Cerebrospinal fluid evaluation system having thermal flow and flow rate measurement pad using a plurality of control sensors

• US 8,551,011 B2
• Filed: 04/01/2009
• Issued: 10/08/2013
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: Neuro Diagnostic Devices, Inc.
• Original Assignee: Neuro Diagnostic Devices, Inc.
• Inventors: Fritz, Frederick J., Swoboda, Marek
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US12/936,162
• Publication Number:
  US 20110054382A1
• Time in Patent Office: 1,651 Days
• Field of Search: 600/549, 732/041.1
• US Class Current: 600/549
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A method and device for testing for the presence, absence and/or rate of flow in a shunt tubing implanted under the skin by using a measurement pad having a plurality of temperature sensors, one of which is aligned with the shunt and the other sensors being symmetrically displaced on either side of the first temperature sensor in a direction transverse to the shunt tubing. These “outer” temperature sensors act as control temperature sensors. A temperature source, e.g., a cooling agent, positioned within an insulated enclosure, is then applied at a predetermined location on the measurement pad that is insulated from the temperature sensors. The movement of this temperature “pulse” is detected by the shunt-aligned temperature sensor via the shunt tubing as the CSF carries the temperature pulse while the control sensors detect the pulse via convection through the skin. The temperature data from these sensors are provided to a CSF analyzer that determines a CSF shunt flow status or flow rate.

Claims

1. An apparatus for evaluating cerebrospinal fluid (CSF) flow rate or flow status in a CSF shunt applied to the body of a patient for transmitting said CSF between first and second locations of said body, said apparatus comprising:

a single pad that is adapted to be placed against the skin of a patient over the location of the CSF shunt, said pad comprising a plurality of temperature sensors that are configured to be aligned in a first direction that is transverse to the CSF shunt and wherein one of said plurality of temperature sensors is configured to be aligned with the CSF shunt, each of said temperature sensors configured to generate respective temperature data, said plurality of sensors comprising three temperature sensors and wherein said one of said plurality of sensors is located between the other two temperature sensors; and

a sensor processing device that is electrically coupled to said pad for receiving temperature data from each of said temperature sensors, said sensor processing device using said temperature data to determine a flow rate or flow status of said CSF through said shunt when a temperature source is applied to said pad, and wherein said sensor processing device is configured to obtain said temperature data and is configured to generate a resultant temperature signal;

2. The apparatus of claim 1 wherein said one of said plurality of sensors is located 8 mm from each of said other two temperature sensors.

3. The apparatus of claim 1 wherein said pad comprises a region for receiving a temperature source to be positioned thereon and an edge that is adjacent said plurality of temperature sensors.

4. The apparatus of claim 3 wherein said edge is 8 mm from said plurality of sensors.

5. The apparatus of claim 1 wherein said pad comprises thermal insulation comprising an air bubble or air dome which is positioned on top of each one of said plurality of temperature sensors.

6. An apparatus for evaluating cerebrospinal fluid (CSF) flow rate or flow status in a CSF shunt applied to the body of a patient for transmitting said CSF between first and second locations of said body, said apparatus comprising:

a single pad that is adapted to be placed against the skin of a patient over the location of the CSF shunt, said pad comprising a plurality of temperature sensors that are configured to be aligned in a first direction and wherein one of said plurality of temperature sensors is configured to be aligned with the CSF shunt, each of said temperature sensors configured to generate respective temperature data;

a sensor processing device that is electrically coupled to said pad for receiving temperature data from each of said temperature sensors, said sensor processing device using said temperature data to determine a flow rate or flow status of said CSF through said shunt when a temperature source is applied to said pad; and

an insulated enclosure, said insulated enclosure adapted for receiving the temperature source and wherein said insulated enclosure, along with said temperature source, is positioned within an opening in said pad for applying a temperature spike or wave against the skin over the CSF shunt and not through the air.

7. The apparatus of claim 6 wherein the temperature source is an ice cube.

8. A method for evaluating cerebrospinal fluid (CSF) flow rate or flow status in a CSF shunt, said method comprising:

applying a plurality of temperature sensors against the skin over the location of the CSF shunt and aligned in a first direction, and wherein only one of said plurality of temperature sensors is aligned with the CSF shunt;

applying a temperature source over the CSF shunt and upstream of said plurality of temperature sensors for a predetermined period;

collecting temperature data from said plurality of temperature sensors after said predetermined period of time has elapsed;

generating a resultant temperature signal; and

determining a flow rate or flow status of the CSF through the shunt from said resultant temperature signal.

9. The method of claim 8 wherein said first direction comprises a direction that is transverse to the CSF shunt.

10. The method of claim 9 wherein said plurality of sensors comprises three temperature sensors and wherein said one of said plurality of sensors is located between the other two sensors.

11. The method of claim 10 wherein said step of generating said resultant temperature signal comprises:

12. The method of claim 8 wherein said step of applying a plurality of temperature sensors comprises positioning said one of said plurality of temperature sensors symmetrically from the other two temperature sensors.

13. The method of claim 12 wherein said one of said plurality of temperature sensors is positioned 8 mm from each of the other temperature sensors.

14. The method of claim 8 wherein said step of applying a plurality of temperature sensors comprises positioning an air bubble or air dome within a thermal insulator over each of said temperature sensors which are then positioned against the skin.

15. The method of claim 8 further comprising the step of enclosing the temperature source within an insulated enclosure prior to said step of applying a temperature source, said step of enclosing the temperature source within an insulated enclosure permitting the transference of a temperature spike or wave against the skin over the CSF shunt and not through the air.

16. The method of claim 15 wherein said temperature source is an ice cube.

17. The method of claim 8 wherein said predetermined period is 60 seconds.

18. The method of claim 8 wherein said step of applying a plurality of temperature sensors comprises having the patient lie in a supine position for a second predetermined period of time before applying said temperature source.

19. The method of claim 8 wherein said step of applying a plurality of temperature sensors comprises allowing said plurality of temperature sensors to remain against the skin for a third predetermined period of time.

20. The method of claim 8 wherein said step of applying a plurality of temperature sensors comprises using three fast response thermistors each having a time constant of <

5 seconds.

21. The method of claim 8 wherein said step of applying a temperature source comprises applying a cooling means.

22. The method of claim 8 wherein said step of collecting temperature data comprises preventing such data from being collected if said temperature sensors have been used previously.

23. The method of claim 8 wherein said step of applying a temperature source comprises distributing the temperature from said temperature source in a uniform or symmetric manner while applying a uniform pressure.

24. The method of claim 23 wherein said step of applying a temperature source comprises applying said source approximately 8 mm away from said plurality of temperature sensors.