Reusable Biosensor Patch with Asymmetric Snap-Fit

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Solution Overview

Problem

Existing patch and cable mechanisms for biosensors in electrophysiology mapping and ablation systems are radiopaque, large, and prone to rotation, causing conflicts with other medical devices, and lack reusability without performance degradation.

Innovation Solution

A patch and sensor assembly with a reusable magnetic-based biosensor and disposable electrode patch, featuring a snap-fit connection and strain relief elements, allowing for easy attachment and multiple orientations without rotation, using conductive materials like silver chloride and polymers for the electrode and housing, respectively.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a reusable cable and housing containing a biosensor is attached to a conductive and adhesive patch assembly, then reusability and performance consistency are improved, but the complexity of the attachment mechanism increases

Engineering Contradiction:
ImprovereusabilityVSAvoidattachment mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system is divided into a reusable portion (cable and housing containing the biosensor) and a disposable portion (adhesive patch assembly with engagement element). This segmentation allows the expensive biosensor to be reused while the simple patch is discarded, resolving the contradiction between reusability and complexity by making only the necessary components reusable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a disposable adhesive patch assembly with a simple engagement element that is discarded after use, while the expensive biosensor housed in a reusable housing is retained. This approach eliminates the need for complex cleaning and sterilization mechanisms, reducing overall system complexity while maintaining reusability of the critical sensor component.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Stability of the object's composition

If multiple snaps are used to provide a secure and non-rotating connection, then connection stability is improved, but the patch size and visibility under fluoroscopy increase

Engineering Contradiction:
Improveconnection stabilityVSAvoidpatch area
Core Design Contradiction:
Stability of the object's compositionVSArea of stationary object

Solution Approach 1:

The engagement element features an asymmetric T-shaped configuration with a vertical portion and a horizontal portion. This asymmetric design provides rotational stability and secure connection without requiring multiple symmetric snaps, thereby reducing the patch area and minimizing visibility under fluoroscopy while maintaining connection stability.

Inventive Principle:
Principle #4Asymmetry

3Area of stationary object

If the patch is made smaller to minimize space usage, then conflict with other medical devices is reduced, but the connection security and anti-rotation capability may be compromised

Engineering Contradiction:
Improvepatch areaVSAvoidconnection security
Core Design Contradiction:
Area of stationary objectVSReliability

Solution Approach 1:

The T-shaped engagement element with its asymmetric geometry provides inherent anti-rotation capability and secure connection within a minimized patch area. The vertical portion engages with the housing while the horizontal portion prevents rotation, achieving reliable connection security without increasing patch size or creating conflicts with other medical devices.

Inventive Principle:
Principle #4Asymmetry

4Strength

If stainless steel snaps and studs are used for connection, then connection strength is improved, but radiopacity and conflict with other devices increase

Engineering Contradiction:
Improveconnection strengthVSAvoidradiopacity
Core Design Contradiction:
StrengthVSObject-generated harmful factors

Solution Approach 1:

The material of the engagement element is changed from radiopaque stainless steel to radiolucent polymer. This parameter change maintains sufficient connection strength for the application while eliminating radiopacity, thereby preventing conflicts with other medical devices and improving visibility during fluoroscopic procedures.

Inventive Principle:
Principle #35Parameter changes

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, reusable, and easy-to-attach biosensor system that minimizes space usage, reduces conflicts with other medical devices, and maintains performance through repeated use, while being invisible under fluoroscopy.

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

Methodology Applied
Scientific EffectMagnetic field detection: Magnetic Field

Implementation Method 2

using conductive materials like silver chloride and polymers for the electrode and housing, respectively

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS9737225B2Patch and sensor assembly for use in medical device localization and mapping systems
Publication Date: 2017.08.22 BIOSENSE WEBSTER INC
  • US9737225B2 patent drawing
  • US9737225B2 patent drawing
  • US9737225B2 patent drawing

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.