Devices and methods for retrievable intra-atrial implants

• US 9,232,997 B2
• Filed: 03/15/2013
• Issued: 01/12/2016
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Sugimoto, Hiroatsu, Forcucci, Stephen J., McNamara, Edward, Finch, Matthew J., Magnin, Christopher
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/838,192
• Publication Number:
  US 20140012368A1
• Time in Patent Office: 1,033 Days
• Field of Search: 623 21- 219, 606/151
• US Class Current: 1/1
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/00597 Implements comprising a membrane
• 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 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9522 : Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/006 : Y-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/022 : Metals or alloys

Abstract

Devices and methods to enhance the implantation, retreivability, or repositionability are provided. Embodiments of devices include pivotable sections providing the ability to maintain the device'"'"'s engagement with a delivery system during implantation where the deliver system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

Claims

1. A percutaneously deliverable device for treating a heart condition in a patient comprising:

a first flange section having a plurality of flange segments angularly spaced about a longitudinal axis of the device, each flange segment of the first flange section comprising two prongs meeting at a junction; and

a second flange section having a plurality of flange segments angularly spaced about the longitudinal axis of the device, each flange segment of the second flange section comprising two elements meeting at a junction;

wherein each of the flange segments the each of the first and second flange sections are adapted to fold in the same direction upon the device being drawn into an opening of a percutaneous catheter to assume a collapsed configuration in which the junctions of the flange segments of the first flange section and of the second flange section are disposed distal to their corresponding prongs.

2. The device of claim 1, wherein the device also comprises a hub.

3. The device of claim 2, wherein two or more of the flange segments of the first flange section each has a proximal end connected to the hub.

4. The device of claim 2, wherein the hub has at least one of internal threads and external threads which are adapted to releasably connect with complementary threads of at least one of a delivery device and a retrieval device.

5. The device of claim 2, wherein the hub has a groove, the groove being adapted to cooperate with a collet of at least one of a delivery device and a retrieval device to form a releasable connection.

6. The device of claim 2, wherein the hub has a ball, the ball being adapted to cooperate with a claw device of at least one of a delivery device and a retrieval device to form a releasable connection.

7. The device of claim 2, wherein the hub has a c-shaped connector section, the c-shaped connector section being adapted to cooperate with a complementary c-shaped connector section of at least one of a delivery device and a retrieval device to form a releasable connection.

8. The device of claim 2, wherein the hub has an aperture, the aperture being adapted to receive at least one of a pin or a finger of at least one of a delivery device and a retrieval device to form a releasable connection.

9. The device of claim 1, wherein the device comprises a core section adapted to permit fluid flow therethrough.

10. The device of claim 1, wherein at least one flange segment of at least one of the first and second flange sections has a first region having a first thickness and a first width and a second region having a second thickness and a second width wherein the respective magnitude of at least one of the first thickness and the first width is different than the respective magnitude of, respectively, the second thickness and the second width so that the flexibility of the first region is different from the flexibility of the second region.

11. A reversibly collapsible device for treating a heart condition in a patient comprising a first flange section, a second flange section, and a longitudinal axis, wherein each of the first and second flange sections comprise a plurality of separate, adjacent segments, each segment comprising two prongs meeting at a junction, and is adapted to fold in the same axial direction upon the device being drawn into an opening of a percutaneous catheter to assume a collapsed configuration in which the junctions of the flange segments of the first flange section and of the second flange section are disposed distal to their corresponding prongs.

12. The device of claim 11, wherein the device also comprises a hub.

13. The device of claim 12, wherein two or more of the flange segments of the first flange section each has a proximal end connected to the hub.

14. The device of claim 12, wherein the hub has at least one of internal threads and external threads which are adapted to releasably connect with complementary threads of at least one of a delivery device and a retrieval device.

15. The device of claim 12, wherein the hub has a groove, the groove being adapted to cooperate with a collet of at least one of a delivery device and a retrieval device to form a releasable connection.

16. The device of claim 12, wherein the hub has a ball, the ball being adapted to cooperate with a claw device of at least one of a delivery device and a retrieval device to form a releasable connection.

17. The device of claim 12, wherein the hub has a c-shaped connector section, the c-shaped connector section being adapted to cooperate with a complementary c-shaped connector section of at least one of a delivery device and a retrieval device to form a releasable connection.

18. The device of claim 12, wherein the hub has an aperture, the aperture being adapted to receive at least one of a pin or a finger of at least one of a delivery device and a retrieval device to form a releasable connection.

19. The device of claim 11, wherein the device comprises a core section adapted to permit fluid flow therethrough.

20. The device of claim 11, wherein at least one flange segment of at least one of the first and second flange sections has a first region having a first thickness and a first width and a second region having a second thickness and a second width wherein the respective magnitude of at least one of the first thickness and the first width is different than the respective magnitude of, respectively, the second thickness and the second width so that the flexibility of the first region is different from the flexibility of the second region.

21. A percutaneous deliverable device adapted to be implanted into or retracted from, via a catheter, a patient'"'"'s atrial septum, comprising:

a first annular flange section having a plurality of separate, adjacent flange segments, each flange segment of the first annular flange section comprising two prongs meeting at a junction; and

a second annular flange section having a plurality of separate, adjacent flange segments, each flange segment of the first annular flange section comprising two prongs meeting at a junction, wherein the flange segments of the first annular flange section and the flange segments of the second annular flange section are configured to collapse in the same direction upon retraction by said catheter to assume a collapsed configuration in which the junctions of the flange segments of the first flange section and of the second flange section are disposed distal to their corresponding prongs.

22. The device of claim 21, wherein the device also comprises a hub.

23. The device of claim 22, wherein two or more of the flange segments of the first flange section each has a proximal end connected to the hub.

24. The device of claim 22, wherein the hub has at least one of internal threads and external threads which are adapted to releasably connect with complementary threads of at least one of a delivery device and a retrieval device.

25. The device of claim 22, wherein the hub has a groove, the groove being adapted to cooperate with a collet of at least one of a delivery device and a retrieval device to form a releasable connection.

26. The device of claim 22, wherein the hub has a ball, the ball being adapted to cooperate with a claw device of at least one of a delivery device and a retrieval device to form a releasable connection.

27. The device of claim 22, wherein the hub has a c-shaped connector section, the c-shaped connector section being adapted to cooperate with a complementary c-shaped connector section of at least one of a delivery device and a retrieval device to form a releasable connection.

28. The device of claim 22, wherein the hub has an aperture, the aperture being adapted to receive at least one of a pin or a finger of at least one of a delivery device and a retrieval device to form a releasable connection.

29. The device of claim 21, wherein the device comprises a core section adapted to permit fluid flow therethrough.

30. The device of claim 21, wherein at least one flange segment of at least one of the first and second flange sections has a first region having a first thickness and a first width and a second region having a second thickness and a second width wherein the respective magnitude of at least one of the first thickness and the first width is different than the respective magnitude of, respectively, the second thickness and the second width so that the flexibility of the first region is different from the flexibility of the second region.