Dual-Function Balloon Catheter for Lesion Crossing and Angioplasty
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Solution Overview
Problem
Current endovascular catheter procedures require separate devices to cross chronic total occlusions (CTOs) and perform percutaneous transluminal angioplasty, complicating the process and increasing time and expense.
Innovation Solution
A single catheter with a shaft featuring a guidewire lumen, inflation lumen, and a tapered tip, equipped with an inflatable balloon that forms a continuous sloping transition, allowing for both crossing lesions and performing angioplasty, with a braided shaft for enhanced pushability and a non-compliant balloon for robustness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate devices are used to cross CTO and perform PTA, then each device can be optimized for its specific function, but the procedure becomes more complex and requires multiple vascular accesses
Solution Approach 1:
The patent combines two separate devices (crossing catheter and PTA balloon catheter) into a single integrated device. The crossing catheter includes a balloon mounted on its shaft, allowing the same device to both cross the CTO using its tapered tip and subsequently perform PTA using the balloon, eliminating the need for separate devices and multiple accesses
Solution Approach 2:
The crossing catheter is designed with multi-functionality to perform both CTO crossing and PTA procedures. The device universally handles both tasks through its dual components: the tapered tip for crossing and the inflatable balloon for angioplasty, making it adaptable to different procedural needs without requiring device changes
2Reliability
If separate devices are used for crossing and treatment, then specialized functions are achieved, but the procedure time and expense increase
Solution Approach 1:
By merging the crossing catheter and PTA balloon into one device, the patent eliminates the time required to introduce, position, and operate separate devices. The integrated design allows sequential use of the tapered tip for crossing followed immediately by the balloon for PTA within a single procedural sequence
Solution Approach 2:
The multi-functional device reduces procedure time by performing both CTO crossing and PTA treatment without requiring device exchanges. The universal design allows the operator to complete both specialized functions using one introduced device, thereby reducing overall procedural duration and associated costs
3Device complexity
If a single catheter performs both crossing and PTA, then procedural simplicity is improved, but the catheter must be robust enough to withstand both functions
Solution Approach 1:
The patent merges two devices into one while maintaining the structural integrity needed for both functions. The crossing catheter shaft is designed with sufficient strength to support the tapered tip for crossing and the balloon for PTA, ensuring the single device can withstand the mechanical demands of both procedures
Solution Approach 2:
The catheter employs local quality by having different structural characteristics in different sections: the tapered tip is designed for penetrating the CTO with appropriate strength and geometry, while the balloon section is designed for expansion and PTA function, with the shaft providing overall structural support and robustness throughout
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
Enables efficient and robust single-intervention treatment of lesions by facilitating guidewire access and lesion compaction, reducing procedural complexity and costs while maintaining catheter integrity for subsequent use.
Implementation Method 1
an inflatable balloon having a proximal portion, a barrel portion having a working surface for compacting the lesion, and a distal tapered portion
Data Source
AI summary
A catheter is provided for both crossing a lesion, such as a chronic total occlusion, in a vessel and performing percutaneous transluminal angioplasty thereupon. The catheter includes a shaft having a tapered tip adapted for being pushed into the lesion to advance through the lesion. An inflatable balloon is mounted on the shaft, which may be braided to provide enhanced pushability and kink-resistance. The inflatable balloon includes a proximal portion and a distal tapered portion connected to the tapered tip, and having a shallow taper. The taper of the distal tapered portion and the tapered tip may together create a continuous sloping transition from a distal end of the distal tapered portion to an adjacent portion of the tapered tip to facilitate crossing a lesion. The balloon may also be selectively inflated or deflated during crossing of the lesion, and ultimately used to compact the lesion when inflated.