Distal Re-Entry Probe for Crossing Chronic Total Occlusions
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Solution Overview
Problem
Existing endovascular devices struggle with inefficiency, high risk of vessel perforation, and poor efficacy in crossing chronic total occlusions, making it difficult to establish blood flow past these blockages, especially in coronary and leg arteries, and bypass surgery is often the preferred but less invasive alternatives are sought.
Innovation Solution
The development of a tissue-piercing distal probe and associated methods, including a re-entry device that anchors to the intima of the blood vessel to create a pathway through the occlusion, using orienting and crossing devices to navigate the subintimal space and re-enter the true lumen, allowing for the advancement of catheters like balloon angioplasty, atherectomy, and stent delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endovascular devices are used to cross chronic total occlusions, then the procedure can be performed with standard equipment, but the procedure is inefficient (time consuming), has high risk of vessel perforation, and fails to cross the occlusion
Solution Approach 1:
The device is divided into distinct functional segments: a shaft, a tip member with atraumatic design, and a separate probe component. This segmentation allows the tip member to provide safe navigation while the probe performs the specific function of piercing the occlusion, resolving the contradiction between safety and efficacy.
Solution Approach 2:
Different parts of the device have different properties: the tip member is relatively atraumatic for safe vessel navigation, while the probe is shaped to produce controlled trauma for piercing the occlusion. This local differentiation of properties allows the device to be both safe during navigation and effective at crossing the occlusion.
2Ease of operation
If conventional endovascular devices are used, then the device structure can be simple, but physicians cannot accurately direct devices toward the visualized lumen or advance devices through the lesion
Solution Approach 1:
The probe is specifically shaped with a tapered distal end to facilitate accurate direction toward the visualized lumen. This localized design feature improves ease of operation without requiring complex overall device structure.
3Productivity
If a tissue-piercing probe is added to the device, then the ability to cross occlusions is improved, but the device structure becomes more complex
Solution Approach 1:
The probe is designed as a separate, removable component that can be attached to or integrated with the shaft and tip member. This segmentation allows the occlusion-crossing capability to be added without permanently complicating the base device structure.
Solution Approach 2:
The probe serves multiple functions: it pierces the occlusion, creates a pathway through the lesion, and can be used in conjunction with various catheters (balloon angioplasty, atherectomy, stent delivery). This multi-functionality justifies the added structural complexity by eliminating the need for multiple separate devices.
Data Source
AI summary
Devices, systems and methods for treating diseases and disorders effecting the cardiovascular system of the human body are disclosed. An exemplary device in accordance with this disclosure comprises a shaft, tip member fixed to the shaft, and a probe extending beyond a distal surface of the tip member. In some useful embodiments, the tip member is relatively atraumatic and the probe is shaped so as to be more likely to produce trauma than the tip member.