Medical device including remodelable material attached to frame

Abstract

Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Medical devices preferably comprise a remodelable material attached to a frame with a tension that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, decrease the tension on the remodelable material after implantation. The remodelable material can form one or more valve leaflets adapted to regulate fluid flow in a body vessel, such as a vein.

1 . An endolumenal medical device comprising a support frame having a support member with a weakened frame portion; and a remodelable material attached to the support frame at two or more attachment points with a tension between the first attachment point and the second attachment point; wherein the controlled fracture of the support member at the weakened frame portion or the reduction of the cross sectional area of the support member at the weakened frame portion results in a decrease in the tension of the remodelable material between the first attachment point and the second attachment point.  
   
   
       2 . The medical device of  claim 1 , wherein the remodelable material is attached to the support member.  
   
   
       3 . The medical device of  claim 2 , wherein the weakened frame portion is positioned along the support member and between at least two of the attachment points.  
   
   
       4 . The medical device of  claim 3 , wherein the support member defines the perimeter of an opening in the support frame having three or more sides and the attachment points are positioned along the perimeter of the opening.  
   
   
       5 . The medical device of  claim 4 , wherein the opening in the support frame is covered by the remodelable material.  
   
   
       6 . The medical device of  claim 1 , wherein the support frame is configured as a tubular, radially compressible structure having a lumenal surface defining a tubular lumen and comprising a plurality of support members defining the tubular lumen of the support frame.  
   
   
       7 . The medical device of  claim 6 , wherein the remodelable material is configured as a tube attached to the support frame.  
   
   
       8 . The medical device of  claim 1 , wherein the remodelable material is configured as a valve leaflet having at least two sides attached to the support frame.  
   
   
       9 . The medical device of  claim 1 , wherein the remodelable material is an extracellular matrix material (ECM).  
   
   
       10 . The medical device of  claim 1 , wherein the material is small intestine submucosa (SIS).  
   
   
       11 . The medical device of  claim 1 , wherein the medical device has a substantially tubular structure defining a cylindrical lumen containing a longitudinal axis of the medical device extending therethrough; wherein the controlled fracture of the support member at the weakened frame portion decreases the tension of the remodelable material in a first direction that is substantially parallel to the longitudinal axis of the medical device.  
   
   
       12 . The medical device of  claim 11 , wherein the weakened frame portion is a controlled fracture initiation point.  
   
   
       13 . The medical device of  claim 11 , wherein the reduction of the cross sectional area of the support member at the weakened frame portion decreases the tension of the remodelable material in the first direction.  
   
   
       14 . The medical device of  claim 13 , wherein the weakened frame portion comprises a bioabsorbable material.  
   
   
       15 . The medical device of  claim 1 , wherein the support frame is a radially self-expanding frame.  
   
   
       16 . The medical device of  claim 15 , wherein at least a portion of the remodelable material is configured as a valve leaflet attached to the support member comprising the weakened frame portion, such that the tension on the valve leaflet in a first direction perpendicular to a longitudinal axis of the medical device is reduced by the controlled fracture of the support member at the weakened frame portion or the reduction of the cross sectional area of the support member at the weakened frame portion.  
   
   
       17 . An endolumenal valve comprising a radially-expandable support frame including an arcuate support member comprising a weakened frame portion and at least one bend positioned between two struts; and a valve leaflet comprising a remodelable material tensionably attached to the two struts of the arcuate support member; the remodelable material having a first tension between the two struts, wherein fracturing of the weakened frame portion or a decrease in the cross sectional area of the weakened frame portion of the arcuate support member decreases the first tension of the remodelable material.  
   
   
       18 . The endolumenal valve of  claim 17 , wherein the endoluminal valve defines a substantially tubular lumen having a longitudinal axis of the endoluminal valve passing therethrough, and the two struts of the arcuate support member are substantially parallel to the longitudinal axis.  
   
   
       19 . The endolumenal valve of  claim 17 , wherein the remodelable material comprises small intestine submucosa.  
   
   
       20 . The endolumenal valve of  claim 17 , wherein the valve leaflet is subject to a force of between about 1-5N between the two struts of the arcuate support member.  
   
   
       21 . A method of treating a subject presenting symptoms of venous valve insufficiency, varicose veins, esophageal reflux, restenosis or atherosclerosis comprising the step of endolumenally implanting a valve comprising a support frame having an arcuate member comprising a weakened frame portion and at least one bend positioned between two struts; and a valve leaflet comprising a remodelable material tensionably attached to the two struts of the arcuate member, the remodelable material having a first tension in a first direction, wherein fracturing the weakened frame portion or decreasing the cross sectional area of the weakened frame portion decreases the tension of the remodelable material in the first direction.