Manually actuated hydraulic sphincter

• US 4,571,749 A
• Filed: 09/21/1982
• Issued: 02/25/1986
• Est. Priority Date: 09/21/1982
• Status: Expired due to Fees

• Current Assignee: Johns Hopkins University of Baltimore Maryland
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): ISABELLA, DAVID J
• Application Number:
  US06/421,441
• Time in Patent Office: 1,253 Days
• Field of Search: 128/1 R, 128/DIG. 25, 128/748, 128/79, 604/350 V, 604/9, 3/1
• US Class Current: 600/31
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61M 2039/0217 at least some chambers being stacked separated by another septum
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An implantable hydraulic urinary sphincter system is disclosed for maintaining continence in those patients unable to control or stop inadvertent urinary flow. The invented apparatus generally consists of an artificial urinary sphincter and a control means for obtaining continence while causing the artificial sphincter to apply minimal pressure to the urethra for all conditions of the bladder. The invented apparatus: (1) automatically causes sphincter fluid pressure to increase or decrease with sensed bladder and/or abdominal pressure, and (2) is manually actuated by a patient when he or she desires to urinate. The invented apparatus can be filled with fluid, or the fluid pressure can be reset, after implantation without necessitating a surgical procedure.

Claims

1. An implantable hydraulic urinary sphincter system comprising:

an artificial sphincter means for exerting pressure on a patient'"'"'s urethra;

a control unit having a sphincter fluid chamber filled with incompressible fluid, said sphincter fluid chamber hydraulically coupled to said artificial sphincter means, and wherein pressure exerted by said artificial sphincter means varies according to pressure in said sphincter fluid chamber;

a pressure sensor means for sensing pressure at a preselected location in a patient'"'"'s body;

a minimum pressure means for biasing fluid pressure in said sphincter fluid chamber to a set minimum pressure; and

a pressure transfer means located within said control unit and directly associated with said sphincter fluid chamber and said pressure sensor means for automatically adjusting fluid pressure in said sphincter fluid chamber depending on pressure sensed by said pressure sensor means.

2. The apparatus of claim 1, wherein said pressure sensor means is adapted to be implanted in association with said patient'"'"'s bladder and to sense said patient'"'"'s bladder pressure and wherein said pressure transfer means automatically adjusts fluid pressure in said sphincter fluid chamber according to the valve of said sensed bladder pressure.

3. The apparatus as in claim 1 wherein said control unit comprises:

an actuation means associated with said sphincter fluid chamber, for manually reducing said sphincter fluid pressure thereby reducing pressure exerted by said artificial sphincter means and allowing said patient to urinate, said actuation means is adapted to be controlled by manually applying pressure to an actuation diaphragm forming an external surface of said control unit.

4. The apparatus of claim 3 further comprising a means, associated with said sphincter fluid chamber, for adjusting the level of said set minimum pressure after said apparatus is implanted.

5. The apparatus of claim, 3 wherein said minimum pressure means is a resiliently biased diaphragm means forming at least part of one wall of said sphincter fluid chamber, the spring force of said resiliently biased diaphragm means biasing said sphincter fluid to said set minimum pressure.

6. The apparatus of claim 5, wherein said pressure sensor means further comprises a pressure sensor bulb filled with an incompressible fluid, and adapted to be implanted;

and, wherein said pressure transfer means further comprises a pressure reference chamber, filled with incompressible reference fluid and hydraulically coupled to said pressure sensor bulb, positioned adjacent to said sphincter fluid chamber such that both said sphincter fluid chamber and said pressure reference chamber share said resiliently biased diaphragm means as a common wall, increased fluid pressure in said pressure reference chamber causing said resiliently biased diaphragm means to flex increasing the volume of said pressure reference chamber, decreasing the volume of said sphincter fluid chamber and increasing said sphincter fluid pressure above said set minimum pressure.

7. The apparatus of claim 6, wherein said actuation means comprises:

an actuation chamber, one wall of said actuation chamber containing a flexible actuation diaphragm, a second wall of said actuation chamber containing at least one extensible portion, pressing on said flexible actuation diaphragm causes said at least one extensible portion to elongate, said actuation chamber positioned in association with said sphincter fluid chamber such that when said at least one extensible portion is elongated, pressure is exerted against said resiliently biased diaphragm means thereby decreasing pressure on said sphincter fluid in said sphincter fluid chamber to a value lower than said set minimum pressure.

8. The apparatus of claim 7 wherein said actuation chamber is filled with an incompressible actuation fluid and wherein said at least one extensible portion comprises at least one actuation bellows in fluid communication with said actuation fluid whereby pressing on said flexible actuation diaphragm causes said incompressible actuation fluid to be displaced and to elongate said at least one actuation bellows.

9. The apparatus of claim 8, wherein said at least one actuation bellows comprises four actuation bellows spaced along the inner circumference of said second wall of said actuation chamber.

10. The apparatus of claim 9, wherein said four actuation bellows are connected at their lower extremity to a torroidal actuation ring, said torroidal actuation ring presses against said elastic diaphragm when said actuation bellows are elongated.

11. The apparatus of claim 8, wherein said at least one actuation bellows is adapted to be elongated a set distance before pressing against said resiliently biased diaphragm means and further including an adjustment means associated with said actuation chamber for adjusting said set distance, thereby adjusting the sensitivity of said actuation means.

12. The apparatus of claim 5, wherein said resiliently biased diaphragm means is an elastic diaphragm.

13. The apparatus of claim 12, wherein said resiliently biased diaphragm means is an elastic diaphragm.

14. The apparatus of claim 4, wherein said means for adjusting comprises:

a septum means forming at least a portion of the exterior surface of control unit for providing entry into said sphincter fluid chamber; and

,

a hollow needle for penetrating said septum means and for accessing fluid in said sphincter fluid chamber.

15. The apparatus of claim 5, wherein said actuation means further comprises an extendible member associated with said actuation diaphragm for operably engaging and exerting a force against said resiliently biased diaphragm in response to manual pressure applied to said actuation diaphragm.

16. The apparatus of claim 1, wherein said pressure sensor means is adapted to be implanted intra-abdominally and to sense said patient'"'"'s intra-abdominal pressure and wherein said pressure transfer means automatically adjusts fluid pressure in said sphincter fluid chamber according to the value of said sensed intra-abdominal pressure.

17. An implantable hydraulic urinary sphincter system comprising:

a control unit containing in a casing and adapted to be implanted, subcutaneously comprising;

an actuation chamber filled with an incompressible actuation fluid, said actuation chamber mounted inside said casing, one wall of said actuation chamber containing a flexible actuation diaphragm positioned on the outer face of said casing, a second wall of said actuation chamber contains at least one extensible portion, pressing on said flexible actuation diaphragm causes said at least one extensible portion to elongate;

a sphincter fluid chamber filled with an incompressible sphincter fluid, said sphincter fluid chamber mounted inside said casing, one wall of said sphincter fluid chamber contains a resiliently biased diaphragm, said resiliently biased diaphragm maintaining said sphincter fluid at a set minimum pressure, said sphincter fluid chamber positioned adjacent to said actuation chamber such that said at least one extensible portion when elongated presses against said resiliently biased diaphragm increasing the volume of said sphincter fluid chamber and decreasing the pressure on said sphincter fluid thereby allowing said patient to urinate; and

,

a rigid pressure reference chamber filled with an incompressible reference fluid and positioned inside said casing adjacent to said sphincter fluid chamber such that at least part of said resiliently biased diaphragm is a common wall to both said pressure reference chamber and said sphincter fluid chamber, increased fluid pressure in said pressure reference chamber causing said resiliently biased diaphragm to flex increasing the volume of said pressure reference chamber, decreasing the volume of said sphincter fluid chamber and increasing said sphincter fluid pressure;

an artificial sphincter operably connected to said sphincter fluid chamber, said artificial sphincter chamber being pressurized by said sphincter fluid; and

,

a pressure sensor bulb, connected by a flexible line to said pressure reference chamber, for varying the fluid pressure in said pressure reference chamber, as sensed pressure varies.

18. The apparatus of claim 17 further comprising a means for adjusting fluid pressure in said control unit after said control unit has been implanted.

19. The apparatus of claim 18, wherein said means for adjusting fluid pressure comprises:

an outer septum forming part of said actuation diaphragm;

a first inner septum forming part of said second wall of said actuation chamber, said first inner septum located below said outer septum;

a second inner septum, forming part of said elastic diaphragm, said second inner septum located below said outer septum and said first inner septum; and

,

a needle means for penetrating said outer, said first inner, and said second inner septums and for accessing fluid in said control unit.

20. The apparatus of claim 19, wherein said needle means is a non-coring hypodermic needle having a side hole.

21. The apparatus of claim 20, wherein said side hole is positioned a first distance from the tip of said needle means, said first distance allowing said needle means selective access to fluid in said actuation chamber when said tip of said needle means is positioned in said pressure reference chamber and abutting said inside casing.

22. The apparatus of claim 20, wherein said side hole is positioned a second distance from the tip of said needle means, said second distance allowing said needle means selective access to fluid in said sphincter fluid chamber when said tip of said needle means is positioned in said pressure reference chamber and abutting said inside casing, thereby allowing physician to set said minimum sphincter differential pressure.

23. The apparatus of claim 20, wherein said side hole is positioned a third distance from the tip of said needle means, said third distance allowing said needle means selective access to fluid in said pressure reference chamber when said tip of said needle means is positioned in said pressure reference chamber and abutting said inside casing so that said reference fluid pressure can be adjusted.

24. The apparatus of claim 22, wherein said outer, said first inner, and said second inner septums are made from a self-sealing material.

25. The apparatus of claim 19, further including a pressure gauge operably connected to said needle means to measure fluid pressure.

26. The apparatus of claim 20, further including a syringe operably connected to said needle means to add or remove fluid.