Leadless Pacemaker Diastolic Pressure Estimation

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Solution Overview

Problem

Traditional cardiac rhythm management devices face complications such as infection, reduced mobility, scarring, and lead dislodgment or perforation due to their implantation method, and lack efficient methods for estimating diastolic pressure, which is crucial for heart condition monitoring and therapy optimization.

Innovation Solution

The use of leadless cardiac pacemakers (LCPs) that estimate arterial diastolic pressure by combining ventricular pressure information with heart sound timings, specifically utilizing the timing of first and second heart sounds (S1 and S2) with potential correction factors, to provide accurate systemic or pulmonary diastolic pressure measurements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional CRM devices are implanted with leads and pressure sensors, then diastolic pressure can be monitored, but complications such as infection, lead dislodgment, and perforation occur

Engineering Contradiction:
Improvediastolic pressure monitoring reliabilityVSAvoidinfection, lead dislodgment, and perforation risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the pressure sensing function from the traditional lead-based system and integrates it into a leadless cardiac pacemaker (LCP). The LCP contains an intracardiac pressure sensor that directly measures ventricular pressure without requiring separate leads, thereby eliminating lead-related complications while maintaining pressure monitoring capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent combines multiple functions (pacemaking, pressure sensing, and diastolic pressure estimation) into a single leadless device. The LCP integrates the pressure sensor with the pacemaker functionality, allowing simultaneous delivery of electrical stimulation and pressure measurement without additional leads or sensors

Inventive Principle:
Principle #5Merging (Combining)

2Object-affected harmful factors

If leadless cardiac pacemakers are used, then implantation complications are reduced, but the device has more limited power and processing capabilities

Engineering Contradiction:
Improveimplantation complicationsVSAvoiddevice power and processing capabilities
Core Design Contradiction:
Object-affected harmful factorsVSPower

Solution Approach 1:

The patent applies partial action by using a simplified estimation algorithm that requires only essential measurements (ventricular pressure and heart sound timings) rather than comprehensive hemodynamic monitoring. This approach provides sufficient clinical information for diastolic pressure estimation while consuming minimal power and processing resources

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The LCP uses its own integrated sensors (pressure sensor and heart sound sensor) to generate diastolic pressure estimates without requiring external monitoring equipment. The device autonomously processes its own measurements to provide therapeutic information, reducing the need for additional external power or processing infrastructure

Inventive Principle:
Principle #25Self-service

3Measurement precision

If ventricular pressure and heart sound timings are combined to estimate diastolic pressure, then accurate pressure estimation is achieved, but device complexity increases

Engineering Contradiction:
Improvediastolic pressure estimation accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the measurement process into distinct, independently manageable components: (1) ventricular pressure measurement by the pressure sensor, (2) heart sound detection by the acoustic sensor, (3) timing extraction of S1 and S2 sounds, and (4) diastolic pressure calculation using the extracted features. This segmentation allows each component to be implemented separately and combined in a straightforward manner, minimizing overall system complexity

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

This method allows for non-invasive, efficient estimation of diastolic pressure, reducing complications associated with traditional devices and enabling real-time monitoring and therapy adjustments, improving the management of heart conditions without the need for invasive implantation.

Implementation Method 1

The body sounds, or other physiologic information, can be used to diagnose one or more physiologic conditions

Methodology Applied
Scientific EffectAcoustic detection: Acoustics

Implementation Method 2

the one or more leads can include a pressure sensor positioned in the heart and coupled to the CRM device through a conductor in the lead

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentUS11020011B2Estimate diastolic pressure
Publication Date: 2021.06.01 CARDIAC PACEMAKERS INC
  • US11020011B2 patent drawing
  • US11020011B2 patent drawing
  • US11020011B2 patent drawing

AI summary

Arterial diastolic pressure of a patient can be estimated using ventricular pressure information of a heart of the patient and heart sound information of the heart of the patient, such as a timing of at least one of a first heart sound (S1) or a second heat sound (S2), in certain examples, adjusted by a respective correction factor.