Title of Invention

AN INTRA-VAGINAL SPLINT

Abstract An intra-vaginal splint which includes two longitudinally extending side arms both having first and second ends, said side arms being connected at their respective first ends by a first connecting member and at their respective second ends by a second connecting member wherein said first and second connecting members are of different lengths.
Full Text AN INTRA-VAGINAL SPLINT
METHOD OF SURGICAL REPAIR OF VAGINA DAMAGED BY PELVIC
ORGAN PROLAPSE AND PROSTHETIC MATERIALS AND DEVICES
SUITABLE FOR USE THEREIN
This invention relates to a method for the surgical repair of a vaginal wall
damaged by the prolapse of any one or more of the pelvic organs, various
prosthetic materials and devices useful in such surgery and to kits suitable for
use by surgeons when treating wcmen suffering from pelvic organ prolapse.
Background to the Invention
In Australia almost one in four women undergo surgery for pelvic organ
prolapse. In many other countries the rates are higher. Each year in the USA
approximately 200,000 women undergo pelvic organ prolapse surgery. Pelvic
organ prolapse generally involves the descent of the uterus, the bladder or the
rectum along the vagina towards (or in extreme cases protruding beyond) the
introitus. Women of advancing years or those that have borne several children
are more frequent sufferers of pelvic organ prolapse.
Traditional vaginal surgery is associated with a high failure rate. It is
between 30-40%. Complex and elaborate abdominal, vaginal and laparoscopic
procedures such as abdominal sacral colpopexy, transvaginal sacrospinous
ligament fixation and laparoscopic sacral colpopexy have been developed to
reduce the risk of prolapse recurrence. Unfortunately these procedures require
a high level of surgical expertise and are only available to a small number of
specialist practitioners and therefore to a small number of patients. Details of
various procedures currently in use are described in Boyles SH., Weber AM,
Meyn L. - "Procedures for pelvic organ prolapse in the United States", 1979-
1997. American Journal of Obstetric Gynaecology 2003, 188; 108-115.
More recently there has been a trend towards the use of reinforcing
materials to support a vaginal wall damaged by prolapse. Prosthetic materials
such as donor fascia lata, pig dermis and various types of synthetic mesh have
been utilized with mixed success. These materials are generally positioned
under the vaginal wall or walls and sutured into position. The applicant has
recognized that the synthetic meshes currently in use are far from ideal as they
have been designed principally for the treatment of anterior abdominal wall
herniation and are generally too heavy for the treatment of genital prolapse.
Some of the meshes in current use are associated with long term problems
which include pain with sexual intercourse, erosion of the mesh into the lumen of the vagina (this requires surgery to remedy) and shrinkage of the mesh.
It is an object of the present invention to provide a simplified surgical
procedure suitable for treatment of different forms of pelvic organ prolapse. It is
a further object to provide an improved prosthetic material and device suitable
for use in vaginal repair in the treatment of pelvic organ prolapse.
Summary of the Invention
In accordance with the first aspect of the present invention there is
provided a method for repairing a vaginal wall which has been damaged by one
or more prolapsed pelvic organs, said method including:
(a) mobilising the vaginal epithelium off the underlying fascia of at least a
portion of the damaged vaginal wall;
(b) positioning a prosthetic material over the exposed fascia;
(c) re-fixing the vaginal epithelium over the prosthetic material and the
fascia; and thereafter
(d) locating an intra-vaginal splint into the vagina.
In this description of the method of the invention and elsewhere in this
specification (including the claims) the phrase "intra-vaginal splint" means any
device sized to be located in the lumen of the vagina and which, once located in
the lumen of the vagina, will reduce the mobility of the vaginal walls.
Preferably the prosthetic material once positioned over the exposed
fascia is attached to the fascia. Such attachment is usually achieved by
sutures, but other methods may be utilised such as by the application of
adhesives or surgical staples.
In some cases of prolapse, repair is required to only one of the vaginal
vails. However, in many cases of prolapse, repair is required to the anterior and
>osterior walls of the vagina. In such cases it is not important whether the
, interior or posterior wall is repaired first, although it is usually convenient to
i spair the anterior wall first. Thus, in accordance with the present invention, if
both vaginal walls are to be repaired, an intra-vaginal splint is located in the
vagina after prosthetic material has been positioned over the fascias of both the
anterior and posterior vaginal walls and the vaginal epithelium of both
respective walls has been re-fixed over the prosthetic material and the fascias.
Therefore, in the case where both the anterior and posterior vaginal walls
are being repaired the preferred method of the invention includes the following
steps:
(a) mobilising the vaginal epithelium off the underlying fascia of at least a
portion of the anterior vaginal wall;
(b) positioning a first prosthetic material over the exposed fascia of the
anterior vaginal wall;
(c) re-fixing the vaginal epithelium over the said first prosthetic material
and the fascia of the anterior vaginal wall;
(d) mobilising the vaginal epithelium off the underlying fascia of at least a
portion of the posterior vaginal wall;
(e) positioning a second prosthetic material over the exposed fascia of the
posterior vaginal wall;
(f) re-fixing the vaginal epithelium over the said second prosthetic material
and the fascia of the posterior vaginal wall; and thereafter
(g) locating an intra-vaginal spi'int into the vagina.
Preferably, the surgery is performed vaginally.
Whether repairing one or both vaginal walls, in most cases the intra-
vaginal splint should be removed after the prosthetic material has become
incorporated into the vaginal wall tissue. Preferably the intra-vaginal splint
remains in position in the vagina for at least 3 weeks following insertion. Most
preferably the intra-vaginal splint is removed between 4 to 6 weeks following
nsertion.
When repairing the anterior vaginal wall, the vaginal epithelium covering
he fascia is preferably mobilised by incision and lateral dissection - most
lesirably dissection is carried out to (or proximate to) the arcus tendineous facia
elvie on both sides. If it is only the anterior vaginal wall that is to be repaired it
preferred that dissection is continued towards the sacrospinous ligaments on
both sides. If both the anterior and posterior walls of the vagina are being
repaired it is preferred that the dissection of the epithelium of the anterior wall
continue through the arcus tendineous fascia pelvie and into the paravaginal
space on each side such that the inner aspect of the pubic bone can be
palpated. The fascia may be plicated with sutures before the first prosthetic
material is positioned over the exposed fascia.
Likewise, when repairing the posterior vaginal wall the underlying fascia
(the recto-vaginal septum fascia) may be plicated. The vaginal epithelium
covering the posterior wall is preferably mobilised by incision and dissection -
laterally to the levator ani muscles on each side and in the upper part of the
vagina, in a lateral and cranial direction through the rectal pillars on both sides
towards the sacrospinous ligaments on each side.
Any of the conventional prosthetic materials currently in use for the
treatment of pelvic organ prolapse can be employed when performing the
suigical methods described above. Thus, a xenograft material, such as pig
dermis, an allograft or homograft of skin or a synthetic material suitable for
reinforcing the vaginal wall might be utilized.
It is preferred however, that the prosthetic material used in the method of
the present invention be a synthetic mesh. More particularly it is preferred that
the prosthetic material have the characteristics described below in the
description of a new synthetic mesh.
The use of an intra-vaginal splint after the positioning of the prosthetic
material has been found by the applicant to result in improved wound healing
and a. reduced rate of surgical failure. It is preferred that the intra-vaginal splint
useiin the methods described above have the configuration and characteristics
of the new intra-vaginal splint described below.
In accordance with a further aspect of the present invention there is
provided a flexible synthetic mesh for use in the repair of a vaginal wall
damaged by the prolapse of one or more pelvic organs said synthetic mesh
including a plurality of open pores bounded by strands made of non-woven
polymeric material, wherein the junctions between the respective strands are
withuin open interstices and wherein a majority of the open pores of the mesh
havean area of less than 15 mm2.
Preferably all of the pores of the mesh have an area of less than 15 mm2.
Most preferably, the pore size of a majority of the pores of the mesh have an
area of less than 10mm2.
The mesh may be of any suitable shape but generally will incorporate a
central body portion and two longitudinal side portions. In the most preferred
embodiments the pore size in the central body portion of the mesh is greater
than the pore size in the longitudinal side portions. Most preferably the area of
each of the pores in the body of the mesh are less than 10 mm2 and the area of
each of the pores in the side portions of the mesh will be less than 5 mm2. It is
also preferred that the side portions have a width of at least 3 mm. Most
preferably the width of the side portions is between 4 and 8 mm.
It is highly desirable that the mesh be light and very flexible. Preferably
the mesh has a weight of less than 0.0080 g/cm2. Most preferably its weight is
between 0.0020 and 0.0050 g/cm2. Any flexible biocompatible polymeric
material may be utilised. The preferred polymeric material is polypropylene and
the polypropylene fibres are preferably monofilament fibres.
The mesh of the present invention does not include any open interstices
at the junctions between the respective strands. This is important to minimise
bacterial growth in or around the mesh after it has been positioned under the
virginal epithelium. Thus the mesh will not be woven but instead can be formed
by stamping the profile out of a sheet of the polymeric material being used or
alternatively, adjacent strands may be connected in a way which does not
produce open interstices at the junctions between the respective strands. Most
conveniently this is achieved by bending or welding.
The synthetic mesh of the present invention may be produced in a
substantially oval shape for the repair of the anterior vaginal wall and may be
substantially trapezium shaped with two extension arms extending upwardly
and at an angle away from both side portions of the mesh for repair of the
posterior vaginal wall. In a particularly preferred embodiment the oval shaped
mesh (intended for use in repairing the anterior vaginal wall) includes two lateral
arms, one extending from either side portion of the mesh from the mid section
on each side.
When using the preferred oval shaped mesh with lateral arms shaped for
repair of the anterior vaginal wall, the mesh is used in the methods described
above by being positioned over the pubocervical fascia with each lateral arm
placed into a tunnel extending from the anterior vaginal wall dissection to the
paravaginal space and the inner aspect of the pubic bone.
The preferred mesh described above for use in the method of the
invention for repair of the posterior vaginal wall is positioned over the recto-
vaginal septum fascia with each extension arm placed into the tunnel extending
from the posterior vaginal wall dissection to the sacrospinous ligament. The
mesh is positioned over the fascia and the posterior vaginal wall epithelium is
then closed and re-fixed over the mesh to complete the repair.
The prosthetic material, whether it be a preferred synthetic mesh
described above or some other suitable material is desirably attached to the
respective fascia by using sutures attaching the sides of the prosthetic material
to the fascia wall.
Once the vaginal wall or walls have been repaired an intra-vaginal splint
is located in the vagina and preferably sutured into position to prevent extrusion.
Alternatively the intra-vaginal splint may include lateral spurs. Preferably the
intra-vaginal splint is a semi-rigid device and most preferably it is made of a
flexible medical grade silicone. As the vagina does not have a universal shape
and size it is preferred that the surgeon have available to him at least three
differently sized splints so that a splint may be selected which will be
appropriate for the patient being treated. Most desirably, a sizing kit will be
jtilized allowing the surgeon to choose the appropriately sized splint. The
sizing kit should comprise at least three differently sized model splints
>referably made of medical grade silicone, so that the model splints may be
: terilized allowing multiple use. The surgeon will choose the particular sized
i itra-vaginal splint that matches the corresponding model intra-vaginal splint
f om the sizing kit, preferably choosing the splint that most comfortably fits into
t le vagina following the repair whilst contacting both lateral vaginal walls and
t le superior aspect of the vagina.
In one form, the intra-vaginal splint includes two longitudinally extending
s de arms both having first and second ends; said side arms being connected at
their respective first ends by a first connecting member and at their respective
second ends by a second connecting member wherein said first and second
connecting members are of different lengths.
Preferably, the connecting members are straight and are parallel with
each other. Preferably, the longitudinally extending side arms are straight but
are not parallel with each other.
In a most preferred form the intra-vaginal splint is trapezium shaped.
The intra-vaginal splint is desirably formed so that the longitudinally extending
side arms are disposed in a first plane in the portion of the splint proximate the
first connecting member and in a second plane (which is at an angle to the first
plane) for the remaining portion of the splint. Preferably the angle between the
respective planes is between 8 to 159. Most desirably it is about 109.
Preferably the intra-vaginal splint is resilient and bendable about its
longitudinal axis so that on application of a bending force the two longitudinally
extending side members may be brought into close proximity so that they will be
substantially side by side and whereupon release of the bending force will result
in the longitudinally extending side arms moving away from each other. This
feature facilitates easy insertion of the splint into the vagina.
All or part of the interior of the splint may be closed by a membrane. In
one embodiment the membrane is twin skinned and is inflatable so that inflation
of the membrane once the intra-vaginal splint is in place will permit the surgeon
to tamponade the vagina to prevent and/or control post operative bleeding.
This may avoid the need to use a vaginal pack. However, if the surgeon wishes
to place a vaginal pack this can be placed around the splint and a urethral
catheter can also be placed. Preferably the space between the respective skins
or layers of the membrane is in fluid communication with the inside channel of a
tube attached to or integrally formed with one of the membrane skins.
The intra-vaginal splint is used to improve wound healing and strength,
reduce movement and displacement of the mesh whilst it is becoming
incorporated into the vaginal fascial tissues and to avoid the need to use
supporting sutures into structures such as the sacrospinous ligament high onto
the uterosacral ligaments or paravaginal tissues. Such sutures are often
difficult to place and are associated with significant patient morbidity.
In a further aspect of the present invention there is provided a kit suitable
for use by surgeons when surgically treating women suffering from pelvic organ
prolapse said kit including at least one piece of a flexible synthetic mesh having
a plurality of open pores bounded by strands made of non-woven polymeric
material in which junctions between the respective strands are without open
interstices and wherein a majority of the open pores of the mesh have an area
of less than 15mm2 and one or more differently sized intra-vaginal splints. The
flexible synthetic mesh may be provided in a sheet so that appropriately shaped
segments can be cut out of the sheet for use in the surgical methods of the
invention. Preferably the kit includes a selection of pre-shaped meshes for
treatment of both the anterior arid posterior vaginal walls in the preferred
shapes, pore sizes and configurations as described above. The kit may also
include written directions for the use of the components of the kit in accordance
with the surgical methods hereinbefore described.
The present invention is hereafter further described by reference to
preferred embodiments with reference to the drawings in which:-
Figure 1 is a schematic representation of the anterior vaginal wall
showing incision into the vaginal epithelium;
Figure 2 is a schematic representation of the anterior vaginal wall after
nobilisation of the epithelium;
Figure 3 is a schematic representation of the anterior vaginal wall with
nesh positioned over the exposed fascia and sutured into place;
Figure 4 is a schematic representation of the anterior vaginal wall after
the epithelium has been refixed and closed with sutures;
Figure 5 is a schematic representation of the posterior vaginal wall
slowing incision into the epithelium;
Figure 6 is a schematic representation of the posterior vaginal wall after
rr obilisation of the vaginal epithelium;
Figure 7 is a schematic representation of the posterior vaginal wall with
m jsh positioned over the exposed fascia and sutured into place;
Figure 8 is a schematic representation of the posterior vaginal wall after
tlv epithelium has been refixed and closed with sutures;
Figure 9 is a schematic representation of a preferred shape and
configuration of a mesh of the present invention for repair of the posterior
vaginal wall;
Figure 10 is a schematic representation of a preferred shape and
configuration of a mesh of the present invention for repair of the anterior vaginal
wall;
Figure 11 is a schematic representation of a preferred intra-vaginal splint
(top view);
Figure 12 is a schematic representation of the intra-vaginal splint shown
in Figure 11 (side view);
Figure 13 is a cross-sectioned representation of the intra-vaginal splint
shown in Figure 12 showing the cenlral membrane;
Figure 14 is a schematic representation of the intra-vaginal splint shown
in Figure 11 (end view);
Figure 15 is a perspective schematic representation of the intra-vaginal
splint shown in Figure 11;
Figure 16 is a schematic representation of an intra-vaginal splint of the
nvention incorporating an inflatable membrane;
Figure 17 is a side view of the intra-vaginal splint shown in Figure 16 with
1 ie membrane inflated;
Figure 18 is a schematic representation of a kit of three differently sized
r lodel intra-vaginal splints;
Figure 19 is a schematic representation showing the positioning of a
n esh reinforcing the posterior vaginal wall; and
Figure 20 depicts the intra-vaginal splint once placed within the vagina.
Turning to Figure 1 there is shown the open vagina (1) and anterior
v£ ginal wall (2). The vaginal wall (2) is covered by an epithelium layer (3). An
ini ision into the vaginal epithelium is shown in Figure 1. Once the initial incision
al pe ?led and held away from the fascia (6) as shown in Figure 2. This lateral
dis section is carried out to and then through the arcus tendinous fascia pelvie
on Doth sides, and into the paravaginal spaces on each side. The fascia (6) is
pre erably plicated (not shown) once the epithelium (3) has been mobilized off
the fascia wall. Mesh (7) is then positioned over the defect (4) of the exposed
fascia (6). This is with each lateral extension arm (7a, 7b) of the mesh (7)
placed into the ipsilateral paravaginal space such that the lateral extension
arms (7a, 7b) come into contact with the inner aspect of the pubic bone. The
mesh (7) shown in Figure 3 can be seen in greater detail in Figure 10. The
mesh (7) has a central body portion (8) which is substantially oval in shape and
which has top to base longitudinal side portions (9 and 10) which merge into the
lateral extension arms (7a, 7b). For most cases a mesh having a dimension of
about 50 mm and a width (excluding the lateral extension arms) of between
about 30-40mm will suffice. The lateral extension arms (7a, 7b) in most cases
will be about 30 mm long and 20 mm in width. It will be appreciated that the
mesh size will depend largely on the dimensions of the vaginal wall being
repaired. The mesh shown in Figures 3 and 10 is made from polypropylene. In
the central body portion (8) of the mesh (7) the area of each of the pores is
approximately 9mm2 (3 mm x 3 mm). The side portions (9 and 10) and
extension arms (7a, 7b) have a pore size of approximately 3mm2 (1 mm x 3
mm). The mesh is made from monofilament polypropylene and is a bonded or
welded mesh having a weight of about 0.003 g/cm2. Once the mesh (7) has
been positioned over the fascia (6) of the anterior vaginal wall (2) it is attached
onto the fascia (6) by sutures (11). Excess vaginal epithelium is then trimmed
and the anterior vaginal wall is closed by sutures (12) as shown in Figure 4.
Repair of the posterior vaginal wall is shown in Figures 5 to 8. In Figure
5 posterior vaginal wall (13) is shown with the epithelium (14) of the posterior
vaginal wall in place. A longitudinal' incision is performed in order to mobilise
the epithelium (14) off the underlying fascia (15) as shown in Figure 5. The
defect 15a in fascia 15 is illustrated in Figure 6. Dissection is carried out
laterally to the levator ani muscles on each side. This is also depicted in Figure
6. In the upper part of the vagina, dissection is continued in a lateral and cranial
direction through the rectal pillars on both sides towards the sacrospinous
ligaments on each side. This forms bilateral tunnels from the posterior vaginal
wall dissection to each sacrospinous ligament. The fascia of the recto-vaginal
septum is preferably plicated (not shown). The pre-shaped mesh (16) designed
for the posterior vaginal wall repair is shown in Figures 7 and 9. It is placed over
the recto-vaginal septum facia (15) with each extension arm (17,18) placed into
the tunnel extending from the posterior vaginal wall dissection to the
sacrospinous ligament. The positioning of the mesh (16) is more clearly
depicted in Figure 19 which shows its location relative to the sacrospinous
ligament (33), the rectum (34) and the vagina (35). Turning to Figure 9 it can be
seen that the pre-shaped mesh (16) designed for the posterior vaginal wall (13)
repair has a central body portion (19) and longitudinal side portions (20) and
(21). The width of this mesh varies from about 3 cm at the base to 11 cm at the
top. The width at the top (22) of the central body portion (19) of the mesh (16)
is about 6 cm. The midline length of the mesh (16) is about 7 cm and the length
of each extension arm (17,18) is about 5 cm with a width of about 1.5 cm.
Again the mesh (16) is made from monofilament polypropylene and is a bonded
or welded mesh having a weight of about 0.0030 g/cm2. The area of the pore
size of each of the pores of the central body portion (19) of the mesh is
approximately 9mm2 (3x3 mm) and at the longitudinal side portions (20,21)
approximately 3mm2 (1x3 mm).
Once the mesh (16) has been positioned over the fascia, it is anchored
, ito place by sutures (23) as shown in Figure 7. Excess posterior vaginal wall
( pithelium (14) is trimmed and the vaginal epithelium (14) is refixed over mesh
(16) as shown in Figure 8.
At this point the intra-vaginal splint sizing kit shown in Figure 18 is used.
7 ie surgeon selects from the kit the appropriately sized splint. Once the correct
s ze for the intra-vaginal splint has been determined by using the model splints
fr >m the kit, the intra-vaginal splint is inserted into the vagina and sutured into
p( sition to prevent extrusion. This is best seen in Figure 20 where vaginal
sf lint (36) is shown positioned within the vagina (35). The intra-vaginal splint
shown in Figure 11 has small apertures (33) at one end for receiving sutures.
The preferred intra-vaginal splint is shown in Figures 11 to 17. It includes
lor gitudinally extending side arms (24) and (25), and connecting members (26)
an> I (27). Preferably the base (30) of the splint (that section extending about 20
mn from the connecting member (26) is inclined at about 10° from the
ren aining portion (31) of the splint. This is best seen in Figures 12 and 13.
The central part of the splint is closed by a silicone membrane (32). In one
embodiment the membrane is twin skinned and is inflatable - see Figure 16.
Inflation of the membrane with fluid is possible through tube 32a which provides
a fluid channel into the space between the respective layers 32b ad 32c of the
membrane. This is shown in Figure 16 (perspective view) and 17 (side view).
The intra-vaginal splint is preferably retained in the vagina for a period of
four weeks. Once this period has elapsed the splint can be removed by which
time the synthetic mesh should have become incorporated into the tissue of
each of the respective vaginal walls.
Clinical Trial Results
The method of the invention has been the subject of a clinical trial
involving 49 women. The mean age of the women was 57.7 years (range 34-
79) and mean parity of 2.8 (range 1-6). Twenty-two women (45%) had
undergone a prior hysterectomy and 21 (43%) at least one surgical procedure
for pelvic organ prolapse. Nine women (18%) had undergone surgery for stress
incontinence and five (10.2%) women had undergone two or more operations
or pelvic organ prolapse.
The operations performed on the 49 women are detailed in Table 1 set
>ut below. A synthetic mesh was used for the anterior vaginal repair only in 5
/omen, posterior vaginal repair only in 32 women and both anterior and
I osterior repairs in 12 women.
When mesh was used in the anterior vaginal repair only, the vaginal
i pithelium was dissected off the underlying fascia. Laterally, dissection
c Dntinued until each arcus tendineus fascia pelvis was reached. Superior and
Ic'teral, dissection continued until each sacrospinous ligament was reached. A
V shaped piece of synthetic mesh was placed over the fascia with the extension
a ms of the mesh being placed in the tunnels created by the dissection onto the
s; crospinous ligaments. Sutures v/ere not placed in the sacrospinous
lie aments. The mesh was placed loosely and fixed in place with two to three
si tures securing the mesh onto the fascia. Excess vaginal epithelium was
re noved and the epithelium closed over the mesh.
When mesh was used to reinforce the posterior vaginal repair, the
va jinal epithelium was dissected off the underlying fascia. Dissection
co itinued laterally on each side to the levator ani muscles. Superior and
lateral, the dissection continued through the rectal pillars to each sacrospinous
ligament. A "Y-shaped" piece of mesh was placed over the fascia with the
extension arms of the mesh being placed in the tunnels created by the
dissection onto the sacrospinous ligaments so that the mesh abutted each
sacrospinous ligament. Sutures were not placed into the sacrospinous
ligaments. Excess epithelium was removed and the posterior vaginal wall
epithelium closed over the mesh.
When mesh was used for to reinforce both anterior and posterior vaginal
walls, the mesh was placed under the posterior vaginal wall epithelium as
described above. The placement of mesh under the anterior vaginal wall
epithelium differed from the technique described above. Lateral dissection was
continued through each arcus tendineus fascia pelvi into right and left
Daravaginal spaces so the inner aspect of the pubic bone could be palpated.
Anteriorly, there was no dissection onto the sacrospinous ligaments. A "cross-
;haped" piece of mesh was cut and placed over the fascia with the extension
; rms being placed into each paravaginal space so that the mesh abutted the
i iner aspect of the pubic bone on each side.
All patients received prophylactic antibiotic therapy that was continued for
4 3 hours following surgery. Clexane was routinely used in each patient and
c mtinued until the patient was discharged from hospital.
At the completion of surgery an appropriately sized intra-vaginal splint
was placed in the vagina and sutured in place to prevent dislodgement. The
vaginal splint was made of medical grade silicone and three sizes were used for
th foi r weeks to remove the intra-vaginal splint in the consulting room. By four
we ?ks the sutures holding the vaginal spiint in place had dissolved.
Results
Patients were reviewed four weeks following surgery to remove the
vag nal splint. No woman had developed further symptomatic or objective
evicance of grade 2 (Baden-Walker classification) or more pelvic organ
prolapse. No major intraoperative or postoperative complications occurred.
Discussion
Following surgery for pelvic organ prolapse the repair is exposed to rises
in intra-abdominal pressure as the patient mobilizes or with coughing, vomiting
and straining with bowel evacuation. Potentially, rises in intra-abdominal
pressure may adversely effect the healing of the vaginal repair leading to
surgical failure and recurrent prolapse. By reinforcing the vaginal repair with
mesh and supporting the vagina with a splinting device for four weeks following
surgery the risk of surgical failure and recurrent pelvic organ prolapse has been
reduced. Mesh is incorporated into the body tissues at three weeks. The
vaginal splinting device not only supports the vaginal tissues after surgery but
also supports the position of the mesh. By supporting the position of the mesh
until incorporation into the body tissues occurs it is possible to avoid placing
sutures into the sacrospinous ligaments or paravaginal spaces. This makes
surgery much simpler to perform and avoids the specific complications, which
can occur with suture placement into these structures.
This procedure is sufficiently simple for general gynaecologists,
urogynaecologists and urologists to perform.
Table 1. Details of surgery performed for pelvic organ prolapse
Surgery Cases (n)
Surgery using mesh
Anterior repair 5
Posterior repair 32
Anterior & posterior repair with mesh 12
Surgery (cont'd) Cases (n)
Additional Surgical Procedures
Anterior repair without mesh 7
Posterior repair without mesh 1
TVT 10
Laparoscopic colposuspension 13
Laparoscopic paravaginal repair 14
Vaginal hysterectomy 11
Laparoscopic sacral hysteropexy 3
Urethral reconstruction 1
Transvaginal urethrolysis 2
Martius graft 1
Laparoscopic tubal ligation 1
Laparoscopic oophorectomy 1
Laparoscopic adhesiolysis 1
Vaginoplasty for vaginal stenosis 1
Anal sphincter repair 3
The present invention involves a simplified procedure for the treatment of
pelvic organ prolapse and vaginal repair. The meshes described are
sgnificantly better suited for vaginal surgery as compared with meshes
a/ailable in the past and in current use and the surgical method enables
s jrgeons to treat prolapse without using complex abdominal, vaginal or
laparoscopic procedures.
WE CLAIM
1. An intra-vaginal splint which includes two longitudinally extending side
arms both having first and second ends, said side arms being
connected at their respective first ends by a first connecting member
and at their respective second ends by a second connecting member
wherein said first and second connecting members are of different
lengths.
2. An intra-vaginal splint as claimeid in claim 1 is made from a flexible
medical grade silicone.
3. An intra-vaginal splint as claimed in either claim 1 or claim 2 wherein
said splint is substantially trapezium shaped.
4. An intra-vaginal splint as claimed in any one of claims 1 to 3 wherein
all or part of the interior of the splint is closed by a membrane.
5. An intra-vaginal splint as claimed in claim 4 wherein the membrane is
twin walled and is inflatable.
6. An intra-vaginal splint as claimed in any one of claims 1 to 5 wherein
the longitudinally extending side arms are disposed in a first plane in
the portion of the splint proximate the first connecting member and in
a second plane, which is at an angle to the first plane, for the
remaining portion of the intra-vaginal splint.
7. An intra-vaginal splint as claimed in claim 6 wherein the angle between
the respective planes is between 8 to 15s .
8. An intra-vaginal splint as claimed in claim 7 wherein the angle between
the respective planes is about 101
9. An intra-vaginal splint substantially as hereinbefore described with
reference to what is shown in any of Figures 11 to 17.


An intra-vaginal splint which includes two longitudinally extending side
arms both having first and second ends, said side arms being connected at their respective first ends by a first connecting member and at their
respective second ends by a second connecting member wherein said
first and second connecting members are of different lengths.

Documents:

01147-kolnp-2005-abstract.pdf

01147-kolnp-2005-claims.pdf

01147-kolnp-2005-description complete.pdf

01147-kolnp-2005-drawings.pdf

01147-kolnp-2005-form 1.pdf

01147-kolnp-2005-form 2.pdf

01147-kolnp-2005-form 3.pdf

01147-kolnp-2005-form 5.pdf

01147-kolnp-2005-international publication.pdf

1147-KOLNP-2005-CORRESPONDENCE.pdf

1147-KOLNP-2005-FORM 27.pdf

1147-KOLNP-2005-FORM-27.pdf

1147-kolnp-2005-granted-abstract.pdf

1147-kolnp-2005-granted-assignment.pdf

1147-kolnp-2005-granted-claims.pdf

1147-kolnp-2005-granted-correspondence.pdf

1147-kolnp-2005-granted-description (complete).pdf

1147-kolnp-2005-granted-drawings.pdf

1147-kolnp-2005-granted-examination report.pdf

1147-kolnp-2005-granted-form 1.pdf

1147-kolnp-2005-granted-form 18.pdf

1147-kolnp-2005-granted-form 2.pdf

1147-kolnp-2005-granted-form 26.pdf

1147-kolnp-2005-granted-form 3.pdf

1147-kolnp-2005-granted-form 5.pdf

1147-kolnp-2005-granted-form 6.pdf

1147-kolnp-2005-granted-reply to examination report.pdf

1147-kolnp-2005-granted-specification.pdf

abstract-01147-kolnp-2005.jpg


Patent Number 238375
Indian Patent Application Number 1147/KOLNP/2005
PG Journal Number 06/2010
Publication Date 05-Feb-2010
Grant Date 03-Feb-2010
Date of Filing 15-Jun-2005
Name of Patentee ETHICON INC.
Applicant Address U.S. ROUTE #22, SOMERVILLE, NJ
Inventors:
# Inventor's Name Inventor's Address
1 CAREY, MARCUS, PATRICK 79, LAVENDER PARK ROAD, ELTHAM, VICTORIA 3095
PCT International Classification Number A61F 2/02
PCT International Application Number PCT/AU03/001494
PCT International Filing date 2003-11-12
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 2003904937 2003-09-10 Australia
2 2002952693 2002-11-15 Australia