Disposable Patch and Reusable Sensor Assembly for EP Mapping
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Solution Overview
Problem
Existing patch and sensor cable mechanisms for electrophysiology mapping and ablation systems are not optimally designed, as they are radiopaque, large, and prone to rotation, leading to conflicts with other medical devices and inadequate reusability without performance degradation.
Innovation Solution
A patch and sensor assembly with a reusable magnetic-based biosensor housed in a polymer sensor housing and a disposable adhesive hydrogel electrode patch, featuring a snap-fit connection that prevents rotation and allows for easy attachment and detachment, using carbon composite electrodes and strain relief elements to maintain performance across multiple uses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a metallic snap connection is used to attach the sensor cable to the patch, then the connection is secure, but the assembly becomes radiopaque and large
Solution Approach 1:
The patent employs a disposable patch assembly with a reusable sensor cable. The patch portion containing the electrode and engagement element is designed as a single-use component that is discarded after one use, while the expensive sensor cable housing is reused. This resolves the contradiction by using a simple, small disposable patch that doesn't require large metallic snaps, as the connection mechanism is integrated into the disposable portion.
Solution Approach 2:
The system is divided into two separate segments: a disposable patch assembly and a reusable sensor cable assembly. The patch contains the engagement element and electrode, while the cable contains the biosensor and housing. This segmentation allows the disposable patch to be small and non-radiopaque, while the reusable cable housing protects the expensive components without requiring large connection elements.
2Stability of the object's composition
If multiple snaps are used to prevent rotation, then rotational stability is improved, but the patch area increases and conflicts with other devices
Solution Approach 1:
The engagement element and recess are designed with asymmetric, complementary shapes that fit together in a specific orientation. The engagement element has a shape that corresponds to the recess geometry, allowing the cable to be attached in only one correct orientation. This asymmetric design prevents rotation without requiring multiple snaps, thereby maintaining a small patch area.
3Reliability
If the sensor cable housing is made reusable, then cost is reduced, but attachment and detachment become more complex
Solution Approach 1:
The complex reusable sensor cable housing is separated from the disposable patch assembly. The engagement element is extracted and placed in the simple disposable patch, while the recess is placed in the reusable cable housing. This extraction allows the reusable portion to maintain its complexity for protection and reusability, while the attachment interface itself remains simple through the snap-fit mechanism.
4Area of stationary object
If a compact design is used to minimize space usage, then device conflicts are reduced, but attachment mechanism complexity increases
Solution Approach 1:
The engagement element and the electrode are merged into a single integrated structure within the disposable patch assembly. The engagement element serves dual purposes: it provides mechanical attachment functionality and integrates with the electrode structure. This merging reduces the overall patch area by eliminating separate components while maintaining a simple attachment mechanism through the integrated design.
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 solution provides a compact, non-radiopaque, and easily attachable patch system that minimizes space usage, reduces conflicts with other medical devices, and enables repeated use without performance degradation, enhancing the efficiency of electrophysiology mapping and ablation procedures.
Implementation Method 1
The reusable portion includes a magnetic-based biosensor for providing location information about the location of the device within the body of the patient
Implementation Method 2
The disposable portion includes an adhesive hydrogel layer for adhering the electrode to the body of the patient
Data Source
AI summary
An patch and sensor assembly for use in an EP mapping system has two portions: a reusable portion and a disposable portion. The reusable portion houses the biosensors used in magnetic based location and mapping systems and the electrical lead necessary to communicate between the biosensor and the mapping system. The reusable portion may also contain a portion of the electrode necessary to receive electrical signals from the body of the patient. The disposable portion of the patch and sensor assembly contains an adhesive covered flexible patch having at least a portion of the electrode used to receive electrical signals form the body of the patient and may contain the electrical lead necessary to communicate such an electrical signal to the mapping system. The disposable portion contains a receptacle adapted to receive and mechanically secure the reusable portion to the disposable portion of the assembly. Such a patch and sensor assembly is useful in hybrid magnetic and impedance based location and mapping systems such as those used in electrophysiology.