U.S. patent application number 10/005837 was filed with the patent office on 2002-10-10 for surgical articles and methods.
Invention is credited to Anderson, Kimberly A., Bouchier, Mark S., Lund, Robert E., Moore, Terence M., Morningstar, Randy L., Neisz, Johann J., Rocheleau, Gary A., Vandersloot, Vicki R..
Application Number | 20020147382 10/005837 |
Document ID | / |
Family ID | 27573916 |
Filed Date | 2002-10-10 |
United States Patent
Application |
20020147382 |
Kind Code |
A1 |
Neisz, Johann J. ; et
al. |
October 10, 2002 |
Surgical articles and methods
Abstract
Surgical instruments, implantable articles and surgical
procedures disclosed for treating medical disorders, particularly
incontinence. Improved surgical sling procedures are disclosed.
Novel surgical instruments and kits for use in sling procedures are
also disclosed. The present invention affords options for surgeons
with concomitant advantages to the patient and the healthcare
provider.
Inventors: |
Neisz, Johann J.; (Coon
Rapids, MN) ; Lund, Robert E.; (St. Michael, MN)
; Anderson, Kimberly A.; (Eagan, MN) ;
Vandersloot, Vicki R.; (Minneapolis, MN) ; Moore,
Terence M.; (Minnetonka, MN) ; Bouchier, Mark S.;
(Lakeville, MN) ; Morningstar, Randy L.; (Brooklyn
Park, MN) ; Rocheleau, Gary A.; (Maple Grove,
MN) |
Correspondence
Address: |
American Medical Systems
10700 Bren Road West
Minnetonka
MN
55343
US
|
Family ID: |
27573916 |
Appl. No.: |
10/005837 |
Filed: |
November 9, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10005837 |
Nov 9, 2001 |
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09917443 |
Jul 27, 2001 |
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10005837 |
Nov 9, 2001 |
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09917562 |
Jul 27, 2001 |
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60263472 |
Jan 23, 2001 |
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60269829 |
Feb 20, 2001 |
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60281350 |
Apr 4, 2001 |
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60295068 |
Jun 1, 2001 |
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60306915 |
Jul 20, 2001 |
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Current U.S.
Class: |
600/29 ;
600/37 |
Current CPC
Class: |
A61B 17/30 20130101;
A61B 2017/06042 20130101; A61B 17/42 20130101; A61B 17/3468
20130101; A61B 2017/00464 20130101; A61B 90/02 20160201; A61F
2002/0068 20130101; A61B 2017/06009 20130101; A61F 2220/0016
20130101; A61B 2017/00946 20130101; A61B 17/06066 20130101; A61B
2017/0046 20130101; A61B 2017/00805 20130101; A61F 2/0045 20130101;
A61B 2017/06085 20130101; A61B 17/0482 20130101; A61F 2/0063
20130101; A61B 2017/06014 20130101; A61B 17/06109 20130101; A61F
2250/0007 20130101; A61B 17/0469 20130101; A61B 2017/0454 20130101;
A61B 17/3211 20130101; A61B 2017/0458 20130101; A61F 2002/0072
20130101; A61F 2002/3055 20130101; A61B 17/0401 20130101; A61B
17/06004 20130101; A61B 50/30 20160201; A61B 50/3001 20160201; A61B
17/0487 20130101 |
Class at
Publication: |
600/29 ;
600/37 |
International
Class: |
A61F 002/00; A61F
013/00 |
Claims
What is claimed is:
1. A surgical kit for treating incontinence comprising: an
implantable material suitable for a sling procedure, at least one
of a first type of needle suitable for a sling procedure, and at
least one of a second type of needle suitable for a sling
procedure, wherein the first type of needle is different than the
second type of needle.
2. A surgical kit according to claim 1 wherein the first type of
needle comprises a substantially straight needle and the second
type of needle comprises a needle with a curved portion.
3. A surgical kit according to claim 1 further including a
synthetic insertion sheath associated with the implantable material
to form a sling assembly.
4. A surgical kit according to claim 3 further including an adapter
for associating the sling assembly with a surgical needle.
5. A surgical kit according to claim 4 wherein the adapter for
associating the sling assembly with a surgical needle comprises a
dilator.
6. A surgical kit according to claim 1 wherein the first type of
needle comprises a needle with at least two handles.
7. A surgical kit according to claim 1 wherein the first type of
needle includes an end portion with a passageway for receiving a
suture.
8. A surgical kit according to claim 7 wherein the passageway for
receiving a suture comprises a hole.
9. A surgical kit according to claim 1 wherein the first type of
needle comprises a movable inner member with a blunt end portion
having a suture passageway and an outer sheath member with a sheath
end, and means for moving the blunt end portion between i) an
extended position with the suture passageway extending beyond the
outer sheath member, and ii) a retracted position with the blunt
end portion spaced closer to the end of the outer sheath member
than in the extended position.
10. A surgical kit according to claim 9 wherein the sheath end
comprises a substantially sharp surface for cutting tissue, and the
first type of needle includes a means for locking the blunt end
portion in the extended position.
11. A surgical kit according to claim 1 wherein the first type of
needle includes at least two straight portions situated at a
predetermined angle.
12. A surgical kit according to claim 1 further comprising a first
type of handle and a second type of handle wherein the first type
of handle is different than the second type of handle.
13. A surgical kit according to claim 1 wherein the first type of
needle is larger than the second type of needle.
14. A surgical kit according to claim 1 wherein the first type of
needle includes a bladder perforation detector.
15. A surgical kit for treating incontinence comprising: a first
type of sling material for implanting during a sling procedure, a
second type of sling material for implanting during a sling
procedure, at least one needle that is sized and shaped for
inserting a sling material.
16. A surgical kit according to claim 15 wherein the first type of
sling material is a synthetic sling material and the second type of
sling material is a non-synthetic sling material.
17. A surgical kit according to claim 15 further including a
universal adapter for associating a sling material with the
needle.
18. A surgical kit according to claim 15 wherein the universal
adapter comprises a compression collet.
19. A surgical kit according to claim 15 further including a means
for constructing a sling from the first type of sling material and
the second type of sling material.
20. A sling assembly for implantation without bone anchors, the
sling assembly comprising: a synthetic surgical mesh having first
and second ends and a plurality of holes that are sized and shaped
to afford tissue ingrowth, the synthetic surgical mesh being sized
and shaped to be implanted during a surgical sling procedure, a
removable synthetic insertion sheath situated about the surgical
mesh, at least one suture operatively associated with the surgical
mesh and extending beyond the first end of the surgical mesh a
length sufficient to afford associating the mesh with a needle, and
at least one other suture operatively associated with the surgical
mesh and extending beyond the second end of the surgical mesh a
length sufficient to afford associating the mesh with a needle.
21. A sling assembly according to claim 20 wherein the insertion
sheath defines an interior portion that includes the surgical mesh,
and an exterior portion, and the suture extending beyond the first
end of the surgical mesh extends from the interior portion of the
sheath to an exterior portion of the sheath.
22. A sling assembly for implantation without bone anchors, the
sling assembly comprising: a synthetic surgical mesh having a
plurality of holes that are sized and shaped to afford tissue
ingrowth, the synthetic surgical mesh being sized and shaped to be
implanted during a surgical sling procedure, a removable synthetic
insertion sheath situated about the surgical mesh and having first
and second ends, at least one suture operatively associated with
the insertion sheath and extending beyond the first end of the
insertion sheath a length sufficient to afford attachment of the
sling assembly to a needle, and at least one other suture
operatively associated with the insertion sheath and extending
beyond the second end of the insertion sheath a length sufficient
to afford attachment of the sling assembly with a needle.
23. A sling assembly according to claim 22 wherein the insertion
sheath defines an interior portion that includes the surgical mesh,
and an exterior portion, and the sutures extending beyond the first
and second ends of the insertion sheath are completely situated on
the exterior portion of the sheath.
24. An article for use in a surgical sling procedure, the article
comprising: a body portion having first and second opposite end
portions, the first end portion having surfaces for associating the
article with a needle, and the second end portion having a sling
associator for associating the article with a sling.
25. An article according to claim 24 wherein the sling associator
comprises a hole.
26. An article according to claim 24 wherein the sling associator
includes a slot for receiving a first or a second type of sling or
sling assembly and a securement means for securing the first or the
second type of sling or sling assembly to the article.
27. An article according to claim 24, wherein the sling associator
comprises jaws movable from an open position for receiving a sling
material to a closed position that firmly retains the sling and
that resists separation of the sling from the article.
28. A surgical kit assembly comprising: a sling assembly comprising
a sling mesh material and an adapter, the adapter having an end
portion having a passageway, a first type of needle having first
and second end portions, at least one of the end portions being
sized and shaped to engage complementary surfaces in the passageway
of the end portion of the adapter to associate the needle with the
sling assembly, and a needle converter having a first end portion
having surfaces that are sized and shaped to engage complementary
surfaces in the passageway of the adapter to associate the needle
converter with the adapter, the needle converter having a second
end portion, opposite the first end portion, which second end
portion has a means for attaching the needle converter to a second
type of needle that is different than the first type of needle.
29. A needle converter for use in a surgical sling procedure that
utilizes a dilator for use with a first type of needle, the needle
converter comprising: a body portion, a first end portion having
surfaces that are sized and shaped to engage complementary surfaces
in a passageway of a dilator to associate the needle converter with
the dilator, second end portion, opposite the first end portion,
which second end portion has a means for attaching the needle
converter to a second type of needle that is different than the
first type of needle.
30. A surgical kit assembly comprising: a first type of sling
material for implanting during a sling procedure, at least one
needle that is sized and shaped for inserting a sling material, and
sling assembly means for affording construction of a customized
sling from the first type of sling material and a second type of
sling material.
31. A surgical kit according to claim 30 wherein the sling assembly
means comprises a grommet constructed from a biocompatible
material.
32. A surgical sling procedure comprising the steps of: providing a
kit comprising a first type of sling material for implanting during
a sling procedure, and a sling assembly means for affording
construction of a sling from the first type of sling material and a
second type of sling material, constructing a sling by selecting at
least a portion of the first type of sling material and a second
type of sling material and by associating the selected first type
of sling material with the second type of sling material, and
implanting the constructed sling.
33. A surgical sling procedure according to claim 32 wherein the
step of providing a sling assembly means comprises the step of
providing a mechanical fastener to attach the first type of sling
material to the second type of sling material.
34. A surgical sling procedure for treating incontinence comprising
the steps of: providing a surgical kit having a first type of sling
material for implanting during a sling procedure, a second type of
sling material for implanting during a sling procedure, and a
surgical instrument for implanting a sling material, selecting the
first type of sling material or the second type of sling material
from the surgical kit, and implanting the selected sling material
with the surgical instrument.
35. A surgical procedure according to claim 34 where in the step of
providing a first type of sling material comprises providing a
first type of polymeric sling material, and the step of providing a
second type of sling material comprises the step of providing a
second type of polymeric sling material that is different than the
first type of polymeric sling material.
36. A surgical sling procedure for treating incontinence comprising
the steps of: providing a surgical kit with an implantable material
suitable for a sling procedure, at least one of a first type of
needle that is sized and shaped for inserting a sling, and at least
one of a second type of needle that is sized and shaped for
inserting a sling, wherein the first type of needle is different
than the second type of needle, selecting the first or the second
type of needle, and implanting the implantable material using the
selected needle.
37. A method of implanting a sling to treat urinary incontinence in
a patient comprising the steps of: providing a surgical kit
comprising at least one guide needle, and at least one sling
transport needle with a tip, a sling attached to the sling
transport needle, and an adapter having tip receiving surfaces for
receiving the tip of the sling transport needle, creating at least
one vaginal incision, creating at least one suprapubic incision,
initially passing the guide needle through the suprapubic incision
and then through the vaginal incision, attaching the adapter to the
needle, placing the tip of the sling transport needle in the tip
receiving surfaces of the adapter, and guiding the sling transport
needle from the vaginal incision to the suprapubic incision with
the guide needle to implant the sling.
38. A surgical kit for treating incontinence comprising: at least
one guide needle, at least one sling transport needle with a tip,
and a sling attached to the sling transport needle, and an adapter
having tip receiving surfaces for receiving the tip of the sling
transport needle and having means for attaching to the at least one
guide needle.
39. A surgical kit according to claim 38 wherein the adapter is
integral with the guide needle.
40. A method of treating incontinence in a female patient
comprising the steps of: providing a synthetic surgical mesh having
first and second ends and a plurality of holes that are sized and
shaped to afford tissue ingrowth, and a removable synthetic
insertion sheath situated about the surgical mesh, extending a
first suture through the surgical mesh and beyond the first end of
the surgical mesh, extending a second suture through the surgical
mesh and extending beyond the second end of the surgical mesh,
creating at least one vaginal incision, creating at least one
suprapubic incision, passing a leading end of a needle initially
through a suprapubic incision and then through the vaginal incision
on one side of the patient's urethra, passing a leading end of a
needle initially through a suprapubic incision and then through the
vaginal incision on the other side of the patient's urethra,
attaching the first suture to the leading end of a needle on one
side of the patient's urethra, attaching the second suture to the
leading end of a needle on the other side of the patient's urethra,
implanting the sling by moving the leading end of a needle from the
vaginal incision toward a suprapubic incision, and then removing
the synthetic insertion sheath.
41. A method of treating incontinence in a female patient
comprising the steps of: providing a synthetic surgical mesh having
a plurality of holes that are sized and shaped to afford tissue
ingrowth, a removable synthetic insertion sheath situated about the
surgical mesh and having first and second ends, associating a first
suture with the insertion sheath and extending the first suture
beyond the first end of the insertion sheath, associated a second
suture with the insertion sheath and extending the second suture
beyond the second end of the insertion sheath, creating at least
one vaginal incision, creating at least one suprapubic incision,
passing a leading end of a needle initially through a suprapubic
incision and then through the vaginal incision on one side of the
patient's urethra, passing a leading end of a needle initially
through a suprapubic incision and then through the vaginal incision
on the other side of the patient's urethra, attaching the first
suture to a leading end of a needle on one side of the patient's
urethra, attaching the second suture to the leading end of a needle
on the other side of the patient's urethra, implanting the sling by
moving the leading end of a needle from the vaginal incision toward
a suprapubic incision, cutting end portions of the sling mesh and
synthetic insertion sheath to separate them from portions implanted
in the patient, and removing a remaining portion of the synthetic
insertion sheath from the surgical mesh.
42. A surgical kit for treating incontinence comprising: an
implantable material suitable for a sling procedure, a needle that
is sized and shaped for inserting a sling, the needle having
surfaces for engaging a handle, and at least one of a first type of
handle having surfaces for attaching the handle to the needle, and
at least one of a second type of handle having surfaces for
attaching the handle to the needle, wherein the first type of
needle is different than the second type of needle.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 09/917,443 filed Jul. 27, 2001 and U.S.
patent application Ser. No. 09/917,562 filed Jul. 27, 2001 and
claims priority thereto and of U.S. Provisional Application Serial
No. 60/263,472, filed Jan. 23, 2001; and U.S. Provisional
Application Serial Number 60/269,829, filed Feb. 20, 2001, and U.S.
Provisional Application Serial No. 60/281,350, filed Apr. 4, 2001;
and U.S. Provisional Application Serial Number 60/295,068, filed
Jun. 1, 2001, and U.S. Provisional Application No. 60/306,915,
filed Jul. 20, 2001; all of whose contents are fully incorporated
herein by reference.
BACKGROUND
[0002] Urinary incontinence is a significant health concern
worldwide. Incontinence may occur when the pelvic floor weakens.
There are five basic types of incontinence: stress incontinence,
urge incontinence, mixed incontinence, overflow incontinence and
functional incontinence. There are a large number of surgical
interventions and procedures for addressing incontinence.
[0003] Some surgeons are slow to adopt promising new surgical
techniques for treating incontinence for a variety of reasons. Some
are untrained or lack experience with the new procedure. Others are
simply unwilling to try new instrumentation that seems
unfamiliar.
[0004] Surgical centers and hospitals have an inventory of surgical
instruments commonly used in surgery. Surgeons are trained with
these stock surgical instruments at an early stage and become
familiar with them. In the urology field, needles, suture passers
and ligature carriers are commonly available and surgeons often
develop significant experience and comfort with procedures that
utilize them. Examples of such surgical instruments included Stamey
needles, Raz needles, and Pereyra needles. See Stamey, Endoscopic
Suspension of the Vesical Neck for Urinary Incontinence in Females,
Ann. Surgery, pp. 465-471, October 1980; and Pereyra, A Simplified
Surgical Procedure for the Correction of Stress Incontinence in
Women, West. J. Surg., Obstetrics & Gynecology, pp. 243-246,
July-August 1959. Some surgeons may reject a new technique simply
because the instrumentation associated with the technique is
unfamiliar.
[0005] A variety of surgical procedure options are currently
available to treat incontinence. Depending on age, medical
condition, and personal preference, surgical procedures can be used
to completely restore continence. One type of procedure, found to
be an especially successful treatment option for SUI in both men
and women, is a sling procedure.
[0006] A sling procedure is a surgical method involving the
placement of a sling to stabilize or support the bladder neck or
urethra. There are a variety of different sling procedures.
Descriptions of different sling procedures are disclosed in U.S.
Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909;
6,039,686, 6,042,534 and 6,110,101.
[0007] Sling procedures differ in the type of material used for the
sling, the method of anchoring the sling material in the body and
how the sling material is inserted in the body. The time required
for a surgical procedure varies, but is preferably as short as
possible. This factor is frequently reported in urology and
gynecology literature. See Atherton M. J., et al., A Comparison of
Bladder Neck Movement and Elevation After Tension-free Vaginal Tape
and Colposuspension, British Journal of Obstetrics and Gynaecology,
November 2000, Vol. 17, p. 366-1370, Nilsson et al, The
Tension-free Vaginal Tape Procedure is Successful in the Majority
of Women with Indications for Surgical Treatment of Urinary Stress
Incontinence, British Journal of Obstetrics and Gynaecology, April
2001, Vol. 108, P. 414-419; and Ulmsten et al., An Ambulatory
Surgical Procedure Under Local Anesthesia For Treatment of Female
Urinary Incontinence, Int. Urogynecol. J. (1996), v. 7, pps.
81-86.
[0008] Although serious complications associated with sling
procedures are infrequent, they do occur. Complications include
urethral obstruction, development of de novo urge incontinence,
hemorrhage, prolonged urinary retention, infection, and damage to
surrounding tissue and sling erosion.
[0009] The Tension-free Vaginal Tape (TVT) procedure (available
from Ethicon, of N.J.) utilizes a Prolene.TM. nonabsorbable,
polypropylene mesh. The mesh is a substantially flat, rectangular
knitted article. The mesh includes a plurality of holes that are
sized to allow tissue ingrowth to help avoid infection. A plastic
sheath surrounds the mesh and is used to insert the mesh. During
the sling procedure, incisions are made in the abdominal (i.e.
suprapubic) area and in the vaginal wall. Two curved, relatively
large (5 mm or larger) needle-like elements are each connected to
an end of the vaginal sling mesh. A sling-free, sharp tip end of
one of the needle-like elements is initially pushed through the
vaginal incision and into the paraurethral space. Using a handle
attached to the needle, the needle is angulated laterally (for
example, to the right) to perforate the endopelvic fascia, guided
through the retropubic space and passed through the abdominal
incision. The handle is disconnected and the needle is then
withdrawn through the abdominal wall, thereby threading a portion
of the sling through the tissue of the patient. The handle is then
connected to the other needle and the technique is repeated on the
contralateral side, so that the mesh is looped beneath the bladder
neck or urethra. The sling is positioned to provide appropriate
support to the bladder neck or urethra. At the end of the
procedure, the sling ends are cut at the abdominal wall, the sheath
is removed and all incisions are closed.
[0010] Complications associated with the TVT procedure and other
known sling procedures include injury to blood vessels of the
pelvic sidewall and abdominal wall, hematomas, urinary retention,
and bladder and bowel injury due to passage of large needles.
Further, a separate cystoscopy procedure is usually required in
order to confirm bladder integrity or recognize a bladder
perforation after each insertion of the needle-like element. One
serious disadvantage of the TVT procedure, particularly for
surgeons unfamiliar with the surgical method, is the lack of
information concerning the precise location of the needle tip
relative to adjacent pelvic anatomy. A cadaver study indicated that
the TVT needle is placed in close proximity to sensitive tissue
such as superficial epigastric vessels, inferior epigastric
vessels, the external iliac vessel and the obturator. See, Walters,
Mark D., Percutaneous Suburethral Slings: State of the Art,
presented at the conference of the American Urogynecologic Society,
Chicago (October 2001).
[0011] If the TVT needle tip is allowed to accidentally pass across
the surface of any blood vessel, lymphatic duct, nerve, nerve
bundle or organ, serious complications can arise. These
shortcomings, attempts to address these shortcomings and other
problems associated with the TVT procedure are disclosed in PCT
publication nos. PCT WO 00/74613 and PCT WO 00/74594.
[0012] Additional problems are associated with the TVT and other
sling procedures. Removal and reuse of the handle of the TVT
product is a cumbersome, time consuming process, requiring the
surgeon to manually rotate the handle until the handle is unscrewed
from the needle. Reusing the handle presents a contamination risk,
particularly if the handle and screw threads are not properly
cleaned and sterilized after use on the patient.
BRIEF SUMMARY
[0013] The present invention includes surgical instruments and
implantable articles for urological applications, particularly
incontinence surgical procedures.
[0014] The present invention is also directed to surgical kits for
use in surgical procedures for treating incontinence, and improved
surgical procedures for treating incontinence. The present
invention can afford increased convenience for surgeons with the
attendant advantages for the patient. The present invention can
also exploit existing surgeon training and preferences to
contribute to better surgical outcomes. Surgical procedures
utilizing the present invention have the capacity to be shorter
with concomitant advantages enjoyed by patients and the healthcare
system.
[0015] In one aspect, the present invention comprises a surgical
kit or assembly of surgical instruments for treating incontinence
comprising an implantable material (e.g. a sling), at least one of
a first type of needle, and at least one of a second type of
needle. The first type of needle is different than the second type
of needle. For example, one needle could be straight and the other
curved, or one needle may be larger or longer than the other needle
or shaped differently. A variety of different types of needles are
described herein. Providing different types of needles can afford
the surgeon options that are unavailable with existing surgical
kits.
[0016] The needles in the kit need not serve the same purpose. For
example, one needle may comprise a relatively small profile (e.g.
less than about 3.5 mm diameter in cross section) guide needle, and
the other needle may comprise a larger sling transport needle. The
guide needle may be initially inserted suprapubically (e.g. through
an abdominal incision) and then guided through a vaginal incision.
The larger sling transport needle can then be associated with the
guide needle (e.g. with an optional adapter or dilator) and then
guided upward through the body of a patient (first through the
vaginal incision and then through the suprapubic incision) by the
guide needle.
[0017] In another aspect, the invention comprises a kit with a
first type of sling material, a second type of sling material, and
at least one needle for inserting a sling material. The sling
materials can comprise synthetic or non-synthetic sling materials.
In one embodiment, the sling materials can be both synthetic
materials, but different types of synthetic materials (e.g. a
polypropylene mesh material and a silicone coated material). There
are also many different types of non-synthetic materials
contemplated herein. Optionally, instead of having a non-synthetic
sling material that has short term shelf life relative to the rest
of the elements in the kit, the kit may include an accessory to
afford construction of a sling from two different materials. This
enables the surgeon to customize a hybrid or composite sling from
different materials (e.g. from different packages) to exploit the
different properties of the materials and to coordinate them with
the intended physiological environment.
[0018] Another kit according to the present invention includes an
implantable material (e.g. a sling), a needle for inserting the
sling, and a first and second type of handle for use in the
surgical procedure. A variety of different types of handles are
contemplated herein.
[0019] The present invention also includes articles useful in
urological surgical procedures. The present invention includes an
adapter comprising a body portion having first and second opposite
end portions. The first end portion has surfaces for associating
the article with a needle. The second end portion has a sling
associator for associating the article with a sling. The sling
associator can comprise a universal adapter for connecting a
surgical needle with different types of sling materials (e.g.
synthetic or non-synthetic). The adapter allows the surgeon to
select one of the many options of sling materials available so that
the remaining components of the surgical kit may be utilized to
implant any sling material.
[0020] The present invention also includes a needle converter for
use with a sling assembly having an adapter or dilator. The adapter
or dilator has surfaces for associating with a first type of needle
(e.g. a specialized needle in a kit). The needle converter
comprises a first end portion having surfaces that are sized and
shaped to engage complementary surfaces in the passageway of the
dilator to associate the needle converter with the dilator. The
needle converter has a second end portion that is generally
opposite the first end portion. The second end portion has a means
for attaching the needle converter to a second type of needle that
is different than the first type of needle. The needle converter
allows the dilator of a sling assembly to be attached with a needle
that is commonly used in surgical procedures for treating
urological disorders (e.g. a Stamey needle). Thus, the needle
converter allows a surgeon to connect a sling assembly with a
preferred, standard needle.
[0021] The present invention also includes novel slings and sling
assemblies. The slings may be conveniently implanted without the
use of bone anchors. A sling according to the present invention
comprises a synthetic surgical mesh (e.g. polypropylene) having
first and second ends and a plurality of holes that are sized and
shaped to afford tissue ingrowth. The assembly includes a removable
synthetic insertion sheath situated about the surgical mesh. At
least one suture is operatively associated with the surgical mesh
and extends beyond the first end of the surgical mesh. At least one
other suture is operatively associated with the surgical mesh and
extends beyond the second end of the surgical mesh. The sutures are
adapted to be associated with a surgical needle. For example, the
sutures may be tied to a needle that has a hole in it or placed in
a suture passageway of a ligature carrier.
[0022] Another sling according to the present invention comprises a
synthetic surgical mesh (e.g. polypropylene) having a plurality of
holes that are sized and shaped to afford tissue ingrowth. The
assembly has a removable synthetic insertion sheath situated about
the surgical mesh. The sheath has first and second ends. At least
one suture is operatively associated with the insertion sheath and
extends beyond the first end of the insertion sheath. At least one
other suture is operatively associated with the insertion sheath
and extends beyond the second end of the insertion sheath. The
sutures in this embodiment are also adapted to be associated with
surgical needles.
[0023] The novel slings may be used in novel surgical procedures
according to the present invention. The novel surgical procedures
comprise the steps of i) providing a novel sling according to the
present invention, ii) creating at least one vaginal incision, ii)
creating at least one suprapubic incision, iii) passing a leading
end of a needle initially through a suprapubic incision and then
through the vaginal incision on one side of the patient's urethra,
iv) passing a leading end of a needle initially through a
suprapubic incision and then through the vaginal incision on the
other side of the patient's urethra, v) attaching the first suture
to the leading end of a needle, vi) attaching the second suture to
the leading end of a needle, vii) implanting the sling by moving
the leading end of a needle from the vaginal incision toward a
suprapubic incision, and viii) then removing the synthetic
insertion sheath.
[0024] Another surgical procedure according to the present
invention includes the use of a plurality of needles with different
purposes. A novel surgical procedure includes the steps of i)
providing a surgical kit comprising at least one guide needle, and
at least one sling transport needle with a tip, a sling attached to
the sling transport needle, and an adapter having tip receiving
surfaces for receiving the tip of the sling transport needle, ii)
creating at least one vaginal incision, iii) creating at least one
suprapubic incision, iv) initially passing the guide needle through
the suprapubic incision and then through the vaginal incision, v)
attaching the adapter to the needle, vi) placing the tip of the
sling transport needle in the tip receiving surfaces of the
adapter, and vii) guiding the sling transport needle from the
vaginal incision to the suprapubic incision with the guide needle
to implant the sling. This procedure allow the surgeon to exploit
the control provided by the smaller guide needle to avoid sensitive
anatomical structures while retaining the benefit of the sling
transport needle.
[0025] The present invention also includes kits having the novel
surgical instruments, accessories, articles and slings described
herein, and surgical procedures that utilize the novel
structures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Other features and advantages of the present invention will
be seen as the following description of particular embodiments
progresses in conjunction with the drawings, in which:
[0027] FIG. 1 is a top view of a surgical kit according to one
aspect of the present invention;
[0028] FIG. 1A is a top view of a surgical kit according to another
aspect of the present invention;
[0029] FIG. 2 is a perspective view of one embodiment of sling
delivery system of the present invention, showing the sling
delivery system disassembled;
[0030] FIG. 2A is an enlarged perspective view of an optional
connector for use in the kit of FIG. 2;
[0031] FIG. 2B is a perspective view of a sling constructed from
two different sling materials according to the present
invention;
[0032] FIG. 2C is a perspective view of a sling having a suture
associated therewith by means of a suture anchor;
[0033] FIG. 3 is a perspective view of a substantially straight
needle for optional use in a kit according to the present
invention;
[0034] FIG. 4 is a perspective view of a needle with a curved
portion for optional use in a kit according to the present
invention;
[0035] FIG. 5 is a side view of a needle with first and second
handles for optional use in a kit according to the present
invention;
[0036] FIG. 6 is a side view of another embodiment of needle for
optional use in a kit according to the present invention;
[0037] FIG. 6a is an enlarged side view of a portion of FIG. 6;
[0038] FIG. 7 is a side view of another embodiment of needle for
optional use in a kit according to the present invention;
[0039] FIG. 8 is a side view of an end portion of a needle for
optional use in a kit according to the present invention;
[0040] FIG. 9 is a side view of another embodiment of needle for
optional use in a kit according to the present invention;
[0041] FIG. 9A is an enlarged view of a portion of FIG. 9;
[0042] FIG. 10 is a side view of another embodiment of needle for
optional use in a kit according to the present invention;
[0043] FIGS. 11-14 are side views of another embodiment of needle
for optional use in a kit according to the present invention,
wherein
[0044] FIG. 11 shows the needle with a blunt member in an unlocked,
extended position that is extended beyond a sharp surface,
[0045] FIG. 12 shows the sharp surface and blunt member as the
blunt member is initially deflected by tissue;
[0046] FIG. 13 illustrates the blunt member deflected to
substantially the level of the sharp surface, such as when the
needle encounters significant resistance from tissue; and
[0047] FIG. 14 shows the blunt member in a locked, extended
position after the resistance associated with the tissue ends and a
spring has returned the blunt member to the extended position;
[0048] FIG. 15 is a side view of a handle and several different
embodiments of needles adapted for use in the present
invention;
[0049] FIG. 16 is a top view of the handle and the needles of FIG.
15;
[0050] FIG. 17 is an enlarged view of the ends of the needles shown
in FIG. 16;
[0051] FIG. 18 is a perspective view of an embodiment of an adapter
for associating a needle with a sling according to an aspect of the
present invention, and portions of a sling assembly or sling;
[0052] FIG. 18A is a perspective view showing another embodiment of
an adapter for associating a needle with a sling according to an
aspect of the present invention, and an end portion of a
needle;
[0053] FIG. 18B is a side view of another embodiment of an adapter
for associating a needle with a sling according to an aspect of the
present invention, and portions of a sling or sling assembly;
[0054] FIG. 19 includes perspective views of various optional
handles for optional use according to the present invention;
[0055] FIG. 20 is a side view of a needle with an optional
strengthening handle for use in an aspect of the present
invention;
[0056] FIG. 21 is a perspective view of another embodiment of sling
delivery system of the present invention, showing the sling
delivery system disassembled;
[0057] FIG. 21A is a perspective view showing a sling constructed
from a material different than the material shown in FIG. 21;
[0058] FIG. 21B is a side view of a suture anchor for use in an
optional sling according to the present invention;
[0059] FIG. 22 is a top view of a sling assembly according to an
aspect of the present invention;
[0060] FIG. 22A is a top view of a sling assembly according to
another aspect of the present invention;
[0061] FIG. 23 is a perspective view of one embodiment of an
adapter for associating a needle with a sling according to an
aspect of the present invention;
[0062] FIG. 24 is a top view of the adapter of FIG. 23 shown
sutured to a sling assembly;
[0063] FIG. 25 is a side view of the adapter of FIG. 23 and a
suture threaded through a passageway in the adapter and through a
sling anchor on a non-synthetic sling;
[0064] FIG. 26 is a sectional view of the adapter of FIG. 23;
[0065] FIG. 27 is a side view of a sling assembly, needle converter
and needle in a disassembled condition;
[0066] FIG. 27A shows the elements of FIG. 27 in an assembled
condition;
[0067] FIG. 28 is a flow chart showing a process according to an
aspect of the present invention;
[0068] FIG. 29 is a flow chart showing another process according to
another aspect of the present invention;
[0069] FIGS. 30 through 33 are perspective views sequentially
showing the insertion of a needle suprapubically in accordance with
one aspect of the present invention, wherein:
[0070] FIG. 30 shows the needle just passing an abdominal
incision;
[0071] FIG. 31 illustrates the needle as the surgeon seeks to
identify the tactile feel of the resistance provided in part by the
posterior portion of the pubic bone;
[0072] FIG. 32 shows the needle as it passes along the posterior
surface of the pubic bone which may be used as an anatomical guide
for a surgeon as the needle approaches a vaginal incision;
[0073] FIG. 33 illustrates the needle as it passes out of a vaginal
incision;
[0074] FIG. 34 is a perspective view of a sling system attached to
two needles according to an embodiment of the present
invention;
[0075] FIG. 35 is a perspective view of a sling assembly being
pulled upward by a needle in accordance with the present
invention,
[0076] FIG. 36 is a perspective view of the sling according to the
present invention after the adapters have been separated from the
rest of the assembly, but prior to final trimming;
[0077] FIG. 37 is a perspective view of the sling according to the
present invention after the sheath has been removed and the sling
has been trimmed;
[0078] FIG. 38 is a perspective view of a small guide needle after
it has been inserted suprapubically, an adapter connected to the
small guide needle after the needle has been inserted
suprapubically, and another large needle for implanting a sling
that is inserted in an open end of the adapter in preparation for
being guided through the patient by the small needle;
[0079] FIG. 39 is a perspective view of an accessory for use in a
kit according to the present invention;
[0080] FIG. 40 is a perspective view of another needle according to
the present invention that includes a schematic depiction of a
feature of the needle;
[0081] FIG. 41 is a side view of another embodiment of adapter and
sling material according to the present invention; with the
elements shown in a disassembled condition;
[0082] FIG. 42 is a side view of another embodiment of adapter and
a sling material according to another aspect of the present
invention; and
[0083] FIG. 43 is a side view of the elements of FIG. 41 with the
elements shown in an assembled condition.
DETAILED DESCRIPTION
[0084] The following description is meant to be illustrative only
and not limiting. Other embodiments of this invention will be
apparent to those of ordinary skill in the art in view of this
description.
[0085] The present invention is directed to surgical instruments,
and implantable articles for treating medical disorders such as
incontinence or stress urinary incontinence (SUI) in both men and
women. The present invention is also directed to improved surgical
procedures that utilize the surgical articles. Although the
invention as disclosed herein generally refers to SUI, treatment of
other urological disorders, such as urge incontinence, fecal
incontinence, mixed incontinence, overflow incontinence, functional
incontinence, prolapse (e.g. vaginal and uterine), enteroceles
(e.g. of the uterus or small bowel), rectoceles, cystoceles and
other disorders are also included within the scope of the present
invention. It is contemplated that the present invention may also
be utilized in conjunction with concomitant procedures, such as,
but not limited to, procedures for addressing cystocele, rectocele,
vaginal prolapse and anatomic corrections.
[0086] In one aspect, the present invention comprises a surgical
kit. FIG. 1A illustrates an example of such a kit 15. The kit 15
comprises an implantable material (e.g. a sling mesh provided as
part of a sling assembly 46), at least one (preferably two) samples
of a first type of needle 60, and at least one (preferably two) of
a second type of needle 60A. The first type of needle 60 is
preferably different than the second type of needle 60A.
[0087] As used herein, the term "needle" is used generally to
describe a variety of surgical instruments including suture
passers, ligature carriers, needles and the like. Typically, the
needle will have an elongate body and a pair of ends. The needle
facilitates passage through tissue, preferably from an abdominal
incision to a vaginal incision or, alternatively from the vaginal
incision to an abdominal incision. As used in this application,
when it is said that one needle is of a different type than another
needle, it is meant that the needles substantially differ in a
feature that can potentially affect a surgical procedure for
treating a urological disorder. Features that can be different
according to the present invention include, but are not limited to
the size of the needles, the length of the needles, the shape of
the needles, the characteristics of an end of the needles (e.g.
sharp or blunt surfaces, closed or open lumen), the capacity of the
needle to operate with a bladder perforation detector or a means
for avoiding perforations of the bladder, the material of the
needles, whether the needles have the capacity to be tied to a
suture, the strength of the needles, the cross sectional size (e.g.
diameter) or shape of the needle, the presence of an integral
handle, the presence of a bladder perforation detection feature,
the degree that the needles are malleable, whether the needles are
reusable or only provided for use on a single patient, the capacity
of the needles to be sterilized by a particular sterilization
procedure, whether the needles have surfaces that are sized and
shaped to engage complementary surfaces on another surgical
article, the capacity of the needle to deliver a medicament such as
an anaesthetic, the capacity of the needle to include a lighting
feature, whether the needles have a portion that is movable
relative to remaining portions of the needle, and other
features.
[0088] FIG. 4 illustrates a curved needle 60. The needle 60 is
preferably arc-shaped and includes end 58 and end 62. The ends or
tip of the needle 60 are preferably not sharp, but may be tapered
to afford easy passage through tissue while providing a blunt
surface that avoids cutting sensitive tissue such as the bladder or
urethra. In a preferred embodiment, the length of the needle 60 is
approximately within the range of 16.5 cm to 24.1 cm (6.5 inches to
9.5 inches) and has a preferred external diameter of approximately
3.175 mm (0.125 inch). Preferably, the diameter of the needle 60 is
small relative to the prior art to reduce tissue trauma.
[0089] The needle 60 is preferably made of a malleable, yet
durable, biocompatable surgical instrument material such as, but
not limited to, stainless steel (e.g. 316 stainless steel or 17-4
stainless steel), titanium, Nitinol, polymers, plastics and other
materials, including combinations of materials. The needle 60
should have sufficient structural integrity to withstand the
various forces (e.g. forces caused by dilator attachment, and
penetration/passage of the needle 60 through the various tissues)
without undergoing any significant structural deformation.
Optionally, the needles 60 could be sufficiently malleable to allow
a practitioner or user of the device to modify the needle 60 to a
desired shape and, thereby, optimize the procedural approach.
[0090] FIG. 3 illustrates a substantially straight needle 60A. Some
surgeons prefer a curved needle to a straight needle for some
urological procedures. Others prefer straight needles to curved
needles. Providing the surgeon the option to use either needle from
a surgical kit can increase the convenience for the surgeon and can
match the skills possessed by a particular surgeon with the
surgical instrumentation provided in the surgical kit.
[0091] FIG. 6 illustrates a different type of curved needle 40 with
integral handle 44. The leading end portion 42 of the needle 40
includes a passageway (hole 42) for receiving a suture 6 used
during the surgical procedure. FIGS. 7 and 8 illustrate a curved
needle assembly 50 with a curved portion 53, an end 54, a movable
handle 52 and a handle lock or stabilizer 51.
[0092] FIGS. 9, 9A and 10 show a different type of needle assembly
80 comprising an end portion 81 with a passageway 82 for receiving
a suture 6. The passageway 82 for receiving a suture 6 is
illustrated as a hole. Alternatively, the passageway could include
a slot, slit or other shape for receiving and securely grasping the
suture 6.
[0093] The needle assembly 80 includes shaft 87. The end portion 81
and passageway 82 are placeable within the sheath 87. Preferably
the end portion 81 is blunt and free of any sharp surfaces. The
needle 80 also includes a mechanism 85 that is capable of moving
the blunt end portion 81 between i) an extended position with the
suture passageway 82 extending beyond the end of the outer sheath
member 87 so that the suture passageway can conveniently receive a
suture 6, and ii) a retracted position with the blunt end portion
spaced closer to the end of the outer sheath member 87 than in the
extended position and for securely holding a suture placed within
suture passageway 82. Preferably, in the retracted position, the
passageway 82 is completely within the sheath member 87 to securely
hold the suture 6 to the needle 80 and to resist separation of the
suture 6 and needle 80. A button 88 is used to conveniently move
the elements between the extended and retracted positions.
Preferably, a spring is utilized to bias the elements toward the
retracted position.
[0094] FIGS. 11-14 illustrate another embodiment of needle 500 for
optional use in a kit according to the present invention. The
needle 500 includes a handle and a sheath that remain relatively
stationary. The sheath includes a relatively sharp surface 518 for
cutting tissue. The needle 500 also includes an inner member that
is movable relative to the handle. The inner member has a blunt end
528. Preferably, the movable member also includes a suture
passageway 529. Alternatively, the inner member could include a
means for snapping onto a dilator as described more fully
below.
[0095] FIG. 11 shows the needle 500 with a blunt member 528 in an
unlocked, extended position that is extended beyond sharp surface
518. In this position, the blunt member 528 protects tissue from
the sharp surface 518 but the blunt member 528 is free to deflect
inwardly when the needle is pressed against tough tissue (e.g.
abdominal fascia). FIG. 12 shows the sharp surface 518 and blunt
member 528 as the blunt member 528 is initially deflected by
tissue.
[0096] FIG. 13 illustrates the blunt member 528 deflected to
substantially the level of the sharp surface 518, such as when the
needle encounters significant resistance from tissue. In this
condition, the sharp surface may now be exploited to cut through
the tough tissue to avoid the sudden needle lurch associated with a
blunt ended, prior art needle. FIG. 14 shows the blunt member 528
in a locked, extended position after the resistance associated with
the tissue ends and spring 510 has returned the blunt member 528 to
the extended position.
[0097] Preferably, the needle 500 has a locking means for locking
the blunt end portion 528 in the extended position to avoid
injuring tissue once the needle passes through the tough tissue.
The locking means preferably comprises a locking leaf spring 502.
One end of the leaf spring 502 is preferably attached to the handle
and the other end of the leaf spring 502 is movable between a
locking position (FIG. 14) and a release position (FIGS.
11-13).
[0098] The inner movable member with blunt end 528 includes a
spring shoulder 509, and extension arm 530 with leaf spring cam
surface 537 and blocking surface 532. When the needle 500 is
initially pressed against the tissue to be cut, the leaf spring cam
surface 537 cams the end of the leaf spring 502 off of a retaining
lip 520 (described in more detail below). The blocking surface 532
is adapted to engage the end of the locking leaf spring 502 to lock
the movable member in the extended position. Spring 510 biases the
inner member toward the extended position. A floating spring
attachment member is operatively associated with one end of the
spring 510 and the other end engages spring shoulder 509 of the
inner movable member.
[0099] The needle 500 also preferably includes a release mechanism
for releasing the inner member with blunt end 528 from the locked
position. The release mechanism includes a slidable button 525
assembly with a leaf spring retaining lip 520. The leaf spring
retaining lip 520 is sized and shaped to retain the leaf spring in
the release position shown in FIG. 11. The release mechanism also
includes a deflection surface (just adjacent retaining lip 520) to
move the leaf spring from the locked position (FIG. 14) to the
release position (FIG. 11) when the button 525 is pressed.
[0100] FIGS. 15 through 17 illustrate additional examples of
different types of needles for use in a kit according to the
present invention. Needle 202 includes two substantially straight
portions situated at a predetermined angle. The needle 202 has two
substantially disc shaped integral handles, and a diamond-shaped,
substantially flat end portion. The end portion includes a
passageway. Needle 204 has two substantially straight portions at a
predetermined angle that is different than the angle of needle 202.
Needle 204 is also longer than needle 202 and has a different
shaped end portion. Needle 206 has a straight and a curved portion.
Needle 206 includes a substantially flat end portion with a
passageway 208. A handle 200 with a set screw may be attached to
the needle 206 (e.g. at complementary surface 209).
[0101] Needles 202, 204 and 206 are sized and shaped to be suitable
for use in surgical procedures. The needles are particularly useful
for treating urological disorders. Preferably, the needles are
constructed from a strong biocompatible material such as stainless
steel. They may be reusable and can be sterilized by steam
sterilization procedures, including flash sterilization procedures
commonly located close to the surgical location.
[0102] The different sizes and shapes of the needles provide a
surgeon with the option to use a different needle depending upon
the needs of a particular surgical procedure (e.g. size of the
patient, previous surgical procedures, scarring, concomitant
procedures, condition of the patient, and the anatomy of the
patient, etc.).
[0103] In another aspect of the present invention, the different
types of needles need not serve the same purpose in a surgical
procedure, but could serve a different purpose. FIG. 38 illustrates
a surgical guide needle 602 (e.g. with a diameter of about 4 mm, or
less, preferably about 3 mm) and a relatively larger sling
transport needle 604 (e.g. with a diameter of 5 mm). Preferably,
the sling transport member has a sling assembly 610 (e.g. a sling
mesh and insertion sheath) attached thereto.
[0104] The guide needle 602 serves a different purpose than the
surgical transport needle 604. The surgical guide needle 602 is
preferably small and has a blunt tip. The blunt tip is initially
inserted through an abdominal or suprapubic incision 400 and then
through a vaginal incision 404. Inserting a small, blunt needle in
this fashion provides the surgeon with addition control in
maneuvering through the anatomy of a patent and in avoiding
sensitive tissue.
[0105] A surgical kit according to an aspect of the present
invention may include an adapter 54 on the end of needle 602. The
sling transport needle 604 may optionally include a sharp tip. The
adapter receives the tip of the needle 604. Pushing upward on the
sling transport needle 604 with one hand while steering the tip of
the needle 604 by holding guide needle 602 with the other hand is
believed to provide better control over insertion of a prior art
large needle that is initially inserted through the vaginal
incision 404 and then through the suprapubic incision.
[0106] Alternatively, the adapter can include surfaces for firmly
engaging and attaching to needle 604. Those surfaces can include
mechanical interlocking structures, grasping structures or
interlocking structures. Optionally, a biocompatible adhesive may
be used to adhere the tip of sling transport needle 604 to the
adapter.
[0107] FIG. 40 illustrates a needle 60 with a bladder perforation
detector 121. A variety of means may be used as the bladder
perforation detector. The needle perforation detector can include a
ph sensor for determining whether the ph encountered by the needle
is outside anticipated limits. For example, if the bladder has been
perforated, fluid associated with such a perforation is likely to
encounter the end 58 of the needle and change the ph encountered by
the needle. The change in ph can be used to signal that the bladder
has been perforated.
[0108] The bladder perforation detector 121 preferably signals an
impending bladder perforation prior to its occurrence so that it
prevents bladder perforations. For example, an object may be placed
in the bladder 14 of the patient. The needle 60 and object can have
complementary light source and detection means (e.g. a
photoelectric sensor) for avoiding bladder perforations by the end
58 of the needle 60. For example, the object can include a light
source and a light emitter. The needle 60 can include a light
detector tuned to receive light emitted from the object.
Preferably, the object emits light through the bladder 14 so that
the needle 60 detects the light prior to perforating the bladder
14.
[0109] Alternatively, needle 60 may be associated with a light
source and can emit light. In this embodiment, the object placed in
the bladder includes a photosensitive detector/receptor and can be
associated with an alarm and controller. The controller can set a
threshold of light intensity detected. Above that threshold, an
alarm may be used to warn a surgeon that the needle is in proximity
to the bladder and that a bladder perforation may be impending.
Optionally, the bladder may be filled with a photoconductive medium
to enhance bladder perforation detection.
[0110] In another embodiment, the needle can have a resistance or
capacitance detector capable of detecting the change in resistance
encountered after the bladder is perforated. In another embodiment,
an object can be placed in the bladder through the urethra. The
needle can include a proximity sensor for detecting the proximity
of the needle to the object. This type of needle can be constructed
to be operatively associated with an alarm mechanism (e.g. audible,
visual or tactile) that informs the surgeon that the needle is in
proximity to the object that is placed in the bladder. Such a
device is believed to avoid bladder perforations as, upon sensing
the alarm, the surgeon may change the path of the needle to a path
that is away from a close proximity to the bladder. Alternatively,
the proximity of the needle and an object in the bladder can close
a circuit and actuate an alarm. The alarm may be audible, visual or
tactile to the user by an integral part of the needle or a separate
device integrated into the system.
[0111] In another aspect of the present invention, a needle may
optionally include the capacity to deliver a medicament (e.g.
anesthesia) during the surgical procedure. For example, the needle
may be hollow with an open end. The needle may have a connector for
associating with a medicament reservoir and delivery mechanism
(e.g. a syringe). As another alternative, the needle may comprise a
means for connecting to a light source to enhance visibility or for
being monitored by a light detector placed in the bladder (e.g. to
avoid bladder perforations).
[0112] Referring to FIG. 1, in another aspect the present invention
comprises a surgical kit 11 comprising a first type of sling
material (e.g. as part of the sling assembly 46), a second type of
sling material 10, and at least one needle (e.g. 60). As used
herein, the terms "sling" or "article" or "mesh" or the phrases
"implantable material" or "implantable article" or "sling mesh" (or
combinations thereof) are used generally to describe a variety of
materials including synthetic and non-synthetic materials.
Typically, the implantable article will be elongate and
substantially flat. It can be used as a hammock, sling, strip or
support member. As used in this application, when it is said that
one sling material is of a different type than another sling
material, it is meant that the materials substantially differ in a
feature that can potentially affect a surgical procedure for
treating a urological disorder. Features that can be different
according to the present invention include, but are not limited to
the ability of the sling to avoid infections or tissue erosion, the
shelf life of the product, the type of material, the shape of the
material, the presence of a sling tensioning member (e.g. as
disclosed in U.S. patent application Ser. No. 09/917,562, filed
Jul. 27, 2001), the present of a sling adjustment feature as
described in U.S. Pat. Appl. Attorney Docket No. AMS-018 filed Oct.
30, 2001 which claims priority to U.S. Provisional Application No.
60/237,075 filed Oct. 3, 2001, sling material treatment, the
porosity of the sling material, the shape of the sling material,
the sling length, the strength of the material, the elastic
property of the material, the potential for tissue ingrowth, the
biocompatibility of the material, and the presence or absence of an
insertion sheath.
[0113] While the slings are preferably rectangular for treating SUI
in females, other shapes are also contemplated. Depending on the
treatment addressed (e.g. to provide hammock support for the
bladder or bladder neck, or to address a rectocele, enterocele or
prolapse) the slings may be any of a wide variety of shapes. As an
example, the sling may be of the general shape of the slings
described and shown in Moir et al., The Gauze-Hammock Operation,
Journal of Obstetrics and Gynaecology of the British Commonwealth,
Volume 75, No. 1, Pps. 1-9 (1968).
[0114] Suitable non-synthetic materials include allografts,
homografts, heterografts, autologous tissues, cadaveric fascia and
fascia lata. Some surgeons believe that non-synthetic materials are
i) more consistent from lot to lot in terms of material
characteristics, as opposed to some synthetic slings whose
characteristics may be believed to vary, ii) less likely to cause
tissue erosion or are less likely to elicit an adverse reaction
from the patient's foreign body response mechanism as the body is
less likely to recognize a non-synthetic material as a foreign
material, and iii) are less likely to be rejected by the body long
term.
[0115] Suitably synthetic materials for a sling include polymerics,
and plastics and any combination of such materials may also be used
in a kit of the present invention. Commercial examples of such
materials include Marlex.TM., Prolene.TM., and Vaskutek.TM.. Other
examples of suitable materials include those disclosed in U.S.
patent application Ser. No. 09/939,098 filed Aug. 24, 2001 (the
entire contents of which are herein incorporated by reference).
Specific examples of synthetic sling materials include, but are not
limited to polypropylene, polyethylene, nylon, PLLA and PGA. For
example, some surgeons prefer synthetic materials because they
believe such materials: i) are stronger and/or more durable than
many non-synthetic materials (e.g. less likely to experience suture
detachment failure), ii) have different elastic properties, iii)
are more likely to afford desirable tissue ingrowth, iv) can be
readily and effectively incorporated with desirable features such
as antimicrobial agents, v) many non-synthetic sling materials are
difficult to acquire, and vi) present no issues of cross
contamination between species.
[0116] The sling material may be resorbable, absorbable or
non-absorbable. Optionally portions may be absorbable and other
portions may be non-absorbable.
[0117] In one aspect of the invention, the sling may comprise a
mesh material. The mesh material comprises one or more woven,
knitted or inter-linked filaments or fibers that form multiple
fiber junctions throughout the mesh. The fiber junctions may be
formed via weaving, knitting, braiding, bonding, ultrasonic welding
or other junction forming techniques, including combinations
thereof. In addition, the size of the resultant openings or pores
of the mesh may be sufficient to allow tissue in-growth and
fixation within surrounding tissue. As an example, not intended to
be limiting, the holes may comprise polygonal shaped holes with
diagonals of 0.132 inches and 0.076 inches. Holes much smaller than
this are not preferred as they may facilitate bacterial
colonization.
[0118] The quantity and type of fiber junctions, fiber weave,
pattern, and material type influence various sling properties or
characteristics. Non-mesh sling configurations are also included
within the scope of the invention. As another example, not intended
to be limiting, the mesh may be woven polypropylene monofilament,
knitted with a warp tricot. The stitch count may be 27.5
courses/inch (+or -2 courses) and 13 wales/inch (+or -2 wales). The
thickness of this example is 0.024 inches.
[0119] In another embodiment the sling material may have one or
more substances associated therewith through a process such as
coating. Examples of appropriate substances include, without
limitation, drugs, hormones, antibiotics, antimicrobial substances,
dyes, silicone elastomers, polyurethanes, radiopaque filaments or
substances, anti-bacterial substances, chemicals or agents,
including any combinations thereof. The substances may be used to
enhance treatment effects, reduce potential sling rejection by the
body, reduce the chances of tissue erosion, enhance visualization,
indicate proper sling orientation, resist infection or other
effects. For example, the sling may be coated by the process
described in U.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745;
5,902,283 and 6,162,487 (the entire contents of which are hereby
incorporated by reference).
[0120] FIG. 2 illustrates a sling assembly comprising sling 42 and
sheath 44 that are made of biocompatible materials having
sufficient strength and structural integrity to withstand the
various forces exerted upon these components during an implant
procedure and/or following implantation within a patient.
[0121] Preferably, the overall dimensions of the sling assembly 46,
including insertion sheath 44 and sling 42 are sufficient to extend
from an abdominal incision, to an undersurface of the urethra and
back to another abdominal incision with additional size to account
for the imprecision associated with the range of human anatomy
sizes. In a preferred embodiment, the sheath length of the assembly
of the present invention is approximately within the range of 52.0
cm to 58.5 cm (20.5 inches to 23.0 inches), sheath width is
approximately within the range of 1.0 cm to 1.63 cm (0.482 inch to
0.642 inch) and sheath material thickness is approximately within
the range of 0.127 mm to 0.203 mm (0.005 inch to 0.008 inch),
respectively. The associated sling 42 has a length, width and
thickness approximately within the range of 40 cm to 51 cm (15.7
inches to 20.1 inches), 1.0 cm to 1.2 cm (0.394 inch to 0.472 inch)
and 0.508 mm to 0.711 mm (0.020 inch to 0.028 inch),
respectively.
[0122] The sling 42 of the present invention can be implanted
without the need for bone screws. Upon implantation, a portion of
the sling 42 is passed and/or woven through various layers of
abdominal/pelvic tissue.
[0123] The sling 42 is designed to remain within the body of a
patient as an implant for a predetermined therapeutically effective
amount of time. The sling may be non-absorbable, absorbable or
resorbable, including any combinations of these material
properties, depending on the desired treatment. The general
characteristics of the sling material and design should be such as
to withstand the various forces exerted upon it during implantation
(for example, frictional forces associated with tissue resistance)
and after implantation (for example, increased abdominal or bladder
pressure caused by a stress event).
[0124] The precise, final location of the sling 42 will depend on a
variety of factors including the particular surgical procedure(s)
performed, and any preconditions of the patient such as scar tissue
or previous surgeries. For example, it may be preferred to place
the sling 42 in close proximity to, but not in contact with, a mid
portion of the urethra to treat incontinence.
[0125] In another aspect, the present invention includes an element
that affords construction of a hybrid sling from different types of
sling materials. FIG. 2 shows a sling constructed from a synthetic
material 42. FIG. 2B illustrates a sling constructed from a
synthetic material 42 and a non-synthetic material 10. FIG. 2C
shows a sling assembly constructed from a non-synthetic material
10. The connector 8 shown in FIG. 2A may be used to connect one
type of sling material 10 to another type of sling material 42 or
to connect a sling with a needle. Any suitable biocompatible
structure may be used as the connector 8. For example, one or more
of the connectors described in U.S. patent application Ser. No.
09/749,301, filed Dec. 27, 2000, entitled "Apparatus and Methods
For Enhancing the Functional Longevity and For Facilitating the
Implantation of Medical Devices" (the entire contents incorporated
herein by reference) may be used.
[0126] Referring to FIG. 2, the connector 8 may be used to attach a
loop 48 of sheath 44 to a dilator 54 (described more fully below)
or the connector 8 may be used to operatively associate a suture 6
with the sling assembly 46. The suture 6 may then be used to attach
the sling assembly 46 to needle 60 or another type of needle.
[0127] In use, a particular surgeon may prefer to place
non-synthetic material (e.g. 10) in the mid portion of the sling,
believing that such a sling is less likely to erode the urethra of
a patient. That surgeon may also desire to have synthetic materials
along the end portions of the sling, believing that such synthetic
end portions are more likely to anchor in tissue and promote tissue
ingrowth. In another alternative, a surgeon may construct a
silicone coated synthetic sling material in the mid portion of the
sling to avoid tissue erosion and a polypropylene mesh material
along the end portions of the sling.
[0128] The connector 8 allows the hybrid sling to be constructed
just prior to the surgical procedure so that it may be customized
for a particular surgical procedure. A customized sling can account
for factors such as pre-existing scarring, patient anatomy size and
the intended use for the sling (e.g. to raise the bladder neck or
to merely support it). It can also be constructed to be
complementary to concomitant procedures (e.g. for addressing a
prolapse). The connector 8 can be made of Delrin, ABS, nylon,
polycarbonate, acetal, polyetherimide, polysulfone or other
sterilizable materials.
[0129] Other elements may be used as a means for constructing a
hybrid sling from a first type of sling material and a second type
of sling material. For example, a biocompatible adhesive or sealant
(e.g. a tissue adhesive or sealant) may be used. The biocompatible
adhesive may comprise any of the adhesives, sealants and
implantable materials disclosed or referenced in U.S. Provisional
Patent Application Nos. 60/302,929 filed Jul. 3, 2001, and
60/307,836 filed Jul. 25, 2001, and 60/325,870 filed Sep. 28, 2001
(the entire contents of which are herein incorporated by
reference). Additional commercial examples of such adhesives,
sealants and implantable materials include Tissuebond and
Tissuepatch available from Tissuemed, RapiSeal from Fusion,
CoStasis from Cohesion and FocalSeal from Focal.
[0130] According to one embodiment, the sling may include a
protective sheath 44 (see FIG. 2). The sheath 44 is used during
insertion of the strip 42. After the sling 42 is implanted, the
sheath 44 is removed and discarded. Preferably, the protective
sheath 44 is constructed of a material that affords visual
examination of the implantable sling material 42 and that affords
convenient passage of the assembly 46 through tissue of the
patient.
[0131] In a preferred embodiment, the sheath 44 is made of
polyethylene. Other materials including, without limitation,
polypropylene, nylon, polyester or Teflon may also be used to
construct the sheath 44. The sheath material should be flexible and
provide sufficient structural integrity to withstand the various
forces exerted on the sheath 44 throughout the sling delivery
procedure. In general, the sheath 44 is configured to have
sufficient flexibility to facilitate user manipulation and adequate
structural strength to withstand the various forces applied to the
sheath 44 during delivery and/or positioning of the sling assembly
46. It should also conveniently separate from the sling material 42
after the sling 42 is implanted without materially changing the
position of the sling 42.
[0132] The sheath 44 may comprise two elongate, separable sections.
Optionally, portions of the sheath 44 may detachably and
telescopically overlap near the middle portion of the sling. In
addition to resisting sling exposure and contamination, the
overlapping section may also be used as a visual indicator for the
practitioner or user of the device. Additionally, orientation
indicia (not shown) may be placed on the overlapping portion to
indicate proper orientation of the sling relative to the urethra.
Alternatively, other configurations of the sheath 44 are within the
scope of the present invention. In particular, the sheath may be
unitary as opposed to telescoping with perforations, slits, holes,
scores or tear lines designed to allow separation and removal of
the sheath 44.
[0133] During sheath removal, the first section and the second
section of the sheath are slid off the sling 42 by pulling each end
of the sheath 44 away from the middle portion of the sling assembly
46. Removal of the sheath 44 causes separation of the overlapping
sheath sections, thereby exposing the sling 42. In addition, the
smooth outer surface of the sheath 44 provides a relatively
frictionless surface to facilitate passage of the sheath 44 through
the various tissues. The relatively frictionless motion also avoids
disturbing the position of the sling 42 relative to the anatomy of
the patient.
[0134] In another embodiment of the invention, the sheath 44, or a
portion thereof, is associated with one or more substances
including those substances identified with respect to sling 42. The
substances may be used to enhance sheath removal, identify twists
along the sheath 44 (and thereby indicate proper sling
orientation), indicate cutting/separation points, indicate
center-point, resist infection or provide other desirable effects.
For example, a first surface of the sheath 44 may include indicia
that should lie opposite the urethra or bladder neck to ensure
proper sling orientation. Thus, the indicia provide the
practitioner/surgeon with a visual indicator to aid in properly
orienting the sling assembly 46, and ultimately the sling 42,
within the patient.
[0135] In another aspect, the present invention comprises an
article (e.g. 54, FIG. 2) for use in a surgical sling procedure.
The article 54 comprises a body portion having first end portion 56
and second end portion 52 opposite the first end portion 56. The
first end portion 56 has surfaces for associating the article 54
with a needle (e.g. end 58 of needle 60). The second end portion 52
has sling association means for associating the article with a
sling. The sling association means may comprise a hole 90.
[0136] Preferably, the article 54 comprises a dilator that dilates
a needle track for ease of sling introduction and positioning
within the patient. End 58 of the needle 60 is preferably keyed to
allow for convenient, secure attachment of the needle 60 relative
to the dilator 54. In a preferred embodiment, the key feature
prevents rotation of the dilator 54 relative to the needle 60.
[0137] The kits shown in FIG. 1, 1A and 2 include two dilators. The
dilator 54 atraumatically creates and/or expands the passageway
through the tissues for sling assembly delivery. The dilator 54 is
preferably short relative to a needle 60 for ease of passage of the
assembly and to reduce the overall amount of tissue that is
deflected at one time. Preferably, the dilator is less than 2.5
inches in length, and more preferably, it is less than one inch in
length. The maximum radius of a dilator 54 is preferably less than
10 mm, more preferably less than 7.5 mm, even more preferably less
than 5 mm. The tip of the dilator 54 is preferably blunt, as, in
preferred embodiments, the leading tip of the dilator 54 will pass
through tissue that has already been pierced by a needle 60.
[0138] The dilator 54 may be made from a variety of biocompatible
and sterilizable materials including, without limitation, acetal,
Delrin.RTM.), Acrylonitrile-Butadiene-Styrene (ABS), polyethylene,
nylon and any combination of biocompatible materials.
[0139] The dilator 54 preferably includes means for associating
with a surgical needle 60. In a preferred embodiment, the
association means affords a permanent affixation between the
dilator 54 and the needle 60. By "permanent affixation", it is
meant that it would be very difficult to manually separate the
dilator from the needle after they have become permanently affixed.
After implantation of the sling 42, to separate the sling 42 from
the dilator 54/needle 60, the surgeon cuts an end of the sling 42
as described more fully below. The association means preferably
affords quick and convenient attachment of the dilator 54 to the
needle 60 to avoid wasting time in the midst of a surgical
procedure. The attachment should also be secure to avoid separation
of the needle 60 and dilator 54 while the combination is passed
through tissue.
[0140] As seen in FIGS. 4 and 18A, the first and second ends 58 and
62 of the needle 60 may include a keying feature affording secure
association between the needle and dilator 54 and/or sheath
assembly 46. In one embodiment, the keying feature comprises a
recess 130 and/or square-shaped portion 126. As previously
described, the recess 130 and square-shaped portion 126 are
designed for complementary engagement to the appropriate end of a
dilator 54. Alternatively, a suture 6 may simply be tied to the
recessed portion of the end of the needle 60.
[0141] The dilator 54 also includes a universal sling association
means (e.g. hole 90) for associating with the surgeon's choice of
sling. Optionally, the dilator 54 may be preattached to the sling
42 and/or sheath 44, particularly if the sling is a synthetic
material. Alternatively, the synthetic sling 42 can be cut and
removed from dilator 54, and the dilator may be attached to a
non-synthetic sling material (e.g. cadaveric or autologous sling
material) just prior to sling placement.
[0142] Referring to the embodiment of dilator shown in FIGS. 23-26,
the dilator 54 may be approximately 3.1 cm (1.2 inches) in length.
The dilator 54 preferably includes a gentle taper 88 near its first
end 56. The dilator is sized and shaped to provide atraumatic
passage through body tissue. The taper 88 and relatively smooth
outer surface of the dilator 54 facilitate atraumatic passage of
the dilator 54 and attached sling assembly 46 through the various
tissues of the patient. The presence of the dilator 54 allows a
gentle transition between the diameter of the needle, to the shape
of the dilator, and finally to the sling assembly 46, as opposed to
prior art assemblies, where the structure of the sling assembly
abruptly increases the profile of the needle and thereby the size
of the structure that must pass through tissue.
[0143] Preferably, the second end 52 of the dilator 54 associates
the dilator with one end of a sling 42, or sheath 44 or sling
assembly 46. The sheath 44 or sling 42 is preferably attached to
the dilator 54 via a first opening or through-hole 90 located near
the second end of the dilator 54. In this embodiment, the opening
90 operates as a universal sling material or assembly attachment
point which can receive a variety of materials, such as fascia,
autologous materials, synthetics, biologic tissues and any other
similar tissues, including any combinations.
[0144] FIG. 21 illustrates a first sling 42 constructed of
synthetic material with a plurality of through holes and a suture 6
threaded through a hole in synthetic material 42 that is spaced
from the end of the synthetic material 42. FIG. 21A shows a
non-synthetic sling material 3 with a suture anchor 7 attached
thereto. The suture anchor 7 firmly associates the sling 3 with the
suture 6 and resists separation of the sling 3 and the suture 6.
Either sling material 3 or 42 can be conveniently associated with
dilator 54 by threading suture 6 through hole 90 and tying the
suture. In this fashion the dilator/adapter 54 can universally
connect to either a synthetic (e.g. polypropylene) mesh 42 or a
non-synthetic sling (e.g. cadaveric fascia 10).
[0145] In the embodiment shown in FIG. 2, the end portion 48 or 50
of one end of the sheath 44 is threaded through the opening 90 of
the dilator 54 and secured to the sheath 44, thereby forming a
loop. Optionally, a connector 8 may be used to secure the loop. The
edge portion 48 or 50 alternatively may be fastened onto the sheath
44 via ultrasonic welding, bonding, melting, suturing, sealing or
other attachment techniques. Further, as shown in FIG. 23, the end
52 of the dilator 54 preferably includes a cut-away section 94 to
provide room to receive sling assembly material to reduce the
overall profile of the sling assembly experienced by tissue during
sling passage. Therefore, when the sheath is attached to the
cut-away section, the additional sheath material is not apt to
significantly increase the relative thickness, diameter or profile
of the dilator 54.
[0146] As shown in FIGS. 24 and 25, one or more sutures 6 may be
threaded through hole 90 and used to connect a sling to the
dilator. This gives the surgeon the option to associate the dilator
with a particular sling material just prior to implantation.
Optionally, a suture anchor article 8D (FIG. 24) may be used to
enhance the attachment of the suture 6 to the sling material,
particularly if the sling material is sensitive to suture pull
through (e.g. such as some cadaveric fascia).
[0147] Alternatively, for dilators 54 manufactured via molding
techniques, the end of the sheath 44 may be encased within and
secured to the second end 52 of the dilator 54 during the molding
process. In yet another embodiment, the end of the sheath 44 may be
fixedly attached within a longitudinal slot located near the first
end 52 of the dilator 44 using an adhesive, ultrasonic welding or
other attachment techniques.
[0148] Referring to FIGS. 23-26, the first end 56 of the dilator 54
includes a second opening or through-hole or lumen 96 that extends
substantially internally along the longitudinal axis of the dilator
54. The hole 96 preferably extends the length of the dilator
54.
[0149] The lumen 96 has an internal diameter generally configured
for convenient attachment to a needle 60 or similar sling-delivery
device. In one embodiment, the internal diameter of the second
opening 96 of the dilator 54 is approximately within the range of
0.239 cm to 0.318 cm (0.094 inch to 0.125 inch). A shoulder 98
located on the surface 100 of the second opening 96 of the dilator
54 and a complementary mating recess located on the surface of the
first end of the needle 60 securely and permanently attach or lock
the dilator 54 and needle 60 together. Once the needle 60 is
inserted into the dilator 54, they are preferably not separated
thereafter. After the sling 42 is implanted, the connected needle
60 and dilator 54 are removed from the sling by cutting an end of
the sling as described in greater detail below. Preferable, the
needle 60 and dilator 54 are discarded after the surgical
procedure.
[0150] One or more longitudinal slots 102 located on the outer
surface of the dilator 54 and in communication with the second
opening 96 allow the wall of the dilator 54 to expand in a radially
outward direction when the first end of the needle 60 is inserted
into the second opening 96 of the dilator 54. When the shoulder 98
of the dilator 54 passes the recess of the needle 60, the wall of
the dilator 54 collapses around the needle 60 as the shoulder 98
seats into the recess, thereby securing the dilator 54 on the
needle 60 and blocking separation of the dilator 54 and needle
60.
[0151] Although the invention has been described in terms of a
shoulder 98 and mating recess, alternative dilator-needle
attachment mechanisms such as bumps, grooves, slots, wedges,
detents and other mechanisms are also included within the scope of
the claimed invention. The dilator 54 preferably includes one or
more relief ports 104 to facilitate convenient needle connection.
The relief ports 104 may be formed at the ends of the longitudinal
slots 102 or at various high-resistance locations along the dilator
54. The relief ports 104 decrease the rigidity or resistance of
radially outward expansion of the dilator wall and, reduce the
amount of force required to insert or securely attach the needle 60
to the dilator 54. In yet another embodiment, superficial bands or
rings, arc-shaped slots, superficial grooves or other mechanisms
may provide improved expansion or attachment characteristics.
[0152] A portion of the dilator 54 includes a taper 88 having a
decreasing profile toward the second end 56 of the dilator 54. The
taper 88 preferably gently cams tissue out of the path of the sling
assembly 46 as the sling assembly is inserted in the body. The
taper 88 is also sized and shaped to reduce the amount of friction
or resistance as the device is drawn through the tissues of the
patient. The amount of force required to manipulate the device
through the tissues is thereby reduced. This in turn provides the
user of the assembly with additional control over device insertion
and maneuverability through tissue and within the patient. In
addition to tapered profiles, other dilator profiles such as
conical, flared, frusto-conical, pyramid-shaped, elliptical or
other applicable profiles may also be used. Overall, the profile of
the dilator 54 is preferably configured to provide easy dilation of
the tissue to accommodate smooth passage of the sling 42/sling
assembly 46 and subsequent collapse of the surrounding tissue to
securely anchor the sling 42 into the tissue (after sheath
removal).
[0153] In other embodiments of the invention, shown in FIGS. 18 and
18A, a dilator 54A or 54B includes a sling fastening snap mechanism
106 or 106' on one end of the dilator. The embodiment disclosed in
FIG. 18A includes a keyed/locking mechanism on its other end.
Referring to FIG. 18, the end of the dilator 54a includes a slot or
slot-shaped opening 110 configured for convenient insertion of one
end of a sling 42 (such as one made from non-synthetic tissue) or
sling assembly 46 (e.g. of synthetic materials) either at the
surgical site (e.g. by the operating room nurse or surgeon) or
other location (such as manufacturing location). Additional shapes
for the dilator opening 110 include, without limitation, oval,
circular, square, rectangular and other shapes. The slot-shaped
opening 110 is located along a portion of the longitudinal axis of
the dilator 54A.
[0154] Referring to FIG. 18A, snap-like element 112' is located on
an outer surface near the first end of the dilator 54B. The
snap-like element 112' includes a barb or spike 114 that fits
within an opening 116 situated near the first end of the dilator
54B. The opening 116 for the barb 114, preferably configured
perpendicular to the slot-shaped opening 110', is sized and shaped
to match or mate with the barb 114 of the snap-like element 112'.
When the barb 114 is fully seated within the opening 116 of the
dilator 54B, the tip 118 of the barb 114 extends into the
slot-shaped opening 110' of the dilator 54B. A first ridge 120 and
a second ridge 122 located along the length of the barb 114 further
secure and/or fasten the barb 114 within the opening 116 of the
dilator 54B. Other fastening configurations including, but not
limited to, bumps, shoulders, tabs, detents, tongue in grooves,
snaps and any combinations of fastening means may also be used with
the present invention.
[0155] During use, one end of the sling (e.g. 10 or 42, in FIG. 1),
sheath 44 or sling assembly 46 is inserted into the slot 110' of
the dilator 54B. With the end of the sling 42/sling assembly 46
properly positioned within the slot 110', the barb 114 of the
snap-like element 112' is inserted into the opening 116 of the
dilator 54B. The barb 114 is fully seated within the opening 116
when both ridges 120, 122 pass through the opening 116 of the
dilator 54B. This causes the tip 118 of the barb 114 to bear down
on or penetrate a portion of the sling 42/sling assembly 46
extending within the slot 110' of the dilator 54B, thereby securely
fastening the sling 42/sling assembly 46 to the dilator 54B.
[0156] A keyed/locking mechanism 108 is located near the second end
56B of the dilator 54B. As shown in FIG. 18A, a square-shaped
opening 124 extends along a portion of the longitudinal axis near
the second end 56B of the dilator 54B. The shape of the dilator
opening 124 matches the square-shaped perimeter of the
keying-segment 126 located near the first end 58 of the needle 60
and allows keyed-rotation of the dilator 54B at ninety-degree
intervals. Other appropriate shapes for the dilator opening 124 may
also be used provided that the shape of the opening 124 complements
the corresponding keying-segment shape located near the first end
58 of the needle 60. When the first end 58 of the needle 60 is
positioned within the dilator 54B, the square-shaped opening 124 of
the dilator 54B together with the keying-segment 126 of the needle
60 prevents axial rotation of the dilator 54B relative to the
needle 60 and, thus, twisting of the sling 42/sling assembly 46.
This Ad optional feature provides the practitioner or user of the
assembly with control and maneuverability of the assembly before
and during the insertion procedure.
[0157] The dilator 54B also includes a locking mechanism 128.
Referring to FIG. 18A, the locking mechanism 128 comprises one or
more tension-loaded ribs located within the longitudinal opening of
the dilator 54B. The configuration of the ribs generally matches
and corresponds to a complementary recess 130 located near the
first end 58 of the needle 60. Thus, the first end 58 of the needle
60 is inserted through the longitudinal opening 124 of the dilator
54B until the ribs of the dilator 54B seat within the recess 130 of
the needle 60. The dilator 54B is securely attached or locked onto
the needle 60 when the dilator ribs are fully seated within the
needle recess 130.
[0158] Referring to FIG. 18B, in an alternate embodiment of the
invention, the sheath 44 (or sling 42 or 10 or assembly 46) is
attached to the dilator 54C via a locking (or compression) collet
132 and adapter connector 134. The compression collet 132 comprises
a ring-shaped portion 136 having one or more barbed snap tongs 138.
The complementary adapter 134 comprises a cylindrical element 140
having a first end 142 and a second end 144. The internal profile
near the first end 144 of the adapter connector 134 includes a
tubular lumen or channel 146, having one or more recesses,
shoulders, grooves or similar indentations 148, surrounding an
internal prong 150. The second end 144 of the adapter connector 134
includes one or more barbed snap tongs 152, similar to the tongs
138 of the compression collet 132. In addition, the first end 52C
of the dilator 54C includes a longitudinal opening 154 having one
or more recesses, grooves, slots or related types of indentations
156 configured to engage the tongs 152 of the adapter connector
134.
[0159] In use, one end of the sling (e.g. 10 or 42/sling assembly
46) of the present invention is configured into a tubular or
appropriate shape that enables a sufficient portion of the end of
the sling 42/sling assembly 46 to be inserted through the
compression collet 132. The tongs 138 of the compression collet 132
are then inserted into the first end 142 of the adapter connector
134, causing the tongs 138 to snap into engagement with the adapter
connector 134. The end portion of the sling 42/sling assembly 46 is
compressed between the tongs 138 of the compression collet 132 and
the internal prong 150 of the adapter connector 134, thereby
securely fixing the sling 42/sling assembly 46 to the
collet/adapter assembly. In a similar fashion, the tongs 152 of the
adapter 134 are then inserted and snap-locked into the first end
52C of the dilator 54C, creating a secure fixation between the
collet/adapter assembly and dilator 54C. Alternatively, a
non-synthetic sling 10 could replace sling 42 in this embodiment of
the present invention.
[0160] In another aspect of the present invention, a dilator or
adapter need not be present. Referring to FIGS. 22 and 22A, there
are shown sling assemblies that may optionally be free of adapters
or dilators according to additional embodiments of the present
invention.
[0161] FIG. 22 illustrates a sling assembly 240 for implantation
without the need to use bone anchors or screws. The sling assembly
240 comprises a synthetic surgical mesh 42A (e.g. a polypropylene
surgical mesh) having a plurality of holes. The holes are
preferably sized and shaped to afford tissue ingrowth. The
synthetic surgical mesh is sized and shaped to be implanted during
a surgical sling procedure.
[0162] Some synthetic mesh used for slings are relatively
extensible. Unlike cadaveric fascia and other non-synthetic
materials which tend to be relatively slippery, an extensible sling
mesh may be difficult to thread through tissue alone. Also, even if
such slings could be inserted alone, some synthetic slings could be
damaged during insertion, or could damage tissue. A removable
synthetic insertion sheath 44A (e.g. polyethylene) is situated
about the surgical mesh to assist in inserting the sling mesh
42A.
[0163] The insertion sheath has first and second ends. In the
embodiment shown in FIG. 22, at least one suture 6A is associated
with the insertion sheath 44A and extends beyond the first end of
the insertion sheath 44A a length sufficient to afford attachment
of the sling assembly to a needle. At least one other suture 6A is
associated with the insertion sheath 44 and extends beyond the
second end of the insertion sheath 44A a length sufficient to
afford association of the sling assembly with a needle. Sutures 6A
may be associated with sheath 44A via knotting, suture anchor,
tying, weaving, bonding, ultrasonic welding or other attachment
techniques, including combinations thereof, to prevent suture 6A
detachment during and/or following sling implantation. The sling
42A may optionally be associated with the sheath 44A through such
techniques.
[0164] The suture 6A can be attached to the needle by a multitude
of approaches, such as being tied, knotted, or placed in a suture
passageway and retracted into the needle as described above. For
example, the straight needle shown in FIGS. 9, 9A and 10 could be
used to implant the sling assembly 240. In use, the needle 80 is
inserted suprapubically and emerges from the body through a vaginal
incision. The button 88 can then be extended to expose the suture
accept hole 82 and the suture 6A can be passed through hole 82 and
tied. The tied suture could then be retracted within the sheath 87
by manipulating button 88. The needle 80 could then be pulled up
through the body to implant the sling 240. Alternatively, a stock
ligature carrier could be used instead of needle 80.
[0165] Optionally, the suture 6A could be tied to a dilator or
other component of a needle assembly as shown in FIG. 34.
Preferably, the insertion sheath 44A defines an interior portion
that includes the surgical mesh, and an exterior portion, and the
sutures 6A that extend beyond the first and second ends of the
insertion sheath 44A are completely situated on the exterior
portion of the sheath. Also preferably, the insertion sheath 44A is
securely attached to the sling 42A, by a means such as ultrasonic
welding, suturing or adhesive. A tensioning member 66 may
optionally be provided.
[0166] FIG. 22A illustrates another embodiment of a sling assembly
250 for use in an incontinence procedure. The sling assembly 250 is
particularly suitable for implantation without bone anchors and
need not include a dilator or adapter. The sling assembly comprises
a synthetic surgical mesh 42D having first and second ends and a
plurality of holes that are sized and shaped to afford tissue
ingrowth. The synthetic surgical mesh 42D is preferably sized and
shaped to be implanted during a surgical sling procedure designed
to treat incontinence in females. It may be sized and shaped to be
placed mid-urethra in a tension free fashion to treat SUI. It may
be long enough to extend from the patient's abdominal fascia to the
patient's urethra and back again or it may be shorter and utilize
sutures 252 for anchoring in the abdominal fascia.
[0167] The sling assembly 250 includes a removable synthetic
insertion sheath 44D situated about the surgical mesh 42D. At least
one suture 252 is associated with the surgical mesh 42D and extends
beyond the first end of the surgical mesh 42D. Preferably the
suture 252 has a length sufficient to afford attachment of the
sling mesh 42D to a needle. Another suture 252 is operatively
associated with the surgical mesh and extends beyond the second end
of the surgical mesh a length sufficient to afford attachment of
the mesh to a needle. Sutures 252 may be operatively associated
with the mesh 42D in a variety of fashions (e.g. by tying,
knotting, weaving, adhering, or welding). Alternatively, a suture
anchor or pledget may be used to anchor the sutures 252 to the mesh
42D.
[0168] Preferably, the insertion sheath 44D defines an interior
portion that includes the surgical mesh 42D, and an exterior
portion. Suture 252 preferably extends beyond the first end of the
surgical mesh and extends from the interior portion of the sheath
44D to an exterior portion of the sheath 44D.
[0169] Optionally, sutures 6D may be tied to the end of the sheath
44D. Preferably, sutures 6D are provided in a different color than
sutures 252. Alternatively, sutures 6D can be omitted and sutures
252 can be tied to external portions of the sheath 44D.
[0170] The sutures 252 may optionally be anchored to tissue in the
body (e.g. the abdominal rectus fascia) to help secure the sling.
In this embodiment, it is preferred that the sutures 252 are of a
different color than sutures 6D.
[0171] Referring now to FIGS. 1 and 19, there is shown another
aspect of the present invention. In this embodiment, the present
invention comprises a surgical kit for treating incontinence. The
kit comprises an implantable material (e.g. 10), and a needle 60.
The needle 60 has surfaces for engaging a handle. The kit also
includes at least one of a first type of handle 64 having surfaces
for attaching the handle to the needle 60, and at least one of a
second type of handle (e.g. see FIG. 19) having surfaces for
attaching the handle to the needle 60.
[0172] As used in this application, when it is said that one handle
is a different type than another handle, it is meant that the
handles substantially differ in a feature that can potentially
affect a surgical procedure for treating a urological disorder.
Features that can be different according to the present invention
include the size of the handles, the shape of the handles, the
materials used to construct the handles, the presence, absence or
location of finger indents, whether the handle is movable, whether
the handles are repositionable, whether the handles are releasable,
whether the handle can be indexed between a plurality of positions,
and the location of operable elements. The handles may have any of
the structure and features described in U.S. patent application
Ser. No. 09/917,443 filed Jul. 27, 2001 (the entire contents of
which are herein incorporated by reference).
[0173] FIG. 19 illustrates a plurality of different types of
handles. Handle 22 comprises a slim, elongate structure with a
button near the proximal end. Handles 31, 35, 37 and 39 have an
operable member (e.g. button) near the distal end of the handle.
Handle 31 is rounded, while handles 33, 35, 37 and 39 are elongate.
The handles may be movable relative to a needle (e.g. slidable or
rotatable), repositionable on a needle (e.g. it may be indexed
between different positions) and/or replaceable on a needle (e.g.
moved from one end to the other end of the needle).
[0174] FIGS. 15-16 show needles 202 and 204 with integral handles.
FIG. 5 illustrates a first handle 64B and a second handle 64' that
may be placed on the same needle 60B.
[0175] FIG. 20 illustrates a handle 172 that may be attached to a
needle 60. The handle 172 includes a strengthening portion 174
designed to strengthen the needle 174. The handle 172 optionally
includes releasable attachment means 177 for releasably attaching
the handle 172 to the needle 60. The handle 172 is particularly
useful when the needle 60 includes a relatively small cross
sectional area or is relatively susceptible to bending during an
anticipated procedure. A kit with the handle 172 enables the
surgeon to place the handle 172 on the needle 60 to avoid bending,
twisting or other deformation of the needle 60 during the surgical
procedure.
[0176] Instead of a hole 90 in the dilator 54, another mechanism
may be utilized to connect a dilator 54 to a surgical sling
material, sheath or sling assembly. FIGS. 41 and 43 illustrate an
adapter 54I. One end of the adapter includes a mechanism for
attaching to a needle 60. The other end of the adapter 54I includes
a means for attaching to a sling 10. The means for attaching to a
sling includes jaws 366 movable between an open position (FIG. 41)
for receiving the sling 10 and a closed position (see FIG. 43) for
firmly holding the sling 10 and resisting separation of the sling
10 from the adapter 54I.
[0177] A fastening arm 365 with securement flange may fit in a hook
shaped receiving slot 364 within adapter 54I. Optionally, a spring
(not shown) may be utilized to bias the securement flange to the
end of the hook to resist separation of the jaws 366 from the
remaining portion of the adapter 54I. When the fastening arm 364 is
fully inserted in the slot 364, inner surfaces of the adapter 54I
engage outer surfaces of the jaws 366 to retain the jaws 366 in the
closed position and to block movement of the jaws toward the open
position. Secure association between the jaws 366 resists
undesirable separation of the sling 10 and the adapter 54I within
the body of the patient.
[0178] FIG. 42 illustrates another portion of an adapter. The
element shown in FIG. 42 includes jaws 359, and threads 357 that
can be screwed into complementary threads in an adapter. The jaws
359 include a piercing member 353 that can penetrate through sling
or insertion sheath 44. Preferably the piercing member 359 includes
an enlarged end portion that can retain the jaws 359 in a closed
position and can block separation of the sling material. The
piercing member is a positive barrier to separation between the
jaws 359 and the sling or insertion sheath 44.
[0179] Operating theatres often stock specialized surgical needles
that are commonly used by urologists. Such needles include Stamey,
Raz, and Pereyra needles. FIGS. 27 and 27A illustrate a needle
converter 712 that can exploit a surgeon's comfort in using a stock
needle.
[0180] FIG. 27A shows a sling assembly comprising a sling mesh
material 42 and a dilator 54. An optional sheath 44 is also shown.
The sheath 44 is threaded through hole 90 and attached to itself
(e.g. by ultrasonic welding). The dilator 54 has an end portion
(opposite the end near hole 90) with a passageway. The passageway
in the dilator (best seen in FIG. 26) includes surfaces for
receiving a first type of needle (e.g. 60).
[0181] Preferably, the surgical kit that includes needle converter
712 would also include a needle 60. Needle 60 has an end portion
that is sized and shaped to engage complementary surfaces in the
passageway of the dilator 54 to associate the needle with the sling
assembly. However, for a variety of reasons, a particular surgeon
may eschew the use of a first type of needle (e.g. 60) and instead
opt to use a commonly available, standard needle (e.g. a Stamey
needle 204 having a hole). Such a surgeon may utilize the needle
converter 712.
[0182] The needle converter 712 includes a first end portion having
surfaces 126D and 130D that are sized and shaped to engage
complementary surfaces in the passageway of the dilator to
associate the needle converter 712 with the dilator 54. Surfaces
126D and 130D are substantially the same shape as surfaces 126 and
130 of needle 60 (see FIG. 4). The needle converter 712 has a
second end portion that is opposite the first end portion. The
second end portion has a means for attaching the needle converter
712 to a second type of needle (e.g. Stamey needle 204) that is
different than the first type of needle 60.
[0183] The connection to the second type of needle can take a
variety of shapes. A plurality of needle converters can be supplied
in the same surgical kit. FIG. 27 shows the needle converter 712 in
an unassembled condition. The needle converter includes a leaf
spring 710 with a locking pin, a locking sleeve 720 and a slot 718
for receiving the end of the second type of needle 204.
[0184] The locking pin of leaf spring 710 is preferably movable
between a needle accept position (FIG. 27) that allows the needle
204 to be inserted in the needle converter, and a needle engaged
position (FIG. 27A) with the locking pin firmly and securely
attached to the needle 204. The locking sleeve 720 is moveable
between a needle accept position (FIG. 27) and a blocking position
(FIG. 27A) that retains the locking pin of leaf spring 710 in the
needle engaged position. Preferably, a leading end of the locking
pin of leaf spring 710 is angled to cam the leaf spring to the
needle accept position when the end of needle 204 is slid into slot
718. An inherent bias of the leaf spring 710 preferably causes the
locking pin to move to the needle engaged position and fully seat
in the hole in needle 204 when the needle 204 is fully inserted in
the converter 712.
[0185] FIG. 27A shows the needle converter 712 in an assembled
condition. The locking pin of the leaf spring 710 is seated in a
hole in the second type of needle 204. The locking sleeve 720 has
been slid in the direction of the arrow in FIG. 27 to encompass the
leaf spring 710 and to prevent the locking pin from moving out of
engagement with the hole in needle 204. Sleeve 720 is preferably
blunt with rounded surfaces to resist damage to the patient while
it is pulled through the body. Notably, resistance by the body
while the sling assembly 42, 44 is pulled through the body will
tend to urge the locking sleeve 720 toward the blocking position to
resist separation of needle 204 and needle converter 712.
[0186] A surgical kit according to the present invention may
optionally include additional accessories. FIG. 39 illustrates a
cystoscopy aid 12. The cystoscopy aid 12 may be inserted over a
thin needle 60. The cystoscopy aid includes one or more apertures
or perforations 160, that function to facilitate verification of
bladder and urethra integrity, are disposed along the length of the
cystoscopy aid 12. For example, during use, after the needles 60
have been inserted within the patient, the cystoscopy aid 12 may be
pushed along the exterior surface of each needle 60. If the bladder
has been punctured during needle insertion causing urine leakage or
drainage within the patient, the urine or bladder fluid will enter
the apertures 160 of the cystoscopy aid 12 and flow along the
surface and out from the needle 60. This allows the practitioner to
quickly and easily confirm urethra and bladder integrity.
[0187] Other accessories may also optionally be included in a kit
according to the present invention. For example, a surgical drape
specifically designed for urological procedures such as a sling
procedure may be included in a kit of the present invention. Such a
drape is disclosed in U.S. patent application Ser. No. 09/749,254,
filed Dec. 27, 2001 (the entire contents incorporated herein by
reference). Alternatively, an article for objectively setting
tension of the device, such as those described in U.S. patent
application Ser. No. 09/968,239, filed Oct. 1, 2001 (the entire
contents of which are incorporated by reference) may be included in
the kit.
[0188] Other accessories may also be included for convenience. For
example, if a needle includes an optical feature, then a optical
elements may be included. If a needle includes a resistance
detector, then the kit may include a means for detecting a bladder
perforation due to the change in resistance encountered by a needle
due to a bladder puncture.
[0189] The kits according to the present invention preferably
include at least two needles. Two or more needles reduce the need
to reuse a needle at a different location with a patient, thereby
eliminating cross contamination issues. Additional needles,
handles, dilators and other elements may also be included for
surgical convenience, for avoidance of contamination from one
portion of the body to another, for ease of manufacturing or
sterilization or for surgical requirements.
[0190] The individual elements of the kits of the present invention
may be packaged together, separately or in subassemblies depending
on a variety of factors such as shelf life and sterilization
requirements. They may be assembled at the manufacturing location
or at the healthcare location. Any suitable sterilization procedure
may be utilized to sterilize the contents of a kit. Suitable
sterilization techniques include, but are not limited to steam,
ethylene oxide, electron beam, vapor (e.g. hydrogen peroxide or
peracetic acid), or plasma procedures.
Examples of Surgical Procedures
[0191] Several methods are contemplated herein. Although the
methods of use as disclosed herein generally relate to female
incontinence conditions and treatments/procedures, male
incontinence conditions and treatments/procedures are also included
within the scope of the present invention. Procedures that address
problems other than incontinence (e.g. cystocele, enterocele or
prolapse) are also contemplated alone or in conjunction with the
present invention. Further, the term "urethra," with respect to
sling positioning, is used for brevity and reader convenience. It
should be noted that the present invention is particularly suitable
for placing a sling in a therapeutically effective position. The
method may be utilized to support a variety of structures at
different anatomical locations. As such, the terms "target site,"
"bladder", "urethro-vesical juncture", "vaginal vault", "U-V
juncture" and "bladder neck" are also included within the scope of
the present invention.
[0192] The present invention includes surgical procedures that
utilize the novel surgical instruments, articles and kits described
above. The present invention also includes improved surgical sling
procedures.
[0193] Referring now to FIGS. 1A and 28, there is shown a first
embodiment of method according to the present invention. The method
includes step 292 of providing a surgical kit with an implantable
material (e.g. a sling mesh from sling assembly 46), at least one
of a first type of needle (e.g. needle with curved portion 60), and
at least one of a second type of needle (e.g. straight needle
60A).
[0194] The method also includes step 294 of selecting the first 60
or the second 60A type of needle. Next, in step 296, a decision is
made as to whether the needle is initially placed through an
abdominal incision and then through a vaginal decision (e.g. a
suprapubic approach). If the suprapubic approach is utilized, the
needle is inserted in the body in step 291, a sling is then
associated with a portion of the needle extending through a vaginal
incision in step 293. The sling is implanted in step 295. After the
sling is implanted, the incisions are closed at the end of the
procedure (step 287).
[0195] Alternatively, step 298 may decide that the needle will be
initially inserted in a vaginal incision and then passed through an
abdominal incision (a suprapubic approach). If an optional
removable handle is used, in step 297, it may be desirable to
initially associate the handle with the needle and then insert the
needle in step 291. If no removable handle is used or once it is
removed, the sling may then be associated with the needle (e.g.
step 289) used in the transvaginal approach. The needle is inserted
(e.g. step 283), the sling is implanted (step 281), incisions are
closed and the procedure ends 288.
[0196] The present invention preferably utilizes a suprapubic
approach. A suprapubic approach affords greater control over the
end of a needle to avoid areas with sensitive vascular structures
and the obturator nerves. Further the heightened control associated
with a caudad passage is believed to avoid injury to bowel
tissue.
[0197] Additional methods according to the present invention are
shown in FIGS. 1, 2, 21 and 29. Referring to FIGS. 1 and 29,
another method according to the present invention comprises the
steps providing a surgical kit 312 having a first type of sling
material (e.g. a synthetic material associated with sling assembly
46), a second type of sling material (e.g. a different type of
synthetic sling material or a non-synthetic sling 10), and a
surgical instrument (e.g. needle 60) for implanting a sling
material. The method includes step 314 of selecting the first type
of sling material or the second type of sling material, step 320 of
associating the sling with the needle 60, and step 322 of
implanting the sling material with the needle 60.
[0198] The method may optionally include the steps of constructing
or assembling the sling from the plurality of sling material types.
Step 316 decides whether a sling should be constructed or whether a
pre-existing sling may be used. If it is decided that a hybrid
sling need not be assembled (i.e. that synthetic sling assembly 46
could be used alone), then sutures 6 and the mechanical fastener
(e.g. grommet 8) may be used to attach a sling assembly 46 to
dilator 54.
[0199] Notably, non-synthetic sling materials typically include
storage and sterilization requirements quite different than
synthetic slings. As a result, non-synthetic slings are preferably
not packaged with synthetic slings due to considerations such as
shelf life. Referring to FIG. 2, a mechanical fastener (e.g.
grommet 8) may be included in a surgical kit to enable a bulk
non-synthetic sling material 14 to be cut and assembled to a
synthetic sling material 42. As a result, a surgeon has the option
of constructing a hybrid sling according to an aspect of the
present invention.
[0200] A surgeon may desire to assemble a hybrid sling for a
variety of reasons. For example, some sling materials may be
believed to be less likely to erode sensitive tissue such as the
urethra. Silicone coated slings and non-synthetic slings may be
believed to be less likely to erode the urethra than some synthetic
slings. Additionally, some synthetic slings may be more likely to
encourage tissue ingrowth. As a result, as shown in FIG. 2B, the
surgeon may wish to assemble a sling with a mid portion made of one
type of sling material and another portion made of another type of
sling material. Other factors may also influence the surgeon's
decision, such as previous failure of a particular type of sling
material, the existence of scarring or other anatomical
characteristics of a patient, and the influence of concomitant
procedures.
[0201] Referring now to FIGS. 21 and 30 through 37, a preferred
embodiment of surgical procedure is disclosed. Initially, the
patient is placed under local, spinal or general anesthesia. A
small transverse incision 404 is made in the anterior vaginal wall
20 of a female patient followed by a transurethral dissection. Two
small transverse suprapubic abdominal stab incisions 400 are also
made near the back of the pubic bone (e.g. each about 1 cm from the
midline, or alternatively, one large incision may be made) to allow
for needle entry. Optionally, two paraurethral dissections
(incisions next to the urethra) lateral to the midline may be
created to allow the surgeon's finger to meet the end 58 of the
needle 60 during the procedure.
[0202] A handle 64 is optionally adjusted relative to needle 60
according to surgeon preference and securely associated with the
end 62 of the needle 60. FIG. 30 shows the end 58 of needle 60 just
passing an abdominal incision 400. Preferably, after the end 58 of
the needle 60 passes the suprapubic abdominal incision 400, the
surgeons seeks to encounter resistance associated with the
posterior portion of the patient's pubic bone 402 with the end 58
of the needle 60 to controllably move the end 58 of the needle
toward the vaginal incision 404 and to help avoid damaging
structures such as the urethra and bladder of the patient. The end
58 of the needle 60 is used to identify the location of the pubic
bone 402. The surgeon exploits the resistance provided by the pubic
bone 402 to controllably pass the end of the needle 58. This
approach is preferred as it helps keep the needle 60 away from
major pelvic vessels, nerves and anatomical structures such as the
urethra, bowels and bladder.
[0203] FIG. 31 illustrates the end of the needle as it just passes
the suprapubic incision. FIG. 32 illustrates the needle 60 as the
surgeon experiences the tactile feel of the resistance provided in
part by the posterior portion of the pubic bone 402. FIG. 32 shows
the needle 60 as it passes in proximity to the posterior surface of
the pubic bone 402 which continues to operate as an anatomical
guide for the surgeon as the needle end 58 approaches vaginal
incision 404 (see FIG. 33).
[0204] FIG. 33 illustrates the needle as it passes out of a vaginal
incision 404. Optionally, with the index finger of a hand, the
surgeon may meet the end 58 of the needle via the paraurethral
dissection. The surgeon's finger may be delicately placed adjacent
endopelvic fascia of the patient and used to guide the needle 60
through the relatively tough endopelvic fascia and into the vaginal
incision 404. This helps the surgeon keep away from structures such
as the bladder, urethra and other sensitive tissue.
[0205] The small diameter and curvature of the needles 60 help to
provide precise passage of the needles 60 to the vaginal incision
404. In addition, this needle configuration creates a minimally
invasive pathway through tissue extending between the abdominal
wall and pubic space, thereby reducing the risk of perforating the
bowel and/or blood vessels and nerves located lateral to the
bladder 14.
[0206] The steps described above are repeated as needed for a
second needle 60 on the other side of the urethra 16. Once both
needles are placed, surgeons typically perform a cystoscopy to
ensure that the bladder is not punctured before implanting the
sling. A cystoscopy confirms the integrity of the bladder 14 and
urethra 16 or recognizes a bladder perforation. The plastic
cystoscopy aid shown in FIG. 39 may optionally be used for this
purpose. The cystoscopy aid may be used separately or in
conjunction with cystoscopy.
[0207] FIG. 34 is a perspective view of a sling system associated
with two needles 60. Optional adapters (e.g. dilators 54) are
pushed onto the ends 58 of needles 60 as shown in FIG. 34. The
dilators 54 are preferably snapped irreversibly into place for a
secure connection. Next, if a synthetic sling assembly (such as the
sling assembly of FIG. 22) is used, the plastic sheath 44A is
oriented so that the optional center orientation indicia (e.g. a
blue mark) is facing away from the surgical field, toward the
surgeon
[0208] After the dilators 54 are attached to the needles 60, the
sling assembly 46A is properly oriented so that the sling assembly
46A is not twisted when attached to the dilators 54. After the
dilators 54 and sling assembly 46A are properly positioned, the
dilators 54 are securely attached to the sling assembly 46A by
tying sutures 6 through holes 90 so that none of the assembly
separates as the needles 60, dilators 54 and sling assembly 46A are
pulled through the tissues of the patient. Alternatively, the sling
assemblies 240 and 250 could be associated with dilators 54 by
tying any of sutures 6A, 6D or 252 to the holes 90 of dilators 54.
Alternatively, the sling assembly 46 (FIG. 2) may include a loop 48
that is threaded through hole 90 and secured via mechanical
fastener 8. A sling assembly that includes a sheath and sling
material (e.g. 42) preassembled to the dilator 54 is also within
the scope of the present invention. Additionally, it is noted that
the dilator 54 is completely optional and that instead, the sutures
(e.g. 6, 6A, 6D or 252) could be tied directly to a needle (e.g. 80
or stock ligature carrier) without the necessity to include the
adapter/dilator 54.
[0209] Once the dilators 54 are securely attached, the needles are
pulled up through the suprapubic incisions, taking care to avoid
contact with sensitive tissue. The sling is then clamped with
surgical clamps (not shown). During this portion of the process,
the attached dilators 54 and sling assembly 46A are atraumatically
pulled up through the needle paths, advancing the sling assembly
46A adjacent to and looped beneath the urethra 16 or target site. A
portion of each end of the sling assembly 46A extending beyond the
suprapubic incisions 400 is clamped and then cut to release the
needles 60 and attached dilators 54.
[0210] The sling is placed in a therapeutically effective position.
The precise anatomical position will depend upon a variety of
factors including the type and degree of anatomical damage or
insufficiency, whether the sling procedure is combined with other
procedures and other surgeon decisions. Typically, the sling is
placed midurethra, without tension, but in position to support the
midurethra. Alternatively, the sling could be placed to support the
bladder neck and/or UV junction.
[0211] Once the sling assembly 46A is carefully positioned under
the midurethra or target site to provide sufficient support to the
target site, the overlapping portion of the sheath 44A located near
the center of the sling assembly 46A and optional member 66 (i.e.
tensioning filament) may then be used to center and properly
position the sling assembly 46A under the midurethra. The sheath
44A is then removed.
[0212] FIG. 35 shows the sling being tightened during the surgical
procedure. Sling tension may be tightened by placing a device, such
as a clamp, across one or both ends of the sling 42,
suprapubically. Generally, the surgeon grasps the mesh and
tensioning filament together adjacent the suprapubic incision 400
and pulls to increase the degree of tightness of the mesh. FIG. 35
shows the sling after the dilators have been cut off, but prior to
final trimming.
[0213] After the dilators 54 are trimmed off, the plastic sheath
44A is removed from the sling mesh 42A by pulling up on both sides
of the sheath 44A, preferably one at a time. Optionally, to avoid
overtightening the sling mesh 42A while removing the sheath 44A, a
forceps or other blunt instrument may be placed between the sling
and the urethra.
[0214] In another embodiment of the invention, shown with reference
to FIG. 38, a method includes the steps of: providing a surgical
kit comprising at least one guide needle 602 with a relatively
small diameter (e.g. less than 4 mm), and at least one sling
transport needle 604 with a sharp tip, a sling 610 attached to the
sling transport needle 604, and an adapter (e.g. dilator 54) having
tip receiving surfaces (e.g. an end of innerpassageway 96 near end
of the dilator having hole 90) for receiving the sharp tip of the
sling transport needle 604. For example, the sling transport needle
604 and sling 610 may comprise a TVT needle and sling available
from Ethicon of New Jersey.
[0215] The method includes the steps of creating at least one
vaginal incision 404, creating at least one suprapubic incision
400, and initially passing the guide needle 602 through the
suprapubic incision 400 and then through the vaginal incision 404,
and associating or attaching the adapter 54 to the needle 602
(preferably after but optionally before passage of the needle 602
from the suprapubic incision to the vaginal incision 404).
[0216] Needles 604 are initially passed through a vaginal incision
404 and toward one of the suprapubic incisions 400. While inserting
the needles 604 initially through the vagina is not preferred, it
is within the scope of the present invention as some surgeons may
prefer this approach due to previous surgical training, custom or
personal preference. The method includes the step of placing the
sharp tip of the sling transport needle 604 in the tip receiving
surfaces of the adapter 54, and then guiding the sling transport
needle 604 from the vaginal incision 404 to the suprapubic incision
400 with the guide needle 602 to implant the sling 610. Handle 620
may be connected to sling attachment end of needle 604 for this
purpose. Guiding the sharp tip of the large sling transport needle
604 in this fashion is believed to help avoid contact between the
sharp tip of needle 604 and sensitive structures such as obturator
nerves, and vascular structures such as the superficial epigastric
vessel, the inferior epigastric vessel, the external iliac artery
and the obturator. Optionally the adapter with receiving surfaces
may be integrally formed in the needle 602 to avoid the need to
separately attach the adapter to the needle 602. Also optionally,
the adapter and sling transport needle 604 may include
complementary engagement surfaces for securely attaching the needle
602 to the needle 604.
[0217] In another aspect of the present invention, a needle dilator
or adapter may not be needed in a surgical procedure. For example,
the procedure may utilize a sling assembly that includes a suture
extending from the end of the sling assembly (e.g. a sling as
described in conjunction with FIGS. 22 or 22A). The method includes
the steps of: i) providing the sling, ii) creating at least one
vaginal incision, ii) creating at least one suprapubic incision,
iii) passing a leading end of a needle initially through a
suprapubic incision and then through the vaginal incision on one
side of the patient's urethra, iv) passing a leading end of a
needle initially through a suprapubic incision and then through the
vaginal incision on the other side of the patient's urethra, v)
attaching the first suture to the leading end of a needle, vi)
attaching the second suture to the leading end of a needle, vii)
implanting the sling by moving the leading end of a needle from the
vaginal incision toward a suprapubic incision, and viii) then
removing the synthetic insertion sheath. In one embodiment, the
needle may comprise a needle or ligature carrier (e.g. such as
needle 80 shown in FIGS. 9, 9A and 10) that includes a retractable
suture holder for securely holding the suture to the needle while
the needle and sling assembly are drawn up through the body. A
single needle (e.g. the same needle 80 used on both sides of the
urethra) or two needles could be used in this embodiment of
surgical procedure.
[0218] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
* * * * *