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Patent 2020881 Summary

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(12) Patent: (11) CA 2020881
(54) English Title: URETHRAL INDWELLING CATHETER WITH MAGNETICALLY CONTROLLED DRAINAGE VALVE AND METHOD
(54) French Title: SONDE URETRALE A DEMEURE A ROBINET D'EVACUATION MAGNETOCOMMANDE ET METHODE D'UTILISATION
Status: Deemed expired
Bibliographic Data
(52) Canadian Patent Classification (CPC):
  • 128/110
(51) International Patent Classification (IPC):
  • A61F 2/02 (2006.01)
  • A61F 2/00 (2006.01)
  • A61F 5/44 (2006.01)
  • A61M 25/00 (2006.01)
(72) Inventors :
  • BARWICK, CARL (United States of America)
(73) Owners :
  • UROCATH CORPORATION (United States of America)
(71) Applicants :
(74) Agent: GOUDREAU GAGE DUBUC
(74) Associate agent:
(45) Issued: 2002-04-02
(22) Filed Date: 1990-07-11
(41) Open to Public Inspection: 1991-03-01
Examination requested: 1997-06-02
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
400,194 United States of America 1989-08-29

Abstracts

English Abstract




The catheter includes a user controlled incontinence
portion that is combinable with a combination inflation/
drainage member. The inflation/drainage member can be
detached from the incontinence portion to provide a user
controlled device. A magnetic valve means is incorporated
in the user controlled incontinence portion for magnetic
actuation with an external magnet. The valve means is
normally closed and magnetically actuatable to an open
condition. Removal of the external magnet from proximity to
the penis enables the valve means to assume its normally
closes position. In one embodiment of the invention the
valve means includes a pressure relief feature. In another
embodiment of the invention these is no pressure relief
feature.


Claims

Note: Claims are shown in the official language in which they were submitted.




21



The embodiments of the invention in which an exclusive
property or privilege is claimed are defined as follows:

1. A urethral catheter for controlling incontinence in males
comprising:
a flexible elongated tubular member having first and second
opposing end portions, said end portions each having an opening, said
tubular member having a drainage passage extending between said
openings, said tubular member being predeterminedly dimensioned so
as to be positionable indwelling within the male urethra with said first
end portion at least proximate to the bladder and said second end
portion in the pendulous penis;
valve means in said second end portion of said tubular member
for controlling fluid flow through said drainage passage, said valve
means having a normally closed position for preventing flow of fluid
through said drainage passage, said valve means being magnetically
actuatable into an open condition by a magnet placed external to the
pendulous penis proximate to said valve means for permitting flow
through said drainage passage; and
retaining means secured to said tubular member for retaining
said indwelling tubular member within the urethra.

2. The urethral catheter as claimed in claim 1, wherein said valve
means includes a movable valve member, a valve seat engageable by
said valve member and biasing means for biasing said valve member into
engagement with said valve seat when said valve means is in said
normally closed position.




22



3. The urethral catheter as claimed in claim 2, further comprising a
magnet for imposing a magnetic deflection force on said biasing means
to unseat said valve member from said valve seat thereby placing said
valve means into the open condition, said biasing means reseating said
valve member upon removal of said magnetic deflection force.

4. The urethral catheter as claimed in claim 2, wherein said biasing
means includes a spring having a fixed end portion and a deflectable end
portion.

5. The urethral catheter as claimed in claim 2, wherein said biasing
means includes a magnetically actuatable member having a first
predetermined location relative to said valve seat when said valve means
is in said closed position and magnetically movable away from said first
predetermined location relative to said valve seat when said valve means
is in said open condition.

6. The urethral catheter as claimed in claim 5, further comprising
actuating means for imposing a magnetic deflection force on said
magnetically actuatable member to move said magnetically actuatable
member away from said first predetermined location relative to said valve
seat to place said valve means in said open condition, and wherein
removal of said magnetic deflection force enables said biasing means to
automatically urge said valve member on said valve seat to place said
valve means in said normally closed position.



23



7. The urethral catheter as claimed in claim 6, wherein said
magnetically actuatable member is a first predetermined distance from
said valve seat when said valve means is in said closed position and a
second predetermined distance greater than said first predetermined
distance from said valve seat when said valve means is in said open
condition.

8. The urethral catheter as claimed in claim 2, wherein said valve
means includes a longitudinal axis and a magnetically actuatable member,
said magnetically actuatable member being in axial alignment with said
valve seat when said valve means is in said closed position, said
magnetically actuatable member being out of axial alignment with said
valve seat when said valve means is in said open condition.

9. The urethral catheter as claimed in claim 5, wherein said
magnetically actuatable member is formed of a magnetic or magnetically
attractive material.

10. The urethral catheter as claimed in claim 5, wherein said
magnetically actuatable member is in a general shape of a cylinder.

11. The urethral catheter as claimed in claim 9, wherein said
magnetically actuatable member includes opposite ends and said biasing
means further include a spring having opposite ends, one end of said
magnetically actuatable member being in contact with one end of said
spring, the other end of said spring having a fixed position in said valve
means, and the other said end of said magnetically actuatable member




24



being engageable with said valve member.

12. The urethral catheter as claimed in claim 11, wherein said valve
member is a ball.

13. The urethral catheter as claimed in claim 5, wherein said
magnetically actuatable member includes opposite ends and said biasing
means further include a spring having opposite ends, one end of said
magnetically actuatable member being in contact with one end of said
spring, the other end of said spring having a fixed position in said valve
means, and the other said end of said magnetically actuatable member
being engageable with said valve member.

14. The urethral catheter as claimed in claim 13, wherein said valve
member is a ball.

15. The urethral catheter as claimed in claim 2, wherein said valve
member is oriented in said tubular member such that the normal path of
fluid flow through the tubular member is in a direction from the valve seat
to the valve member.

16. The urethral catheter as claimed in claim 2, wherein said valve
means is oriented in said tubular member such that the normal path of
fluid flow through the tubular member is in a direction from the valve
member to the valve seat.

17. A urethral catheter for controlling incontinence in males



25


comprising:
(a) a flexible elongated tubular member having a fluid drainage
passageway, said tubular member being predeterminedly dimensioned so
as to be insertable and properly positionable within the urethra with one
end at least proximate to the bladder and the other end in the pendulous
penis;
(b) a valve within said tubular member proximate to said other end so
as to be within the pendulous penis when said tubular member is properly
positioned, said valve including:
(i) a valve seat with an orifice;
(ii) a valve member removably engageable with said valve
seat, said valve member being in a closed position when engaged
with said valve seat and closing said orifice, said valve member
being in an open condition when unseated from said valve seat and
opening said orifice;
(iii) biasing means for urging said valve member into
engagement with said valve seat to normally maintain said valve
member in said closed position;
(iv) said biasing means including a deflectable magnetically
actuatable member having a first nondeflected position
corresponding to said closed position of said valve member and a
deflected position corresponding to an open condition for said valve
member;
(c) actuating means operable totally external to the body and
removably positionable proximate to the pendulous penis for imposing
when proximate to the pendulous penis a magnetic deflection force on
said magnetically actuatable member for deflecting said magnetically


26



actuatable member from said first nondeflected position and placing said
valve member in said open condition, and for removing said imposed
magnetic deflection force when distant from the pendulous penis enabling
said biasing means to automatically urge said valve member into said
normally closed position; and
(d) retaining means secured to said tubular member for retaining said
tubular member within the urethra.

Description

Note: Descriptions are shown in the official language in which they were submitted.


2~~0~$1
0'~°~HRAL INDWELLING CAZ°HETEIt
twIITH lIAGNETICALLY OONTROLLED D1RAINAGB VALVE
AND 1~8~'HOD
~RG~G~,~T7~1~ I~TLN
This invention relates to user controlleu
incontinence devices for males and more particularly to an
indwelling catheter with a magnetically operable drainage
valve.
Male urinary incontinence is a common problem that
can arise from muscle weakness, post-operative surgical
damage to the urinary sphincter or a variety of other
debilitating problems. Thus far there have been no
satisfactory surgical procedures for correcting incontinence
to the extent that bladder control is substantially
restored.
Some known devices that deal with the problem of
male incontinence include a urethral catheter that allows
the bladder to continuously drain into a collection bag
without enabling the user to control urinary discharge.
Such devices thus limit the physical activity of the user.
Other known devices which address the problem of
male incontinence attempt some form of drainage control and
include user controlled valves, such as shown in U.S.
Patents 3,331,371; 3,768,102; 4,026,298 and 4,350,161.
The foregoing patents require manipulation of a
valve through the penis in order to place the valve in an
1

2020~~1
e.~en position to permit urinary flow. Occasionally the
manipulation of the penis that is intended to actuate a
valve into an open position to permit urinary discharge may
cause pain or may constrict the urethral passage and impede
bladder drainage.
U.S. Patent 3,812,841 shows a magnetically
controlled valve installed near the bladder. The valve is
actuated into an open condition by an external battery
powered magnetic activating device packaged in a relatively
large housing making it cumbersome and unwieldy to use.
Such device inhibits the activity of the user since it is
necessary to have access to the magnetic actuator in order
to drain the bladder. The user must thus carry the magnetic
activator with him at all times or confine his activities to
a location where a magnetic activator is available for use.
U.S. Patent 3,495,620 also shows a magnetic valve
arrangement requiring external actuation of the valve by a
battery powered magnetic activator.
U.S. Patent 3,731,670 shows a magnetically
activated binary duct valve with two valve seats that
respectively carrespond to open and closed positions of the
valve. The valve is actuated by an external magnet into the
open or closed gosition. Aowever there is no automatic
shutoff of fluid flow when urinary discharge is completed.
Thus a uses may inadvertently forget to actuate the valve
from its open position to its closed position. A further
2


CA 02020881 2001-06-22
3
problem is that the user may be unable to detect when he has actuated
the valve into a closed position, and may think he has the valve in a closed
position while it is actually in an open position.
U.S. Patents Nos. 3,419,008; 3,926,175; 3,939,821 and
4,024,855 relate to magnetically actuated valve clamps that pinch or
clamp a body passage, such as a urethra, into a closed condition. Such
devices require surgical implantation of a clarnping device and cannot be
easily removed for repair or replacement.
It is thus desirable to provide a user controlled
incontinence device having a drainage valve which can be actuated
without manipulation, without batteries, wiring arrangements or other
bulky, cumbersome accessories that inhibit the activity of the user. It is
further desirable to provide a user controlled incontinence device which is
magnetically actuatable to an open position to permit urinary drainage and
automatically reverts to a closed position whE:n the magnetic actuation is
removed.
OBJECTS AND SUMMARY OF 1'HE INVENTION
Among the several objects of the invention may be
noted the provision of a novel indwelling urethral catheter with
incontinence control, a novel indwelling urethral catheter having a
magnetically manipulable control valve for controlling bladder draining, a
novel indwelling urethral catheter with incontinence control that can be
entirely recessed within the penis in substantially undetectable fashion, a
novel indwelling urethral catheter with an incontinence control valve that


CA 02020881 2001-06-22
4
can be easily actuated with the magnet that i:> small enough to be carried
in a pocket, and a novel indwelling urethral catheter with a valve that
automatically closes when a magnetic actuating device is moved away
from the penis.
Other objects and features of the invention will be in
part apparent and in part pointed out hereinafter.
More specifically, in accordance with irhe present invention, there
is provided a urethral catheter for controlling incontinence in males
comprising:
a flexible elongated tubular memk>er having first and second
opposing end portions, these end portions each having an opening, the
tubular member having a drainage passage extending between these
openings, the tubular member being predeterminedly dimensioned so
as to be positionable indwelling within the male urethra with the first
end portion at least proximate to the bladder and the second end
portion in the pendulous penis;
valve means in the second end portion of the tubular member
for controlling fluid flow through the drainage passage, these valve
means having a normally closed position for preventing flow of fluid
through the drainage passage, the valve means being magnetically
actuatable into an open condition by a magnet placed external to the
pendulous penis proximate to the valve means for permitting flow
through the drainage passage; and
retaining means secured to the tubular member for retaining the
indwelling tubular member within the urethra.


CA 02020881 2001-06-22
In accordance with preferred embodiments of the urethral
catheter:
- the valve means includes a movable valve member, a valve seat
5 engageable by the valve member and biasing means for biasing the
valve member into engagement with the valve seat when the valve
means is in the normally closed position;
- the urethral catheter further comprises a magnet for imposing a
magnetic deflection force on the biasing means to unseat the valve
member from the valve seat thereby placing the valve means into the
open condition, these biasing means resenting the valve member upon
removal of the magnetic deflection force;
- the biasing means includes a spring having a fixed end portion and a
deflectable end portion;
- the biasing means includes a magnetically actuatable member having
a first predetermined location relative to the valve seat when the valve
means is in the closed position and magnetically movable away from
the first predetermined location relative to the valve seat when the
valve means is in the open condition;
- the urethral catheter further comprises actuating means for imposing
a magnetic deflection force on the magnetically actuatable member to
move this magnetically actuatable member away from the first
predetermined location relative to the valve seat to place the valve
means in the open condition, wherein removal of the magnetic


CA 02020881 2001-06-22
6
deflection force enables the biasing means to automatically urge the
valve member on the valve seat to place the valve means in the
normally closed position;
- the magnetically actuatable member is a first predetermined distance
from the valve seat when the valve means is in the closed position and
a second predetermined distance greater than the first predetermined
distance from the valve seat when the valve means is in the open
condition;
- the valve means includes a longitudinal axis and a magnetically
actuatable member, the magnetically actuatable member being in axial
alignment with the valve seat when the valve means is in said closed
position, the magnetically actuatable member being out of axial
alignment with the valve seat when the valve means is in the open
condition;
- the magnetically actuatable member is formed of a magnetic or
magnetically attractive material;
- the magnetically actuatable member is in a general shape of a cylinder;
- the magnetically actuatable member includes opposite ends and the
biasing means further include a spring having opposite ends, one end
of the magnetically actuatable member bE~ing in contact with one end
of the spring, the other end of the spring Having a fixed position in the
valve means, and the other end of the magnetically actuatable
member being engageable with the valve member;


CA 02020881 2001-06-22
6a
- the valve member is a ball;
- the magnetically actuatable member includes opposite ends and the
biasing means further include a spring having opposite ends, one end
of the magnetically actuatable member bE:ing in contact with one end
of this spring, the other end of the spring having a fixed position in the
valve means, and the other end of the magnetically actuatable
member being engageable with the valve member;
- the valve member is oriented in the tubular member such that the
normal path of fluid flow through the tubular member is in a direction
from the valve seat to the valve member; and
- the valve means is oriented in the tubular member such that the
normal path of fluid flow through the tubular member is in a direction
from the valve member to the valve seat.
According to another aspect of the present invention, there is
provided a urethral catheter for controlling incontinence in males
comprising:
(a) a flexible elongated tubular membf:r having a fluid drainage
passageway, this tubular member being predeterminedly dimensioned so
as to be insertable and properly positionable~ within the urethra with one
end at least proximate to the bladder and the other end in the pendulous
penis;
(b) a valve within the tubular member proximate to the other end so as
to be within the pendulous penis when the tubular member is properly


CA 02020881 2001-06-22
6b
positioned, the valve including:
(i) a valve seat with an orifice;
(ii) a valve member removably engageable with the valve
seat, this valve member being in a closed position when engaged
with the valve seat and closing the orifice, the valve member being
in an open condition when unseated from the valve seat and
opening the orifice;
(iii) biasing means for urging the valve member into
engagement with the valve seat to normally maintain the valve
member in the closed position;
(iv) the biasing means including a deflectable magnetically
actuatable member having a first nondeflected position
corresponding to the closed position of the valve member and a
deflected position corresponding to an open condition for the valve
member;
(c) actuating means operable totally external to the body and
removably positionable proximate to the pendulous penis for imposing
when proximate to the pendulous penis a magnetic deflection force on the
magnetically actuatable member for deflecting the magnetically actuatable
member from the first nondeflected position and placing the valve member
in the open condition, and for removing the imposed magnetic deflection
force when distant from the pendulous penis enabling the biasing means
to automatically urge the valve member into the normally closed position;
and
(d) retaining means secured to the tubular member for retaining the
tubular member within the urethra.
The invention accordingly comprises the constructions and method


CA 02020881 2001-06-22
6c
hereinafter described, the scope of the inveintion being indicated in the
claims.
Other objects, advantages and features of the present invention will
become more apparent upon reading of the following non-restrictive
description of preferred embodiments thereof, given by way of example
only with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
In the appended drawings:
FIG. 1 is a simplified schernatic view of the indwelling
urethral catheter with incontinence control incorporating one embodiment
of the invention, during installation in a penis;
FIG. 2 is a view similar to FIG. 1 with the collection bag
and inflation arrangement removed;
FIG. 3 is a view similar to FIG. 2 showing the manner in
which the incontinence device is magnetically actuated to permit drainage
of fluid from the bladder;
FIG. 4 is a disassembled perspective view of the
indwelling urethral catheter with incontinencE: control prior to installation
in the urethral passage and bladder;


CA 02020881 2001-06-22
6d
FIG. 5 is an enlarged fragmentary perspective view
thereof;

D
20~03~~.
FIG. 6 is a view similar to Fig. 5 in assembled
condition;
FIG. 7 is an enlarged fragmentary sectional view
thereof corresponding to Fig. 5;
FIG. 8 is an enlarged fragmentary sectional view
thereof corresponding to Fig. 6;
FIG. 9 is a sectional view taken on the line 9-9 of
Fig. 8;
FIG. 10 is an enlarged fragmentary view thereof in
operational position with the valve means in a valve closed
position;
FIG. 11 is a view similar to Fig. 10 showing the
valve means magnetically actuated to an open position to
permit fluid flow;
FIGS. 12 and 13 illustrate a further embodiment of
the invention in valve closed and valve open positions
corresponding to that shown in the embodiments of Figs. 10
and 11.
Corresponding reference characters indicate
corresponding parts throughout the several views of the
drawings.
7

::'
~~f?0~38~.
A catheter assembly incorporating one embodiment of
the invention is generally indicated by the reference number
in Fig. 1.
5 Referring to Figs. 4-9, the catheter assembly 10
includes an incontinence portion 12 and an inflation/
drainage member 14 adapted to be detachably joined to the
incontinence portion 12.
The incontinence portion 12 comprises an elongated
10 tubular member 16 which can be formed of silicone. The
tubular member 16 has an outside tubular surface 18 and an
interior fluid drainage passage 20. The drainage passage 20
extends from an end portion 22 of the tubular member 16 to
an opposite end portion 28 thereof. The end portion 22 of
the tubular member 16 is provided with oppositely disposed
bladder drainage openings 24 and 26 that communicate with
the drainage passage 20.
An inflatable bladder balloon 30, preferably formed
of silicone is joined to the periphery of the tubular member
16 at a predetermined distance from the end portion 22. An
inflatable urethral cuff 32 also'formed of silicone is
joined to the periphery of the tubular member 16 at a
predetermined distance from the bladder balloon 30. The
bladder balloon 30 and the urethral cuff 32 are initially
deflated as shown in Fig. 4.
8

~J
2020881
Opposite end portions 34 and 36 of the bladder
balloon 30 are secured to the outer surface 18 of the
tubular member 16 in leak-tight arrangement using a suitable
known silicone adhesive. In similar fashion, opposite end
portions 38 and 40 of the urethral cuff 32 are secured to
the tubular surface 18 of the tubular member 16 in leak-
tight fashion.
As most c7.early shown in Fig. 8, a pair of inflation
lumen 42 and 44 are formed on the interior of the tubular
member 16. The inflation lumen 42, for example,
communicates with the bladder balloon 30, and the inflation
lumen 44 communicates with the urethral cuff 32.
A distal end portion 46 of the inflation lumen 42
is provided with a spring biased ball valve 48 that is in a
normally closed position against a valve seat 50. Similarly
the inflation lumen 44 at a distal portion 52 includes a
spring biased ball valve 54 that is normally in a closed
position against a valve seat 56.
An incontinence valve 60 is provided in the
incontinence portion 12 a predetermined distance from the
end portion 28 of the tubular member 16.
The incontinence valve 60 includes a ball member 64
normally biased against a valve seat portion 66 having a
surface of conical form and a valve orifice 68. The ball
member 64 can be formed, for example of stainless steel with
gold plating, plastic, silicone or borosilicate glass.
9

Biasing means 70 for urging the ball member 64 to
close the orifice 68 include a biasing spring 72 and a
magnetically actuatable member 74 in the form of a cylinder,
secured to one end of the biasing spring 72. The biasing
spring 70 can be formed of stainless steel (MP35N), monel or
any other suitable nonmagnetic spring material.
A spring seat member 76 is provided a predetermined
distance from the valve seat 66 for retaining an opposite
end of the biasing spring 72. The spring seat 76 can be
formed of stainless steel or plastic, for example.
The incontinence valve 60, which is in a normally
closed position, is actuated to an open condition by an
external manually movable magnet 77 (Figs. 3, 11 and 13).
The magnet 77 can be formed of a rare earth magnet such as
neodymium-iron-baron or samarium-cobalt. The magnetically
actuatable member 74 can also be formed of neodymium-iron-
boron or samarium-cobalt.
The incontinence valve 60, when normally closed as
shown in Fig. 10, prevents fluid from the fluid drainage
passage 20 from passing through the valve orifice 68, thus
maintaining continence. The biasing spring 72 and the
magnetically actuatable member 74 are selected to provide a
predetermined biasing force on the ball member 64 that is
sufficient to maintain the ball member 64 in a closed
position during activities associated with a relatively
active individual. Thus there is little likelihood that the


2~208~1
call member 64 would inadvertently unseat from the valve
seat 66 as a result of physical activity or movement of the
user .
However if fluid pressure in the fluid passage 20
reaches a predetermined level which overcomes the biasing
force of the biasing spring 72, the ball member 64 will
unseat from the valve seat 66 to permit fluid to flow past
the incontinence valve 60 whether or not the magnetically
actuatable member 74 is actuated. This result is intended
to avoid excess pressure buildup in the bladder which might
be harmful to the bladder or other portions of the body such
as the kidneys. Thus the incontinence valve 60 provides an
automatic pressure relief safety feature wherein the relief
pressure is a function of the spring force.
When it is desired to actuate the incontinence
valve 60 to an open condition, the magnet 77 is manually
placed adjacent the penis 79 as shown in Fig. 11, thereby
attracting (or repelling) the magnetically actuatable member
74 from the position of Fig. 10. Movement of the
magnetically actuatable member 74 from its position of
alignment with the ball 64 and the orifice 6B enables the
ball 64 to unseat from the valve seat 66 and permit fluid to
flow through the orifice in the manner shown in Fig. 11.
The magnetically actuatable member 74 and the ball
member 64 are sized such that the ball cannot pass between
the magnetically actuatable member 74 and the wall of the
11

~r ,
2020881
tubular member 16. Thus for all possible deflections of the
magnetically actuatable member 74 the ball member 64 is
always retained between the free end portion of the
magnetically actuatable member 74 and the valve seat 66.
When the manually movable magnet 77 is withdrawn from
proximity to the incontinence valve 60, the biasing spring
72 and the magnetically actuatable member 74 urge the ball
member 64 against the valve seat 66 into the normally closed
position wherein the ball member 64 closes the orifice 68.
l0 The externally movable magnet 77 is preferably of a
size that is unobtrusive and can be stored in a pocket, such
as for example, 1 inch x 3 inches x 3/16 inches thick. If
desired, the externally movable magnet 77 can be sheathed in
a bag or container that is nonmagnetic.
The inflation/drainage member 14 comprises a
drainage duct member 78 having an interior duct passage 80
that extends from an end portion 82 (Fig. 4) to an opposite
end portion 84. The drainage duct member can be formed of
silicone, polyvinyl chloride, or any other suitable known
biocompatible thermoplastic.
A pair of inflation lumen 86 and 88 (Figs. 5-8)
corresponding to the inflation lumen 42 and 44 are formed
on the inner surface of the duct passage 80.
An engagement assembly 90 formed of a suitable
plastic or metal such as stainless steel, includes a cap
portion 92 adapted to form a leak-tight seal around the end
12

~Q20881
portion 82 of the drainage duct member 78. A pair of
inflation needles 94 and 96, having respective inflation
openings 98 and 100, extend longitudinally from the cap
portion 92. The inflation needles 94 and 96 align with and
form a continuation of the inflation lumen 86 and 88. Blunt
ends 102 and 104 are formed at the respective free ends of
the inflation needles 94 and 96.
A duct extension piece 106 which can be formed of
plastic or stainless steel, projects from the cap portion 92
intermediate the inflation needles 94 and 96. The duct
extension 106 defines a duct extension passage 107 that is a
continuation of the duct passage 80 and is of complementary
cross section with the drainage passage 20 at the distal end
28 of the tubular member 16.
A branch member 110 (Figs. 1 and 4) joins the end
portion 84 of the drainage duct member 78 and includes a
drainage extension 112 that communicates with the duct
passage 80. The branch member 110 also includes syringe
receivers 114 and 116 that respectively communicate with the
inflation lumen 86 and 88.
In using the catheter assembly Z0, the inflation/
drainage member 14 is joined to the incontinence portion 12
by aligning the inflation needles 94 and 96 with the lumen
portions 42 and 44 of the tubular member 12 as shown in
Fig. 5. A free end portion of the duct extension 106
will thus be received in the fluid passage 20 downstream
13

-. ,
202~~~1
from the incontinence valve 60 as the inflation needles 94
and 96 are received in the lumen portions 42 and 44 for
engagement in the manner shown in Figs. 6 and 8. The
periphery of the tubular member 12 is substantially
identical to the periphery of the cap portion 92 to provide
a smooth continuous surface where the tubular member 12 and
the engagement assembly 90 join.
The inflation needles 94 and 96, as they pass into
the distal ends 46 and 52 of the lumen portions 42 and 44,
unseat the respective balls 48 and 54 from their respective
valve seats 50 and 56 for entry into the inflation lumens 42
and 44 of the tubular member 16 as shown in Fig. 8.
A collection bag 118 (Fig. 4) is connected to the
drainage extension 112 and respective syringes 120 and 122
are positioned in the syringe receivers 114 and 116 with
appropriate predetermined amounts of a suitable known
inflation fluid.
After the incontinence portion 12 and the inflation/
drainage member 14 are joined together, a suitable known
lubricant (not shown) is applied to the tubular surface 18
of the tubular member 16. The tubular member 16 is inserted
into the urethra 128 to position the uninflated bladder
balloon 30 in the bladder 130. The tubular member 16 is
sized such that the incontinence valve 60 substantially
aligns with the penile meatus. Tubular members 16 of
14

.
202881
various different lengths can be inventoried to ensure
such alignment with the penile meatus.
With the uninflated b?adder balloon 30 thus
positioned in the bladder 130, the syringes 120 and 122 can
be operated to force fluid through the respective lumen
passages 86-42 and 88-44 to inflate the bladder balloon 30
and the urethral cuff 32 in the manner shown in Fig. 2.
When inflation is completed, the syringes 120 and
122 are removed and self-sealing valves 124 and 126 provided
on the syringe receivers 114 and 116 ensure that the
inflation volume of the bladder balloon 30 and the urethral
cuff 32 is maintained.
Bladder fluid 132 (Fig. 4) is thus enabled to pass
into the openings 24 and 26 for passage through the fluid
drainage passage 20, into the duct extension passage 107 and
through the duct passage 80 into the collection bag 118.
There is no communication between the fluid passages 20,
107, 80 and the inflation lumens 42, 44 and 86, 88.
Under this arrangement, bladder fluid 132 can be
continuously drained from the bladder 130 past the
incontinence valve 60 into the collection bag 118, provided
the external magnet 77 is maintained proximate the penis, in
any suitable manner, such as for example, in a truss-like
arrangement (not shown) which holds the magnet 77 proximate
the penis. Tf continuous drainage is not desired tut the
collection bag 118 is to be used, the incontinence valve 60

,
2020881
is maintained in the normally closed position and operated
using the magnet 77 in the manner previously described. The
filled collection bag 118 can be emptied or replaced as
needed.
When it is feasible for a patient to control his own
bladder drainage without the collection bag 118, the
inflation/drainage member 14 is detached from the
incontinence portion 12 in the manner shown in Fig. 2. Thus
the patient can manually control bladder drainage by
selectively opening the incontinence valve 60 using the
magnet 77.
As the inflation/drainage member 14 is separated
from the incontinence portion 12, the inflation needles 94
and 96 are withdrawn from the lumen 42 and 44 and the spring
biased ball valves 48 and 54 assume their normally closed
positions. Inflation volume of the bladder balloon 30 and
urethral cuff 32 is thus maintained.
As bladder fluid 132 accumulates in the bladder 130
to a point where bladder drainage is desired, the patient
manually holds the magnet 77 adjacent the penis in the
manner shown in Fig. 11. The magnet 77 need not be
accurately located since it has sufficient flux to open the
valve 60 when placed alongside the penis near the penile
meatus.
When bladder drainage is completed, removal of the
magnet 77 from the area of the penile meatus enables the
16

2020881
valve 60 to reassume its normally closed position, thereby
shutting off the fluid drainage passage 20 and allowing
bladder fluid 132 to accumulate in the bladder 130.
A patient can thus control and limit bladder
discharge as he chooses. As will be apparent, the
incontinence portion 12 which permits such control is
entirely recessed in the penis and substantially
undetectable.
If there is a need to remove the incontinence
portion 12 from the urethra 128, the penis is collapsed
against the pubis, exposing the distal end of the
incontinence portion 12. The tube member 16 is cut just
proximal to the valves 48 and 54 to enable the bladder
balloon 30 and the urethral cuff 32 to deflate. The
incontinence portion 12 can then be removed.
Another embodiment of the catheter assembly is
generally indicated by the reference number 140 in Figs. 12
and 13. The catheter assembly 140, which includes an
incontinence portion 142, does not have a pressure relief
feature and is structurally identical to the catheter
assembly 10 except for the orientation of an incontinence
valve 150 in the incontinence portion 142.
The incontinence valve 150 includes components that
are identical to the incontinence valve 60. However the
valve seat 66 and the ball member 64 are at a downstream
flow portion of the tubular member 16.
17

'~' ~ ,
2020881.
Under this arrangement the accumulation of bladder
fluid 132 in the fluid drainage passage 20 tends to maintain
the ball 64 in its closed position on the valve seat 66.
Actuation of the incontinence valve 150 into an open
position requires placement of the manually movable magnet
77 in proximity of the valve 150 as shown in Fig. 13.
Operation of the valve 150 is in all other respects similar
to operation of the valve 60.
Accordingly, placement of the magnet 77 proximate
the valve 150 causes the magnetically actuatable member 74
to deflect from its alignment with the orifice 68. Once the
magnetically actuatable member 74 is so deflected, the ball
member 64 is no longer stably positioned against the orifice
68 and fluid within the fluid drainage passage 20 unseats
the ball and flows through the orifice 68 for discharge from
the penis as shown schematically in Fig. 13.
Removal of the magnet 77 from its position adjacent
the penis enables the biasing spring 72 to urge the
magnetically actuatable member 74 toward the orifice 68 and
confine the ball member 64 against the orifice 68. Flow of
fluid through the drainage passage 20 thus ceases without
magnetic actuation of the magnetically actuatable member 74.
Installation and operation of the catheter assembly
140 with the inflation/drainage member 14 is accomplished in
a manner similar to that previously described for the
catheter assembly 10.
18

202~88~.
It should be noted that other suitable known means
of anchoring the incontinence portions 12 and 142 in the
bladder such as non-inflatable spirals and malecot portions
can be used, and other suitable known non--inflatable cuff
arrangements can be used for preventing migration of the
incontinence portions 12 and 142 in the urethra.
Some advantages of the invention evident from the
foregoing description include a urethral indwelling catheter
with incontinence control that provides the option of
continuous bladder drainage as well as the option of user
controlled bladder drainage. Either option can be obtained
with just one installation of a catheter assembly in the
urethra and bladder.
A further advantage is that the valve means for
controlling movement of fluid from the bladder can be
magnetically actuatable by a small, relatively innocuous
magnet that is no larger than a small key case and can be
easily carried around by the user. A further advantage is
that the incontinence valve does not require manual
manipulation of the penis to actuate the valve. Such manual
manipulation can cause discomfort and may require manual
dexterity. Use of the present magnetic device requires
little manual dexterity, and does not require manipulation
of the penis to actuate the incontinence valve and thus does
not cause discomfort.
19

.
202088.
In view of the above, it will be seen that the
several objects of the invention are achieved and other
advantageous results attained.
As various changes can be made in the above
constructions and method without departing from the scope of
the invention, it is intended that all matter contained in
the above description or shown in the accompanying drawings
shall be interpreted as illustrative and not in a limiting
sense.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date 2002-04-02
(22) Filed 1990-07-11
(41) Open to Public Inspection 1991-03-01
Examination Requested 1997-06-02
(45) Issued 2002-04-02
Deemed Expired 2008-07-11

Abandonment History

Abandonment Date Reason Reinstatement Date
2000-06-23 R30(2) - Failure to Respond 2001-06-22
2000-07-11 FAILURE TO PAY APPLICATION MAINTENANCE FEE 2001-06-22

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1990-07-11
Registration of a document - section 124 $0.00 1990-11-28
Maintenance Fee - Application - New Act 2 1992-07-13 $100.00 1992-06-26
Maintenance Fee - Application - New Act 3 1993-07-12 $100.00 1993-06-23
Maintenance Fee - Application - New Act 4 1994-07-11 $100.00 1994-07-11
Maintenance Fee - Application - New Act 5 1995-07-11 $150.00 1995-07-04
Maintenance Fee - Application - New Act 6 1996-07-11 $150.00 1996-07-02
Request for Examination $400.00 1997-06-02
Maintenance Fee - Application - New Act 7 1997-07-11 $150.00 1997-06-05
Maintenance Fee - Application - New Act 8 1998-07-13 $150.00 1998-06-16
Registration of a document - section 124 $0.00 1999-04-21
Registration of a document - section 124 $0.00 1999-04-21
Registration of a document - section 124 $0.00 1999-04-21
Maintenance Fee - Application - New Act 9 1999-07-12 $150.00 1999-05-06
Reinstatement - failure to respond to examiners report $200.00 2001-06-22
Reinstatement: Failure to Pay Application Maintenance Fees $200.00 2001-06-22
Maintenance Fee - Application - New Act 10 2000-07-11 $200.00 2001-06-22
Maintenance Fee - Application - New Act 11 2001-07-11 $200.00 2001-06-22
Final Fee $300.00 2002-01-09
Maintenance Fee - Patent - New Act 12 2002-07-11 $200.00 2002-06-20
Maintenance Fee - Patent - New Act 13 2003-07-11 $200.00 2003-06-20
Maintenance Fee - Patent - New Act 14 2004-07-12 $250.00 2004-06-21
Maintenance Fee - Patent - New Act 15 2005-07-11 $450.00 2005-06-22
Maintenance Fee - Patent - New Act 16 2006-07-11 $450.00 2006-06-19
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
UROCATH CORPORATION
Past Owners on Record
BARWICK, CARL
BRISTOL-MYERS COMPANY
BRISTOL-MYERS SQUIBB COMPANY
CABOT TECHNOLOGY CORPORATION
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 1999-07-14 1 12
Drawings 1993-12-14 5 140
Description 1993-12-14 20 627
Cover Page 1993-12-14 1 14
Abstract 1993-12-14 1 20
Claims 1993-12-14 7 182
Description 2001-06-22 24 756
Claims 2001-06-22 6 205
Cover Page 2002-02-26 1 41
Representative Drawing 2001-07-26 1 10
Prosecution-Amendment 1999-12-23 3 11
Correspondence 2002-09-10 2 63
Assignment 1990-07-11 42 1,551
Prosecution-Amendment 1997-06-02 1 37
Correspondence 1993-06-01 4 200
Prosecution-Amendment 1997-09-22 2 39
Prosecution-Amendment 2001-06-22 17 559
Fees 2001-06-22 1 48
Correspondence 2002-01-09 1 32
Correspondence 2002-07-16 1 16
Correspondence 2002-09-10 1 19
Fees 2001-06-22 1 42
Fees 1997-06-05 1 52
Fees 1998-06-16 1 51
Fees 1999-05-06 1 44
Fees 1996-07-02 1 35
Fees 1995-07-04 1 27
Fees 1994-07-11 1 29
Fees 1993-06-23 1 28
Fees 1992-06-26 1 32