Cerebrospinal fluid purification system
Inventors
Lad, Shivanand • Mobley, William C. • Nikolich, Karoly • Saul, Thomas
Assignees
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Publication Number
US-12280229-B2
Publication Date
2025-04-22
Expiration Date
Abstract
The present invention provides methods and systems for conditioning cerebrospinal fluid (CSF) by removing target compounds from CSF. The systems provide for a catheter flow path and exchange of a majority volume portion of CSF in the CSF space. The removal and/or delivery of specific compounds can be tailored to the pathology of the specific disease. The removal is targeted and specific, for example, through the use of specific size-exclusion thresholds, antibodies against specific toxins, and other chromatographic techniques, as well as delivery and/or removal of targeted therapeutic agents.
Core Innovation
A method ameliorates a symptom of one or more of Amyotrophic Lateral Sclerosis and Huntington's Disease by selecting a patient having a symptom. Cerebrospinal fluid is removed from a first location in a cerebrospinal fluid space, and a causative agent is removed from the removed cerebrospinal fluid to condition it. The conditioned cerebrospinal fluid is returned to a second location in the cerebrospinal fluid space at substantially the same flow rate as the removal.
The conditioned cerebrospinal fluid is free of artificial cerebrospinal fluid, and the removing and returning steps are performed concurrently using a single catheter. The single catheter comprises a first lumen with a first proximal port at the first location and a second lumen having a second distal port at the second location during at least a portion of a conditioning treatment. The first proximal port and the second distal port are axially spaced apart along the single catheter.
In certain implementations, removing a causative agent includes one or more separation processes selected from biospecific affinity, cationic exchange, anionic exchange, hydrophobicity, and size exclusion. The conditioned cerebrospinal fluid is conditioned using externally performed separation processes, including one or more of chromatography columns. The disclosed approach is applied to ameliorating disease symptoms by conditioning cerebrospinal fluid through removal of causative agents.
Claims Coverage
The independent claims share a common inventive framework comprising concurrent cerebrospinal fluid removal and return at substantially the same flow rate using a single catheter with axially spaced proximal and distal ports, coupled to conditioning by removing a causative agent and returning conditioned cerebrospinal fluid free of artificial cerebrospinal fluid.
Concurrent CSF removal and return using single catheter with axially spaced ports
The removing and returning steps are performed concurrently using a single catheter, the single catheter comprising a first lumen with a first proximal port at the first location and a second lumen having a second distal port at the second location, wherein the first proximal port and the second distal port are axially spaced apart along the single catheter; the conditioned cerebrospinal fluid is returned at substantially the same flow rate at which it is removed.
Conditioning CSF by removing a causative agent and returning conditioned CSF free of artificial CSF
Removing cerebrospinal fluid from a first location, removing a causative agent from the removed cerebrospinal fluid, thereby conditioning the cerebrospinal fluid, and returning the conditioned cerebrospinal fluid to a second location at substantially the same flow rate, wherein the conditioned cerebrospinal fluid is free of artificial cerebrospinal fluid.
Separating causative agents using selected separation processes
Removing the causative agent from the removed cerebrospinal fluid includes one or more separation processes selected from the group comprising biospecific affinity, cationic exchange, anionic exchange, hydrophobicity, and size exclusion.
Conditioning causative-agent removal using chromatography columns
Removing the causative agent from CSF uses one or more chromatography columns selected from immunoaffinity columns and size exclusion, anionic exchange, cationic exchange columns, and named protein columns including Protein A and Protein G.
Constraining CSF flow and removed volume
The removing and returning are performed at a flow rate within the range of 0.04 ml/min to 30 ml/min, and the method limits the amount of cerebrospinal fluid removed from a patient at any time so it never exceeds 40 ml.
Periodically reversing CSF flow directions
The method periodically reverses the flow directions of removing and returning cerebrospinal fluid so that CSF is returned to an original location and removed from a second location during part of the treatment.
Across the independent claims, the inventive core is concurrent conditioning of patient cerebrospinal fluid by removing a causative agent and returning conditioned cerebrospinal fluid free of artificial cerebrospinal fluid using a single catheter with axially spaced proximal and distal ports, with substantially the same removal and return flow rate.
Stated Advantages
Ameliorating a symptom of one or more of Amyotrophic Lateral Sclerosis and Huntington's Disease.
Conditioning cerebrospinal fluid by removing a causative agent rather than using conditioned cerebrospinal fluid containing artificial cerebrospinal fluid.
Performing removing and returning concurrently using a single catheter with axially spaced proximal and distal ports.
Documented Applications
Ameliorating symptoms of Amyotrophic Lateral Sclerosis.
Ameliorating symptoms of Huntington's Disease.
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