Intercostal Pacemaker with Skin-Penetrating LED Visual Feedback

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Solution Overview

Problem

Conventional pacemaker and defibrillator systems face challenges such as inadequate signal detection due to distance from the heart, high impedance from anatomical structures like the sternum and ribs, and inappropriate shocks, which can be life-threatening and psychologically devastating. Additionally, they lack the ability to provide instantaneous visual feedback of cardiac parameters and battery status without external testing equipment.

Innovation Solution

A subcutaneous pacemaker defibrillator system with flexible, miniature generators implanted in the intercostal space, equipped with LEDs and LCDs for visible light signals indicating cardiac activity and system status, using electric, echocardiographic, and Doppler sensors to accurately diagnose cardiac conditions and prevent inappropriate shocks, and capable of wireless recharging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional pacemaker and defibrillator systems are used, then the system can provide cardiac pacing and defibrillation, but the generators are positioned at a distance from the heart resulting in inadequate signal detection and high impedance from anatomical structures

Engineering Contradiction:
Improvesignal detection accuracyVSAvoiddistance from heart
Core Design Contradiction:
Measurement precisionVSLength of moving object

Solution Approach 1:

The patent positions the generator locally in the intercostal space adjacent to the heart, transforming the system from a distant placement to a localized one. This local positioning eliminates the distance problem and provides direct proximity to cardiac structures for accurate signal detection without high impedance interference from the sternum and ribs.

Inventive Principle:
Principle #3Local quality

2Reliability

If conventional systems provide defibrillation capability, then life-threatening arrhythmias can be treated, but inappropriate shocks may be delivered causing life-threatening and psychologically devastating effects

Engineering Contradiction:
Improveappropriate shock deliveryVSAvoidinappropriate shocks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates multiple sensors including electrical, echocardiographic, and Doppler sensors that provide continuous feedback about cardiac function. This multi-parameter feedback system allows the device to accurately distinguish between life-threatening and non-life-threatening arrhythmias, delivering shocks only when truly necessary and avoiding inappropriate shocks that would harm the patient.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs preliminary assessment using multiple sensing modalities before delivering defibrillation shocks. By evaluating electrical signals, echocardiographic images, and Doppler flow data in advance, the system determines whether shock delivery is appropriate, preventing harmful shocks from being delivered to patients with non-life-threatening conditions.

Inventive Principle:
Principle #10Preliminary action

3Loss of information

If conventional pacemaker systems are used, then cardiac pacing can be provided, but there is no instantaneous visual feedback of cardiac parameters and battery status without external testing equipment

Engineering Contradiction:
Improvecardiac parameter monitoringVSAvoidvisual feedback availability
Core Design Contradiction:
Loss of informationVSEase of operation

Solution Approach 1:

The patent incorporates LEDs that change color to provide visual feedback about cardiac parameters and device status. Different colors indicate different cardiac rhythms, battery levels, and operational states, allowing patients and clinicians to instantly assess system status without external equipment. This color-coded visual feedback system makes information accessible and easy to interpret.

Inventive Principle:
Principle #32Color changes

4Measurement precision

If implantable generators are positioned close to the heart, then accurate signal detection is achieved, but the implantation becomes more complex and may interfere with sternum and ribs

Engineering Contradiction:
Improvecardiac signal detectionVSAvoidimplantation procedure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the implantation approach by utilizing the intercostal space between ribs as a dedicated pathway. This segmentation allows the generator to be positioned close to the heart while avoiding interference with the sternum and ribs. The intercostal space provides a natural anatomical corridor that simplifies the implantation procedure compared to other approaches.

Inventive Principle:
Principle #1Segmentation

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 system provides accurate and timely diagnosis of cardiac conditions, reduces the risk of inappropriate shocks, and offers continuous, visible monitoring of cardiac parameters and battery status through the skin, enhancing patient safety and reducing psychological impact.

Implementation Method 1

The present invention also relates to implantable pacemaker and/or defibrillator equipment operating with internal generators which use one or more Light Emitting Diodes (LED)... where colored light visible signals emitted by the LEDs (and transmitted to the LCD) reflect physical patient cardiac parameters and/or equipment operation parameters

Methodology Applied
Scientific EffectLight Emitting Diode: Light Emitting Diode

Implementation Method 2

a liquid crystal display (LCD) embedded in the front facing surface of the system... where colored light visible signals emitted by the LEDs (and transmitted to the LCD) reflect physical patient cardiac parameters

Methodology Applied
Scientific EffectLiquid Crystal Display: Liquid Crystals

Implementation Method 3

the sensors are capable of detection of the heart electrical parameters, Doppler cardiac/vascular blood flow, and echocardiographic mechanical cardiac activity

Methodology Applied
Scientific EffectDoppler Effect: Doppler Effect

Implementation Method 4

with the help of a piezoelectric crystal which provides physiologic pacing needed for treating heart failure

Methodology Applied
Scientific EffectPiezoelectric Effect: Piezoelectric Effect

Implementation Method 5

a miniature generator implant that is rechargeable from a power source external to the chest wall through inductive charging capable of wireless transfer of energy from the external power source to the generator's battery

Methodology Applied
Scientific EffectElectromagnetic Induction: Electromagnetic Induction

Data Source

PatentUS10821281B1Implantable pacing and defibrillation system with illuminated generators
Publication Date: 2020.11.03 HAKKI A HAMID
  • US10821281B1 patent drawing
  • US10821281B1 patent drawing
  • US10821281B1 patent drawing

AI summary

A pacemaker defibrillator system implantable in the intercostal space of a mammalian patient is configured with sensors to sense electrical, mechanical and blood flow activity of the heart from the base to the apex, and the patient position, and to generate corresponding signals responsive to the sensed cardiac situation, as well as to provide instantaneous display of the cardiac situation and the system operational situation using an LCD and multicolor LEDs generating signals which can be seen through the skin of the patient. The system includes at least two flexible electrical generators contoured to conform to the anatomy of the intercostal space and embedded with electrodes for measuring electrical activity, as well as echocardiographic piezoelectric electrodes for measuring mechanical activity of the heart and Doppler blood flow. The system is equipped with microprocessors to analyze a cardiac situation based on the sensors' readings, produce a diagnosis, and generate the therapeutic strategy, such as “pacing or shocking pulse” in a life-threatening situation, or “observe” in non-life-threatening situations, meanwhile providing a bedside instantaneous on-demand display of the heart rhythm and the system's functionality through the patient's skin.