SELF-ANCHORING SLING AND INTRODUCER SYSTEM

• US 20140303430A1
• Filed: 05/09/2014
• Published: 10/09/2014
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Evans, Douglas G., Butcher, Ken, Davis, Michele Gandy
• Granted Patent: US 9,532,862 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• 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:

securing a tip portion of an introducer shaft to a first connector of a surgical implant using a snap fit connection, the surgical implant including a support portion having a first end and a second end;

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 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 has an opening, the method further comprising receiving the first connector in the opening of the tip portion.

4. 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.

5. 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.

6. 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.

7. 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 element coupled to the first end of the support portion and releasably connected to a tip member of an introducer; and

disconnecting the first connector element from the introducer by activating an actuation assembly of the introducer and longitudinally moving the tip member relative to a shaft of the introducer.

8. The method of claim 7, wherein the tip member includes a conical end configured for tissue penetration, and wherein positioning the support portion under the urethra of the patient further comprises advancing the conical end through soft tissue during positioning of the support portion under the urethra of the patient.

9. The method of claim 7, further comprising extending the tip member outward from a lumen of the shaft of the introducer and retracting the tip member inward into the lumen of the shaft.

10. The method of claim 7, wherein the tip member includes a groove and the first connector element is secured within the groove of the tip.

11. The method of claim 7, wherein the shaft is curved and the actuation assembly includes a flexible member extending longitudinally within the shaft, the method further comprising longitudinally actuating the flexible member within the shaft to move the tip member relative to the shaft of the introducer.

12. The method of claim 11, wherein the flexible member has a first end at the handle, the actuation assembly further includes a push button maintained by a handle of the introducer, and the method further comprises actuating the push button to move the first end of the flexible member.

13. The method of claim 11, further comprising moving the flexible member through an arcuate path.

14. The method of claim 11, wherein the actuation assembly includes a biasing mechanism, the method further comprising overcoming a biasing force of the biasing mechanism when actuating the push button.

15. The method of claim 7, further comprising partially projecting the tip from the shaft.

16. 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 forming a rectangular opening into which the first connector is received.

17. The method of claim 16, 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.

18. The method of claim 16, 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.

19. The method of claim 16, 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.

20. The method of claim 19, 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.