Deformable lumen support devices and methods of use

Abstract

Lumen support devices and methods of their use are provided. A lumen support includes one or more plastically deformable cells having two stable configurations with no stable configurations between the two stable configurations. The lumen support device may be plastically deformed to other stable configurations.

1 . A lumen support configured to be expanded and contracted to a plurality of stable positions, the support comprising a plurality of cells, each of the plurality of cells defined by at least a first segment and a second segment, the cell comprising a first stable collapsed configuration, a second stable collapsed configuration, a first stable expanded configuration, and a second stable expanded configuration, the first segment, comprising a material having an elastic range between about 0.15 to about 1% and an elongation of above 30% and an ultimate tensile strength greater than 500 MPa, the material exhibiting reduced recoil to an applied force, and the second segment being less flexible than the first segment, said first segment of each cell being configured to transition from a first stable contracted position to a first stable expanded position relative to said second segment thereby causing each cell to transition from the first stable collapsed configuration to the first stable expanded configuration, wherein said first segment is configured to plastically deform to a second stable contracted position creating an area for each cell less than the area created when said first segment is at said first stable contracted position, and wherein said first segment is configured to plastically deform to a second stable expanded position creating an area for each cell greater than the area created when said first segment is at said first stable expanded position. 
   
   
       2 . The support of  claim 1 , wherein the first segment is configured to transition between contracted and expanded positions through an inversion point in which force is reduced in order to complete the transition. 
   
   
       3 . The support of  claim 1 , wherein the first segment has an elastic range between about 0.2 to about 0.8%. 
   
   
       4 . The support of  claim 1 , wherein the support comprises a medical device selected from the group consisting of a stent, an occlusion device, a multistable valve, an expander, a clip, a loop, and a ring. 
   
   
       5 . The support of  claim 1 , wherein the first segment substantially conforms to the shape of the second segment in the first stable collapsed configuration 
   
   
       6 . The support of  claim 1 , wherein the second segment comprises a plastically deformable segment comprises the material of the first segment. 
   
   
       7 . A lumen support comprising a plastically deformable structure made of a material having an elastic range between about 0.15 to about 1% and an elongation of above 30% and an ultimate tensile strength greater than 500 MPa, the structure capable of assuming an original collapsed configuration or a plastically deformed collapsed configuration and an original expanded configuration or a plastically deformed expanded configuration, wherein no stable configurations exist between the original collapsed configurations or the original expanded configuration. 
   
   
       8 . The support of  claim 7 , wherein the structure is defined in part by a first segment and a second segment, the first segment being more flexible than the second segment. 
   
   
       9 . The support of  claim 8 , wherein the first segment is capable of transitioning between a contracted position and an expanded position, relative to the second segment, wherein the first segment passes a transition point between the contracted position and the expanded position that allows force to be decreased during the transition. 
   
   
       10 . A method of crimping a lumen support on a delivery device comprising:
 delivering a lumen support onto a delivery device, the lumen support comprising one or more unit cells, the one or more unit cells having a thick strut and a thin strut and capable of assuming an original collapsed configuration or a plastically deformed collapsed configuration and an original expanded configuration or a plastically deformed expanded configuration, wherein no stable configurations exist between the original collapsed configurations or the original expanded configuration;   applying a radially inward force to the lumen support; and   deforming one or more unit cells of the lumen support to a plastically deformed collapsed configuration.   
   
   
       11 . The method of  claim 10 , further comprising transitioning the lumen support to a stable collapsed configuration from a stable expanded configuration by application of a force through an inversion point of decreased force. 
   
   
       12 . The method of  claim 10 , wherein lumen support has a smaller diameter in the plastically deformed collapsed configuration. 
   
   
       13 . The method of  claim 10 , wherein the lumen support comprises a first segment and a second segment, the first segment being more pliable than the second segment. 
   
   
       14 . The method of  claim 10 , wherein the lumen support comprises a material having an elastic range between about 0.15 to about 1% and an elongation of above 30% and an ultimate tensile strength greater than 500 MPa. 
   
   
       15 . A lumen support comprising:
 a plurality of unit cells arranged in a first column and a second column, the first and second columns having a tubular shape and being interconnected by at least one flexible connector, wherein each unit cell in the first column of unit cells is coupled by first flexible articulations, and wherein each unit cell in the second column of unit cells is coupled by second flexible articulations;   wherein at least some of the unit cells of the plurality of unit cells are capable of transitioning between a stable expanded configuration and a stable collapsed configuration by application of a force through an inversion point of decreased force.   
   
   
       16 . The support of  claim 15 , wherein first flexible articulations and the flexible connector are configured to allow one or more unit cells of the first column to conform to a lumen. 
   
   
       17 . The support of  claim 15 , wherein the plurality of unit cells comprises a material having an elastic range between about 0.15 to about 1% and an elongation of above 30% and an ultimate tensile strength greater than 500 MPa. 
   
   
       18 . The support of  claim 17 , wherein the material is a cobalt alloy. 
   
   
       19 . A balloon catheter comprising:
 a balloon; and   a lumen support device in a crimped configuration coupled to the balloon, the device comprising one or more unit cells capable of transitioning from a stable collapsed configuration to a stable expanded configuration by application of a force through an inversion point of decreased force, the one or more unit cells capable of plastically deforming to an expanded plastically deformed configuration; wherein the lumen support device comprises a material having an elastic range between about 0.15 to about 1% and an elongation of above 30% and an ultimate tensile strength greater than 500 MPa.   
   
   
       20 . The catheter of  claim 19 , wherein the material is a cobalt alloy.