Intracranial monitoring and therapy delivery control device, system and method

• US 6,248,080 B1
• Filed: 04/26/1999
• Issued: 06/19/2001
• Est. Priority Date: 09/03/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Stylos, Lee
• Primary Examiner(s): Layno, Carl H.
• Application Number:
  US09/299,774
• Time in Patent Office: 785 Days
• Field of Search: 600/561, 600/311
• US Class Current: 600/561
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: Y10S 977/90 having step or means utilizing mechanical or thermal property, e.g. pressure, heat

Abstract

An implantable medical device having an hermetically sealed enclosure housing electrical and electronic circuitry and a battery for powering such circuitry is connected to an intracranial lead or pigtail which measures or senses intracranial physiologic signals such as intracranial fluid pressure and/or temperature. The implantable medical device is preferably implanted subcutaneously beneath a patient'"'"'s skin and telemeters stored data or real-time-sensed data to an external device which may be configured to combine barometric pressure data with intracranial pressure data to derive intracranial gage pressure. The implantable medical device and its associated lead reduce the risk of intracranial infections.

Claims

1. A system for measuring intracranial fluid pressure in a patient, the system comprising:

(a) a subcutaneously implanted hermetically sealed implantable medical device;

(b) a lead coupled to the implantable medical device having a capacitive pressure sensor for measuring absolute intracranial fluid pressure;

(c) an external device having a barometric pressure sensor;

wherein the external device and the implantable medical device are configured to communicate telemetrically with one another such that the external device may uplink data sensed, stored or processed by the implantable medical device, a proximal end of the lead being configured for attachment to the implantable medical device, the capacitive pressure sensor being configured to receive electrical power from an electrical energy source disposed within the implantable medical device, the capacitive pressure sensor having a metal diaphragm for sensing pressure and generating signals representative thereof, electrical and electronic circuitry being disposed within the implantable medical device and configured to receive signals generated by the capacitive pressure sensor; and

wherein the implantable medical device is configured to combine first data representative of the intracranial fluid pressure signals and second data representative of the barometric pressure signals to derive third data representative of intracranial gage pressure.

2. The system of claim 1, wherein the external device is a programmer.

3. The system of claim 1, wherein the metal for forming the metal diaphragm is selected from the group consisting of titanium, nobium, tantalum, gold, stainless steel, and combination or alloys thereof.

4. The system of claim 1, wherein a sheath is disposed over at least a portion of the diaphragm to prevent brain or other tissue from impinging directly thereupon following implantation.

5. The system of claim 1, wherein implantable medical device is configured to combine the first and the second data.

6. The system of claim 1, wherein the external device is configured to combine the first and the second data.

7. The system of claim 1, wherein the implantable medical device and the external device are configured to communicate by radio frequency telemetry means.

8. The system of claim 1, wherein the external device is configured to permit programming of the implantable medical device so that the implantable medical device operates in a predetermined manner defined by the external device.

9. The system of claim 1, wherein the third data are displayed in the external device for viewing by a user.

10. The system of claim 1, wherein the capacitive pressure sensor is configured such that the output signals provided thereby drift less than about 1 mm Hg over a one week period of time.

11. The system of claim 1, wherein the capacitive pressure sensor is configured such that the output signals provided thereby drift less than about 1 mm Hg over a one month period of time.

12. The system of claim 1, wherein the capacitive pressure sensor is configured such that the output signals provided thereby drift less than about 1 mm Hg over a one year period of time.

13. The system of claim 1, further comprising means for calculating intracranial temperature on the basis of signals provided by the intracranial sensor.

14. The system of claim 1, further comprising means for delivering a therapy to the patient upon detecting a predetermined intracranial condition or state of the patient.