U.S. patent application number 09/883565 was filed with the patent office on 2001-12-06 for surgical instrument and method for treating female urinary incontinence.
Invention is credited to Chen, Chao-Chen, Lehe, Jorn, Luscombe, Brian H..
Application Number | 20010049467 09/883565 |
Document ID | / |
Family ID | 26836003 |
Filed Date | 2001-12-06 |
United States Patent
Application |
20010049467 |
Kind Code |
A1 |
Lehe, Jorn ; et al. |
December 6, 2001 |
Surgical instrument and method for treating female urinary
incontinence
Abstract
Described is a surgical instrument and method for treating
female urinary stress incontinence. The instrument includes a
curved needle-like element defining in part a curved shaft having a
distal end and a proximal end. The diameter of the needle decreases
from the proximal end to the distal end, and the needle terminates
in a blunt tip. A tape attaches to the needle for implanting into
the lower abdomen of a female to provide support to the urethra.
The tape may be made from synthetic and natural materials. The
needle and tape may also be modified to allow the surgeon to attach
and detach the tape during the surgical operation.
Inventors: |
Lehe, Jorn; (Hamburg,
DE) ; Chen, Chao-Chen; (Edison, NJ) ;
Luscombe, Brian H.; (Warren, NJ) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
26836003 |
Appl. No.: |
09/883565 |
Filed: |
June 18, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09883565 |
Jun 18, 2001 |
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09521801 |
Mar 9, 2000 |
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6273852 |
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60138231 |
Jun 9, 1999 |
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Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61B 2017/06047
20130101; A61B 2090/306 20160201; A61B 1/00087 20130101; Y10S
128/25 20130101; A61B 1/042 20130101; A61B 2017/06028 20130101;
A61B 2017/06085 20130101; A61F 2/0045 20130101; A61B 2017/00805
20130101; A61B 2090/3614 20160201; A61B 1/307 20130101; A61B
17/0469 20130101; A61B 2017/0608 20130101; A61B 2017/06042
20130101; A61B 2017/06057 20130101; A61B 17/06109 20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 002/02 |
Claims
We claim:
1. A surgical instrument for treating female urinary stress
incontinence comprising: a) a tape for implanting into the lower
abdomen of a female to provide support to the urethra; b) a
removable sheath surrounding the tape; and c) a curved needle-like
element defining in part a curved shaft having a distal end and a
proximal end, and means at the distal end for attaching to the
tape.
2. The surgical instrument of claim 1 wherein the diameter of the
needle varies from the distal end to the proximal end.
3. The surgical instrument of claim 2 wherein the distal end of the
needle has a diameter from about 3 mm to about 5 mm.
4. The surgical instrument of claim 3 wherein the proximal end of
the needle has a diameter from about 5 mm to about 6 mm.
5. The surgical instrument of claim 1 wherein the tape comprises
connecting means and the needle comprises attaching means for
detachably accepting the connecting means.
6. The surgical instrument of claim 1 wherein the connecting means
is a tab-like element and the attaching means is a slot.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present invention claims the benefit of earlier-filed
U.S. provisional patent application Ser. No. 60/138,231, filed on
Jun. 9, 1999, which is hereby incorporated by reference in its
entirety herein.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to a surgical
instrument and a method for treating female urinary incontinence
and in particular to a conical needle for facilitating the
perforation of different layers of tissue, with each tissue layer
having a different resistance against perforation.
[0003] Women account for more than 11 million of incontinence
cases. Moreover, a majority of women with incontinence suffer from
stress urinary incontinence (SUI). Women with SUI involuntarily
lose urine during normal daily activities and movements, such as
laughing, coughing, sneezing and regular exercise.
[0004] SUI may be caused by a functional defect of the tissue or
ligaments connecting the vaginal wall with the pelvic muscles and
pubic bone. Common causes include repetitive straining of the
pelvic muscles, childbirth, loss of pelvic muscle tone, and
estrogen loss. Such a defect results in an improperly functioning
urethra. Unlike other types of incontinence, SUI is not a problem
of the bladder.
[0005] Normally, the urethra, when properly supported by strong
pelvic floor muscles and healthy connective tissue, maintains a
tight seal to prevent involuntary loss of urine. When a woman
suffers from the most common form of SUI, however, weakened muscle
and pelvic tissues are unable to adequately support the urethra in
its correct position. As a result, during normal movements when
pressure is exerted on the bladder from the diaphragm, the urethra
cannot retain its seal, permitting urine to escape. Because SUI is
both embarrassing and unpredictable, many women with SUI avoid an
active lifestyle, shying away from social situations.
[0006] U.S. Pat. No. 5,112,344 describes a method and apparatus for
treating female incontinence. The surgical instrument for the
application of a filamentary element into the body comprises a
tubular shaft having a handle at one end and a flexible needle
slidably receivable in the shaft and adapted at one end to receive
a filamentary element. The method of treating female incontinence
comprises looping a filamentary element between the wall of the
vagina and the rectus abdominis sheath in the anterior wall of the
abdomen whereby it passes to each side of the urethra, tightening
the loop to bring the vaginal wall the urethra into the correct
spatial relationship to the pubis allowing the development of scar
tissue between the vaginal wall and the anterior wall of the
abdomen pubic symphysis and removing the filamentary element.
[0007] U.S. Pat. No. 5,899,909 discloses a surgical instrument
comprising a shank having a handle at one end and connecting means
at the other end to receive, one at a time, two curved needle-like
elements which are connected at one end to one end of a tape
intended to be implanted into the body. In practice, the tape is
passed into the body via the vagina first at one end and then at
the other end at one side and the other, respectively, of the
urethra to form a loop around the urethra, located between the
urethra and vaginal wall. The tape is extended over the pubis and
through the abdominal wall and is tightened. The tape ends are cut
at the abdominal wall, and the tape is left implanted in the
body.
[0008] Current needles for implanting tapes have a short conical
tip and a curved body with a constant diameter. When the conical
needle tip perforates a layer of human tissue having a high
resistance against perforation (like fascia or muscle), the force
required is high compared to the force required to perforate soft
human tissue (like fat). To lower the maximum force required by the
surgeon to penetrate fascia or muscle, the needle tip is pointed.
After the conical tip passes through a tissue layer with a high
perforation resistance, however, the force required to further pass
the needle through the tissue suddenly drops close to zero. As an
undesirable consequence then, the needle may penetrate through
tissue faster than the surgeon intends, possibly causing the
surgeon to lose control of the needle and risking the possibility
of unintentionally perforating other body structures, such as,
bone, organs or blood vessels, with the pointed needle tip.
[0009] It would be beneficial to provide a needle for use in
implanting a mesh tape within a female body to prevent incontinence
that has a design that provides for a more even resistance for
perforating differing types of tissue.
[0010] It would also be beneficial to simplify the design of the
surgical instrument to facilitate the loading of the tape onto a
needle during the operation. In this manner, the instrument would
be more receptive to various types of tapes, such as synthetic,
cadaver tissue and engineered tissue.
SUMMARY OF THE INVENTION
[0011] The invention overcomes the deficiencies of the prior art
and provides for an improved needle for use with an apparatus and a
method for the treatment of female stress urinary incontinence. The
invention provides a surgical instrument comprising a handle at one
end and connecting means at the other end to receive, one at a
time, two curved needle-like elements, each of which have a blunt
tip and varying diameter. Each needle connects at one end to
separate ends of a tape intended to be implanted within the body.
In practice, a first end of the tape is passed, via one of the
curved needles, into the body via the vagina at one side of the
urethra. The needle and first end of the tape pass over the pubis
and through the abdominal wall.
[0012] The second needle element connects to the handle and to the
second end of the tape. The needle and second end of the tape pass
into the body via the vagina at the opposite site of the urethra
from the first end of the tape thereby forming a loop or sling
around the urethra with the tape. The second end of the tape is
extended over the pubis and through the abdominal wall. The tape
ends are cut at the abdominal wall, and the tape is left in the
body.
[0013] The invention further provides for a single curved needle
element having a blunt tip and varying diameter and further
provides for a easy attachment means enabling the surgeon to
connect both the first and second tape ends to the single needle to
perform the above-stated procedure.
[0014] The invention still further provides for a tape comprising
of a synthetic mesh in combination with a natural material whereby
the natural material would reside below the urethra to eliminate
potential erosion issues.
[0015] In one aspect the invention provides a needle element having
a distal end and a proximal end. The diameter of the needle varies
increasingly from the distal end to the proximal end. The distal
end further defines a tip having a blunt end. The proximal end
provides for a connecting means to the handle.
[0016] The object of the invention is to provide a surgical
instrument that requires a reduced maximum force to pass the tape
through body tissue.
[0017] A further object of the invention is to provide a needle
that requires a more constant force to pass through body
tissue.
[0018] An advantage of the invention is that it reduces the risk of
perforating other body structures.
[0019] A further advantage of the invention is that it provides for
a quick connecting means of the tape to the needle thus allowing
for the use of non-synthetic tissue as the supporting element.
[0020] These and other features and advantages of the present
invention will become apparent from the following more detailed
description, when taken in conjunction with the accompanying
drawings which illustrate, by way of example, the principles of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a side view of the needle in one embodiment
thereof;
[0022] FIG. 2a is a side view of two needles and a tape
interconnecting the needles;
[0023] FIG. 2b-d are alternate embodiments of the tape and
connecting means between the tape and needle;
[0024] FIG. 3a is a side view of an alternate embodiment of the
needle;
[0025] FIG. 3b-c is an enlarged view of the distal tip of the
needle shown in FIG. 3a and a means for detachably connecting the
tape to the needle;
[0026] FIGS. 3d-e is an enlarged view of the distal tip of the
needle shown in FIG. 3a and an alternate means for detachably
connecting the tape to the needle;
[0027] FIGS. 3f-g is an enlarged view of the distal tip of the
needle shown in FIG. 3a and an alternate means for detachably
connecting the tape to the needle;
[0028] FIGS. 4a-g illustrate diagrammatically several surgical
steps of the method utilizing two needles according to the
invention to treat SUI;
[0029] FIG. 4h illustrates the final position of the tape within
the body before the tape ends are cut;
[0030] FIGS. 5a-g illustrate diagrammatically surgical steps of the
method utilizing one needle according to the invention to treat
SUI; and
[0031] FIG. 5h illustrates the final position of and alternate
embodiment of the tape within the body before the tape ends are
cut.
DETAILED DESCRIPTION OF THE INVENTION
[0032] Before explaining the present invention in detail, it should
be noted that the invention is not limited in its application or
use to the details of construction and arrangement of parts
illustrated in the accompanying drawings and description, because
the illustrative embodiments of the invention may be implemented or
incorporated in other embodiments, variations and modifications,
and may be practiced or carried out in various ways. Furthermore,
unless otherwise indicated, the terms and expressions employed
herein have been chosen for the purpose of describing the
illustrative embodiments of the present invention for the
[0033] The invention discloses an apparatus and method for treating
SUI. A tape is passed through pelvic tissue and positioned
underneath the urethra, creating a supportive sling. The tape
provides a structure means for tissue ingrowth and thereby provides
a newly created body tissue supporting means for the urethra. When
pressure is exerted upon the lower abdomen, such as during a cough
or sneeze, the tape provides support to the urethra, allowing it to
keep its seal and prevent the unwanted discharge of urine.
[0034] Referring to FIGS. 1 and 2, the surgical instrument
comprises a needle-like element 10 that attaches to a mesh tape 12.
Needle element 10 defines a certain radius R to perform the
surgical procedure discussed herein. The distal end of needle
element 10 terminates at a conical section 14 having a tip 16.
Alternate configurations, such as a blade-like, arrow or burr tips
are also possible. Preferably, tip 16 is blunt, wherein the tip 16
has a radius of about 0.6 millimeters. A blunt tip is preferred
since it is less likely to stick in bone or penetrate bladder wall
tissue or blood vessel wall tissue as will be appreciated from the
method of implanting the tape as described below.
[0035] The proximal end of needle 10 terminates in an attachment
segment 20 that is adapted to mate and lock into a handle 21 as
disclosed in U.S. Pat. No. 5,899,909, previously incorporated
herein by reference.
[0036] Disposed between tip 14 and segment 20 is a curved shaft
segment 18 having a distal end 17 and a proximal end 19. The shape
of shaft 18 extends substantially a quarter of a circle in order to
follow substantially the profile of the pubis between the vagina
and the abdominal wall. For the purposes of the method as will be
discussed in more detail below, shaft 18 has a preferred radius R
of about 106 millimeters. Further, the diameter of segment 18
transitions from a smaller diameter at distal end 17 to a larger
diameter at proximal end 19. The minimum diameter of distal end 17
may be as small as 0.5 mm due to the minimal stresses at this
point. The minimal diameter of proximal end 19 is about 4 mm.
Preferably, the diameter at the proximal end is about 6 mm, and
reduces in a continuous manner to a diameter of about 3 mm at the
distal end 17. This design takes into account, that in the method
to implant the tape 12, the bending stresses are lowest at distal
end 17, while the bending stresses are highest at the proximal end
19. Stated differently, during the procedure, the inner bending
moment at distal end 17 is negligible, while the inner bending
moment at the proximal end 19 is substantial. The design is also
beneficial in that the needle provides a tactile feedback to the
surgeon as the needle passes through differing layers of tissue as
opposed to a needle having a minimal diameter.
[0037] An expected result of needle 10 having a blunt tip 16 and a
varying diameter shaft 18 is a reduced maximum force required to
perforate a layer of tissue, such as fascia, muscle, fat and skin.
Further, after needle tip 16 has passed through a tissue layer, the
force required by the surgeon to continue the needle 10 through the
tissue layer or subsequent tissue layers having lower resistances
to perforation does not precipitiously decrease as in the prior
art. This is result of the shaft 18, having an increasing diameter
from the distal end 17 to proximal end 19, having to continue to
pass through the tissue, thereby requiring a more constant force
from the surgeon.
[0038] Table 1 compares the force required to penetrate a fascia of
a pig (lateral to the linea alba) between a needle of the prior art
and a needle of the present invention. The prior art needle was
characterized as having a 5 mm constant diameter and a needle tip
having a radius of 0.2 mm. The needle of the current invention was
characterized as having a varying diameter of 3 mm to 6 mm from the
distal end to proximal end of curved shaft 18 and a needle tip
having a radius of 0.6 mm. The fascia as placed into a testing
device, and each needle perforated the fascia at an angle of
90.degree. at a speed of 50 mm/min. Table 1 lists the maximum force
needed to penetrate the test tissue:
1TABLE 1 Needle of the present Prior Art Needle invention Maximum
Test No. Maximum Force (N) Force (N) 1 7.10 6.41 2 7.32 7.85 3 8.16
5.75 4 9.20 6.60 5 13.14 5.30 Avg. Force (N) 8.98 6.38 s 2.47
0.97
[0039] The test results indicate that the needle of the present
invention reduces the penetration force by 29% over the prior art
needle.
[0040] Needle 10 is preferably tubular with a circular cross
section and is made from a material that is compatible with the
human body. It is also preferred that needle 10 is made from a
material that can be autoclaved to enable multiple surgical
procedures of needle 10. Preferably, needle 10 is made from AISI
303 stainless steel. The surface of shaft 18 may be smooth,
preferably polished, to facilitate penetration of the soft tissue.
Alternatively, the surface of needle 10 may have a somewhat rougher
surface. A rougher surface would result in slightly additional
tissue trauma, which in turn stimulates fibroblast activity around
the tape 12.
[0041] Needle 10 may be manufactured as a single, continuous unit,
or alternatively, curved portion 18 may be manufactured separately
from linear portion 20. In this manner the two pieces would attach
using any conventional attaching means, such as, screwing, or other
conventional means as is known to those skilled in the art.
[0042] Referring to FIGS. 2a-d, tape 12 comprises any
tissue-compatible synthetic material, or any natural material,
including, but not limited to, autologous, allograft, xenograft, a
tissue engineered matrix, or a combination thereof. An exemplary
synthetic material is PROLENE.RTM. polypropylene mesh, a mesh
having a thickness of 0.7 mm and openings of about 1 mm
manufactured by Ethicon, Inc., Somerville, N.J., U.S.A. This
material is approved by the U.S. Food and Drug Administration for
implantation into the human body. A still further embodiment of the
tape 12 is a combination of a synthetic material 11 and a natural
material 13 centered between the synthetic material 11 as shown in
FIGS. 2b-c. A still further embodiment of the tape 12 includes a
combination of synthetic material 11 and natural material 13,
whereby the natural material is placed over or incorporated within
a generally central portion of the synthetic material 11. One
advantage of the tape configurations is that natural material 13 is
along the center region of tape 12 so that after installation of
tape 12, natural material 13 is positioned below the urethra and
eliminates possible erosion issues at the interface of the urethra
and tape. Natural material 13 may be connected to the synthetic
material 11 by means of sewing, a bio-compatible glue, cell
culturing techniques or other known means.
[0043] Tape 12 may be of any convenient shape that suits the
intended purpose of the invention. An exemplary width is about 1 cm
and the length would be dependent upon the size of the female
undergoing the procedure. Tape 12 may be single or double ply,
generally planar in structure, or tubular (FIG. 2d) to provide
additional supporting strength and more surface area on which
tissue fibers may attach.
[0044] Moreover, tape 12 may consist of different types of
material, such as a bioabsorbable and non-bioabsorbable material.
Tape 12 may also be coated with an antimicrobial additive to
prevent or minimize infection and a lubricous coating, for example,
a bioabsorbable hydrogel, to facilitate the tape passing through
the tissue as discussed below. Preferably, tape 12 is covered by a
removal plastic sheath as disclosed in U.S. Pat. No. 5,899,909. The
tape may also be made radio-opaque and/or of a contrasting color to
the body tissue to allow for future diagnostic visualization.
[0045] In one embodiment tape 12 may be attached to needle segment
20 by means of tying, gluing or other suitable attaching means.
Preferably, a bio- compatible heat shrink tube fixes tape 12 onto
needle portion 20, FIG. 2a. In a further embodiment, as shown in
FIGS. 2b-d and 3a-g, needle 10 and tape 12 are further configured
to enable easy attachment and detachment of tape 12 to and from
needle 10 by the surgeon during the operation. This embodiment
allows for the use 20 of a single needle for the procedure. This
embodiment also allows for the use of a tape constructed, at least
in part, of natural materials, which are otherwise not suitable in
the pre-affixed embodiment due to the inability of the natural
material to survive extended periods in inventory.
[0046] In one embodiment, shown in FIGS. 3a-c, shaft 18 provides
for a notch or slot 40 to slidably receive connecting tabs 32 and
32a that are attached at either ends of tape 12. Preferably, slot
40 extends through curved shaft 18 and is further located at the
distal end 17 of needle 10 so that tape 12 may be disconnected from
needle immediately after needle 10 penetrates the abdomen wall,
discussed below.
[0047] Tab 32 may be constructed from any bio-compatible material,
such as plastic or metal. Tab 32 can be any shape, such as a square
or arrow shape, so long as tap 32 can be securely inserted into
notch or slot 40. FIG. 3b-c illustrates tab 32 having two spring
arms 33 and 33a that when inserted into slot 40 expand and securely
fasten tab 32 within slot 40. Tab 32 may be attached to tape 12 in
any number of convenient methods as previously discussed and well
known to those skilled in the art.
[0048] FIG. 3d-e illustrates a two-tier slot 40, wherein tab 32
slides into the lower tier which holds tab 32 in place. Alternate
means of capturing tab 32 within slot 40 are available as is well
known in the art.
[0049] FIGS. 3f-g illustrate an alternate embodiment of affixing
tape 12 to the distal end 17a of needle 10. A detachable blunt tip
16a having a connecting post 15, attaches to the distal end 17a by
means of a mounting hole 15a to accept post 15. Post 15 may be
securely attached to hole 15a either by compression fit, mating
threads or other convenient attachment methods. Distal end 17a
further defines a groove 23 of varying depth to allow the end of
tape 12 connected to post 15 to transition from within hole 15a to
the exterior of needle 10. Along with the embodiment of FIGS. 3a-e,
this embodiment allows the surgeon to affix tape 12 to needle 10
just prior to the surgical procedure. One advantage is the ability
to use a tape 12 constructed of, at least in part, a natural
material.
[0050] As would be appreciated by one skilled in the art, there
exist multiple means for detachably connecting the tape to the
needle. Alternate embodiments would include tying the ends of tape
12 to form a knot and securely inserting the knot into a V-type
groove in shaft 18. Alternately, a diagonal slit in shaft 18 could
accept tape 12 or a suture extending from tape 12.
[0051] The surgical procedure for implanting tape 12 using two
needles is shown in FIGS. 4a-g. In the figures the relevant parts
of the female lower abdomen are disclosed, the vagina being 50, the
uterus 52, the urethra 54, the pubic bone 56, the urinary bladder
58 and the abdominal wall 60. The first needle 10a penetrates the
vaginal wall, an incision having first been made in the wall to
create a tissue flap. The needle is attached to handle 21, and the
surgeon guides needle 10a through the vaginal wall and through the
soft tissue on one side of the urethra 54, the needle then
according to FIG. 4b being passed close to the back of the pubic
bone 56, through additional layers of fat, muscle and fascia, and
then through the abdominal wall 60 above the pubic bone 56. An
incision can be made through the abdominal wall for the passage of
the needle therethrough. Handle 21 is disconnected from needle 10a,
FIG. 4c, and the needle 10a along with tape 12 are withdrawn from
the abdomen wall by means of forceps, FIG. 4d.
[0052] Referring to FIG. 4e, needle 10b is now attached to handle
21, and needle 10b is passed through the incision in the vaginal
wall as guided by the surgeon and through the soft tissue on the
opposite side of the urethra than the previous end of tape 12.
Needle 10b passes close to the back of the pubic bone, through
additional layers of fat, muscle and fascia, FIG. 4f, and then
through the abdominal wall above the pubic bone and withdrawn, FIG.
4g.
[0053] FIGS. 5a-g illustrate an alternate method of implanting tape
12 using a single needle 10. Tape 12 is attached to needle 10 by
means of tab 32 (not shown). Needle 10 penetrates the vaginal wall,
an incision having first been made in the wall to create a tissue
flap. The surgeon guides needle 10 through the vaginal wall and
through the soft tissue on one side of the urethra 54, the needle
then according to FIG. 5b being passed close to the back of the
pubic bone 56, through additional layers of fat, muscle and fascia,
and then through the abdominal wall 60 above the pubic bone 56. An
incision can be made through the abdominal wall for the passage of
the distal end 17 therethrough. Needle 10 only continues to pass
through the abdominal wall until tab 32 may be disconnected from
shaft 18, FIG. 5c. To do so, the surgeon simply inserts a narrow
instrument into slot 40 to force tab 32 out of slot 40 opposite the
side in which tab 32 was inserted. Tab 32 may then be cut off and
tape 12 may be pulled out of the abdominal wall to allow the
surgeon additional length for the procedure. Needle 10 is then
removed from the patient along the same path that it entered, but
in the opposite direction, FIG. 5d. Alternatively, needle 10 may be
disconnected from handle 21 and pulled out through the abdomen wall
60 using forceps as discussed with regard to the two needle
procedure.
[0054] Referring to FIG. 5e, needle 10 is now attached to the
opposite end of tape 12 using connector 32a. The surgeon passes
needle 10 through the incision in the vaginal wall and through the
soft tissue on the opposite side of the urethra than the previous
end of tape 12. Needle 10 passes close to the back of the pubic
bone, through additional layers of fat, muscle and fascia, FIG. 5f,
and then through the abdominal wall above the pubic bone. Needle 10
continues to pass through the abdominal wall only until tab 32a may
be disconnected from shaft 18, FIG. 5g. Tape 12 may be pulled out
of the abdominal wall to allow the surgeon additional length for
the procedure. Needle 10 is then removed from the patient along the
same path that it entered, but in the opposite direction.
Alternatively, needle 10 may be disconnected from handle 21 and
pulled out through the abdomen wall 60 using forceps.
[0055] Since both procedures may be performed using a local
anesthesia, the patient is able to provide feedback to the surgeon
after tape 12 is in place. Typically, the urinary bladder 58 is
filled with a fluid, such as water, using a catheter and the
patient is requested to cough. The surgeon is able to determine the
operation of the urethra and may adjust the tension of the tape 12,
as necessary, by adjusting the ends of tape 12 located at the
outside of the abdomen 60, FIGS. 4h and 5h. After adjustments, the
surplus tape at the abdomen is cut off, and the ends of the tape
are secured within the abdomen and the abdomen is closed. Likewise,
the incision at the vaginal wall is closed whereby the tissue flap
seals the tape between the urethra 54 and the wall of vagina
50.
[0056] Tape 12 is left in the body and forms an artificial ligament
attached to the abdominal wall that provides the support for the
urethra as required in order to restore urinary continence to the
patient.
[0057] It will be apparent from the foregoing that, while
particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. Accordingly, it is not
intended that the invention be limited, except as by the appended
claims.
* * * * *