IP Library › Granted Patent US 12,728,190
Granted Patent B2
US 12,728,190 · App. 17/868,484 · Granted Sep 8, 2026

CSF diagnostics platform

Inventors: Rajan Patel (Newburyport, MA); Gianna N. Riccardi (South Berwick, ME); Kevin Kalish (Newburyport, MA); Marcie Glicksman (Salem, MA)
Assignee: EnClear Therapies, Inc.
A61M1/3687A61M1/16A61M1/1601A61M27/006A61M1/3655A61M1/3659A61M2027/004A61M2202/0464A61M2205/103A61M2205/12A61M2205/3334A61M2205/3344A61M2205/3379A61M2210/1003A61M2210/1039
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Quick Facts
Patent No.
US 12,728,190
App. No.
17/868,484
Granted
Sep 8, 2026
Kind
B2
Abstract

The present disclosure generally relates to a system for flowing a fluid, e.g., CSF, from a body of a patient for sampling and analysis. In some embodiments, the system can include a diagnostic module having one or more conduits for flowing fluid therethrough. The flow of the fluid through the valves can be regulated using a control board that changes an orientation of valves disposed in the conduits between a dead-end orientation and a flow-through orientation to sample and/or analyze the fluid from the system. In some embodiments, the fluid can be recirculated into the system through one or more of the valves, with sampling and recirculating occurring substantially simultaneously.

Claims (75)

1 . A CSF management method for use with a patient having a body with CSF, the method comprising:

forming a CSF circuit having at least one pump and catheter, the CSF circuit configured to channel the flow of the patient's CSF;

adding a therapeutic material to the CSF circuit;

flowing, using the pump and the catheter, the patient's CSF through the CSF circuit at one or more flow rates;

monitoring, when CSF is flowing in the CSF circuit, at least one quality of the CSF related to the therapeutic material, the at least one quality including a concentration of the therapeutic material in the CSF, after adding the therapeutic material to the CSF; and

controlling the one or more flow rates of the CSF as a function of a monitored concentration of the therapeutic material in the CSF to control absorption or distribution of the therapeutic material.

2 . The CSF management method as defined by claim 1 , further comprising:

determining, as a function of said monitoring, that the concentration of therapeutic material in the CSF is low; further wherein controlling comprises increasing the rate of flow of the patient's CSF through the CSF circuit to decrease the patient's absorption of the therapeutic material.

3 . The CSF management method as defined by claim 1 , further comprising:

determining, as a function of said monitoring, that the concentration of therapeutic material in the CSF is high, further wherein controlling comprises decreasing the rate of flow of the patient's CSF through the CSF circuit to increase the patient's absorption of the therapeutic material.

4 . The CSF management method as defined by claim 1 , wherein controlling the one or more flow rates comprises reversing the flow of the CSF.

5 . The CSF management method as defined by claim 1 , further comprising:

adding more therapeutic material to the CSF circuit as a function of said monitoring at least one quality of the CSF.

6 . The CSF management method as defined by claim 1 , wherein the at least one quality comprises one or more of the following: CSF protein levels; osmolarity; pH levels; glucose levels; CSF pressure; IgG; therapeutic material levels; cytokine levels; sodium levels; potassium levels; or magnesium levels.

7 . The CSF management method as defined by claim 1 , wherein the at least one quality comprises the concentration of a biomarker in the CSF or the concentration of the therapeutic in the CSF.

8 . The CSF management method as defined by claim 1 , further comprising:

disconnecting at least a portion of the CSF circuit to remove control of the flow of the CSF, said disconnecting concluding a single CSF session, said controlling comprising changing the rate of flow of the patient's CSF before said disconnecting.

9 . The CSF management method as defined by claim 1 , further comprising:

disconnecting at least a portion of the CSF circuit to remove control of the flow of the CSF, said disconnecting concluding a single CSF session, said controlling comprising setting a new rate of flow of the patient's CSF after disconnecting, the new rate of flow being used during a later CSF session.

10 . The CSF management method as defined by claim 1 , wherein said controlling comprises automatically controlling the one or more flow rates of the CSF as a function of the monitored concentration of the therapeutic material in the CSF.

11 . The CSF management method as defined by claim 1 , further comprising:

completing a first CSF session and a second CSF session in series, the method using a first catheter with the first CSF session and a second catheter with the second CSF session, the first catheter and second catheters being different, the first catheter not used during the second CSF session.

12 . The CSF management method as defined by claim 1 , wherein the CSF circuit has a flow-through segment with at least one sensor configured to monitor the CSF, said monitoring comprising flowing the CSF through the flow-through segment for analysis by the at least one sensor.

13 . The CSF management method as defined by claim 1 , wherein the CSF circuit comprises an end segment forming an output port, the output port being sealable and configured to enable removal of CSF from the circuit.

14 . The CSF management method as defined by claim 13 , further comprising:

fluidly coupling a removable sample collection container to the output port.

15 . The CSF management method as defined by claim 13 , wherein the output port comprises a plurality of output ports, the CSF circuit comprising at least one flow controller configured to direct CSF flow toward or away from one or more of the plurality of output ports.

16 . The CSF management method as defined by claim 13 , further comprising:

fluidly coupling a sampler to the output port, the sampler being configured to monitor one or more of the at least one quality of the CSF, further wherein said controlling comprises controlling the one or more flow rates of the CSF after receipt of a sample signal from the sampler, the sample signal having information relating to the concentration of the therapeutic material in the CSF.

17 . A CSF management system for use with a patient having a body with CSF and a port to the patient's CSF, the system comprising:

a CSF circuit having a catheter and a valve system, the CSF circuit configured to control flow of the patient's CSF and being removably couplable with the patient's port to form a closed fluid flow system, the CSF circuit being accessible via a sealable port;

a CSF monitor configured to monitor at least one quality of the CSF related to a therapeutic material, the at least one quality including a concentration of the therapeutic material in the CSF, when the CSF is flowing in the CSF circuit; and

a flow controller operatively coupled with the CSF monitor, the flow controller configured to control the flow rate of the CSF through the CSF circuit as a function of a monitored concentration of the therapeutic material in the CSF to control absorption or distribution of the therapeutic material.

18 . The CSF management system as defined by claim 17 , further comprising:

a pump configured to pump CSF through the CSF circuit, the pump being a dry pump.

19 . The CSF management system as defined by claim 17 , wherein the flow controller is configured to increase the rate of flow of the patient's CSF through the CSF circuit to decrease the patient's absorption of the therapeutic material when the concentration of therapeutic material in the CSF is below a threshold concentration.

20 . The CSF management system as defined by claim 17 , wherein the flow controller is configured to decrease the rate of flow of the patient's CSF through the CSF circuit to increase the patient's absorption of the therapeutic material when the concentration of therapeutic material in the CSF is above a threshold concentration.

21 . The CSF management system as defined by claim 17 , wherein the flow controller is configured to reverse or stop the flow of the CSF.

22 . The CSF management system as defined by claim 17 , wherein the at least one quality comprises one or more of the following: CSF protein levels; osmolarity; pH levels; glucose levels; CSF pressure; IgG; cytokine levels; sodium levels; potassium levels; or magnesium levels.

23 . The CSF management system as defined by claim 17 , wherein the at least one quality comprises the concentration of a biomarker in the CSF or the concentration of the therapeutic in the CSF.

24 . The CSF management system as defined by claim 17 , wherein the flow controller is configured to automatically control the one or more flow rates of the CSF as a function of the concentration of the therapeutic material in the CSF.

25 . The CSF management system as defined by claim 17 , wherein the CSF circuit has a flow-through segment with at least one sensor configured to monitor the CSF for the at least one quality.

26 . The CSF management system as defined by claim 17 , wherein the sealable port comprises an end segment forming an output port, the output port being sealable and configured to enable removal of CSF from the circuit.

27 . The CSF management system as defined by claim 26 , further comprising:

a removable sample collection container that is removably couplable to the output port.

28 . The CSF management system as defined by claim 26 , wherein the sealable port comprises a plurality of output ports, the flow controller configured to cooperate with the valve system to direct CSF flow toward or away from one or more of the plurality of output ports.

29 . The CSF management system as defined by claim 28 , further comprising:

a manifold coupled with a plurality of the output ports, the system further comprising a plurality of containers that are removably and sealably couplable with the CSF ports.

30 . The CSF management system as defined by claim 17 , further comprising:

a sampler configured to fluidly couple with the sealable port, the sampler being configured to monitor one or more of the at least one quality of the CSF, further wherein the flow controller is configured to control the one or more flow rates of the CSF after receipt of a sample signal from the sampler, the sample signal having information relating to the concentration of the therapeutic material in the CSF.

31 . The CSF management system as defined by claim 17 , wherein said monitoring occurs during a given CSF session and after the given CSF session, further wherein monitoring comprises gathering at least one sample of the CSF for off-site analysis after the end of the CSF session.

32 . The CSF management system as defined by claim 17 , further comprising a base substrate comprising:

a dry pump and a catheter pump interface for operatively coupling with the catheter;

a manifold having a plurality of output ports configured to receive a plurality of containers for CSF;

at least a portion of the valve system to control fluid flow into the manifold;

a sensor region to receive at least a portion of the CSF monitor;

a guide configured to receive and secure at least a portion of the catheter to the base substrate.

33 . The CSF management system as defined by claim 17 , wherein the CSF circuit has a flow-through segment with at least one sensor configured to monitor the CSF for the concentration of the therapeutic material in, the CSF management system further comprising a base substrate having:

a dry pump and a catheter pump interface for operatively coupling with the catheter;

a sensor region to receive at least a portion of the CSF monitor;

a guide configured to receive and secure at least a portion of the catheter to the base substrate.

34 . A medical kit comprising:

a catheter comprising a body forming a fluid traversing bore, the body having a first end and a second end in fluid communication with the bore, the first and second ends of the body being removably couplable between first and second exterior ports of the patient, the bore being configured to be in fluid communication with both the first and second exterior ports when removably coupled therebetween, the body being configured to form a closed loop CSF channel when removably coupled between the first and second exterior ports, the CSF channel and bore being in fluid communication with the patient's subarachnoid space when the body is removably coupled;

a valve configured to redirect fluid flow within the CSF channel;

a CSF monitor having a sensor configured to monitor at least one quality of the CSF related to the therapeutic material within the closed loop CSF channel; and

a flow controller configured to control the flow rate of the CSF through the CSF circuit as a function of a monitored concentration of the therapeutic material in the CSF to control absorption or distribution of the therapeutic material.

35 . The medical kit as defined by claim 34 , further comprising:

at least one CSF container configured to removably and fluidly couple with the CSF channel.

36 . The medical kit as defined by claim 35 , further comprising:

a manifold having a plurality of output ports, the manifold being configured to couple with the CSF channel.

37 . The medical kit as defined by claim 34 , further comprising:

a flow-through segment that is part of the CSF channel, the flow-through segment being part of the catheter or separate from the catheter.

38 . The medical kit as defined by claim 34 , further comprising:

a therapeutic material reservoir configured to removably couple with the CSF channel.

39 . The medical kit as defined by claim 38 , wherein the therapeutic material reservoir contains a fluid therapeutic material.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 20, 2022
From: PATEL, RAJAN; RICCARDI, GIANNA N.; KALISH, KEVIN; GLICKSMAN, MARCIE
To: ENCLEAR THERAPIES, INC.
Reel/Frame 061483/0143 →
Continuity (14)
Continuation In Part 17848211 · Jun 23, 2022
Continuation In Part 17669883 · Feb 11, 2022
Continuation In Part 17495682 · Oct 6, 2021
Continuation In Part 17489620 · Sep 29, 2021
Continuation 17062440 · Oct 2, 2020
Continuation PCTUS2020027683 · Apr 10, 2020
Provisional Application 63223248 · Jul 19, 2021
Provisional Application 63214239 · Jun 23, 2021
Provisional Application 63117975 · Nov 24, 2020
Provisional Application 63088401 · Oct 6, 2020
Provisional Application 63084996 · Sep 29, 2020
Provisional Application 62960861 · Jan 14, 2020
Provisional Application 62832486 · Apr 11, 2019
Related Publication 20220355015A1 · Nov 10, 2022
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