Devices for reducing left atrial pressure having biodegradable constriction, and methods of making and using same
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.
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, a first flared end region, a second flared end region, and a passageway through the neck region and the first and second flared end regions, the neck region disposed between the first and second flared end regions and configured to engage a fossa ovalis of the patient's atrial septum, the stent configured to shunt blood between the left atrium and the right atrium;
a biocompatible material disposed on the stent to define a continuous sheath that inhibits excessive tissue ingrowth and channels blood flow through the passageway, the biocompatible material disposed on the stent at least at the neck region; and
a biodegradable material disposed on the biocompatible material at the neck region to define a diameter, the biodegradable material configured to biodegrade after implantation to change the diameter at the neck region.
2. The device of claim 1 , wherein the stent comprises a plurality of rings interconnected by longitudinally extending struts.
3. The device of claim 1 , wherein the stent comprises a shape memory metal coated with the biocompatible material from the neck region to the second flared end region.
4. 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.
5. The device of claim 4 , wherein the stent has an hourglass configuration in the expanded state.
6. The device of claim 1 , 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.
7. The device of claim 1 , wherein the diameter at the neck region is between 3 and 6 mm.
8. 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.
9. The device of claim 1 , wherein the biocompatible material is disposed in the neck region, the second flared end region, and a portion of the first flared end region of the stent.
10. The device of claim 1 , wherein an edge of the biocompatible material is at least partially before a distal end of the first flared end region.
11. The device of claim 1 , wherein the biocompatible material comprises expanded-polytetrafluoroethylene (ePTFE), polyurethane, DACRON (polyethylene terephthalate), silicone, polycarbonate urethane, or pericardial tissue from an equine, bovine, or porcine source, or any combination thereof.
12. 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, or any combination thereof.
13. The device of claim 1 , wherein the biodegradable material has a thickness of 0.10 to 0.50 mm.
14. The device of claim 1 , wherein the biodegradable material is further disposed on the biocompatible material at the second flared end region.
15. The device of claim 1 , wherein the biodegradable material is disposed on an inner surface of the biocompatible material at the neck region.
16. The device of claim 1 , wherein the biodegradable material is bioresorbable.
17. The device of claim 1 , wherein the biodegradable material biodegrades after implantation to increase a cross-sectional area of a blood flow path.
18. The device of claim 1 , wherein the biodegradable material comprises one or more biodegradable components.
19. A device configured for implantation in fossa ovalis between a patient's left atrium and right atrium without loss of patency, the device comprising:
an hourglass-shaped stent having a neck region, a first flared end region, a second flared end region, and a passageway through the neck region and the first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis, the hourglass-shaped stent configured to shunt blood between the left atrium and the right atrium;
a biocompatible material disposed on the hourglass-shaped stent to channel blood flow through the passageway, the biocompatible material disposed on the stent at least at the neck region; and
a biodegradable material disposed on the biocompatible material at the neck region to define a diameter, the biodegradable material configured to biodegrade after implantation to change the diameter at the neck region.
20. The device of claim 19 , wherein the hourglass-shaped stent comprises a shape memory metal and the biocompatible material comprises expanded-polytetrafluoroethylene (ePTFE).
21. The device of claim 19 , 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(gylcerol sebacate) (PGS), polysialic acid (PSA), collagen type I/III, chitosan, or chitin, or any combination thereof.