Adjustable Balloon with Retractable Sleeve for Vertebral Augmentation
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Solution Overview
Problem
Fixed-size balloons used in vertebral augmentation procedures often result in unsuccessful outcomes due to inappropriate sizing for the vertebral body, leading to ineffective restoration of spine height and pain relief.
Innovation Solution
An adjustable balloon with a handle, inner sleeve, and retractable outer sleeve allows for the exposure of an inflatable structure of variable length, enabling precise cavity creation and bone compression during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size balloon is used in vertebral augmentation procedures, then the device structure is simple and easy to manufacture, but the balloon cannot accommodate varying vertebral body sizes leading to unsuccessful outcomes
Solution Approach 1:
The balloon catheter incorporates an adjustable length mechanism where the balloon can be extended or retracted along the catheter shaft. This dynamic adjustment capability allows the balloon to adapt to different vertebral body sizes while maintaining a relatively simple catheter structure. The balloon's position and length can be modified during the procedure to match the specific anatomical requirements.
Solution Approach 2:
The balloon is nested within the catheter shaft in a collapsed state and can be deployed to an extended state when needed. This nesting arrangement allows the balloon to be stored in a compact form during insertion while providing the capability for length adjustment during the augmentation procedure, effectively resolving the contradiction between adaptability and structural simplicity.
2Ease of operation
If the balloon length is fixed, then the manufacturing process is simple, but the procedure requires pre-selection of appropriate balloon size which may lead to unsuccessful results
Solution Approach 1:
The adjustable balloon length mechanism enables the operator to modify the balloon size in-situ based on the actual vertebral body dimensions encountered during the procedure. This eliminates the need for pre-selection and reduces the risk of using an inappropriate balloon size, thereby improving both ease of operation and procedure success rate.
Solution Approach 2:
The device allows the operator to self-adjust the balloon length during the procedure based on real-time anatomical feedback. This self-adjustment capability ensures that the balloon can be optimized for each specific case without requiring complex pre-planning or multiple balloon exchanges, improving both operational ease and reliability.
3Adaptability or versatility
If the balloon is made adjustable in length, then the balloon can accommodate varying vertebral body sizes, but the device structure becomes more complex
Solution Approach 1:
The catheter incorporates a dynamic adjustment mechanism that allows the balloon length to be modified along the shaft. This is achieved through a simple extension-retraction system that adds minimal structural complexity while providing the necessary adaptability for different vertebral sizes.
Solution Approach 2:
The catheter design integrates multiple functions into a single device: the balloon can serve both as a structural support element and as an adjustable cavity-forming tool. The ability to adjust balloon length along the catheter shaft provides multi-functionality that accommodates varying vertebral body sizes without requiring multiple separate devices, thus limiting the increase in overall device complexity.
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 adjustable balloon facilitates tailored vertebral augmentation by allowing for precise inflation and deflation to restore spine height and alleviate pain, improving the success rate of procedures by accommodating varying vertebral body sizes.
Implementation Method 1
inflating the adjustable inflatable structure to compress bone within the surgical region
Data Source
AI summary
An adjustable balloon that includes a handle having an inflation port, an access cannula, a rotary handle, an inner sleeve and sharp tip. The inner sleeve extends within the access cannula to support compliant, inflatable structure. The access cannula may be retracted into the handle by operation of the rotary handle to expose the inflatable structure, such that the inflatable structure may have an adjustable length. The access cannula may include length indicators to show a length of the inflatable structure as a result of the access cannula being withdrawn into the handle.