Methods and Implants for Treating Urinary Incontinence

• US 20100030016A1
• Filed: 07/31/2009
• Published: 02/04/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Knoll L. Dean
• Inventors: Knoll, L. Dean
• Granted Patent: US 8,727,963 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0078 Gender-specific, e.g. different for male and female patients

Abstract

Described are methods, implants, insertion tools, and related systems and kits, for placing an implant to treat urinary incontinence; the implants include soft tissue anchors that are capable of engaging needles of the insertion tools, and the implants are designed to place a central support portion at a location to support a urethra with extension portions and soft tissue anchors extending to tissue at regions of an obturator foramen.

Claims

1. An implant for treating urinary incontinence in a male, the implant comprising

a central support portion comprising two opposing sides and two opposing ends, and capable of supporting a urethra,

at least two extension portions extending from opposing sides of the central support portion, each extension portion comprising a proximal end attached to the central support portion, and a distal end,

four soft tissue anchors, each located at a distal end of an extension portion,

wherein when the central support portion is placed to support the urethra, the extension portions are capable of extending from the central support portion to soft tissue at a region of an obturator foramen.

2. An implant according to claim 1 comprising

a left extension portion,

a right extension portion, and

two soft tissue anchors at each distal end of each of the right extension portion and the left extension portion.

3. An implant according to claim 1 wherein the extensions portions have a width in the range from 2.4 to 4 centimeters and the two soft tissue anchors at ends of each extension portion are located approximately 1.2 to 1.6 centimeters apart in a side-by-side orientation.

4. An implant according to claim 1 comprising four extension portions comprising

a left anterior extension portion,

a left posterior extension portion,

a right anterior extension portion, and

a right posterior extension portion, and

a soft tissue anchor at a distal end of each of the four extension portions.

5. An implant according to claim 4 wherein each posterior extension portion has a length that is shorter than each anterior extension portion.

6. An implant according to claim 4 wherein each extension portion has a width in the range from 1.2 to 1.8 centimeters.

7. An implant according to claim 1 wherein the tissue at a region of an obturator foramen is selected from endopelvic fascia, obturator internus muscle, and combinations thereof.

8. An implant according to claim 1 comprising at least one additional tissue anchor located along a length of an extension portion between the proximal end and the distal end.

9. An implant according to claim 1 comprising at least two additional soft tissue anchors located along extension portions, between proximal distal ends.

10. An implant according to claim 1 wherein the extension portions include a length in the range from 0.8 to 1.2 inches.

11. In combination, an implant according to claim 1 and an insertion tool, the insertion tool comprising

a handle,

a first needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor, and

a second needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor.

15. An insertion tool according to claim 12, in combination with an implant according to claim 1.

12. An insertion tool useful to place a sling for urinary incontinence, the insertion tool comprising

a handle,

a first needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor, and

a second needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor.

13. An insertion tool according to claim 12 wherein the first and second needles are of the same length, are straight or curved, and if curved exhibit the same curvature.

14. An insertion tool according to claim 12 wherein the handle comprises a midplane and the first and second needles lie in the midplane.

16. A method of treating urinary incontinence in a male, the method comprising:

providing an implant comprising

a central support portion comprising two opposing sides and two opposing ends, and capable of supporting a urethra,

at least two extension portions extending from opposing sides of the central support portion, each extension portion comprising a proximal end attached to the central support portion, and a distal end,

four soft tissue anchors, each located at a distal end of an extension portion, two on a right side of the implant and two on a left side of the implant, wherein when the central support portion is placed to support the urethra, the extension portions are capable of extending from the central support portion to soft tissue at a region of an obturator foramen,

providing an insertion tool comprising

a first needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor, and

a second needle comprising a proximal end and a distal end, the proximal end connected to the handle and the distal end adapted to engage a soft tissue anchor,

creating a medial incision at a perineum,

placing the central support portion to support a urethra,

engaging the two needle tips with two soft tissue anchors on a right side of the implant and placing the soft tissue anchors through tissue paths extending toward a region of an obturator foramen on one side of the patient, and

engaging the two needle tips with two soft tissue anchors on a left side of the implant and placing the soft tissue anchors through tissue paths extending toward a region of an obturator foramen on another side of the patient.

17. A method according to claim 16 comprising

placing two soft tissue anchors on a right side of the implant at support tissue selected from endopelvic fascia, obturator internus muscle, and combinations thereof, on a first side of the patient, and

placing two soft tissue anchors on a left side of the implant at support tissue selected from endopelvic fascia, obturator internus muscle, and combinations thereof, on a second side of the patient.

18. A method according to claim 16, comprising

creating an incision at the perineum,

exposing bulbospongiosus muscle,

dissecting bulbospongiosus muscle to expose corpus spongiosum, and

placing the central support portion to contact the corpus spongiosum.

19. A method according to claim 16 wherein the insertion tool comprises

a handle,

two needles extending from proximal ends connected to the handle to distal ends, and

a tip at a distal end of each needle, the tip capable of engaging a soft tissue anchor.