Prosthetic sphincter

• US 4,551,862 A
• Filed: 12/15/1982
• Issued: 11/12/1985
• Est. Priority Date: 12/15/1982
• 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): Isabella, David J.
• Application Number:
  US06/435,761
• Time in Patent Office: 1,063 Days
• Field of Search: 128/1 R, 128/678, 128/676, 128/DIG. 25, 354/226, 354/270, 354/269, 3/1, 3/1.4, 3/1.5
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A prosthetic sphincter is designed to surround a waste elimination passage in a patient, such as the lower colon or urethra for realizing continence. The artificial sphincter itself comprises a stationary ring and a rotatable ring supported for rotation by the stationary ring. Three occlusion elements extend from 120° circumferentially spaced points on the rotatable ring to similarly oriented points on the stationary ring, offset from the first dimensioned points by a given number of degrees. The length of the various elements is such that when the rotatable ring is in a first position, the elements follow the inner peripheral curvature of the rings to maximize the opening through the rings and thus through the elimination passage circumscribed by said rings. When the rotatable ring is rotated to a second position, the displacement of the second ends of the elements from the first ends is increased, to cause all three elements to enter the opening and thereby occlude the elimination passage contained therein by applying pressure at 120° circumferentially spaced areas, or at the appropriate angular degree division(s) with respect to the selected number of occlusion elements to achieve a state of prosthetic continence.

Claims

1. A prosthetic sphincter suitable for implantantion for embracing an elimination passage of a patient to control the movement of material therethrough for realizing continence, said sphincter including, in combination:

(a) a stationary ring;

(b) a rotatable ring axially aligned with said stationary ring to define a ring assembly having an occlusion opening through the rings for surrounding the patient'"'"'s elimination passage;

(c) occlusion spring means interconnecting said stationary ring and said rotatable ring such that rotation of said rotatable ring relative to said stationary ring from a first position causes said occlusion spring means to enter said occlusion opening to cause a closing of the occlusion opening around the elimination passage and a corresponding application of occlusive pressures to the elimination passage being surrounded by the rings to maintain the passage in an occluded condition until the rotatable ring is rotated back to its first position relative to the stationary ring; and

(d) a tear resistant skin for enclosing said ring assembly and occlusion spring means, said skin having fatigue relief folds on top and bottom surfaces thereof arranged coaxially with the occlusion opening through said rings for accommodating the closing of the occlusion opening when the rotatable ring is moved from its first position, said skin having a pliable filling material located within the enclosure formed thereby for encapsulating said ring assembly and said occlusion spring means.

2. A prosthetic sphincter according to claim 1, in which said occlusion spring means comprises three individual elongated bendable and flexible elements, each having a spring characteristic biasing it to a rectilinear position and each having a given length essentially inextensible, said elements being secured at first ends to said rotatable ring at 120°

circumferentially spaced points and at second ends to said stationary ring at 120°

circumferentially spaced points, in turn, respectively circumferentially displaced from said first mentioned circumferentially spaced points a given number of degrees, said given length and said given number of degrees being such that when said rotatable ring is in said first position, the elements follow the inner periphery of the rings to maximize the opening through the rings and when said rotatable ring is in said second position, the displacement of the second ends from the first ends is increased to cause all three elements to enter the opening through the rings in an interwoven relationship to thereby restrict the passage when surrounded by the rings by applying pressure at 120°

circumferentially spaced areas.

3. A prosthetic sphincter according to claim 1, including a force applying means connected to said rotatable ring and operable from a remote location to rotate said rotatable ring from its first position, the spring characteristic of said occlusion spring means being such as to return the rotatable ring to its first position in the absence of any force on said force applying means so that a fail safe system results.

4. A prosthetic sphincter according to claim 1, in which said stationary ring includes a radially inwardly directed flange on its inner periphery defining a ledge for seating and supporting said rotatable ring, both said stationary ring and rotatable ring having splits such that the opposed ring ends at the splits can be biased apart so that the rings can be positioned about said passage without requiring access to either end of the passage, the connection of said occlusion spring means to said stationary ring being separable to permit surrounding the passage by the ring assembly.

5. A prosthetic sphincter according to claim 2, in which said given number of degrees is from 180°

to 270°

.

6. A prosthetic sphincter according to claim 2, in which each of said elongated bendable elements includes periodic cushioning enlargements to gently engage the elimination passage and effect proper occlusion of the elimination passage.

7. A prosthetic sphincter according to claim 1, including sensor responsive means on each of said stationary ring and rotatable ring so that the relative rotational positions of the rings can be detected from outside the patient'"'"'s body.

8. A prosthetic sphincter according to claim 2, in which each of said elongated bendable elements incorporates a sensor responsive means so that the degree of occlusion opening closure caused by the elements can be detected outside a patient'"'"'s body.

9. A prosthetic sphincter according to claim 1, further including

suture attachment means circumferentially spaced at outer peripheral portions of said stationary ring to enable attachment of the ring assembly to surrounding tissue, bone or facia;

and

anti-bacterial medium means disposed between said stationary and rotatable rings.

10. A prosthetic sphincter according to claim 3, in which said force applying means includes a cable extending around at least a peripheral portion of said rotatable ring and extending from said ring assembly to said remote location, said force applying means also including means for supplying an actuating force to said cable from said remote location to cause the rotation of said rotatable ring.

11. A prosthetic sphincter according to claim 10, in which

said means for supplying an actuating force includes a motor, on-off switch means for controlling said motor, and rack and pinion means operated by said motor for supplying the actuating force to said cable, the remote end of said cable being connected to said rack and pinion means,

said means for supplying an actuating force being implanted in a surgically accessible subcutaneous area of the patient'"'"'s body proximal to an epidermal portion, such that said switch means can be manually operated at the epidermal portion.

12. An artificial sphincter comprising a prosthetic device suitable for implantation to embrace a patient'"'"'s lumen for occluding and opening the lumen and controlling the movement of material therethrough, said sphincter comprising:

ring assembly means defining an occlusion orifice for surrounding the patient'"'"'s lumen, said ring assembly means having a stationary ring and a rotatable ring axially aligned with and supported for rotation by said stationary ring;

a plurality of flexible occlusion elements extending between first circumferentially spaced locations at said rotatable ring and respective second circumferentially spaced locations at said stationary ring, such that when said rotatable ring is in a first position, said occlusion elements follow the inner periphery of said ring assembly means to maximize the size of the occlusion orifice as defined by said ring assembly means, and when said rotatable ring is rotated to a second position, said occlusion elements being extended and thereby caused to enter the occlusion orifice to overlap one another in an interwoven relationship and thereby cause both a closing of the occlusion orifice around the lumen and a corresponding application of occlusive pressures to the lumen being surrounded by said ring assembly means until said occlusion elements return to the first position, said occlusion elements having a spring-like characteristic for biasing said rotatable ring towards its first position; and

force applying means interfaced with said rotatable ring to selectively rotate said rotatable ring to a particular second position whereby to adjustably vary the corresponding application of occlusive pressures to the patient'"'"'s lumen;

said force applying means including cable means and switch means, said cable means surrounding and being rotatable around an outer peripheral portion of said rotatable ring for rotating said ring between the first and second positions, and said switch means being implanted at a location remote from said ring assembly means at a surgically accessible subcutaneous area of the patient'"'"'s body proximal to an epidermal portion, such that said switch means can be manually operated at the epidermal portion to cause the rotation of said cable means and a corresponding rotation of said rotatable ring to the second position to thereby close said occlusion orifice and apply the occlusive pressures to the lumen being surrounded by said ring assembly means.

13. The artificial sphincter recited in claim 12, wherein said cable means extends from said ring assembly means to a remote location, at which remote location said switch means is operated to cause the rotation of said cable means and the corresponding rotation of said rotatable ring to the second position.

14. The artificial sphincter recited in claim 12, further comprising

a tear resistant envelope having a toroid shape for enclosing said ring assembly means and said occlusion elements, said envelope having annular fatigue relief folds on top and bottom surfaces thereof arranged coaxially with the occlusion orifice of said ring assembly means for accommodating the closing of the occlusion orifice when the rotatable ring is rotated from the first position, and

filler material located within said envelope and encapsulating said ring assembly means and occlusion elements.

15. The artificial sphincter recited in claim 12, further comprising sensor responsive means located on each of said rotatable and stationary rings, so that the positions of said rings relative to one another can be detected by a sensor from outside the patient'"'"'s body.

16. The artificial sphincter recited in claim 12, further comprising sensor responsive means located on each of flexible occlusion elements, so that the positions of said occlusion elements relative to said occlusion orifice can be detected by a sensor from outside the patient'"'"'s body.

17. The artificial sphincter recited in claim 12, wherein each of said stationary and rotatable rings has a respective split formed therein to permit said rings to be opened at said splits and positioned around the patient'"'"'s lumen without requiring access to either end of the lumen or invading the lumen.