Surgical Articles and Methods for Treating Pelvic Conditions

• US 20090240104A1
• Filed: 05/18/2009
• Published: 09/24/2009
• Est. Priority Date: 10/26/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Solari, Michelle L., Dahdah, Mona N., Binkowski, Brent A., Jimenez, Jose' W., Otte, John F., Khamis, Chaouki A., Roll, Jessica L., Ogdahl, Jason W.
• Granted Patent: US 8,951,185 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 2017/0409 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 2017/044 with a threaded shaft, e.g. screws
• 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 2017/22038 with a guide wire
• 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

Abstract

An implant, insertion tool, 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. A threading guide is provided to assist in threading the guide through the aperture. An anchor also provided to with a retaining member to retain the anchor in tissue.

Claims

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

a threading guide being removably connectable to the needle tip to aid in threading the guide into the aperture, the threading guide having an axial passageway in registration with the aperture.

2. The tool of claim 1 wherein the aperture includes a bore having a diameter in the range from 0.1 to 2 millimeters.

3. The tool of claim 1 wherein the aperture comprises a bore extending through the needle tip in a direction that includes a component transverse to a longitudinal axis at the needle tip.

4. The tool of claim 1 wherein the aperture comprises a longitudinal bore extending from a needle tip end into the needle tip, and a channel extending from the bore further along a surface of the needle tip.

5. The tool of claim 1 wherein the threading guide further comprises a needle engagement portion for engaging the needle and a funneling portion for funneling the guide to the aperture in the needle tip.

6. The tool of claim 5 wherein the axial passageway tapers from the funneling portion toward the needle engagement portion.

7. The tool of claim 1 further comprising an axially extending slit extending through the threading guide for passing the guide during removal of the threading guide from the needle tip.

8. The tool of claim 1 further comprising a handle extending away from the threading guide for handling by a user.

9. The tool of claim 1 further comprising an attachment member attached to and extending away from the threading for attaching said threading guide to a portion of the tool.

10. The tool of claim 9, wherein the attachment member comprises a tether connected to the threading guide and a coupler connected to an end of the tether for coupling to a portion of the tool.

11. The tool of claim 10, wherein the coupler comprises a ring for threading over a portion of the needle.

12. The tool of claim 1 further comprising an anchor connected to the guide and removably connectable to the needle tip for insertion into tissue.

13. The tool of claim 12 wherein the anchor comprises an anchor tip for inserting into tissue and a retaining member for retaining the anchor in tissue.

14. The tool of claim 13 further comprising concentric ridges about the anchor tip to aid in resisting pullout of the anchor.

15. The tool of claim 13 wherein the retaining member comprises a lattice framework having a free end that flares away from a central axis of the anchor to aid in resisting pullout of the anchor.

16. A system to re-thread a guide and tool comprising:

an anchor for inserting into tissue;

a guide having a first end connected to a portion of the anchor and a free second end;

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

a threading guide being removably connectable to the needle tip to aid in threading the free end of the guide into the aperture, the threading guide having an axial passageway in registration with the aperture.

17. The system of claim 16 wherein the threading guide further comprises a needle engagement portion for engaging the needle and a funneling portion for funneling the guide to the aperture in the needle tip.

18. The tool of claim 17, wherein the axial passageway tapers from the funneling portion toward the needle engagement portion.

19. The tool of claim 16 further comprising an axially extending slit extending through the threading guide for passing the guide during removal of the threading guide from the needle tip.

20. A method of threading a guide onto a tool comprising the steps of:

providing a tool having 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;

connecting a threading guide having a needle engagement portion and a funneling portion to the needle tip of the needle wherein the aperture is in registration with an axially extending passageway through the threading guide;

guiding a guide having a free end extending away from an anchor disposed in tissue into the funnel portion which directs the free end of the guide into the aperture of the needle tip;

pulling the guide through the aperture; and

removing the threading guide from the needle tip and passing the guide through an axially extending slit of the threading guide, wherein the threading guide is removed and the needle tip can be re-connected to the anchor.