Surgical implants, tools, and methods for treating pelvic conditions

• US 10,271,936 B2
• Filed: 08/18/2014
• Issued: 04/30/2019
• Est. Priority Date: 06/16/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Chapman, Kelly Ann, Kaleta, Richard C., Khamis, Chaouki A., Montpetit, Karen Pilney, Ogdahl, Jason W., O'Hern, Jeffrey M., Otte, John F., Roll, Jessica L., Wolfe, Steven J.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/462,140
• Publication Number:
  US 20140357941A1
• Time in Patent Office: 1,716 Days
• Field of Search: 600 29, 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

Described are pelvic implants (e.g., urinary incontinence sling, hammock, etc.) and method of implanting a pelvic implant that provide treatment for pelvic floor disorders such as incontinence, stress urinary incontinence, prolapse (e.g., cystocele, enterocele, rectocele, vault prolapse), fecal incontinence, and the like, wherein the implant and methods involve various features, such as the ability to adjust dimensions of an implant before, during, or after implantation.

Claims

1. A pelvic implant comprising:

a tissue support member having a first end portion and a second end portion;

an extension mesh member, the extension mesh member being a physically separate mesh construct from the tissue support member, the extension mesh member including a proximal end portion and a distal end portion; and

a frictional adjusting element securely coupled to the proximal end portion of the extension mesh member, the frictional adjusting element including a body that defines an aperture, the body also defining frictional engagements,

wherein the first end portion of the tissue support member is configured to extend through the aperture and contact the frictional engagements to adjustably couple the tissue support member to the extension mesh member, wherein the frictional engagements allow movement of the first end portion of the tissue support member through the aperture in one direction and inhibit movement of the first end portion of the tissue support member in an opposing direction.

2. The pelvic implant according to claim 1, wherein the extension mesh member is a first extension mesh member, and the frictional adjusting element is a first frictional adjusting element, the pelvic implant further comprising:

a second mesh extension member, the second extension mesh member being a physically separate mesh construct from the tissue support member and the first extension mesh member, the second extension mesh member including a proximal end portion and a distal end portion; and

a second frictional adjusting element securely coupled to the proximal end portion of the second extension mesh member, the second frictional adjusting element including a body that defines an aperture and frictional engagements,

wherein the second end portion of the tissue support member is configured to extend through the aperture of the second frictional adjusting element and contact the frictional engagements of the second frictional adjusting element to adjustably couple the tissue support member to the second mesh extension member,

wherein the frictional engagements of the second frictional adjusting element allow movement of the second end portion of the tissue support member through the aperture of the second frictional adjusting element in one direction and inhibit movement of the second end portion of the tissue support member in an opposing direction.

3. The implant of claim 1, wherein the frictional engagements include one or more teeth that frictionally engage the first end portion of the tissue support member.

4. A method of treating a pelvic condition in a female patient, the method comprising:

creating a vaginal incision;

providing the pelvic implant as recited at claim 1;

passing the pelvic implant through the incision; and

positioning the pelvic implant to a supporting position relative to tissue of the pelvic region.

5. The method according to claim 4, wherein the pelvic condition is vaginal prolapse.

6. A method of treating a pelvic condition in a female patient, the method comprising:

creating a vaginal incision;

providing the pelvic implant as recited at claim 1;

passing the pelvic implant through the incision;

positioning the pelvic implant to a supporting position relative to tissue of the pelvic region; and

placing the distal end portion of the extension mesh member at tissue of an obturator foramen.

7. A medical assembly, comprising:

an implant including;

a support mesh portion including a grommet having an aperture, and

an elongate mesh arm, the elongate mesh arm being a physically separate mesh construct from the support mesh portion, the elongate mesh arm configured to fit through the aperture of the grommet;

a frictional adjusting element being movable at a portion of the elongated mesh arm to adjust a length of the elongated mesh arm in a first direction; and

an adjusting tool including an elongate shaft and a distal end, the distal end configured to engage the grommet to move the grommet along a length of the elongate mesh arm.

8. The medical assembly according to claim 7, wherein the distal end includes an aperture and the elongate mesh arm fits through the aperture at the distal end of the adjusting tool and through the aperture of the grommet.

9. The medical assembly according to claim 7, wherein the grommet includes an annular polymeric body.

10. The medical assembly according to claim 7, wherein the elongate mesh arm is a first elongate mesh arm, the implant including:

a second elongate mesh arm, the second elongate mesh arm being a separate mesh construct from the first elongate mesh arm and the support mesh portion.

11. The medical assembly according to claim 10, wherein the grommet is a first grommet, the medical assembly further comprising a second grommet having an aperture,

wherein the first grommet is configured to move along the first elongate mesh arm to adjust a length of the first elongate mesh arm from the support mesh portion, and

wherein the second grommet is configured to move along the second elongate mesh arm to adjust a length of the second elongate mesh arm from the support mesh portion.

12. The medical assembly according to claim 7, wherein the frictional adjusting element is configured to allow a length between the frictional adjusting element and a fastener to be reduced in the first direction.

13. The medical assembly according to claim 7, wherein the frictional adjusting element is configured to resist movement in a second direction, the second direction is opposite the first direction.