Biosensor Insertion Device Hydration and Sterility Mechanism

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Solution Overview

Problem

Existing biosensor insertion devices fail to maintain biosensor integrity and hydration, particularly in moisture-rich environments, and lack effective sterilization and hydration mechanisms before and during insertion.

Innovation Solution

A device with a hydration storage compartment and a plunger system that ensures the biosensor remains sterile and hydrated, featuring a support device with ramps for guided insertion and a package assembly for maintaining sterility and hydration before use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a projection is used to trap the biosensor in place by friction fitting, then the biosensor is secured during insertion, but the projection can damage the coating of the biosensor

Engineering Contradiction:
Improvesecuring biosensor during insertionVSAvoiddamage to biosensor coating
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a separate trapping mechanism within the hollow tube that acts as an intermediary between the plunger and the biosensor. This mechanism traps the biosensor without requiring direct contact between the plunger projection and the biosensor coating, thereby preventing damage while maintaining securing functionality.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the trapping function from the plunger itself and implements it as a separate component within the hollow tube. This separation allows the plunger to push the biosensor without its projection directly contacting and potentially damaging the biosensor coating.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If the biosensor is stored in a sterile environment, then infection risk is reduced, but the biosensor exterior becomes sensitive to drying effects and requires constant hydration

Engineering Contradiction:
Improvesterility maintenanceVSAvoidbiosensor exterior integrity
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent merges the sterile storage environment with a hydration system by incorporating a hydrating solution reservoir and delivery mechanism within the same device. This allows the biosensor to be simultaneously kept sterile and hydrated throughout storage and insertion.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent implements preliminary hydration by pre-filling the hollow tube or associated reservoir with hydrating solution before biosensor insertion. This ensures the biosensor is hydrated in advance, preventing drying effects during the storage and insertion process.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the biosensor is kept sterilized prior to insertion, then infection risk is avoided, but the biosensor must be constantly hydrated to maintain device integrity

Engineering Contradiction:
Improveinfection preventionVSAvoidhydration maintenance system
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent implements multi-functionality by designing the hollow tube and associated components to simultaneously perform multiple functions: maintaining sterility, providing hydration, and enabling insertion. This reduces the need for separate systems and manages complexity through integration.

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 solution effectively maintains biosensor integrity and hydration during storage and insertion, ensuring proper function and reducing the risk of infection by providing a sterile and hydrated environment.

Implementation Method 1

The plunger, biosensor and hollow tube are configured such that the biosensor can be driven out of the distal end of the hollow tube by the plunger and into the desired location in the subject

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 2

The insertion device in accordance with one aspect of the present invention also provides a hydration storage compartment for the storage of the biosensor preferably in a sterile, hydrating environment

Methodology Applied
Scientific EffectHydration: Solvation

Data Source

PatentUS9241660B2Insertion device and method
Publication Date: 2016.01.26 SENSEONICS INC
  • US9241660B2 patent drawing
  • US9241660B2 patent drawing
  • US9241660B2 patent drawing

AI summary

The present invention provides an insertion device and method for implanting a biosensor into a patient subject. In one embodiment, a biosensor is stored in the instrument's hydration chamber which enables the biosensor to maintain proper hydration and sterilization prior to insertion. The instrument further includes a plunger that travels along a channel within the support device. After the biosensor is placed into the channel, the user pushes the plunger causing the biosensor to move through the channel and a hollow tube and into the patient subject. The present invention also provides for packaging and storing a biosensor and insertion device so that the biosensor is hydrated and sterile prior to insertion.