Method for visualizing tissue with an ICG dye composition during ablation procedures

Inventors

Melsky, Gerald

Assignees

Cardiofocus Inc

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Publication Number

US-11246476-B2

Patent

Publication Date

2022-02-15

Expiration Date


Abstract

A system is provided for identifying the sufficiency of lesions formed during a tissue ablation procedure. The system and method include administering an ICG composition to the patient and forming one or more lesions at a surgical site. The method further includes applying energy of a type and in an amount sufficient to cause ICG in the patient to fluoresce. An image of the tissue and lesion at the surgical site is obtained while the ICG fluoresces. The lesion is distinguished from surrounding de novo tissue based on areas of fluorescence to allow a user to evaluate the quality of the lesion.

Core Innovation

The invention relates to an ICG-based visualization system and method for distinguishing lesions from de novo tissue during a surgical procedure. An ICG composition is administered to a patient, one or more lesions are formed at a surgical site, and energy is applied in an amount and type sufficient to cause the ICG in the patient to fluoresce while the lesion is being formed.

An image of the tissue and lesion at the surgical site is obtained while the ICG fluoresces. The lesion is distinguished from surrounding de novo tissue based on areas of fluorescence, so that a user evaluates lesion quality and identifies one or more breaks in the lesion, each break being identified as an area of fluorescence between parts of the lesion that define the break.

After the breaks are identified, the lesion is completed by ablating tissue within the one or more breaks until there is a lack of fluorescence between parts of the lesion that define each break. The approach uses near-infrared fluorescence imaging with filtered imaging to provide fluorescence versus non-fluorescence contrast, where de novo tissue and blood/perfusion show fluorescence and ablated or coagulative-necrosis lesions show lack of fluorescence.

The processor modules provide lesion-quality assessment, composite or overlay visualization, and warning signals to prompt completion when gaps or breaks appear as fluorescent hot spots along a generally dark lesion.

Claims Coverage

The document provides one independent claim defining the core method, with dependent claims refining imaging, fluorescence characterization, wavelength constraints, and an integrated ablation instrument configuration. The independent claim includes eight inventive features.

Icg administration and fluorescence-induced lesion formation

Administering an ICG composition to the patient, forming one or more lesions at a surgical site, and applying energy of a type and in an amount sufficient to cause ICG in the patient to fluoresce.

Fluorescence imaging to distinguish lesion and identify breaks

Obtaining an image of the tissue and lesion at the surgical site while the ICG fluoresces, and distinguishing the lesion from surrounding de novo tissue based on areas of fluorescence to allow a user to evaluate the quality of the lesion and to identify one or more breaks in the lesion, each break being identified as an area of fluorescence between parts of the lesion that define the break.

Lesion completion by ablating within fluorescence-identified breaks until lack of fluorescence

Completing the lesion by ablating the tissue within the one or more breaks in the lesion until there is a lack of fluorescence between parts of the lesion that define the respective break.

Combined visible and fluorescence images over anatomical landmarks

Combining visible-light endoscope images showing anatomical landmarks with ICG fluorescence images into a single combined image so breaks in the lesion can be seen over the anatomical landmarks.

Characterizing non-fluorescent lesion areas

Characterizing lesion areas that show a lack of fluorescence.

Applying light with wavelength sufficient to cause ICG fluorescence

Applying energy by applying light with a wavelength sufficient to cause ICG to fluoresce.

Using about 805 nm excitation wavelength

Carrying out the method using a wavelength of about 805 nm.

Common ablation instrument integrating energy emitter and fluorescence-inducing light beam

Performing the method using a common ablation instrument that combines an energy emitter and a light beam to apply energy in an amount sufficient to make the ICG composition fluoresce while forming a lesion.

Overall, the claims cover distinguishing lesions from de novo tissue by administering an ICG composition, inducing fluorescence during lesion formation with applied energy, imaging during fluorescence, and using fluorescence areas to identify and then eliminate lesion breaks by completing ablation until lack of fluorescence appears between lesion parts. The dependent claims further specify combining fluorescence with visible-light endoscopic landmarks, characterizing non-fluorescent areas, constraining the excitation wavelength, and using an integrated ablation instrument that provides both energy emission and fluorescence-inducing illumination.

Stated Advantages

Allows a user to evaluate the quality of the lesion.

Identifies one or more breaks in the lesion indicating an incomplete, non-continuous lesion is formed.

Enables completion of the lesion by ablating tissue within identified breaks until lack of fluorescence is present between parts defining each break.

Provides combined image visualization to show lesion breaks over anatomical landmarks.

Uses warning signals/audio-visual cues to prompt spot retreatment when gaps or breaks appear.

Documented Applications

No documented applications found

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