Methods and devices for intra-atrial shunts having selectable flow rates

• US 9,642,993 B2
• Filed: 12/24/2012
• Issued: 05/09/2017
• Est. Priority Date: 12/22/2011
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: McNamara, Edward, Sutherland, Michael W., Finch, Matthew J., Forcucci, Stephen J., Mitzel, John
• Primary Examiner(s): Stephens, Jacqueline
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/726,472
• Publication Number:
  US 20130184634A1
• Time in Patent Office: 1,597 Days
• Field of Search: 604 8- 10
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00584 Clips
• 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: 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 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart'"'"'s pumping cycle.

Claims

1. A device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising anchors which are adapted to hold the device in place within the aperture by contacting first and second sides of the membrane of the patient'"'"'s heart, and a shunting section connected to the anchors, the shunting section having a first diameter at a first time after delivery and a second diameter at a second time after delivery, and the first time different from the second time, wherein the shunting section has a first length corresponding to the first diameter and a second length corresponding to the second diameter, the first length greater than the second length.

2. The device of claim 1, wherein the first diameter is less than the second diameter.

3. The device of claim 1, wherein the second diameter is less than the first diameter.

4. The device of claim 1, wherein at least a portion of the shunting section is biased to cause the shunting section to have a first hydraulic diameter.

5. The device of claim 4, wherein the shunting section is adapted to have a second hydraulic diameter upon removal of at least portion of the bias.

6. The device of claim 1, wherein at least one of the shunting section and the pair of anchors comprises a shape memory material.

7. The device of claim 1, wherein the shunting section is adapted to change from the first diameter to the second diameter automatically.

8. The device of claim 1, wherein the shunting section has a third diameter.

9. The device of claim 8, wherein the third diameter is greater than at least one of the first and second diameters.

10. The device of claim 8, wherein the third diameter is less than at least one of the first and second diameters.

11. The device of claim 8, wherein the shunting section is adapted to change from the second diameter to the third diameter automatically.

12. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane of the patient'"'"'s heart; and

a shunt connected to the first and second anchors and having a bio-resorbable material, the shunt comprising a first inner diameter, changing to a second, different inner diameter, the second diameter greater than the first diameter;

upon absorption of at least a portion of the bio-resorbable material.

13. The device of claim 12, wherein at least a portion of the shunting section is biased by the bio-resorbable material to cause the shunting section to have a first hydraulic diameter.

14. The device of claim 12, wherein the shunt is further adapted to permit blood to flow across the membrane at a third flow rate upon further absorption of at least a portion of the bio-resorbable material.

15. The device of claim 14, wherein the third flow rate is greater than at least one of the first and second flow rates.

16. The device of claim 14, wherein the third flow rate is less than at least one of the first and second flow rates.

17. The device of claim 12, further comprising a protruding member adapted to be engaged by a percutaneous retrieval device.

18. The device of claim 12, wherein each of the first and second anchors comprises a plurality of segments.

19. The device of claim 12, wherein the first anchor, the second anchor, and the shunt are integrally connected.

20. The device of claim 12, wherein the absorption of the bio-resorbable material occurs at a pre-determined rate.

21. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane; and

a shunt having a first dimension and connected to the first and second anchors, the shunt being adapted to permit blood to flow across the membrane at a first flow rate corresponding to a first dimension and comprising a frame having a plurality of struts,

wherein at least a set of the struts are interconnected by a first bio-resorbable material configured to degrade while the struts remain,

wherein the shunt has a first dimension when the first bio-resorbable material is intact and a second dimension when the first bio-resorbable material is not intact, and

wherein the shunt is adapted to permit blood to flow across the membrane at a second flow rate corresponding to the second dimension.

22. The device of claim 21, wherein each of the first and second anchors comprises a plurality of segments.

23. The device of claim 21, wherein the first anchor, the second anchor, and the shunt are integrally connected.

24. The device of claim 21, wherein the absorption of the first bio-resorbable material occurs at a pre-determined rate.

25. The device of claim 21, further comprising a sheath situated within and attached to the frame.

26. The device of claim 21, wherein at least some of the struts are arranged in diamond-pattern sets, each of the diamond-pattern sets having a first and a second diagonal.

27. The device of claim 26, wherein at least some of the struts in the diamond-pattern sets are interconnected by the first bio-resorbable material to restrain the diamond-pattern sets to which the interconnected struts belong from changing the length of their respective first diagonals.

28. The device of claim 27, wherein the shunt has a longitudinal axis and at least some of the first diagonals are aligned parallel to the shunt'"'"'s longitudinal axis.

29. The device of claim 27, further comprising a sheath situated within and attached to the frame.

30. The device of claim 21, wherein the shunt has a first end and a second end and at least one of the first and second ends is adapted to have a contracted configuration and a expanded configuration and the first bio-resorbable material interconnection is adapted to releasably maintain at least one of the first and second ends in at least one of its respective contracted and expanded configurations.

31. The device of claim 30, wherein the shunt further comprises a sheath situated within and attached to the frame.

32. The device of claim 21, wherein the shunt has a first end having a first contracted configuration and a first expanded configuration and a second end have a second contracted configuration and a second expanded configuration, the first end being constrained by the first bio-resorbable material to releasably maintain either its first expanded configuration or its first contracted configuration, and wherein the shunt has a second end having a second contracted configuration and a second expanded configuration, the second end being constrained by a second bio-resorbable material to releasably maintain either its second expanded configuration or its second contracted configuration, wherein the absorption of the first bio-esorbable material occurs at a first pre-determined rate and the absorption of the second bio-resorbable material occurs at a second pre-determined rate that is different than the first pre-determined rate.

33. The device of claim 32, wherein the shunt further comprises a sheath situated within and attached to the frame.

34. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

first and second anchors adapted to contact, respectively, a first side and a second side of the membrane;

a core segment interconnecting the first and second anchors

and comprising a bio-resorbable material, the core segment comprising a first diameter when the bio-resorbable material is intact, and a second, different diameter upon degradation of the bio-resorbable material, the second diameter greater than the first diameter.

35. The device of claim 34, wherein the shunt and the core segment are integrally connected.