US 3854469 A
A device for controlling fluid flow through a human body tube, in particular the flow of urine through the urethra, comprising inflatable means in the form of a flexible chamber containing fluid and held against the outer surface of the urethra of a patient for normally applying pressure against the urethra to close the same, storage means in the form of a second flexible chamber, and valve means connecting the chambers together. In response to manipulation of the first chamber by the patient, the valve is opened allowing fluid to flow into the second chamber thereby releasing the pressure applied by the first chamber and permitting urine to flow through the patient's urethra. The valve allows a return flow of fluid to the first chamber whereby pressure is reapplied to the urethra to close the same a predetermined time thereafter, and this can be accelerated by manipulation of the second chamber by the patient.
Description (OCR text may contain errors)
Giori et al.
'[ Dec. 17, 1974 EPIURETHRAL VALVE  Inventors: Francis A. Giori, Clarence; Alvin S.
Topolski, Tonawanda, both of NY.
 Assignee: Electro Sciences for Medicine, Inc.,
 Filed: Oct. 31, 1972  App]. No.: 302,602
 US. Cl. 128/1 R, 3/1, 128/346,
'  Int. Cl. A61b 19/00, A6lfOl/OO  Field of Search... 128/1 R, 274, 325, 344,
- 128/349 BV, 350 V, DIG. 25, 346; 3/1
 References Cited UNITED STATES PATENTS 2,455,859 12/1948 Foley 128/346 2,493,326 l/l950 Trinder 128/325 3,744.06 7/l973 McWhorter et al. 3/l
OTHER PUBLICATIONS Timm et al., IEEE Trans. on Bio Med. Engr., Oct.
Kintzonidis et al., Trans. Amer. Soc. Artif. Inter.
Orgs., Vol. XVII, 1971, (June).
Primary Examiner-Dalton L. Truluck Attorney, Agent, or Firm-Christel & Bean 5 7] ABSTRACT A device for controlling fluid flow through a human body tube, in particular the flow of urine through the urethra, comprising inflatable means in the form of a flexible chamber containing fluid and held against the outer surface of the urethra of a patient for normally applying pressure against the urethra to close the same, storage means in the form of a second flexible chamber, and valve means connecting the chambers together. In response to manipulation of the first chamber by the patient, the valve is opened allowing fluid to flow into the second chamber thereby releasing the pressure applied by the first chamber and permitting urine to flow through the patients urethra. The valve allows a return flow of fluid to the first chamber whereby pressure is reapplied to the urethra to close the same a predetermined time thereafter, and this can be accelerated by manipulation of the second chamber by the patient.
8 Claims, 7 Drawing Figures PATENTEL 181 71974 SHEET 10F 2 l EPIURETHRAL VALVE BACKGROUND OF THE INVENTION This invention relates to the art of medical devices, and more particularly to a new and improved device for preventing urinary incontinence.
A person afflicted with urinary incontinence is unable to control the release or discharge of urine-from his bladder through the urethra often caused by a disorder with the sphincter muscle or the urethra. Various methods and apparatus have been proposed by the prior art such as devices which are surgically implanted in the body of a patient and function to press the urethra closed in a controlled manner. For example, some include an implanted clamping mechanism or the combination of an implanted pump and urethra bypass tube, both operated by the patient externally such as by means of a magnet, but these arrangements are relatively complicated in construction and operation and expensive to obtain. Other types of devices heretofore available of the type which are implanted between the urethra and an appropriate muscle for moving the device are relatively simpler but do not allow a large degree of control by the patient.
SUMMARY OFTHE INVENTION It is, therefore, an object of this invention to provide a new and improved valve for controlling fluid flow through a human body tube such as the urethra.
It is a more particular object of this invention to provide such a device of the type which operates to-press the urethra closed which is relatively simple in construction and operating yet affords a high degree of control by the patient.
It is a further object of this invention to provide such a device which releases the urethra to allow urine flow in response to manipulation of a first portion of the device by the patient and which returns to a condition closing the urethra a predetermined time thereafter.
It is a more particular object of this invention to provide such a device which returns to a condition closing the urethra immediately in response to manipulation of a second portion of the device by the patient.
It is a further object of this invention to provide such a device which has the capability of remaining in a condition releasing the urethra until the device is returned to a condition closing the urethra in response to manipulation of the device by the patient.
It is a further object of this invention to provide such a device which is completely implantable and which does not damage the urethra or surrounding tissue of the patient.
The present invention provides a device for controlling fluid flow through a physiological vessel, in particular the flow or urine through the urethra, comprising inflatable means in the form of flexible chamber means containing fluid for applying pressure against the urethra to close the same or prevent the flow of urine therethrough, means for holding the chamber means in operative relation to the outer surface of the urethra of a patient, and control means in the form of a storage means connected to the chamber means by normally closed valve means. In response to manipulation of the device by the patient, such as by pressing through his skin against the flexible chamber means to force the valve open and then releasing pressure through the skin, fluid is allowed to flow from the chamber to the storage means thereby relieving the prssure against the urethra allowing it to open and permit urine to flow therethrough. The valve means automatically returns fluid fromthe storage means to the chamber whereby the urethra of the patient is again closed after a predetermined time, and this return flow can be accelerated to close the urethra immediately if the patient presses through his skin against the storage means.
The foregoing and additional advantages and characterizing features of the present invention will become clearly apparent upon a reading of the ensuing detailed description together with the included drawing wherein:
BRIEF DESCRIPTION OF THE DRAWING FIGURES FIG. 1 is a sectional view showing the device of the present invention implanted in a patient and attached to the urethra for controlling the flow of urine therethrough;
FIG. 2 is a perspective view of the device of the present invention;
FIG. 3 is a sectional view taken about on line 3-3 in FIG. 1 and showing the urethra of the patient closed by the device;
FIG. 4 is a sectional view similar to FIG. 3 but showing the device when it allows the urethra of the patient to be opened;
FIG. 5 is a longitudinal section'taken about on line 5-5 inFIG. 2;
FIG. 6 is a sectional view taken about on line 66 in FIG. 2; and
FIG. 7 is a sectional view taken about on line 77 in FIG. 5.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT FIG. 1 illustrates a device 10 according to the present invention as it would appear surgically implanted in a male patient for controlling the flow of urine from the bladder 12 through the urethra 14 of the patient. Device 10 is installed so as to apply pressure against the outer surface of the urethra and therefore is designated an epiurethral valve. Device 10 comprises inflatable means 20 defining a first chamber and formed of a material which is flexible and fluidtight, preferably latex material coated with a silicone elastomer material sold under the tradename Silastic. A preferred method of making device 10 from a single piece of latex tubing will be described in detail presently. Device 10 further comprises means 22 for holding chamber means 20 against the outer surface of the urethra 14 of the patient as well as maintaining the location thereof and comprising a first ribbon 24 provided with stress relief patch 25 and a second ribbon 26. When device 10 is implanted in a patient, ribbon 24 extends around chamber 20 and urethra 14 as shown in FIG. 1 to hold them in contact and ribbon 26 is anchored surgically in neighboring tissue as will be described in detail presently. Chamber means 20 contains fluid, preferably a saline solution, in an amount for applying sufficient pressure against urethra 14 to close the same and thereby prevent the flow of urine therethrough, In other words, means 20 is held against urethra l4 and is inflated or distended to apply sufficient force or pressure to compress the urethra to increase its resistance to flow and to cause the inner surfaces thereof to come in contact in the region where the force is applied thereby blocking the flow of urine from bladder 12 further along urethra 14.
Device of the present invention further comprises storage means 30 and means including valve means 32 connecting chamber means to storage means 30, the valve means 32 being normally closed. Storage means and valve means 32 together control the inflation and deflation of chamber means 20. In preferred form storage means 30 comprises means defining a second chamber in flexible, fluid-tight material such as latex provided with a coating of Silastic material, and having substantially the same shape as chamber means 20. Chamber means 30 is usually about one and one-half to about two times larger than chamber means 20. Valve means 32 can have various forms so long as it provides a resistance to fluid flow which may be overpowered quite easily in a manner which presently will be described. A preferred form of valve means 32 is shown in detail in FIGS. 5 and 6 and comprises a region of fluid impervious and resilient material 34 between chambers 20 and 30 and having a relatively small slit or aperture 36 therein extending generally axially along valve means 32 from an end of chamber 20 to an end of chamber 30. Slit 36 allows a relatively small flow or seepage between chambers 20 and 30 until a pressure equilibrium condition exists at which time valve means 32 is effectively closed thereby preventing any further flow of fluid. In other words, when this equilibrium condition is attained, there is no more fluid flow from chamber 20 through valve 32 to chamber 30. Valve means 32 is opened when the patient manipulates either chamber 20 or 30 by pressing against the chamber wall thereby causing the portion of the chamber adjacent the end of valve 32 to assume a generally spherical shape thereby distorting the shape of valve 32 causing slit 36 to define a relatively larger opening permitting flow of fluid therethrough. The manner in which device 10 is manipulated by the patient to open valve 32 will be described in more detail presently.
Device 10 further comprises a sealing means for chamber means 30 in the form of a cap member positioned in the end of chamber means 30 opposite the end thereof communicating with valve means 32 which cap member is of latex material having a relatively larger wall thickness as compared to the wall thickness of chamber means 30. Cap member 40 has an outer diameter slightly less than the inner diameter of the end of chamber 30 and is positioned inwardly of the end of chamber 30 and disposed with the open end thereof toward the interior of chamber 30. Member 40 is sealed in the end of chamber 30 by Silastic material 42 which fills the space between the outer surface of cap member 40 and the adjacent inner surface of chamber means 30. The region of Silastic material 42 extends to the end of chamber 30 whereupon it terminates in a convex exterior surface 44. Silastic material 42 prevents damage to chamber means 30 when fluid is added thereto by a doctor using a hypodermic syringe in a manner which will be described in more detail presently.
Device 10 of the present invention operates in the following manner. Chamber means 20 is attached to the urethra 14 of a male patient by means 22 as shown in FIGS. 1 and 3 and at a position along the urethra 14 such that chamber 30 can be positioned in the scrotum of the patient. The particular way in which ribbons 24,
26 secure device 10 will be explained presently. Chamber means 20 contains fluid, preferably a saline solution, in an amount causing it to be inflated and apply sufficient pressure against the urethra to close the same and thereby prevent the flow of urine therethrough as illustrated in FIG. 3. According to a preferred mode of the present invention, the pressure in chamber 30 initially is greater than the pressure in chamber 20 because the device is filled with fluid by introducing fluid first to chamber 30 in a manner which will be described and then relying on the seepage or slow rate of flow of fluid from chamber 30 through slit 36 of valve means 32 into chamber 20 until a pressure equilibrium condition exists between chamber 20 and 30 whereby the seepage or relatively low flow through valve 32 stops and valve 32 is effectively closed. When this equilibrium condition is reached, chamber 20 contains enough fluid to apply sufficient pressure against urethra 14 to close the same, this pressure being high enough to hold back about a 40 centimeter column of water, and chamber 30 being flexible has the capability to receive fluid from chamber 20 when valve means 32 is overpowered in the following manner.
When the patient feels the need and decides to void, he manually presses on chamber 20 through his skin causing fluid within chamber 20 to pass through valve 32 into chamber 30. In particular, by pressing against the wall of chamber 20, the patient changes its shape to be substantially spherical adjacent the end of valve 32 whereby slit 36 is distorted to assume the shape of a generally cylindrical bore or passageway thereby allowing the fluid to flow through valve 32 into chamber 30. When the patient releases his manual pressure from chamber 20 it remains deflated for a brief time, such as from about 20 to about 40 seconds, controlled only by the valve means 32 between chambers 20 and 30. In particular, the width of slit 36 and the length, width and thickness of valve member 32 control the rate of fluid flow therethrough. While chamber 20 is deflated, i.e., empty or partially empty, the pressure on urethra 14 is reduced thus lowering the overall resistance to flow and allowing urine to flow through the urethra and be expelled by the patient. After about 20 to 40 seconds, enough of the fluid returns to inflate chamber 20 so that the pressure applied to the urethra by chamber 20 causes the urethra to close after the patients bladder has emptied and the flow of urine has stopped.
The predetermined time delay of about twenty to about forty seconds should allow the patient ample time to empty his bladder completely. If the patient should desire to stop the urine flow before his bladder is completely empty, he can squeeze chamber 30 situated in his scrotum. This will accelerate the refilling of chamber 20 and stop the urine flow through urethra 14. If in so doing the patient should overpressure chamber 20, valve means 32 will allow some fluid to return to chamber 30 thereby returning chamber 20 to its normal pressure in equilibrium with the pressure in chamber 30 within a period of 10 to 30 seconds.
By way of example, a device 10 according to the present invention can have an overall length of about 4 inches and a width of about one-half inch. Thus the two chamber means 20 and 30 are closely adjacent, being separated by the relatively short valve means 32. In such a device to obtain the return flow time of about 20 to 40 seconds, valve means 32 is formed to have a length of about 0.80 inch measured longitudinally of device 10, a width of about 0.70 inch, a height or thickness of about.0.22 inch, and the width of slit 36 is about 20 percent of the width of valve means 32. While device has been illustrated for use in a male patient, it could be used for women if the length is increased slightly.
In most instances, valve means 32 will be dimensioned according to the foregoing example whereby fluid returns to chamber means in about 20 to 40 seconds. There are situations where due to paralysis a patient must rely on gravity alone to empty his bladder, and for these patients device 10 will have a valve means 32 dimensioned to provide a relatively longer time delay, for example 10 to 30 minutes, in the return of fluid to chamber means 20. If necessary, valve means 32 can be dimensional so that it functions like an on-off or snap action valve rather than a time delay valve. In other words, when chamber means 20 is pressed to open valve means 32 and force fluid into chamber means 30, valve means 32 will continue to block a return flow of fluid until chamber means 30 is pressed to overpower valve 32.
A preferred method of making device 10 according to the present invention is begun by providing a single piece or length of relatively thin latex tubing 50 having a diameter of about one-half inch and applying a relatively thin primer coating 52 of Silastic material on the inner surface of tubing 50. When the Silastic coating has cured for a sufficient time, valve means 32 is formed by drawing the tubing through a slot of predetermined length, width and thickness in a suitable fixture so that the fixture embraces or surrounds the tubing adjacent the midpoint thereof. A suitable resilient, fluid impervious material such as Silastic RTV resin is introduced to the portion of the tubing within the slot of the fixture to form region 34. The tube is removed from the fixture and the Silastic material is allowed to cure, the thixotropic nature of the Silastic material maintaining the form of region 34. After the material has cured, slit 36 is formed in region 34 with a knife of the required dimensions. It is important to form slit 36 in a manner whereby no material is removed from region 34. The end of the tubing adjacent chamber 20 is brought together and sealed with Silastic material 54 thereby defining an end plug. The end of the tubing adjacent chamber 30 is closed by the combination of cap member 40 and Silastic material 42 as previously described. The completed device is then provided with an exterior coating 56 of Silastic material which is allowed to cure for a suitable time. Ribbon 24 is bonded or secured by Silastic material to the outer surface of chamber means 20 and ribbon 26 is bonded by Silastic material to ribbon 24 as shown in FIGS. 2 and 3. Various alternative methods can be employed for making device 10, for example molding the entire device from latex or similar material.
Device 10 is implanted in'the body of a patient according to prescribed surgical procedures and is attached adjacent to a body tube such as urethra 14 of the patient by placing ribbon 24 around the urethra with stress relief patch contacting the surface of urethra 14 opposite the surface contacted by chamber means 20 and sewing the ends of ribbon 24 together as indicated by stitching 60 in FIG. 3. The two ends of ribbon 26 are sutured at 62, 63 in neighboring tissue to hold device 10 in place so that it does not slide or rotate relative to urethra l4.
Fluid such as saline solution is introduced to device 10 by means of an hypodermic syringe whereby the needle is pushed through Silastic material 42 and cap 40 to fill chamber means 30 with fluid. Then valve 32 is opened by pressing on chamber means 30 to fill chamber means 20, and the procedure is continued until the required degree of inflation of chamber means 20 is achieved. The Silastic material 42 seals itself upon removal of the needle. Situations may arise when after device 10 has been implanted in a patient it becomes necessary to add or remove fluid. This can be done by the surgeon using a hypodermic syringe to first introduce fluid to chamber 30 situated in the patients scrotum. The relatively-large area of surface 44 insures that the syringe needle will extend through Silastic material 42 and cap 40 rather than inadvertently piercing the relatively thin wall of chamber means 30 and disabling the device.
According to a preferred mode of the present invention, chamber means 20 has a shape which varies between tubular, ellipsoidal and spherical depending upon the degree of inflation thereof. With this shape, chamber means 20 is held against or adjacent and applies pressure to a portion of the surface of the body tube or urethra, and device 10 is of relatively simple construction and can be made conveniently and easily. Chamber means 20 can have other shapes, for example like a pillow, cuff or similar shapes whereby it would encircle or encompass the physiological vessel and apply pressure equally around the circumference of the vessel. With this construction it would be necessary only to anchor chamber means 20 against rotation or sliding, such as by a single ribbon sutured in neighboring tissue.
Device 10 of the present invention thus comprises inflatable or distendable means containing fluid in the form of chamber means 20 together with means in the form of chamber means 30 and valve means 32 for controlling the degree of inflation or distention of chamber means 20. Means 20 is adapted to be positioned in operative relation to the outer surface of a physiological vessel such as the urethra. When inflated to a sufficient degree, chamber means 20 applies pressure against the outer surface of the urethra or similar physiological vessel to increase its resistance to flow and preferably to close it. The distention of chamber means 20 is controlled by varying the amount of fluid within the chamber thereby controlling urethral resistance by varying fluid volume and/or pressure within chamber means 20. Inflatable means 20 is operative in response to manipulation of device 10 to relieve pressure against the vessel or urethra and allow it to permit fluid to flow therethrough. Manipulation of device 10 by the patient in conjunction with the functions of valve means 32 and chamber means 30 causes controlled deflation of chamber means 20 allowing the urethra or other body tube to open. Device 10 of the present invention advantageously is relatively simple in construction and operation yet gives the patient a high degree of control. After manipulation of device 10 to release pressure against the urethra, the patient can either allow device 10 to reapply pressure automatically after the time determined by the dimensions of valve means 32 or over power valve means 32 by pressing against chamber means 30 to cause device 10 to close the urethra immediately. Device 10 is implantable at a location on the urethra where few diflerences occur from patient to pa- While a single embodiment of the present invention has been described in detail, this is for the purpose of illustration, not limitation.
We claim: 1. A device for controlling the flow of fluid through a physiological vessel such as the flow of urine through the urethra comprising:
a. first inflatable means defining a chamber initially containing fluid and adapted to be positioned in operative relation to the outer surface of the vessel;
b. second inflatable means defining a chamber for containing fluid, said second inflatable means being of a size sufficient to store fluid initially contained in said first inflatable means;
c. pressure responsive valve means joining said first and second inflatable means, said valve means including a single, common passage means for placing said chambers of said first and second inflatable means in direct fluid communication, said passage means being opened when a fluid pressure difference exists between said first and second inflatable means to allow fluid normally to flow at a relatively low rate between said chambers until a pressure equilibrium therebetween exists at which time said passage closes, the time during which said passage is opened being a function of the length and cross sectional dimension of said passage, and said valve means allowing said passage meansto open in a manner allowing fluid to flow at a relatively high rate in response to sufficiently high pressure applied thereto; and
. said first and second inflatable means being of predetermined and relative size such that initially a pressure equilibrium condition exists therebetween and said first inflatable means contains a sufficient amount of fluid to apply sufficient pressure against the vessel to prevent flow of fluid therethrough and said second inflatable means while storing fluid initially contained in said first inflatable means applies fluid pressure against said valve means to open said passage means for a return fluid flow at said relatively low rate;
e. whereby in response to manual pressure applied by the patient through his skin to said first inflatable means fluid is caused to flow at said relatively high rate from said first inflatable means through said passage means of said valve means and into said second inflatable means thereby deflating said first inflatable means to relieve the pressure against the vessel and allow it to permit fluid to flow therethrough and upon release of the pressure applied to said first inflatable means said second inflatable means applies fluid pressure against said valve means thereby allowing fluid to return from said inflatable means through said passage means to said first inflatable means at said relatively low rate whereupon after a predetermined time a pressure equilibrium again exists between said first and second inflatable means and said first inflatable means again contains a sufficient amount of fluid to apply sufficient pressure against the vessel to prevent flow of fluid therethrough.
2. A device according to claim 1, wherein said inflatable means comprises flexible chamber means shaped to contact a portion of the outer surface of the vessel and wherein said device further comprises means for holding said chamber means adjacent the outer surface of the vessel.
3. A device according to claim 1, wherein said valve means comprises a body of resilient, substantially fluid impervious material provided with a passage therethrough, said passage having a cross-sectional area which is relatively small and normally allows a relatively small fluid flow therethrough until a pressure equilibrium condition exists between said first and second inflatable means at which time said valve means is effectively closed, said body being expandable in a direction enlarging the cross sectional area of said passage to open said valve in response to manipulation of said inflatable means to allow a relatively large flow through said passage.
4. A device'according to claim 1, wherein said second inflatable means comprises flexible chamber means whereby in response to manipulation of said chamber means by the patient said valve means is opened to return fluid relatively quickly to said first inflatable means.
5. A device according to claim 1, further comprising means defining a relatively thick member on a portion of said second inflatable means to facilitate addition of fluid to said second means surgically by means of an hypodermic syringe.
6. A device according to claim 1, wherein said first and second inflatable means comprise axially spaced portions of a length of flexible thin-walled tubing sealed at each end thereof and said valve means comprises a region of substantially fluid impervious, resilient material filling said tubing between said axially spaced portions and having a passage extending therealong to connect said first and second inflatable means together.
7. A device according to claim 1, wherein said valve means comprises a body of resilient, substantially fluid impervious material connected to said first and second inflatable means, said body having a relatively small slit extending therealong to connect said first and second inflatable means in fluid communication.
8. A device according to claim 7, wherein said body is of a silicone elastomer material.