SELF-ANCHORING SLING AND INTRODUCER SYSTEM

• US 20140303429A1
• 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 9,532,861 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
• 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; 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.

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 has an opening for receiving the first connector.

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

5. 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.

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

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

an introducer including,

a handle,

an actuation assembly,

a tip member, and

a shaft having a distal end, a proximal end connected to the handle, and a lumen slidably receiving the tip member, the actuation assembly being operably coupled to tip member such that the tip member is extendable outward from and retractable inward into the lumen of the shaft at the distal end of the shaft, and

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

a support portion configured to be implanted to support the urethra of the 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 configured to be releasably connected to the tip member of the introducer.

8. The system of claim 7, wherein the tip member has a conical end configured for tissue penetration.

9. The system of claim 7, wherein the tip member includes a groove for releasably securing the first connector to the tip member.

10. The system of claim 7, wherein the actuation assembly includes a biasing spring.

11. The system of claim 7, wherein the shaft is curved and the actuation assembly includes a flexible member extending longitudinally in the lumen of the shaft, the flexible member operably coupled to the tip member such that longitudinal movement of the flexible member results in longitudinal movement of the tip member.

12. The system of claim 11, wherein the shaft has a distal portion toward the distal end of the shaft and the flexible member of the actuation assembly extends from the distal portion of the shaft to the handle.

13. The system of claim 7, wherein the shaft subtends at one of an obtuse angle and an actuate angle relative to a longitudinal axis of the handle.

14. The system of claim 7, wherein the actuation assembly includes a push button maintained by the handle.

15. The system of claim 7, wherein the tip member projects partially from the lumen when the tip member is in a fully retracted state.

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

an introducer including,

a handle, and

a shaft, the shaft including a flat spatulated portion forming 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 configured to releasably secure the first endpiece to the shaft of the introducer.

17. The system of claim 16, wherein the connection feature includes an aperture for releasably securing the first endpiece to the shaft of the introducer.

18. The system of claim 16, wherein the anchor feature includes a plurality of barb structures.

19. The system 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.

20. The system 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.