Flexible Vertebral Filling Device for Controlled Material Injection

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Solution Overview

Problem

Current surgical techniques for treating vertebral body disorders, such as osteoporosis and vertebral compression fractures, face challenges with uncontrolled spread of medical materials, potential injury to surrounding tissues, and the need for extensive surgical tools and tool exchanges, which increase risk and infection likelihood. Additionally, polymerizing substances like PMMA pose challenges in consistency and safety.

Innovation Solution

A surgical device with a flexible, permeable filling member that allows controlled insertion and containment of medical materials within a vertebral body, enabling the material to solidify and remain, while the device is extracted, providing support and reducing the risk of material leakage or rejection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If balloon-assisted or mechanically assisted cavity creation techniques are used, then a body cavity can be created and material can be inserted, but the material spreads and flows in an uncontrolled fashion within and beyond targeted tissue regions

Engineering Contradiction:
Improvematerial placement controlVSAvoiduncontrolled material spread
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a controllable delivery device as an intermediary between the injection source and the target tissue. This device includes a needle assembly with a hub, needle, and controllable injection mechanism that allows precise control over material flow and placement, preventing uncontrolled spread while maintaining effective delivery to the target region

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs a controllable injection mechanism that can adjust flow rate, injection pressure, and injection volume as parameters. This allows the operator to precisely control the material delivery process, injecting material at controlled rates to prevent extravasation while ensuring complete filling of the target cavity

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If hypodermic or percutaneous injection of materials is used, then material can be introduced into targeted anatomical region, but material injection is unconstrained and may cause unintended injury to surrounding tissues

Engineering Contradiction:
Improvematerial injection capabilityVSAvoidunintended tissue injury
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The delivery device serves as an intermediary system between the operator and the target tissue, providing controlled access through a needle assembly. The hub and needle configuration allows precise positioning and controlled material release, preventing unconstrained injection that could cause unintended tissue injury

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The controllable injection mechanism provides feedback control over the material delivery process, allowing the operator to monitor and adjust injection parameters in real-time to prevent unintended tissue injury while maintaining effective material delivery

Inventive Principle:
Principle #23Feedback

3Productivity

If balloon-assisted cavity creation techniques are used, then cavity can be created and filled, but extensive array of surgical tools is required and tool exchanges increase risk of infection

Engineering Contradiction:
Improvecavity creation and filling capabilityVSAvoidnumber of surgical tools
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent combines cavity creation and material delivery functions into a single integrated delivery device. The needle assembly with hub and controllable injection mechanism eliminates the need for separate balloon catheters and multiple tool exchanges, reducing infection risk while maintaining the ability to create and fill cavities effectively

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The delivery device is designed as a multi-functional tool that can perform both cavity creation through needle insertion and subsequent material delivery through the same access path. This universal device eliminates the need for multiple specialized tools and sequential tool exchanges

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Productivity

If polymerizing substance like PMMA is introduced too soon, then material can be injected, but material is too thin and likely to extravasate in undesired manner

Engineering Contradiction:
Improveinjection speedVSAvoidmaterial consistency control
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The controllable injection mechanism provides feedback control over injection timing and rate, allowing the operator to wait for optimal material viscosity before injection and to inject at controlled rates that prevent extravasation, thereby maintaining both productivity and precision

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The device allows control over injection parameters including timing, rate, and pressure, enabling the operator to adjust these parameters based on material consistency to prevent premature injection of thin material that could extravasate

Inventive Principle:
Principle #35Parameter changes

5Object-affected harmful factors

If polymerizing substance like PMMA is introduced too late, then material consistency is safer, but material is too thick to extrude from injector or travel down surgical cannula

Engineering Contradiction:
Improvematerial safetyVSAvoidmaterial extrusion capability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The controllable injection mechanism allows adjustment of injection pressure and rate parameters to accommodate materials of varying viscosity. This enables injection of safer, less runny materials by applying appropriate pressure to extrude thick material through the cannula without compromising safety

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 device ensures controlled and directed introduction of medical materials, reduces the risk of unintended tissue injury, and provides immediate structural support to the vertebral body, enhancing the effectiveness and safety of the surgical procedure.

Implementation Method 1

A surgical device with a flexible, permeable filling member that allows controlled insertion and containment of medical materials

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP2195087A1Material control device for inserting material into a targeted anatomical region
Publication Date: 2010.06.16 CROSSTREES MEDICAL

AI summary

An extractable device is used to insert a flowable material into a vertebral body. The device comprises a filling member and a flowable material. The filling member is made of a flexible wall which includes a holding portion and an injection port via which the flowable material is injected into the holding portion after insertion into the vertebral body. The holding portion is provided with an opening which is releasably closed by a closure device so as to make the opening substantially resistant to the passage of material there through. Once the flowable material in the holding portion increases in viscosity, the closure device is released, thereby enabling the filling member to be extracted from the vertebral body so as to leave only the material in the vertebral body. The flowable material should be a material capable of setting to a hardened condition.