Bioactive Releasing Membrane for Implantable Sensor

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Solution Overview

Problem

Current implantable glucose monitoring devices face challenges in providing reliable data due to local tissue responses, leading to reduced sensor life and accuracy over time.

Innovation Solution

A bioactive releasing membrane is integrated with the device, containing releasable bioactive agents like dexamethasone, which modifies tissue responses, reducing immune reactions and extending sensor life by attenuating foreign body responses and maintaining signal accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If implantable glucose monitoring devices are used, then glucose levels can be detected, but local tissue responses reduce sensor life and accuracy

Engineering Contradiction:
Improvesensor accuracyVSAvoidsensor life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

A bioactive releasing membrane is introduced as an intermediary layer between the sensor and the surrounding tissue. This membrane contains and releases bioactive agents that modify the tissue response, preventing direct harmful interaction between the sensor and the immune system, thereby extending sensor life while maintaining accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The membrane modifies the local tissue environment by releasing bioactive agents that change the physiological parameters of the surrounding tissue, reducing immune reactivity and foreign body response, which allows the sensor to function reliably for extended periods

Inventive Principle:
Principle #35Parameter changes

2Reliability

If bioactive agents are released to modify tissue response, then immune reactions are reduced, but device complexity increases

Engineering Contradiction:
Improvetissue response stabilityVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The bioactive releasing membrane is implemented as a thin film structure that encapsulates the bioactive agents. This thin film approach provides the necessary functionality for controlled release while minimizing the added complexity and volume of the device

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The membrane serves multiple functions simultaneously: it acts as a barrier between the sensor and tissue, provides controlled release of bioactive agents, and modifies the local tissue environment. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

The bioactive releasing membrane effectively delays immune responses, maintaining glucose signal noise below 4 mg/dL for extended periods, thereby enhancing the longevity and reliability of glucose monitoring devices.

Implementation Method 1

a bioactive releasing membrane adjacent the sensor substrate, the bioactive releasing membrane comprising at least one releasable bioactive agent capable of modifying a tissue response of a subject

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS20230073214A1Bioactive releasing membrane for analyte sensor
Publication Date: 2023.03.09 DEXCOM INC
  • US20230073214A1 patent drawing
  • US20230073214A1 patent drawing
  • US20230073214A1 patent drawing

AI summary

The present disclosure relates generally to bioactive releasing membranes utilized with implantable devices, such as devices for the detection of analyte concentrations in a biological sample. More particularly, the disclosure relates to novel bioactive releasing membranes, to devices and implantable devices including these membranes, methods for forming the bioactive releasing membranes on or around the implantable devices, and to methods for monitoring analyte levels in a biological fluid sample using an implantable analyte detection device.