U.S. patent application number 11/035486 was filed with the patent office on 2005-06-30 for cystotomy catheter capture device and methods of using same.
Invention is credited to High, Kenneth A..
Application Number | 20050143690 11/035486 |
Document ID | / |
Family ID | 35320911 |
Filed Date | 2005-06-30 |
United States Patent
Application |
20050143690 |
Kind Code |
A1 |
High, Kenneth A. |
June 30, 2005 |
Cystotomy catheter capture device and methods of using same
Abstract
A catheter capture device comprising a urethral sound and a
sleeve that utilizes balloon inflation to capture the catheter. A
catheter capture device comprising a urethral sound and a clamshell
device. The clamshell device comprises two halves, one of which
comprises two pins. One pin passes through the lateral holes in the
tip of the catheter, and the other pin fits into a notch in the
bottom half of the clamshell device. A catheter capture device
comprising a urethral sound, a sleeve and a pin that passes through
the lateral holes in the tip of the catheter. A catheter capture
device comprising a urethral sound, a wire and a nodule, wherein
the nodule captures the catheter by lodging in the tip of the
catheter. The nodule could be a ball, hook, crimped wire or similar
object. A method of capturing a catheter in an obese or non-obese
patient.
Inventors: |
High, Kenneth A.; (Helena,
MT) |
Correspondence
Address: |
Antoinette M. Tease, P.L.L.C.
PO Box 51016
Billings
MT
59105
US
|
Family ID: |
35320911 |
Appl. No.: |
11/035486 |
Filed: |
January 15, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11035486 |
Jan 15, 2005 |
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10837879 |
May 3, 2004 |
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60466959 |
May 1, 2003 |
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Current U.S.
Class: |
604/164.01 |
Current CPC
Class: |
A61M 25/0074 20130101;
A61M 25/0014 20130101; A61B 2017/320052 20130101; A61M 25/007
20130101; A61B 17/3417 20130101; A61B 17/3415 20130101 |
Class at
Publication: |
604/164.01 |
International
Class: |
A61M 005/178 |
Claims
I claim:
1. A catheter capture device comprising: (a) a urethral sound; and
(b) a sleeve, wherein the urethral sound is inserted through a
patient's urethra into the bladder and out the abdominal wall,
wherein the sound comprises a removable tip, wherein the removable
tip of the sound is removed, wherein the sleeve is attached to the
end of the sound from which the removable tip was removed, wherein
the catheter to be captured comprises a balloon and a tip, wherein
the catheter tip is inserted into the sleeve, wherein the balloon
is inflated, and wherein the catheter is pulled into the patient's
bladder by pulling the sound out through the patient's urethra.
2. The catheter capture device of claim 1, wherein the sleeve
comprises a flange, and wherein the flange prevents the catheter
from falling out of the sleeve when the balloon is inflated.
3. A catheter capture device comprising: (a) a urethral sound; and
(b) a clamshell device, wherein the urethral sound is inserted
through a patient's urethra into the bladder and out the abdominal
wall, wherein the clamshell device comprises a top half and a
bottom half, wherein the top half of the clamshell device comprises
two pegs, wherein the catheter to be captured comprises a tip,
wherein the catheter tip comprises two lateral holes, wherein one
of the pegs on the top half of the clamshell device passes through
the lateral holes in the catheter tip, wherein the bottom half of
the clamshell device comprises a notch, wherein the other peg on
the top half of the clamshell device fits into the notch on the
bottom half of the clamshell device, wherein the clamshell device
comprises a threaded end, wherein the sound comprises a distal end,
wherein the distal end of the sound is threaded on the inside,
wherein the threaded end of the clamshell device fits into the
threaded distal end of the sound, and wherein the catheter is
pulled into the patient's bladder by pulling the sound out through
the patient's urethra.
4. A catheter capture device comprising: (a) a urethral sound; (b)
a sleeve; and (c) a pin; wherein the urethral sound is inserted
through a patient's urethra into the bladder and out the abdominal
wall, wherein the urethral sound comprises a threaded extension,
wherein the catheter to be captured comprises a tip, wherein the
sleeve is placed over the tip of the catheter, wherein the catheter
tip comprises lateral holes, wherein the catheter tip is inserted
into the threaded extension of the sound, wherein the threaded
extension comprises a hole, wherein the pin is inserted through the
lateral holes in the catheter tip and through the hole in the
threaded extension, wherein the sleeve is threaded on the inside,
wherein the sleeve is screwed onto the threaded extension of the
sound, and wherein the catheter is pulled into the patient's
bladder by pulling the sound out through the patient's urethra.
5. A catheter capture device comprising: (a) a urethral sound; (b)
a wire; and (c) a ball, wherein the urethral sound is inserted
through a patient's urethra into the bladder and out the abdominal
wall, wherein the urethral sound comprises a tip, wherein the
urethral sound is hollow, wherein a wire is passed through the
urethral sound and out the tip, wherein a catheter is placed on the
wire, wherein the catheter comprises a proximal end and a distal
end, wherein a ball is attached to the wire at the proximal end of
the catheter, wherein the catheter comprises a tip, wherein the
wire is pulled out through the urethral sound until the ball lodges
in the tip of the catheter, and wherein the catheter is pulled into
the patient's bladder by pulling the wire and sound out through the
patient's urethra.
6. A catheter capture device comprising: (a) a urethral sound; (b)
a wire; and (c) a hook, wherein the urethral sound is inserted
through a patient's urethra into the bladder and out the abdominal
wall, wherein the urethral sound comprises a tip, wherein the
urethral sound is hollow, wherein a wire is passed through the
urethral sound and out the tip, wherein a catheter is placed on the
wire, wherein the catheter comprises a proximal end and a distal
end, wherein a hook is attached to the wire at the proximal end of
the catheter, wherein the catheter comprises a tip, wherein the
wire is pulled out through the urethral sound until the hook lodges
in the tip of the catheter, and wherein the catheter is pulled into
the patient's bladder by pulling the wire and sound out through the
patient's urethra.
7. A catheter capture device comprising: (a) a urethral sound; (b)
a wire; and (c) a nodule, wherein the urethral sound is inserted
through a patient's urethra into the bladder and out the abdominal
wall, wherein the urethral sound comprises a tip, wherein the
urethral sound is hollow, wherein a wire is passed through the
urethral sound and out the tip, wherein a catheter is placed on the
wire, wherein the catheter comprises a proximal end and a distal
end, wherein a nodule is attached to the wire at the proximal end
of the catheter, wherein the catheter comprises a tip, wherein the
wire is pulled out through the urethral sound until the nodule
lodges in the tip of the catheter, and wherein the catheter is
pulled into the patient's bladder by pulling the wire and sound out
through the patient's urethra.
8. A catheter capture device comprising: (a) a urethral sound; and
(b) a wire, wherein the urethral sound is inserted through a
patient's urethra into the bladder and out the abdominal wall,
wherein the urethral sound comprises a tip, wherein the urethral
sound is hollow, wherein a wire is passed through the urethral
sound and out the tip, wherein the wire comprises a hook, wherein
the catheter to be captured comprises a tip, wherein the catheter
is placed on the wire such that the hook lodges in the catheter
tip, and wherein the catheter is pulled into the patient's bladder
by pulling the wire and sound out through the patient's
urethra.
9. A catheter capture device comprising: (a) a urethral sound; and
(b) a wire, wherein the urethral sound is inserted through a
patient's urethra into the bladder and out the abdominal wall,
wherein the urethral sound comprises a tip, wherein the urethral
sound is hollow, wherein a wire is passed through the urethral
sound and out the tip, wherein a catheter is placed on the wire,
wherein the catheter comprises a proximal end and a distal end,
wherein the wire is crimped at the proximal end of the catheter,
wherein the catheter comprises a tip, wherein the wire is pulled
out through the urethral sound until the crimp in the wire lodges
in the tip of the catheter, and wherein the catheter is pulled into
the patient's bladder by pulling the wire and sound out through the
patient's urethra.
10. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a removable tip, removing the removable tip; (c)
attaching a sleeve to the end of the sound from which the removable
tip was removed; (d) wherein the catheter to be captured comprises
a tip, inserting the catheter tip into the sleeve; (e) wherein the
catheter to be captured comprises a balloon, inflating the balloon;
and (f) pulling the catheter into the patient's bladder by pulling
the sound out through the patient's urethra.
11. The method of claim 10, wherein the sleeve comprises a flange,
and wherein the flange prevents the catheter from falling out of
the sleeve when the balloon is inflated.
12. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a removable tip, removing the removable tip; (c) wherein
the catheter to be captured comprises a tip, inserting the catheter
tip into the end of the sound from which the removable tip was
removed; (d) wherein the catheter to be captured comprises a
balloon, inflating the balloon; and (e) pulling the catheter into
the patient's bladder by pulling the sound out through the
patient's urethra.
13. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a removable tip, removing the removable tip; (c) wherein
the catheter to be captured comprises a tip, attaching a clamshell
device to the catheter tip; (d) wherein the clamshell device
comprises a top half and a bottom half, wherein the top half
comprises two pegs, wherein the bottom half comprises a notch,
wherein the catheter tip comprises two lateral holes, inserting one
of the pegs through the two lateral holes in the catheter tip and
inserting the other peg into the notch on the bottom half of the
clamshell device; (e) wherein the clamshell device comprises a
threaded end, wherein the sound comprises a distal end, wherein the
distal end of the sound is threaded on the inside, fitting the
threaded end of the clamshell device into the threaded distal end
of the sound; and (f) pulling the catheter into the patient's
bladder by pulling the sound out through the patient's urethra.
14. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a removable tip, removing the removable tip; (c) wherein
the catheter to be captured comprises a tip, placing a sleeve over
the catheter tip; (d) wherein the sound comprises a threaded
extension, inserting the catheter tip into the threaded extension;
(e) wherein the catheter tip comprises two lateral holes, and
wherein the threaded extension comprises a hole, inserting a pin
through the lateral holes in the catheter tip and the hole in the
threaded extension; (f) wherein the sleeve is threaded on the
inside, screwing the sleeve onto the threaded extension of the
sound; and (g) pulling the catheter into the patient's bladder by
pulling the sound out through the patient's urethra.
15. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; (c) placing the
catheter to be captured on the wire; (d) wherein the catheter
comprises a proximal end and a distal end, attaching a ball to the
wire at the proximal end of the catheter; (e) wherein the catheter
comprises a tip, pulling the wire out through the urethral sound
until the ball lodges in the tip of the catheter; and (f) pulling
the catheter into the patient's bladder by pulling the sound out
through the patient's urethra.
16. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; (c) placing the
catheter to be captured on the wire; (d) wherein the catheter
comprises a proximal end and a distal end, attaching a hook to the
wire at the proximal end of the catheter; (e) wherein the catheter
comprises a tip, pulling the wire out through the urethral sound
until the hook lodges in the tip of the catheter; and (f) pulling
the catheter into the patient's bladder by pulling the sound out
through the patient's urethra.
17. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; (c) placing the
catheter to be captured on the wire; (d) wherein the catheter
comprises a proximal end and a distal end, attaching a nodule to
the wire at the proximal end of the catheter; (e) wherein the
catheter comprises a tip, pulling the wire out through the urethral
sound until the nodule lodges in the tip of the catheter; and (f)
pulling the catheter into the patient's bladder by pulling the
sound out through the patient's urethra.
18. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; (c) wherein the
catheter comprises a tip, and wherein the wire comprises a hook,
placing a catheter on the wire such that the hook lodges in the
catheter tip; and (d) pulling the catheter into the patient's
bladder by pulling the sound out through the patient's urethra.
19. A method of capturing a catheter comprising the steps of: (a)
inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; (b) wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; (c) placing the
catheter to be captured on the wire; (d) wherein the catheter
comprises a proximal end and a distal end, crimping the wire at the
proximal end of the catheter; (e) wherein the catheter comprises a
tip, pulling the wire out through the urethral sound until the
crimp in the wire lodges in the tip of the catheter; and (f)
pulling the catheter into the patient's bladder by pulling the
sound out through the patient's urethra.
20. A method of capturing a catheter in an obese patient comprising
the steps of: (a) inserting a urethral sound through a patient's
urethra, into the bladder and as close to the abdominal wall as
possible; (b) wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall; (c)
placing a knife on the wire; (d) pushing the knife through the
abdominal wall until it comes into contact with the tip of the
urethral sound; (e) removing the knife; and (f) capturing the
catheter using the method of claim 15, 16, 17, 18 or 19.
21. A method of capturing a catheter in an obese patient comprising
the steps of: (a) inserting a urethral sound through a patient's
urethra, into the bladder and as close to the abdominal wall as
possible; (b) wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall; (c)
placing a knife on the wire; (d) pushing the knife through the
abdominal wall until it comes into contact with the tip of the
urethral sound; (e) retracting the urethral sound by at least a
distance equal to the length of the tip of the sound; (f) pushing
the knife down on the wire again until it comes into contact with
the tip of the urethral sound; (g) removing the knife; and (h)
capturing the catheter using the method of claim 15, 16, 17, 18 or
19.
22. A method of capturing a catheter in an obese patient comprising
the steps of: (a) inserting a urethral sound through a patient's
urethra, into the bladder and as close to the abdominal wall as
possible; (b) wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall; (c)
placing a trocar on the wire; (d) pushing the trocar through the
abdominal wall until it comes into contact with the tip of the
urethral sound; (e) removing the trocar; and (f) capturing the
catheter using the method of claim 15, 16, 17, 18 or 19.
23. A method of capturing a catheter in an obese patient comprising
the steps of: (a) inserting a urethral sound through a patient's
urethra, into the bladder and as close to the abdominal wall as
possible; (b) wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall; (c)
placing a trocar on the wire; (d) pushing the trocar through the
abdominal wall until it comes into contact with the tip of the
urethral sound; (e) retracting the urethral sound by at least a
distance equal to the length of the tip of the sound; (f) pushing
the trocar down on the wire again until it comes into contact with
the tip of the urethral sound; (g) removing the trocar; and (h)
capturing the catheter using the method of claim 15, 16, 17, 18 or
19.
24. A method of capturing the catheter in an obese patient
comprising the steps of: (a) creating an incision through the
abdominal wall of an obese patient as set forth in claim 20, 21, 22
or 23; (b) after the trocar or knife is removed, placing a
screwdriver on the wire; (c) pushing the screwdriver down on the
wire until it comes into contact with the tip of the urethral
sound; (d) wherein the tip of the urethral sound comprises one or
more slots, wherein the screwdriver comprises a tip, wherein the
tip of the screwdriver comprises one or more blades, fitting the
screwdriver blade(s) into the slot(s) on the tip of the sound; (e)
unscrewing the tip of the sound with the screwdriver; (f) removing
the screwdriver from the wire; (g) attaching a first nodule to the
wire at the end nearest the patient's urethra; (h) pulling the wire
back up through the incision site until the first nodule lodges in
the tip of the sound; (i) pulling the tip of the sound out through
the incision site by pulling the wire up through the incision site;
(j) removing the first nodule from the wire; (k) placing a catheter
on the wire; (l) placing a second nodule on the wire; (m) advancing
the second nodule to the tip of the catheter by pulling the wire
through the patient's urethra; (n) pulling the catheter tip into
the end of the sound from which the removable tip was removed by
pulling the wire through the patient's urethra; (o) wherein the
catheter comprises a balloon, inflating the balloon; (p) pulling
the sound and catheter out through the patient's urethra; (q)
deflating the balloon; (r) separating the catheter from the sound;
(s) pulling the catheter back into the patient's bladder; and (t)
inflating the balloon; and (u) attaching the catheter to
drainage.
25. The method of claim 24, wherein the first nodule is a ball.
26. The method of claim 24, wherein the second nodule is a
ball.
27. The method of claim 24, wherein the first nodule is a hook.
28. The method of claim 24, wherein the second nodule is a
hook.
29. The method of claim 24, wherein the first nodule is a crimp on
the wire.
30. The method of claim 24, wherein the second nodule is a crimp on
the wire.
31. A knife-on-a-wire comprising: (a) a knife; and (b) a wire,
wherein the knife is hollow, wherein the knife is placed on the
wire, wherein the wire is used to guide the knife through a
patient's abdominal wall until it comes into contact with a
urethral sound that has been passed through the patient's urethra,
into the bladder and as close to the abdominal wall as
possible.
32. The knife-on-a-wire of claim 31, wherein the knife comprises
two blades, wherein the blades are oriented so that there is al
80-degree spacing between them, and wherein the blades form a
hexagon shape.
33. The knife-on-a-wire of claim 31, wherein the knife comprises
two blades, wherein the blades are oriented so that there is a
180-degree spacing between them, and wherein the blades form a
diamond shape.
34. A trocar-on-a-wire comprising: (a) a trocar; and (b) a wire,
wherein the trocar is hollow, wherein the trocar is placed on the
wire, wherein the wire is used to guide the trocar through a
patient's abdominal wall until it comes into contact with a
urethral sound that has been passed through the patient's urethra,
into the bladder and as close to the abdominal wall as
possible.
35. A screwdriver-on-a-wire comprising: (a) a screwdriver; and (b)
a wire, wherein the screwdriver is hollow, wherein the screwdriver
is placed on the wire, wherein an incision has been made through a
patient's abdominal wall, wherein the wire is used to guide the
screwdriver through the patient's abdominal wall until it comes
into contact with a urethral sound that has been passed through the
patient's urethra, into the bladder and as close to the abdominal
wall as possible, wherein the urethral sound comprises a removable
tip, wherein the screwdriver is used to unscrew the removable tip
of the sound.
36. The catheter capture device of claims 1, 3, 4, 5, 6, 7, 8 or 9,
wherein the sound comprises a throw, and the throw is at least six
centimeters long.
37. The catheter capture device of claims 1, 3, 4, 5, 6, 7, 8 or 9,
wherein the sound comprises an angle, and the angle is in the range
of sixty to eighty degrees.
38. The method of claims 10, 12, 13, 14, 15, 16, 17, 18, 19, 20,
21, 22, 23 or 24, wherein the sound comprises a throw, and the
throw is at least six centimeters long.
39. The method of claims 10, 12, 13, 14, 15, 16, 17, 18, 19, 20,
21, 22, 23 or 24, wherein the sound comprises an angle, and the
angle is in the range of sixty to eighty degrees.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 10/837,879, which was filed on May 3, 2004.
The latter application in turn claims the benefit under 35 U.S.C.
.sctn. 119(e) of U.S. Application No. 60/466,959, filed on May 5,
2003. The contents of these applications are hereby incorporated by
reference into the present disclosure.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to the field of medical
devices, and more particularly, to a device that facilitates
suprapubic catheter placement, even in the morbidly obese, in
connection with vaginal surgeries for stress urinary incontinence
and pelvic prolapse. The catheter capture device of the present
invention can also be used for permanent suprapubic
catheterizations in those situations in which patients suffer from
incurable incontinence or urinary retention. The catheter capture
device of the present invention includes both standard (reusable)
and disposable embodiments.
[0004] 2. Description of the Related Art
[0005] A million surgical procedures are performed annually to
correct stress urinary incontinence (SUI) in 400,000 American women
and 600,000 women abroad. In this context, "stress" refers to
sneezing, straining and similar actions that can cause
incontinence. A large percentage of these women are unable to void
satisfactorily post-operatively and require a catheter to drain the
bladder for several days or weeks. Post-operative urinary retention
(PUR) occurs in up to forty-one percent (41%) of cases (1, 2). PUR
is generally only a temporary event lasting a few days to weeks,
but it can be painful, frightening and distressing, and it can
complicate postoperative care. In these situations, the suprapubic
catheter placed inside-out (I/O)--by passing a sound through the
urethra, bladder and abdomen, attaching a catheter to the sound,
bringing the catheter into the bladder, and connecting the catheter
to drainage--is superior to all other methods. This procedure
(called "suprapubic cystotomy") is almost always performed during
surgery as opposed to post-operatively because it would require
anesthesia and return to the operating room for a second
operation.
[0006] Suprapubic catheterization may also be necessary with
surgeries involving repair of pelvic prolapse, which refers to
relaxation of the pelvic floor in a female patient and the
descensus or drooping of the bladder, urethra, rectum and/or
uterus-whether or not the patient also requires SUI surgery.
Approximately seventy percent (70%) of women who undergo SUI
surgery also require reconstructive vaginal surgery for repair of
pelvic prolapse (3). Thirty percent (30%) of women in the United
States and other developed countries experience pelvic prolapse at
some point in their lives, and eleven percent (11%) of all women
with this condition will require surgery to correct it. Twenty-nine
percent (29%) of women who are operated on for prolapse repair will
require repeat surgery (4). As these numbers illustrate, the need
for a fast and reliable catheter capture method in women undergoing
surgery to correct SUI and/or pelvic prolapse is widespread.
[0007] When a well functioning suprapubic catheter is in place,
accurate post-operative evaluation of bladder recovery and emptying
is relatively easy. A typical procedure involves leaving the
suprapubic catheter plugged for the first two to three
postoperative weeks so that the patient can attempt to void
normally and the residual urine can be checked without discomfort.
Residual urine is checked by keeping the suprapubic catheter
clamped so that the bladder will fill, having the patient void when
she feels the need to void, and then removing the plug from the
catheter and measuring the urine that drains out of the catheter.
When the post-void residual urine is consistently less than 60 ml,
the catheter may be removed safely because it is highly unlikely
the patient will develop (or redevelop) urinary retention. If
urinary retention is still present two to three weeks after
surgery, then the catheter can be removed and intermittent
self-catheterization (ISC) commenced (5).
[0008] ISC is used in one of two situations: (1) when the patient
has failed the post-operative trial of voiding and the suprapubic
catheter has been removed; or (2) immediately after surgery when a
suprapubic catheter was not used. In the former situation, when the
patient remains unable to void satisfactorily two to three weeks
after surgery, the suprapubic catheter is usually removed, and the
patient begins ISC three to four times daily after voiding. With
ISC, a new catheter is passed by the patient through the urethra
into the bladder each time she voids (to measure the residual
urine). When post-void residual urines are low, the patient is free
to return to normal voiding without catheters.
[0009] The preferred approach is to teach the patient
pre-operatively to perform ISC three to four times daily. Many
women, however, are either unable to learn or do not want to place
a catheter blindly into the urethra and bladder, through a painful,
freshly operated area with sutures that are oozing blood and serum
(5). The developed consensus among medical practitioners is to
place a suprapubic catheter at surgery if the patient has not
demonstrated her ability or willingness to perform ISC (1, 6).
Passage of a suprapubic catheter from the inside-out (I/O) during
surgery is believed to be the best solution because it is safer
than passing a catheter from the outside-in (O/I). Furthermore, the
I/O technique allows physicians to use larger catheters, which are
more reliable in terms of draining the urine. Smaller catheters
(i.e., catheters with a smaller diameter--not length) are used with
the O/I techniques because O/I can cause perforation of the bowel
or peritoneal cavity, and larger tubes (or catheters) would lead to
a higher complication rate. The I/O method, despite its advantages,
has been awkward and difficult with current devices.
[0010] The most commonly employed technique is outside-in (O/I)
suprapubic "punch" cystotomy, which entails passage of a small
(width) catheter through a small trocar that is "punched" through
the abdomen into the bladder. In comparison to I/O techniques, the
O/I technique is simple, cheap and easy, but bladder drainage is
unreliable because the small catheters often kink or become
obstructed when small blood clots enter or form inside the
catheter. As a result, the O/I technique is never used for
permanent catheterization because of unreliable urine drainage. All
O/I devices are more prone to unrecognized bowel or peritoneal
perforation with serious secondary complications than the I/O
devices. For these reasons, the O/I technique has been condemned by
Drs. Ed McGuire and J. Q. Clemens in Campbell's Urology, 8.sup.th
edition, p. 1160. The applicant believes that an important reason
for the current popularity of O/I techniques is because the I/O
devices that are currently available are poorly designed, awkward
and difficult to use. Moreover, catheter capture is difficult to
achieve with these I/O devices.
[0011] Currently, the safest and the only reliable method for
inserting I/O catheters is to pass a hollow stainless steel device
(called a "sound") through the urethra and bladder and then through
the abdominal wall, at which point the catheter is affixed to the
sound and drawn back into the bladder. The catheter is then
inflated and connected to drainage. Each of the devices currently
on the market, however, has serious drawbacks. One drawback that is
common to all of these devices is that the tip of each device has a
short "throw" so that it is difficult to pass the tip of the device
through the abdominal wall. When the device is too short to advance
through the abdominal wall, catheter capture (i.e., securing or
affixing the catheter) becomes extremely difficult. Another
drawback is that existing catheter capture methods do not work. If
the catheter cannot be captured, then the physician will have to
insert an indwelling urethral Foley catheter immediately after
surgery, or the surgeon will have to make an incision through the
abdomen and into the bladder in order to place the suprapubic
catheter. Despite the flaws in current technology, there have been
no significant developments in catheter placement devices for more
than twenty (20) years, although there are a number of patents in
this area.
[0012] U.S. Pat. No. 5,152,749 (Giesy et al., 1992), U.S. Pat. No.
5,232,443 (Leach, 1993) and U.S. Pat. No. 5,348,541 (Lyell, 1994)
all describe suprapubic catheter placement devices. The Giesy
device is limited in that it only describes two means of coupling
the catheter to the placement device. These two means are (i) a
loop on the catheter and an indentation on the placement device and
(ii) a ball and stem on the catheter that fit into a groove and
cavity on the placement device. A sheath slides over the device to
hold the coupling mechanism in place. The Leach device is limited
in that it has a short "throw" and uses a jaw mechanism to capture
the catheter. The jaw mechanism becomes wider after the catheter is
enclosed within the jaws, making it more difficult for the catheter
to be pulled safely through a small hole in the bladder and
potentially resulting in loss of the catheter. Loss of the catheter
requires the surgeon to start all over again, subjecting the
patient to further unnecessary trauma. The Lyell device is limited
in that the only catheter capture means it describes is a hook on
the end of a flexible wire. The hook couples with the lateral hole
provided in the catheter--not with the hole that extends
longitudinally at the tip of the catheter, as in one embodiment of
the present invention. The various embodiments of the present
invention are superior to the embodiments described above in terms
of efficacy and ease of use.
[0013] Because of the problems associated with current suprapubic
catheter placement technologies, many patients have been placed on
urethral catheterization immediately after surgery instead of
suprapubic bladder catheterization during surgery. Urethral
catheterization involves placing the catheter directly into the
bladder through the urethra. Urethral catheterization is simpler,
cheaper and easier than suprapubic catheterization, but it has its
disadvantages. Specifically, residual urine is impossible to
determine while an indwelling urethral catheter is present to drain
the bladder because the catheter fills the urethra and makes it
impossible to void. Patients are much more comfortable with
suprapubic catheters than with urethral catheters exiting the
genitalia, and sexual relations are impossible with a urethral
catheter in place. Thus, the preferred alternative is still I/O
suprapubic catheter placement, but current methods and available
devices are inadequate--particularly in cases involving women,
where the distance from the bladder to the abdominal is often
greater than in men.
[0014] Although designed initially to solve problems relating to
the use of other catheter placement devices in women, the catheter
capture device of the present invention can be used with both women
and men. Suprapubic catheterization is often indicated for those
men and women who are unable to empty their bladders or who have
lost control of their bladders and are required to live in
diapers--patients found commonly in nursing homes. These patients
include men with high-grade prostate obstruction and men and women
with neurologic diseases (such as multiple sclerosis, stroke,
Parkinson's disease, Alzheimer's disease and senility) that destroy
bladder control and bladder emptying. Most of these patients do not
have suprapubic catheterization because it would be a difficult and
formidable procedure for them as currently performed.
[0015] Accordingly, it is an object of the present invention to
provide a fast and reliable method of capturing a suprapubic
catheter for placement in the bladder. It is a further object of
the present invention to provide a catheter capture device with a
"throw" that is sufficiently long to pass through the bladder,
abdominal wall and skin easily and rapidly. It is a further object
of the present invention to provide a catheter capture device with
a modified trocar tip that is suitable for passing over a wire,
traversing the abdominal wall, and passing into the bladder. It is
a further object of the present invention to provide a catheter
capture device that can be used effectively in both women and men
whenever suprapubic catheterization is indicated and an abdominal
incision is not employed. It is a further object of the present
invention to provide a catheter capture device that affords
reliable long-term catheter drainage. It is a further object of the
present invention to allow placement of permanent suprapubic
catheters for chronically ill and elderly men and women instead of
condemning them to diapers or long-term urethral catheterization in
nursing homes. It is a further object of the present invention to
provide a device and method for placing a suprapubic catheter in
the morbidly obese. It is a further object of the present invention
to provide a catheter capture device that is disposable.
BRIEF SUMMARY OF THE INVENTION
[0016] The present invention encompasses a number of embodiments
for a catheter capture device. The device comprises a urethral
sound and a number of different attachments. The urethral sound of
the present invention comprises a shaft, a handle and a removable
tip, wherein the shaft comprises a throw, and the length of the
throw is preferably at least six (6) centimeters. The sound further
comprises an angle, which is preferably in the range of sixty (60)
to eighty (80) degrees.
[0017] A first embodiment of the catheter capture device of the
present invention comprises a urethral sound and a sleeve, wherein
the urethral sound is inserted through a patient's urethra into the
bladder and out the abdominal wall, the sound comprises a removable
tip, the removable tip of the sound is removed, the sleeve is
attached to the end of the sound from which the removable tip was
removed, the catheter to be captured comprises a balloon and a tip,
the catheter tip is inserted into the sleeve, the balloon is
inflated, and the catheter is pulled into the patient's bladder by
pulling the sound out through the patient's urethra. The sleeve
optionally comprises a flange that prevents the catheter from
falling out of the sleeve when the balloon is inflated.
[0018] A second embodiment of the catheter capture device of the
present invention comprises a urethral sound and a clamshell
device, wherein the urethral sound is inserted through a patient's
urethra into the bladder and out the abdominal wall, the clamshell
device comprises a top half and a bottom half, the top half of the
clamshell device comprises two pegs, the catheter to be captured
comprises a tip, the catheter tip comprises two lateral holes, one
of the pegs on the top half of the clamshell device passes through
the lateral holes in the catheter tip, the bottom half of the
clamshell device comprises a notch, the other peg on the top half
of the clamshell device fits into the notch on the bottom half of
the clamshell device, the clamshell device comprises a threaded
end, the sound comprises a distal end, the distal end of the sound
is threaded on the inside, the threaded end of the clamshell device
fits into the threaded distal end of the sound, and the catheter is
pulled into the patient's bladder by pulling the sound out through
the patient's urethra.
[0019] A third embodiment of the catheter capture device of the
present invention comprises a urethral sound, a sleeve and a pin,
wherein the urethral sound is inserted through a patient's urethra
into the bladder and out the abdominal wall, the urethral sound
comprises a threaded extension, the catheter to be captured
comprises a tip, the sleeve is placed over the tip of the catheter,
the catheter tip comprises lateral holes, the catheter tip is
inserted into the threaded extension of the sound, the threaded
extension comprises a hole, the pin is inserted through the lateral
holes in the catheter tip and through the hole in the threaded
extension, the sleeve is threaded on the inside, the sleeve is
screwed onto the threaded extension of the sound, and the catheter
is pulled into the patient's bladder by pulling the sound out
through the patient's urethra.
[0020] A fourth embodiment of the catheter capture device of the
present invention comprises a urethral sound, a wire and a ball,
wherein the urethral sound is inserted through a patient's urethra
into the bladder and out the abdominal wall, the urethral sound
comprises a tip, the urethral sound is hollow, a wire is passed
through the urethral sound and out the tip, a catheter is placed on
the wire, the catheter comprises a proximal end and a distal end, a
ball is attached to the wire at the proximal end of the catheter,
the catheter comprises a tip, the wire is pulled out through the
urethral sound until the ball lodges in the tip of the catheter,
and the catheter is pulled into the patient's bladder by pulling
the wire and sound out through the patient's urethra.
[0021] A fifth embodiment of the catheter capture device of the
present invention comprises a urethral sound, a wire and a hook,
wherein the urethral sound is inserted through a patient's urethra
into the bladder and out the abdominal wall, the urethral sound
comprises a tip, the urethral sound is hollow, a wire is passed
through the urethral sound and out the tip, a catheter is placed on
the wire, the catheter comprises a proximal end and a distal end, a
hook is attached to the wire at the proximal end of the catheter,
the catheter comprises a tip, the wire is pulled out through the
urethral sound until the hook lodges in the tip of the catheter,
and the catheter is pulled into the patient's bladder by pulling
the wire and sound out through the patient's urethra.
[0022] A sixth embodiment of the catheter capture device of the
present invention comprises a urethral sound, a wire and a nodule,
wherein the urethral sound is inserted through a patient's urethra
into the bladder and out the abdominal wall, the urethral sound
comprises a tip, the urethral sound is hollow, a wire is passed
through the urethral sound and out the tip, a catheter is placed on
the wire, the catheter comprises a proximal end and a distal end, a
nodule is attached to the wire at the proximal end of the catheter,
the catheter comprises a tip, the wire is pulled out through the
urethral sound until the nodule lodges in the tip of the catheter,
and the catheter is pulled into the patient's bladder by pulling
the wire and sound out through the patient's urethra.
[0023] A seventh embodiment of the catheter capture device of the
present invention comprises a urethral sound and a wire, wherein
the urethral sound is inserted through a patient's urethra into the
bladder and out the abdominal wall, the urethral sound comprises a
tip, the urethral sound is hollow, a wire is passed through the
urethral sound and out the tip, the wire comprises a hook, the
catheter to be captured comprises a tip, the catheter is placed on
the wire such that the hook lodges in the catheter tip, and the
catheter is pulled into the patient's bladder by pulling the wire
and sound out through the patient's urethra.
[0024] An eighth embodiment of the catheter capture device of the
present invention comprises a urethral sound and a wire, wherein
the urethral sound is inserted through a patient's urethra into the
bladder and out the abdominal wall, the urethral sound comprises a
tip, the urethral sound is hollow, a wire is passed through the
urethral sound and out the tip, a catheter is placed on the wire,
the catheter comprises a proximal end and a distal end, the wire is
crimped at the proximal end of the catheter, the catheter comprises
a tip, the wire is pulled out through the urethral sound until the
crimp in the wire lodges in the tip of the catheter, and the
catheter is pulled into the patient's bladder by pulling the wire
and sound out through the patient's urethra.
[0025] The present invention also covers a number of different
methods of capturing a catheter, corresponding to the catheter
capture devices described above. The first method comprises the
steps of: inserting a urethral sound through a patient's urethra
into the bladder and out the abdominal wall; wherein the urethral
sound comprises a removable tip, removing the removable tip;
attaching a sleeve to the end of the sound from which the removable
tip was removed; wherein the catheter to be captured comprises a
tip, inserting the catheter tip into the sleeve; wherein the
catheter to be captured comprises a balloon, inflating the balloon;
and pulling the catheter into the patient's bladder by pulling the
sound out through the patient's urethra. The sleeve optionally
comprises a flange that prevents the catheter from falling out of
the sleeve when the balloon is inflated.
[0026] The second method of capturing a catheter comprises the
steps of: inserting a urethral sound through a patient's urethra
into the bladder and out the abdominal wall; wherein the urethral
sound comprises a removable tip, removing the removable tip;
wherein the catheter to be captured comprises a tip, inserting the
catheter tip into the end of the sound from which the removable tip
was removed; wherein the catheter to be captured comprises a
balloon, inflating the balloon; and pulling the catheter into the
patient's bladder by pulling the sound out through the patient's
urethra.
[0027] The third method of capturing a catheter comprises the steps
of: inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; wherein the urethral sound
comprises a removable tip, removing the removable tip; wherein the
catheter to be captured comprises a tip, attaching a clamshell
device to the catheter tip; wherein the clamshell device comprises
a top half and a bottom half, wherein the top half comprises two
pegs, wherein the bottom half comprises a notch, wherein the
catheter tip comprises two lateral holes, inserting one of the pegs
through the two lateral holes in the catheter tip and inserting the
other peg into the notch on the bottom half of the clamshell
device; wherein the clamshell device comprises a threaded end,
wherein the sound comprises a distal end, wherein the distal end of
the sound is threaded on the inside, fitting the threaded end of
the clamshell device into the threaded distal end of the sound; and
pulling the catheter into the patient's bladder by pulling the
sound out through the patient's urethra.
[0028] The fourth method of capturing the catheter comprises the
steps of: inserting a urethral sound through a patient's urethra
into the bladder and out the abdominal wall; wherein the urethral
sound comprises a removable tip, removing the removable tip;
wherein the catheter to be captured comprises a tip, placing a
sleeve over the catheter tip; wherein the sound comprises a
threaded extension, inserting the catheter tip into the threaded
extension; wherein the catheter tip comprises two lateral holes,
and wherein the threaded extension comprises a hole, inserting a
pin through the lateral holes in the catheter tip and the hole in
the threaded extension; wherein the sleeve is threaded on the
inside, screwing the sleeve onto the threaded extension of the
sound; and pulling the catheter into the patient's bladder by
pulling the sound out through the patient's urethra.
[0029] The fifth method of capturing the catheter comprises the
steps of: inserting a urethral sound through a patient's urethra
into the bladder and out the abdominal wall; wherein the urethral
sound comprises a tip, and wherein the urethral sound is hollow,
passing a wire through the urethral sound and out the tip; placing
the catheter to be captured on the wire; wherein the catheter
comprises a proximal end and a distal end, attaching a ball to the
wire at the proximal end of the catheter; wherein the catheter
comprises a tip, pulling the wire out through the urethral sound
until the ball lodges in the tip of the catheter; and pulling the
catheter into the patient's bladder by pulling the sound out
through the patient's urethra.
[0030] The sixth method of capturing a catheter comprises the steps
of: inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; placing the
catheter to be captured on the wire; wherein the catheter comprises
a proximal end and a distal end, attaching a hook to the wire at
the proximal end of the catheter; wherein the catheter comprises a
tip, pulling the wire out through the urethral sound until the hook
lodges in the tip of the catheter; and pulling the catheter into
the patient's bladder by pulling the sound out through the
patient's urethra.
[0031] A seventh method of capturing a catheter comprises the steps
of: inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; placing the
catheter to be captured on the wire; wherein the catheter comprises
a proximal end and a distal end, attaching a nodule to the wire at
the proximal end of the catheter; wherein the catheter comprises a
tip, pulling the wire out through the urethral sound until the
nodule lodges in the tip of the catheter; and pulling the catheter
into the patient's bladder by pulling the sound out through the
patient's urethra.
[0032] A eighth method of capturing a catheter comprises the steps
of: inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; wherein the
catheter comprises a tip, and wherein the wire comprises a hook,
placing a catheter on the wire such that the hook lodges in the
catheter tip; and pulling the catheter into the patient's bladder
by pulling the sound out through the patient's urethra.
[0033] A ninth method of capturing a catheter comprises the steps
of: inserting a urethral sound through a patient's urethra into the
bladder and out the abdominal wall; wherein the urethral sound
comprises a tip, and wherein the urethral sound is hollow, passing
a wire through the urethral sound and out the tip; placing the
catheter to be captured on the wire; wherein the catheter comprises
a proximal end and a distal end, crimping the wire at the proximal
end of the catheter; wherein the catheter comprises a tip, pulling
the wire out through the urethral sound until the crimp in the wire
lodges in the tip of the catheter; and pulling the catheter into
the patient's bladder by pulling the sound out through the
patient's urethra.
[0034] The present invention also includes several different
methods of capturing a catheter in an obese patient. The first
method comprises the steps of: inserting a urethral sound through a
patient's urethra, into the bladder and as close to the abdominal
wall as possible; wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall;
placing a knife on the wire; pushing the knife through the
abdominal wall until it comes into contact with the tip of the
urethral sound; removing the knife; and capturing the catheter
using one of the methods described above (ball-on-a-wire,
hook-on-a-wire, nodule-on-a-wire, or crimped wire).
[0035] The second method of capturing a catheter in an obese
patient comprises the steps of: inserting a urethral sound through
a patient's urethra, into the bladder and as close to the abdominal
wall as possible; wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall;
placing a knife on the wire; pushing the knife through the
abdominal wall until it comes into contact with the tip of the
urethral sound; retracting the urethral sound by at least a
distance equal to the length of the tip of the sound; pushing the
knife down on the wire again until it comes into contact with the
tip of the urethral sound; removing the knife; and capturing the
catheter using one of the methods described above (ball-on-a-wire,
hook-on-a-wire, nodule-on-a-wire, or crimped wire).
[0036] The third method of capturing a catheter in an obese patient
comprises the steps of: inserting a urethral sound through a
patient's urethra, into the bladder and as close to the abdominal
wall as possible; wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall;
placing a trocar on the wire; pushing the trocar through the
abdominal wall until it comes into contact with the tip of the
urethral sound; removing the trocar; and capturing the catheter
using one of the methods described above (ball-on-a-wire,
hook-on-a-wire, nodule-on-a-wire, or crimped wire).
[0037] The fourth method of capturing a catheter in an obese
patient comprises the steps of: inserting a urethral sound through
a patient's urethra, into the bladder and as close to the abdominal
wall as possible; wherein the urethral sound comprises a tip, and
wherein the urethral sound is hollow, passing a wire through the
urethral sound, out the tip, and through the abdominal wall;
placing a trocar on the wire; pushing the trocar through the
abdominal wall until it comes into contact with the tip of the
urethral sound; retracting the urethral sound by at least a
distance equal to the length of the tip of the sound; pushing the
trocar down on the wire again until it comes into contact with the
tip of the urethral sound; removing the trocar; and capturing the
catheter using one of the methods described above (ball-on-a-wire,
hook-on-a-wire, nodule-on-a-wire, or crimped wire).
[0038] The fifth method of capturing a catheter in an obese patient
comprises the steps of: creating an incision through the abdominal
wall of an obese patient using a trocar or knife, as described
above; after the trocar or knife is removed, placing a screwdriver
on the wire; pushing the screwdriver down on the wire until it
comes into contact with the tip of the urethral sound; wherein the
tip of the urethral sound comprises one or more slots, wherein the
screwdriver comprises a tip, wherein the tip of the screwdriver
comprises one or more blades, fitting the screwdriver blade(s) into
the slot(s) on the tip of the sound; unscrewing the tip of the
sound with the screwdriver; removing the screwdriver from the wire;
attaching a first nodule to the wire at the end nearest the
patient's urethra; pulling the wire back up through the incision
site until the first nodule lodges in the tip of the sound; pulling
the tip of the sound out through the incision site by pulling the
wire up through the incision site; removing the first nodule from
the wire; placing a catheter on the wire; placing a second nodule
on the wire; advancing the second nodule to the tip of the catheter
by pulling the wire through the patient's urethra; pulling the
catheter tip into the end of the sound from which the removable tip
was removed by pulling the wire through the patient's urethra;
wherein the catheter comprises a balloon, inflating the balloon;
pulling the sound and catheter out through the patient's urethra;
deflating the balloon; separating the catheter from the sound;
pulling the catheter back into the patient's bladder; inflating the
balloon; and attaching the catheter to drainage.
[0039] The present invention also covers a knife-on-a-wire, a
trocar-on-a-wire and a screwdriver-on-a-wire, as used in the
methods described above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a perspective view of the urethral sound of the
present invention.
[0041] FIG. 2 is a section view of the urethral sound of the
present invention.
[0042] FIG. 3 is a perspective view of the urethral sound of the
present invention with the tip removed.
[0043] FIG. 4 is a partial schematic view of four different
embodiments of the urethral sound of the present invention,
illustrating different "throws" available.
[0044] FIG. 5 is a section view of a urethral sound device inserted
into the bladder of a patient. As compared to the sound shown in
FIG. 6, this sound has a relatively shorter throw and a relatively
greater angle.
[0045] FIG. 6 is a section view of the urethral sound of the
present invention inserted into the bladder of a patient. As
compared to the sound shown in FIG. 5, this sound has a relatively
longer throw and a relatively smaller angle.
[0046] FIG. 7 is a perspective view of a Councill catheter.
[0047] FIG. 8 is a perspective view of Councill catheter.
[0048] FIG. 9 is a partial perspective view of the tip of a
Councill catheter.
[0049] FIG. 10 is a partial perspective view of the tip of a
Councill catheter with the balloon inflated.
[0050] FIG. 11 is a perspective view of the balloon capture
embodiment of the present invention with the sleeve disconnected
from the sound.
[0051] FIG. 12 is a perspective view of the balloon capture
embodiment of the present invention with the sleeve connected to
the sound.
[0052] FIG. 13 is a partial section view of the balloon capture
embodiment of the present invention in which the balloon is
deflated.
[0053] FIG. 14 is a partial section view of the balloon capture
embodiment of the present invention in which the balloon is
inflated.
[0054] FIG. 15 is a perspective view of the clamshell capture
embodiment of the present invention in which the clamshell is
disengaged from the catheter and from the sound.
[0055] FIG. 16 is a perspective view of the clamshell capture
embodiment of the present invention in which the clamshell is
closed over the catheter but not attached to the sound.
[0056] FIG. 17 is a perspective view of the clamshell capture
embodiment of the present invention in which the clamshell is
closed over the catheter and attached to the sound.
[0057] FIG. 18 is a section view of the clamshell and a partial
section view of the catheter and sound.
[0058] FIG. 19 is a section view of the clamshell when it is closed
over the catheter and attached to the sound (as shown in FIG.
17).
[0059] FIG. 20 is a perspective view of the sleeve capture
embodiment of the present invention in which the catheter is not
inserted into the threaded extension of the sound, and the sleeve
is not installed over the threaded extension of the sound.
[0060] FIG. 20A is a section view of the removable tip of the sound
for use with the sleeve capture embodiment of the present
invention.
[0061] FIG. 21 is a perspective view of the sleeve capture
embodiment of the present invention in which the catheter is
inserted into the threaded extension of the sound, but the sleeve
is not installed over the threaded extension of the sound.
[0062] FIG. 22 is a perspective view of the sleeve capture
embodiment of the present invention in which the catheter is
inserted into the threaded extension of the sound, and the sleeve
is installed over the threaded extension of the sound.
[0063] FIG. 23 is a partial section view of the catheter inserted
into the threaded extension of the sound and a section view of the
sleeve positioned over the catheter but not over the threaded
extension of the sound.
[0064] FIG. 24 is a partial section view of the catheter inserted
into the threaded extension of the sound and a section view of the
sleeve positioned over the threaded extension of the sound.
[0065] FIG. 25 is a section view of the urethral sound of the
present invention inside the patient's bladder.
[0066] FIG. 26 is a section view of the urethral sound of the
present invention after it has passed through the patient's
abdominal wall.
[0067] FIG. 27 is a section view of the urethral sound of the
present invention with a wire passed through the sound.
[0068] FIG. 28 is a section view of the urethral sound of the
present invention with a wire passed through the sound and a
catheter on the wire.
[0069] FIG. 29 is a partial perspective view of the ball and
wire.
[0070] FIG. 30 is a section view of the urethral sound of the
present invention with a wire passed through the sound and a
catheter and ball on the wire.
[0071] FIG. 31 is a partial perspective view of the ball on the
wire.
[0072] FIG. 32 is a section view of the urethral sound of the
present invention with a wire passed through the sound, a catheter
and ball on the wire, and the ball pulled to the tip of the
catheter.
[0073] FIG. 33 is a section view of the catheter tip with the ball
on the wire and inside the catheter tip.
[0074] FIG. 34 is a section view of the urethral sound of the
present invention with a wire passed through the sound, a catheter
and ball on the wire, the ball pulled to the tip of the catheter,
and the catheter tip pulled to the tip of the sound.
[0075] FIG. 35 is a section view of the urethral sound of the
present invention with a wire passed through the sound, a catheter
and ball on the wire, the ball pulled to the tip of the catheter,
the catheter tip pulled to the tip of the sound, and the catheter
pulled into the bladder.
[0076] FIG. 36 is a section view of the catheter on a wire with a
hook.
[0077] FIG. 37 is a section view of the catheter on a wire with the
hook as it passes through the circular hole in the catheter
tip.
[0078] FIG. 38 is a section view of the hook after it has passed
through the circular hole in the catheter tip and into the inside
of the catheter.
[0079] FIG. 39 is a section view of the hook on the wire as the
wire is being pulled back through the sound.
[0080] FIG. 40 is a section view of the knife on a wire.
[0081] FIGS. 40A and 40B are side views of two alternate
embodiments of the knife.
[0082] FIG. 40C is a section view of the knife, showing the cut
made by the knife blades.
[0083] FIG. 41 is a section view of the knife on a wire with the
tip of the knife in contact with the tip of the sound.
[0084] FIG. 42 is a section view of the trocar on a wire.
[0085] FIG. 42A is a section view of the trocar.
[0086] FIG. 42B is a perspective view of the trocar.
[0087] FIG. 42C is a section view of the trocar, showing the cut
made by the trocar blades.
[0088] FIG. 43 is a section view of the trocar on a wire with the
tip of the trocar in contact with the tip of the sound.
[0089] FIG. 44 is a section view of the screwdriver on a wire.
[0090] FIG. 45 is a section view of the screwdriver on a wire with
the tip of the screwdriver in contact with the tip of the
sound.
[0091] FIG. 46 is a section view of the screwdriver on a wire after
the tip of the sound has been unscrewed from the sound.
REFERENCE NUMBERS
[0092] 1 Sound
[0093] 2 Handle
[0094] 3 Tip of sound (with threaded end)
[0095] 4 Hollow channel
[0096] 5 Threaded end of tip of sound
[0097] 6 Distal end of sound
[0098] 7 Proximal end of sound
[0099] 8 Prior art urethral sound
[0100] 9 Bladder
[0101] 10 Peritoneal cavity
[0102] 11 Abdominal wall
[0103] 12 Pubic bone
[0104] 13 Catheter shaft
[0105] 14 Catheter tip
[0106] 15 Balloon
[0107] 16 Lateral holes (in catheter tip)
[0108] 17 Inflation member
[0109] 18 Drainage connection
[0110] 19 Circular hole (in Councill catheter tip)
[0111] 20 Sleeve (balloon capture embodiment)
[0112] 21 Flange
[0113] 22 Clamshell capture device
[0114] 23 Pegs
[0115] 24 Threaded end of clamshell capture device
[0116] 25 Notch
[0117] 26 Threaded extension (of sound)
[0118] 27 Sleeve
[0119] 28 Pin
[0120] 29 Holes in threaded extension (of sound)
[0121] 30 Wire
[0122] 31 Ball
[0123] 32 Hook
[0124] 33 Knife
[0125] 33a Leading edge of knife
[0126] 33b Knife blades
[0127] 33c Threaded end of knife
[0128] 34 Trocar
[0129] 34a Trocar blades
[0130] 34b Inner threads of trocar
[0131] 35 Screwdriver
[0132] 36 Incision site
[0133] 37 Tip of sound (threaded on the inside)
[0134] 38 Funnel
DETAILED DESCRIPTION OF INVENTION
[0135] FIG. 1 is a perspective view of the urethral sound of the
present invention. This figure shows the sound 1, the handle 2, and
the tip 3. The sound is hollow, and there are holes ar either end
of the sound for the insertion of a wire.
[0136] FIG. 2 is a section view of the urethral sound of the
present invention. This figure shows the sound 1, the handle 2, the
tip 3, and the hollow channel 4, which extends from one end of the
sound to the other.
[0137] FIG. 3 is a perspective view of the urethral sound of the
present invention with the tip removed. This figure shows the sound
1, the handle 2, and the tip 3. It also shows the threaded end 5 of
the tip, which is inserted into the threaded distal end 6 of the
sound. The proximal end of the sound 7 is also threaded for the
addition of a Tuohy-Borst adapter or an endoscopic cap.
[0138] FIG. 4 is a partial schematic view of four different
embodiments of the urethral sound of the present invention,
illustrating different "throws" available. The throw is defined in
this figure as the distance from point A to point B. The sound of
the present invention preferably has a throw that is at least six
(6) centimeters long, although a shorter throw may be appropriate
in certain situations. Different throw lengths may be useful for
different types of patients (for example, male or female, adult or
child). In this figure, the throw length increases from the sound
shown at the bottom to the sound shown at the top. In practice, the
throw will probably not be longer than fourteen (14) centimeters.
The angle of the sound is shown as C. The angle of the sound is
preferably in the range of sixty (60) to eighty (80) degrees. The
angle of all of the sounds shown in this figure is seventy (70)
degrees. FIGS. 5 and 6 illustrate the difference between a sound
with a shorter throw and relatively greater angle (FIG. 5) and a
sound with a longer throw and relatively smaller angle (FIG.
6).
[0139] FIG. 7 is a perspective view of a Councill catheter.
Although the present invention can be used with many different
types of catheters and is not limited to the Councill catheter
(except for the ball-on-a-wire, hook-on-a-wire, nodule-on-a-wire
and crimped wire embodiments), a drawing of the Councill catheter
is provided for illustrative purposes. This figure shows the
catheter shaft 13, the catheter tip 14, one of two lateral holes 16
in the catheter tip 14, and the uninflated balloon 15. On the
proximal end of the catheter, the inflation member 17 and drainage
connection 18 are also shown. The purpose of the inflation member
17 is to inflate the balloon 15 on the distal end of the
catheter.
[0140] FIG. 8 is a perspective view of Councill catheter. As in
FIG. 7, this figure shows the catheter shaft 13, the catheter tip
14, one of two lateral holes 16 in the catheter tip 14, and the
balloon 15. It also shows a circular hole 19 at the end of the
catheter tip 14. A Foley catheter is the same as the Councill
catheter, except that it does not have this circular hole 19 in the
catheter tip. In addition, this figure shows the inflation member
17 and drainage connection 18. The circle at the distal end of the
catheter shows the orientation of FIGS. 9 and 10.
[0141] FIG. 9 is a partial perspective view of the tip of a
Councill catheter. This figure shows the distal end of the catheter
only, with the tip 14, balloon 15, one of two lateral holes 16, and
the circular hole 19 in the catheter tip. FIG. 10 is a partial
perspective view of the tip of a Councill catheter with the balloon
15 inflated.
[0142] FIGS. 11-14 illustrate the balloon capture embodiment of the
present invention. FIG. 11 is a perspective view of the balloon
capture embodiment of the present invention with the sleeve
disconnected from the sound. This figure shows the sound 1, the
catheter 13, the catheter tip 14, and the balloon 15. It also shows
a sleeve 20, which is threaded at one end so that it can be
inserted into the threaded distal end of the sound, where the tip
(not shown) would normally attach.
[0143] FIG. 12 is a perspective view of the balloon capture
embodiment of the present invention with the sleeve connected to
the sound. This figure shows the catheter tip and balloon (not
shown) inserted into the sleeve 20. The circle around the sleeve 20
shows the orientation of FIGS. 13 and 14.
[0144] FIG. 13 is a partial section view of the balloon capture
embodiment of the present invention in which the balloon is
deflated. This figure shows the catheter tip 14 and balloon 15
inserted into the sleeve 20. It also shows a flange 21 that is
integral to the sleeve 20 and that extends inward at the distal end
of the sleeve. The purpose of the flange is to keep the catheter in
place when the balloon is inflated, although in practice the
friction created by the inflated balloon against the inner walls of
the sleeve is sufficient to keep the catheter in place. FIG. 14 is
a partial section view of the balloon capture embodiment of the
present invention in which the balloon 15 is inflated. Both of
these figures show the optional funnel 38 inside the threaded end 5
of the removable tip 3. The funnel 38 is intended to facilitate
passage of a wire (used in connection with other embodiments
described below) through the end of the sound and out the removable
tip 3 and to prevent it from getting hung up in the tip of the
sound.
[0145] An alternate balloon capture method (not shown) does not
utilize a sleeve or pin. In this method, the sound is inserted
through the patient's urethra into the bladder and out the
abdominal wall, and the tip of the sound is removed. The catheter
tip with the balloon is then inserted into the end of the sound
from which the removable tip was removed, and the balloon is
inflated. Inflation of the balloon while inside the sound creates
sufficient friction to hold the catheter in place. The catheter and
sound are then pulled out through the patient's urethra, and the
balloon is deflated. The catheter and sound are separated, and the
catheter is pulled back up into the patient's bladder. The balloon
is re-inflated, and the catheter is attached to drainage.
[0146] FIGS. 15-19 illustrate the clamshell capture embodiment of
the present invention. FIG. 15 is a perspective view of the
clamshell capture embodiment of the present invention in which the
clamshell is disengaged from the catheter and from the sound. This
figure shows the catheter 13 and sound 1 with the tip (not shown)
of the sound removed. It also shows a clamshell capture device 22
that comprises a top half and a bottom half. The top half of the
clamshell capture device 23 comprises two pegs. One peg 23 passes
through the lateral holes 16 in the catheter tip 14. The other peg
23 fits into a notch (not shown) in the bottom half of the
clamshell capture device 23. The clamshell capture device has a
threaded end 24 that fits into the threaded distal end of the
sound.
[0147] FIG. 16 is a perspective view of the clamshell capture
embodiment of the present invention in which the clamshell 22 is
closed over the catheter 13 but not attached to the sound 1. FIG.
17 is a perspective view of the clamshell capture embodiment of the
present invention in which the clamshell 22 is closed over the
catheter 13 and attached to the sound 1. The circle around the
clamshell 22 shows the orientation of FIGS. 18 and 19. Although the
balloon 15 is shown in FIGS. 15-17, it is shown only for
orientation purposes and is not necessary for this embodiment to
function.
[0148] FIG. 18 is a section view of the clamshell and a partial
section view of the catheter and sound. This figure shows the top
and bottom halves of the clamshell 22 in relation to the catheter
13 and the sound 1. The top half of the clamshell comprises pegs
23, one of which passes through the lateral holes 16 in the
catheter tip 14, and the other of which fits into a notch 25 in the
threaded end 24 of the clamshell 22. FIG. 19 is a section view of
the clamshell when it is closed over the catheter and attached to
the sound (as shown in FIG. 17).
[0149] FIGS. 20-24 illustrate the sleeve capture embodiment of the
present invention. FIG. 20 is a perspective view of the sleeve
capture embodiment of the present invention in which the catheter
is not inserted into the threaded extension of the sound, and the
sleeve is not installed over the threaded extension of the sound.
This figure shows the catheter 13, the sound 1, and a threaded
extension 26 on the distal end of the sound. This figure also shows
the sleeve 27 and pin 28. As shown in subsequent figures, the
sleeve 27 is first placed over the catheter tip 14 and slid past
the balloon 15, the catheter tip 14 is then inserted into the
threaded extension 26 of the sound 1, and the pin 28 is inserted
through the lateral holes 16 in the catheter tip 14 and through two
holes 29 (only one of which is shown in FIGS. 20 and 21) the
threaded extension 26. Lastly, the sleeve 27, which is threaded on
the inside, is screwed onto and over the threaded extension 26.
[0150] FIG. 20A is a section view of the removable tip of the sound
for use with the sleeve capture embodiment of the present
invention. As shown in this figure, in order to accommodate the
threaded extension 26 of the sound 1, the removable tip 37 of the
sound is preferably longer than the removable tip shown in FIG. 3,
and it is also threaded on the inside.
[0151] FIG. 21 is a perspective view of the sleeve capture
embodiment of the present invention in which the catheter 13 is
inserted into the threaded extension 26 of the sound 1, but the
sleeve 27 is not installed over the threaded extension 26 of the
sound 1. FIG. 22 is a perspective view of the sleeve capture
embodiment of the present invention in which the catheter 13 is
inserted into the threaded extension 26 of the sound 1, and the
sleeve 27 is installed over the threaded extension 26 of the sound
1. The balloon 15 is shown in FIGS. 20 and 22 for orientation
purposes but is not necessary for this embodiment to function.
[0152] FIG. 23 is a partial section view of the catheter inserted
into the threaded extension of the sound and a section view of the
sleeve positioned over the catheter but not over the threaded
extension of the sound. This figure shows the catheter 13, the
sound 1, and the sleeve 27 with inner threads. It also shows the
catheter tip 14, the lateral holes 16 in the catheter tip 14, the
threaded extension 26, and the holes 29 in the threaded extension.
It also shows the pin 28 extending through the two lateral holes 26
in the catheter tip 14 and the two holes 29 in the threaded
extension. FIG. 24 is a partial section view of the catheter tip 14
inserted into the threaded extension 26 of the sound 1 and a
section view of the sleeve 27 positioned over the threaded
extension 26 of the sound.
[0153] FIGS. 25-35 illustrate the ball-on-a-wire embodiment of the
present invention. In this embodiment, a wire is passed through the
urethral sound and inside the catheter, a ball is attached to the
wire, the ball is pulled to the tip of the catheter, and the ball
is used to guide the catheter to the tip of the sound.
[0154] FIG. 25 is a section view of the urethral sound 1 of the
present invention inside the patient's bladder 9. FIG. 26 is a
section view of the urethral sound 1 of the present invention after
it has passed through the patient's abdominal wall 11. FIG. 27 is a
section view of the urethral sound 1 of the present invention with
a wire 30 passed through the sound. In practice, the wire will most
likely be passed through the sound and held at the tip of the sound
(so that it does not extend beyond the tip of the sound) as the
sound is passed through the patient's urethra and bladder. The wire
may then be advanced through the abdominal wall and act as a
"guidewire" for the sound. Alternatively, the wire could be
inserted into the sound after it has passed through the patient's
urethra and bladder and out the abdominal wall. The wire is
preferably similar to the Lunderquist-Ring torque guidewires or the
Amplatz super-stiff guidewires, and the thickness of the wire may
vary from approximately 0.10 to 0.20 centimeters. The distal end of
the wire may be treated with polyvinyl pyrrolidine or another
suitable substance so that it slides easily through the sound and
through the urethra, bladder and abdominal wall.
[0155] FIG. 28 is a section view of the urethral sound 1 of the
present invention with a wire 30 passed through the sound and a
catheter 13 on the wire. At this stage in the procedure, enough
wire is pushed through the sound so that the catheter can be placed
on the wire. FIG. 29 is a partial perspective view of the ball 31
and wire 30. After the wire is passed completely through the
catheter, a ball 31 is placed on the wire. The ball can be attached
to the wire in a number of different ways. For example, the wire
may be serrated, and a ball with matching grooves may be crimped
over the serrations in the wire. Alternatively, the wire may have a
small threaded section, the ball may be threaded on the inside, and
the ball may be screwed over the threaded section of the wire so
that it passes over the threaded section and onto the smooth
portion of the wire beyond the threads. The ball with then move
freely up and down the wire on only one side of the threaded
section (because the threads only allow the ball to move in one
direction) and will not be able to pass beyond the threaded section
when the wire is being used to pull the catheter into the bladder.
Although a ball is shown for illustrative purposes, any hook,
nodule or similar object could be used. FIG. 30 is a section view
of the urethral sound 1 of the present invention with a wire 30
passed through the sound and a catheter 13 and ball 31 on the wire.
FIG. 31 is a partial perspective view of the ball 31 on the wire
30.
[0156] Next, the wire 30 is pulled back through the sound 1 until
the ball 31 lodges in the tip 14 of the catheter 13. FIG. 32 is a
section view of the urethral sound 1 of the present invention with
a wire 30 passed through the sound, a catheter 13 and ball 31 on
the wire, and the ball 31 pulled to the tip 14 of the catheter.
FIG. 33 is a section view of the catheter tip 14 with the ball 31
on the wire 30 and inside the catheter tip.
[0157] Next, the wire is pulled back through the sound 1 until the
catheter tip 14 comes into contact with the tip 3 of the sound.
FIG. 34 is a section view of the urethral sound 1 of the present
invention with a wire 30 passed through the sound, a catheter 13
and ball 31 on the wire, the ball 31 pulled to the tip 14 of the
catheter, and the catheter tip 14 pulled to the tip 3 of the sound.
Next, the sound 1 is retracted (pulled inside the patient's body
and into the bladder), and the catheter 13 is guided by the ball 31
on the wire 30 into the patient's bladder 9, with the catheter tip
14 in contact with the tip 3 of the sound.
[0158] FIG. 35 is a section view of the urethral sound 1 of the
present invention with a wire 30 passed through the sound, a
catheter 13 and ball 31 on the wire 30, the ball 31 pulled to the
tip 14 of the catheter, the catheter tip 14 pulled to the tip 3 of
the sound, and the catheter 13 pulled into the bladder 9. Once the
catheter is in the desired position inside the bladder, the sound 1
is completely withdrawn through the patient's urethra, and the wire
30 is removed by pulling it out through the proximal end of the
catheter (the end with the inflation member 17 and drainage
connection 18). The balloon 15 is then inflated to keep the
catheter in place inside the bladder 9.
[0159] Although the sound is shown in FIGS. 27-28, 30, 32, and
34-35 with the removable tip, in practice it may be desirable to
remove the tip of the sound before the catheter is placed on the
wire. That way, the catheter tip and balloon may be inserted into
the end of the sound from which the removable tip was removed, and
the balloon may be inflated inside the rigid walls of the sound,
thereby providing additional stability for the catheter as it is
pulled into the patient's bladder.
[0160] FIGS. 36-39 illustrate an alternate method of capturing the
catheter on the wire. The procedure is the same as depicted in
FIGS. 25-35, but a hook is used instead of a ball. FIG. 36 is a
section view of the catheter 13 on a wire 30 with a hook 32. FIG.
36 illustrates one possible hook shape, but the present invention
is not limited to any particular hook shape. If this particular
type of hook is used, then it can be present on the wire before the
wire is inserted through the sound and into the catheter. With
other hook designs, the hook may need to be attached to the wire
after the wire has passed through the sound and through the
catheter, as discussed in connection with the ball-on-a-wire
embodiment.
[0161] FIG. 37 is a section view of the catheter 13 on a wire 30
with the hook 32 as it passes through the circular hole 19 in the
catheter tip 14. FIG. 38 is a section view of the hook 32 after it
has passed through the circular hole 19 and into the inside of the
catheter 13. FIG. 39 is a section view of the hook 32 on the wire
30 as the wire is being pulled back through the sound (not shown).
The hook 32 lodges in the catheter tip 14, thereby capturing the
catheter so that it can be pulled toward the tip of the sound (not
shown) and into the patient's bladder.
[0162] In yet another variation of the ball-on-a-wire and
hook-on-a-wire embodiments, the wire can simply be crimped after
the catheter is placed on the wire, such that the crimp serves the
same purpose as the ball or hook.
[0163] FIGS. 40-43 illustrate a number of different cutting tools
that can be used in connection with the ball-on-a-wire (or
hook-on-a-wire) procedure when the patient is so obese that the
physician cannot get the tip of the sound to pass through the
abdominal wall from the inside-out. FIG. 40 shows a knife 33 on the
wire 30. In this procedure, the knife 33 is placed onto the wire 30
after the wire is passed out through the patient's abdomen. The
knife 33 is then guided by the wire 30 as it is pushed through the
abdominal wall 11. When the knife 33 comes into contact with the
tip 3 of the sound, as shown in FIG. 41, the sound 1 is pulled back
slightly and the knife 33 is pushed down again until it comes into
contact with the tip 3 of the sound. This procedure ensures a
uniform cut where the tip of the sound was when the knife first
came into contact with it. The knife 33 is then removed from the
wire 30, and the catheter is placed onto the wire and guided into
the bladder using one of the methods described above (FIGS.
25-39).
[0164] FIGS. 40A and 40B are side views of two alternate
embodiments of the knife. As shown in these figures, the knife 33
comprises a leading edge 33a, which is sharp, and a threaded end
33c. The threaded end allows an extension to be added to the knife
for extra length. The knife also comprises blades 33b, which may be
shaped either as shown in FIG. 40A or FIG. 40B. In the preferred
embodiment, there are two knife blades 33b, which are oriented so
that there is a 180-degree spacing between them. In FIG. 40A, the
knife blades 33b form a hexagon shape, whereas in FIG. 40B, they
form a diamond shape. FIG. 40C is a section view of the knife,
showing the cut made by the knife blades 33b. Other than in claims
32 and 33, the present invention is not limited to any particular
shape of the knife or knife blades.
[0165] As shown in FIGS. 42 and 43, a trocar 34 may be used in lieu
of a knife for a quicker and easier incision. The trocar 34 is
loaded onto the wire and then pushed down until it makes contact
with the tip 3 of the sound. FIG. 42A is a section view of the
trocar. As shown in this figure, the trocar comprises trocar blades
34a on one end and inner threads 34b on the other end. The inner
threads allow the trocar to be attached to an extension if greater
length is needed. FIG. 42B is a perspective view of the trocar
showing the scalloped blades. FIG. 42C is a section view of the
trocar, showing the cut made by the trocar blades. The trocar
provides a different type of cut than the knife due to the way it
is shaped. The present invention is not limited to any particular
shape of the trocar or trocar blades.
[0166] FIG. 44 is a section view of the screwdriver on a wire. The
screwdriver may be used whenever the tip of the sound will not
reach the skin. The screwdriver enables the physician to remove the
tip of the sound so that a catheter can then be inserted over the
wire into the vacated distal end of the sound. As shown in this
figure, the screwdriver 35 is placed onto the wire 30 after the
wire is passed out through the patient's abdomen and after an
incision 36 has been made with one of the cutting devices depicted
in FIGS. 40-43. The screwdriver 35 is then guided by the wire 30 as
it is pushed through the abdominal wall 11. When the screwdriver 35
comes into contact with the tip 3 of the sound, as shown in FIG.
45, the screwdriver is used to unscrew the removable tip 3 from the
sound 1. In this procedure, a ball (not shown) or other nodule is
placed on the wire and advanced to the tip of the sound so that the
tip 3 can be removed from the patient's body by pulling the wire up
through the incision site 36 after the tip 3 has been unscrewed, as
shown in FIG. 46. Once the tip 3 is removed, the catheter (not
shown) can be placed on the wire (as described in connection with
the ball-on-a-wire, hook-on-a-wire and nodule-on-a-wire embodiments
described above) and the catheter tip advanced into the distal end
of the sound (the end from which the tip was removed). At that
point, the balloon is inflated to assist with lodging the catheter
inside the sound. The catheter and sound are pulled back out
through the urethra, the balloon is deflated, the wire with the
nodule is pulled out the abdominal end of the sound, the catheter
is separated from the sound, and the catheter is pulled back into
the bladder. The balloon is then re-inflated to maintain the
catheter in place, and the catheter is attached to drainage.
[0167] Although several preferred embodiments of the present
invention have been shown and described, it will be apparent to
those skilled in the art that many changes and modifications may be
made without departing from the invention in its broader aspects.
The appended claims are therefore intended to cover all such
changes and modifications as fall within the true spirit and scope
of the invention.
REFERENCES
[0168] (1) Raz, S., Campbell's Urology, 7.sup.th Ed., Vol. 1, p.
1092 (W B Saunders, 1998).
[0169] (2) Hendrix, S. L. et al., "Pelvic Organ Prolapse in the
Women's Health Initiative: Gravity and Gravidity," Am. J. Obstet.
Gynecol. 186(6): 1160-66.
[0170] (3) Waetjen et al., "Stress Urinary Incontinence Surgery in
the United States," Obstet. Gynecol. 101(4): 671-75 (2003).
[0171] (4) Olsen et al., "Epidemiology of Surgically Managed Pelvic
Organ Prolapse and Urinary Incontinence," Obstet. Gynecol. 89:
501-06 (1997).
[0172] (5) Wahle, G. et al., "Complications of Vaginal Surgery," in
Raz, S., Female Urology, 2.sup.nd Ed., pp. 623-24 (1996).
[0173] (6) Kobashi, K. and Leach, G., "Pelvic Prolapse," J Urol.
164(6): 1984 (2000).
Definitions
[0174] The term "cannula" means a flexible tube, usually containing
a trocar at one end, that is inserted into a bodily cavity, duct,
or vessel to drain fluid or administer a substance such as a
medication.
[0175] The term "catheter" means a hollow flexible tube for
insertion into a body cavity, duct or vessel to allow the passage
of fluids or distend a passageway.
[0176] The term "cystotomy" means a procedure in which an incision
is made into the bladder.
[0177] The term "ISC" means intermittent self-catheterization.
[0178] The term "PUR" means post-operative urinary retention.
[0179] The term "sound" means any elongated instrument or probe,
usually metallic, by which cavities of the body are sounded or
explored.
[0180] The term "SUI" means stress urinary incontinence.
[0181] The term "trocar" means a sharply pointed instrument,
usually with an attached cannula, used to perforate a hollow organ
and drain fluid.
* * * * *