U.S. patent application number 09/952310 was filed with the patent office on 2002-06-27 for intravesicular balloon.
This patent application is currently assigned to INNOVENTIONS, INC. Invention is credited to Hirszowicz, Eran, Yachia, Daniel.
Application Number | 20020082551 09/952310 |
Document ID | / |
Family ID | 23021511 |
Filed Date | 2002-06-27 |
United States Patent
Application |
20020082551 |
Kind Code |
A1 |
Yachia, Daniel ; et
al. |
June 27, 2002 |
Intravesicular balloon
Abstract
An expandable balloon for insertion into the urinary bladder of
an individual. The balloon may be used in treating the urinary
bladder, in monitoring the urinary bladder or in the treatment of
urinary incontinence.
Inventors: |
Yachia, Daniel; (Herzliya
onSea, IL) ; Hirszowicz, Eran; (Ramat-Chen,
IL) |
Correspondence
Address: |
LADAS & PARRY
26 WEST 61ST STREET
NEW YORK
NY
10023
US
|
Assignee: |
INNOVENTIONS, INC
|
Family ID: |
23021511 |
Appl. No.: |
09/952310 |
Filed: |
September 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09952310 |
Sep 13, 2001 |
|
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|
09268109 |
Mar 15, 1999 |
|
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|
6293923 |
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Current U.S.
Class: |
604/103.01 ;
606/195 |
Current CPC
Class: |
A61F 2/0027 20130101;
A61M 25/0074 20130101; A61M 2210/1085 20130101; A61M 2209/04
20130101 |
Class at
Publication: |
604/103.01 ;
606/195 |
International
Class: |
A61M 029/00 |
Claims
1. An expandable balloon for insertion into the urinary bladder of
an individual, the balloon having a wall and a lumen.
2. The balloon according to claim 1, being formed with a magnetable
portion.
3. The balloon according to claim 2, wherein the magentable portion
of the balloon comprises one or more magnetable particles in the
lumen of the balloon.
4. The balloon according to claim 2, wherein the magnetable portion
of the balloon comprises one or more magnetable particles attached
to the wall of the balloon.
5. The balloon according to claim 2, wherein the magentable portion
of the balloon comprises one or more magnetable particles embedded
in the wall of the balloon.
6. The balloon according to any one of the preceding claims in
which the balloon further comprises a self-sealing valve.
7. The balloon according to any one of the previous claims, wherein
the balloon upon expansion floats in the bladder.
8. The balloon according to any one of claims 1 to 6, wherein the
balloon sinks in the bladder.
9. The balloon according to any one of the previous claims, wherein
the balloon is capable of storing one or more compounds and
releasing them into the urinary bladder.
10. The balloon according to claim 9, wherein the one or more
substances are stored in the lumen of the balloon.
11. The balloon according to claim 9, wherein the one or more
substances are stored in the wall of the balloon.
12. The balloon according to any one of claims 9 to 11, wherein one
or more of the one or more substances are drugs or antibiotics.
13. The balloon according to any one of claims 9 to 11, wherein one
or more of the one or more substances are radioactive
substances.
14. The balloon according to any one of the previous claims,
further comprising a device for imaging the urinary bladder.
15. The balloon according to any one of the previous claims,
further comprising one or more devices for monitoring urinary
bladder parameters and its contents.
16. The balloon according to claim 15, wherein one or more of the
one or more devices monitors a parameter of the urinary bladder
selected from the list comprising: (a) bladder pressure; (b) urine
temperature; (c) urine density; (d) urine composition.
17. The balloon according to claim 14, further comprising a
transmitter imaging for transmitting signals from the imaging
device to a receiver.
18. The balloon according to claim 15 or 16, further comprising a
transmitter for transmitting signals from the monitoring device to
a receiver.
19. A system for treating the urinary bladder of an individual, the
system comprising: (a) a balloon according to any one of the
previous claims; (b) an applicator for inserting the balloon into
the urinary bladder of an individual or for removing the balloon
from the individual's urinary bladder, the applicator fitted at an
end thereof with a gripping device for releasably gripping the
balloon; (c) an expanding device for expanding the balloon in the
individual's urinary bladder; and (d) a magnetable displacing
member for displacing the balloon within the urinary bladder.
20. The system according to claim 19, further comprising an
immobilizing member comprising a magnetable portion, said
immobilizing member being secured onto the individual's body for
immobilizing the balloon at a desired location in the individual's
urinary bladder.
21. The system according to claim 20, wherein the immobilizing
member is in the form of a hygienic pad to be placed in the
individual's underwear.
22. The system of any one of claims 19 to 21, wherein the gripping
device comprises flanges.
23. The system of any one of claims 19 to 21, wherein the gripping
device comprises a magnetable portion.
24. The system of any one of claims 14 to 23, wherein the expanding
device comprises an injector for injecting a fluid into the balloon
so as to expand the balloon.
25. The system of any one of claims 19 to 23, wherein the expanding
device comprises a decompressor for decompressing a previously
compressed balloon so as to expand the balloon.
26. The system according to any one of claims 19 to 25, for use in
the treatment of a disorder selected from the list comprising: (a)
urinary incontinence; (b) urinary bladder infections; (c) urinary
bladder tumors; (d) bladder dysfunction.
27. The system according to any one of claims 19 to 25 comprising a
balloon according to claim 18, further comprising a receiver
receiving signals from said transmitter.
28. The system according to claim 27, further comprising one or
more components selected from the list comprising: (a) a processing
unit processing signals received from the receiver; (b) a display
for displaying signals received by the receiver; (c) a display for
displaying an output produced by a processing unit.
29. The system according to any one of claims 27 or 28, for use in
monitoring one or more urinary bladder parameters selected from the
list comprising: (a) urine temperature; (b) bladder pressure; (c)
urine density; (d) urine conductivity; (e) urine composition.
30. The system according to any one of claims 19 to 25, comprising
a balloon according to claim 17, further comprising a receiver
receiving signals from said transmitter.
31. The system according to claim 30, further comprising one or
more components selected from the list comprising: (a) a processing
unit processing signals received from the receiver; (b) a display
for displaying signals received by the receiver; (c) a display for
displaying an output produced by a processing unit.
32. The system according to any one of claims 30 or 31, for use in
imaging the urinary bladder of an individual.
33. A method for treating urinary incontinence in an individual
comprising the steps of: (a) inserting a balloon of any one of
claims 2 to 18 into the individual's urinary bladder; (b) expanding
the balloon in the urinary bladder; (c) displacing the balloon into
a sealing position for sealing the urinary bladder; and (d)
displacing the balloon within the urinary bladder into an unsealing
position for voiding the urinary bladder.
34. A method for releasing one or more substances into the urinary
bladder of an individual comprising the steps of: (a) loading the
one or more substances into a balloon according to any one of
claims 9 to 13; (b) inserting the balloon into the individual's
urinary bladder; (c) expanding the balloon in the urinary bladder;
and (d) displacing the balloon within the urinary bladder to a
desired location.
35. The method of claim 34, wherein one or more of the one or more
substances are selected from the list comprising: (a) drugs; (b)
antibiotics; and (c) radioactive substances.
36. A method for monitoring the interior of an individual's urinary
bladder comprising the steps of: (a) inserting a balloon according
to claim 17 into the individual's urinary bladder; (b) expanding
the balloon in the urinary bladder; (c) displacing the balloon
within the urinary bladder to a desired location within the urinary
bladder; and (d) transmitting signals from one or more of the one
or more monitoring devices to a receiver.
37. A method for imagining the interior of an individual's urinary
bladder comprising the steps of: (a) inserting a balloon according
to claim 17 into the individual's urinary bladder; (b) expanding
the balloon in the urinary bladder; (c) displacing the balloon
within the urinary bladder to a desired location within the urinary
bladder; and (d) transmitting signals from the imaging device to a
receiver.
38. The method of claims 36 or 37, further comprising one or more
steps selected from the list comprising: (a) storing the signals in
a computer memory; (b) displaying the signals on a display; (c)
processing the signals in a computer processing unit; (d) storing
results of the processing in a computer memory; and (e) displaying
results of the processing on a display.
Description
FIELD OF THE INVENTION
[0001] The invention is in the field of medical devices. More
specifically, the invention relates to devices for the treatment of
urinary bladder disorders.
BACKGROUND OF THE INVENTION
[0002] Several disorders of the urinary tract are known. Among
these are urinary incontinence, chronic urinary tract infections,
urinary bladder tumors.
[0003] Urinary Incontinence
[0004] Urinary incontinence mostly affects women (approximately 10
million in the U.S.A. alone) primarily after childbirth or due to
old age. In men, urinary incontinence often occurs as a
complication of surgery or old age (approximately 3 million in the
U.S.A.).
[0005] Incontinence has serious economic, health, social and
psychological consequences. Its estimated cost to the health system
in the United States in 1993 was US $16 billion. It leads to
chronic and severe skin irritation in the genital area, an increase
in urinary infections and urosepsis. Fear of incontinence and odors
in public cause incontinent people to severely restrict their
social activities. The impact on the mental health of the affected
people may be even more devastating than the social and health
consequences. They suffer severe embarrassment, loss of
self-esteem, depression and anxiety.
[0006] Urinary incontinence can be divided into 4 groups:
[0007] Stress Incontinence--is the involuntary release of urine due
to a sudden increase in the intraabdominal pressure caused by
laughing, sneezing, coughing, running, etc. This is the most common
type of incontinence and in women may be the result of childbirth,
estrogen deficiency, unsuccessful surgical repairs for incontinence
or pelvic irradiation. In men, it often happens after surgery for
benign enlargement of the prostate gland or after radical removal
of the prostate.
[0008] Total Incontinence--is the continuous leak of urine entering
the bladder due to failure of the sphincteric muscles.
[0009] Urge Incontinence--is involuntary loss of urine due to
involuntary bladder contractions. This type of incontinence mostly
affects the elderly who leak until they reach a toilet.
[0010] Mixed Incontinence--is a combination of stress and urge
incontinence. This condition is more common in elderly women than
men.
[0011] Ideally, treatment of incontinence should provide permanent
dryness and is easy to perform.
[0012] Pharmacological treatments of bladder dysfunctions are based
either on estrogen replacement for treating post-menopausal vaginal
and urethral atrophy or on agents affecting the tonus of the
bladder muscle. Since affected elderly women suffer from both
hormonal deficiency and urge incontinence, both types of agents are
usually prescribed simultaneously.
[0013] Surgical treatments are based on restoring the anatomical
changes causing the incontinence. Although in the short-term most
surgical procedures restore continence, the long-term prognosis is
usually unsatisfactory. Moreover, surgery entails morbidity and
high expenses.
[0014] Conservative/behavioral treatments are based on pelvic floor
muscle exercises, bladder training, biofeedback, vaginal cones,
low-frequency electrostimulation of pelvic floor muscles,
intravaginal bladder neck support pessaries, urethral meatus
suction cups and intraurethral devices. Conservative treatments are
time consuming and require the patients' understanding, cooperation
and persistence.
[0015] Devices which have been used to obtain almost immediate
dryness in incontinent people can be divided into two groups:
[0016] (1) Urethral Plugs/Inserts
[0017] These comprise a flexible rod having a 14 Ch. (approximately
4.5 mm) diameter and a length adjusted to fit the length of the
patient's urethra. The rod has an inflatable balloon on its bladder
end and a flange at other end. After insertion of the device, the
balloon is inflated in the bladder. The balloon and the flange
maintain the device in its proper position within the urethra. The
balloon and rod form a mechanical barrier to retain the urine
within the bladder. The balloon must be deflated and the device
removed and discarded prior to voiding. Such inserts are known in
the art, for example, the device known as RELLANCE.TM. produced by
UroMed Corp., U.S.A.
[0018] Since inserts are discarded after each voiding and replaced
with a new one by the patient, manual dexterity of the patient is
required. Insertion of an insert into a female has the risk of
pushing vaginal and perineal bacteria into the bladder and
insertion of an insert a few times a day increases this risk. The
inconvenience of removing and inserting a new device and its costs,
in addition to the infection risk, are the major disadvantages of
these devices.
[0019] (2) Valve Catheters
[0020] These comprise a tube with a valve at one end. The bladder
end of the device typically has a balloon or flanges for retaining
the device in place and a flange at the other end to prevent
migration into the bladder. The valve is opened for voiding through
the lumen of the catheter with the help of an external magnet. The
tube typically has a 18 Ch. (6 mm.) to 20 Ch. (approximately 7 mm)
diameter and a length adjusted to fit the patient's urethra. For
male incontinence, an active intraurethral Foley-type catheter is
used. This device has a retaining balloon at its bladder end and
another smaller balloon under the prostate for fixing the device in
place. The magnet activated valve is situated at the end of the
device near the distal end of the urethra. Active inserts are
typically left indwelling up to 4 weeks and are then replaced.
Examples of such catheters are disclosed in U.S. Pat. Nos.
5,030,199 and 5,234,409.
[0021] Valve catheters are more convenient for the patient than the
inserts. However, in females they cause ascending infection because
they connect the bladder with the vulva which is rich in pathogenic
bacteria, expecially Escherichia Coli. Even with continuous use of
antibiotics, infection is unpreventable in the majority of
cases.
[0022] During prolonged use of catheters or inserts in female
patients, a relaxation of the urethra occurs and the patients may
start to leak around the device. Unfortunately valve catheters and
inserts are unavailable in increasing diameters.
[0023] A significant disadvantage of both the inserts and the valve
catheters is the discomfort felt by the patient especially when
sitting and during sexual intercourse (felt by the patient and the
partner). The present invention therefore provides a device for the
treatment of urinary incontinence in which the disadvantages of the
prior art devices are substantially reduced or eliminated.
[0024] Urinary Tract Infections
[0025] Nearly half of all women experience urinary tract infection
(UTI) at some point in their lifetime and most of these infections
are confined to the bladder. Isolated UTIs can be treated by short
and effective antibiotic treatment. However, recurrent UTIs often
occur in women due to antibiotic resistant bacteria. In this case
complicated infections often exhibit multidrug resistance and
necessitate longer antimicrobial drug administrations.
[0026] Treatment of UTI often requires urinary levels of
antimicrobial drugs that are several hundred times greater than
those allowable in the blood. Many antibacterials cannot be used in
UTI because, when taken orally or intravenously, they do not attain
the required concentration in the urine, without exceeding the
allowable limit in the blood. It would therefore be desirable to be
able to continuously introduce antimicrobial drugs continuously and
directly into the bladder.
[0027] Bladder Tumors
[0028] Even after resection, bladder tumors may not only recur but
may also invade deeper in the bladder wall. Due to the heterogenity
of these tumors (from low-grade tumors showing a benign course to
highly malignant high-grade tumors), there does not exist a single
approach to the surveillance and treatment of these tumors.
Intravesical drug therapies are often used for reducing tumor
recurrence. In this approach, an immunotherapeutic or
chemotherapeutic agent is inserted into the bladder through a
catheter. This treatment is typically repeated once a week for 6
weeks and then once a month for a period of 6-12 months. However,
periodic treatment has not been established as being effective in
altering the progression of the tumor. Continuous local treatment
with chemotherapeutic or radioactive materials may treat or prevent
not only superficial tumors but also deep tumors as well. It would
therefore be desirable to be able to introduce antitumoral drugs
continuously and directly into the bladder.
[0029] Bladder Dysfunction
[0030] During filling, the bladder muscle relaxes for keeping the
intravesical pressure low while it contracts for voiding. Certain
diseases such as spinal cord injuries, diabetes, multiple
sclerosis, or hormonal changes after menopause or old age in both
sexes may cause a hypo contractility or, paradoxically, hyper
contractility of the muscle. In atonic bladder, pharmacological
treatment is not very effective. In hyperreflexic bladder, drugs
for relaxing the bladder cause constipation and mouth dryness and
are therefore not tolerated well by the patients.
[0031] Diagnosis of bladder dysfunction requires continuously
monitoring various bladder parameters during filling and/or
voiding. These measurements usually are made by inserting a
catheter connected to a measuring device into the bladder. This is
done, for example, in uroflowmetry (measurement of urinary flow
rate) which is non-invasive, simple and inexpensive. However, its
sensitivity and specificity are low. Cystometry is an invasive
technique for measuring bladder capacity, compliance and muscle
tonus. Pressure-flow study is an invasive and costly test for
distinguishing patients with low urinary flow due to obstruction or
bladder antonia, from those with high intravesical pressure and
high urinary flow. It is therefore a need in the art for a simple
and inexpensive technique for intravesicular monitoring.
[0032] In the diagnostic procedure known as "urodynamics", the
bladder is filled through a catheter, and the response of the
bladder is monitored. Available 24 hour urodynamics monitors have
catheters or wires passing through the urethra, connecting sensors
inserted into the bladder to a recorder. The connecting wires and
catheters inadvertently introduce pathogenic bacteria from the
genital areas into the bladder. It is therefore desirable to be
able to monitor bladder function over several cycles of filling and
voiding without the need for such wires or catheters.
[0033] Diagnosis of some intravesical pathological conditions often
involves inserting an endoscope into the bladder and optically
scanning the bladder walls. In cases of bleeding in the ureters or
the kidneys, the observation of blood coming through the ureteral
orifices allows determination of the origin of the bleeding.
However. if the bleeding has temporarily stopped at the time of the
examination, or if the blood concentration in the urine is
insufficient to make the urine red or pink, endoscopy is of little
value in reaching a diagnosis. In such cases more invasive
procedures are performed in order to enter the upper urinary tract.
It is therefore desirable to be able to monitor the bladder over
long periods of time.
[0034] Bladder shape during filling and its contraction during
voiding is important for the diagnosis of certain bladder
pathologies. These functions can be followed in fluoroscopy and by
sonography. These techniques however are not accurate and cannot be
used for monitoring changes in bladder shape over long periods of
time. It would therefore be desirable to be able to continuously
image the bladder interior over long periods of time.
[0035] The present invention therefore provides a device for
continuous monitoring of the bladder interior and for the treatment
of bladder disorders in which the disadvantages of the prior art
devices are substantially reduced or eliminated.
SUMMARY OF THE INVENTION
[0036] The present invention provides a system comprising an
expandable balloon to be inserted into the urinary bladder. The
balloon may be filled and compressed prior to insertion and then
allowed to expand after insertion in the bladder. Alternatively,
the balloon may be filled after insertion so as to expand in the
bladder.
[0037] The invention may be used for the intermittent sealing of
the urinary bladder outlet and the prevention of involuntary urine
leakage. Sealing the urinary bladder outlet involves lodging the
balloon in the outlet so as to seal it. Unsealing the outlet to
allow voiding of the bladder involves dislodging the balloon from
the outlet.
[0038] The invention may also be used for such purposes as for
example, delivery of drugs, imaging the urinary bladder, and
measuring intravesicular parameters such as pressure in the urinary
bladder. When used for such purposes, the balloon may be, for
example, lodged in the urinary bladder outlet, immobilized in some
other desired location in the bladder, freely floating in the urine
in the bladder, etc.
[0039] The invention is entirely confined to the urinary bladder
and has no urethral parts. As will become apparent in the
description below, the balloon is easily inserted and removed. It
may be left in the bladder for prolonged periods of time without
encrusting or causing infections and is displaced within the
bladder at will using a hand held magnet. The invention is
comfortable for the patient and does not interfere with the daily
activities of the patient including sitting, jogging, riding, or
sexual intercourse.
[0040] The invention thus provides an expandable balloon for
insertion into the urinary bladder of an individual, the balloon
having a wall and a lumen and formed with a magnetable portion.
[0041] The invention also provides a system comprising the balloon
together with an applicator for inserting and retrieving the
balloon, a displacing member for displacing the balloon within the
bladder, and an immobilizing member for immobilizing the balloon at
a desired location in the bladder.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] In order to understand the invention and to see how it may
be carried out in practice, a preferred embodiment will now be
described, by way of non-limiting example only, with reference to
the accompanying drawings, in which:
[0043] FIG. 1 shows various embodiments of the balloon according to
the invention;
[0044] FIG. 2 shows a portion of a balloon according to the
invention having a duck-bill valve;
[0045] FIG. 3 shows a portion of a balloon according to the
invention having a ball valve;
[0046] FIG. 4 shows a balloon filled after have been inserted into
the urinary bladder;
[0047] FIG. 5 shows a balloon filled before being inserted into the
urinary bladder;
[0048] FIG. 6 shows a balloon comprising diffusible substances
within its wall or lumen;
[0049] FIG. 7 shows a balloon comprising a microvideo camera;
[0050] FIG. 8 shows a balloon comprising devices for measuring
urinary bladder parameters;
[0051] FIG. 9 shows use of an applicator for inserting a balloon
into the urinary bladder of a female individual;
[0052] FIG. 10 shows use of an applicator for inserting a balloon
into the urinary bladder of a male individual;
[0053] FIG. 11 shows a retrieval device for retrieving a
balloon;
[0054] FIG. 12 shows use of a displacing member to displace a
balloon into a sealing position within the urinary bladder;
[0055] FIG. 13 shows use of a displacing member to displace a
balloon from a sealing position in the urinary bladder; and
[0056] FIG. 14 shows use of an immobilizing member.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0057] Reference is now made to FIG. 1 which shows several
embodiments of the invention. An expandable hollow balloon
generally designated as 1 has a wall 2 made of an elastic
biocompatible material enclosing a lumen 4. The balloon 1 may
further comprise a magnetable portion which may consist for
example, of one or more metal particles which may be free in the
lumen 3a (as in FIG. 1b), attached to the inner surface 3b (as in
FIG. 1c) or embedded in the wall 3c of the balloon (as in FIG. 1d).
The lumen 4 of balloon 1 may be filled with a biocompatible fluid
which may be presterilized such as air, water, saline or an oil
such as liquid paraffin.
[0058] A self-sealing valve 5 in the wall of the balloon is used to
fill the balloon. The valve 5 may be for example a duck-bill type
valve as shown in FIG. 2 or a ball valve as shown in FIG. 3 in
which a ball 8 may be in a sealing position (FIG. 3a) or an
unsealing position (FIG. 3c). The canula 6 of a syringe 7 is
inserted through the valve 5 into the lumen 4 of the balloon. The
fluid injected into the lumen 4 causes the balloon to expand. After
filling, the syringe needle 6 is withdrawn, and the valve 5 seals
itself. After filling, the balloon may adopt a predetermined shape,
for example, a sphere, ellipsoid, or an irregular shape. The filled
inflated balloon may float or sink in urine.
[0059] As shown in FIG. 4, the balloon may first be inserted into
the bladder by means of an applicator 20 to be described below in
detail (FIG. 4a) and following its release from the applicator into
the bladder, the balloon is then filled with fluid 24 from a
syringe 7 (FIG. 4b). Alternatively, as shown in FIG. 5a, the
balloon 1 may be filled and compressed before being inserted into
the bladder by means of applicator 20. The prefilled balloon is
clutched by the flanges 23 which are initially kept closed by
constraining sleeve 26 (FIG. 5a). After insertion of the applicator
20 with the prefilled balloon 1 into the urinary bladder, ring 25
is pulled as indicated by arrow 21 in FIG. 5b to urge the
constraining sleeve 26 away from the flanges 23, allowing flanges
23 to open and release the prefilled balloon 1 into the
bladder.
[0060] FIG. 6 shows a balloon 1 constructed so as to have one or
more diffusible substances contained within its wall 2 or lumen 4.
Such substances could be, for example, drugs, antibiotics
immunoglobulins, or radioactive substances, etc. After insertion of
the balloon 1 into the lumen of the urinary bladder, the substances
diffuse from the balloon 1 into the bladder (arrows 9) in order to
achieve a desired effect.
[0061] FIG. 7 shows a balloon 1 constructed so as to comprise a
microvideo camera 19 for imaging the interior of the bladder. The
video camera 19 may have associated with it a transmitter 10 for
transmitting images to a remote receiver 11. Such microvideo
cameras and transmitters are known in the art, for example, as
disclosed in U.S. Pat. Nos. 5,604,531, 5,579781 and 5,188,109. The
receiver 11 may be connected to a processing unit 12 for processing
the images, or a display 13 for displaying images.
[0062] FIG. 8 shows a balloon 1 constructed so as to comprise one
or more devices 14 for measuring one or more parameters associated
with the urinary bladder, for example, bladder pressure, urine
temperature, urine density, urine conductivity or urine
composition. The devices 14 may be affixed to the outer surface of
the balloon 14a, embedded within the wall 2 of the balloon 14b or
affixed to the inner surface of the balloon 14c. The measuring
devices 14 may have associated with it a transmitter 15 for
transmitting measurements to a remote receiver 16. The receiver may
be connected to a processing unit 17 for processing the
measurements or to a display 18 for displaying results. Such
measuring devices are known in the art, for example as disclosed in
U.S. Pat. Nos. 5,579,781 and 5,188,109.
[0063] FIG. 9 shows use of an applicator 20 for inserting the
balloon 1 into the lumen 41 of the urinary bladder 42 of a female
individual, and FIG. 10 shows use of the applicator 20 inserting
the balloon 1 into the lumen of the urinary bladder 42 of a male
individual. In either case the balloon 1 is initially grasped by
the closed flanges 23a at the distal end of the applicator 20
(FIGS. 9a and 10a). The distal end of the applicator-balloon
combination is inserted into the urethra until it reaches the lumen
41 of the bladder 42. The balloon 1 is then released from the
applicator by opening the flanges 23b by pulling on ring 25 while
holding the constraining sleeve 26. The applicator 20 is then
removed from the body, leaving the balloon 1 in the bladder lumen
41.
[0064] FIG. 11 shows a retrieval device generally designated as 30
for removing the balloon from the bladder. A catheter 27 has at its
distal end 28 a magnetable portion 29 so as to hold the balloon 1
at the distal tip 28 by means of the magnetable particles 3
associated with the balloon 1.
[0065] The retrieval device is inserted into a full bladder. After
opening the flanges 31 of the retrieval device, the engaging probe
32 with magnetable portion 29 in its tip is inserted into the lumen
of the full bladder so as to engage the magnet 3 of the balloon and
push the balloon into the lumen of the bladder. The probe 32 is
then pulled so as to bring the balloon 1 into the grip of flanges
31 of the retrieval device. A piercer 33 is inserted into the
balloon to drain the fluid contained in its lumen 4 into an
attached syringe (not shown) or into the bladder lumen. The
applicator 20 is then withdrawn from the patient together with the
deflated balloon 1.
[0066] FIGS. 12 and 13 show use of a displacing member 51 to
position the balloon 1 at a desired location within the lumen 41 of
an individual's urinary bladder 42. The displacing member 51 is
located outside the individual's body and comprises a magnetable
portion 52. The displacing member 51 is placed at a location on the
surface of the individual's body so as to draw the balloon 1 from
its initial location to the desired location.
[0067] FIG. 12 shows use of the balloon 1 for sealing the urinary
bladder outlet in a female subject. Displacing member 51 is placed
over the urethral meatus 63 such that, due to the magnetable
portion 52 associated with the displacing member 51 and the
magnetable portion 3 associated with balloon 1, the balloon is
drawn into the bladder outlet 64. The balloon thus becomes lodged
in the outlet and seals it. As the amount of urine in the bladder
increases, a hydrostatic pressure is exerted on the balloon further
lodging it in to the outlet and reinforcing the seal. The invention
is used similarly for sealing the urinary bladder outlet in male
subjects.
[0068] As seen in FIG. 13, in order to open the urinary bladder for
voiding, the magnetic displacing member 51 is placed over the upper
edge of the pubic bone 65. Due to the magnetable portion 3 of the
balloon 1, the balloon 1 is raised and dislodged from the bladder
outlet 64 so as to allow voiding of urine as indicated by arrow 66.
After voiding the balloon is redrawn into the bladder outlet 64 by
the displacing member 51 so as to seal the outlet again as shown if
FIG. 12.
[0069] FIG. 14 shows use of an immobilizing member 71 comprising a
magnetable portion 72 affixed to the surface 73 of the individual's
body so as to maintain the balloon 1 at the desired location in the
lumen 41 of the urinary bladder 42. The magnetable portion 72 of
immobilizing member 71 may be enclosed in a coating 75 so as to
form, for example, a hygienic pad. The immobilizing member 71 may
be affixed to the surface 73 by means of tape, or by pressure
applied to it by the individual's underwear.
[0070] The invention has been described with a certain degree of
particularly only for the sake of clarity. However, several
variations and modifications in the invention are possible without
exceeding the scope and spirit of the invention as defined in the
following set of claims.
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