Percutaneous Electrical Stimulator Patch Assembly
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Solution Overview
Problem
Existing neurostimulation systems are cumbersome, prone to stimulation-induced pain, difficult to use, and require complex maintenance, limiting their acceptance as a widely effective treatment due to issues with lead placement, muscle fatigue, and the need for clinical skill and patient training.
Innovation Solution
A compact electrical stimulator system with a patch assembly that includes a power source and percutaneous electrodes, allowing for easy attachment and adjustment, featuring a user-friendly interface and programmable stimulus parameters, enabling convenient and effective neurostimulation with minimal user interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If surface electrodes are used for electrical stimulation, then the device can be applied externally without surgery, but stimulation-induced pain occurs and patient tolerance is limited
Solution Approach 1:
The patent introduces percutaneous leads as an intermediary component that penetrates through the skin to deliver electrodes directly to the target tissue. This mediator allows electrical stimulation to reach deeper structures without stimulating cutaneous pain receptors, thereby maintaining ease of external application while eliminating stimulation-induced pain.
Solution Approach 2:
The patent replaces the mechanical surface electrode contact system with a percutaneous delivery system that uses a needle-like introducer to mechanically penetrate the skin and deposit the electrode tip at the target depth. This substitution allows precise electrode placement while avoiding continuous mechanical pressure on pain-sensitive surface receptors.
2Object-affected harmful factors
If high frequency electrical stimulation is delivered to prevent pain, then pain is reduced, but muscle fatigue occurs early
Solution Approach 1:
The patent enables precise control of stimulation parameters including frequency, pulse width, and amplitude through programmable circuitry. By optimizing these parameters based on the specific application and patient response, the system can provide effective pain relief while minimizing muscle fatigue, allowing for extended duration therapy.
3Length of stationary object
If surface electrodes are used to stimulate deep muscles, then deep muscle stimulation is achieved, but overlying superficial muscles are also stimulated causing unwanted effects
Solution Approach 1:
The percutaneous lead acts as an intermediary delivery mechanism that transports the electrode tip through the skin and subcutaneous tissue to place the active stimulating element directly at the target depth. This allows selective stimulation of deep muscles without activating overlying superficial muscles, eliminating unwanted stimulation effects.
4Ease of operation
If surface electrodes are used for neurostimulation, then the system can be operated externally, but complex lead placement and parameter adjustment require clinical skill and intensive patient training
Solution Approach 1:
The patent incorporates programmable circuitry and control systems that allow the device to be configured and adjusted with minimal manual intervention. The system can store multiple stimulation programs and automatically adjust parameters, reducing the need for intensive patient training and simplifying operation while maintaining external applicability.
5Reliability
If existing neurostimulation systems are used, then therapeutic benefits are provided, but the systems are large and awkward to manipulate and transport
Solution Approach 1:
The patent divides the neurostimulation system into separate modular components: a percutaneous lead with electrode tip, a separate power source, and a control unit. This segmentation allows each component to be optimized independently and enables the system to be collapsed into a compact form for easy transport while maintaining full therapeutic functionality when assembled.
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
The system provides improved usability, reduced pain, extended battery life, and simplified maintenance, enhancing patient compliance and caregiver efficiency while ensuring safe and effective neurostimulation.
Implementation Method 1
a power source having a positive terminal and a negative terminal, each of the positive terminal and the negative terminal being coupled to the substrate, the power source being configured to provide power to an external stimulator coupled to the device
Implementation Method 2
an electrode assembly is coupled to the second surface of the substrate and at least one electrode of the electrode assembly is configured to contact bodily tissue and to facilitate transmission of an electrical current through the bodily tissue
Data Source
Figure 1
Figure 2~3A
Figure 3B~4A
AI summary
Systems and methods according to the present invention relate to a substantially extracorporeal pulse generator system for electrical stimulation of one or more target nerve or their branches using one or more preferably percutaneous leads each having one or more electrodes implanted in, on, around, or near the target nerve. Improved systems include a patch assembly configured to be adhesively mounted to a patient's skin and an electrical stimulation assembly configured to be mechanically mounted to the patch assembly. A preferred patch assembly, in addition to provide mechanical mounting of the stimulation assembly, provides a power source for the stimulation assembly, and may further serve as a return electrode. Associated system components and methods of use are also provided.