Prosthetic insert for improving heart valve function

Abstract

A device and methods for improving the function of a heart valve, such as an aortic valve, is disclosed. In one embodiment, the device includes an insert member configured for insertion between leaflets of an aortic valve. The insert member preferably includes three radial arms extending outwardly from a central portion. The device also includes an anchoring member which is coupled to the insert member and configured for maintaining the insert member within the heart valve. In operation, each of the arms fills gaps between heart valve leaflets, thereby minimizing or preventing regurgitation through the heart valve.

1 . A device for improving the function of a heart valve, comprising:
 an insert member comprising a body configured for insertion between leaflets of the heart valve, the body having at least first and second solid leaflet-contacting surfaces; and   an anchoring member coupled to the insert member, the anchoring member comprising a stent having an open-frame structure configured to be radially compressible to a compressed state for delivery to a deployment site adjacent the heart valve and radially expandable to an expanded state at the deployment site,   wherein each of the leaflet-contacting surfaces is configured to contact a leaflet of the heart valve when the heart valve closes to minimize regurgitation through the heart valve.   
   
   
       2 . The device of  claim 1 , wherein the anchoring member is sized to engage an inner wall of an aorta when in the expanded state. 
   
   
       3 . The device of  claim 1 , further comprising at least one spacer for coupling the insert member to the anchoring member, the at least one spacer being of sufficient length to permit the anchoring member to be deployed within an aorta with the insert member inserted in the an aortic valve such that the anchoring member and insert member are on opposite sides of the coronary ostia. 
   
   
       4 . The device of  claim 3 , wherein the length of the at least one spacer is at least 6 mm. 
   
   
       5 . The device of  claim 1 , wherein the at least first and second solid leaflet-contacting surfaces comprise three solid leaflet-contacting surfaces, each being configured to contact a leaflet of an aortic heart valve when the aortic heart valve closes to minimize regurgitation through the aortic heart valve. 
   
   
       6 . The device of  claim 5 , wherein the body comprises three angularly-spaced extension portions that extend radially outward from a central portion of the insert member, the extension portions defining the leaflet-contacting surfaces. 
   
   
       7 . The device of  claim 6 , wherein each of the extension portions are tapered in width. 
   
   
       8 . The device of  claim 1 , wherein the body is configured to be radially compressible to a compressed state for delivery to the deployment site adjacent the heart valve and radially expandable to an expanded state at the deployment site. 
   
   
       9 . The device of  claim 1 , wherein the stent is self-expanding. 
   
   
       10 . The device of  claim 1 , wherein the stent is balloon-expandable. 
   
   
       11 . The device of  claim 1 , wherein the stent supports a prosthetic valve for occluding blood flow in one direction through the stent. 
   
   
       12 . The device of  claim 1 , wherein the anchoring member is formed from a shape memory alloy. 
   
   
       13 . The device of  claim 1 , wherein the body comprises an inner support and an outer layer defining the leaflet-contacting surfaces, the outer layer comprising a biological material to inhibit abrasion of the heart valve leaflets when the heart valve leaflets contact the leaflet-contact surfaces on the body of the insert member. 
   
   
       14 . The device of  claim 13 , wherein the biological material comprises animal pericardial tissue. 
   
   
       15 . The device of  claim 13 , wherein the inner support comprises a shape memory material. 
   
   
       16 . The device of  claim 1 , wherein the body of the insert member extends partially into the stent. 
   
   
       17 . A device for improving the function of an aortic valve, comprising:
 an insert member comprising a body configured for insertion between leaflets of the aortic valve, the body having a central portion and three angularly-spaced arms extending radially outward from the central portion; and   an anchoring member configured for securement to a muscular wall inside a heart chamber, the anchoring member comprising at least one engagement member configured to engage the muscular wall,   wherein the anchoring member comprises an elongated shaft having a first end connected to the insert member and a second end connected to the at least one engagement member.   
   
   
       18 . The device of  claim 17 , wherein the heart chamber is a left ventricle. 
   
   
       19 . The device of  claim 17 , wherein the body has at least one tapered end region. 
   
   
       20 . The device of  claim 17 , wherein the at least one engagement member comprises a plurality of expandable fingers configured to penetrate and engage the muscular wall of the heart. 
   
   
       21 . The device of  claim 17 , wherein the at least one engagement member comprises a first plate and a second plate, the first and second plates being located on opposites sides of the muscular wall of the heart, wherein the first plate is disposed on the elongated shaft inside the chamber of the heart and the second plate is disposed on the elongated shaft outside of the chamber of the heart. 
   
   
       22 . A device for improving the function of an aortic valve, comprising:
 an insert member comprising a body having three angularly-spaced arms extending radially outwardly for insertion between leaflets of the aortic valve, the three angularly-spaced arms being shaped to prevent regurgitation through the aortic valve; and   an expandable anchoring member coupled to the insert member, the anchoring member configured for deployment within an aorta.   
   
   
       23 . The device of  claim 22 , further comprising at least one spacer extending between the insert member and the anchor member. 
   
   
       24 . The device of  claim 23 , wherein the at least one spacer has sufficient length to permit the anchoring member to be deployed in an aorta while the insert member is deployed in the aortic valve such that the anchoring member and the insert member are on opposite sides of the coronary ostia. 
   
   
       25 . The device of  claim 23 , wherein the at least one spacer is an elongated rod. 
   
   
       26 . The device of  claim 22 , wherein the anchoring member is an expandable stent having an open-frame construction. 
   
   
       27 . The device of  claim 23 , wherein the spacer comprises a plurality of elongated rods extending between and connected to the anchoring member and the insert member. 
   
   
       28 . A method for improving the function of an aortic valve, comprising:
 providing a prosthetic device having an anchoring member and an insert member, the insert member being configured to reduce regurgitation through the aortic valve;   deploying the anchoring member in an aorta; and   deploying the insert member in the aortic valve, wherein the anchoring member maintains the insert member within the aortic valve.   
   
   
       29 . The method of  claim 28 , wherein the anchoring member and the insert member are delivered percutaneously through the subject's vasculature in a compressed state. 
   
   
       30 . The method of  claim 29 , wherein the insert member of the prosthetic device is retained in a delivery sheath while delivered through the subject's vasculature. 
   
   
       31 . The method of  claim 29 , wherein the anchoring member comprises an expandable stent that is mounted in a compressed state on a balloon of a delivery catheter. 
   
   
       32 . The method of  claim 28 , wherein deploying the anchoring member of the prosthetic device comprises deploying the anchoring member above the ostia of the coronary arteries. 
   
   
       33 . The method of  claim 28 , wherein the insert member has three arms extending radially outward from a central portion and deploying the insert member in the aortic valve comprises positioning the insert member such that the arms are located within gaps between leaflets of the aortic valve. 
   
   
       34 . The method of  claim 29 , wherein the anchoring member and the insert member are mounted on a common delivery catheter for simultaneous delivery through the subject's vasculature.