U.S. patent number 3,812,841 [Application Number 05/282,041] was granted by the patent office on 1974-05-28 for urethra magnetic valve structure.
Invention is credited to Leland H. Isaacson.
United States Patent |
3,812,841 |
Isaacson |
May 28, 1974 |
URETHRA MAGNETIC VALVE STRUCTURE
Abstract
A urethra magnetic valve structure comprising an implantable
tubular valve housing to be located in the urethra at its juncture
with the bladder. The valve housing has a pair of spaced,
inflatable retention collars to be inflated for supporting the
valve unit in proper position with a slotted head portion of the
housing in the bladder. A valve member is resiliently biased to
closed position against an apertured valve seat, and a magnetic
core is connected to the valve member, to be moved by a force field
generated by an electromagnet activating device external of the
patient's body to open the valve and void the bladder.
Inventors: |
Isaacson; Leland H.
(Hyattsville, MD) |
Family
ID: |
23079855 |
Appl.
No.: |
05/282,041 |
Filed: |
August 21, 1972 |
Current U.S.
Class: |
600/29;
128/DIG.25; 251/65; 604/249; 604/101.05; 604/103.03 |
Current CPC
Class: |
A61M
25/0075 (20130101); A61F 2/0022 (20130101); A61M
2025/0078 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61b 019/00 () |
Field of
Search: |
;128/1R,273,274,349R,349B,35R,DIG.25 ;251/65 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Mason, Fenwick & Lawrence
Claims
What is claimed is:
1. A valve unit to be implanted in the urethra of a patient at the
juncture of the urethra with the bladder to be operated by a
magnetic force field generated by an external electromagnetic
device for controlling the flow of urine through the urethra, the
valve comprising an axially elongated hollow tubular housing of
substantially cylindrical configuration having an upper spherical
end and a lower open end, a valve assembly in the intermediate
region of said housing including a centrally apertured annular
valve seat member, a movable valve member below said valve seat
member normally urged toward said valve seat member to closed
position, a magnetic core member connected to said valve member and
guided for movement in said housing to retract the valve member to
open position responsive to a magnetic force field generated
externally of the patient's body, and a pair of radially inwardly
deformable annular collars located on the exterior surface of said
housing at axially spaced locations to assume relatively enlarged
condition upon implanting of the valve unit in the urethra and
provide retaining collars at the opposite ends of the urethra
portion passing through the prostate gland to restrain the valve
unit in implanted position, and the portion of said housing above
the uppermost collar, defining a head portion having openings for
passage of urine from the bladder into the interior of the housing,
and a coupling ring at the lower end of said housing having an
upwardly converging throat adjoining an upwardly facing annular
restraining shoulder for removable coupling of an insertion and
removing instrument therewith.
2. A valve unit as defined in claim 1, said collars being normally
collapsed inflatable collars which are inflated after insertion to
assume such relatively enlarged condition.
3. A valve unit as defined in claim 2, including conduit means
interconnecting said pair of inflatable collars whereby inflating
fluid may be introduced into and withdrawn from the lowermost
collar for inflating or deflating both collars, said lowermost
collar being self-sealing and being puncturable by a syringe needle
for inflating and deflating the same.
4. A valve unit as defined in claim 1, including a centrally
apertured valve retainer member below said valve seat member having
openings for passage of urine therethrough when the valve is in
open position, said movable valve member being located between said
valve seat member and said valve retainer member.
5. A valve unit as defined in claim 4, wherein said collars are
normally collapsed inflatable collars, and conduit means
interconnecting said pair of inflatable collars whereby inflating
fluid may be introduced into and withdrawn from the lowermost
collar for inflating or deflating both collars, said lowermost
collar being self-sealing and being puncturable by a syringe needle
for inflating and deflating the same.
6. A valve unit as defined in claim 5 including tension spring
means coupled at one end thereof through the aperture in said valve
seat member to said valve member and adjustably fastened at its
other end to said housing for adjustment of the spring tension
force tending to close said valve member against said valve seat
member prior to implanting of the valve unit in the urethra.
7. A valve unit to be implanted in the urethra of a patient at the
juncture of the urethra with the bladder to be operated by a
magnetic force field generated by an external electromagnetic
device for controlling the flow of urine through the urethra, the
valve comprising an axially elongated hollow tubular housing of
substantially cylindrical configuration having an upper spherical
end and a lower open end, a valve assembly in the intermediate
region of said housing including a centrally apertured annular
valve seat member, a movable valve member below said valve seat
member normally urged toward said valve seat member to closed
position, a magnetic core member connected to said valve member and
guided for movement in said housing to retract the valve member to
open position responsive to a magnetic force field generated
externally of the patient's body, and a pair of radially inwardly
deformable annular collars located on the exterior surface of said
housing at axially spaced locations to assume relatively enlarged
condition upon implanting of the valve unit in the urethra and
provide retaining collars at the opposite ends of the urethra
portion passing through the prostate gland to restrain the valve
unit in implanted position, and the portion of said housing above
the uppermost collar defining a head portion having openings for
passage of urine from the bladder into the interior of said
housing, a coupling ring at the lower end of said housing having an
upwardly converging throat adjoining an upwardly facing annular
restraining shoulder for removable coupling of an insertion and
removing instrument therewith, an insertion and removing instrument
including an elongated instrument tube having a convergently
tapering leading end of truncated conical configuration, an
expandable chuck at said leading end releasably coupled to said
coupling ring and defining a cone which is an extension of said
tapering leading end when in contracted condition and which is made
up of conic segments which are radially outwardly movable to
expanded position in said valve housing interlocking against said
annular restraining shoulder of said coupling ring, spring wires in
said instrument tube supporting said conic segments and normally
urging them to said expanded position, and a contracting ring in
said instrument tube surrounding said wires and mounted for
reciprocation axially of the tube by a plunger to expand and
contract the conic segments.
8. A valve unit as defined in claim 7, wherein said collars are
normally collapsed inflatable collars which are inflated after
insertion to assume such relatively enlarged condition.
9. A valve unit as defined in claim 8, including conduit means
interconnecting said pair of inflatable collars whereby inflating
fluid may be introduced into and withdrawn from the lowermost
collar for inflating or deflating both collars, said lowermost
collar being self-sealing and being puncturable by a syringe needle
for inflating and deflating the same.
10. A valve unit as defined in claim 7, wherein said collars are
formed of resiliently deformable material normally elastically
urged to selected radially enlarged annular formations and
resiliently contractible to approximately flat condition adjacent
the surface of said tubular housing.
11. A valve unit as defined in claim 7, including a centrally
apertured valve retainer member below said valve seat member having
openings for passage of uring therethrough when the valve is in
open position, said movable valve member being located between said
valve seat member and said valve retainer member.
12. A valve unit as defined in claim 11, wherein said collars are
normally collapsed inflatable collars, conduit means
interconnecting said pair of inflatable collars whereby inflating
fluid may be introduced into and withdrawn from the lowermost
collar for inflating or deflating both collars, said lowermost
collar being self-sealing and being puncturable by a syringe needle
for inflating and deflating the same, and tension spring means
coupled at one end of the valve unit through the aperture in said
valve seat member to said valve member and adjustably fastened at
its other end to said housing for adjustment of the spring tension
force tending to close said valve member against said valve seat
member prior to implanting of the valve unit in the urethra.
Description
BACKGROUND AND OBJECTS OF THE INVENTION
The present invention relates in general to an implantable control
valve for controlling discharge of fluid from the urethra, and more
particularly to an implantable valve device having magnetic movable
parts which will respond to a magnetic field produced by an
external device to control the flow of urine in patients without
physical control capabilities.
Urinary incontinence is a long recognized problem in the medical
field to which much effort has been directed in providing devices
for handling of this problem in some way. Urinary incontinence,
which is defined as the inability to control automatically or under
command the elimination function of the bladder, is a widespread
disorder which results from some form of neurological disfunction,
usually incurable, which effects either or both the ability to
sense an over capacity condition which causes involuntary forced
elimination, or to control the bladder sphincters. Such
incontinence may be caused by birth defects, disease, injury or
aging, frequently resulting from infection in the urinary tract,
and sometimes resulting after prostate removel. Waste water is
discharged from the body through the urethra which leads from the
bladder and is controlled by the sphincter associated with the
urethra in the area of its junction with the bladder. When the
sphincter becomes disabled or incapacitated, the incontinence and
loss of control of the passage of waste liquids through the urethra
is a circumstance which is common but quite embarrassing, awkward,
uncomfortable and inconvenient.
While many methods and expedients have been employed and proposed
to control and alleviate such urinary incontinence, these have
possessed numerous drawbacks and disadvantages and have done little
to solve this problem. The usual medical treatment has been to
insert a catheter through the urethra into the bladder with an
exterior water-tight collecting bag connected to the catheter tube
and a flow control clamp or similar device associated with the
catheter and located externally of the body. Other management
techniques have included wearing of absorbent diaperlike clothing
or plastic pants, but such devices present a continuing and
distressing problem of odor. Also, penile clamps have been
proposed, for exerting enough pressure to occlude the urethra, but
extreme care must be taken in the use of such devices to prevent
forces that would impair circulation or cause edema. Also, use of
such a device over a long period of time may cause a urethral
diverticulum at the point of pressure, and skin irritations may
also develop.
An object of the present invention is the provision of an
implantable magnetic valve device which serves as a semipermanent
implant in the urethra to control the flow of urine by creation of
a magnetic field eminating from an external device when it is
desired to open the valve, and thus replace the use of catheters,
urinal bags and similar devices usually employed to manage the
urinary incontinence problem.
Another object of the present invention is the provision of a novel
urethra valve structure of magnetic character which can be
conveniently inserted in the urethra to alleviate problems of
urinary incontinence, which has inflatable retention collars to
keep the device in position, and which is of such design that it
may be inserted in a convenient manner.
Other objects, advantages and capabilities of the present invention
will become apparent from the following detailed description, taken
in conjunction with the accompanying drawings illustrating
preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 is an elevation view of the urethra magnetic valve of the
present invention, shown to approximate full scale;
FIG. 2 is an enlarged longitudinal section view of the urethra
magnetic valve, illustrating the device at a scale enlargement of
about 4 to 1;
FIG. 3 is a transverse section view of the urethra valve, taken
along the line 3--3 of FIG. 2;
FIG. 4 is a transverse section view through the urethra valve,
taken along the line 4--4 of FIG. 2;
FIG. 5 is a transverse section view through the urethra valve,
taken along the line 5--5 of FIG. 2;
FIG. 6 is an elevation view of an insertion and removing instrument
for implanting and removing the valve in the urethra, with parts of
the instrument broken away to reveal the interior thereof and
showing adjacent portions of the urethra valve in section;
FIG. 6A is a fragmentary elevation view of the working end portion
of the insertion instrument, showing the chuck or collet in
collapsed condition;
FIG. 7 is a somewhat diagrammatic view illustrating the urethra
valve in implanted position and illustrating the electromagnetic
activator in a position of use to activate the urethra valve;
FIG. 8 is a diagrammatic view of a modified form of electromagnetic
activator for the valve;
FIG. 9 is an enlarged fragmentary section view of the magnetic head
portion of the activating device; and
FIG. 10 is an enlarged sectional view, similar to FIG. 2, showing a
modified form of my urethra magnetic valve.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to the drawings, wherein like reference characters
designate corresponding parts throughout the several figures, and
referring particularly to FIGS. 1 through 6, the urethra magnetic
valve unit of the present invention is a small implantable device,
indicated by the reference character 10, formed of an elongated,
generally cylindrical housing tube 11, molded for example from a
slightly flexibly deformable plastic material and having a
cylindrical tubular outer wall 12 defining an elongated lower main
body portion 13 and a head portion 14. The head portion 14 extends
over, for example, approximately one third of the axial length of
the tube 11 and terminates at its upper end in a spherically
configurated closed leading end or inner end 14a. The head portion
14 also is provided with a plurality of axially elongated slots or
holes 14b for admitting fluid into the interior of the housing tube
11. The trailing or lower end of the main body portion 13 of the
housing tube 11 is indicated at 11a, and has fixed therein a
coupling ring 13a defining a constricted, upwardly converging and
conically tapering throat portion 13b and an annular restraining
shoulder 13c. Within the housing tube 11 in the intermediate or
central zone thereof is a valve structure formed by a valve member
15 which may be of spherical or conical configuration. The valve
member 15 is normally held against a valve seat 16 by a coiled
tension spring 17, secured for example to the valve member stem
portion 15a extending through the valve opening 16a in the valve
seat 16 and secured at its other end to an adjustment screw 18
threaded into a threaded anchor sleeve 19 at the closed end of the
head portion 14. By adjusting the screw 18 and therefore the
tension of the spring 17, the tension of the valve may be
controlled as required to accommodate to bladder volume and
pressure and to enable the valve to weep if the pressure gets too
great and the bladder has not been emptied at periodic intervals,
as may be necessary for paraplegics, who have no sensation.
A valve retainer member 20 is also fixed in the housing tube 11
spaced toward the lower end 11a thereof from the valve, this being
a slotted collar member having slots 20a for passage of fluid and
having a central opening which assists in guiding the valve member
15 by means of a connecting stem or rod 21 extending from the valve
member 15 to a magnetic core member 22, for example an Alnico
magnetic core of cylindrical configuration. Another guide rod 23
extends from the opposite end of magnetic core 22 along the center
axis of the core and the valve member and into a guide opening in a
guide collar 24 fixed in the lower region of the housing tube 11
near the lower end 11a thereof.
It will be noted that the valve retainer 20 is slotted as indicated
at 20a in FIG. 4, and the guide collar 24 has a series of
circumferentially spaced apertures 24a spaced outwardly from the
center guide aperture 24b thereof, the slots and the apertures
being provided to permit free passage of fluid which is allowed to
enter the head portion 14 through the slots 14a and pass through
the opening of the valve seat 16 and through the lower section of
the housing tube 11.
Mounted on the external surface of the housing tube 11, near the
lower end 11a thereof and adjacent the lower end of the head
portion 14, are a pair of upper and lower inflatable retention
collars 25 and 26 interconnected by one or more interconnecting
inflation tubes 27 extending between the collars 25 and 26. The
interconnecting tubes 27, shown here as a pair of tubes located at
diametrically opposite parts of housing tube 11, form a unitary
inflation chamber with the interior chamber portions of the collars
25 and 26 to facilitate inflation of both collars upon inflating of
the lower collar 26. It is intended that the inflation chamber
portions defined by the collars 25 and 26 and the inflation tubes
27 be inflated with some liquid, such as saline solution, or other
desired solution, to which may be added, if desired, anitbiotics to
retard possible infection and possibly desensitising drugs. The
inflatable collars should be constructed of self-sealing material
forming a semi-permeable membrane through which the osmotic process
might function to permit the collar fluids to leak at a very slow
rate and thereby permit any drug used in the solution to accomplish
the desired physiological effect.
The inflatable collars 25, 26 are spaced apart an appropriate
distance so that the upper collar, upon inflation, will be disposed
at the site where the urethra enters the bladder and thus form a
restraining collar against the bladder wall or the top of the
prostate gland. while the lower collar 26 is located at the
position where the urethra leaves the prostate gland. Upon
implanting of the urethra valve and inflation of the collars 25 and
26, the inflatable collars thus form enlarged rings or restraining
collars at the approximate positions illustrated in FIGS. 7 and 8
where the urethra emerges from opposite portions of the prostate
gland, to hold the valve in desired position in the urethra with
the head portion 14 disposed within the bladder. In the drawings,
the bladder is indicated by the reference character 28 and the
prostate gland by the reference character 29. It will be noted from
FIG. 7 that a slight curvature is imparted to the body portion 13
of the urethra valve 10, which is permitted by reason of the
slightly flexibly deformable character of the plastic material
forming the cylindrical housing 11 and valve member, or by
preforming of the valve housing and valve member to this
configuration.
The urethra valve 10 is conveniently inserted into the urethra and
advanced to the appropriate site by a suitable insertion and
removing instrument, indicated generally by the reference character
30 in FIG. 6 and shown in decoupled, contracted condition in FIG.
6A. This insertion and removing instrument 30 has an elongated
cylindrical instrument tube or body 31 terminating at its forward
end in a tapered leading end portion 32 of truncated conical
configuration having a conical expansion collet or chuck 33 at the
leading end thereof. The collet or chuck 33 is formed of a
plurality of split segments 33a which, when contracted into tightly
nested condition, define a conical surface which is an extension of
the truncated conical surface of the end portion 32. The segments
33a of the expansion collet or expanding chuck are spring biased to
the outwardly extended position illustrated in FIG. 6 by means of
the spring wires 34 which support the chuck segments 33, the spring
wires 34 and chuck segments 33a being contractable to the closed
position illustrated in FIG. 6A by forward movement of the
contracting ring 35 surrounding the spring wires 34 and coupled by
connecting rod 36 to the activator or plunger 37 at the outer end
of the insertion and removing instrument 30.
When the plunger 37 and the ring 35 connected thereto is moved to
its forwardmost position, the spring wires 34 are contracted toward
each other by the ring 35 from their normal diverging positions,
disposing the chuck segments 33a in the nested conical position
illustrated in FIG. 6A. When the plunger 37 of the instrument 30 is
retracted to its outermost position, the ring 35 occupies the
position illustrated in FIG. 6, allowing the spring wires 34 to
resiliently move the chuck setments 33a radially outwardly from the
axis of the instrument 30 to engage the shoulder on the segments
against the annular restraining shoulder 14c of the ring 14a,
thereby coupling the valve 10 to the insertion and removing
instrument 30. The insertion and removing instrument 30 also
preferably contains a guide sleeve 38 extending along the length
thereof fixed to the external surface of the cylindrical body 31
through which a flexible syringe needle 39 may be inserted to
puncture the lower retention collar 26. A tubular conduit 38a, such
as plastic tubing, connects the syringe needle 39 to a supply
container, such as a collapsible syringe 38b, filled with saline
solution or any other antibiotic solution to inflate the collars
25, 26.
With the collars 25, 26 in deflated condition, the complete urethra
magnetic valve 10 may be implanted in the urethra by locking the
valve unit 10 to the insertion and removing instrument 30 through
use of the expanding chuck segments 33a inserted into the throat
portion 13b of the coupling ring 13a to interlock with the
restraining shoulder 13c. The valve unit 10 is then inserted in the
urethra and advanced by the insertion and removing instrument 30 to
the proper position in the zone of the prostate gland 29, whereupon
the flexible syringe needle 39 is inserted through the guide sleeve
38 to puncture the lower retention collar 26 and inflate the two
interconnected retention collars 25 and 26 with the fluid in the
syringe 38b. The needle 39 is then withdrawn from the guide sleeve
and the plunger or actuator 37 of the instrument 30 pushed
inwardly, advancing the contracting ring 35 along the spring wires
34 to cause the chuck to collapse to the condition illustrated in
FIG. 6A, so that the insertion tool can be withdrawn from
interlocking relation with the ring 13a to leave the valve in the
urethra as a temporary implant.
The valve seat member 16, in one preferred embodiment, may be a
teflon valve seat designed to accommodate the valve member 15,
either of spherical ball shape or of conical shape, with the
opening 16a in the valve seat sized so that when the valve is
activated and the urine begins to flow, the increased surface of
the exposed valve member should permit hydrostatic pressure to
assist in keeping the valve open. The design and the tension on the
spring 17 should be of such nature so that under normally full
bladder pressure, the valve will weep sufficiently to warn the
patient that he has exceeded the normal void time, for example if
the patient is a paraplegic.
The valve is designed to be controlled by the patient to open the
valve and achieve voiding, by the use of an external
electromagnetic device creating a magnetic force field of
sufficient strength to penetrate the distance between the valve and
the external surface back of the scrotum. Examples of such magnetic
activating devices are illustrated in FIGS. 7 and 8 and indicated
generally by the reference characters 40 and 41. The magnetic
activating devices 40 and 41 each include a magnetic head 42 formed
for example of a metallic core 43 of any desired configuration and
windings indicated generally at 44 creating a force field of
sufficient strength to attract the magnetic core member 22 of the
valve structure and cause the valve member 15 to be drawn open to
permit the fluid to flow freely from the bladder. Power for the
windings of the magnetic head can be a standard DC battery or array
of batteries, or a small step-down transformer operating off of a
standard 110 volt 60 cycle supply and having a full wave DC
rectifying bridge formed of diodes to produce the supply current of
proper voltage, for example about 15 volts, across the windings of
the magnetic head. In the form illustrated in FIG. 7, the external
electromagnetic device 40 is shown to have an elongated curved
handle portion 45 shaped to extend forwardly around the scrotum
from the electromagnetic head to a convenient access position and
having, for example, a pushbutton switch 46 thereon to be operated
by the thumb of the patient. In the form shown in FIG. 8, the
external electromagnetic device 41 has a curved portion 47
projecting forwardly from the head 42 to extend around the scrotum
and terminates in a C-shaped clamp portion 48 adapted to releasibly
clamp about the neck of a bottle or receptacle 49 to collect the
fluid voided from the bladder upon electromagnetic activation of
the valve to withdraw the valve member 15 to open position.
A modified form of the implantable device of the present invention
is illustrated in FIG. 10, indicated by reference character 10',
formed of an elongated generally cylindrical housing tube 11', head
portion 12' and a pair of retention collars 25', 26'. The
components of this embodiment corresponding to parts of the
first-described embodiment are indicated by reference characters
which are primes of the reference characters used in describing the
first embodiment. One or both of the collars 25', 26' in this
second embodiment are formed of highly resilient soft rubber or
plastic material whose elastic memory normally urges them to the
relatively radially enlarged annular configuration shown. The
collars 25', 26' are deformed inwardly by unyielding wall regions
of the urethra during insertion, to approach substantially
conformation to the cylindrical configuration and diameter of the
exterior surface of the housing tube 11', but spring back to their
enlarged condition when they reach the implant site astride the
prostate gland. In this way, the need for the inflation tube 27 and
for inflating means is eliminated. Also, need for the spring 17 is
eliminated by making the valve seat 16' of magnetic material
magnetized to produce a North or South magnetic pole adjacent the
ball valve 15', and the ball valve 15' is made of magnetic material
of opposite polarity to be permanently attracted to the valve seat.
The valve is opened by the magnetic activator device 40 or 41
creating a force field of sufficient strength to move the magnet
core 22', and the valve 15' connected thereto, with such force as
to overcome the attractive force of the valve seat 16' and retract
the valve member 15' to open position. When the field of the
activator device 40 or 41 collapses upon deenergization of its
electro-magnet, the ball valve member 15' is again attracted
magnetically to closed position against the valve seat 16'.
The implant valve assembly 10 or 10' need not be especially formed
to be coupled to the insertion and removing instrument 30, but may
be inserted in the urethra by other known urethra examination
devices, such as the telescoping tubes of known urethrascopes.
* * * * *