Remote Control Module for External Cardiac Pacing

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Solution Overview

Problem

Current external cardiac pacing systems during transcatheter heart valve replacement procedures rely on manual operation by a third person, leading to potential human errors due to verbal communication and execution, which can introduce unnecessary risks during the procedure.

Innovation Solution

A system and method that allow the cardiologist to directly control pacing activities by placing control features in the sterile field, using an external pulse generator connected to a guidewire via a remote-control module, which includes user inputs and automatic algorithms for assisted pacing, such as continuity tests, capture checks, rapid pacing, and back-up pacing routines.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a third person manually operates the external pulse generator based on verbal instructions, then the cardiologist can focus on valve delivery and deployment, but human error in communication and execution increases procedural risk

Engineering Contradiction:
ImproveCardiologist focus on valve deliveryVSAvoidPacing control accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent extracts the pacing control functionality from the main external pulse generator and places it in a separate remote-control module that can be positioned in the sterile field near the cardiologist. This allows the cardiologist to directly control pacing parameters without relying on verbal communication with a third person, eliminating communication errors while maintaining focus on valve delivery.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The remote-control module serves as an intermediary device between the cardiologist and the external pulse generator. It receives direct input from the cardiologist and transmits control signals to the pulse generator, eliminating the need for verbal communication chains and reducing human error in pacing control.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the external pulse generator is placed outside the sterile field, then it remains uncontaminated, but the cardiologist cannot directly control pacing activities

Engineering Contradiction:
ImprovePacing control accessibilityVSAvoidSystem configuration
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system is segmented into two distinct components: the external pulse generator that remains outside the sterile field, and the remote-control module that can be placed in the sterile field. This segmentation allows each component to fulfill its specific role - the pulse generator maintains sterility while the remote module provides direct cardiologist access to pacing controls.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The remote-control module acts as an intermediary that bridges the sterile and non-sterile zones. It can be positioned in the sterile field near the cardiologist while maintaining wireless or isolated communication with the pulse generator outside the sterile field, enabling direct control without compromising sterility.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If manual control of the external pulse generator is used, then the system is simple to operate, but the risk of human error increases

Engineering Contradiction:
ImproveControl system simplicityVSAvoidPacing execution accuracy
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The remote-control module provides direct feedback to the cardiologist about pacing parameters and heart rate in real-time, allowing for immediate adjustments. This feedback loop enables the cardiologist to verify pacing effectiveness directly without relying on indirect verbal communication, improving execution accuracy while maintaining simple manual control interfaces.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS11872403B2Systems, methods, and apparatus for external cardiac pacing
Publication Date: 2024.01.16 MERIT MEDICAL SYSTEMS INC
  • US11872403B2 patent drawing
  • US11872403B2 patent drawing
  • US11872403B2 patent drawing

AI summary

Systems and methods for cardiac pacing during a procedure are disclosed and may include an external pulse generator (EPG) for connecting to a lead. A remote-control module (RCM) wirelessly connected to the EPG may include user inputs to control the EPG. A central processing unit (CPU) with a memory unit for storing code and a processor for executing the code may be included where the CPU is connected to the EPG and RCM. The code may control the EPG in response to user input from the RCM. The CPU may be disposed in the EPG or the RCM, or an interface module (IM) configured to communicate between an otherwise conventional EPG and the RCM. The executable code may perform a continuity test (CT) routine, a capture check (CC) routine, rapid pacing (RP) routine, and/or a back-up pacing (BP) routine, in response to user input from the RCM.