Devices and methods for mapping cardiac tissue

Inventors

Sachse, Frank B.Hitchcock, Robert W.Marrouche, Nassir F.Knighton, Nathan J.Huang, Chao

Assignees

University of UtahUniversity of Utah Research Foundation Inc

Publication Number

US-11602270-B2

Publication Date

2023-03-14

Expiration Date

2038-01-31

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Abstract

The present disclosure relates to systems and methods for generating three-dimensional tissue maps, and particularly fibrosis maps of cardiac tissue. An intravascular device includes an elongated member and a distal tip. An imaging assembly is integrated with the elongated member to enable imaging of the microstructure of tissue near the distal tip. One or more navigation electrodes are positioned at or near the distal tip. Electrical mapping and/or ablation assemblies may also be integrated with the device. Images may be characterized according to a level of fibrosis and, using the corresponding determined locations of the images, a three-dimensional map showing areas of differential fibrosis may be generated. Electrical mapping data may also be integrated with the fibrosis map to generate a composite fibrosis and voltage map.

Core Innovation

The invention relates to devices, systems, and methods for in-situ imaging of tissue at the microstructure level within a patient’s body, particularly for generating three-dimensional tissue maps such as fibrosis maps of cardiac tissue. An intravascular device includes an elongated member with a distal tip configured for delivery to targeted tissue regions. Integrated into the device is an imaging assembly that provides microstructural imaging, including an optical transmission member and a forward-facing aperture aligned with the device's longitudinal axis. The imaging assembly enables imaging at subcellular and submicron resolutions to visualize microstructural features of cardiac tissue.

This device also incorporates a localization assembly with one or more electrodes disposed at or near the distal tip to provide spatial location information within a three-dimensional anatomical working space. In certain embodiments, the device includes an electrical assembly for measuring electrical signals at the targeted tissue and/or a treatment assembly for ablating, treating, or delivering agents to selected tissue. A computer system can generate a three-dimensional tissue map by associating characterized tissue microstructure images with their corresponding locations, enabling creation of composite maps integrating both microstructural (e.g., fibrosis) and electrical data.

The problem addressed is the lack of devices and methods capable of imaging cardiac tissue at the microstructure scale, particularly for improving visualization, targeting, and assessment of tissue during procedures such as ablation for atrial fibrillation. Conventional approaches such as voltage mapping do not provide reliable information on the persistence of ablation effects, while MRI is limited in availability and lacks microscopic detail. The invention aims to improve outcomes by providing practitioners with real-time, high-resolution structural and functional tissue information.

Claims Coverage

There are three principal independent inventive features described in the patent: an intravascular device for microstructure imaging, a system for generating tissue microstructure maps, and a method for generating fibrosis maps.

Intravascular device for forward-facing microstructure imaging with integrated localization and electrical mapping

An intravascular device comprises: - An elongated member with a proximal end and a distal tip configured for delivery to targeted tissue. - An imaging assembly that provides forward-facing microstructure imaging at a depth within targeted tissue, using an optical transmission member and a forward-facing aperture axially aligned with the elongated member. - A localization assembly with one or more electrodes at or near the distal tip to provide location information within a three-dimensional anatomical working space. - An electrical assembly with one or more electrical sensors at or near the distal tip, configured to contact targeted tissue and measure one or more electrical signals when the distal tip is in contact with the tissue.

System for three-dimensional mapping of tissue microstructure using characterized images and spatial locations

A system includes the intravascular device and a computer system with processors and hardware storage. The system is configured to: - Receive forward-facing tissue microstructure images obtained by the intravascular device. - Determine the three-dimensional anatomical location for each image. - Characterize each image according to an exhibited level of a tissue microstructure attribute. - Generate a three-dimensional tissue microstructure attribute map based on the characterized images and their corresponding locations.

Method for generating a three-dimensional fibrosis map

A method comprises: - Providing the claimed intravascular device. - Directing the distal tip to multiple locations within the heart. - At each location, obtaining forward-facing tissue microstructure images and determining the location of the distal tip. - Associating each image with its corresponding location. - At each location, obtaining one or more electrical readings while the distal tip is in contact with cardiac tissue. - Characterizing each image according to level of exhibited fibrosis. - Generating a three-dimensional fibrosis map of the anatomical working space based on characterized images and locations.

Collectively, the claims provide coverage for an integrated device, system, and method that combine forward-facing microstructure imaging, spatial localization, electrical mapping, and three-dimensional tissue map generation, specifically targeting cardiac tissue such as for mapping fibrosis.

Stated Advantages

The invention enables imaging of cardiac tissue at the microstructure scale, allowing visualization at the cellular and subcellular level for identification of tissue abnormalities like fibrosis.

It provides real-time characterization and mapping of targeted tissue during procedures, facilitating more accurate diagnosis, treatment targeting, and treatment assessment.

The integrated device simplifies procedures by combining imaging, localization, electrical mapping, and ablative or therapeutic capabilities into a single instrument.

Generating three-dimensional tissue microstructure maps can improve outcomes and reduce recurrence rates in procedures such as ablation for atrial fibrillation.

Documented Applications

Mapping cardiac tissue microstructure, particularly for fibrosis assessment in heart chambers such as the left atrium.

Real-time characterization and visualization of cardiac tissue during ablation and other interventional procedures.

Guiding and assessing ablation treatments for atrial fibrillation by providing structural and functional tissue information.

Visualizing and mapping microstructural attributes within other internal tissues, including pulmonary, gastrointestinal, urogynecologic, endocrine, neural, and vascular tissues.

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