Pelvic implant with suspending system

• US 8,888,678 B2
• Filed: 06/12/2011
• Issued: 11/18/2014
• Est. Priority Date: 10/12/2000
• Status: Expired due to Term

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/158,424
• Publication Number:
  US 20110237877A1
• Time in Patent Office: 1,255 Days
• Field of Search: 600 29- 32, 600/37, 128/DIG.25
• 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 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the 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 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

A method of providing support to an anatomical structure of the pelvis includes inserting a first suspending member into a pelvic space on a first side of a urethra of a patient, the first suspending member being slidably received through a first end of a support. A second suspending member is inserted into a pelvic space on a second side of the urethra of the patient, the second suspending member being slidably received through a second end of the support. A position of the support under the urethra of the patient is adjusted by tensioning the first suspending member. The first suspending member is pulled through the first end of the support.

Claims

1. A method of providing support to an anatomical structure of the pelvis, the method comprising:

inserting an implant into a patient, the implant including a first end portion and a second end portion that are configured to stabilize the implant in the patient, the first end portion disposed opposite the second end portion, the first end portion including a first aperture receiving a first elongate member, the second end portion including a second aperture receiving a second elongate member;

inserting a first elongate member into a pelvic space on a first side of a urethra of a patient, the first elongate member being slidably received through the first aperture of the implant such that the first elongate member is looped through the first aperture to secure the first elongate member to the implant;

inserting a second elongate member into a pelvic space on a second side of the urethra of the patient, the second elongate member being slidably received through the second aperture of the implant such that the second elongate member is looped through the second aperture to secure the second elongate member to the implant;

directing the first and second elongate members through the skin of the patient to locations outside of the body of the patient;

adjusting a position of the implant under the urethra of the patient by applying tension to the first elongate member from the locations outside the body of the patient; and

cutting the first and second elongate members.

2. The method of claim 1, further comprising positioning the implant loosely under the urethra of the patient.

3. The method of claim 1, further comprising positioning the implant under a mid-urethra of the patient.

4. The method of claim 1, further comprising making an incision in a vaginal wall of the patient, wherein the first and second elongate members are inserted through the incision.

5. The method of claim 1, further comprising inserting the first elongate member into the pelvic space using an introducer having a curved shaft.

6. The method of claim 1, further comprising inserting the first elongate member into the pelvic space along a curved path.

7. A method for treating urinary incontinence in a patient, the method comprising:

making a vaginal incision;

directing an end portion of a first elongate member of a pelvic implant through the vaginal incision to a first location outside of a body of the patient, the pelvic implant including a suburethral support having a first end through which the first elongate member is looped such that the first elongate member is secured to the first end of the suburethral support and having a second end through which a second elongate member is looped to secure the second elongate member such that the second elongate member is secured to the second end of the suburethral support, the first and second elongate members being substantially thread-like in form;

directing an end portion of the second elongate member of the pelvic implant through the vaginal incision to a second location outside of the body of the patient;

directing the suburethral support of the pelvic implant through the vaginal incision into the pelvis to a suburethral position;

tensioning the end portions of the first and second elongate members to tension the suburethral support; and

cutting the end portions of the first and second elongate members.

8. The method of claim 7, wherein the first and second elongate members do not pass through the obturators of the patient.

9. The method of claim 7, wherein the first and second ends of the suburethral support are configured to stabilize the suburethral support while allowing the suburethral support to be advanced and withdrawn through tissue of the pelvis during tensioning.

10. The method of claim 7, wherein the first end of the suburethral support includes an integrally formed first stabilizer that is configured to resist movement along a tissue path in the pelvis while allowing atraumatic advancement and withdrawal of the first stabilizer along the tissue path.

11. A method of assembling an implant for treatment of urinary incontinence, the method comprising:

providing a suburethral support including a mesh material, the suburethral support having a first end and a second end;

looping a first elongate member through a first aperture in the first end of the suburethral support such that the first elongate member defines a first loop having a first side and a second side, the first elongate member being substantially thread-like in form;

securing the first side of the first loop with the second side of the first loop such that the first elongate member is secured to the first end of the suburethral support;

looping a second elongate member through a second aperture in the second end of the suburethral support such that the second elongate member defines a second loop having a first side and a second side, the second elongate member being substantially thread-like in form; and

securing the first side of the second loop with the second side of the second loop such that the second elongate member is secured to the second end of the suburethral support.

12. The method of claim 11, wherein the first end of the suburethral support includes an integrally formed first stabilizer that is configured to resist movement along a tissue path in the pelvis while allowing atraumatic advancement and withdrawal of the first stabilizer along the tissue path, the first stabilizer defining the first aperture.