Valvuloplasty device

Abstract

The disclosure pertains to valvuloplasty devices which include a first outer shaft, a second inner shaft, a plurality of elongate members disposed therebetween and adapted to be expanded radially by relative motion between the first outer shaft and second inner shaft and a circumferential member disposed about the central portions of the plurality of elongate members, wherein the circumferential member is urged by radial expansion of the plurality of elongate members to contact the valve to be treated thereby effecting a valvuloplasty and methods of use therefor.

What is claimed is: 
     
         1 . A valvuloplasty device comprising:
 a first elongate shaft having a longitudinal axis, a length, a proximal end, a distal end, and a lumen therebetween;   a second elongate shaft slideably received within the lumen of the first elongate shaft having a proximal end and a distal end,   wherein the second elongate shaft has a length greater than the length of the first elongate shaft;   a plurality of elongate members each having a distal end, a proximal end and a central portion disposed between and connected at their proximal and distal ends to the first elongate shaft and the second elongate shaft;   a circumferential member disposed about the plurality of elongate members,   wherein the circumferential member is fixedly attached to the plurality of elongate members; and   wherein a central portion of each elongate member is fixedly attached to the circumferential member such that the plurality of elongate members are distributed in a spaced-apart relationship about the circumferential member.   
     
     
         2 . The valvuloplasty device of  claim 1 , wherein the valvuloplasty device has a first configuration in which the distal end of the second elongate shaft extends distally beyond the distal end of the first elongate shaft and the plurality of elongate members lie generally parallel to the longitudinal axis of the first elongate shaft and a second configuration in which the distal end of the second elongate shaft lies closer to the distal end of the first elongate shaft and the central portions of each elongate member are adapted to extend radially outward from longitudinal axis of the first elongate shaft. 
     
     
         3 . The valvuloplasty device of  claim 2 , wherein the plurality of elongate members further comprise elongate members having at least two distinct lengths. 
     
     
         4 . The valvuloplasty device of  claim 2 , wherein the plurality of elongate members are of non-uniform cross-section along their length. 
     
     
         5 . The valvuloplasty device of  claim 4 , wherein at least some of the plurality of elongate members include two or more regions which differ in cross-section along their length from an adjacent region of the two or more regions of the elongate members. 
     
     
         6 . The valvuloplasty device of  claim 2 , wherein the distal end of the first elongate shaft includes a collar to which the proximal ends of the plurality of elongate members are attached, said collar having a variable distal extent around its circumference. 
     
     
         7 . The valvuloplasty device of  claim 6 , wherein the collar and the plurality of elongate members are integrally formed from a tubular member. 
     
     
         8 . The valvuloplasty device of  claim 1 , wherein the proximal end of the second elongate shaft is operably connected to a collar to which the distal ends of the plurality of elongate members are attached, said collar having a variable proximal extent around its circumference. 
     
     
         9 . The valvuloplasty device of  claim 8 , wherein the collar and the plurality of elongate members disposed between and operably connected to the first elongate shaft and the second elongate shaft are integrally formed from a tubular member. 
     
     
         10 . The valvuloplasty device of  claim 1 , wherein the plurality of elongate members are fixedly attached to the circumferential member disposed about the plurality of elongate members such that circumferential spacings between adjacent elongate members are uniformly distributed about the circumferential member. 
     
     
         11 . The valvuloplasty device of  claim 1 , wherein the plurality of elongate members are fixedly attached to the circumferential member disposed about the plurality of elongate members such that the circumferential spacing between adjacent elongate members are non-uniformly distributed about the circumferential member. 
     
     
         12 . The valvuloplasty device of  claim 1 , wherein the circumferential member is textured on its radially outermost surface. 
     
     
         13 . The valvuloplasty device of  claim 1 , wherein the circumferential member is of uniform thickness between the plurality of elongate members. 
     
     
         14 . The valvuloplasty device of  claim 1 , wherein the circumferential member is of non-uniform thickness between the plurality of elongate members. 
     
     
         15 . The valvuloplasty device of  claim 1 , wherein the circumferential member includes one or more cutting edges extending radially outward therefrom. 
     
     
         16 . The valvuloplasty device of  claim 1 , further comprising radially expandable element located between the distal ends of the first elongate shaft and the second elongate shaft, said radially expandable element being adapted to urge the circumferential member radially outward. 
     
     
         17 . The valvuloplasty device of  claim 1 , further comprising a drug coating on at least a portion thereof. 
     
     
         18 . The valvuloplasty device of  claim 1 , further comprising a one-way valve. 
     
     
         19 . A method of performing a valvuloplasty, comprising:
 inserting a valvuloplasty device intravascularly,   said valvuloplasty device comprising:
 an outer shaft; 
 an inner shaft; 
 a plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft; 
 and a circumferential member affixed to the plurality of elongate members and disposed between the distal end of the outer shaft and the distal end of the inner shaft; 
   advancing the valvuloplasty device to a position within the valve to be treated;   reducing the distance between the distal end of the outer shaft and the distal end of the inner shaft thereby causing a central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to expand radially outward and press the circumferential member against the valve to be treated;   increasing the distance between the distal end of the outer shaft and the distal end of the inner shaft thereby causing a central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to contract radially;   removing the valvuloplasty device from the patient in a radially contracted configuration in which the distal end of the inner shaft extends distally beyond the distal end of the outer shaft and the plurality of elongate members disposed between and operably connected to the inner shaft and the outer shaft lie generally parallel to a longitudinal axis of the inner shaft.   
     
     
         20 . The method of  claim 19 , wherein the valvuloplasty device includes one or more cutting edges extending radially outward therefrom and the step of reducing the distance between the distal end of the outer shaft and the distal end of the inner shaft thereby causing a central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to expand radially outward and the cutting edges extending radially outward to cut the valve to be treated.