Undulating Coil Guidewire for Crossing Vessel Occlusions
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Solution Overview
Problem
Current intravascular medical devices face challenges in effectively crossing occlusions in vessels due to their limited pushability and torqueability, particularly in tortuous anatomies, and lack of flexibility to navigate through blocked regions.
Innovation Solution
A guidewire design featuring an elongated core member with an intermediate member and a coil having an undulating outer surface, which includes recessed and protruding portions, enhancing pushability and flexibility to aid in crossing occlusions by engaging and screwing through occlusions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the guidewire is made more flexible to navigate tortuous vasculature, then its ability to cross occlusions is improved, but its pushability and torqueability deteriorate
Solution Approach 1:
The guidewire is divided into multiple sections with different structural characteristics: a distal section with enhanced flexibility for navigating tortuous anatomy, and a proximal section with a strengthenable member for improved pushability and torqueability. This segmentation allows each section to optimize its properties for its specific function.
Solution Approach 2:
Different portions of the guidewire are given different mechanical properties. The distal portion maintains high flexibility for navigation, while the proximal portion incorporates a strengthenable member that provides localized enhancement of pushability and torqueability without affecting the overall flexibility needed for occlusion crossing.
2Force
If the guidewire structure is strengthened to improve pushability, then its ability to cross occlusions is improved, but its flexibility to navigate tortuous anatomy deteriorates
Solution Approach 1:
The guidewire structure is segmented into a proximal section with a strengthenable member for pushability and a distal section for flexibility. This allows the strengthened portion to provide the necessary force for occlusion crossing while the distal portion maintains the flexibility needed for navigating tortuous vasculature.
Solution Approach 2:
The strengthenable member can be selectively activated or adjusted during the procedure. When enhanced pushability is needed to cross an occlusion, the strengthenable member is engaged. When navigating tortuous anatomy is required, the guidewire can rely on the flexibility of the distal section without the strengthenable member interfering.
3Ease of manufacture
If the guidewire has a simple structure for ease of manufacture, then production cost is reduced, but its ability to provide both pushability and flexibility deteriorates
Solution Approach 1:
The strengthenable member is disposed within the lumen of the guidewire, creating a nested structure. This allows the guidewire to maintain a relatively simple outer structure that is easy to manufacture, while the internal strengthenable member provides the additional functionality needed for both pushability and flexibility without requiring a completely complex redesign.
Solution Approach 2:
The strengthenable member serves multiple functions: it enhances pushability when needed for occlusion crossing, and its presence within the lumen allows the guidewire to maintain flexibility for navigating tortuous anatomy. This single component provides dual functionality that would otherwise require multiple separate structural elements.
Data Source
AI summary
The invention provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes an elongated core member including an outer surface, an intermediate member disposed about at least a portion of the outer surface of the core member, and a coil disposed about at least a portion of the intermediate member in the distal region. At least a portion of an outer surface of the coil can include an undulating surface in a portion of the distal region.


