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, the support frame comprising:
 a proximal portion, a distal portion, a first connector segment, a second connector segment, a third connector segment, and a fourth connector segment, the proximal portion and the distal portion connected by the first, second, third, and fourth connector segments; 
 the proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; 
 the distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments; 
 the first connector segment having an axial length and comprising first and second struts and a first connecting bar extending between and joining the first and second struts, the first connecting bar positioned on a first transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the distal portion and about ½ the axial length of the first connector segment; 
 the second connector segment disposed substantially opposite the first connector segment with respect to the longitudinal axis, the second connector segment comprising third and fourth struts and a second connecting bar extending between and joining the third and fourth struts; 
 the third connector segment disposed circumferentially adjacent the first and second connector segments, the third connector segment being only a single strut; and 
 the fourth connector segment disposed substantially opposite the third connector segment with respect to the longitudinal axis; 
   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 extending from the distal portion and toward the proximal portion and a first portion of the second connector segment extending from the distal portion and toward the proximal portion, the first leaflet having a first free edge; 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, the second leaflet having a second free edge;   wherein the first and second free edges cooperatively define a valve orifice.   
     
     
         2 . The medical device of  claim 1 , wherein the first transverse axis of the support frame orthogonally intersects the first connector segment at a point that is about ¼ th  the axial length of the first connector segment. 
     
     
         3 . The medical device of  claim 1 , wherein the second connector segment has an axial length; and
 wherein the second connecting bar is positioned on a second transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the distal portion and about ½ the axial length of the second connector segment.   
     
     
         4 . The medical device of  claim 3 , wherein the second transverse axis of the support frame orthogonally intersects the second connector segment at a point that is about ¼ th  the axial length of the second connector segment. 
     
     
         5 . The medical device of  claim 1 , wherein the first connector segment has a third connecting bar extending between and joining the first and second struts. 
     
     
         6 . The medical device of  claim 5 , wherein the third connecting bar is positioned on a third transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the first connecting bar and the proximal portion. 
     
     
         7 . The medical device of  claim 5 , wherein the second connector segment has a fourth connecting bar extending between and joining the third and fourth struts. 
     
     
         8 . The medical device of  claim 7 , wherein the second connector segment has an axial length;
 wherein the second connecting bar is positioned on a second transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the distal portion and about ½ the axial length of the second connector segment; and   wherein the fourth connecting bar is positioned on a fourth transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the second connecting bar and the proximal portion.   
     
     
         9 . The medical device of  claim 1 , wherein the first and second struts of the first connector segment are substantially parallel; and
 wherein the third and fourth struts of the second connector segment are substantially parallel.   
     
     
         10 . The medical device of  claim 1 , wherein the fourth connector segment is only a single strut. 
     
     
         11 . The medical device of  claim 1 , wherein each of the first connector strut, the second connector strut, the third connector strut, and the fourth connector strut comprise a curvilinear strut that includes a straight portion. 
     
     
         12 . The medical device of  claim 11 , wherein the distal portion includes terminal structures; and
 wherein each of the first connector strut, the second connector strut, the third connector strut, and the fourth connector strut lies on a first plane that is disposed at an angle to a second plane that orthogonally transects the longitudinal axis and includes the terminal structures.   
     
     
         13 . The medical device of  claim 12 , wherein the angle is between about 30° and about 50°. 
     
     
         14 . The medical device of  claim 12 , wherein the angle is about 35°. 
     
     
         15 . The medical device of  claim 1 , wherein the first portion of the first connector segment is between about ⅛ th  and about ¾ th  the axial length of the first connector segment;
 wherein the second connector segment has an axial length; and 
 wherein the first portion of the second connector segment is between about ⅛ th  and about ¾ th  the axial length of the second connector segment. 
 
     
     
         16 . The medical device of  claim 1 , wherein the first portion of the first connector segment is about ¼ th  the axial length of the first connector segment;
 wherein the second connector segment has an axial length; and 
 wherein the first portion of the second connector segment is about ¼ th  the axial length of the second connector segment. 
 
     
     
         17 . The medical device of  claim 1 , wherein the support frame is free of additional struts between the first connector segment and the third connector segment;
 wherein the support frame is free of additional struts between the second connector segment and the third connector segment;   wherein the support frame is free of additional struts between the first connector segment and the fourth connector segment; and   wherein the support frame is free of additional struts between the second connector segment and the fourth connector segment.   
     
     
         18 . The medical device of  claim 1 , wherein the first and second leaflets comprise a natural material. 
     
     
         19 . 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, the support frame comprising:
 a proximal portion, a distal portion, a first connector segment, a second connector segment, a third connector segment, and a fourth connector segment, the proximal portion and the distal portion connected by the first, second, third, and fourth connector segments; 
 the proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; 
 the distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments; 
 the first connector segment having an axial length and comprising first and second struts and first and second connecting bars, each of the first and second connecting bars extending between and joining the first and second struts, the first connecting bar positioned on a first transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the distal portion and about ½ the axial length of the first connector segment, the second connecting bar positioned on a second transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the first connecting bar and the proximal portion; 
 the second connector segment having an axial length and disposed substantially opposite the first connector segment with respect to the longitudinal axis, the second connector segment comprising third and fourth struts and third and fourth connecting bars, each of the third and fourth connecting bars extending between and joining the third and fourth struts, the third connecting bar positioned on a third transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the distal portion and about ½ the axial length of the second connector segment, the fourth connecting bar positioned on a fourth transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the third connecting bar and the proximal portion; 
 the third connector segment disposed circumferentially adjacent the first and second connector segments, the third connector segment being only a single strut; and 
 the fourth connector segment disposed substantially opposite the third connector segment with respect to the longitudinal axis; 
   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 extending from the distal portion and toward the proximal portion and a first portion of the second connector segment extending from the distal portion and toward the proximal portion, the first leaflet having a first free edge; 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, the second leaflet having a second free edge;   wherein the first and second free edges cooperatively define a valve orifice.   
     
     
         20 . 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, the support frame comprising:
 a proximal portion, a distal portion, a first connector segment, a second connector segment, a third connector segment, and a fourth connector segment, the proximal portion and the distal portion connected by the first, second, third, and fourth connector segments; 
 the proximal portion defining a first circumferential serpentine path joined to the first, second, third, and fourth connector segments; 
 the distal portion defining a second circumferential serpentine path joined to the first, second, third, and fourth connector segments and comprising a first connector strut extending between and joining the first and third connector segments, a second connector strut extending between and joining the second and third connector segments, a third connector strut extending between and joining the first and fourth connector segments, and a fourth connector strut extending between and joining the second and fourth connector segments; 
 the first connector segment having an axial length and comprising first and second substantially parallel struts and first and second connecting bars, each of the first and second connecting bars extending between and joining the first and second struts, the first connecting bar positioned on a first transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the distal portion and about ½ the axial length of the first connector segment, the second connecting bar positioned on a second transverse axis of the support frame that orthogonally intersects the first connector segment at a point between the first connecting bar and the proximal portion; 
 the second connector segment having an axial length and disposed substantially opposite the first connector segment with respect to the longitudinal axis, the second connector segment comprising third and fourth substantially parallel struts and third and fourth connecting bars, each of the third and fourth connecting bars extending between and joining the third and fourth struts, the third connecting bar positioned on a third transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the distal portion and about ½ the axial length of the second connector segment, the fourth connecting bar positioned on a fourth transverse axis of the support frame that orthogonally intersects the second connector segment at a point between the third connecting bar and the proximal portion; 
 the third connector segment disposed circumferentially adjacent the first and second connector segments, the third connector segment being only a single strut; and 
 the fourth connector segment disposed substantially opposite the third connector segment with respect to the longitudinal axis, the fourth connector segment being only a single strut; 
   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 extending from the distal portion and toward the proximal portion and a first portion of the second connector segment extending from the distal portion and toward the proximal portion, the first leaflet having a first free edge; 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, the second leaflet having a second free edge;   wherein the first and second free edges cooperatively define a valve orifice.