Implantable sling systems and methods

• US 9,345,473 B2
• Filed: 12/30/2010
• Issued: 05/24/2016
• Est. Priority Date: 12/30/2009
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Fisher, Brian G.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US13/520,125
• Publication Number:
  US 20130006048A1
• Time in Patent Office: 1,972 Days
• Field of Search: 600/37, 128897-899
• US Class Current: 1/1
• 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Various embodiments of sling or implant systems are provided. The sling or implant systems can be employed to treat incontinence, prolapse, and like conditions. A needle delivery device can be included, wherein the delivery device includes a needle and a rotatable sheath. The rotatable sheath can rotate upon actuation relative to the needle to selectively deploy or disengage an implant anchor from the distal end of the needle.

Claims

1. A sling implant system for treating a pelvic condition, comprising:

a sling implant having a support portion and one or more end anchors;

a needle delivery device having a handle body and a needle, wherein the needle includes a distal end portion adapted for selective engagement with the one or more end anchors of the sling implant;

an elongate sheath having a proximal end and a distal end, and adapted to at least partially shroud a length of the needle, with the proximal end housed within the handle body; and

an actuation mechanism having an actuator and at least one cam mechanism housed within the handle body and in operable communication with the elongate sheath, with the actuator including a barrel portion moveable in and out of the handle body such that activation of the actuator operably rotates the sheath about the needle such that the sheath does not move distally, such that the distal end of the elongate sheath rotatably abuts the one or more anchors to deploy the one or more anchors from the distal end portion.

2. The system of claim 1, wherein the one or more end anchors include an end anchor on each end of the sling implant.

3. The system of claim 1, wherein the one or more end anchors include extending anchor tines.

4. The system of claim 3, wherein the elongate sheath includes a barb guard adapted to abut against the extending anchor tines.

5. The system of claim 1, wherein the elongate sheath includes an angled end surface adapted to engage with the one or more anchors such that rotation of the elongate sheath forces the one or more anchors from the distal end portion of the needle.

6. The system of claim 1, wherein the actuator is a pushable button in operable communication with the at least one cam mechanism and rotatable sheath.

7. The system of claim 1, wherein the needle is curved.

8. The system of claim 1, wherein the needle is straight.

9. The system of claim 1, wherein the one or more anchors include at least one internal lumen protrusion and the distal end portion of the needle includes a corresponding mating feature to facilitate snap engagement of the one or more anchors with the distal end portion.

10. The system of claim 9, wherein the at least one internal lumen protrusion includes two opposing internal lumen protrusions.

11. An implant system for treating a pelvic condition, comprising:

sling implant having a support portion and end tissue anchors;

a needle delivery device having a handle housing and a needle, wherein the needle includes a distal tip adapted for selective engagement with at least one of the end tissue anchors;

an elongate sheath having a proximal tip shrouded and rotatable within the handle housing, a distal tip, and adapted to at least partially shroud a length of the needle; and

an actuation mechanism shrouded within the handle housing and having an actuator in operable communication with the elongate sheath, and including a shaft adapted to traverse in and out of the handle housing, such that activation of the actuator operably rotates the sheath about the needle without moving the sheath distally, such that the distal tip of the elongate sheath rotatably abuts at least one of the end tissue anchors to facilitate deployment.

12. The system of claim 11, wherein the end tissue anchors each include extending anchor tines.

13. The system of claim 12, wherein the elongate sheath includes a barb guard adapted to abut against the extending anchor tines.

14. The system of claim 11, wherein the elongate sheath includes an angled end surface adapted to engage with at least one of the end anchors such that rotation of the elongate sheath forces at least one of the end anchors from the distal tip of the needle.

15. The system of claim 11, wherein the actuator is a pushable button in operable communication with the rotatable sheath.

16. The system of claim 11, wherein the needle is curved.

17. The system of claim 11, wherein the needle is straight.

18. The system of claim 11, wherein at least one of the end anchors includes at least one internal lumen protrusion and the distal tip of the needle includes a corresponding mating feature to facilitate snap engagement of the at least one end anchor with the distal tip.

19. The system of claim 11, further including a second needle delivery device adapted to engage with one of the end anchors.

20. The system of claim 11, wherein the actuation mechanism further includes a cam mechanism adapted to operably facilitate the rotation of the rotatable sheath about the needle.