Pulsed Field Electroporation for Precise Nonthermal Tissue Ablation
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Solution Overview
Problem
Existing thermal ablative techniques for treating chronic rhinitis and other nasal conditions risk unintended injury to healthy tissue and adjacent structures due to thermal energy extension beyond the targeted tissue, causing complications such as crusting and damage to critical structures like arteries and nerves.
Innovation Solution
A Pulsed Field Electroporation (PFE) system is used to deliver controlled electrical pulses that induce irreversible electroporation (IRE) to target tissue, causing apoptosis without thermal ablation, thereby reducing the risk of injury to non-targeted tissues and allowing for localized treatment with reduced need for general anesthesia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal ablative techniques (RF, CA, lasers) are used to treat targeted tissue, then cell death is achieved through necrosis, but significant temperature changes occur causing inflammatory effects, painful crust formation, and risk of unintended injury to healthy tissue and adjacent structures
Solution Approach 1:
The patent replaces thermal ablation mechanisms (RF, CA, lasers) with a mechanical/electrical field-based mechanism. Electroporation uses high-voltage electrical pulses to create pores in cell membranes through electrostatic forces, fundamentally substituting thermal energy with electrical field energy to achieve tissue ablation without heat generation
Solution Approach 2:
The patent changes the fundamental parameter of energy delivery from thermal (temperature-based) to electrical (voltage/pulse-based). By controlling pulse duration, voltage amplitude, and pulse train characteristics, the system achieves precise tissue targeting while avoiding the thermal diffusion that causes damage to adjacent structures
2Manufacturing precision
If overlapping ablation lesions are delivered in targeted tissue area, then more complete tissue coverage is achieved, but the overlapped region is at higher risk of severe crusting or scab formation
Solution Approach 1:
The patent replaces thermal ablation with electrical field-based electroporation. Since electroporation does not generate heat, overlapping pulses do not accumulate thermal energy to cause severe crusting or scab formation, allowing for more complete tissue coverage without exacerbating harmful effects
Solution Approach 2:
The patent uses pulsed electrical fields with specific pulse trains (multiple pulses delivered in sequence with controlled intervals). This periodic action allows tissue permeabilization to accumulate effectively while providing intervals that prevent thermal buildup, enabling safer overlapping treatment patterns
3Reliability
If thermal ablation energy is delivered to targeted tissue, then cell death is achieved, but the thermal profile may extend ablative effects beyond targeted tissue type into other types of tissues and adjacent structures
Solution Approach 1:
The patent substitutes thermal energy with electrical field energy for tissue ablation. Electrical fields can be more precisely confined to targeted regions through electrode geometry and pulse parameter control, preventing thermal diffusion that causes unintended damage to adjacent structures like arteries and nerves
Solution Approach 2:
The patent applies electrical field energy with locally optimized parameters (pulse duration, voltage, electrode configuration) to achieve uniform ablation within the targeted tissue volume while maintaining sharp boundaries that prevent energy extension into non-targeted tissues
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 PFE system effectively treats targeted tissue by inducing apoptosis while minimizing damage to surrounding tissues, offering a less invasive and more convenient treatment option with potential for drug delivery and nerve stimulation, all without significant temperature change.
Implementation Method 1
PFE is a kind of electrical stimulation therapy that involves delivering short, high-amplitude electrical pulses to targeted tissue of a patient. These electrical pulses create temporary pores in the cell membranes of affected cells, causing permeabilization of the membrane without significant damage to the cells.
Implementation Method 2
The PFE can induce electroporation in the targeted tissue and stimulate one or more nerves proximate to the target tissue. As described in additional detail below, some embodiments of the system can cause localized PFE by using an electric field, which is applied to the targeted tissue in rapid bursts to cause irreversible electroporation (IRE).
Data Source
AI summary
An improved system described herein equipped with one or more Pulsed Field Electroporation (PFE) electrodes configured to cause localized and targeted PFE output at the targeted tissue, for example, in an ear, nose, or throat.