Pulsed Electric Field Duodenal Treatment with Expandable Electrode Array
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Solution Overview
Problem
Conventional treatments for chronic diseases like diabetes and obesity through duodenal resurfacing face challenges such as excessive heating and damage to non-targeted tissue layers, and/or incomplete and uneven treatment due to thermal energy application.
Innovation Solution
The use of pulsed electric fields (PEF) applied through an expandable member with an electrode array, coupled to an elongate body, which includes temperature feedback and visualization, to treat duodenal tissue selectively, minimizing damage to deeper layers like the muscularis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal energy is applied to treat duodenal tissue, then treatment effectiveness is improved, but excessive heating and damage to non-targeted tissue layers occurs
Solution Approach 1:
The patent replaces thermal energy application with pulsed electric field (PEF) energy application. The PEF device uses electrical pulses delivered through electrodes positioned against the duodenal wall to achieve tissue treatment without the excessive heating problems associated with thermal methods. This substitution of energy type resolves the contradiction by maintaining treatment effectiveness while eliminating harmful thermal damage to non-targeted layers.
Solution Approach 2:
The patent changes the fundamental parameter of energy delivery from continuous thermal energy to pulsed electric field energy with specific parameters (pulse duration, frequency, voltage). By controlling these electrical parameters, the treatment can be precisely targeted to the mucosal layer without propagating heat to deeper tissues, thus resolving the contradiction between treatment effectiveness and harmful thermal effects.
2Manufacturing precision
If thermal energy is applied to ensure complete treatment, then treatment coverage is improved, but uneven and incomplete treatment occurs in practice
Solution Approach 1:
The patent replaces thermal energy delivery with pulsed electric field delivery, which provides more uniform and predictable tissue penetration. The electrical fields generated by the electrode array create consistent treatment zones across the duodenal surface, eliminating the uneven heating and incomplete treatment zones that occur with thermal methods.
Solution Approach 2:
The patent incorporates temperature feedback mechanisms and visualization systems that monitor treatment in real-time. This feedback allows for adjustment of treatment parameters to ensure complete and uniform coverage, resolving the contradiction between achieving complete treatment and maintaining even distribution across the tissue surface.
3Length of stationary object
If deeper tissue layers are treated to ensure thorough treatment, then treatment depth is improved, but damage to non-targeted layers like muscularis occurs
Solution Approach 1:
The patent applies local quality by targeting treatment specifically to the mucosal layer of the duodenum while preserving deeper layers. The PEF electrodes are positioned and configured to deliver electrical pulses that penetrate only the necessary depth (mucosal layer), creating a localized treatment zone that spares the muscularis and other non-targeted structures from damage.
Solution Approach 2:
The patent changes the energy delivery parameters from thermal to pulsed electric field, with controlled pulse duration, voltage, and frequency. These electrical parameters are specifically tuned to achieve the required treatment depth in the mucosal layer while the electric field intensity naturally attenuates before reaching deeper layers like the muscularis, thus preventing damage to non-targeted structures.
Data Source
AI summary
Described here are devices, systems, and methods for applying pulsed or modulated electric fields to tissue. In some variations, a device may comprise a first elongate body comprising a lumen, a second elongate body at least partially positioned within the lumen, and an expandable member rolled about the second elongate body. The expandable member may comprise an inner end coupled to the second elongate body, an outer end coupled to the first elongate body, and an electrode array.