Self-anchoring sling and introducer system

• US 9,532,862 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:
  US14/274,432
• Publication Number:
  US 20140303430A1
• 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 for prosthetic joint-implanting tools A61F2/4603
• 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 for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• 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 MIS suturing instruments A61B17/0469; jaws of MIS forceps A61B2017/2926
• 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.

Claims

1. A method of treating urinary incontinence, the method comprising:

receiving at least one projection of a first connector of a surgical implant in an opening of a tip portion of an introducer shaft, the surgical implant including a support portion having a first end and a second end;

securing the tip portion of the introducer shaft to the first connector of the surgical implant using a snap fit connection including the at least one projection inserted into another portion of the first connector;

positioning the support portion under the urethra of the patient by inserting the first end of the support portion into the pelvic area of a patient; and

releasing the snap fit connection and disconnecting the tip portion of the introducer shaft from the surgical implant.

2. The method of claim 1, wherein the tip portion of the introducer defines a spatulated section of the introducer, the method further comprising receiving the connector with the spatulated section.

3. The method of claim 1, wherein the tip portion of the introducer includes a substantially rectangular opening, the method further comprising receiving the first connector in the substantially rectangular opening of the tip portion.

4. The method of claim 1, wherein the tip portion of the introducer has a substantially flat portion and a dissecting terminal end, the method further comprising advancing the flat portion of the tip portion through soft tissue during positioning of the support portion under the urethra of the patient.

5. The method of claim 1, wherein positioning the support portion under the urethra of the patient further includes inserting a second end of the support portion into the pelvic area of a patient.

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

positioning a support portion under a urethra of a patient by inserting a first end of a support portion of a surgical implant into a pelvic area of a patient, the surgical implant including a first connector coupled to the first end of the support portion and releasably connected to a tip of an introducer, the first connector having an anchor feature configured for anchoring in soft tissue and a connection feature configured to releasably secure the first connector to the shaft of the introducer; and

disconnecting the first connector from the introducer, the introducer having a flat spatulated portion having a rectangular opening into which at least a portion of the first connector is received to connect the with another portion of the first connector.

7. The method of claim 6, wherein the connection feature includes an aperture, the method further comprising releasably securing the first connector to the shaft of the introducer with the aperture.

8. The method of claim 6, wherein the anchor feature of the first connector includes a barb structure, wherein inserting the first end of a support portion of a surgical implant into the pelvic area of a patient includes inserting the barb structure into soft tissue of the pelvic area.

9. The method 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, wherein inserting the first end of a support portion of the surgical implant into the pelvic area of the patient includes inserting the spatulated portion through tissue of the pelvic area of the patient.

10. The method 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, wherein inserting the first end of a support portion of the surgical implant into the pelvic area of the patient includes inserting the spatulated portion through tissue of the pelvic area of the patient.

11. A method of treating urinary incontinence, the method comprising:

receiving a cylindrical projection having a tapered portion of a first connector of a surgical implant in an opening of a tip portion of an introducer shaft, the surgical implant including a support portion having a first end and a second end;

securing the tip portion of the introducer shaft to the first connector of the surgical implant with a first snap fit connection using the tapered portion and a second snap-fit connection between other portions of the first connector;

positioning the support portion under the urethra of the patient by inserting the first end of the support portion into the pelvic area of a patient; and

releasing the first snap fit connection and disconnecting the tip portion of the introducer shaft from the surgical implant.