Skull-mounted drug and pressure sensor

• US 10,786,155 B2
• Filed: 05/12/2017
• Issued: 09/29/2020
• 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
• Primary Examiner(s): Farrar, Lauren P
• Application Number:
  US15/594,251
• Publication Number:
  US 20170325685A1
• Time in Patent Office: 1,236 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 comprises;

an optical ventricular catheter;

an LED bundle coupled to the optical ventricular catheter, the LED bundle comprising a plurality of LEDs which are each configured to measure at least one optical absorption profile of cerebrospinal fluid (CSF); and

a photodetector coupled to the optical ventricular catheter; and

a second microcontroller subsystem for controlling the LED bundle and photodetector, wherein the second microcontroller subsystem communicates a measurement detected by the photodetector to the first microcontroller subsystem,

where the optical ventricular catheter comprises;

a CSF optical sensing chamber configured to receive light from the LED bundle and reflect it back to the photodetector; and

a drug delivery port.

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. 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;

measuring at least one optical absorption profile of cerebrospinal fluid (CSF);

communicating the measured at least one optical absorption profile of the CSF to an external monitor; and

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

wherein measuring at least one optical absorption profile of the CSF comprises introducing light from an LED bundle into an optical sensing chamber filled with the CSF and reflecting the introduced light back to a photodetector.

7. The method of claim 6 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.

8. The method of claim 6 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.

9. The method of claim 6 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.

10. The method of claim 6 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.

11. The method of claim 6 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.

12. The method of claim 6 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.