Disposable ECG Electrode Assembly for Self-Administered Monitoring
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Solution Overview
Problem
Current portable ECG recording devices are bulky, expensive, and not suitable for large-scale use, leading to poor patient compliance and inefficiencies in monitoring arrhythmias and drug-induced heart conditions, especially in remote locations and for large patient populations, and they pose challenges in infection control.
Innovation Solution
A portable, non-ambulatory ECG recording device with a mailable base and electrode assembly that allows self-administered ECG examinations, using flexible materials and eco-friendly components, enabling real-time data collection and transmission, and designed for single-use or recyclable components to facilitate large-scale, cost-effective monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional portable ECG recording devices are used, then ECG data can be collected from patients, but the devices are bulky and interfere with patients' normal lives, leading to poor patient compliance
Solution Approach 1:
The ECG recording system is divided into separate components: a disposable electrode assembly that contacts the patient and a reusable processing unit. This segmentation allows the patient-facing component to be minimal and non-intrusive while the complex processing functions are separated, thereby improving patient compliance without sacrificing functionality.
Solution Approach 2:
The electrode assembly is designed as a disposable component that is discarded after a single use or limited number of uses. This eliminates the need for cleaning and sterilization, reduces infection risks, and allows the use of simpler, more comfortable materials that would not be suitable for reusable devices, thereby improving patient compliance.
2Reliability
If body-worn lead-type monitors are used, then ECG signals can be recorded, but they cause skin irritation and require removal before showering or bathing
Solution Approach 1:
The electrode assembly is designed as a disposable component that is discarded after a single use or limited number of uses. This eliminates the need for cleaning and sterilization, reduces infection risks, and allows the use of simpler, more comfortable materials that would not be suitable for reusable devices, thereby improving patient compliance.
3Productivity
If portable ECG recording devices are used for large-scale monitoring, then more patients can be monitored, but the devices are expensive to produce and maintain
Solution Approach 1:
The system is segmented into expensive reusable components (processing unit, software, display) and inexpensive disposable components (electrode assembly). This allows the expensive parts to be shared across multiple patients and uses, while the disposable parts are produced at low cost using simple materials and manufacturing processes, thereby enabling large-scale deployment.
Solution Approach 2:
The electrode assembly is designed as a disposable component that is discarded after a single use or limited number of uses. This eliminates the need for cleaning and sterilization, reduces infection risks, and allows the use of simpler, more comfortable materials that would not be suitable for reusable devices, thereby improving patient compliance.
4Ease of manufacture
If reusable ECG devices are used, then cost can be reduced, but infection control becomes difficult
Solution Approach 1:
The electrode assembly is designed as a disposable component that is discarded after a single use or limited number of uses. This eliminates the need for cleaning and sterilization, reduces infection risks, and allows the use of simpler, more comfortable materials that would not be suitable for reusable devices, thereby improving patient compliance.
Solution Approach 2:
The disposable electrode assembly is discarded after use and not returned to the patient, eliminating cross-contamination risks. The reusable processing unit is isolated from direct patient contact except through the disposable interface, and can be shared across multiple patients without infection risk.
Data Source
AI summary
Devices and methods comprise or provide an ECG recording device containing a mailable base and electrode assembly and/or other means engageable with the base to receive ECG signals from a subject during a self-administered ECG examination. The devices and methods may also include a single-use or limited-use ECG recording device, in which the base is disposable or reusable or recyclable. In addition, the device may be self-contained, battery-operated, portable, disposable, mailable to a location remote from an ECG examination, provide feedback, indicate its method of use, including graphically depicting same, contain a finger cuff and/or sensor pad for receiving ECG signals, and/or contain a memory. Preferably, the base conforms to various body shapes and/or sizes, is made of flexible and/or semi-flexible material, and/or contains a receptor, such as sealable blood well. The device can also communicate the ECG signals to an ECG processing system, which can be remote from the ECG examinations and comprise wireless communications.


