Cloverleaf Catheter Basket Spines Prevent Buckling

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Solution Overview

Problem

Current catheter manufacturing processes for cardiac ablation, particularly those using multi-electrode systems for irreversible electroporation, face challenges in forming reliable and efficient basket assemblies due to small electrode sizes and complex geometries, leading to increased manufacturing time and costs, as well as potential misalignment and failure risks.

Innovation Solution

The development of a medical probe with a basket assembly featuring a plurality of linear spines formed from planar sheet material or tube stock, converging at a central spine intersection with cutouts to allow bending, forming an approximately spherical or oblate-spheroid shape, which can be compressed for deployment and expanded for treatment, with electrodes affixed to the spines using a retention hub and insulative jackets to prevent buckling and ensure secure attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple linear spines are assembled together by attaching both ends to a tubular shaft to form a spherical basket, then the basket assembly can be formed, but the manufacturing time and cost increase due to the difficult task of adhering small electrodes to spines and forming the basket

Engineering Contradiction:
Improvebasket assembly formationVSAvoidmanufacturing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The basket assembly is divided into multiple independent linear spines that can be manufactured separately and then assembled. Each spine is a discrete component with electrodes attached individually, allowing for modular manufacturing and assembly rather than forming a complete basket structure at once, thereby reducing overall manufacturing time and complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Electrodes are attached to spines during the spine manufacturing process rather than after the basket is formed. This preliminary attachment ensures proper alignment and secure bonding before assembly, reducing subsequent manufacturing steps and time required for basket formation.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If electrodes are attached to spines using soldering, welding, or adhesive, then the electrodes are secured in place, but the small size of spines and electrodes makes adhering them difficult, increasing manufacturing time and cost

Engineering Contradiction:
Improveelectrode attachmentVSAvoidelectrode adhesion
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

A retention hub is introduced as an intermediary component between the spine and electrode assembly. The retention hub provides a standardized interface that simplifies the attachment process, ensuring reliable connection while reducing the difficulty of manufacturing by providing a dedicated mounting structure rather than relying solely on direct adhesion between small components.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If a cloverleaf structure is used at the distal end of spines to prevent buckling during compression, then the basket can be compressed for deployment, but the structural complexity increases

Engineering Contradiction:
Improvecompression deploymentVSAvoidbasket structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The distal end of each spine incorporates a cloverleaf structure with curved, leaf-like projections that provide mechanical support during compression. This curved geometric design prevents buckling of the spines when the basket is compressed for deployment, enabling easy operation while the symmetrical pattern maintains structural efficiency.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Data Source

PatentUS20230346464A1Basket catheter with cloverleaf structure to prevent buckling and retention feature for electrodes
Publication Date: 2023.11.02 BIOSENSE WEBSTER (ISRAEL) LTD
  • US20230346464A1 patent drawing
  • US20230346464A1 patent drawing
  • US20230346464A1 patent drawing

AI summary

A medical probe is presented including an expandable basket assembly coupled to a distal end of a tubular shaft. The basket assembly includes a cloverleaf cutout structure at its distal end and spines extending proximally from the cloverleaf structure and coupling to the tubular shaft. The cloverleaf structure includes a sinusoidal-like member extending from one spine to an adjacent spine in a direction around the longitudinal axis. The sinusoidal-like member meanders around a first, second and third virtual circle such that the first and third virtual circles are approximately the same distance from a longitudinal axis of the medical probe and approximately the same size and the second virtual circle is between the first and second virtual circles, closer to the longitudinal axis, and having approximately 90% of the first open area of the first and third virtual circles.