Single circuit elastofluidic sphincter

• US 4,634,443 A
• Filed: 07/05/1985
• Issued: 01/06/1987
• Est. Priority Date: 07/05/1985
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Haber, Terry M.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/752,137
• Time in Patent Office: 550 Days
• Field of Search: 128/1 R, 128/346, 128/DIG. 25, 128/327, 128/774, 128/780, 128/79, 623/14
• 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 gastrointestinal sphincter to be surgically implanted around a lumen (e.g. bowel) of a patient to apply variable occlusive pressures for articulating the lumen. The sphincter includes an occlusion cuff having a hollow, expansible chamber formed therein to embrace the lumen. Communicating in a single, continuous fluid circuit with the expansible chamber are first and second fluid circuits having respective reservoir supplies of fluid located therein. Each of the reservoir supplies may be selectively actuated in order that fluid will be delivered to the expansible chamber to controllably expand the chamber and thereby produce variable occlusive pressure levels for achieving coaptive continence. A fluid filled physician control port is interconnected with one of the fluid circuits and surgically implanted so as to be accessible to a fluid filled syringe. A carefully controlled volume of fluid from the port can be delivered to the expansible chamber via the associated fluid path to generate the minimum increased occlusive pressure necessary to achieve coaptive continence according to the tissue requirements of the patient.

Claims

1. A prosthetic sphincter for surgical implantation to apply occlusive pressures to a patient'"'"'s lumen for achieving coaptive continence, said sphincter comprising:

an occlusion cuff surrounding the lumen and having an expandable chamber thereof for engaging and articulating the lumen;

a first fluid filled path communicating with said expandable chamber;

a second fluid filled path communicating with said expandable chamber; and

first and second fluid filled reservoirs respectively interconnected with said first and second fluid paths by which to selectively deliver a supply of fluid under pressure via either one or both of said paths to said expandable chamber for controlling the expansion of said chamber and varying the occlusive pressures being applied to the lumen for achieving coaptive continence,

each of said reservoirs being surgically implanted at a manually accessible area of the patient and having respective flexible surfaces to be manually depressed to compress its associated reservoir and force fluid therefrom and into a corresponding fluid path for delivery to said expandable chamber, such that the successive compression of the first and then the second of said reservoirs variably increasing the occlusive pressure being applied to said lumen from a first to a second pressure level.

2. The prosthetic sphincter recited in claim 1, wherein the expandable chamber of said occlusion cuff and the first and second fluid paths are interconnected as a single, continuous fluid circuit.

3. The prosthetic sphincter recited in claim 2, wherein each reservoir also has a rigid locating means by which a patient can locate said reservoir in order that said flexible surface thereof can be manually depressed.

4. The prosthetic sphincter recited in claim 3, wherein said means to deliver a supply of fluid to said expandable chamber also includes a fluid filled, physician actuated port, said fluid filled port being surgically implanted at a manually accessible area of the patient and interconnected with at least one of said first and second fluid paths, said fluid filled port having a region in which to receive a fluid filled syringe so that an additional supply of fluid can be introduced to said port to force existing fluid therefrom and into said corresponding fluid path for delivery to said expandable chamber.

5. The prosthetic sphincter recited in claim 4, wherein said fluid filled port also has a puncture healing region interfaced with the region in which to receive the syringe, said puncture healing region healing any punction wound remaining after the withdrawal of the syringe and preventing leakage of fluid from said port.

6. The prosthetic sphincter recited in claim 1, including fluid pressure indicating means communicating with the expandable chamber of said occlusion cuff for receiving fluid therefrom and providing an indication of the fluid pressure within said chamber.

7. The prosthetic sphincter recited in claim 1, wherein said occlusion cuff includes an extensible region formed therein, said extensible region having a spring-like memory to accommodate a distension of the patient'"'"'s lumen when said occlusion cuff is located therearound.

8. The prosthetic sphincter recited in claim 7, wherein said extensible region has one or more apertures formed therein, the size and number of said apertures establishing a minimum threshhold pressure level at which said extensible region first begins to stretch in response to a distended lumen.

9. The prosthetic sphincter recited in claim 1, wherein said occlusion cuff has first and second ends to be releasably connected together to surround the patient'"'"'s lumen, one of said cuff ends having a raised portion and the other of said cuff ends having a retaining clip, said raised portion and retaining clip cooperating to form interlocking means to connect said first and second cuff ends together when the raised portion of said first cuff end is pulled through the retaining clip of said second cuff end.

10. The prosthetic sphincter recited in claim 9, wherein said first cuff end includes a tab projecting therefrom and said second cuff end includes a locking loop, said projecting tab and said locking loop cooperating to form an additional, redundant interlocking means to connect said first and said second cuff ends together when the projecting tab of said first cuff end is pulled through the locking loop of said second cuff end.

11. The prosthetic sphincter recited in claim 1, wherein said means to deliver a supply of fluid to said expandable chamber includes first and second check valves respectively interconnected with said first and second fluid paths to control the flow of fluid therethrough.

12. A prosthetic sphincter for surgical implantation, said sphincter including a continence producing occlusion cuff being relatively inextensible and resistant to elongation in response to tensile stretching forces and surrounding a patient'"'"'s lumen to apply occlusive pressure for occluding and relaxing the lumen and thereby controlling the movement of material therethrough, said occlusive cuff having an expansible chamber to embrace the lumen, said sphincter further comprising:

means to selectively deliver fluid to said expansible chamber to controllably expand said chamber and thereby produce occlusive pressure for achieving coaptive continence, and

relatively extensible membrane means subject to variable elongation in response to at least predetermined minimum tensile stretching forces, said membrane means interconnected with said occlusion cuff to increase the inside circumference of said cuff and thereby accommodate a distension of the lumen when said occlusion cuff is positioned therearound.

13. The prosthetic sphincter recited in claim 12, wherein said means to selectively deliver fluid to said expansible chamber comprises a first fluid filled path communicating with said chamber and having a fluid filled reservoir located therein and a second fluid filled path also communicating with said chamber and having a fluid filled reservoir located therein.

14. The prosthetic sphincter recited in claim 13, wherein each of said first and second fluid paths and said expansible chamber are interconnected as a single, continuous fluid circuit.

15. The prosthetic sphincter recited in claim 13, wherein each of said fluid filled reservoirs has a flexible surface which is adapted to be depressed so as to compress said reservoirs and force fluid therefrom into respective fluid paths for delivery to said expansible chamber.

16. The prosthetic sphincter recited in claim 13, wherein said means to selectively deliver fluid to said expansible chamber also comprises at least one fluid filled port interconnected with one of said first or second fluid filled paths and surgically located to be accessible to a fluid filled syringe so that an additional supply of fluid can be introduced to said port to force existing fluid therefrom into said corresponding fluid path for delivery to said expansible chamber.

17. The prosthetic sphincter recited in claim 13, wherein said means to selectively deliver fluid to said expansible chamber also comprises first and second check valves respectively interconnected with said first and second fluid paths to control the flow of fluid therethrough.

18. The prosthetic sphincter recited in claim 12, wherein said extensible means has one or more apertures formed therein, the size and number of said apertures establishing a minimum threshhold pressure level at which said extensible means first begins to stretch in response to a distension of the lumen.

19. A prosthetic sphincter for surgical implantation to apply occlusive pressures to a patient'"'"'s lumen for achieving coaptive continence, said sphincter comprising:

an occlusion cuff being relatively inextensible and resistant to elongation in response to tensile stretching forces and surrounding the lumen and having an expandable chamber thereof for engaging and articulating the lumen;

a first fluid filled path communicating with said expandable chamber;

a second fluid filled path communicating with said expandable chamber;

first and second fluid filled reservoirs respectively interconnected with said first and second fluid paths and having respective flexible surfaces to be manually depressed to force fluid outwardly therefrom and into a corresponding fluid path for delivery to said expandable chamber for filling said chamber and increasing the occlusive pressure being applied to the patient'"'"'s lumen such that the successive compression of the first and then the second of said reservoirs variably increases the occlusive pressure being applied to said lumen from a first to a second pressure level;

a fluid filled physician actuated port, said fluid filled port being surgically implanted at a manually accessible area of the patient and interconnected with at least one of said first and second fluid paths, said fluid filled port having a region in which to receive a fluid filled syringe so that an additional supply of fluid can be introduced to said port to force existing fluid therefrom and into said corresponding fluid path for delivery to said expandable chamber; and

relatively extensible membrane means subject to variable elongation in response to at least predetermined minimum tensile stretching forces, said membrane means interconnected with said occlusion cuff to increase the inside circumference thereof and thereby accommodate a distension of the lumen when said membrane means and occlusion cuff are positioned therearound.