U.S. patent number 3,744,063 [Application Number 05/188,585] was granted by the patent office on 1973-07-10 for artifical sphincter for controlling urinary incontinence.
This patent grant is currently assigned to The Kendall Company. Invention is credited to Daniel M. McWhorter, Glenn N. Taylor.
United States Patent |
3,744,063 |
McWhorter , et al. |
July 10, 1973 |
ARTIFICAL SPHINCTER FOR CONTROLLING URINARY INCONTINENCE
Abstract
An artificial sphincter for the control of urinary incontinence
is provided by wrapping around the urethral canal an inflatable
plastic collar connected to a system of small pumps and valves
governing the flow of fluid into and out of a fluid reservoir. The
valves and pumps are so arranged that inflation and deflation of
the collar is carried out in incremental steps, so that the applied
pressure or release of pressure is graduated and controlled.
Inventors: |
McWhorter; Daniel M. (Arlington
Heights, IL), Taylor; Glenn N. (Barrington, IL) |
Assignee: |
The Kendall Company (Walpole,
MA)
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Family
ID: |
22693760 |
Appl.
No.: |
05/188,585 |
Filed: |
October 12, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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888368 |
Dec 29, 1969 |
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Current U.S.
Class: |
623/23.66;
600/31; 128/DIG.25 |
Current CPC
Class: |
A61F
2/004 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61f 001/00 (); A61b 017/00 () |
Field of
Search: |
;3/1
;128/1R,327,344,346,DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This is a continuation of application Ser. No. 888,368, filed Dec.
29, 1969 and now abandoned.
Claims
Having thus described our invention, we claim:
1. An artificial sphincter for controlling urinary incontinence
which comprises
an inflatable urethral collar connected by a flexible tube to an
inflation-deflation mechanism which comprises
pump and valve means for incrementally increasing fluid pressure in
said urethral collar,
and separate pump and valve means for incrementally decreasing
fluid pressure in said collar.
2. The sphincter according to claim 1 in which the urethral collar
is a substantially rectangular hollow inflatable plastic pouch.
3. The sphincter according to claim 1 in which the urethral collar
is an extended length of collapsible plastic tubing sealed at one
end and capable of being wrapped around the urethral canal.
4. The sphincter according to claim 1, said sphincter being made
from a material which is non-toxic and non-irritating to the human
body so as to be wholly implantable in fixed position within the
human body.
5. The sphincter according to claim 1 wherein the inflatable
urethral collar has attached thereto an elongated conformable
generally rectangular strip of material which in length is greater
than the circumference of the average urethral passage.
6. The sphincter according to claim 1 in which the pump and valve
means for the inflation of the urethral collar and the separate
pump and valve means for deflation of said collar are both
connected to a single fluid reservoir.
7. An artificial sphincter in accordance with claim 1 wherein said
inflation-deflation mechanism includes a fluid reservoir and
wherein said pump and valve means for increasing fluid pressure in
said collar, said reservoir, and said separate pump and valve means
are interconnected in series in the order recited with the outlet
side of said pump and valve means for increasing pressure in the
collar connected to the inlet side of said separate pump and valve
means,
said flexible tube interconnecting said collar with said
inflation-deflation mechanism between said outlet side and said
inlet side of the pump and valve means.
8. An artificial sphincter in accordance with claim 7 wherein each
of said pump and valve means comprises, in series, a first one-way
valve, a pump, and a second one-way valve,
said one-way valves permitting the flow of fluid from the reservoir
to and from said collar through said tube when the pumps of the
respective said pump and valve means are actuated.
9. An artificial sphincter in accordance with claim 8 wherein the
first and second valves of the separate pump and valve means are
pressure-actuatable, one-way valves which are actuatable to an open
position at a pressure greater the pressure of the inflated collar
when the sphincter is in use to control urinary incontinency,
whereby excess pressure created by pumping of the pump of said pump
and valve means for increasing fluid pressure may be relieved by
opening of said first and second valves at the excess pressure and
the return of fluid therethrough to the reservoir.
Description
This invention relates to a device for controlling the flow of
fluid. More particularly, it relates to a controllable sphincter
device by means of which a controllable degree of restrictive
pressure may be applied to a body passage as, for example, in the
control of urinary incontinence.
Urinary incontinence, whether due to anatomical or neurological
causes, is a serious problem, and numerous attempts have been made
to solve it. Among these, the simplest method is not to regulate
the flow at all, but to collect the urine in a bag or pouch affixed
to the body. Such devices are generally cumbersome, odorous, and
demand constant attention to sanitation.
An alternative prior art device is the use of clamps, of various
contours and configurations, intended to restrict the urethra by
external compression of the entire penis, an uncomfortable
expedient.
Still a third procedure for coping with the problem is an
artificial sphincter applied to the urethral passage, as described
in U.S. Pat. No. 2,455,859. Such devices, meritorious as they may
be, are lacking in the features of comfort, versatility, and
variable control which are desirable in a device of this nature. It
is with improvements in devices of this type that the present
invention is concerned.
It is an object of this invention to provide an artificial
sphincter capable of applying graduated degrees of restriction to a
body passage.
It is a further object of this invention to provide a comfortable
controllable sphincter which may be wholly implanted in the human
body.
It is still another object of the invention to provide an
controllable sphincter which may be controlled by digital
pressure.
Other objects of the invention will appear more fully from the
following description and drawings, in which
FIG. 1 is a perspective view of the device of this invention.
FIG. 2 is a side elevation of the reservoir-valve-pump section 10
of FIG. 1.
FIG. 3 is a flow diagram illustrating the operation of the device
of FIG. 1.
FIG. 4 is a front elevation of the urethral collar 12 of FIG. 1, in
an inflated state.
FIG. 5 is a perspective view of the collar of FIG. 4.
FIG. 6 is a perspective view of an alternative type of inflation
collar or cut-off device.
FIGS. 7 and 8 are views of embodiments of one-way valves suitable
for use in the valve chambers of this invention.
Referring to FIG. 1, the controllable sphincter of the present
invention is seen in its preferred form as comprising a
reservoir-valve-pump system 10 connected to an urethral collar 12
by means of a connecting tube 14. The reservoir-valve-pump system
10 may be composed principally of a soft, essentially flaccid
polymeric material, such as natural or synthetic elastomers,
silicone resins, and the like. It is conveniently formed in two
pieces, as shown in FIG. 2, composed of an essentially flat slab or
thin block of polymer 11, with the various cavities for the valves,
pumps, and reservoir moulded or cast into an upper and coextensive
block of polymer 13, blocks 11 and 13 being adhesively or thermally
united around their peripheries and on both sides of the fluid
channels, the reservoir, and the pumps, as shown by cross-hatching
in FIG. 1.
In cases of incontinence which promise to be permanent or of long
duration, it may be desirable that the device be permanently
implanted in the body. In such instances, it is composed of
materials which are non-irritating and non-toxic. For cases of
temporary incontinence, where the device may be worn in a pocket or
attached to the clothing, the reservoir-valve-pump section may be
fashioned from any convenient materials.
As shown in FIGS. 1 and 2, the hydraulic system comprises a fluid
reservoir 18, two digitally operated hollow chamber pumps 24 and
30, and four one-way valves set in valve chambers 20, 22, 26, and
28, all these parts being interconnected in series. The two lower
valves 20 and 26 operate to allow a fluid flow from the viewer's
left to right: the two upper valves allow flow from viewer's right
to left, in the flow diagram shown in FIG. 3. The opposite
direction of flow is of course equally effective and may be
attained by reversing the flow direction of the one-way valves.
Preferably, the domes of the pump chambers 24 and 30 are
resiliently depressable, while the outer wall of the reservoir 18
is limp and collapsible, but does not exert an appreciable positive
pressure on the fluid which it contains.
The device as put into operation is normally filled with fluid such
as sterile water, the total capacity of the system being, for
example, 5 to 10 cubic centimeters, the major portion of which
resides in the reservoir 18. In order to make the inflation pouch
38 as limp and flat as possible prior to its being wrapped around
the urethral canal, any fluid in the pouch and in the connecting
tube 14 may be transferred back to the reservoir 18 by depressing
and releasing the depressable dome of the pump chamber 30. The four
one-way valves all operate under some degree of positive pressure:
therefore, transfer of fluid from chamber 30 to reservoir 18 causes
a relative vacuum in the chamber 30 when the resilient dome springs
back. Fluid is thereby drawn from the pouch 38 down through the
valve 28 to the chamber 30.
After the urethral collar has been secured in place as described
below, digital pressure on the depressable dome of the pump chamber
24 forces fluid upwardly out of the pump and through the one-way
valve chamber 22.
The hydraulic pressure necessary to operate the valve in chamber 28
is greater than the pressure necessary to inflate the inflatable
section 38 of the urethral collar 12, as discussed below:
therefore, the course of fluid flow is out of the
reservoir-valve-pump system 10, through the connecting tube 14 and
into the inflatable collar 12.
The hydraulic pressure necessary to operate the valve in chamber
28, however, should be so selected that when the inflatable section
of the urethral collar has been inflated sufficiently to constrict
the urethral canal to shut off urinary flow, further accidental
pumping of fluid will not deliver more fluid to the collar, but
will instead deliver fluid through the valve in chamber 28 and
thence back to the reservoir. The valve in chamber 28 therefore
acts as a safety shunt to prevent the application of a painful or
dangerous degree of constriction through the inflatable collar. The
dimensions of the pump 24 are preferably such that approximately
one cubic centimeter of fluid is ejected into the inflation collar
14 for each average stroke of digital pressure applied. Release of
the pressure creates a negative pressure in the pump 24 with
respect to the larger reservoir 18, equilibrium being reestablished
by the automatic passage of fluid from the reservoir 18 through the
one-way valve 20 and thence into the pumping chamber 24. Simple
repetition of the pumping operation by the alternate application
and release of pressure on the pump chamber 24 results in the
gradual transfer of sufficient fluid to the urethral collar 12 to
cut off the flow of urine by collapsing the urethral passage, as
explained below.
The uretheral collar into which fluid is pumped by manipulation of
the pump 24 is shown in perspective in FIG. 1. A generally
rectangular strip of soft, pliable film 32 is heat-sealed or
otherwise adhesively secured to a coextensive strip of a somewhat
less pliable film 34, adhesion being peripheral as shown by the
cross-hatched area 40. The connecting tube 14 is sealed into the
assembly. By this peripheral sealing of the two strips of film, a
pouch 38 is formed, inflatable by fluid delivered through the
sealed-in tube 14.
In application, a longitudinal segment of the urethral canal,
together with a certain amount of surrounding tissue, is separated
from its surroundings. As shown in FIG. 5, the introduction of
fluid into the urethral collar causes the inflation pouch 38 to
enlarge, thereby compressing the tissue 50 and constricting the
urethral canal 52 to the extent needed to shut off urinary flow.
The overwrap 36 shown in FIGS. 1, 4 and 5 is a flexible wraparound
strip, generally long enough to be wrapped for a multiplicity of
turns around the wrapped urethral collar. It is adhesively attached
to the collar 12 as shown at 42 in FIG. 1, and is a soft, strong,
comformable strip such as a close-weave polyester fabric reinforced
by and impregnated with an elastomeric silicone resin. Although
this wraparound strip 36 is shown as pendent in FIG. 1, in actual
use it is wrapped around the urethral collar 12, once the latter is
in place, as shown in FIGS. 4 and 5. The strip 36 is then attached
to the collar, adhesively or by stitching, and serves to maintain
the collar in position.
The degree of pressure needed to restrict the passage of urine is a
highly variable factor, influenced by anatomical, emotional, and
neurological conditions. Although a figure of 20 millimeters of
mercury has been mentioned, it has been estimated that the
necessary pressure may range from 5 to 50 millimeters of mercury.
Prior art devices which apply fluid inflation to an urethral collar
suffer from the fact that there is no graduated degree of control
in the applied pressure, total pressure being applied or released
in a single operation. The degree of variable control offered by
the present invention affords a wide latitude of applied pressure,
which may be varied at will by the wearer to suit his particular
circumstances.
Deflation, with release of compression around the urethral canal,
is effected by digital pressure on the pump chamber 30, which
forces an amount of fluid through the one-way valve 26 and into the
reservoir 18.
Release of pressure on the pump chamber 30 creates a partial vacuum
within said chamber, resulting in the release of fluid from the
urethral collar downwardly through the valve 28 and into the pump
chamber 30. Digital pressure on the pump chamber 30 is repeated and
released until the urethral canal has opened sufficiently to allow
a satisfactory flow of urine, after which the inflation cycle, set
forth above, is repeated.
Variations on this principle of equilibrating pressure by
incremental pumping of fluid will readily suggest themselves to
those skilled in the art. In place of a urethral collar in the form
of an inflatable flat strip, the embodiment of a constricting
device shown in FIG. 6 may be employed. Here the fluid-carrying
connective tube 14 is sealed to a collapsible length of plastic
tubing 60, sealed at the opposite end. The tubing should be
thin-walled enough to be wrapped spirally more or less like a tape
around the tissue 50. When inflated by fluid pumped through the
tube 14, however, the tubing 60 expands and eventually compresses
the urethral canal 52. The tube 60 may conveniently be held in
position by means of the suture plates 62 and 64, or may be tied to
pelvic bone structures.
The one-way valves controlling the fluid flow in response to the
actuation of the pump chambers may be chosen from any of the
well-known valve devices responsive to fluid pressure in a single
direction. They may be slit valves 21 of resilient, deformable
plastic material, as shown in closed position in FIG. 7. The slit
valve 21, as shown, is in the shape of one-half of a tubular
capsule open at one end and closed at the other, but provided with
a slit 23 cut completely through the closed end. As long as the
fluid pressure on both sides of the valve is equal, the valve
remains closed. However, if an increment of fluid is delivered to
the canal 17, raising the pressure at the input side of the valve,
or if an increment of fluid is withdrawn from the chamber 20,
lowering the pressure at the output side of the valve, the valve
will open and will remain open until an equilibrium pressure is
reestablished on both sides. The valves should be capable of
maintaining an in-equilibrium -- that is, they should not operate
at very small pressure differentials. For this reason, the valve 21
is provided with a reinforcing collar 19, which allows a
significant pressure differential to be maintained on either side
of the valve.
As an alternative, the valve may take the form shown in FIG. 8,
where a ball 25, loaded by a spring 27, closes the canal 17 so long
as the fluid pressure in the chamber 20 is the same as in the
canal. The spring 27 conveniently rests on the downstream and
against a sealed-in collar 29 provided with a central opening 31.
In this modification, the pressure differential maintainable on
each side of the valve depends on the force exerted by the spring
on the ball.
Various other expedients and arrangements in this and in the
reservoir-valve-pump system may be used without departing from the
spirit of the invention.
* * * * *