Expandable Electrode Catheter for Precise Soft Tissue PFA
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Solution Overview
Problem
Existing devices for pulsed field ablation are not suitable for treating tumors in soft tissues like pancreatic tissue, lacking the necessary precision and minimizing collateral damage.
Innovation Solution
A catheter system with an expandable electrode and a needle tip for delivering pulsed electric field ablation, where the electrode transitions from a compressed to an expanded conical shape and the needle tip is electrically exposed to apply ablation, with a conductive fluid path established for effective tissue treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional ablation devices are used for soft tissue tumors, then ablation can be achieved, but precision is insufficient and collateral damage occurs
Solution Approach 1:
The needle electrode delivers pulsed electric field energy through a localized conductive path defined by the expandable electrode and needle tip, concentrating the ablation effect precisely at the target tissue site while leaving surrounding tissues unaffected. This localised energy delivery resolves the contradiction between achieving sufficient ablation and minimizing collateral damage.
Solution Approach 2:
A conductive fluid is introduced as an intermediary medium between the expandable electrode and the target tissue, establishing a controlled conductive path for energy delivery. This intermediary enables precise energy confinement to the intended treatment zone, improving ablation precision while preventing harmful effects to adjacent tissues.
2Strength
If thermal ablation methods are used, then tissue destruction is achieved, but tissue integrity and extracellular matrix are damaged
Solution Approach 1:
The patent replaces thermal ablation mechanisms with pulsed electric field ablation, using electrical fields instead of thermal energy to achieve tissue destruction. This substitution eliminates thermal damage to the extracellular matrix while maintaining effective tumor ablation, thereby preserving tissue integrity.
Solution Approach 2:
The invention changes the fundamental parameter of energy delivery from thermal to electrical, using pulsed electric fields with specific voltage and duration parameters to achieve non-thermal tissue ablation. This parameter change allows selective tumor cell destruction while preserving the structural integrity of surrounding tissue and extracellular matrix.
3Device complexity
If a simple catheter structure is used, then device complexity is reduced, but delivery precision and control are insufficient
Solution Approach 1:
The catheter is segmented into distinct functional components: an outer catheter for delivery, an expandable electrode for energy delivery, and a needle electrode for precise targeting. This segmentation allows each component to perform its specific function optimally, achieving high delivery precision while keeping the overall device manageable in complexity.
Solution Approach 2:
The expandable electrode transitions from a compressed delivery state to an expanded treatment state, providing dynamic adaptability. This dynamic transformation allows the device to maintain low profile during delivery for precision positioning, then expand at the target site to establish the conductive path, thereby achieving high delivery precision without excessive static complexity.
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
The system provides precise and minimally invasive pulsed field ablation for soft tissue tumors, preserving tissue integrity and minimizing collateral damage.
Implementation Method 1
The expandable electrode and the distal tip of the needle, when (1) the expandable electrode is disposed distal to the outer shaft and (2) the needle is extended relative to the inner shaft such that the distal tip of the needle is disposed distally of the distal end of the inner shaft, being configured to apply pulsed field ablation to a zone of tissue at the tissue site
Implementation Method 2
The outer shaft and the inner shaft define an annular space therebetween that is configured to deliver a conductive fluid to a region surrounding the expandable electrode. The expandable electrode and the distal tip of the needle, when the needle is inserted into the tissue site and the conductive fluid surrounds the expandable electrode, configured to apply pulsed field ablation via a conductive path established by the conductive fluid to a zone of tissue at the tissue site
Data Source
AI summary
Systems, devices, and methods described herein relate to catheter devices for therapy delivery. In some embodiments, a catheter device includes an expandable electrode and a needle, where the needle can be advanced distal to a distal end of the expandable electrode and inserted into a tissue site. The expandable electrode and the distal end of the needle can be configured to deliver electroporation to the tissue site.