U.S. patent application number 09/288865 was filed with the patent office on 2002-01-17 for urethral catheter holder.
Invention is credited to CLAUDE, JOHN P., INGLE, FRANK W., MOSEL, BRIAN J., ROY, LOREN L..
Application Number | 20020007159 09/288865 |
Document ID | / |
Family ID | 26801982 |
Filed Date | 2002-01-17 |
United States Patent
Application |
20020007159 |
Kind Code |
A1 |
MOSEL, BRIAN J. ; et
al. |
January 17, 2002 |
URETHRAL CATHETER HOLDER
Abstract
A urethral catheter holder (10), comprising a supporting base
(20); a suspension housing (22) mounted to supporting base (20); a
catheter securement device (24) adapted to hold a catheter (30)
passing longitudinally therethrough, catheter securement device
(24) being adapted to slide longitudinally within suspension
housing (22); and a biasing device (26) adapted to push a catheter
guide (28) of catheter securement device (24) into engagement with
the patient's external meatus (EM).
Inventors: |
MOSEL, BRIAN J.; (DUBLIN,
CA) ; ROY, LOREN L.; (SAN JOSE, CA) ; CLAUDE,
JOHN P.; (SAN CARLOS, CA) ; INGLE, FRANK W.;
(PALO ALTO, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Family ID: |
26801982 |
Appl. No.: |
09/288865 |
Filed: |
April 9, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60104818 |
Oct 19, 1998 |
|
|
|
Current U.S.
Class: |
604/349 ;
604/544 |
Current CPC
Class: |
A61B 18/1485 20130101;
A61B 5/202 20130101; A61B 5/205 20130101 |
Class at
Publication: |
604/349 ;
604/544 |
International
Class: |
A61M 001/00; A61F
005/44 |
Claims
What is claimed is:
1. A urethral catheter holder, comprising: a supporting base; a
suspension housing mounted to the supporting base; a catheter
securement device adapted to hold a catheter passing longitudinally
therethrough, the catheter securement device being adapted to slide
longitudinally within the suspension housing; and a biasing device
adapted to push the catheter securement device against the external
meatus of a patient's urethra.
2. The catheter holder of claim 1, wherein the catheter securement
device comprises: a torroidal balloon; a generally ring-shaped
balloon support mount surrounding the torroidal balloon; and a
pneumatic or hydraulic pressure tube for inflating and deflating
the torroidal balloon, the pressure tube passing through the
balloon support mount.
3. The catheter holder of claim 2, wherein, the pressure tube
extends from the torroidal balloon to a position external to the
suspension housing.
4. The catheter holder of claim 3, wherein the pressure tube moves
longitudinally in a groove in the suspension housing as the balloon
support mount slides longitudinally within the suspension
housing.
5. The catheter holder of claim 1, wherein, the catheter is
received longitudinally through the supporting base and the
suspension housing.
6. The catheter holder of claim 1, further comprising: a
longitudinally extending catheter guide mounted to the catheter
securement device.
7. The catheter holder of claim 6, wherein, the catheter securement
device is adapted to move in response to an abdominal pressure
pulse.
8. The catheter holder of claim 7, wherein, the catheter securement
device remains in generally the same position relative to a
surrounding urethra when the patient coughs.
9. The catheter holder of claim 7, wherein, longitudinal
displacement of the catheter securement device is approximately
equal to longitudinal displacement of the urethra of a patient
during the pelvic pressure pulse.
10. The catheter holder of claim 1, wherein, the biasing device is
a spring.
11. The catheter holder of claim 2, wherein, the torroidal balloon
is made of silicone rubber.
12. The catheter holder of claim 1, wherein, the support housing is
fabricated of aluminum or a polycarbonate material.
13. The catheter holder of claim 1, wherein, the supporting base is
adapted to register against the labia of the patient.
14. The catheter holder of claim 6, wherein, the catheter guide is
adapted to contact the urethral external meatus of the patient.
15. The catheter holder of claim 1, further comprising: a pair of
leg straps, with opposite ends of each leg strap fastened to the
supporting frame, such that each leg strap is adapted to be wrapped
around one of the patient's thighs.
16. The catheter holder of claim 1, further comprising: a
stretchable undergarment; and a plurality of leg straps, each leg
strap being attachable to the supporting frame at one end and to
the stretchable undergarment at an opposite end.
17. The catheter holder of claim 16, wherein, each leg strap is
attachable to the stretchable undergarment by a Velcro-type
fastener.
18. The catheter holder of claim 1, further comprising: a catheter
retraction device for withdrawing the catheter from the patient at
a controlled speed.
19. A system for evaluating female urinary incontinence,
comprising: a catheter having at least one pressure sensor
positioned thereon; and a catheter holder adapted to support the
catheter and to allow movement of the catheter in response to a
pelvic pressure pulse, wherein the movement of the catheter tracks
movement of the urethra of a patient during the pelvic pressure
pulse.
20. The system of claim 19, further comprising: a computer system
in communication with the pressure sensor of the catheter, the
computer system being adapted to generate a pressuregram of the
relationship between urethral pressure and vesicle pressure in
response to changes in pelvic pressure as the pressure sensor on
the catheter is moved through the urethra of a patient.
21. The system of claim 19 or 20, further comprising: a catheter
retraction device for withdrawing the catheter to selectively
position a pressure sensor on the catheter at each of proximal, mid
and distal positions along the urethra.
22. The system of claim 20, further comprising: a display terminal
adapted to display the pressuregram.
23. The system of claim 19, wherein the pressure sensing catheter
comprises: a catheter positioning surface positioned to engage soft
tissues of the urethra so as to inhibit movement of the catheter
within the urethra.
24. The system of claim 23, wherein the catheter positioning
surface comprises: a high friction surface of the catheter for
engaging the surrounding urethra.
25. The system of claim 24, further comprising: a removable sheath
positioned over the high friction surface of the catheter.
26. The system of claim 19, wherein the pressure sensing catheter
comprises: a balloon positioned to engage soft tissues of the
urethra so as to inhibit movement of the catheter within the
urethra when the balloon is inflated.
27. The urethral catheter of claim 1, wherein the catheter
securement device comprises: a mechanical clamp adapted to be
longitudinally movable within the suspension housing.
28. The urethral catheter of claim 27, wherein, the mechanical
clamp is secured to a longitudinally movable backing.
Description
[0001] This application claims the benefit and priority of U.S.
patent application Ser. No. 60/104,818, filed Oct. 19, 1998, the
full disclosure of which is hereby incorporated by reference for
all purposes.
TECHNICAL FIELD
[0002] The present invention relates to catheter based pressure
sensing systems for diagnosing female urinary incontinence, and in
particular to systems for determining the relationship between
urethral pressure and vesicle pressure in response to changes in
abdominal pressure. Preferred aspects of the present invention
relate to urethral catheter holder mechanisms.
BACKGROUND OF THE INVENTION
[0003] Female urinary incontinence can be evaluated by determining
the relationship between a patient's urethral pressure and her
vesicle (i.e.: bladder) pressure. Specifically, incontinence will
occur when her vesicle pressure exceeds her urethral pressure. A
continence margin can thus be defined by the difference between the
patient's urethral pressure and the vesicle pressure.
[0004] Both urethral pressure and vesicle pressure will change in
response to changes in abdominal pressure, however, the urethral
and vesicle pressures may change at different rates as the
abdominal pressure changes. Accordingly, incontinence may occur at
various abdominal pressures at which the vesicle pressure exceeds
the urethral pressure. Incontinence can therefore be evaluated by
producing a pressuregram showing the relationship between the
urethral pressure and the vesicle pressure of the patient at
different abdominal pressures.
[0005] Measuring the patient's vesicular and urethral pressures
with a pressure sensing catheter can be accomplished by moving a
pressure sensor on the catheter from the patient's bladder, (at
which the vesicle pressure is measured), through the patient's
urethra (at which maximum urethral pressure is measured).
Specifically, a urinary catheter with internal or external pressure
transducers can be used to take pressure measurements at the
proximal urethra, mid-urethra, and distal urethra. Typically, such
a pressure sensing catheter is first introduced through the urethra
into the bladder. The pressure sensing catheter is then withdrawn
through the urethra with pressure measurements taken at the
proximal urethra (being 5-10 mm from the urethro-vesicular
junction), the mid-urethra (being the point of maximum resting
urethral pressure) and the distal urethra, (being 5-10 mm from the
external meatus).
[0006] The measurements of the patient's vesicular and urethral
pressures are preferably taken at various abdominal pressures. Such
different abdominal pressures can conveniently be generated simply
by having the patient cough with different amounts of effort. For
example, a mild couch would generate a minimal increase in
abdominal pressure, whereas a more intense cough will generate a
greater abdominal pressure. The increase in abdominal pressure will
cause both the urethral and vesicle pressures to increase.
[0007] Unfortunately, such coughing will also tend to cause
movement of the patient's bladder and urethra. As such, it is
difficult to maintain the position of the pressure sensing catheter
relative to the urethra during the jarring movement of the urethra
caused by the patient coughing. Unwanted movement of the catheter
relative to the urethra caused by the jarring action of the patient
coughing tends to compromise the accuracy of the pressure
measurements.
[0008] It is important, therefore, to maintain the catheter at each
of the desired measurement positions in the urethra when taking the
pressure measurements. To date, an effective solution for
maintaining the position of the pressure sensing catheter at
preferred locations along the urethra when the urethra moves in
response to the patient's cough have not been found.
SUMMARY OF THE INVENTION
[0009] The present invention provides a female urethral catheter
holder which is adapted to support a pressure sensing catheter such
that the catheter can be positioned at various desired locations
along the patient's urethra, allowing for the catheter to move in
response to urethral movement, such that a pressure sensing
transducer disposed on the catheter does not move relative to the
urethra when the patient coughs.
[0010] In a preferred aspect of the present invention, the urethral
catheter holder comprises a supporting base, which is adapted to
register against the labia of the patient; a suspension housing
mounted to the supporting base; a catheter securement device,
(which is adapted to move within the suspension housing when the
patient coughs such that the catheter moves with the urethra); and
a biasing device. In preferred aspects, the catheter securement
device comprises a catheter guide which is adapted to contact
against the external meatus of the patient's urethra. The biasing
device operates to provide a pre-loading force on the catheter
guide, thereby holding the catheter guide against the external
meatus of the patient's urethra such that the catheter securement
device moves with the movement of the urethra. Additionally, the
biasing device operates to push the catheter securement device
against the supporting base, thereby minimizing unwanted motion of
the catheter securement device within the suspension housing.
[0011] The catheter securement device is adapted to support the
catheter in a manner such that the catheter moves in response to
movement of the urethra, with the catheter remaining in generally
the same position relative to the surrounding urethra when the
patient coughs. In a preferred aspect, the catheter securement
device comprises a torroidal balloon, a generally ring-shaped
balloon support mount surrounding the torroidal balloon and a
pneumatic or hydraulic pressure tube for inflating or deflating the
torroidal balloon. The catheter passes longitudinally through the
catheter holder and is received through the orifice defined by the
torroidal balloon. Inflation of the torroidal balloon will cause it
to expand radially inwardly such that it's central orifice
contracts, thereby gently pushing against the sides of the
catheter.
[0012] In other preferred aspects of the invention, the catheter
securement device comprises a mechanical clamp which is mounted to
move longitudinally within the suspension housing.
[0013] Optionally, the present urethral catheter holder may also
comprise a pair of leg straps, which can be wrapped around the
patient's thighs, (or a stretchable undergarment with leg straps
attachable thereto), such that the supporting base of the catheter
holder can be held at a generally fixed position against the labia
of the patient. An advantage of such leg straps is that pressure
measurements can then be taken easily with the patient in different
positions, including supine and sitting. An additional advantage of
the present system is that it allows hands-free operation for the
clinician.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an exploded view of the urethral catheter
holder.
[0015] FIG. 2 is a top view of the urethral catheter holder.
[0016] FIG. 3 is a front view of the urethral catheter holder.
[0017] FIG. 4 is a right-side view of the urethral catheter
holder.
[0018] FIG. 5 is a rear view of the urethral catheter holder.
[0019] FIG. 6 is a sectional plan view of the urethral catheter
holder taken along line 6-6 in FIG. 5.
[0020] FIG. 7A is a sectional elevation view of the urethral
catheter holder taken along line 7-6 in FIG. 5.
[0021] FIG. 7B is a view corresponding to FIG. 7A, but with a
catheter received therethrough.
[0022] FIG. 8 shows positioning of the catheter holder by way of
leg straps.
[0023] FIG. 9 shows positioning of the catheter holder by way of
leg straps and a stretchable undergarment.
[0024] FIG. 10 is a schematic view of a system for evaluating
female urinary incontinence incorporating the present urethral
catheter holder.
[0025] FIG. 11 is an illustration of a pressuregram showing the
relationship between the vesicle pressure and the urethral pressure
for two different patients at different abdominal pressures.
[0026] FIG. 12 shows a mechanical clamp for use in the catheter
securement device.
[0027] FIG. 13 shows a perspective view of an alternate embodiment
of the present invention, comprising the mechanical clamp of FIG.
12.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0028] In preferred aspects of the present invention, a urethral
catheter holder is provided. FIG. 1 shows an exploded view of the
assembly of urethra catheter holder 10, comprising a supporting
base 20, a suspension housing 22, a catheter securement device 24,
a biasing element 26, and a catheter guide 28. Assembled views of
catheter holder 10 are shown in FIGS. 2, 3, 4, and 5. As shown in
FIG. 2, a catheter 30 is received longitudinally through catheter
holder 10, as shown.
[0029] Catheter holder 10 is adapted to hold catheter 30 such that
supporting base 20 can remain in contact with the patient's labia
while catheter 30 moves longitudinally in response to movement of
the patient's urethra when the patient coughs. Accordingly, one
advantage of the present invention is that catheter 30 can be
positioned to remain in at the same relative location with respect
to the patient's urethra when the patient coughs. The ability of
catheter securement device 24 to hold catheter 30 to allow for
catheter movement in response to urethra movement, without tightly
pinching catheter 30 is accomplished by the present novel catheter
securement system, as follows.
[0030] Referring to FIGS. 6 and 7A, catheter securement device 24
preferably comprises a torroidal balloon 41, a generally
ring-shaped balloon support mount 42, a pneumatic or hydraulic
pressure tube 43, and a catheter guide 28, as shown. Together,
torroidal balloon 41, balloon support 42, pressure tube 43, and
catheter guide 28 are adapted to slide longitudinally as a unit
within the suspension housing 22. A bushing 29, which may be made
of Teflon, is provided to enable catheter guide 28 to slide freely
through supporting base 20. Biasing element 26, which may
preferably comprise a mechanical spring, provides a pre-loading
force which gently pushes catheter guide 28 against the external
meatus EM of the patient's urethra 50, (see FIG. 10). Accordingly,
catheter guide 28 will move together with the patient's urethra
such that catheter guide 28 identically tracks the movement of
urethra 50.
[0031] As shown in FIG. 7B, catheter 30 is preferably received
through an opening 23 in suspension housing 22 and passes
longitudinally through catheter holder 10, as shown. Torroidal
balloon 41 is inflated by way of pressure tube 43, which can be
connected a pneumatic or a hydraulic pressure system (not shown).
As torroidal balloon 41 is inflated, its center orifice will tend
to close as the innermost sides of balloon 41 expand inwardly,
thereby gently pushing radially inwardly upon the side of catheter
30 around its circumference, thus holding catheter 30 in a fixed
position relative to balloon 41.
[0032] Catheter securement device 24, (comprising torroidal balloon
41, support mount 42, pressure tube 43, and catheter guide 28), is
adapted to slide longitudinally within suspension housing 22. As
can be seen in FIGS. 1 and 4, a groove 45 running longitudinally
through suspension housing 22 provides freedom of longitudinal
movement for pressure tube 43, which passes therethrough, as
shown.
[0033] In preferred aspects of the invention, torroidal balloon 41
is made of silicon rubber, and support housing 22 and catheter
guide 28 are made either of aluminum, or a polycarbonate material.
It is to be understood, however, that support housing 22 and
catheter guide 28 can be made of any suitable bio-compatible
material.
[0034] Further structural details of the present invention are seen
in the exploded view of FIG. 1. A pair of fasteners 50 can be used
to secure housing flange 52 to supporting base 20. Backing plates
54 and 56 can also be provided on opposite sides of catheter
securement device 24. Backing plates 54 and 56 may preferably be
made of aluminum. Fasteners 58 can be provided for securing backing
plates 54 and 56 to catheter securement device 24.
[0035] An alternate embodiment of the catheter securement device is
shown in FIGS. 12 and 13. The system shown in FIGS. 12 and 13
operates similar to catheter system 24, moving to track movement of
the patient's urethra, as explained herein. Instead of requiring a
torroidal balloon and balloon support mount, a mechanical clamping
system which moves longitudinally is response to urethral movement
is provided.
[0036] Referring to FIG. 12, a mechanical clamp 70 is provided.
Clamp 70 comprises a pair of hard opposite portions 72 and 74
supporting soft inner surfaces 73 and 75 which may be manufactured
of silicone or medical tubing. A notch 71 is provided for
supporting a catheter therein as illustrated in FIG. 13. A spring
76 will bias hard opposite portions 72 and 74 together, closing
clamp 70 around a catheter received therein. As seen in FIG. 13,
clamp 70 can be mounted to a backing 80, wherein backing 80 moves
longitudinally in suspension housing 22 under the influence of a
biasing element, (functioning in the manner of biasing element 26
as herein described). As can be seen, levers 77 and 79 project out
through groove 43. Pinching on levers 77 and 79 causes opposite
portions 72 and 74 to separate, such that catheter 30 can be
received therein. Levers 77 and 79 move longitudinally in groove 43
when catheter groove 28 and backing 80 move in response to movement
of the patient's urethra. Clamp 70 may be secured to backing 80 by
a pair of pins 78. It is to be understood that other mechanical
clamping systems are possible, all keeping within the scope of the
present invention, including the use of both expansion and
compression springs to cause the mechanical clamp to securely hold
the catheter in position.
[0037] In a preferred aspect of the invention, optional leg straps
are provided for registering the supporting base 20 of catheter
holder 10 against the labia of the patient as catheter guide 28
moves with the urethra. Referring to FIG. 8, catheter holder 10 can
be held in position with two leg straps 12 connected at opposite
ends to supporting base 20, as shown. Alternatively, as shown in
FIG. 9, a stretchable undergarment 60 can be worn by the patient.
Undergarment 60 has an opening 62 over which catheter holder 10 can
be fastened in position by way of four leg straps 13, wherein each
of leg straps 13 have a Velcro-type patch 15 at their ends as shown
for connecting fastening leg straps 13 directly to stretchable
undergarment 60. Leg straps 12 may themselves be secured to slots
48 in supporting base 20 either by hooks (not shown) or by passing
an end of each leg strap 12 through slot 60 and then folding the
leg strap over upon itself and securing it into position with a
Velcro-type fastener.
[0038] In another aspect of the present invention, a system for
evaluating female urinary incontinence is provided. Preferably, the
system for evaluating female urinary incontinence comprises the
present urethral catheter system as above described. Referring to
FIG. 10, catheter 30 has pressure sensors 32 and 34 disposed
thereon, as shown. Catheter 30 is preferably inserted through
urethra 50 into bladder B. Catheter 30 is then controllably
retracted through urethra 50 by a mechanical retractor 60.
Accordingly, pressure sensors 32 and 34 can be positioned to take
pressure measurements at each of the proximal urethra PU (which is
located approximately 5-10 mm from the urethro-vesicular junction
U-VJ), the mid-urethra MU, (where the vesicle pressure is
greatest), to the distal urethra (which is located approximately
5-10 mm from the external meatus EM). It is to be understood that
the present invention can operate with one or more pressure sensors
32 and 34 since catheter 30 can be retracted through urethra 50. As
can be seen, supporting plate 20 rests against the patient's labia
L.
[0039] In a preferred aspect, catheter 30 can comprise a catheter
positioning surface 31, such as an expandable balloon positioned
between the patient's distal urethra DU and external meatus EM to
engage soft tissues of urethra 50 so as to inhibit movement of
catheter 30 within urethra 50 when the patent coughs.
Alternatively, the outer surface of catheter 30 can be textured so
as to gently grip against the sides of urethra 50, thereby holding
catheter 30 in a fixed relative position to urethra 50. In a
preferred aspect, a removable sheath is preferably received over
the high friction surface such that the catheter can be
conveniently inserted into the patient and positioned at a desired
location. The sheath is then removed, such that the high friction
surface of the catheter engages the walls of the urethra.
Alternatively, fluid may be injected into the urethra, causing it
to expand while the high friction surface catheter is inserted.
Removal of the fluid surrounding the catheter will cause the
urethra to collapse inwardly, such that the high friction surface
of the catheter engages the walls of the urethra.
[0040] The pressures measured by pressure sensor 30 are received by
computer system 62 and are displayed as a pressuregram on display
terminal 64. FIG. 11 shows an exemplary pressuregram in which
urethral pressure is plotted against vesicle pressure. The
pressuregram shows the relationship between urethral and vesicle
pressure for two different patients for different abdominal
pressures caused by the patient coughing. Patient A's urethral
pressure always exceeds her vesicle pressure, therefore patient A
remains continent. For patient "B", however, her urethral pressure
may be above or below her vesicle pressure, (as signified by her
pressure data dropping below line P.sub.urethral-P.sub.vesicular),
thus indicating incontinence at certain abdominal pressures.
* * * * *