Implantable prosthetic valve
First Claim
1. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
- an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction;
at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; and
a restraining member contacting the second edge of the at least one leaflet, the anchoring member, and/or vessel wall, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions;
wherein the restraining member is sized to be left within the blood vessel after implantation of the valve and closure of an implantation site to thereby prevent substantial movement of the at least one leaflet for a sufficient length of time to allow endothelial tissue overgrowth of one or both of the at least one leaflet and the anchoring member.
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Accused Products
Abstract
An implantable prosthetic valve for regulating fluid flow through a body vessel is provided. The prosthetic valve comprises an anchoring member, at least one leaflet, and a restraining member capable of temporarily preventing substantial movement of the leaflet between and open and closed position so as to allow fluid flow in the antegrade and retrograde directions. In various embodiments, the prosthetic valve reduces the risk of thrombosis. In various embodiments, the prosthetic valve reduces the appearance of potentially thrombogenic abnormal flow patterns at the site of implantation immediately following the implantation, allows cell deposition making the valve more biocompatible, less thrombogenic before flow changes resulting from valving action set in and allows tissue growth so that a partially or completely biological functioning valve may form on the scaffold provided by the implant.
30 Citations
25 Claims
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1. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; and a restraining member contacting the second edge of the at least one leaflet, the anchoring member, and/or vessel wall, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions; wherein the restraining member is sized to be left within the blood vessel after implantation of the valve and closure of an implantation site to thereby prevent substantial movement of the at least one leaflet for a sufficient length of time to allow endothelial tissue overgrowth of one or both of the at least one leaflet and the anchoring member. - View Dependent Claims (2, 3, 5, 6, 7, 8, 10, 11)
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4. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; and a restraining member contacting the second edge of the at least one leaflet, the anchoring member, and/or vessel wall, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions; wherein the restraining member contacts the second edge of the leaflet and the interior surface of the anchoring member.
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9. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; and a restraining member contacting the second edge of the at least one leaflet, the anchoring member, and/or vessel wall, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions; wherein the at least one leaflet; i) is substantially coincident with all or a portion of the interior surface of the anchoring member; ii) is shorter than the anchoring member; or iii) is longer than the anchoring member and the restraining member contacts the vessel wall.
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12. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; and a restraining member contacting the second edge of the at least one leaflet, the anchoring member, and/or vessel wall, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions; wherein the restraining member is degradable.
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13. An implantable prosthetic valve for regulating fluid flow through a body vessel, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a substantially open position and a substantially closed position, the open position substantially permits fluid flow and the closed position substantially prevents fluid flow; and a restraining member contacting the second edge of the at least one leaflet, the restraining member capable of temporarily holding the at least one leaflet in the substantially open position to allow fluid flow; wherein the restraining member is sized to be left within the blood vessel after implantation of the valve and closure of an implantation site to thereby prevent substantial movement of the at least one leaflet for a sufficient length of time to allow endothelial tissue overgrowth of one or both of the at least one leaflet and the anchoring member. - View Dependent Claims (14)
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15. A kit for implanting a prosthetic valve, comprising:
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an anchoring member having exterior and interior surfaces, the exterior surface of the anchoring member capable of contacting an inner wall of the body vessel, the interior surface of the anchoring member defining an opening for fluid flow in an antegrade and a retrograde direction; at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits fluid flow in the antegrade direction and the second position substantially prevents the fluid flow in the retrograde direction; a restraining member for contacting the second edge of the at least one leaflet, the anchoring member and/or vessel, the restraining member capable of temporarily preventing substantial movement of the at least one leaflet between the first position and the second position so as to allow fluid flow in the antegrade and retrograde directions; wherein the restraining member is sized to be left within the blood vessel after implantation of the valve and closure of an implantation site to thereby prevent substantial movement of the at least one leaflet for a sufficient length of time to allow endothelial tissue overgrowth of one or both of the at least one leaflet and the anchoring member; packaging for the implantable prosthetic valve; and instructions for implanting the prosthetic valve. - View Dependent Claims (16)
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17. An implantable prosthetic valve leaflet for regulating fluid flow through a body vessel, the leaflet comprising a first edge and a second edge, the first edge capable of being attached to a wall of the body vessel, and/or an anchoring member, the second edge of the leaflet having a restraining member capable of temporarily restraining the second edge of the leaflet against the wall of the body vessel and/or anchoring member so as to substantially prevent movement of the leaflet between a first position and a second position.
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18. A method of implanting a prosthetic valve within a blood vessel at a desired position therein, comprising:
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a) providing a prosthetic valve which comprises; (i) an anchoring member having exterior and interior surfaces, the interior surface of the anchoring member defining an opening for blood flow in an antegrade and a retrograde direction; (ii) at least one leaflet having a first edge attached to the anchoring member and a second edge being moveable between a first position and a second position, the first position substantially permits blood flow in the antegrade direction and the second position substantially prevents blood flow in the retrograde direction; b) forming an opening in the blood vessel; c) inserting the valve through the formed opening and delivering the valve to the desired position at which the valve is to be implanted and implanting the valve so that the exterior surface of the anchoring member is substantially coincident with a portion of an inner wall of the blood vessel; d) restraining the second edge of the at least one leaflet with a restraining member to temporarily prevent substantial movement of the at least one leaflet between the first position and the second position so as to allow blood flow in the antegrade and retrograde directions; e) allowing the vessel to heal after the valve is implanted; and f) later removing the restraining member or allowing the restraining member to be removed by the body so that the second edge of the leaflet is moveable between the first position to permit blood flow in the antegrade direction and the second position to substantially prevent blood flow in the retrograde direction. - View Dependent Claims (19, 20, 21)
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22. A method of implanting a prosthetic valve within a blood vessel at a desired position therein, comprising:
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a) providing a prosthetic valve which comprises at least one leaflet having a first edge attached to the vessel wall and a second edge being moveable between a first position and a second position, the first position substantially permits blood flow in the antegrade direction and the second position substantially prevents blood flow in the retrograde direction; b) forming an opening in the blood vessel; c) inserting the valve through the formed opening and delivering the valve to the desired position at which the valve is to be implanted and implanting the valve so that the first edge of the leaflet is attached to the inner wall of the blood vessel; d) restraining the second edge of the at least one leaflet with a restraining member to temporarily prevent substantial movement of the at least one leaflet between the first position and the second position so as to allow blood flow in the antegrade and retrograde directions; e) allowing the vessel to heal after the valve is implanted; and f) later removing the restraining member or allowing the restraining member to be removed by the body so that the second edge of the leaflet is moveable between the first position to permit blood flow in the antegrade direction and the second position to substantially prevent blood flow in the retrograde direction. - View Dependent Claims (23, 24, 25)
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Specification