Urinary incontinence valve with distal and proximal anchoring means

• US 5,711,314 A
• Filed: 11/08/1996
• Issued: 01/27/1998
• Est. Priority Date: 11/08/1996
• Status: Expired due to Fees

• Current Assignee: Cystomedix, Inc.
• Original Assignee: Primed International Corporation
• Inventors: Ardito, James R.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/746,429
• Time in Patent Office: 445 Days
• Field of Search: 128/846, 128/885, 128/DIG. 25, 600/29-31, 604/347-353, 604/330
• US Class Current: 128/885
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

The present invention is a urinary incontinence valve for positioning in a patient'"'"'s urethra and bladder. and controlling the flow of urine therethrough. The valve includes an annular valve seat surface and a valve member cooperating with the valve seat surface for normally blocking urine flow. A compression spring normally urges valve member into sealing contact relative to the annular valve seat surface with a predetermined force. An actuator rod, supporting a first permanent magnet, is affixed to said valve and projects into the urinary bladder of the patient. A first anchoring mechanism comprises a deflectable spring mechanism which extends into the bladder and contacts an inner bladder surface adjacent an opening of the bladder into the urethra. A second anchoring mechanism comprising a retaining spring is positionable proximate the urethra meatus. The first and second anchoring mechanisms prevent migration of the urinary incontinence valve after it is properly positioned in the patient.

Claims

1. A urinary incontinence valve disposable in the urethra in a patient for controlling the flow of urine therethrough comprising:

(a) a tubular member having a proximal end and an distal end and a lumen extending longitudinally from said proximal end to said distal end through which urine can flow;

(b) a valve mechanism in said tubular body for selectively allowing passage of urine through said lumen;

(c) a first anchoring mechanism affixed proximate said distal end of said tubular body; and

(d) a second anchoring mechanism selectively positioned on said proximal end of said tubular body whereby said second anchoring mechanism is selectively positioned to custom-fit said valve for said patient, wherein said first anchoring means includes a deployable mechanism affixed to said tubular body proximate its distal end.

2. An urinary incontinence valve of claim 1 wherein said first anchoring mechanism includes a deployable umbrella spring mechanism positionable within the bladder of the patient adjacent the opening of the bladder into the urethra.

3. The urinary incontinence valve of claim 1 wherein said second anchoring mechanism includes a stop member selectively positionable proximate the meatus of the urethra.

4. A urinary incontinence valve of claim 1 and further including a tubular member surrounding said tubular body and said first anchoring mechanism for insertion and removal of said urinary incontinence valve into said urethra.

5. A urinary incontinence valve disposable in the urethra in a patient for controlling the flow of urine therethrough comprising:

(a) a tubular member having a proximal end and an distal end and a lumen extending longitudinally from said proximal end to said distal end through which urine can flow;

(b) a valve mechanism in said tubular body for selectively allowing passage of urine through said lumen;

(c) a first anchoring mechanism affixed proximate said distal end of said tubular body, said first anchoring mechanism includes a deployable umbrella spring mechanism positionable within the bladder of the patient adjacent the opening of the bladder into the urethra, said umbrella spring mechanism is selectively movable between a first position extending generally transverse to a longitudinal axis of said tubular body and a second position generally parallel to said longitudinal axis of said tubular body; and

(d) a second anchoring mechanism selectively positioned on said proximal end of said tubular body whereby said second anchoring mechanism is selectively positioned to custom-fit said valve for said patient.

6. A urinary incontinence valve disposable in the urethra in a patient for controlling the flow of urine therethrough comprising:

(a) a tubular member having a proximal end and an distal end and a lumen extending longitudinally from said proximal end to said distal end through which urine can flow;

(b) a valve mechanism in said tubular body for selectively allowing passage of urine through said lumen;

(c) a first anchoring mechanism affixed proximate said distal end of said tubular body; and

(d) a second anchoring mechanism selectively coupled to said proximal end of said tubular body, wherein the urinary incontinence valve is made of stainless steel and includes a gold plating on the exterior surface thereof and a compatible polymeric film coating on a wall surface defining said lumen.

7. A urinary incontinence valve for positioning in a patient'"'"'s urethra and bladder and controlling the flow of urine therethrough, comprising:

(a) a tubular body having a proximal end, a distal end and an outer diameter sufficiently small to allow insertion into the urethra of the patient and a lumen extending longitudinally from said proximate end to said distal end through which urine can flow;

(b) a generally planar annular valve seat surface disposed in said lumen of said tubular body proximate said distal end;

(c) a valve member having a greater planar valve surface cooperating with said planar valve seat surface for normally blocking urine flow through said lumen;

(d) an actuator rod affixed to said valve member so as to project outward from said distal end of said tubular body into the urinary bladder of the patient when said tubular body is in the urethra, said actuator rod supporting a first permanent magnet outside said lumen;

(e) a second permanent magnet when located exterior the patient'"'"'s body proximate to said urinary incontinence valve, attracts said first permanent magnet to tip said actuator rod and said valve member relative to said valve seat surface, allowing urine flow through said annular valve seat surface of said lumen;

(f) a first foldable anchoring mechanism located on said distal end of said tubular body comprising a multi-lobed spring mechanism which when disposed in the bladder resists migration of the tubular body in the proximal direction; and

(g) a second anchoring mechanism comprising a retaining spring selectively positionable proximate said urethra meatus for inhibiting migration of the tubular body in the distal direction in the urethra.

8. Urinary incontinence valve as in claim 7 and further including a compression spring disposed in said lumen for normally urging said generally planar valve member into sealing contact relative to said generally planar, annular valve seat surface with a predetermined force.

9. The urinary incontinence valve as in claim 8 wherein said compression spring is disposed proximal said valve surface.

10. A urinary incontinence valve of claim 7 wherein said multi-lobed umbrella spring mechanism is selectively movable between a first position extending generally transverse to a longitudinal axis of said tubular body and a second position generally parallel to said longitudinal axis of said tubular body.

11. A urinary incontinence valve of claim 7 wherein said second anchoring mechanism is selectively positionable with respect to said tubular body.

12. A urinary incontinence valve of claim 7 wherein said second anchoring mechanism is selectively removable from said tubular body.

13. A urinary incontinence valve of claim 7 and further including a tubular member surrounding said tubular body and folding the multi-lobed spring mechanism to said first position to facilitate insertion and removal of said incontinence valve.