Pliable Sternal Cover for Hemostasis and Fracture Prevention

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Solution Overview

Problem

Current methods for controlling bleeding from an exposed sternum during cardiac surgery are inadequate, particularly due to variations in sternum size and shape, leading to ineffective hemostasis, increased reoperation rates, and risk of sternal fractures, with existing solutions like bone wax and topical haemostatic agents being ineffective or difficult to apply.

Innovation Solution

A pliable apparatus with a rigid central strip and deformable portions that can be adapted to fit differently sized and shaped sternums, incorporating a haemostatic material and compressible layer to reduce bleeding and distribute retractor force evenly, reducing the risk of sternal fractures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid cover device is used to seal against the exposed sternal end, then hemostasis is improved, but the device cannot adapt to different sternal sizes and shapes

Engineering Contradiction:

Improvehemostasis effectivenessVSAvoidadaptability to different sternal sizes and shapes

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device incorporates a flexible membrane that can dynamically adapt its shape to conform to the exposed sternal end, allowing the same device design to effectively seal various sternal configurations while maintaining hemostasis

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The flexible membrane changes its physical parameters (shape, contour) to match the specific geometry of the exposed sternal end, enabling universal applicability across different patient anatomies without compromising sealing effectiveness

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If sternal retractors are placed directly in contact with the sternum to maintain separation, then surgical access is improved, but concentrated loading causes sternal fractures

Engineering Contradiction:

Improvesurgical accessVSAvoidsternal integrity

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The flexible membrane acts as an intermediary layer between the retractor and sternal end, distributing the mechanical load across a broader area while maintaining the necessary separation for surgical access, thereby preventing concentrated loading and potential fractures

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The flexible membrane serves as a mediator between the retractor system and the sternal end, providing both the separation needed for surgical access and the load distribution needed to protect sternal integrity

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If bone wax is inserted into the sternal medullar to control bleeding, then hemostasis is improved, but infection risk increases and osseous fusion is inhibited

Engineering Contradiction:

ImprovehemostasisVSAvoidinfection risk and fusion inhibition

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The flexible membrane provides an alternative hemostatic mechanism that eliminates the need to insert bone wax into the sternal medullar cavity, thereby removing the source of potential infection and fusion inhibition while still achieving effective bleeding control

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The flexible membrane serves as a temporary, disposable barrier that achieves hemostasis during the critical post-operative period without introducing permanent foreign bodies that could cause long-term complications

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Reliability

If topical haemostatic agents are applied to the sternum to control bleeding, then hemostasis is improved, but the application process becomes difficult and cumbersome

Engineering Contradiction:

ImprovehemostasisVSAvoidapplication ease

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The flexible membrane combines the hemostatic function with the protective and sealing functions in a single integrated component, eliminating the need for separate application steps and making the hemostatic intervention as simple as placing the membrane over the exposed sternal end

Inventive Principle:

Principle #5Merging (Combining)

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 apparatus effectively reduces bleeding from the sternum by forming a secure seal and distributing retractor force, improving hemostasis and reducing the risk of sternal fractures and reoperation, while being adaptable to various sternum sizes and shapes.

Implementation Method 1

incorporating a haemostatic material and compressible layer to reduce bleeding

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

incorporating a haemostatic material and compressible layer to reduce bleeding

Methodology Applied

Scientific EffectCompression: Compression

Implementation Method 3

manually pliable portions which are able to be deformed over sides of the exposed end so as to retain the strip against the exposed end

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11253244B2Apparatus for covering an exposed end of a severed sternum

Publication Date: 2022.02.22 PROTEGO MEDICAL PTY

AI summary

The invention comprises an apparatus for covering an exposed end of a severed sternum, comprising a strip operative to cover the exposed end and pliable portions which are able to be manually deformed over sides of the exposed end so as to retain the strip against the exposed end to stop or at least reduce flow of blood from the exposed end.