URINARY INCONTINENCE TREATMENT AND DEVICES

• US 20140039244A1
• Filed: 08/14/2013
• Published: 02/06/2014
• 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 9,089,396 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A system for treating urinary incontinence includes a suburethral support, first and second soft tissue anchors, and an introducer. The suburethral support is formed of a mesh material, the first and second soft tissue anchors each have a tip, a base, a first face, a second face, a plurality of barbs, and an aperture extending from the first face to the second face. The introducer is configured for delivering the first soft tissue anchor to a desired anchoring site of the pelvis, the 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 introducer forming a longitudinal recess adapted to receive the first soft tissue anchor such that a portion of the first soft tissue anchor engages a distal most end of the distal portion of the 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 having a first end, a second end, and a substantially rectangular outer profile;

a first soft tissue anchor including a tip, a base, a first face, a second face, a plurality of barbs, and an aperture extending from the first face to the second face of the first soft tissue anchor, a second soft tissue anchor including a tip, a base, a first face, a second face and an aperture extending from the first face to the second face of the second soft tissue anchor, the first soft tissue anchor being coupled to the first end of the suburethral support, the second soft tissue anchor being coupled to the second end of the suburethral support; and

an introducer for delivering the first soft tissue anchor to a desired anchoring site of a pelvic region of the patient, the 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 introducer forming a longitudinal recess adapted to receive the first soft tissue anchor such that a portion of the first soft tissue anchor engages a distal most end of the distal portion of the introducer.

2. The system of claim 1, wherein the longitudinal recess of the introducer is sized to receive a portion of the first soft tissue anchor.

3. The system of claim 1, wherein the longitudinal recess of the introducer is adapted to receive a substantially flat portion of the first soft tissue anchor.

4. The system of claim 1, wherein the tip of the first soft tissue anchor extends from the first end of the suburethral support.

5. The system of claim 1, wherein the first soft tissue anchor is arrow-head shaped.

6. The system of claim 1, wherein the introducer includes a curved elongate shaft.

7. The system of claim 6, wherein the curved elongate shaft is curved at an angle of about 30 degrees.

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

making a vaginal incision for providing access for placement of a suburethral support below the urethra of the patient, the suburethral support being formed of a mesh material having a first end, a second end and a substantially rectangular outer profile;

preparing the suburethral support for implantation on a first side of the urethra by coupling a first soft tissue anchor to an introducer, the first soft tissue anchor being coupled to the first end of the suburethral support, the 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 introducer forming a longitudinal recess adapted to receive the first soft tissue anchor such that a portion of the first soft tissue anchor engages a distal most end of the distal end of the elongate shaft;

penetrating soft tissue by advancing a tip of the first soft tissue anchor into the soft tissue and delivering the first soft tissue anchor to a desired anchoring site in the pelvic anatomy of the patient, the first soft tissue anchor including the tip, a base, a plurality of barbs, and an aperture extending from a first face to a second and opposite face in the first soft tissue anchor.

9. The method of claim 8, further comprising preparing the suburethral support for implantation on a second side of the urethra by coupling a second soft tissue anchor to an introducer, the second soft tissue anchor including a tip, a base, a plurality of barbs, and an aperture extending from a first face to a second and opposite face of the second soft tissue anchor, the second soft tissue anchor being coupled to the second end of the suburethral support, the distal portion of the introducer forming the longitudinal recess adapted to receive the second soft tissue anchor such that a portion of the second soft tissue anchor engages the distal most end of the elongate shaft of the introducer.

10. The method of claim 9, further comprising penetrating soft tissue by advancing the tip of the second soft tissue anchor into the soft tissue and delivering the second soft tissue anchor to the desired anchoring site in pelvic anatomy of the patient.

11. The method of claim 8, wherein a portion the first soft tissue anchor is inserted into the longitudinal recess until the elongate shaft of the introducer engages a portion of the first soft tissue anchor including the aperture.

12. The method of claim 8, wherein the first soft tissue anchor is releasably coupled to the introducer such that the introducer is retractable from the first soft tissue anchor.