Subarachnoid fluid management method and system with varying rates

Inventors

Riccardi, Gianna N. • SIOPES, Jr., William X. • Glicksman, Marcie • DePasqua, Anthony • Kalish, Kevin • Vose, Joshua G. • Patel, Rajan

Assignees

Enclear Therapies Inc

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Publication Number

US-12337140-B2

Patent

Publication Date

2025-06-24

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 provides a CSF management system and method that forms a closed loop subarachnoid CSF circuit between two points on a patient body. The system includes a therapeutic inlet to receive a therapeutic material at a therapeutic rate, a catheter configured to at least in part form the closed loop CSF circuit, and a pump that directs CSF carrying the therapeutic material along the CSF circuit in a controlled manner.

A controller controls the pump to direct the CSF at a CSF rate that is different from the natural flow rate of the CSF. The controller is configured to set the CSF rate to be different from the therapeutic rate and to set the CSF rate individually controllable separate from the therapeutic rate. The CSF rate may be constant or time-varying, including multiple rates.

The system supports distributing CSF flow across locations in the circuit, including simultaneously driving different flow rates at different circuit locations. Drug delivery localization is supported by coordinated CSF rate control and infusion rate control, and by bolus delivery with alternating flow direction, oscillation, pulsatile flow, and optionally includes mixing chambers and imaging tags. Circuit implementations include internal/external catheters, patient access ports, removable connections, sensors for flow and pressure, and smart disposable external catheters with electronics and memory for patient customization and catheter usage tracking.

Claims Coverage

The document includes one independent claim that sets out the core closed-loop CSF management system, with multiple dependent claims refining how the CSF rate is controlled, how the circuit targets CSF-containing compartments, and additional system features such as constant versus varying CSF rate and catheter use tracking. Across the claim set, the central inventive theme is independent control of a controllable CSF rate different from natural flow rate and independent from the therapeutic rate while directing therapeutic material through a closed-loop CSF circuit.

Closed-loop CSF circuit between two points on the body

A catheter configured to at least in part form a closed loop CSF circuit between two points on the body.

Therapeutic inlet at a therapeutic rate

A therapeutic inlet to the CSF circuit configured to receive a therapeutic material at a therapeutic rate.

Pump directing CSF carrying therapeutic material along the circuit

A pump configured to direct CSF carrying the therapeutic material along the CSF circuit.

Independently controllable CSF rate different from natural flow and different from therapeutic rate

A controller operatively coupled with the pump, the controller configured to control the pump to direct the CSF at a CSF rate, the CSF rate being different from the natural flow rate, and configured to set the CSF rate to be different from the therapeutic rate, the CSF rate individually controllable separate from the therapeutic rate.

Constant CSF rate control

The system further configured such that the CSF rate is constant.

Time-varying CSF rate control

The system further configured such that the CSF rate changes over time.

CSF rate greater than the therapeutic rate

The system further characterized by a CSF rate that is greater than the therapeutic rate.

Accessing CSF-containing compartments in patient anatomy

A CSF circuit configured to access CSF-containing compartments in patient anatomy, including the lateral ventricles, lumbar thecal sac, third ventricle, fourth ventricle, and cisterna magna.

Catheter controller tracking and limiting catheter use

A system in which a catheter includes a controller configured to track and limit use of the catheter.

The claim coverage centers on a catheter-based closed loop CSF circuit with a therapeutic inlet and pump, where a controller sets a CSF rate that is different from both natural CSF flow and the therapeutic rate, with CSF rate individually controllable separate from therapeutic rate. Dependent refinements specify constant versus time-varying CSF rate behavior, comparative constraints between CSF rate and therapeutic rate, anatomical compartment access, and catheter-side control for tracking and limiting catheter use.

Stated Advantages

Documented Applications

No documented applications found

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