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

• US 10,376,680 B2
• Filed: 10/08/2015
• Issued: 08/13/2019
• Est. Priority Date: 12/22/2011
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: McNamara, Edward I., Sutherland, Michael W., Finch, Matthew J., Forcucci, Stephen J.
• Primary Examiner(s): Klein, Benjamin J
• Application Number:
  US14/878,710
• Publication Number:
  US 20160022423A1
• Time in Patent Office: 1,405 Days
• 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:

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

a retainer interconnecting the first and second anchors, the retainer being adapted to permit blood to flow across the membrane at a first flow rate; and

a shunt removably attachable to the retainer, the shunt being receivable within the retainer so as to enable the device to conduct blood across the membrane at a second flow rate, the shunt configured to be percutaneously delivered to the retainer after the retainer is implanted into the membrane of the patient'"'"'s heart, wherein the shunt comprises a frame having at least one aperture associated with a flap releasably secured in place with a bio-resorbable material so as to partially close the aperture.

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

3. The device of claim 1, wherein the shunt comprises a protruding member adapted to be engaged by a percutaneous retrieval device.

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

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

6. The device of claim 1, wherein shunt comprises a plurality of apertures adapted to influence the second flow rate.

7. The device of claim 6, 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 when the bio-resorbable material has become at least partially absorbed.

8. The device of claim 7, wherein at least one other of the apertures has no flap associated with it.

9. The device of claim 6, 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.

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

11. The device of claim 1, wherein the shunt comprises a plurality of first apertures, each of the first apertures being adapted to influence the second flow rate and having associated with it a first flap releasably secured in place with a bio-resorbable material.

12. The device of claim 11, 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.

13. The device of claim 11, 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.

14. The device of claim 13, wherein the shunt further 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.

15. The device of claim 14, 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.

16. The device of claim 15, 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.

17. The device of claim 15, 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.

18. The device of claim 14, 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.

19. The device of claim 18, 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.

20. The device of claim 18, 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.

21. The device of claim 1, wherein the shunt 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.

22. The device of claim 1, wherein the shunt 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.

23. The device of claim 1, wherein the shunt comprises an inner portion of a diameter smaller than a diameter of the shunt.