External Controller Battery Algorithm for Implantable Pulse Generator Selection
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Solution Overview
Problem
Clinicians lack guidance on determining whether a patient would benefit from an implantable pulse generator (IPG) with a rechargeable or primary battery, as existing methods do not provide clear criteria for selecting between the two based on patient-specific needs.
Innovation Solution
An external controller with a battery algorithm that estimates battery performance parameters during an external trial stimulation phase, allowing clinicians to determine whether a rechargeable or primary battery IPG is more suitable for a patient by analyzing current draw and providing recommendations based on estimated recharging frequency and primary battery lifespan.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a rechargeable battery IPG is implanted, then the patient can have extended therapy duration through recharging, but the device complexity increases due to additional charging coil and external charger requirements
Solution Approach 1:
The patent applies preliminary action by performing battery performance estimation during the external trial stimulation phase before implantation. The external controller calculates expected primary battery lifespan and rechargeable battery recharging frequency using measured current draw data and stored battery characteristics. This allows clinicians to determine the most appropriate battery type in advance, avoiding the need to implant a complex rechargeable system when a primary battery would suffice, or vice versa.
2Device complexity
If a primary battery IPG is implanted, then the device complexity is reduced, but the therapy duration is limited by battery lifespan
Solution Approach 1:
The system performs preliminary calculation of expected primary battery lifespan during the external trial phase by using measured current draw and stored battery characteristics. This allows clinicians to predict whether a primary battery will provide sufficient therapy duration before implantation, eliminating the need for trial-and-error implantation and subsequent explantation if the battery lifespan is inadequate.
Solution Approach 2:
The external controller serves as an intermediary that bridges the gap between simple primary battery and complex rechargeable battery systems. It performs calculations to predict battery performance and provides recommendation outputs that guide clinician decision-making, effectively mediating the choice between the two battery types based on patient-specific parameters.
3Ease of manufacture
If battery type is selected without patient-specific analysis, then the implantation process is simplified, but unnecessary implantations or explantations may occur
Solution Approach 1:
The patent implements preliminary battery selection analysis during the external trial stimulation phase. The external controller measures current draw, retrieves battery characteristics from storage, and calculates performance parameters such as expected primary battery lifespan or rechargeable battery recharging frequency. This preliminary analysis provides evidence-based recommendations that increase the reliability of battery type selection, reducing the likelihood of unnecessary implantations or subsequent explantations while maintaining a streamlined process.
Solution Approach 2:
The system incorporates feedback by using actual measured current draw data from the patient-specific external trial stimulation to inform the battery selection decision. The external controller processes this feedback data through calculations and generates recommendation outputs that reflect the actual patient conditions, ensuring the selected battery type is appropriate for that specific patient's needs.
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
Enables clinicians to make informed decisions about battery type selection, optimizing therapy delivery and reducing the need for unnecessary implantations or explantations by assessing battery performance and recommending the most appropriate IPG type for each patient.
Implementation Method 1
charging coil 38 allows an external charger 50 to provide power 90 to recharge the battery 14a when necessary. This occurs transcutaneously via magnetic induction: the external charger 50 is turned on, and an AC current is generated in coil 52 in the external charger. This produces an AC magnetic field 90, which induces an AC current in charging coil 38 in the IPG 10a.
Data Source
Figure 1~2B
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AI summary
An external controller is disclosed for communicating with an external trial stimulator (ETS) for an implantable medical device. The external controller is programmed with a battery algorithm able to assist a clinician in choosing a suitable implant for the patient based on battery performance parameters estimated for a number of implants during an external trial stimulation phase that precedes implantation of the implant. The algorithm is particularly useful in assisting the clinician in choosing between a rechargeable-battery implant or a primary-battery implant for the patient.