Enhanced Flexible Circuit for Electrophysiology Catheters with Integrated Thermal Management and Biocompatibility Features
Legal Citation
Summary of the Inventive Concept
An improved flexible circuit for electrophysiology catheters, incorporating thermal management, biocompatibility, and impedance sensing features to enhance ablative energy delivery, minimize thermal damage, and optimize cardiac tissue ablation procedures.
Background and Problem Solved
The original patent disclosed a flexible circuit for split-tip catheters, but it had limitations in thermal resistance, biocompatibility, and impedance sensing. The new inventive concept addresses these limitations by integrating a thermal management system, nanocoating for biocompatibility, and an impedance sensor to optimize energy delivery and minimize complications.
Detailed Description of the Inventive Concept
The enhanced flexible circuit comprises a thermal management system integrated into the transition section to reduce thermal resistance and enhance ablative energy delivery. Additionally, the lateral wall section is coated with a nanocoating to enhance biocompatibility and reduce thrombus formation. The circuit also features an integrated impedance sensor to optimize energy delivery and minimize complications. Furthermore, the electrode configuration can be dynamically adjusted to adapt to varying cardiac tissue geometries and optimize ablative energy delivery.
Novelty and Inventive Step
The new claims introduce novel features not present in the original patent, including the thermal management system, nanocoating, impedance sensor, and dynamically adjustable electrode configuration. These features provide a non-obvious improvement over the original patent, enabling more efficient and safer cardiac tissue ablation procedures.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include varying thermal management systems, such as micro-channel cooling or thermoelectric cooling. The nanocoating could be replaced with other biocompatible materials or surface treatments. The impedance sensor could be integrated into the catheter tip or used in conjunction with other sensing modalities. The dynamically adjustable electrode configuration could be achieved through various mechanisms, such as shape-memory alloy wires or micro-electromechanical systems (MEMS).
Potential Commercial Applications and Market
The enhanced flexible circuit has significant commercial potential in the electrophysiology catheter market, which is expected to grow due to the increasing prevalence of cardiac arrhythmias. The inventive concept could be integrated into catheter systems for ablative procedures, offering a competitive advantage in terms of safety, efficacy, and procedural efficiency.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61B18/1492 |
| A | A61 | A61B5/287 |
| A | A61 | A61B5/367 |
| A | A61 | A61B8/4494 |
| A | A61 | A61B2018/00351 |
| A | A61 | A61B2018/00577 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Electrophysiology medical device engineering, focusing on flexible circuit design for cardiac intervention catheters, requiring advanced knowledge of biomedical engineering, electrical circuit design, thermal management, and minimally invasive medical device technologies
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer with expertise in medical device design, electrical circuit fabrication, thermal management techniques, and catheter-based intervention technologies, holding advanced degrees in bioengineering or electrical engineering with specialized medical device design experience
Obviousness Rationale
A PHOSITA would recognize that the disclosed thermal management, nanocoating, and impedance sensing features represent predictable engineering improvements to the existing flexible circuit catheter design. The variations address known challenges in cardiac ablation procedures by applying standard engineering techniques to optimize thermal control, biocompatibility, and energy delivery. These modifications represent incremental yet meaningful advancements that would be apparent to a skilled practitioner seeking to enhance catheter performance.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,251 |
|---|---|
| Title | Flexible circuit for use with a catheter and related manufacturing method |
| Assignee(s) | Biosense Webster (Israel) Ltd. |