U.S. patent application number 13/169671 was filed with the patent office on 2011-10-20 for method and apparatus for cystocele repair.
Invention is credited to Kimberly A. Anderson, Karen Pilney Montpetit, Brian P. Watschke.
Application Number | 20110257472 13/169671 |
Document ID | / |
Family ID | 34967598 |
Filed Date | 2011-10-20 |
United States Patent
Application |
20110257472 |
Kind Code |
A1 |
Montpetit; Karen Pilney ; et
al. |
October 20, 2011 |
METHOD AND APPARATUS FOR CYSTOCELE REPAIR
Abstract
A method for cystocele repair comprising the steps of:
establishing four pathways in tissue around a bladder of a patient,
introducing a strap into each of said pathways, and positioning
beneath said bladder of said patient a support member having each
said strap connected thereto such that said bladder of said patient
is supported by said support member and a bulge of said bladder
into a vagina of said patient is reduced.
Inventors: |
Montpetit; Karen Pilney;
(Mendota Heights, MN) ; Anderson; Kimberly A.;
(Eagen, MN) ; Watschke; Brian P.; (Eden Prairie,
MN) |
Family ID: |
34967598 |
Appl. No.: |
13/169671 |
Filed: |
June 27, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12059117 |
Mar 31, 2008 |
7993261 |
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13169671 |
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10840646 |
May 7, 2004 |
7351197 |
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12059117 |
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Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61B 17/06109 20130101;
A61B 2017/00805 20130101; A61B 2017/06009 20130101; A61F 2250/0087
20130101; A61F 2002/3071 20130101; A61B 2017/0496 20130101; A61F
2/0045 20130101; A61F 2250/0085 20130101; A61B 2017/0046 20130101;
A61B 2017/06076 20130101; A61B 17/06066 20130101; A61F 2250/0089
20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1-15. (canceled)
16. A surgical repair kit comprising: a support apparatus
comprising at least two straps, each of said straps comprising a
connector configured to mate with a tip of a needle; a first
helical needle configured to extend from an incision on a right
side of a patient through a right obturator foramen of said
patient, to an incision in a vagina of said patient; and a second
helical needle configured to extend from an incision on a left side
of said patient through a left obturator foramen of said patient,
to said incision in said vagina of said patient, wherein said
support apparatus comprises: a support member; a first strap
connected to the support member; a second strap connected to the
support member, and wherein the support member is made of an
implant material different from an implant material of at least one
of the first strap and the second strap.
17. The kit recited in claim 16 wherein said support member
comprises a biologic graft, and the at least one strap comprises
mesh.
18. The kit recited in claim 17 wherein said first strap comprises
mesh, said second strap comprises mesh, and said biologic graft is
pre-attached to said first and second mesh straps.
19. The kit recited in claim 16 wherein said support apparatus
comprises: a pair of straps, each strap having a central portion
and a connector at each end of said strap; and a biologic graft
connected to said central portion of each strap.
20. The kit recited in claim 16 wherein said support apparatus
comprises a biologic graft fixed over a knitted support member.
21. The kit recited in claim 16 wherein said support apparatus
comprises: a mesh support member having two short sides and two
long sides, a first end of said rectangular member at a first of
said two short sides, a second end of said rectangular member at a
second of said two short sides; a first mesh strap connected to a
first long side proximate said first end of said member; a second
mesh strap connected to a second long side proximate said first end
of said member; a third mesh strap connected to a first long side
proximate a middle portion of said first long side; and a fourth
mesh strap connected to a second long side proximate a middle
portion of said second long side, wherein the mesh support member
has pores that are larger than pores of the first mesh strap,
second mesh strap, third mesh strap, and fourth mesh strap.
22. The kit recited in claim 16 wherein said support apparatus
comprises: a support member knitted with a first bar setting; and a
plurality of straps straps knitted with a second bar setting.
23. (canceled)
24. The apparatus recited in claim 22 wherein said first bar
setting is: Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2:
1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3,
2/1.
25. The kit recited in claim 16 further comprising: a third helical
needle configured to extend from an incision on said right side of
said patient, through said right obturator foramen of said patient,
to said incision in said vagina of said patient; and a fourth
helical needle configured to extend from an incision on said left
side of said patient, through said left obturator foramen of said
patient, to said incision in said vagina of said patient.
26-28. (canceled)
29. A kit according to claim 16 wherein: each strap comprises a
plastic sheath, each needle comprises a helical portion, each
connecter is configured to mate with a needle tip to produce a
substantially permanent attachment between the connector and the
needle tip.
30. A kit according to claim 16 wherein each needle comprises a
handle and each handle comprises a length, a longitudinal axis
along the length, opposing major surfaces along the length,
opposing minor sides, and a cross section of each handle along the
longitudinal axis exhibits an elongate, non-circular form.
31. A kit according to claim 29 wherein each needle comprises a
handle and each handle comprises a length, a longitudinal axis
along the length, opposing major surfaces along the length,
opposing minor sides, and a cross section of each handle along the
longitudinal axis exhibits an elongate, non-circular form.
32. A kit according to claim 16 wherein a connector includes an
aperture configured to mate with a needle tip, the aperture having
a shape that corresponds to a shape of the needle tip, the shape
allowing entry of the needle tip into the connector at at least one
rotational orientation of the needle tip relative to the connector,
while preventing entry of the needle tip into the connector at at
least one other rotational orientation of the needle tip relative
to the connector.
33. A kit according to claim 29 wherein a connector includes an
aperture configured to mate with a needle tip, the aperture having
a shape that corresponds to a shape of the needle tip, the shape
allowing entry of the needle tip into the connector at at least one
rotational orientation of the needle tip relative to the connector,
while preventing entry of the needle tip into the connector at at
least one other rotational orientation of the needle tip relative
to the connector.
34. A surgical repair kit comprising: a support apparatus
comprising at least two straps, each of said straps comprising a
connector configured to mate with a tip of a needle; a first
helical needle configured to extend from an incision on a right
side of a patient, through a right obturator foramen of said
patient, to an incision in a vagina of said patient; and a second
helical needle configured to extend from an incision on a left side
of said patient, lateral to an edge of said pubic ramus bone,
through a left obturator foramen of said patient, to said incision
in said vagina of said patient, wherein said support apparatus
comprises: a substantially rectangular member having two short
sides and two long sides, a first end of said rectangular member at
a first of said two short sides, a second end of said rectangular
member at a second of said two short sides; a first strap connected
to a first long side proximate said first end of said member; a
second strap connected to a second long side proximate said first
end of said member; a third strap connected to a first long side
proximate a middle portion of said first long side; and a fourth
strap connected to a second long side proximate a middle portion of
said second long side, and wherein said support member is made of
an implant material different from an implant material of at least
one of the first strap and the second strap.
35. The kit recited in claim 34 wherein the mesh support member has
pores that are larger than pores of the first mesh strap, second
mesh strap, third mesh strap, and fourth mesh strap.
36. The kit recited in claim 16 wherein said support apparatus
comprises: a support member knitted with a first bar setting; and a
plurality of straps knitted with a second bar setting.
37. The apparatus recited in claim 36 wherein said first bar
setting is: Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2:
1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3,
2/1.
38. The kit recited in claim 16 wherein said support member
comprises a biologic graft, and the at least one strap comprises
mesh.
39. The kit recited in claim 17 wherein said first strap comprises
mesh, said second strap comprises mesh, and said biologic graft is
pre-attached to said first and second mesh straps.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
10/840,646, filed May 7, 2004.
BACKGROUND OF THE INVENTION
[0002] 1. FIELD OF THE INVENTION
[0003] Urogenital Surgery
[0004] 2. Description of the Related Art
[0005] Female genital prolapse has long plagued women. It is
estimated by the U.S. National Center for Health Statistics that
247,000 operations for genital prolapse were performed in 1998.
With the increasing age of the U.S. population, these problems will
likely assume additional importance.
[0006] Vaginal prolapse develops when intra-abdominal pressure
pushes the vagina outside the body. In a normal situation, the
levator ani muscles close the pelvic floor. This results in little
force being applied to the fasciae and ligaments that support the
genital organs. Increases in abdominal pressure, failure of the
muscles to keep the pelvic floor closed, and damage to the
ligaments and fasciae all contribute to the development of
prolapse.
[0007] Many techniques have been tried to correct or ameliorate the
prolapse and its symptoms, with varying degrees of success.
Nonsurgical treatment of prolapse involves measures to improve the
factors associated with prolapse, including treating chronic cough,
obesity, and constipation. Other nonsurgical treatments may include
pelvic muscles exercises or supplementation with estrogen. These
therapies may alleviate symptoms and prevent worsening, but the
actual hernia will remain. Vaginal pessaries are the primary type
of nonsurgical treatment, but there can be complications due to
vaginal wall ulceration.
[0008] There is a desire to obtain a minimally invasive yet highly
effective device and method that can be used to treat pelvic organ
prolapse with minimal to no side effects. Such a device should
reduce the complexity of the surgical procedure, be biocompatible,
adjustable, and non-toxic. The treatment methods using the device
should reduce pain, operative risks, infections and post operative
hospital stays. Further, the method of treatment should also
improve the quality of life for patients.
SUMMARY OF THE INVENTION
[0009] The present invention broadly provides a method and
apparatus for cystocele repair. In one embodiment, the method
includes the steps of: establishing four pathways in tissue around
a bladder of a patient, introducing a strap into each of the
pathways, and positioning beneath the bladder of the patient a
support member having each of the straps connected thereto such
that the bladder of the patient is supported by the support member.
A bulge of the bladder into a vagina of the patient is reduced as a
consequence of applying this method.
[0010] In another embodiment, an apparatus for repairing cystocele
includes a support surface knitted with a first bar setting and a
plurality of straps continuously knitted with the support member.
The plurality of straps are knitted with a second bar setting.
[0011] In another embodiment, a kit for repairing cystocele
includes a support apparatus including at least two straps, each of
the straps including a connector configured to mate with a tip of a
needle. The kit further includes a first needle configured to
extend from an incision on the left side of the patient where a
left inferior edge of the pubic ramus bone of the patient ends at
the bottom of the left obturator foramen of the patient, through
the left obturator foramen of the patient, to an incision in the
vagina of the patient; and a second needle configured to extend
from an incision on the right side of the patient where a right
inferior edge of the pubic ramus bone of the patient ends at the
bottom of the right obturator foramen of the patient, through the
right obturator foramen of the patient, to the incision in the
vagina of the patient.
[0012] In another embodiment, a surgical implant kit includes a
support apparatus including at least two straps, each of the straps
comprising a connector configured to mate with a tip of a needle.
Each connector has an aperture configured to receive the tip of the
needle. Each aperture has a different shape. The kit further
includes at least two needles, each needle having a tip having a
shape configured to mate with one aperture of the at least two
connectors.
[0013] In another embodiment, a surgical implant kit includes a
support apparatus including at least two straps, each of the straps
including a connector configured to mate with a tip of a needle.
Each connector has identifying indicia thereon. The kit further
includes at least two needles.
[0014] In another embodiment, a surgical implant kit includes a
support apparatus including at least two straps, each of the straps
including a connector configured to mate with a tip of a needle.
Each connector has a color. The kit further includes at least two
needles, each needle having a handle and each handle having a color
matching a color of a corresponding connector.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] A more complete appreciation of the invention and many of
the attendant advantages thereof will be readily obtained as the
same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0016] FIG. 1 is a perspective view of a first embodiment of a
support apparatus of the present invention;
[0017] FIG. 2 is a fragmentary front view of a first embodiment of
the support apparatus;
[0018] FIG. 3 is a side view of a strap of a support apparatus of
the present invention;
[0019] FIG. 4 is a top view of a front view of a strap of a support
apparatus of the present invention;
[0020] FIG. 5 is a fragmentary front view of a second embodiment of
a support apparatus of the present invention;
[0021] FIG. 6 is a fragmentary front view of a third embodiment of
a support apparatus of the present invention;
[0022] FIG. 7 is a front view of a biologic graft attached to a
central portion of two straps, each strap having a connector at
each end;
[0023] FIG. 8 is a front view of a support member including both a
biologic graft and a synthetic support member;
[0024] FIG. 8A is a side view of a support member including both a
biologic graft and a synthetic support member;
[0025] FIG. 9 is a front view of a support member of the second
embodiment of the support apparatus;
[0026] FIG. 10 is a front view of a support member of the first
embodiment of the support apparatus;
[0027] FIG. 11 is a close up view of the weave pattern of an
embodiment of the support apparatus;
[0028] FIG. 11A is a close up view of an alternate weave pattern
for the support member;
[0029] FIG. 12 is a front view of a surgical kit of an embodiment
of the present invention;
[0030] FIG. 13 is a perspective view of an embodiment of a right
superior needle (the superior needle held in the surgeon's right
hand) of the present invention;
[0031] FIG. 14 is a top view of an embodiment of the right superior
needle of the present invention;
[0032] FIG. 15 is a bottom view of an embodiment of the right
superior needle of the present invention;
[0033] FIG. 16 is a left side view of an embodiment of the right
superior needle of the present invention;
[0034] FIG. 17 is a right side view of an embodiment of the right
superior needle of the present invention;
[0035] FIG. 18 is a front view of an embodiment of the right
superior needle of the present invention;
[0036] FIG. 19 is a rear view of an embodiment of the right
superior needle of the present invention;
[0037] FIG. 20 is a side perspective view of an embodiment of a
left inferior needle shaft of the present invention, without a
handle;
[0038] FIG. 21 is a front perspective view of an embodiment of the
left inferior needle shaft of the present invention, without a
handle;
[0039] FIG. 22 is a right side view of an embodiment of a left
inferior needle shaft of the present invention, without a
handle;
[0040] FIG. 23 is a bottom view of an embodiment of the left
inferior needle shaft of the present invention, without a
handle;
[0041] FIG. 24 is a front view of an embodiment of the left
inferior needle shaft of the present invention, without a
handle;
[0042] FIG. 25 is a front view of an embodiment of a left superior
strap connector having symbolic indicia thereon;
[0043] FIG. 26 is a front view of an embodiment of a right superior
strap connector having symbolic indicia thereon;
[0044] FIG. 27 is a front view of an embodiment of a left inferior
strap connector having symbolic indicia thereon;
[0045] FIG. 28 is a front view of an embodiment of a right inferior
strap connector having symbolic indicia thereon;
[0046] FIG. 29 is a front view of an embodiment of a set of four
needles and a support apparatus with four connectors, wherein the
connectors are matched to the needles using colors;
[0047] FIG. 30 is a perspective view of a first needle tip and
connector of an embodiment of the present invention;
[0048] FIG. 31 is a perspective view of a second needle tip and
connector of an embodiment of the present invention;
[0049] FIG. 32 is a front view of a patient showing the four needle
entry incisions;
[0050] FIG. 33 is a perspective view of a right superior needle tip
entering the left superior incision (the superior incision on the
patient's left side);
[0051] FIG. 34 is a perspective view of a right superior needle tip
exiting the vaginal incision;
[0052] FIG. 35 is a front view of a right superior needle tip
exiting the vaginal incision;
[0053] FIG. 36 is a perspective view of a right superior needle tip
connected to the right superior connector (the superior connector
on the surgeon's right side);
[0054] FIG. 37 is a perspective view of the superior straps and the
support member in place and the inferior straps extending outside
the vaginal incision;
[0055] FIG. 38 is a perspective view of a right inferior needle tip
exiting the vaginal incision;
[0056] FIG. 39 is a perspective view of all the straps and the
support member in place and the sheaths removed;
[0057] FIG. 40 is a flow chart illustrating a method of practicing
the present invention; and
[0058] FIG. 41 is a flow chart illustrating an alternate method of
practicing the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0059] Referring now to the drawings, wherein like reference
numerals designate identical or corresponding parts throughout the
several views.
[0060] FIGS. 1 and 2 illustrate a surgical support apparatus 10 of
a first embodiment of the present invention. The apparatus 10 is
configured to be surgically implanted in a female patient to repair
anterior prolapse of the vagina. The present invention may be used
to correct central defects, midline defects, or both midline and
central defects at once. In the embodiment shown in FIGS. 1 and 2,
apparatus 10 comprises two superior straps 12, two inferior straps
13, a support member 40, and four loosening sutures 16. Each of
straps 12 and 13 include a connector 30. Each strap 12 and 13 is
covered by a sheath 14. Each suture 16 includes a tab 18. Straps 12
and 13 are connected to tabs 42 and 43 of support member 40 by
known means.
[0061] In one embodiment, sheath 14 is made of polyethylene. Other
material may be used, such as polypropylene, nylon, polyester, or
Teflon. The sheath is configured to be removed from the strap after
the strap is in the correct position in the body.
[0062] In one embodiment, straps 12 and 13 are 19.69 inches long
and 0.433 inches wide. The straps are 0.024 inches thick. Straps 12
and 13 are knitted of 4 or 6 mil polypropylene monofilament and are
heat set at 280-300 degrees Fahrenheit for 5-8 minutes. Also, in
one embodiment, support member 40 is 10 cm long by 5 cm wide and
0.021 inches thick. Member 40 is knitted of 4 mil polypropylene
monofilament and heat set at 310-330 degrees Fahrenheit for 5-8
minutes. Both the strap and support member have a stitch count of
27.5 courses/inch (.+-.2 courses) and 13 wales/inch (.+-.2
wales).
[0063] In one embodiment, the straps are knitted with bar settings
of: Bar 1: 1/0, 2/1 and Bar 2: 0/1, 1/2. The support member is a
large pore mesh, knitted with bar settings of: Bar 1: 1/0, 2/3,
2/1, 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2: 1/0, 2/3, 2/3, 1/0; and Bar 3:
2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1. The straps are connected to
the support member after knitting. Weaving according to a given bar
pattern is described, for example, in "Warp Knitting Production" by
Dr. S. Raz, Melliand Textilberichte GmbH, Rohrbacher Str. 76,
D-6900 Heidelberg, Germany (1987), the contents of which are
incorporated by reference herein.
[0064] Straps 12 and 13 and or sheaths 14 may also include indicia
thereon to signify the correct orientation for implantation into a
patient. In the embodiment shown in FIGS. 1 and 2, sheaths 14
around straps 12 include indicia 12A to show that straps 12 are the
superior straps, and sheaths 14 around straps 13 include indicia
13A to show that straps 13 are the inferior straps. Words, symbols,
and colors are all possible indicia that may be used, and these
modifications are intended to be within the spirit and scope of the
invention as claimed. Further, the indicia may be located on the
straps, the sheaths, or both.
[0065] Apparatus 10 includes dilating connectors 30. Suitable
dilating connectors are disclosed in Published U.S. patent
application Ser. Nos. 2002/151762 and 2002/147382 and U.S. patent
application Ser. No. 10/386,897, filed Mar. 11, 2003.
[0066] Support member 40 is sized and shaped to afford repair of a
cystocele without lifting the patient's bladder and without placing
undue tension on the bladder or vaginal wall. The shape of member
40 may be predetermined, or the member may be trimmed based on
patient anatomy before implantation.
[0067] FIGS. 3 and 4 illustrate an embodiment of a strap for a
surgical apparatus of the present invention. In one embodiment,
strap 12 includes tensioning suture 17. Tensioning suture 17 passes
through the mesh of strap 12 multiple times, as shown in FIGS. 3
and 4. Tensioning suture 17 is affixed to strap 12 at points 19, to
allow transfer of tension from the suture to the strap. In one
embodiment, tensioning sutures are included in all the straps of
the support apparatus. It should be readily apparent to one skilled
in the art that other configurations of tensioning sutures and
attachment points to a mesh strap are possible, and these
modifications are within the scope of the invention as claimed.
[0068] Tensioning suture 17 is configured to eliminate slack in a
strap that is already surgically implanted in the body. By
tightening the strap with suture 17, rather than pulling on the
strap itself, the surgeon prevents damage to the strap due to
deformation. Damage to surrounding tissues due to excessive
movement of the strap during adjustment is also avoided. Straps
including tensioning sutures are disclosed in copending U.S. patent
application Ser. No. 10/616,925, incorporated by reference
herein.
[0069] Strap 12 also includes a connection point for loosening
suture 16. As discussed below, loosening suture 16 is pulled by the
surgeon to loosen the installed support member, if necessary.
[0070] FIG. 5 illustrates a second embodiment of the surgical
support apparatus of the present invention. Apparatus 110 includes
a biological graft for a support member 140. To attach the graft to
straps 12 and 13, clamps 150 are used to hold the surfaces of the
strap and member together. The surfaces are then secured together,
as discussed below in the method for preparing the biologic graft.
Straps 12 and 13, sheaths 14, and connectors 30 are described
above.
[0071] In another embodiment, biologic graft comes in a kit already
secured to straps 12 and 13. In this case, the preparation method
below is unnecessary.
[0072] FIG. 6 shows a third embodiment of the surgical support
apparatus of the present invention. Apparatus 210 includes straps
12 and 13, sheaths 14, and support member 240. In this embodiment,
support member 240 and straps 12 and 13 are continuously knitted.
Thus, there is no seam between the straps and support member, as
they are one continuous piece. This results in a thinner transition
area 243 from the straps to the support member, which results in a
less bulky apparatus for installment into the patient. An apparatus
that is less bulky will be less likely to abrade the surrounding
tissue.
[0073] The support member is knitted with a first bar pattern, and
the straps are knitted with a second bar pattern. This allows
larger pores in the support member, creating a support member that
is more flexible and more likely to allow tissue ingrowth. A second
bar pattern for the straps allows a smaller pore size for the
straps, creating a strap that can carry a larger load with a
smaller, less intrusive strap width.
[0074] In one embodiment, the straps and support member are
continuously knitted of 4 mil polypropylene monofilaments, knitted
with a warp tricot. The stitch count is 27.5 courses/inch (.+-.2
courses) and 13 wales/inch (.+-.2 wales). The support member is a
large pore mesh, with bar settings of Bar 1: 1/0, 2/3, 2/1, 2/3,
1/0, 1/2, 1/0, 1/2; Bar 2: 1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0,
1/2, 1/0, 2/3, 2/1, 2/3, 2/1. The thickness of the support member
is about 0.21 inches.
[0075] FIG. 7 shows an alternate embodiment of the surgical
apparatus of the present invention. Apparatus 310 includes straps
312 and 313 and biologic graft 140. Straps 12 and 13 have
connectors 30 at each end thereof. Biologic graft 140 is connected
to a central portion of each strap. In the embodiment shown in FIG.
7, biologic graft 140 is connected to strap 12 and strap 13 at a
portion equidistant from each end of the straps. It should be
readily apparent to one skilled in the art that other
configurations are possible, and these modifications are within the
scope of the invention as claimed.
[0076] FIGS. 8 and 8A illustrate a surgical apparatus according to
another alternate embodiment of the present invention. Apparatus
410 includes a biologic graft 140 and a synthetic support member
40. In the embodiment shown in FIGS. 8 and 8A, biologic graft 140
and synthetic support member 40 have the same area and are attached
to overlie one another. However, it should be readily apparent to
one skilled in the art that a surgical support apparatus having a
biologic graft and a synthetic support member having different
areas and/or offset from one another could be used, and these
modifications are within the scope of the invention as claimed.
Further, apparatus 410 may be implanted in the patient such that
biologic graft 140 faces the bladder and support member 40 faces
the vaginal wall, or such that biologic graft 140 faces the vaginal
wall and support member 40 faces the bladder. The implantation
configuration is based on the preference of the surgeon.
[0077] FIG. 9 shows support member 140 made of a non-synthetic
material. Suitable non-synthetic materials include allografts,
homografts, heterografts, autologous tissues, cadaveric fascia,
autodermal grafts, dermal collagen grafts, autofascial
heterografts, whole skin grafts, porcine dermal collagen,
lyophilized aortic homografts, preserved dural homografts, bovine
pericardium and fascia lata. Member 140 includes tabs 142 and 143
for connecting to straps, as shown in FIG. 5.
[0078] FIG. 10 shows support member 40 made of a synthetic
material. Member 40 includes tabs 42 and 43 for connecting to
straps, as shown in FIG. 1. Commercial examples of synthetic
materials include Marlex.TM. (polypropylene) available from Bard of
Covington, R.I., Prolene.TM. (polypropylene), Prolene Soft
Polypropylene Mesh or Gynemesh (nonabsorbable synthetic surgical
mesh), both available from Ethicon, of N.J., and Mersilene
(polyethylene terphthalate) Hernia Mesh also available from
Ethicon, Gore-Tex.TM. (expanded polytetrafluoroethylene) available
from W. L. Gore and Associates, Phoenix, Ariz., and the
polypropylene sling available in the SPARC.TM. sling system,
available from American Medical Systems, Inc. of Minnetonka, Minn.,
Dexon.TM. (polyglycolic acid) available from Davis and Geck of
Danbury, Conn., and Vicryl.TM. available from Ethicon.
[0079] Other examples of suitable materials include those disclosed
in published U.S. patent application Ser. No. 2002/0072694. More
specific examples of synthetic materials include, but are not
limited to, polypropylene, cellulose, polyvinyl, silicone,
polytetrafluoroethylene, polygalactin, Silastic, carbon-fiber,
polyethylene, nylon, polyester (e.g. Dacron) polyanhydrides,
polycaprolactone, polyglycolic acid, poly-L-lactic acid,
poly-D-L-lactic acid and polyphosphate esters. See Cervigni et al.,
The Use of Synthetics in the Treatment of Pelvic Organ Prolapse,
Current Opinion in Urology (2001), 11: 429-435.
[0080] FIGS. 11 and 11A illustrate two possible embodiments for the
stitching of synthetic support member 40. However, it should be
readily apparent to one skilled in the art that other knitting
patterns are possible, and these modifications are within the scope
of the invention as claimed.
[0081] Referring to FIG. 12, in another aspect, the present
invention includes a surgical kit 400. The kit 400 preferably
includes at least two superior needles 70R and 70L. Right superior
needle 70R is configured to be held in the surgeon's right hand and
such that the tip of the needle enters an incision on the left side
of the patient where the left adductor longus tendon of the patient
inserts into a left portion of the pubic ramus bone of the patient,
lateral to the edge of the pubic ramus bone, and travels through
the top of the left obturator foramen to exit through an incision
in the vagina of the patient. Left superior needle 70L is
configured to be held in the surgeon's left hand and such that the
tip of the needle enters an incision on the right side of the
patient where the right adductor longus tendon of the patient
inserts into a right portion of the pubic ramus bone of the
patient, lateral to the edge of the pubic ramus bone, and travels
through the top of the right obturator foramen to exit through an
incision in the vagina of the patient.
[0082] In various embodiments of the present invention, the kits
may further include the needles described in published U.S. patent
application Ser. Nos. 20023-0065246-A1; 2002-0151762-A1;
2002-0147382-A1; 2002-0107430-A1, U.S. patent application Ser. No.
2002-0099258-A1 and U.S. patent application Ser. No.
2002-0099259-A1; and U.S. Provisional Application Ser. Nos.
60/263,472, filed Jan. 23, 2001; No. 60/269,829, filed Feb. 20,
2001; No. 60/281,350, filed Apr. 4, 2001; No. 60/295,068, filed
Jun. 1, 2001; No. 60/306,915, filed Jul. 20, 2001, and No.
60/332,330, filed Nov. 20, 2001. In an embodiment that is
particularly suitable for a transobturator surgical procedure, the
needles include needles as described in U.S. patent application
Ser. No. 10/306,179 filed Nov. 27, 2002.
[0083] The individual elements of the kits of the present invention
may be packaged together as shown in FIG. 12 with a cover 52 and
tray 54. Alternatively, the individual elements may be separately
packaged or packaged in subassemblies depending on a variety of
factors such as shelf life and sterilization requirements. They may
be assembled at the manufacturing location or at the healthcare
location. Any suitable sterilization procedure may be utilized to
sterilize the contents of a kit. Suitable sterilization techniques
include, but are not limited to, steam, ethylene oxide, electron
beam, vapor (e.g. hydrogen peroxide or peracetic acid), gamma or
plasma procedures.
[0084] The kit shown in FIG. 12 includes a support apparatus
including a mesh support member 40. It should be readily apparent
to one skilled in the art that kits using biological support
members, as described above, may be made, and these modifications
are within the scope of the invention as claimed. Further, a kit
comprising a biologic graft may have the biologic graft
pre-attached to the straps, or the graft may be separate from the
straps and require the surgeon to attach the straps to the graft,
as discussed below.
[0085] The kit shown in FIG. 12 also includes four needles: right
inferior needle 60R, left inferior needle 60L, right superior
needle 70R, and left superior needle 70L. Embodiments of these
needles are shown in FIGS. 13-24 and are described herebelow.
[0086] FIGS. 13-19 illustrate an embodiment of right superior
needle 70R of the present invention. (Left superior needle 70L is a
mirror image of the right superior needle 70R.) Right superior
needle 70R includes indicia 71R, handle 72R, shaft 74R, curved
portion 76R, and tip portion 78R. Indicia 71R designates whether
the needle is the right or left needle by pointing to the surgeon's
right or left side, as the surgeon holds the needle handle. (The
surgeon's right side corresponds to the patient's left side.)
[0087] FIGS. 20-24 illustrate an exemplary shaft of left inferior
needle 60L, without handle 62L. (Right inferior needle 60R is a
minor image of the left inferior needle 60L.) Left inferior needle
60L includes a handle 62L, a shaft 64L, a curved portion 66L, and a
tip portion 68L. Left inferior needle 60L is configured to be held
in a surgeon's left hand such that tip 68L enters an incision 530L
on the right side of the patient where a right inferior edge of the
pubic ramus bone of the patient ends at a bottom of the right
obturator foramen of the patient, and travels through the right
obturator foramen to exit through an incision in the vagina of the
patient. Right inferior needle 60R is configured to be held in a
surgeon's right hand such that tip 68R enters an incision on the
left side of the patient where a left inferior edge of the pubic
ramus bone of the patient ends at a bottom of the left obturator
foramen of the patient, and travels through the left obturator
foramen to exit through an incision in the vagina of the patient.
This is shown in FIG. 38.
[0088] The above-described needles may be disposable or
reusable.
[0089] FIGS. 25-28 show connectors of the present invention having
indicia thereon. FIG. 25 shows left superior connector 330A having
indicia 331. Indicia 331 includes symbol 331A indicating that the
connector is the left superior connector. FIG. 26 shows right
superior connector 330B having indicia 331. Indicia 331 includes
symbol 331B indicating that the connector is the right superior
connector. FIG. 27 shows left inferior connector 330C having
indicia 331. Indicia 331 includes symbol 331C indicating that the
connector is the left inferior connector. FIG. 28 shows right
inferior connector 330D having indicia 331. Indicia 331 includes
symbol 331D indicating that the connector is the right inferior
connector. Right connectors are located on the surgeon's right side
and left connectors are located on the surgeon's left side.
[0090] FIGS. 25-28 show connectors including symbolic indicia to
identify each connector. It should be readily apparent to one
skilled in the art that other symbols, markings, or words could be
used to identify the connectors, and that these modifications are
within the scope of the invention as claimed.
[0091] FIG. 29 shows another embodiment of the present invention
wherein connectors and the handles of the corresponding needles are
matching colors. For example, the color of the handle of needle 70L
matches the color of connector 430A. The color of the handle of
needle 70R matches the color of connector 430B. The color of the
handle of needle 60R matches the color of connector 430D. The color
of the handle of needle 60L matches the color of connector
430C.
[0092] FIGS. 30 and 31 are perspective views of a needle tips
having a cross sections that are configured to match the cross
sections of a connector aperture. FIG. 30 shows that the cross
section of portion 450A of needle tip portion 478A is a triangle.
The cross section of portion 450A matches triangle shaped aperture
460A in connector 490A. FIG. 31 shows that the cross section of
portion 450B of needle tip portion 478B is a square. The cross
section of portion 450B matches square shaped aperture 460B in
connector 490B.
[0093] In one embodiment, each needle tip has a cross section that
matches the cross section of an aperture of the corresponding
connector, and the tip cross section is incompatible with the other
connector apertures. For example, the cross section of the portion
450A, a triangle, would not fit in aperture 460B, a square, and
vice versa. Thus, even if the connectors are confused, it is
physically impossible for a surgeon to insert the needle tip in the
incorrect connector without damaging the tip or connector. It
should be readily apparent to one skilled in the art that other
shaped tips and apertures are possible, and these modifications are
within the scope of the invention as claimed.
[0094] Example of a Surgical Procedure
[0095] The following description, illustrated in FIGS. 32-39, is an
exemplary method for using the disclosed surgical support apparatus
10 having a mesh support member 40. It should be readily apparent
to those skilled in the art that modifications may be made to the
following method, and these modifications are within the scope of
the invention as claimed.
[0096] If the embodiment of the surgical support apparatus 110
including a biological support member 140 is used, the biological
support member 140 must be prepared before making the vaginal
incision. Instructions for preparing the biological support member
are given after the present description.
[0097] In preparation for surgery, the patient is placed in a
modified dorsal lithotomic position with hips flexed, legs elevated
in stirrups and buttocks even with edge of the surgical table. The
patient's bladder is emptied. A catheter is not required during the
procedure, but may aid in identifying the urethra during the
procedure. A weighted vaginal retractor or other suitable vaginal
retraction is used, if desired.
[0098] The length of the vaginal incision is marked with a skin
pencil starting below the bladder neck, over the most prominent
part of the prolapse, to the lowermost part of the prolapse.
(Variations may occur in specific incisions due to individual
technique and patient anatomy.) An incision is made over this
marking. The incision site may be infiltrated with saline, if
desired. An Allis forceps is placed on the incision margin to
expose the incision. The patient's bladder is dissected off the
vagina up to the lateral sulcus and posterior to the vaginal vault.
This dissection allows palpation of the medial edge of the inferior
pubic ramus, assisting in guiding the superior and inferior needles
to the exit points free from the bladder. The patient's cystocele
is then reduced using midline plication, if desired.
[0099] Next, markings are made to identify the locations for needle
entry incisions. The vaginal dissection is completed prior to
marking needle entry incisions to allow for digital palpation along
the ischiopubic ramus. The needle entry points are palpated
internally and externally with the thumb and index finger before
marking, as discussed hereafter.
[0100] The edge of the ischiopubic ramus beginning at the level of
the vaginal incision is palpated, continuing along the edge of the
bone cephalad toward the level of the clitoris denoting where the
adductor longus tendon inserts into the pubic ramus. The superior
skin incisions are marked approximately at this location and
lateral to the edge of the bone. The markings are made according to
the same method on both sides (right and left) of the patient's
body. Both marks lie in a straight line at the approximate level of
the clitoris. The edge of the inferior pubic ramus is palpated
until it ends at the bottom of the obturator foramen. The inferior
skin incisions are then marked. The inferior skin incisions are
located at a point approximately 3 centimeters below and 2
centimeters lateral to the superior marks. Again, the markings are
made according to the same method on both sides of the patient's
body.
[0101] A small vertical stab incision is made over all four
markings to provide needle entry incisions. Right superior incision
540R, left superior incision 540L, right inferior incision 530R,
and left inferior incision 530L are all shown in FIG. 32. (Right
and left with regard to the incisions are the patient's right and
left sides.)
[0102] The above-described surgical kit is opened. The package
integrity is checked to ensure that the kit was not compromised in
shipping, and the components of the kit are inspected for
damage.
[0103] The following method describes the straps on the surgeon's
right side (the patient's left side) being surgically installed
before the straps on the surgeon's left side (the patient's right
side). However, it should be readily apparent to one skilled in the
art that the straps of either side could be installed first, and
this modification is within the scope of the invention as
claimed.
[0104] Tip 78R of right superior needle 70R is now inserted through
left superior incision 540L, through the left obturator foramen,
and then through the vaginal incision 524. Tip of right superior
needle 70R is pointed perpendicular to the skin with tip 78R in the
left superior incision 540L, shown in FIG. 33. The thumb from the
surgeon's right hand is on the outside curve of needle to control
the needle movement as it perforates the obturator membrane and
muscle. The right thumb pushes the needle through the obturator
muscle and membrane. The needle shaft and handle is positioned at a
45.degree. angle to the patient's vertical axis and close to the
patient's body. The needle handle is rotated to move the needle tip
and curve around the posterior surface of the ischial pubic ramus
toward the vaginal incision and index finger. (If the needle tip
hits the pubic bone during rotation, the needle is retracted. The
needle tip is then penetrated beyond initial insertion depth and
rotate again toward the vaginal incision.) The needle tip is
palpated with the surgeon's finger. The finger meets the needle tip
as it moves around the pubic ramus. (If the needle tip can not be
located, the needle tip is retracted to just behind the pubic ramus
and advanced again.) The needle tip is guided by the surgeon with
the surgeon's finger towards the vaginal incision until the needle
tip extends through the vaginal incision, shown in FIGS. 34 and
35.
[0105] The support member is then oriented so that the tail of the
graft is pointing away from the surgeon. (The marking indicia
disclosed herein may be used to determine the correct orientation
of the support member.) The right superior connector is connected
to the tip of the right superior needle, the tip extending out of
the vaginal incision, as shown in FIG. 36. The superior needle
connectors are closest to the leading edge of the graft that will
be below the bladder neck.
[0106] Before attaching the connectors, the surgeon ensures that
the self-fixating mesh and graft are not twisted, as the connectors
are not removable once snapped onto the needle. Once the connector
is attached to the needle, the needle is rotated back through the
skin incision pulling the connector and associated plastic
insertion sheath and graft into position.
[0107] The above process is repeated with the left needle on the
patient's right side. The partially implanted apparatus is shown in
FIG. 37, with superior straps and support member 40 implanted and
the inferior straps extending outside the body through the vaginal
incision.
[0108] The insertion sheaths and mesh are then cut below the blue
mark on the end portion of the plastic sheath and discarded. This
step allows the sheath to slide freely relative to the mesh. The
sheaths are not removed at this time.
[0109] The tip of the right inferior needle is now inserted through
left inferior incision 530L, through the left obturator foramen,
and then through the vaginal incision. The tip of the right
inferior needle is pointed perpendicular to the skin with the tip
in the left inferior incision. The exit point for the needle is
confirmed to be clear of the bladder wall by the surgeon placing
their right index finger at the distal end of the vaginal incision
and visualizing where needle exits the distal end of vaginal
incision. The surgeon's right thumb is on the outside curve of
needle to control the needle movement as it perforates the
obturator membrane and muscle. The right thumb pushes the needle
through the obturator muscle and membrane.
[0110] The needle shaft and handle is positioned parallel to the
patient's vertical axis and close to the patient's body. The needle
handle is rotated, moving the needle tip and curve toward the
distal end of the vaginal incision. The surgeon is careful to avoid
buttonholing the fornix to prevent bleeding. The needle tip is
palpated as it moves through the distal end of the vaginal
incision. The right inferior needle tip is shown extending outside
the vaginal incision in FIG. 38.
[0111] The right inferior connector is connected to the right
inferior needle tip. Again, before attaching the connectors, the
surgeon ensures that the self-fixating mesh and graft are not
twisted, as the connectors are not removable once snapped onto the
needle. The needle is rotated back through the skin incision
pulling the connector and associated plastic insertion sheath and
graft into position.
[0112] The above process is repeated with the left inferior needle
on the patient's right side.
[0113] The insertion sheath and mesh are then cut below the blue
mark on the end portion of the plastic sheath and discarded. This
step allows the sheath to slide freely relative to the mesh. The
sheaths are not removed at this time.
[0114] A cystoscopy is done to check the integrity of the ureters
and bladder.
[0115] Any vaginal retraction is now removed to allow adjusting the
tension of the mesh to reduce bladder bulge. The surgeon confirms
the mesh is lying flat and not overlapping under the vaginal wall.
The superior leading edge of the support member should be
positioned below the bladder neck without tension. The inferior
tail portion of the support member should be positioned at the
distal end of the vaginal incision or towards the vaginal apex
without tension.
[0116] If the mesh needs to be loosened, an instrument is placed
between the mesh and vaginal wall and pulled down, or away from the
vaginal wall until proper tension is achieved.
[0117] Each of the four plastic sheaths are removed and discarded,
while ensuring the support member graft is not being over
tensioned. Once the plastic sheaths are removed, further adjustment
is minimized.
[0118] If the mesh needs to be tightened, the tensioning suture
exiting the skin incision on each side is grasped using a hemostat.
The suture is wrapped around the hemostat to improve the grip and
pulled up or out to tighten until proper tension is achieved.
[0119] To loosen a biologic graft, the surgeon uses a hemostat or a
clamp to pull from each of the hanging loosening sutures. The
surgeon uses the clamps to pull down and loosen the strap mesh as
desired. The surgeon is careful not to pull on tab 18 on loosening
suture 16 to loosen the strap mesh.
[0120] The surgeon cuts one end of each loosening sutures and pulls
tab 18 until the entire loosening suture is removed. The mesh is
then trimmed at the level of the subcutaneous tissue and all five
incisions are closed. Excess vaginal tissue may be excised.
Variations of this step may occur due to individual technique and
patient anatomy. The final implanted apparatus is shown in FIG.
39.
[0121] After the operation, a catheter and/or vaginal pack can be
used at the discretion of the surgeon. It is removed prior to
discharge. Antibiotic prophylaxis should be given. The ability of
the patient to empty the bladder should be confirmed prior to
discharge.
[0122] If a biologic graft is used, the following steps are
performed before making the vaginal incision. The biologic graft is
removed from the package and prepared per included instructions, if
needed. A precut biologic is prepared by orienting the graft with
the tail portion pointing at the surgeon. Beginning with the right
or left inferior landing tabs on the biologic graft (closest to the
surgeon), the graft is attached to clamps 150. Attaching the
inferior tabs first allows space to attach the two superior mesh
appendages with the clamp. The clamps are squeezed to separate mesh
tape. The graft material is inserted into the open clamp using
printed marks as guides to center the graft. (The printed side of
the plastic sheath is facing the surgeon as the surgical apparatus
is placed in the body.) The clamp is released to secure graft
material. A desired suture is passed up through the clamp using a
suturing mark as a guide. The suture is then passed down using the
opposite suturing mark as the guide. The passed sutures are then
secured using the surgeon's knot(s) of choice. Additional throws
are made if needed. The clamp sutures are cut by passing a scissors
or a scalpel down the scissors slot on each side of the clamp. The
clamps are then removed. The clamp attachment sutures remain with
the clamp. The surgeon assesses the attachment of the graft
material mesh tape. The protective sheath is slid over the mesh
connection to aid deployment.
[0123] The preceding steps are repeated on the opposite side of the
graft. The sutures are passed such that the attachment knots are
all on the same side of the graft. The biologic is placed in a
saline bath to keep it hydrated during the remainder of the
procedure. The graft tail is trimmed at the time of vaginal marking
and dissection to reflect patients anatomy, if needed.
[0124] In addition, when using the biologic graft, the surgeon is
careful when drawing the strap through the body that the sheath
covers the graft connections and that the graft material and graft
connections are not damaged.
[0125] FIG. 40 illustrates one embodiment of method of practicing
the present invention. Method 600 includes the steps of:
establishing four pathways in tissue around a bladder of a patient
(step 610), introducing a strap into each of the pathways (step
620), and positioning beneath the bladder of the patient a support
member having each strap connected thereto such that the bladder of
the patient is supported by the support member and a bulge of the
bladder into the vagina of the patient is reduced (step 630). Step
610 comprises the steps of: making an incision in the vagina of the
patient (step 612), making an incision on a left side of the
patient where a left adductor longus tendon of the patient inserts
into a left portion of the pubic ramus bone of the patient, lateral
to an edge of the pubic ramus bone (step 614), making an incision
on a right side of the patient where a right adductor longus tendon
of the patient inserts into a right portion of the pubic ramus bone
of the patient, lateral to an edge of the pubic ramus bone (step
616), making an incision on a left side of the patient where a left
inferior edge of the pubic ramus bone of the patient ends at the
bottom of the left obturator foramen of the patient (step 618), and
making an incision on a right side of the patient where a right
inferior edge of the pubic ramus bone of the patient ends at the
bottom of the right obturator foramen of the patient (step
619).
[0126] FIG. 41 illustrates an alternate embodiment of method of
practicing the present invention. Method 700 includes the steps of:
establishing four pathways in tissue around a bladder of a patient
(step 710), atraumatically dilating the pathways (step 720),
introducing a strap into each of the pathways while the pathways
are atraumatically dilated (step 730), and positioning beneath the
bladder of the patient a support member having each strap connected
thereto such that the bladder of the patient is supported by the
support member and a bulge of the bladder into the vagina of the
patient is reduced (step 740). Step 710 comprises the steps of:
making an incision in the vagina of the patient (step 712), making
an incision on a left side of the patient where a left adductor
longus tendon of the patient inserts into a left portion of the
pubic ramus bone of the patient, lateral to an edge of the pubic
ramus bone (step 714), making an incision on a right side of the
patient where a right adductor longus tendon of the patient inserts
into a right portion of the pubic ramus bone of the patient,
lateral to the edge of the pubic ramus bone (step 716), making an
incision on a left side of the patient where a left inferior edge
of the pubic ramus bone of the patient ends at the bottom of the
left obturator foramen of the patient (step 718), and making an
incision on a right side of the patient where a right inferior edge
of the pubic ramus bone of the patient ends at the bottom of the
right obturator foramen of the patient (step 719).
[0127] All patents, patent applications, and publications cited
herein are hereby incorporated by reference in their entirety as if
individually incorporated.
[0128] Obviously, numerous modifications and variations of the
present invention are possible in light of the above teachings. It
is therefore to be understood that within the scope of the appended
claims, the invention may be practiced otherwise than as
specifically described herein.
* * * * *