U.S. patent application number 14/070102 was filed with the patent office on 2014-02-27 for adjustable tissue support member.
This patent application is currently assigned to C. R. BARD, INC.. The applicant listed for this patent is C. R. BARD, INC.. Invention is credited to Doug Evans, Henry Holsten.
Application Number | 20140058193 14/070102 |
Document ID | / |
Family ID | 40639118 |
Filed Date | 2014-02-27 |
United States Patent
Application |
20140058193 |
Kind Code |
A1 |
Evans; Doug ; et
al. |
February 27, 2014 |
Adjustable Tissue Support Member
Abstract
An adjustable single-incision sling system, includes a tissue
support portion, a first tissue anchor, and a second tissue anchor.
The first tissue anchor connects to the tissue support portion via
a first arm, which spaces the first tissue anchor from the tissue
support portion a fixed first distance. The second tissue anchor
connects to the tissue support portion via a second arm, which has
a free end passing through the second tissue anchor spacing the
second tissue anchor from the tissue support portion a variable
second distance, such that movement of the free end with respect to
the second tissue anchor decreases the second distance.
Inventors: |
Evans; Doug; (Snellville,
GA) ; Holsten; Henry; (Covington, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C. R. BARD, INC. |
Murray Hill |
NJ |
US |
|
|
Assignee: |
C. R. BARD, INC.
Murray Hill
NJ
|
Family ID: |
40639118 |
Appl. No.: |
14/070102 |
Filed: |
November 1, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13524408 |
Jun 15, 2012 |
8574149 |
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14070102 |
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12269749 |
Nov 12, 2008 |
8206280 |
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13524408 |
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61102147 |
Oct 2, 2008 |
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61025461 |
Feb 1, 2008 |
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61020231 |
Jan 10, 2008 |
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61015741 |
Dec 21, 2007 |
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60987469 |
Nov 13, 2007 |
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Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61B 2017/0437 20130101;
A61F 2/0045 20130101; A61B 17/06109 20130101; A61B 2017/0448
20130101; A61B 17/0401 20130101; A61B 2017/06042 20130101; A61B
2017/06009 20130101; A61B 2017/0446 20130101; A61B 2017/0409
20130101; A61B 2017/00805 20130101; A61B 2017/0427 20130101; A61B
2017/0464 20130101; A61B 2017/0414 20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. An adjustable single-incision sling system, comprising: a tissue
support portion; a first tissue anchor connected to the tissue
support portion via a first arm, the first arm spacing the first
tissue anchor from the tissue support portion a fixed first
distance; and a second tissue anchor connected to the tissue
support portion via a second arm, the second arm having a free end
passing through the second tissue anchor spacing the second tissue
anchor from the tissue support portion a variable second distance,
wherein movement of the free end with respect to the second tissue
anchor decreases the second distance.
2. The tissue support system according to claim 1, wherein the
second arm is formed by a tubular knit construction of a mesh
material.
3. The tissue support system according to claim 1, wherein the
second tissue anchor includes a head with a tissue penetrating tip
and a base.
4. The tissue support system according to claim 3, wherein the base
includes an aperture through which the second arm is
positioned.
5. The tissue support system according to claim 4, wherein the
aperture is normal to a longitudinal axis of the second tissue
anchor.
6. The tissue support system according to claim 4, wherein the
aperture resists unconstrained movement of the second arm
therethrough.
7. The tissue support system according to claim 1, further
comprising a locking member disposed in a lumen of the second arm
between the second tissue anchor and a second end of the second
arm, wherein the locking member is shaped to permit movement toward
the second tissue anchor, but to resist movement away from the
second tissue anchor.
8. The tissue support system according to claim 7, further
comprising a stylet for introduction into the lumen of the second
arm, and for urging the locking member in the direction of the
second tissue anchor.
9. The tissue support system according to claim 1, further
comprising an introducer needle capable of releasably securing the
first and second tissue anchors.
10. The tissue support system according to claim 9, wherein the
introducer needle comprises a shaft and a handle.
11. The tissue support system according to claim 10, wherein the
shaft has a curved portion.
12. The tissue support system according to claim 11, wherein the
shaft has a substantially helical shape.
13. The tissue support system according to claim 10, wherein the
handle comprises a manually operable mechanism for releasing the
anchor from the distal end of the shaft.
14. The tissue support system according to claim 1, wherein the
tissue support portion comprises orientating indicia.
15. The tissue support system according to claim 14, wherein the
orientating indicia comprises a colored feature in the center of
the tissue support portion.
16. The tissue support system according to claim 1, wherein the
first and second tissue anchors are shaped to penetrate tissue when
urged in a first direction, and resist movement in a second
direction opposite of the first direction.
17. The tissue support system according to claim 1, wherein the
tissue support portion, the first arm, and the second arm are
formed from mesh.
18. The tissue support system according to claim 17, wherein the
tissue support portion is formed from a single layer of mesh.
19. The tissue support system according to claim 17, wherein the
tissue support portion, the first arm, and the second arm are
constructed from a unitary tubular member.
20. A method for supporting body tissue, comprising: making an
incision in a vaginal wall of a patient; inserting a first tissue
anchor into the incision in the direction of an obturator membrane
on a first side of the patient, the first tissue anchor connected
to a tissue support portion via a first arm, the first arm spacing
the first tissue anchor from the tissue support portion a fixed
first distance; perforating the obturator membrane on the first
side of the patient with the first tissue anchor; inserting a
second tissue anchor into the incision in the direction of an
obturator membrane on a second side of the patient, the second
tissue anchor connected to the tissue support portion via a second
arm, the second arm spacing the second tissue anchor from the
tissue support portion a variable second distance; perforating the
obturator membrane on the second side of the patient with the
second tissue anchor; and pulling on the second arm to adjust the
tension exerted by the tissue support portion on the body tissue.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/524,408, filed Jun. 15, 2012, now U.S. Pat.
No. 8,574,149, which is a continuation of U.S. patent application
Ser. No. 12/269,749, filed Nov. 12, 2008, now U.S. Pat. No.
8,206,280, which claims the benefit of priority to U.S. Provisional
Application Nos. 60/987,469, filed Nov. 13, 2007, titled "Implant
with Adjustability Feature;" 61/015,741, filed Dec. 21, 2007,
titled "Tissue Anchor Insertion Device;" 61/020,231 filed Jan. 10,
2008, titled "Continuous Knit Tubular Mesh Implant;" 61/025,461
filed Feb. 1, 2008, titled "Adjustable Tissue Support Member;" and
61/102,147, filed Oct. 2, 2008, titled "Adjustable Tissue Support
Member," the disclosures of which are all incorporated herein by
reference in their entirety.
[0002] Female urinary incontinence is commonly treated by a sling
suspension procedure. Generally, sling suspension procedures
involve the placement of a sling member beneath a patient's
urethra. The sling member is suitably implanted in the patient's
tissue with an introducer needle, which helps draw the sling into
position.
[0003] Slings have been made of numerous materials, synthetic and
natural, and are generally in the form of a mesh. A traditional
sling procedure involves placing a strip of implant material
(natural tissue, synthetic mesh, or a combination of the two) under
the urethra and securing it to the rectus fascia or other portions
of the patient's anatomy with sutures to hold the implant in
position during the healing process.
[0004] Improved techniques have been developed that speed the
implant process by reducing the number of incisions made and by
altering the pathways by which the implant is introduced into the
body. These improvements, which employ specialized instrumentation,
help to reduce operative time and have made the procedure less
invasive. The improved techniques generally require that an implant
be joined to an introducer needle. The implant is then inserted
into, and pulled through, the body. Subsequently, the implant is
detached from the introducer needle.
[0005] Such procedures may require long needle passes and
substantial tissue dissection, such as in the case of a retropubic
or suprapubic procedure. Long needle passes increase the likelihood
of an unintended perforation of a body structure (e.g., the
bladder). In addition, the procedures typically require not only at
least one vaginal incision, but also two external incisions at the
locus of the obturator foramina in the case of a transobturator
approach, and above the pubic bone in the retro- and suprapubic
approaches.
[0006] Such procedures often use instrumentation that lacks an
adjustability feature. A mesh sling has to exert an appropriate
amount of tension on the urethra. Excessive tension can result in
kinking of the urethra and/or undue tissue erosion, whereas
insufficient tension can result in an ineffective sling. It might
be desirable to be able to adjust the tension of the sling after
both ends of the sling have been anchored in tissue, but before the
tension is fixed and surgery is concluded. In addition, it could be
desirable to provide bi-directional adjustment and not just
adjustment in a single direction. Features that further the
achievement of at least one of the foregoing goals could be
desirable.
[0007] In view of the above, it would be beneficial to have a
minimally invasive sling suitable for treating various conditions,
such as incontinence, for example fecal and urinary incontinence,
such as female urinary incontinence. According to various
embodiments, each end of the implanted minimally invasive sling
terminates in a tissue anchor. The length of the sling (and the
tension exerted by the sling on the urethra) is configured for
adjustment once at least one of the tissue anchors has been
implanted.
SUMMARY
[0008] According to one embodiment, there is disclosed herein a
tissue support system comprising an implantable tissue support
member, wherein the implantable tissue support member comprises a
tissue support portion having a length and a width, a first arm
disposed at one end of the tissue support portion, and a second arm
disposed at an opposite end of the tissue support portion, a first
tissue anchor connected to the first arm, and a second tissue
anchor connected to the second arm, wherein the second tissue
anchor is slideable along a length of said second arm.
[0009] According to another embodiment, there is disclosed herein a
tissue support system comprising an implantable tissue support
member, wherein the implantable tissue support member comprises a
tissue support portion having a first end and a second end, a first
arm having a first end and a second end, wherein the first end is
joined to the first end of the tissue support portion, a second arm
having a first end and a second end, wherein the first end is
joined to the second end of the tissue support portion, a first
tissue anchor fixed to the second end of the first arm, and a
second tissue anchor having an aperture therein, wherein the
aperture is configured to at least partially enclose a portion of
the second arm.
[0010] According to yet another embodiment, there is disclosed
herein a method for providing support to body tissue, comprising
making an incision in the vaginal wall, inserting an introducer
needle having a first tissue anchor at the distal end thereof into
the incision in the direction of the obturator membrane, wherein
the first introducer needle is connected to an implant, ejecting
the first tissue anchor from the introducer needle, withdrawing the
introducer needle from the incision, and inserting a second tissue
anchor in the distal end thereof wherein the second tissue anchor
is connected to an implant, re-inserting the introducer needle into
the incision in the direction of the contra-lateral obturator
membrane, ejecting the second tissue anchor from the introducer
needle, and applying traction to the implant until the desired
amount of tissue support is obtained.
[0011] According to another embodiment, there is disclosed herein a
medical device configured for implantation in tissue, comprising a
lumen formed from a flexible material, at least one tissue anchor
having at least one aperture therein, said at least one aperture
configured to receive said lumen formed from a flexible material,
and an anchor stop disposed in said lumen, wherein said anchor stop
is configured to resist movement when urged in one direction within
said lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The disclosed embodiments can be better understood with
reference to the following drawings. The components in the drawings
are not necessarily to scale.
[0013] FIG. 1 illustrates one aspect of a tissue support system in
accordance with the present disclosure.
[0014] FIG. 2 illustrates an aspect of an implantable tissue
support member and an introducer needle.
[0015] FIG. 3 illustrates a tissue anchor being released from an
introducer needle.
[0016] FIG. 4 illustrates a stylet being urged into a lumen.
[0017] FIG. 5 illustrates a view of a tissue support member.
[0018] FIG. 6 illustrates an exploded view of a tissue support
member.
[0019] FIG. 7 illustrates a view of one aspect of a tissue support
member.
[0020] FIG. 8 illustrates an exploded view of an introducer
needle.
[0021] FIGS. 9A-9B illustrate cut-away views of exemplary tissue
anchors.
[0022] FIG. 10 illustrates an embodiment of a tissue support
system.
[0023] FIG. 11 illustrates cut-away views of exemplary tissue
anchors.
[0024] FIGS. 12A-12B illustrate bottom and side views of an
exemplary tissue anchor.
DESCRIPTION
[0025] The following description should be read with reference to
the drawings. The drawings, which are not necessarily to scale,
depict selected embodiments and are not intended to limit the scope
of the invention.
[0026] FIG. 1 illustrates a tissue support system 10 according to
various aspects of the present disclosure. The system includes an
implantable tissue support member 100, a stylet 185, and an
introducer needle 200. The tissue support member comprises a tissue
support portion 130 having ends 132 and 134 connected to arms 120
and 160, and orienting indicia 140. The arm 129 has ends 121 and
122, and arm 160 has ends 162 and 164.
[0027] The orienting indicator 140 can comprise, by way of
non-limiting example, a dyed centerline, or a colored thread woven
into the center portion of the implant. According to one
embodiment, the indicator is colored midline indicator in the form
of a blue polypropylene thread woven through the middle of tissue
support portion 130.
[0028] The implantable support member 100 further comprises a first
tissue anchor 110, and a second tissue anchor 150. Tissue anchor
150 is configured to be connected to, but moveable along (i.e.,
slidably attached to), a length of arm 160. According to one
embodiment, tissue anchor 150 slides along a length of arm 160.
According to various embodiments, tissue anchor 150 has an aperture
therein, through which arm 160 is received. According to certain
embodiments, anchor 110 is fixed to end 121 of arm 120. According
to another embodiment, anchor 110 is configured to be connected to,
but moveable along, a length of arm 120.
[0029] According to one embodiment, tissue support portion 130 is a
flat, single layer of mesh, and arms 120 and 160 are tubular mesh
constructs. The tubular knit pattern allows for bi-directional
adjustability of the implant once the tissue anchors 110 and 150
are in place. The arms are joined to the support feature via any
suitable means, including by stitching, adhesive, sonic welding,
and heat-staking. According to one embodiment, each of the arms is
sewn to the tissue support portion 130 using the same type and size
of polypropylene fiber from which the tissue support portion 130
and arms 120 and 160 are constructed.
[0030] According to another embodiment, tissue support portion 130
and arms 120 and 160 are constructed from a unitary tubular member
having a single lumen running longitudinally therethrough. In such
an embodiment, the diameter of the arms transition at 162 and 122
to form the tissue support portion 130. According to this
embodiment, there is no joint at 162 or 122. According to various
embodiments, the tubular mesh is smooth, providing a slight
"ratcheting" effect during adjustment to give tactile feedback to
the user.
[0031] Tubular mesh implants can be prepared by a number of known
methods. For example, the tubular mesh can be manufactured by
circular knitting, either single-ended or double-ended for added
strength to provide a stable knit, uniform cross section, and
smooth profile. The mesh can be manufactured by weft knitting via a
"glove" style knitting machine to make smooth chain link stitches,
which can allow diameter variation over a given length. According
to another embodiment, the tubular mesh is a double warp knit,
providing a high strength, multi-end knit using two flat mesh warp
knits that are joined on the sides to make a tube mesh. According
to another embodiment, the tubular mesh is made from a flat
knitting machine, such as a Shimatronic.RTM. flat knitting machine
sold by Shima Seiki Mfg., Ltd. of Wakayama, JP.
[0032] The mesh portions of implant 100 can have a single-strand or
double-strand construction. According to certain embodiments, the
tissue support portion 130 is a flat mesh comprising a knitted,
open porosity, monofilament, polypropylene mesh strip. The open
porosity of the mesh design and large pore sizes allow for
macrophage penetration and the creation of an inert scaffold for
tissue ingrowth to create a permanent support for the urethra. The
pore sizes can be of any suitable diameter to allow tissue
ingrowth. The tissue support portion 130 of implant 100 can have
smaller pores ranging in diameter from 0.4 mm to 1.1 mm, for
example 0.5 mm to 1.0 mm, such as 0.6 to 0.9 mm. The mesh can
additionally have larger pores ranging in diameter from 0.8 mm to
1.3 mm, for example 1.0 mm to 1.2 mm.
[0033] According to one embodiment, the mesh is a polypropylene
knit made from a small diameter fiber to create a soft and pliable
material. According to various embodiments, the mesh is constructed
so as to avoid, or at least minimize, curling of the implant upon
application of a tensile force in the lengthwise direction.
According to one embodiment, the mesh implant is a single-knit,
double-stranded construction. The fibers can be of any suitable
diameter. For example, the fibers can have a diameter ranging from
0.0015'' to 0.100'', for example 0.002'', 0.0025'', 0.003'' or
0.004''.
[0034] The implants disclosed herein can be constructed from
different types of mesh. One suitable non-limiting example is a
knitted polypropylene monofilament mesh fabric, such as BARD MESH
from C. R. Bard, Inc. Other materials include SOFT TISSUE PATCH
(microporous ePTFE--available from W.L. Gore & Associates,
Inc.); SURGIPRO (available from US Surgical, Inc.); TRELEX
(available from Meadox Medical); PROLENE and MERSILENE (available
from Ethicon, Inc.); and other mesh materials (e.g., available from
Atrium Medical Corporation). It is also contemplated that the mesh
fabric may be formed from multifilament yarns and that any suitable
method, such as knitting, weaving, braiding, molding, and the like,
may be employed to form the prosthetic mesh material. The mesh may
also be constructed from absorbable materials, such as polylactic
acid. According to various embodiments, the mesh implants disclosed
herein are manufactured via a knitting machine, such as a
computerized Jacquard flat knitting machine.
[0035] The implants disclosed herein can include, or be constructed
entirely from, a natural material. For example, the natural
material can be disposed over at least one surface of the tissue
support members disclosed herein. The natural material can be any
suitable material including, but not limited to, biologically
derived materials, such as cadaveric (human) or xenograft tissue
(particularly of porcine or bovine origin)--for example dermis
processed to make an acellular collagen scaffold or intestinal
submucosa or other biological material and/or bioengineered
materials. Collagen materials can be obtained from various sources,
such as that available from Cook Biomedical, Inc. under the name
COOK SURGISIS soft tissue graft. In one embodiment, the natural
material comprises a cross-linked porcine dermal collagen material,
such as COLLAMEND surgical implant from Davol (R.I.). Other
suitable bioengineered materials may be employed as the present
disclosure is not limited in this respect.
[0036] The arms 120 and 160 can have any width sufficient for the
implant's intended purpose. For example, the arms can have a width
ranging from 0.5 to 5.0 mm, including 1 mm to 5 mm, for example 2.0
mm to 4 mm, or 2.5 mm to 3.5 mm. The arms can have a length ranging
from 10 mm to 100 mm, for example 20 mm to 60 mm, including 30 mm
to 50 mm. According to various embodiments, tissue support portion
130 has a length ranging from about 30 mm to about 100 mm, for
example about 40 mm to about 80 mm, including 65 mm. The support
portion 130 can have any width sufficient to provide support to a
body tissue. According to various embodiments, the width can range
from 5 mm to 20 mm, for example 7 mm to 15 mm, including 10 mm to
14 mm. According to one embodiment, the width of tissue support
portion 130 ranges from 5 mm to 15 mm, for example 10 mm to 12 mm.
According to various embodiments, arms 120 and 160 have the same
length, or substantially the same length. According to another
embodiment, arms 120 and 160 have different lengths. For example,
arm 120 is 5 mm to 20 mm long, for example 80 mm to 15 mm long, and
arm 160 is 80 mm to 200 mm, for example 100 mm to 150 mm in
length.
[0037] According to various embodiments, a tissue anchor can be
fixed, either directly or indirectly (i.e., via a connector) to one
or both of arms 120 and 160. Any anchor suitable for anchoring an
implant to tissue, such as soft tissue, for example muscle tissue,
a ligament, a tendon, or a membrane, such as the transobturator
membrane, will suffice. The anchor may be fixed to the arms via any
suitable means, including mechanically, by adhesive, friction fit,
ultrasonic welding, solvent bonding, and heat staking.
[0038] According to various embodiments, a first tissue anchor 110
is configured to move freely along a length of arm 120, and a
second anchor 150 is also configured to move freely along a length
of arm 160. Once the anchors are implanted and the desired tension
is obtained, both anchors can be fixed in position to arms 120 and
160. According to another embodiment, a first tissue anchor 110 is
permanently fixed to the terminal end 121 of arm 120, and a second
anchor 150 is configured to move freely along a length of arm 160.
This facilitates the adjustment feature of the implant, such that
once the first anchor and then the second anchor are implanted, the
tension exerted on the urethra by the sling is adjusted by
manipulating arm 160 in either direction relative to the anchor
150. The manipulation is via gripping feature 180, disposed at end
164 of arm 160. Once the desired tension is reached, the arm 160 is
fixed in position to the anchor.
[0039] According to one embodiment, at least one of the tissue
anchors, such as tissue anchor 150, contains an aperture that is
normal to the longitudinal axis of the anchor. This is illustrated
in FIGS. 9A-9B and FIG. 11. FIG. 9A illustrates anchor 150a having
barbs 151a, and aperture 152a configured to receive mesh arm 160.
The aperture 151a and mesh arm 160 are respectively sized so that
movement of arm 160 therethrough is restricted. The degree of
restriction will depend on the fit between the arm and the edges of
the aperture. According to one embodiment, the arm 160 and aperture
152a are relatively sized so that a slippage resistance in an
amount of force ranging from 4 ounces to 6 pounds, for example 2 to
6 pounds, or 1 to 2 pounds, is required to pull 1 cm of the arm
through the anchor aperture. FIG. 9B illustrates tissue anchor 150b
having a triangularly-shaped aperture 152b. Arm 160 is received in
aperture 152b, and exemplary feature 153b (the distal end of
aperture 152b) assists in resisting movement of the arm. Additional
exemplary tissue anchors are illustrated in FIG. 11.
[0040] FIG. 12A illustrates a bottom view of an exemplary tissue
anchor 150 according to the present disclosure. According to one
embodiment, the tissue anchor has a longitudinal axis defined by a
lumen. According to one embodiment, the lumen is configured to
receive a pin that can pierce, and thereby anchor into position,
arm 160. FIG. 12B illustrates a side view of tissue anchor 150.
[0041] FIG. 10 illustrates another embodiment in accordance with
the present disclosure. A tissue support portion 130 is disposed
underneath urethra 310 to assist in managing the flow of urine from
bladder 300. Anchors 110a and 150a having barbs 111a and 151a,
respectively, are anchored in the two obturator membranes 330a and
330b, respectively. A first adjustment suture 410 is attached to
arm 160 at location 412. The distal end of first adjustment suture
410 is attached to tab 414. A second adjustment suture 416 is
attached to tissue support portion 130 at location 418. The distal
end of adjustment suture 416 is attached to tab 420. Both
adjustment sutures 416 and 410 are configured to be disposed
outside vaginal incision 320. According to various embodiments, and
like the tissue anchors and the tissue support system, the
adjustment sutures can be bioabsorbable.
[0042] Once the anchors 110a and 151a are securely anchored in the
two obturator membranes, the surgeon may adjust the amount of
tension exerted by tissue support portion 130 on urethra 310.
According to one embodiment, the tension may be decreased by
pulling suture 416 via tab 420. Alternatively, tension may be
increased by pulling on suture 410 via tab 414. According to
various embodiments, the adjustment sutures 410 and 416 may be
differently colored to aid in identification. According to one
embodiment, tabs 414 and 420 are differently shaped, differently
colored, and/or marked to aid in distinguishing one suture from the
other. According to another embodiment, sutures 410 and 416 are
each in the form of a loop (not shown) that freely passes through
respective points 412 and 418. That way, when the loops are cut
following final tensioning of the implant, the entire length of
suture is removed from the body.
[0043] According to various embodiments, immediately after the
implant is tensioned, sutured 410 and 416 are cut and removed, and
incision 320 is sutured closed. According to another embodiment,
the implant is initially tensioned, and the incision is temporarily
sutured and/or packed. The patient returns to the surgeon after 12
to 72 hours, and the patient's degree of continence or retention is
reviewed. A final adjustment is made to the implant via tabs 414
and/or 420, the sutures 410 and 416 are cut and removed, and
incision 320 is sutured closed.
[0044] The tissue anchors disclosed herein may be constructed from
any biocompatible material, including stainless steel,
polypropylene, and absorbable materials, including but not limited
to polylactic acid, polyglactin, and polyglycolic acid, or other
materials commonly used in absorbable surgical materials. According
to various embodiments, the anchors disclosed herein can be of any
dimension suitable to withstand particular pulling forces. The
anchors can range in length from, for example, 5 mm to 20 mm, for
example 10 mm to 15 mm, such as 10.1, 10.2, 10.3, 10.4, or 10.5 mm.
The anchors have a thickness ranging from 1 mm to 5 mm, for example
2 mm to 3 mm thick. The anchors have a base of approximately 2.5
mm, for example 2.2 mm to 2.3 mm.
[0045] With reference to FIG. 1, the tissue support system 10 may
further include stylet 185. Stylet 185 is configured for insertion
into gripping feature 180, and then into the lumen 166 of arm 160.
Stylet 185 includes a shaft 190 having a proximal end 194 and
distal end 192, gripping feature 196, and a distal end 198. Stylet
185 can range in length from, for example, 12 cm to 25 cm,
including 18 cm to 22 cm, such as 21 cm.
[0046] The tissue support system may further comprise introducer
needle 200 having a handle 210, shaft 220, collet 240 configured to
releasably secure a tissue anchor, and manually operable actuator
230. The actuator 230 is configured to secure a tissue anchor to
the collet 240 when in position 231 (FIG. 2), and release the
tissue anchor when moved to position 232 (FIG. 3). The illustrated
introducer needle 200 has a curved shaft 220, where the curve is in
substantially the same plane as the handle. With reference to FIG.
2, shaft 220 can have a length 213 ranging from 3 cm to 7 cm, such
as 4 cm to 6 cm, for example 5 cm. Shaft 220 can have a length 214
ranging from 3.5 cm to 5.5 cm, for example 4 cm to 5 cm, and 4.5
cm. According to various embodiments, shaft 220 is sized and shaped
so that it snugly rotates around the ischiopubic ramus when an
anchor is inserted in the region of the obturator foramen.
According to another embodiment, the shaft has a helical shape.
According to this embodiment, the system may be provided to a
clinician with two helically-shaped needles, one for each side of a
patient's anatomy.
[0047] FIGS. 1-6 illustrate locking member 170 disposed in lumen
166 in accordance with the present disclosure. According to various
embodiments, the locking member 170 is constructed from
polypropylene. The locking member 170 can have any size suitable
for its intended purpose. By way of non-limiting example, the
locking member has a diameter ranging from 1 mm to 2 mm, for
example 1.2 mm to 1.8 mm, a width ranging from 1.5 mm to 2.5 mm,
and a length ranging from 2.5 mm to 5.5 mm, for example 4.5 mm.
[0048] With reference to FIG. 4, the locking member 170 is
configured to be initially disposed within the lumen 166 of arm 160
at a location proximal to grasping feature 180. After anchor 150 is
set in a desired tissue location, arm 160 is fixed in position
relative to the locking feature until it abuts anchor 150. The
sliding can be accomplished by insertion of flexible stylet 185
through lumen 182 in grasping feature 185, which lumen is in fluid
communication with lumen 166 in arm 160. The distal end 198 of
stylet 185 contacts locking member 170, and urges the locking
member in the direction of anchor 150. Movement of the locking
member in the reverse direction, i.e., towards end 164 of arm 160,
is arrested by the prongs 172. When the anchor stop is urged
towards the end 164, the prongs 170 will tend to anchor into the
mesh, thus arresting further movement.
[0049] FIG. 5 illustrates another view of the implantable tissue
support member 100. FIG. 6 illustrates a partially exploded view of
the tissue support member. FIG. 7 illustrates one embodiment of the
fixation of anchor 110 to arm 120. End 121 of arm 120 is inserted
into aperture 112 of anchor 110. Plug 111 is then inserted into
lumen 166 and aperture 112, thereby providing a friction fit
between the plug 112, the arm 120, and anchor 110.
[0050] The tissue support system in accordance with the present
disclosure can be used to restore correct support to various types
of tissue. For example, the system can be used to treat female and
male urinary incontinence, for example stress incontinence. The
system can be used to treat fecal incontinence. In addition, the
system can be used for pelvic floor repair, such as pelvic organ
prolapse, by fixing a tissue support portion to ligament and/or
muscle for anterior, posterior, and apical vaginal vault
repair.
[0051] According to one embodiment, the tissue support system
disclosed herein comprises a urethral sling. According to one
embodiment, a procedure for implanting the urethral sling generally
comprises making a mid-urethral incision and dissecting the vaginal
tissue out laterally in the direction of the superior-medial aspect
of the obturator foramen. The ends of the sling are then passed
through the obturator internus muscle/obturator membrane using an
introducer device. According to one embodiment, two exit incisions
are made in the groin to allow for exteriorization of the
introducer needle and sling ends. These exit incisions allow for
adjustment of the sling tension under the urethra using the free
arms of the mesh at the exit incisions. According to another
embodiment of the present disclosure, the urethral sling does not
require any exit incisions because mesh adjustment can be done at
the vaginal incision.
[0052] The following illustrates one way in which a tissue support
system in accordance with the present disclosure may be used to
treat female urinary incontinence. The patient is placed in a
dorsal lithotomy position with hips in flexion at approximately 90
degrees and the buttocks even with the edge of the table. Standard
operative preparation of the surgical site is completed, and the
bladder is emptied with a Foley catheter. The mid-urethra is
identified by first locating the external urethral meatus and then
the bladder neck by identifying the Foley catheter bulb.
[0053] Hydro-dissection is performed by injecting a solution (e.g.,
1% lidocaine with epinephrine) at the midline between the vaginal
wall and urethra, thereby creating a urethro-vaginal space.
Additional hydro-dissection can be performed by injecting solution
laterally towards the cephalad aspect of the ischiopubic ramus in
order to better identify the lateral sulci. Allis clamps are placed
at the level of the mid-urethra on the anterior vaginal wall.
[0054] A small (approximately 1.5 cm) incision is made in the
anterior vaginal wall beginning approximately 1 cm under the
urethral meatus. The depth of the incision may extend into the
vaginal muscularis. The urethra is gently freed from the anterior
vaginal wall. Next, dissection is made using scissors (e.g.,
Metzenbaum scissors) laterally in a 45 degree angle until the tip
of the scissors makes contact with the medial-cephalad aspect of
the ischiopubic ramus (approximately 1-2 cm). This procedure is
then repeated on the contralateral side.
[0055] The introducer needle 200 is loaded with anchor 110, as
shown in FIG. 2. The introducer is then inserted into the vaginal
dissection laterally through one of the dissected planes toward the
cephalad aspect of the ischiopubic ramus. The introducer 200 is
angled towards the superior-medial aspect of the obturator foramen.
Once the fixed anchor is behind the ischiopubic ramus, anchor 110
is pushed into the tissue until it is slightly beyond the
ramus.
[0056] The handle 210 is pivoted to insert the anchor 110 through
the obturator internus muscle/membrane at the superior-medial
aspect of the obturator foramen, such that the orienting indicia
140 is at or slightly past the midurethra (about 0.5 cm) in the
direction of insertion. A distinctive pop may be heard, indicating
perforation of the muscle/membrane. The anchor 110 is released by
pushing the actuator 230 forward from position 231 to position 232
in the introducer handle 210. The introducer is then gently
retracted by reversing through the insertion path.
[0057] After anchor 110 is released from collet 240, gentle
traction is applied to the sub-urethral sling to confirm secure
fixation in the tissue.
[0058] Next, adjustable anchor 150 is loaded into the introducer
and secured by retracting the manual actuator 230 on the handle 210
from position 232 to position 231. A slight "click" may be felt or
heard, confirming secure loading. At this point in the procedure,
care is taken to ensure the implant is not twisted.
[0059] Next, it may be desirable to confirm at least 4 cm of
adjustable mesh between the tissue support portion 130 and the
anchor 150 prior to insertion.
[0060] The anchor 150 is inserted in the contralateral dissection
plane, and the introducer needle 200 is oriented towards the
superior-medial aspect of the obturator foramen. Anchor 150 is
pushed into the tissue slightly beyond the ischiopubic ramus, and
handle 210 is pivoted to insert anchor 150 through the obturator
internus muscle/membrane in the superior-medial aspect of the
obturator foramen.
[0061] Anchor 150 is released from collet 240 by pushing the
actuator 230 from position 231 to position 232 in the introducer
handle 210. Introducer needle 200 is retracted by reversing through
the insertion path. After anchor 150 is released, gentle traction
is applied on the tissue support system 100 to confirm secure
fixation in the tissue.
[0062] Grasping feature 180 is gently pulled to adjust the tension
exerted by the tissue support portion 130 on the urethra. To aid in
adjustment, a finger is inserted vaginally to stabilize anchor 150
at the obturator internus muscle. The sling can also be loosened by
using gentle counter-traction on the tissue support portion 130 on
the side closest to anchor 150. A thin, blunt instrument (such as a
hemostat) between the urethra and the sub-urethral sling may be
used as a spacer to aid in setting the appropriate tension. A cough
or crede test can also be employed to achieve the appropriate
tension. The orienting indicia 140 should be visible at the
midline, no more than 1 cm away from the urethra in either
direction.
[0063] Once proper tensioning is achieved, stylet 185 is inserted
into lumen 182 of gripping feature 180. The stylet 185 is inserted
into lumen 166 to urge locking member 170 into place at anchor 150.
When properly seated, the stylet 185 will bow, signifying that the
locking member 170 is in the proper location and the tissue support
member has been secured. Once anchor 150 is locked into position,
additional tightening can be achieved using the gripping feature
180.
[0064] Stylet 185 is removed after final securement of the tissue
support member 100. According to one embodiment, arm 160 is cut
between anchor 150 and end 164. The vaginal incision is then closed
using suture. According to various embodiments, the incision is
temporarily closed and packed around arm 160. This would allow the
clinician to post-operatively modify the amount tension exerted by
the implant on the urethra. Once desired degree of tension is
obtained and confirmed, the anchor 150 can optionally be fixed to
arm 160, and the remaining material can be cut and, in the case
wherein the implant is constructed of non-bioabsorbable material,
be removed from the body.
[0065] According to various embodiments, a sheath can enclose at
least a portion of the tissue support member disclosed herein to
facilitate their passage into tissue. In such an embodiment, the
tissue support member, or at least the support portion thereof, is
sandwiched between two sheaths. The sheath sides are suitably made
out of a material with a low coefficient of friction, such as
polytetrafluoroethylene (PTFE). According to another embodiment,
the tissue support member is implanted without a sheath.
[0066] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. The
terminology used in the description of the invention herein is for
describing particular embodiments only and is not intended to be
limiting of the invention. As used in the description of the
invention and the appended claims, the singular forms "a," "an,"
and "the" are intended to include the plural forms as well, unless
the context clearly indicates otherwise. All publications, patent
applications, patents, and other references mentioned herein are
expressly incorporated by reference in their entirety.
[0067] Also, unless otherwise indicated, all numbers expressing
quantities of physical parameters and so forth used in the
specification and claims are to be understood as being modified in
all instances by the term "about." Accordingly, unless indicated to
the contrary, the numerical parameters set forth in the following
specification and attached claims are approximations that may vary
depending upon the desired properties sought to be obtained by the
present invention. At the very least, and not as an attempt to
limit the application of the doctrine of equivalents to the scope
of the claims, each numerical parameter should be construed in
light of the number of significant digits and ordinary rounding
approaches.
[0068] Notwithstanding that the numerical ranges and parameters
setting forth the broad scope of the invention are approximations,
the numerical values set forth in the specific examples are
reported as precisely as possible. Any numerical value, however,
inherently contains certain errors necessarily resulting from the
standard deviation found in their respective testing measurements.
Numerical ranges given throughout this specification will include
every narrower numerical range that falls within such broader
numerical range, as if such narrower numerical ranges were all
expressly written herein.
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