Self-Actuating Nitinol Anchor for Secure Catheter Fixation

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Solution Overview

Problem

Existing medical devices, such as catheters, face challenges in securely anchoring to the patient's body without causing trauma during insertion and removal, and require separate actuation devices to extend or retract anchoring barbs.

Innovation Solution

A bendable anchor mechanism with non-retractable barbs made from superelastic nitinol or biocompatible polymers that flex during insertion and removal, allowing self-actuation without external devices, providing secure anchorage in the subcutaneous layer and minimizing skin trauma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional anchoring methods (tape patches or suturing) are used to secure catheters, then the catheter can be held in place, but skin trauma and discomfort occur during insertion and removal

Engineering Contradiction:

Improvecatheter anchoring securityVSAvoidskin trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces traditional mechanical anchoring systems (tape patches, sutures) with a self-actuating anchor mechanism that uses superelastic nitinol barbs. These barbs automatically deploy from a low-profile configuration during insertion to an extended anchoring configuration, securing the catheter without requiring external mechanical fastening devices that cause skin trauma.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The anchor mechanism utilizes phase transformation of nitinol material, changing from austenite (low-profile) to martensite (extended barb) phase during insertion and removal. This parameter change in material properties allows the barbs to flexibly deploy and retract, providing secure anchoring during procedures while minimizing trauma during insertion and removal.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If retractable barbs are used in anchor mechanisms, then secure anchoring can be achieved, but separate actuation devices are required which increase device complexity

Engineering Contradiction:

Improveanchor holding strengthVSAvoidactuation device requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The anchor mechanism is designed to self-actuate using the insertion and removal forces of the catheter itself. During insertion, the barbs automatically deploy from a low-profile to an extended configuration without requiring external actuation. During removal, the barbs automatically retract as the catheter is pulled through the skin, eliminating the need for separate actuation devices.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The barbs are designed with dynamic flexibility, transitioning from a static low-profile state during insertion to an active extended state during anchoring, and back to a retracted state during removal. This dynamic behavior allows the anchor to adapt its configuration based on the operational phase, providing secure holding strength without complex actuation mechanisms.

Inventive Principle:

Principle #15Dynamics

3Reliability

If barbs are extended during insertion, then secure anchoring is achieved, but skin trauma increases during the insertion process

Engineering Contradiction:

Improveanchor deployment effectivenessVSAvoidinsertion trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The barbs are pre-configured in a low-profile, retracted state that minimizes tissue displacement and trauma during insertion. Only after the catheter has been fully inserted into the subcutaneous layer do the barbs deploy to their extended anchoring configuration, ensuring that the anchoring action occurs after the insertion trauma has already been minimized.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The barbs exhibit dynamic behavior, remaining flexible and retracted during insertion to minimize trauma, then automatically deploying to an extended rigid configuration once insertion is complete. This temporal separation of the retraction and extension states ensures that anchoring effectiveness is achieved without compromising insertion comfort.

Inventive Principle:

Principle #15Dynamics

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 anchor mechanism securely holds medical devices in place during procedures and reduces the risk of skin trauma during insertion and removal, providing a reliable and trauma-free anchoring solution without the need for additional actuation devices.

Implementation Method 1

made from superelastic nitinol or biocompatible polymers that flex during insertion and removal

Methodology Applied

Scientific EffectSuperelasticity: Pseudoelasticity

Implementation Method 2

made from superelastic nitinol or biocompatible polymers that flex during insertion and removal

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11738177B2Anchor device and method

Publication Date: 2023.08.29 INTERRAD MEDICAL

AI summary

Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient's body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.