U.S. patent application number 10/625200 was filed with the patent office on 2005-01-06 for methods and apparatus for correction of urinary and gynecological pathologies, including treatment of male incontinence, and female cystocele.
Invention is credited to Beyar, Mordechay, Globerman, Oren, Raz, Shlomo.
Application Number | 20050004424 10/625200 |
Document ID | / |
Family ID | 26767981 |
Filed Date | 2005-01-06 |
United States Patent
Application |
20050004424 |
Kind Code |
A1 |
Raz, Shlomo ; et
al. |
January 6, 2005 |
Methods and apparatus for correction of urinary and gynecological
pathologies, including treatment of male incontinence, and female
cystocele
Abstract
The present invention relates to apparatus and methods for
treatment of male incontinence and a method for female cystocele
repair in which a sling material is positioned between the
descending rami of the pubic bone. In such an operation a
"hammock-like" sling material is positioned below the urethra in
males, or below the posterior bladder wall in the case of cystocele
in females.
Inventors: |
Raz, Shlomo; (Los Angeles,
CA) ; Beyar, Mordechay; (Caesarea, IL) ;
Globerman, Oren; (Herzelia B., IL) |
Correspondence
Address: |
Jeffrey J. Hohenshell
AMS Research Corporation
10700 Bren Road West
Minnetonka
MN
55343
US
|
Family ID: |
26767981 |
Appl. No.: |
10/625200 |
Filed: |
July 23, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10625200 |
Jul 23, 2003 |
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10252179 |
Sep 23, 2002 |
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6691711 |
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10252179 |
Sep 23, 2002 |
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09748963 |
Dec 27, 2000 |
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6502578 |
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09748963 |
Dec 27, 2000 |
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09296735 |
Apr 22, 1999 |
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6382214 |
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60082905 |
Apr 24, 1998 |
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Current U.S.
Class: |
600/30 ;
600/37 |
Current CPC
Class: |
A61B 17/06109 20130101;
A61B 2017/0409 20130101; A61B 17/0401 20130101; A61B 2017/0417
20130101; A61B 2017/00805 20130101; A61F 2/0045 20130101 |
Class at
Publication: |
600/030 ;
600/037 |
International
Class: |
A61F 002/02 |
Claims
1-12. (canceled)
13. A system for inserting a sling through a vaginal incision to
treat a patient's incontinence comprising: a sling having end
portions, at least two sling anchors, each sling anchor adapted to
be associated with an end portion of the sling to anchor the sling;
and a sling anchor inserter adapted to insert a sling anchor
initially through a vaginal incision and then into the patient's
retropubic space, the sling anchor inserter adapted to anchor the
sling anchor without requiring an abdominal incision.
14. A system according to claim 13 wherein the sling anchor
inserter is adapted to anchor the sling anchor just above the
periosteum near the patient's superior rami and pubic symphysis.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods and devices for
treatment of urinary pathologies.
BACKGROUND
[0002] Male incontinence is a condition characterized by
involuntary loss of urine, beyond the individual's control. One
cause for this condition is damage to the urethral sphincter, such
as can occur after prostatectomy, after radiation or after pelvic
accidents. Other accepted reasons for male incontinence include
bladder instability, over-flowing incontinence and fistulas.
[0003] The present application is directed to the treatment of male
urinary incontinence which is related to urethral sphincter damage.
Currently, the treatment of choice involves implantation of a
Kaufman Prosthesis, an artificial sphincter (such as AMS-800), and
a sling procedure in which a sling is inserted beneath the urethra
and advanced in the retro pubic space, and perforating the
abdominal fascia, such as in female sling procedures. See, Joseph
J. Kaufman and Shlomo Raz, Urethral compression procedure for the
treatment of male urinary incontinence, Journal of Urology 121:
605-608 (1979).
[0004] Cystocele is a condition in which, due to laxity of the
pelvic floor, the bladder extrudes out and downwards. The severity
of this bladder collapse is rated between grades 1-4. In grade four
cystocele, the bladder extrudes out of the vaginal opening. The
treatment of choice for this condition includes the reduction or
closing of the pelvic floor opening from which the bladder descends
using sutures.
[0005] As background to the inventions of the present application,
further information is provided in the following publications, the
disclosures of which are fully incorporated herein by reference:
Eddie H. M. Sze, M. D and Mickey M. Karrara, M. D., Transvaginal
repair of vault prolapse: a review, Obstetrics & Gynecology
89(3): 466-475 (1997); Shlomo Raz, M. D., Female Urology, Chapter
29 (Pathogenesis of Cystocele), Chapter 43 (Uterine Prolapse),
Chapter 44 (Enterocele and Vault Prolapse); Joseph J. Kaufman and
Shlomo Raz, Urethral compression procedure for the treatment of
male urinary incontinence, Journal of Urology 121: 60568 (1979);
Robert Cox and Peter H. L. Worth, Results of Treatment of
Post-Prostatectony Incontinence Using the Kaufman Prosthesis, Eur.
Urol. 12: 154-157 (1986); Olavi A. Lukkarinen, Matti J. Kontturi,
et al., Treatment of Urinary Incontinence with an Implantable
Prosthesis, Scan. J. Urol. Nephrol. 23: 85-88 (1989); Sender
Herschom and Sidney B. Radomski, Fascial Slings and Bladder Neck
Tapering in the Treatment of Male Neurogenic Incontinence, J.
Urology 147: 1073-1075 (1992); Gene R. Barrett, M. D. Stephen H.
Treacy, M. D. and Cynthia G. Ruff, M. S., Preliminary Results of
the T-Fix Endoscopic Meniscus Repair Technique in an Anterior
Cruciate Ligament Reconstruction Population, Arthroscopy: The
Journal of Arthroscopic and Related Surgery, 13: 218-223
(1997).
SUMMARY OF THE INVENTIONS
[0006] In one embodiment, the present invention relates to
apparatus and methods for treatment of male incontinence and a
method for female cystocele repair in which a sling material is
positioned between the descending rami of the pubic bone. In such
an operation a "hammock-like" sling material is positioned below
the urethra in males, or below the posterior bladder wall in the
case of cystocele in females.
[0007] In the male case, this sling applies passive compression
against the bulbar urethra. The compression, either by itself or in
conjunction with urethral mobility, prevents urine leak during
strain. If additional passive pressure is required on the urethra
after surgery is completed, collagen or other bulky material can be
injected with a tiny needle through the perineum, causing more
pressure created by the bulky material held on one side (the lower
side) by the sling, and on the other side compressing the
urethra.
[0008] In another embodiment of the invention, an especially flat
shaped balloon is positioned between the sling material and the
urethra to provide desired compression. Examples of inflatable
balloon devices are disclosed in the currently pending U.S. Patent
Application entitled Systems for Percutaneous Bone and Spinal
Stabilization, Fixation and Repair, (serial number to be assigned),
filed Mar. 6, 1998 by Mordechay Beyar, Oren Globerman and Elad
Magal, the disclosure of which is fully incorporated herein by
reference. This balloon is inflated with fluid, and the volume can
be adjusted by inflation or reduction of the fluid inside the
balloon, using a tiny needle inserted through the perineal area. In
a further embodiment of the invention, the sling material is part
of the flat balloon. The sling material and the balloon can either
be an integral single unit, or the sling material can be attached
or secured to the balloon. Inflation and deflation of the balloon,
in conjunction with the sling (which is preferably secured using
suitable bone anchors and suture), is used to correct the urinary
pathology, in accordance with the methods disclosed herein. The
sling is attached to the bone by means of bone anchors.
[0009] In another embodiment of the invention, T-anchors and anchor
inserters are provided herein. The anchors and inserters are
designed for use with gynecological and urological procedures,
including, but not limited to, bladder neck suspension,
sacrospinous ligament procedures for the treatment of vaginal vault
prolapse, and sling procedures for the treatment of urinary stress
incontinence and cystocele repair.
[0010] Further disclosure of the surgical procedures in the sling
procedure are provided below.
BRIEF DESCRIPTION OF THE FIGURES
[0011] FIG. 1 is a plan view of a first embodiment of a
T-inserter.TM., in accordance with the present invention.
[0012] FIG. 2 is a plan view of a first embodiment of a
T-anchor.TM., in accordance with the present invention.
[0013] FIG. 3 is a plan view of a second embodiment of a
T-inserter.TM., in accordance with the present invention.
[0014] FIG. 4 is a plan view of a second embodiment of a
T-anchor.TM., in accordance with the present invention.
[0015] FIG. 5a-c are plan views of a third embodiment of a
T-inserter.TM., in accordance with the present invention.
[0016] FIG. 6 is a plan view of the third embodiment of the
T-inserter.TM., after release of a T-anchor.TM. therefrom.
[0017] FIG. 7 is a perspective and enlarged view of a T-anchor.TM.,
in accordance with the present invention.
[0018] FIGS. 8a and 8b are plan views of the first and second
embodiments of the T-inserter.TM., with the threaded anchor loaded
into the tip of the inserter's tube up to the anchor's midpoint, so
that the suture loop is located outside of the tube.
[0019] FIG. 9 is cross sectional view of the second embodiment of
the T-inserter.TM., with the anchor having attached suture thread
loaded thereon.
[0020] FIG. 10 is a sectional view showing the placement of a
fascial anchor inserter and an anchor in accordance with the
procedure for bladder neck suspension of the present invention.
[0021] FIG. 11 shows two sectional views of the placement of a
fascial anchor inserter and an anchor in accordance with the
procedure for sacrospinous fixation of the present invention.
[0022] FIG. 12 is a view of an exposed pelvic bone showing the
schematic location of the bone anchors and sling material using in
a male sling procedure in accordance with the present
invention.
DETAILED DESCRIPTION OF THE INVENTION AND THE PREFERRED
EMBODIMENTS
Fascial "T-Anchors" For Sacrospinous Fixation
[0023] In accordance with the present invention, fascial anchor or
screw devices are provided herein for fixation of soft tissue to
soft tissue. These "T-Anchors" are positioned on a special delivery
system, either straight or curved. They can be either absorbable or
non-absorbable.
[0024] The anchors and inserters of the present inventions are
designed for use with gynecological and urological procedures. The
T-Anchor system is particularly designed for soft tissue fixation
in sacrospinous ligament fixation procedures, for the treatment of
vault prolapse, uterine prolapse, or prevention of vault prolapse.
In such cases, the posterior wall of the vagina is opened, the
sacrospinous ligament is palpated with a finger or is observed
visibly, and the anchor (which is loaded on a long delivery system)
is positioned on the sacrospinous ligament and pushed to perforate
the ligament. Once perforated, the anchor is released, the delivery
system is removed, and the suture is used to approximate the
posterior vaginal wall and surrounding tissue. It is also possible
to affix the suture, which is attached to an anchor positioned
below the sacrospinous ligament, to the uterus.
[0025] One embodiment of the T-anchor inserter of the present
invention is disclosed in FIG. 1. The anchor inserter is
particularly designed for soft tissue fixation in bladder neck
suspension and sling procedures for the treatment of urinary stress
incontinence and for cystocele repair. The inserter has a handle 20
and a body 24. Body 24 extends perpendicular from handle 20.
Extending from body 24 is tube or needle 28. Tube 28 is a curved
anchor deployment tube, preferably constructed from stainless
steel. The tube 28 is preferably of a narrow diameter such that it
can be easily inserted into and manipulated within the vaginal
canal for precise positioning of an anchor therein.
[0026] At the end of tube 28 is an anchor guide for holding an
anchor, the anchor guide being at the distal end of the tube 28. In
one embodiment of this guide, the outer end of the anchor guide can
be formed as a thin-walled tube or bore, the bore receiving an
anchor therein for securing the anchor to the inserter. In one
preferred embodiment, the tube curves such that the end of the tube
points back towards the inserter handle 20, or approximately to the
handle of the inserter, and/or the distal end of the tube 28 is
approximately parallel to the inserter body 24.
[0027] Handle 20 further includes a release button or trigger. Upon
activation of the release button, the anchor is deployed from the
inserter device. In the preferred embodiment, the anchor is
designed for ejection from the inserter device to penetrate into
soft tissue. The inserter is preferably constructed as a stainless
steel tube 28 in which a plunger is positioned, such that upon
pressing the release button, the plunger pushes the anchor out of
the tube 28 and into the tissue. In addition to a release trigger,
it is preferred that handle 20 further include a safety lock, to
prevent premature ejection or release of the anchor.
[0028] In the preferred embodiment, straight anchors 32 are used
with this inseter, each of the anchors being approximately 15 mm in
length and 1.4 mm in diameter with a tapered end and a bore in the
middle of the anchor for threading a suture thread therethrough.
Each anchor is preferably made of Titanium or biocompatible plastic
and is threaded through its bore with a non-absorbable suture such
as braided polyester or polypropylene no. 0-1.
[0029] A second embodiment of the T-inserter of the present
invention is shown in FIG. 3. This embodiment of the inserter is
particularly designed for the sacrospinous ligament fixation
procedures in accordance with the present invention. T-inserter 40
includes a handle 42 having a release button or trigger means 44.
In the preferred embodiment, the T-inserter further includes a
safety means for preventing accidental or premature release of an
anchor from the T-inserter. Attached to the handle of the
T-inserter is a straight tube or needle 46. At the end of tube 46
is an anchor guide for holding an anchor 48, the anchor guide being
at the distal end of the tube, as shown in FIG. 9. In one
embodiment of this guide, the outer end of the anchor guide can be
formed with a bore, the bore receiving an anchor therein for
securing the anchor to the inserter.
[0030] In the preferred embodiment, each of the anchors 48 for use
with the T-inserter of FIG. 3 are approximately 11 mm in length and
1.5 mm in diameter, with a tapered end and a bore in the middle for
threading the suture therethrough. The anchors are made of
absorbable/resorbable materials such as Poly-1-lactide, and are
threaded with an absorbable suture such as Vicryl suture
no.0-1.
[0031] A further T-inserter 50, in accordance with the present
invention, is shown in FIGS. 5 and 6. The T-inserter 50 includes a
handle 52, a body 54, and a tube or needle 56. The inserter further
includes a rigid segment or safety lock 58. This inserter is
similar in its features to the inserters described above. In
inserter 50, however, a different release technique is used. Handle
52 consists of a scissor or pincer like design in which handle 52
is separated into two separate segments or halves 52a and 52b, both
connected at joint 60.
[0032] To use the inserter, an anchor with suture thread is
inserted into the distal end of the tube 56, as described above.
During the positioning of the inserter 50 within the body, safety
lock 58 is kept in place to restrain handle segments 52a and 52b
from movement, as shown in FIGS. 5b and 5c. When the inserter is in
place, such that the distal end of tube 56 is correctly positioned
with the distal end located at the proper point of anchor
insertion, safety lock 58 is released as shown in FIG. 5a. Upon
release of the safety lock 58, handle segments 52a and 52b can be
squeezed together to cause a plunger to push through tube 56,
pushing against the rear of an anchor to be released from the
distal end of the inserter device, as shown in FIG. 6.
[0033] As described above, T-anchors for use in accordance with the
present invention are disclosed in FIGS. 2 and 4. A further
illustration of the T-anchor of the present invention is provided
in FIG. 7. As shown in FIG. 7, anchor 60 consists of a basically
cylindrical body 63 having a tapered end 66, a blunt end 68 and a
bore 64 (in the preferred embodiment, extending perpendicularly to
the longitudinal axis of the anchor) for receipt of a threaded
suture 62 therethrough.
[0034] With the inserters of FIGS. 1, 3, and 5, and in accordance
with the procedure of the present invention, approximately half the
length of a suture is threaded through the bore of an anchor. As a
result, the bore of the anchor, as shown in FIGS. 2, 4 and 7, sits
midway on the strand of suture. Holding the threaded anchor at the
tapered end 66, the blunt end of the anchor 68 is pressed into the
bore at the tip of the inserter tube or needle. The threaded anchor
is pushed backwardly into the tip of the inserter's needle up to
the anchor's midpoint, so that the suture loop is outside of the
tube 28, as shown in FIGS. 8a and 8b. Alternatively, the sides of
the tube 28 can be provided with bayonet slots for accommodating
the suture extending therethrough, with the anchor then being able
to be fully recessed into the tube.
[0035] Bladder Neck Suspension Procedure with T-Anchor System
[0036] In accordance with the invention, to perform a bladder neck
suspension procedure, it is preferred that the anchor inserter of
FIG. 1 be used. Once the patient has been placed under anesthesia,
and is in the lithotomy position, a foley catheter is inserted into
the bladder and the balloon is inflated. As shown in FIG. 10, the
inserter is inserted through the anterior vaginal wall, lateral to
the urethra, and is advanced along the posterior surface of the
pubic bone, until the device's tip passes the abdominal fascia just
above the superior pubic ramous. The safety lock on the inserter is
then released, and the anchor is deployed, by pushing on the
trigger of the inserter, into tissue. The inserter device is then
removed from the vaginal canal, and the suture of the anchor is
pulled to securely hold the anchor in the tissue. By pulling on the
suture attached to the center of the anchor, the anchor assumes a
parallel orientation relative to the fascial layer.
[0037] The procedure is then repeated on the contralateral side,
and cystoscopy is performed to verify bladder and urethral
integrity. At this point, anchor fixation to the abdominal fascia
has been achieved and the vaginal suspension, using the free ends
of the suture thread, is continued according to one of the
procedures known in the art, including such procedures as the Raz,
Pereyra, Gittes or sling procedure.
[0038] T-Sacrospinous Fixation Procedure
[0039] In accordance with the present invention, a T-Sacrospinous
fixation procedure is further provided herein, as shown in FIG. 11.
An T-anchor.TM. is threaded with suture and loaded onto the
anchoring device of FIG. 3. With the patient under anaesthesia and
in the lithotomy position, the surgical area and the vagina are
disinfected. The posterior vaginal wall is opened, the rectum is
pushed to the left, and the sacrospinous ligament is palpated.
Palpating the ligament with a finger, the inserter is advanced
along the finger until the tip of the anchor perforates the
sacrospinous ligament. The insertion lever is then pressed (after
disengaging the safety), causing the anchor to be deployed in the
sacrospinous ligament, resulting in a firm attachment to the
ligament. The inserter is then pulled out, and the suture is pulled
for proper anchoring as disclosed above. The procedure is then
repeated on the contralateral side. Colporrhaphy is then
performed.
[0040] In accordance with additional inventions of the present
application, a variety of further surgical procedures using bone
screws to correct urological and gynecological pathologies are
further disclosed below. The disclosures of U.S. patent application
Ser. Nos. 08/733,798 (filed Oct. 18, 1996) and 08/804,172 (filed
Feb. 21, 1997), relating to bone anchors and inserters, including
bone screw and screw inserters, are fully incorporated herein by
reference.
[0041] Sling Procedure for Male Incontinence Using Pubic Bone
Anchors
[0042] In accordance with one invention, a sling procedure is
disclosed herein for treatment of male incontinence, and in
particular for treatment of patients suffering from
post-prostatectomy incontinence. For the procedure to be performed,
the patient should have no urethral obstruction or any pathology
involving the bulbar urethra. In this embodiment, bone anchors are
used to suspend a sling material below the bulbomembranous
urethra.
[0043] In accordance with the invention, the patient is first
placed in the lithotomy position. After preparation and draping, a
16Fr. Foley catheter is inserted into the urethra, and the scrotum
is elevated. A vertical incision is made over the midline in the
perineum. The skin and subcutaneous tissues are dissected free. The
bulbocavernous muscle is then exposed and dissection is carried out
posteriorly to the area of the transverse perineum to completely
free the bulbar urethra. Lateral dissection is used to expose the
corpora cavemosum.
[0044] Upon exposure of the corpora cavemosum, four bone screws or
anchors are inserted in the inner portion of the descending rami of
the pubic bone using a straight screw or anchor inserter. Each bone
screw is loaded with No. 1 Prolene sutures. The first pair of bone
screws is inserted just below the symphysis, while the second pair
is inserted at the level of the ischial tuberosity.
[0045] When insertion of the second pair has been completed, a
template is obtained from the bulbar urethral area and is measured.
A segment of synthetic material or cadaveric or autologous' fascia
is fashioned over the template to create a sling. The four corners
of the sling are then transfixed with the preloaded Prolene suture
at each end. One side of the sling is tied tight over the pubic
bone while in the contralateral side the tension will be adjusted.
An example of the adjusted anatomy at this point, with the anchors
and sling in place, is shown in FIG. 12.
[0046] The Foley catheter is then deflated and removed. The Foley
catheter is connected to a sterile saline perfusion line. A zero
pressure state is obtained by lowering the bag to the level of the
symphysis. The tip of the catheter is repositioned at the
penoscrotal angle and the urethral resistance to start the flow is
recorded (by distance above the zero line). In patients under
anesthesia suffering from sphincter incontinence, the resistance is
very low. Tension is then applied to the untied side of the sling,
and the pressure is adjusted to increase urethral resistance
between 30 and 60 cm water. The second pair of sutures are then
tied to the selected degree of tension.
[0047] The Foley catheter is then advanced to the bladder (which
should advance without difficulties), and the wound is irrigated
with Bethadine solution and closed in layers. Subsequently, the
Foley catheter is removed after 2 hours, and the patient can be
discharged home on oral antibiotics and pain medication.
[0048] Repair of Grade Four Cystocele Using Retropubic and Lateral
Pubic Bone Anchors
[0049] In accordance with another invention of the present
application, a method is provided for repair of cystocele using
retropubic and lateral pubic bone anchors. This surgery is
indicated for patients with grade four cystocele and urethral
hypermobility. The procedure repairs the central defect, the
lateral defect, approximates the cardinal ligaments to the midline,
and creates a sling of the urethra.
[0050] After preparation and draping, a Foley catheter is inserted
in the bladder. Once the catheter is in place, a "goal post"
incision is made. The vertical bars of the goal post extend
laterally from the distal urethra to the horizontal bar that is
made just proximal to the bladder neck. The vertical bars reach the
vaginal cuff.
[0051] After creation of the goal post incision, the vaginal wall
is dissected free to expose the perivesical fascia laterally and
the cardinal ligaments posteriorly. A figure eight 2-0 absorbable
suture is applied to approximate the cardinal ligament to the
midline without tying it. If an enterocele sac is encountered, it
should be repaired at this stage.
[0052] The retropubic space is then entered over the periurethral
fascia at the level of the vertical bars of the incision, and the
urethropelvic ligaments are exposed. Two fascial anchors (the upper
pair) are inserted into the tissue of the suprapubic area. Each of
these anchors contains a preloaded No. 1 Prolene suture.
[0053] In an alternative embodiment, at this stage of the
procedure, the retropubic space is not open and two bone anchors
are applied to the inner surface of the symphisis using a right
angle drill.
[0054] After application of the first set of anchors, a second pair
of bone anchors or screws is applied to the inner surface of the
descending rami of the symphysis. These anchors (the lower pair)
also have No. 1 Prolene sutures preloaded in the bores of the
screws.
[0055] Once the four anchors are in place, the bladder prolapse is
reduced using a moist sponge over a right angle retractor.
Alternatively, a Dexon mesh is applied and left in place. The lower
pair of Prolene sutures are then used to incorporate the
perivesical fascia and the cardinal ligaments area. Interrupted 2-0
absorbable sutures are used to approximate the perivesical fascia
to the midline over the Dexon mesh.
[0056] The transverse segment of the goal post incision is then
dissected free to create a groove or tunnel for the sling to be
embedded or inlayed into. A synthetic rectangular sling or,
alternatively, an autologous or cadaveric segment of fascia (of
approximately 6 by 2 cm) is used to create the urethral sling. The
end of the sling is transfixed with the upper pair of Prolene
suture. Cystoscopy is performed after injection of indigocarmine to
ensure ureteric patency, bladder integrity, and normal positioning
of the sling.
[0057] Once the sling has been properly positioned, and ureteric
patency and bladder integrity have been verified, the perivesical
and cardinal ligament sutures are tied to close the central defect.
The lateral defect suture is tied without tension.
[0058] The sling sutures are then tied over a cystoscope sheath at
a 30 degree angle to avoid obstruction. The excess of the vaginal
wall is excised, the vaginal wall is closed with running sutures,
and a packing is inserted for 2 hours.
[0059] Transvaginal Repair of Enterocele Using Fascial Anchors
[0060] In a further invention, a procedure for transvaginal repair
of enterocele using fascial anchors is provided herein.
[0061] In accordance with the invention, the patient is first
placed in the lithotomy position. During preparation and draping, a
rectal packing is inserted to facilitate the surgical procedure. A
Foley catheter or suprapubic catheter is inserted to drain the
bladder, and a ring retractor with six hooks is used to expose the
vaginal canal.
[0062] The vaginal cuff is then held with Allis clamps and a
vertical incision is made. The vaginal wall is dissected free,
exposing the enterocele sac. The hooks of the ring retractor are
used to hold the vaginal wall internally. Once the vaginal wall is
securely held, the enterocele sac is dissected free, exposing
posteriorly the pre rectal fascia and anteriorly the bladder wall.
The enterocele sac is then opened, exposing the peritoneal
contents. A large moist pad is inserted in the peritoneal cavity
and a deep right angle retractor is used to elevate the anterior
segment (bladder). The small bowel or distal colon is pushed away
from the operating field.
[0063] A deep posterior retractor is then inserted posteriorly to
displace the rectum laterally to the left side exposing the right
pararectal area. By sliding a finger over this space, the soft
levator musculature can be felt, and, just posteriorly, the hard
surface of the coccigeus muscle and sacrospinous ligament, running
from the ischial spine to the sacrum.
[0064] Using a straight fascial anchor and under finger control,
two absorbable anchors are inserted through the right sacrospinous
ligament 2-3 cm medial to the ischial spine. Each of the anchors
are preloaded with suture, such that the sutures are threaded
through the anchor, and can slide through the anchor freely when
pulling on only one end. The strength and fixedness of each
anchor's insertion is tested by a strong pull on both ends of the
anchor's sutures.
[0065] At the deepest point of the vagina, one free end of the
sutures is used for threading through a good sized portion of
vaginal wall, and the end is then transferred to the vaginal lumen.
Then the other end of the suture is likewise also transferred to
the vaginal lumen, at a distance of approximately 1 to 2 cm from
the prior suture.
[0066] Two sequential purse string sutures of No. 1 Vycryl are then
used to close the peritoneal cavity. The suture includes the pre
rectal fascia, the sacrouterine and cardinal ligaments, and the
perivesical area. Alternatively, a Dexon mesh can be included with
the last suture to reinforce the closure of the cul de sac. The
sutures are tied and the excess of peritoneum is excised.
[0067] The pre rectal fascia is then closed using a running
absorbable suture. The excess of vaginal wall is excised, and the
vaginal wall closed with a running suture. The sacrospinous sutures
are tied individually with the help of a right angle retractor,
making sure that the vaginal dome slides tension to the anchoring
point deep in the vagina.
[0068] A vaginal packing is then inserted for 2 hours and the
patient can be discharged home after recuperation from
anesthesia.
[0069] Sling Procedure Using Fascial Anchors (Using Synthetic
Material, Cadaveric or Autologous Fascia)
[0070] In a further invention, a sling procedure using fascial
anchors (using synthetic material, cadaveric or autologous fascia)
is provided herein. This technique is a vaginal sling procedure
which provides treatment of stress incontinence in patients with
minimal or mild urethral mobility (intrinsic sphincter
deficiency).
[0071] In accordance with the invention, the patient is first
placed under general, spinal or local anesthesia with controlled
sedation. Once anesthetized, two oblique incisions are made in the
anterior vaginal wall. The vaginal wall is dissected laterally over
the periurethral fascia.
[0072] Using Mayo scissors and pointing toward the ipsilateral
shoulder, the retropubic space is entered in each side. The
urethropelvic pelvic ligament is detached creating a small window
in the retropubic space, the window being large enough to pass two
fingers. The retropubic space is then freed from adhesions.
[0073] Under careful finger control, the curved fascial anchor is
passed from the vaginal to the suprapubic area. The tip of the
instrument is pointed just above the periostium of the superior
rami of the symphisis. It is strongly recommended to transfer the
anchor as close to the pubic bone as possible in order to minimize
suprapubic pain.
[0074] Keeping this guideline in mind, a fascial anchor having a
No. 1 Prolene suture is inserted in the suprapubic area. After
fixation of the anchor, the ends of the anchor's sutures are pulled
on to verify that the anchor has been strongly fixated into the
tissue. A total of two anchors are inserted. The free end of the
Prolene sutures will be used to support the fascial sling.
[0075] A segment of sling 7 to 8 cm by 2 cms in size is then
obtained. Various options are available for the sling material. The
sling can be made from cadaveric or autologous fascia (from the
abdominal wall or fascia lata). Or, if desired, the sling can be
made from any FDA approved synthetic material.
[0076] One of the Prolene sutures is used to firmly anchor one end
of the sling. Several passes of the needle over the tissue is
recommended. It is important for the sling to slide freely from the
suture.
[0077] Using a long beak right angle clamp, a tunnel is made
underneath the vaginal wall at the level of the bladder neck. Using
a free suture as a guide, the sling is transferred beneath the
vaginal wall to the contralateral side. As an alternative in
difficult cases, a transverse incision is made at the level of the
bladder neck and the sling is transferred to the contralateral
side.
[0078] In a similar fashion, the second Prolene suture in the
contralateral side will include the other side of the sling, while
ensuring that the sling can freely slide from the suture.
Cystoscopy is performed in order to assure bladder integrity and
good positioning of the sling. By the nature of the procedure,
there is no need to check for ureteric efflux. A suprapubic
catheter is inserted for drainage and its position is controlled
during the cystoscopy.
[0079] The Prolene sutures are then tied sequentially after
inserting a cystoscopy sheath into the urethra at a 30-degree
angle. Alternatively, a clip applier can be used, obviating the
need for suture ties. The vaginal wall is closed with a running 2-0
Vycryl suture. After two hours, the vaginal packing is removed and
the suprapubic catheter is plugged. The patient is instructed to
check post void residuals every 2-3 hours or as required by the
urgency to urinate. The patient can be discharged home after 4-6
hours on a regular diet, oral antibiotics and pain medication. The
patient can resume normal activities (walking, standing, sitting,
etc.) as soon as they feel comfortable. Impact exercise or heavy
lifting should be avoided for one month. The suprapubic catheter is
removed as soon as the residuals of urine are less than 60 cc.
[0080] Vaginal Wall Sling Using Facial Anchors
[0081] In a further invention, a vaginal sling procedure is
provided herein for the treatment of stress incontinence in
patients with mild to moderate cystocele (lateral defect only).
[0082] In accordance with the invention, under general, spinal or
local anesthesia with controlled sedation, two oblique incisions
are made in the anterior vaginal wall. The vaginal wall is
dissected laterally over the periurethral fascia. Using Mayo
scissors and pointing toward the ipsilateral shoulder, the
retropubic space is entered in each side. The urethropelvic pelvic
ligament is detached, creating a small window in the retropubic
space sufficiently large to pass two fingers. The retropubic space
is then freed from adhesions.
[0083] Under careful finger control, the curved fascial anchor is
passed from the vaginal to the suprapubic area. The tip of the
instrument is pointed just above the periostium of the superior
rami of the symphisis. It is strongly recommended to transfer the
anchor as close to the public bone as possible in order to minimize
suprapubic pain.
[0084] A fascial anchor having a No. 1 Prolene suture is then
inserted into the tissue of the suprapubic area. After the
inserting the anchor into the tissue, the ends of the sutures are
pulled down to ensure that the anchor has been securely fixed into
to the tissue. A total of four anchors are fixed in the tissue, in
all. The free end of the Prolene sutures will be used to support
the anterior vaginal wall.
[0085] The first suture will include the perivesical fascia and
medial edge of the urethropelvic ligament at the level of the
bladder neck. The second suture will include the urethropelvic
ligament (midurethral complex), the edge of the urethropelvic
ligament, and the periurethral fascia.
[0086] The same maneuver is then performed in the contra lateral
side.
[0087] Once these steps have been completed, cystoscopy is
performed in order to ensure bladder integrity and good efflux of
urine from the ureteric orifices. A suprapubic catheter is inserted
for drainage and its position is controlled during the cystoscopy.
The Prolene sutures are then tied sequentially after inserting a
cystoscopy sheath into the urethra at a 30 degree angle.
Alternatively, a clip applier can be used, obviating the need for
suture ties.
[0088] The vaginal wall is then closed with a running 2-0 Vycryl
suture. After two hours, the vaginal packing is removed and the
suprapubic catheter is plugged. The patient is instructed to check
post void residuals every 2-3 hours or as required by the urgency
to urinate. The patient can be discharged home after 4-6 hours on
regular diet, oral antibiotics and pain medication. The patient can
resume normal activities (walking, standing, sitting, etc.) as soon
as they feel comfortable. Impact exercise or heavy lifting should
be avoided for one month. The suprapubic catheter is removed as
soon as the residuals of urine are less than 60 cc.
[0089] Supporting the Vaginal Cuff During Vaginal Hysterectony
Using Fascial Anchors.
[0090] In a further invention, a technique for supporting the
vaginal cuff during vaginal hysterectomy using fascial anchors is
also provided herein. This technique is is recommended for closure
of the vaginal cuff at the time of vaginal hysterectomy for
prolapse. It is aimed at preventing prolapse of the vaginal cuff,
preservation of vaginal depth and restoration of the normal vaginal
axis.
[0091] Once the hysterectomy has been completed, marking sutures
are left in place at the sacrouterine-cardinal complex, uterine
artery and broad ligaments, and the peritoneal sac is left open. A
large moist pad is inserted in the peritoneal sac and retracted
with a deep right angle retractor. The small bowel or distal colon
is pushed away from the operating field.
[0092] A deep posterior retractor is inserted to displace the
rectum to the left, exposing the right pararectal area. Sliding a
finger over this space the soft levator musculature is felt, and
just posteriorly, the hard surface of the coccigeus muscle and
sacrospinous ligament, running between the ischial spine and the
sacrum.
[0093] Using a straight fascial anchor and under finger control,
two absorbable anchors are inserted through the right sacrospinous
ligament, 2-3 cm medial to the ischial spine. The strength of the
anchor is tested by a strong pull on the sutures that are
preloaded. The sutures should slide freely.
[0094] At the deepest point of the vagina, one free end of the
suture is used for threading through a good sized segment of the
vaginal wall. This free end of the suture is then transferred to
the vaginal lumen. The other end of the suture is also threaded
through the vaginal lumen, at a distance of 1 to 2 cm from the
prior suture.
[0095] Two sequential purse string sutures of No. 1 Vycryl are then
used to close the peritoneal cavity. The suture includes the
pre-rectal fascia, the sacrouterine and cardinal ligaments, and the
perivesical area. Alternatively, a Dexon mesh can be included with
the last suture to reinforce the closure of the cul de sac. The
sutures are tied and the excess of peritoneum is excised.
[0096] The broad ligament sutures are then tied together in the
midline. Then the uterine artery sutures and the sacrouterine
ligament sutures are cut. The vaginal cuff is closed in a
transverse fashion with running locking sutures. The rest of the
vaginal reconstruction is performed as indicated.
[0097] Repair of Vaginal Vault Prolapse Using Fascial Anchors
[0098] In a further invention, a technique for repair of vaginal
vault prolapse using fascial anchors is also provided herein. A
similar technique can be used to support the uterus and vaginal
cuff in cases of severe vault prolapse. No hysterectomy or opening
of the peritoneum is required.
[0099] This surgery is similar to the enterocele repair. A vertical
incision is made over the posterior and superior vaginal wall. The
dissection is carried out laterally to enter the extraperitoneal
pararectal space, toward the coccigeus muscle (above levators,
beneath peritoneum and lateral to the rectum). The sacrospinous
ligament is felt as it attaches to the ischial spine. Two fascial
anchors are applied 2-3 cm medial from the spine. The end to the
sutures is used to anchor the vaginal wall in a similar fashion, as
described above. After closing the vaginal wall, the sutures are
tied, making sure that the vaginal wall slides easy to the
anchoring point.
[0100] Having described this invention with regard to specific
embodiments, it is to be understood that the description is not
meant as a limitation since further modifications and variations
may be apparent or may suggest themselves to those skilled in the
art. It is intended that the present application cover all such
modifications and variations.
* * * * *