Leadless Cardiac Stimulation via Epicardial Stent Extraction

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current cardiac resynchronization therapy (CRT) technologies face limitations due to the need for multiple leads, which increase the risk of vascular complications, lead displacement, and limited multisite pacing capabilities, particularly in patients with left bundle branch block (LBBB), and are invasive and prone to complications such as thrombosis and infection.

Innovation Solution

A leadless cardiac stimulation system using self-powered stent electrodes positioned at the origin of the coronary sinus for both atrial and ventricular sensing, with remote communication to stimulation stents placed in veins around the heart, enabling multisite pacing and defibrillation without the need for leads, thereby reducing invasive procedures and complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple leads are implanted through veins leading to the heart for CRT, then biventricular pacing capability is improved, but the risk of vascular complications increases

Engineering Contradiction:
Improvebiventricular pacing capabilityVSAvoidvascular complications
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the lead from the traditional transvenous implantation approach and positions it directly on the epicardial surface of the heart. This eliminates the need for multiple transvenous leads and their associated vascular complications while maintaining biventricular pacing capability through direct cardiac contact

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary delivery system (catheter with balloon) that facilitates the placement of the epicardial lead without requiring permanent transvenous leads. The balloon-based delivery mechanism allows temporary positioning during implantation, eliminating the need for long-term vascular access points

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If multiple leads are implanted for CRT, then pacing coverage is improved, but the potential for lead displacement increases

Engineering Contradiction:
Improvepacing coverageVSAvoidlead displacement
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent removes the lead from the transvenous pathway and places it directly on the epicardial surface, eliminating the mechanical interface between lead and vein that causes displacement. This direct epicardial contact prevents the lead from migrating through vascular tissue

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs preliminary fixation measures during implantation, where the lead is secured to the epicardial surface using a delivery system with balloon inflation before final positioning. This preliminary anchoring ensures stable lead placement and prevents subsequent displacement

Inventive Principle:
Principle #10Preliminary action

3Duration of action of stationary object

If leads are implanted long-term for CRT, then therapeutic benefit is improved, but the risk of infection increases

Engineering Contradiction:
Improvetherapeutic benefit durationVSAvoidinfection risk
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the lead from the transvenous implantation approach, eliminating the chronic foreign body presence in vascular tissue that predisposes to infection. By placing the lead directly on the epicardial surface with no transvenous component, the infection risk is significantly reduced while maintaining long-term therapeutic benefit

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent converts the potential harm of invasive lead implantation into a benefit by using a minimally invasive epicardial approach. The direct cardiac contact provides stable pacing while the absence of transvenous leads eliminates the vascular infection pathway, turning a high-risk procedure into a lower-risk alternative

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

4Ease of operation

If traditional transvenous lead implantation is used for CRT, then pacing function is achieved, but the procedure is invasive and complex

Engineering Contradiction:
Improvepacing function achievementVSAvoidprocedure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent extracts the complex transvenous lead implantation procedure and replaces it with a simpler epicardial approach. By eliminating the need to navigate leads through multiple veins and chambers, the procedure becomes less invasive and technically simpler while achieving the same pacing function

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent segments the pacing system into a separate epicardial lead component and a delivery system, allowing the lead to be implanted as a standalone element rather than as part of a complex transvenous assembly. This segmentation simplifies the implantation process and reduces procedural complexity

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3057657B1Apparatus for artificial cardiac stimulation
Publication Date: 2019.03.13 GLOUCESTERSHIRE HOSPITALS NHS FOUND TRUST
  • EP3057657B1 patent drawingFigure 1A~1B
  • EP3057657B1 patent drawingFigure 2
  • EP3057657B1 patent drawingFigure 3A~3B

AI summary

A system for artificial stimulation of the heart of a subject comprises a controller comprising a receiver for receiving signal data, a processor for processing received signal data, and a transmitter for transmitting signal data; a sensing stent for location in the proximal coronary sinus of the subject and comprising a sensing electrode assembly for sensing atrial and/or ventricular signals from the heart of the subject and a transmitter for transmitting signal data to the receiver; a stimulation stent for location in a vein of the subject distal of the sensing stent and comprising a receiver for receiving signal data from the transmitter and an electrode assembly for providing a stimulating electrical signal to the heart in response to the data received; and a defibrillator assembly for providing stimulation to the heart sufficient to defibrillate the heart in response to a signal received from the controller assembly.