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

• US 9,072,866 B2
• Filed: 08/29/2013
• Issued: 07/07/2015
• 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:
  US14/013,644
• Publication Number:
  US 20140005589A1
• Time in Patent Office: 677 Days
• Field of Search: 600/549
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/031 Intracranial pressure
• 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: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: G01F 1/6847 where sensing or heating elements are not disturbing the fluid flow, e.g. elements mounted outside the flow duct

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 and comprising an opening that is adapted to apply a temperature source against the skin and a temperature pulse into the CSF, said pad comprising a plurality of temperature sensors 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 related to movement of said temperature pulse in the CSF or in surrounding skin; 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 determining a flow rate or flow status of said CSF through said shunt based upon said temperature data when said temperature source is applied to said opening.

2. The apparatus of claim 1 wherein at least a second one of said plurality of temperature sensors is a control temperature sensor, said at least a second one of said plurality of temperature sensors is configured not to be aligned with the CSF shunt.

3. The apparatus of claim 2 wherein said at least a second one of said plurality of temperature sensors comprises a temperature sensor on one side of said temperature sensor configured to be aligned with the CSF shunt and another temperature sensor on the other side of said temperature sensor configured to be aligned with the CSF shunt.

4. The apparatus of claim 3 wherein said one of said plurality of temperature sensors configured to be aligned with the CSF shunt and said temperature sensor on one side of said sensor configured to be aligned with the CSF shunt and said another temperature sensor on the other side of said temperature sensor configured to be aligned with the CSF shunt are configured to be aligned transversely with respect to the CSF shunt.

5. The apparatus of claim 1 further comprising an insulated enclosure, said insulated enclosure adapted for receiving said temperature source and wherein said insulated enclosure, along with said temperature source, is positioned within said opening in said pad for applying said temperature pulse against the skin over the CSF shunt and preventing transfer of said temperature pulse through the air.

6. The apparatus of claim 1 wherein said temperature source is an ice cube.

7. The apparatus of claim 1 wherein said flow rate or flow status comprises a resultant temperature signal formed by said sensor processing device by comparing said temperature data from said one of said plurality of temperature sensors configured to be aligned with the CSF shunt with said temperature data from the other of said plurality of temperature sensors that are configured to be not aligned with the CSF shunt.

8. The apparatus of claim 7 wherein said plurality of temperature sensors comprises three temperature sensors and wherein said temperature data of said one (T1) of said plurality of temperature sensors configured to be aligned with the CSF shunt is compared to said temperature data of said one (T2) of said other of said plurality of temperature sensors configured to be not aligned with the CSF shunt, and wherein said temperature data of said one (T1) of said plurality of temperature sensors configured to be aligned with the CSF shunt is also compared with said temperature data of another one (T3) of said plurality of temperature sensors configured to be not aligned with the CSF shunt.

9. The apparatus of claim 1 wherein said temperature source is an ice cube.

10. The apparatus of claim 1 wherein said opening is spaced away from said plurality of temperature sensors by 8 mm.