Devices and Methods of Treating Or Ameliorating Diastolic Heart Failure through Pulmonary Valve Intervention

• US 20140012181A1
• Filed: 07/08/2013
• Published: 01/09/2014
• Est. Priority Date: 07/06/2012
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: Sugimoto, Hiroatsu, Magnin, Christopher J.
• Granted Patent: US 9,649,480 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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

The present teachings provide a device and methods of making and use thereof. Specifically, one aspect of the present teachings provides a device for restricting blood flow entering the lung after each right bean systole. Certain embodiments of the present teachings provide a device that prevents a complete closure of the pulmonary valve leaflets so that a certain amount of blood is allowed to flow from the pulmonary artery to the right ventricle at the end of a right ventricle systole. Other embodiments of the present teachings provide a device that restricts the amount of blood outflowing from the right ventricle to the pulmonary artery. In addition, the present teachings also provide a delivery system for implanting such a device approximately to or at the pulmonary valve.

Claims

1. An implantable medical device for restricting blood flow from the right ventricle to the pulmonary artery, having an elongated delivery configuration and an expanded deployed configuration, and comprising:

a hollow body portion comprising a distal end and a proximal end,

wherein the distal end of the device is configured to be positioned distally to the pulmonary valve annulus, the proximal end of the device is configured to be positioned proximally to the pulmonary valve annulus, and the hollow body portion of the device is configured to be positioned through the pulmonary valve and prevent the pulmonary valve leaflets from closing, and

wherein the hollow body portion is configured to allow the blood to flow from the proximal end to the distal end.

2. The implantable medical device of claim 1, wherein one of the distal end and proximal end of the device is larger than the other.

3. The implantable medical device of claim 1, wherein the device further comprises at least one tissue anchor protruding radially outwardly from the device towards the surrounding heart tissue.

4. The implantable medical device of claim 3, wherein the at least one tissue anchor is near or at the distal end of the device.

5. The implantable medical device of claim 3, wherein the at least one tissue anchor is near or at the proximal end of the device.

6. The implantable medical device of claim 3, wherein the at least one tissue anchor is configured to secure the device against the tissue inside the right ventricle outflow track, or secure the device against the tissue inside the pulmonary artery.

7. The implantable medical device of claim 3, wherein the at least one tissue anchor is in the shape of a hook, a grasper, a loop, a ring, a spine, a tine, a helix, a barb, or a clip.

8. An implantable medical device for restricting blood flow from the right ventricle to the pulmonary artery, having an elongated delivery configuration and an expanded deployed configuration, and comprising:

a hollow body portion comprising a distal portion comprising a distal end and a proximal end,

wherein the distal portion of the device has a radially collapsed first configuration, and a radially expanded second configuration, and

wherein the distal portion of the device transitions from the first configuration to the second configuration when the right ventricle reaches a set pressure,

and the hollow body portion of the device is configured to allow the blood to flow from the proximal end to the distal end.

9. The implantable medical device of claim 8, wherein the proximal end of the device is larger radially than the distal end of the device at the radially collapsed first configuration.

10. The implantable medical device of claim 8, wherein the distal portion of the device comprises a mesh-like structure, wherein the mesh closes at the radially collapsed first configuration, and the mesh opens at the radially expanded second configuration.

11. The implantable medical device of claim 8, wherein the distal portion of the device comprises a folded tubular surface, wherein the folds close at the radially collapsed first configuration, and the folds unfold at the radially expanded second configuration.

12. The implantable medical device of claim 8, wherein the device further comprises at least one tissue anchor protruding radially outwardly from the device toward the surrounding heart tissue.

13. The implantable medical device of claim 12, wherein the at least one tissue anchor is near or at the distal end of the device.

14. The implantable medical device of claim 12, wherein the at least one tissue anchor is near or at the proximal can of the device.

15. The implantable medical device of claim 12, wherein the at least one tissue anchor is along the body portion of the device.

16. The implantable medical device of claim 12, wherein the at least one tissue anchor is in the shape of a hook, a grasper, a loop, a ring, a spine, a tine, a helix, a bath, or a clip.

17. A method of treating a patient with a diastolic heart failure by restricting blood flow from the right ventricle to the pulmonary artery comprising:

providing a delivery system and an implantable device,

wherein the delivery system comprises a delivery sheath comprising a proximal end, a distal end, and an axial lumen, a delivery catheter slidably disposed within the axial lumen of the delivery sheath, and the delivery catheter comprises a proximal end and a distal end,

wherein the implantable device comprises a distal end, a proximal end, and a hallow body portion, and the implantable device has a first elongated profile when slidably disposed within the axial lumen of the delivery sheath with the distal end of the delivery catheter contacting the proximal end of the implantable device, and a second expanded profile when the device is outside of the delivery sheath,

advancing the delivery system and the implantable device in its first elongated profile at or near the pulmonary valve,

advancing the device outside of the distal end of the delivery sheath, and

retracting the delivery sheath and the delivery catheter from the body.

18. The method of treating a patient claim 17 comprising, disengaging the distal end of the delivery catheter from the proximal end of the device.

19. The method of treating a patient of claim 17 comprising engaging at least one tissue anchor on the implantable device to the surrounding tissue.

20. The method of treating a patient of claim 17, wherein the implantable device comprises a radially expandable distal portion with a collapsed first configuration and a radially expanded second configuration, wherein the method comprises the distal portion of the device transitions from the first configuration to the second configuration when the right ventricle reaches a set pressure.