Pulmonary vein valve implant

• US 20050273160A1
• Filed: 04/22/2005
• Published: 12/08/2005
• Est. Priority Date: 04/23/2004
• Status: Active Grant

• Current Assignee: DFM, LLC (PDL BioPharma, Inc.)
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Granted Patent: US 7,641,686 B2
• Time in Patent Office: Days
• US Class Current: 623/1.250
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

The present invention involves placing a valve between the left atrium and the lung to prevent regurgitant flow from increasing the pulmonary pressures, which may lead to pulmonary edema and congestion. Mitral stenosis or poor synchronization of the mitral valve may add additional pressures to the left atrium thus raising the pulmonary pressures and leading to congestion in the lung vasculature. By blocking the additional pressures from the mitral regurgitant flow from reaching the pulmonary circulation, the left atrium may act as a sealed vessel to allow additional aortic output. The valve placement can be intralumenal or attached to the ostium of the atrium. The device can be placed via the vascular conduits or through a surgical procedure into the pulmonary circulation. One or more devices may be placed in each of the four pulmonary veins. Additionally only one, two, three or all four veins may be implanted with the valve as desired by the physician.

Claims

1. A flow control device dimensioned for implantation in a human pulmonary vein, the device comprising an inflatable support structure and at least one moveable occluder that controls the flow of blood into and out of the pulmonary veins.

2. The device of claim 1 where the device contains a therapeutic agent that is gradually released.

3. The device of claim 2 where the therapeutic agent is contained in a polymer coating on at least a portion of the device.

4. The device of claim 3 where the polymer is a bioerodable polymer

5. The device of claim 3 where the therapeutic agent is contained within porosity of the polymer.

6. A method of monitoring a patient, comprising monitoring the blood flow through the pulmonary veins during the implantation of the device of claim 1.

7. The method of claim 6 using Trans Esophageal Echocardiography (TEE)

8. The method of claim 6 using Trans Thoracic Echocardiography (TTE)

9. The method of claim 6 using Intracardiac Echocardiography

10. A method of monitoring blood pressure comprising monitoring blood pressure through the pulmonary veins during the implantation of the device of claim 1.

11. The method of claim 10 further comprising measuring wedge pressure.

12. A method of visualization of the position of a valve comprising visualizing the position of the valve of claim 1 during implantation using fluoroscopy.

13. The method of visualization of the position of the valve of claim 1 during implantation using Magnetic resonance imagine (MRI)

14. A method of treating a patient comprising rerouting blood flow from the pulmonary veins into a prosthetic chamber, and then back into a portion of the heart.

15. The method of claim 14 where the procedure is accomplished percutaneously.

16. The method of claim 14 where the procedure is accomplished thorascopicaly.

17. The method of claim 14 where the procedure is accomplished surgically.

18. The method of claim 14 where the procedure is accomplished on a beating heart.

19. The method of claim 14 where the prosthetic chamber includes a flow control device.

20. The method of claim 19 where the flow control device permits flow in one direction, but restricts flow in a second direction.

21. The method of claim 14 where the return conduit is attached to the left ventricle.

22. the method of claim 14 where the return conduit is attached near the apex of the heart.

23. The method of claim 14 where the return conduit is attached in a first step, and a portion of the pulmonary veins are connected to the prosthetic chamber, before all of the pulmonary veins are disconnected from the native atrium.

24. A prosthetic chamber made from implantable materials, including a one way valve, an outlet conduit and more than one inlet conduit and the inlet conduits are designed to attach to the pulmonary veins.

25. The device of claim 24 where the conduits are manufactured from a woven fabric tube.

26. The device of claim 24 where the valve is a tissue valve.

27. The device of claim 24 where the valve is a mechanical valve.

28. The device of claim 27 where the valve is a single leaflet valve.

29. The device of claim 27 where the valve is a bileaflet valve.