MULTIPURPOSE CEREBROSPINAL FLUID SENSOR ASSEMBLY AND METHOD OF OPERATION OF THE SAME

• US 20140303455A1
• Filed: 04/03/2014
• Published: 10/09/2014
• Est. Priority Date: 04/03/2013
• Status: Abandoned Application

• Current Assignee: Pharmaco Kinesis Corporation
• Original Assignee: Pharmaco Kinesis Corporation
• Inventors: Shachar, Yehoshua, Chen, Thomas, Murray, Dan, Purnell, Robert
• Application Number:
  US14/244,722
• Publication Number:
  US 20140303455A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/1032 Determining colour for diagnostic purposes measuring colour in general G01J3/46
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A cerebrospinal fluid (CSF) monitoring device for the detection of obstructions in real time through the collection of pressure data from an on-board pressure sensor. This system is designed to integrate into medical devices equipped with a CSF drainage system, such as implantable shunts. CSF analysis data can be transmitted in real-time wirelessly to a physician or can be stored on-board in a memory card and retrieved wirelessly at a later time. Information from the CSF sensors can be used by physicians to monitor CSF conditions known to cause shunt malfunction/obstruction such as elevated protein concentrations, evidence of an on-going or recent hemorrhage such as presence of heme proteins, and concentrations of administered medications/drugs over time. It can be used to monitor for CSF infections, in which increased pressure, increased temperature, CSF high protein and low glucose, would be suggestive of CSF infections.

Claims

1. A shunt monitoring system for use with cerebrospinal fluid drainage systems in a patient, the shunt monitoring system comprising:

a flow channel disposed through the system in which cerebrospinal fluid (CSF) is optically analyzed by a plurality of sensors, wherein the plurality of sensors comprise;

a pressure sensor for measuring the intracranial pressure (ICP) of the patient;

a glucose sensor; and

a temperature sensor;

an integrated memory chip for archiving recorded sensor data disposed in the system and coupled to the suite of sensors;

an integrated wireless radio transmitter coupled to the integrated memory chip; and

a battery coupled to the suite of sensors, the wireless radio transmitter, and the integrated memory chip.

4. The monitoring system of claim 1 where the plurality of sensors further comprise a spectrophotometer for measuring the optical density and color/pigmentation of the CSF.

5. The monitoring system of claim 1 where the flow channel is comprised of a low flow-resistance, biocompatible material.

6. The monitoring system of claim 1 where the flow channel has the same inner diameter as the catheter, shunt valve opening, or drainage shunt terminal tip used in the cerebrospinal fluid drainage system in the patient in order to avoid CSF flow changes.

7. The monitoring system of claim 1 where the pressure sensor measures pressures in range of 3-20 mm Hg of positive pressure within an accuracy of 0.1 mm Hg.

8. The monitoring system of claim 1 where the pressure sensor is disposed inside the flow channel where the pressure sensor monitors for signs of obstructions inside the monitoring system.

9. The monitoring system of claim 1 where the pressure sensor is disposed in an upstream portion of the flow channel to aid in the identification of signs of obstructions inside the flow channel.

12. The monitoring system of claim 1 further comprising a check valve to prevent the back flow of other body fluids into the monitoring system.

2. The monitoring system of claim 0 where the monitoring system comprises means for being used in a conventional shunt system and is coupled to a distal catheter of the shunt system and is implanted into the peritoneum of the patient.

3. The monitoring system of claim 0 where the plurality of sensors monitor the CSF of the patient in real-time and in-vivo.

10. The monitoring system of claim 0 where the plurality of sensors, the flow channel, the integrated memory chip, and the battery are comprised of sterilized and biocompatible materials.

11. The monitoring system of claim 0 where the integrated wireless radio transmitter comprises means for communicating data wirelessly with an external processing unit.

13. The monitoring system of claim 0 further comprising an alarm circuit coupled to the suite of sensors for generating warning or alarm signals.

14. A method for monitoring a cerebrospinal fluid (CSF) drainage system in a patient comprising:

directing a flow of CSF through a flow channel;

measuring a plurality of physical parameters of the CSF using a plurality of sensors disposed within the flow channel;

recording the measured parameters in an integrated memory chip coupled to the plurality of sensors; and

transmitting the recorded parameters wirelessly to an external processing unit.

15. The method of claim 14 where measuring the plurality of parameters of the CSF comprises:

identifying abnormalities in the physical characteristics of the CSF; and

detecting any obstructions in the shunt.

16. The method of claim 14 where measuring the plurality of parameters of the CSF measuring the protein concentration within the CSF of the patient.

17. The method of claim 14 where recording the measured parameters comprises recording a measured intracranial pressure and a protein concentration value obtained by the plurality of sensors and forming a baseline profile for each measured parameter.

18. The method of claim 14 where measuring the plurality of parameters of the CSF comprises:

measuring parameter conditions associated with CSF infections;

measuring parameter conditions associated with on-going hemorrhaging or recent hemorrhaging;

measuring parameter conditions associated with blood brain barrier (BBB) dysfunction; and

measuring parameter conditions associated with a response to treatment.

19. The method of claim 15 where identifying abnormalities in the physical characteristics of the CSF comprises measuring the intracranial pressure (ICP) of the patient and non-invasively detecting a potential shunt infection while minimizing the need for tapping a shunt.

20. The method of claim 14 where measuring a plurality of physical parameters of the CSF using a plurality of sensors disposed within the flow channel comprises detecting the presence of cells alien to normal and healthy sample of the patient'"'"'s CSF, including red blood cells, bacterial cells, and/or cancer cells.

21. The method of claim 14 where measuring a plurality of physical parameters of the CSF using a plurality of sensors disposed within the flow channel comprises measuring the absorption or transmission of light through the CSF at one or more wavelengths using a UV-Vis spectrophotometer.

22. The method of claim 21 where the measured data obtained by the UV-Vis spectrophotometer is used for:

estimating the amount of total proteins in CSF;

detecting heme proteins or decomposing heme proteins;

or

determining if light scattering objects such as human cells, bacterium cells, or debris are present in amounts higher than a predetermined baseline amount.

23. The method of claim 21 where the measured data obtained by the UV-Vis spectrophotometer is used for deriving the concentration of a drug molecule in the CSF.

24. The method of claim 14 where measuring a plurality of physical parameters of the CSF using a plurality of sensors disposed within the flow channel comprises measuring a CSF parameter during hypothermia treatment, head trauma treatment, or any procedure requiring monitoring of the intracranial pressure (ICP).

25. A method for monitoring the response to a pharmacological therapy performed on a patient comprising:

performing the pharmacological therapy to the patient;

measuring a plurality of physical parameters of the cerebrospinal fluid (CSF) of the patient; and

analyzing the measured parameters of the CSF and its constituent concentrations.

26. The method of claim 25 where analyzing the measured parameters of the CSF comprise analyzing and fitting the measured parameters related to CSF to evaluate the response to the therapy using modeling software.