Surgical articles and methods for treating pelvic conditions

• US 8,388,514 B2
• Filed: 10/26/2007
• Issued: 03/05/2013
• Est. Priority Date: 10/26/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Ogdahl, Jason W., Jimenez, Jose W., Roll, Jessica L., Solari, Michelle L., Dahdah, Mona N., Khamls, Chaouki A., Otta, John F.
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US12/446,492
• Publication Number:
  US 20110034759A1
• Time in Patent Office: 1,957 Days
• Field of Search: 600/29, 600/30, 600/37, 128/885, 606/151, 606/222
• 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 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Described are devices, implants, insertion tools, combinations, and associated methods, that involve placement of a self-fixating tip at tissue of the pelvic region, wherein an insertion tool includes one or more of an aperture for engaging a guide and an extension guard, the method optionally allowing for initial placement of a self-fixating tip at tissue of the pelvic region and adjustment of the location of the self-fixating tip.

Claims

1. In combination, an insertion tool, an implant, and a guide:

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 that includes a needle tip, the needle tip comprises an aperture that allows guided relative movement of the needle tip along the guide, and

the implant comprising a support portion, an extension portion, and a self-fixating tip connected to the extension portion, wherein

the self-fixating tip engages the needle tip to allow the needle to push the self-fixating tip for surgical implantation,

the self-fixating tip comprises an aperture that allows passage of the guide, and

when the needle tip engages the self-fixating tip the guide can pass through the aperature of the needle tip and the self-fixating tip.

2. The combination according to claim 1 wherein the self-fixating tip comprises

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 aperture extending from the proximal base end through the base to the distal base end, and

a lateral extension extending from the base.

3. The combination according to claim 2 wherein the insertion tool includes an extension guard at the distal end that, when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the extension guard is located proximal to the lateral extension and reduces the force required to move the self-fixating tip in a proximal direction through muscle tissue.

4. The combination according to claim 3 wherein the extension guard is removable from the insertion tool.

5. The combination according to claim 1 wherein the implant is selected from the group consisting of:

a urinary incontinence sling,

two, four, or six-legged implant useful to treat vaginal prolapse, and

an implant useful for treating a condition of the pelvic floor.

6. A method of preparing an assembly for surgical treatment, the method comprising

providing a combination according to claim 1,

providing the guide engaged with the self-fixating tip,

engaging the self-fixating tip with the needle tip in a configuration that allows the needle to push the self-fixating tip, and

passing the guide through the aperture in the needle tip.

7. The combination according to claim 1 wherein the guide is engaged with the self-fixating tip in a manner selected from:

being fixed to the self-fixating tip,

being loosely threaded through the aperature in the self-fixating tip, and

being loosely threaded through the aperature in the self-fixating tip and the guide including an enlargement along a length of the guide that can engage the self-fixating tip to allow the guide to place traction on the self-fixating tip.

8. The combination according to claim 1 wherein the guide is selected from the group consisting of a thread, suture, plastic wire, and metal wire.

9. In combination, an insertion tool, an implant, and a guide:

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 that includes a needle tip, the needle tip comprises an aperture that allows guided relative movement of the needle tip along the guide, and

the implant comprising a support portion, an extension portion, and a self-fixating tip connected to the extension portion, wherein

the self-fixating tip engages the needle tip to allow the needle to push the self-fixating tip for surgical implantation, and

the self-fixating tip comprises

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 aperture extending from the proximal base end through the base to the distal base end, and

a lateral extension extending from the base.

10. The combination according to claim 9 wherein the insertion tool includes an extension guard at the distal end that, when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the extension guard is located proximal to the lateral extension and reduces the force required to move the self-fixating tip in a proximal direction through muscle tissue.

11. The combination according to claim 10 wherein the extension guard is removable from the insertion tool.

12. The combination according to claim 9 wherein the implant is selected from the group consisting of:

a urinary incontinence sling,

two, four, or six-legged implant useful to treat vaginal prolapse, and

an implant useful for treating a condition of the pelvic floor.

13. A method of preparing an assembly for surgical treatment, the method comprising

providing a combination according to claim 9,

providing a guide engaged with the self-fixating tip,

engaging the self-fixating tip with the needle tip in a configuration that allows the needle to push the self-fixating tip, and

passing the guide through the aperture in the needle tip.

14. The combination according to claim 9 wherein the guide is engaged with the self-fixating tip in a manner selected from:

being fixed to the self-fixating tip,

being loosely threaded through the aperature in the base, and

being loosely threaded through the aperature in the base and the guide including an enlargement along a length of the guide that can engage the self-fixating tip to allow the guide to place traction on the self-fixating tip.

15. The combination according to claim 9 wherein the guide is selected from the group consisting of a thread, suture, plastic wire, and metal wire.