Device and method for controlling in-vivo pressure
A differential pressure regulating device is provided for controlling in-vivo pressure in a body, particular 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 implantation in an opening in a septal wall in a heart of a patient, the device comprising:
a core segment defining a passage, after implantation of the device, that enables flow to traverse from one side of the septal wall to another side of the septal wall, the core segment having a first diameter when deployed;
a first annular structure contiguous with the core segment; and
a second annular structure contiguous with the core segment,
wherein the device is collapsible, so that the core segment has a second diameter less than the first diameter to enable percutaneous delivery of the device to the heart of the patient, and
wherein the core segment comprises a tube that extends beyond the first annular structure or the second annular structure into an atrial chamber.
2 . The device of claim 1 , wherein the first annular structure is configured to form a substantially flat surface that contacts one side of the septal wall, thereby forming a first contacting surface.
3 . The device of claim 2 , wherein a distal portion of the second annular structure is configured to lie parallel to and in contact with the other side of the septal wall, thereby forming a second contacting surface.
4 . The device of claim 3 , wherein at least a portion of the first and second annular structures define an annular gap.
5 . The device of claim 4 , wherein the annular gap has a width greater than a thickness of the septum.
6 . The device of claim 3 , wherein a size of the first contacting surface is equal to a size as the second contacting surface.
7 . The device of claim 1 , wherein each of the first annular structure and the second annular structure are flexible.
8 . The device of claim 1 , wherein the device is configured to provide enhanced blood flow from a first atrium to a second atrium via the passage in amounts sufficient to treat heart failure.
9 . The device of claim 1 , wherein the device is configured to provide enhanced blood flow from a first atrium to a second atrium via the passage in amounts sufficient to treat pulmonary hypertension.
10 . The device of claim 1 , wherein the core segment has a helical shape.
11 . The device of claim 1 , wherein at least one of the first annular structure and the second annular structure is flexible.
12 . The device of claim 1 , wherein at least one of the first annular structure and the second annular structure comprises a plurality of arms.
13 . The device of claim 12 , wherein at least one of the plurality of arms has a length equal to a length of another one of the plurality of arms.
14 . The device of claim 1 , wherein the first and second annular structures are integrally formed with the core segment.
15 . The device of claim 1 , wherein the device is configured to self-expand upon deployment.
16 . The device of claim 1 , wherein the first and second annular structures define a gap to accommodate a range of thicknesses of the septal wall.
17 . The device of claim 1 , wherein the flow from one side of the septal wall to the other side of the septal wall through the core segment is controllable via localized heating.
18 . The device of claim 1 , wherein the passage maintains a continuous opening in the septal wall.
19 . The device of claim 1 , wherein the passage defines a cross-sectional orifice area from 3.5 mm 2 to 24 mm 2 for flow from a first atrium to a second atrium.
20 . The device of claim 1 , wherein the passage provides enhanced blood flow from a first atrium to a second atrium when an interatrial pressure gradient ranges from greater than 0 to 25 mmHg.
21 . The device of claim 1 , wherein the device is at least partially coated to increase bio-compatibility or a degree of endothelialization.
22 . The device of claim 1 , wherein the core segment and the first and second annular structures are formed from a frame of nitinol wire.
23 . A device for implantation in an opening in a septal wall in a heart of a patient, the device comprising:
a core segment defining a passage, after implantation of the device, that enables flow to traverse from one side of the septal wall to another side of the septal wall, the core segment having a first diameter when deployed;
a first annular structure contiguous with the core segment; and
a second annular structure contiguous with the core segment,
wherein the device is collapsible, so that the core segment has a second diameter less than the first diameter to enable percutaneous delivery of the device to the heart of the patient,
wherein the first annular structure is configured to form a substantially flat surface that contacts one side of the septal wall, thereby forming a first contacting surface,
wherein a distal portion of the second annular structure is configured to lie parallel to and in contact with the other side of the septal wall, thereby forming a second contacting surface,
wherein at least a portion of the first and second annular structures define an annular gap, and
wherein the annular gap has a width less than a length of the core segment.
24 . The device of claim 23 , wherein the core segment comprises a tube that extends beyond the first annular structure or the second annular structure into an atrial chamber.
25 . The device of claim 23 , wherein the core segment comprises a tube.
26 . A device for implantation in an opening in a septal wall in a heart of a patient, the device comprising:
a core segment defining a passage, after implantation of the device, that enables flow to traverse from one side of the septal wall to another side of the septal wall, the core segment having a first diameter when deployed;
a first annular structure contiguous with the core segment;
a second annular structure contiguous with the core segment; and
a flow control element attached to the core segment and actuated by a shape-memory component,
wherein the device is collapsible, so that the core segment has a second diameter less than the first diameter to enable percutaneous delivery of the device to the heart of the patient.
27 . The device of claim 26 , wherein the flow control element allows fluid to flow through the passage from an area of higher pressure to an area of lower pressure.
28 . The device of claim 26 , wherein the flow control element is a valve comprising at least one leaflet.
29 . A device for directing blood flow across an atrial septum in a heart of a patient, the device comprising:
a core segment having a length greater than a width of the atrial septum, the core segment configured to define a passage having a first diameter when deployed;
a first flexible annular structure coupled to the core segment, the first flexible annular structure having a first contacting surface configured to lie substantially flat surface against one side of the atrial septum when deployed; and
a second flexible annular structure coupled to the core segment, a distal portion of the second flexible annular structure having a second contacting surface configured to lie parallel to and to contact the other side of the atrial septum when deployed,
wherein the device is collapsible, and the core segment has a second diameter less than the first diameter to enable percutaneous delivery of the device to the heart of the patient,
wherein at least a portion of the first and second annular structures defines an annular gap, and
wherein the core segment comprises a tube that extends beyond the first flexible annular structure or the second flexible annular structure into an atrial chamber.
30 . The device of claim 29 , wherein a size of the first contacting surface is equal to a size of the second contacting surface.