U.S. patent number 3,642,004 [Application Number 05/000,525] was granted by the patent office on 1972-02-15 for urethral valve.
This patent grant is currently assigned to Life Support Equipment Corp. Invention is credited to Sven M. Osthagen, Henry M. Wise, Jr..
United States Patent |
3,642,004 |
Osthagen , et al. |
February 15, 1972 |
URETHRAL VALVE
Abstract
A valved drainage-control device adapted to be retained in the
urinary canal, comprising a slim, elongate, flexible catheter tube
at one end connected to both a valve housing and a collapsible
enlargement or bulb which latter is adapted to be inflated and to
occupy the bladder for retaining the catheter tube in place. At its
inner end, the catheter tube is closed and contains an
electromagnetic valve comprising a magnet coil and a magnetic core
of permanent magnet material. A flexible corrugated diaphragm spans
the interior of the flexible tube adjacent the magnetic valve, said
diaphragm forming with the closed end of the tube a sealed chamber
in which the magnet coil and magnetic core are located. Adjoining
the diaphragm and exterior to the sealed chamber is an annular
valve seat which is engageable by a valve facing carried by the
diaphragm. The diaphragm is connected with the magnetic core to be
actuated thereby, for opening and closing the valve. Openings in
the sidewall of the flexible tube communicate with the valve, to
provide for a controlled drainage of the bladder. Extending along
the flexible tube is a channel which communicates with the
inflatable bulb for the purpose of providing an inflating fluid
therein. The connecting wires for the electromagnet extend in said
fluid channel and are brought out at the other or exterior end of
the flexible tube, for connection to a battery and switch whereby
the valve may be actuated from the exterior of the user's body.
Inventors: |
Osthagen; Sven M. (South
Dennis, MA), Wise, Jr.; Henry M. (Silver Spring, MD) |
Assignee: |
Life Support Equipment Corp
(Burlington, MA)
|
Family
ID: |
21691887 |
Appl.
No.: |
05/000,525 |
Filed: |
January 5, 1970 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
652916 |
Jul 12, 1967 |
|
|
|
|
Current U.S.
Class: |
604/249;
128/DIG.25; 604/915 |
Current CPC
Class: |
A61M
25/10 (20130101); A61M 25/0075 (20130101); Y10S
128/25 (20130101) |
Current International
Class: |
A61M
25/10 (20060101); A61M 25/00 (20060101); A61m
025/00 () |
Field of
Search: |
;128/239-241,348-350 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Parent Case Text
The present application is a continuation-in-part of our above
identified copending application, Ser. No. 652,916, filed July 12,
1967 and entitled, "Urethral Valve."
Claims
We claim:
1. A valved drainage-control device adapted to be implanted in a
cavity and passage of a living body for the purpose of shutting off
or allowing the flow of liquid from the cavity through said
passage, comprising in combination:
a. valve means adapted to be disposed in said body cavity for
controlling liquid flow therefrom through said passage, said valve
means including a valve housing having a valve seat and a movable
valve cooperable with said seat,
b. actuator means for said valve, including at least one slender,
flexible wire adapted to extend through said body passage to the
exterior of the body,
c. means providing a collapsible enlargement, attached to said
valve housing for retaining the housing in said body cavity during
normal movements of the body,
d. a slim elongate flexible tube at one end connected to said valve
housing and collapsible enlargement means and adapted for
disposition in said body passage to provide for the flow of liquid
therethrough, said flexible wire extending through the flexible
tube to the exterior of the body and having a fluidtight seal with
said tube to prevent loss of pressure from the tube,
e. the other end of said tube being disposed outside of the body
and constituting a discharge orifice.
2. A valved drainage-control device as in claim 1, wherein:
a. the flexible tube has multiple perforations in its walls, to
permit a flushing of the walls of the body passage when the valve
is actuated to the open position.
3. A valved drainage-control device as in claim 2, wherein:
a. the flexible tube comprises an inert plastic,
b. said wall perforations having rounded edges.
4. A valved drainage-control device as in claim 1, wherein:
a. the actuator means comprises an electromagnet connected to the
valve, and a circuit therefor comprising the said slender, flexible
wire.
5. A valved drainage-control device as in claim 4 and further
including:
a. means providing a channel extending longitudinally along said
flexible tube,
b. said tube and channel-providing means being constituted of inert
plastic,
c. said retainer means comprising an inflatable bulb surrounding
said flexible tube and communicating with said channel to receive
an inflating fluid therefrom,
d. said slender wire extending through said channel.
6. A valved drainage-control device as in claim 4, wherein:
a. the valve comprises a permanent magnet,
b. said electromagnet being adapted for battery energization.
7. A valved drainage-control device as in claim 4, wherein:
a. the movable valve comprises a magnetic core, and
b. one end of the flexible tube being closed and containing said
valve means and electromagnet,
c. said movable valve comprising a flexible and resilient
deflectable diaphragm spanning the interior of the flexible tube at
the location of the valve means, and forming a sealed chamber at
the closed end of the tube,
d. said magnetic core and electromagnet being disposed in said
sealed chamber.
8. A valved drainage-control device as in claim 7, wherein:
a. said movable valve further comprises a facing carried by said
diaphragm,
b. said diaphragm and facing being attached to said magnetic
core.
9. A valved drainage-control device as in claim 4, and further
including:
a. a flat tape extending along the inside wall of the flexible
tube,
b. said slender wire being disposed in said flat tape.
10. A valved drainage-control device as in claim 8, wherein:
a. said valve seat comprises polytetrafluorethylene plastic,
b. said diaphragm comprising a rubberlike plastic material.
Description
CROSS-REFERENCE TO RELATED COPENDING APPLICATIONS
1. Copending application of Sven M. Osthagen, et al., Ser. No.
652,916, filed July 12, 1967, entitled "Urethral Valve," and having
common ownership with the present application, now U.S. Pat. No.
3,503,400, issued Mar. 31, 1970.
PRIOR ART REFERENCES
1. U.S. Pat. No. 396,754.
2. U.S. Pat. No. 1,878,671
3. U.S. Pat. No. 1,920,006
4. U.S. Pat. No. 2,024,982
5. U.S. Pat. No. 2,616,429.
BACKGROUND
This invention relates to drainage devices intended to be implanted
in a living body, and more particularly to devices of this type
which are valve controlled and intended to be retained in the
bladder and urethral canal for the purpose of controlling drainage
therefrom.
Heretofore, various kinds of drainage devices, commonly known as
catheters, draining probes, dilators, surgical instruments, etc.,
have been proposed and/or produced to cope with problems involving
obstruction, operative procedures, examination of tissue, removal
of fluids and the like. These prior devices were as a rule
restricted in their use to the specific purpose originally in mind,
and none could be satisfactorily utilized, for instance, as a
fairly long term implant in the urethra or urinary tract to permit
drainage of urine at will from the bladder. Such a long term
drainage control device, moreover, is greatly needed and would find
widespread use and acceptance.
It is known that patients who have neurogenic bladders due to
congenital spinal cord defects, spinal cord or brain injury, or
other neurologic diseases present a major economic problem because
of persistent incontinence.
Also, patients who have incontinence of urination caused either by
muscle weakness or postoperative surgical damage to the urinary
sphincter, are candidates for a satisfactory, long term drainage
device which could provide controlled periodic emptying of the
bladder. Many such patients are not suitable for surgical
correction of incontinence.
In addition, patients who have lower urinary tract obstruction,
whose physical condition does not permit operative relief of this
obstruction, can greatly benefit by having their bladder drained
periodically by use of a long term drainage control implant, until
such time as operative intervention is permitted.
Efforts to meet and solve this longstanding problem have in general
been directed toward the provision of an externally carried
reservoir or bag, in which the urine collected, to be periodically
removed at the user's convenience. This type of device was, at the
very best, a poor solution to the problem, for many quite obvious
reasons not considered necessary to enumerate in connection with
the present invention.
SUMMARY
The above disadvantages and drawbacks of prior devices are obviated
by the present invention, and one object of the invention is to
provide a novel and improved self-operated, internally contained
valved drainage control device which can be implanted in the
urinary tract and readily retained therein for extended periods of
time so as to effect urinary continence, thereby to successfully
cope with the above-mentioned urinary problems arising from various
causes. Another object is to provide a readily operated valved
drainage implant suitable for extended periods of use, which can be
utilized in various, different locations in the body for the
indicated purpose, being not restricted to the urinary tract.
These objects are accomplished by the provision of a novel valve
means adapted to be disposed in the body, actuator means for the
valve which includes at least one flexible wire, which either
extends through or along the inside of an elongate novel pervious
means comprising a slim flexible catheter tube having multiple
perforations in its walls to permit a flushing of the walls of the
body passage, particularly when the valve is actuated to the open
position. The control cable or wire extends through the perforated
tube to the external orifice, and the perforations of the tube
enable an exchange and passage of liquids to occur, facilitating
drainage and the natural functioning of the surrounding tissues
whereby the likelihood of irritation, infection and incompatibility
is greatly minimized, to the extent that the implant can be well
tolerated without giving rise to undesired side effects.
The novel valve means comprises an electromagnet and a permanent
magnet core disposed in a sealed chamber at the inner end of the
catheter tube. One wall of the chamber comprises a corrugated
diaphragm which spans the interior of the tube and which
constitutes the valve element that is actuated by the magnetic
core. Adjoining the diaphragm is an annular valve seat which is
engaged by a valve facing of the diaphragm, for the purpose of
controlling fluid flow.
Other objects of the invention are to provide an improved long term
drainage implant as above set forth, which is especially simple in
construction, economical to fabricate and produce, small and
compact, readily adaptable to both male and female patients, safe
to use, and effective and reliable in operation.
Yet other features and advantages will hereinafter appear.
In the drawings:
FIG. 1 is a side elevational view of a valved drainage control
device as provided by the invention.
FIG. 2 is a fragmentary sagittal median section through a female
pelvis showing the present improved valved drainage control device
in its implanted operative position extending through the
urethra.
FIG. 3 is an axial sectional view, enlarged, of the valve drainage
control device of the invention, shown with the valve in its closed
condition.
FIG. 4 is a fragmentary axial sectional view of the valve portion
of the drainage control device, with the valve in the open
position.
Referring first to FIG. 1, the drainage control device of the
invention as shown therein comprises a slim, flexible catheter tube
10 of inert plastic material, said tube having a closed and pointed
forward or inner end portion 12 provided at a distance from its tip
with a plurality of inlet openings 14. Adjacent the inlet openings
14 is a collapsible and inflatable enlargement or bulb 16 adapted
to be expanded or inflated to a position such as is shown in FIG.
3.
The catheter device of FIG. 1 is intended to be inserted into and
retained in the urethral canal 18 of a living person, as
illustrated in FIG. 2, with the inflated retainer bulb 16 occupying
the bladder 20, the other end of the catheter being located at the
exterior of the body and having a discharge orifice fitting 22. It
will be understood that during the insertion of the catheter the
bulb 16 is in the deflated condition as shown in FIG. 1, and that
after insertion the bulb is inflated by a suitable fluid such as
water, in the manner of the well-known Foley catheter.
Referring to FIG. 3, for the purposes of inflation of the bulb, the
tube 10 is provided with an internal channel 24 which communicates
with an inflation fitting 26 provided with a plug or check valve 28
at its end. The wall of the catheter tube 10 has an opening 30
through which fluid introduced into the inflation fitting 10 can
enter the bulb 16 and expand it to the position shown in FIGS. 2
and 3 for purposes of retaining the device in the desired
position.
In accordance with the present invention, the catheter tube 10 is
provided with multiple perforations or apertures 32 to facilitate a
flushing of the walls of the body passage or urethra when drainage
of the bladder 20 is occurring through the tube 10. The provision
of such perforations tends to reduce the likelihood of irritation
of the walls of the urethral canal, since there is minimized the
possibility of accumulation of any discharge with accompanying
discomfort and possible infection. Instead, the walls of the
urethral canal have communication with the interior of the catheter
tube 10 at a large number of locations, enabling a drainage to
occur which tends to improve the condition of the urethral
wall.
Also in accordance with the invention, a novel and improved valve
arrangement is provided at the innermost end of the catheter tube
10. Considering FIGS. 3 and 4 there is shown flexible circular
diaphragm 34 which spans the interior of the tube 10 adjacent the
inner, closed end portion 12 thereof, said diaphragm forming with
said closed end portion a sealed chamber 36. Located in the chamber
36 is a DC electromagnet coil 38 and also a magnetic core 40
constituted of permanent magnet material. The core 40 is biased
away from the end wall of the tube 10 by a helical compression
spring 42, and is able to move vertically in the coil 38 as viewed
in FIGS. 3 and 4. The magnet core 40 is secured to the inner face
of the central portion of the diaphragm 34, as by a suitable
adhesive. The outer face 44 of the central portion of the diaphragm
34 constitutes the valve element, being cooperable with an annular
valve seat 46 which is disposed in the tube 10 to span the interior
thereof adjacent the diaphragm 34. Above the valve seat 46 are the
inlet openings 14 of the tube.
Considering FIG. 3, when the electromagnet coil 38 is not
energized, the biasing spring 42 will maintain the magnet core 40
and valve facing 44 of the diaphragm in a lowered position wherein
the opening of the valve seat 46 is closed, preventing drainage of
liquid from the bladder 20. When the electromagnet coil 38 is
energized with proper polarity, it will pull upward the core 40 and
the diaphragm 34, uncovering the central opening of the valve seat
46 whereby drainage from the bladder 20 can occur through the
openings 14, valve seat 46, and then through the catheter tube
10.
Energization of the coil 38 can be effected by means of lead wires
48 carried in a flat tape 50 which is adhered to the interior of
the catheter tube 10.
In place of the wire-containing tape 44, the lead wires from the
coil 38 may be brought through the inflation channel for the bulb
16. Thus, as seen in FIGS. 3 and 4, a second set of lead wires 52
is shown as extending through the channel 24, such wires being
brought out at the inflation fitting 26 and being connected with a
battery 54 and with a manually operable on-off switch 56. For such
arrangement, the channel 24 will extend closely adjacent the
annular valve seat 46. The channel 24 is formed by an interior
beadlike wall portion 58 which is either molded in the tube 10 or
attached to the tube after the latter has been initially formed.
The entrance and exit arrangements of the lead wires 52 are done in
such a manner that a fluidtight seal is had, thereby to not impair
the inflation of the bulb 16, as will now be understood. By having
the lead wires 52 brought through the inflation channel 24, the
flat tape 50 with the wires 48 may be dispensed with; or such tape
may be retained and constitute an alternative conductor for
effecting energization of the coil 38 if the conductor 52 should
fail or break for some unforseen reason.
The sealed valve arrangement which is shown in FIG. 4 has
considerable advantage, since the locating of the movable core 40
in the sealed chamber 36 prevents contamination of the core and the
spring 42, and the formation of deposits or caked material which
might impair the functioning of the valve.
The diaphragm 34 is formed of an inert, flexible rubberlike
material such as silicone rubber, neoprene rubber or the like. The
valve seat 46 can be formed of a tough resilient plastic such as
polytetrafluorethylene, known commercially as "Teflon." The bulb 16
and catheter tube 10 are formed of inert resilient plastic or
rubberlike material. The sealed tip portion 12 of the catheter tube
10 may be constituted as a separate part to facilitate insertion of
the electromagnetic valve in the inner end of the tube. After
placement of the valve mechanism, the tip portion 12 may be sealed
to the tube 10 by a suitable heat-sealing or cementing procedure.
The flexible nature of the diaphragm 34 tends to prevent caking and
deposits from forming on it, to impair the functioning thereof.
Also, the slippery surface characteristics of the Teflon valve seat
46 will similarly prevent the adhering of deposits whereby the
valve mechanism is not likely to malfunction during an extended
period of use.
Referring to FIGS. 3 and 4 it will be noted that the openings 14
and the drainage openings 32 in the tube 10 are provided with
well-rounded edges, thereby to prevent any possibility of
irritation to the walls of the urethral canal at the time that the
drainage device is being inserted, retained or removed, and this is
an important feature of the invention.
It will now be understood from the foregoing that I have provided a
novel and improved drainage catheter which may remain for extended
periods of time in the urethral canal for the purpose of
controlling and preventing incontinence, said device being so
constituted as to provide for improved drainage from and around the
walls of the urethral canal to minimize the likelihood of
irritation thereof. Further, the drainage device has a novel sealed
electromagnetic valve mechanism by which remote control is had in a
reliable and convenient manner, such valve mechanism being
especially constituted by location in a sealed chamber and
utilizing a flexible diaphragm valving element, to minimize the
likelihood of malfunctioning or jamming of the valve.
Variations and modifications are possible without departing from
the spirit of the invention.
* * * * *