Prosthetic device for heart valve
An implantable device includes a spacer member configured to be disposed between leaflets of a native heart valve that is located between a first chamber and a second chamber of the heart. The device further includes a plurality of anchor members coupled to the spacer member and configured to capture the leaflets such that the device is retained between the leaflets. The spacer member is configured to provide a flow path through the device between the first chamber and the second chamber when the leaflets are captured such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member.
1 . An implantable device, comprising:
a spacer member configured to be disposed between first and second leaflets of a native heart valve of a heart, the native heart valve being located between a first chamber and a second chamber of the heart, wherein the spacer member comprises:
a porous body formed from a wire mesh;
a porous covering arranged on the porous body;
a first anchor member;
a second anchor member;
wherein the first anchor member and the second anchor member are coupled to the spacer member;
where the first anchor member is configured to capture the first leaflet between the first anchor member and the spacer member and the second anchor member is configured to capture the second leaflet between the second anchor member and the spacer member such that the spacer member is retained between the leaflets;
wherein the porous covering is disposed over the first anchor member, extends from the first anchor member over a distal end of the implantable device to the second anchor member, and is disposed over the second anchor member; and
wherein the spacer member is configured to provide a flow path through the implantable device between the first chamber and the second chamber when the leaflets are captured between the first and second anchor members and the spacer member such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member.
2 . The implantable device of claim 1 , wherein:
the first chamber is a left ventricle and the second chamber is a left atrium; and
the spacer member is configured to allow a regurgitant blood flow volume through the implantable device from the left ventricle to the left atrium of from 5% to 30% of a left ventricle stroke volume of the left ventricle at a time the implantable device is implanted.
3 . The implantable device of claim 1 , wherein the porous covering comprises a knitted fabric.
4 . The implantable device of claim 1 , wherein the porous covering comprises an openwork fabric.
5 . The implantable device of claim 1 , wherein:
the first chamber is a left ventricle and the second chamber is a left atrium; and
the porous covering is configured to promote tissue ingrowth such that regurgitant blood flow through the implantable device from the left ventricle to the left atrium is reduced from 15% to 30% of a left ventricle stroke volume of the left ventricle at a time the implantable device is implanted, to 0% to 20% of a left ventricle stroke volume of the left ventricle over a time period of one month to six months.
6 . The implantable device of claim 1 , wherein:
the native heart valve is a mitral valve; and
the porous covering is configured to promote tissue ingrowth such that regurgitant blood flow through the implantable device from the second chamber to the first chamber is reduced from a volume equivalent to mitral regurgitation having an angiographic grade of MR≥3+ at a time the implantable device is implanted, to a volume equivalent to mitral regurgitation having an angiographic grade of MR≤2+ over a time period of one month to six months.
7 . The implantable device of claim 1 , wherein:
the native heart valve is a mitral valve;
the implantable device is coupled to a delivery apparatus prior to implantation; and
the implantable device is configured to allow regurgitant blood flow through the spacer member after the implantable device is released from the delivery apparatus, a volume of the regurgitant blood flow being equivalent to mitral regurgitation having an angiographic grade of MR>2+.
8 . The implantable device of claim 7 , wherein the implantable device is configured to allow the regurgitant blood flow through the spacer member having a volume equivalent to mitral regurgitation having an angiographic grade of MR>3+.
9 . The implantable device of claim 7 , wherein the implantable device is configured to allow the regurgitant blood flow through the spacer member having a volume equivalent to mitral regurgitation having an angiographic grade of MR>4+.
10 . A valve repair system comprising:
a delivery sheath;
a valve repair device comprising:
a spacer member configured to be disposed between first and second leaflets of a native heart valve of a heart, the native heart valve being located between a first chamber and a second chamber of the heart, wherein the spacer member comprises:
a porous body formed from a wire mesh;
a porous covering arranged on the porous body;
a first anchor member;
a second anchor member;
wherein the first anchor member and the second anchor member are coupled to the spacer member;
wherein the first anchor member is configured to capture the first leaflet between the first anchor member and the spacer member and the second anchor member is configured to capture the second leaflet between the second anchor member and the spacer member such that the spacer member is retained between the leaflets;
wherein the porous covering is disposed over the first anchor member, extends from the first anchor member over a distal end of the valve repair device to the second anchor member, and is disposed over the second anchor member; and
wherein the spacer member is configured to provide a flow path through the valve repair device between the first chamber and the second chamber when the leaflets are captured between the first and second anchor members and the spacer member such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member.
11 . The valve repair system of claim 10 , wherein:
the first chamber is a left ventricle and the second chamber is a left atrium; and
the spacer member is configured to allow a regurgitant blood flow volume through the valve repair device from the left ventricle to the left atrium of from 5% to 30% of a left ventricle stroke volume of the left ventricle at a time the valve repair device is implanted.
12 . The valve repair system of claim 10 , wherein:
the native heart valve is a mitral valve; and
the porous covering is configured to promote tissue ingrowth such that regurgitant blood flow through the valve repair device from the second chamber to the first chamber is reduced from a volume equivalent to mitral regurgitation having an angiographic grade of MR≥3+ at a time the valve repair device is implanted, to a volume equivalent to mitral regurgitation having an angiographic grade of MR≤2+ over a time period of one month to six months.
13 . The valve repair system of claim 10 , wherein:
the native heart valve is a mitral valve;
the valve repair device is coupled to a delivery apparatus prior to implantation; and
the valve repair device is configured to allow regurgitant blood flow through the spacer member after the valve repair device is released from the delivery apparatus, a volume of the regurgitant blood flow being equivalent to mitral regurgitation having an angiographic grade of MR>2+.
14 . An implantable device, comprising:
a spacer member configured to be disposed between first and second leaflets of a native heart valve of a heart, the native heart valve being located between a first chamber and a second chamber of the heart, wherein the spacer member comprises:
a porous body formed from a wire mesh;
a porous covering arranged on the porous body;
a first anchor member;
a second anchor member;
wherein the first anchor member and the second anchor member are coupled to the spacer member;
wherein the first anchor member is configured to capture the first leaflet between the first anchor member and the spacer member and wherein the second anchor member is configured to capture the second leaflet between the second anchor member and the spacer member such that the spacer member is retained between the leaflets;
wherein the porous covering is disposed over the first anchor member, extends from the first anchor member over a distal end of the implantable device to the second anchor member, and is disposed over the second anchor member;
wherein the spacer member is configured to provide a flow path through the implantable device between the first chamber and the second chamber when the leaflets are captured such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member;
wherein the native heart valve is a mitral valve; and
the spacer member is configured to promote tissue ingrowth such that regurgitant blood flow through the implantable device from the second chamber to the first chamber is reduced from a volume equivalent to mitral regurgitation having an angiographic grade of MR≥3+ at a time the implantable device is implanted, to a volume equivalent to mitral regurgitation having an angiographic grade of MR≤2+ over a time period of one month to six months.
15 . The implantable device of claim 14 , wherein:
the first chamber is a left ventricle and the second chamber is a left atrium; and
the spacer member is configured to allow a regurgitant blood flow volume through the implantable device from the left ventricle to the left atrium of from 5% to 30% of a left ventricle stroke volume of the left ventricle at a time the implantable device is implanted.
16 . The implantable device of claim 14 , wherein the porous covering comprises an openwork fabric.
17 . The valve repair system of claim 10 , wherein the porous covering comprises a knitted fabric.
18 . The valve repair system of claim 10 , wherein the porous covering comprises an openwork fabric.
19 . The implantable device of claim 16 , wherein the porous covering comprises a knitted fabric.