Soft Cannula Insertion Device with Retractable Guiding Needle

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Solution Overview

Problem

Current insertion devices for infusion sets and sensors into body tissue are painful, require skilled handling, and pose risks of irritation and contamination due to the need for manual removal and handling of guiding needles, which can lead to unintended contact and injury.

Innovation Solution

A device with a housing, insertion arrangement, and drive mechanism that automatically inserts and affixes an insertion member with a puncturing tip to the skin, using a base plate with skin-compatible glue for secure fixation and a retractable guiding member to minimize pain and risk of contamination during insertion and removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a guiding needle is used to stiffen the soft cannula during insertion, then the insertion becomes easier and safer, but the guiding needle requires manual removal which poses contamination risks and requires skilled handling

Engineering Contradiction:
Improveinsertion safetyVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The guiding needle is extracted from the device after insertion, allowing the soft cannula to remain in the body while the guiding needle is removed. This separation eliminates the contamination risk associated with leaving the guiding needle in place while maintaining the insertion benefits.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The soft cannula acts as an intermediary between the guiding needle and the final insertion position. The guiding needle provides structural support during insertion, then is removed, leaving the flexible soft cannula in place for long-term use without contamination risks.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If manual application of infusion sets is performed, then flexibility is maintained, but pain and application difficulty increase significantly

Engineering Contradiction:
Improveapplication easeVSAvoidapplication pain
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device performs the insertion action automatically through a spring mechanism that propels the guiding needle and soft cannula into the skin without requiring manual manipulation by the user, thereby reducing both pain and operational complexity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual mechanical application process is replaced with an automated spring-driven mechanism that provides controlled insertion force, eliminating the need for skilled manual handling and reducing application pain.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If the cannula is made soft to reduce irritation, then comfort is improved, but a guiding element is required which increases device complexity and contamination risk

Engineering Contradiction:
Improveirritation levelVSAvoidguiding element requirement
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The device is segmented into two functional parts: a soft cannula for long-term comfort and a removable guiding needle for insertion support. This segmentation allows the soft cannula to provide comfort while the guiding needle temporarily provides structural support during insertion, then is removed to eliminate ongoing complexity and contamination risks.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS9522228B2Device for inserting an insertion member, or a soft member, into body tissue
Publication Date: 2016.12.20 ROCHE DIABETES CARE INC
  • US9522228B2 patent drawing
  • US9522228B2 patent drawing
  • US9522228B2 patent drawing

AI summary

A soft cannula is inserted into tissue and affixed to skin. A cannula arrangement moves within a housing and provides the soft cannula and a guiding needle extending through the cannula to temporarily stiffen it. A drive effects an insertion movement of the cannula arrangement from a first position, where a puncturing tip is pulled back relative to a face of the housing, into a second position, where the puncturing tip protrudes beyond the face, and automatically effects a retracting movement of the guiding needle into a third position, where the puncturing tip is pulled back relative to the face. The face is formed by a base plate affixed to the housing so that when the cannula arrangement is in the second position, the face detaches from the housing. A holder element is connected to the soft cannula and couples to the base plate in the cannula arrangement's second position.