Large-Lumen Thrombectomy Catheter for Fragmentation-Resistant Aspiration
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Solution Overview
Problem
Existing catheters used for thrombectomy procedures face challenges in effectively removing thrombus, particularly organized thrombus, due to their small lumens, which can lead to fragmentation and lodging, wasting valuable treatment time and potentially causing poor patient outcomes.
Innovation Solution
A thrombectomy system featuring an elongate catheter with a large inner diameter, reinforced with materials like nitinol and stainless steel, and an aspiration pump capable of generating optimized pressure waveforms to efficiently remove thrombus without fragmentation, using a design that minimizes pressure dampening and includes a programmable controller for real-time adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If small diameter microcatheters are used to navigate tortuous anatomy, then vascular access is achieved, but the catheter lumen is too small to remove thrombus without fragmentation
Solution Approach 1:
The catheter is divided into multiple sections with different properties: a distal section with small diameter for navigation, and a proximal section with large lumen for thrombus removal. This segmentation allows the catheter to perform both navigation and effective thrombus aspiration without fragmentation.
Solution Approach 2:
The distal navigation section is nested within the proximal large lumen section. The smaller distal catheter fits inside the larger proximal catheter, allowing the system to maintain both the navigability of a small catheter and the thrombus removal capability of a large catheter.
2Productivity
If large lumen catheters are used to remove thrombus efficiently, then thrombus removal capability is improved, but the catheter cannot navigate tortuous anatomy
Solution Approach 1:
The catheter is divided into multiple sections with different properties: a distal section with small diameter for navigation, and a proximal section with large lumen for thrombus removal. This segmentation allows the catheter to perform both navigation and effective thrombus aspiration without fragmentation.
3Strength
If rigid reinforcement is added to maintain catheter shape under negative pressure, then catheter structural integrity is improved, but the catheter becomes too stiff to navigate tortuous vessels
Solution Approach 1:
Reinforcement elements are applied locally only where needed - in the proximal large lumen section where negative pressure is applied - rather than throughout the entire catheter. This allows the catheter to maintain structural integrity during aspiration while remaining flexible in the distal navigation section.
Solution Approach 2:
The catheter uses composite construction combining flexible polymer materials with reinforcement elements (braided wires or helical coils). This composite structure provides the necessary strength to withstand negative pressure while maintaining flexibility for navigation through tortuous anatomy.
4Productivity
If aspiration pressure is increased to remove organized thrombus, then thrombus removal speed is improved, but thrombus fragmentation increases
Solution Approach 1:
The catheter is divided into multiple sections with different properties: a distal section with small diameter for navigation, and a proximal section with large lumen for thrombus removal. This segmentation allows the catheter to perform both navigation and effective thrombus aspiration without fragmentation.
Solution Approach 2:
The system optimizes the balance between aspiration pressure and lumen diameter. By using a large lumen (greater than 0.070 inches), the system can apply higher negative pressures to remove organized thrombus efficiently while the larger diameter prevents fragmentation and lodging of thrombus pieces.
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 system enables efficient and effective removal of thrombus, including organized thrombus, by maintaining catheter integrity and applying dynamic pressure waveforms, thereby reducing treatment time and improving patient outcomes.
Implementation Method 1
aspiration pump to provide negative pressure to the lumen of the catheter thereby suctioning thrombus through the catheter lumen
Implementation Method 2
The elongate catheter is has a distal section that preferably includes a helical wire reinforcement and is of a construction that can be subjected to negative pressures of 29 inHg without causing catastrophic damage
Data Source
AI summary
The present invention relates to methods, devices and systems for performing the removal of thrombus from a vessel lumen. More particularly the present invention relates to a thrombectomy system that includes an elongate catheter and a disposable aspiration pump and methods of performing medical procedures to remove clots, thrombus and emboli to re-establish the normal intravascular flow of blood.