Internal Bone Fixation With Conformable Balloon Cement Containment

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Solution Overview

Problem

Conventional bone cement injection devices face challenges in adjusting injection volume and rate in response to bone density, leading to complications like leakage and damage to surrounding tissues during bone repair.

Innovation Solution

An internal bone fixation device with a conformable member that inflates within the bone using a reinforcing material, guided by a delivery catheter, and is hardened using a light source to provide support and alignment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional bone cement injection devices are used to repair fractured bone, then bone repair can be achieved, but the injection volume and rate cannot be adjusted in real time in response to bone density conditions, leading to leakage and soft tissue damage

Engineering Contradiction:

Improveadjustment of injection volume and rate in response to bone densityVSAvoidleakage of bone cement and soft tissue damage

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The device employs a compliant balloon catheter that dynamically adapts its volume and shape in response to bone density conditions. The balloon can be inflated to different volumes and pressures based on real-time assessment of bone cancellous volume and density, allowing the injection rate and volume to be adjusted dynamically during the procedure to prevent leakage and tissue damage

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes physical parameters of the bone cement injection process by controlling the balloon's inflation state, internal pressure, and volume. These parameter changes enable real-time adjustment of the injection characteristics to match bone density conditions, preventing harmful leakage while ensuring adequate bone repair

Inventive Principle:

Principle #35Parameter changes

2Reliability

If conventional bone cement injection is performed, then bone repair is achieved, but bone cement may leak outside the fractured bone site causing soft tissue damage and nerve root pain

Engineering Contradiction:

Improvecontainment of bone cement within fractured bone siteVSAvoidsoft tissue damage and nerve root pain from cement leakage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device uses a compliant balloon catheter with a flexible membrane that can conform to the irregular inner surfaces of the fractured bone site. This flexible shell creates a contained environment that prevents bone cement from leaking outside the fractured bone site, thereby avoiding soft tissue damage and nerve root pain while ensuring reliable bone repair

Inventive Principle:

Principle #30Flexible shells and thin films

3Object-affected harmful factors

If minimally invasive techniques are used for internal bone fixation, then tissue damage is reduced, but the device must be easily deliverable through small access points while maintaining structural integrity

Engineering Contradiction:

Improvedamage to bone and supporting tissuesVSAvoiddeliverability through small access points

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The device employs a nested structure where the compliant balloon catheter is delivered through a delivery catheter system. The balloon is collapsed within the delivery catheter for minimally invasive insertion through small access points, then expanded at the target site to provide structural support. This nested configuration enables easy deliverability while maintaining structural integrity during the procedure

Inventive Principle:

Principle #7Nested doll (Nesting)

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 device minimizes tissue damage and ensures precise bone alignment and support through a minimally invasive procedure, reducing the risk of leakage and enhancing healing.

Implementation Method 1

the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is added to the conformable member

Methodology Applied

Scientific EffectInflation:

Implementation Method 2

wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is added to the conformable member

Methodology Applied

Scientific EffectLight hardening: Photopolymerisation

Data Source

PatentUS12349946B2Systems and methods for internal bone fixation

Publication Date: 2025.07.08 ILLUMINOSS MEDICAL INC

AI summary

Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. A device for use in repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of at least one reinforcing material and an inner lumen for passage of a light source; a conformable member releasably engaging the distal end of the delivery catheter, wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light source and the at least one reinforcing material.