Implantable devices and methods for treating urinary incontinence

• US 20050096751A1
• Filed: 11/01/2003
• Published: 05/05/2005
• Est. Priority Date: 11/01/2003
• Status: Active Grant

• Current Assignee: THD SpA
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Swoyer, John M., Starkebaum, Warren L., Gerber, Martin T.
• Granted Patent: US 7,585,271 B2
• Time in Patent Office: Days
• US Class Current: 623/23.66
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids

Abstract

In general, the invention is directed to treatment of urinary incontinence by the implantation of one or more bulking prostheses proximate to a urethral sphincter. These bulking prostheses, which may include biocompatible hydrogel, are implanted into the tissue outside the urethra, proximate to a urethral sphincter. When implanted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the external urethral sphincter. With the extra bulk, the patient can exercise voluntary control over the external urethral sphincter to close or maintain closure of the urethra and maintain urinary continence.

Claims

1. A method for treating urinary incontinence comprising:

applying vacuum pressure to an instrument proximate to a urethral wall to draw a portion of the urethral wall into a cavity in the instrument;

forming a hole in the portion of the urethral wall disposed in the cavity; and

implanting a bulking prosthesis through the hole proximate to a urethral sphincter.

2. The method of claim 1, wherein the bulking prosthesis is in a miniature state at the time of implantation and assumes an enlarged state after implantation.

3. The method of claim 1, wherein

forming the hole comprises forming the hole with a needle having a lumen, and

wherein implanting the bulking prosthesis comprises pushing the bulking prosthesis through the lumen in the needle.

4. The method of claim 1, wherein the bulking prosthesis comprises a hydrogel.

5. The method of claim 1, wherein the bulking prosthesis comprises a material that absorbs fluid to assume the enlarged state.

6. A system comprising:

a tubular instrument having a distal end, the distal end including a cavity;

a vacuum port to draw a portion of a urethral wall into the cavity;

a needle to make a hole through the urethral wall in the portion of the urethral wall disposed in the cavity; and

a pushing agent to push a bulking prosthesis through the tubular instrument and through the hole in the urethral wall.

7. The system of claim 6, further comprising:

a source of vacuum pressure; and

a conduit to deliver the vacuum pressure from the source to the urethral wall.

8. The system of claim 6, wherein the tubular instrument comprises the needle.

9. The system of claim 6, wherein the tubular instrument comprises a cystoscope.

10. A device comprising:

a bulking prosthesis in the shape of a partial cylinder having an inner radius,

wherein the bulking prosthesis comprises a hydrophilic polymer that forms a hydrogel in the presence of water, and

wherein the inner radius of the partial cylinder is sized to conform to close the urethra of a patient when the bulking prosthesis is implanted in the patient with an inner surface coaxial with the urethra of the patient and when the patient exercises voluntary control over an external urethral sphincter.

11. The device of claim 10, wherein the bulking prosthesis has a substantially half-cylinder shape.

12. The device of claim 11, wherein the bulking prosthesis assumes one of a miniature state and an enlarged state, and the prosthesis assumes the shape of the partial cylinder in the enlarged state.

13. The device of claim 10, further comprising a Dacron mesh surrounding the hydrophilic polymer.

14. The device of claim 10, further comprising a radiopaque material.

15. The device of claim 10, wherein the device includes a non-uniform cross-section.

16. A method for treating urinary incontinence comprising:

implanting a bulking prosthesis in tissue proximate to a urethral sphincter,

wherein the bulking prosthesis is in a miniature state at the time of implantation and assumes an enlarged state after implantation, and wherein the bulking prosthesis includes a long dimension of at least two millimeters in the enlarged state.

17. The method of claim 16, wherein the bulking prosthesis is a capsule-shaped bulking prosthesis comprising a length of at least four millimeters.

18. The method of claim 16, wherein the bulking prosthesis is a spherical bulking prosthesis.

19. The method of claim 16, wherein the bulking prosthesis is a partial cylinder bulking prosthesis.