Selective Submucosal Ablation Laser Catheter
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Solution Overview
Problem
Current methods for treating obesity-related type 2 diabetes, such as bariatric surgery and minimally invasive devices, face challenges in effectively ablating the duodenal submucosal layer with minimal collateral damage to surrounding layers, leading to adverse events and limited efficacy.
Innovation Solution
A method and device utilizing a laser with a spot diameter of less than 100 microns and a fixed distance between the laser and the duodenal wall, combined with an expandable member to stretch the duodenum, providing a controlled ablative dose that selectively targets the submucosal layer while minimizing damage to the mucosal, muscularis, and serosal layers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If a laser with a large spot diameter is used for ablation, then the ablation area is larger, but the lateral impact to surrounding layers (mucosal, muscularis, serosal) increases causing collateral damage
Solution Approach 1:
The patent applies local quality by using a focused laser beam with a small spot diameter (less than 100 microns) to deliver high energy density precisely to the submucosal layer. This localized energy delivery achieves effective ablation of the target layer while minimizing thermal diffusion and collateral damage to adjacent layers, resolving the contradiction between ablation area and collateral damage.
2Device complexity
If the duodenal wall is not stretched, then the procedure is simpler, but the distance between laser and wall varies causing uncontrolled ablation and potential perforation
Solution Approach 1:
The patent implements preliminary action by deploying an expandable balloon catheter to stretch and stabilize the duodenal wall before laser ablation. This pre-positioning action creates a fixed, controlled distance between the laser source and the duodenal wall, ensuring precise and uniform energy delivery throughout the ablation procedure while preventing uncontrolled tissue damage.
3Reliability
If ablation energy is increased to ensure sustainable neural impairment, then the treatment efficacy improves, but the risk of damaging surrounding layers increases
Solution Approach 1:
The patent applies parameter changes by optimizing the laser beam parameters, specifically using a spot diameter of less than 100 microns combined with controlled energy delivery. This parameter optimization allows sufficient energy to be delivered to ensure sustainable neural impairment in the submucosal layer while the concentrated beam geometry prevents excessive thermal spread that would damage surrounding layers.
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
This approach allows for wider and sustainable ablation of neural structures in the duodenum with reduced side effects, shortening procedure duration and ensuring minimal damage to surrounding tissues, thus offering a more effective treatment for type 2 diabetes management.
Implementation Method 1
transmitting a laser beam in a direction essentially perpendicular to a longitudinal axis of the catheter, towards the duodenal wall, wherein the laser beam has a spot diameter of less than 200 microns and is configured to provide an ablative dose of 0.5-2.5 J/mm
Data Source
AI summary
Device and method for selectively ablating a submucosal layer of a duodenal wall and/or of sensory neurons therein, including a laser transmitting element coupled with the catheter body and configured to transmit a laser beam having a spot diameter of less than 200 microns and to provide an ablative dose of 0.5-2.5 J/mm; wherein the laser beam is configured to selectively ablate an area of the submucosal layer that is at least twice the size of the spot diameter, while essentially preventing damage of the surrounding mucosal, muscularis and/or serosal layers of the duodenal wall; and an expandable member configured to stretch the duodenal wall and to generate a fixed distance between the catheter's laser transmitting element and the duodenal wall.