Oscillating Tip Catheter for Crossing Calcified Lesions
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Solution Overview
Problem
Existing catheter devices struggle to effectively penetrate and treat resistant fibrotic and calcified lesions, such as chronic total occlusions (CTOs), while minimizing the risk of trauma to blood vessels, and similar challenges exist for treating occlusions in other body lumens like kidney stones.
Innovation Solution
A lesion crossing catheter with an oscillating impactor at its distal end, driven by a motor, translates in an oscillatory manner to deliver direct mechanical impact forces to occlusions, utilizing a cam assembly and actuator for controlled oscillation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional guide wires and angioplasty balloons are used to treat chronic total occlusions, then the procedure can be performed with basic equipment, but the guide wire has difficulty penetrating thick fibrous lesions and may cause trauma to blood vessels
Solution Approach 1:
The patent applies mechanical vibration through an oscillating impactor that delivers controlled mechanical forces to the occlusion. The impactor oscillates at specific frequencies and amplitudes to fracture calcified plaque and penetrate fibrous tissue, enabling guide wire advancement through lesions that would otherwise be impassable, while the controlled nature of the vibration minimizes damage to surrounding healthy tissue.
Solution Approach 2:
The patent employs periodic action through the oscillating impactor that delivers repeated mechanical impacts to the occlusion. The periodic oscillation allows the impactor to progressively fracture and remove calcified material over time, enabling penetration through thick fibrous lesions while distributing mechanical stress to avoid acute vessel trauma.
2Reliability
If atherectomy procedures are implemented to form a channel in a lesion, then penetration of resistant lesions is improved, but the risk of vessel perforation or vessel dissection increases
Solution Approach 1:
The patent applies local quality by concentrating mechanical energy at the distal tip of the impactor where it contacts the occlusion. The oscillating motion is localized to the impactor tip, allowing precise fracture of calcified plaque only at the treatment site while leaving surrounding healthy vessel wall intact, thus reducing the risk of vessel perforation compared to rotating atherectomy devices.
Solution Approach 2:
The patent substitutes rotating mechanical cutting systems with an oscillating impactor that uses controlled mechanical vibration and impact forces. This replacement reduces the risk of vessel dissection and perforation associated with rotating blades, as the oscillating impactor fractures plaque through controlled impacts rather than continuous cutting contact.
3Productivity
If high pressure is applied to expand the balloon to push calcified plaques back into the vessel wall, then the occlusion is cleared, but the risk of trauma to blood vessels increases
Solution Approach 1:
The patent uses mechanical vibration through the oscillating impactor to fracture calcified plaques and clear occlusions. This approach is more efficient than balloon angioplasty alone, as the vibration directly breaks up resistant calcified material, enabling occlusion clearance with lower overall mechanical forces and reduced risk of vessel trauma compared to high-pressure balloon expansion.
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
The catheter efficiently penetrates and clears treatment-resistant lesions by concentrating mechanical forces, allowing quicker and more effective treatment of occlusions with reduced risk to healthy tissue.
Implementation Method 1
The impactor may be oscillated by a cam assembly that is driven by a motor positioned in a handle of a catheter
Implementation Method 2
The impactor may be oscillated by a cam assembly that is driven by a motor positioned in a handle of a catheter
Implementation Method 3
The impactor may translate forward and backward (i.e., advance in a distal direction and then return in a proximal direction) in an oscillatory manner to deliver repeated mechanical impact forces to an occlusion
Data Source
AI summary
A catheter includes an elongate body, a rotatable shaft disposed within the elongate body, an impactor forming a distal end of the catheter and configured to translate relative to the elongate body for impacting an occlusion in the body lumen, and an actuator configured to translate the impactor. The actuator includes a cam and cam follower operatively coupled to the rotatable shaft such that rotation of the rotatable shaft causes relative rotation and translation between the cam and cam follower. The impactor is coupled to the cam or the cam follower such that the impactor translates in conjunction with the cam or the cam follower to impact the occlusion in the body lumen.