Implantable telemetric transcranial doppler device

• US 6,468,219 B1
• Filed: 04/24/2000
• Issued: 10/22/2002
• Est. Priority Date: 04/24/2000
• Status: Expired due to Term

• Current Assignee: Philip Chidi Njemanze
• Original Assignee: Philip Chidi Njemanze
• Inventors: Njemanze, Philip Chidi
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Jain, Ruby
• Application Number:
  US09/559,006
• Time in Patent Office: 911 Days
• Field of Search: 607/17-19, 607/23, 607/24, 600/459, 600/443, 600/437, 600/422, 600/455, 600/462, 600/465, 600/467, 600/480, 600/454, 600/486, 604/891, 604/500, 604/66
• US Class Current: 600/454
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/065 to determine blood output from the heart in general A61B5/029
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4236 characterised by adhesive patches
• CPC Class Codes: A61B 8/4427 Device being portable or laptop-like
• CPC Class Codes: A61B 8/4444 related to the probe
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body

Abstract

The invention relates to a cerebral blood flow velocity monitoring system and method that comprises a transcranial Doppler ultrasound device that is adapted to be implanted in the human body, an oximeter, an external handheld computer and a drug delivery system. The system provides for monitoring of microembolic signals and operatively activates the drug delivery system for infusion of medication into the blood circulation for thrombolysis and neuroprotection.

Claims

1. A cerebral blood flow velocity monitoring system comprising:

a transcranial Doppler ultrasound device adapted to be surgically implanted in the human body;

a probe housing adapted to be surgically implanted on the temporal bone of the human head, said probe housing including the ultrasound transducer, and having a reservoir for refillable ultrasound gel;

a surgically implantable transducer cable having a proximal end and a distal end oriented such that the proximal end is attached to the transducer and the distal end having a connector for the implanted transcranial Doppler ultrasound device; and

an external handheld computer means for telemetering controlling signals to and receiving spectral signals from the implanted transcranial Doppler ultrasound device, the said handheld computer having a microcomputer, a monitor , input keyboard, a loud speaker, a communication means to the Internet and means of electrical power supply.

2. The system of claim 1 further including adhesive means on the probe housing base for fixation of the probe housing on the temporal bone and trapping the gel in place, so that the gel reservoir provides continuing coupling means between the ultrasound transducer and the temporal bone.

3. The system of claim 2 further wherein the implanted transcranial Doppler ultrasound device comprises a voltage generator/gate, receiver/gate, microprocessor, a radio-frequency transmitter/receiver and a battery power source.

4. The system of claim 3 further including oximeter means for measuring the oxygen saturation in blood, and communication means deriving signals responsive to the oxygen saturation and delivering said signals to the microprocessor of the transcranial Doppler ultrasound device.

5. The system of claim 4 further including a programming means for detection of microembolic signals, said programming means for regulation of infusion of medication for thrombolysis and neuroprotection.

6. The system of claim 5 further including an implantable drug infusion pump means for delivery of medication, said infusion pump operatively responsive to set threshold changes in cerebral blood flow velocity and rate of detection of microembolic signals.

7. The system of claim 6 further including a global positioning system means for determining the time and location of the event, said global positioning system operatively responsive to set threshold changes in cerebral blood flow velocity and rate of detection of microembolic signals.

8. The system of claim 7 further including an implanted pacemaker means for pacing the heart, said implanted pacemaker operatively responsive to set threshold changes in cerebral blood flow velocity.

9. The system of claim 7 further including a defibrillator means for ventricular defibrillation, said defibrillator operatively responsive to set threshold changes in cerebral blood flow velocity.

10. The system of claim 5 further including an external drug delivery system means for providing medication, said external drug delivery system operatively responsive to set threshold changes in cerebral blood flow velocity and rate of detection of microembolic signals.

11. The system of claim 4 further including a nasal continuous positive airway pressure device means for delivering breathing air, said nasal continuous positive airway pressure device is operatively responsive to set threshold changes in cerebral blood flow velocity and rate of detection of microembolic signals.

12. The system of claim 3 further including a programming means for detection of onset of seizures, said programming means for regulation of infusion of anti-epileptic medication.

13. The system of claim 6 further including a programming means for workload assessment.

14. A cerebral blood flow velocity monitoring system comprising:

a transcranial Doppler ultrasound device adapted to be surgically implanted in the human body having a voltage generator/gate, a receiver/gate, a microprocessor, a radio-frequency transmitter, a connection terminal for the transducer cable and a battery power source;

a surgically implantable silicon elastomer probe housing, said probe housing having a polypropylene base, said polypropylene base has an adhesive surface for fixation on the acoustic window of the temporal bone on the head, an ultrasound transducer with attached proximal end of the transducer cable, a reservoir made of silicon dome and having a valve;

a surgically implantable transducer cable covered with kink resistant radiopaque silicon elastomer material, said transducer cable connected at the proximal end to the transducer and having at the distal end a connector; and

an external handheld computer, said external handheld computer having a microcomputer, a monitor, input keyboard, a loudspeaker, a radio-frequency transmitter/receiver, a global positioning system, and a wire/wireless Internet communication.

15. The system of claim 14 further including an implantable drug infusion pump, said infusion pump for programmed delivery of medication and operatively responsive to set threshold of cerebral blood flow velocity and rate of detection of microembolic signals.

16. The system of claim 15 further wherein the sources of microembolic signals comprises vascular stent, vascular graft or prosthetic heart valves.

17. The system of claim 15 further wherein the source of microembolic signals comprises implanted ventricular assist devices.

18. A cerebral blood flow velocity monitoring system and method comprising:

a transcranial Doppler ultrasound device adapted to be surgically implanted in the human body into a subcutaneous space by means of an incision below the clavicle and including a voltage generator/gate, a receiver/gate, a microprocessor, a radio-frequency transmitter and a battery power source;

a surgically implantable silicon elastomer probe housing, said probe housing having a base made of polypropylene, said polypropylene base is adhesively fixated on the acoustic window of the temporal bone on the head and covered by skin above the zygomatic arc, and having an ultrasound transducer placed on the polypropylene base, said ultrasound transducer focused on a major cerebral vessel at a constant probe-to-vessel angle and coupled to the temporal bone with gel continually filled from a silicon dome reservoir, said reservoir externally refilled with gel under X-ray guidance via a radiopaque needle injection site, said gel expunged from the reservoir into the gel sheet placed in the space between the ultrasound transducer and the temporal bone;

a surgically implantable transducer cable covered with kink resistant radiopaque silicon elastomer material, said transducer cable fixed at the proximal end to the ultrasound transducer and connected at the distal end to the transcranial Doppler ultrasound device by means of a connector, said transducer cable is tunneled subcutaneously from behind the ear on the mastoid bone and along the stenocleidomastoid muscle to the subcutaneous space below the clavicle by means of a transducer cable passer, said transducer cable passer comprising polypropylene handle, nylon obturator with end fitting and malleable tubular passer shaft; and

an external handheld computer means for operatively controlling the internally implanted transcranial Doppler ultrasound device, said handheld computer having a microcomputer for processing data, a monitor means for displaying the spectral Doppler signals, input keyboard means for data entry and control of the functions of the system, a loudspeaker means for production of audio signals, a radio-frequency transmitter/receiver means for telemetering signals to and receiving signals from the internally implanted transcranial Doppler ultrasound device, a wire/wireless communication means to send and receive information on the Internet, a global positioning system means to locate the patient, and electrical power source means to provide electrical charge to the system;

whereby the probe housing, the transducer cable and the transcranial Doppler ultrasound device are implanted using a specified operative procedure and methodology starting with an incision made on the skin covering the temporal bone, then the probe housing is placed on the temporal bone to allow insonation of the cerebral vessels using the ultrasound transducer to identify appropriate probe position, wherein the probe position is marked, and the bone surface prepared using an abrasive surgical instrument, then the adhesive polypropylene base of the probe housing is fixated to the bone, and the transducer cable is tunneled subcutaneously from behind the ear on the mastoid along the stenocleidomastoid muscle to below the clavicle using the transducer cable passer, the tunneling is accomplished by first placing the transducer cable passer in the subcutaneous space, then unlocking the obturator from the handle and removing the handle from the tubular shaft, and placing the distal end of the transducer cable with connector in the obturator end fitting so that the obturator and transducer cable are then drawn through the tubular shaft by pulling the distal obturator tip, the obturator is then removed from the transducer cable and the tubular shaft withdrawn caudally through the incision below the clavicle leaving the said transducer cable in place, the distal end connector of the transducer cable is then connected to the terminal at the transcranial Doppler ultrasound device, the said transcranial Doppler device is then implanted in the subcutaneous space below the clavicle, and the incision sites sutured.

19. The system of claim 18 further including an implanted refillable drug delivery system, said means for delivery of medication and operatively responsive to set threshold changes in cerebral blood flow velocity and rate of detection of microembolic signals.

20. The system of claim 19 further including an external drug delivery system, said means for delivery of medication and operatively responsive to set changes in cerebral blood flow velocity and rate of detection of microembolic signals.