Umbilical Cord Vessel Balloon for Vertebral Stabilization

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Solution Overview

Problem

Current vertebral compression fracture treatments using bone cement in procedures like kyphoplasty can lead to adverse effects such as bone disease, increased fracture risk, and complications like infection and paralysis due to the foreign body nature and stiffness of the cement, as well as leakage issues.

Innovation Solution

A surgical balloon composed of an umbilical cord vessel, optionally containing demineralized bone matrix or human birth tissue material, is used to create a space within the vertebral body, which can be filled with a biocompatible inflation medium to stabilize and potentially aid in healing, while being designed for safe expansion and contraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bone cement is injected into the vertebral body, then the vertebral body is stabilized and fractures are treated, but adverse effects occur such as bone disease, increased fracture risk, and complications like infection and paralysis

Engineering Contradiction:

Improvestabilization of vertebral bodyVSAvoidadverse effects including bone disease, infection, and paralysis

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from synthetic bone cement to biologic materials (autologous bone, allograft, or synthetic bone substitute), transforming the chemical composition and biological compatibility parameters to eliminate foreign body reactions while maintaining structural stabilization function

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses composite material approaches by combining biologic materials with varying degrees of mineralization or using layered structures of different bone graft materials to achieve both mechanical support and biological integration, avoiding the homogeneous synthetic material approach that causes adverse reactions

Inventive Principle:

Principle #40Composite materials

2Strength

If bone cement is used to stabilize the vertebral body, then fracture treatment is achieved, but the stiffness of the cement increases the incidence of adjacent level fractures

Engineering Contradiction:

Improvestabilization strengthVSAvoidadjacent level fractures

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the mechanical parameter of the filling material from high-stiffness bone cement to materials with bone-like elasticity and strength characteristics, matching the mechanical properties to reduce stress shielding and prevent adjacent level fractures while maintaining adequate stabilization

Inventive Principle:

Principle #35Parameter changes

3Reliability

If bone cement is injected into the vertebral body, then vertebral stabilization is achieved, but leakage outside the vertebral body causes complications such as infection, bleeding, numbness, tingling, headache, and paralysis

Engineering Contradiction:

Improvevertebral stabilizationVSAvoidleakage complications including infection, bleeding, and neurological damage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the viscosity and flow characteristics parameter of the injection material from low-viscosity bone cement that can leak to materials with appropriate rheological properties that remain contained within the vertebral body while still providing effective stabilization

Inventive Principle:

Principle #35Parameter changes

4Productivity

If traditional bone cement is used, then the procedure is simple and quick, but complete healing cannot occur due to the foreign body nature of the cement

Engineering Contradiction:

Improveprocedure efficiencyVSAvoidcomplete healing capability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent changes the biocompatibility parameter from foreign body synthetic material to biologic materials that can be integrated into the host bone tissue, enabling complete healing while maintaining procedural efficiency through standardized preparation protocols

Inventive Principle:

Principle #35Parameter changes

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 balloon provides a biocompatible and potentially healing-promoting solution for vertebral compression fractures, reducing the risk of adverse effects associated with traditional bone cement methods and promoting bone health through the use of natural tissue components.

Implementation Method 1

a surgical balloon composed of an aseptically recovered umbilical cord vessel... inflating the at least one balloon to create a void or space in the vertebral body

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Implementation Method 2

the balloon further contains an effective amount of a demineralized bone matrix composition

Methodology Applied

Scientific EffectOsteoconduction:

Implementation Method 3

promoting bone health through the use of natural tissue components

Methodology Applied

Scientific EffectBiocompatibility:

Data Source

PatentUS10314715B2Biologic balloon and method of use

Publication Date: 2019.06.11 BIODLOGICS LLC

AI summary

A surgical balloon composed of an aseptically recovered umbilical cord vessel is provided. Methods of preparing a balloon and methods of using the same are also provided.