Self-anchoring sling and introducer system

• US 9,532,861 B2
• Filed: 05/09/2014
• Issued: 01/03/2017
• Est. Priority Date: 08/02/2002
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: Coloplast A/S
• Inventors: Evans, Douglas G., Butcher, Ken, Davis, Michele Gandy
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/274,423
• Publication Number:
  US 20140303429A1
• Time in Patent Office: 970 Days
• US Class Current: 1/1
• 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 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/06085 having a blunt tip
• CPC Class Codes: A61B 2017/0609 having sharp tips at both ends, e.g. shuttle needle alternately retained and released by first and second facing jaws of a suturing instrument
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A system for supporting the urethra using an introducer needle, the ends of which are flattened and which have openings therethrough, a handle having a latch mechanism which engages the opening in the flattened portion of the first end of the introducer needle, an implant, and a connector joining the end of the implant to the flattened portion of one of the ends of the introducer needle. These components are used to draw the implant into position, either through vaginal or abdominal incisions, to form a U-shaped loop beneath the urethra. The ends of the implant are adjusted to provide proper support for the urethra. The implant can have slits that open under applied tensile force.

Claims

1. A system for treating urinary incontinence, the system comprising:

an introducer including a handle and a shaft, the shaft having a tip portion having an opening; and

a surgical implant for treating urinary incontinence, the surgical implant including,

a support portion configured to be implanted to support a urethra of a patient, the support portion having a first end and a second end opposite the first end, and

a first connector coupled to the first end of the support portion and having an anchoring portion, the first connector configured to form a snap-fit connection between the tip portion of the introducer and the surgical implant, the snap-fit connection being configured to facilitate passage of the surgical implant into the patient using the introducer, the opening in the tip being configured to receive at least one projection of the first connector to form the snap-fit connection with another portion of the first connector.

2. The system of claim 1, wherein the tip portion of the introducer includes a spatulated shape.

3. The system of claim 1, wherein the tip portion of the introducer includes a substantially rectangular opening.

4. The system of claim 1, wherein the tip portion of the introducer has a substantially flat portion and a dissecting terminal end, the flat portion having a gradual taper that facilitates advancement of the flat portion through tissue.

5. The system of claim 1, wherein the first connector is a soft tissue anchor.

6. A system for treating urinary incontinence, the system comprising:

an introducer including,

a handle, and

a shaft, the shaft including a flat spatulated portion having a rectangular opening, and

a surgical implant configured to be implanted to support a urethra of a patient to treat urinary incontinence, the surgical implant including,

a support portion configured to be implanted to support a urethra of a patient, the support portion having a first end and a second end opposite the first end, and

a first endpiece coupled to the first end of the support portion, the first endpiece having an anchor feature configured for anchoring in soft tissue and a connection feature, the rectangular opening being configured to receive a portion of the first endpiece to releasably secure the first endpiece to the shaft of the introducer and form a connection with another portion of the first endpiece.

7. The system of claim 6, wherein the connection feature includes an aperture for releasably securing the first endpiece to the shaft of the introducer.

8. The system of claim 6, wherein the anchor feature includes a plurality of barb structures.

9. The system of claim 6, wherein the flat spatulated portion has a first edge and a second edge opposite the first edge, the first and second edges tapering outwardly in a longitudinal direction toward a distal end of the flat spatulated portion.

10. The system of claim 9, wherein the flat spatulated portion has a third edge and a fourth edge opposite the third edge, the third and fourth edges tapering inwardly in a longitudinal direction toward a distal end of the flat spatulated portion.

11. A system for treating urinary incontinence, the system comprising:

an introducer including a handle and a shaft, the shaft having a tip portion having an opening; and

a surgical implant for treating urinary incontinence, the surgical implant including,

a support portion configured to be implanted to support a urethra of a patient, the support portion having a first end and a second end opposite the first end, and

a first connector coupled to the first end of the support portion and having an anchoring portion, the first connector including a cylindrical projection having a tapered portion configured to form first a snap-fit connection between the tip portion of the introducer and the surgical implant and a second snap-fit connection between other portions of the first connector, the first snap-fit connection being configured to facilitate passage of the surgical implant into the patient using the introducer, the opening in the tip portion being configured to receive at least a portion of cylindrical projection of the first connector.