Scoring Balloon Catheter Spring Structure for Flexible Lesion Grooving
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Solution Overview
Problem
Existing cutting and scoring catheters face challenges in flexibility, maneuverability, and efficacy for treating tortuous vascular lesions, with limitations in creating controlled cuts or grooves, and often require additional devices for therapeutic substance delivery.
Innovation Solution
A flexible tubular spring structure with annular ring structures and indexed longitudinal elements, configured to create evenly spaced cuts or grooves in lesions, integrated with an angioplasty balloon for controlled dissection and optional therapeutic substance delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If rigid steel blades are adhered to the balloon for creating longitudinal cuts, then cutting efficacy is improved, but device flexibility and maneuverability deteriorate
Solution Approach 1:
The cutting structure is divided into multiple independent scoring elements (3-12 elements) distributed around the balloon circumference, each capable of independent action. This segmentation allows the device to maintain flexibility while providing precise cutting capability at multiple locations simultaneously.
Solution Approach 2:
The patent employs a flexible balloon structure with thin-walled design that can conform to tortuous vascular pathways. The balloon material is selected to provide adequate flexibility for navigation while maintaining sufficient radial strength for lesion expansion and cutting element deployment.
2Productivity
If multiple longitudinal scoring elements are added to create more grooves, then lesion dissection efficacy is improved, but device complexity increases
Solution Approach 1:
The balloon serves multiple functions: it acts as both the expanding element for lesion dilation and the mounting structure for scoring elements. The same balloon inflation mechanism simultaneously deploys both the expansion function and the cutting function, eliminating the need for separate deployment mechanisms.
Solution Approach 2:
The scoring elements are integrated directly into the balloon structure through adhesive bonding or mechanical attachment, merging the cutting function with the expansion function. This integration reduces overall device complexity compared to having separate scoring and expansion components.
3Manufacturing precision
If the balloon is expanded to create controlled dissection, then lesion compliance is improved, but risk of uncontrolled spiral dissection increases
Solution Approach 1:
The scoring elements are strategically positioned at specific circumferential locations around the balloon, creating localized cutting zones rather than uniform circumferential cutting. This localized approach allows controlled dissection at predetermined sites while preserving vessel wall integrity in intervening areas.
Solution Approach 2:
The patent replaces the mechanical rotation mechanism of spiral scoring with a stationary multi-element array that creates grooves through radial expansion force alone. This eliminates the mechanical complexity and potential for uncontrolled spiral dissection associated with rotating scoring mechanisms.
4Adaptability or versatility
If additional devices are used for therapeutic substance delivery, then treatment versatility is improved, but procedural time and cost increase
Solution Approach 1:
The balloon is designed to perform multiple functions in sequence: lesion scoring, controlled dissection, and therapeutic substance delivery. The same balloon structure that creates grooves also serves as the delivery vehicle for drugs or other therapeutics, eliminating the need for a second separate delivery device.
Solution Approach 2:
The therapeutic substance delivery function is merged with the scoring and expansion balloon. The balloon can be coated with therapeutic agents or contain reservoirs that release substances during or after expansion, combining multiple treatment steps into a single device and procedure.
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 tubular spring structure allows for flexible and controlled lesion treatment, reducing procedural time and cost by creating multiple uniform lobes with minimal trauma, and facilitating therapeutic substance entry into the vessel wall.
Implementation Method 1
each annular ring structure comprises a pair of resiliently expandable rings... each ring structure is configured for elastic expansion and deformation in response to expansion of the angioplasty balloon
Implementation Method 2
each distinct pair of adjacent ring structures is coupled by a set of scoring elements... wherein each scoring element comprises a traumatic structure configured for scoring or cutting tissue
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3B
AI summary
A resiliently expandable elongate tubular spring structure, e.g., corresponding to a metal mesh type structure, mountable or mounted to a scoring balloon catheter includes multiple ring structures that are longitudinally separated from each other along portions of a balloon working region, and which are resiliently radially expandable in response to outwardly directed balloon expansion forces. Pairwise adjacent ring structures are structurally coupled and separated from each other by a scoring link, e.g., a single scoring link, configured as a traumatic structure with respect to vascular tissue, e.g., by way of having a square, trapezoidal, or raised blade tissue scoring / cutting profile. Each ring structure includes a pair of radially resiliently radially expandable annular springs, longitudinally separated from each other by a plurality of spacing elements, e.g., wire links, and which are atraumatic or substantially atraumatic structures relative to the scoring link with respect to tissue.