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

• US 9,629,715 B2
• Filed: 07/28/2011
• Issued: 04/25/2017
• Est. Priority Date: 07/28/2011
• 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:
  US13/193,309
• Publication Number:
  US 20130030521A1
• Time in Patent Office: 2,098 Days
• Field of Search: 623 21, 623 213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

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 device may include a biodegradable material that biodegrades to offset flow changes caused by tissue ingrowth. The inventive device 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.

Claims

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

a metallic stent defining a lumen having 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;

a one-way tissue valve disposed in the lumen and having an outlet coupled to a first portion of the first flared end region, a cross-sectional flow area, and an inlet coupled to a second portion of the first flared end region proximal to the neck region, the valve configured to shunt blood from the left atrium to the right atrium through the cross-sectional flow area when blood pressure in the left atrium exceeds blood pressure in the right atrium; and

a biodegradable material disposed in the lumen on the neck region of the stent to reduce the cross-sectional flow area after initial implantation of the device, the biodegradable material configured to biodegrade at a rate to maintain the cross-sectional flow area within the lumen to offset changes in the cross-sectional flow area caused by tissue ingrowth within the lumen.

2. The device of claim 1, wherein the biodegradable material comprises collagen-terpolymer, polylactic acid (PLA), poly L-lactic acid (PLLA), polyglycolic acid (PGA), poly(lactic-co-glycolic) acid copolymer (PLGA), poly(ε

-caprolactone), methacrylated dextran-aminoethyl methacrylate copolymer (Dex-MA/AEMA), polydiaxanone, poly(glycerol sebacate) (PGS), polysialic acid (PSA), collagen type I/III, chitosan, or chitin.

3. The device of claim 1, wherein the biodegradable material has a thickness of 0.10 to 0.50 mm.

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

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

6. The device of claim 1, wherein the stent comprises a shape memory material, and wherein the shape memory material is coated with a biocompatible material from the neck region to the second flared end region.

7. The device of claim 6, wherein the shape memory material comprises a shape memory metal.

8. The device of claim 6, wherein the tissue valve extends between the first flared end region and the biocompatible material, and an edge of the biocompatible material is 1-3 mm from a narrowest portion of the neck region.

9. The device of claim 1, wherein the inlet of the tissue valve is about 1-3 mm from a narrowest portion of the neck region, and the outlet of the tissue valve is about 5-8 mm from the narrowest portion of the neck region.

10. The device of claim 9, wherein the tissue valve comprises a sheet of tissue having a flattened length of about 10-16 mm, and the sheet of tissue is folded and sutured to define two or more leaflets each having a length of about 5-8 mm.

11. The device of claim 1, wherein the tissue valve has a flattened length no greater than 18 mm, a flattened height no greater than 10 mm, and a flattened area no greater than 150 square mm.

12. 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.

13. The device of claim 12, 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.

14. The device of claim 13, wherein the neck has a diameter of 4.5 to 5.5 mm.

15. The device of claim 14, wherein the first flared end region has a diameter between 9 and 13 mm, and wherein the second flared end region has a diameter between 8 and 15 mm.

16. 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 fossa ovalis.

17. The device of claim 1, wherein the stent has an hourglass configuration in the expanded state.

18. The device of claim 1, wherein the one-way tissue valve comprises pericardial tissue of bovine, porcine, or equine origin.

19. The device of claim 18, wherein the pericardial tissue consists primarily of mesothelial and connective tissue layers and substantially no dense fibrous layer.

20. The device of claim 1, wherein the one-valve tissue valve comprises two or more leaflets.

21. The device of claim 1, wherein the stent is configured for implantation through the middle of the fossa ovalis, away from a surrounding limbus, inferior vena cava, and atrial wall.

22. The device of claim 6, wherein the biocompatible material comprises expanded-polytetrafluoroethylene, polyurethane, DACRON (polyethylene terephthalate), silicone, polycarbonate urethane, or pericardial tissue from an equine, bovine, or porcine source.

23. The device of claim 1, including means for measuring cardiac output of the subject, wherein shunting blood from the left atrium to the right atrium increases the cardiac output of the subject.

24. The device of claim 1, including means for measuring pulmonary congestion of the subject, wherein shunting blood from the left atrium to the right atrium decreases pulmonary congestion of the subject.

25. The device of claim 1, including means for measuring pulmonary artery pressure of the subject, wherein shunting blood from the left atrium to the right atrium decreases the pulmonary artery pressure of the subject.

26. The device of claim 1, including means for measuring ejection fraction of the subject, wherein shunting blood from the left atrium to the right atrium increases the ejection fraction of the subject.

27. The device of claim 1, including means for measuring fractional shortening of the subject, wherein shunting blood from the left atrium to the right atrium increases the fractional shortening of the subject.

28. The device of claim 1, including means for measuring fractional shortening of the subject, wherein shunting blood from the left atrium to the right atrium decreases the left ventricle internal diameter in systole of the subject.