Infusion Site Interface Single Septum and Pivotable Needle Cover

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Solution Overview

Problem

Existing infusion site interfaces with two septums are costly to manufacture, prone to catching on clothing, and pose a risk of injury due to sharp needles, with inadequate disposal options for used needles, especially for self-administering patients.

Innovation Solution

A device with a single septum and a pivotable needle cover that allows safe handling and disposal, featuring a lock mechanism and spring element for easy insertion and removal of the needle, and a guide for parallel tubing connection, reducing the risk of accidental exposure and clothing entanglement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If two septums are used in the infusion site interface, then the sealing and connection reliability is improved, but the manufacturing cost increases and the device complexity increases

Engineering Contradiction:
Improvesealing and connection reliabilityVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent combines two separate septums into a single integrated septum structure. The single septum performs both sealing functions: sealing the cavity when the insertion needle is removed and providing fluid connection with the infusion tubing. This merging reduces manufacturing complexity and cost while maintaining the reliability of sealing and connection through the integrated design.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If two septums are used in the infusion site interface, then the sealing and connection reliability is improved, but the device complexity increases

Engineering Contradiction:
Improvesealing and connection reliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges two separate septums into one integrated septum structure that performs multiple functions. The single septum is designed to seal the cavity and provide fluid connection simultaneously, reducing the number of components and simplifying the overall device structure while maintaining sealing and connection reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single septum is designed with multi-functionality, serving both as a seal for the cavity and as a connection point for the infusion tubing. This universal design eliminates the need for separate septums, reducing device complexity while maintaining the required reliability for both sealing and connection functions.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Volume of stationary object

If the infusion site interface has a higher overall height, then the cavity volume is increased, but the risk of catching on clothing increases

Engineering Contradiction:
Improvecavity volumeVSAvoidrisk of catching on clothing
Core Design Contradiction:
Volume of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent repositions the cavity and its opening in a different spatial orientation. The cavity opening is positioned to face upward, allowing the cavity to be integrated into a low-profile interface structure. This dimensional re arrangement enables sufficient cavity volume without increasing the overall height, thereby reducing the risk of catching on clothing.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

4Strength

If a rigid insertion needle is used, then the penetration capability is improved, but the risk of injury and difficulty of disposal increases

Engineering Contradiction:
Improvepenetration capabilityVSAvoidrisk of injury
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent segments the insertion device into two separate components: a rigid insertion needle for penetration and a soft cannula for remaining in the body. The rigid needle provides the necessary penetration capability, while the soft cannula remains in the patient's tissue after insertion. This segmentation allows the rigid needle to be easily removed and disposed of, reducing the risk of injury during handling and disposal.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent extracts the rigid insertion needle from the soft cannula after insertion. The rigid needle serves its purpose of penetrating the skin and introducing the soft cannula, then is removed and discarded. This extraction eliminates the ongoing risk associated with retaining a sharp rigid needle in or near the patient's body, reducing injury risk during subsequent handling and disposal.

Inventive Principle:
Principle #2Taking out (Extraction)

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 enables safe, easy, and cost-effective handling and disposal of infusion cannulas and sensors, with a low-profile interface that minimizes the risk of injury and entanglement, while maintaining efficient fluid connection.

Implementation Method 1

spring element for easy insertion and removal of the needle

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

interface body mounted on a pad adhesively attached to a body of a patient

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS10307532B2Infusion site interfaces and insertion devices for infusion site interfaces
Publication Date: 2019.06.04 ROCHE DIABETES CARE INC
  • US10307532B2 patent drawing
  • US10307532B2 patent drawing
  • US10307532B2 patent drawing

AI summary

A device for inserting an infusion cannula, or sensor, into a patient is presented. The device comprises an insertion needle removable within the infusion cannula, a handle connected to the insertion needle, and a needle cover. The needle cover pivotably mounted on the handle is rotatably movable between a first position, i.e., the front of the insertion needle is in the needle cover, and a second position, i.e., the front is exposed. An infusion site interface comprises a body mounted on a pad attached to the patient; an infusion cannula for inserting into the patient that is connected to the body; a cavity within the body fluidly connected to the cannula; and a septum that seals closed the cavity. The septum is penetrable by an insertion needle in the infusion cannula and by a hollow needle of an infusion tubing connector coupled to the infusion site interface.