Wearable PPG Sensor and Medication Delivery for Bradycardia

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Solution Overview

Problem

There is a need for a wearable medical device that can continuously monitor heart rate, detect life-threatening bradycardia and asystole, alert the user, and automatically administer non-electronic therapy outside a hospital setting, particularly for patients post-transfemoral aortic valve replacement (TAVR) procedure who are at risk of developing cardiac standstill due to atrioventricular block.

Innovation Solution

A device integrated into eyeglass frames that includes a photoplethysmography (PPG) sensor to monitor heart rate, an anticholinergic medication reservoir to administer Atropine to the conjunctiva, and an ammonia vapor inhalant to stimulate adrenaline release via the olfactory reflex, providing immediate treatment for bradyarrhythmia events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a permanent pacemaker is implanted to treat bradycardia, then heart rhythm is controlled and life-threatening episodes are prevented, but the device requires surgical implantation and continuous hospital monitoring which is not feasible for outpatient or post-discharge patients

Engineering Contradiction:
Improveprevention of life-threatening bradycardiaVSAvoidsurgical implantation requirement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the mechanical/surgical pacemaker implantation system with a wearable optical monitoring system using PPG sensors that can detect bradycardia without surgical intervention. The system uses photoplethysmography to monitor heart rate continuously and triggers automated medication delivery when bradycardia is detected, eliminating the need for surgical implantation while maintaining reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The wearable device incorporates automated detection and response mechanisms that operate without continuous human intervention. The PPG sensor continuously monitors heart rate, the processor automatically detects bradycardia episodes, and the system autonomously delivers medication through the inhalant or conjunctival administration mechanisms, enabling the system to serve itself in monitoring and treating bradycardia.

Inventive Principle:
Principle #25Self-service

2Reliability

If external pacemakers/defibrillators are worn to prevent cardiac arrest, then life-threatening tachyarrhythmias are managed, but these devices are designed for tachycardia prevention rather than bradycardia detection and treatment

Engineering Contradiction:
Improveprevention of cardiac arrestVSAvoiddevice functionality for specific arrhythmia type
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The wearable device is designed with multi-functionality to detect and treat various types of arrhythmias. The PPG sensor can detect both tachycardia and bradycardia, and the system is configured to deliver appropriate treatments for each condition, making it adaptable to different arrhythmia types rather than being specialized for only one condition.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system monitors multiple physiological parameters including heart rate, respiratory rate, and oxygen saturation. By tracking changes in these parameters, the device can identify different arrhythmia patterns and adjust its response accordingly, enabling it to handle both tachycardia and bradycardia events with appropriate treatment protocols.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If PPG sensors are worn on the wristband for heart rate monitoring, then heart rate can be measured continuously, but the device cannot automatically administer medication for detected bradycardia events

Engineering Contradiction:
Improvecontinuous heart rate monitoringVSAvoidautomated medication administration
Core Design Contradiction:
Measurement precisionVSExtent of automation

Solution Approach 1:

The patent combines the PPG monitoring function with automated medication delivery mechanisms in a single integrated wearable device. The PPG sensor, processor, and medication delivery system (including inhalant reservoir and conjunctival administration components) are merged into one unit that can both detect bradycardia and automatically respond with appropriate medication administration without requiring separate devices.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The processor acts as an intermediary between the PPG sensor and the medication delivery system. It receives continuous heart rate data from the PPG sensor, analyzes the data to detect bradycardia episodes, and triggers the medication delivery mechanism when thresholds are met, enabling automated response between monitoring and treatment functions.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Speed

If intravenous Atropine is administered to treat bradycardia, then heart rate increases quickly, but the treatment requires hospital setting and intravenous access which is not available to discharged patients

Engineering Contradiction:
Improveheart rate increase rateVSAvoidhospital setting requirement
Core Design Contradiction:
SpeedVSEase of operation

Solution Approach 1:

The system uses disposable or replaceable medication cartridges containing Atropine in inhalant or conjunctival form that can be administered outside the hospital. These single-use medication delivery components eliminate the need for intravenous access and hospital infrastructure, allowing quick treatment of bradycardia in outpatient or home settings while maintaining the speed of medication delivery.

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

Solution Approach 2:

The patent substitutes the intravenous administration mechanism with alternative delivery methods including inhalant administration through a respiratory interface or conjunctival administration through eye contact. These mechanisms eliminate the need for intravenous access and hospital-based medical infrastructure while maintaining rapid medication delivery to treat bradycardia effectively.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 device effectively increases the chances of survival for patients experiencing bradyarrhythmia events by administering medication and stimulating adrenaline release within seconds of an event, preventing progression to cardiac arrest outside a hospital setting, especially during the critical healing period post-TAVR.

Implementation Method 1

Some wearable heart rate monitors use photoplethysmography (PPG) sensors to measure heart rate.

Methodology Applied
Scientific EffectPhotoplethysmography: Absorption (EM radiation)

Implementation Method 2

The fastest way to increase the endogenous adrenaline production is by inhaling ammonia vapor which works through the olfactory reflex within seconds after inhalation.

Methodology Applied
Scientific EffectOlfactory reflex:

Implementation Method 3

an anticholinergic medication such as Atropine administered to the conjunctiva

Methodology Applied
Scientific EffectAnticholinergic blocking:

Data Source

PatentUS11471657B1Device and method for monitoring and treating advanced bradycardia
Publication Date: 2022.10.18 STAT CAPSULE INC
  • US11471657B1 patent drawing
  • US11471657B1 patent drawing
  • US11471657B1 patent drawing

AI summary

A device and method for monitoring the heart rate of a patient for a bradyarrhythmia event and thereafter administering medications is disclosed. The method comprises the steps of monitoring heart rate via at least one sensor secured to the neck or head of a patient; and if a bradyarrhythmia event is determined; applying an anticholinergic medication to the conjunctiva of at least one eye and releasing ammonia vapor in close proximity to the nostrils of a patient.