Needle Insertion Retraction Assembly with Rotator

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Solution Overview

Problem

The variability in insertion and retraction forces, speeds, and angles of introducer needles in infusion sets for diabetes management leads to increased catheter insertion failures and exposes users to accidental needle sticks, necessitating a more reliable and safer insertion and retraction mechanism.

Innovation Solution

A needle insertor assembly for a medicament delivery device featuring a driver with movable parts, a rotator, and an energy accumulation member that applies rotational force to move the needle assembly through the skin, ensuring precise insertion and automatic retraction, while a cannula assembly remains in place for continuous medicament delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual insertion and retraction of the introducer needle is used, then the device complexity is reduced, but the reliability of catheter insertion decreases due to variability in insertion and retraction forces, speeds, and angles

Engineering Contradiction:
Improvecatheter insertion reliabilityVSAvoidinsertion device complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the introducer needle, catheter, and insertion device into a single integrated assembly. The needle and catheter are co-axially arranged within the same hub, and the insertion device simultaneously controls both components. This merging eliminates the need for separate manual manipulation of multiple components, providing consistent insertion forces and angles while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The insertion device is designed to automatically control the insertion and retraction processes without requiring manual manipulation. The device self-regulates the forces, speeds, and angles through its mechanical design, including spring-loaded mechanisms and guide structures that ensure consistent performance. This self-service capability eliminates human variability while keeping the device operationally simple.

Inventive Principle:
Principle #25Self-service

2Object-affected harmful factors

If the introducer needle is completely removed from the infusion set after insertion, then the needle can be reused, but the user is exposed to accidental needle sticks from handling the removed needle

Engineering Contradiction:
Improveaccidental needle stick exposureVSAvoidneedles
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The patent extracts the introducer needle from the infusion set after catheter insertion is complete. The needle is designed to be detachable from the hub, allowing it to be removed separately from the catheter assembly. This extraction enables the needle to be reused in subsequent procedures while the catheter remains in place for continuous medicament delivery, thereby reducing needle waste.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The hub serves as an intermediary component that temporarily holds both the needle and catheter during insertion, then facilitates their separation. The hub's design allows the needle to be detached and disposed of or reused, while the catheter remains connected to the infusion system. This intermediary structure enables safe needle removal without direct hand manipulation, reducing accidental stick exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a mechanized insertor is used to automatically insert and remove the introducer needle, then user safety is improved, but the device complexity and number of components increase

Engineering Contradiction:
Improveaccidental needle stick exposureVSAvoidinsertor mechanism complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges the automated insertion and removal functions into a single integrated insertor mechanism. The insertor simultaneously controls both the introducer needle and catheter, performing insertion, catheter deployment, and needle retraction in one automated sequence. This consolidation reduces the number of separate components and simplifies the overall device structure while maintaining automated safety features.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The insertor mechanism is designed to automatically perform all insertion and removal operations without requiring manual manipulation of the needle. The device self-regulates the entire process through spring-loaded mechanisms, guide structures, and coordinated movement of components. This self-service capability eliminates accidental needle stick exposure while keeping the device operationally simple and reducing the number of user-interaction components.

Inventive Principle:
Principle #25Self-service

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 reduces the number of components needed for users and minimizes accidental needle sticks by providing consistent and controlled needle insertion and retraction, enhancing the reliability of catheter placement and user safety.

Implementation Method 1

an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator

Methodology Applied
Scientific EffectElastic energy storage and release: Spring

Data Source

PatentUS20230090486A1Injector needle insertion retraction assembly
Publication Date: 2023.03.23 SHL MEDICAL AG
  • US20230090486A1 patent drawing
  • US20230090486A1 patent drawing
  • US20230090486A1 patent drawing

AI summary

A needle insertor for a medicament delivery device is presented having a driver having a first part movably arranged within the case and a second part connected to the base, a needle assembly movably held by the first part in the case, a rotator arranged in the case and configured to engage the first part for moving the driver, an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator, a movable stop arranged on the base and configured to interact with the rotator for preventing the rotator from rotating. The first part has a first position where the needle assembly is held inside the case, a second position where the needle portion is positioned outside the case after being moved to pass through the injection site end, and a third position where the needle portion is positioned inside the case.