Urinary catheter having palpitatable discharge valve with protective shoulders

• US 6,050,934 A
• Filed: 02/25/1998
• Issued: 04/18/2000
• Est. Priority Date: 02/26/1997
• Status: Expired due to Fees

• Current Assignee: CV Dynamics Incorporated
• Original Assignee: CV Dynamics Incorporated
• Inventors: Hashw, Adel M., Johnson, Shelley N., Mikhail, Adel A., Stobbs, Gene E.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/030,132
• Time in Patent Office: 783 Days
• Field of Search: 600/29-31, 128/DIG. 25, 604/96-104, 604/174, 604/256, 604/247, 604/349, 604/329, 604/54, 604/55, 604/93, 604/246, 604/250, 251/342, 137/849
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An indwelling urinary catheter having a palpitatable multi-axial dome-type discharge valve with protective shoulders. The protective shoulders are preferably raised above other unprotected portions of an outer surface of the valve. In preferred embodiments, the valve wall is made substantially of a first material and each of the protective shoulders include an elongated thickness of a second material which is more rigid than the first material. The valve has a peripheral trough to maximize drainage. Valve openings traverse an arcuate pathway, and adjacent valve elements are separated by an intermediate rib to ensure a reliable closure.

Claims

1. An indwelling urinary catheter for use by a patient to manage urinary incontinence or retention, the patient having a bladder for retaining urine, the bladder communicating with a urethra, the catheter comprising:

(a) a catheter body defining both an exterior surface and interior surface, the interior surface defining a central lumen through which the urine can flow from the bladder when the catheter is inserted at least partially into the urethra; and

(b) a discharge valve in fluid communication with the central lumen, the discharge valve having a valve body including a valve wall defining an outer surface, the discharge valve further including a valve membrane having at least one valve opening, the valve openings having both a closed and an open position, wherein the patient can selectively manipulate the valve such that the at least one valve openings can be opened from a closed position to allow urine to pass through the valve from the bladder and the central lumen, and be closed from an open position to restrain the flow of urine from the bladder through the central lumen, such that the valve can be manipulated by the patient from the closed position to the open position where the patient compresses opposite sides of the valve wall toward one another when engaging the outer surface of the valve wall, the outer surface having a plurality of protective shoulders, the plurality of protective shoulders including at least a pair of protective shoulders, each pair of protective shoulders being separated by an unprotected portion, the plurality of protective shoulders providing structural support to the valve wall such that each of the valve opening can remain in the closed position when a force is applied to the outer surface of the valve wall proximate any of the plurality of protective shoulders, which force would be sufficient to manipulate the valve such that at least one of the valve openings would be opened from a closed position if the force was applied to the unprotected portion of the valve wall, wherein the protective shoulders provide a measure of protection against an accidental opening of the at least one valve openings due the inadvertent application of a force to the outer surface of the valve wall.

2. The indwelling urinary catheter of claim 1 wherein the valve membrane is interconnected at its periphery to the inner surface of the valve wall and has a plurality of valve openings, the valve membrane being dome-shaped in a convex center portion and having trough generally encircling the convex center portion proximate the outer edge or periphery, wherein the upper surface of the valve membrane proximate the trough is further distally removed from proximal portions of the catheter body than the upper surface proximate the convex center portion, each of said plurality of valve openings being an elongated slit in the valve membrane which passes through both the upper and lower surfaces of the valve membrane.

3. The indwelling urinary catheter of claim 2 wherein the valve is multi-axial such that at least one of said plurality of valve openings can be manipulated by the patient from a closed position to an open position when the patient compresses opposite sides of the valve wall together when engaging the outer surface of the valve wall.

4. The indwelling urinary catheter of claim 1 wherein the plurality of protective shoulders are raised above the unprotected portions of the outer surface of the valve wall and provide structural support to the valve wall such that the valve wall can resist a force applied to the outer surface proximate any of the plurality of raised protective shoulders, which force would be sufficient to manipulate the valve such that at least one of the valve openings can be opened from a closed position if the force is applied to an unprotected portion of the valve wall, wherein the protective shoulders provide a measure of protection against an accidental opening of one of the valve openings due the inadvertent application of a force on the outer surface of the valve wall.

5. The indwelling urinary catheter of claim 1 wherein the valve wall and the valve membrane are substantially made of a first material which is a flexible polymeric material which can be deformed such that the valve openings can be opened from a closed position when sufficient force is applied the valve wall to deform the valve membrane, wherein the valve opening will generally return to the closed position from the open position when the force is no longer applied, the valve wall including an elongated thickness of a second material proximate each of the plurality of protective shoulders, the second material being more rigid than the first material such that the second material is more resistant to deformation than the first material.

6. The indwelling urinary catheter of claim 3 wherein the second material is stainless steel.

7. The indwelling urinary catheter of claim 3 wherein the second material is a hard plastic.

8. The indwelling urinary catheter of claim 3 wherein the second material is a flexible polymeric material having a greater hardness than the first material.

9. The indwelling urinary catheter of claim 1, at least one of said plurality of valve openings having an arcuate shape, the elongated slit passing from a first location proximate the trough on the upper surface, to a second location closer to an apex of the convex center portion relative to the first location, and then to a third location more removed from the apex of the convex center portion as compared to the second location, wherein there are at least two valve openings having an arcuate shape and the respective elongated slits pass from said first location, to said second location, to said third location.

10. The indwelling urinary catheter of claim 1 wherein the catheter has an inflation lumen and an inflatable retention balloon, said retention balloon being axially symmetrical with respect to the catheter body.

11. The indwelling urinary catheter of claim 1 wherein the catheter body has a threaded area on its exterior surface and a retention collar engaged around the catheter body proximate the threaded area, the threaded area providing helical threading disposed along a portion of the exterior surface of the catheter body, the retention collar having mated threading disposed within a bore of the collar such that the collar can be mounted on the catheter body in threaded engagement therewith.

12. The indwelling urinary catheter of claim 9 wherein the hardness of the catheter and elements thereof, as measured by durometer measurements, differs in that the balloon has a lower durometer than other portions of the catheter and the valve.

13. The indwelling urinary catheter of claim 1 wherein the discharge valve has a discharge opening at the distal end of the valve and a drainage tube connector can be inserted into and engaged within the discharge opening such that the connector engages the lower surface of the valve membrane so that the membrane is deformed and the valve membrane can be deformed such that the valve openings remain in an open position when the valve membrane is so engaged.

23. The indwelling urinary catheter of claim 5 wherein the elongated thickness of the second material is a bar extending along the valve wall generally parallel with the central lumen of the catheter.

24. The indwelling urinary catheter of claim 5 wherein each of the protective shoulders generally include the valve.

25. The indwelling urinary catheter of claim 24 wherein the elongated thickness of the second material is ring encircling the valve.

14. In a catheter for use by a patient to control urinary incontinence or retention, said patient having a bladder for retaining urine and a urethra in fluid communication with the bladder, the urethra having a distal end, said catheter comprising:

a catheter body to be disposed at least partially within said urethra of said patient, said catheter body defining a lumen through which urine flows from said bladder to said distal end of said urethra when the catheter body is so disposed, a valve connected to said catheter body in fluid communication with said lumen such that said patient can selectively manipulate said valve between a closed position and an open position to void urine from the bladder through said lumen, said valve including a valve body having a valve wall defining an outer surface, an interior region, an inner surface, and a valve membrane connected to said valve wall and disposed within said interior region, the valve membrane having a generally arcuate segment defining a generally convex surface, a generally concave surface, and a peripheral edge, said convex surface of said valve membrane being oriented facing generally upstream opposing the flow of urine through the valve body, the valve membrane further defining a first valve opening and a second valve opening each extending entirely therethrough and disposed in fluid communication with the lumen, the valve membrane being generally deformable when the patient selectively manipulates the valve so as to permit the flow of urine through said first valve opening or said second valve opening or both, the valve membrane including a first segment, a second segment, and a rib member, at least a portion of said rib member being disposed between and contacting both said first segment and said second segment of said valve membrane when the valve is closed, said first segment or said second segment or both being displaced a distance apart from said rib member when said valve membrane is deformed, the outer surface having a plurality of protective shoulders which provide structural support to the valve wall such that each of the valve openings can remain in the closed position when a force is applied to the outer surface of the valve wall proximate any of the plurality of protective shoulders, which force would be sufficient to manipulate the valve such that at least one of the valve openings would be opened from a closed position if the force was applied to an unprotected portion of the valve wall, wherein the protective shoulders provide a measure of protection against an accidental opening of one of the valve openings due the inadvertent application of a force to the outer surface of the valve wall, wherein the plurality of protective shoulders are raised above the unprotected portions of the outer surface of the valve wall and provide structural support to the valve wall such that the valve wall can resist a force applied to the outer surface proximate any of the plurality of raised protective shoulders.

15. The catheter of claim 14 wherein the first segment, the second segment, and the rib member of the arcuate segment of the valve membrane are integral with one another.

16. The catheter of claim 14 wherein the first segment, the second segment, and the rib member of the arcuate segment of the valve membrane are formed integrally with one another.

17. The catheter of claim 14 wherein the first valve opening and the second valve opening are separated from and do not intersect one another, and wherein the first segment, the second segment, and the rib member of the arcuate segment of the valve membrane are a fabricated as one piece.

18. The catheter of claim 14 wherein the first segment of the valve membrane defines a first surface contacting the rib member when the valve is in the closed position, and the second segment of the valve membrane defines a second surface contacting the rib member when the valve is in the closed position, said first surface of the first segment and said second surface of the second segment not contacting one another when the valve is in the closed position.

19. The catheter of claim 14 wherein the first valve opening does not intersect the second valve opening.

20. The catheter of claim 14 wherein the valve membrane defines a third segment and a third valve opening, at least a second portion of the rib member being disposed between and contacting both the first segment and said third segment of the valve membrane when the valve is closed, at least a third portion of the rib member being disposed between and contacting both the second segment and said third segment of the valve membrane when the valve is closed.

21. The catheter of claim 20 wherein the third segment of the valve membrane defines a third surface contacting the rib member when the valve is in the closed position, said third surface of the third segment not contacting either the first surface of the first element or the second surface of the second element when the valve is in the closed position.

22. The catheter of claim 20 wherein the third valve opening does not intersect either the first valve opening or the second valve opening.