Methods and implants for treating urinary incontinence

• US 8,727,963 B2
• Filed: 07/31/2009
• Issued: 05/20/2014
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Knoll, L. Dean
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/533,515
• Publication Number:
  US 20100030016A1
• Time in Patent Office: 1,754 Days
• Field of Search: 600/30, 600/37, 606/144, 66/63, 604/264
• US Class Current: 600/30
• 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. A combination comprising an implant for treating urinary incontinence in a male, and an insertion tool, 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, one extension portion extending from each of the two 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 one of the distal ends,

wherein a first pair of soft tissue anchors is located on a first side of the central support portion and a second pair of soft tissue anchors is located on a second side of the central support 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, and

the insertion tool comprising a handle, a first needle extending from the handle and comprising a first needle proximal end and a first needle distal end, the first needle proximal end in connected contact with the handle and the first needle distal end adapted to engage one of the soft tissue anchors at an end of an extension portion extending from the first side of the central support portion, and

a second needle extending from the handle and comprising a second needle proximal end and a second needle distal end, the second needle proximal end in connected contact with the handle and the second needle distal end adapted to engage one of the soft tissue anchors at an end of an extension portion extending from the first side of the central support portion.

2. The combination according to claim 1 wherein the at least two extension portions comprise

a left extension portion, and a right extension portion, and

the first pair of soft tissue anchors is located at a distal end of the right extension portion and the second pair of soft tissue anchors is located at the distal end of the left extension portion.

3. The combination according to claim 1 wherein the extension portions have a width in the range from 2.4 to 4 centimeters and two soft tissue anchors of the first pair of soft tissue anchors are located at an end of one of the two extension portions and are approximately 1.2 to 1.6 centimeters apart in a side-by-side orientation.

4. The combination according to claim 1 wherein the at least two extension portions comprise a left anterior extension portion, a left posterior extension portion, a right anterior extension portion, and a right posterior extension portion, and one of said four soft tissue anchors at a distal end of each of the four extension portions.

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

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

7. The combination 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. The combination according to claim 1 comprising at least one additional soft tissue anchor located along a length of one of the at least two extension portions between the proximal end and the distal end.

9. The combination according to claim 1 comprising at least two additional soft tissue anchors located along one of the at least two extension portions.

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

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

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

a second needle in connected contact with the handle and comprising a second needle distal end adapted to engage a soft tissue anchor, wherein a position of the first needle distal end is fixed relative to the handle and a position of the second needle distal end is fixed relative to the handle,

the insertion tool, in combination with an implant, 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,

and adapted to engage the first or second needle,

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.

12. The insertion tool according to claim 11 wherein a distance between a location on the handle of the first needle in connected contact with the handle and the first needle distal end, and a distance between a location on the handle of the second needle in connected contact with the handle and the second needle distal end, are the same.

13. The insertion tool according to claim 11 wherein the handle comprises a midplane and at least a portion of the first needle and at least a portion of the second needle lie in the midplane.

14. The insertion tool according to claim 11 wherein

the handle comprises a handle proximal end and a handle distal end,

the first needle comprises a first needle proximal end that extends from a first location at the handle distal end, and

the second needle comprises a second needle proximal end that extends from a second location at the handle distal end.

15. The insertion tool according to claim 14 wherein the first and second needles are of the same length, are straight or curved, and if curved exhibit the same curvature.