Integrated Angioplasty Device with Small-Pore Embolic Filter
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Solution Overview
Problem
Current angioplasty procedures require multiple devices for vascular stenosis treatment, leading to longer procedure times, clinical risks, and increased costs, with existing embolic filters being inadequate for capturing smaller embolic particles that can cause stroke.
Innovation Solution
A percutaneous transluminal angioplasty device combining a multi-lumen catheter, a filter with small diameter pores, an expandable balloon, and a self-expanding stent, allowing for simultaneous embolic protection, stent deployment, and post-dilation in a single system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate devices are used for embolic protection, stent deployment, and post-dilation, then each device can be optimized for its specific function, but procedure time increases and clinical risks increase
Solution Approach 1:
The patent combines multiple separate devices (embolic protection device, stent, and angioplasty balloon) into a single integrated angioplasty system. The embolic protection device is positioned within the catheter assembly, allowing simultaneous deployment of stent and embolic filter in one procedure, thereby reducing procedure time while maintaining clinical safety
Solution Approach 2:
The integrated angioplasty device performs multiple functions simultaneously: embolic protection, stent deployment, and post-dilation. The single device system eliminates the need for multiple separate devices, reducing the number of manipulations and interactions required during the procedure
2Reliability
If multiple separate devices are used for vascular stenosis treatment, then each device can be specialized, but device complexity and cost increase
Solution Approach 1:
The patent integrates multiple specialized functions into a single device system, reducing the total number of devices from three separate devices to one integrated angioplasty device. This simplifies the treatment workflow while maintaining the specialized capabilities of each individual component
3Productivity
If embolic filters with large pores are used, then blood flow is maintained, but smaller embolic particles cannot be captured
Solution Approach 1:
The embolic protection device incorporates a filter with small diameter pores (40 microns) that is specifically positioned to capture smaller embolic particles. The filter is integrated into the catheter assembly at a location where it can effectively intercept embolic material while maintaining adequate blood flow through the controlled pore size
Solution Approach 2:
The patent specifies that the embolic protection device includes a filter with pores of 40 microns or less, changing the pore size parameter from the conventional large pores (100 microns or greater) to capture smaller embolic particles while still allowing adequate blood flow
4Strength
If stents with high radial strength are used, then calcified lesions are kept open, but flexibility to travel through tortuous vessels is reduced
Solution Approach 1:
The stent is designed with differentiated strut characteristics: the proximal portion has thicker struts providing higher radial strength for calcified lesions, while the distal portion has thinner struts providing greater flexibility for navigation through tortuous vessels. This local variation in strut thickness optimizes both strength and flexibility
5Object-affected harmful factors
If stent struts have high density, then plaque embolization is prevented, but device flexibility is reduced
Solution Approach 1:
The stent features non-uniform strut thickness where the proximal portion has thicker struts to prevent plaque embolization, while the distal portion has thinner struts to maintain flexibility for navigation. This local differentiation allows the stent to provide dense strut coverage where needed while remaining flexible where required
Data Source
AI summary
A percutaneous transluminal angioplasty device includes a catheter defining one or more lumens. A filter is coupled to the catheter adjacent a distal end of the catheter, and the filter is movable between an unexpanded and expanded configuration via a filter activation wire that extends through a lumen. An expandable balloon is coupled to the catheter proximally of the filter, and a stent is disposed over at least a portion of the balloon. To deploy the stent to a target site, the filter is first moved into its expanded position via the filter activation wire. Then, the stent is expanded, and the balloon is inflated to expand the stent further radially. The balloon is then deflated, the filter is contracted, and the catheter, balloon, and filter are removed from the body.