Pass through introducer and sling

• US 8,449,450 B2
• Filed: 06/01/2011
• Issued: 05/28/2013
• 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:
  US13/149,982
• Publication Number:
  US 20110230709A1
• Time in Patent Office: 727 Days
• Field of Search: 600 29- 31, 600/37, 128/DIG.25, 128897-898, 606139-144, 606151-158, 606232-233
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• 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 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A system for providing support to an anatomical structure of the pelvis includes a surgical implant and an introducer. The surgical implant includes first and second soft tissue anchors and a support. The first soft tissue anchor has a proximal end and a distal end and an introducer channel extending through the first soft tissue anchor from the proximal end to the distal end. The support has first and second ends, where the first soft tissue anchor is connected to the first end and the second soft tissue anchor to the second end. The introducer has a shaft and a handle, the shaft having a proximal end at the handle and a distal end, the distal end configured to be inserted through the introducer aperture of the first soft tissue anchor such that the distal end of the shaft protrudes from the distal end of the first soft tissue anchor.

Claims

1. A system for treating urinary incontinence by providing support to a urethra of a patient, the system comprising:

a surgical implant configured to treat urinary incontinence, the surgical implant including;

a first soft tissue anchor having a proximal end and a distal end, the first soft tissue anchor having an introducer channel extending through the first soft tissue anchor from the proximal end to the distal end;

a second soft tissue anchor; and

a support having first and second ends, the first soft tissue anchor being connected to the first end of the support and the second soft tissue anchor being connected to the second end of the support; and

an introducer for delivering the first soft tissue anchor to a desired pelvic location in association with a procedure for treating urinary incontinence, the introducer having a shaft and a handle, the shaft having a proximal end at the handle and a distal end, the distal end configured to be inserted through the introducer channel of the first soft tissue anchor such that the distal end of the shaft protrudes from the distal end of the first soft tissue anchor, the shaft defining an abutment toward the distal end of the shaft for limiting the first soft tissue anchor from moving along the shaft of the introducer.

2. The system of claim 1, wherein the first soft tissue anchor is configured to rest on the abutment with the distal end of the introducer inserted through the introducer channel, the abutment limiting the first soft tissue anchor from moving further down the shaft of the introducer.

3. The system of claim 1, wherein the first and second soft tissue anchors each include a base, a plurality of barbs, and a tip, the introducer channel extending longitudinally from the base to the tip.

4. The system of claim 3, wherein the tip of each of the first and second soft tissue anchors is blunt.

5. The system of claim 1, wherein the distal end of the shaft forms a tip configured to penetrate soft tissue.

6. The system of claim 1, wherein the support is formed of a polymeric tape material.

7. The system of claim 1, wherein the distal end of the first soft tissue anchor is substantially flat.

8. The system of claim 1, wherein the implant further comprises:

a first suspending member connecting the first soft tissue anchor and the first end of the support, the first soft tissue anchor further comprising a tube into which the first suspending member is inserted, the tube being clamped around the suspending member to fix the first suspending member to the first anchor; and

a second suspending member connecting the second soft tissue anchor and the second end of the support.

9. The system of claim 8, wherein the implant defines a length between the first and second soft tissue anchors and is configured for selective adjustment of the length of the implant between the first and second soft tissue anchors.

10. The system of claim 8, wherein the first and second suspending members are sutures.

11. A method for treating incontinence by providing support to a urethra of a patient, the method comprising:

making a vaginal incision for implanting a surgical implant configured for treatment of urinary incontinence and having a first soft tissue anchor, a second soft tissue anchor, and a support connected to the first and second soft tissue anchors;

passing a tip of an introducer through an introducer aperture of the first soft tissue anchor such that the tip protrudes from a distal end of the first soft tissue anchor, the introducer including a narrowed portion defining an abutment, wherein passing the tip of the introducer through the aperture of the first soft tissue anchor includes passing the tip of the introducer through the aperture of the of the first soft tissue anchor until the first soft tissue anchor is seated on the abutment;

inserting the first soft tissue anchor through the vaginal incision;

pressing the tip of the introducer into tissue on a first side of the urethra;

inserting the second soft tissue anchor through the vaginal incision and pressing the second soft tissue anchor into tissue on a second side of the urethra; and

suspending the support from the first and second soft tissue anchors under the urethra.

12. The method of claim 11, wherein the support is supported from the first and second soft tissue anchors under the urethra without penetrating a rectus sheath of a patient.

13. The method of claim 11, wherein suspending the support from the first and second soft tissue anchors under the urethra includes suspending the support from first and second suspending members connecting the support to the first and second soft tissue anchors, respectively.

14. The method of claim 11 further comprising:

adjusting a position of the support relative to the patient'"'"'s urethra after inserting the first and second tissue anchors, including pulling the first member through the vaginal incision to adjust the distance between the suburethral support and the second anchor; and

fixing the distance between the suburethral support and the second anchor after adjusting the position of the suburethral support.