Patent foramen ovale (PFO) closure clips
First Claim
1. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, and at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein said connecting members extend between the overlapping layers of septum primum and septum secundum such that said first and second closure members cooperate to provide a compressive force to the overlapping layers of septum primum and septum secundum.
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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 may be formed of various materials. In at least some embodiments, the clips are formed of metals, nonmetallic materials, bioabsorbable polymers, spring steel, shape memory materials, bioabsorbable shape memory polymers, or combinations thereof. 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. In yet other embodiments, the closure members include centering elements for centering the device in the desired delivery location. In at least some embodiments, the clips of the present invention are repositionable and/or retrievable. In some embodiments, at least one of the closure members includes a tissue scaffold.
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Citations
98 Claims
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1. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, and
at least two connecting members attached to each of said closure members at a location on the periphery of said closure members, wherein said connecting members extend between the overlapping layers of septum primum and septum secundum such that said first and second closure members cooperate to provide a compressive force to the overlapping layers of septum primum and septum secundum.
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31. A method of closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising:
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a. inserting a catheter into the right atrium of said heart, said catheter containing a closure device including first and second closure members and at least two spaced central connecting members, wherein each of said closure members has a periphery and each of said central connecting members is attached to each of said closure members at a location on the periphery of said closure members;
b. inserting said catheter between the overlapping layers of septum primum and septum secundum and into the left atrium of said heart;
c. deploying said second closure member into the left atrium;
d. retracting said catheter between the overlapping layers of septum primum and septum secundum and into the right atrium, said at least two spaced central connecting members extending at an angle between septum primum and septum secundum;
e. further retracting said catheter out of the right atrium, such that said first closure member is deployed into the right atrium and applies a compressive force to said overlapping layers of septum primum and septum secundum in said right atrium, whereby said first and second closure members cooperate to close said overlapping layers of septum primum and septum secundum. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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57. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising at least one closure member disposed on one side of the septum, said at least one closure member having a periphery, and
a connecting member attached to said periphery of said closure member, wherein said connecting member extends between the overlapping layers of septum primum and septum secundum such that said closure member cooperates with the connecting member to provide a compressive force to the overlapping layers of septum primum and septum secundum.
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63. A system for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, comprising first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, and 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, said system having a second configuration once delivered into the desired delivery site, said second configuration including said connecting members adapted to extend between the overlapping layers of septum primum and septum secundum such that said first and second closure members cooperate to provide a compressive force to the overlapping layers of septum primum and septum secundum.
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89. A system for closing two overlapping layers of tissue, comprising first and second opposed closure members disposed on opposite sides of the septum, each closure member having a periphery, and
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, wherein said central connecting members extend between the overlapping layers of tissue such that said first and second closure members cooperate to provide a closure force to the overlapping layers of tissue.
Specification