Urinary incontinence valve device

• US 5,140,999 A
• Filed: 09/30/1991
• Issued: 08/25/1992
• Est. Priority Date: 09/30/1991
• Status: Expired due to Fees

• Current Assignee: Primed International Corporation
• Original Assignee: Primed International Corporation
• Inventors: Ardito, James R.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): BROWN, MICHAEL A
• Application Number:
  US07/768,169
• Time in Patent Office: 330 Days
• Field of Search: 128/842, 128/885, 128/DIG. 25, 600/29-31, 623/11, 251/65
• US Class Current: 128/885
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61F 2/0018 magnetic
• 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

A urinary incontinence valve for placement in the urethra of a male or female patient and which is magnetically-actuable from outside the body. The valve body is designed to fit into the neck of the bladder and includes an actuator rod which extends out of the valve body and into the bladder itself, providing greater freedom of movement of a valve surface relative to the valve seat. A compression spring normally urges the valve member to its closed position and when so closed, the compression spring is maintained in a urine-free environment.

Claims

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

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

(b) a valve seat disposed in said lumen of said body member proximate said distal end;

(c) a valve member including a valve surface cooperating with said valve seat for normally blocking liquid flow through said lumen;

(d) an actuator rod affixed to said valve member projecting outward of said lumen at said distal end of said body member, said actuator rod including a magnetizable member attached to an end which is opposite an end extending into the lumen; and

(e) stylet means for releasably gripping said proximal end of said tubular body.

2. The urinary incontinence valve as in claim 1 and further including a compression spring disposed in said lumen for normally urging said valve surface into sealing contact with said valve seat with a predetermined force.

3. The urinary incontinence valve as in claim 2 wherein said compression spring is disposed proximal of said valve surface.

4. The urinary incontinence valve as in claim 5 and further including means disposed at said proximal end of said body member for supporting said compression spring against said valve member.

5. The urinary incontinence valve as in claim 6 wherein said supporting means includes an annular plate disposed at said proximal end of said body member and a threaded nut affixed to said distal end of said body member.

6. The urinary incontinence valve as in claim 1 wherein said predetermined force is generally greater than the hydraulic force exerted on the valve member by the presence of a normal quantity of urine in the urinary bladder.

7. The urinary incontinence valve as in claim 1 wherein said actuator rod is of a sufficient length to position said magnetizable member within the bladder of the patient when said tubular body member is surrounded by the external sphincter of the patient.

8. The urinary incontinence valve as in claim 1 and further including a permanent magnet, which when disposed within a predetermined distance of said magnetizable member on said actuator rod and exterior to the body, displaces said valve surface relative to said valve seat.

9. The urinary incontinence valve as in claim 1 wherein the tubular body is made of stainless steel and includes an elastomeric coating on the exterior surface thereof and a compatible polymeric film coating on the wall surface defining said lumen.

10. The urinary incontinence valve as in claim 9 wherein said polymeric film coating is polytetrafluoroethylene and said elastomeric coating is selected from the group consisting of polyurethane, polyethylene and silicone rubber.

11. The urinary incontinence valve as in claim 1 wherein said stylet means comprises an elongated rigid tube having a proximal end, a distal end and a lumen extending therebetween;

a scissors mechanism secured to said distal end of said rigid tube, said scissors mechanism capable of assuming a closed and an open position and means located at said proximal end of said rigid tube and affixed to said scissors mechanism for selectively urging said scissors mechanism to assume either said closed or said open position.

12. The urinary incontinence valve as in claim 11 wherein said scissors mechanism, when in said open position firmly engages said proximal end of said tubular body member and when in said closed position can be disengaged from said proximal end of said tubular body member.

13. A urinary incontinence valve for positioning in the urethra of a patient and controlling the flow of urine therethrough, comprising:

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

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

(c) a valve member having a generally 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 member into the urinary bladder of the patient when said body member is in the urethra, said actuator rod supporting a first permanent magnet outside said lumen; and

(e) a second permanent magnet which when located exterior of the patient'"'"'s body and 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, permitting urine flow through said annular valve seat surface and said lumen.

14. The urinary incontinence valve as in claim 13 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.

15. The urinary incontinence valve as in claim 14 wherein said compression spring is disposed proximal of said valve surface.

16. The urinary incontinence valve as in claim 13 wherein the length of said tubular body member is such that when said body member is surrounded by the patient'"'"'s urinary sphincter, said valve body does not interfere with the ejaculatory ducts of the patient.

17. The urinary incontinence valve as in claim 13 wherein said tubular body is made of metal and is coated, as least in part, with polytetrafluoroethylene.