Interventional Device Membrane for Fracture Mitigation

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Solution Overview

Problem

Interventional medical devices, such as ultrasonic catheters and vascular filters, are prone to fracture and migration within patients, posing health complications due to the risk of fragmented pieces causing harm.

Innovation Solution

A membrane is applied over portions of the medical device susceptible to fracture, encapsulating the distal end portion of the corewire or wire projections in ultrasonic catheters and vascular filters, to tie together any fractured fragments and reduce migration risks, allowing for retrieval and minimizing the likelihood of further fractures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the corewire is subjected to ultrasonic frequency vibration to break through calcified vascular occlusion, then the atherectomy procedure is effective, but the distal end portion of the corewire may fracture

Engineering Contradiction:

Improveatherectomy effectivenessVSAvoidcorewire fracture risk

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

A membrane is applied over the distal end portion of the corewire before the atherectomy procedure. This membrane acts as a protective covering that prevents fracture of the corewire during ultrasonic vibration, while still allowing the ultrasonic energy to effectively break through calcified vascular occlusion.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The membrane is a thin, flexible covering that encapsulates the distal end portion of the corewire. This flexible shell protects the corewire from fracturing under ultrasonic stress while maintaining the functional integrity of the atherectomy device.

Inventive Principle:

Principle #30Flexible shells and thin films

2Productivity

If the vascular filter is designed to capture embolism in the blood stream, then the filter function is effective, but the filter structure may fracture and migrate

Engineering Contradiction:

Improveembolism capture effectivenessVSAvoidfilter fracture and migration risk

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

Membranes are applied over the wire projections of the vascular filter before deployment. These membranes protect the wire projections from fracturing under blood flow stress, preventing filter fragmentation and migration while maintaining embolism capture functionality.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The membranes covering the wire projections act as flexible protective shells that prevent fracture of the filter structure. This ensures the filter remains intact and stationary in the blood vessel while effectively capturing embolisms.

Inventive Principle:

Principle #30Flexible shells and thin films

3Reliability

If a membrane is applied over the distal end portion of the corewire to prevent fracture, then the fracture risk is reduced, but the device complexity increases

Engineering Contradiction:

Improvecorewire fracture resistanceVSAvoiddevice structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The membrane is a simple thin-film covering that can be applied directly to the corewire without complex assembly procedures. This minimalistic approach protects against fracture while adding little to the device complexity.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The membrane serves multiple functions: it protects the corewire from fracture, allows ultrasonic energy transmission, and can facilitate retrieval if fracture occurs. This multi-functionality justifies the added component by providing multiple benefits from a single simple structure.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 membrane effectively ties together fractured fragments, reducing the risk of migration and facilitating retrieval of the device, while also acting as a mechanical damper to reduce the likelihood of fractures and frictional wear, thereby enhancing patient safety.

Implementation Method 1

The membrane encapsulates at least the distal end portion of the corewire. The membrane is configured to tie together a fractured portion of the distal end portion of the corewire.

Methodology Applied

Scientific EffectPhysical containment: Physical Containment

Implementation Method 2

acting as a mechanical damper to reduce the likelihood of fractures and frictional wear

Methodology Applied

Scientific EffectDamping: Damping

Implementation Method 3

the distal end portion of the corewire vibrates at the ultrasonic frequency to produce a radial and axial vibrating motion of the distal end portion

Methodology Applied

Scientific EffectUltrasonic vibration: Ultrasonic Vibration

Data Source

PatentUS12048444B2Interventional medical device having reduced fracture risk

Publication Date: 2024.07.30 CR BARD INC

AI summary

An interventional medical device, and method of manufacturing the same, is provided to reduce risk to the patient of a fracture of the interventional medical device. At least one portion of the interventional medical device that is subject to fracture and migration within a patient is identified. A membrane is applied over each portion of the interventional medical device that is subject to fracture and migration, such that any fractured portion of the interventional medical device is tied together by the membrane.