Intraurethral bladder control device with retainer apparatus

• US 6,193,646 B1
• Filed: 02/09/1999
• Issued: 02/27/2001
• Est. Priority Date: 08/16/1995
• Status: Expired due to Fees

• Current Assignee: Feelsure Health Corporation
• Original Assignee: HK Medical Technologies, Inc.
• Inventors: Kulisz, Andre A., Migachyov, Valery
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/246,466
• Time in Patent Office: 749 Days
• Field of Search: 600/29-31, 128/885, 128/DIG.25, 604/347-353
• US Class Current: 600/29
• 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: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An intraurethral bladder control apparatus including housing means having a fluid flow path therethrough, valve means mounted within the fluid valve path and normally bias closed, the valvings responsive to pressure from fluid within the bladder of the patient for opening to allow fluid flow from the bladder through the apparatus of this invention and out of the urethra. A pair of retaining devices are connected to each of the distal and proximal ends of the intraurethral bladder control apparatus. The retainer at the distal end of the apparatus preferably comprises a leaf spring having a plurality of leaves, in the preferred embodiment described herein the plurality comprising four leaves, with a safety device connected to the tip of each leaf to inhibit piercing of the bladder wall when the leaves of the distal end retainer automatically open within the bladder of the patient after placement of the intraurethral bladder control apparatus. The proximal or lower retainer connects to the proximal end of the bladder control apparatus after it is placed in the urethra of the patient, and a portion of the lower retainer abuts the labia.

Claims

1. A device for placement in the urethra of a patient to selectively allow urine flow therethrough, comprising:

a generally tubular housing defining a lumen for draining urine from a bladder positioned at a distal end thereof;

a valve assembly for controlling the flow of urine through the lumen;

the valve assembly comprising a stopper, a compression spring, and a valve housing defining an inner chamber in fluid communication with the lumen of the generally tubular housing;

the spring having a proximal end, a distal end, and a lumen extending therethrough;

the valve housing defining a valve seat at a first end of the inner chamber and a means for seating adapted to receive the proximal end of the spring disposed at an opposite end of the inner chamber;

the stopper having a valve head adapted to sealingly engage the valve seat, and an elongated smaller diameter portion adapted to be received within the lumen of the compression spring;

the distal end of the spring is connected to the stopper, and the proximal end of the spring being seated against the means for seating;

wherein the compression spring urges the valve head toward the valve seat; and

a selectively expandable retainer connected adjacent the distal end of the generally tubular housing;

wherein the retainer is selectively expanded inside the bladder preventing the generally tubular housing from migrating out of the urethra.

2. The apparatus of claim 1, wherein the compression spring is a coil spring and the means for seating defines a passage allowing urine flow into an interior of the coil spring.

3. The apparatus of claim 1, wherein the compression spring has a conical shape.

4. The apparatus of claim 1, wherein the spring has a generally conical shape with the spring'"'"'s apex engaging the elongated smaller diameter portion of the stopper.

5. The apparatus of claim 1, wherein the retainer includes at least one spherical surface adapted to contact the internal wall of the bladder.

6. A device for placement in the urethra of a patient for selectively draining urine therethrough, comprising:

a generally tubular housing having a distal end and defining a lumen;

a valve assembly comprising a stopper, a compression spring, and a valve chamber in fluid communication with the lumen of the generally tubular housing;

the spring having a proximal end, a distal end, and a lumen extending therethrough;

the valve chamber defining a valve seat at a first end of the valve chamber and a means of seating adapted to receive the proximal end of the spring disposed at an opposite end of the valve chamber;

the stopper having a valve head adapted to sealingly engage the valve seat, and an elongated smaller diameter portion adapted to be received within the lumen of the compression spring;

the distal end of the spring being disposed about the elongated smaller diameter portion of the stopper, and the proximal end of the spring being seated against the means for seating;

wherein, the compression spring urges the valve head toward the valve seat; and

a selectively expandable retainer connected adjacent the distal end of the generally tubular housing.

7. The apparatus of claim 6, wherein the compression spring is a coil spring and the means for seating defines a passage allowing urine flow into an interior of the coil spring.

8. The apparatus of claim 6, wherein the compression spring has a generally conical shape.

9. The apparatus of claim 6, wherein the spring has a generally conical shape with the spring'"'"'s apex engaging the elongated smaller diameter portion of the stopper.

10. The apparatus of claim 6, wherein the retainer includes at least one spherical surface adapted to contact the internal wall of the bladder.

11. A urethral indwelling device for selectively draining urine from a bladder, comprising:

a drainage housing having a distal end and defining a drainage lumen;

a valve comprising a poppet, a compression spring, and a valve chamber in fluid communication with the drainage lumen of the drainage housing;

the spring having a proximal end, a distal end, and a lumen extending therethrough;

the valve chamber defining a valve seat at a first end thereof, and a means for seating adapted to receive the proximal end of the spring disposed at an opposite end of the valve chamber;

the poppet having a valve head adapted to close against the valve seat, and spring engaging portion adapted to be received in the lumen of the compression spring;

the distal end of the spring being disposed about the spring engaging portion of the poppet, and the proximal end of the spring being seated against the means for seating; and

a selectively expandable retainer connected adjacent the distal end of the generally tubular housing.

12. The apparatus of claim 11, wherein the compression spring is a coil spring and the means for seating defines a passage allowing urine flow into an interior of the coil spring.

13. The apparatus of claim 11, the compression spring being generally conically shaped.

14. The apparatus of claim 11, the spring being generally conical shaped with the spring'"'"'s apex engaging the spring engaging portion of the stopper.

15. The apparatus of claim 11, wherein the retainer includes at least one spherical surface adapted to contact the internal wall of the bladder.