PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS

• US 20100274074A1
• Filed: 09/19/2008
• Published: 10/28/2010
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Kupiecki, David J., Wignall, Shawn Michael, O'Hern, Jeffrey M., Khamis, Chaouki A.
• Granted Patent: US 8,708,885 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 17/3468 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
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• 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

Abstract

Described are implants, tools, and methods useful for treating pelvic conditions such as prolapse, by placing an implant to support pelvic tissue, the implants, tools, and methods involving one or more of an insertion tool that works in coordination with a sheath, adjusting engagements, specific implants and pieces of implants, placement of implants at locations within the pelvic region, and insertion, adjusting, and grommet management tools.

Claims

1. A surgical insertion tool useful for implanting a pelvic implant, the tool comprising

a handle,

a shaft comprising a proximal shaft end attached to the handle, and a distal shaft end,

a sheath that engages the shaft and allows at least two configurations:

a covered configuration in which the sheath covers the distal shaft end, and an uncovered configuration in which the sheath covers a portion of the shaft and does not cover the distal shaft end,

wherein;

in the covered configuration the sheath covers the distal shaft end and the proximal shaft end, and in the uncovered configuration the sheath covers the proximal shaft end and not the distal shaft end.

3. The tool of claim 1 wherein the sheath is a hollow polymeric tube.

4. A tool according to claim 1 wherein

the sheath is a hollow polymeric tube,

the sheath can slide over the distal shaft end to place the sheath in the covered configuration,

the sheath engages a mechanical stop when in the covered configuration,

the mechanical stop can be removed and the sheath can be placed in the uncovered configuration.

5. A tool according to claim 4 wherein the mechanical stop comprises a moveable extension that can be moved to engage or disengage the sheath by an actuator located on the handle.

6. A tool according to claim 4 wherein

the hollow tube sheath comprises a proximal tube end and a distal tube end,

the handle comprises a recess at a connection of the handle to the shaft proximal end, the recess being capable of accepting the proximal end of the hollow tube sheath,

the hollow tube sheath moves from the covered configuration to the uncovered configuration by the proximal tube end moving in a direction toward the recess.

7. A tool according to claim 5 wherein

the hollow tube sheath comprises an aperture in a sidewall at the proximal tube end,

in the covered configuration, the extension is located within the aperture and inhibits movement of the hollow tube sheath in a proximal direction and in a distal direction along the shaft,

the extension can be removed from the aperture to allow the hollow tube to be placed in the uncovered configuration.

8. A tool according to claim 1 wherein, in the uncovered configuration, a length of from 0.5 to 1.5 centimeters of the distal end of the shaft is uncovered.

9. In combination, a tool as recited in claim 1, in combination with an extension portion of an implant, wherein

the extension portion comprises a tissue fastener at a distal end,

the tissue fastener is capable of engaging a distal end of the shaft.

10. The combination of claim 9 wherein the extension portion is an extension portion piece, the combination further comprising a support portion piece.

11. A combination as recited in claim 9, wherein

when the tissue fastener engages the distal end of the shaft, the sheath can fit over the shaft,

the sheath can be moved between the covered configuration and the uncovered configuration, and

the sheath covers the self-fixating tip when the sheath is in the covered configuration and the sheath does not cover the self-fixating tip when the sheath is in the uncovered configuration.

12. A combination as recited in claim 9, wherein the implant comprises

a tissue support portion, and

a set of two superior extension portions extending from the tissue support portion, and a set of two inferior extension portions extending from the tissue support portion, wherein, when the tissue support portion is placed to support tissue of a vagina, each superior extension portion can be connected to tissue of an opposing obturator foramen, and each inferior extension portion can be connected to sacrospinous ligament.

13. A combination as recited in claim 9, comprising one or more of a grommet management tool and an adjusting tool.

14. A combination as recited in claim 9, wherein

the tool is adapted to engage a tissue fastener and to place the tissue fastener transvaginally at a sacrospinous ligament,

the combination further comprising a second insertion tool adapted to place a tissue fastener transvaginally at an obturator foramen.

15. A method of implanting an implant in a patient, the method comprising

providing a combination of tool as recited in claim 1, and an implant, the implant comprising an extension portion comprising a tissue fastener at a distal shaft end,

engaging the tissue fastener with the distal shaft end,

placing the sheath over the shaft and engaged tissue fastener with the sheath in a covered configuration that covers the distal shaft end and engaged tissue fastener,

inserting the shaft and engaged tissue fastener into a patient, with the sheath placed over the shaft in the covered configuration,

moving the sheath to an uncovered configuration that uncovers the tissue fastener, and

fastening the tissue fastener to tissue.

16. The method of claim 15 comprising inserting the tissue fastener into soft tissue selected from sacrospinous ligament and coccygeus muscle.

17. The method of claim 16 wherein the implant comprises

a tissue support portion, and

a set of two superior extension portions extending from the tissue support portion, and a set of two inferior extension portions extending from the tissue support portion,

the method comprising placing the tissue support portion to support tissue of a vagina,

fixing each superior extension portion to tissue of an opposing obturator foramen,

fixing each inferior extension portion to soft tissue of sacrospinous ligament or coccygeus muscle.

18. The combination of claim 10 wherein the extension portion piece comprises a mesh portion and a non-mesh portion.

19. The combination of claim 18 wherein the extension portion piece comprises a tissue fastener at an end of the mesh portion.

20. The combination of claim 18 wherein the support portion piece comprises an adjusting engagement for adjustably engaging the extension portion piece.

21. The combination of claim 20 wherein the support portion piece further comprises two additional tissue fasteners.

2. (canceled)