SURGICAL IMPLANTS, TOOLS, AND METHODS FOR TREATING PELVIC CONDITIONS

• US 20110112357A1
• Filed: 06/15/2007
• Published: 05/12/2011
• Est. Priority Date: 06/16/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Otte, John F., Ogdahl, Jason, Wolfe, Steven James, Kaleta, Richard, O'Hern, Jeffrey Michael, Montpetit, Karen Pilney, Chapman, Kelly Ann, Khamis, Chaouki A., Roll, Jessica L.
• Granted Patent: US 8,834,350 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• 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 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• 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 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• 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 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

Described are pelvic implants (e.g., urinary incontinence sling, hammock, etc.) that provide treatment for pelvic floor disorders such as incontinence, stress urinary incontinence, prolapse (e.g., cystocele, enterocele, rectocele, vault prolapse), fecal incontinence, and the like, wherein the implant involves the ability to adjust dimensions of an implant before, during, or after implantation. In a preferred embodiment the implant (680) comprises a support portion piece (682) and an extension portion piece (688, 690) adjustably connected to the support portion piece through a frictional adjusting element (696) comprising an aperture through which a segment of extension portion extends.

Claims

1. A multi-piece pelvic implant comprising a tissue support portion an extension portion, the implant comprising pieces that include:

a support portion piece comprising a tissue support portion and optional support portion piece arm, and

an extension portion piece,

wherein the extension portion piece is adjustably connected to the support portion piece, and the implant includes a frictional adjusting element that allows adjustment of a length of the extension portion, the frictional adjusting element comprising an aperture through which a segment of extension portion extends and a surface that frictionally engages the segment of extension portion, wherein the frictional engagement preferentially allows movement of the segment of extension portion through the aperture in one direction and inhibits movement of the segment of extension portion in an opposing direction.

2. The implant of claim 1 wherein the frictional adjusting element comprises a grommet.

12. An implant of claim 1 wherein a frictional adjusting element is secured to the implant at a location selected from a tissue support portion of a support portion piece, a support portion piece arm, and an extension portion piece.

13. An implant of claim 12 wherein a frictional adjusting element is secured to a proximal end of an extension portion piece.

14. An implant of claim 1 wherein the support portion piece comprises

a tissue support portion,

at least two support portion piece arms extending from the tissue support portion, and

frictional adjusting elements secured to the support portion piece arms.

15. An implant of claim 1 wherein

the frictional adjusting element is secured to a proximal end of the extension portion piece,

a tissue fastener is attached at a distal end of the extension portion piece, and

the support portion piece comprises an elongate support portion piece arm extending through the frictional adjusting element aperture.

16. An implant of claim 15 wherein the support portion piece arm comprises folds held together by sutures, wherein the sutures can be removed to increase the length of the support portion piece arm.

17. An implant of claim 1 wherein the support portion piece comprises multiple layers of material, the layers comprising a layer of synthetic material and a layer of biologic material.

18. An implant according to claim 17 wherein the layer of synthetic material has an area smaller than an area of the layer of biologic material, and the layer of synthetic material extends across a width of the tissue support portion between opposing extension portions.

21. An implant according to claim 1 comprising a support portion and exactly two extension portions.

22. An implant according to claim 1 comprising a support portion and four extension portions including two superior extension portions of fixed length and two inferior extension portions of adjustable length.

3. A multi-piece pelvic implant comprising a tissue support portion and an extension portion, the implant comprising pieces that include:

a support portion piece comprising a tissue support portion and optional support portion piece arm, and

an extension portion piece,

the extension portion piece is adjustably connected to the support portion piece by a frictional adjusting element that allows adjustment of a length of the extension portion, the frictional adjusting element comprising;

an aperture through which a segment of extension portion extends, and

a surface that frictionally engages the segment of extension portion,

wherein the frictional adjusting element can exhibit two configurations, a first configuration that allows two-way movement of the segment of extension portion through the aperture, and a second configuration wherein the surface frictionally engages the segment of extension portion and prevents movement of the segment of extension portion through the aperture in at least one direction.

4. The implant of claim 3 wherein the frictional adjusting element comprises a moveable guard that can be positioned to either prevent or allow contact between the surface and the segment of extension portion.

5. The implant of claim 3 wherein the surface comprises multiple teeth and the guard comprises complementary nesting teeth.

6. The implant of claim 3 wherein the surface comprises multiple teeth and the guard comprises a flat surface that covers the teeth.

7. The implant of claim 3 wherein the guard comprises plastic film.

8. A multi-piece pelvic implant comprising a tissue support portion and an extension portion, the implant comprising pieces that include:

a support portion piece comprising a tissue support portion and optional support portion piece arm, and

an extension portion piece,

wherein the extension portion piece is adjustably connected to the support portion piece by an elongate segment of extension portion of one of the two pieces passing through an opening of the other of the two pieces, and

a frictional adjusting element is located on the elongate segment of extension portion to allow adjustment of a length of the extension portion, the frictional adjusting element comprising an aperture through which the elongate segment of extension portion extends and a surface that frictionally engages the segment of extension portion, wherein the frictional engagement preferentially allows movement of the segment of extension portion through the aperture in one direction and inhibits movement of the segment of extension portion in an opposing direction.

9. The implant of claim 8 wherein the opening is in the support portion piece, a proximal end of the extension portion piece extends through the opening, and the frictional adjusting element is located at the extension portion piece between a proximal end of the extension portion piece and the opening of the support portion piece.

10. An implant of claim 8 wherein the frictional adjusting element comprises a polymeric body that defines the aperture and one or more teeth that frictionally engage the segment of extension portion.

11. An implant of claim 8 comprising a tissue fastener attached at a distal end of the extension portion piece, the tissue fastener selected from the group consisting of:

a self-fixating tip, a tissue clamp, a biologic adhesive, and a set of opposing male and female engaging elements.

19-20. -20. (canceled)

23-43. -43. (canceled)