Skull-Mounted Drug and Pressure Sensor

• US 20170325685A1
• Filed: 05/12/2017
• Published: 11/16/2017
• Est. Priority Date: 05/13/2016
• Status: Active Grant

• Current Assignee: Cognos Therapeutics, Inc.
• Original Assignee: Cognos Therapeutics, Inc.
• Inventors: Shachar, Yehoshua, Chen, Thomas, Lobl, Thomas J., Brydle, Jeffrey A., Gonzalez, Juan R., Indravudh, Virote, Merot, Christian, Schwartz, Allan R., Srisathapat, Chad
• Granted Patent: US 10,786,155 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61M 1/60 Containers for suction drainage, adapted to be used with an external suction source containers not adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps

Abstract

A skull-mounted drug and pressure sensor (SOS), a smart pump (ISP) electrically coupled to the SOS and a drug delivery and communications catheter communicating the SOS with the ISP are combined for a first embodiment. A skull-mounted (SOS), a metronomic biofeedback pump (MBP) electrically coupled to the SOS and a drug delivery and communications catheter having a sending and receiving optical fiber communicating the SOS with the MBP are combined for a second embodiment. A third embodiment combines a (SOS), an implantable power and communication unit (PCU) electrically coupled to the SOS, and a drug delivery and communications catheter for communicating the SOS with the PCU and for communicating the exterior source of the drug to the SOS. A fourth embodiment combines a ventricular catheter with a CSF accessible chamber and drug delivery port; and an implantable stand-alone skull-mounted drug and pressure sensor (SPS).

Claims

1. An apparatus comprising:

an implantable skull-mounted drug and pressure sensor (SOS);

an implantable smart pump (ISP) electrically coupled to the SOS;

a drug delivery and communications catheter communicating the SOS with the ISP,

where the ISP includes a drug reservoir, a pump communicated to the drug reservoir, a first pressure sensor coupled to the pump, and a first microcontroller subsystem for controlling the pump and bidirectionally communicating with the first pressure sensor and pump, and

where the SOS includes an optical ventricular catheter with a CSF accessible optical chamber and drug delivery port, an LED bundle and photodetector coupled to the optical ventricular catheter and a second microcontroller subsystem for controlling the LED bundle and photodetector.

2. The apparatus of claim 1 where the first microcontroller subsystem for controlling the pump and bidirectionally communicating with the first pressure sensor and pump comprises:

a first microcontroller,

a Bluetooth radio coupled to the first microcontroller;

an antenna coupled to the Bluetooth radio;

a power and analog circuit coupled to the first microcontroller and Bluetooth radio; and

a power source coupled to the pump, to the Bluetooth radio, and to the first pressure sensor.

3. The apparatus of claim 1 where the second microcontroller subsystem for controlling the LED bundle and photodetector comprises:

a second microcontroller, and

a control and analog circuit coupled to the second microcontroller and LED bundle and photodetector.

4. The apparatus of claim 3 further comprising a pressure and temperature sensor coupled between the optical ventricular catheter and drug delivery and communications catheter.

5. The apparatus of claim 1 further comprising a second pressure sensor coupled to the reservoir and communicated to the first microcontroller subsystem, the second pressure sensor including a selectively operated valve.

6. An apparatus comprising:

an implantable skull-mounted drug and pressure sensor (SOS);

a metronomic biofeedback pump (MBP) electrically coupled to the SOS;

a drug delivery and communications catheter having a sending and receiving optical fiber communicating the SOS with the MBP,

where the SOS includes an optical ventricular catheter with a drug delivery port and a CSF accessible optical chamber communicated with the sending and receiving optical fibers included in the drug delivery and communications catheter, and

where the MBP includes a drug reservoir, a pump communicated to the drug reservoir, a first pressure sensor coupled to the pump, an optical source and sensor circuit coupled to the sending and receiving optical fibers, and a microcontroller subsystem for controlling the pump and bidirectionally communicating with the first pressure sensor and pump and the optical source and sensor circuit.

7. The apparatus of claim 6 where the microcontroller subsystem for controlling the pump and bidirectionally communicating with the first pressure sensor and pump comprises:

a microcontroller;

a Bluetooth radio coupled to the microcontroller;

an antenna coupled to the Bluetooth radio;

a power and analog circuit coupled to the optical source and sensor circuit, microcontroller and Bluetooth radio; and

a power source coupled to the pump, to the microcontroller, to the Bluetooth radio, to the optical source and sensor circuit and to the first pressure sensor,

8. The apparatus of claim 6 further comprising a second pressure sensor coupled to the reservoir and communicated to the microcontroller subsystem, the second pressure sensor including a selectively operated valve.

9. An apparatus for use with an exterior source of a drug and an exterior monitor comprising:

an implantable skull-mounted drug and pressure sensor (SOS);

an implantable power and communication unit (PCU) electrically coupled to the SOS;

a drug delivery and communications catheter for communicating the SOS with the PCU and for communicating the exterior source of the drug to the SOS,

where the PCU includes a ventricular access port through which a drug may be provided from the exterior source, and a first microcontroller subsystem for bidirectionally communicating with the first pressure sensor and the exterior monitor, and

where the SOS includes an optical ventricular catheter with a CSF accessible optical chamber and drug delivery port, an LED bundle and photodetector coupled to the optical ventricular catheter and a second microcontroller subsystem for controlling the LED bundle and photodetector.

10. The apparatus of claim 9 where the first microcontroller subsystem for bidirectionally communicating comprises:

a first microcontroller,

a Bluetooth radio coupled to the first microcontroller;

an antenna coupled to the Bluetooth radio;

a power and analog circuit coupled to the first microcontroller and Bluetooth radio; and

a power source coupled to the Bluetooth radio.

11. The apparatus of claim 9 where the second microcontroller subsystem for controlling the LED bundle and photodetector comprises:

a second microcontroller; and

a control and analog circuit coupled to the second microcontroller and LED bundle and photodetector.

12. The apparatus of claim 11 further comprising a pressure sensor coupled between the optical ventricular catheter and drug delivery and communications catheter.

13. An apparatus for use with an exterior source of a drug and an exterior monitor comprising:

a ventricular catheter with a CSF accessible chamber and drug delivery port; and

an implantable stand-alone skull-mounted drug and pressure sensor (SPS) comprising;

a vascular access port (VAP) communicated with the ventricular catheter through which the drug may be provided from the exterior source;

a pressure sensor communicated to the optical ventricular catheter for measuring CSF pressure;

a microcontroller subsystem for bidirectionally communicating with the exterior monitor, the microcontroller subsystem communicated to the pressure sensor;

a Bluetooth radio communicated to the microcontroller subsystem for communicating with the exterior monitor,

an antenna couple to the Bluetooth radio and

a power source coupled to the pressure sensor,

microcontroller subsystem and Bluetooth radio.

14. The apparatus of claim 13 further comprising an over-pressure valve communicated to CSF accessible chamber of the ventricular catheter and a peritoneal catheter coupled to the over-pressure valve for delivery of excess CSF fluid.

15. A method comprising:

supplying a drug for treatment of a disease to a body space via an implanted catheter and delivery system;

monitoring pressure of fluid in the body space with an implanted pressure sensor; and

wirelessly communicating the monitored pressure of the fluid to an external monitor using an implanted wireless communication subsystem.

16. The method of claim 15 where supplying a drug for treatment of a disease to a body space via an implanted catheter and delivery system comprises supplying the drug from an implanted pumped reservoir of the drug.

17. The method of claim 15 where supplying a drug for treatment of a disease to a body space via an implanted catheter and delivery system comprises supplying the drug through an implanted vascular access port (VAP) communicated to the implanted catheter and delivery system.

18. The method of claim 15 where monitoring pressure of fluid in the body space with an implanted pressure sensor comprises detecting blockages to or leaks from the implanted catheter or components communicated with the catheter.

19. The method of claim 15 where monitoring pressure of fluid in the body space with an implanted pressure sensor comprises detecting over-pressure of fluid in the implanted catheter and releasing excess fluid pressure when the over-pressure is detected.

20. The method of claim 15 where supplying a drug for treatment of a disease to a body space via an implanted catheter and delivery system comprises supplying a drug to a brain ventricle, and monitoring pressure of fluid in the brain ventricle with the implanted pressure sensor.

21. The method of claim 15 using an apparatus comprising an implantable skull-mounted drug and pressure sensor (SOS), an implantable smart pump (ISP) electrically coupled to the SOS, a drug delivery and communications catheter communicating the SOS with the ISP, where the ISP includes a drug reservoir, a pump communicated to the drug reservoir, a first pressure sensor coupled to the pump, and a first microcontroller subsystem for controlling the pump and bidirectionally communicating with the first pressure sensor and pump, and where the SOS includes an optical ventricular catheter with a CSF accessible optical chamber and drug delivery port, an LED bundle and photodetector coupled to the optical ventricular catheter and a second microcontroller subsystem for controlling the LED bundle and photodetector,

further comprising operating the ISP and SOS in a closed loop fashion to detect a leak or a blockage in the drug delivery and communications catheter and to detect the location of the blockage.