Variable Size Probe for Pulmonary Vein Lesions
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Solution Overview
Problem
Conventional medical devices face challenges in forming circumferential lesions around pulmonary veins without occluding blood flow or causing tissue damage, particularly due to the difficulty in achieving adequate tissue contact and varying sizes of the target structure.
Innovation Solution
A probe with a variable size structure that includes a shaft and a distal region with electrodes, capable of conforming to the size of the body structure, allowing for adequate electrode-tissue contact and blood flow passage, and featuring a flexible spline design that adjusts to different diameters to prevent damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size structure is used to form circumferential lesions, then the device structure is simple, but it cannot accommodate varying sizes of target structures and achieves inadequate tissue contact
Solution Approach 1:
The device employs a dynamic structure where the distal portion can expand from a compressed delivery configuration to an expanded operational configuration. The variable size structure includes expandable elements such as balloons or self-expanding frames that can adjust their diameter to match different pulmonary vein sizes, allowing the same device to adapt to varying anatomical conditions without requiring multiple fixed-size devices.
Solution Approach 2:
The variable size structure is designed to be nested within a delivery catheter during insertion. The expandable framework or balloon elements are collapsed into a compact form that fits within the catheter lumen, then deployed at the target site where they expand outward to engage the tissue. This nesting principle allows the complex expanded structure to be delivered through a relatively simple catheter.
2Reliability
If a balloon-like expandable device is used to create circumferential lesions, then adequate tissue contact is achieved, but blood flow through the pulmonary vein is occluded
Solution Approach 1:
Instead of using a single continuous balloon that would completely occlude the vessel, the device segments the contact surface into discrete electrode elements distributed around the circumference. These segmented electrodes can contact the tissue at multiple points while leaving gaps between them that allow blood to continue flowing through the pulmonary vein, thus maintaining both reliable tissue contact and patency of the vessel.
Solution Approach 2:
The device applies contact and energy delivery locally at discrete electrode-tissue interface points rather than creating a complete circumferential seal. Each electrode element provides localized tissue contact for lesion formation while the spaces between elements maintain open channels for blood flow, creating a local quality of contact that avoids global occlusion.
3Ease of operation
If conventional catheters with long flexible shafts are used, then access to the heart is achieved, but it is difficult to achieve adequate tissue contact for lesion formation
Solution Approach 1:
The device transitions from a flexible, conformable state during delivery to a structured, expandable state at the target site. Once deployed, the variable size structure expands to provide rigid support and stable positioning of the electrodes against the tissue, ensuring reliable and consistent contact for lesion formation while maintaining the ability to navigate the vasculature during delivery.
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 the formation of circumferential lesions without occluding blood flow or causing tissue damage, providing consistent electrode-tissue contact and flexibility to accommodate varying body structure sizes.
Implementation Method 1
a variable size structure (106) capable of conforming to the size of the body structure into which it is deployed
Implementation Method 2
The application of electromagnetic radio frequency ('RF') energy to heat and eventually kill (i.e. 'ablate') tissue is one method of forming a lesion
Implementation Method 3
During the ablation of soft tissue (i.e. tissue other than blood, bone and connective tissue), tissue coagulation occurs and it is the coagulation that kills the tissue
Data Source
AI summary
A probe that facilitates the creation of circumferential lesions in body structures that may vary in size.


