Intestinal Stimulation System with Adaptive Feedback Control

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Solution Overview

Problem

Current treatments for intestinal and metabolic disorders often require frequent adjustments to electrical stimulation settings due to changes in lead placement, scar tissue buildup, and disease progression, necessitating multiple office visits. Additionally, there is a lack of non-surgical screening methods to assess the efficacy of stimulation therapy before implantation, leading to potential ineffective treatments and associated risks.

Innovation Solution

The development of systems and methods that utilize sensors to collect data on autonomic nervous system and intestinal activity parameters, which are then used to adjust stimulation parameters automatically or through an external programmer. This includes the use of an implantable pulse generator and signal delivery devices that can deliver electrical stimulation in synchrony with intestinal slow wave activity, as well as a non-surgical screening phase using temporary signal delivery devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If implantable stimulation devices are used to treat intestinal disorders, then therapy can be delivered to the target tissue, but the stimulation parameters become unsuitable over time due to lead placement changes, scar tissue buildup, and disease progression, requiring frequent office visits for adjustment

Engineering Contradiction:
Improvetherapy efficacyVSAvoidoffice visits for parameter adjustment
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The implantable device autonomously monitors intestinal activity parameters (electrical, mechanical, thermal) and adjusts stimulation parameters without requiring external programmer intervention. The device self-calibrates by detecting changes in intestinal slow wave activity, contractility, and temperature, automatically adapting to lead displacement, scar tissue formation, and disease progression.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system continuously monitors intestinal activity parameters and uses this feedback to dynamically adjust stimulation parameters. Sensors detect intestinal slow wave frequency, amplitude, and contractility changes, which are fed back to the pulse generator to optimize stimulation delivery in real-time, ensuring consistent therapy efficacy despite physiological changes.

Inventive Principle:
Principle #23Feedback

2Productivity

If implantable stimulation devices are deployed without pre-screening, then treatment can begin immediately, but patients may not receive sufficient therapy efficacy to justify the costs and risks of implantation surgery

Engineering Contradiction:
Improvetreatment initiation speedVSAvoidtherapy efficacy
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs a non-surgical screening phase using temporary external signal delivery devices before implantation. During this phase, the device monitors intestinal activity parameters and delivers test stimulation to predict likely therapy efficacy. Only patients who demonstrate sufficient response during screening proceed to implantation, ensuring appropriate candidate selection.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The temporary external device replicates the functionality of the implantable device during the screening phase. It uses identical sensors and stimulation parameters to predict how the patient would respond to permanent implantation, allowing clinicians to assess therapy efficacy without surgical risk.

Inventive Principle:
Principle #26Copying

3Duration of action of moving object

If conventional electrical stimulation is delivered without synchronization to intestinal slow wave activity, then stimulation can be applied continuously, but the precision and adaptability of therapy delivery is reduced

Engineering Contradiction:
Improvecontinuous stimulation deliveryVSAvoidsynchronization with intestinal activity
Core Design Contradiction:
Duration of action of moving objectVSMeasurement precision

Solution Approach 1:

The device synchronizes stimulation pulses with the periodic intestinal slow wave activity. Sensors detect the frequency and amplitude of slow waves, and the pulse generator delivers stimulation in rhythmic patterns that match the natural intestinal cycling. This ensures therapy is delivered at optimal moments in the motility cycle, enhancing efficacy while maintaining continuous monitoring and adjustment.

Inventive Principle:
Principle #19Periodic action

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

These systems enable more precise and adaptive delivery of electrical stimulation, improving treatment efficacy while reducing the need for frequent adjustments and office visits. The non-surgical screening phase allows for a more informed decision regarding the suitability of stimulation therapy, potentially reducing the risks and costs associated with implantation surgery.

Implementation Method 1

deliver electrical stimulation in synchrony with intestinal slow wave activity

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS12268872B2Devices, systems, and methods for delivering therapy to intestinal muscle
Publication Date: 2025.04.08 ENTEROMED LTD
  • US12268872B2 patent drawing
  • US12268872B2 patent drawing
  • US12268872B2 patent drawing

AI summary

Systems for delivering therapy to an intestinal muscle in a patient may comprise a cardiac sensor, an intestinal sensor, an implantable pulse generator and a signal delivery device. The signal delivery device may be configured to deliver a stimulation signal to the muscle. The implantable pulse generator may comprise a microcontroller configured to receive cardiac data from the cardiac sensor and calculate a heart rate parameter therefrom, receive intestinal activity data from the intestinal sensor and calculate an intestinal activity parameter therefrom, determine a physiological state of a patient based on the parameters, adjust a stimulation parameter of the stimulation signal based on the determined state, and instruct the signal delivery device to deliver an adjusted stimulation signal.