Expandable Electroporation Probe for Lumen Tissue Treatment
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Solution Overview
Problem
Existing electroporation devices struggle to effectively access and treat tumour tissue within a lumen due to obstruction, limited visibility, and risk of tissue damage or perforation during electrode placement.
Innovation Solution
An electroporation probe with an elongate support and deformable electrodes that radially expand to engage tissue, allowing for improved access and delivery of electroporation treatment within a lumen, while minimizing the risk of tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional needle electrodes are used for electroporation treatment, then the treatment can be applied where electrodes can be placed on two sides of the intended treatment zone, but the device cannot fully access the lumen due to tumour obstruction and limited visibility
Solution Approach 1:
The electrode assembly transitions from a static configuration to a dynamic expandable structure. The electrodes are mounted on an expandable body that can be deployed from a compressed delivery state to an expanded treatment state, allowing the device to adapt to the lumen geometry and achieve full circumferential contact with the tumour tissue, thereby resolving the contradiction between access and treatment coverage
Solution Approach 2:
The invention transitions from a linear needle electrode approach to a three-dimensional expandable basket structure. By expanding the electrodes radially in the radial dimension, the device achieves circumferential coverage of the tumour tissue, effectively adding a spatial dimension to the treatment approach and overcoming the limitations of linear access
2Ease of operation
If full dilation of malignant tissue is performed to improve access, then visibility and access are enhanced, but there is a high risk of perforation or tearing
Solution Approach 1:
The device changes the mechanical parameters of tissue interaction by using controlled radial expansion rather than axial dilation. The expandable body distributes force uniformly across the tissue circumference, maintaining force within safe parameters (0.1-1 N/mm²) while achieving adequate access and positioning, thus avoiding the harmful effects of excessive localized dilation
3Productivity
If alternative therapies like Radio Frequency Ablation or Microwave Ablation are used, then tissue ablation is achieved, but damage to surrounding tissue structures including blood vessels and nerves occurs
Solution Approach 1:
The invention replaces thermal and chemical ablation mechanisms with a mechanical-electrical system. Instead of using heat (RF/Microwave) or extreme cold (Cryo) that diffuse through tissue and damage surrounding structures, the device uses controlled mechanical expansion to position electrodes precisely, then applies localized electrical fields for ablation, confining the harmful effects to the target tissue only
Solution Approach 2:
The expandable body acts as an intermediary between the delivery catheter and the tumour tissue. It provides a stable platform that positions electrodes in optimal configuration while isolating the delivery system from direct tissue contact, enabling precise energy delivery without transferring mechanical stress or thermal damage to surrounding structures
4Reliability
If the probe uses expandable electrodes to engage tissue, then full coverage of treatment area is achieved, but the device complexity increases
Solution Approach 1:
The expandable electrode assembly is nested within a delivery catheter in a compact configuration for insertion. Once positioned, the inner electrode structure expands outward from the catheter, transforming from a nested compact state to an expanded treatment state. This nesting principle allows the complex expandable structure to be delivered through standard endoscopic channels without excessive complexity in the delivery mechanism
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 probe enables effective electroporation treatment of tumour tissue by ensuring full coverage of the treatment area with reduced risk of tissue dissection or perforation, thus enhancing the delivery of therapeutic agents.
Implementation Method 1
Electroporation has become established as a safe and effective clinical tool which permeabilises the cell membrane and can enable the rapid passive diffusion and targeted uptake of therapeutic agents
Implementation Method 2
at least one electrode is deformable for radial expansion from a retracted position
Implementation Method 3
at least one of the electrodes has a shape memory and is configured for at least some of said radial expansion upon removal of a constraint
Data Source
AI summary
A pulsed field delivery device for delivery of electroporation treatment to cancerous and pre-cancerous regions of the gastrointestinal tract is described. It has a first expanding body coupled non-conductively to a second expanding body wherein the non-conductive coupling allows elements of the expanding bodies to sit on opposite sides of a tissue across which pulsed electric fields are applied. An elongate shaft has a proximal end which extends exterior of the patient so that a user can advance and withdraw the device when required. The device also comprises an elongate member or sheath which can be advanced over or retracted back off of the distal end of the device providing protection during device movement. The electrodes are arranged to radially expand and to move closer together to pinch diseased tissue being treated.