Methods, systems, and devices for resizable intra-atrial shunts

• US 9,205,236 B2
• Filed: 12/24/2012
• Issued: 12/08/2015
• 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.
• Primary Examiner(s): Wiest, Philip R
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US13/726,425
• Publication Number:
  US 20130184633A1
• Time in Patent Office: 1,079 Days
• US Class Current: 1/1
• 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. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.

Claims

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

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

a first shunt removably attachable to the retainer, the first shunt being adapted to permit blood to flow across the membrane at a first flow rate;

a second shunt removably attachable to the retainer, the second shunt being adapted to permit blood to flow across the membrane at a second flow rate;

wherein the first and second shunts are adapted to be alternatively connected to the retainer, wherein the first and second shunts, respectively, are configured to be percutaneously delivered to the retainer after the retainer is implanted into the membrane of the patient'"'"'s heart.

2. The device of claim 1, the retainer and first shunt further comprising, respectively first and second complimentary portions of a releasable locking mechanism, wherein the locking mechanism is adapted to removably attach the first shunt to the retainer.

3. The device of claim 1, the retainer and second shunt further comprising, respectively first and third complimentary portions of a releasable locking mechanism, wherein the locking mechanism is adapted to removably attach the second shunt to the retainer.

4. The device of claim 1, wherein at least one of the first and second shunts comprises a protruding member adapted to be engaged by a percutaneous retrieval device.

5. The device of claim 1, wherein the first flow rate is greater than the second flow rate.

6. The device of claim 1, wherein the second flow rate is greater than the first flow rate.

7. The device of claim 1, wherein at least one of the first and second shunts comprises a plurality of apertures adapted to influence, respectively, the first and second flow rates.

8. The device of claim 7, wherein at least one of the apertures has associated with it a flap releasably secured in place with a bio-resorbable material so as to prevent blood flow through the at least one aperture until a time when the bio-resorbable material has become at least partially absorbed.

9. The device of claim 8, wherein at least one other of the apertures has no flap associated with it.

10. The device of claim 7, wherein at least one of the apertures has associated with it a flap releasably secured in place with a bio-resorbable material so as to permit blood flow through the at least one aperture until a time when the bio-resorbable material has become at least partially absorbed.

11. The device of claim 10, wherein at least one other of the apertures has no flap associated with it.

12. The device of claim 1, wherein at least one of the first and second shunts comprises a plurality of first apertures, each of the first apertures being adapted to influence, respectively, the first and second flow rates and having associated with it a first flap releasably secured in place with a bio-resorbable material.

13. The device of claim 12, wherein the bio-resorbable material securing at least one of the first flaps is adapted to release the at least one first flap at a preselected first time and the bio-resorbable material securing at least one other of the first flaps is adapted to release the at least one other of the first flaps at a preselected second time that is different than the preselected first time.

14. The device of claim 12, wherein at least one of the first flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

15. The device of claim 14, wherein at least one of the first and second shunts comprises a plurality of second apertures, each of the second apertures being adapted to influence, respectively, the first and second flow rates and having associated with it a second flap releasably secured in place with a bio-resorbable material.

16. The device of claim 15, wherein at least one of the first flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

17. The device of claim 16, wherein at least one of the second flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

18. The device of claim 16, wherein at least one of the second flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

19. The device of claim 15, wherein at least one of the first flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

20. The device of claim 19, wherein at least one of the second flaps is secured in place so as to permit blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

21. The device of claim 19, wherein at least one of the second flaps is secured in place so as to prevent blood flow through its associated aperture until a time when the bio-resorbable material has become at least partially absorbed.

22. The device of claim 1, wherein at least one of the first and second shunts is configured as a disk having at least one aperture adapted to permit blood to flow across the membrane at, respectively, the first or second flow rate.

23. The device of claim 1, wherein at least one of the first and second shunts is configured as a cylinder having a first end, the first end having at least one aperture adapted to permit blood to flow across the membrane at, respectively, the first or second flow rate.

24. The device of claim 1, wherein at least one of the first and second shunts comprises a frame having a first aperture situated therein and a plurality of flaps attached to the frame so as to at least partially close the first aperture.

25. The device of claim 24, wherein each of the flaps is releasably attached to at least one other of the flaps with a bio-resorbable material.

26. The device of claim 25, wherein the plurality of flaps form the rim of a second aperture.

27. The device of claim 25, wherein the bio-resorbable material has a first region having a first rate of bio-resorbability and a second region having a second rate of bio-resorbability that is different from the first rate of bio-resorbability.

28. The device of claim 25, wherein the first rate is greater than the second rate.

29. The device of claim 26, wherein the first region includes at least a portion of the rim of the second aperture.

30. The device of claim 29, wherein the first rate is greater than the second rate.

31. The device of claim 1, wherein at least one of the first and second shunts comprises a frame having a first aperture situated therein an a bio-resorbable material forming the rim of a second aperture, the bio-resorbable material being attached to the frame so as to at least partially close the first aperture.