Long-term implantable monitoring system and methods of use

• US 9,814,413 B2
• Filed: 07/24/2015
• Issued: 11/14/2017
• 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
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/808,331
• Publication Number:
  US 20160022180A1
• Time in Patent Office: 844 Days
• 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 method of measuring a level of analyte in body fluid, comprising:

implanting a monitoring system into a body of a patient, the implanted monitoring system having a first multi-layer porous membrane, a second multi-layer porous membrane, and a sensor, the monitoring system further comprising a catheter, the first multi-layer porous membrane forming a wall of the catheter;

creating an ultra-filtrate from a body fluid by imparting a pressure differential to filter a portion of the body fluid through the first multi-layer porous membrane of the implanted monitoring system, the first multi-layer porous membrane having an outer layer and an inner layer, the outer layer having larger pores than the inner layer;

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

returning the ultra-filtrate to the body fluid through the second multi-layer porous membrane.

2. The method of claim 1, further comprising calibrating the monitoring system based upon an external measurement of the analyte.

3. The method of claim 1, wherein the implanting step comprises implanting the catheter into subcutaneous vascular tissue, the method further comprising promoting ingrowth of the subcutaneous vascular tissue into the pores of the outer layer.

4. The method of claim 1, wherein the implanting step comprises implanting at least a portion of the catheter into a blood vessel.

5. The method of claim 1, wherein the implanting step comprises implanting the catheter into a blood vessel and implanting a central module connected to the porous catheter into subcutaneous tissue.

6. The method of claim 1, wherein the implanting step comprises implanting the monitoring system between a vein and an artery as a vascular shunt.

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

8. The method of claim 1, wherein the pressure differential pulls the ultra-filtrate into the sensor and returns the ultra-filtrate to the body.

9. The method of claim 8, further comprising maintaining a constant pressure differential despite dynamic changes in hydrostatic pressure or oncotic pressure.

10. The method of claim 1, wherein a rate of creating the ultra-filtrate is between 0.5 μ

L/min and 20 μ

L/min.

11. The method of claim 1, further comprising displaying the measured amount of analyte.

12. The method of claim 1, wherein the analyte is glucose and wherein the body fluid is interstitial fluid or blood.

13. The method of claim 12, 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.

14. The method of claim 5, wherein the first multi-layer porous membrane includes a third layer configured to provide structural support to the membrane.

15. The method of claim 1, wherein the inner layer of the first multi-layer porous membrane comprises a plurality of extensions configured to extend into the outer layer of the first multi-layer porous membrane.

16. The method of claim 3, wherein creating the ultra-filtrate from a body fluid using a first multi-porous membrane comprises creating the ultra-filtrate using the inner layer of the first multi-porous membrane.

17. The method of claim 1, further comprising reversing a direction of flow through the first and second multi-layer porous membranes such that the body fluid flows through the second multi-layer porous membrane and the ultra-filtrate returns to the body through the first multi-layer porous membrane.

18. The method of claim 1, wherein the second multi-layer porous membrane includes an outer layer and an inner layer, the outer layer having larger pores than pores of the inner layer.