U.S. patent number 3,768,102 [Application Number 05/176,759] was granted by the patent office on 1973-10-30 for implantable artificial urethral valve.
This patent grant is currently assigned to University of Utah. Invention is credited to Stephen C. Jacobsen, Clifford S. Kwan-Gett.
United States Patent |
3,768,102 |
Kwan-Gett , et al. |
October 30, 1973 |
IMPLANTABLE ARTIFICIAL URETHRAL VALVE
Abstract
An artificial urethral valve for implantation in the bladder or
urethra of an incontinent person comprising a movable valve
occluding means which is retained in the closed position by means
of a spring that requires a relatively high opening force and then
substantially collapses to allow the passage of bladder contents
through the valve. The valve occluding member retaining spring
requires a relatively high breakaway or opening force to open.
Thereafter the normal outflow of bladder contents through the valve
is sufficient to substantially keep the valve open. After the
contents of the bladder have been voluntarily evacuated, the valve
occluding member is automatically returned to the valve seat to
again close the valve to a leakproof seal.
Inventors: |
Kwan-Gett; Clifford S. (Salt
Lake City, UT), Jacobsen; Stephen C. (Arlington, MA) |
Assignee: |
University of Utah (Salt Lake
City, UT)
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Family
ID: |
22645707 |
Appl.
No.: |
05/176,759 |
Filed: |
February 3, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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849720 |
Aug 13, 1969 |
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Current U.S.
Class: |
623/23.66;
128/DIG.25; 137/535; 137/538; 137/539; 600/31; 604/175; 604/247;
623/23.68 |
Current CPC
Class: |
A61F
2/0022 (20130101); Y10T 137/7925 (20150401); Y10T
137/7922 (20150401); Y10T 137/7927 (20150401); Y10S
128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61f 001/00 (); A61f 001/24 () |
Field of
Search: |
;3/1
;128/1R,348-351,DIG.25 ;137/535,538,539 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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837,009 |
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Apr 1952 |
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DT |
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11,158 |
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1892 |
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GB |
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Other References
"A Mechanical Urethral Valve", by F. P. Kohler et al., The Bulletin
of the Dow Corning Center for Aid to Medical Research, Vol. 2, No.
2, Apr. 1960..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This is a division of an application for U.S. Pat. Ser. No.
849,720, filed Aug. 13, 1969 and now abandoned.
Claims
We claim:
1. In an artificial urethral valve for implantation in the lower
urinary tract of an incontinent person for the purpose of allowing
the incontinent person to regain voluntary control over the
evacuation of bladder contents, said valve comprising a body of a
size for wholly implanting and blocking the lower urinary tract of
the incontinent person and having a tunnel which extends
therethrough for the passage of bladder contents through said valve
body wherein the internal diameter of a first downstream portion of
the inlet section of said tunnel is of a lesser diameter than an
adjacent second downstream section of said tunnel, the downstream
face of said lesser diameter portion being located in a plane
generally transverse to the longitudinal axis of said tunnel and
serving as a valve seat for an occluding member of said valve
tunnel, which occluding member resides within the second section of
the tunnel downstream of said valve seat, said occluding member
being held in the occluding position against said valve seat by the
resilience of a spring means, said spring means having a first
greater resiliency to movement to a predetermined position away
from said seat and thereafter substantially collapses to a
condition of lesser resiliency under a force exerted upon the
bladder contents sufficient to initiate urination whereupon said
occluding member is held away from said occluding position by the
force of the outflow of bladder contents from the bladder through
said valve body until said outflow of said bladder contents has
substantially ceased whereupon the residual resilience of said
spring is sufficient to return said occluding member to said
occluding position.
2. In an artificial urethral valve as defined in claim 1 wherein
said occluding member is in the shape generally of an apex of a
blunted cone wherein the blunted tip of said cone resides within
the center of said valve seat and the sloping sides of said cone
serve as a liquid proof contact between said valve seat and said
occluding member said occluding member acting as a lifting body
under a flow of bladder contents through said tunnel, said lifting
body action serving to assist in overcoming any remaining resistive
force tending to return said occluding member to said valve
seat.
3. An artificial urethral valve as defined in claim 1 wherein all
materials of construction exposed to living tissue are inert to and
compatible with living tissue.
4. An artificial urethral valve as defined in claim 1 wherein all
materials of construction exposed to bladder contents are inert to
said bladder contents.
5. An implantable artificial urethral valve comprising valving
means operable under a first, greater pressure to open said valve
and retained in said open position under a second, lesser,
pressure, said valving means comprising a body of a size to be
implanted wholly within the lower urinary tract, a tunnel extending
through said body having a valve seat therein, an occluding member
engaging said seat, and a spring engaging said occluding member to
normally retain said occluding member against said valve seat in a
sealing relationship until opened by said first greater pressure,
said spring having a first greater resiliency to movement to a
predetermined position away from said seat and a second lesser
resiliency to movement beyond said predetermined position.
Description
Voluntary control over the discharge of bladder contents has long
been a serious and distressing problem for persons whose natural
urethral valve is no longer capable of completely controlling the
outflow of urine from the bladder for such reasons as advanced age,
surgery, disease, or malformation of the natural urethral valve.
Persons with this problem have attempted other means of control or
correction which have proved to be uncomfortable, inconvenient,
unsanitary, offensive, and inadequate.
One such method of caring for involuntary bladder emissions
consists of the incontinent person wearing a pad of absorbant
material in close proximity to the external opening of the urethra
to absorb all the fluid that escapes past the malfunctioning
natural urethral valve. This method is very undesirable in that the
wearer is continually confronted with the embarrassment of having
to wear a bulky pad of absorbant material that can create skin
irritations and offensive odors. A person thus equipped will of
necessity feel unduly restricted in his activities since he must
always be aware of the problems associated with urination, used pad
removal and disposal, and pad replacement.
Another method of caring for involuntary urinary emissions has been
for the incontinent person to wear a receiving container attached
to the leg or suspended from the waist and connected to the
external opening of the urethra in such a manner as to allow the
urine to flow by the force of graivty into the receiving container.
Such a device is disclosed by Snyder, U. S. Pat. No. 3,447,536. Not
only is such a device cumbersome, but it can be odoriferous and has
on occasion been known to spill or otherwise accidently discharge
its contents.
Neither of the foregoing methods is directed towards solving the
underlying problem of the incontinent person nor do they attempt to
return the evacuation of bladder contents to the completely
voluntary control of the afflicted person.
Beliveau et al., U. S. Pat. No. 3,372,695, propose a device that is
inserted up the urethra until a retainer portion resides inside the
bladder and an appendage thereto or plug passes out of the bladder
into the urethra such that the plug resides within the confines of
the urethral sphincter muscle. The appendage or plug portion of
their device that passes out through the urethral sphincter muscle
is smaller in diameter than the internal diameter of the urethra
but of sufficient diameter to form a fluids barrier when the
urethral sphincter muscle is closed about it. Their invention is
adaptable only for those persons who are able to partially close
the uethral sphincter muscle sufficiently to completely restrict
the urethra when the plug is located within the confines of the
muscle and thus overcome incontinence of urination. Their invention
would not be usable in a person who was unable to exercise any form
of voluntary control over the urethral sphincter muscle or in a
person whose urethral sphincter muscle has been damaged by disease
such that the plug portion would not complete the seal when acted
upon by the muscle. Nor would it be operable in a person whose
urethral sphincter muscle has been surgically removed for one
reason or another. Also, it is well known in the medical field that
an unrestrained foreign object in the urethra is a source of
irritation to the lining of the urethra and substantially increases
the dangers of infection of the urethra. The cord in their
invention, which extends out the urethra (see column 4, lines
32-36), is such a source of irritation to the urethra since it
would reside within the urethra while the appliance is in place as
a method of overcoming incontinence.
The apparatus of the present invention does not require the use of
any external appliances as disclosed by Snyder or the adaptation of
other voluntary muscles to the task of supplying motive power to a
urethral closure device located externally of the urethra as
disclosed by Berry, U. S. Pat. No. 3,066,667. Berry discloses an
inert and rigid body that is pressed against the urethra to pinch
it closed or otherwise cause the urethra to be kinked in such a
manner as to prevent the passage of bladder contents through the
urethra. From the foregoing, a serious question arises as to
whether the pinching of the living tissue will tend to cause
necrosis of that section of tissue.
The present invention completely replaces the natural urethral
sphincter muscle as the urethra closure means and utilizes only the
normal muscles used in urination to create sufficient pressure upon
the bladder contents to overcome the spring tension force that
holds the occluding member to the valve seat to form the leakproof
seal. Once the initial spring tension force is overcome, the valve
will remain open under the normal flow of the bladder contents with
very little pressure required to be exerted upon the bladder to
keep the valve open and the bladder contents flowing.
After the bladder contents have been evacuated, there is sufficient
spring tension in the resilient member to return the occluding
member to the closed position to form again a leakproof seal.
It is an object of this invention to provide an artificial urethral
valve suitable for implantation in the urethra or bladder of an
incontinent person for the purpose of returning the evacuation of
bladder contents to the voluntary control of the user.
A further object of this invention is to provide an artificial
urethral valve that requires an opening force greater than the
static pressures normally exerted on the bladder and thereafter
remains open under a minimal force such as the gravitational flow
of urine from the bladder.
A still further object of this invention is to provide an
artificial urethral valve that automatically returns to the closed
position when the contents of the bladder have been voluntarily
evacuated.
These and other objects and advantages of the present invention
will become apparent from the following drawing and accompanying
descriptions of the drawing.
FIG. 1 is a schematic of one embodiment of the artifical urethral
valve with a spherical occluding member.
FIG. 2 is a schematic of another embodiment of the artifical
urethral valve with a conical occluding member.
FIG. 3 is an end view of both embodiments set forth in FIGS. 1 and
2.
Referring to FIG. 1, an artificial urethral valve is shown
generally at 10 and comprises a fluids occluding member 11 in the
shape of a sphere which occludes the distal end of the inlet
portion 12 of a tunnel through the body of the valve when held by
the spring tension force of a spring 17 against a valve seat 14.
Valve seat 14 is formed circumferentially about the distal end of
the inlet tunnel 12. When dislodged from the valve seat 14 by the
voluntary exertion of force upon the bladder and its contents
sufficient to initiate urination, occluding member 11 is forced
away from valve seat 14 whereupon the spring tension force of
spring 17 tending to return occluding member 11 to valve seat 14
rapidly collapses. Once dislodged from valve seat 14, occluding
member 11 is held away from the valve seat by the force of the flow
of bladder contents through inlet tunnel 12 of valve 10.
The diameter of occluding member 11 is less than the internal
diameter of the cavity or tunnel within which it resides to allow
the passage of bladder contents through the valve once the
occluding member has been dislodged from the valve seat 14.
After the bladder contents have been voluntarily evacuated, the
spring tension force of spring 17 acting upon occluding member 11
is sufficient to return occluding member 11 to valve seat 14 and
again form a leakproof seal. In this manner, the artificial
urethral valve very closely approximates the functions of a
normally functioning natural urethral valve.
Spring 17 is in the form of a spring that has relatively high
resistance to movement up to a certain point but movement beyond
that point causes the spring to substantially collapse to a
condition of weaker resilience. Such a spring is similar to the
common noisemaker or "cricket" which has a leaf of spring metal
with a depression or dimple formed therein which creates the high
resistance to movement up to a point after which the spring
collapses with a loud noise to the condition of weaker resistance.
Spring 17 is also similar in principle to the commercially
available Belleville spring wherein opposing compressive and
tensive forces within the body of the spring create the condition
of relatively high resistance to movement up to a certain point and
any movement beyond that point causes the spring to substantially
collapse to a condition of weaker resistance.
Utilizing this type of spring, occluding member 11 is held against
valve seat 14 until forced away by the voluntary exertion of force
sufficient to cause urination at which time spring 17 substantially
collapses and allows occluding member 11 to move away from valve
seat 14 to allow the bladder contents to be evacuated through the
valve. The flow of the bladder contents through the valve is
sufficient to overcome the resilience of spring 17 in its
substantially collapsed state. After the flow has ceased, the
remaining resilience of the substantially collapsed spring 17 is
sufficient to return occluding member 11 to the closed position
against valve seat 14 whereupon the spring again requires a
relatively high force to open the valve.
It would be obvious to one skilled in the surgical arts that an
artificial urethral valve as shown is designed for implantation in
the bladder over the bladder outlet to the urethra in such a manner
as to completely control the outflow of bladder contents into the
urethra and subsequently from the body.
Referring to FIG. 2, occluding member 11 is generally in the form
of a right circular cone with a blunted apex and gently rounded
corners. The apex of the cone resides within the inlet tunnel 12
and the sloping sides of the cone contact valve seat 14 to form a
leakproof seal. This cone shape of the occluding member causes it
to act as a lifting body under the flow of bladder contents in that
the flow of fluids around the cone shape in a direction generally
parallel to the axis of the cone will tend to create an area of
decreased pressure behind the cone. This area of decreased pressure
will in turn assist in the movement of the occluding member 11
further from the valve seat 14 and in overcoming the resistance of
spring 17.
The cone shape is merely one suggested embodiment of the occluding
member 11. Other forms or shapes could easily be adapted for use as
an occluding member for the artificial urethral valve.
FIG. 3 is an end view of the valves shown in FIGS. 1 and 2 and
serves to illustrate how openings 15 between restraining members 16
allow the passage of bladder contents from the valve into the
urethra. In all embodiments, restraining members 16 prevent the
downstream travel of occluding member 11.
In all embodiments of the artificial urethral valve all materials
of construction in contact with living tissue are inert and
non-irritating to living tissue in addition to being inert to urine
wherever the materials come into actual contact with the bladder
contents.
The artificial urethral valve shown could be surgically implanted
in the appropriate position in the lower urinary tract of the
incontinent person; however, it could also be constructed of such a
small external diameter that it could be inserted through the
external opening of the urethra and up the urethra until in a
position proximal to the natural urethral valve muscle such that
the natural urethral valve muscle would retain the artificial
urethral valve in place. As an alternative, the artificial urethral
valve could be bonded in place by means of tissue compatible
adhesives or by means of expandable barbs that could be expanded
when the valve is in place to engage the inner wall of the urethra
sufficient to hold the valve in place in the uethra against the
pressures of the bladder contents.
* * * * *