Implantable Ultrafiltrate Monitoring System for Glucose

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Solution Overview

Problem

Current long-term implantable glucose monitoring systems face challenges such as inaccurate measurements, short lifespan, and premature failure due to issues like fibrous capsule thickening, enzyme degradation, and biofouling, which affect the accuracy, stability, and longevity of continuous glucose monitoring.

Innovation Solution

A long-term implantable ultra-filtrate monitoring system using micro-porous membranes to produce an ultra-filtrate of interstitial fluid or blood plasma, which is then transported through a flow-through sensor for continuous monitoring, and subsequently returned to the subcutaneous tissue for absorption, utilizing a battery-powered pump and pressure transducers to control fluid flow and mimic the kidney's glomerulus function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a continuous glucose monitoring system is implanted in subcutaneous tissue, then real-time glucose monitoring is achieved, but the sensor lifespan is limited due to fibrous capsule thickening and biofouling

Engineering Contradiction:
Improveglucose monitoring accuracyVSAvoidsensor lifespan
Core Design Contradiction:
Measurement precisionVSDuration of action of stationary object

Solution Approach 1:

The patent introduces an ultrafiltration membrane as an intermediary layer between the blood and the glucose sensor. This membrane allows small molecules like glucose to pass through while blocking proteins and other large molecules that cause biofouling and fibrous capsule formation, thereby extending sensor lifespan while maintaining monitoring accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs a porous ultrafiltration membrane with specific pore sizes (molecular weight cutoff of 10,000-100,000 Daltons) to selectively filter the interstitial fluid. The porous structure enables glucose permeation while preventing the accumulation of fouling substances on the sensor surface

Inventive Principle:
Principle #31Porous materials

2Measurement precision

If enzyme-based sensors are used for glucose detection, then glucose monitoring is achieved, but enzyme degradation occurs over time leading to signal instability

Engineering Contradiction:
Improveglucose detection accuracyVSAvoidenzyme stability
Core Design Contradiction:
Measurement precisionVSStability of the object's composition

Solution Approach 1:

The ultrafiltration membrane serves as a protective intermediary that shields the enzyme from direct exposure to blood components and immune cells. By filtering out proteins and cellular elements before they reach the enzyme, the membrane prevents enzyme degradation and maintains signal stability

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the physical-chemical parameters of the sensing environment by controlling the composition of interstitial fluid through ultrafiltration. This creates a more stable chemical environment for the enzyme, reducing degradation rates and extending operational lifespan

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If subcutaneous tissue CGM sensors are used, then glucose monitoring is achieved, but frequent self-insertion and calibration are required which is difficult for elderly patients

Engineering Contradiction:
Improveglucose monitoring capabilityVSAvoiduser operation difficulty
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent implements a long-duration sensor design that provides more than sufficient monitoring coverage (excessive action) with a single insertion. The extended lifespan eliminates the need for frequent insertions and calibrations, making the system easier to operate for elderly patients with limited dexterity

Inventive Principle:
Principle #16Partial or excessive action

4Duration of action of stationary object

If the monitoring system operates long-term in the body, then continuous data is obtained, but biofouling and inflammation increase measurement errors

Engineering Contradiction:
Improvemonitoring durationVSAvoidmeasurement accuracy
Core Design Contradiction:
Duration of action of stationary objectVSMeasurement precision

Solution Approach 1:

The ultrafiltration membrane acts as a protective intermediary barrier that prevents proteins, cells, and other biological substances from directly contacting the sensor surface. This eliminates biofouling and inflammatory responses that would otherwise increase measurement errors over time

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The selective porous structure of the ultrafiltration membrane allows continuous operation by maintaining a clean sensor interface. The pore size distribution enables glucose transport while blocking fouling substances, ensuring measurement accuracy is maintained throughout the extended monitoring period

Inventive Principle:
Principle #31Porous materials

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This system enables reliable and stable long-term monitoring of glucose levels and other analytes by maintaining a continuous flow of ultra-filtrate, minimizing biofouling, and ensuring accurate and precise measurements over an extended period, potentially exceeding one year.

Implementation Method 1

A long-term implantable ultra-filtrate monitoring system using micro-porous membranes to produce an ultra-filtrate of interstitial fluid or blood plasma

Methodology Applied
Scientific EffectUltra-filtration: Semipermeable Membrane

Implementation Method 2

utilizing a battery-powered pump and pressure transducers to control fluid flow

Methodology Applied
Scientific EffectPump: Pump

Data Source

PatentUS10682079B2Long-term implantable monitoring system and methods of use
Publication Date: 2020.06.16 THOMAS JEFFERSON UNIV
  • US10682079B2 patent drawing
  • US10682079B2 patent drawing
  • US10682079B2 patent drawing

AI summary

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.