Device and method for controlling in-vivo pressure
A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.
1. A device for treating a heart condition in a patient, the device for implanting into an atrial septum of the patient's heart, the device comprising:
a core segment defining a tube having an unobstructed passageway, the core segment comprising a flexible material and configured to transition between a collapsed state having a first diameter suitable for percutaneous delivery and an expanded, deployed state having a second diameter larger than the first diameter, the core segment configured in the deployed state to engage an opening in the atrial septum and to permit flow of blood through the unobstructed passageway across the atrial septum;
a first annular structure comprising a plurality of support arm segments adapted to engage a first surface of the atrial septum; and
a second annular structure comprising a plurality of support arm segments adapted to engage a second surface of the atrial septum,
wherein each of the first annular structure and the second annular structure comprises flexible materials configured to transition between a collapsed delivery state and an expanded deployed state.
2. The device of claim 1 , wherein the core segment comprises a superelastic material.
3. The device of claim 2 , wherein the core segment comprises a flexible frame.
4. The device of claim 1 , wherein the support arm segments are more flexible than the core segment.
5. The device of claim 1 , wherein said second annular structure further comprises at least one support arm segment that is longer than said plurality of second support arm segments.
6. A shunt for treating a heart condition in a patient, the shunt configured to be implanted into an atrial septum of the patient's heart, the shunt comprising:
a frame defining a tube having an unobstructed passageway, the frame comprising a flexible material and configured to transition between a collapsed state having a first diameter suitable for percutaneous delivery and an expanded, deployed state having a second diameter larger than the first diameter, the frame configured in the deployed state to engage an opening in the atrial septum and to permit flow of blood through the unobstructed passageway across the atrial septum;
a first annular structure adapted to engage a first wall of the atrial septum; and
a second annular structure adapted to engage a second wall of the atrial septum,
wherein each of the first annular structure and the second annular structure comprises flexible materials configured to transition between a collapsed delivery state and an expanded deployed state.
7. The shunt of claim 6 , wherein the frame comprises a flexible metal.
8. The shunt of claim 7 , wherein the frame comprises Nitinol or Nitinol wire.
9. The shunt of claim 6 , wherein the frame comprises a helical shape.
10. The shunt of claim 6 , wherein the first and second annular structures are integrally formed with the frame.
11. The shunt of claim 6 , wherein the first and second annular structures each comprises a curved portion when deployed.
12. The shunt of claim 6 , wherein the first and second annular structures comprise curved arms at opposing ends of the frame.
13. The shunt of claim 6 , wherein the frame is configured for percutaneous delivery in a delivery tube.