Devices for reducing left atrial pressure, and methods of making and using same

• US 9,980,815 B2
• Filed: 05/14/2015
• Issued: 05/29/2018
• Est. Priority Date: 05/04/2009
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Nitzan, Yaacov, Yacoby, Menashe
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US14/712,801
• Publication Number:
  US 20150245908A1
• Time in Patent Office: 1,111 Days
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient'"'"'s atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Claims

1. A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the device comprising:

a stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the patient'"'"'s atrial septum;

a biocompatible material disposed on the stent in the neck region and the second flared end region, but not on a first portion of the first flared end region; and

an opening within the stent configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium, the opening having an outlet at the first flared end region and an inlet at an edge of the biocompatible material, the biocompatible material adapted to inhibit excessive tissue ingrowth into the opening and channel blood flow through the opening.

2. The device of claim 1, wherein the biocompatible material promotes limited tissue ingrowth into the opening, the tissue ingrowth comprising an endothelial layer inhibiting thrombogenicity of the device.

3. The device of claim 1, wherein an outlet edge of the biocompatible material is about 1-3 mm from a narrowest portion of the neck region.

4. The device of claim 1, wherein the biocompatible material is adapted to smoothly channel blood flow from the left atrium to the right atrium through the opening without high shear rates, stagnation points, or turbulence, and

wherein the biocompatible material is adapted to promote ingrowth of a neointima layer to a thickness of less than 0.2 mm so as to render the material inert and inhibit hyperplasia.

5. The device of claim 1, further comprising leaflets disposed completely in the first flared end region and configured to be continuously flushed by blood circulating in the right atrium so as to inhibit excessive tissue ingrowth, stiffening of the leaflets, and impairment of leaflet closure.

21. The device of claim 1, wherein the first and second flared end regions each flare by about 50 to 120 degrees.

22. The device of claim 1, wherein the stent comprises a plurality of sinusoidal rings interconnected by longitudinally extending struts.

23. The device of claim 1, wherein the stent comprises a shape memory material.

24. The device of claim 23, wherein the shape memory material comprises a shape memory metal.

25. The device of claim 1, wherein the device is configured so that, when the shunt is deployed across the patient'"'"'s atrial septum, the first flared end region protrudes 5.5 to 7.5 mm into the right atrium.

26. The device of claim 25, wherein the device is configured so that, when the shunt is deployed across the patient'"'"'s atrial septum, the second flared end region protrudes 2.5 to 7 mm into the left atrium.

27. The device of claim 1, wherein the neck region has a diameter of 3 to 6 mm.

28. The device of claim 27, wherein the first flared end region has a diameter between 9 and 13 mm and the second flared end region has a diameter between 8 and 15 mm.

29. The device of claim 1, wherein the stent is configured to transition between a collapsed state suitable for percutaneous delivery and an expanded state when deployed across the patient'"'"'s atrial septum.

30. The device of claim 29, wherein the stent has an hourglass configuration in the expanded state.

31. The device of claim 1, wherein the biocompatible material comprises expanded-polytetrafluoroethylene.

32. The device of claim 1, wherein an opposing edge of the biocompatible material is at least partially before a distal end of the first flared end region.

33. The device of claim 1, wherein the first and second flared end regions each flare outwardly away from the atrial septum.

34. The device of claim 1, wherein respective distal ends of each of the first and second flared end regions do not contact the atrial septum when the device is deployed.

6. A method of treating a subject with heart pathology, the subject having a heart with an atrial septum between a right atrium and a left atrium, the method comprising:

providing a device having first and second flared end regions and a neck region disposed therebetween, an opening within the device, and a biocompatible material disposed on the device in the neck region and the second flared end region, but not on a first portion of the first flared end region;

deploying the device across a puncture through the atrial septum such that the neck region is positioned in the puncture, the first flared end region is disposed in the right atrium, and the second flared end region is disposed in the left atrium; and

reducing left atrial pressure and left ventricular end diastolic pressure by shunting blood from the left atrium to the right atrium through the device when the left atrial pressure exceeds the right atrial pressure.

7. The method of claim 6, further comprising identifying a middle of a fossa ovalis of the atrial septum by pressing a needle against the fossa ovalis to partially tent the fossa ovalis, and puncturing the middle of the fossa ovalis with the needle.

8. The method of claim 6, wherein the puncture is through a middle of a fossa ovalis of the atrial septum and the device is deployed away from the limbus, atrial wall, and the ridge between the inferior vena cava and coronary sinus.

9. The method of claim 6, wherein the heart pathology comprises heart failure, pulmonary congestion, pulmonary hypertension, or myocardial infarction, or any combination thereof.

10. The method of claim 9, comprising deploying the device during a period immediately following the myocardial infarction.

11. The method of claim 10, wherein the period immediately following the myocardial infarction is at least two weeks after the myocardial infarction.

12. The method of claim 6, wherein shunting blood from the left atrium to the right atrium increases the cardiac output of the subject, decreases pulmonary congestion of the subject, or decreases the pulmonary artery pressure of the subject, or any combination thereof.

13. The method of claim 6, wherein shunting blood from the left atrium to the right atrium increases the ejection fraction of the subject or increases the fractional shortening of the subject or both.

14. The method of claim 6, wherein shunting blood from the left atrium to the right atrium decreases the left ventricle internal diameter in systole of the subject.

15. The method of claim 6, wherein deploying the device across the puncture comprises deploying the second flared end region by advancing the second flared end region out of a sheath and into the left atrium with a pusher, then partially retracting the sheath such that the second flared end region engages the left side of the atrial septum, and then deploying the first flared end region by fully retracting the sheath such that the first flared end region deploys in the right atrium.

16. The method of claim 15, wherein the pusher is configured to advance only the second flared end region out of the sheath.

17. The method of claim 6, further comprising:

prior to providing the device;

providing a tube of shape-memory metal;

expanding the tube on a mandrel to define the first and second flared end regions and the neck region therebetween, and heating the expanded tube to set the shape; and

coating the neck region and the second flared end region, but not the first portion of the first flared end region, with the biocompatible material.

18. The method of claim 17, wherein the biocompatible material comprises expanded-polytetrafluoroethylene, polyurethane, DACRON (polyethylene terephthalate), silicone, polycarbonate urethane, or pericardial tissue from an equine, bovine, or porcine source.

19. The method of claim 17, further comprising securing leaflets to an outlet edge of the biocompatible material at a portion of the first flared end region that is about 1-3 mm from a narrowest portion of the neck region.

20. The method of claim 17, wherein the device comprises a plurality of sinusoidal rings and longitudinally extending struts, further comprising a valve sutured to the longitudinally extending struts and to the biocompatible material, the valve comprising leaflets.