Implantable Lead Voiding Sensor for Incontinence Monitoring
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Solution Overview
Problem
Current methods for monitoring urinary and fecal incontinence require patients to manually track voiding events, which is inconvenient, prone to errors, and can undermine the accuracy of clinical assessments.
Innovation Solution
An implantable medical device system that automatically records voiding events using sensors and processes electrical signals to detect and record urinary and fecal voiding events, eliminating the need for patient interaction and providing accurate data for clinical diagnosis and therapy adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If patients manually track voiding events using diaries or logs, then clinicians can obtain voiding event data for diagnosis and therapy adjustment, but the method is prone to errors, inconvenient for patients, and may undermine accuracy of clinical assessments
Solution Approach 1:
The system enables automatic self-monitoring of voiding events through implantable sensors that detect and record voiding events without requiring patient action. The sensor autonomously monitors physiological parameters and triggers voiding event detection, eliminating the need for patients to manually track events in diaries or logs.
Solution Approach 2:
The patent replaces the mechanical/manual system of patient-filled diaries with an electronic sensing system. Implantable sensors detect voiding events through physiological parameter changes (such as pressure or flow detection), converting manual tracking into an automated electronic measurement system that records data objectively.
2Loss of information
If patients manually track voiding events, then clinicians can review the data for diagnosis, but the process requires significant patient interaction and time commitment
Solution Approach 1:
The implantable sensor system provides continuous monitoring of voiding events without interruption. The sensor remains implanted and continuously detects physiological parameters, ensuring that no voiding events are missed and providing complete data coverage throughout the monitoring period, unlike manual diary methods where patients may forget to log events.
Solution Approach 2:
The system performs automatic data collection and storage without requiring patient time or effort. The sensor autonomously detects, records, and stores voiding event data in memory, eliminating the time patients would otherwise spend manually logging events while maintaining complete and accurate records.
3Reliability
If manual voiding diaries are used, then clinicians can assess patient condition, but the data collection process is complex and requires patient compliance
Solution Approach 1:
The patent extracts the data collection function from the patient and places it in the implantable sensor system. The sensor is implanted within the patient's body and directly measures physiological parameters related to voiding events, removing the need for patients to externally track and report events, thereby eliminating compliance issues and improving data reliability.
Solution Approach 2:
The implantable sensor system serves multiple functions: it monitors physiological parameters, detects voiding events, records data in memory, and can communicate with external devices. This multi-functional integrated system replaces the simple diary approach while providing more reliable data through automated physiological measurement rather than patient reporting.
Data Source
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AI summary
An implantable medical lead includes at least one stimulation electrode and at least one sensor configured to generate an electrical signal that varies as a function of a parameter associated with a voiding event of a patient. In some embodiments, the sensor may be at least one of a microphone that captures sounds associated with voiding events, a pressure sensor, a flow sensor, a strain gauge, a physiological parameter sensing electrode or a temperature sensor. The electrical signal generated by the sensor may used to detect an occurrence of a voiding event. Thus, the lead may be coupled wirelessly or via a wired connection to a device that processes the electrical signal from the sensor, generates voiding information based on the electrical signal, and in some cases, records the voiding information for later retrieval and analysis.