Integrated Needle-Mounted Balloon for Bone Expansion
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Solution Overview
Problem
Current bone expansion devices for procedures like vertebroplasty and kyphoplasty require separate cannula and balloon components, making them more complex and time-consuming, with increased risk of trauma and discomfort for patients.
Innovation Solution
A needle-mounted balloon system integrating a cannula and expandable balloon, where the balloon is reconfigurable between contracted and expanded configurations, allowing for direct insertion and inflation within the body structure, reducing the need for additional components and simplifying the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate cannula and balloon components are used, then the device can perform bone expansion, but the device complexity increases and procedural time increases
Solution Approach 1:
The patent combines the cannula and balloon into a single integrated needle-mounted balloon system. The balloon is mounted directly on the cannula shaft, eliminating the need for separate components. This integration reduces the number of parts while maintaining the bone expansion capability, directly resolving the contradiction between reliability and device complexity.
Solution Approach 2:
The integrated needle-mounted balloon system performs multiple functions: the cannula serves as both the delivery vehicle and the structural support, while the mounted balloon provides both the expansion function and the sealing function. This multi-functionality reduces the need for additional components, addressing the device complexity issue while maintaining operational reliability.
2Reliability
If separate cannula and balloon components are used, then the device can perform bone expansion, but the procedural time increases
Solution Approach 1:
By merging the cannula and balloon into a single pre-assembled unit, the procedure eliminates the time required for separate component insertion and assembly. The integrated system is inserted as one unit, reducing procedural steps and overall time while maintaining the bone expansion function.
Solution Approach 2:
The balloon is pre-mounted on the cannula during manufacturing, so that during the procedure, the operator only needs to insert the pre-assembled unit rather than assembling components during the procedure. This preliminary assembly action reduces procedural time while maintaining operational reliability.
3Reliability
If separate cannula and balloon components are used, then the device can perform bone expansion, but the risk of trauma and discomfort increases
Solution Approach 1:
The integrated design reduces the number of interactions between multiple components and the bone structure. With a single unified device, there are fewer potential points of trauma from component misalignment or excessive manipulation, thereby reducing trauma and discomfort while maintaining bone expansion capability.
Solution Approach 2:
The balloon is segmented into inflatable and deflatable portions, allowing controlled expansion only where needed. This segmentation enables precise bone expansion with minimal trauma to surrounding tissues, reducing discomfort while maintaining the necessary bone expansion function.
4Ease of operation
If integrated needle-mounted balloon system is used, then the ease of use improves, but the device complexity increases
Solution Approach 1:
The integration of cannula and balloon creates a simpler operational interface with fewer components to manage. The single unified device reduces the cognitive load and manual steps required during the procedure, improving ease of use. The integration is achieved through straightforward mechanical attachment, so the complexity increase is minimal while the operational simplicity is significant.
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
This integrated system enhances ease of use, reduces procedural time, minimizes patient discomfort, and lowers costs by combining the cannula and balloon into a single device, facilitating safer and more efficient bone expansion procedures.
Implementation Method 1
an expandable member coupled to the cannula tube portion. The expandable member is reconfigurable between a diametrically contracted configuration and a diametrically expanded configuration
Data Source
AI summary
A needle-mounted balloon system can include a cannula and a stylet. The cannula may include a handle and an outer sheath, and the outer sheath may be configured to retract and expose at least a portion of an expandable member. The stylet may include a stylet needle and a sharp distal tip portion. The stylet needle may be used to insert the system into a body structure, after which the stylet may be disengaged from the cannula. The expandable member may then be exposed and inflated to create a space in the body structure. Filler material may be injected through the cannula to the open space in an effort to stabilize an injured or otherwise destabilized portion of the body structure.