Ventricular infarct assist device and methods for using it

Abstract

This relates to surgical devices and methods of using them. In particular, the devices are used to support and to reform myocardial tissue in the region of and across an infarct. The devices provide tension across the infarct in varying degrees by attachment of the device to the myocardium at sites adjacent the infarct. A support-providing component across the infarct, between the heart attachment sites, provides support to the myocardial wall and support across the infarct. Optionally, but preferably, the support-providing component includes a time-delay element that variously may allow the device to be introduced onto the myocardial surface and to change the support of the support element over time.

1 . A device for reforming the shape of a beating heart, said device comprising:
 a first anchor adapted to adhere directly to a first surface of the heart, the first surface adjacent the damaged tissue;   a second anchor adapted to adhere directly to a second surface of the heart, the second surface adjacent the damaged tissue, and opposite the first surface; and   a resiliently elongatable support member having a first end and a second end opposite the first end, wherein the first anchor is coupled to the first end, and the second anchor is coupled to the second end, the support member adapted to resiliently contract from an elongated configuration to a contracted configuration so as to decrease distance between the first and the second ends over a period of time following implantation in the heart tissue.   
   
   
       2 . The device of  claim 1 , wherein the first anchor comprises a fastener coupled therewith and adapted to penetrate at least partially into the heart so as to secure the first anchor thereto. 
   
   
       3 . The device of  claim 1 , wherein the second anchor comprises a fastener coupled therewith and adapted to penetrate at least partially into the heart so as to secure the second anchor thereto. 
   
   
       4 . The device of  claim 1 , further comprising an adhesive, wherein the adhesive adheres at least one of the anchors to its respective surface. 
   
   
       5 . The device of  claim 1 , wherein the support member comprises a first spring. 
   
   
       6 . The device of  claim 5 , wherein the first spring comprises a flat spring or a coil spring. 
   
   
       7 . The device of  claim 5 , wherein the support member comprises a second spring. 
   
   
       8 . The device of  claim 7 , wherein the second spring comprises a flat spring or a coil spring. 
   
   
       9 . The device of  claim 1 , wherein the support member comprises a time delay member coupled with the support member, the time delay member having a first state in which contraction of the support member is prevented, and a second state in which the support member can contract. 
   
   
       10 . The device of  claim 9 , wherein the time delay member comprises a biodegradable polymer. 
   
   
       11 . The device of  claim 1 , further comprising a radiopaque marker attached to one or more of the anchors or to the support member. 
   
   
       12 . The device of  claim 1 , further comprising a bioactive agent coupled with at least one of the anchors or the support member, the bioactive agent adapted to be delivered therefrom to facilitate healing of the damaged tissue. 
   
   
       13 . The device of  claim 12 , wherein the bioactive agent promotes angiogenesis in the damaged tissue and in tissue adjacent thereto. 
   
   
       14 . A method for reforming the shape of a beating heart, said method comprising:
 providing a support device having first and second anchors and a support member therebetween;   attaching the first anchor directly to a first sufficiently healthy surface of the heart, wherein the first surface is adjacent the damaged tissue;   attaching the second anchor directly to a second sufficiently healthy surface of the heart, wherein the second surface is adjacent the damaged tissue, and opposite the first surface;   resiliently contracting the support member to draw the first and the second sufficiently healthy surfaces together over a period of time following attachment of the first and second anchors thereby reforming the shape of the heart.   
   
   
       15 . The method of  claim 14 , wherein the first anchor comprises a fastener and the step of attaching the first anchor comprises positioning the fastener at least partially into the heart. 
   
   
       16 . The method of  claim 14 , wherein the second anchor comprises a fastener and the step of attaching the second anchor comprises positioning the fastener at least partially into the heart. 
   
   
       17 . The method of  claim 14 , wherein the step of attaching the first anchor or the step of attaching the second anchor comprises bonding one of the anchors to its respective surface. 
   
   
       18 . The method of  claim 14 , wherein the step of drawing the first surface to the second surface comprises providing a time delay member coupled with the support member, the time delay member having a first state in which contraction of the support member is prevented, and a second state in which the support member can contract. 
   
   
       19 . The method of  claim 18 , wherein the step of drawing the first surface to the second surface comprises biodegrading the time delay member. 
   
   
       20 . The method of  claim 14 , further comprising delivering a bioactive agent from the support device to the damaged tissue, the bioactive agent adapted to facilitate healing of the damaged tissue. 
   
   
       21 . The method of  claim 20 , wherein the bioactive agent promotes angiogenesis in the damaged tissue and in tissue adjacent thereto. 
   
   
       22 . The method of  claim 14 , wherein the heart is reformed so as to reduce mitral regurgitation.