SYSTEMS AND METHODS FOR TREATING SEPTAL DEFECTS

• US 20110093007A1
• Filed: 06/21/2010
• Published: 04/21/2011
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Promed, Inc.
• Original Assignee: Ovalis, Inc.
• Inventors: Heanue, Taylor A., Abbott, Ryan, Belef, W. Martin, Pantages, Anthony J., Jabba, Ronald J., Carson, Dean
• Granted Patent: US 8,579,936 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/2912 transmission of forces to actuating rod or piston
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus, devices for controlling delivery of the treatment apparatus and methods for treating a septal defect are provided. The implantable treatment apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the implantable apparatus, and a proximal control device for controlling delivery of the implantable apparatus, among others.

Claims

1. An apparatus for treating a patent foramen ovale (“

PFO”

), comprising;

an elongate body member;

an elongate delivery member slidably housed within an inner lumen of the elongate body member;

a tissue engagement device pivotally coupled with the elongate body member with a first hinge and pivotally coupled with the elongate delivery device with a second hinge; and

at least two centering arms coupled with a hub element, the hub element and centering arms being slidable with respect to the elongate body member.

2. The apparatus of claim 1, further comprising an elongate core element coupled with the hub element and slidable with respect to the elongate body member.

3. The apparatus of claim 2, wherein the centering arms are biased to deflect laterally outwards away from the body member.

4. The apparatus of claim 3, further comprising a guidewire, the hub element being slidable over the guidewire.

5. The apparatus of claim 4, wherein the centering arms are configured to deflect outwards upon advancement of the hub element distally over the guidewire.

6. The apparatus of claim 5, wherein the centering arms form a tear-drop shape profile when deployed.

7. The apparatus of claim 5, wherein the centering arms are configured to deploy through a recess in the elongate body member.

8. The apparatus of claim 5, further comprising an elongate piercing element slidably housed within the elongate delivery member.

9. The apparatus of claim 8, further comprising an implantable closure device releasably coupled with a pusher member, the pusher member and closure device being slidably housed within the elongate piercing element.

10. The apparatus of claim 1, further comprising a proximal controller for controlling deployment of the centering arms.

11. The apparatus of claim 10, wherein the proximal controller comprises a centering actuator assembly comprising a slidable actuator base.

12. The apparatus of claim 11, wherein the slidable actuator base is coupled with the centering arms.

13. The apparatus of claim 2, further comprising a proximal controller for controlling deployment of the centering arms and core member.

14. The apparatus of claim 13, wherein the proximal controller comprises a centering actuator assembly comprising a slidable actuator base and a core hub configured to slide with respect to the actuator base.

15. The apparatus of claim 14, wherein the core hub is coupled with the core member and the actuator base is coupled with the centering arms.

16. The apparatus of claim 15, wherein the core hub is releasably lockable to the actuator base.

17. The apparatus of claim 16, wherein the core hub is slidable within a seat in the actuator base.

18. The apparatus of claim 17, further comprising a spring for locking the actuator base to the core hub.

19. The apparatus of claim 17, wherein the spring is configured to unlock the actuator base from the core hub as the actuator base is advanced distally.

20. The apparatus of claim 17, wherein the core hub is coupled with the core member by way of a sleeve.