Scoring Lithotripsy Balloon Catheter for Eccentric Calcific Lesions
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Solution Overview
Problem
Existing medical devices face challenges in effectively treating eccentric calcific lesions in blood vessels, particularly in terms of reduced efficacy of intravascular lithotripsy and lack of control over the orientation of ultrasound emitters.
Innovation Solution
A catheter design incorporating an expandable member with cutting or scoring elements and an ultrasound transducer, where the emitter shaft is rotatable and aligned towards the lesion using tethers, allowing for uniform acoustic pressure application and enhanced treatment efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravascular lithotripsy is used to treat calcific lesions, then the lesion can be modified, but the efficacy is reduced for eccentric calcific lesions
Solution Approach 1:
The catheter incorporates both cutting members and an ultrasound emitter, dividing the treatment approach into two complementary functions: mechanical scoring/cutting and acoustic pressure application. This segmentation allows each component to address specific aspects of the lesion, improving overall efficacy for eccentric calcific lesions where a single method would be insufficient
Solution Approach 2:
The patent merges cutting/scoring elements with an ultrasound transducer into a single integrated catheter system. The cutting members and ultrasound emitter work together synergistically, with the cutting elements creating initial fractures and the ultrasound delivering acoustic pressure to further modify the calcific lesion, thereby overcoming the limitations of each individual method
2Device complexity
If a fixed ultrasound emitter is used, then the device structure is simpler, but the orientation control towards the lesion is limited
Solution Approach 1:
The emitter shaft is designed to be rotatable relative to the catheter shaft, transforming the fixed emitter configuration into a dynamic, adjustable one. This rotational capability allows the operator to orient the ultrasound transducer towards eccentric calcific lesions, improving ease of operation and treatment precision without significantly increasing device complexity
Solution Approach 2:
The rotatable emitter shaft allows preliminary positioning and orientation adjustment before ultrasound delivery. The operator can pre-align the transducer towards the target lesion using the rotational degree of freedom, ensuring optimal orientation is achieved before activating the ultrasound emitter, thereby enhancing operational ease
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 combination of cutting/scoring elements and ultrasound energy improves treatment efficacy by covering a broader circumferential area, especially in lesions with a low circumferential angle of calcification, enhancing lesion modification and reducing vessel trauma.
Implementation Method 1
the cutting member is configured to score a lesion while the ultrasound transducer delivers acoustic pressure waves to the lesion
Data Source
AI summary
Catheters configured to substantially simultaneously cut or score a lesion and deliver a pressure wave to the lesion. An illustrative catheter may comprise a catheter shaft, an expandable member secured to a distal portion of the catheter shaft, a cutting member secured to the expandable member, and an ultrasound transducer disposed within the expandable member. Tethers may be attached between the expandable member and the emitter that self-orientate the emitter towards target tissue due to uneven expansion of expandable member due to different compliance between target tissue and surrounding tissue.


