Shape-Memory Wound Occlusion Device with Expandable Sealing Element

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Solution Overview

Problem

Current methods for treating massively bleeding external wounds, such as pressure dressings, are inadequate for controlling bleeding due to inflexibility and the risk of infection, and existing haemostatic compositions lack controlled removal and accessibility in deep wounds.

Innovation Solution

A wound occlusion device comprising a base element, a sealing element with a frame and layer made of shape-memory materials, and a release mechanism that expands to form a form-locked connection with the wound, allowing for easy application and removal, and potentially includes a dispensing mechanism for drugs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If pressure dressings are applied to mitigate bleeding, then bleeding control is attempted, but the dressings are inadequate and inflexible to adapt sufficiently to the specific wound cavity and often insufficient to stop bleeding

Engineering Contradiction:
Improveadaptability to wound cavityVSAvoidbleeding control effectiveness
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The sealing element is designed to be transformable between a contracted configuration for delivery and an expanded configuration for sealing. This dynamic transformation allows the device to adapt to various wound cavity shapes and sizes while providing reliable bleeding control through the expanded sealing element that forms a form-locked and/or force-locked connection with the wound

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sealing element changes its physical parameters (volume, shape, rigidity) through transformation from contracted to expanded configuration. This parameter change enables the device to adapt to different wound geometries while maintaining effective sealing pressure to control bleeding

Inventive Principle:
Principle #35Parameter changes

2Reliability

If pressure dressings are used to stop bleeding, then acute haemorrhage mitigation is attempted, but the frequent necessity of repeated change of the wound dressing increases the risk for infection

Engineering Contradiction:
Improvehaemorrhage mitigationVSAvoidinfection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The sealing element provides excessive sealing action by expanding to fill and occlude the entire wound cavity, creating a form-locked and/or force-locked connection that ensures reliable haemorrhage mitigation. This comprehensive sealing reduces the need for repeated dressing changes, thereby lowering infection risk

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The sealing element undergoes a phase transition from a compressed delivery state to an expanded functional state within the wound cavity. This transformation allows the device to provide robust, long-lasting sealing that mitigates bleeding effectively and reduces the frequency of dressing changes, thus minimizing infection risk

Inventive Principle:
Principle #36Phase transitions

3Reliability

If haemostatic compositions expand upon contact with liquid to fill the wound cavity, then haemorrhage control is achieved, but means for the controlled removal of the expanded articles at the hospital prior to any surgical intervention are not specified

Engineering Contradiction:
Improvehaemorrhage controlVSAvoidcontrolled removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device is segmented into a base element that remains in the wound for haemorrhage control and a sealing element that can be selectively removed. The retention mechanism is also separable, allowing the sealing element to be removed at the hospital prior to surgical intervention while leaving the base element in place, providing controlled removal capability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The retention mechanism acts as an intermediary between the sealing element and the base element. It provides temporary anchoring during delivery and application, then can be selectively released to allow controlled removal of the sealing element at the hospital, facilitating the transition from haemorrhage control to surgical preparation

Inventive Principle:
Principle #24Intermediary (Mediator)

4Adaptability or versatility

If deep and narrow wound shapes are treated, then haemorrhage control in difficult-to-reach areas is attempted, but the accessibility of every sector of the wound cavity remains unspecified

Engineering Contradiction:
Improveaccessibility to wound sectorsVSAvoidhaemorrhage control completeness
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The sealing element transitions from a one-dimensional linear compressed state during delivery to a three-dimensional expanded state within the wound cavity. This dimensional transformation allows the device to access and seal deep and narrow wound sectors that would be difficult to reach with traditional linear dressings, ensuring complete haemorrhage control throughout the cavity

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

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 provides effective and controlled occlusion of bleeding wounds, reducing the risk of infection and allowing for easy removal, even in deep wounds, and can be applied by non-medical personnel, with the ability to be used in combat or emergency situations.

Implementation Method 1

The sealing element may comprise a frame element and a layer element. The sealing element has a contracted configuration and an expanded configuration, and can be transformed between the two configurations. The expanded configuration may be achieved by the release mechanism as soon as the wound occlusion device is placed into the wound.

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3142566B1Wound occlusion device
Publication Date: 2023.08.09 PLASS MEDTECH AG
  • EP3142566B1 patent drawingFigure 1
  • EP3142566B1 patent drawingFigure 2
  • EP3142566B1 patent drawingFigure 3

AI summary

Novel wound occlusion devices (100') and methods for the acute treatment of massively bleeding external wounds are suggested. The novel devices which are insertable into wounds W are characterised by a base element (12'); a sealing element (3) and a release mechanism of the sealing element (3). The sealing element (3) comprises a frame element (31) and a layer element (32) and is transformable between a contracted and an expanded configuration (3') by the release mechanism. The sealing element (3) has in the expanded configuration (3') a shape adaptable to the shape of the wound W and forms a form-locked and/or force-locked connection with the wound W thereby occluding the wound and effectively stopping blood loss.