Double-Sided Ostomy Sensor Layout for Early Leak Detection

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Solution Overview

Problem

Ostomy appliances are susceptible to effluent leakage due to a weakened seal, which users often cannot easily detect, leading to unnoticed leaks.

Innovation Solution

A sensor device with a sensor layer and skin barrier layer, featuring sensing electrodes and connecting traces, is attached to the ostomy appliance to detect changes in electrical resistance caused by leakage, providing a control unit for alerting the user.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a sensor device with multiple electrodes and connecting traces is added to the ostomy appliance, then leakage detection capability is improved, but device complexity increases

Engineering Contradiction:
Improveleakage detection capabilityVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The sensor device is segmented into distinct functional layers: a sensor layer containing multiple sensing electrodes arranged in specific patterns, a substrate layer providing structural support and electrical insulation, and a skin barrier layer for attachment. This segmentation allows each layer to perform its specific function efficiently while simplifying the overall design and manufacturing process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The substrate acts as an intermediary element between the sensing electrodes and the external environment. It provides mechanical support to the fragile electrodes, electrical insulation to prevent short circuits, and a platform for connecting traces to route signals to external processing units. This intermediary structure enables the sensor device to function reliably without requiring complex integrated circuitry.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If sensing electrodes are placed close to the skin barrier for accurate leakage detection, then measurement precision is improved, but risk of electrical short circuit increases

Engineering Contradiction:
Improveleakage detection accuracyVSAvoidelectrical insulation reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The substrate serves as a critical intermediary layer positioned between the sensing electrodes and the skin barrier layer. It provides robust electrical insulation that prevents short circuits while allowing the electrodes to remain close to the barrier for accurate detection. The substrate's insulating properties enable reliable operation in the moist environment near the skin without requiring complex isolation schemes.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The substrate is implemented as a thin, flexible film that conformally covers the sensing electrodes and extends to the edges of the sensor device. This thin film structure provides adequate electrical insulation while maintaining flexibility for attachment to the curved surface of the ostomy appliance and allowing close proximity to the skin barrier for sensitive detection.

Inventive Principle:
Principle #30Flexible shells and thin films

3Measurement precision

If multiple connecting traces are used to connect all sensing electrodes, then measurement capability is improved, but manufacturing complexity increases

Engineering Contradiction:
Improveelectrode connection capabilityVSAvoidmanufacturing complexity
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

Multiple connecting traces are merged into a single integrated substrate layer that contains pre-formed conductive pathways. The substrate is manufactured as a single piece with embedded traces that automatically connect all sensing electrodes to external contact points. This merging eliminates the need for separate wiring for each electrode, significantly simplifying the assembly process while maintaining full measurement capability across all sensor elements.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The substrate is designed to be self-connecting, with conductive traces that automatically establish electrical connections between all sensing electrodes and external contact points during the manufacturing process. The traces are pre-positioned and pre-connected, eliminating the need for manual wiring or complex assembly steps. This self-service approach to electrical connection greatly reduces manufacturing complexity while ensuring reliable connections.

Inventive Principle:
Principle #25Self-service

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 sensor device accurately detects and locates ostomy effluent leakage, enabling timely notification to the user, thereby preventing external leaks.

Implementation Method 1

detect changes in electrical resistance caused by leakage

Methodology Applied
Scientific EffectElectrical resistance change: Electrical Resistance

Data Source

PatentUS12472085B2Double-sided sensor device for ostomy leak detection system
Publication Date: 2025.11.18 HOLLISTER INCORPORAED
  • US12472085B2 patent drawing
  • US12472085B2 patent drawing
  • US12472085B2 patent drawing

AI summary

A sensor device for detecting ostomy effluent leakage in an ostomy appliance includes a sensor layer and a skin barrier layer for attaching the sensor device to a user. The sensor layer includes a substrate, a plurality of sensing electrodes arranged on a proximal side of the substrate, a plurality of connecting traces arranged on a distal side of the substrate, and a plurality of connection points configured to electrically connect the sensor device to a control unit.