MEDICAL DEVICE FOR PERCUTANEOUS PARAVALVULAR LEAK AND RELATED SYSTEMS AND METHODS
The present invention provides devices, systems and methods for closing a paravalvular leak. In accordance with one embodiment, a medical device includes at least one multicellular frame member configured to be implanted at a paravalvular leak. The medical device further includes at least one tissue in-growth member associated with the frame member, the tissue in-growth member being configured to promote tissue growth and permanently maintain the frame member at the leak. The frame member may be self expanding device formed, for example, of a shape-memory alloy. The tissue in-growth member may be formed from a polymer material. In one particular embodiment, the frame member may be a substantially tubular structure and the tissue in-growth member may be disposed within an interior space defined by the tubular structure. In another embodiment, the frame ember may be a substantially flat or planar structure.
1 . A medical device for repairing a paravalvular leak, comprising:
at least one multicellular frame member configured to be implanted at a paravalvular leak; and
at least one tissue in-growth member associated with the frame member, the tissue in-growth member configured to promote tissue growth and permanently maintain the frame member at the leak.
2 . The medical device of claim 1 , wherein the at least one multicellular frame member is a substantially tubular structure.
3 . The medical device of claim 1 , wherein the at least one tissue in-growth member is disposed within an internal space defined by the substantially tubular structure.
4 . The medical device of claim 3 , wherein the at least one multicellular frame member is formed of a material comprising a shape memory alloy.
5 . The medical device of claim 4 , wherein the shape memory alloy comprises a nickel-titanium alloy.
6 . The medical device of claim 1 , wherein the at least one tissue in-growth material is formed of a polymer material.
7 . The medical device of claim 1 , wherein the at least one multicellular frame member is a substantially planar structure.
8 . The medical device of claim 7 , wherein the at least one multicellular frame member is formed of a material comprising a shape-memory alloy.
9 . The medical device of claim 1 , further comprising a plurality of tines associated with the at least one multicellular frame member, the plurality of tines being configured to engage a wall of a valvular leak and anchor the medical device relative thereto.
10 . The medical device of claim 1 , wherein the at least one multi-cellular frame member comprises a first frame member and a second frame member, and wherein the at least one tissue in-growth member is disposed between the first frame member and the second frame member.
11 . The medical device of claim 10 , wherein the first frame member and the second frame member are substantially planar members and are arranged to lie in substantially parallel planes.
12 . A method of closing a paravalvular leak, the method comprising:
disposing a multicellular frame member within the paravalvular leak; and
disposing a tissue in-growth member within the paravalvular leak at a location adjacent the multicellular frame member to promote tissue growth and permanently maintain the frame member at the leak.
13 . The method according to claim 12 , wherein disposing a multicellular frame member within the paravalvular leak and disposing a tissue in-growth member within the paravalvular leak occurs substantially simultaneously.
14 . The method according to claim 12 , wherein disposing a multicellular structure includes disposing a self expanding structure within the paravalvular leak.
15 . The method according to claim 12 , wherein disposing a self expanding structure includes disposing a substantially planar structure within the paravalvular leak.
16 . The method according to claim 12 , wherein disposing a self expanding structure includes disposing a substantially tubular structure within the paravalvular leak.
17 . The method according to claim 14 , wherein disposing a tissue in-growth member includes disposing the tissue in-growth member within an inner space defined by the substantially tubular structure.
18 . The method according to claim 15 , wherein disposing a tissue in-growth member within the paravalvular leak further comprises disposing a foam material within the paravalvular leak.
19 . The method according to claim 12 , wherein disposing a multicellular frame member within the paravalvular leak and disposing a tissue in-growth member within the paravalvular leak further comprises disposing a first frame member and a second frame member, with the tissue in-growth member disposed between the first and second frame members, within the paravalvular leak.
20 . The method according to claim 19 , further comprising configuring the first and second frame members to be substantially planar members and arranging the first and second frame members to lie in substantially parallel planes.
21 . A medical device for repairing a paravalvular leak, comprising:
a frame member having at least two elongated arms biased in two different directions; and
a tissue in-growth member configured to be attached to the frame member to promote tissue growth and permanently seal the leak.
22 . The medical device of claim 21 , wherein the at least two different directions include a first direction and a second direction that is substantially opposite of the first direction.
23 . The medical device of claim 21 , wherein the at least two elongate arms include a first pair of elongated arms and a second pair of elongated arms.
24 . The medical device of claim 21 , wherein the frame member is formed of a material comprising a shape-memory alloy.
25 . The medical device of claim 24 , wherein the shape-memory alloy comprises a nickel-titanium alloy.
26 . The medical device of claim 24 , wherein the tissue in-growth member is formed of a polymer material.