Pelvic implant system and method

• US 9,414,903 B2
• Filed: 07/23/2012
• Issued: 08/16/2016
• Est. Priority Date: 07/22/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Allen, John J., Mujwid, James R., Arnal, Kevin R., Felton, Jessica E., Lund, Robert E.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/556,167
• Publication Number:
  US 20130023724A1
• Time in Patent Office: 1,485 Days
• Field of Search: 600/29, 600/30
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Systems and methods are provided and adapted to engage and pull (e.g., pull up) or reposition paraurethral support tissue, such as the perineal membrane. The perineal membrane intersects the urethra and vagina at the midurethra or distal location and can thus be stabilized or controlled in a manner that helps restore continence. As such, the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings.

Claims

1. A system for treating incontinence in a patient, comprising:

a first implant device having at least one non-mesh first medial anchor, a first distal anchor, and a first extension member operably connecting the at least one first medial anchor and the first distal anchor, the first medial anchor having an extendable transverse extension portion adapted to engage a portion of the perineal membrane to provide support for the urethra to restore continence; and

a second implant device separate and not physically connected, directly or indirectly, with the first implant device and having at least one non-mesh second medial anchor, a second distal anchor, and a second extension member operably connecting the second medial anchor and the second distal anchor, the second medial anchor having an extendable transverse extension portion adapted to engage a portion of the perineal membrane, separate from the portion of the perineal membrane, and at an opposing side of the urethra, engaged by the at least one first medial anchor, to assist in supporting the urethra to restore continence, and wherein the separated first and second implant devices together form a general V-shaped support configuration relative to the perineal membrane.

2. The system of claim 1, wherein the first extension member includes a suture.

3. The system of claim 1, wherein the first extension member is selected from a group consisting of:

a braided member, an elongated mesh, a flexible rod, a rigid rod and a length-adjustable member.

4. The system of claim 1, wherein the first distal anchor includes a first array of anchors, each of the first array of anchors having expandable barbs and being operably connected to the first extension member.

5. The system of claim 4, further including an introduction needle having a lumen extending therethrough, wherein at least the first array of anchors are adapted to traverse the lumen in a compressed state.

6. The system of claim 1, wherein the second distal anchor includes a second array of anchors, each of the second array of anchors having expandable barbs and being operably connected to the second extension member.

7. The system of claim 1, wherein the at least one first medial anchor includes one or more expandable fins adapted for engagement with the portion of the perineal membrane.

8. The system of claim 1, wherein at least the second medial anchor includes expandable fins adapted to engage the second medial anchor device to the portion of the perineal membrane separate from the portion of the perineal membrane engaged by the at least one first medial anchor.

9. The system of claim 1, wherein the portion of the perineal membrane engaged by the at least one first medial anchor is on a side of the urethra.

10. The system of claim 1, wherein the portion of the perineal membrane engaged by the at least one first medial anchor is generally above the urethra.

11. The system of claim 1, wherein the portion of the perineal membrane engaged by the at least one first medial anchor is generally below the urethra.

12. The system of claim 1, wherein the first distal anchor is adapted to engage a target tissue site selected from the group consisting of:

the obturator foramen, obturator internus, abdominal fascia, sacrospinous ligament, prepubic fascia, rectus fascia, the tendinous arch of the levator ani, the Cooper'"'"'s ligament, and the pubic symphysis cartilage.

13. The system of claim 1, wherein the at least one first medial anchor or the first distal anchor include an adhesive to assist in tissue engagement.

14. The system of claim 13, wherein the adhesive is a light-activated adhesive.

15. A system for treating incontinence in a patient, comprising:

a first implant device having a non-mesh first medial anchor and a first extension member, the first medial anchor having a pivotable radial extension portion adapted to affix to a portion of the perineal membrane of the patient on a first side of the urethra;

a second implant device separate and unconnected from, directly or indirectly, the first implant device and having a non-mesh second medial anchor and a second extension member, the second medial anchor having a pivotable radial extension portion adapted to affix to a portion of the perineal membrane of the patient on a second side of the urethra opposite the first side of the urethra, such that the separated first and second implant devices together form a general V-shaped support configuration relative to the perineal membrane; and

wherein tensioning adjustment on at least the first implant device provides support for the urethra to restore continence.

16. The system of claim 15, wherein tensioning adjustment on the first implant device and the second implant device provides support for the urethra to restore continence.

17. The system of claim 15, wherein at least one of the first extension member and the second extension member includes a suture.

18. The system of claim 15, wherein at least one of the first extension member and the second extension member includes an elongate mesh.

19. The system of claim 15, further including a first distal anchor device operably connected to the first medial anchor via the first extension member.

20. The system of claim 19, wherein the first distal anchor device includes a first array of anchors, each of the first array of anchors having expandable barbs and being operably connected to the first extension member.

21. The system of claim 20, further including an introduction needle having a lumen extending therethrough, wherein at least the first array of anchors are adapted to traverse the lumen in a compressed state.

22. The system of claim 19, wherein the first distal anchor is adapted to engage a target tissue site selected from the group consisting of:

the obturator foramen, abdominal fascia, rectus fascia, the tendinous arch of the levator ani, the Cooper'"'"'s ligament, and the pubic symphysis cartilage.

23. The system of claim 15, further including a second distal anchor device operably connected to the second medial anchor via the second extension member.

24. The system of claim 23, wherein the second distal anchor device includes a second array of anchors, each of the second array of anchors having expandable barbs and being operably connected to the second extension member.

25. The system of claim 15, wherein at least the first medial anchor device includes expandable fins adapted to affix the first medial anchor device to the portion of the perineal membrane.

26. The system of claim 15, further including an introduction needle having a lumen extending therethrough.

27. A system for treating incontinence in a patient, comprising:

a first implant device having a non-mesh first medial anchor device, a first distal anchor device, and a first extension member operably extending between the first medial anchor device and the first distal anchor device, the first medial anchor device having one or more member portions extendable out radially therefrom and adapted to affix to a portion of the perineal membrane of the patient on a first side of the urethra and the distal anchor device adapted to affix to tissue away from the perineal membrane;

a second implant device physically separate and unconnected, directly or indirectly, with the first implant device and having a non-mesh second medial anchor device, a second distal anchor device, and a second extension member operably extending between the second medial anchor device and the second distal anchor device, the second medial anchor device having one or more member portions extendable out radially therefrom and adapted to affix to a portion of the perineal membrane of the patient on a second side of the urethra, opposite the first side of the urethra, and the second distal anchor device adapted to affix to tissue away from the perineal membrane, such that the separated first and second implant devices together form a general V-shaped support configuration relative to the perineal membrane; and

wherein tensioning adjustment on the first and second implant devices provides support for the urethra to restore continence.

28. The system of claim 27, wherein at least one of the first extension member and the second extension member includes a suture.

29. The system of claim 27, wherein at least one of the first extension member and the second extension member includes an elongate mesh.

30. The system of claim 27, wherein the first distal anchor device includes a first array of anchors, each of the first array of anchors having expandable barbs and being operably connected to the first extension member.

31. The system of claim 30, further including an introduction needle having a lumen extending therethrough, wherein at least the first array of anchors are adapted to traverse the lumen in a compressed state.

32. The system of claim 27, wherein the second distal anchor device includes a second array of anchors, each of the second array of anchors having expandable barbs and being operably connected to the second extension member.

33. The system of claim 27, wherein at least the first medial anchor device includes expandable fins adapted to affix the first medial anchor device to the portion of the perineal membrane.

34. The system of claim 27, wherein at least one of the first distal anchor device and the second distal anchor device is adapted to engage a target tissue site selected from the group consisting of:

the obturator foramen, abdominal fascia, rectus fascia, the tendinous arch of the levator ani, the Cooper'"'"'s ligament, and the pubic symphysis cartilage.

35. The system of claim 27, wherein at least one of the first medial anchor device and the first distal anchor device includes an adhesive to assist in tissue engagement.

36. The system of claim 35, wherein the adhesive is a light-activated adhesive.