Subcutaneous Cardiac System with Blood Sensor Verification
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Solution Overview
Problem
Current implantable cardiac rhythm management systems are limited in accessibility due to the need for specialized physicians and facilities for transvenous lead/electrode implantation, restricting their use in preventing Sudden Cardiac Death (SCD) in at-risk patients.
Innovation Solution
Development of subcutaneously placed cardiac monitoring and stimulation systems that utilize both ECG and blood information for rhythm evaluation and treatment, incorporating a housing with detection and energy delivery circuitry, electrodes, and an implantable blood sensor to verify cardiac signals and deliver therapies like defibrillation and pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous lead/electrode implantation is used, then cardiac rhythm management effectiveness is improved, but device accessibility and ease of implantation deteriorate due to limited specialized physicians and facilities
Solution Approach 1:
The patent extracts the sensing and stimulation functions from the traditional transvenous lead system and places them in a subcutaneous implantable device. The device contains electrodes that contact the myocardium through the chest wall, eliminating the need for venous access and transvenous leads. This extraction allows the complex function of cardiac rhythm management to be delivered through a simpler, more accessible implantation approach.
Solution Approach 2:
The patent introduces an intermediary structure - the subcutaneous device housing with integrated electrodes - that mediates between the external environment and the myocardium. The electrodes are positioned to contact the myocardium through the chest wall without requiring venous access, serving as an intermediary pathway that simplifies implantation while maintaining therapeutic effectiveness.
2Ease of operation
If subcutaneous placement is used, then ease of implantation is improved, but signal detection precision may deteriorate
Solution Approach 1:
The patent replaces the mechanical/electrical signal transmission path of transvenous leads with an optical detection system. The device includes optical detectors that detect light emitted by the myocardium during contraction, substituting the traditional electrical signal pathway with an optical one. This allows for precise detection of cardiac activity from a subcutaneous position without the signal attenuation problems of transvenous approaches.
Solution Approach 2:
The patent changes the detection parameter from electrical voltage (traditional ECG) to optical properties of blood during cardiac contraction. By detecting changes in light absorption or emission properties of blood as it flows through the myocardium during contraction, the system achieves precise detection of cardiac events from a subcutaneous location, transforming the detection modality to overcome distance-related signal degradation.
3Reliability
If blood sensor verification is added, then therapy delivery accuracy is improved, but device complexity increases
Solution Approach 1:
The patent merges the blood sensing function with the existing optical detection system. The same optical detectors used to detect cardiac contraction also serve to analyze blood properties (such as oxygen saturation or hemoglobin concentration). By combining these functions into a single optical detection pathway, the system achieves therapy verification capability without proportionally increasing device complexity, as the blood analysis is performed using the existing optical infrastructure.
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
Enables effective monitoring and treatment of cardiac arrhythmias without the need for invasive procedures, improving accessibility and reducing the risk of inappropriate therapy delivery by using subcutaneous placement and multi-parameter signal verification.
Implementation Method 1
a blood sensor signal from a blood sensor is received. The blood sensor signal may be used to verify that the ECG signal comprises a cardiac signal
Data Source
AI summary
Cardiac systems and methods using ECG and blood information for arrhythmia detection and discrimination. Detection circuitry is configured to produce an ECG. An implantable blood sensor configured to produce a blood sensor signal is coupled to a processor. The processor is coupled to the detection and energy delivery circuitry, and used to evaluate and treat cardiac rhythms using both the cardiac electrophysiologic and blood sensor signals. The blood sensor is configured for subcutaneous non-intrathoracic placement and provided in or on the housing, on a lead coupled to the housing, and/or separate to the housing and coupled to the processor via hardwire or wireless link. The blood sensor may be configured for optical sensing, using a blood oxygen saturation sensor or pulse oximeter. A cardiac rhythm may be evaluated using the electrocardiogram signal and the blood sensor signal, and tachyarrhythmias may be treated after confirmation using the blood sense signal.