Skin Fixation Device with Automatic Base Plate Separation

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Solution Overview

Problem

Existing insertion devices for infusion sets and sensor arrangements often require manual fixation, leading to potential flexing or partial removal of cannulas, causing irritation and pain, and lack satisfactory skin fixation, increasing the risk of infection.

Innovation Solution

A device with a housing, insertion arrangement, and drive means that uses skin-compatible glue for fixation, allowing the insertion member to be automatically secured to the skin, reducing the need for manual force and minimizing the risk of irritation by using a soft cannula and guiding needle that stiffens during insertion and retracts safely.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual fixation is used to secure the insertion member to the skin, then the device structure is simple, but the fixation is unsatisfactory leading to flexing or partial removal of cannulas

Engineering Contradiction:
Improveskin fixation reliabilityVSAvoiddevice structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The base plate is prepared with adhesive material before use, and the insertion member is pre-assembled with the base plate. The adhesive is activated by breaking a protective foil, ensuring proper fixation is established before the insertion procedure begins, preventing subsequent flexing or removal issues

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The base plate with adhesive material is designed as a disposable component that is discarded after a single use. This eliminates the need for complex reusable fixation mechanisms while ensuring reliable single-use fixation, reducing device complexity for the same reliability outcome

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Object-affected harmful factors

If manual force is applied during insertion, then no additional drive means are needed, but the insertion causes irritation and pain

Engineering Contradiction:
Improveirritation and painVSAvoiddrive means complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The drive means propel the insertion member through the skin rapidly in a single motion, completing the insertion before pain receptors can fully activate. This 'rushing through' approach minimizes the duration of tissue disruption, reducing irritation and pain compared to slow manual insertion

Inventive Principle:
Principle #21Skipping (Rushing through)

Solution Approach 2:

A guiding needle serves as an intermediary element that facilitates smooth passage through the tissue. The needle guides the soft cannula through the skin with minimal resistance and trauma, reducing pain and irritation while the drive means provide the necessary propulsion force

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a soft cannula is used for insertion, then tissue irritation is reduced, but the cannula lacks stiffness for accurate insertion

Engineering Contradiction:
Improvetissue irritationVSAvoidcannula stiffness
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The insertion system is divided into two functional segments: a stiff guiding needle for accurate puncture and penetration, and a soft cannula for comfortable long-term presence in the tissue. Each segment performs its specific function optimally without compromise

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guiding needle acts as an intermediary that temporarily provides the stiffness needed for accurate insertion. Once the needle creates the tract, the soft cannula is advanced through it, and the needle is removed, leaving only the compliant cannula in the tissue

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If the base plate is permanently fixed to the housing, then assembly is simple, but the base plate cannot be properly fixed to the skin before insertion

Engineering Contradiction:
Improvebase plate skin fixationVSAvoidbase plate attachment mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The base plate is pre-assembled with the insertion member in a movable configuration, allowing the adhesive surface to be exposed and activated before insertion. This preliminary preparation ensures the base plate can be properly fixed to the skin at the optimal location before the insertion procedure begins

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The connection between the base plate and housing is designed to be dynamic rather than static - it allows movement during insertion preparation, then transitions to a fixed state during the insertion procedure, and finally allows separation after insertion is complete

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 device enables faster and less painful insertion with improved skin fixation, reducing the risk of irritation and infection, and facilitates easy handling and disposal, making it suitable for unskilled users.

Implementation Method 1

The contact face (3) carries a layer (4) of skin compatible glue for fixing it to the skin

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

at least one of the one or several insertion members (11, 12) of the insertion arrangement (6) comprises at least one soft member (11) for being inserted into the tissue and at least one guiding member (12) for temporarily stiffening the at least one soft member (11) during insertion into the tissue

Methodology Applied
Scientific EffectMechanical support:

Data Source

PatentEP3020429B1Device for inserting an insertion member into the tissue of the body of a patient
Publication Date: 2020.07.01 F HOFFMANN LA ROCHE & CO AG
  • EP3020429B1 patent drawingFigure 1a~1b
  • EP3020429B1 patent drawingFigure 2a~2b
  • EP3020429B1 patent drawingFigure 3a~3b

AI summary

A Device (1) for inserting at least one insertion member (11, 12) having a puncturing tip (9), in particular at least one infusion cannula and/or at least one sensor tip, into the tissue of the body of a patient and for fixing it to the skin of the body, comprises a housing (2, 2a, 2b, 10, 21) providing at least one contact face (3) for placing the device (1) onto the skin of the body of the patient, wherein the contact face (3) carries a layer (4) of skin compatible glue for fixing it to the skin, which layer (4) in particular is covered by a removable protecting layer (5), an insertion arrangement (6) movably arranged within the housing comprising the at least one insertion member (11, 12) to be inserted into the tissue and a holder element (7) fixedly connected with at least a part (11) of the at least one insertion member (11, 12) which is intended to remain for a longer period inside the tissue of the body, and drive means (8) arranged within the housing for effecting an insertion movement of the insertion arrangement (6) from a first position, in which the puncturing tip (9) of the at least one insertion member (11, 12) is set back relative to the contact face (3), into a second position, in which the puncturing tip (9) of the at least one insertion member (11, 12) protrudes beyond the contact face (3), so that the at least one insertion member (11, 12) is inserted into the tissue of the body of the patient when the device (1) during the insertion movement of the insertion arrangement (6) is placed with its contact face (3) on said body, wherein the contact face (3) is formed by a base plate (10) which is fixed in such a manner that, after the insertion movement has been performed, it is detachable from the rest of the housing, wherein the holder element (7) of the insertion arrangement (6) comprises coupling means (23) by which it is coupled to the base plate (10) when the insertion arrangement (6) by the insertion movement is brought into the second position, and wherein the device is designed in such a manner that the base plate is automatically separated from the rest of the housing when the insertion arrangement is brought into the second position.