Sternal Wire Sheath Assembly Abrasion Prevention

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Solution Overview

Problem

Surgical wires used in sternotomy procedures often abrade and damage the sternal bone due to high tension and soft bone nature, leading to complications like wire loosening, non-union, and infection, especially in patients with poor bone quality or high BMI.

Innovation Solution

A protective sheath assembly is designed to cover the surgical wire, reducing direct contact with the bone by increasing the surface area of contact and dissipating stresses, which can be customized to fit the bone and includes features like a core channel, relief areas, and optional teeth for traction, to prevent abrasion and facilitate healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If surgical wire is used to compress sternal segments, then the sternal segments are held securely together for healing, but the wire abrades and damages the sternal bone surface due to high tension and soft bone nature

Engineering Contradiction:
Improvecompressive force on sternal segmentsVSAvoidwire abrasion on bone surface
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

A protective sheath is introduced as an intermediary component between the surgical wire and the sternal bone surface. The sheath covers the wire along its length, preventing direct contact between the wire and bone while allowing the wire to maintain compressive force on the sternal segments. This resolves the contradiction by mediating the interaction between the wire (which provides compression) and the bone (which is vulnerable to abrasion).

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The protective sheath is designed as a flexible thin-walled structure that can conform to the contours of the sternal bone while covering the wire. The sheath's flexibility allows it to accommodate the curved geometry of the sternum and the compression forces applied by the wire, while its wall structure prevents wire-induced abrasion on the bone surface.

Inventive Principle:
Principle #30Flexible shells and thin films

2Ease of operation

If wire surface area is kept minimal, then the wire remains thin and easy to insert, but the wire has high propensity to abrade and damage the bone surface

Engineering Contradiction:
Improvewire insertion easeVSAvoidbone surface abrasion
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sheath acts as a mediator that increases the effective surface area in contact with the bone without requiring the wire itself to be thicker. The wire remains thin for easy insertion, while the sheath provides the protective surface area that prevents abrasion, thus resolving the contradiction between wire thinness and abrasion resistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The solution moves the surface area function from the wire dimension to the sheath dimension. Instead of increasing wire diameter to reduce stress concentration, the sheath provides the necessary surface area in a separate dimensional layer, allowing the wire to remain thin while still protecting the bone surface.

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

3Strength

If additional wires are placed side by side to counteract higher biomechanical stresses, then the compressive force is improved, but the complexity of the wiring procedure increases

Engineering Contradiction:
Improvebiomechanical stress resistanceVSAvoidwiring procedure complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The protective sheath provides multi-functionality: it protects the bone surface from abrasion, maintains the compressive force generated by the wire, and can be used with a single wire to achieve the same protective effect as multiple wires. This reduces procedural complexity while maintaining biomechanical strength.

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 sheath assembly effectively reduces the risk of wire-induced bone damage, enhances healing by allowing biologic fluid passage, and simplifies the surgical process by minimizing complications such as wire loosening and infection.

Implementation Method 1

the sheath may reduce or prevent the tensioning element from abrading and damaging the bone surface when the tensioning element is under tension

Methodology Applied
Scientific EffectAbrasion prevention: Abrasion

Implementation Method 2

The sheath substantially increases the surface area of contact on the bone and therefore dissipates stresses in an improved manner compared to a tensioned exposed tensioning element

Methodology Applied
Scientific EffectStress dissipation:

Implementation Method 3

enhances healing by allowing biologic fluid passage

Methodology Applied
Scientific EffectFluid passage through porous material: Porosity

Data Source

PatentUS20230404640A1Sheath assembly for sternal wire
Publication Date: 2023.12.21 CIRCUMFIX SOLUTIONS INC
  • US20230404640A1 patent drawing
  • US20230404640A1 patent drawing
  • US20230404640A1 patent drawing

AI summary

A sheath is provided. The sheath includes a core channel, and the core channel is configured to receive a tensioning element. The tensioning element is configured to circumscribe a bone, and the sheath is configured to be placed around a bone when the tensioning element received in the core channel circumscribes the bone. The sheath is configured to prevent direct contact between the tensioning element and the bone as the tensioning element is tensioned.