Tools and methods for treatment of pelvic conditions

• US 9,492,191 B2
• Filed: 08/03/2012
• Issued: 11/15/2016
• Est. Priority Date: 08/04/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Fischer, Brian G., Jagger, Karl A., Ogdahl, Jason W., O'Hern, Jeffrey M., Otte, John F., Roll, Jessica L., VanDeWeghe, Andrew P., Huelman, Justin H., Khamis, Chaouki A.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/566,613
• Publication Number:
  US 20130035543A1
• Time in Patent Office: 1,565 Days
• Field of Search: 600/29, 600/30, 600/37, 606/151, 606/157
• US Class Current: 1/1
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Surgical procedures, systems, implants, devices, tools, and methods that are used for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to tissue, adjusting the length of implant components, and cutting the implant to a desired length.

Claims

1. An adjustment tool for adjusting a length of an elongate portion of a pelvic implant, the tool comprising:

a proximal end;

a distal end;

an elongate shaft extending between the proximal and distal ends along a first longitudinal axis; and

a cylindrical member at the distal end that is engageable with the elongate portion of the implant for manipulation of the elongate portion, wherein the cylindrical member comprises;

a distal end surface at the distal end of the tool and facing in a distal direction, a proximal end surface at a proximal end of the cylindrical member and spaced from the distal end surface along a length of the cylindrical member, and an aperture extending through the length of the cylindrical member, wherein the proximal end surface faces in a proximal direction that is generally opposite the distal direction that the distal end surface faces; and

a second longitudinal axis extending along the length of the cylindrical member, wherein the second longitudinal axis is generally parallel to the first longitudinal axis and offset along the second longitudinal axis length by a fixed distance from the first longitudinal axis of the elongate shaft;

wherein the cylindrical member further comprises a gasket positioned within the aperture; and

wherein the cylindrical member further comprises a locking eyelet system within the aperture and adjacent to the gasket.

2. The adjustment tool of claim 1, wherein the elongate portion of the implant comprises an elongate mesh or rod of an extension portion piece of an adjustable multi-piece implant.

3. The adjustment tool of claim 1, wherein the locking eyelet system comprises multiple prongs that are radially moveable relative to the aperture.

4. The adjustment tool of claim 1, wherein the cylindrical member comprises a slot extending along the length of the cylindrical member, wherein the slot extends between an outer surface of the cylinder and the aperture.

5. The adjustment tool of claim 1, in combination with a multi-piece pelvic implant that comprises an extension portion piece and a support portion piece.

6. The adjustment tool of claim 5, wherein the multi-piece implant comprises an adjusting engagement between an extension portion piece and a support portion piece, and wherein the extension portion piece comprises an anchor at a distal end of the extension portion piece, the anchor comprising one of a helical anchor and a self-fixating tip.

7. The adjustment tool of claim 1, wherein the elongate shaft comprises a curved portion at the distal end of the elongate shaft, wherein the curved portion comprises a distal end that extends directly from an outer curved surface of the cylindrical member.

8. A surgical tool for adjusting and cutting a length of an elongate portion of a pelvic implant, the tool comprising:

a top surface;

a bottom surface opposite the top surface;

a proximal end;

a distal end engageable with the elongate portion to allow manipulation and cutting of the elongate portion, wherein the distal end comprises;

an aperture extending from the top surface to the bottom surface and comprising an aperture axis extending through the aperture in a generally perpendicular direction relative to the top and bottom surfaces;

a recess extending around at least a portion of the aperture; and

a moveable cutting mechanism having a cutting surface facing toward the proximal end of the tool, wherein the cutting mechanism is at least partially positionable within the recess and moveable from the recess and across a width of the aperture, wherein the recess is sized to enclose at least a portion of the cutting mechanism; and

an elongate shaft extending between the proximal and distal ends; and

an actuation mechanism comprising at least one wire comprising a proximal wire end positioned generally at the proximal end of the tool that is operatively attached at a distal wire end to the cutting mechanism for moving the cutting mechanism in a proximal direction across a width of the aperture;

wherein the cutting mechanism is a semi-circular cutting blade comprising at least one cutting surface.

9. The surgical tool of claim 8, in combination with a multi-piece pelvic implant.

10. The surgical tool of claim 9, wherein the multi-piece implant comprises an adjusting engagement between an extension portion piece and a support portion piece, and wherein the extension portion piece comprises an anchor at a distal end of the extension portion piece, the anchor comprising one of a helical anchor and a self-fixating tip.

11. The surgical tool of claim 8, wherein the actuation mechanism comprises one of a spring and a threaded structure.

12. The surgical tool of claim 8, wherein the cutting mechanism comprises at least two cutting blades that are moveable relative to each other and that are moveable across at least a portion of the width of the aperture.

13. A method of treating vaginal prolapse, the method comprising the steps of:

providing a multi-piece implant comprising an extension portion piece and a support portion piece, wherein the support portion piece comprises a mesh portion from which an anchor extends at a first end and from which a rod extends at a second end, and wherein the extension portion piece comprises an anchor at first end and a grommet at a second end,

placing the support portion piece to contact vaginal tissue,

placing the extension portion piece to contact tissue of a component of sacral anatomy,

engaging the support portion piece and the extension portion piece at an adjusting engagement by passing the rod through the grommet,

providing an adjusting and cutting tool comprising;

a proximal end;

a distal end engageable with the extension portion piece to allow manipulation and cutting of the extension portion piece, wherein the distal end of the tool comprises an aperture, a recess extending around at least a portion of the aperture, and

a moveable cutting mechanism having a cutting surface facing toward the proximal end of the tool, wherein the cutting mechanism is at least partially positionable within the recess and moveable from the recess and across a width of the aperture, wherein the recess is sized to enclose at least a portion of the cutting mechanism;

wherein the cutting mechanism is a semi-circular cutting blade comprising at least one cutting surface,

an elongate shaft extending between the proximal and distal ends of the tool; and

an actuation mechanism comprising at least one wire comprising a proximal wire end positioned generally at the proximal end of the tool that is operatively attached at a distal wire end to the cutting mechanism for moving the cutting mechanism in a proximal direction across a width of the aperture;

using the adjusting and cutting tool to adjust a location of the extension portion piece relative to the support portion piece, and

using the adjusting and cutting tool to cut the extension portion piece.

14. The method of claim 13, wherein the cutting mechanism is a cutting blade comprising at least one cutting surface.