Urinary sphincter control device

• US 6,319,237 B1
• Filed: 04/23/1999
• Issued: 11/20/2001
• Est. Priority Date: 04/23/1999
• Status: Expired due to Fees

• Current Assignee: ICD Labs, Inc.
• Original Assignee: ICD Labs, Inc.
• Inventors: Krumme, John F.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/298,392
• Time in Patent Office: 942 Days
• Field of Search: 604/256, 600/29-32, 623/14, 128/DIG.25, 128/885, 128/887
• US Class Current: 604/256
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A urinary sphincter control device for application to a urethra to control flow of fluid through the urethra, comprises a cuff which can be fitted around the urethra. The cuff comprises a plurality of chambers which extend generally parallel to the axis of the cuff, and which can be inflated by supply of pressurised control fluid thereto. Inflation of the chambers causing the configuration of the cuff to change so as to alter the resistance that is provided by the cuff to flow of fluid along the urethra.

Claims

1. A urinary sphincter control device for application to a urethra to control flow of fluid through the urethra, comprising a cuff configured be fitted around the urethra, the cuff comprising a plurality of chambers which are discontinuous around the urethra so that blood is able to flow along the urethra in its wall even when the urethra is closed against fluid flow, which can be inflated to cause the configuration of the cuff to change so as to alter the resistance that is provided by the cuff to flow of fluid through the urethra, and at least one of the chambers containing therein a resiliently deformable biassing element for biassing the chamber configuration towards an uninflated configuration, and wherein the biassing element is formed from a shape memory alloy which exhibits non-linear superelastic properties.

2. A urinary sphincter control device as claimed in claim 1, in which the cuff chambers are arranged so that they extend substantially parallel to the axis of the cuff.

3. A urinary sphincter control device as claimed in claim 2, in which the angle between the axis of the cuff and the axis of the chambers is less than about 20°

.

4. A urinary sphincter control device as claimed in claim 1, in which flow of fluid along the urethra is restricted by the cuff when it is in its uninflated configuration, and in which the effective internal perimeter dimension of the cuff is increased when it is in its inflated configuration so that the pressure imposed by the cuff on the urethra is reduced and so that the urethra is opened to flow of fluid therethrough.

5. A urinary sphincter control device as claimed in claim 1, in which the chambers have a generally flattened cross-section when viewed along their axes when uninflated, and in which supply of control fluid to the chamber causes the cross-section of the chambers to become more rounded.

6. A urinary sphincter control device as claimed in claim 5, in which the biassing element has a generally tubular configuration with the axis of the tube extending generally parallel to the axis of the chamber, the biassing element having a generally flattened cross-section when viewed along the axis of the chamber in its uninflated configuration, and in which supply of control fluid to the chamber causes its cross-section to become more rounded.

7. A urinary sphincter control device as claimed in claim 6, in which the biassing element comprises a tube which has a plurality of slots formed in it which extend around at least part of the periphery of the tube.

8. A urinary sphincter control device as claimed in claim 7, in which the slots are arranged in a plane which is generally perpendicular to the axis of the tube.

9. A urinary sphincter control device as claimed in claim 1, in which the cuff comprises an array of the said chambers which extends around the entire periphery of the cuff.

10. A urinary sphincter control device as claimed in claim 9, in which the cuff comprises at least 8 chambers in the said array.

11. A urinary sphincter control device as claimed in claim 1, in which the cuff has at least one array of closely spaced chambers which extends around only part of the periphery of the cuff.

12. A urinary sphincter control device as claimed in claim 11, in which the cuff has at least two of the said arrays of chambers, the arrays being spaced apart around the periphery of the cuff.

13. A urinary sphincter control device for application to a urethra to control flow along the urethra, which comprises

(a) a cuff configured to be fitted around the urethra and configured to be inflated to cause the configuration of the device to change between an uninflated configuration in which flow of fluid along the urethra is restricted and an inflated configuration in which fluid is able to flow along the urethra, and

(b) an element for biassing the device towards the uninflated configuration. the element is formed from a shape memory alloy which has been treated so that it exhibits non-linear superelastic properties at body temperature, allowing it to be deformed by inflation of the cuff and to recover elastically when the cuff deflates.

14. A urinary sphincter control device as claimed in claim 13, in which the cuff comprises a plurality of chambers configured be inflated by supply of pressurised control fluid thereto to cause the configuration of the cuff to change so as to alter the resistance that is provided by the cuff to flow of fluid along the urethra.

15. A urinary sphincter control device as claimed in claim 14, in which the biassing element is located in one of the chambers.

16. A urinary sphincter control device as claimed in claim 15, in which the biassing element has a generally tubular configuration with the axis of the tube extending generally parallel to the axis of the chamber in which it is located, the biassing element having a generally flattened cross-section when viewed along the axis of the chamber in its uninflated configuration, and in which supply of control fluid to the chamber causes its cross-section to become more rounded.