Systems, devices, and methods for sub-urethral support

• US 20060229493A1
• Filed: 04/06/2006
• Published: 10/12/2006
• Est. Priority Date: 04/06/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Nowlin, Brett, Chu, Michael S.H., Weiser, Michael F., Mamo, George
• Granted Patent: US 8,016,741 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30617 : Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/005 : differing in colour
• CPC Class Codes: A61F 2250/0087 : colour-coded
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia

Abstract

Disclosed are single-incision surgical procedures for treatment of urinary incontinence and/or pelvic floor disorders and related uses, devices, kits, and methods. Implants are also disclosed for use in the exemplary procedures. In certain embodiments, soft tissue anchors are used to anchor the surgical implants to obturator membranes of a patient.

Claims

1. A surgical sling assembly for treating urinary incontinence in a patient, comprising

a surgical sling for supporting at least one of a urethra and a bladderneck of the patient, and

a sling housing disposed about a first end of the sling, wherein

the sling housing includes an aperture and tapers away from the end of the sling.

2. The assembly of claim 1, wherein the sling housing is flexible.

3. The assembly of claim 1, wherein the sling housing includes a ring for coupling to a delivery device, and at least two legs radially extending from the ring for anchoring to soft tissue.

4. The assembly of claim 3, wherein the legs adjoin at an angle and the legs can flex to vary the angle.

5. The assembly of claim 3, wherein the legs extend beyond a width of the sling.

6. The assembly of claim 3, wherein the ring is configured at an angle with respect to a plane extending through the legs and the ring can flex to vary the angle.

7. The assembly of claim 1 wherein the aperture lies in a plane extending through the sling.

8. The assembly of claim 1, wherein the aperture lies in a plane perpendicular to a plane extending through the sling.

9. The assembly of claim 1, wherein the sling is interdisposed between a top half of the sling housing and a bottom half of the sling housing.

10. The assembly of claim 9, wherein the top half of the sling housing includes a plurality of cavities, and the bottom half of the sling housing includes protrusions for interfitting with the plurality of cavities.

11. The assembly of claim 1, further comprising a second sling housing disposed about a contra-lateral end of the sling, wherein the first end and the contra-lateral end of the implant span a length between a first obturator foramen and a contra-lateral obturator foramen of the patient.

13. The assembly of claim 11, wherein the end termination is molded directly about an end of the implant.

12. A surgical sling assembly for treating urinary incontinence in a patient, comprising

a surgical sling for supporting at least one of a urethra and a bladderneck of the patient, and

an end termination formed directly about an end of the implant.

14. A method of manufacturing a surgical implant assembly for a patient'"'"'s suburethral space or pelvic floor, comprising

providing a mesh material,

coupling the mesh material to a mold,

injecting a curable material into the mold,

allowing the curable material to cure, and

removing the mesh material from the mold.

15. The method of claim 14, comprising injecting the material into a ring shaped cavity disposed within the mold.

16. A surgical implant for supporting a patient'"'"'s sub-urethral space or pelvic floor, comprising

a first set of strands, and

a second set of strands separate from the first set of strands, wherein

the first set of strands and the second set of strands are fixedly attached at a plurality attachment points.

17. The implant of claim 16, wherein the plurality of attachment points include intersection points of the first set of strands with the second set of strands.

18. The implant of claim 16, wherein the first set of strands are substantially perpendicular to the second set of strands.

19. The implant of claim 16, wherein the first set of strands are adhesively attached to the second set of strands.

20. The implant of claim 16, wherein the first set of strands are fused to the second set of strands.

21. The implant of claim 16, further comprising a third set of strands fixedly attached to at least one of the first set of strands and the second set of strands at a second plurality of attachment points.

22. The assembly of claim 16, wherein at least one of the first set of strands and the second set of strands comprise circular strands.

23. The assembly of claim 16, wherein the implant includes a central region for supporting an pelvic structure, and one or more extensions extending from the central region for securing to soft tissue regions.

24. The implant of claim 16, comprising a tanged portion of the sling wherein a plurality of strands of the first set of strands extend beyond a width spanned by the second set of strands.

25. A method for manufacturing an implantable surgical sling, comprising

extruding a first set of strands in a first direction,

extruding a second set of strands in a second direction different from the first direction, and

attaching the first set of strands and the second set of strands at attachment points.

26. The method of claim 25, wherein attaching the first set of strands and the second set of strands comprises fusing the first set of strands and the second set of strands at intersection points of the first set of strands and the second set of strands.

27. The method of claim 26, comprising

fusing the first set of strands and the second set of strands to form a tubular structure, and

cutting a lateral surface of the tubular structure to open the tubular structure.

28. The method of claim 25, further comprising forming a non-tanged portion of the sling by shortening one or more of the first set of strands to about a width spanned by the second set of strands.

29. The method of claim 28, wherein shortening includes cutting.

30. The method of claim 25, further comprising forming a tanged portion of the sling by

shortening one or more of the first set of strands to about a width spanned by the second set of strands, and

removing outermost ones of the second set of strands to expose ends of the shortened strands.

31. A method for treating urinary incontinence in a patient, comprising

providing an implant having at least one tanged portion formed as a unitary body with the implant,

creating an incision in the vaginal wall of the patient,

coupling an implant to a delivery device,

inserting the delivery device through the incision in the vaginal wall via the external vaginal opening of the patient,

guiding the device to a location beneath the patient'"'"'s epidermis, and

securing, by the at least one tanged portion, the implant to the patient'"'"'s soft tissue.

32. The method of claim 31, comprising securing a first tanged portion of the implant to a first obturator membrane and securing a second tanged portion of the implant to a second obturator membrane.

33. The method of claim 31, wherein providing at implant having at least one tanged portion includes providing an implant having at least one portion in which a plurality of transverse strands of the implant extend beyond a width of lateral strands of the implant.

34. The method of claim 31, wherein the transverse strands extend between about 2 mm and about 4 mm beyond the width of the lateral strands of the implant.

35. The method of claim 31, comprising directly engaging an extremity of the implant with the patient'"'"'s soft tissue for anchoring the implant to the patient'"'"'s soft tissue.