Methods and implants for treating urinary incontinence

• US 9,022,922 B2
• Filed: 03/27/2014
• Issued: 05/05/2015
• Est. Priority Date: 07/31/2008
• Status: Expired due to Fees

• 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 H
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/227,534
• Publication Number:
  US 20140288360A1
• Time in Patent Office: 404 Days
• Field of Search: 600/37, 600/30, 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 method of treating urinary incontinence in a male patient, 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 the 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 of one of the extension portions,

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 handle,

a first needle comprising a proximal end and a distal end, the first needle proximal end in connected contact with the handle and the first needle distal end comprising a needle tip adapted to engage one of the soft tissue anchors, and

a second needle comprising a proximal end and a distal end, the second needle proximal end in connected contact with the handle and the second needle distal end comprising a needle tip adapted to engage one of the soft tissue anchors,

creating a medial incision at a perineum,

placing the central support portion to support a urethra,

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

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

2. A method according to claim 1 comprising

placing the two soft tissue anchors on the right side of the implant 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 male patient, and

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

3. A method according to claim 1, comprising

exposing bulbospongiosus muscle,

dissecting bulbospongiosus muscle to expose corpus spongiosum, and

placing the central support portion to contact the corpus spongiosum.

4. A method according to claim 1, wherein the at least two extension portions comprise:

a left extension portion having at least one of the soft tissue anchors at the extension portion distal end, and

a right extension portion having at least one of the soft tissue anchors at the extension portion distal end.

5. A method according to claim 4 wherein

the left extension portion has a width in the range from 2.4 to 4 centimeters and two of the soft tissue anchors at the extension portion distal end, and

the right extension portion has a width in the range from 2.4 to 4 centimeters and two of the soft tissue anchors at the extension portion distal end.

6. A method according to claim 1 wherein the at least two extension portions comprise:

a left anterior extension portion having one of the soft tissue anchors at the extension portion distal end,

a left posterior extension portion having one of the soft tissue anchors at the extension portion distal end,

a right anterior extension portion having one of the soft tissue anchors at the extension portion distal end, and

a right posterior extension portion having one of the soft tissue anchors at the extension portion distal end.

7. A method according to claim 6 wherein each posterior extension portion has a length that is shorter than each anterior extension portion.

8. A method according to claim 6 wherein each extension portion has a width in the range from 1.2 to 1.8 centimeters.

9. A method according to claim 1 wherein the implant comprises an additional tissue anchor located along a length of one of the at least two extension portions between the extension portion proximal end and the extension portion distal end.

10. A method according to claim 1 wherein the extension portions have a length in the range from 0.8 to 1.2 inches.

11. A method according to claim 1 wherein the first and second needles are of the same length and if curved exhibit the same curvature.

12. A method according to claim 1 wherein the handle comprises a midplane and the first and second needles lie in the midplane.