Septal closure devices
A closure device for a patent foramen ovale (PFO) has proximal and distal occlusion members for applying compressive forces to tissue on opposite sides of septal defects to help close the defects. The devices are collapsible for delivery and deployment, and can be easily retrieved and redeployed or repositioned if needed.
1. An apparatus comprising:
a patent foramen ovale (PFO) closure device movable from a collapsed configuration when within a delivery device to a deployed configuration for providing compressive force to a septum primum and a septum secundum, the device further comprising:
a central body for extending through the PFO, wherein the central body is elongated and substantially linear and extends along a longitudinal axis of the device,
a first end cap, and a second end cap in line with the central body;
at least a first wire and a second wire extending through the central body from the first end cap to the second end cap;
the first wire and the second wire defining a first occlusion member on a first side of the central body each wire of which extends in a substantially planar manner along the longitudinal axis of the device when in the collapsed configuration and forming a first and a second collapsible loop which are generally perpendicular to the longitudinal axis of the device and which extend in a first plane perpendicular to the central body when in the deployed configuration, and the first and second wire defining a second occlusion member on a second side of the central body, each wire of which extends in a substantially planar manner along the longitudinal axis of the device when in the collapsed configuration and forming a third and a fourth collapsible loop which are generally perpendicular to the longitudinal axis of the device and which extend in a second plane perpendicular to the central body when in the deployed configuration, wherein the first and second plane are generally parallel, wherein each collapsible loop is a single loop extending from the central body to the first or second end cap;
wherein moving the first end cap toward the central body moves the first occlusion member from the collapsed configuration to the deployed configuration and moving the second end cap moves the second occlusion member from the collapsed configuration to the deployed configuration;
wherein when in the deployed configuration, the first and second occlusion members each cooperate with the central body to apply a generally perpendicular force to overlapping layers of the septum primum and the septum secundum to close the PFO;
wherein each of the collapsible loops is independent from one another; and
wherein further, the first wire and the second wire extending through the central body from the first end cap to the second end cap extend in a substantially planar manner along the longitudinal axis of the device when in the collapsed configuration within the delivery device.
2. The apparatus of claim 1 , wherein the device includes nitinol.
3. The apparatus of claim 1 , wherein the device includes a shape memory polymeric material.
4. The apparatus of claim 1 , wherein the device is made from a shape memory material with properties such that the device, when delivered into a body, has a phase transition and assumes the deployed configuration.
5. The apparatus of claim 1 , wherein the device is retrievable, redeployable, and repositionable.
6. A method comprising delivering the PFO closure device of claim 5 through a catheter to a PFO.
7. The apparatus of claim 1 , further comprising a material over the first and second loops for promoting tissue ingrowth.
8. The apparatus of claim 7 , wherein the loops are made of a bioresorbable material.
9. A method comprising delivering the PFO closure device of claim 8 through a catheter to a PFO.
10. A method comprising delivering the PFO closure device of claim 8 through a catheter to a PFO, and drawing the device back into the catheter.
11. The apparatus of claim 7 , further comprising a material over the third and fourth loops for promoting tissue ingrowth.
12. A method comprising delivering the PFO closure device of claim 7 through a catheter to a PFO.
13. A method comprising delivering the PFO closure device of claim 1 through a catheter to a PFO.
14. The method of claim 13 , further comprising aligning a first axis defined by the first and second loops when in the deployed configuration with a longitudinal axis defined by the septum primum and septum secundum, wherein the first axis extends from a point on the first loop furthest from the central body to a point on the second loop furthest from the central body.
15. The method of claim 14 , further comprising aligning a second axis defined by the third and fourth loops when in the deployed configuration with the longitudinal axis defined by the septum primum and septum secundum, wherein the second axis extends from a point on the third loop furthest from the central body to a point on the fourth loop furthest from the central body.
16. A method comprising delivering the PFO closure device of claim 1 through a catheter to a PFO, wherein the device includes a shape memory material.
17. The apparatus of claim 1 , wherein each loop is petal shaped.