Patent foramen ovale (PFO) closure clips
First Claim
1. A device for closing a septal defect with two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, the device having a delivery configuration and a deployed configuration, the device comprising:
- an elongated element arranged in a closed loop in both the delivery and deployed configurations, the elongated element defining a first and a second opposed closure member and at least two connecting members, the elongated element being elongated and straightened in the delivery configuration,the first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, the two curved portions of the first closure member being connected at a first peak at a vertical center of the first closure member, the two curved portions of the second closure member being connected at a second peak at a vertical center of the second closure member, wherein the first and second peak generally oppose one another on opposite sides of the septum in the deployed configuration, and the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the deployed configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the deployed configuration,the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein the connecting members extend between the overlapping layers of septum primum and septum secundum, andportions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members disposed to provide a compressive force to the overlapping layers of septum primum and septum secundum, wherein, in the deployed configuration, the first and second closure members are substantially symmetric, the first closure member is directed generally in a first direction, and the second closure member is directed generally in a direction opposite to the first direction across a longitudinal axis transverse to the connecting members, and wherein, in the deployed configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the deployed configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first closure member and the vertical center of the second closure member.
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Accused Products
Abstract
The present invention provides a patent foramen ovale (PFO) closure clip. The clips of the present invention include two closure members joined by at least two spaced central connecting members. Each of the at least two spaced central connecting members is attached to each closure member at a location on the periphery of the closure member. The clips are designed such that the at least two central connecting members extend through the inclined PFO tunnel and the two closure members compress the overlapping layers of septal tissue, i.e. septum primum and septum secundum, together to close the PFO tunnel. The clips of the present invention take various forms depending, in part, upon the distribution of force required to close a given PFO. Thus, in some embodiments, the closure members include arcuate peaks. In other embodiments, the closure members include loops. In still other embodiments, the closure members include prongs.
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Citations
52 Claims
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1. A device for closing a septal defect with two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, the device having a delivery configuration and a deployed configuration, the device comprising:
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an elongated element arranged in a closed loop in both the delivery and deployed configurations, the elongated element defining a first and a second opposed closure member and at least two connecting members, the elongated element being elongated and straightened in the delivery configuration, the first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, the two curved portions of the first closure member being connected at a first peak at a vertical center of the first closure member, the two curved portions of the second closure member being connected at a second peak at a vertical center of the second closure member, wherein the first and second peak generally oppose one another on opposite sides of the septum in the deployed configuration, and the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the deployed configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the deployed configuration, the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein the connecting members extend between the overlapping layers of septum primum and septum secundum, and portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members disposed to provide a compressive force to the overlapping layers of septum primum and septum secundum, wherein, in the deployed configuration, the first and second closure members are substantially symmetric, the first closure member is directed generally in a first direction, and the second closure member is directed generally in a direction opposite to the first direction across a longitudinal axis transverse to the connecting members, and wherein, in the deployed configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the deployed configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first closure member and the vertical center of the second closure member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A system for closing a septal defect with two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, the system comprising:
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an elongated element defining a first and a second closure member and at least two connecting members, the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, said system having a first configuration adapted to be delivered through a catheter, said first configuration being of a generally low profile, the elongated element being arranged in a closed loop and being elongated and straightened in the first configuration, said system having a second configuration once delivered into the desired delivery site, the elongated element being arranged in a closed loop in the second configuration, the first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, the two curved portions of the first closure member being connected at a first peak at a vertical center of the first closure member, the two curved portions of the second closure member being connected at a second peak at a vertical center of the second closure member, wherein the first and second peak generally oppose one another on opposite sides of the septum in the second configuration, and the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the second configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the second configuration, and wherein in said second configuration including said connecting members, the system is adapted to extend between the overlapping layers of septum primum and septum secundum such that portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members are disposed to provide a compressive force to the overlapping layers of septum primum and septum secundum, and wherein, in the second configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the second configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first closure member and the vertical center of the second closure member. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A system for closing a septal defect with two overlapping layers of tissue, the system having a delivery configuration and a deployed configuration, the system comprising:
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an elongated element arranged in a closed loop in both the delivery and deployed configurations, the elongated element defining a first and a second closure members and at least two connecting members, the elongated element being elongated and straightened in the delivery configuration, the first and second opposed closure members disposed on opposite sides of the tissue, each closure member having a periphery, wherein each of the first and second closure members includes two curved portions, two elongate side strands, and a peak at a vertical center of the first and second closure members, the peak joining the two elongate side strands, and each peak having a peak angle of about 90 degrees or less, the first closure member and the second closure member configured to apply a compressive force to the overlapping layers in the deployed configuration, and wherein the first and second opposed closure members are substantially parallel to each other in the deployed configuration, the at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, said connecting members attached to said closure members at an acute angle such that said closure members and said connecting members form a relatively flat device in the deployed configuration, wherein the connecting members extend between the overlapping layers of tissue, and portions of the at least two connecting members and the two curved portions of each of the first and second opposed closure members disposed to provide a compressive force to the overlapping layers, and wherein, in the deployed configuration, the compressive force is applied to the overlapping layers at locations where portions of the elongated element overlap, and wherein in the deployed configuration, the compressive force is concentrated at the center of the septal defect along the vertical center of the first and second closure members. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52)
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Specification