implant is comprised of resilient material
such that if the implant is not restrained it adopts the original
shape defined during production of the implant.
[0114] It would be advantageous if the implant was capable of
longitudinal extension such that it still provides suitable support
to the urethra during periods of increased abdominal pressure, but
is able to move and extend in a similar fashion to tissues which
physiologically support the urethra.
[0115] In suitable embodiments of the implant, there may be
provided a resilient zone wherein the resilient zone provides for
the resilient extension of the surgical implant in a longitudinal
direction such that the surgical implant behaves in a similar
manner to dynamic bodily tissue.
[0116] In particular embodiments of the implant the resilient zone
is located in at least one of the anchors of the implant.
[0117] Alternatively the resilient zone is interposed between an
anchor and the suburethral support.
[0118] The resilient zone of the implant may be capable of allowing
the resilient extension of at least part of the implant due to its
geometric design.
[0119] Alternatively the resilient zone of the implant may be
capable of allowing resilient extension of at least part of the
implant due to its micro material design.
[0120] In particular embodiments of the implant, the resilient zone
of the implant may be capable of allowing the resilient extension
of the implant due to a combination of its geometric and micro
material design.
[0121] The geometric design may include multiple strips of
material.
[0122] In particular embodiments the geometric design may include
multiple strips of material arranged into bows, the bows being
capable of deforming and providing resilient extension to the
implant.
[0123] Alternatively the geometric design may comprise a concertina
portion such that a part of the implant can extend in a direction
substantially perpendicular to the folds of the concertina.
[0124] In other words the implant may comprise a folded portion,
the fold perpendicular to the longitudinal axis of the implant,
which allows limited extension of the implant in a longitudinal
direction. In an extended position a folded portion is moved away
from a second folded position. In a closed portion the folded
portions are brought together. Different amounts of force in a
longitudinal direction may be required to move the concertina
portion from a closed to an open position.
[0125] Suitably resilient extension of a portion of the implant may
occur when an extension force of 1 to 5 N is applied to the implant
along its length.
[0126] Resilient extension of a portion of the implant may occur
when an extension force of 2 to 3 N is applied to the implant along
its length.
[0127] The resilient zone may provide for the extension of the
implant along its longitudinal length of around 2 to 5 mm.
[0128] In embodiments of the surgical implant the unextended
implant may be of length 6 to 22 cm.
[0129] More preferably the unextended implant is of length 8 to 20
cm.
[0130] Most preferably the surgical implant is of unextended length
10 to 15 cm.
[0131] It will be understood that in embodiments of the implant
which do not include a resilient zone, the unextended length is
equal to the length of the implant.
[0132] In particular embodiments of the implant each soft tissue
anchor is of at least 1 cm in length and not greater than 8 cm in
length.
[0133] Suitably each anchor may be 5 cm in length.
[0134] Suitably the suburethral support may be of at least 2 cm in
length.
[0135] According to a second aspect of the present invention there
is provided a method of supporting the urethra comprising the steps
of, introducing a surgical implant as described above into an
incision made on the upper wall of the vagina, inserting a soft
tissue anchor on a first side of the urethra behind the pubic bone,
inserting a second soft tissue anchor on a second side of the
urethra behind the pubic bone, such that the suburethral support is
suspended from the soft tissue anchor and supports the urethra.
[0136] The invention also provides the use of the method of
supporting the urethra in treating urinary incontinence or
uterovaginal prolapse.
[0137] In one embodiment of the method the soft tissue anchors are
inserted in the rectus sheath.
[0138] In an alternative embodiment of the method the soft tissue
anchors are inserted in the fibro-fatty soft tissue of the
retropubic tissue space and do not penetrate the rectus sheath.
[0139] In an alternative embodiment of the method the soft tissue
anchors are inserted in and fix in the soft tissue of the
perineum.
[0140] As indicated above, the above methods have the advantage
that only a single vaginal incision is required for introduction of
the surgical implant and the need for exit of the surgical implant
and thus exit wounds is removed, for example exit wounds in the
abdomen or at the obturator foramen are not required.
[0141] In particular embodiments of the method wherein the soft
tissue anchors are inserted in and fix in the soft tissue of the
perineum, the surgical implant does not penetrate the endopelvic
fascia.
[0142] In none of the embodiments of the method does the surgical
implant penetrate of extend through the obturator foramen.
[0143] Suitably in one embodiment of the method wherein the soft
tissue anchors are inserted and fix in the soft tissue of the
perineum there is provided a method of supporting the urethra
comprising the steps of: introducing a surgical implant comprising
first and second soft tissue anchors and a suburethral support
therebetween into at least one incision made on the upper wall of
the vagina, inserting a first soft tissue anchor on a first side of
the urethra in a lateral direction away from the urethra, inserting
a second soft tissue anchor on a second side of the urethra in an
opposite lateral direction from the first soft tissue anchor and
away from the urethra, such that the suburethral support is
suspended from the first and second soft tissue anchors and
supports the urethra, wherein each of the first and second soft
tissue anchors is positioned in the soft tissue which comprise the
perineum.
[0144] In another embodiment a method of supporting the urethra
comprises the steps of: introducing a surgical implant into at
least one incision made on the upper wall of the vagina the
surgical implant comprising first and second ends and a suburethral
support section therebetween; inserting a first end of the surgical
implant on a first side of the urethra and positioning the first
end into the soft tissue of the perineum without penetrating the
obturator foramen; inserting a second end of the surgical implant
on a second side of the urethra and positioning the second end into
the soft tissue of the perineum without penetrating the obturator
foramen such that the suburethral support section is positioned
under the urethra and provides support thereto.
[0145] In a further embodiment the method of supporting a urethra,
comprises the steps of: introducing a first end of a surgical
implant into at least one incision made in a vaginal wall, the
surgical implant comprising first and second ends and a suburethral
portion there between; inserting the first end of the surgical
implant on a first side of the urethra and positioning the first
end into tissue of a perineum without penetrating the endopelvic
fascia; introducing the second end of a surgical implant into the
at least one incision made in a vaginal wall; inserting a second
end of the surgical implant on a second side of the urethra and
positioning the second end into tissue of the perineum without
penetrating the endopelvic fascia such that the suburethral support
portion is positioned underneath the urethra and provides support
thereto.
[0146] Suitably a portion of the surgical implant grips at least
one of first and second soft tissue portions of the perineum.
[0147] Suitably location of a first soft tissue anchor on a first
side of the urethra in a first tissue of a perineum and a second
soft tissue on a second side of the urethra in a second tissue of
the perineum, wherein the urethra is positioned between said first
and second soft tissue portions and the surgical implant is
positioned underneath the urethra to provide support thereto,
mechanically couples a first tissue of the perineum to the second
tissue of the perineum.
[0148] In this method no part of the surgical implant penetrates
the obturator foramen. In particular, no part of the surgical
implant extends through the obturator foramen.
[0149] The soft tissue anchor(s) or ends do not penetrate or fix
into bone.
[0150] In one embodiment of the method of anchoring the soft tissue
anchors in the soft tissue of the perineum, a soft tissue anchor of
an implant is inserted through an incision in an upper wall of a
vagina and inserted towards a first obturator foramen behind an
inferior pubic ramus until about half of the length of the implant
is inserted. The soft tissue anchor of the implant is thus placed
such that the soft tissue anchor is located in the soft tissue of
the perineum. A second soft tissue anchor may then be inserted into
the vaginal incision and inserted towards a second obturator
foramen behind an inferior pubic ramus until the second half of the
implant is inserted. The second soft tissue anchor of the implant
is thus placed such that the soft tissue anchor is located in the
soft tissue of the perineum.
[0151] In an embodiment of the method a first end of a surgical
implant may be inserted through an incision in an upper wall of a
vagina and inserted towards a first obturator foramen behind an
inferior pubic ramus such that around 7 cm of the implant is
inserted. A second end of a surgical implant may then be inserted
through an incision in an upper wall of a vagina and inserted
towards a second obturator foramen behind an inferior pubic ramus
such that around 7 cm of the implant is inserted.
[0152] The locating of a soft tissue anchor in the soft tissue of
the perineum may be advantageous as it is less likely that the
bladder may be perforated than in retropubic methods where the
needle passage is medial and therefore near to the bladder.
[0153] Typically the suburethral support is placed midurethra,
without tension, but in a position to support the urethra. However,
as will be understood by those skilled in the art, the suburethral
support may be positioned at an alternative suitable anatomical
location such as to be therapeutically effective should for example
the midurethra be damaged or have significant scar tissue.
[0154] In an embodiment of the method, the soft tissue anchors do
not penetrate the obturator muscle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0155] The above and further advantages of the invention may be
better understood by referring to the following description in
conjunction with the accompanying drawings in which:
[0156] FIG. 1 is an illustration of a surgical implant for
anchoring in the rectus sheath,
[0157] FIGS. 2a and 2b are line drawings of the suspending means
attached to the suburethral support, positioned underneath the
urethra,
[0158] FIG. 3 is an illustration of one embodiment of a suburethral
support,
[0159] FIG. 4 is an illustration of a second embodiment of a
suburethral support,
[0160] FIG. 5 shows suspending means being threaded through an
attachment tab of a suburethral support,
[0161] FIGS. 6A, B and C show alternative methods of attaching
suspending means to a suburethral support,
[0162] FIGS. 7A, 7B and 7C are illustrations of a soft tissue
anchor for insertion through the rectus sheath,
[0163] FIGS. 8A-C are sequential illustrations of insertion of a
soft tissue anchor of FIG. 7,
[0164] FIG. 9 is an illustration of a soft tissue anchor mounted on
an introducing tool for insertion through the rectus sheath,
[0165] FIG. 10 is an illustration of a retropubic soft tissue
anchor for use in the fibro-fatty tissues of the para-urethral
tunnel,
[0166] FIG. 11 is an illustration of the placement of a soft tissue
anchor of FIG. 10,
[0167] FIG. 12 is an illustration of an implanting tool and a soft
tissue anchor inserted into the rectus sheath,
[0168] FIG. 13 is an illustration of the surgical implant implanted
into the rectus sheath,
[0169] FIG. 14 is an illustration of the prior art contrasted with
the technique wherein the anchor is inserted in the rectus
sheath,
[0170] FIG. 15 is an illustration of the tool used to insert the
surgical implant,
[0171] FIG. 16 is an illustration of the surface architecture of
the suspending means,
[0172] FIG. 17 illustrates a diagrammatic side view of an
embodiment of an implant with portions of glue provided on the soft
tissue anchors,
[0173] FIG. 18(a) illustrates an embodiment of an implant
comprising a suburethral support formed from mesh,
[0174] FIG. 18(b) is a further illustration of the embodiment of
the implant of FIG. 18(a),
[0175] FIG. 19 is an embodiment of an implant comprising resilient
zones,
[0176] FIG. 20 illustrates a diagrammatic view of an implant
wherein the soft tissue anchors are provided with grooves and pores
and portions of glue,
[0177] FIG. 21 is a diagrammatic representation of the anatomy of
the pelvic region illustrating the obturator foramen, inferior
pubic ramus, pubic symphysis and the safe transorbturator exit zone
as used in prior art methods,
[0178] FIG. 22 is a cross-section illustration of FIG. 26 that
illustrates insertion of an embodiment of a surgical implant
wherein the soft tissue anchors are fixed in the soft tissue of the
perineum,
[0179] FIG. 23 is a cross-section illustration of FIG. 26 that
illustrates an embodiment of a surgical implant wherein the soft
tissue anchors are fixed in the soft tissue of the perineum,
[0180] FIG. 24 illustrates a prior art device anchored in the skin
above the obturator foramen,
[0181] FIG. 25 illustrates a prior art device anchored in the skin
above the obturator foramen,
[0182] FIG. 26 illustrates placement of an embodiment of a surgical
implant in the soft tissue of the perineum without insertion into
the obturator foramen wherein the implant is in the body,
[0183] FIG. 27 illustrates placement of an embodiment of a surgical
implant in the soft tissue of the perineum without insertion
through the obturator foramen,
[0184] FIG. 28 illustrates an embodiment of a surgical implant
comprising a marker on the suburethral support and soft tissue
anchors comprising projections and glue, and
[0185] FIG. 29 illustrates a further embodiment of a surgical
implant comprising a marker on the suburethral support.
DETAILED DESCRIPTION
[0186] Referring to FIG. 1, a surgical implant for treating female
urinary incontinence has a suburethral support 10, suspending means
20 and at least two soft tissue anchors 30, the suburethral support
10 being positioned in use, loosely under the urethra. The
suburethral support has a length L of around 25 mm and a width W of
around 10 mm such that it passes around the urethra with a minimum
of excess material, although other similar dimensions would also be
suitable. In this example, the suburethral support 10 is made from
flat polymer tape. At each side 11,13 of the suburethral support 10
suspending means 20 are provided which attach to the suburethral
support 10 at a first end 22,24.
[0187] The suspending means 20 are attached at a second end 26 to a
respective soft tissue anchor 30.
[0188] As shown in FIGS. 7a-7C, the soft tissue anchor 30 of the
embodiment described comprises a central portion 32 and four winged
sections 34 which are attached to the central portion at a first
end 38 by resilient hinge means 36 and radially extend from the
central portion 32 such that when viewed from the front the anchor
device resembles a cross.
[0189] As shown in FIG. 8A the wing sections 34 of the soft tissue
anchor 30 having a resting position in which they are inclined
towards the rear 40 of the central portion 32 at an angle of around
45.degree.. In FIG. 8B during penetration of the anchor through
tissue (the point 60 of the introducing tool enabling the soft
tissue anchor to be pushed through the tissue and rectus sheath
120) the wing sections 34 of the soft tissue element 30 may adopt a
deflected position which means the penetration of the soft tissue
anchor through the tissue and rectus sheath 120 is more
effective.
[0190] As shown in FIG. 8C once the rectus sheath 120 has been
pierced the resilient hinge means 36 cause the wing sections 34 to
return to their resting position.
[0191] Movement of the soft tissue anchor in a direction opposite
to which it was introduced into the soft tissue causes the wing
section to be deflected until an endstop 46 is reached which
prevents the wing sections 34 moving beyond a point substantially
perpendicular to the central portion 32 and prevents retraction of
the soft tissue anchor 30 from the soft tissue.
[0192] The soft tissue anchor 30 further comprises a hollow portion
48 which extends from the first end 38 to the second rear end 40 of
the central portion 32 through which an introducing tool 50 may be
placed, as shown in FIGS. 8A-8C.
[0193] The introducing tool 50 extends through the hollow portion
48 such that it extends as a sharp point 60 from the first end 38
of the soft tissue anchor 30 such that the sharp point 60 allows
penetration of the tissue by the soft tissue anchor 30.
[0194] Stud like projections 42 which extend radially from the
central portion 32 are angled such that they extend further
radially from the central portion 32 as they extend towards the
rear 40 of the central portion 32, this inclination allowing the
soft tissue anchor 30 to pass more easily into the soft tissue.
[0195] A recessed portion 44 is positioned toward the rear end 40
of the central portion 32 to facilitate attachment of the
suspending means 20 to the soft tissue anchor 30.
[0196] The suspending means 30 may be respectively attached to the
soft tissue anchor 30 at this recessed point 44 by crimping a tube
around the suspending means 20 to fix the suspending means 20 to
the soft tissue anchor 30.
[0197] In the embodiment shown the soft tissue anchor may be
suitably positioned in the rectus sheath 120 using an introducing
tool 50. As shown in FIG. 15 the tool 50 comprises a handle 52 and
elongate body 54. The elongate body 54 is curved through an angle
of approximately 30.degree. to facilitate positioning of the soft
tissue anchor 30 in the rectus sheath or surrounding soft tissue of
the human body from an incision in the upper wall of the vagina (as
described below). The soft tissue anchor 30 is located on the
elongate body at a narrowed portion 58 of the introducing tool such
that the soft tissue anchor is held in place by an abutment 56 such
that the narrowed portion 58 may extend through the hollow portion
48 of the soft tissue anchor 30 such that the point 60 of the
insertion tool 50 protrudes from the first end 38 of the soft
tissue anchor and allows the soft tissue anchor to be inserted into
the human body through the soft tissues and more specifically
through the rectus sheath 120 during the placement of the soft
tissue anchor.
[0198] The placement of the soft tissue anchor 30 on the insertion
tool 50 is shown in FIGS. 8B and 8C, which shows the soft tissue
anchor 30 being pushed through soft tissue fascia, such as the
rectus sheath 120. Once the soft tissue anchor has penetrated the
rectus sheath fascia 120, as shown in FIG. 8B, the introducing tool
50 can be withdrawn, as shown in FIG. 8C, leaving the soft tissue
anchor 30 in place.
[0199] As shown in FIG. 10 the soft tissue anchor may alternatively
be comprised of a central portion 70 and a plurality of projections
72 the projections extending radially from the central portion 70
and arranged along a substantial portion of the length of the
central portion 70. The projections 72 may be of any shape such
that they provide resistance within the fibro-fatty soft tissue and
blood tissues of the para-urethral tunnel in the direction opposite
to that in which the soft tissue anchor is introduced.
[0200] This resistance is also provided by the multiple layers,
typically between 5-10 layers of projections 72 which extend from
the central portion 70.
[0201] Using these multiple layers of projections 72 it is not
necessary to insert the soft tissue anchor through the rectus
sheath 120. Instead the soft tissue anchor should be positioned as
high in the retropubic space as possible in the fibro-fatty soft
tissue.
[0202] In embodiments of the anchors suitable for anchoring in the
soft tissue of the perineum, the soft tissue anchors may be
provided with projections which allow penetration of the soft
tissue of the perineum and which provide resistance to removal of
the anchors from the soft tissue of the perineum.
[0203] In the embodiment of the method wherein the anchors are
anchored in the soft tissues of the perineum, an embodiment of an
anchor comprises multiple layers of projections 72. The multiple
layers of projections enable the anchors to be fixed in the soft
tissue of the perineum with suitable fixation without requiring the
extending through the obturator foramen.
[0204] In the embodiment of the soft tissue anchor comprising
multiple layers of projections 72 which resembles a Christmas tree,
as shown in FIG. 10, the introducing tool comprises a collar which
releasably retains the projections during insertion into the
retropubic space. The collar may comprise a semi-sharp beveled
needle. Following insertion of the Christmas tree like anchor into
the fibro-fatty soft tissue of the retropubic space the introducing
tool is withdrawn removing the collar from around the plurality of
projections 72 of the soft tissue anchor, which due to their memory
expand outwards from the central portion 70 and grip the
fibro-fatty soft tissue of the retropubic space at multiple layers.
The collar of the introducing tool which extends around the soft
tissue may contain a cross-sectional opening such that once the
tool is withdrawn the collar may be removed from the surgical
implant by passing the implant through the cross-sectional
opening.
[0205] Accordingly the invention also provides an introducing tool
for use in inserting the soft tissue anchor.
[0206] Suspending means 20 attached to the soft tissue anchors are
formed from a strip of plastics material such as polypropylene
which is sufficiently soft to avoid damaging the urethra or
surrounding body tissue and suitably inert such that it can be left
in the human body for a long period of time without causing adverse
reactions. Again, other suitable materials will be apparent to
those skilled in the art.
[0207] The polypropylene mesh strip of 3-5 mm in width which forms
the suspending means 20 has smooth edges to avoid adhesion of the
soft tissue to the strip, reducing problems associated with leaving
foreign material in the human body for long periods of time.
[0208] As shown in FIG. 16 the polypropylene mesh strip further
comprises pores or pits 80 ranging in width across the surface of
the strip from 50mm to 200 mm, which extend through the strip from
a first surface of the strip 26 to a second opposite surface 28 of
the strip the pores 80 allowing tissue in-growth to secure the
suspending means 20 in the body.
[0209] The pores 80 are created by post synthesis treatment of the
polypropylene mesh material by a laser.
[0210] The polypropylene mesh which forms the suspending means 20
also comprises microgrooves 82 of width 5 .mu.m and of depth 5
.mu.m on the surfaces of the polypropylene mesh.
[0211] The microgrooves 82 are aligned such that they are
substantially parallel with each other and separated by ridges of
around 5 .mu.m in width.
[0212] The ridges are formed by square pillars the base of the
microgroove being substantially perpendicular to the square pillars
or beveled in relation to the pillars. The microgrooving 82 being
present on both surfaces of the suspending means to orientate and
align the proliferating fibroblasts on the surface of the plastics
material and cause axial alignment of collagen fibres and formation
of at least one strong ordered neoligament.
[0213] This orientation and alignment of the proliferating cells
adding mechanical strength to the tissue which forms around the
plastics material such that it is more able to support the
urethra.
[0214] The suburethral support is not provided with pores, pits or
grooves to discourage the formation of peri-urethral adhesions.
[0215] Once the soft tissue anchors have been suitably positioned
in either the soft tissue of the para-urethral tunnel or through
the rectus sheath 120 the length of the suspending means 20 can be
altered such that the suburethral support 10 hangs loosely under
the urethra.
[0216] As shown In FIGS. 2a and 2b the suspending means 20 are
attached at a first end 22, 24 to the sides 12, 14 of the
suburethral support 10, which extend on either side of the
urethra.
[0217] As shown in FIGS. 6a-6c a preferred method of altering the
length of the suspending means 20 attached to the suburethral
support 10 comprises a tunneled element 25 at each of the free ends
22,24 of the suburethral support 10 on either side of the urethra.
The tunneled element 25 extends from the edges of the suburethral
support 10 to an aperture 15, the aperture being present on the
opposite surface 16 of the suburethral support 10 to the surface
which contacts the urethra 17, the aperture 15 having an edge 18
able to co-operate with a ring element 19 such that the ring
element which has memory can be pushed onto the edge 18 of the
aperture 15 trapping the suspending means 20 between the edge of
the aperture 18 and the ring element 19 thus securing the
suburethral support 10 along a particular desired length of the
suspending means 20 such that the suburethral support 10 hangs
loosely under the urethra.
[0218] FIG. 5 shows an alternative method of attaching the
suspending means 20 to the suburethral support 10, the suspending
means 20 being threaded through jamming slots 21 such that the
suspending means 20 are permanently attached to the jamming slots
21 by being pulled into the jamming slots 21 as shown in FIG. 5
such that the suspending means is held tightly in position.
[0219] Alternatively as shown in FIG. 6 the suspending means 20 may
be passed through slots and the suspending means permanently
attached to the slots by tying.
[0220] In use, as shown in FIG. 12 the soft tissue anchor 30 is
placed on the introducing tool 50 as described above. An incision
117 is made in the upper wall 116 of the vagina, as shown in FIG.
11, and the introducing tool 112 is passed through the incision
117, past one side of the urethra 118, behind the pubic bone 119
and into the rectus sheath 120. It is apparent to the surgeon when
the rectus sheath 120 has been penetrated as this stage of
insertion presents significant resistance. Once the head 58 of the
introducing tool 50 and the soft tissue anchor 30 have passed
through the rectus sheath 120, the resistance diminishes and the
surgeon ceases to insert the introducing tool 50.
[0221] The introducing tool 50 is retracted from the body releasing
the soft tissue anchor 30. Due to the wing sections 34 on the
central portion 32 of the soft tissue anchor 30, the soft tissue
anchor 30 is retained by the rectus sheath 120 as the introducing
tool 50 is retracted. Thus, the suspending means remains in the
body, secured by the soft tissue anchor which is opposed by the
rectus sheath 120, as shown in FIG. 13.
[0222] This procedure is repeated, with a second soft tissue anchor
30 and suspending means 20, with the introducing tool 50 being
passed through the incision 117 and past the other side of the
urethra 118. Thus, two suspending means 20 are provided, attached
to the rectus sheath 120, one passing either side of the urethra
118.
[0223] The suspending means 20 are passed through the tunneled
elements 25 of the suburethral support 10, and the suspending means
20 are pulled through the aperture 15 until the suburethral support
10 is positioned such that it passes under the urethra 118. The
suspending means 20 are then fixed in place by placing a ring
element 19 over the edge 18 of the aperture 15 such that the
suspending means are trapped between the edge 18 and the ring
element 19 securing them in place.
[0224] Alternatively as shown in FIG. 5 the suspending means may be
fixed in the attachment tabs by threading them through jamming
slots 21 or tying, as described above. The optimal lengths of the
suspending means 20 are such that the suburethral support 10 passes
under the urethra 118, but exerts no pressure on the urethra 118
unless the bladder 121 is displaced. The optimal positioning of the
suburethral support 20 is roughly as illustrated in FIG. 14. When
the bladder is displaced, the suburethral support 10 aids closure
of the urethra 118, thus alleviating urinary incontinence.
[0225] In this example, a portion of the surgical implant is
impregnated with methylene blue, which is a harmless water soluble
dye. At the end of the procedure a small amount of fluid is
expelled from the bladder 121. Should this fluid contain any
dissolved methylene blue, it is very likely that the bladder has
been perforated on placing the soft tissue anchor 30. In this case,
cystoscopy should be carried out. If no methylene blue is present,
the need for cystoscopy is advantageously obviated. Other suitable
water-soluble dyes may, of course, be used.
[0226] Referring to FIG. 14, it can be appreciated that the
surgical implant of the present invention, when inserted in the
human body, may extend from the rectus sheath 120, through the
paraurethral space 130 on one side of the urethra 118, around the
urethra and back to the rectus sheath 120 on the other side. In
contrast, the prior art device comprises a tape 200 that also
extends through the abdominal wall 127 and represents a far greater
implanted mass.
[0227] Referring to FIG. 11, in use, the further embodiment of soft
tissue anchor illustrated in FIG. 9 for placement in fibro-fatty
soft tissue of the retropubic space is placed on an introducing
tool. An incision 117 is made in the upper wall 116 of the vagina,
as shown in FIG. 11, and the introducing tool 112 is passed through
the incision 117, past one side of the urethra 118, and located in
the fibro-fatty soft tissue and blood vessels of the para-urethral
tunnel. In this case the surgeon does not introduce the soft tissue
anchor as far into the body as described previously and the rectus
sheath 120 is not penetrated. Once the soft tissue anchor has been
suitably positioned in the soft tissue the surgeon ceases to insert
the introducing tool and retracts the introducing tool from the
body releasing the projections of the soft tissue anchor 72. The
release of the projections 72 of soft tissue anchor by the
introducing tool allows the projections to grip the soft tissue
surrounding the soft tissue anchor and provide resistance to
movement of the soft tissue anchor in a direction opposite to that
which it was inserted.
[0228] This procedure is repeated, with a second soft tissue anchor
such that the projections 72 of the soft tissue anchor also provide
resistance to movement of the soft tissue anchor in a direction
opposite to that which it was inserted the introducing tool being
passed through the incision 117 and past the other side of the
urethra 118.
[0229] Thus, two suspending means 20 are provided, which are held
in the soft tissue comprising fibro-fatty tissue and blood
vessels.
[0230] As described above the suspending means 20 are passed
through the attachment tabs of the suburethral support 10, and the
suburethral support 10 positioned such that it passes under the
urethra 118.
[0231] As described above, in one embodiment of the present
invention, a soft tissue anchor(s) is inserted in and fixed in the
soft tissue of the perineum.
[0232] The perineum corresponds to the outlet of the pelvis
inferior to the pelvic diaphragm (levator ani and coccygeus). The
boundaries of the perineum are provided by the pubic arch and the
arcuate ligament of the pubis; the tip of the coccyx; and on either
side the inferior rami of the pubis (140) and ischium, and the
sacrotuberous ligament. A line joining the anterior parts of the
ischial tuberosities divides the perineum into two portions, the
posterior anal triangle portion and the smaller anterior urogenital
triangle. FIG. 21 is an illustration of the anatomy of the pelvis
indicating the pubic symphysis (142), the inferior pubic ramus
(142), the obturator foramen (134) and the region (138) of the
obturator foramen though which devices of the prior art extend.
[0233] In this embodiment of the method of the present, the
surgical implant does not penetrate or extend through the obturator
foramen (134).
[0234] A surgical implant for use in the embodiment of the method
wherein the soft tissue anchors are inserted in and anchor in the
soft tissue of the perineum may be the same as the implant
described in relation to the method of supporting the urethra by
anchoring in the tissues of the retropubic space.
[0235] As illustrated in FIG. 17, in one embodiment of a surgical
implant suitable for anchoring in the tissue of the perineum, the
soft tissue anchors (30) are provided with glue (210) for fixation
of the implant to the surrounding tissues. Prior to insertion, the
implant may be curled or folded around a midline (212) of a soft
tissue anchor (30) of the implant, and then a tool may be inserted
through an aperture (214) at a first end of the implant (216) such
that the implant can be inserted into the body via a vaginal
incision (117) on an upper wall of a vagina (116). Once the first
end (216) of the implant is suitably located in the soft tissue of
the perineum on a first side of the urethra (118), the soft tissue
anchor (30) may be uncurled such that the glue comes into contact
with the surrounding tissue to adhere the tissue to the implant.
The second anchor portion is then inserted through the vaginal
incision and suitably located in soft tissue of the perineum on a
second side of the urethra (118). The second soft tissue anchor may
then be uncurled such that the glue comes into contact with the
surrounding tissue to adhere the tissue to the implant.
[0236] Alternative embodiments of implants suitable for insertion
into the soft tissue of the perineum are illustrated in FIGS. 18a,
18b, 19, 20, 28 and 29. As illustrated, the soft tissue anchor
portions (30) can comprise projections, glue or a combination of
glue and projections to allow anchorage of the soft tissue anchors
in the soft tissue of the perineum.
[0237] As illustrated in FIGS. 19, 28 and 29, a marker (220) may be
provided on the implant to aid location of the implant within the
body following insertion. The marker may be, for example, a
protrusion of the suburethral support, or a marked line on the
implant. Other suitable means provided on the suburethral support
to indicate the midpoint of the implant may be provided as would be
appreciated to those skilled in the art.
[0238] As illustrated in FIG. 19, resilient zones (222) can be
formed from several strip portions conjoined at a first end to the
suburethral support and at a second opposite end to soft tissue
anchor of the implant.
[0239] When not under tension these strip portions are bow shaped
and are arranged such that they form a series of alternate and side
by side convex and concave strips arranged in substantially the
same plane as the implant.
[0240] On application of an extending force of up to 3 N to the
implant along its length, the implant can show 2-3 mm of extension,
as the bowshaped portions of the tape are pulled into straight
strips, the ends of the bowshaped strips being brought together,
enabling extension of the tape. The movement of the strips from the
resting bowshape into the tensioned straight strips of implant
allows the implant to resiliently extend along its length.
[0241] The maximum length to which the implant can be extended, is
when the convex and concave strips are pulled such that these
strips are brought into alignment with the longitudinal axis of the
implant. Depending on the nature and length of the bow shaped
portion, the extended length and the force required to promote
extension of the implant can be controlled.
[0242] On release of the extending force these now straightened
strips of implant of the resilient zone return to their previous
non-extended bowshape causing the implant to resiliently return to
its non-extended length.
[0243] The ability of the implant to show limited extension
following the application of an extending force means that the
implant more accurately mimics the movement of dynamic bodily
tissue.
[0244] In order that the bowshape like portions of the implant can
be pulled such that they are straightened, the material of the
implant must be resilient to an extent, The amount of resilience of
the material will influence the resilience of the implant to an
extending force.
[0245] FIGS. 22, 23, 26 and 27 illustrate an embodiment of the
method wherein the soft tissue anchors are inserted in and fix in
the tissue of the perineum. It should be noted that FIGS. 22 and 23
are cross-sections of FIG. 26, taken along the line A-A. In
accordance with one embodiment of the method, the patient is
suitably placed in a modified lithotomy position with hips flexed
and the legs (136) elevated. A small incision (117) is made in the
upper wall of the vagina (116) followed by pariurethral dissection.
A first soft tissue anchor (30) is inserted through the vaginal
incision (117) and advanced laterally on a first side of the
urethra (118), as illustrated in FIG. 27, into the tissues of the
perineum towards and behind the inferior pubic ramus (140), but not
through, the obturator foramen (134). The length of surgical
implant which is to be inserted into the body for anchorage in the
soft tissue of the perineum may be indicated by providing a marker
on the implant. In an embodiment of a surgical implant for use in
this method around 7 cm of the surgical implant is inserted on each
side of the urethra.
[0246] The surgical implant and method for anchorage in the soft
tissue of the perineum contrasts the devices and methods of the
prior art in which the devices are required to be of sufficient
length to extend through the obturator foramen (134) in a "safe"
zone (138) close to the inferior pubic ramus (140) as illustrated
in FIG. 21 and through the skin.
[0247] Provision of an implant capable of anchoring in the soft
tissue of the perineum without requiring to pass through the
obturator foramen is advantageous as it minimizes the likelihood of
anatomical damage to nerves and blood vessels which may occur
during procedures which penetrate the obturator foramen.
[0248] Following insertion of a first soft tissue anchor, a second
soft tissue anchor is inserted into said vaginal incision on the
second side of the urethra and then advanced in an opposing lateral
direction to the first soft tissue anchor, as illustrated in FIG.
27, into the tissues of the perineum towards, but not through, the
obturator foramen (134).
[0249] Suitably a centering marker (220) provided on the
suburethral support is aligned under the urethra such that the
first and second anchors are suitably provided into the soft tissue
of the perineum.
[0250] In the embodiment of the method of locating the anchors in
the soft tissue of the perineum illustrated, the soft tissue
anchors are not anchored above the endopelvic fascia (139).
[0251] Again this device contrasts that described by the prior art
device in that it does not extend through the abdominal wall or the
obturator foramen and thus does not represent as much implanted
mass.
[0252] Various embodiments of the present invention can be
envisaged within the scope of the invention, for example the soft
tissue anchor may comprise a cone or a half cone such that a
circular or semi-circular base is provided as a retaining means to
prevent retraction of the soft tissue anchor in a direction
opposite to that in which it is inserted into the tissue.
[0253] Alternatively the soft tissue anchor may comprises a
substantially flat or disc shaped head. In this case the
introducing tool may have a conical head with a sharp point at its
apex and a slot for receiving the flat or disc shaped head.
[0254] In yet another example, the soft tissue anchor may be formed
of two sections. The upper section, i.e. the portion of the anchor
that forms the sharp point 10, may be made from an absorbable
material, such as polyglactin such that a sharp point is provided
for insertion of the anchor into the body, but this sharp point is
later absorbed by the body so as to eliminate any discomfort or
disadvantage caused by a sharp pointed object being retained inside
the body.
[0255] The soft tissue anchor may be made from metal, such as
titanium, as this is a hard material that can easily be formed into
the head having the sharp point at its apex, and is sufficiently
malleable to provide a tube that may be crimped to the suspending
means.
* * * * *