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 . A method for improving fluid flow through a stenotic body lumen of a human or mammalian subject, said method comprising the step of placing an endovascular or exovascular device in or near the stenotic body lumen, wherein the method further includes at least one additional step selected from the group consisting of:
 a) imaging or measuring the stenotic body lumen and, prior to placing the device, customizing at least part of the device to correspond to the image or measurements of the body lumen;   b) initially self-expanding the device to a first expanded configuration and, thereafter, further expanding all or part(s) of the device to conform to the anatomy of the stenotic body lumen;   c) causing the device to communicate with one or more sensors such that the device will exert varying force of the stenotic body lumen in response to information received from the one or more sensors;   d) placing a plurality of said devices at separate locations corresponding to the anatomy and/or locations of stenotic regions of the body lumen to treat CCVI;   e) causing the device to pump body fluid through the body lumen to treat CCVI;   f) forming a full-thickness or partial-thickness cut in or through a wall of the body lumen to relieve constraint or stricture or to otherwise widen the body lumen to treat CCVI;   g) tuning (e.g., modifying, adjusting shape, adjusting size, etc.) the device after it has been placed in or near the body lumen to treat CCVI;   h) delivering from the device or by other means an active substance for providing some desired therapeutic effect to treat CCVI; or   i) causing the device or some other means to cause muscle to relax or expand thereby decreasing muscle compression of the stenotic body lumen to treat CCVI.   
     
     
         2 . A method according to  claim 1  wherein the stenotic body lumen comprises a stenotic vein. 
     
     
         3 . A method according to  claim 2  wherein the subject suffers from CCVI and the method is carried out to treat CCVI. 
     
     
         4 . A method according to  claim 2  wherein the subject suffers from MS or another neurodegenerative disease and the method is carried out to treat the MS or other neurodegenerative disease. 
     
     
         5 . A method for treating stenosis of a vein in a human or animal subject comprising the steps of:
 inserting into the vein a stent device that comprises a self-expanding portion and at least one deformable constraining member, said stent device being in a collapsed configuration;   allowing the self expanding portion to self-expand from the collapsed configuration to a first expanded configuration; and, thereafter   pressure-deforming at least one deformable constraining member to modify the shape and/or diameter of the stent device.   
     
     
         6 . A method according to  claim 5  whereon the self-expanding portion comprises a generally tubular body and the at least one deformable constraining member comprises a member that extends at least part way around the generally tubular body to deter its expansion beyond the first expanded configuration; and further comprising:
 deforming at least one constraining member so that it allows at least part of the generally tubular body to expand to a diameter that is larger than its diameter when in the first expanded configuration. 
 
     
     
         7 . A method according to  claim 5  wherein the vein is the lumen of an internal jugular or azygous vein. 
     
     
         8 . A method according to  claim 5  wherein the vein is the lumen of a stenotic vein and wherein the method is performed to relieve stenosis of the vein. 
     
     
         9 . A method according to  claim 5  wherein the vein is the lumen of a stenotic vein through which blood drains from the brain and wherein the subject suffers from MS or another neurodegenerative disorder and wherein the method is performed to treat the MS or other neurodegenerative disorder. 
     
     
         10 . A stent device comprising:
 at least one self-expanding stent member; and   at least one deformable constraining member connected to the at least one self-expanding stent member;   the at least one self-expanding stent member being initially deployable in a collapsed configuration and thereafter self-expandable to a first expanded configuration, the at least one deformable constraining member being operative to diametrically constrain the at least one self-expanding stent member so that it does not self expand beyond the first expanded configuration; and   all or part of the at least one deformable constraining member being thereafter deformable to a deformed configuration that allows all or part of the at least one self-expanding stent member to further expand to a second expanded configuration.   
     
     
         11 . A stent device according to  claim 10  wherein the at least one self-expanding stent member comprises one or more self-expanding rings. 
     
     
         12 . A stent device according to  claim 10  wherein the at least one self-expanding stent member comprises one or more self-expanding zig-zag rings. 
     
     
         13 . A stent device according to  claim 10  wherein the at least one self-expanding stent member comprises one or more self-expanding mesh rings. 
     
     
         14 . A stent device according to  claim 10  wherein the at least one deformable constraining member comprises one or more deformable filaments. 
     
     
         15 . A stent device according to  claim 10  wherein the at least one deformable constraining member comprises one or more deformable bands. 
     
     
         16 . A stent device according to  claim 10  wherein the at least one deformable constraining member comprises at least one deformable sheaths. 
     
     
         17 . A stent device according to  claim 16  wherein the at least one deformable sheath comprises an inner polymer layer and an outer polymer and wherein the least one self-expanding stent member is positioned between the inner and outer polymer layers. 
     
     
         18 . A stent device according to  claim 16  wherein the at least one deformable sheath has perforations formed therein. 
     
     
         19 . A stent device according to  claim 18  wherein the size, shape, number and location of the perforations are selected to provide desired amounts of flexibility and diametric constraint. 
     
     
         20 . A stent device according to  claim 18  wherein the perforations are round. 
     
     
         21 - 62 . (canceled)