Mechanical urinary sphincter device

• US 5,520,606 A
• Filed: 06/14/1993
• Issued: 05/28/1996
• Est. Priority Date: 10/18/1990
• Status: Expired due to Fees

• Current Assignee: Arnold Schoolman, Henry N. Habib
• Original Assignee: Arnold Schoolman, Henry N. Habib
• Inventors: Schoolman, Arnold, Habib, Henry N.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US08/076,485
• Time in Patent Office: 1,079 Days
• Field of Search: 128/DIG. 25, 128/885, 600/29-31
• US Class Current: 600/31
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A method and apparatus for the treatment of urinary incontinence comprising the application of a compressive force to the tissue surrounding the urethra from below the urethra upwards towards the pubic bone. The apparatus comprises an inflatable, urethra-compressing balloon having a tissue-engaging surface positioned between layers of tissue adjacent the urethra on a side of the urethra opposite the pubic bone. The balloon flow communicates with a fluid reservoir secured to the frontal portion of the pubic bone. A patient having the apparatus surgically-implanted therein may selectively advance hydraulic fluid between the reservoir and the balloon so as to inflate or deflate the balloon and prevent or allow bladder emptying respectively.

Claims

1. An apparatus for treating urinary incontinence comprising:

(a) a compressible frame adapted for secure mounting to a frontal portion of a pubic bone of a user;

(b) a rigid support member comprising an extension arm having first and second ends;

said extension arm first end being attached to said compressible frame;

said support member including a support plate attached to said second end of said extension arm;

said support plate being positionable between layers of tissue adjacent an urethra of the user on a single side of the urethra opposite and remote from the pubic bone so as to extend completely beneath a cross-section of the urethra when said frame is mounted to the pubic bone;

(c) an inflatable, urethra-compressible balloon positioned on a side of said support plate adapted to be closest to the urethra;

said balloon having a tissue-engageable surface adapted to engage an adjacent layer of tissue on the single, opposite and remote side of the urethra and a support plate-engaging surface engaging the support plate on the side of said support plate adapted to be closest the urethra;

(d) said extension arm having associated therewith a tube extending from a compressible fluid reservoir to said balloon;

(e) said compressible fluid reservoir maintained within said frame and flow communicating with said balloon through said tube;

said reservoir being filled with a hydraulic fluid, said fluid reservoir and said balloon cooperating so that when a compressive force is applied to said fluid reservoir, said reservoir is compressed so that said hydraulic fluid is transferred to said balloon, inflating said balloon and causing said balloon to exert force against said support plate, which is adapted to cause said tissue-engageable surface to advance towards the urethra and the pubic bone in a single direction so as to compress the urethra therebetween, thereby preventing flow of fluid through the urethra, and so that when the compressive force is removed from said reservoir, said reservoir expands back to a relaxed state thereof such that hydraulic fluid flows from said balloon into said reservoir deflating said balloon which is adapted to cause decompression of the urethra so as to allow flow of fluid through the urethra; and

wherein said compressible frame comprises;

(f) a base plate divisible into a first half and a second half;

said first half receiving said reservoir;

(g) a circumferential wall extending around said base plate; and

(h) a compression plate, having a compression half and a releasing half;

said compression plate pivotally and medially mounted to said circumferential wall so that said compression half extends over said first half of said base plate and said releasing half extends over said second half of said base plate, said base plate, said compression plate and said fluid reservoir being positioned relative to one another in such a manner that when a compression force is applied to said compression half, said compression half advances towards said first half of said base plate and compresses said reservoir, transferring said hydraulic fluid from said reservoir to said balloon, and when a compressive force is applied to said releasing half, said releasing half advances towards said second half of said base plate and said compression half is pivotally advanced away from said first half so that said reservoir is allowed to expand so as to draw said hydraulic fluid from said balloon to said reservoir.

2. The apparatus as described in claim 1 for use in treating male urinary incontinence wherein the tissue layers comprise the bulbo-spongiosis;

and

(a) said tissue-engageable surface includes means for engaging the bulbo-spongiosis on the single, opposite and remote side of the urethra.

3. The apparatus as described in claim 1 and further comprising:

(a) locking means locking said compression plate in a locked position when said compression half has been advanced towards the first half of said base plate so as to maintain said reservoir in a compressed state and said balloon in an inflated state, thereby allowing extended prevention of bladder emptying; and

(b) unlocking means for selectively releasing said locking means and allowing said compression plate to be advanced away from the first half of said base plate to selectively allow bladder emptying.

4. An apparatus for treating urinary incontinence comprising:

(a) a compressible frame adapted for mounting to a user;

(b) a compressible fluid reservoir maintained within said frame and flow communicating with a balloon through a tube;

said reservoir being filled with a hydraulic fluid, so that when a compressive force is applied to said fluid reservoir during use, said reservoir is compressed so that said hydraulic fluid is transferred to said balloon, inflating said balloon;

(c) said balloon adapted to be positioned close to an urethra of the user so that expansion of said balloon compresses the urethra and blocks flow through the urethra so as to prevent bladder emptying;

(d) said frame comprising a base plate divisible into a first half and a second half;

said first half receiving said reservoir;

(e) said frame also including a circumferential wall extending around said base plate; and

(f) said frame further including a compression plate, having a compression half and a releasing half;

said compression plate pivotally and medially mounted to said circumferential wall so that said compression half extends over said first half of said base plate and said releasing half extends over said second half of said base plate, said base plate, said compression plate and said fluid reservoir being positioned relative to one another in such a manner that when a compression force is applied to said compression half, said compression half advances towards said first half of said base plate and compresses said reservoir, transferring said hydraulic fluid from said reservoir to said balloon, and when a compressive force is applied to said releasing half, said releasing half advances towards said second half of said base plate and said compression half is pivotally advanced away from said first half so that said reservoir is allowed to expand so as to draw said hydraulic fluid from said balloon to said reservoir.