Combined Cardiac Pacing and IRE Pulse Generator
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Solution Overview
Problem
Current methods for treating cardiac arrhythmia through cardiac pacing and irreversible electroporation (IRE) face challenges in synchronizing the procedures due to cardiac motion and the need for separate driving electronics with different voltage requirements, making it difficult to perform both diagnostics and treatment simultaneously at the same location effectively.
Innovation Solution
A combined system that generates and applies interleaved cardiac pacing and IRE pulses using a shared pulse generator with a shaping circuit, allowing for simultaneous or sequential delivery of pacing and IRE pulses, with the ability to vary pulse sequencing and amplitude, enabling efficient treatment while reducing the workload for physicians.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate driving electronics are used for cardiac pacing and IRE with different voltage requirements, then each procedure can be performed with optimized voltage control, but the device complexity and synchronization difficulty increase
Solution Approach 1:
The patent combines separate pacing and IRE driving electronics into a single integrated pulse generator. The generator produces a unified pulse train that is then split into two separate output channels: one for pacing and one for IRE. This merging approach maintains the voltage optimization benefits of separate control while eliminating the complexity of coordinating multiple independent devices, as the synchronization is inherently built into the single generator's pulse train timing.
Solution Approach 2:
The unified pulse train from the single generator is segmented into separate pacing and IRE output channels. Each channel can be independently configured for its specific voltage requirements while originating from the same synchronized source. This segmentation allows optimized voltage control for each procedure type while maintaining device simplicity through a single generator architecture.
2Reliability
If cardiac pacing and IRE are performed sequentially at the same location, then diagnostic and treatment procedures can be completed, but the treatment time and procedural complexity increase
Solution Approach 1:
The system enables continuous useful action by allowing pacing and IRE pulses to be delivered in an interleaved manner without interruption. The single generator produces a continuous pulse train where pacing pulses and IRE pulses alternate, eliminating idle time between procedures. This maintains both diagnostic pacing functionality and therapeutic IRE delivery continuously throughout the procedure.
Solution Approach 2:
The pulse train follows a periodic pattern with alternating pacing and IRE pulses at predetermined intervals. This periodic structure allows systematic delivery of both diagnostic and therapeutic functions in a rhythmized sequence, optimizing the timing between procedures while maintaining continuous operational flow and reducing overall procedural time.
3Device complexity
If a shared pulse generator is used for both pacing and IRE, then device complexity is reduced and synchronization is improved, but the ability to independently control voltage parameters for each procedure is limited
Solution Approach 1:
The single generator's unified pulse train is segmented into separate output channels, each capable of independent voltage control. The generator produces a master pulse train at a base frequency, then uses segmentation to create derived pulse trains for pacing and IRE with independently adjustable amplitudes. This allows the simplicity of a single generator while maintaining the versatility of independent parameter control through channel-specific voltage adjustment.
4Productivity
If interleaved pacing and IRE pulses are applied simultaneously, then treatment efficiency is improved and procedural time is reduced, but the precision of pulse delivery and tissue targeting becomes more challenging
Solution Approach 1:
The interleaved pulse delivery follows a strict periodic pattern with predetermined intervals between pacing and IRE pulses. This rhythmic, periodic structure provides temporal precision and predictability to the interleaved delivery, making it easier to control and monitor despite the simultaneous nature of the procedures. The periodic timing ensures consistent spacing that aids in precise pulse delivery and tissue targeting.
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 combined system improves clinical outcomes for arrhythmia treatment by allowing simultaneous or sequential pacing and IRE procedures, reducing the complexity and time required for the invasive treatment while maintaining precise control over pulse generation and application.
Implementation Method 1
irreversible electroporation (IRE) pulses... applying the output signal to heart tissue... high-voltage electrical pulses to cardiac tissue to induce irreversible electroporation, creating permanent pores in cell membranes that lead to cell death
Implementation Method 2
The shaping circuit is configured to convert some of the IRE pulses into pacing pulses of a prespecified frequency and amplitude
Data Source
Figure 1
Figure 2~3
AI summary
A cardiac pacing and irreversible electroporation (IRE) apparatus includes a pulse generator and a shaping circuit. The pulse generator is configured to generate IRE pulses of prespecified shape and repetition rate. The shaping circuit is configured to convert some of the IRE pulses into pacing pulses of prespecified frequency and amplitude, to generate an output signal including ones of the IRE pulses interleaved with ones of the pacing pulses, and to output the output signal to a probe in a heart of a patient for applying the output signal to cardiac tissue.