Intrathecal drug delivery system

An implantable intrathecal drug-delivery system, comprising:

• a device housing configured for subcutaneous implantation, the device housing having:
• a multi-lumen catheter operatively coupled to the device housing and configured to position a distal tip within a spinal intrathecal space;
• a plurality of reservoirs disposed in the device housing, each of the plurality reservoirs being configured to contain at least one therapeutic agent;
• at least one pump fluidly coupled to at least one of the plurality of reservoirs and to a drug delivery lumen of the multi-lumen catheter;
• at least one cerebrospinal-fluid (CSF) reservoir disposed in the device housing and configured to receive and store CSF sampled from the spinal intrathecal space;
• at least one biosensor comprising a near-infrared (NIR) spectroscopic sensor positioned at or near the distal tip of the multi-lumen catheter, or optically coupled to the distal tip, the biosensor being disposed in the catheter and/or in the device housing, the biosensor configured to obtain, from CSF, a sensor signal indicative of a concentration of at least one therapeutic agent;
• wherein the multi-lumen catheter comprises fluid-isolated lumens including:
• (i) a CSF inflow lumen configured to direct CSF from the spinal intrathecal space into the device housing;
• (ii) a CSF return lumen configured to direct CSF from the device housing to the spinal intrathecal space;
• (iii) the drug-delivery lumen configured to deliver the therapeutic agent from the device housing to the spinal intrathecal space;
• and
• (iv) a power/data lumen configured to provide power and/or data transmission for the biosensor;
• a processor operatively coupled to the biosensor, pump, and the plurality of reservoirs, the processor being configured to receive biosensor-derived concentration data based on the sensor signal determine, in real time, the concentration of the at least one therapeutic agent in the CSF, compare the concentration with a predefined therapeutic concentration range, and adjust an infusion rate of the therapeutic agent through the drug-delivery lumen based on the comparison while maintaining separation between CSF inflow/return and drug delivery;
• a wireless communication module operatively coupled to the processor and configured for bidirectional communication with an external device;
• and
• at least one transdermal access port in the device housing, the access port comprising a self-sealing septum and configured to permit reservoir refilling and CSF sampling.