Vertebral Augmentation Cannula with Balloon Occlusion

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Solution Overview

Problem

Current minimally invasive procedures for treating vertebral compression fractures, such as vertebroplasty and balloon kyphoplasty, face challenges including high costs, complications from cement leakage, and difficulty in repositioning and augmenting vertebral bodies effectively, particularly due to the complexity and invasiveness of the apparatus used.

Innovation Solution

The development of a cannula system with a rigid and flexible member combination, along with articulating instruments and implants, allows for minimally invasive vertebral augmentation and restoration of spinal lordosis, enabling safe and effective repositioning and augmentation of vertebral bodies through a posterior approach, using biocompatible materials and resorbable components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If rigid cannula or needle is used for vertebroplasty, then cement can be injected into vertebral body, but cement leakage occurs in 30-80% of procedures causing pulmonary embolism

Engineering Contradiction:

Improvecement injection safetyVSAvoidcement leakage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible catheter with a balloon occlusion device instead of a rigid needle. The flexible catheter can navigate the venous system to reach the vertebral body, and the balloon can be inflated to occlude the venous outlet, preventing cement leakage into the spinal canal or perivertebral venous system while still allowing cement injection into the vertebral body.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent introduces a balloon occlusion device as an intermediary between the cement injection site and the venous system. The balloon acts as a physical barrier that prevents cement from entering the venous circulation, thereby eliminating the harmful effect of cement leakage while maintaining the therapeutic benefit of vertebral body augmentation.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive procedures are used, then tissue damage is reduced, but repositioning and augmentation of vertebral bodies becomes more difficult

Engineering Contradiction:

Improvetissue damageVSAvoidvertebral repositioning capability

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent integrates multiple functions into a single minimally invasive system: the flexible catheter provides both access for cement injection and a mechanism for vertebral body repositioning through balloon inflation. The balloon serves dual purposes of occluding venous outlets to prevent leakage and providing mechanical force to restore vertebral body height and spinal alignment, thereby maintaining ease of operation while enabling repositioning capability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent uses pneumatic pressure from balloon inflation to achieve vertebral body repositioning. By inflating the balloon within the vertebral body, hydraulic/pneumatic force is generated to push the fractured bone fragments back into alignment and restore the normal spinal curvature, all through a minimally invasive percutaneous approach.

Inventive Principle:

Principle #29Pneumatics and hydraulics

3Strength

If high-pressure cement injection is used, then vertebral body can be augmented, but cement leaks into spinal canal or venous system causing death

Engineering Contradiction:

Improvevertebral body augmentationVSAvoidcement embolism

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary anti-action by inflating the balloon to occlude the venous outlet before cement injection. This pre-established barrier prevents the high-pressure cement from entering the venous system, thereby counteracting the potential harmful effect of cement embolism before it can occur during the augmentation process.

Inventive Principle:

Principle #9Preliminary anti-action

Solution Approach 2:

The balloon occlusion device serves as an intermediary barrier between the high-pressure cement injection and the venous system. It allows the cement to be injected at high pressure into the vertebral body for effective augmentation while simultaneously preventing the cement from leaking into the spinal canal or perivertebral venous system.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS8157806B2Apparatus and methods for vertebral augmentation

Publication Date: 2012.04.17 SYNTHES (USA) LLC

AI summary

Apparatuses and methods of treating a collapsed vertebra may include inserting cannulae into the damaged vertebral body and one or more adjacent vertebral bodies and repositioning the one or more adjacent vertebral bodies by manipulating one or more of the cannulae. Before or after repositioning the vertebral bodies, the method may further include passing through the cannula and into the damaged vertebra a disruption tool for fracturing the damaged vertebral body. Once the cortical bone is broken or otherwise disrupted, the height of the damaged vertebral body may be restored, for example by removing the disruption tool and inserting through the cannula another tool, implant, device and/or material to restore the height of the vertebral body and to restore normal spinal curvature in the affected area. Bone cement, bone chips, demineralized bone or other grafting material or filler may be added with or without an implanted device to augment the damaged vertebral body.