Systems and methods for flow detection and measurement in CSF shunts

• US 20040068201A1
• Filed: 02/14/2003
• Published: 04/08/2004
• Est. Priority Date: 02/15/2002
• Status: Abandoned Application

• Current Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Original Assignee: Eunoe, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Saul, Tom
• Application Number:
  US10/367,666
• Publication Number:
  US 20040068201A1
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

Devices and methods for removing cerebrospinal fluid (CSF) from a CSF space of a patient at relatively constant flow rates for patients having normal intracranial pressures, e.g. patients not suffering from hydrocephalus. The devices and methods provide drainage paths which permit the removal of CSF at relatively low flow rates, usually below 0.2 ml/day, at normal intracranial pressures, e.g. an intracranial pressure between −170 mm of H2O in upright patients and 200 mm of H2O in reclining patients. The removal of CSF at relatively low, constant rates is particularly suitable for treating Alzheimer'"'"'s disease and other conditions related to the presence of toxic and/or pathogenic substances in the CSF.

Claims

1. A method for monitoring cerebrospinal fluid (CSF) flow in a normal pressure patient having an implanted CSF drainage shunt, said method comprising:

externally receiving an output signal from a flow sensor in a flow lumen of the implanted CSF drainage shunt, said signal being representative of CSF flow through the flow lumen.

2. A method as in claim 1, further comprising transmitting an interrogation signal to the flow sensor prior to receiving the output signal.

3. A method as in claim 2, wherein the transmitting interrogation signal comprises transmitting power to the flow sensor, wherein said power activates the flow sensor to detect flow and generate the output signal.

4. A method as in claim 3, wherein the flow sensor is selected from the group consisting of a thermal device, a dye release device, a differential pressure measuring device, a turbine meter, an angular momentum measuring device, a positive displacement measuring device, and an accumulator.

5. A method as in claim 3, wherein the flow sensor is a thermal device in which interrogation signal induces heat generation in the flow lumen and the flow sensor measures temperature.

6. A method as in claim 5, wherein the flow sensor produces a signal which is an inverse function of temperature based on a thermal dilution heat transfer model.

7. A method as in claim 5, wherein the flow sensor produces a signal which is based on a thermal diffusion heat transfer model.

8. A method as in any of claims 2 to 7, wherein transmitting comprises directing radiofrequency energy to an antenna coupled to the fluid sensor.

9. A method as in claim 7, wherein the radiofrequency energy provides energy to the flow sensor.

10. A method as in claim 1, wherein the expected CSF flow in the lumen is in the range from 12 ml/day to 1200 ml/day.

11. A method as in claim 1, wherein the signal indicates whether there is a flow of 0.5 ml/hour or greater at the time the signal was generated.

12. A method as in claim 1, wherein the signal indicates whether there has been a cumulative flow through the shunt of at least 12 ml/day.

13. A method for monitoring cerebrospinal fluid (CSF) flow in a patient having an implanted CSF drainage shunt, said shunt assembly having a heat source and a temperature sensor proximate the heat source, said method comprising;

directing energy to heat the heat source, wherein an increase in the CSF flow rate reduces the temperature detected by the temperature sensor;

externally receiving an output signal from the temperature sensor; and

determining based on the output signal whether the shunt is draining CSF.

14. A method as in claim 13, wherein directing comprises transmitting energy selected from the group consisting of radiofrequency energy, ultrasonic energy, and optical energy.

15. A method as in claim 13, wherein the output signal comprises energy selected from the group consisting of radiofrequency energy, ultrasonic energy, and optical energy.

16. An implantable apparatus for draining cerebrospinal fluid (CSF), said apparatus comprising:

an implantable drainage catheter having one end adapted for implantation in a subarachnoid space (SAS), a drainage end adapted for implantation in a drainage space, and a flow lumen therebetween; and

a flow sensor which is coupled to sense flow through the flow lumen of the drainage catheter and which transmits a signal representative of flow through the flow lumen, wherein the sensor is capable of detecting flows at least as low as 12 ml/day.

17. An apparatus as in claim 16, wherein the sensor is adapted to detect a minimum instantaneous flow rate corresponding to 12 ml/day.

18. An apparatus as in claim 16, wherein the sensor is adapted to detect a minimum cumulative flow rate corresponding to 12 ml/day.

19. An implantable apparatus as in claim 16, wherein the implantable drainage catheter includes a first conduit implantable in the SAS, a second conduit implantable in the drainage space, and a flow control valve assembly therebetween.

20. An apparatus as in claim 19, wherein the flow sensor is disposed in or on the flow control valve assembly.

21. An apparatus as in any of claims 16 to 20, wherein the control valve assembly is configured to allow flow rates from 0.01 ml/min to 0.2 ml/min so long as pressure across the valve is in the range from 5 mmH₂O to 450 mm H₂O.

22. An apparatus as in any of claims 16 to 20, wherein the flow sensor is selected from the group consisting of a thermal device, a dye release device, a differential pressure measuring device, a turbine meter, an angular momentum measuring device, a positive displacement measuring device, and an accumulator.

23. An apparatus as in claim 22, wherein the flow sensor comprises a heater and a temperature detector, wherein the heater can be externally energized and the temperature detector can be externally interrogated.

24. An apparatus as in claim 23, wherein the temperature detector is spaced-apart from the heater in a direction toward the drainage end, whereby the flow signal is a function of the temperature measured by the temperature detector based on a thermal dilution heat transfer model.

25. An apparatus as in claim 24, wherein the temperature detector is disposed at or on the heater, whereby the flow signal is a function of the temperature detector based on a thermal diffusion heat transfer model.

26. An implantable apparatus as in any of claims 16 to 20, wherein the flow sensor includes a receiver for receiving an externally generated signal.

27. An implantable apparatus as in claim 26, wherein the receiver receives externally generated energy, and provides energy to the flow sensor.

28. A system for draining cerebrospinal fluid (CSF) and monitoring such drainage, said system comprising;

an implantable drainage catheter having a flow sensor adapted to detect a flow corresponding to a flow rate at least as low as 12 ml/day;

a power supply having an antenna adapted to externally deliver energy to the flow sensor when the flow sensor is implanted; and

an external receiver adapted to receive signals from the flow sensor when the flow sensor is implanted.