Balloon-Expandable Rotational Catheter for Tortuous Vessel Debulking
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Solution Overview
Problem
Existing methods for restoring patency of body lumens by removing occlusive tissue or material, such as plaque, are inefficient or limited in their ability to navigate tortuous paths and effectively abrade or remove tissue.
Innovation Solution
A catheter with a rotational, balloon-expandable, and abrasive design that includes a rotatable drive shaft with an abrasive burr and an expandable balloon, allowing for navigation through narrow anatomy and controlled tissue removal by expanding the burr to engage tissue radially and abrade it effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a rotatable tissue-removing element is advanced into occlusive material to remove tissue, then tissue removal capability is improved, but the ability to navigate tortuous paths deteriorates
Solution Approach 1:
The catheter employs a dynamically adjustable system where the burr assembly can be expanded and contracted. In the contracted state, the catheter is flexible enough to navigate tortuous anatomical paths. Once positioned at the occlusion site, the burr is expanded to provide effective tissue removal capability. This dynamic transformation allows the device to adapt to different operational requirements along its deployment path.
Solution Approach 2:
The catheter is divided into distinct functional segments: a flexible delivery catheter for navigation, an expandable burr assembly for tissue removal, and a drive shaft for rotation. This segmentation allows each component to be optimized independently - the delivery catheter for navigability and the burr assembly for cutting efficiency - while working together as an integrated system.
2Productivity
If an expandable burr is used to engage tissue radially, then tissue removal effectiveness is improved, but device complexity increases
Solution Approach 1:
The invention merges multiple functions into the expandable burr assembly: the burr itself for cutting, the expansion mechanism for radial engagement, and the drive shaft integration for rotation. By combining these functions into a single integrated assembly rather than separate components, the device achieves effective radial tissue engagement while minimizing overall system complexity.
Solution Approach 2:
The drive shaft serves as an intermediary component that transmits rotational force from the external drive mechanism to the expandable burr. This intermediary allows the burr to be rotated effectively for tissue removal without requiring direct connection between the external drive and the burr, simplifying the overall mechanical interface while maintaining rotational effectiveness.
3Ease of operation
If a balloon is used to expand the burr, then controlled tissue removal is improved, but the risk of balloon pinching between burr struts increases
Solution Approach 1:
The balloon is designed as a flexible thin-film structure that can conform to the internal geometry of the burr assembly. This flexibility allows the balloon to expand uniformly against the burr struts without being pinched, while still providing controlled expansion for effective tissue removal. The thin-film nature of the balloon enables it to navigate the constrained space within the burr assembly without failure.
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 removes occlusive tissue by expanding to engage and abrade tissue radially, effectively restoring patency of body lumens, including blood vessels, while navigating complex anatomical paths.
Implementation Method 1
These catheters are intended to abrade, cut, or otherwise remove material from the body lumen and can employ a rotatable tissue-removing element
Implementation Method 2
Expandable catheters such as balloon catheters have also been used in various ways to restore the patency of body lumen. For example an expandable element such as a balloon can be used to enlarge a passage through an occlusion in a body lumen
Data Source
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AI summary
A catheter can restore the patency of a body lumen, for example, by removing tissue from a body lumen (e.g., a blood vessel). The catheter can be a rotational catheter having a rotatable drive shaft and a tissue-removing element secured to the drive shaft to be driven in rotation by the drive shaft. The catheter can have an abrasive burr configured to abrade tissue in a body lumen. The catheter can have an expandable tissue-removing element. The catheter can include a balloon and an inflation conduit. The catheter can also be configured to move over a guidewire through a body lumen. In one embodiment, the catheter comprises an over-the-wire, balloon-expandable, rotational, and abrasive tissue-removing catheter.