Retractable Nested Ablation Device for Precise Cardiac Lesions
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Solution Overview
Problem
Intravascular or percutaneous medical devices face challenges in correctly deploying and positioning within bodily cavities, particularly in creating lesions for treating atrial fibrillation, due to the complexity of navigating through small catheter sheaths and the lack of direct visual contact, which can lead to incorrect lesion placement and adverse outcomes.
Innovation Solution
A medical device with elongate members that can transition from an unexpanded configuration for catheter delivery to an expanded configuration for precise positioning, using elongate members that fan out or cross each other to facilitate accurate placement and ablation, and incorporate transducer elements for tissue discrimination and ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the medical device is delivered through a small catheter sheath, then the invasiveness is reduced and patient recovery is improved, but the device cannot assume its functional configuration for precise positioning and ablation
Solution Approach 1:
The device is divided into multiple elongate members that can be independently controlled and positioned. Each elongate member can be selectively advanced or retracted to achieve the expanded configuration for ablation while maintaining a compact form for delivery through the catheter sheath
Solution Approach 2:
The device transitions from a static compact configuration during delivery to a dynamic expanded configuration during operation. The elongate members can be moved between retracted and advanced positions to transform the device structure, enabling both minimally invasive delivery and precise positioning for ablation
2Device complexity
If the device structure is simplified for easy deployment, then the device complexity is reduced, but the ability to achieve precise lesion placement relative to cardiac features is compromised
Solution Approach 1:
The patent replaces complex mechanical positioning systems with a combination of elongate member advancement and tissue discrimination capabilities. The device uses transducer elements to detect tissue characteristics and determine positions of cardiac features, substituting mechanical complexity with sensing and control systems that enable precise lesion placement
Solution Approach 2:
The elongate members serve as intermediaries between the delivery system and the ablation site. They can be selectively advanced to position the ablation elements at precise locations relative to cardiac features identified by the tissue discrimination system, enabling accurate lesion placement without requiring complex direct mechanical positioning
3Reliability
If the device assumes an expanded configuration for ablation, then the ablation effectiveness is improved, but the device cannot be delivered through small catheter sheaths
Solution Approach 1:
The device employs a nested configuration where multiple elongate members are arranged concentrically or in a compact stacked arrangement during delivery. This allows the device to fit within small catheter sheaths while maintaining the capability to expand into the functional configuration needed for effective ablation at the target site
Data Source
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AI summary
Systems, methods, and devices allow intravascular or percutaneous mapping, orientation or ablation, or combinations thereof in bodily cavities or lumens. A device includes a plurality of elongate members which are moveable between an unexpanded configuration, a bent or coiled stack configuration and an expanded or fanned configuration. The elongate members form a stack arrangement in the unexpanded configuration to fit through a catheter sheath, The elongate members follow respective arcuate or curvilinear paths as advanced from the sheath into the bent or coiled stack configuration, adopting volute, scroll or rho shapes, and may be nested. The elongated members are fanned or radially spaced circumferentially with respect to one another into the expanded or fanned configuration. Transducers carried by elongate members may sense various physiological characteristics of or proximate tissue, for instance temperature, and/or may apply energy to or proximate tissue, for example to perform ablation. The device is retractable.