METHOD FOR SOFT TISSUE ANCHORING WITH INTRODUCER

• US 20110230705A1
• Filed: 06/01/2011
• Published: 09/22/2011
• Est. Priority Date: 10/12/2000
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Granted Patent: US 8,821,369 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• 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 method of providing support to an anatomical structure of the pelvis includes making a vaginal incision for providing access for placement of a mesh support device below a urethra of a patient without penetrating an abdominal wall of the patient. The mesh support device includes a sling portion and first and second soft tissues connected to first and second ends of the sling portion. The mesh support device is delivered through the vaginal incision using an introducer including a curved elongate shaft having a distal portion and a proximal portion connected to a handle. A suture is passed through a hollow tubular section of the first soft tissue anchor. The suture passed through an aperture in a distal end of the introducer and the introducer is advanced over the suture until the first soft tissue anchor is located at the distal end of the introducer.

Claims

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

making a vaginal incision for providing access for placement of a mesh support device below a urethra of a patient without penetrating an abdominal wall of the patient, the mesh support device including a sling portion having a first end and a second end, a first soft tissue anchor connected to the first end, and a second soft tissue anchor connected to the second end;

delivering the mesh support device through the vaginal incision using an introducer such that the sling portion is suspended from the first and second anchors under the urethra, the introducer including a curved elongate shaft having a distal portion for connecting with the first anchor and a proximal portion connected to a handle; and

passing a suture through a hollow tubular section of the first soft tissue anchor and passing the suture through an aperture in a distal end of the introducer and advancing the introducer over the suture until the first soft tissue anchor is located at the distal end of the introducer.

2. The method of claim 1, further comprising releasing the first soft tissue anchor from the introducer, wherein the suture remains threaded through the aperture in the distal end of the introducer.

3. The method of claim 1, wherein the sling portion has a visual marker indicating a mid-point of the sling portion, the method further comprising positioning the sling portion under the urethra using the visual marker.

4. The method of claim 1, further comprising inserting the first soft tissue anchor into soft tissue along a curved path that is on a first side of the urethra.

5. The method of claim 1, wherein the handle has a first face and a second face opposite the first face, the method further comprising grasping the handle of the introducer and inserting the first soft tissue anchor into the tissue along a curved path that is perpendicular to the first and second faces of the handle.

6. The method of claim 1, wherein the handle has a first face and a second face opposite the first face with an edge between the first and second faces, and the elongate shaft has a curvature in a direction perpendicular to the first and second faces of the handle, the method further comprising inserting the first soft tissue anchor into the tissue with the sling portion positioned along an outer part of the curvature of the introducer.

7. The method of claim 1, further comprising:

delivering the first soft tissue anchor into soft tissue on a first side of the urethra and the second soft tissue anchor into soft tissue on a second side of the urethra;

positioning the sling under the urethra of the patient; and

suspending the sling from the first and second soft tissue anchors.

8. The method of claim 1, further comprising passing the first soft tissue anchor to one side of the urethra, through soft tissues of the perineal space, and behind an inferior pubic ramus of the patient.

9. The method of claim 1, wherein the first soft tissue anchor has a proximal end and a distal end and includes a base, a plurality of barbs, and a tip, and further has an introducer aperture extending through the base and the tip of the first soft tissue anchor, the method further comprising:

passing a narrowed portion of an introducer through the introducer aperture of the first soft tissue anchor, the introducer having an elongate shaft and a handle, the elongate shaft having a proximal end at the handle and a distal end, the elongate shaft defining the narrowed portion toward the distal end of the elongate shaft that forms an abutment where the elongate shaft widens from the narrowed portion;

seating the first soft tissue anchor on the introducer such that the distal end of the elongate shaft protrudes from the distal end of the anchor and the anchor rests on the abutment thereby preventing the first soft tissue anchor from moving further down the elongate shaft of the introducer;

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

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 such that the sling portion is suspended from the first and second soft tissue anchors under the urethra without the first and second soft tissue anchors penetrating an abdominal wall of the patient.

10. The method of claim 1, wherein the sling portion is suspended below a mid-urethra of the patient.

11. The method of claim 1, further comprising suspending the sling portion in a suburethral pressure space below endopelvic fascia of the patient.

12. The method of claim 1, further comprising suspending the sling portion in a perineal space of the patient.