Memory material valve

Abstract

A replacement heart valve comprising a memory shape element. The various embodiments use internal body heat to seat and retain the valve within a blood passage. The element can be provided in a variety of shapes and sizes, and is at least partially encased within an inert and pliant encasing material. The encasing material is one that is adapted to be contiguous with the structure of the valve nozzle or backflow-resistant leaf structure, and may be used in combination with existing stents or an incorporated stent, including ones having a structure similar to conventional stents.

I claim: 
     
         1 . a method of manufacturing, comprising:
 a step of providing a memory shape element,   a step of encasing the memory shape element in a pliant, non-reactive, inert encasing material, and   a step of forming a valve in connection with the encasing material,   wherein the memory shape element comprises a memory shape material.   
     
     
         2 . The method of  claim 1 , wherein the step of forming the valve comprises a procedure in which the encasing material is grasped and drawn to a desired length and then cut or otherwise attenuated to a desired size and shape. 
     
     
         3 . The method of  claim 1 , wherein the step of encasing comprises a step of casting the encasing material around the memory shape element. 
     
     
         4 . The method of  claim 1 , wherein the memory shape element comprises a metal ply rolled or bent or curved into a substantially circumferential ring. 
     
     
         5 . The method of  claim 1 , wherein the memory shape element comprises a section helical section of a memory shape material, one selected from a list comprising a nickel-titanium wire coil and a helical nickel-titanium ribbon. 
     
     
         6 . The method of  claim 1 , further comprising a step of augmenting at least one of the memory shape element and encasing material with a supplemental stent. 
     
     
         7 . The method of  claim 1 , wherein the memory shape element is a stent. 
     
     
         8 . The method of  claim 1 , wherein the valve is a distending nozzle. 
     
     
         9 . The method of  claim 1 , wherein the valve is a three-leaf valve. 
     
     
         10 . The method of  claim 1 , wherein the valve is in connection with the encasing material by being integrally formed and materially contiguous with the encasing material. 
     
     
         11 . The method of  claim 6 , wherein the supplemental stent is dissimilarly shaped to the memory shape element and comprises a memory shape material. 
     
     
         12 . The method of  claim 6 , wherein at least one end of the supplemental stent is a free end, and further comprising a step of appending the free end of the supplemental stent with an additional memory shape element. 
     
     
         13 . The message of  claim 12 , wherein the memory shape element and the additional memory shape element abut opposite ends of the supplemental stent and do not otherwise contact one another. 
     
     
         14 . The method of  claim 6 , wherein the supplemental stent is a counter-rotation helical coil. 
     
     
         15 . The method of  claim 6 , wherein the supplemental stent is an expandable mesh stent. 
     
     
         16 . The method of  claim 1 , wherein the memory shape element is provided and encased in the encasing material such that the element and material and valve are sized and shaped and sufficiently collapsible so as to be deliverable by a catheter to an internal organ of a mammal. 
     
     
         17 . The method of  claim 16 , wherein the memory shape material and encasing material and valve are adjustable, and further comprising a step of adjusting the memory shape material and subjecting the memory shape material to conditions such that the memory shape material adopts a desired memory state, the memory state being one of a desired size and shape for any pre-existing valve in any particular mammal. 
     
     
         18 . The method of  claim 17 , wherein the memory shape material and encasing material and valve are able to be retrieved and reset to a memory shape or size that is adapted to fit any of: the largest pre-existing valve in a particular mammal, the smallest valve of the same mammal, any size or shape that is between those of the largest valve and smallest valve, and any shape or size which is adapted to fit a valve which has changed in shape or size over time.