Reinforced Inflatable Medical Device Shell Structure
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Solution Overview
Problem
Current inflatable medical devices, such as balloons used for trans-cutaneous heart valve implantation, face issues with blocking blood flow, poor dimensional control, and vulnerability to tear and puncture during procedures like Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI), leading to safety concerns and limited inflation time.
Innovation Solution
The development of an inflatable medical device with a shell structure that includes a central fluid passage and a balloon fixed inside, featuring a unique neck section design with varying diameters and reinforcement elements like straps and apertures for enhanced stiffness and flow-through capabilities, allowing for precise control and resistance to tear and puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a typical balloon is used for TAVI/BAV procedures, then the balloon can be inserted and inflated to open stenosed valves, but the balloon blocks entire blood flow causing pressure buildup and may be ejected from the valve
Solution Approach 1:
The shell structure provides localized support at the balloon-aortic valve interface through its rigid or semi-rigid construction, while the balloon itself maintains its inflation capability. The shell's geometric design (frustoconical or bell-shaped) concentrates structural support where needed at the neck sections, allowing the balloon to exert force on the valve without requiring complete occlusion of blood flow.
2Duration of action of moving object
If a typical balloon is inflated for extended periods, then more time is available for the procedure, but the balloon suffers from poor dimensional control and may tear or puncture
Solution Approach 1:
The device combines a rigid or semi-rigid shell structure with an inflatable balloon element. The shell provides tear resistance and dimensional stability, while the balloon provides inflation capability. This composite structure allows extended inflation durations without the balloon tearing or losing dimensional control, as the shell bears the mechanical stress rather than the balloon material alone.
Solution Approach 2:
The shell is divided into different sections (central section and neck sections) with potentially different stiffness characteristics. The neck sections can be made stiffer to provide localized support at critical interfaces, while the central section allows balloon expansion. This segmentation enables the structure to maintain integrity during prolonged inflation while providing appropriate dimensional control in different regions.
3Duration of action of moving object
If rapid pacing is used to minimize pressure buildup, then the balloon can remain inflated longer, but rapid pacing carries risk for the patient
Solution Approach 1:
The invention extracts the function of preventing pressure buildup from the physiological system (heart rate control via rapid pacing) and transfers it to the mechanical system (shell structure with flow-through apertures). The shell's rigid construction and apertures passively manage pressure and flow without requiring physiological intervention, eliminating the need for rapid pacing and its associated patient risks.
4Ease of manufacture
If a typical balloon is used, then the device is simple to manufacture, but the balloon provides poor dimensional control and resistance to tear and puncture
Solution Approach 1:
The invention uses a shell structure that can be rigid or semi-rigid, providing dimensional control and tear resistance. The shell serves as a pre-formed structural element that guides and constrains the balloon's expansion, ensuring precise dimensional control. The balloon itself can remain a simple inflatable element, maintaining ease of manufacture, while the shell provides the enhanced structural properties.
Data Source
Figure 1A~1B
Figure 2A~3A
Figure 2D~2E
AI summary
An inflatable structure apparatus for use as an inflatable medical device, wherein the apparatus has a shell having a shell longitudinal axis, a central section, a first neck section and a second neck section, strips extending between the first neck section and the second neck section to provide added longitudinal stiffness to the apparatus, wherein the apparatus has a first aperture on the first neck section and/or a second aperture on the second neck section.