Systems and methods for selective his bundle mapping and pacing
Inventors
Efimov, Igor R. • Brennan, Jaclyn Ann • Rogers, John A.
Assignees
George Washing University • George Washington University • Northwestern University
Publication Number
US-12290689-B2
Publication Date
2025-05-06
Expiration Date
2042-01-19
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Abstract
Systems and methods are disclosed for an electrical sensing, pacing, and ablation device comprising a bendable and stretchable balloon catheter and a bendable and stretchable first layer connected to or embedded in said balloon catheter, where the first layer has an electrode array with a plurality of electrodes. The is also a bendable and stretchable second layer connected to or embedded in the balloon catheter, and the second layer has a pressure sensor array with a plurality of pressure sensors.
Core Innovation
The invention discloses systems and methods for an electrical sensing, pacing, and ablation device comprising a bendable and stretchable balloon catheter equipped with an electrode array, a pressure sensor array, and optionally a temperature sensor array, each in distinct, multilayer, soft conformal configurations. The device enables high-resolution, minimally invasive mapping and selective pacing of the His bundle region in the human heart by providing precise, simultaneous electrical, pressure, and temperature measurements, allowing spatiotemporal mapping and identification of optimal pacing sites unique to each heart.
The problem addressed is the technical challenge of accurately sensing and selectively pacing the His bundle for cardiac resynchronization therapy (CRT), which has limitations due to the anatomical location and suboptimal current methods such as lead screws that present risks and may compromise follow-up or adjustment. Current CRT methods can be ineffective due to issues like scar burden, suboptimal lead positioning, and difficulties in electrical synchronization, and existing His bundle pacing (HBP) techniques are limited by difficulties in mapping and reliable stimulation at the required anatomical site.
The core technology employs a multifunctional conformal bioelectronic system mounted on a balloon catheter, allowing for precise mapping of AV node conduction pathways and selective pacing using a modular, multilayer design. The device leverages advanced sensor arrays capable of measuring pressure, temperature, and electrical activity with high fidelity and spatial resolution, aiming to optimize placement and effectiveness of s-HBP (selective His bundle pacing) and provide an integrated platform for mapping, pacing, and potential ablation without invasive or damaging fixation methods.
Claims Coverage
The patent includes one independent claim specifying the main inventive features of the electrical sensing and pacing device, focusing on a particular arrangement of components and their functions for mapping and pacing the His bundle.
Electrical sensing and pacing on a multilayer balloon catheter
An electrical sensing and pacing device comprises: - A balloon catheter. - A first layer connected to or embedded in the balloon catheter, which includes an electrode array with multiple electrodes configured or adapted to be positioned on the atrioventricular junction or His bundle anatomical area. The electrode array determines electrical His bundle activation with high spatial and temporal resolution, and comprises a top polymer film layer with openings where the electrodes are placed, and a bottom polymer film layer. - A second layer connected to or embedded in the balloon catheter, including a pressure sensor array with multiple pressure sensors, built into a silicon layer with cavities where the sensors are positioned, and also having a bottom polymer film layer. This configuration enables the device to map and pace the His bundle with combined electrical and pressure measurement capabilities from a stretchable, conformal, multilayer catheter platform.
The inventive feature defined in the independent claim addresses a novel, multilayer stretchable balloon catheter that enables high-resolution, multimodal mapping and selective pacing of the His bundle region through an arrangement of electrode and pressure sensor arrays integrated into separate conformal layers.
Stated Advantages
Allows high-resolution, minimally invasive mapping and selective pacing of the His bundle region using a multimodal, multilayer conformal catheter system.
Enables simultaneous, multimodal electrical, pressure, and temperature measurements for optimized identification of optimal pacing sites and guidance of permanent pacing lead implantation.
Provides effective tissue contact through integrated pressure sensors, improving fidelity of mapping and pacing procedures.
Reduces need for damaging fixation methods by employing a soft, stretchable, and removable device, potentially minimizing long-term complications and allowing for post-implant adjustment.
Facilitates shorter surgical times and richer physiological information acquisition using a single instrumented catheter system for mapping, pacing, and ablation.
Documented Applications
Electrical mapping and selective pacing of the His bundle region for cardiac resynchronization therapy and conduction system pacing.
Guidance of permanent pacing lead implantation at identified optimal sites of the His bundle, including selective His bundle pacing without active fixation.
Electrophysiological mapping, pacing, and ablation within cardiac tissue for diagnostic and therapeutic applications, including mapping of AV node conduction pathways and identification of conduction blocks.
Multimodal mapping and stimulation for cardiac procedures, including use during AV node ablation and for optimizing pacing threshold capture in individual hearts.
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