Implantable Device Automatic Electrical Therapy Titration

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Solution Overview

Problem

Manual titration of electrical therapy parameters in implantable medical devices is time-consuming, costly, and delays patients in receiving therapeutic benefits, as it requires frequent medical office visits and gradual dosage adjustments.

Innovation Solution

An automated titration method that programs the medical device to adjust electrical therapy parameters from an initial value to a target value over a specified time period, using titration parameters such as time period, step interval, and step magnitude, with feedback mechanisms to adjust based on patient body signals and adverse effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual titration of electrical therapy parameters is performed, then patient safety and tolerability are maintained through gradual dosage adjustments, but treatment time is extended and medical resource utilization increases

Engineering Contradiction:

Improvepatient safetyVSAvoidtreatment time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The IMD performs automatic titration of electrical therapy parameters using pre-programmed algorithms and titration parameters stored in its memory. The device autonomously adjusts stimulation parameters (amplitude, pulse width, frequency) based on elapsed time and programmed protocols without requiring external programming interventions, thereby reducing treatment time while maintaining safety through controlled incremental changes

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The healthcare provider pre-programs the IMD with titration parameters, target values, and adjustment algorithms before implantation or during initial programming. These pre-configured parameters enable the device to automatically execute the titration schedule without requiring multiple follow-up programming visits, thus reducing treatment time while preserving safety through pre-planned gradual adjustments

Inventive Principle:

Principle #10Preliminary action

2Manufacturing precision

If manual titration adjustments are made through multiple medical office visits, then precise control over parameter changes is achieved, but cost and patient burden increase

Engineering Contradiction:

Improveparameter control precisionVSAvoidtreatment cost

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The IMD autonomously executes pre-programmed titration protocols by automatically adjusting electrical therapy parameters according to stored algorithms and titration parameters. This self-service capability eliminates the need for multiple programming visits to medical offices, thereby maintaining precise parameter control through programmed logic while significantly reducing treatment costs and patient burden

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system incorporates feedback mechanisms where the IMD monitors patient response to electrical therapy and automatically adjusts parameters based on pre-programmed titration rules. The device tracks parameter changes over time and uses this information to guide subsequent adjustments, ensuring precise control while reducing the need for external programming interventions

Inventive Principle:

Principle #23Feedback

3Productivity

If rapid dosage escalation is implemented, then time to therapeutic benefit is reduced, but risk of adverse effects increases

Engineering Contradiction:

Improvetreatment efficiencyVSAvoidadverse effects

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The IMD implements dynamic titration by automatically adjusting electrical therapy parameters in real-time based on pre-programmed algorithms that consider elapsed time, current parameter values, and target values. The device dynamically modifies stimulation amplitude, pulse width, and frequency in controlled increments, enabling rapid yet safe escalation to therapeutic dosages while monitoring for and responding to adverse effects through programmed safety thresholds

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system uses pre-programmed titration parameters and adjustment algorithms that define safe escalation rates and target values before treatment begins. These preliminary configurations ensure that rapid dosage escalation occurs within predetermined safety boundaries, reducing time to therapeutic benefit while minimizing the risk of adverse effects through pre-planned controlled increments

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20220134112A1Programmable autotitrating of electrical parameters of implantable medical device

Publication Date: 2022.05.05 FLINT HILLS SCIENTIFIC LLC

AI summary

We report a method of automatically titrating an electrical therapy administered to a patient by an implanted medical device to a target dosage, comprising programming the medical device with a programmed electrical therapy comprising a first target value for a first therapy parameter; programming at least one titration parameter for automatically adjusting the first therapy parameter from a first value to the first target value over a titration time period initiating the electrical therapy, wherein the first therapy parameter comprises said first value; and automatically titrating the electrical therapy by making a plurality of adjustments to the value of the first therapy parameter, whereby the first electrical therapy parameter is changed from the first value to the first target value according to a titration function. We also report a medical device system configured to implement the method.