Subarachnoid fluid management method and system
Inventors
Riccardi, Gianna N. • SIOPES, Jr., William X. • Glicksman, Marcie • DePasqua, Anthony • Kalish, Kevin • Vose, Joshua G. • Patel, Rajan
Assignees
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Publication Number
US-12329930-B2
Publication Date
2025-06-17
Expiration Date
Abstract
A CSF management method for use with a patient forms a closed loop CSF circuit between two points on the patient's body. The CSF circuit has a therapeutic inlet to receive a therapeutic material (e.g. a drug), and a pump having a pump outlet to direct CSF along the CSF circuit. The method controls the pump to direct CSF from the pump outlet at a CSF rate that is different from the natural flow rate (i.e., the natural CSF flow rate). The therapeutic material is added to the CSF via the therapeutic input at a therapeutic rate. The CSF rate is different than the therapeutic rate and/or may be greater than the therapeutic rate. Alternative methods may control a bolus drug infusion to localize the application to a target region.
Core Innovation
The invention relates to a CSF management system for use with a patient having a body with CSF having a natural flow rate. The system comprises a CSF circuit configured to control flow of the CSF in the body and a therapeutic input fluidly coupled with the CSF circuit to receive a bolus of therapeutic material into the CSF circuit. A pump directs the therapeutic material, via the CSF circuit, toward a prescribed portion of the body, while a controller varies the flow of the CSF in the CSF circuit to localize the CSF at that prescribed portion.
A central aspect of localization is that varying the CSF flow comprises oscillating a direction of the CSF flow between opposing directions within the CSF circuit. By oscillating the flow direction within the CSF circuit, the system maintains therapeutic material in the prescribed portion of the body. The disclosed localization approach also includes oscillating for a prescribed time and at a prescribed frequency, including patterns that produce pulsatile CSF flow.
The disclosure further supports localization by varying the CSF through the CSF circuit at two or more flow rates during two or more different times, and includes an architecture configured for subarachnoid space management. The system is described as having components such as catheters, ports, valves, and a mixing chamber, and may include sensors and real-time spectroscopy. The documented targeting includes specified CSF-containing compartments, including lateral ventricles, lumbar thecal sac, third and fourth ventricles, and cisterna magna.
Claims Coverage
The provided excerpt contains two independent claims: clm-00001 and clm-00013. Claim clm-00001 covers the CSF circuit, therapeutic input bolus, pump delivery toward a prescribed portion, and controller-driven localization by oscillating opposing CSF flow directions, while claim clm-00013 covers a sensor-equipped CSF circuit using flow and/or pressure sensing.
Oscillatory CSF flow localization with therapeutic bolus delivery
A CSF management system with a CSF circuit configured to control flow of CSF in the body, a therapeutic input fluidly coupled to the CSF circuit and configured to receive a bolus of therapeutic material into the CSF circuit, a pump configured to direct the therapeutic material via the CSF circuit toward a prescribed portion of the body, and a controller configured to vary the flow of the CSF in the CSF circuit to localize the CSF at the prescribed portion by oscillating a direction of the CSF flow between opposing directions within the CSF circuit to maintain therapeutic material in the prescribed portion.
CSF circuit with flow sensor and/or pressure sensor
A system in which the CSF circuit comprises a flow sensor, a pressure sensor, or both the flow sensor and the pressure sensor.
Across the independent claims, the core coverage is localization of therapeutic material to a prescribed portion of the body by oscillating CSF flow direction between opposing directions within the CSF circuit, together with sensing elements in the CSF circuit using flow and/or pressure sensors.
Stated Advantages
Localizes therapeutic material to a prescribed portion of the body by oscillating CSF flow direction between opposing directions within the CSF circuit.
Documented Applications
Sheep examples for methotrexate and antisense oligonucleotide delivery, including measurement of drug presence across brain/spinal cord regions and localization-related observations.
Therapeutic localization to CSF-containing compartments including lateral ventricles, lumbar thecal sac, third and fourth ventricles, and cisterna magna.
Use in connection with a therapeutic context described as including Huntington's disease and targeting of blood-brain barrier crossing outcomes.
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