Implantable and Transcutaneous GI Stimulation for Dysmotility
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Solution Overview
Problem
Current treatments for gastrointestinal dysmotility, such as post-operative ileus and chronic GI disorders, lack effective pharmacological interventions and often resort to invasive surgeries like bowel resection, while transient dysmotility conditions like POI lead to inflammation and prolonged recovery with limited treatment options.
Innovation Solution
Development of miniaturized implants and non-invasive transcutaneous stimulation systems that provide electrical stimulation to the gastrointestinal tract and vagus nerve to regulate motility, incorporating SoC technology, electrode arrays, and wireless recording capabilities, with disposable options for transient conditions and permanent implants for chronic cases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrical stimulation systems are developed to treat gastrointestinal dysmotility, then treatment effectiveness is improved, but device complexity increases
Solution Approach 1:
The system is divided into separate functional modules: an implantable stimulator unit with electrode arrays for electrical stimulation, an external controller for programming and monitoring, and wireless communication interfaces. This segmentation allows each module to be optimized independently, improving overall treatment effectiveness while managing complexity through modular design.
Solution Approach 2:
The stimulator device is designed to perform multiple functions: electrical stimulation of gastrointestinal muscles, wireless data transmission, battery management, and programmable stimulation patterns. By integrating these functions into a single implantable device, the system improves treatment effectiveness without requiring multiple separate devices, thus managing complexity.
2Ease of operation
If miniaturized implants are used for transient conditions like POI, then ease of removal is improved, but device functionality is reduced
Solution Approach 1:
The system offers dynamic configuration options where the implantable stimulator can be designed in different sizes and configurations depending on the clinical indication. For transient conditions like POI, a smaller, simpler device is used that can be easily removed, while for chronic conditions, a more sophisticated permanent implant is deployed. This dynamic adaptation resolves the contradiction between ease of removal and functionality.
Solution Approach 2:
For transient conditions such as post-operative ileus, the system employs disposable or temporary implantable stimulators that are designed for short-term use and easy removal. These simplified devices provide adequate functionality for transient conditions without the complexity of permanent implants, resolving the contradiction between ease of removal and device functionality.
3Reliability
If invasive surgical interventions are performed for GI dysmotility, then treatment effectiveness is improved, but patient trauma increases
Solution Approach 1:
The system replaces invasive mechanical surgical interventions with electrical stimulation therapy. Instead of performing bowel resection or other surgical procedures, the implantable stimulator delivers controlled electrical pulses to gastrointestinal muscles and nerves to restore motility. This substitution maintains treatment effectiveness while eliminating the trauma associated with invasive surgery.
Solution Approach 2:
The implantable stimulator acts as an intermediary between the nervous system and gastrointestinal muscles. Rather than directly removing or repairing damaged tissue through surgery, the device uses electrical signals to modulate muscle contractions and stimulate peristalsis. This intermediary approach provides effective treatment while avoiding the direct tissue damage and recovery trauma of surgical intervention.
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 systems effectively restore gastrointestinal motility, reduce inflammation, and facilitate healing by directly stimulating the enteric nervous system and smooth muscles, offering a less invasive and more effective alternative to surgical interventions.
Implementation Method 1
electrical stimulation to the gastrointestinal tract and vagus nerve to regulate motility
Data Source
AI summary
Systems and methods for implementation of a disposable miniaturized implant for treatment of Post-Operative Ileums (POI), a miniaturized implant for treating chronic GI dysmotility (e.g., dysphagia, gastroesophageal reflux disease (GERD), nausea, functional dyspepsia, blockage of transit, and gastroparesis, inflammatory bowel disease) and obesity, by providing electrical stimulation to the part of bowel going through surgery to expedite the healing process while recording the smooth muscle activities simultaneously, or providing stimulation on a treatment location of the GI tract or the branch of the vagus nerve. Systems and methods are also provided for non-invasive, transcutaneous stimulation of anatomy within the abdomen of the patient.