Multi-chambered Spinal Disc Balloon for Load Distribution
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Solution Overview
Problem
Existing spinal disc augmentation and replacement devices often fail due to uneven compression and rapid expulsion of filler material through annulus defects, leading to further complications such as nerve impingement and loss of disc height, and are prone to device ejection upon deflation.
Innovation Solution
Multi-chambered inflatable balloon devices with a filling manifold that allows even load distribution across multiple chambers, mitigating the impact of single chamber failure by load sharing and reducing material expulsion, and featuring a design that maintains structural integrity and prevents device ejection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-chamber device is used for spinal disc augmentation, then the device structure is simple, but the device is prone to complete failure and rapid expulsion of filler material through annulus defects
Solution Approach 1:
The device is divided into multiple independent chambers (at least two chambers) within a single balloon structure. Each chamber can be independently filled with filler material through a single manifold. This segmentation ensures that failure of one chamber does not lead to complete device failure, as other chambers remain intact and continue to provide support and contain their filler material.
2Strength
If a single-chamber device is inflated to restore disc height, then the device can effectively distract vertebral elements, but uneven compression during flexion and extension leads to improper loading and device ejection
Solution Approach 1:
Multiple chambers are arranged within the balloon to distribute the load-bearing function across several independent compartments. This allows for more uniform distribution of compressive forces during spinal flexion and extension movements, preventing localized stress concentrations that could lead to device ejection or improper loading.
3Quantity of substance
If filler material is injected into a single-chamber device, then the device achieves sufficient volume to restore disc space, but failure leads to rapid expulsion of all filler material causing nerve impingement
Solution Approach 1:
The filler material is distributed across multiple independent chambers. If one chamber fails due to annulus defects or other issues, only the filler material in that specific chamber is expelled, while filler material in other chambers remains contained. This significantly reduces the risk of rapid, large-volume expulsion that could impinge on neural elements.
4Reliability
If a multi-chambered device is used, then chamber failure is mitigated by load sharing and material expulsion is reduced, but the device complexity increases
Solution Approach 1:
Multiple chambers are merged within a single balloon structure, sharing common walls and a single filling manifold. This integration reduces the number of separate components, seals, and filling mechanisms needed, thereby limiting the increase in device complexity while still providing the reliability benefits of multiple chambers.
Data Source
AI summary
Inflatable multi-chambered devices are provided for repairing or replacing spinal discs and distracting neighboring vertebral elements. Also included are cushioning devices that may be used in a joint replacement device cushioning system. Further included are kits and systems that include such devices, methods for making such devices, and methods of treating patients in need of such devices. Examples further include cosmetic augmentation and restoration devices.