Device, system and methods for introducing soft tissue anchors

• US 8,821,370 B2
• Filed: 08/14/2013
• Issued: 09/02/2014
• Est. Priority Date: 10/12/2000
• Status: Expired due to Fees

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/966,818
• Publication Number:
  US 20140039247A1
• Time in Patent Office: 384 Days
• Field of Search: 600 29- 32, 600/37, 128/DIG.25, 128897-898, 606139-144, 606151-158, 606232-233
• 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 system for providing support to an anatomical structure of the pelvis includes first and second soft tissue anchors, a suburethral support, an introducer, and a filament. The first soft tissue anchor has a proximal end and a distal end and includes a base having a hollow tubular structure, a plurality of barbs, and a tip. The sub-urethral support portion has first and second ends, the first and second soft tissue anchors extending from the first and second ends of the sub-urethral support portion. The introducer has an elongate shaft and a handle, the elongate shaft having a proximal end at the handle and a distal end with an aperture extending through the distal end. The filament extends through the hollow tubular section of the first soft tissue anchor and through the aperture in the distal end of introducer.

Claims

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

a suburethral support formed of a mesh material and being substantially rectangular in shape, the suburethral support defining a first end portion and a second end portion, the first end portion located opposite the second end portion;

a first soft tissue anchor coupled to the first end portion of the suburethral support and a second soft tissue anchor coupled to the second end portion of the suburethral support, the first soft tissue anchor having a base, an apex opposite the base, and a plurality of barbs adapted for soft tissue anchoring, the second soft tissue anchor having a base, an apex opposite the base, and a plurality of barbs adapted for soft tissue anchoring;

a first filament connected to the base of the first soft tissue anchor and a second filament connected to the base of the second soft tissue anchor; and

an introducer having an elongate shaft and a handle, the elongate shaft having a distal portion and a proximal portion, the elongate shaft being coupled at the proximal portion to the handle, the distal portion of the elongate shaft defining an aperture adapted to receive the first filament, the distal portion of the elongate shaft having a terminal end adapted to engage with the first soft tissue anchor.

2. The system of claim 1, wherein the first filament is attached around a portion of the base of first soft tissue anchor.

3. The system of claim 1, further comprising a second filament connected to the base of the second soft tissue anchor.

4. The system of claim 1, wherein the terminal end of the distal portion of the elongate shaft is adapted to releasably couple to the base of the first soft tissue anchor.

5. The system of claim 1, wherein the base of the first soft tissue anchor defines a first section and a second section, the first section having a first width and the second section having a second width, the second width being greater than the first width.

6. The system of claim 5, wherein the first section of the base of the first soft tissue anchor is adapted for securing the first filament to the first soft tissue anchor.

7. The system of claim 5, wherein the first section of the base of the first soft tissue anchor defines a recessed portion of the base.

8. The system of claim 1, wherein the plurality of barbs of the first soft tissue anchor have surfaces directed rearwardly with respect to the apex of the first soft tissue anchor such that the first soft tissue anchor substantially resists being pulled back through soft tissue in a direction opposite to that in which the first soft tissue anchor was inserted.

9. The system of claim 1, wherein the second soft tissue anchor has an apex opposite a base and a plurality of barbs adapted for soft tissue anchoring.

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

making a vaginal incision for securing a suburethral support under a urethra of a patient, the suburethral support being formed of a mesh material, defining a substantially rectangular outer profile, and having a first end portion and a second end portion;

passing a first filament through an aperture of a first introducer, the first filament being connected to a base of a first soft tissue anchor, the first soft tissue anchor including a plurality of barbs and an apex opposite the base, the first introducer having an elongate shaft and a handle, the elongate shaft having a distal portion with a terminal end and a proximal portion coupled to the handle, the distal portion of the elongate shaft defining the aperture adapted to receive the first filament;

releasably coupling the first soft tissue anchor with the first introducer by advancing the first introducer over the first filament until the first soft tissue anchor engages the terminal end of the distal portion of the elongate shaft;

inserting the first soft tissue anchor through the vaginal incision and penetrating soft tissue by pressing the apex of the first soft tissue anchor into the soft tissue on a first side of the urethra using the first introducer.

11. The method of claim 10, further comprising attaching the first filament around a portion of the base of the first soft tissue anchor.

12. The method of claim 10, further comprising pulling the first filament to generate tension and bringing the base of the first soft tissue anchor against the terminal end of the elongate shaft of the first introducer.

13. The method of claim 12, further comprising decoupling the first soft tissue anchor from the first introducer by releasing the tension on the first filament and retracting the first introducer.

14. The method of claim 10, further comprising repositioning the first soft tissue anchor by one of advancing and retracting the first introducer in cooperation with the first soft tissue anchor.

15. The method of claim 10, further comprising passing a second filament through one of the aperture in the first introducer or an aperture of a second introducer, the second filament being connected to a base of a second soft tissue anchor, the second soft tissue anchor including a plurality of barbs and an apex opposite the base.