Expandable Support Frame and Medical Device

Abstract

Support frames and medical devices are described. An example medical device comprises an expandable support frame with first and second leaflets attached to the support frame. Each of the first and second leaflets defines a domed radius that is equal to or less than the radius of the expandable support frame when the expandable support frame is in an expanded configuration and the leaflets are subjected to fluid pressure sufficient to affect closure of the valve orifice.

What is claimed is: 
     
         1 . A medical device for regulating fluid flow through a body vessel of a patient, comprising:
 an expandable support frame having a longitudinal axis, an outer circumference, an unexpanded configuration, and an expanded configuration with an expanded configuration radius extending from the longitudinal axis to the outer circumference, the support frame comprising:
 a first circumferential serpentine path; 
 a second circumferential serpentine path; 
 a first connector segment joining the first and second serpentine paths, the first connector segment comprising substantially parallel first and second struts; 
 a second connector segment disposed substantially opposite the first connector segment with respect to said longitudinal axis and joining the first and second serpentine paths, the second connector segment comprising substantially parallel third and fourth struts; 
 a third connector segment disposed circumferentially adjacent the first and second connector segments and joining the first and second serpentine paths; 
 a fourth connector segment disposed substantially opposite the third connector segment and joining the first and second serpentine paths; 
 a first connector strut extending between and joining the first and third connector segments; and 
 a second connector strut extending between and joining the second and third connector segments; and 
   a first leaflet attached to the support frame along an attachment pathway extending along the first and second connector struts and along a first portion of the first connector segment and a first portion of the second connector segment, the first leaflet having a first inner surface that defines a first domed radius equal to or less than the expanded configuration radius when the support frame is in the expanded configuration.   
     
     
         2 . The medical device of  claim 1 , wherein the first domed radius is between about ⅛ th  the expanded configuration radius and the expanded configuration radius. 
     
     
         3 . The medical device of  claim 1 , wherein the first domed radius is between about ¼ th  the expanded configuration radius and about ¾ th  the expanded configuration radius. 
     
     
         4 . The medical device of  claim 1 , wherein the first domed radius is about ¼ th  the expanded configuration radius. 
     
     
         5 . The medical device of  claim 1 , wherein the first portion of the first connector segment is about ¼ th  the height of the first connector segment. 
     
     
         6 . The medical device of  claim 5 , wherein the first portion of the second connector segment is about ¼ th  the height of the second connector segment. 
     
     
         7 . The medical device of  claim 1 , further comprising a third connector strut extending between and joining the first and fourth connector segments;
 a fourth connector strut extending between and joining the second and fourth connector segments; and   a second leaflet attached to the support frame along a second attachment pathway extending along the third and fourth connector struts and along a second portion of the first connector segment and a second portion of the second connector segment.   
     
     
         8 . The medical device of  claim 7 , wherein the second leaflet has a second inner surface that defines a second domed radius equal to or less than the expanded configuration radius when the support frame is in the expanded configuration 
     
     
         9 . The medical device of  claim 8 , wherein the second domed radius is between about ⅛ th  the expanded configuration radius and the expanded configuration radius. 
     
     
         10 . The medical device of  claim 8 , wherein the second domed radius is between about ¼ th  the expanded configuration radius and about ¾ th  the expanded configuration radius. 
     
     
         11 . The medical device of  claim 8 , wherein the second domed radius is about ¼ th  the expanded configuration radius. 
     
     
         12 . The support frame of  claim 8 , wherein the first and second domed radii are substantially equal. 
     
     
         13 . A medical device for regulating fluid flow through a body vessel of a patient, comprising:
 an expandable support frame having a longitudinal axis, an outer circumference, an unexpanded configuration, and an expanded configuration with an expanded configuration radius extending from the longitudinal axis to the outer circumference;   a first leaflet attached to the support frame along a first attachment pathway, the first leaflet having a first inner surface that defines a first domed radius equal to or less than the expanded configuration radius when the support frame is in the expanded configuration; and   a second leaflet attached to the support frame along a second attachment pathway, the second leaflet having a second inner surface that defines a second domed radius equal to or less than the expanded configuration radius when the support frame is in the expanded configuration.   
     
     
         14 . The medical device of  claim 13 , wherein each of the first and second domed radii is between about ⅛ th  the expanded configuration radius and the expanded configuration radius. 
     
     
         15 . The medical device of  claim 13 , wherein each of the first and second domed radii is between about ¼ th  the expanded configuration radius and about ¾ th  the expanded configuration radius. 
     
     
         16 . The medical device of  claim 13 , wherein each of the first and second domed radii is about ¼ th  the expanded configuration radius. 
     
     
         17 . The support frame of  claim 13 , wherein the first and second domed radii are substantially equal. 
     
     
         18 . A medical device for regulating fluid flow through a body vessel of a patient, comprising:
 an expandable support frame having a longitudinal axis, a distal end, an outer circumference, an unexpanded configuration, and an expanded configuration, the support frame comprising:
 a first circumferential serpentine path; 
 a second circumferential serpentine path; 
 a first connector segment joining the first and second serpentine paths, the first connector segment comprising substantially parallel first and second struts; 
 a second connector segment disposed substantially opposite the first connector segment with respect to said longitudinal axis and joining the first and second serpentine paths, the second connector segment comprising substantially parallel third and fourth struts; 
 a third connector segment disposed circumferentially adjacent the first and second connector segments and joining the first and second serpentine paths; 
 a first connector strut extending between and joining the first and third connector segments, a portion of the first connector strut disposed on a first plane that is disposed at a first angle to a second plane that orthogonally transects the longitudinal axis and includes distal end of the support frame; and 
 a second connector strut extending between and joining the second and third connector segments, a portion of the second connector strut disposed on a third plane that is disposed at a second angle to the second plane; and 
   a first leaflet attached to the support frame along an attachment pathway extending along the first and second connector struts and along a first portion of the first connector segment and a first portion of the second connector segment;   wherein the first angle and the second angle are between about 30° and about 50°;   wherein the first portion of the first connector segment is about ¼ th  the height of the first connector segment; and   wherein the first portion of the second connector segment is about ¼ th  the height of the second connector segment.   
     
     
         19 . The medical device according to  claim 18 , wherein the first angle and the second angle are between about 30° and about 40°. 
     
     
         20 . The medical device according to  claim 18 , wherein the first angle and the second angle are about 35°.