Neuromodulation Device Closed-Loop GI Motility Control
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Solution Overview
Problem
Current electrical neuromuscular stimulation devices for treating GI motility disorders lack closed-loop sensing and stimulation capabilities, coordinated activation of neuromuscular layers, and suitable implantation tools, limiting their effectiveness and invasiveness.
Innovation Solution
Development of an implantable device with polymeric components, electrodes, and microfluidic channels for controlled electrochemical stimulation, combined with a minimally invasive implantation tool featuring a hollow needle with a specialized tip and impedance sensor for precise submucosal or intramuscular implantation, enabling closed-loop neuromodulation and stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If electrical neuromuscular stimulation devices are used to treat GI motility disorders, then stimulation capability is provided, but closed-loop sensing and stimulation capabilities are lacking
Solution Approach 1:
The patent combines multiple functions (sensing, stimulation, and delivery) into a single integrated device. The implantable device includes electrodes for stimulation and sensing, microfluidic channels for drug delivery, and a polymeric component that houses all elements, enabling closed-loop operation where the device can sense physiological conditions and provide appropriate stimulation or drug delivery responses
Solution Approach 2:
The device is designed with multi-functionality to perform sensing, electrical stimulation, and pharmacological drug delivery through microfluidic channels. This universal approach allows a single device to address multiple therapeutic needs and provide both electrical and chemical stimulation modes for treating GI motility disorders
2Measurement precision
If conventional implantation methods are used, then implantation is achieved, but invasiveness is high and precision is low
Solution Approach 1:
The patent introduces an overtube as an intermediary component that facilitates the delivery of the implantable device through the GI tract. The overtube receives the implantable device and enables its delivery to the target location with minimal invasiveness, acting as a mediator between the implantation tool and the final implantation site
Solution Approach 2:
The implantable device uses a flexible polymeric component that can be compressed and delivered through narrow catheters and overtubes. This flexible shell structure allows the device to navigate through the GI tract with minimal invasiveness while maintaining its functional integrity at the implantation site
3Ease of operation
If electrical stimulation is applied to GI tract, then neuromuscular activation is achieved, but coordinated activation of neuromuscular layers is difficult
Solution Approach 1:
The device segments the stimulation function into multiple independent electrodes positioned at different locations along the polymeric component. This segmentation allows for independent control of each electrode, enabling coordinated activation of different neuromuscular layers through selective stimulation of specific electrode segments
Solution Approach 2:
The device enables dynamic control of stimulation patterns through a controller that can adjust the timing, duration, and intensity of electrical pulses delivered to different electrodes. This dynamic capability allows for coordinated activation sequences that mimic physiological neuromuscular patterns
4Reliability
If pharmacological treatments and surgical approaches are used, then treatment of GI motility disorders is attempted, but success rate is limited
Solution Approach 1:
The device incorporates sensing capabilities that detect physiological parameters such as pressure, flow, or electrical activity in the GI tract. This feedback information is used to adjust stimulation and drug delivery in real-time, creating a closed-loop system that adapts to the patient's physiological state to improve treatment effectiveness
Solution Approach 2:
The device combines different therapeutic modalities (electrical stimulation and pharmacological drug delivery) into a single composite treatment approach. The polymeric component houses both electrodes for electrical stimulation and microfluidic channels for drug delivery, allowing simultaneous or sequential application of multiple treatment mechanisms
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 solution allows for targeted and controlled neuromodulation of the GI tract, mimicking metabolic responses to food stimuli, treating various GI disorders by enhancing motility and hormonal production, while minimizing invasive procedures.
Implementation Method 1
an impedance sensor associated with the hollow needle, wherein the incision force of the hollow needle at an angle of 20 degrees relative to the lumen is less than or equal to 5 mN
Implementation Method 2
one or more electrodes disposed within the polymeric component, each electrode having a largest dimension aligned parallel to a largest dimension of the polymeric component
Implementation Method 3
one or more microfluidic channels disposed within the polymeric component, the microfluidic channel having a largest dimension aligned parallel to the largest dimension of the polymeric component
Data Source
AI summary
Articles and systems configured for treating GI motility disorders are generally provided. In some embodiments, an article comprising one or more electrodes (with both sensing and stimulating capabilities) may be configured to stimulate one or more tissues in the GI tract, electrically and/or chemically, to modulate peristalsis and/or allow neuromodulation. In some embodiments, a system comprises a controller that allows for close-loop operation of the article, e.g., such that the article may stimulate (e.g., via a feedback loop) the one or more organs in the GI tract upon receiving sensed parameters in the GI tract. In some embodiments, an implantation tool comprising a sensor may allow for submucosal or intramuscular implantation of an article. The implantation tool and the article may be useful for, for example, as a general platform for delivery of treating GI motility disorders and/or neuromodulation of the GI tract.