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.

Description

RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Patent Application Ser. No. 61 / 303,274 filed Feb. 10, 2010, the entire disclosure of which is expressly incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates generally to biology and medicine and more particularly to methods, systems and devices for treating venous obstruction or venous insufficiency and for treatment of neurological or other disorders, such as multiple sclerosis (MS), which may be associated with venous obstruction or insufficiency.BACKGROUND OF THE INVENTION[0003]Pursuant to 37 CFR 1.71(e), this patent document contains material which is subject to copyright protection. The copyright owner has no objection to facsimile reproduction of the complete patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.[0004]Nerve cells of the central nerv...

AI Technical Summary

Benefits of technology

[0034]In accordance with yet another aspect of the present invention, there are provided methods for improving flow through a stenotic body lumen in a human or animal subject (e.g., the lumen of a vein in a patient suffering from CCVI, MS or another neurodegenerative disease), comprising the step of delivering energy to a wall of the stenotic body lumen or to tissue located near the stenotic body lumen or to obstructive matter located within the stenotic body lumen to cause shrinkage, contraction or other movement of tissue or obstructive matter in a manner that improves fluid flow or equalization of pressure through the stenotic body lumen. The energy is delivered from a catheter or other delivery device that is outside or inserted into the body lumen or from an endovascular or exovascular device implanted within or near the body lumen. The energy comprises any suitable type of energy including but not limited to heat, light, laser light, infrared light, a plasma field, sound, ultrasound, electromagnetic radiation and ionizing radiation.

[0035]In accordance with yet another aspect of the present invention, there are provided methods for improving flow through a stenotic body lumen in a human or animal subject (e.g., the lumen of a vein in a patient suffering from CCVI, MS or another neurodegenerative disease), comprising the step of delivering a quantity of material (e.g., a gel or foam) to a location within the subject's body so that the material exerts force(s) which enlarge the stenotic body lumen or deter compression or contraction of the stenotic body lumen (e.g., shield the vein so that forces of muscular contraction do not cause the vein to collapse). In some embodiments, the material may undergo a change in volume or shape after it has been delivered. For example, the material may contract (e.g., shrink) in situ so as to pull on adjacent tissue, causing enlargement of the stenotic body lumen.

Problems solved by technology

Multiple sclerosis (MS) causes demyelination and scarring of the axons, which in turn results in impaired conduction of action potentials, neuroaxonal apoptosis and degeneration.

MS is difficult to diagnose in its early stages.

There is no known cure for MS and the specific pathophysiology by which MS progresses is not fully understood.

MS is not considered a hereditary disease but certain genetic variations are associated with increased risk of developing MS.

The patient's immune system can then activate those T lymphocytes, causing autoimmune damage to the neural cells.

However, this initial study, the devices and techniques employed were generally designed for treatment of other types of obstructions in other lumens of the body and, thus, are less than optimal for use in this application.

Also, other investigators have failed to confirm any increased incidence of CCVI in MS patients.

One recent publication has reported that the re-stenosis rate following angioplasty without stenting was unacceptably high (approximately 50% for internal jugular vein occlusions) and that such re-stenosis was often accompanied by worsening neurological symptoms.

Generally, use of these stents is less than optimal because a number of adverse complications can occur.

None of the existing methods, devices or systems are believed to be optimal for treating all cases of chronic cerebrospinal venous insufficiency in MS patients.

There is an absence in the market of dedicated devices of the proper size, length and functional characteristics for treating CCVI.

Using existing stents at the level of the internal jugular vein and / or azygous vein creates risk of displacement, migration along the vein, stenosis, thrombosis, thromboembolism, migration thru and / or perforation of the venous wall and pulmonary migration, thus affecting venous outflow.

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