Sensor, circuitry, and method for wireless intracranial pressure monitoring

• US 9,901,268 B2
• Filed: 04/13/2012
• Issued: 02/27/2018
• Est. Priority Date: 04/13/2011
• Status: Active Grant

• Current Assignee: Branchpoint & AURA Development LLC
• Original Assignee: Branchpoint Technologies, Inc.
• Inventors: Hughes, Kevin, Strachan, Alexander
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/446,068
• Publication Number:
  US 20120265028A1
• Time in Patent Office: 2,146 Days
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/168 Fluid filled sensor housings
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 5/6868 Brain

Abstract

An intracranial pressure monitoring device includes a housing defining a first internal chamber, a plurality of strain gauges disposed on an inner surface of a diaphragm defined by a wall of the first internal chamber, a device for generating orientation signals, and circuitry coupled to the plurality of strain gauges and to the device. The circuitry is configured to generate intracranial pressure data from signals received from the plurality of strain gauges, generate orientation data based on the orientation signals received from the device, and store the intracranial pressure data and the orientation data in a computer readable storage such that the intracranial pressure data and orientation data are associated with each other.

Claims

1. An intracranial pressure monitoring device, comprising:

a housing defining a first internal chamber, the first internal chamber being hermetically sealed and having controlled contents to produce an internal pressure in the chamber;

a plurality of strain gauges disposed on an inner surface of a diaphragm defined by a wall of the first internal chamber;

a device for generating orientation signals; and

circuitry coupled to the plurality of strain gauges and to the device for generating orientation signals, the circuitry configured to;

generate intracranial pressure data based at least in part on signals received from the plurality of strain gauges,

generate orientation data based on the orientation signals received from the device for generating orientation signals;

store the intracranial pressure data and the orientation data in a computer readable storage such that the intracranial pressure data and orientation data are associated with each other; and

determine the intracranial pressure based on the association of the intracranial pressure data with the orientation data and on the internal pressure in the first internal chamber.

2. The intracranial pressure monitoring device of claim 1, wherein the circuitry is configured to wirelessly transmit intracranial pressure data and orientation data to a separate device.

3. The intracranial pressure monitoring device of claim 1, wherein the device for generating orientation signals includes at least one of an accelerometer and a gyroscope.

4. The intracranial pressure monitoring device of claim 1, wherein the device and the circuitry are disposed on a printed circuit board disposed in a second chamber defined by the housing.

5. The intracranial pressure monitoring device of claim 1, wherein the device for generating orientation signals and the circuitry are disposed on a printed circuit board disposed in the first internal chamber.

6. The intracranial pressure monitoring device of claim 1, wherein the housing includes a proximal portion and a distal portion, the proximal portion including threads disposed on an exterior surface for engaging bone of a skull.

7. The intracranial pressure monitoring device of claim 6, wherein the distal portion defines a circumferential trough along its length.

8. The intracranial pressure monitoring device of claim 6, wherein the proximal portion and the distal portion are welded together.

9. The intracranial pressure monitoring device of claim 6, wherein the proximal portion and the distal portion are coupled together via a threaded engagement.

10. The intracranial pressure monitoring device of claim 1, wherein the internal pressure within the first internal chamber is less than a pressure outside of the first internal chamber.

11. The intracranial pressure monitoring device of claim 1, wherein the plurality of strain gauges includes:

first and second strain gauges aligned with each other and disposed adjacent to a radial center of the diaphragm, and

third and fourth strain gauges aligned with each other and perpendicular to the first and second strain gauges, the third strain gauge disposed between a side wall extending from the diaphragm and the first strain gauge, and the fourth strain gauge disposed between the side wall and the second strain gauge.

12. The intracranial pressure monitoring device of claim 11, wherein the first, second, third, and fourth strain gauges are electrically connected in a Wheatstone bridge.

13. The intracranial pressure monitoring device of claim 12, wherein

the first and third strain gauges are electrically coupled together at a first node,

the second and fourth strain gauges are electrically coupled together at a second node,

the second and third strain gauges are electrically coupled together at a third node set at a first voltage level, and

the first and fourth strain gauges are electrically coupled together at a fourth node set at a second voltage level.

14. The intracranial pressure monitoring device of claim 13, wherein the circuitry includes a differential amplifier having an output coupled to a processor, the differential processor including a first input coupled to the first node and a second input coupled to the second node.

15. The intracranial pressure monitoring device of claim 11, wherein a first end of the third and fourth strain gauges are aligned with a first axis of the diaphragm, and a second end of the third and fourth strain gauges are aligned with a second axis of the diaphragm, the first and second axes of the diaphragm experience less of one of net compression or net tension than experienced by an area disposed between the first and second axes.

16. The intracranial pressure monitoring device of claim 15, wherein first and second ends of the first and second strain gauges are aligned with the second axis of the diaphragm.

17. The intracranial pressure monitoring device of claim 11, wherein the side wall extends from the diaphragm in a perpendicular direction, and a ridge extends between the side wall and the inner surface of the diaphragm at a non-perpendicular angle with respect to the side wall and the diaphragm.

18. The intracranial pressure monitoring device of claim 1, wherein an external surface of the diaphragm includes a coating for preventing scar tissue overgrowth.

19. The intracranial pressure monitoring device of claim 18, wherein the coating includes at least one of polyvinylpyrrolidone, phosphoryl colene, polyethylene oxide, a hydro-gel, paralene, an anti-inflammatory agent, a cell cycle inhibitor, an anti-platelet agent, an anti-thrombin compound, and a thrombolytic agent.

20. The intracranial pressure monitoring device of claim 1, wherein the circuitry includes an inductive coil and a capacitor, the capacitor configured to store energy in response to receiving a current from the inductive coil.

21. The intracranial pressure monitoring device of claim 1, wherein the diaphragm has a thickness between 0.004 inches and 0.005 inches.

22. The intracranial pressure monitoring device of claim 1, wherein the plurality of strain gauges, the device for generating orientation signals, and the circuitry are all disposed within the hermetically sealed chamber.

23. The intracranial pressure monitoring device of claim 22, wherein the computer readable storage is disposed within the hermetically sealed chamber.

24. The intracranial pressure monitoring device of claim 1, wherein the plurality of strain gauges, the device for generating orientation signals, and the circuitry are all in fluid communication with the hermetically sealed chamber.

25. The intracranial pressure monitoring device of claim 22, wherein the computer readable storage is in fluid communication with the hermetically sealed chamber.

26. The intracranial pressure monitoring device of claim 1, wherein the diaphragm comprises titanium.

27. The intracranial pressure monitoring device of claim 1, wherein the first internal chamber is configured to be coupled with a skull.

28. The intracranial pressure monitoring device of claim 1, wherein the intracranial pressure data and the orientation data are generated simultaneously.

29. The intracranial pressure monitoring device of claim 1, wherein the orientation data is indicative of an orientation of a patient'"'"'s head.

30. An intracranial pressure monitoring device, comprising:

a housing defining a first internal chamber and configured to be coupled with a skull, the first internal chamber being hermetically sealed and having controlled contents to produce an internal pressure in the first internal chamber that is less than a pressure outside of the first internal chamber;

a plurality of strain gauges disposed on an inner surface of a diaphragm defined by a wall of the first internal chamber; and

circuitry coupled to the plurality of strain gauges, the circuitry configured to generate intracranial pressure data based at least in part on signals received from the plurality of strain gauges and to determine the intracranial pressure,

wherein the intracranial pressure data is associated with an orientation data, the orientation data indicative of an orientation of the intracranial pressure monitoring device; and

wherein the intracranial pressure is determined based on the association of the intracranial pressure data with the orientation data and on the internal pressure in the first internal chamber.