Expandable Intraluminal Sensing Device for Reliable ECG Acquisition
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Solution Overview
Problem
Current ECG signal acquisition methods using external electrode pads on the skin are cumbersome, prone to malfunction, and may not be feasible in patients with limited skin surface area or trauma, leading to delays in obtaining critical cardiac signals.
Innovation Solution
A sensing device with an elongate member and actuation portion that can be inserted into body lumens, featuring expandable sensors to contact internal surfaces, eliminating the need for external pads and providing reliable electrocardiogram signals without the need for conductive gel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If external electrode pads are placed on the skin to acquire ECG signals, then ECG signals can be obtained, but the procedure becomes cumbersome and time-consuming
Solution Approach 1:
The patent extracts the ECG sensing function from the traditional external skin-based electrode pad system and relocates it to an internal body lumen environment. The expandable device with conductive elements is inserted into body lumens (esophagus, stomach, intestines) to acquire ECG signals directly from internal mucosal surfaces, eliminating the need for external adhesive electrode pads and their associated placement procedures
Solution Approach 2:
The patent introduces an expandable device as an intermediary between the external monitoring system and the internal body environment. This device serves as a mediator that carries conductive elements to contact internal mucosal surfaces, enabling ECG signal acquisition without direct external skin contact. The expandable device acts as a bridge that transfers the sensing function from external to internal placement
2Adaptability or versatility
If multiple electrode pads are placed on the body surface, then multi-lead ECG signals can be acquired, but the pads may interfere with diagnostic and therapeutic procedures
Solution Approach 1:
The patent removes the electrode pads from the external body surface location and relocates them to internal body lumens. By extracting the sensing elements from the external environment and placing them internally in the esophagus, stomach, or intestines, the system maintains multi-lead ECG capability while eliminating interference with external diagnostic and therapeutic procedures
Solution Approach 2:
The patent transitions the ECG sensing from a two-dimensional external skin surface placement to a three-dimensional internal body lumen environment. The expandable device can be positioned at various depths and orientations within body lumens, providing spatial flexibility that eliminates interference with external procedures while maintaining signal acquisition capability
3Reliability
If electrode pads with coupling gel are used on the skin, then electrical contact is achieved, but the gel properties change over time causing malfunction
Solution Approach 1:
The patent employs a disposable expandable device that is inserted into the body lumen and used for the duration of the procedure. The device with its conductive elements is designed for single-use, eliminating the need for reusable electrode pads with coupling gel. The disposable nature ensures consistent electrical contact performance throughout the procedure without degradation from gel property changes
Solution Approach 2:
The patent replaces the chemical coupling mechanism (adhesive gel) with a mechanical contact system. The expandable device physically contacts the internal mucosal surfaces through expansion within the body lumen, creating stable electrical contact without relying on chemical adhesives. This mechanical contact system eliminates the reliability issues associated with gel property changes over time
4Productivity
If electrode pads are placed on limited skin areas in trauma patients, then ECG signals can be obtained, but sufficient skin area may not be available
Solution Approach 1:
The patent extracts the ECG sensing function from the external skin surface and relocates it to internal body lumens. By moving the sensing elements from the external environment to internal locations (esophagus, stomach, intestines), the system enables ECG signal acquisition in patients with limited or compromised skin surface area, such as trauma or burn patients
Solution Approach 2:
The expandable device serves multiple functions: it provides ECG signal acquisition capability while being adaptable to various body lumens and patient conditions. The device can be inserted into different internal locations (esophagus, stomach, intestines) depending on patient anatomy and procedural needs, providing universal applicability across different clinical scenarios including trauma patients with limited skin availability
Data Source
AI summary
A system for obtaining signals related to electrical activity of the heart of a subject includes a sensing device including an elongate member having a distal end configured for placement within a body lumen of a subject, and a proximal end configured to extend from the subject, an actuation portion carried by the elongate member and configured for placement within the body lumen, the actuation portion having a low-profile state for delivery within the body lumen and an expanded state, and one or more sensors disposed on the actuation portion, each including a contact surface configured to contact an interior wall of the body lumen, wherein the actuation portion is configured to cause the contact surface of each of the one or more sensors to contact a location on the interior wall of the body lumen to provide a signal component for producing one or more electrocardiogram signals.