Prosthetic valve with vessel engaging member

Abstract

Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

1 . A medical device kit, comprising:
 a valve member comprising a main body defining a passageway and a valve disposed in the passageway, the valve adapted to permit fluid flow through the passageway in a first direction and to substantially prevent fluid flow through the passageway in a second, opposite direction;   a plurality of vessel engaging members, each of the plurality of vessel engaging members comprising inner and outer edges, defining an aperture adapted to receive the main body, and having a radial dimension extending from the inner edge to the outer edge;   at least one vessel engaging member of the plurality of vessel engaging members being separate from the valve member in said medical device kit; and   at least two vessel engaging members of the plurality of vessel engaging members comprising different radial dimensions;   wherein the main body of the valve member is adapted to be independently disposed in the aperture of each vessel engaging member of the plurality of vessel engaging members to form a medical device adapted for implantation in a body vessel, the medical device having an outer diameter based on the radial dimension of the vessel engaging member defining the aperture in which the main body is disposed.   
   
   
       2 . The medical device kit of  claim 1 , wherein the main body comprises a self-expanding support frame. 
   
   
       3 . The medical device kit of  claim 1 , wherein each vessel engaging member of the plurality of vessel engaging members comprises a disc-shaped member. 
   
   
       4 . The medical device kit of  claim 1 , wherein each vessel engaging member of the plurality of vessel engaging members further comprises a bioremodellable material. 
   
   
       5 . The medical device kit of  claim 1 , wherein each vessel engaging member of the plurality of vessel engaging members further comprises a hydrogel. 
   
   
       6 . The medical device kit of  claim 1 , wherein each vessel engaging member of the plurality of vessel engaging members further comprises an extracellular matrix material. 
   
   
       7 . The medical device kit of  claim 1 , wherein each vessel engaging member of the plurality of vessel engaging members further comprises small intestine submucosa. 
   
   
       8 . The medical device of  claim 1 , wherein the valve comprises a leaflet attached to the main body. 
   
   
       9 . The medical device kit of  claim 8 , wherein the leaflet is adapted to move between a first position to permit fluid flow through the passageway in the first direction and a second position to substantially prevent fluid flow through the passageway in the second, opposite direction. 
   
   
       10 . The medical device kit of  claim 8 , wherein the leaflet comprises a bioremodellable material. 
   
   
       11 . The medical device kit of  claim 8 , wherein the leaflet comprises an extracellular matrix material. 
   
   
       12 . The medical device kit of  claim 8 , wherein the leaflet comprises small intestine submucosa. 
   
   
       13 . The medical device kit of  claim 8 , wherein the valve further comprises a second leaflet attached to the main body. 
   
   
       14 . The medical device kit of  claim 10 , wherein the first and second leaflets individually move between first and second positions to cooperatively permit fluid flow through the passageway in the first direction and substantially prevent fluid flow through the passageway in the second, opposite direction. 
   
   
       15 . The medical device kit of  claim 1 , wherein at least three vessel engaging members of the plurality of vessel engaging members comprise different radial dimensions. 
   
   
       16 . The medical device kit of  claim 1 , wherein the aperture of each vessel engaging member of the plurality of vessel engaging members has an aperture diameter; and
 wherein the aperture diameters of all vessel engaging members of the plurality of vessel engaging members are the same.   
   
   
       17 . The medical device kit of  claim 1 , wherein the aperture of each vessel engaging member of the plurality of vessel engaging members has an aperture diameter; and
 wherein two vessel engaging members of the plurality of vessel engaging members comprise different aperture diameters.   
   
   
       18 . The medical device kit of  claim 17 , wherein the main body has a first outer diameter;
 further comprising a second main body having a second outer diameter; and   wherein the first outer diameter is different than the second outer diameter.   
   
   
       19 . A medical device kit, comprising:
 a plurality of valve members, each valve member of the plurality of valve members comprising a main body having an outer diameter and defining a passageway, and a valve disposed in the passageway, the valve adapted to permit fluid flow through the passageway in a first direction and to substantially prevent fluid flow through the passageway in a second, opposite direction;   a plurality of vessel engaging members, each of the plurality of vessel engaging members comprising inner and outer edges, defining an aperture adapted to receive the main body, and having a radial dimension extending from the inner edge to the outer edge;   at least one vessel engaging member of the plurality of vessel engaging members being separate from the valve member in said medical device kit;   at least two vessel engaging members of the plurality of vessel engaging members comprising different radial dimensions; and   at least two valve members of the plurality of valve members comprising different outer diameters;   wherein the main body of each valve member is adapted to be independently disposed in the aperture of each vessel engaging member of the plurality of vessel engaging members to form a medical device adapted for implantation in a body vessel, the medical device having a device outer diameter based on the radial dimension of the vessel engaging member defining the aperture in which the main body is disposed.   
   
   
       20 . A method of treating a patient, comprising:
 providing a medical device kit according to  claim 1 ;   determining an inner diameter of a body vessel of said patient at a point of treatment;   selecting a suitable vessel engaging member from the plurality of vessel engaging members based on the determined inner diameter;   disposing the main body of the valve member in the aperture of the selected vessel engaging member to form a medical device adapted for implantation in the body vessel at the point of treatment; and   implanting the medical device at the point of treatment in the body vessel.