Neurostimulation System Pulse Shape Control

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Solution Overview

Problem

Current neurostimulation systems face challenges in optimizing therapeutic effects due to limitations in controlling nerve fiber recruitment and synchronization, leading to suboptimal treatment outcomes, particularly in spinal cord stimulation, where over-stimulation of large diameter nerve fibers can cause uncomfortable side effects and limit therapeutic coverage.

Innovation Solution

The system modifies the pulse shape of electrical stimulation energy by selecting from various types such as square, exponential, or ramped pulses, and adjusts time constants, allowing independent or dependent modification of pulse parameters to maintain uniform charge, and incorporates monitoring circuitry to adjust based on measured tissue impedance, enabling precise control of nerve fiber recruitment and synchronization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard square waveforms are used for neural stimulation, then the system is simple to operate, but the ability to control nerve fiber recruitment and synchronization is limited, resulting in suboptimal therapeutic effects

Engineering Contradiction:
Improvetherapeutic effectVSAvoidwaveform complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system dynamically adjusts waveform parameters including pulse shape (square, exponential, ramped), amplitude, duration, and rate based on real-time feedback from tissue impedance monitoring. This allows the stimulation parameters to adapt to changing physiological conditions, optimizing therapeutic effect while maintaining system operability through automated control.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system employs multiple waveform types (square, exponential, ramped pulses) with adjustable parameters such as amplitude, duration, and rate. By changing these parameters based on monitored tissue impedance, the system can selectively recruit different nerve fiber diameters and control synchronization, thereby improving therapeutic reliability without requiring complex manual programming.

Inventive Principle:
Principle #35Parameter changes

2Area of stationary object

If large diameter sensory fibers are over-stimulated to maximize therapeutic coverage, then broader area coverage is achieved, but uncomfortable side effects and intense sensations occur in unwanted areas

Engineering Contradiction:
Improvetherapeutic coverageVSAvoidside effects
Core Design Contradiction:
Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The system applies different waveform characteristics to selectively target specific nerve fiber populations. By using exponential or ramped pulses with specific time constants, the stimulation can be tuned to preferentially activate large diameter sensory fibers in the target area while minimizing activation of fibers in surrounding areas, thus achieving local optimization of therapeutic coverage without widespread side effects.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system continuously monitors tissue impedance to detect real-time changes in nerve fiber recruitment patterns. This feedback allows the control system to adjust waveform parameters dynamically, increasing stimulation in areas needing therapeutic coverage while reducing stimulation in areas where side effects occur, thereby optimizing the ratio of beneficial to harmful effects.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If multiple waveform parameters are independently adjustable, then precise control of nerve fiber recruitment is achieved, but the programming and operation becomes more complex

Engineering Contradiction:
Improvecontrol precisionVSAvoidprogramming ease
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system performs self-adjustment of waveform parameters based on automatic monitoring of tissue impedance. The control circuitry independently modifies pulse shape, amplitude, duration, and rate in response to impedance changes, eliminating the need for complex manual programming while maintaining precise control over nerve fiber recruitment. The system serves itself by automatically optimizing parameters based on real-time physiological feedback.

Inventive Principle:
Principle #25Self-service

4Adaptability or versatility

If waveform pulse shape is modified to control nerve fiber recruitment, then selective activation of different fiber diameters is achieved, but the system complexity increases due to additional circuit components

Engineering Contradiction:
Improvewaveform versatilityVSAvoidcircuit complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system uses a single programmable waveform generation circuit that can produce multiple pulse shapes (square, exponential, ramped) by changing software-controlled parameters rather than requiring separate hardware circuits for each waveform type. This multi-functional approach allows versatile waveform control for selective nerve fiber activation while minimizing hardware complexity through software-based parameter adjustment.

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

Data Source

PatentUS20240299749A1Neural stimulation system to deliver different waveforms
Publication Date: 2024.09.12 BOSTON SCI NEUROMODULATION CORP
  • US20240299749A1 patent drawing
  • US20240299749A1 patent drawing
  • US20240299749A1 patent drawing

AI summary

A method, electrical tissue stimulation system, and programmer for providing therapy to a patient are provided. Electrodes are placed adjacent tissue (e.g., spinal cord tissue) of the patient, electrical stimulation energy is delivered from the electrodes to the tissue in accordance with a defined waveform, and a pulse shape of the defined waveform is modified, thereby changing the characteristics of the electrical stimulation energy delivered from the electrode(s) to the tissue. The pulse shape may be modified by selecting one of a plurality of different pulse shape types or by adjusting a time constant of the pulse shape.