Calcium-Dependent Sealant for Bone Cement Extravasation

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Solution Overview

Problem

The use of bone cement in surgical procedures, such as spinal fracture repair and vertebroplasty, is associated with risks of extravasation, which can lead to necrosis, pulmonary embolism, and neurologic deficits due to its exothermic polymerization and toxicity, especially when it leaks from the bone environment.

Innovation Solution

Applying a calcium-dependent polymerizing sealant, like sodium alginate, to the bone structure before delivering bone cement to block leakage paths, thereby preventing extravasation by filling cracks and crevices and ensuring the bone cement remains in the desired area.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If bone cement is used to augment pull-out strength of bone screws, then fixation strength is improved, but risk of extravasation increases causing necrosis and pulmonary embolism

Engineering Contradiction:

Improvefixation strengthVSAvoidextravasation risk

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The sealant is applied to the bone structure before bone cement delivery to pre-block potential leakage paths. This preliminary sealing action prevents extravasation before it can occur during subsequent cement injection, while still allowing the cement to achieve its fixation strengthening function.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

A sealant layer is introduced as an intermediary substance between the bone structure and the bone cement. This sealant acts as a barrier that prevents cement extravasation while allowing the cement to maintain its fixation function, thus mediating between the conflicting requirements of strong fixation and extravasation prevention.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If bone cement is injected under pressure to ensure distribution, then fixation reliability is improved, but extravasation risk increases due to forced leakage

Engineering Contradiction:

Improvefixation reliabilityVSAvoidextravasation during injection

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The sealant is applied beforehand to create a containment barrier within the bone structure. This preliminary sealing allows subsequent high-pressure cement injection to proceed safely, as the sealant prevents forced leakage even under pressure, maintaining both fixation reliability and preventing extravasation.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The sealant layer serves as a protective cushion or barrier prepared in advance. This beforehand protection absorbs or prevents the harmful effect of high-pressure injection forces that would otherwise cause extravasation, allowing reliable fixation to be achieved through pressurized cement delivery.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Strength

If fenestrated screws are used to distribute bone cement, then fixation strength is improved, but leakage paths are created increasing extravasation risk

Engineering Contradiction:

Improvefixation strengthVSAvoidscrew structure complexity

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The sealant is applied to the bone structure before cement delivery through the fenestrated screw. This preliminary sealing of the surrounding bone converts the potentially harmful fenestrations into controlled delivery channels, allowing the complex screw structure to achieve its fixation strength purpose without creating uncontrolled leakage paths.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The fenestrations in the screw, which could create leakage paths, are converted into beneficial controlled delivery channels. By applying sealant to the surrounding bone first, the fenestrations become precise conduits for cement delivery rather than sources of uncontrolled extravasation, transforming a potential harm into a benefit.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 use of a calcium-dependent polymerizing sealant effectively minimizes the risk of bone cement extravasation, ensuring secure fixation of bone screws and stabilization of bone structures while reducing the risk of adverse reactions by containing the bone cement within the target area.

Implementation Method 1

Applying a calcium-dependent polymerizing sealant (e.g., sodium alginate) to a target bone structure prior to delivery of bone cement

Methodology Applied

Scientific EffectCalcium-dependent polymerization: Photopolymerisation

Data Source

PatentUS11234748B2Reduced extravasation of bone cement

Publication Date: 2022.02.01 MEDTRONIC EUROPE SÀRL

AI summary

The risk of bone cement extravasation can be reduced by delivering a calcium-dependent polymerizing sealant into a bone structure prior to delivery of bone cement into that structure. The polymerization of the sealant in response to the calcium within the bone structure can fill cracks and any other potential cement leakage paths, thereby minimizing the potential for subsequent extravasation. The benefits of the use of a calcium-dependent polymerizing sealant can be provided in any procedure involving the use of bone cement, such as spinal fixation, vertebroplasty, and kyphoplasty, among others.