Medical Insertion Device Ramp Mechanism for Skin Bulging

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Solution Overview

Problem

Existing insertion devices for medical devices, such as analyte sensors, often face challenges with incomplete subcutaneous insertion due to skin bulging and the soft, flexible nature of the sensors, leading to partial or unsuccessful penetration, which can result in the sensor not performing its function effectively.

Innovation Solution

An insertion device comprising a guide sleeve with a ramp, an insertion component retractor, a cap, and an elastic member, which allows for controlled movement and twisting of the insertion component to ensure full penetration of the sensor into the skin, along with a sensor patch to apply pressure and compensate for skin bulging, ensuring reliable insertion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the sensor is made soft and flexible to minimize skin irritation, then the sensor can be more comfortable for the user, but the sensor cannot effectively pierce and advance into the skin when the insertion component retracts

Engineering Contradiction:

Improveskin irritationVSAvoidinsertion effectiveness

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The system is divided into two functional parts: a soft sensor for comfort and a separate insertion component (needle) for penetration. The needle can be retracted after insertion, leaving only the soft sensor in the skin to minimize irritation while ensuring reliable initial penetration.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insertion component acts as an intermediary that enables the soft sensor to reach the target depth. The needle provides the necessary mechanical strength for penetration, then retracts, allowing the soft sensor to remain without causing irritation.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If the insertion component is retracted deeply into the housing to minimize infection risk, then safety is improved, but the sensor may not be fully inserted into the skin

Engineering Contradiction:

Improveinfection riskVSAvoidinsertion depth accuracy

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The insertion component performs the insertion action first, ensuring the sensor reaches the correct depth before retraction. The system is designed so that full insertion is achieved during the forward motion, then the component retracts to the safe position.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The insertion process is designed as a continuous motion where the sensor is pushed to full depth and then the insertion component retracts in a continuous sequence, ensuring the sensor remains properly positioned throughout the process.

Inventive Principle:

Principle #20Continuity of useful action

3Force

If the insertion needle exerts force to penetrate the skin, then insertion is achieved, but the skin bulges inward causing the sensor to not fully insert when the needle retracts

Engineering Contradiction:

Improvepenetration forceVSAvoidfinal insertion position

Core Design Contradiction:

ForceVSManufacturing precision

Solution Approach 1:

The system anticipates the skin bulging effect and designs the insertion component to overcome this by maintaining sufficient forward force through the bulging phase. The component is designed to push the sensor past the point where skin relaxation might cause incomplete insertion.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 device ensures safe and user-friendly handling, facilitating complete subcutaneous insertion of medical devices, enhancing reliability and preventing partial insertion issues, thereby ensuring the sensor can effectively monitor analyte concentrations.

Implementation Method 1

an elastic member configured for storing energy upon compression or stretching of the elastic member and releasing the stored energy

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

the ramp of the guide sleeve is configured to twist the insertion component retractor relative to the guide sleeve and the insertion sleeve when the cap is moved from its distal position to its proximal position

Methodology Applied

Scientific EffectMechanical Advantage: Mechanical Advantage

Data Source

PatentUS12042145B2Insertion device and method for inserting a medical device

Publication Date: 2024.07.23 ROCHE DIABETES CARE INC

AI summary

An insertion device includes an insertion component that inserts a medical device into body tissue of a user. The insertion device also includes an insertion component retractor, a cap, a guide sleeve having a ramp, an insertion sleeve and an elastic member. For inserting the medical device, the cap, the insertion component retractor and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. The ramp twists the insertion component retractor relative to the guide sleeve and the insertion sleeve when the cap is moved from its distal position to its proximal position. The cap is movable from its proximal position to its distal position and the insertion component retractor is thereby moved from its proximal position to its distal position. An associated method of using the insertion device is also disclosed.