Endovascular Crossing Device with Retractable Piercing Probe
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Solution Overview
Problem
Current endovascular devices are inefficient, risky, and often fail to cross chronic total occlusions in blood vessels, making it difficult to establish blood flow past these blockages, which poses significant health risks to patients.
Innovation Solution
The development of a crossing device with a shaft, atraumatic tip member, and a probe that can be advanced through the vessel wall to create a pathway past occlusions, using an orienting device to direct the crossing device and a re-entry device to establish fluid communication between proximal and distal segments of the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tissue piercing distal probe is used to cross chronic total occlusions, then the efficacy of crossing the occlusion is improved, but the risk of vessel perforation increases
Solution Approach 1:
The distal end of the crossing device is divided into separate functional components: an atraumatic tip member for initial contact and a tissue-piercing probe for penetrating the occlusion. This segmentation allows the device to first engage the vessel wall safely with the tip member, then use the protruding probe to pierce the occlusion, and finally retract the probe to reduce perforation risk while maintaining crossing efficacy.
Solution Approach 2:
The probe is designed to extend beyond the tip member during the crossing maneuver to pierce the occlusion, then is inverted by retracting it back into the tip member after the crossing is achieved. This inversion allows the device to aggressively pierce the occlusion when needed while returning to a safer configuration to minimize vessel perforation risk.
2Productivity
If current endovascular devices are used, then the procedure is simpler, but the efficiency of crossing chronic total occlusions is poor
Solution Approach 1:
The crossing device integrates multiple functions into a single device: the tip member provides atraumatic engagement and initial orientation, the protruding probe performs tissue piercing to cross the occlusion, and the retraction mechanism allows safe withdrawal. This multi-functionality improves crossing efficiency without requiring multiple separate devices, making the complex capabilities accessible through a unified tool.
3Reliability
If the probe extends beyond the tip member to pierce tissue, then the ability to cross occlusions is improved, but the trauma to the vessel wall increases
Solution Approach 1:
The atraumatic tip member makes initial contact with and engages the vessel wall and occlusion tissue before the probe is advanced to pierce. This preliminary action by the tip member positions the probe accurately and prepares the tissue for piercing, ensuring that the probe engages the occlusion effectively while the tip member protects surrounding healthy tissue from trauma during the piercing process.
Solution Approach 2:
After the probe successfully pierces the occlusion and establishes a pathway, it is inverted by retracting it back into the tip member. This inversion removes the traumatic probe from exposure to healthy vessel wall tissue, minimizing ongoing trauma while maintaining the crossing achievement.
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.