Surgical Articles and Methods for Treating Pelvic Conditions

• US 20100256442A1
• Filed: 02/16/2007
• Published: 10/07/2010
• Est. Priority Date: 02/16/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Kaleta, Richard C., Wold, Jelica D., Otte, John F., Montpetit, Karen Pilney, Chapman, Kelly Ann, Khamis, Chaouki A., Roll, Jessica L., Ogdahl, Jason W., Dahdah, Mona N., Lund, Robert E.
• Granted Patent: US 9,144,426 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• 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 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A pelvic implant assembly (100) comprising a support portion (128) and an extension portion (124), a self-fixating tip (10, 120) connected to the extension portion, the self-fixating tip comprising a base (12) comprising a proximal base end (14) and a distal base end (16), the proximal base end being connected to the extension portion, the base comprising an internal channel (18) extending from the proximal base end and at least partially along a length of the base toward the distal base end, a fixed lateral extension (20) extending from the base.

Claims

1. A pelvic implant assembly comprising

a support portion and an extension portion,

a self-fixating tip connected to the extension portion, the self-fixating tip comprising

a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion,

the base comprising an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end,

a fixed lateral extension extending from the base.

2. The implant of claim 1, wherein

the lateral extension comprises a lateral extension body comprising boundaries that include a leading edge, a trailing edge, and a length at which the lateral extension meets the base, wherein the trailing edge has a thickness greater than the leading edge.

3. The implant of claim 1 wherein the self-fixating tip has a length measured from the proximal base end to the distal base end, in the range from 0.4 to 1.0 centimeter.

4. The implant of claim 1 wherein the self-fixating tip includes two or more lateral extensions, all lateral extensions extending in a different direction from locations that are at the same length-wise position of the base.

6. The implant of claim 1 wherein the lateral extension comprises a fixed leading edge that extends away from the base and proximally to meet a trailing edge at a pointed lateral extension tip.

8. The implant of claim 1 wherein the lateral extension comprises a trailing edge that includes a portion having a thickness in the range from 0.2 to 1.5 millimeters.

37. The implant of claim 1, wherein the implant is a urethral sling comprising a mesh strip and two self-fixating tips, one self-fixating tip at each end of the mesh strip.

38. The implant of claim 37 wherein the sling has a length in the range from 6 to 10 centimeters.

39. The implant of claim 1 for treating posterior vaginal prolapse, wherein

the implant comprises a tissue support portion, two posterior extension portions, and a self-fixating tip at a distal end of each posterior extension portion, and

with the tissue support portion placed at posterior vaginal tissue, the self-fixating tips can be placed at tissue of the sacrospinous ligament.

40. An implant according to claim 1 for treating anterior vaginal prolapse, wherein

the implant comprises

a tissue support portion,

two anterior extension portions, with two anterior self-fixating tips, one anterior self-fixating tip at a distal end of each anterior extension portion, and

two posterior extension portions, with two posterior self-fixating tips, one posterior self-fixating tip at a distal end of each posterior extension portion,

with the tissue support portion placed at vaginal tissue, each anterior self-fixating tip can be placed at an obturator foramen, and each posterior self-fixating tip can be placed at tissue of the sacrospinous ligament.

5. (canceled)

7. (canceled)

9-11. -11. (canceled)

12. In combination, the implant of claim 1 and an insertion tool, the insertion tool comprising a handle and a needle extending from the handle, the needle comprising a proximal end attached to the handle and a distal end, the distal end comprising a tip that engages the self-fixating tip. 13-14. (canceled)

15. A method of treating a pelvic condition, the method comprising

providing an implant comprising

a support portion and an extension portion,

a self-fixating tip connected to the extension portion, the self-fixating tip comprising

a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion,

the base comprising an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end,

a fixed lateral extension extending from the base,

providing an insertion tool comprising a handle and a needle extending from the handle, the needle comprising a proximal end attached to the handle and a distal end, the distal end comprising a needle distal end that removably engages a self-fixating tip,

engaging the needle distal end with the self-fixating tip,

inserting the needle distal end and self-fixating tip through a perineal or vaginal incision in a patient, and

inserting the self-fixating tip into tissue in the pelvic region.

16. The method of claim 15 wherein the pelvic condition is selected from the group consisting of:

urinary incontinence, fecal incontinence, enterocele, cystocele, rectocele, and vaginal vault prolapse.

18. The method of claim 15 wherein

the pelvic condition is selected from the group consisting of female urinary incontinence, male urinary incontinence, and anterior vaginal prolapse, and

the tissue is obturator internus muscle.

17. (canceled)

19-20. -20. (canceled)

21. A method of treating a pelvic condition in a patient, the method comprising:

creating a single incision through the vagina or perineal floor;

dissecting tissue near a tissue to be supported;

providing a pelvic implant comprising

a support portion and an extension portion,

a self-fixating tip connected to the extension portion, the self-fixating tip comprising

a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion,

the base comprising an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end, and

a fixed lateral extension extending from the base,

passing the pelvic implant through the incision,

implanting the self-fixating tip at tissue of the pelvic region.

22. The method of claim 21 comprising:

creating a single incision through the vagina or perineal floor;

dissecting tissue beneath a tissue to be supported;

implanting a self-fixating tip at the obturator foramen on one side of the patient;

implanting a second self-fixating tip at the obturator foramen on a second side of the patient, whereby the implant is suspended between the two obturator foramen;

positioning a portion of the implant below the urethra to support the urethra.

23. The method of claim 21 comprising adjusting the implant to provide the desired position and amount of support for the urethra by selecting one or more of the point of insertion of the self-fixating tip within the obturator foramen, and the depth of insertion of a tip within the obturator foramen.

24. The method of claim 21 comprising positioning the first and second tips in the obturator internus muscle without puncturing the obturator membrane.

25. The method of claim 21 wherein implanting a self-fixating tip into an obturator foramen comprises engaging the self-fixating tip with an end of an insertion tool and pushing the self-fixating tip into tissue of the obturator foramen.

27. The method of claim 21 comprising treating a condition selected from the group consisting of incontinence, enterocele, cystocele, rectocele, and vaginal vault prolapse, in a female;

and incontinence in a male.

29. The method of claim 21 comprising implanting a self-fixating tip in fibrous tissue selected from the group consisting of:

the uterosacral ligament, the coccygeous muscle, the sacrospinous ligament, the iliococcygeous muscle, the obturator internus muscle, and the obturator externus muscle.

26. (canceled)

28. (canceled)

30-36. -36. (canceled)