LONG-TERM IMPLANTABLE MONITORING SYSTEM & METHODS OF USE

• US 20160022180A1
• Filed: 07/24/2015
• Published: 01/28/2016
• Est. Priority Date: 07/24/2014
• Status: Active Grant

• Current Assignee: Thomas Jefferson University (Main Line Health System)
• Original Assignee: Thomas Jefferson University (Main Line Health System)
• Inventors: Joseph, Jeffrey I., Joseph, Amanda L.
• Granted Patent: US 9,814,413 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14556 by fluorescence A61B5/14555 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Methods and systems include a long-term implantable ultra-filtrate monitoring system that uses micro-porous membranes to produce an ultra-filtrate of tissue interstitial fluid or blood plasma. The ultra-filtrate is transported through a sensor to detect a level of analyte in the ultra-filtrate. The long-term implantable fluid monitoring system thus includes a first porous catheter, a second porous catheter, a sensor configured to measure an amount of analyte in fluid, and a pump configured to move fluid through the first porous catheter to the sensor and from the sensor through the second porous catheter.

Claims

1. A long-term implantable fluid monitoring system, comprising:

a first implantable porous catheter;

a second implantable porous catheter;

an implantable sensor configured to measure an amount of analyte in fluid; and

an implantable pump configured to move fluid through the first porous catheter to the sensor and from the sensor through the second porous catheter.

2. The system of claim 1, wherein the first implantable porous catheter includes a multi-layer wall including an outer layer, a middle layer, and an inner layer.

3. The system of claim 2, wherein the outer layer has larger pores than the middle layer.

4. The system of claim 2, wherein the inner layer is configured to provide structural support.

5. The system of claim 1, wherein the implantable pump is a microelectromechanical pump or a nanoelectromechanical pump.

6. The system of claim 1, further comprising a controller and at least one pressure sensor, the controller configured to regulate the pump based upon readings from the at least one pressure sensor to maintain a constant flow of fluid through the sensor.

7. The system of claim 1, wherein the implantable sensor is an optical sensor.

8. The system of claim 1, wherein the implantable sensor is a differential oxygen sensor, an enzyme sensor, an electrochemical sensor, a fluorescence sensor, or a physical change sensor.

9. The system of claim 1, wherein the first implantable porous catheter is configured to produce an ultra-filtrate from body fluid, and wherein the implantable sensor is configured to measure an amount of analyte in the ultra-filtrate.

10. The system of claim 1, wherein the analyte is glucose.

11. The system of claim 1, further comprising an external display configured to display the amount of analyte in the fluid.

12. The system of claim 1, further comprising a communications module configured to communicate the amount of analyte in the fluid to a remote monitoring station.

13. The system of claim 1, further comprising an implantable battery configured to provide power to the pump.

14. The system of claim 1, further comprising an alarm mechanism configured to alert for hyperglycemia based upon the measured amount of analyte, hypoglycemia based upon the measured amount of analyte, or a rapid rate of change in the amount of analyte.

15. The system of claim 1, further comprising a controller configured to determine an optimal infusion dose of insulin or glucagon based upon the measured amount of analyte.

16. The system of claim 1, wherein the pump is configured to produce a series of hydrostatic pressure differentials along the system.

17. A method of measuring a level of analyte in body fluid, comprising:

implanting a monitoring system into a body of a patient;

creating an ultra-filtrate from a body fluid using the implanted monitoring system;

measuring an amount of analyte in the ultra-filtrate with a sensor of the implanted monitoring system; and

returning the ultra-filtrate to the body.

18. The method of claim 17, further comprising calibrating the monitoring system based upon an external measurement of the analyte.

19. The method of claim 17, wherein the implanting step comprises implanting into subcutaneous vascular tissue.

20. The method of claim 17, wherein the implanting step comprises implanting at least a portion of the system into a blood vessel.

21. The method of claim 17, wherein the implanting step comprises implanting a porous catheter in a blood vessel and a central module connected to the porous catheter in subcutaneous tissue.

22. The method of claim 17, wherein the implanting step comprises implanting between a vein and an artery as a vascular shunt.

23. The method of claim 17, wherein creating an ultra-filtrate comprises creating an ultra-filtrate with a multi-layer porous membrane.

24. The method of claim 17, wherein the sensor is an optical sensor.

25. The method of claim 17, further comprising creating a pressure differential to pull the ultra-filtrate into the sensor and return the ultra-filtrate to the body.

26. The method of claim 25, further comprising maintaining a constant pressure differential despite dynamic changes in hydrostatic pressure or oncotic pressure.

27. The method of claim 17, wherein a rate of creating the ultra-filtrate is greater than 0.5 μ

L/min.

28. The method of claim 17, further comprising displaying the measured amount of analyte.

29. The method of claim 17, further comprising activating an alarm for hyperglycemia based upon the amount of analyte, hypoglycemia based upon the amount of analyte, or a rapid rate of change in the amount of analyte.

30. The method of claim 17, wherein the analyte is glucose and wherein the body fluid is interstitial fluid or blood.