Shape Memory Introducer for Transcutaneous Sensor Implantation

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Solution Overview

Problem

Existing transcutaneous analyte sensors require complex and costly insertion tools, leading to mechanical trauma, immune response, and reduced sensor accuracy due to the size and complexity of these tools.

Innovation Solution

A shape memory material-based introducer system that transitions from a heat-unstable to a heat-stable state, or from a loaded to an unloaded configuration, allowing for self-implantation of medical devices without the need for separate tools, using a housing with an electrical current generating component or a driving mechanism to facilitate skin penetration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional complex insertion tools are used, then sensor implantation can be achieved, but device complexity and manufacturing costs increase

Engineering Contradiction:

Improvemanufacturing costVSAvoidinsertion tool complexity

Core Design Contradiction:

Ease of manufactureVSDevice complexity

Solution Approach 1:

The patent combines the sensor and introducer into a single integrated assembly where the sensor is positioned within the introducer's lumen. This merging eliminates the need for separate insertion tools, reducing both device complexity and manufacturing costs while maintaining implantation functionality

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The introducer is designed to serve multiple functions: it acts as both the insertion tool and a protective sheath for the sensor during implantation. The introducer's hollow cylindrical structure provides a universal platform that can accommodate different sensor types while simplifying the overall system architecture

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Ease of operation

If larger introducer size is used to carry the sensor, then sensor implantation is facilitated, but patient trauma and immune response increase

Engineering Contradiction:

Improvesensor insertion easeVSAvoidpatient trauma

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sensor is nested within the introducer's lumen, allowing the smaller sensor to be carried by the slightly larger introducer. This nesting arrangement minimizes the introducer's cross-sectional dimension while still facilitating easy sensor implantation, thereby reducing patient trauma and immune response

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The introducer is designed with a thin-walled hollow cylindrical structure that provides sufficient strength for insertion while minimizing the overall size. This thin-film approach allows the introducer to be small enough to reduce patient trauma yet large enough to carry the sensor effectively

Inventive Principle:

Principle #30Flexible shells and thin films

3Reliability

If multiple separate components are used, then functional requirements are met, but mechanical complexity and costs increase

Engineering Contradiction:

Improvesensor implantation reliabilityVSAvoidnumber of components

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the sensor and introducer into a single integrated assembly, reducing the number of components from multiple separate parts to two main components (sensor-introducer assembly and insertion tool). This merging maintains implantation reliability while significantly reducing mechanical complexity and associated costs

Inventive Principle:

Principle #5Merging (Combining)

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 solution reduces mechanical complexity, manufacturing costs, and patient trauma, while maintaining sensor accuracy by minimizing the size and complexity of the introducer, enabling efficient and precise transcutaneous implantation of medical devices.

Implementation Method 1

the introducer is at least partially formed from a shape memory material, and an activating component to activate the introducer to transition from a first operative shape memory state to a second operative shape memory state

Methodology Applied

Scientific EffectShape memory material transition: Shape Memory Alloy

Implementation Method 2

an electrical current generating component electrically coupled to the introducer for activating the introducer to transition from a heat-unstable shape to a heat-stable shape

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS9743862B2Systems and methods for transcutaneously implanting medical devices

Publication Date: 2017.08.29 ABBOTT DIABETES CARE INC

AI summary

Systems and methods for transcutaneously implanting medical devices, such as in vivo analyte sensors, are provided. The systems and methods involve the use of introducers or inserters made of shape memory alloy (SMA) materials which are transitionable from one operative state or configuration to another operative state or configuration, wherein the transition from state to state enables the transcutaneous implantation and/or transcutaneous explantation of the medical device.