U.S. patent application number 11/906969 was filed with the patent office on 2008-04-03 for systems, devices and methods for treating pelvic floor disorders.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Michael S.H. Chu.
Application Number | 20080082105 11/906969 |
Document ID | / |
Family ID | 39047818 |
Filed Date | 2008-04-03 |
United States Patent
Application |
20080082105 |
Kind Code |
A1 |
Chu; Michael S.H. |
April 3, 2008 |
Systems, devices and methods for treating pelvic floor
disorders
Abstract
Disclosed are implants for pelvic floor repair and related uses,
and devices, kits, and methods which can be used to deliver the
implants. In certain embodiments, the devices are used to deliver
extensions of a surgical implant to respective target tissue
regions of the levator ani muscle and the sacrospinous
ligament.
Inventors: |
Chu; Michael S.H.;
(Brookline, MA) |
Correspondence
Address: |
ROPES & GRAY LLP;PATENT DOCKETING 39/41
ONE INTERNATIONAL PLACE
BOSTON
MA
02110-2624
US
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
39047818 |
Appl. No.: |
11/906969 |
Filed: |
October 3, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60849199 |
Oct 3, 2006 |
|
|
|
Current U.S.
Class: |
606/99 ;
600/37 |
Current CPC
Class: |
A61B 2017/00424
20130101; A61B 17/06066 20130101; A61B 2017/2927 20130101; A61B
2017/06085 20130101; A61B 2017/06042 20130101; A61B 2017/00805
20130101; A61F 2/0045 20130101; A61B 17/06109 20130101; A61B
2017/06076 20130101 |
Class at
Publication: |
606/99 ;
600/37 |
International
Class: |
A61B 17/58 20060101
A61B017/58; A61F 2/00 20060101 A61F002/00 |
Claims
1. A device for delivering an implantable sling to an anatomical
location within a patient, comprising a shaft having a distal end
and a proximal end, a head having a curved region, a tip disposed
at a distal end of the curved region, and a substantially linear
region at a proximal end of the curved region, and a curved
junction connecting the proximal end of the curved region and the
distal end of the shaft, wherein an axis of the substantially
linear region is perpendicular to a longitudinal axis of the
shaft.
2. The device of claim 1, wherein an end of the tip is equiplanar
with the longitudinal axis of the shaft portion.
3. The device of claim 1, wherein the head lies in a plane, and the
longitudinal axis of the shaft portion is normal to the plane.
4. The device of claim 3, wherein the head extends in a
counterclockwise path from the distal end of the shaft.
5. The device of claim 3, wherein the head extends in a clockwise
path from the distal end of the shaft.
6. The device of claim 1, wherein the head lies in a plane, and the
longitudinal axis of the shaft has a non-normal incidence with the
plane.
7. The device of claim 1, wherein the tip includes a stopping
mechanism configured to prevent passage of an implant associator in
a proximal direction along the device.
8. The device of claim 7, wherein the stopping mechanism includes a
shoulder with a cross-sectional area, and the cross-sectional area
is greater than a cross-sectional area of a portion of the tip
distal to the shoulder.
9. The device of claim 7, wherein the implant associator comprises
a ring.
10. The device of claim 7, wherein the implant associator includes
two linear flexible wings extending radially from the ring.
11. The device of claim 1, further comprising an implantable sling
including a central region and three or more extensions extending
from the central region.
12. The device of claim 1, wherein the curved region is
semi-circular.
13. A device for delivering an implantable sling to an anatomical
location within a patient, comprising a shaft including a distal
end and a proximal end, a rotatable head distal to the shaft
including a tip at a distal end of the head, and a pivotable
junction connecting the head and the shaft.
14. The device of claim 13, wherein the rotatable head includes a
curved region.
15. The device of claim 13, wherein the curved region is
semi-circular.
16. The device of claim 13, wherein the rotatable head is rotatable
about the distal end of the shaft.
17. The device of claim 13, wherein the shaft portion includes a
stop surface to prevent rotation of the rotatable head portion
beyond a predetermined angle of rotation.
18. The device of claim 13, further comprising a cannula disposed
about the shaft and operably coupled with the rotatable head to
control a rotation of the rotatable head.
19. The device of claim 13, wherein the tip includes a stopping
mechanism configured to prevent passage of an implant associator in
a proximal direction along the device.
20. The device of claim 19, wherein the implant associator
comprises a ring.
21. The device of claim 20, wherein the implant associator includes
two linear flexible wings extending radially from the ring.
22. The device of claim 19, wherein the stopping mechanism includes
a shoulder with a cross-sectional area, and the cross-sectional
area is greater than a cross-sectional area of a portion of the tip
distal to the shoulder.
23. A method for delivering to a patient an implant with a central
region and at least four extensions, comprising securing a first
extension of the implant to at least one of a sacrospinous ligament
and a levator ani muscle on a first side of a patient, securing a
second extension of the implant to at least one of a sacrospinous
ligament and a levator ani muscle on a contralateral side of the
patient, delivering a third extension of the implant through an
obturator foramen on the first side of the patient, and delivering
a fourth extension of the implant through an obturator foramen on
the contralateral side of the patient.
24. The method of claim 23, further comprising securing the first
extension with a first delivery device, securing the second
extension with a second delivery device different from the first
delivery device, and delivering the third extension with a third
delivery device different from the first delivery device and
different from the second delivery device.
25. The method of claim 23, further comprising securing a fifth
extension to at least one of a sacrospinous ligament and a levator
ani muscle on the first side of a patient, and securing a sixth
extension to at least one of a sacrospinous ligament and a levator
ani muscle on the contralateral side of the patient.
26. The method of claim 25, comprising securing the fifth extension
with a delivery device different from the first delivery device,
different from the second delivery device, and different from the
third delivery device.
27. The method of claim 25, wherein at least one of securing the
first extension and securing the second extension includes
associating the respective first or second extensions with a
delivery device including a head, the head portion including a tip,
and driving the tip of the delivery device through the respective
sacrospinous ligament or levator ani muscle.
28. The method of claim 27, wherein driving the tip of the delivery
device through the respective sacrospinous ligament or levator ani
muscle includes placing the tip against the respective sacrospinous
ligament or levator ani muscle, and applying pressure directly on
the head.
29. The method of claim 23, wherein at least one of securing the
first extension and securing the second extension includes suturing
the respective first or second extension to the respective
sacrospinous ligament or levator ani muscle.
30. A surgical kit for use in delivering an implant within a
patient, including a first delivery device having a first shaft for
delivering a first implant region, and a second delivery device
having a second shaft for delivering a second implant region,
wherein the first shaft is longer than the second shaft.
31. The kit of claim 30, wherein the first shaft is more than about
20% longer than the second shaft.
32. The kit of claim 30, further comprising a third delivery device
having a third shaft for delivering a third implant region.
33. The kit of claim 32, wherein the second delivery device
includes a second head extending in a counterclockwise path from
the distal end of the second shaft, and the third delivery device
includes a third head extending in a clockwise path from the distal
end of the third shaft.
34. The kit of claim 30, further including an implantable sling
having a central region and three or more extension regions.
35. A surgical kit for use in delivering an implant within a
patient, including a first delivery device having a first shaft and
a first head for delivering a first implant region, a second
delivery device having a second shaft and a second head for
delivering a second implant region, and a third delivery device
having a third shaft and a third head for delivering a third
implant region, wherein the second head extends in a
counterclockwise path from the distal end of the second shaft, and
the third head extends in a clockwise path from the distal end of
the third shaft.
36. The surgical kit of claim 35, wherein the first shaft is longer
than the second shaft.
37. The kit of claim 35, further including an implantable sling
having a central region and three or more extension regions.
38. The kit of claim 37, further including an implant associator
configured to inter-fit with a tip of at least one of the delivery
devices and configured to attach to an extension of the sling.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 60/849,199, filed Oct. 3, 2006 and titled
"Systems, Devices and Methods for Treating Pelvic Floor Disorders,"
the entire contents of which are incorporated herein by
reference.
BACKGROUND
[0002] Pelvic floor disorders afflict many women. According to some
studies, about 1 out of 11 women needs surgery for a pelvic floor
disorder during her lifetime. The pelvic floor generally includes
muscles, ligaments, and tissues that collectively act to support
anatomical structures of the pelvic region, including the uterus,
the rectum, the bladder, and the vagina. Pelvic floor disorders
include vaginal prolapse, vaginal hernia, cystocele, rectocele, and
enterocele. Such disorders are characterized in that the muscles,
ligaments and/or tissues are damaged, stretched, or otherwise
weakened, which causes the pelvic anatomical structures to fall or
shift and protrude into each other or other anatomical
structures.
[0003] Moreover, pelvic floor disorders often cause or exacerbate
female urinary incontinence (UI). One type of UI, called stress
urinary incontinence (SUI), affects primarily women and is
generally caused by two conditions-intrinsic sphincter deficiency
(ISD) and hypernobility. These conditions may occur independently
or in combination. In ISD, the urinary sphincter valve, located
within the urethra, fails to close (or "coapt") properly, causing
urine to leak out of the urethra during stressful activity. In
hypermobility, the pelvic floor is distended, weakened, or damaged,
resulting in increases in intra-abdominal pressure (e.g., due to
sneezing, coughing, straining, etc.) and consequently the bladder
neck and proximal urethra rotate and descend. As a result, the
urethra does not close with sufficient response time, and urine
leaks through the urethra.
[0004] UI and pelvic floor disorders, which are usually accompanied
by significant pain and discomfort, are typically treated by
implanting a supportive sling in or near the pelvic floor region to
support the fallen or shifted anatomical structures or to, more
generally, strengthen the pelvic region by, for example, promoting
tissue ingrowth. Often, treatments of stress incontinence are made
without treating the pelvic floor disorders at all, potentially
leading to an early recurrence of the pelvic floor disorder.
[0005] Existing devices, methods, and kits for treatment typically
apply delivery devices to position a supportive sling into a
desired position in the pelvic region. However, these devices may
be difficult for a surgeon to manipulate within the posterior
pelvic region without adversely affecting surrounding anatomical
structures during the delivery process. Moreover, when treating
pelvic floor disorders and UI it is desirable to anchor the sling
to a plurality of locations in the pelvic region, but most commonly
available surgical kits do not provide devices that are suitably
sized and/or shaped. Thus, surgeons have limited ability to access
different locations in the pelvic region. Accordingly, medical
operators and patients need improved systems, methods, and surgical
kits for the treatment of pelvic floor disorders and/or urinary
incontinence.
SUMMARY
[0006] The invention generally pertains to devices, systems, and
methods to deliver surgical implants within patients. The devices
include delivery devices which can be used to implant a supportive
mesh in the pelvic region of a patient for pelvic floor repair
and/or for treatment of urinary incontinence. The devices also
include surgical implants that are sized, shaped, and constructed
to support various organs within the pelvic region of a patient, or
more generally to promote tissue growth within and generally
stabilize the pelvic region.
[0007] In one aspect, the invention includes a delivery device for
delivering an implantable sling to an anatomical location within a
patient. The devise includes a shaft having a distal end and a
proximal end, a head having a curved region, a tip disposed at a
distal end of the curved region, and a substantially linear region
at a proximal end of the curved region, and a curved junction
connecting the proximal end of the curved region and the distal end
of the shaft, wherein an axis of the substantially linear region is
perpendicular to a longitudinal axis of the shaft.
[0008] In another implementation, the delivery device includes a
shaft having a distal end and a proximal end, a rotatable head
distal to the shaft including a tip at a distal end of the head,
and a pivotable junction connecting the head and the shaft. The
rotatable head may include a curved region. In one feature, the
rotatable head is rotatable about the distal end of the shaft. The
curved regions may be semi-circular.
[0009] In one configuration, the tips employed with the device are
equiplanar with the longitudinal axis of the shaft portion. In
another configuration, the head lies in a plane, and the
longitudinal axis of the shaft portion is normal to the plane. For
example, the head may extend in a counterclockwise path from the
distal end of the shaft, or the head may extend in a clockwise path
from the distal end of the shaft. In other configurations, the head
lies in a plane, and the longitudinal axis of the shaft has a
non-normal incidence with the plane. The device may be used to
implant a sling within a patient. The device may include other
components such as stopping mechanisms, implant associators, and
soft tissue anchors adapted to aid the implantation of the
sling.
[0010] In another aspect, the invention includes methods for
delivering to a patient an implant having a central region and at
least four extension/appendage regions. The methods include
securing a first extension of the implant to at least one of a
sacrospinous ligament, a coccygeus muscle, an ischiococcygeus
muscle, an iliococcygeus muscle, and a levator ani muscle on a
first side of a patient, securing a second extension of the implant
to at least one of a sacrospinous ligament, a coccygeus muscle, an
ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani
muscle on a contra-lateral side of the patient, delivering a third
extension of the implant through an obturator foramen on the first
side of the patient, and delivering a fourth extension of the
implant through an obturator foramen on the contra-lateral side of
the patient.
[0011] In one implementation, the methods include securing the
first extension with a first delivery device, securing the second
extension with a second delivery device different from the first
delivery device, and delivering the third extension with a third
delivery device different from the first delivery device and
different from the second delivery device.
[0012] The methods may also include securing a fifth extension to
at least one of a sacrospinous ligament, a coccygeus muscle, an
ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani
muscle on the first side of a patient, and securing a sixth
extension to at least one of a sacrospinous ligament, a coccygeus
muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a
levator ani muscle on the contra-lateral side of the patient. In
one implementation, the methods contemplate the use of a plurality
of devices having different lengths. In one configuration, the
methods include securing a fifth extension with a delivery device
different from the first delivery device, different from the second
delivery device, and different from the third delivery device.
[0013] In one feature, the methods include associating the
respective first or second extension with a delivery device
including a head, the head portion including a tip, and driving the
tip of the delivery device through the respective sacrospinous
ligament, coccygeus muscle, or levator ani muscle. This may include
placing the tip against the respective sacrospinous ligament,
coccygeus muscle, or levator ani muscle, and applying pressure
directly on the head. In one feature, at least one of securing the
first extension and securing the second extension may include
suturing the respective first or second extension to the respective
sacrospinous ligament, coccygeus muscle, or levator ani muscle.
[0014] In an additional aspect, the invention includes a surgical
kit having one or more of the devices described herein for use in
delivering an implant within a patient. In certain embodiments the
kit includes a first delivery device having a first shaft for
delivering a first implant region, and a second delivery device
having a second shaft for delivering a second implant region. The
kit may include a third delivery device having a third shaft for
delivering a third implant region. In certain embodiments, the
shafts are provided with differing lengths.
[0015] In one configuration, one shaft is more than about 20%
longer than one or more other shafts in the kit. The kit may also
include an implant, and optionally, other devices for assisting in
the exemplary surgical procedures. Methods for associating the
delivery devices with the implants, methods for delivering the
implants to desired locations within a patient, and methods for
positioning, tensioning, and/or fixating the implants within a
patient are also contemplated. Exemplary applications of the
devices and methods include the treatment of conditions such as
prolapse, vaginal hernia, cystocele, rectocele, enterocele, and
urinary incontinence. These and other aspects will be described
herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] These and other features and advantages of the invention
will be more fully understood by the following illustrative
description with reference to the appended drawings, in which like
elements are labeled with like reference designations and which may
not be to scale.
[0017] FIG. 1A shows a delivery device for delivering a pelvic
floor implant to an anatomical location.
[0018] FIG. 1B illustrates another embodiment of a delivery device
for delivering a pelvic floor implant to an anatomical
location.
[0019] FIGS. 2A-2B show close-up views of the head portions of an
exemplary pelvic floor delivery device.
[0020] FIG. 3 shows an alternative embodiment of an exemplary
pelvic floor delivery device having a head oriented perpendicularly
to a shaft.
[0021] FIG. 4 shows an alternative configuration of the device of
FIG. 3 having a head oriented on a contra-lateral side of the
shaft.
[0022] FIG. 5 shows an exemplary pelvic floor device and an
implantable mesh strap assembly including an implant
associator.
[0023] FIG. 6 shows the delivery device of FIG. 5 coupled with the
mesh strap of FIG. 5.
[0024] FIG. 7 shows the mesh strap of FIG. 5, with an alternative
implant associator.
[0025] FIG. 8 illustrates the use of an exemplary pelvic floor
device in implanting a mesh strap into tissue.
[0026] FIG. 9 shows an alternative embodiment of a pelvic floor
delivery device having a rotatable head.
[0027] FIG. 10 illustrates the use of the device of FIG. 9 in
penetrating tissue.
[0028] FIG. 11 shows the device of FIG. 9 in association with a
mesh strap implant associator and penetrating through a target
ligament.
[0029] FIG. 12 shows a Miya device which may be used to place one
or more mesh straps of an implant.
[0030] FIG. 13A illustrates an inferior view of a sling implanted
within a patient using a device according to the invention.
[0031] FIG. 13B illustrates a lateral view of the sling implant
illustrated in FIG. 13A.
[0032] FIG. 14 illustrates a surgical kit for use in pelvic floor
repair.
[0033] FIGS. 15A-15B show delivery devices for delivering an
anterior implant strap.
[0034] FIGS. 16A-16C show various views of a delivery device for
delivering anterior implant straps.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0035] The devices, methods, and kits of this invention are
generally used to deliver a surgical implant, such as an
implantable sling, to the pelvic region of a patient for pelvic
floor repair and/or for treatment of urinary incontinence. The
devices include improved delivery tools that are sized and shaped
to deliver the surgical implant to the pelvic region, and improved
surgical implants sized, shaped, and constructed to support various
organs within the pelvic region, or more generally to promote
tissue growth in and the general stability of the pelvic region. In
certain embodiments, the implant includes a central region and a
plurality of extensions, such as mesh straps, that extend from the
central region and are anchored at respective locations in the
pelvic region of a patient to appropriately position and/or tension
the implant. The extensions are anchored to the patient's pelvic
floor using delivery devices that drive the extensions through the
tissues, ligaments, and/or muscle regions thereof.
[0036] The devices may be configured to allow the operator to
deliver and secure the implant to posterior regions of the pelvic
floor, such as the sacrospinous ligament, the coccygeus muscle, the
ischiococcygeus muscle, the iliococcygeus mscule, and the tendinous
arch of the levator ani muscle. Such anatomical locations are
useful locations for anchoring the straps of pelvic floor implants
within the pelvic region. An operator accesses these anatomical
locations by guiding the devices through a vaginal incision.
[0037] Methods for associating the delivery devices with the
implants, methods for delivering the implants to desired locations
within a patient, and methods for positioning, tensioning, and/or
fixating the implants within a patient are described.
[0038] The delivery devices used to implant the various extension
need not be the same, and in one implementation, a surgical kit
including three delivery devices is provided. In such
implementations, each of these devices are sized and shaped to
facilitate delivery to certain ones of the tissue regions.
[0039] FIG. 1A depicts an exemplary embodiment of a device 100 that
is adapted to deliver, through a vaginal incision, a mesh strap to
a target tissue region of the sacrospinous ligament. The
sacrospinous ligament is a thin and triangular tissue that is
attached by its apex to the spine of the patient's ischium, and
medially, by its broad base, to the lateral margins of the sacrum
and coccyx in front of the sacrotuberous ligament. The sacrospinous
ligament is a convenient location to anchor mesh straps in the
posterior regions of the pelvic floor in order to provide posterior
support.
[0040] The device 100 may also be adapted to deliver, through a
vaginal incision, a mesh strap to a target tissue region of the
coccygeus (or ischiococcygeus) muscle. The coccygeus muscle is a
triangular muscle that originates from the ischial spine and the
sacrospinous ligament and the coccyx, and inserts on the lateral
aspects of the lower sacrum and the upper coccyx.
[0041] The delivery device 100 includes a shaft 105, a handle 122,
a head 120 for attaching to an implant and delivering the implant
to the patient's anatomy, and a curved junction 124 configured
within an arc that allows the head 120 to penetrate the patient's
anatomy. The shaft 105 includes a distal end 105a, a proximal end
105b, and a longitudinal axis 111. The shaft 105 has a length 107
that is substantially longer than the length 108 of the head 120.
The relatively long shaft length 107 allows an operator to insert
the device through the vaginal cavity of a patient and place the
head 120 within the posterior pelvic region in proximity to the
sacrospinous ligament or the coccygeus muscle.
[0042] The shaft 105 is shown to be substantially linear, but it
may be slightly curved to form either a convex or a concave arc to
further facilitate delivery of the head . FIG. 1B illustrates an
alternate embodiment 101 of the delivery device 100 of FIG. 1A
having a curved shaft 103 instead of the linear shaft 105 of FIG.
1A. The curved shaft 103 may facilitate passage of the device
through the vaginal canal to access the sacrospinous ligament or
coccygeus muscle of the patient. In addition, the curved shaft
allows rotation of the delivery device 101 for insertion of the
head 120 into the patient's tissues. This may be done, for example,
by applying a force in direction 140 to the proximal end 103b of
the device 101 thereby rotating the device about the middle area
103c of the shaft 103 such that the distal end 103a of the shaft
103 and the head 120 rotate into the tissues in the direction 141.
The amount of curvature will typically be chosen to facilitate
delivery of the device into the patient using a preferred method
and path of insertion, described in exemplary embodiments
below.
[0043] Referring again to FIG. 1A, the shaft 105 also has a
circular cross-section 113 with a radius selected as needed to suit
an intended path and location for delivery of the implant. In
certain embodiments, the radius is about 0.05 inches, about 0.0625
inches, or about 0.075 inches which allows the device 100 to be
inserted through a vaginal incision and into the sacrospinous
ligament or coccygeus muscle, as described more particularly in
connection with FIGS. 13A-13B. In certain embodiments, the radius
is about 0.5 inches or less. In certain embodiments, the radius is
about 0.125 inches. In certain embodiments, the radius is between
about 0.01 inches and about 0.5 inches, or as otherwise desired to
aid in implantation within other pelvic floor areas.
[0044] As noted, the device includes a handle 122 that is
configured to allow an operator to grasp and manipulate the device
as required to deliver a surgical implant to a desired location in
a patient's anatomy.
[0045] The handle 122 is generally a looped region of the shaft 105
at the proximal end 105b of the shaft 105. However, the depicted
handle 122 is not intended to be limiting and other suitable handle
configurations can be used. By way of example, the device 100 can
include the handle 119 of the device 300 illustrated in FIG. 8. The
handle 119 is sized and shaped to be comfortably grasped and
manipulated by an operator. The handle can be made of a single
material, or a combination of materials. Exemplary materials
include acrylonitrile butadiene styrene and soft durometer TPE.
Other suitable materials may be used, including thermoplastic
materials and other materials suitable for surgical
environments.
[0046] As noted, the device 100 includes a head 120 that is
configured to enable an operator to deliver and secure an implant
to a desired anatomical structure in the body, such as a region of
the sacrospinous ligament, coccygeus muscle, or other positions
within the pelvic region. More particularly, the head 120 includes
a curved region 120a, a substantially linear region 120b at a
proximal end of the curved region 120a, and an end region 120c at a
distal end of the curved region 120a. The depicted curved region
120a is C-shaped. It can alternatively be semi-elliptical, and in
certain embodiments semi-circular with a radius of curvature 121 of
between about 0.125 inches and about 0.75 inches, though this
length can be larger or smaller as desired. The substantially
linear region 120b of the head 120 is configured to have a desired
length. The region 120b shown in FIG. 1A is between about 0.125
inches and about 0.5 inches in length to allow the head 120 to fit
properly through the sacrospinous ligament or coccygeus muscle,
though this length can be larger or smaller as desired. The
substantially linear region 120b includes a longitudinal axis 123
oriented to be substantially perpendicular to the longitudinal axis
111 of the shaft 105. However, in alternative embodiments the axes
111 and 123 are not perpendicular, but intersect at angles of about
90.degree. or at an angle chosen to suit an intended path and
location for delivery of the implant. In certain embodiments, the
length 107 of the shaft 105 along the axis 111 is about ten times
longer than the length 108 of the head 120 along the axis 111.
[0047] As noted, the head 120 also includes an end region 120c.
FIG. 2A shows a close-up view of the head 120 of the device 100 and
in particular, the end region 120c. As shown, the end region 120c
has a tip 130 that extends along a longitudinal axis 131 which
intersects the longitudinal axis 111 of the shaft 105, such that
the end of the tip 130 is substantially equiplanar with the
longitudinal axis 111. The tip 130 is sharp and configured to
dissect tissue material, including contractile tissue, epithelium,
and/or connective tissue. The tip 130 is preferably sharp enough to
dissect muscle and ligament. As discussed below, in one exemplary
method, the tip 130 is associated with an implant and driven
through a target region in the sacrospinous ligament, coccygues
muscle, iliococcygeus muscle, and/or the levator ani muscle. In
alternate embodiments, as depicted in FIG. 2B, the tip 130 is
blunt, allowing for the blunt dissection of tissue.
[0048] As shown in FIG. 2A, the tip 130 further includes a shoulder
225 which provides a stopping mechanism for an implant associator
of a surgical implant, as discussed below with reference to FIGS.
5-6. As illustrated, the shoulder 225 is generally shaped as a
circular step that juts out from the tip 130, resulting in the
end-region 120c having varying cross-sections. More specifically, a
cross section 134 of the device taken in a location proximal to the
shoulder (i.e., away from the tip) has a larger radius than a
radius of a cross section 136 of the device taken in a location
just distal to the shoulder (i.e., toward the tip).
[0049] With continued reference to FIG. 2A, the device 100 also
includes a junction 124 that connects the head 120 and the shaft
105, and in particular connects the substantially linear region
120b of the head 120 to the distal end 105a of the shaft 105. The
depicted junction 124 is curved. In certain embodiments, the
junction 124 has a radius of curvature 140 between about 0.1 inches
and about 0.7 inches. The radius of curvature 140 may be smaller or
larger than the radius of curvature 121 of the curved region 120a.
The junction 124 alternatively need not be curved at all. Instead,
the junction 124 may include an angled junction formed by the
substantially linear region 120b and the shaft 105, with no
intervening curvature. The appropriate radius of curvature 140 or
angle of the junction 124 can be chosen to suit a preferred method
and location of delivery of the surgical implant. As discussed
below, the junction 124 may also include a hinge about which the
head 120 is rotatable.
[0050] FIG. 3 shows an alternative embodiment 300 of the device of
FIG. 1A having a head 320 oriented perpendicularly to the shaft 305
to allow the operator to deliver a surgical implant to a region of
a patient's levator ani muscle, such as the tendinous arch of the
levator ani or the iliococcygeus muscle, through a vaginal
incision. The levator ani muscle is a broad, thin muscle situated
generally on the side of the pelvis that is attached to the inner
surface of the lesser pelvis. It is a convenient location to anchor
mesh straps in order to provide lateral and/or posterior support
and tension for a surgical implant. The iliococcygeus is a portion
of the levator ani muscle originating from the ischial spine and
the arcus tendineus levator ani and sloping inferiorly toward the
midline. The iliococcygeus includes fibers that blend with the
longitudinal muscle of the rectum.
[0051] As shown, the delivery device 300 is similar to the device
100, but its head 320 is positioned about 90 degrees clockwise 350
with respect to the operator of the device to allow the head 320 to
align next to the levator ani muscle when the device 300 is passed
through a vaginal incision. Generally, the head 320 of the device
300 lies substantially in a plane, and the longitudinal axis 311 of
the shaft 305 is normal to the plane. The head 320 traces a counter
clockwise 360 path from its linear region 320b to its tip 330 with
respect to a distally-looking vantage of the delivery device (i.e.,
with respect to an operator's vantage). This configuration allows
the operator to position the implant through a vaginal incision
next to the levator ani muscle so the head 120 (coupled to the
implant strap) can be driven into the muscle, thereby inserting the
strap into the muscle to secure the implant.
[0052] FIG. 4 shows an alternative embodiment 400 of the device 100
of FIG. 1a having a head 420 oriented on the contra lateral side of
its shaft 405 compared to the head 320 and shaft 305 of FIG. 3. The
device 400 is then suited to deliver a surgical implant, such as a
pelvic floor mesh strap, to a region of a patient's levator ani
muscle contra-lateral to the region of the levator ani muscle
discussed with respect to FIG. 3. More particularly, the delivery
device 400 is similar to the device 100, but with the head 420
rotated by about 90 degrees counterclockwise 450 with respect to
the operator of the device. Generally, the head 420 of the device
400 lies substantially in a plane, and the longitudinal axis 411 of
the shaft 405 is normal to the plane. The head 420 traces a
clockwise 460 path from the linear region 420b to the tip 430, with
respect to a distally-looking vantage of the delivery device (i.e.,
with respect to an operator's vantage). This configuration allows
the operator to position the implant through a vaginal incision and
next to the levator ani muscle, so the head 120 (with the implant
strap) can be driven into the muscle, thereby inserting the strap
into the muscle to secure the implant.
[0053] In other embodiments not illustrated, the head can be
rotated by more or less than 90 degrees in either the
counterclockwise 450 or clockwise 350 directions to allow the
implant or its straps to be inserted within any ligaments, muscles
or other desired pelvic tissues. In these cases, the heads will lie
substantially in a plane, and the respective longitudinal axes of
the shaft will have a non-normal incidence with the plane. The
appropriate incidence angle can be chosen to facilitate insertion
of the device using a preferred method and location for
delivery.
[0054] In certain embodiments, the shafts 305 and 405 of the
delivery devices 300 and 400, respectively, are of about equal
length and are shorter in length than the shaft 105 of the delivery
device 100. This is beneficial because the sacrospinous ligament
and coccygeus muscle are located posterior to the tendinous arch of
the levator ani muscle and the iliococcygeus muscle. The shafts 305
and 405 are, in certain embodiments, about 8 times longer than
respective heads 320 and 420. The shaft 105 is generally between
about 15% and about 50% longer than the shafts 305 and 405, and in
some embodiments is about 20% longer than the shafts 305 and
405.
[0055] FIG. 5 more particularly shows an exemplary device, such as
the device 100 of FIG. 1A, in operation with an implantable mesh
strap assembly including an implant 505. The depicted implant 505
is a mesh strap 505 portion of a surgical implant assembly that can
be used to treat pelvic floor disorders, UI, or other conditions.
The implant 505 is configured to couple with the tip 130 of device
100 for delivery of the implant 505 to a target tissue region. It
is to be understood that the other tips 330 and 430 of devices 300
and 400 respectively, as well as other device tips discussed
herein, can be used in similar operative combinations with surgical
implants such as mesh strap 505.
[0056] As shown, the mesh strap 505 includes an implant associator
510 for associating with the tip 130 of the delivery device 100,
and in certain embodiments the implant associator 510 also anchors
the mesh strap 505 in tissue. The depicted implant associator 510
has a ring 509 and wings 511a and 511b. In operation, an operator
places the ring 509 over the tip 130 and the ring 509 slides down
the tip 130 until the ring 509 abuts the shoulder 225. The step or
shoulder 225 of the end-region 120c prevents passage of the ring
509 in a direction that is proximal and further down 515 along the
delivery device.
[0057] The ring 509 includes an inner surface 507 that is tapered,
and thereby the ring 509 inter-fits with the outer surface 226 of
the tip 130. The depicted ring 509 is coplanar with the mesh strap
505.
[0058] The wings 511a and 511b of the implant associator 510 extend
radially from the ring 509 and form an angle 512. The angle allows
the wings 511a and 511b to be inserted within a patient's tissue to
secure the mesh strap 505 in a desired location. In one embodiment,
the implant associator 510 is flexible such that the angle 512 can
be increased or decreased upon application of appropriate
mechanical pressure. By way of example, if the mesh strap 505 is
passed through tissue in a forward direction 580, the wings 511a
and 511b interact with the tissue to reduce the angle 512. If the
mesh strap 505 is passed through tissue in a retrograde direction
582, the wings 511a and 511b interact with the tissue to increase
the angle 512. The varying angle 512 facilitates movement of the
mesh strap 505 in the forward direction 580, and impedes movement
of the mesh strap 505 in the retrograde direction 582. The angle
512 formed between the wings 511a and 511b can be configured so
that it varies, as can the flexibility of the connector 505. These
properties are generally chosen to suit the particular delivery
path location for delivering the implant, as well as the condition
being treated. In certain exemplary embodiments, wings 511a-b are
not included and the ring 509 is molded, glued or otherwise affixed
to the mesh so that, by itself, it couples the mesh strap 505 and
the end region 120c. The ring 509 of implant associator 510 can
have varying thicknesses and/or varying lengths.
[0059] FIG. 6 shows the delivery device 100 coupled with the mesh
strap 505 of FIG. 5. The end-region 120c of the device 100
protrudes through the ring 509 even after the device 100 has been
associated with the mesh strap 505. This allows the delivery device
100 to dissect tissue as it implants the mesh strap 505. In
operation, the tip 130 of the device is pushed into the tissue and
the associated ring 509 follows into the tissue.
[0060] FIG. 7 shows the mesh strap 505 of FIGS. 5-6, with an
alternative implant associator 514. The implant associator 514
includes a ring 513 that has circular cross-sections lying in a
plane that is perpendicular to a plane of the mesh strap. The
implant associator 514 is, in certain embodiments, used in
operative combination with the delivery devices described herein.
The alternative orientation of the ring 513 with respect to implant
associator 514 in comparison to the ring 509 with respect to
implant associator 510 results in a different orientation of the
mesh strap 505 with respect to the delivery device 100 when the
mesh strap 505 and the device 100 are coupled. This alternative
orientation results in the strap 505 aligning with the end-region
120c of the head 120, as opposed to extending from the end-region
120c of the head 120 at about a 90 degree angle as illustrated in
FIG. 6. The alternative orientation using implant associator 514
may be preferred by a medical operator when the operator is
delivering the mesh strap 505 through a narrow anatomical incision
and/or a narrow pathway through a patient's anatomy.
[0061] Other exemplary alternatives to implant associators 510 and
514 as well as alternate configurations for the tip 130 and/or end
region 120c of the device 100 are disclosed in U.S. patent
application Ser. No. 10/542365 and U.S. patent application Ser. No.
11/152898, the contents of which are incorporated by reference
herein in their entirety.
[0062] As noted above, the devices can be used to deliver implants
to patient tissue. FIG. 8 more particularly depicts the use of
device 300 of FIG. 3 to implant a mesh strap 505 through a region
810 of the levator ani muscle 810, more particularly, about the
tendinous arch of the levator ani muscle or "white line" 805.
[0063] In operation, the operator associates the mesh strap 505
with the delivery device 300 using implant associator 510. The
operator then places the tip 330 of the delivery device 300
proximal to a target tissue region 810. The operator rotates the
device 300 counter clockwise along a longitudinal axis 311 of the
shaft 305 of the device 300, applying sufficient force to the shaft
305 to cause the tip 300 to dissect tissue and trace a path 811
below and around the tendinous arch 805 of the levator ani muscle.
The tip 330 exits the tissue near a tissue region 812, while the
mesh strap 505 remains associated with the device 300 via implant
associator 510. The user then retracts the device 300, leaving mesh
strap 505 implanted in the levator ani muscle, by rotating the
device 300 in a clockwise direction about the longitudinal axis
311. Upon retraction, the implant associator 510 dissassociates
from the delivery device 300 when the back side 510a of the implant
associator 510 abuts against the tissue surface near tissue region
812, thereby preventing the implant associator 510 from continuing
in a retrograde direction along path 811. In certain embodiments,
the mesh strap 505 includes tanged edges or barbs to help anchor
the strap in surrounding tissue proximal to the path 811.
[0064] To assist in the retraction, the operator may use a tonged
forceps instrument or other tong-like or tweezer-like instrument
(not shown) to grasp and hold in place the implant associator 510
as the device 300 is retracted. In certain embodiments, the
operator grasps the implant associator 510 with the forceps and
pulls the implant associator 510 away from the tip 330, thereby
dissassociating the mesh strap 505 from the delivery device 300,
before retracting the delivery device 300. Optionally, after the
delivery device 300 is retracted, the operator uses the forceps
instrument to grasp the implant associator 510 and pull the implant
associator 510 generally away from the tissue region 812. This
allows the operator to tension an implant, as discussed further
below.
[0065] Alternately, the operator can use the device 400 of FIG. 4
to carry out the above procedure. In such an implementation, the
operator inserts the device 400 above the white line 805 using a
clockwise rotation for insertion and a counterclockwise rotation
for retraction. In that case, the insertion will be near tissue
region 812, and the tip 430 will exit the tissue near region
810.
[0066] As shown, the devices described above include a head that is
fixed to a shaft. In certain alternative embodiments, the head and
shaft are configured to rotate with respect to each other, thereby
allowing the operator to adjust the placement of the head without
moving the shaft. FIG. 9 shows such an exemplary alternative
delivery device 900 including a shaft 905 with a distal end 905a
and a proximal end (not shown) opposite the distal end 905a, and a
head 920, connected to the shaft 905 by pivotable junction 924.
[0067] The pivotable junction 924 allows the head 920 to rotate
about the distal end 905a of the shaft 905, and in particular about
an axis 925 in directions 930 and 932 without moving the shaft 905.
As shown, the axis 925 is perpendicular to the longitudinal axis
911 of the shaft 905 and normal to the plane of the rotatable head
920.
[0068] In certain embodiments, the pivotable junction 924 is
adjustable to fix the position of the head 920 with respect to the
shaft 905 at a desired position. In particular, the depicted
junction 924 may include a hinge and pin assembly for fitting into
a slot 927 about which the head 920 rotates. The hinge 924 and pin
assembly can be configured to provide sufficient tightness such
that the rotatable head 920 can be manually rotated to a desired
position upon application of appropriate mechanical force to the
head 920, and then remain substantially fixed in that position upon
insertion of the pin into the slot 927. The pin can be released
from the slot 927 to allow the head 920 to freely rotate about the
shaft 905, and then pushed fully into its slot 927 to fix the head
920 at a preferred orientation.
[0069] Also shown, the device 900 has a stop surface 926 that
restricts the range of motion of the rotatable head 920.
Operatively, a surface 920a of rotatable head 920 aligns with the
stop surface 926, thereby preventing further rotation of the
rotatable head 920 in the direction 930. The stop surface 926 can
be oriented at varying angles with respect to the longitudinal axis
911 in order to alter the angle beyond which rotation is prevented.
As described below, the rotatable head feature allows an operator
to adapt the configuration of the head 920 to facilitate insertion
into various anatomical locations of a patient.
[0070] In an alternative embodiment, the device 900 is configured
to rotate about an axis 935, which is tangential to the rotatable
head 920 at region 920b, where the head 920 meets the shaft 905.
This embodiment enables an operator to modify the orientation of
the head 920 to be similar to the 90 degree angled configurations
of the heads 320 and 420 in FIGS. 3-4, or to be oriented with other
preferred angles. In one exemplary embodiment, rotation about the
axis 935 is accomplished by inserting a pin in the shaft 911, the
pin's longitudinal axis being aligned with axis 935, at location
905c with a point of the needle extending in direction 933.
[0071] In still another embodiment, the junction 924 allows the
device to rotate about any of axes 925, 935, and 911 independently
or in combination. By way of example, the hinge may include a
ball-and-socket joint. Any of the devices described herein may be
configured with a pivotable junction 924. As shown, the shaft 905
and the head 920 of device 900 are substantially similar to the
shaft 105 and the head 120 of the device 100 of FIG. 1, and the
various alternative embodiments and features of other delivery
devices described herein may apply to device 900.
[0072] In operation, the device 900 can be used to secure one or
more mesh straps of a surgical implant to a target tissue, for
example the sacrospinous ligament or coccygeus muscle. In an
exemplary method, an operator first couples a mesh strap 505 (not
shown in FIG. 9) to the device 900 using an implant associator 510
(not shown in FIG. 9) as described above. The operator then
positions the device 900 so that its tip 930 overlies a target
region 940a of the tissue 940. Next, the operator applies
appropriate torque to the device 900 from its handle (not shown)
and thereby drives the tip through the tissue 940, as shown in FIG.
10 which depicts the head 920 partially disposed within the target
tissue 940. The operator may position a forefinger on the head 920
for leverage, thereby rotating the head 920 about the pivotable
junction 924 and driving the head 920 into the tissue 940 without
moving the shaft 905.
[0073] FIG. 11 shows the device 900 with its tip 930 associated
with mesh strap 505 through implant associator 510 after having
penetrated through the target tissue 940. The operator drives the
head 920 through the tissue 940, such that the tip 930, coupled
with implant associator 510, emerges through the tissue 940. The
operator then retracts the rotatable head 920, leaving the mesh
implanted through the tissue 940 and anchored by the implant
associator 510. Alternatively, an operator uses a forceps or other
tong-like instrument to prevent the connector from retracting
through the tissue 940 as discussed above. Also as discussed above,
the mesh strap 505 may have tanged edges that help to anchor the
strap in the ligament 940.
[0074] The delivery device 900 may, in one optional aspect, include
a cannula 950 disposed about the shaft 905. The cannula 950 is
operably coupled to the rotatable pivot head 920 and is configured
to control rotation of the head 920. In particular, the cannula 950
includes a distal end 950a that rotates the end of the pivot head
920 near or in contact with the junction 924 as desired by an
operator. The operator may use external control mechanisms, such as
knobs and/or buttons located near the handle (not shown) to rotate
the head 920.
[0075] An another embodiment, a Miya hook 990, as shown in FIG. 12,
may be modified and used to place one or more mesh straps of an
implant. The Miya hook 990 includes a rounded head portion 992, a
shaft 994, and scissor-like handles 996. The rounded head portion
992 and the shaft 994 are configured to rotate with respect to each
other, thereby allowing the operator to adjust the placement of the
head portion 992 without moving the shaft. The head portion 992
includes a shoulder 993, such that the tip of the head portion 992
may associate with an associator, such as implant associator 510 of
FIG. 5.
[0076] The illustrative embodiments discussed above illustrate
devices and methods for securing a mesh strap 505 to a target
tissue, such as a muscle or a ligament. As mentioned above, the
mesh strap 505 can be a portion of a larger surgical implant which
can be used for pelvic floor support and/or repair. FIG. 13A
depicts an inferior view of a pelvic floor implant 960 positioned
within a patient by the use of one or more of the devices described
herein. As shown, the implant 960 includes a central region 964 and
a plurality of straps 962a-962f similar to mesh strap 505. The
straps 962a-962f include two anterior straps 962a and 962b, and
four posterior straps, 962c and 962e on one side, and 962d and 962f
on the contra-lateral side.
[0077] While the depicted implant 960 includes 6 straps, more or
fewer straps may be used depending on the nature of the condition
being treated, and exemplary embodiments include 2, 3, 4, or 5
straps. For example, if a medical operator determines that a
patient requires posterior support but not anterior support, an
implant may consist of four straps 962c-962f, but not straps
962a-962b.
[0078] The mesh implant 960 is sized and shaped to fit on or near
the pelvic floor and support the bladder, the vagina, and/or the
rectum. The straps 962a-962f are spaced apart so as to align with
particular anatomical locations within the pelvic region for
securing the implant 960 thereto. As shown in the depicted example,
the anterior straps 962a and 962b are positioned to align with the
patient's obturator foramen (not shown, but generally located at
regions 976a and 976b) and optionally can ultimately be pushed
through the patient's obturator membranes. Posterior straps 962c
and 962d are positioned to align with the tendinous arch of the
levator ani muscle 973, only a portion of which is depicted in FIG.
13A, and posterior straps 962e and 962f are positioned to align
with the sacrospinous ligament 975, only a portion of which is
depicted in FIG. 12. In an alternative embodiment, the posterior
straps 962c and 962d are placed in the iliococcygeus muscle. The
posterior straps 962e and 962f may be positioned in the
sacrospinous ligament and the coccygeus muscle, or alternatively,
only in the coccygeus muscle. The mesh straps 962a-962f may include
respective implant associators (not shown), similar to implant
associator 510.
[0079] In one aspect, the devices and systems described herein may
be used in surgical procedures to treat a patient suffering from
pelvic floor disorders or urinary incontinence. An exemplary
technique for implanting and securing the surgical mesh 960 in an
anatomy of a patient is now described.
[0080] The exemplary technique consists of three phases. In a first
phase, the operator inserts and secures the posterior straps 960e
and 960f into the sacrospinous ligament, the coccygeus muscle, or
both the sacrospinous ligament and coccygeus muscle. In a second
phase, the operator inserts and secures the posterior straps 962c
and 962d into the levator ani muscle, for example, the tendinous
arch of the levator ani muscle or the iliococcygeus muscle. In a
third phase, the operator inserts the anterior straps 962a and 962b
through the obturator foramen and secures the straps in either
obturator membranes or in the patient's tissues proximal to the
obturator canals.
[0081] More particularly, in the first phase, to insert the strap
962e a medical operator creates an incision in a patient's anterior
vaginal wall (not shown). The incision can be dissected or extended
as required to facilitate access of delivery device 100 to target
region 974e. Next, the operator couples, preferably external to the
body, mesh strap 962e with delivery device 100 via an implant
associator (not shown) similar to implant associator 510. The
operator then inserts the device 100 and coupled mesh strap 962e
through the vaginal opening 972, into the vaginal canal, and
through the vaginal incision. The operator pierces and drives the
mesh strap 962e through the target region 974e of the sacrospinous
ligament, and then retracts the device, using methods similar to
those described above. As mentioned above, the operator may use
forceps to facilitate the disassociation of the delivery device 100
from the mesh strap 962e.
[0082] The operator then delivers the mesh strap 962f through the
vaginal opening 972 and through the vaginal incision in a similar
manner as 962e. The vaginal incision may be dissected or extended
as necessary to facilitate access of delivery device 100 to target
region 974f. The operator may use the same delivery device 100 for
delivery of strap 962f, or alternatively may use a second delivery
device 100.
[0083] The first phase can also be carried out using delivery
device 900 of FIG. 9 or delivery device 101 of FIG. 1B instead of
delivery device 100. The use of delivery device 900 is beneficial
in part because the operator can adjust the rotation of the
rotatable head 920 to suit the operator's preference and/or the
particular anatomy of the patient. The use of delivery device 101
is beneficial in part because its curved shaft 103 may facilitate
passage of the device through the vaginal canal in order to access
the target regions 974e and 974f of the sacrospinous ligament.
[0084] In the second phase, the operator inserts the straps 962c
and 962d into target regions 974c and 974d of the levator ani
muscle. To insert strap 962c, the operator first couples delivery
device 300 to the mesh strap 962c using an implant associator (not
shown), then inserts the device 300 into the vaginal canal, and
through the vaginal incision. The vaginal incision provides access
to the target region 974c in part because the head 320 of the
device 300 is rotated so its tip 330 aligns with the target region
974c. However, if the rotated head 320 does not align with target
region 974c using the vaginal incision in a particular patient's
anatomy, the operator can choose a device 900 and adjust the
rotation of rotatable head 920 to align the tip 930 with target
region 974c.
[0085] With the device 300 appropriately placed proximal to the
target tissue region 974c, the operator then pierces and drives the
mesh strap 962c through the target region 974c of the levator ani
muscle, and retracts the delivery device 300 using the method
discussed with respect to FIG. 8.
[0086] The operator similarly delivers mesh strap 962d to target
region 974d of the tendinous arch of the levator ani muscle
contra-lateral to target region 974c using delivery device 400.
Similar to delivery device 300 accessing target region 974c, device
400 accesses target region 974d through the vaginal incision used
to deliver strap 962f. Alternatively, the operator can choose a
device 900 and adjust the rotation of rotatable head 920 to align
the tip 930 with target region 974d.
[0087] In a third phase, the operator inserts the anterior straps
962a and 962b through the obturator foramen and secures the straps
either to respective obturator membranes or to the patient's
tissues proximal the obturator canals as discussed in, for example,
U.S. patent application Ser. No. 10/957926, the entire contents of
which are incorporated by reference herein in their entirety.
[0088] More particularly, according to one method of use, an
operator implants the anterior strips 962a and 962b using delivery
devices that create passages through body tissue from an inferior
pubic ramus through an obturator foramen to a location proximal the
vaginal opening 972. The operator creates such a passage on each
side of the patient. In order to create the passages, the delivery
devices may include needles and/or dilators having curved portions
that can trace paths through an obturator foramen located generally
at 976a or 976b, through the vaginal incision in the anterior
vaginal wall, and ultimately to a region externally accessible via
vaginal opening 972. By way of example, FIG. 15A shows a delivery
device 983 that can deliver anterior strap 962a, and FIG. 15B shows
a delivery device 984 that can deliver anterior strap 962b.
Alternatively, device 985, depicted in various perspectives in
FIGS. 16A, 16B, and 16C, can deliver anterior strap 962b, while a
symmetric device can deliver anterior strap 962a.
[0089] In one implementation of the anterior straps, two incisions
are made on the body of the patient. A first incision is made just
to the side of the edge of the ishiopubic ramus in the region of
the urethral meatus. A second incision, corresponding to the first
incision, is made on the contra-lateral side. In an inside-out
approach, the strap 962a is associated with the delivery device 983
of FIG. 15A, which is inserted through the vaginal incision toward
the obturator foramen. The delivery device 983 pierces the
obturator membrane, and the tip of the delivery device 983 along
with the end of the strap 962a exits the patient tissue through the
first incision. The operator delivers and secures strap 962b by
repeating this process symmetrically with delivery device 984 on
the contra-lateral side of the body.
[0090] In an alternative approach, the operator extends the
delivery device 983 to an anatomical position in front of the
obturator membrane without piercing the membrane. In this approach,
the strap 962a is configured with soft tissue anchor end portions
for anchoring into the soft tissue in front of the membrane. Sling
assemblies with soft tissue anchors and devices and methods for
applying slings with soft tissue anchors are disclosed, for
example, in commonly assigned U.S. patent application Ser. No.
11/400111, filed Apr. 6, 2006 and entitled "Systems, Devices and
Methods for Treating Pelvic Floor Disorders," U.S. patent
application Ser. No. 11/399913, filed Apr. 6, 2006 and entitled
"Systems, Devices and Methods for Suburethral Support," and U.S.
patent application Ser. No. 11/152898, filed Jun. 14, 2005 and
entitled "Systems, Methods and Devices Relating to Implantable
Supportive Slings," the contents of each of which are incorporated
by reference herein in their entirety.
[0091] In an outside-in approach, the delivery device 983 of FIG.
15A is inserted through one ishiopubic incision, piercing the
obturator muscle and obturator membrane. A forefinger is placed in
the vaginal incision and on the distal end of the delivery device.
The forefinger is used to guide the distal end of delivery device
983 around the ishiopubic ramus through the vaginal incision.
[0092] Next, the operator associates strap 962a with the delivery
device 983. The delivery device 983 and the mesh strap 962a can be
associated with any of the implant associators discussed herein, or
the implant association techniques discussed in U.S. patent
application Ser. No. 10/542365. For example, the delivery device
983 may include an L-slot near the distal tip, which may be used to
associate the mesh strap 962a with the delivery device 983, such
that the delivery device can pull the mesh strap 962a back out
through the ischiopubic incision.
[0093] The delivery device 983 is then withdrawn from the
ischiopubic incision, drawing the end of the mesh strap 962a
through the passage created by the delivery device 983. Finally,
the operator delivers and secures strap 962b by repeating this
process symmetrically with delivery device 984 on the
contra-lateral side of the body.
[0094] FIG. 13B shows a lateral view of the pelvic region of the
patient, and more particularly shows the device 100 aligned with
the sacrospinous ligament 975, and the device 300 aligned with the
tendinous arch of the levator ani muscle 973, of which only a
portion is shown. The implant 960 is not shown.
[0095] The straps and incisions need not be inserted or made,
respectively, in the order described above. An operator can choose
any suitable order for creating incisions and delivering straps
962a-962f. The operator, at his discretion, optionally performs one
or more cystoscopies after inserting one or more of the mesh straps
962a-962f to check for damage to the bladder.
[0096] In one embodiment, for posterior pelvic floor support, the
anterior straps 962a-962b may be cut off or otherwise removed from
the implant 960. The anterior straps 962a-962b may be removed from
the implant 960 before implantation. In this embodiment, the
central region 964 of the implant 960 may be sutured or otherwise
attached to the pubococcygeus muscle and/or the anterior portion of
the tendinous arch of the levator ani muscle.
[0097] The exemplary three phase technique described above employed
various ones of the delivery devices 100, 101, 300, 400, 983, 984,
985, and/or 900 to delivery various ones of the straps 962a-962f.
Each of these devices can be provided with a handle 119 shown in
FIG. 8 that is color-coded to match the color of the implant
associator corresponding to the mesh strap 962a-962f that the
device delivers. The operator can thereby visually identify which
of the devices 100, 101, 300, 400, 983, 984, 985, and/or 900 will
deliver which of the straps 962a-962f. Since certain devices, such
as device 100, can be used to deliver multiple straps, the device
100 may include a handle 119 with multiple color codes. Other
visual indications or markers may also be used.
[0098] Other delivery methods can be used for implant 960. For
example, suprapubic, prepubic, and transvaginal approaches,
disclosed in the patents and patent applications cited herein, can
be used to delivery one or more of the straps 962a-962f. All
operative combinations between the disclosed delivery devices and
these alternative procedures are contemplated. Any of the delivery
devices described above may be employed to create appropriate
passageways to target regions in a patient's anatomy.
[0099] After the mesh straps 962a-962f are in place near their
respective target regions 974a-f, the operator adjusts the tension
of the implant 960 by pulling the mesh straps 962a-962f further
through their respective target tissue regions. In certain
implementations, an operator inserts a forceps through one of the
vaginal incisions to one of the target regions 962a-962f. The
operator may grasp and pull a respective implant associator (not
shown) and thereby pull the respective mesh strap 962a-962f further
through its tissue or ligament, as described above. This increases
the tension of the implant. The operator may perform this process
for one or more of the mesh straps until the desired tension is
achieved.
[0100] Other methods of delivering and securing the mesh are
envisioned. In some embodiments, the mesh straps, such as mesh
straps 962a-962f, are not driven through muscle or ligament, but
instead are anchored into general surrounding tissue by barbs or
tangs on the edges and/or surfaces of the implant 960 and/or its
straps 962a-962f. The straps 962a-962f can alternately be secured
to soft tissue regions of the pelvic floor using soft tissue
anchors as discussed in U.S. Provisional Application No. 60/715362,
the contents of which are incorporated herein by reference in their
entirety. Alternatively, one or more of the straps 962a-962f may be
secured to target tissue regions by suturing the straps. For
example, straps 962c-f can be sutured to target tissue regions of
the levator ani muscle and/or the sacrospinous ligament.
[0101] In another aspect, the invention includes a kit with devices
for use in supporting or repairing pelvic floor problems. FIG. 14
illustrates an exemplary surgical kit 980 for use in surgery
related to pelvic floor repair. The kit 980 includes these
devices--device 100, device 300, and device 400. In certain
embodiments, the shafts 305 and 405 are about equal in length and
shaft 105 is between about 15% and 60% longer than shafts 305 and
405. In certain embodiments, shaft 105 is about 20% longer than
shafts 305 and 405.
[0102] Optionally, the kit also includes one or more surgical
implants, such as the implant 960. In this illustration, the straps
962a-962f are coupled with respective implant associators similar
to implant associator 510, however in alternate embodiments the
implant associators can be provided in the kit separate from the
straps 962a-962f or may not be provided at all.
[0103] In another optional embodiment, the kit 980 includes one or
more of the devices 983 and 984 of FIG. 15A and FIG. 15B.
Additionally or alternatively, the kit 980 may include one or more
of device 985 of FIGS. 16A-16C, as well as a symmetric device for
use on a contra-lateral side of a patient. The kit 980 may
additionally or alternatively include one or more of the delivery
devices discussed in U.S. patent application Ser. No. 10/957926
and/or device 101 of FIG. 1B. In alternative embodiments, device
900 is provided with (or without) one or more of the devices
included in kit 980.
[0104] FIGS. 15A and 15B depict a pair of delivery devices 983 and
984, each having an angled handle, according to another
illustrative embodiment of the invention. The devices 983 and 984
are substantially mirror images of each other for ease of use on
either side of a patients body. Accordingly, for illustrative
purposes, only FIG. 12A is discussed. The handle 987 of the
delivery device 983 includes a first section 987a extending along a
first longitudinal axis substantially in a first plane. A second
section 987b of the handle 987 extends distally from, but at an
angle to, the axis of the first section 987a. The first 987a and
second 987b sections of the handle 987 are substantially coplanar
in the first plane. A shaft 989 includes a curved section that
extends from a mounting location at a distal end of the second
handle section 987b. The curved section first extends out of the
first plane of the first 987a and second 987b handle sections, then
extends back toward the first plane. In some configurations, the
distal tip 989a (conically shaped in the illustrative embodiment)
of the delivery device 983 extends back through the first plane. In
other configurations, the distal tip 989a extends up to or short of
the first plane. According to one feature, the shaft 989 rotates
about an axis that is substantially orthogonal to the first plane.
However, according to other illustrative embodiments, the axis need
not be substantially orthogonal to the first plane. According to
alternative illustrative embodiment, at least one of the first 987a
and second 987b sections of the handle 987 tapers to have a
narrower width as the handle 987 extends distally toward the
shaft.
[0105] FIGS. 16A-16C depict various views of a delivery device 985
having a handle 991 with first 991a and second 991c substantially
straight sections located substantially in a first plane and angled
relative to each other at 991b, a transitional portion 993
extending out of a distal end of the handle 991, and a shaft 995
extending from a distal end of the transitional portion 993. The
shaft includes curved section 995a, a straight section 995b, and
terminates in a conical tip 995c.
[0106] The transitional portion 993 interfits and extends axially
out of the distal end of the second handle section 991c to affix
the shaft 995 to the handle 991. As a result, the transitional
portion 993 is substantially co-planar with the handle 991 in the
first plane. The curved section 995a of the shaft 995 extends from
a distal end of the transitional portion 993. The straight section
995b of the shaft 995 extends from a distal end of the curved
section 995a. The curved section 995a and the straight section 995b
are substantially coplanar in a second plane. According to the
illustrative embodiment of FIGS. 16A-16C, the first and second
planes are substantially orthogonal to each other. However, the
first and second planes may be at any suitable angle (e.g., about
10, 20, 30, 45, 60, 70 or 80 degrees) to each other. In another
illustrative embodiment of FIGS. 16A-16C, the first and second
sections 991a and 991c of the handle 991 are at an angle of about
150 degrees to each other. However, first and second sections 991a
and 991c of the handle 991 may be at any suitable angle (e.g.,
about 80, 90, 100, 110, 120, 130, 140, 160, 170 or 180 degrees) to
each other.
[0107] To provide structural reinforcement, sections 991b and 991c
have a cross sectional diameter that tapers to be smaller at the
distal end 143 of the handle 991. Additionally, rather than having
the tapered section of the transitional portion being formed as
part of the shaft, the tapered portions 991a, 991b, and 991c of the
embodiment of FIG. 16 are formed as part of the handle 991.
According to one feature, this configuration reduces the length of
the transitional portion 993 and thus, provides improved structural
support for the curved section 995a. Preferably, in operation,
neither the handle 991 nor the transitional portion 993 extends
into the body of the patient, and the angle at transitional portion
993 provides a positive stop against this occurring.
[0108] As mentioned above, the surgical implants of this invention,
such as implant 960 of FIG. 14, are typically a mesh material.
There are many possible mesh materials, and the sling may, in the
alternative or in combination, be made of other types of materials.
Exemplary mesh materials include, for example, synthetic materials,
natural materials (e.g., biological) or a combination thereof. The
mesh may be fabricated from any of a number of biocompatible
materials, such as nylon, silicone, polyethylene, polyester,
polyethylene, polyimide, polyurethane, polypropylene,
fluoropolymers, copolymers thereof, combinations thereof, or other
suitable synthetic material(s). The material may be, for example, a
biodegradable synthetic material. The term "biodegradable," as used
herein, refers to the property of a material that dissolves in the
body. Such materials may also be absorbed into the body, i.e.,
bioabsorbable.
[0109] Suitable bioabsorbable synthetic materials include, without
limitation, polylactic acid (PLA), polyglycolic acid (PGA),
poly-L-lactic acid (PLLA), poly(amino acids), polypeptides, human
dermis and decellularized animal tissue. Human tissues may be
derived, for example, from human cadaveric or engineered human
tissue. Animal tissues may be derived, for example, from porcine,
ovine, bovine, and equine tissue sources. The material may be an
omnidirectional material, a material that has equivalent tensile
strength from any direction, such as pericardium or dermis.
Alternatively, the material may be an oriented material, a material
that has a single direction where the tensile strength of the
material is the highest. Oriented materials may include rectus
fascia and/or facia lata, as well as oriented synthetic
materials.
[0110] Exemplary biodegradable polymers, which may be used to form
the tubular mesh 100, in addition to those listed above, include,
without limitation, polylactic acid, polyglycolic acid and
copolymers and mixtures thereof, such as poly(L-lactide) (PLLA),
poly(D,L-lactide) (PLA), polyglycolic acid [polyglycolide (PGA)],
poly(L-lactide-co-D,L-lactide) (PLLA/PLA),
poly(L-lactide-co-glycolide) (PLLA/PGA),
poly(D,L-lactide-co-glycolide) (PLA/PGA),
poly(glycolide-co-trimethylene carbonate) (PGA/PTMC),
poly(D,L-lactide-co-caprolactone) (PLA/PCL), and
poly(glycolide-co-caprolactone) (PGA/PCL); polyethylene oxide
(PEO); polydioxanone (PDS); polypropylene fumarate;
polydepsipeptides, poly(ethyl glutamate-co-glutamic acid),
poly(tert-butyloxy-carbonylmethyl glutamate); polycaprolactone
(PCL), poly(hydroxy butyrate), polycaprolactone co-butylacrylate,
polyhydroxybutyrate (PHBT) and copolymers of polyhydroxybutyrate;
polyphosphazenes, poly(phosphate ester); maleic anhydride
copolymers, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene
carbonate)-co-(2.5% trimethylene carbonate)], cyanoacrylate,
hydroxypropylmethylcellulose; polysaccharides, such as hyaluronic
acid, chitosan, alginates and regenerate cellulose; poly(amino
acid) and proteins, such as poly(lysine), Poly(glutamic acid),
gelatin and collagen; and mixtures and copolymers thereof.
[0111] The implant 960, either as a whole or on a fiber by fiber
basis, may include an agent for release into the patient's tissues.
One illustrative agent is a tissue growth factor that promotes,
when applied to the patient's tissues in a pharmaceutically
acceptable amount, well-organized collagenous tissue growth, such
as scar tissue growth, preferably, in large quantities. According
to one feature, the agent may or may not block or delay the
dissolvability of the biodegradable materials. This may be
controlled by selecting differing methods for loading the agent
onto the sling. The tissue growth factor may include natural and/or
recombinant proteins for stimulating a tissue response so that
collagenous tissue such as scar tissue growth is enhanced.
Exemplary growth factors that may be used include, but are not
limited to, platelet-derived growth factor (PDGF), fibroblast
growth factor (FGF), transforming growth factor-beta (TGF-beta),
vascular endothelium growth factor (VEGF), Activin/TGF and sex
steroid, bone marrow growth factor, growth hormone, Insulin-like
growth factor 1, and combinations thereof. The agent may also
include a hormone, including but not limited to estrogen, steroid
hormones, and other hormones to promote growth of appropriate
collagenous tissue such as scar tissue. The agent may also include
stem cells or other suitable cells derived from the host patient.
These cells may be fibroblast, myoblast, or other progenitor cells
to mature into appropriate tissues. Besides applying active
pharmaceutical agents, passive agents may be applied to promote
tissue ingrowth. For example, titanium sputtering or chrome
sputtering can be used.
[0112] In various illustrative embodiments, the agent may include
one or more therapeutic agents. The therapeutic agents may be, for
example, anti-inflammatory agents, including steroidal and
non-steroidal anti-inflammatory agents, analgesic agents, including
narcotic and non-narcotic analgesics, local anesthetic agents,
antispasmodic agents, growth factors, gene-based therapeutic
agents, and combinations thereof.
[0113] Exemplary steroidal anti-inflammatory therapeutic agents
(glucocorticoids) include, but are not limited to,
21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide,
beclomethasone, betamethasone, budesonide, chloroprednisone,
clobetasol, clobetasone, clocortolone, cloprednol, corticosterone,
cortisone, cortivazol, deflazacort, desonide, desoximetasone,
dexamethasone, diflorasone, diflucortolone, difluprednate,
enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide,
fluocinolone acetonide, fluocinonide, fluocortin butyl,
fluocortolone, fluorometholone, fluperolone acetate, fluprednidene
acetate, fluprednisolone, flurandrenolide, fluticasone propionate,
formocortal, halcinonide, halobetasol priopionate, halometasone,
halopredone acetate, hydrocortamate, hydrocortisone, loteprednol
etabonate, mazipredone, medrysone, meprednisone,
methyolprednisolone, mometasone furoate, paramethasone,
prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate,
prednisone sodium phosphate, prednisone, prednival, prednylidene,
rimexolone, tixocortal, triamcinolone, triamcinolone acetonide,
triamcinolone benetonide, triamcinolone hexacetonide, and
pharmaceutically acceptable salts thereof.
[0114] Exemplary non-steroidal anti-inflammatory therapeutic agents
include, but are not limited to, aminoarylcarboxylic acid
derivatives such as enfenamic acid, etofenamate, flufenamic acid,
isonixin, meclofenamic acid, mefanamic acid, niflumic acid,
talniflumate, terofenamate and tolfenamic acid; arylacetic acid
derivatives such as acemetacin, alclofenac, amfenac, bufexamac,
cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac,
fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin,
ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic
acid, oxametacine, proglumetacin, sulindac, tiaramide, tolmetin and
zomepirac; arylbutyric acid derivatives such as bumadizon,
butibufen, fenbufen and xenbucin; arylcarboxylic acids such as
clidanac, ketorolac and tinoridine; arylpropionic acid derivatives
such as alminoprofen, benoxaprofen, bucloxic acid; carprofen,
fenoprofen, flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam,
indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen,
oxaprozin, piketoprofen, pirprofen, pranoprofen, protizinic acid,
suprofen and tiaprofenic acid; pyrazoles such as difenamizole and
epirizole; pyrazolones such as apazone, benzpiperylon, feprazone,
mofebutazone, morazone, oxyphenbutazone, phenybutazone, pipebuzone,
propyphenazone, ramifenazone, suxibuzone and thiazolinobutazone;
salicylic acid derivatives such as acetaminosalol, aspirin,
benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal,
etersalate, fendosal, gentisic acid, glycol salicylate, imidazole
salicylate, lysine acetylsalicylate, mesalamine, morpholine
salicylate, 1-naphthyl salicylate, olsalazine, parsalmide, phenyl
acetylsalicylate, phenyl salicylate, salacetamide, salicylamine
o-acetic acid, salicylsulfuric acid, salsalate and sulfasalazine;
thiazinecarboxamides such as droxicam, isoxicam, piroxicam and
tenoxicam; others such as .epsilon.-acetamidocaproic acid,
s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine,
bendazac, benzydamine, bucolome, difenpiramide, ditazol,
emorfazone, guaiazulene, nabumetone, nimesulide, orgotein,
oxaceprol, paranyline, perisoxal, pifoxime, proquazone, proxazole
and tenidap; and pharmaceutically acceptable salts thereof.
[0115] Exemplary narcotic analgesic therapeutic agents include, but
are not limited to, alfentanil, allylprodine, alphaprodine,
anileridine, benzylmorphine, bezitramide, buprenorphine,
butorphanol, clonitazene, codeine, codeine methyl bromide, codeine
phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine,
diampromide, dihydrocodeine, dihydrocodeinone enol acetate,
dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene,
dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine,
ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl,
hydrocodone, hydromorphone, hydroxypethidine, isomethadone,
ketobemidone, levorphanol, lofentanil, meperidine, meptazinol,
metazocine, methadone hydrochloride, metopon, morphine, myrophine,
nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone,
normorphine, norpipanone, opium, oxycodone, oxymorphone,
papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine,
piminodine, piritramide, proheptazine, promedol, properidine,
propiram, propoxyphene, rumifentanil, sufentanil, tilidine, and
pharmaceutically acceptable salts thereof.
[0116] Exemplary non-narcotic analgesic agents that may be combined
with the slings of the invention include, but are not limited to,
aceclofenac, acetaminophen, acetaminosalol, acetanilide,
acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin,
aluminum bis(acetylsalicylate), aminochlorthenoxazin,
2-amino-4-picoline, aminopropylon, aminopyrine, ammonium
salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate,
antrafenine, apazone, aspirin, benorylate, benoxaprofen,
benzpiperylon, benzydamine, bermoprofen, brofenac,
p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin,
bufexamac, bumadizon, butacetin, calcium acetylsalicylate,
carbamazepine, carbiphene, carsalam, chloralantipyrine,
chlorthenoxazin(e), choline salicylate, cinchophen, ciramadol,
clometacin, cropropamide, crotethamide, dexoxadrol, difenamizole,
diflunisal, dihydroxyaluminum acetylsalicylate, dipyrocetyl,
dipyrone, emorfazone, enfenamic acid, epirizole, etersalate,
ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,
floctafenine, flufenamic acid, fluoresone, flupirtine,
fluproquazone, flurbiprofen, fosfosal, gentisic acid, glafenine,
ibufenac, imidazole salicylate, indomethacin, indoprofen,
isofezolac, isoladol, isonixin, ketoprofen, ketorolac,
p-lactophenetide, lefetamine, loxoprofen, lysine acetylsalicylate,
magnesium acetylsalicylate, methotrimeprazine, metofoline,
miroprofen, morazone, morpholine salicylate, naproxen, nefopam,
nifenazone, 5'nitro-2'propoxyacetanilide, parsalmide, perisoxal,
phenacetin, phenazopyridine hydrochloride, phenocoll,
phenopyrazone, phenyl acetylsalicylate, phenyl salicylate,
phenyramidol, pipebuzone, piperylone, prodilidine, propacetamol,
propyphenazone, proxazole, quinine salicylate, ramifenazone,
rimazolium metilsulfate, salacetamide, salicin, salicylamide,
salicylamide o-acetic acid, salicylsulfuric acid, salsalte,
salverine, simetride, sodium salicylate, sulfamipyrine, suprofen,
talniflumate, tenoxicam, terofenamate, tetradrine, tinoridine,
tolfenamic acid, tolpronine, tramadol, viminol, xenbucin,
zomepirac, and pharmaceutically acceptable salts thereof.
[0117] Exemplary local anesthetic therapeutic agents include, but
are not limited to, ambucaine, amolanone, amylocaine hydrochloride,
benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine,
butacaine, butaben, butanilicaine, butethamine, butoxycaine,
carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine,
cyclomethycaine, dibucaine hydrochloride, dimethisoquin,
dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine,
ecgonine, ethyl chloride, beta-eucaine, euprocin, fenalcomine,
fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl
p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine,
mepivacaine, meprylcaine, metabutoxycaine, methyl chloride,
myrtecaine, naepaine, octacaine, orthocaine, oxethazaine,
parethoxycaine, phenacaine hydrochloride, phenol, piperocaine,
piridocaine, polidocanol, pramoxine, prilocaine, procaine,
propanocaine, proparacaine, propipocaine, propoxycaine
hydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl
alcohol, tetracaine hydrochloride, tolycaine, trimecaine, zolamine,
and pharmaceutically acceptable salts thereof.
[0118] Exemplary antispasmodic therapeutic agents include, but are
not limited to, alibendol, ambucetamide, aminopromazine,
apoatropine, bevonium methyl sulfate, bietamiverine, butaverine,
butropium bromide, n-butylscopolammonium bromide, caroverine,
cimetropium bromide, cinnamedrine, clebopride, coniine
hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine,
diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine,
emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine,
fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate,
flopropione, gluconic acid, guaiactamine, hydramitrazine,
hymecromone, leiopyrrole, mebeverine, moxaverine, nafiverine,
octamylamine, octaverine, oxybutynin chloride, pentapiperide,
phenamacide hydrochloride, phloroglucinol, pinaverium bromide,
piperilate, pipoxolan hydrochloride, pramiverin, prifinium bromide,
properidine, propivane, propyromazine, prozapine, racefemine,
rociverine, spasmolytol, stilonium iodide, sultroponium, tiemonium
iodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,
trifolium, trimebutine, n,n-ltrimethyl-3,3-diphenyl-propylamine,
tropenzile, trospium chloride, xenytropium bromide, and
pharmaceutically acceptable salts thereof.
[0119] According to another feature, the implants, such as implant
800, of the invention may include any suitable end portions, such
as tissue dilators, anchors, and association mechanisms for
associating the sling with the delivery devices of the invention.
They may also include other slings, sling assemblies, sling
delivery approaches, sling assembly-to-delivery device association
mechanisms, and sling anchoring mechanisms. These and other
features with which the delivery devices, implants, methods, and
kits of the invention may be employed are disclosed in U.S. Pat.
No. 6,042,534, entitled "Stabilization sling for use in minimally
invasive pelvic surgery," U.S. Pat. No. 6,755,781, entitled
"Medical slings," U.S. Pat. No. 6,666,817, entitled "Expandable
surgical implants and methods of using them," U.S. Pat. No.
6,042,592, entitled "Thin soft tissue surgical support mesh," U.S.
Pat. No. 6,375,662, entitled "Thin soft tissue surgical support
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patent application Ser. No. 10/641,192, entitled "Medical slings,"
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patent application Ser. No. 11/400111, entitled "Systems, Devices,
and Methods for Treating Pelvic Floor Disorders," and U.S. patent
application Ser. No. 11/399913, entitled "Systems, Devices, and
Methods for Sub-Urethral Support". It is intended that the scope of
the invention not be limited by this detailed description.
[0120] The present disclosure contemplates all combinations of
features and elements disclosed herein. For example, various
embodiments of delivery devices, transfer pins, implants, implant
associators, and other features described herein are
interchangeable with one another, unless explicitly stated
otherwise. As such, combinations of these embodiments, if not
explicitly disclosed, are contemplated and within the scope of the
present disclosure.
[0121] The contents of all references, patents and published patent
applications cited throughout this Application, as well as their
associated figures are hereby incorporated by reference in
entirety.
[0122] The Figures and drawings referred to herein are not
necessarily to scale; emphasis instead is generally placed upon
illustrating the principles of the illustrated embodiments.
[0123] Variations, modifications, and other implementations of what
is described herein will occur to those of ordinary skill without
departing from the spirit and the scope of the present disclosure.
Hence, many equivalents to the specific systems, methods, and other
embodiments described herein exist and are considered to be within
the scope of the present disclosure. For additional illustrative
features that may be used with the present disclosure, including
the embodiments described here, refer to the documents listed
herein above and incorporated by reference in their entirety. All
operative combinations between the above described illustrative
embodiments and those features described in the documents
incorporated by reference herein are considered to be potentially
patentable embodiments of the claimed invention.
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