Implants, tools, and methods for treatments of pelvic conditions

• US 9,351,723 B2
• Filed: 06/29/2012
• Issued: 05/31/2016
• Est. Priority Date: 06/30/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Alexander, James A., Khamis, Chaouki A., Huelman, Justin H., Tremulis, William S., Viker, Thomas O.
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US13/537,612
• Publication Number:
  US 20130006275A1
• Time in Patent Office: 1,432 Days
• Field of Search: 606/139, 606144-146
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor

Abstract

Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful 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.

Claims

1. A suturing instrument comprising:

a handle comprising an actuation member;

a connecting rod extending distally from a proximal end of the handle, wherein the connecting rod comprises a pivot point adjacent to its distal end;

a needle operatively attached to the suturing instrument only at the pivot point of the connecting rod, wherein the needle is independently rotatable about the pivot point relative to a longitudinal axis of the connecting rod;

a slider rod extending distally from the proximal end of the handle, the slider rod being adjacent to the connecting rod and comprising a longitudinal axis, wherein the longitudinal axis of the connecting rod is spaced from the longitudinal axis of the slider rod, and wherein the slider rod and the connecting rod are linearly positionable relative to each other along their respective longitudinal axes;

a base member extending from a distal end of the slider rod; and

at least two arms extending from a distal end of the base member of the slider rod, wherein each of the arms comprises an aperture,

wherein a distance between the pivot point of the needle and the base member of the slider rod is changeable during movement of the slider rod and the connecting rod relative to each other.

2. The suturing instrument of claim 1, wherein the actuation member is a sliding member positionable within a groove of the handle.

3. The suturing instrument of claim 1, wherein the needle comprises a curved shaft member and a flared end portion extending from the curved shaft member.

4. The suturing instrument of claim 1, wherein the at least two arms are spaced from each other to provide a gap between their inner surfaces.

5. The suturing instrument of claim 4, wherein the needle comprises a suture engagement member adjacent to its distal tip, and wherein the needle is rotatable so that its suture engagement member is positioned between the at least two arms of the base member of the slider rod.

6. The suturing instrument of claim 1, further comprising a needle base member extending from the distal end of the connecting rod, wherein the needle is rotatably attached to the needle base member.

7. The suturing instrument of claim 1, wherein the longitudinal axis of the connecting rod is generally parallel to the longitudinal axis of the slider rod.

8. A method of suturing tissue comprising the steps of:

preparing a suturing instrument for a suturing process, wherein the suturing instrument comprises;

a handle comprising an actuation member;

a connecting rod extending distally from a proximal end of the handle, wherein the connecting rod comprises a pivot point adjacent to its distal end;

a needle operatively attached to the suturing instrument only at the pivot point of the connecting rod, wherein the needle is independently rotatable about the pivot point relative to a longitudinal axis of the connecting rod;

a slider rod extending distally from the proximal end of the handle, the slider rod being adjacent to the connecting rod and comprising a longitudinal axis, wherein the longitudinal axis of the connecting rod is spaced from the longitudinal axis of the slider rod, and wherein the slider rod and the connecting rod are linearly slideable relative to each other along their respective longitudinal axes;

a base member extending from a distal end of the slider rod; and

at least two arms extending from a distal end of the base member of the slider rod, wherein each of the arms comprises an aperture;

wherein a distance between the pivot point of the needle and the base member of the slider rod is changeable during movement of the slider rod and the connecting rod relative to each other;

loading a suture material through the apertures of the at least two arms of the slider rod;

engaging the needle with a target tissue to penetrate the tissue in two spaced locations with the pivot point of the needle in a first longitudinal position relative to the base member of the slider rod;

engaging the needle with the suture material adjacent to the apertures of the at least two arms;

pulling the suture material through the two spaced locations in the tissue with the needle, wherein the pivot point of the needle is in a second longitudinal position that is proximal to the first longitudinal position relative to the base member of the slider rod.

9. The method of claim 8, wherein the suturing instrument further comprises a gap between the at least two arms such that when the suture material is loaded through the apertures of the at least two arms, the suture material extends across the gap.

10. The method of claim 9, wherein the step of engaging the needle with the suture material further comprises engaging an engagement portion of the needle with a suture material extending across the gap.

11. The method of claim 8, wherein the needle comprises a curved shaft.

12. The method of claim 8, wherein the actuation member comprises a slider operatively connected to the connecting rod, wherein the suturing instrument comprises a first configuration in which the slider is in an actuation position and a second configuration in which the slider is in a resting position.

13. The method of claim 12, wherein movement of the slider from the first configuration to the second configuration comprises movement of the slider in a generally parallel direction to the longitudinal axis of the connecting rod.

14. The method of claim 8, wherein the needle comprises a suture engagement member adjacent to its distal tip, and wherein the needle is rotatable so that its suture engagement member is positioned between the at least two arms of the base member of the slider rod.