Surgical implants, tools, and methods for treating pelvic conditions

• US 8,834,350 B2
• Filed: 06/15/2007
• Issued: 09/16/2014
• 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: Chapman, Kelly Ann, Kaleta, Richard, Khamis, Chaouki A., Montpetit, Karen Pilney, Ogdahl, Jason, O'Hern, Jeffrey Michael, Otte, John F., Roll, Jessica L., Wolfe, Steven James
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/308,436
• Publication Number:
  US 20110112357A1
• Time in Patent Office: 2,650 Days
• Field of Search: 600/37, 600/29
• 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, a first extension portion, and a second extension portion, the implant comprising pieces that include:

a support portion piece comprising the tissue support portion,

the first extension portion comprising a first extension portion piece, and

the second extension portion comprising a second extension portion piece,

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

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

wherein the first frictional adjusting element comprises a grommet and the second frictional adjusting element comprises a grommet.

2. The implant of claim 1 wherein the first frictional adjusting element is secured to the implant at a location selected from the tissue support portion of the support portion piece, a support portion piece arm, and the first extension portion piece, and wherein the second frictional adjusting element is secured to the implant at a location selected from the tissue support portion of the support portion piece, a support portion piece arm, and the second extension portion piece.

3. The implant of claim 2 wherein the first and second frictional adjusting elements are secured to a proximal end of the first and second extension portion pieces.

4. The implant of claim 1 wherein the support portion piece comprises

the tissue support portion,

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

the first and the second frictional adjusting elements secured to the support portion piece arms.

5. The implant of claim 1 wherein

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

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

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

6. The implant according to claim 1 comprising the tissue support portion and four extension portions including two superior extension portions of fixed length and two inferior extension portions of adjustable length.

7. The implant of claim 1, wherein the grommet of the first frictional adjusting element is located at the first extension portion piece, and the grommet of the second frictional adjusting element is located at the second extension portion piece.

8. The implant of claim 1, wherein the grommet of the first frictional adjusting element is secured to the support portion piece, and the grommet of the second frictional adjusting element is secured to the support portion piece.

9. In combination, the pelvic implant according to claim 1 and an adjusting tool, the adjusting tool comprising an elongate shaft and a distal end, the distal end being capable of engaging the grommet of the first frictional adjusting element to move the grommet of the first adjusting element along a length of the segment of the first extension portion.