U.S. patent number RE37,815 [Application Number 09/819,426] was granted by the patent office on 2002-08-06 for suturing needle assemblies and methods of use thereof.
Invention is credited to Syed Rizvi.
United States Patent |
RE37,815 |
Rizvi |
August 6, 2002 |
Suturing needle assemblies and methods of use thereof
Abstract
A suturing needle assembly enables simultaneous passage of
suture and introduction of local anesthetic into body tissue. Two
suturing needle assembly embodiments are described and methods of
using the needle assemblies include cystopexy, cystourethropexy,
urethropexy and uteropexy procedures.
Inventors: |
Rizvi; Syed (Bakersfield,
CA) |
Family
ID: |
23546616 |
Appl.
No.: |
09/819,426 |
Filed: |
March 29, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
391442 |
Sep 8, 1999 |
06168611 |
Jan 2, 2001 |
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Current U.S.
Class: |
606/222 |
Current CPC
Class: |
A61B
17/06 (20130101); A61B 17/06066 (20130101); A61B
17/06109 (20130101); A61B 17/42 (20130101); A61B
17/4241 (20130101); A61B 2017/0042 (20130101); A61B
2017/00805 (20130101); A61B 2017/06019 (20130101); A61B
2017/06042 (20130101) |
Current International
Class: |
A61B
17/06 (20060101); A61B 17/42 (20060101); A61B
17/00 (20060101); A61B 017/06 () |
Field of
Search: |
;606/222,223-224,184-189,119,170,167,144-148,228-233
;604/272,19,27,264,22 ;600/29 ;128/898 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Milano; Michael J.
Assistant Examiner: Ho; (Jackie) Tan-Uyen T.
Attorney, Agent or Firm: Kettlestrings; Donald A.
Claims
What is claimed is:
1. A suturing needle assembly for enabling simultaneous passage of
suture and introduction of local anesthetic into body tissue, said
assembly comprising: a hollow needle body defining an interior
passageway and further defining first and second ends having first
and second openings therein, respectively, in fluid communication
with said passageway; said first end further defining a third
opening therein for removably receiving a suture; means connected
to said second end for removably attaching said needle assembly to
a source of local anesthetic; said first end being bevelled with
respect to said needle body to form a bevelled end surface; and
said third opening extending through said bevelled end surface.
2. An assembly as in claim 1 further including means attached to
said needle body for enhancing a user's grip of said assembly
during use.
3. An assembly as in claim 2 wherein said needle body defines a
first substantially straight portion adjacent to said first end and
a second substantially straight portion connected to said first
straight portion and adjacent to said second end, said first and
second straight portions defining an angle of substantially one
hundred forty-five degrees therebetween.
4. An assembly as in claim 3 wherein said angle is from one hundred
ten degrees to one hundred eighty degrees.
5. An assembly as in claim 2 wherein said needle body defines a
first substantially straight portion adjacent to said first end; a
second substantially straight portion adjacent to said second end;
a third substantially straight portion connected to said first
straight portion; and a fourth substantially straight portion
connected between said second and third straight portions defining
first and second angles of substantially one hundred forty-five
degrees with each of said second and third straight portions,
respectively, and said first and third straight portions defining a
third angle of substantially one hundred thirty-five degrees
therebetween.
6. An assembly as in claim 5 wherein said first and second angles
are from one hundred fifteen degrees to one hundred seventy-five
degrees and wherein said third angle is from one hundred five
degrees to one hundred sixty-five degrees.
7. An assembly as in claim 6 wherein said second straight portion
defines an extended imaginary straight centerline there through
which intersects said first straight portion.
8. A method of simultaneously passing suture and introducing local
anesthetic into body tissue, said method comprising the steps of:
providing the suturing needle assembly of claim 1; positioning said
suture into and through said third opening; attaching said source
of local anesthetic to said needle assembly; and introducing said
first end of said needle assembly, said suture and said local
anesthetic substantially simultaneously into said body tissue.
9. The method of claim 8 wherein said step of introducing said
local anesthetic into said body tissue further includes the step
of: passing said local anesthetic from said source of local
anesthetic through said second opening, through said interior
passageway of said hollow needle body, and through said first
opening into said body tissue.
10. A method of suspending a bladder neck of a patient, comprising
the steps of: placing first and second sutures at first and second
locations, respectively, at the level of the bladder neck through
the entire thickness of the vagina on both sides from the midline
of the patient's body; holding the first and second sutures;
simultaneously introducing and driving a first said needle body of
a first said needle assembly of claim 3 into a third location,
which is a predetermined distance toward a first side from the
midline of the patient's body just above the edge of the pubis, and
into the retropubic space paravesically along the posterior aspect
of the pubic bone and introducing local anesthetic through said
first needle body as said first needle body is driven; guiding said
first needle body until it emerges through the vagina;
disconnecting a first said source of local anesthetic from said
first needle assembly; simultaneously introducing and driving a
second said needle body of a second said needle assembly of claim 3
into a fourth location a predetermined distance toward a second
side from the midline of the patient's body just above the edge of
the pubis and into the retropubic space paravesically along the
posterior aspect of the pubic bone and introducing local anesthetic
through said second needle body as said second needle body is
driven; guiding said second needle body until it emerges through
the vagina; disconnecting a second said source of local anesthetic
from said second needle assembly; passing said first and second
sutures through said third openings in said first and second needle
bodies, respectively; pulling said first and second needle bodies
back along the posterior aspect of the pubis until said first and
second sutures are pulled through the anterior abdominal wall of
the patient; removing said first and second needle bodies from said
first and second sutures, respectively; grasping said first and
second sutures; releasing a first portion of said first suture and
threading said first suture portion through said third opening of a
first said needle body of a first said needle assembly of claim 5;
holding a second portion of said first suture; introducing said
first needle body of said first needle assembly of claim 5 into a
third location on the patient's body a predetermined distance
laterally from the midline above the edge of the pubis;
simultaneously introducing said local anesthetic through said first
needle body of said first needle assembly of claim 5 and driving
said first needle body of said first needle assembly of claim 5
downwardly and then laterally just above the fascia and then
upwardly until said last-mentioned needle body emerges through the
skin at a fourth location on the patient's body a predetermined
distance laterally from the midline above the edge of the pubis;
releasing said first suture from said last-mentioned needle body;
releasing a first portion of said second suture and threading said
last-mentioned first suture portion through said third opening of
said first needle body of said first needle assembly of claim 5;
holding a second portion of said second suture together with said
first portion of said first suture; pulling said last-mentioned
needle body backwardly until said second suture emerges through
said third location on the patient's body; releasing said second
suture from said last-mentioned needle body and holding said second
suture; releasing said first and second sutures; applying traction
on said first and second sutures and then reholding said first and
second sutures; elevating the bladder neck to a normal anatomical
position; tieing said first and second sutures into knots when said
bladder neck is elevated to a normal anatomical position; and
cutting said first and second sutures above said knots.
11. A method as in claim 10 wherein said first and second locations
are each substantially one centimeter laterally .[.from the midline
of the patient's body.]. .Iadd.at the level of the bladder
neck.Iaddend..
12. A method of bladder neck and urethral suspension of a patient,
comprising the steps of: placing first and second sutures at first
and second locations, respectively, at the level of the bladder
neck through the entire thickness of the vagina on both sides from
the midline of the patient's body; holding the first and second
sutures; placing third and fourth sutures at third and fourth
locations, respectively, at the level of proximal one-third of the
urethra on both sides from the midline of the patient's body
through the entire thickness of the vagina; marking ends of said
third and fourth sutures for later identification; holding said
third and fourth sutures; simultaneously introducing and driving a
first said needle body of a first said needle assembly of claim 5
into a fifth location, which is a predetermined distance toward a
first side from the midline of the patient's body just above the
edge of the pubis, and into the retropubic space paravesically
along the posterior aspect of the pubic bone and introducing local
anesthetic through said first needle body as said first needle body
is driven; guiding said first needle body until it emerges through
the vagina; disconnecting a first said source of local anesthetic
from said first needle assembly; simultaneously introducing and
driving a second said needle body of a second said needle assembly
of claim 5 into a sixth location a predetermined distance toward a
second side from the midline of the patient's body just above the
edge of the pubis and into the retropubic space paravesically along
the posterior aspect of the pubic bone and introducing local
anesthetic through said second needle body as said second needle
body is driven; guiding said second needle body until it emerges
through the vagina; disconnecting a second said source of local
anesthetic from said second needle assembly; passing said first and
third sutures through said third opening in said first needle body;
passing said second and fourth sutures through said third opening
in said second needle body; pulling said first and second needle
bodies back along the posterior aspect of the pubis until said
first, second, third and fourth sutures are pulled through the
anterior abdominal wall of the patient; removing said first needle
body from said first and third sutures; removing said second needle
body from said second and fourth sutures; grasping said first,
second, third and fourth sutures; releasing first portions of said
first and third sutures and threading said first and third suture
portions through said third opening of a first said needle body of
a first said needle assembly of claim 5; holding second portions of
said first and third sutures; introducing said first needle body of
said first needle assembly of claim 5 into said fifth location on
the patient's body a predetermined distance laterally from the
midline above the edge of the pubis; simultaneously introducing
said local anesthetic through said first needle body of said first
needle assembly of claim 5 and driving said first needle body of
said first needle assembly of claim 5 downwardly and then laterally
just above the fascia and then upwardly until said last-mentioned
needle body emerges through the skin at said sixth location on the
patient's body a predetermined distance laterally from the midline
above the edge of the pubis; releasing said first and third sutures
from said last-mentioned needle body; releasing first portions of
said second and fourth sutures and threading said last-mentioned
first suture portions through said third opening of said first
needle body of said first needle assembly of claim 5; holding
second portions of said second and fourth sutures together with
said first portions of said first and third sutures; pulling said
last-mentioned needle body backwardly until said second and fourth
sutures emerge through said fifth location on the patient's body;
releasing said second and fourth sutures from said last-mentioned
needle body and holding said second and fourth sutures; releasing
said first, second, third and fourth sutures; applying traction on
said first, second, third and fourth sutures and then reholding
said first, second, third and fourth sutures; elevating the bladder
neck to a normal anatomical position; tieing said first, second,
third and fourth sutures into knots when said bladder neck is
elevated to a normal anatomical position; and cutting said first,
second, third and fourth sutures above said knots.
13. A method as in claim 12 wherein said first and second locations
are each substantially one centimeter laterally .[.from the midline
of the patient's body.]. .Iadd.at the level of the bladder
neck.Iaddend..
14. A method of urethral suspension of a patient, comprising the
steps of: placing first and second sutures at first and second
locations, respectively, at the level of proximal one-third of the
urethra through the entire thickness of the vagina on both sides
from the midline of the patient's body; holding the first and
second sutures; simultaneously introducing and driving a first said
needle body of a first said needle assembly of claim 3 into a third
location, which is a predetermined distance toward a first side
from the midline of the patient's body just above the edge of the
pubis, and into the retropubic space paravesically along the
posterior aspect of the pubic bone and introducing local anesthetic
through said first needle body as said first needle body is driven;
guiding said first needle body until it emerges through the vagina;
disconnecting a first said source of local anesthetic from said
first needle assembly; simultaneously introducing and driving a
second said needle body of a second said needle assembly of claim 5
into a fourth location a predetermined distance toward a second
side from the midline of the patient's body just above the edge of
the pubis and into the retropubic space paravesically along the
posterior aspect of the pubic bone and introducing local anesthetic
through said second needle body as said second needle body is
driven; guiding said second needle body until it emerges through
the vagina; disconnecting a second said source of local anesthetic
from said second needle assembly; passing said first and second
sutures through said third openings in said first and second needle
bodies, respectively; pulling said first and second needle bodies
back along the posterior aspect of the pubis until said first and
second sutures are pulled through the anterior abdominal wall of
the patient; removing said first and second needle bodies from said
first and second sutures, respectively; grasping said first and
second sutures; releasing a first portion of said first suture and
threading said first suture portion through said third opening of a
first said needle body of a first said needle assembly of claim 5;
holding a second portion of said first suture; introducing said
first needle body of said first needle assembly of claim 5 into a
third location on the patient's body a predetermined distance
laterally from the midline above the edge of the pubis;
simultaneously introducing said local anesthetic through said first
needle body of said first needle assembly of claim 5 and driving
said first needle body of said first needle assembly of claim 5
downwardly and then laterally just above the fascia and then
upwardly until said last-mentioned needle body emerges through the
skin at a fourth location on the patient's body a predetermined
distance laterally from the midline above the edge of the pubis;
releasing said first suture from said last-mentioned needle body;
releasing a first portion of said second suture and threading said
last-mentioned first suture portion through said third opening of
said first needle body of said first needle assembly of claim 5;
holding a second portion of said second suture together with said
first portion of said first suture; pulling said last-mentioned
needle body backwardly until said second suture emerges through
said third location on the patient's body; releasing said second
suture from said last-mentioned needle body and holding said second
suture; releasing said first and second sutures; applying traction
on said first and second sutures and then reholding said first and
second sutures; elevating the distal urethra to a normal anatomical
position; tieing said first and second sutures into knots when said
distal urethra is elevated to a normal anatomical position; and
cutting said first and second sutures above said knots.
15. A method as in claim 14 wherein said first and second locations
are each substantially one centimeter laterally .[.from the midline
of the patient's body.]. .Iadd.at the level of proximal one-third
of the urethra.Iaddend..
16. A method of uterine suspension for uterine prolapse of a
patient, comprising the steps of: placing first and second
submucosal sutures at first and second locations, respectively,
around a predetermined ligament; passing said first and second
sutures underneath the mucosa from said ligament to the
urethrovesical angle; holding the first and second sutures;
simultaneously introducing and driving a first said needle body of
a first said needle assembly of claim 5 into a third location,
which is a predetermined distance toward a first side from the
midline of the patient's body just above the edge of the pubis, and
into the retropubic space paravesically along the posterior aspect
of the pubic bone and introducing local anesthetic through said
first needle body as said first needle body is driven; guiding said
first needle body until it emerges through the vagina;
disconnecting a first said source of local anesthetic from said
first needle assembly; simultaneously introducing and driving a
second said needle body of a second said needle assembly of claim 3
into a fourth location a predetermined distance toward a second
side from the midline of the patient's body just above the edge of
the pubis and into the retropubic space paravesically along the
posterior aspect of the pubic bone and introducing local anesthetic
through said second needle body as said second needle body is
driven; guiding said second needle body until it emerges through
the vagina; disconnecting a second said source of local anesthetic
from said second needle assembly; passing said first and second
sutures through said third openings in said first and second needle
bodies, respectively; pulling said first and second needle bodies
back along the posterior aspect of the pubis until said first and
second sutures are pulled through the anterior abdominal wall of
the patient; removing said first and second needle bodies from said
first and second sutures, respectively; grasping said first and
second sutures; releasing a first portion of said first suture and
threading said first suture portion through said third opening of a
first said needle body of a first said needle assembly of claim 5;
holding a second portion of said first suture; introducing said
first needle body of said first needle assembly of claim 5 into a
third location on the patient's body a predetermined distance
laterally from the midline above the edge of the pubis;
simultaneously introducing said local anesthetic through said first
needle body of said first needle assembly of claim 5 and driving
said first needle body of said first needle assembly of claim 5
downwardly and then laterally just above the fascia and then
upwardly until said last-mentioned needle body emerges through the
skin at a fourth location on the patient's body a predetermined
distance laterally from the midline above the edge of the pubis;
releasing said first suture from said last-mentioned needle body;
releasing a first portion of said second suture and threading said
last-mentioned first suture portion through said third opening of
said first needle body of said first needle assembly of claim 5;
holding a second portion of said second suture together with said
first portion of said first suture; pulling said last-mentioned
needle body backwardly until said second suture emerges through
said third location on the patient's body; releasing said second
suture from said last-mentioned needle body and holding said second
suture; releasing said first and second sutures; applying traction
on said first and second sutures and then reholding said first and
second sutures; elevating the uterus to a normal anatomical
position; tieing said first and second sutures into knots when said
uterus is elevated to a normal anatomical position; and cutting
said first and second sutures above said knots.
Description
BACKGROUND OF THE INVENTION
This invention relates to suturing needle assemblies and methods of
use thereof and more particularly to suturing needle assemblies for
enabling simultaneous passage of suture and introduction of local
anesthetic into body tissue. Methods of using the suturing needle
assemblies include cystopexy, cystourethropexy, urethropexy and
uteropexy procedures.
Stress urinary incontinence is a very common problem among females
and is defined as involuntary loss of urine during coughing,
laughing, sneezing or other physical activity. The most common
cause of stress urinary incontinence among females is urethral
hypermobility, significant displacement or prolapse of the urethra
and bladder neck during strenuous physical activity, or the
intrinsic urethral sphincter deficiency. Labor during childbirth,
pelvic surgeries and menopause, among other conditions, lead to
defects in the endopelvic fascia and the weakening of the support
structures of the urethra and the bladder. During intrinsic
sphincter deficiency the urethral sphincter is unable to generate
enough resistance to retain urine in the bladder. This type of
incontinence is commonly seen after vaginal surgeries, trauma,
radiation, neurological disorders, aging or menopause. Patients
with intrinsic sphincter deficiency may leak urine continuously or
with minimal exertion.
Currently available methods of surgical treatment are expensive,
invasive, require general anesthesia and are contraindicated in
patients with other medical problems which put them into a higher
surgical risk group. These methods (e.g. Kelly plication, Pereyra,
Marshall-Marchetti-Krantz, Burch, Paravaginal repair) require
incision that increases the risk of morbidity from the procedure.
Patients with employment cannot afford to leave work for the time
required for recovery from the conventional procedures, and these
patients choose to suffer from urinary incontinence rather than
being disabled temporarily. Commonly available procedures do not
provide correction of urethral hypermobility or the intrinsic
sphincter deficiency and simultaneous correction of the anatomical
defects leading to cystocele and the drop in bladder neck.
Marshall-Marchetti-Krantz described a procedure where periurethral
tissue is approximated to the symphysis pubis. This procedure
involves abdominal incision and related complications including
osteitis pubis. Burch described a procedure where the vaginal wall
lateral to the bladder neck is elevated towards the cooper's
ligament. This procedure also involves abdominal incision and
related complications, including bladder damage with the suture
material accidentally placed in the bladder as well as
postoperative symptomatic enterocele and rectocele. The paravaginal
repair involves reapproximating the endopelvic fascia to the pelvic
wall at the arcus tendineus. This procedure also involves abdominal
incision and related complications.
Pereyra described a technique where vaginal tissue on each side of
the urethra is sutured to the fascia of the abdominal wall. This
procedure also involves incision and related complications
including injury to the surgeon's fingers with the risk of
transmission of HIV, hepatitis and other infectious diseases.
Kelly plication involves dissection of vaginal wall and plication
of pubocervical fascia. Procedures for intrinsic sphincter
deficiency are sling procedures, artificial sphincter or the
periurethral bulking injections. Sling procedures and artificial
sphincter are more invasive procedures requiring extensive use of
synthetic materials. Periurethral injections are expensive and
provide only temporary relief.
Against this background, a need exists for surgical devices and
procedures offering the least invasive, safe and effective
alternative to existing methods for the surgical treatment of
urinary incontinence.
It is, therefore, an object of the present invention to provide
surgical tools and methods for overcoming the problems and
limitations of the prior art.
Another object of the present invention is to provide suturing
needle assemblies and surgical procedures for enabling simultaneous
passage of suture and introduction of local anesthetic into body
tissue.
Another object is to provide such needle assemblies and procedures
which are used for surgical management of female urinary
incontinence and other pelvic floor disorders under local
anesthesia without the need for use of general anesthesia.
A further object of the invention is the provision of such needle
assemblies and procedures for use in the surgical management of
female urinary incontinence and other pelvic floor disorders
without requiring an incision in the patient.
Still another object is to provide such needle assemblies and
procedures which reduce the risk of complications, such as bleeding
and infections.
Yet another object of the present invention is the provision such
needle assemblies and procedures which enable patients to go home
more promptly after surgery.
Another object is to provide such needle assemblies and procedures
which permit the surgeon to safely perform the procedures of this
invention on patients in whom traditional procedures are
contraindicated due to other medical conditions.
A further object of the invention is the provision of such needle
assemblies and procedures which reduce the cost of traditional
surgical procedures for management of female urinary incontinence
and other pelvic floor disorders.
Another object is to provide needle assemblies and procedures and
procedures for use of the needle assemblies which enable the
procedures to be performed in a physician's office, outpatient
surgery center or mobile medical unit so as to provide patients
from rural areas access to modern medical care.
Another object is to provide needle assemblies and procedures for
surgical management of female urinary incontinence and other pelvic
floor disorders which reduce the chance of injury or transmission
of infectious disease to the surgeon.
A further object of the invention is the provision of needle
assemblies and methods of using the needle assemblies for surgical
management of female urinary incontinence and other pelvic floor
disorders which reduces the cost of surgery by eliminating the cost
of inpatient care after surgery and by eliminating the cost for
general anesthesia.
Another object is to provide such needle assemblies and procedures
which reduce the possibility of accidental damage to organs of the
patient during the surgical procedures.
Another object is to provide instruments and surgical techniques
which allow for permanent correction of the anatomical defects
leading to pelvic organ prolapse and urinary incontinence.
A further object is to provide instruments and surgical techniques
that are minimally invasive and which provide a bigger, stronger
area of anchoring on the abdominal muscles.
Still another object is to provide instruments and surgical
techniques which decrease the chances of sutures cutting
through.
Another object is to provide instruments and surgical techniques
where there is no synthetic support material under the bladder or
on the abdomen.
A further object is to provide instruments and surgical techniques
for their use wherein the techniques are easy to perform,
reproducible and safe for the surgeon and the patient.
Additional objects and advantages of the invention will be set
forth in part in the description which follows, and in part will be
obvious from the description, or may be learned by practice of the
invention. The objects and advantages are realized and attained by
means of the instrumentalities and combinations particularly
pointed out in the appended claims.
SUMMARY OF THE INVENTION
To achieve these and other objects, the present invention provides
a suturing needle assembly for enabling simultaneous passage of
suture and introduction of local anesthetic into body tissue, the
assembly comprising: a hollow needle body defining an interior
passageway and further defining first and second ends having first
and second openings therein, respectively, in fluid communication
with the passageway; the first end further defining a third opening
therein for removably receiving a suture; and means connected to
the second end for removably attaching the needle assembly to a
source of local anesthetic.
It is to be understood that both the foregoing general description
and the following detailed description are exemplary and
explanatory but are not restrictive of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate preferred embodiments of
the invention and, together with the description, serve to explain
the principles of the invention.
FIG. 1 is a top plan view showing a first embodiment of a needle
assembly in accordance with the invention;
FIG. 1A is a fragmentary perspective view of an end portion of the
needle assembly shown in FIG. 1;
FIG. 2 is a side elevation view of the needle assembly shown in
FIG. 1;
FIG. 3 is a perspective view of the needle assembly shown in FIG.
1;
FIG. 4 is an end elevation view of the needle assembly shown in
FIG. 1;
FIG. 5 is a top plan view of a second needle assembly embodiment in
accordance with the invention;
FIG. 6 is a side elevation view of the needle assembly shown in
FIG. 5;
FIG. 7 is an end elevation view of the needle assembly shown in
FIG. 5;
FIG. 8 is a perspective view of the needle assembly shown in FIG.
5;
FIG. 8A is a fragmentary perspective view of an end portion of the
needle assembly shown in FIG. 5;
FIGS. 9-19 show use of the needle assemblies illustrated in FIGS. 1
and 5 in cystopexy, uteropexy and urethropexy surgical procedures;
and
FIGS. 20-28 show use of the needle assemblies illustrated in FIGS.
1 and 5 in a cystouretheropexy surgical procedure.
DESCRIPTION OF THE PREFERRED EMBODIMENT
With reference now to the drawings, wherein like reference
characters designate like or corresponding parts throughout the
several views, there is shown in FIGS. 1-4 a first suturing needle
assembly embodiment 50 for enabling simultaneous passage of suture
and introduction of local anesthetic into body tissue. In
accordance with the invention, assembly 50 comprises a hollow,
elongated needle body 52 defining an interior passageway 54 which
extends the full length of needle body 52, and further defining
first and second ends 56, 58 having first and second openings 56',
58', respectively, therein in fluid communication with passageway
54.
First end 56 further defines a third opening 60 therein for
removably receiving a suture, and means 62 are connected to second
end 58 for removably attaching needle assembly 50 to a source of
local anesthetic 64 (see FIG. 10) in a conventional manner.
In accordance with the invention, first end 56 is a slightly
blunted sharp end for decreasing the risk of accidental injuries
and is beveled with respect to needle body 52 to form a beveled end
surface 66 (see FIG. 1A). Third opening 60 extends through beveled
end surface 66 for enabling a suture to removably pass through
opening 60.
Means 68 are attached to needle body 52 in a conventional manner,
such as by welding, for enhancing a user's grip of needle assembly
50 during use thereof. Surface 70 of gripping means 68 is
preferably roughened or scored to provide enhanced gripping of
gripping means 68 by a user and to provide enhanced control of
needle assembly 50 during surgical procedures.
Needle body 52 defines a first straight portion 72 adjacent to
first end 56 and a second straight portion 74 connected to first
straight portion 72 and adjacent to second end 58. First and second
straight portions 72, 74 define an angle 75 therebetween of from
one hundred ten degrees to one hundred eighty degrees, but
preferably one hundred forty-five degrees. Needle assembly 50 is
preferably made from stainless steel.
A second needle assembly embodiment 50' is shown in FIGS. 5-8A.
Needle assembly 50' comprises a hollow, elongated needle body 52'
which defines a first straight portion 76 adjacent to first end 78.
Needle body 52' further defines a second straight portion 80
adjacent to second end 82. Needle body 52' further defines a third
straight portion 84 connected to first straight portion 76 and a
fourth straight portion 86 connected between portions 80 and 84.
Fourth portion 86 defines first and second angles 88, 90 with each
of straight portions 80, 84, respectively. Angles 88, 90 are from
one hundred fifteen degrees to one hundred seventy-five degrees but
preferably one hundred forty-five degrees, and angles 88, 90 are
equal to each other.
First and third straight portions 76, 84 define a third angle 92
therebetween of from one hundred five degrees to one hundred
sixty-five degrees but preferably one hundred thirty-five
degrees.
Needle assembly 50' is preferably configured wherein second
straight portion 80 defines an extended imaginary straight center
line therethrough (not shown) which intersects with first straight
portion 76. This configuration is best seen in FIG. 6.
Needle assembly 50' defines an interior passageway 54' which
extends the entire length of assembly 50' between ends 78 and 82.
First end 78 is a slightly blunted sharp end for decreasing
accidental injuries and is beveled with respect to straight portion
76 of needle body 52' to form a beveled end surface 66' (see FIG.
8A). Opening 60' extends through beveled end surface 66' for
enabling a suture to removably pass through opening 60'.
Means 68' are attached to portion 80 of needle assembly 50' in a
conventional manner, such as by welding, for enhancing a user's
grip of needle assembly 50' during use thereof. Surface 70' of
gripping means 68' is preferably roughened or scored to provide
enhanced gripping of gripping means 68' by a user and to provide
enhanced control of needle assembly 50' during surgical
procedures.
Means 62' are conventionally connected to second end 82 for
removably attaching needle assembly 50' to a source of local
anesthetic 64' (see FIG. 16) in a conventional manner. Needle
assembly 50' is preferably made from stainless steel.
Needle assembly 50 is configured for allowing simultaneous
infiltration of local anesthetic and the passage of suture from the
patient's bladder neck and paraurethral area in the vaginal wall to
the anterior abdominal wall for urinary incontinence or other
pelvic floor relaxation surgeries. Needle assembly 50' is
configured for allowing simultaneous infiltration of local
anesthetic and the passage of suture from one side of the patient's
anterior abdominal wall to the other side for urinary incontinence
and other pelvic floor relaxation surgeries. Needle assembly 50'
allows passage of suture under the skin, therefore eliminating the
need for an incision.
It should be understood, however, that this invention also
contemplates needles of different configurations for enabling the
simultaneous passage of suture and the introduction of local
anestheic through the hollow needle into body tissue.
The configuration of needle assembly 50 protects organs of the
patient from being damaged by needle assembly 50 because blunted
sharp end 56 points toward the patient's pubic bone during the
surgical procedures. The chances of accidentally damaging other
organs of the patient during the surgical procedures are almost
eliminated and allows the surgeon to comfortably drive needle
assembly 50 behind the patient's pubic bone.
The configuration of needle assembly 50' also protects organs of
the patient from being damaged by needle assembly 50' during the
surgical procedures because blunted sharp end 78 of needle assembly
50' points toward the patient's skin during the procedures. The
configuration of needle assembly 50' also gives the surgeon peace
of mind because the chances of accidentally damaging other organs
of the patient are eliminated and allows the surgeon to comfortably
drive the needle of assembly 50' underneath the patient's skin. The
configuration of needle assembly 50', angle 92 and the relative
length of straight portion 76 allows comfortable passage of
suture.
Use of needle assemblies 50 and 50' generally comprises the steps
of positioning a conventional suture into and through openings 60,
60' of needle assemblies 50, 50', respectively, and attaching a
source 64, 64' of local anesthetic to needle assemblies 50, 50' in
a conventional manner to attaching means 62, 62' of needle
assemblies 50, 50', respectively.
Blunted sharp ends 56, 78 of needle assemblies 50, 50',
respectively, are introduced with the attached sutures into body
tissue while local anesthetic is simultaneously passed from sources
64, 64' through hollow interior passageways 54, 54' of assemblies
50, 50', respectively.
The local anesthetic is introduced into the body tissue by passing
the local anesthetic from sources 64, 64' through openings 58',
82', respectively, of assemblies 50, 50' and through interior
passageways 54, 54' of assemblies 50, 50', respectively, and
through openings 56', 78', of assemblies 50, 50', respectively,
into the body tissue. Specific surgical procedures are provided in
accordance with this invention which use needle assemblies 50, and
50'. The specific surgical procedures will now be described in
detail.
Cystopexy
1. Prep and drape the patient in usual fashion in low lithotomy
position. Drain the bladder.
2. Place a dot with marking pen 4 cm lateral from the midline on
both sides just above the edge of the pubis.
3. Apply 1% Xylocaine jelly in the urethra and bladder.
4. Place a 4 inch.times.4 inch gauze pad soaked with 1% Xylocaine
jelly in anterior portion of the vagina and remove after a few
minutes.
5. Insert a weighted speculum to depress the posterior vagina.
6. Insert a 20 French Foley catheter 91 with 30 cc balloon, inflate
and clamp.
7. Inject 1 cc of 1% Xylocaine into the skin at pen marks on both
sides above the pubis.
8. Inject 1 cc of 1% Xylocaine on both sides 1 cm lateral at the
level of the bladder neck.
9. Place a 3 loop suture 1 cm lateral at the level of the bladder
neck on both sides using a #1 Novafil on CT1 needle (or similar
permanent suture) through the entire thickness of the vagina. Do
not tie the knot. Hold the suture with straight Kelly clamps. (See
FIG. 9.)
10. Fill a 15 cc syringe 93 with 1% Xylocaine. Attach syringe 93 to
needle assembly 50 with small IV extension tubing 94 in a
conventional manner.
11. Drain needle 50 to remove the air.
12. Thumbpiece 68 on needle 50 is firmly grasped, angled and
directed towards the posterior pubis at the right pen mark. Needle
50 is introduced into the retropubic space paravesically along the
posterior aspect of the pubic bone. (See FIG. 10.) Assistant
continuously injects Xylocaine while needle 50 is driven. Assistant
as well pulls the Foley catheter to the contralateral side.
13. Index finger with a thimble 96 is placed in the right side of
vagina lateral to the bladder neck and pushed upwardly behind the
pubis. Needle 50 is guided over thimble 96 until it emerges through
the vagina. (See FIGS. 10-12.)
14. Disconnect needle 50 from tubing 94.
15. Steps 10 through 14 are repeated on the contralateral side.
16. Catheter 91 is removed and cystoscopy is performed with a
70-degree lens to rule out bladder perforation.
17. Foley catheter 91 is placed as in step 6.
18. Suture from the straight Kelly clamps is passed through hole 60
in needle 50 on both sides of the patient. (See FIG. 13.)
19. Needles 50 are pulled back slowly along the posterior aspect of
the pubis until sutures are pulled through the anterior abdominal
wall. (See FIGS. 14 and 15.)
20. Needle 50 is removed and suture grasped with straight Kelly
clamp on both sides.
21. Steps 10 and 11 are repeated with needle assembly 50'.
22. Release one arm of the left suture and thread through hole 60'
in needle 50'. (See FIG. 16.) Hold the other suture arm with a
straight Kelly clamp.
23. Introduce needle 50' into the left skin puncture site.
Continuously injecting Xylocaine drive needle 50' pointing
downwardly then laterally just above the fascia and finally
upwardly until it emerges through the right skin puncture site.
(See FIG. 17.)
24. Release the suture from needle 50'.
25. Release one arm of the right suture and thread through hole 60'
in needle 50'. (See FIG. 17.) Hold the other suture arm with the
straight Kelly clamp along with the remaining left suture arm.
26. Pull needle 50' back until suture emerges through the left
puncture site. Release the right suture from needle 50' and hold
the right suture with left straight Kelly clamp.
27. Release Kelly clamps, apply slight traction on the sutures on
both sides and reapply the Kelly clamps.
28. Assistant elevates the patient's bladder neck by pushing the
anterior vaginal wall upwardly behind the pubis with fingers.
29. When the bladder neck is in normal anatomical position,
elevated by assistant's fingers, tie the sutures on both sides with
8 knots into the skin puncture sites (see FIGS. 18 and 19) and cut
the sutures right above the knots.
30. Lift the edges of the puncture sites bilaterally with Edson
forceps and allow the knots to retract.
31. Apply sterile strips on puncture sites.
32. Clamp on the Foley catheter 91 is now removed. Patient is
transferred to the recovery area with urinary drainage bag. Foley
catheter 91 is removed before transfer if patient is prescribed
intermittent self-catheterization.
Cystourethropexy
1. Prep and drape the patient in usual fashion in low lithotomy
position. Drain the bladder.
2. Place a dot with marking pen 4 cm lateral from the midline on
both sides just above the edge of the pubis.
3. Apply 1% Xylocaine jelly in the urethra and bladder.
4. Place a 4 inch.times.4 inch gauze pad soaked with 1% Xylocaine
jelly in anterior portion of the vagina and remove after a few
minutes.
5. Insert a weighted speculum to depress the posterior vagina.
6. Insert a 20 French Foley catheter 91 with 30 cc balloon, inflate
and clamp.
7. Inject 1 cc of 1% Xylocaine into the patient's skin at pen marks
on both sides above the pubis.
8. Inject 1 cc of 1% Xylocaine on both sides 1 cm lateral at the
level of the bladder neck.
9. Place a 3 loop suture 1 cm lateral at the level of the bladder
neck on both sides using a #1 Novafil on CT1 needle (or similar
permanent suture) through the entire thickness of the vagina. Do
not tie the knot. Hold the suture with straight Kelly clamps. (See
FIG. 20.)
10. Place a 3 loop suture 1 cm lateral at the level of proximal 1/3
of the urethra on both sides using #1 Novafil on CT1 needle (or
similar permanent suture) through the entire thickness of the
vagina. Do not tie the knot. Crush the ends with the needle holder
for later identification. Hold the suture with curved Kelly clamps.
(See FIG. 20.)
11. Fill a 15 cc syringe 93 with 1% Xylocaine. Attach the syringe
to needle 50 with small IV extension tubing 94 in a conventional
manner.
12. Drain needle 50 to remove the air.
13. Thumbpiece 68 on needle 50 is firmly grasped, angled and
directed towards the posterior pubis at the right pen mark. Needle
50 is introduced into the retropubic space paravesically along the
posterior aspect of the pubic bone. (See FIG. 21.) Assistant
continuously injects Xylocaine while needle 50 is driven. Assistant
as well pulls the Foley catheter 91 to the contralateral side.
14. Index finger with thimble 96 is placed in the right side of the
vagina lateral to the bladder neck and pushed upwardly behind the
pubis. Needle 50 is guided over thimble 96 until needle 50 emerges
through the vagina. (See FIG. 22.)
15. Disconnect needle 50 from tubing 94.
16. Steps 11 through 14 are repeated on the contralateral side.
17. Catheter 91 is removed and cystoscopy is performed with a
70-degree lens to rule out bladder perforation.
18. Foley catheter 91 is placed as in step 6.
19. Sutures from both the curved and straight Kelly clamps are
passed through hole 60 in needle 50 on both sides of the patient.
(See FIG. 23.)
20. Needles 50 are pulled back slowly along the posterior aspect of
the pubis until sutures are pulled through the anterior abdominal
wall. (See FIGS. 24 and 25.)
21. Needle 50 is removed. On both sides crush marked suture is
grasped with the curved Kelly clamp and unmarked suture is grasped
with the straight Kelly clamp.
22. Steps 11 and 12 are repeated with needle 50'.
23. Release one arm of the left marked and unmarked suture and
thread through hole 60' in needle 50'. Hold the other suture arms
with curved and straight Kelly clamps. (See FIG. 26.)
24. Introduce needle 50' into the left skin puncture site.
Continuously injecting Xylocaine drive needle 50' pointing
downwardly then laterally just above the fascia and finally
upwardly until needle 50' emerges through the right skin puncture
site.
25. Release the suture from needle 50'.
26. Release one arm of the right marked and unmarked suture and
thread through hole 60' in needle 50'. Hold the other suture arms
with curved and straight Kelly clamps along with the remaining left
marked and unmarked suture arms. (See FIG. 27.)
27. Pull needle 50' back until suture emerges through the left
puncture site. Release suture from needle 50' and hold the released
suture with left marked and unmarked sutures using curved and
straight Kelly clamps.
28. On both sides release Kelly clamps one at a time, apply slight
traction on the sutures and reapply the Kelly clamps.
29. Assistant elevates the bladder neck by pushing anterior vaginal
wall upwardly behind the pubis with fingers.
30. When bladder neck is in normal anatomical position, elevated by
assistant's fingers, tie the sutures on both sides releasing each
Kelly clamp with 8 knots into the skin puncture sites and cut the
sutures right above the knots. (See FIG. 28.)
31. Lift the edges of the puncture sites bilaterally with Edson
forceps and allow the knots to retract.
32. Apply sterile strips on puncture sites.
33. Clamp on the Foley catheter 91 is now removed. Patient is
transferred to the recovery area with urinary drainage bag. Foley
catheter 91 is removed before transfer if patient is prescribed
intermittent self-catheterization.
Urethropexy
1. Prep and drape the patient in usual fashion in low lithotomy
position. Drain the bladder.
2. Place a dot with marking pen 4 cm lateral from the midline on
both sides just above the edge of the pubis.
3. Apply 1% Xylocaine jelly in the urethra and bladder.
4. Place a 4 inch.times.4 inch gauze pad soaked with 1% Xylocaine
jelly in anterior portion of the vagina and remove after a few
minutes.
5. Insert a weighted speculum to depress the posterior vagina.
6 Insert a 20 French Foley catheter 91 with 30 cc balloon, inflate
and clamp.
7. Inject 1 cc of 1% Xylocaine into the skin at pen marks on both
sides above the pubis.
8. Inject 1 cc of 1% Xylocaine on both sides 1 cm lateral at the
level of the bladder neck.
9. Place a 3 loop suture 1 cm lateral at the level of proximal 1/3
of urethra on both sides using a #1 Novafil on CT1 needle (or
similar permanent suture) through the entire thickness of the
vagina. Do not tie the knot. Hold the suture with straight Kelly
clamps. (See FIG. 9.)
10. Fill a 15 cc syringe 93 with 1% Xylocaine. Attach syringe 93 to
needle assembly 50 with small IV extension tubing 94 in a
conventional manner.
11. Drain needle 50 to remove the air.
12. Thumbpiece 68 on needle 50 is firmly grasped, angled and
directed towards the posterior pubis at the right pen mark. Needle
50 is introduced into the retropubic space paravesically along the
posterior aspect of the pubic bone. (See FIG. 10.) Assistant
continuously injects Xylocaine while needle 50 is driven. Assistant
as well pulls the Foley catheter 91 to the contralateral side.
13. Index finger with thimble 96 is placed in the right side of
vagina lateral to the bladder neck and pushed upwardly behind the
pubis. Needle 50 is guided over thimble 96 until needle 50 emerges
through the vagina. (See FIGS. 10-12.)
14. Disconnect needle 50 from tubing 94.
15. Steps 10 through 14 are repeated on the contralateral side.
16. Catheter 91 is removed and cystoscopy is performed with a
70-degree lens to rule out bladder perforation.
17. Foley catheter 91 is placed as in step 6.
18. Suture from the straight Kelly clamps is passed through hole 60
in needle 50 on both sides of the patient. (See FIG. 13.)
19. Needles 50 are pulled back slowly along the posterior aspect of
the pubis until sutures are pulled through the anterior abdominal
wall. (See FIGS. 14 and 15.)
20. Needle 50 is removed and suture grasped with straight Kelly
clamp on both sides.
21. Steps 10 and 11 are repeated with needle assembly 50'.
22. Release one arm of the left suture and thread through hole 60'
in needle 50'. (See FIG. 16.) Hold the other suture arm with a
straight Kelly clamp.
23. Introduce needle 50' into the left skin puncture site.
Continuously injecting Xylocaine drive needle 50' pointing
downwardly then laterally just above the fascia and finally
upwardly until needle 50' emerges through the right skin puncture
site. (See FIG. 17.)
24. Release the suture from needle 50'.
25. Release one arm of the right suture and thread through hole 60'
in needle 50'. (See FIG. 17.) Hold the other suture arm with the
straight Kelly clamp along with the remaining left suture arm.
26. Pull needle 50' back until suture emerges through the left
puncture site. Release the right suture from needle 50' and hold
the right suture with left straight Kelly clamp.
27. Release Kelly clamps, apply slight traction on the sutures on
both sides and reapply the Kelly clamps.
28. Assistant elevates the patient's distal urethra by pushing the
anterior vaginal wall upwardly behind the pubis with fingers.
29. When the distal urethra is in normal anatomical position,
elevated by assistant's fingers, tie the sutures on both sides with
8 knots into the skin puncture sites (see FIGS. 18 and 19) and cut
the sutures right above the knots.
30. Lift the edges of the puncture sites bilaterally with Edson
forceps and allow the knots to retract.
31. Apply sterile strips on puncture sites.
32. Clamp on the Foley catheter 91 is now removed. Patient is
transferred to the recovery area with urinary drainage bag. Foley
catheter 91 is removed before transfer if patient is prescribed
intermittent self-catheterization.
Uteropexy
Uterine Suspension for Uterine Prolapse
Labor during childbirth and menopause among other conditions can
lead to defects and weakening of the support structures of the
uterus leading to uterine prolapse along with the weakening of the
support structures of the bladder and the urethra. Suspension of
the uterus in incontinence patients with uterine prolapse improves
the outcome of the incontinence procedure.
1. Prep and drape the patient in usual fashion in low lithotomy
position. Drain the bladder.
2. Place a dot with marking pen 4 cm lateral from the midline on
both sides just above the edge of the pubis.
3. Apply 1% Xylocaine jelly in the urethra and bladder.
4. Place a 4 inch.times.4 inch gauze pad soaked with 1% Xylocaine
jelly in anterior portion of the vagina and remove after a few
minutes.
5. Insert a weighted speculum to depress the posterior vagina.
6. Insert a 20 French Foley catheter 91 with 30 cc balloon, inflate
and clamp.
7. Inject 1 cc of 1% Xylocaine into the skin at pen marks on both
sides above the pubis.
8. About 3 cc of local anesthetic is injected into the uterine wall
at the level of the cardinal ligament or uterosacral ligament on
both sides.
9. 5-10 cc of local anesthetic is infiltrated submucosally from the
ligament to the urethrovesical junction on both sides.
10. Using #1 permanent sutures (Prolene or Novafil) a two to three
loop submucosal suture is placed around the ligament (cardinal or
uterosacral). To place a submucosal suture the suture needle is
introduced into the uterine wall (first puncture site) and exited.
After the exit, the needle is introduced back into the exit site,
advanced submucosally and delivered through the first puncture
site. This allows the sutures to be buried entirely into the
tissue.
11. If combining with a different procedure (bladder suspension,
etc.) for later identification a crush mark using a needle holder
is placed about 2 cm from the tip of each suture arm.
12. Needle is removed from the suture.
13. A free needle is used to pass both arms of the suture
underneath the mucosa from the ligament to the urethrovesical
angle.
14. Both arms of the suture are held with a clamp.
15. Steps 10-13 are performed on the contralateral side. (Steps
10-13 are performed on both sides.)
16. Fill a 15 cc syringe 93 with 1% Xylocaine. Attach syringe 93 to
needle assembly 50 with small IV extension tubing 94 in a
conventional manner.
17. Drain needle 50 to remove the air.
18. Thumbpiece 68 on needle 50 is firmly grasped, angled and
directed towards the posterior pubis at the right pen mark. Needle
50 is introduced into the retropubic space paravesically along the
posterior aspect of the pubic bone. (See FIG. 10.) Assistant
continuously injects Xylocaine while needle 50 is driven. Assistant
as well pulls the Foley catheter to the contralateral side.
19. Index finger with a thimble 96 is placed in the right side of
vagina lateral to the bladder neck and pushed upwardly behind the
pubis. Needle 50 is guided over thimble 96 until it emerges through
the vagina. (See FIGS. 10-12.)
20. Disconnect needle 50 from tubing 94.
21. Steps 16 through 20 are repeated on the contralateral side.
22. Catheter 91 is removed and cystoscopy is performed with a
70-degree lens to rule out bladder perforation.
23. catheter 91 is placed as in step 6.
24. Suture from the straight Kelly clamps is passed through hole 60
in needle 50 on both sides of the patient. (See FIG. 13.)
25. Needles 50 are pulled back slowly along the posterior aspect of
the pubis until sutures are pulled through the anterior abdominal
wall. (See FIGS. 14 and 15)
26. Needle 50 is removed and suture grasped with straight Kelly
clamp on both sides.
27. Steps 16 and 17 are repeated with needle assembly 50'.
28. Release one arm of the left suture and thread through hole 60
in needle 50'. (See FIG. 16.) Hold the other suture arm with a
straight Kelly clamp.
29. Introduce needle 50' into the left skin puncture site.
Continuously injecting Xylocaine drive needle 50' pointing
downwardly then laterally just above the fascia and finally
upwardly until needle 50' emerges through the right skin puncture
site. (See FIG. 17.)
30. Release the suture from needle 50'.
31. Release one arm of the right suture and thread through hole 60'
in needle 50'. (See FIG. 17.) Hold the other suture arm with the
straight Kelly clamp along with the remaining left suture arm.
32. Pull needle 50' back until suture emerges through the left
puncture site. Release the right suture from needle 50' and hold
the right suture with left straight Kelly clamp.
33. Release Kelly clamps, apply slight traction on the sutures on
both sides and reapply the Kelly clamps.
34. Assistant elevates the patient's uterus by pushing the anterior
vaginal wall upwardly behind the pubis with fingers.
35. When uterus is in normal anatomical position, elevated by
assistant's fingers, tie the sutures on both sides with 8 knots
into the skin puncture sites (see .[.FIGS..]. .Iadd.FIG.
.Iaddend.18 .[.and 19.]. ) and cut the sutures right above the
knots.
36. Lift the edges of the puncture sites bilaterally with Edson
forceps and allow the knots to retract.
37. Apply sterile strips on puncture sites.
38. Clamp on the Foley catheter 91 is now removed. Patient is
transferred to the recovery area with urinary drainage bag. Foley
catheter 91 is removed before transfer if the patient is prescribed
intermittent self-catheterization.
It should be understood that a permanent suture like Prolene can be
used instead of Novafil and that other local anesthetic, instead of
Xylocaine, can be used in the procedures described.
The invention in its broader aspects is not limited to the specific
details shown and described, and departures may be made from such
details without departing from the principles of the invention and
without sacrificing its chief advantages.
* * * * *