Intra-urethral prosthetic sphincter valve

• US 4,553,533 A
• Filed: 11/08/1983
• Issued: 11/19/1985
• Est. Priority Date: 11/08/1983
• Status: Expired due to Term

• Current Assignee: United States Department Of Health And Human Services (Government of the United States of America)
• Original Assignee: United States Department Of Health And Human Services (Government of the United States of America)
• Inventors: Leighton, Stephen B.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US06/550,040
• Time in Patent Office: 742 Days
• Field of Search: 128/DIG. 25, 128/344, 128/1 R, 604/335, 604/256, 604/34, 604/247, 3/1
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022

Abstract

A prosthetic urethral sphincter valve that is placed totally within a patient'"'"'s urethra, the valve including a collapsible flexible thin-walled annular bag member secured in a rigid casing with flexible retaining petals at its top end receivable in the patient'"'"'s bladder. An upstanding annular flexible thin-walled diaphragm is provided over an inturned top flange on the casing, the flange having small flow apertures forming damping ports communicating with the flexible bag member. The bottom end of the bag member is engaged with an annular guide urged upwardly by a coiled spring bearing on an inturned bottom flange of the casing. The working space between the bag member and the diaphragm is filled with viscous grease. The bag member has a central tubular passage which is normally occluded or kinked by the upward biasing force of the coiled spring. When the patient exerts sustained bladder pressure, the flexible bag member is distended downwardly, causing the central tubular passage to elongate and thereby open up, enabling it to pass urine. After urination, the bladder pressure is released, allowing the spring to return the bag member to its collapsed state and restore the occlusion of its central tubular passage, providing positive shut-off of the valve.

Claims

1. A prosthetic urethral sphincter valve comprising a rigid tubular casing adapted to be placed in a patient'"'"'s urethra with its top end portion located adjacent and exposed to the patient'"'"'s bladder, inturned annular flange means on the top end portion of said casing, said flange means being provided with flow-damping aperture means, annular upstanding thin-walled flexible diaphragm means secured peripherally on said flange means and overlying said aperture means, substantially annular thin-walled flexible bag means connected between the inner peripheral edge portion of said flange means and the inside peripheral wall surface of said casing and having a depending annular thrust portion and inner wall means defining a substantially tubular central through passage, viscous liquid material substantially filling the bag means and said flexible diaphragm means, and upward biasing means in the rigid casing drivingly engaging said depending annular thrust portion to normally urge the bag means to assume a collapsed state wherein said tubular central passage is occluded, said bag means being downwardly extensible to open said tubular central through passage responsive to sustained bladder pressure acting externally on said flexible diaphragm means.

2. The prosthetic valve of claim 1, and outwardly biased resilient retaining petal means on the top end portion of said casing retentively engageable in the patient'"'"'s bladder.

3. The prosthetic valve of claim 2, and wherein said retaining petal means comprises a plurality of resilient petal elements secured to the top rim portion of said casing and being biased to diverge upwardly and outwardly from said top rim portion.

4. The prosthetic valve of claim 1, and wherein the upward biasing means comprises an annular guide member having an annular seat receiving said depending annular thrust portion, and spring means mounted in the casing and bearing upwardly on said guide member.

5. The prosthetic valve of claim 4, and wherein the casing has an inturned bottom annular flange and wherein said spring means bears between said bottom annular flange and said annular guide member.

6. The prosthetic valve of claim 1, and wherein said flowdamping aperture means comprises a plurality of relatively small apertures formed in the flange means and being angularly spaced around the central axis of the casing.

7. The prosthetic valve of claim 1, and wherein the liquid material filling the bag means and the flexible diaphragm means comprises viscous grease material.

8. The prosthetic valve of claim 1, and wherein said upward biasing means comprises an annular guide member slidably mounted in the casing, said guide member comprising a large annular bottom chamber formed coaxially with a reduced upstanding thrust collar externally defining an annular seat receiving said depending annular thrust portion of the bag means, and spring means mounted in the casing below said guide member and bearing upwardly in said large annular bottom chamber.

9. The prosthetic valve of claim 8, and wherein said casing has an inturned bottom flange and said spring means bears between said inturned bottom flange and said large annular bottom chamber.

10. The prosthetic valve of claim 1, and wherein said upstanding annular diaphragm means is secured at its inner periphery to the inner peripheral edge of said inturned annular flange means and is secured at its outer periphery to the peripheral outer rim portion of the rigid casing.

11. A prosthetic urethral sphincter valve for implantation within the urethra adjacent the bladder, and capable of control by the exertion by the patient of sustained intra-abdominal pressure for at least several seconds, said valve comprising

tubular casing means for said valve, said casing means being adapted to be placed in a patient'"'"'s urethra with its top end portion located adjacent and exposed to the patient'"'"'s bladder;

holding means on the top end portion of said casing for holding said casing in place within the patient'"'"'s urethra;

valve means for maintaining said urethra in a normally closed condition;

damping means for transmitting sustained intra-abdominal pressure from the patient to the valve means, whereby sustained intra-abdominal pressure from the patient causes movement of said damping means from an initial at rest position to a threshold detection position;

biasing means for biasing and returning said damping means to said initial position;

threshold detection means for detecting when said damping means has reached said threshold position; and

wherein the valve means opens to permit passage of urine therethrough upon actuation by said threshold detection means upon said damping means reaching said threshold position, said valve closing as said biasing means moves said damping means away from said threshold position.

12. A prosthetic urethral sphincter valve according to claim 11, wherein said damping means comprises a flow-damping restricted aperture means, annular upstanding thin-walled flexible diaphragm means secured on said tubular casing above said flow damping aperture means and a quantity of a viscous liquid within said diaphragm;

said valve means comprises a substantially annular thin-walled flexible bag means connected to the interior of said tubular casing, and a quantity of said viscous liquid, retained within said substantially annular thin-walled flexible bag means,

with at least a portion of said viscous liquid being able to move between said diaphragm means and said bag means through said flow-damping aperture means; and

said threshold detector means and said valve together comprise a kinked tube which forms the inner annular surface of said substantially annular thin-walled flexible bag means.