Variable Geometry Catheter Shaping Element for Multi-Configuration Ablation
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Solution Overview
Problem
Minimally invasive medical devices, such as catheters, require multiple geometric configurations to create various ablative patterns, leading to inaccuracies and prolonged procedures due to the need for sequential replacement and repositioning, which increases the risk to patients.
Innovation Solution
A medical device with an elongate body and a shaping element that can transition between multiple geometric configurations using mechanical, thermal, and electrical forces, allowing for a single device to create diverse ablative patterns without the need for multiple catheters, featuring a guidewire lumen, expandable element, and a shaping element made from elastic and shape-memory materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple catheters with different geometric configurations are used to create various ablative patterns, then the ability to create diverse ablative patterns is improved, but the procedural time and risk are increased due to sequential replacement and repositioning
Solution Approach 1:
The catheter integrates multiple ablative elements with different geometric configurations (e.g., circular, linear, multi-focal patterns) into a single device, allowing the physician to select and activate different elements as needed. This eliminates the need to exchange multiple catheters while maintaining the ability to create diverse ablative patterns throughout the procedure.
Solution Approach 2:
The catheter incorporates expandable or reconfigurable elements that can change their geometric configuration during the procedure. For example, balloon elements can be inflated to different shapes or sizes, and ablative elements can be repositioned or reconfigured to match different treatment requirements, providing dynamic adaptability without requiring catheter exchange.
2Adaptability or versatility
If multiple catheters with different geometric configurations are used to create various ablative patterns, then the ability to create diverse ablative patterns is improved, but the placement accuracy is reduced due to repeated removal and repositioning
Solution Approach 1:
The single catheter maintains a stable distal tip position while providing multiple ablative element configurations, eliminating the cumulative positioning errors that occur with repeated catheter exchanges. The physician can switch between different ablative patterns without moving the catheter, ensuring consistent and accurate lesion placement.
Solution Approach 2:
The catheter is designed with all necessary ablative elements pre-positioned and configured for different treatment patterns. The elements are prepared in advance within the catheter structure, allowing immediate activation of the required pattern without repositioning, thereby maintaining precise placement accuracy throughout the procedure.
3Loss of time
If a single catheter with multiple geometric configurations is used, then the procedural time is reduced and placement accuracy is improved, but the device complexity is increased
Solution Approach 1:
The catheter design places multiple ablative elements and configuration mechanisms within a compact, nested structure. Smaller components are housed within larger structures, allowing the complex multi-configuration device to be delivered through standard catheter access routes and manipulated within the vascular system without excessive bulk or complexity.
Solution Approach 2:
The catheter utilizes flexible materials and thin-film structures to achieve multiple geometric configurations. Expandable balloons, shape-memory alloys, and flexible ablative elements can be transformed between configurations using minimal actuation mechanisms, reducing the overall mechanical complexity while enabling diverse ablative patterns.
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
Enables precise and efficient creation of multiple ablative lesions with varying shapes and dimensions on a single device, reducing procedural inaccuracies and time, thereby minimizing patient risk and improving treatment efficacy.
Implementation Method 1
The shaping element may be made from elastic and shape-memory materials
Data Source
AI summary
The present invention provides a medical device that may include a catheter body having proximal and distal portions, a fluid injection lumen disposed within elongate body, and a guidewire lumen disposed within the elongate body. A tip portion defining a cavity in fluid communication with the fluid injection lumen may be coupled to the distal end of the guidewire lumen, and an expandable element may be coupled to the distal portion of the catheter body and to the tip portion, such that the expandable element is in fluid communication with the fluid injection lumen. A shaping element may at least partially surround the expandable element, where the shaping element is configurable in a first geometric configuration and a second geometric configuration.