Methods, systems and devices for treatment of cerebrospinal venous insufficiency and multiple sclerosis

Abstract

Methods and devices for relieving stenoses in, or otherwise improving blood flow through, body lumens. Although applicable in a variety of different body lumens, the methods and devices of this invention are specifically useable for relieving stenoses in, or otherwise improving blood flow through, veins which drain blood from the brain for treatment of multiple sclerosis or other neurodegenerative disorders that are caused, triggered or exacerbated by venous occlusion or venous insufficiency.

1 - 41 . (canceled) 
     
     
         42 . A device for treating stenosis of, or maintaining patency of, a blood vessel lumen comprising:
 at least one expandable scaffold member that is compressible to a collapsed configuration and biased to self-expand to a fully expanded configuration; and   an expansion limiting member which initially limits expansion of the at least one scaffold member to a first expanded configuration that is smaller in diameter than the fully expanded configuration;   the expansion limiting member being pressure-deformable while the at least one scaffold member is in the first expanded configuration to allow the at least one scaffold member to further self-expand to a second expanded configuration that is larger in diameter than the first expanded configuration.   
     
     
         43 . A device according to  claim 42  wherein said at least one scaffold member comprises a plurality of scaffold members connected to one another. 
     
     
         44 . A device according to  claim 43  wherein the size of and spacing between the scaffold members is determined by prior imaging or measurement of stenotic areas of the blood vessel. 
     
     
         45 . A device according to  claim 42  wherein the at least one scaffold member is an endovascular scaffold member that is implantable within the lumen of the blood vessel. 
     
     
         46 . A device according to  claim 42  wherein the at least one scaffold member is an exovascular scaffold member that is implantable on the exterior of the blood vessel. 
     
     
         47 . A device according to  claim 42  wherein the expansion limiting member comprises a plastically deformable member that undergoes a plastic deformation of a type selected from: bending, elongating or stretching. 
     
     
         48 . A device according to  claim 47  wherein the plastically deformable member is formed at least in part of a plastically deformable metal or polymer. 
     
     
         49 . (canceled) 
     
     
         50 . A device according to  claim 42  wherein the expansion limiting member comprises a plastically deformable band that extends around the at least one scaffold member. 
     
     
         51 . A device according to  claim 42  wherein the expansion limiting member comprises a plastically deformable member extends only part way around the at least one scaffold member. 
     
     
         52 . A device according to  claim 42  wherein the expansion limiting member comprises a plastically deformable polymer covering that is fused or affixed to the at least one scaffold member. 
     
     
         53 . A device according to  claim 52  wherein perforations or cut away areas are formed in the polymer covering. 
     
     
         54 . A device according to  claim 42  wherein the expansion limiting member comprises a mechanism that deforms in response to pressure. 
     
     
         55 . A method for treating stenosis of a blood vessel lumen comprising the steps of:
 delivering to an implantation site an implantable device comprising a) at least one expandable scaffold member that is constrained in a collapsed configuration during delivery to the implantation site and biased to self-expand to a fully expanded configuration and b) an expansion limiting member which initially limits expansion of the at least one scaffold member to a first expanded configuration that is smaller in diameter than the fully expanded configuration, said expansion limiting member being pressure-deformable while the at least one scaffold member is in the first expanded configuration to allow the at least one scaffold member to further self-expand to a second expanded configuration that is larger in diameter than the first expanded configuration;   removing constraint from the at least one scaffold, thereby allowing it to self-expand to the first expanded configuration;   inserting a pressure-exerting apparatus; and   using the pressure-exerting apparatus to apply pressure to concurrently dilate the stenosis and pressure-deform the expansion limiting member, thereby allowing the at least one scaffold member to further self-expand to a second expanded configuration.   
     
     
         56 . A method according to  claim 55  wherein there are a plurality of stenotic areas in the blood vessel and the at least one scaffold member comprises a plurality of interconnected scaffold members, each of said scaffold members having an expansion limiting member, and wherein:
 the delivering step comprises positioning each scaffold member in a separate stenotic area of the blood vessel; and 
 the using step comprises using one or more pressure exerting apparatus a plurality of times to separately dilate each stenotic area and to separately deform each expansion limiting member to its desired second diameter. 
 
     
     
         57 . A method according to  claim 56  wherein the method further comprises the steps of imaging or measuring the stenotic areas and forming the implantable device such that the size and spacing of the scaffold members substantially matches the size and spacing of the stenotic areas. 
     
     
         58 . A method according to  claim 55  wherein the expansion limiting member is plastically deformable and wherein the using step comprises using the pressure exerting member to concurrently dilate the stenosis and plastically deform the expansion limiting member. 
     
     
         59 . A method according to  claim 55  wherein the expansion limiting member is a mechanism that deforms in response to pressure and wherein the using step comprises using the pressure exerting member to concurrently dilate the stenosis and cause the mechanism to deform. 
     
     
         60 . A method according to  claim 55  wherein the pressure exerting member comprises a balloon and wherein the using step comprises inflating the balloon. 
     
     
         61 . A method according to  claim 55  wherein the blood vessel is a vein through which blood flows from the brain. 
     
     
         62 . A method according to  claim 61  wherein the vein is in the body of a subject who suffers from multiple sclerosis.