Patterned sling implant and method

• US 9,848,970 B2
• Filed: 06/22/2015
• Issued: 12/26/2017
• Est. Priority Date: 11/23/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Mujwid, James R., Roll, Jessica L., Jagger, Karl A., Grant, Robert C.
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US14/746,694
• Publication Number:
  US 20150282917A1
• Time in Patent Office: 918 Days
• Field of Search: 600 30, 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 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Embodiments of elongate pelvic implants and methods for treating pelvic conditions, such as incontinence, are provided. The implants can include a tissue support portion, one or more extension portions and one or more anchors. The implant is constructed as a unitary sling implant. The implant can be constructed or formed in a generally elongate shape to provide a lattice support structure of repeated cells.

Claims

1. A unitary patterned implant for treating incontinence in a patient, comprising:

a non-woven unitary elongate sling having;

a support portion including a plurality of strut members defining a plurality of support voids;

first and second extension portions;

at least one tissue anchor provided at a distal portion of one of the first and second extension portions and adapted for fixation to soft tissue of the patient; and

a transition strength zone including a plurality of members integrally formed with the at least one tissue anchor and extending between the at least one tissue anchor and an end of one of the first and second extension portions to define a plurality of transition voids larger than the plurality of support voids, to facilitate stress or tension distribution between the at least one tissue anchor and one of the first and second extension portions.

2. The implant of claim 1, wherein the at least one tissue anchor extends out generally transverse from a plane defined by the support portion.

3. The implant of claim 1, wherein the at least one tissue anchor extends out generally in plane with the support portion.

4. The implant of claim 1, wherein the at least one tissue anchor is substantially equal in thickness to at least one of the first and second extension portions.

5. The implant of claim 1, wherein the at least one tissue anchor includes two opposing end anchors.

6. The implant of claim 1, wherein the at least one tissue anchor includes one or more extending tines.

7. The implant of claim 1, wherein the plurality of strut members are sinusoidal shaped to define a plurality of pinwheel cell configurations.

8. The implant of claim 1, wherein the at least one tissue anchor includes a body lumen adapted to receive a distal end of a needle tool.

9. The implant of claim 1, wherein the plurality of strut members includes one or more edge retention features extending to provide tissue engagement.

10. The implant of claim 1, wherein the support portion is generally wider than the first and second extension portions.

11. A unitary patterned implant system for treating incontinence in a patient, comprising:

a non-woven unitary elongate sling including;

a support portion having a plurality of undulating strut members defining a plurality of strut voids;

first and second extension portions;

a first end anchor extending out from the first extension portion;

a second end anchor extending out from the second extension portion;

a first transition strength zone including a plurality of elongate members and integrally formed with the first end anchor and the first extension portion to define a plurality of first elongate voids larger than the plurality of strut voids between the first end anchor and an end of the first extension portion;

a second transition strength zone including a plurality of elongate members and integrally formed with the second end anchor and the second extension portion to define a plurality of second elongate voids larger than the plurality of strut voids between the second end anchor and an end of the second extension portion; and

an introducer needle tool having a handle portion and a needle, wherein the needle includes a distal tip adapted to selectively engage with at least one of the first or second end anchors.

12. The system of claim 11, wherein at least the plurality of elongate members of the first transition strength zone are generally arcuate.

13. The system of claim 11, wherein the first and second end anchors are substantially equal in thickness to the first and second extension portions.

14. The system of claim 11, wherein the plurality of undulating strut members are sinusoidal shaped to define a plurality of pinwheel cell configurations.

15. The system of claim 11, wherein at least one of the first and second end anchors includes a body lumen adapted to receive the distal tip of the introducer needle tool.

16. The system of claim 11, wherein the plurality of undulating strut members include one or more edge retention features extending to provide tissue engagement.

17. The system of claim 11, wherein the support portion is generally wider than the first and second extension portions.

18. The system of claim 11, wherein the support portion is generally narrower than the first and second extension portions.

19. The system of claim 11, wherein the introducer needle tool includes an actuation mechanism in operable communication with the distal tip to facilitate selective disengagement of the first or second end anchors.

20. The system of claim 11, wherein the needle of the introducer needle tool is generally curved.