Implantable Pulse Generator Waveform Player for Wireless Therapy Programming

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Solution Overview

Problem

Existing implantable medical devices (IMDs) face challenges in efficiently communicating with external devices using commercial wireless protocols, limiting their functionality and flexibility in providing neuromodulation therapies.

Innovation Solution

An IMD system with a waveform player module that receives program records from external devices, storing them in persistent memory and generating control signals to drive electrodes based on pulse definitions, allowing for various neuromodulation therapies like SCS, DRG, DBS, and others, using a two-way associative cache for efficient pulse mapping.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If IMD uses commercial wireless protocols for communication with external devices, then communication flexibility and ease of operation are improved, but device complexity and reliability may worsen due to limited functionality and compatibility issues

Engineering Contradiction:
Improvecommunication with external devicesVSAvoidcommunication interface
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent introduces a communication module as an intermediary layer between the implantable medical device and external devices. This module handles protocol conversion and data formatting, allowing the IMD to work with various commercial wireless protocols (Bluetooth, WiFi, Zigbee) without requiring complex internal changes. The communication module translates between different protocol formats and the device's internal data structures, simplifying the overall system architecture while maintaining compatibility with multiple external devices.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If IMD stores multiple program records with pulse definitions, then therapy versatility is improved, but memory requirements and device complexity increase

Engineering Contradiction:
Improveneuromodulation therapy typesVSAvoidmemory structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent segments the therapy program into multiple independent program records, each containing specific pulse definitions and parameter sets for different neuromodulation therapies (SCS, DRG, DBS, etc.). This segmentation allows the device to store diverse therapy protocols in a structured manner, where each record is self-contained and can be independently selected and executed. The segmentation approach enables versatile therapy options while maintaining a manageable memory structure through organized data partitioning.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements a universal program record structure that can accommodate multiple types of neuromodulation therapies through a standardized format. The pulse definition fields are designed to be therapy-agnostic, allowing the same memory structure to store parameters for spinal cord stimulation, dorsal root ganglion stimulation, deep brain stimulation, and other neuromodulation techniques. This universal structure reduces device complexity by avoiding the need for separate specialized storage for each therapy type.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If IMD uses waveform player with buffer for runtime images, then therapy delivery precision is improved, but device complexity and power consumption increase

Engineering Contradiction:
Improvepulse characteristic deliveryVSAvoidwaveform player architecture
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent implements a buffer that pre-loads and stores runtime images of program records in memory before actual therapy delivery. This preliminary action allows the waveform player to access pre-prepared pulse definitions and parameter sets during therapy execution, ensuring precise and consistent pulse characteristic delivery. The buffer acts as a temporary storage that holds the therapy program data ready for execution, eliminating the need for real-time computation during pulse generation and improving delivery precision.

Inventive Principle:
Principle #10Preliminary action

4Adaptability or versatility

If IMD supports multiple pulse definitions with time interval definitions, then therapy customization is improved, but processing requirements and device complexity increase

Engineering Contradiction:
Improvepulse parameter configurationVSAvoidprogram record structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies local quality by allowing different pulse definitions within the same program record to have specific, localized parameter configurations tailored to different therapeutic needs. Each pulse definition can have its own amplitude, width, and timing characteristics optimized for specific electrode configurations or therapy phases. This localized parameter customization enables precise control over pulse characteristics at each stage of therapy delivery while maintaining an organized program record structure that manages the complexity through hierarchical data organization.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS12364867B2System and method for operating an implantable pulse generator for neuromodulation
Publication Date: 2025.07.22 ADVANCED NEUROMODULATION SYSTEMS INC
  • US12364867B2 patent drawing
  • US12364867B2 patent drawing
  • US12364867B2 patent drawing

AI summary

A system and method for operating an implanted medical device (IMD) based on a waveform player. In one arrangement, the IMD may comprise a first module operative to effectuate a communication interface with an external device for receiving a plurality of program records for storage in a persistent memory, the program records each comprising a plurality of pulse definitions and a plurality of time interval definitions, wherein a pulse definition comprises a set of pulse characteristics to be applied in a particular time interval. A second module may be communicatively coupled to the first module, the second module including a buffer for containing a runtime image of a selected program record loaded from the persistent memory. A waveform player provided as part of the second module is operative to interpret the runtime image to generate control signals to drive an output driver circuit for applying pulse characteristics to a select set of electrodes according to the pulse definitions of the selected program record.