Self-Expanding Canalization Device with Cutting Extensions
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Solution Overview
Problem
Current methods for penetrating chronic total occlusions in coronary arteries are invasive, costly, time-consuming, and often result in debris spread through the bloodstream, posing safety risks and requiring open-heart surgery in many cases.
Innovation Solution
A canalization device with a radially expandable and crimpable tubular member featuring shape memory materials and sharp extensions that can spontaneously invert and expand within the body to create channels without pre-existing openings, allowing for self-penetration and minimization of debris dispersion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional guidewires and needles are used to penetrate chronic total occlusions, then the procedure is simple and well-established, but the penetration fails in 30% of cases requiring open-heart surgery
Solution Approach 1:
The device is divided into multiple functional segments: a delivery catheter for navigation, a self-expanding stent structure with cutting elements for tissue penetration, and a separate balloon for dilation. This segmentation allows each component to perform its specific function optimally, achieving reliable penetration while maintaining manageable complexity through modular design.
Solution Approach 2:
The stent structure is designed with self-expanding properties and integrated cutting elements that automatically engage tissue upon deployment. The device performs its own penetration function without requiring external surgical intervention, converting previously failed cases into successful percutaneous procedures.
2Reliability
If open-heart surgery (CABG) is performed to treat chronic total occlusions, then reliable penetration and treatment are achieved, but patient recovery time increases to weeks or months
Solution Approach 1:
The invention replaces the mechanical open-heart surgery system with a percutaneous catheter-based system. The self-expanding stent with cutting elements delivers treatment through small vascular access points, eliminating the need for sternotomy and cardiopulmonary bypass, thereby reducing recovery time from weeks/months to days while maintaining treatment effectiveness.
3Force
If a stiffer guidewire is used to traverse the stenosis, then penetration capability improves, but the risk of vessel wall injury and debris creation increases
Solution Approach 1:
The device concentrates penetration force locally at the cutting elements of the stent structure rather than distributing it through a stiff guidewire. The cutting elements are positioned to engage only the occlusive tissue, applying force precisely where needed while minimizing damage to the surrounding healthy vessel wall and reducing debris generation.
Solution Approach 2:
The self-expanding stent structure acts as an intermediary between the delivery catheter and the occlusive tissue. It provides controlled expansion and localized cutting action, mediating the interaction to achieve penetration while protecting the vessel wall from excessive forces and minimizing debris creation compared to direct stiff guidewire manipulation.
4Reliability
If multiple procedural steps are performed (needle passage, balloon dilation, stent insertion), then channel creation is achieved, but the procedure becomes time-consuming and complex
Solution Approach 1:
The invention merges the functions of channel creation, tissue penetration, and vessel support into a single integrated device. The self-expanding stent with cutting elements simultaneously performs penetration and provides structural support, eliminating the need for separate needle passage and stent insertion steps, thereby improving procedural efficiency while maintaining reliable channel creation.
Solution Approach 2:
The device is designed as a multi-functional unit that combines navigation, penetration, dilation, and support functions. This universal design allows a single device to perform multiple tasks that previously required separate instruments and procedural steps, reducing overall procedure time and complexity while ensuring reliable treatment outcomes.
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 safe and effective creation of channels in solid tissues, reducing the need for open-heart surgery and minimizing debris spread, thus improving patient safety and procedural efficiency.
Implementation Method 1
A canalization device with a radially expandable and crimpable tubular member featuring shape memory materials
Implementation Method 2
sharp extensions that can spontaneously invert and expand within the body to create channels
Data Source
AI summary
A medical device for canalization of a tissue comprises a radially expandable and crimpable or collapsible substantially tubular member that has a rear end, a front end, and a pattern of struts or a mesh of wires arranged in-between the rear end and the front end, arranged around an interior of the device. The tubular member has extensions, which are arranged towards the interior of the device in a first state of the device, and towards an exterior of the medical device in a second state of the device, wherein the second state of the medical device is the tubular member turned inside out. During storage, the device is restrained in a delivery catheter in the second state. During delivery the device turns outside in and digs into the tissue to create a channel therein, thus preventing or fixating debris or other matter to spread from the channel.