Imaging system

Abstract

Provided herein are imaging systems for a patient including an imaging probe and an imaging assembly. Methods of performing an imaging procedure are also provided. The imaging probe includes: a first elongate shaft; a second elongate shaft positioned within a lumen of the first elongate shaft; a rotatable optical core positioned within a lumen of the second elongate shaft; and an optical assembly positioned proximate a distal end of the rotatable optical core. The optical assembly can direct light to tissue to be imaged and to collect reflected light from the tissue to be imaged. The imaging assembly can emit light into the imaging probe and receive the reflected light collected by the optical assembly.

Description

IMAGING SYSTEMDESCRIPTIONRELATED APPLICATIONS[1] This application claims benefit to United States Provisional Application Serial Number 63 / 542,279 (Docket No. GTY-026-PR1), titled “Imaging System”, filed October 3, 2023, the content of which is incorporated by reference in its entirety.[2] This application is related to United States Provisional Application Serial Number 63 / 635,908 (Docket No. GTY-026-PR2), titled “Imaging System”, filed April 18, 2024, the content of which is incorporated by reference in its entirety.[3] This application is related to United States Provisional Application Serial Number 62 / 148,355 (Docket No.: GTY-001-PR1), titled “Micro-Optic Probes for Neurology”, filed April 16, 2015, the content of which is incorporated by reference in its entirety.[4] This application is related to United States Provisional Application Serial Number 62 / 322,182 (Docket No. GTY-001-PR2), titled “Micro-Optic Probes for Neurology”, filed April 13, 2016, the content of which is incorporated by reference in its entirety.[5] This application is related to International PCT Patent Application Serial Number PCT / US2016 / 027764 (Docket No. GTY-001-PCT), titled “Micro-Optic Probes for Neurology” filed April 15, 2016, Publication Number WO 2016 / 168605, published October 20, 2016, the content of which is incorporated by reference in its entirety.[6] This application is related to United States Patent Application Serial Number 15 / 566,041 (Docket No. GTY-001-US), titled “Micro-Optic Probes for Neurology”, filed October 12, 2017, United States Patent No. 11,278,206, issued March 22, 2022, the content of which is incorporated by reference in its entirety.This application is related to United States Patent Application Serial Number 17 / 668,757 (Docket No. GTY-001-US-CON1), titled “Micro Optic Probes for Neurology”, filed February 10, 2022, United States Publication Number 2022-0218206, published July 14, 2022, the content of which is incorporated by reference in its entirety.[7] This application is related to United States Provisional Application Serial Number 62 / 212,173 (Docket No. GTY-002-PR1), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed August 31, 2015, the content of which is incorporated by reference in its entirety.[8] This application is related to United States Provisional Application Serial Number 62 / 368,387 (Docket No. GTY-002-PR2), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed July 29, 2016, the content of which is incorporated by reference in its entirety.[9] This application is related to International PCT Patent Application Serial Number PCT / US2016 / 049415 (Docket No. GTY-002-PCT), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed August 30, 2016, Publication Number WO 2017 / 040484, published March 9, 2017, the content of which is incorporated by reference in its entirety.

[0010] This application is related to United States Patent Application Serial Number 15 / 751,570 (Docket No. GTY-002-US), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed February 9, 2018, United States Patent No. 10,631,718, issued April 28, 2020, the content of which is incorporated by reference in its entirety.

[0011] This application is related to United States Patent Application Serial Number 16 / 820,991 (Docket No. GTY-002-US-CON1), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed March 17, 2020, United States Patent No. 11,064,873, issued July 20, 2021, the content of which is incorporated by reference in its entirety.

[0012] This application is related to United States Patent Application Serial Number 17 / 350,021 (Docket No. GTY-002-US-CON2), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed June 17, 2021, United States Patent No. 11,583,172, issued February 21, 2023, the content of which is incorporated by reference in its entirety.

[0013] This application is related to United States Patent Application Serial Number 18 / 096,678 (Docket No. GTY-002-US-CON3), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 13, 2023, United States Patent No. 11,937,786, issued March 26, 2024, the content of which is incorporated by reference in its entirety.

[0014] This application is related to United States Patent Application Serial Number 18 / 425,104 (Docket No. GTY-002-US-CON4), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 29, 2024, Publication Number , published , the content of which is incorporated by reference in its entirety.

[0015] This application is related to United States Provisional Application Serial Number 62 / 591,403 (Docket No. GTY-003-PR1), titled “Imaging System”, filed November 28, 2017, the content of which is incorporated by reference in its entirety.

[0016] This application is related to United States Provisional Application Serial Number 62 / 671,142 (Docket No. GTY-003-PR2), titled “Imaging System”, filed May 14, 2018, the content of which is incorporated by reference in its entirety.

[0017] This application is related to International PCT Patent Application Serial Number PCT / US2018 / 062766 (Docket No. GTY-003-PCT), titled “Imaging System”, filed November 28, 2018, Publication Number WO 2019 / 108598, published June 6, 2019, the content of which is incorporated by reference in its entirety.

[0018] This application is related to United States Patent Application Serial Number 16 / 764,087 (Docket No. GTY-003-US), titled “Imaging System”, filed May 14, 2020, Publication Number 2020-0288950, published September 17, 2020, United States Patent No.11,684,242, issued June 27, 2023, the content of which is incorporated by reference in its entirety.

[0019] This application is related to United States Patent Application Serial Number 18 / 144,462 (Docket No. GT Y-003 -US-CON), titled “Imaging System”, filed May 8, 2023, Publication Number 2024-0099564, published March 28, 2024, the content of which is incorporated by reference in its entirety.

[0020] This application is related to United States Provisional Application Serial Number 62 / 732,114 (Docket No. GTY-004-PR1), titled “Imaging System with Optical Pathway”, filed September 17, 2018, the content of which is incorporated by reference in its entirety.

[0021] This application is related to International PCT Patent Application Serial Number PCT / US2019 / 051447 (Docket No. GTY-004-PCT), titled “Imaging System with Optical Pathway”, filed September 17, 2019, Publication Number WO 2020 / 061001, published March 26, 2020, the content of which is incorporated by reference in its entirety.

[0022] This application is related to United States Patent Application Serial Number 17 / 276,500 (Docket No. GTY-004-US), filed March 16, 2021, titled “Imaging system with Optical Pathway”, Publication Number 2021-0267442, published September 2, 2021, the content of which is incorporated by reference in its entirety.

[0023] This application is related to United States Provisional Application Serial Number 63 / 017,258 (Docket No. GTY-005-PR1), titled “Imaging System”, filed April 29, 2020, the content of which is incorporated by reference in its entirety.

[0024] This application is related to International PCT Patent Application Serial Number PCT / US2021 / 29836 (Docket No. GTY-005-PCT), titled “Imaging System”, filed April 29,2021, Publication Number WO 2021 / 222530, published November 4, 2021, the content of which is incorporated by reference in its entirety.

[0025] This application is related to United States Patent Application Serial Number 17 / 919,809 (Docket No. GTY-005-US), filed October 19, 2022, titled “Imaging System”, Publication Number 2023-0181016 published June 15, 2023, the content of which is incorporated by reference in its entirety.

[0026] This application is related to United States Provisional Application Serial Number 62 / 840,450 (Docket No. GTY-011-PR1), titled “Imaging Probe with Fluid Pressurization Element”, filed April 30, 2019, the content of which is incorporated by reference in its entirety.

[0027] This application is related to International PCT Patent Application Serial Number PCT / US2020 / 030616 (Docket No. GTY-011 -PCT), titled “Imaging Probe with Fluid Pressurization Element”, filed April 30, 2020, Publication Number WO 2020 / 223433, published November 5, 2020, the content of which is incorporated by reference in its entirety.

[0028] This application is related to United States Patent Application Serial Number 17 / 600,212 (Docket No. GTY-011-US), titled “Imaging Probe with Fluid Pressurization Element”, filed September 30, 2021, Publication Number 2022-0142462, published May 12,2022, the content of which is incorporated by reference in its entirety.

[0029] This application is related to United States Provisional Application Serial Number 62 / 850,945 (Docket No. GTY-013-PR1), titled “OCT-Guided Treatment of a Patient”, filed May 21, 2019, the content of which is incorporated by reference in its entirety.

[0030] This application is related to United States Provisional Application Serial Number 62 / 906,353 (GTY-013 -PR2), titled “OCT-Guided Treatment of a Patient”, filed September 26, 2019, the content of which is incorporated by reference in its entirety.

[0031] This application is related to International PCT Patent Application Serial Number PCT / US2020 / 033953 (Docket No. GTY-013-PCT), titled “Systems and Methods for OCT- Guided Treatment of a Patient”, filed May 21, 2020, Publication Number WO 2020 / 237024, published November 26, 2020, the content of which is incorporated by reference in its entirety.

[0032] This application is related to United States Patent Application Serial Number 17 / 603,689 (Docket No. GTY-013-US), titled “Systems and Methods for OCT-GuidedTreatment of a Patient”, filed October 14, 2021, Publication Number 2022-0061670, published March 3, 2022, the content of which is incorporated by reference in its entirety.

[0033] This application is related to United States Provisional Application Serial Number 63 / 154,934 (Docket No. GTY-021-PR1), titled “Optical Imaging System”, filed March 1,2021, the content of which is incorporated by reference in its entirety.

[0034] This application is related to United States Patent Application Serial Number 17 / 682,197 (Docket No. GTY-021-US), titled “Optical Imaging System”, filed February 28,2022, Publication Number 2023-0000321, published January 5, 2023, the content of which is incorporated by reference in its entirety.

[0035] This application is related to United States Provisional Application Serial Number 63 / 298,086 (Docket No. GTY-022-PR1), titled “Imaging System for Calculating Fluid Dynamics”, filed January 10, 2022, the content of which is incorporated by reference in its entirety.

[0036] This application is related to International PCT Patent Application Serial Number PCT / US2023 / 010508 (Docket No. GTY-022-PCT), titled “Imaging System for Calculating Fluid Dynamics”, filed January 10, 2023, Publication Number WO 2023 / 133355, published July 13, 2023, the content of which is incorporated by reference in its entirety.

[0037] This application is related to United States Patent Application Serial Number 18 / 724,841 (Docket No. GTY-022-US), titled “Imaging System for Calculating Fluid Dynamics”, filed June 27, 2024, Publication Number , published, the content of which is incorporated by reference in its entirety.

[0038] This application is related to United States Provisional Application Serial Number 63 / 416,170 (Docket No. GTY-023-PR1), titled “Imaging System”, filed October 14, 2022, the content of which is incorporated by reference in its entirety.

[0039] This application is related to International PCT Patent Application Serial Number PCT / US2023 / 035132 (Docket No. GTY-023-PCT), titled “Imaging System”, filed October 13, 2023, Publication Number WO 2024 / 081414, published April 18, 2024, the content of which is incorporated by reference in its entirety.TECHNICAL FIELD

[0040] The present invention relates generally to imaging systems, and in particular, neurovascular and other intravascular imaging systems including imaging probes and delivery devices.BACKGROUND

[0041] Imaging probes have been commercialized for imaging various internal locations of a patient, such as an intravascular probe for imaging a patient's heart. Current imaging probes are limited in their ability to reach certain anatomical locations due to their size and rigidity. Current imaging probes are inserted over a guidewire, which can compromise their placement and limit use of one or more delivery catheters through which the imaging probe is inserted. There is a need for imaging systems that include probes with reduced diameter and high flexibility, as well as systems with one or more delivery devices compatible with these improved imaging probes.BRIEF SUMMARY

[0042] According to a first aspect of the inventive concepts, a method of performing a medical procedure on a patient comprises: selecting an imaging system for a patient. The system can comprise an imaging probe. The imaging probe can comprise: a first elongate shaft comprising a proximal end, a distal portion, a distal end, and a lumen extending at least between the proximal end and the distal portion; a second elongate shaft comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, where at least a portion of the second elongate shaft is positioned within the lumen of the first elongate shaft; a rotatable optical core comprising a proximal end and a distal end, where at least a portion of the rotatable optical core is positioned within the lumen of the second elongate shaft; and an optical assembly positioned proximate the distal end of the rotatable optical core, where the optical assembly configured to direct light to tissue to be imaged and to collect reflected light from the tissue to be imaged. The system can further comprise a console, the console comprising: an imaging assembly constructed and arranged to optically couple to the imaging probe, where the imaging assembly is configured to emit light into the imaging probe and to receive the reflected light collected by the optical assembly. The system can further comprise an implant device for implantation at a location within the brainof the patient. The method further comprises using the system to produce a first set of image data of the patient’s brain prior to, during, and / or after the implantation of the implant device.

[0043] In some embodiments, the implant device comprises an aneurysm treatment device.

[0044] In some embodiments, the implant device comprises one, two, or more devices selected from the group consisting of: a flow diverter; an embolization coil; a stent; a covered stent; an aneurysm treatment implant; and combinations thereof.

[0045] In some embodiments, the method further comprises analyzing the first set of image data. The analysis can be performed by the system, by an operator, or both.

[0046] In some embodiments, the first set of image data comprises one or more vessel measurements. The one or more vessel measurements can comprise side branch diameter measurements, aneurysm diameter measurements, or both.

[0047] In some embodiments, the method further comprises determining one or more implant metrics based on the first set of image data. The one or more implant metrics can comprise a stent apposition assessment, a stent expansion assessment, or both. The system and / or the method can be configured to improve likelihood of successful stent apposition to a level of at least 70%, such as a level of at least 75%, 80%, 85%, 90%, 92%, 94%, and / or 96%. The system and / or the method can be configured to improve likelihood of clinical efficacy to a level of at least 70%, such as a level of at least 75%, 80%, 85%, 90%, 92%, 94%, or 96%.

[0048] The system can further comprise a second imaging device, and the method can further comprise: producing a second set of image data using the second imaging device, and determining one or more implant metrics based on both the first set of image data and the second set of image data. The second imaging device can comprise a fluoroscope, and the second set of image data can comprise angiography data. The one or more implant metrics can comprise a stent apposition assessment, a stent expansion assessment, or both. The first set of image data and / or the second set of image data can comprise one or more vessel measurements. The one or more vessel measurements can comprise side branch diameter measurements, aneurysm diameter measurements, or both. The system and / or the method can be configured to improve likelihood of successful stent apposition to a level of at least 70%, such as a level of at least 75%, 80%, 85%, 90%, 92%, 94%, and / or 96%. The system and / or the method can be configured to improve likelihood of clinical efficacy to a level of at least 70%, such as a level of at least 75%, 80%, 85%, 90%, 92%, 94%, or 96%.

[0049] In some embodiments, the system is configured to produce the first set of image data using no more than 20ml of flushing fluid.

[0050] In some embodiments, the imaging probe is configured to translate and gather the first set of image data when positioned in a blood vessel with a radius of curvature as low as 1.95mm.

[0051] In some embodiments, the system and / or the method are configured to diagnose and / or treat an aneurysm, such as a brain aneurysm, using the first set of image data. The aneurysm can comprise a large aneurysm. The aneurysm can comprise an aneurysm in the posterior cerebral artery. The aneurysm can comprise a small, unruptured aneurysm in the right middle cerebral artery. The aneurysm can comprise a ruptured aneurysm. A stenosis can be present proximate the aneurysm.

[0052] In some embodiments, the first set of image data is collected in a first clinical procedure, and a second clinical procedure is performed based on an analysis of the first set of image data.

[0053] In some embodiments, the system and / or the method are configured to diagnose and / or a treat a patient with multiple comorbidities associated with the patient’s brain.

[0054] In some embodiments, the system and / or the method are configured to diagnose and / or treat intracranial atherosclerotic disease of the patient.

[0055] In some embodiments, the system and / or the method are configured to diagnose and / or treat a patient with a left hemisphere stroke and / or other stroke.

[0056] In some embodiments, the system and / or the method are configured to diagnose and / or treat a patient with presence of thrombus in a blood vessel of the patient’s brain.

[0057] In some embodiments, the first set of image data comprises data related to a previously performed neurovascular treatment.

[0058] In some embodiments, the first set of image data comprises images of structures located outside of the blood vessel in which the imaging probe is positioned. The structures can comprise one, two, or more structures selected from the group consisting of an artery; a vein; one or more structures in the subarachnoid space; one or more small perforating arteries; a meningeal layer; a bony structure; parenchyma; subarachnoid trabeculae; the transition between intracranial and extracranial ICA location; and combinations thereof. The structure can comprise an implanted device that has been planted at a location outside of the blood vessel in which the imaging probe can be positioned. The structure can comprise a structure that can be located at least 3mm, 5mm, and / or 7mm from the imaging probe when the first set of image data can be produced. The structure can comprise a structure that can belocated at least 1mm, 3mm, and / or 5mm from the wall of the blood vessel in which the imaging probe is positioned when the first set of image data can be produced.

[0059] In some embodiments, the system and / or the method are configured to assess a parameter selected from the group consisting of: aneurysm dome shape; aneurysm dome thickness; aneurysm thickness; presence of arterial wall pathologies, such as disruption of the internal elastic lamina; and combinations of these.

[0060] In some embodiments, the system and / or the method are configured to evaluate cerebrospinal fluid appearance in the perivascular space.

[0061] In some embodiments, the system and / or the method are configured to assess the interaction between an implanted device and the wall and / or neck of an aneurysm. The assessment can comprise identifying coverage gaps and / or communicating malapposition of the device with the aneurysm.

[0062] In some embodiments, the system and / or the method are configured to assess healing of a treated aneurysm.

[0063] In some embodiments, the system and / or the method are configured to characterize plaque composition and / or anatomy. The characterization can comprise a characterization of: macrophage accumulations; cholesterol crystals; and / or other inflammation marker. The system and / or the method can be configured to determine stent sizing, stent placement, or both.

[0064] In some embodiments, the system and / or the method are configured to be used in an angioplasty procedure and to detect: a dissection; a plaque rupture; and / or other procedure related iatrogenic effect.

[0065] In some embodiments, the system and / or the method are configured to assess: stent apposition; stent edge apposition; stent degree of expansion; luminal size gain; and / or other stent-plaque interaction.

[0066] In some embodiments, the system and / or the method are configured to assess healing progression related to implantation of a stent or other implantable device. The stent and / or other implantable device can be positioned at least partially over an ostium of a blood vessel.

[0067] In some embodiments, the system and / or the method are configured to assess one, two, or more of: a wall of an artery; an intraluminal implant or other intraluminal material; a structure in the subarachnoid space such as small perforating arteries, veins, brain parenchyma, cranial nerves, and membranes; and combinations of these.

[0068] In some embodiments, the system is configured to deliver light into the patient’s spine, and the first set of image data comprises data related to the patient’s spine. The system and / or the method can be configured to identify cerebrospinal fluid leaks, such as cerebrospinal fluid leaks from a dural / vein fistula.

[0069] In some embodiments, the system further comprises: a user interface comprising a display; and a processing unit comprising a processor and a memory storage component coupled to the processor, where the memory storage component stores instructions for the processor to perform an algorithm, and the algorithm is configured to assess at least the first set of image data. The algorithm can be further configured to assess a second set of image data comprising angiography and / or other data.

[0070] In some embodiments, the system is configured to rotate the rotatable optical core at a rotational rate of at least 200 rotations per second, and / or at least 250 rotations per second.

[0071] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.INCORPORATION BY REFERENCE

[0072] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Fig. 1 illustrates a schematic view of a diagnostic system comprising an imaging probe and one or more algorithms for processing image data, consistent with the present inventive concepts.

[0074] Fig. 1A illustrates a table of patient criteria, consistent with the present inventive concepts.

[0075] Figs. 2A-D illustrate various views of neuro intravascular imaging, consistent with the present inventive concepts.

[0076] Figs. 3A-C illustrate images of various treatments of recurrent aneurysms, consistent with the present inventive concepts.

[0077] Figs. 4A and B illustrate images of various treatments of native brain aneurysms, consistent with the present inventive concepts.

[0078] Fig. 5 illustrates various images of intracranial in-stent restenosis, consistent with the present inventive concepts.

[0079] Figs. 6A-D illustrate various images of intracranial atherosclerotic disease, consistent with the present inventive concepts.

[0080] Figs. 7A and B illustrate various images of thrombectomy procedures in the middle cerebral artery, consistent with the present inventive concepts.

[0081] Figs. 8A and B illustrate various images of neurovascular intervention followups, consistent with the present inventive concepts.

[0082] Figs. 9A and B illustrate various images of two aneurysms treated with intrasaccular devices, consistent with the present inventive concepts.

[0083] Figs. 10A and B illustrate various images of the subarachnoid space, consistent with the present inventive concepts.

[0084] Fig. 11 illustrates various images of a calcified nodule, consistent with the present inventive concepts.

[0085] Fig. 12 illustrates various images of intracranial artery calcifications, consistent with the present inventive concepts.

[0086] Figs. 13A-C illustrate various images of structures surrounding the middle cerebral artery, a ruptured aneurysm, and a vasospasm, respectively, consistent with the present inventive concepts.DETAILED DESCRIPTION OF THE DRAWINGS

[0087] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0088] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and"has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0089] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0090] It will be further understood that when an element is referred to as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0091] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0092] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g., a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0093] Spatially relative terms, such as "beneath," "below," "lower," "above,""upper" and the like may be used to describe an element and / or feature's relationship toanother element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0094] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0095] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example, "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0096] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0097] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0098] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[0099] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0100] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0101] As used herein, the terms “about” or “approximately” shall refer to ±5% of a stated value.

[0102] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0103] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0104] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, theterm “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross section of the component being described.

[0105] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0106] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor, a transducer, or both. In some embodiments, a functional element is configured to deliver energy, deliver a therapeutic treatment, and / or otherwise perform a function. Alternatively or additionally, a functional element (e.g., a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0107] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb), sound (e.g., a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g., an appliedpressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g., a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0108] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0109] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0110] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0111] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0112] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, includingtechnical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0113] Provided herein are systems for diagnosing and / or treating a patient, such as to be used in a medical procedure comprising a diagnostic procedure, a therapeutic procedure (also referred to as a “treatment procedure”), or both. The systems of the present inventive concepts comprise an imaging probe and an imaging assembly. The imaging probe can comprise an elongate shaft, a rotatable optical core, and an optical assembly. The shaft can comprise a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion. The rotatable optical core can comprise a proximal end and a distal end, and at least a portion of the rotatable optical core can be positioned within the lumen of the elongate shaft. The optical assembly can be positioned proximate the distal end of the rotatable optical core and can be configured to direct light to tissue and collect reflected light from the tissue. The imaging systems can comprise one or more algorithms configured to enhance the performance of the system.

[0114] The imaging systems of the present inventive concepts can be used to provide image data representing arteries, veins, and / or other body conduits, and to image one or more devices inserted into those conduits. The imaging system can be used to image tissue and / or other structures outside of the blood vessel and / or other lumen into which the imaging probe is inserted. The imaging systems can provide image data related to healthy tissue, as well as diseased tissue, such as blood vessels including a stenosis, myocardial bridge, and / or other vessel narrowing (“lesion” or “stenosis” herein), and / or blood vessels including an aneurysm. The systems can be configured to provide treatment information (e.g., suggested treatment steps to be performed), such as when the treatment information is used by an operator (e.g., a clinician of the patient) to plan a treatment and / or to predict a treatment outcome.

[0115] Referring now to Fig. 1, a schematic view of a diagnostic system comprising an imaging probe and one or more algorithms for processing image data is illustrated, consistent with the present inventive concepts. System 10 can be configured as a diagnostic system thatis configured to record image data from a patient and produce one or more images based on the recorded data. System 10 can be further configured to analyze the recorded data and / or the produced images (either or both, “image data” herein), such as to provide: diagnostic data relating to a disease or condition of a patient; planning data relating to the planning of a treatment procedure to be performed on a patient; and / or outcome data relating to the efficacy and / or technical outcomes of a treatment procedure.

[0116] System 10 can be constructed and arranged to record optical coherence tomography (OCT) data from an imaging location (e.g., OCT data recorded from a segment of a blood vessel during a pullback procedure, as described herein). In some embodiments, the OCT data recorded by system 10 comprises high-frequency OCT (HF-OCT) data.System 10 can comprise a catheter-based probe, imaging probe 100, as well as a probe interface unit, PIU 200, that is configured to operably attach to imaging probe 100. PIU 200 can comprise rotation assembly 210 and / or retraction assembly 220, where each of these can operably attach to imaging probe 100 to rotate and / or retract, respectively, at least a portion of imaging probe 100. System 10 can comprise console 300 that operably attaches to imaging probe 100, such as via PIU 200. Imaging probe 100 can be introduced into a conduit of the patient, such as a blood vessel or other conduit of the patient, using (e.g., passing through) one or more delivery catheters, delivery catheter 80 shown. Additionally or alternatively, imaging probe 100 can be introduced through an introducer device, such as an endoscope, arthroscope, balloon dilator, or the like. In some embodiments, imaging probe 100 is configured to be introduced into a patient conduit and / or other patient internal site selected from the group consisting of an artery; a vein; an artery within or proximate the heart; a vein within or proximate the heart; an artery within or proximate the brain; a vein within or proximate the brain; a peripheral artery; a peripheral vein; a patient internal site that is accessed through a natural body orifice, such as the esophagus; a patient internal site that is accessed through a surgically created orifice, such as a conduit or other site within the abdomen; and combinations of one or more of these.

[0117] In some embodiments, imaging probe 100 and / or another component of system 10 can be of similar construction and arrangement to the similar components described in applicants co-pending United States Patent Application Serial Number 17 / 668,757 (Docket No. GTY-001-US-CON1), titled “Micro-Optic Probes for Neurology”, filed February 10, 2022. Imaging probe 100 can be constructed and arranged to collect image data from a patient site, such as an intravascular cardiac site, an intracranial site, or other site accessible via the vasculature of the patient. In some embodiments, system 10 can be of similarconstruction and arrangement to the similar systems and their methods of use described in applicants co-pending United States Patent Application Serial Number 18 / 425,104 (Docket No. GTY-002-US-CON4), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 29, 2024.

[0118] Imaging probe 100 can comprise an elongate body comprising one or more elongate shafts and / or tubes, shaft 120 herein. Shaft 120 comprises a proximal end 1201, distal end 1209, and a lumen 1205 extending therebetween. In some embodiments, lumen 1205 can include multiple coaxial lumens within the one or more elongate shafts of shaft 120, such as one or more lumens (e.g., axially aligned lumens) abutting each other to define a single lumen 1205. In some embodiments, at least a portion of shaft 120 comprises a torque shaft. In some embodiments, a portion of shaft 120 comprises a braided construction. In some embodiments, a portion of shaft 120 comprises a spiral cut tube (e.g., shaft 120 includes a spiral cut metal tube). In some embodiments, the pitch of the spiral cut can be varied along the length of the cut, such as to vary the stiffness of shaft 120 along its length. A portion of shaft 120 can comprise a tube constructed of nickel -titanium alloy. Shaft 120 operably surrounds a rotatable optical fiber, optical core 110 (e.g., optical core 110 is positioned within lumen 1205), where core 110 comprises a proximal end 1101 and a distal end 1109. Optical core 110 can comprise a dispersion shifted optical fiber, such as a depressed cladding dispersion shifted fiber (e.g., a Non-Zero Dispersion Shifted, NZDS, fiber). Shaft 120 further comprises a distal portion 1208, including a transparent portion, window 130 (e.g., a window that is relatively transparent to the one or more frequencies of light transmitted through optical core 110). An optical assembly, optical assembly 115, is operably attached to the distal end 1109 of optical core 110. Optical assembly 115 is positioned within window 130 of shaft 120. Optical assembly 115 can comprise a GRIN lens optically coupled to the distal end 1109 of optical core 110. Optical assembly 115 can comprise a construction and arrangement similar to optical assembly 115 as described in applicant’s co-pending United States Patent Application Serial Number 18 / 144,462 (Docket No. GTY-003-US-CON1), titled “Imaging System”, filed May 8, 2023, and applicant’s co-pending United States Patent Application Serial Number 17 / 276,500 (Docket No. GTY-004-US), titled “Imaging System with Optical Pathway”, filed March 16, 2021. In some embodiments, optical core 110 comprises a single continuous length of optical fiber comprising zero splices along its length. In some embodiments, imaging probe 100 comprises a single optical splice, such as a splice being between optical assembly 115 and distal end 1109 of optical core 110 (e.g., when there are zero splices along the length of optical core 110).

[0119] A connector assembly, connector assembly 150, is positioned on the proximal end of shaft 120. Connector assembly 150 operably attaches imaging probe 100 to rotation assembly 210. In some embodiments, connector assembly 150 comprises an optical connector fixedly attached to the proximal end of optical core 110. Imaging probe 100 can comprise a second connector, connector 180, that can be positioned on shaft 120. Connector 180 can be removably attached and / or adjustably positioned along the length of shaft 120. Connector 180 can be positioned along shaft 120, such as by a clinician, technician, and / or other user of system 10 (“user” or “operator” herein), proximate the proximal end of delivery catheter 80 after imaging probe 100 has been inserted into a patient via delivery catheter 80. Shaft 120 can comprise a portion between connector assembly 150 and the placement location of connector 180 that is configured to provide and / or accommodate slack in shaft 120, service loop 185.

[0120] In some embodiments, shaft 120 comprises a multi-part construction, such as an assembly of two or more tubes that can be connected in various ways. In some embodiments, one or more tubes of shaft 120 can comprise tubes made of polyethylene terephthalate (PET), such as when a PET tube surrounds the junction between two tubes (e.g., two portions of shaft 120) in an axial arrangement to create a joint between the two tubes. In some embodiments, one or more PET tubes are under tension after assembly (e.g., the tubes are longitudinally stretched when shaft 120 is assembled), such as to prevent or at least reduce the tendency of the PET tube to wrinkle while shaft 120 is advanced through a tortuous path. In some embodiments, one or more portions of shaft 120 include a coating comprising one, two, or more materials and / or surface modifying processes, such as to provide a hydrophilic coating or a lubricious coating. In some embodiments, one or more metal portions of shaft 120 (e.g., nickel -titanium portions) are surrounded by a tube (e.g., a polymer tube), such as to improve the adhesion of a coating to that portion of shaft 120.

[0121] Imaging probe 100 can comprise one or more visualizable markers along its length (e.g., along shaft 120), marker 131 shown. Marker 131 can comprise one or more markers selected from the group consisting of: radiopaque markers; ultrasonically reflective markers; magnetic markers; ferrous material; and combinations of one or more of these. In some embodiments, marker 131 is positioned at a location along imaging probe 100 selected to assist an operator of system 10 in performing a pullback procedure (“pullback procedure” or “pullback” herein). For example, marker 131 can be positioned approximately one pullback length from distal end 1209 of shaft 120, such that following a pullback, distal end 1209 will be no more proximal than the starting position of marker 131. In someembodiments, prior to a pullback, the operator can position marker 131 at a location distal to the proximal end of an implant, such that after the pullback is completed access into the implant is maintained (e.g., such that imaging probe 100 can be safely advanced through the implant after the pullback).

[0122] In some embodiments, imaging probe 100 includes a viscous dampening material, gel 118 Gel 118 can be positioned within shaft 120 surrounding a distal portion of optical core 110 (e.g., a gel injected or otherwise installed in a manufacturing process). In some embodiment, gel 118 surrounds a portion of optical assembly 115. Alternatively, gel 118 does not surround a portion of optical assembly 115, for example when optical assembly 115 is configured to operate in air. Gel 118 can comprise a non-Newtonian fluid, for example a shear-thinning fluid. In some embodiments, gel 118 comprises a static viscosity of at least 500 centipoise, and a shear viscosity that is less than the static viscosity. In these embodiments, the ratio of static viscosity to shear viscosity of gel 118 can be between 1.2: 1 and 100:1. In some embodiments, gel 118 is injected from the distal end of window 130 (e.g., in a manufacturing process). In some embodiments, gel 118 comprises a gel which is visualizable (e.g., visualizable under UV light, such as when gel 118 includes one or more materials that fluoresce under UV light). In some embodiments, during a manufacturing process in which gel 118 is injected into shaft 120 via window 130, shaft 120 is monitored while gel 118 is visualized (e.g., being illuminated by UV light) such that the injection process can be controlled (e.g., injection is stopped when gel 118 sufficiently ingresses into shaft 120). Gel 118 can comprise a gel as described in reference to applicants co-pending United States Patent Application Serial Number 17 / 668,757 (Docket No. GTY-001-US- CON1), titled “Micro-Optic Probes for Neurology”, filed February 10, 2022, and applicant’s co-pending United States Patent Application Serial Number 18 / 144,462 (Docket No. GTY- 003-US-CON1), titled “Imaging System”, filed May 8, 2023.

[0123] Imaging probe 100 can include a distal tip portion, distal tip 119. In some embodiments, distal tip 119 can comprise a spring tip, such as a spring tip configured to improve the “navigability” of imaging probe 100 (e.g., to improve “trackability” and / or “steerability” of imaging probe 100), for example when probe 100 is translated within a tortuous pathway (e.g., within a blood vessel of the brain or heart with a tortuous pathway). In some embodiments, distal tip 119 comprises a length of between 5mm and 100mm (e.g., a spring with a length between 5mm and 100mm). In some embodiments, distal tip 119 can comprise an operator-shapeable spring tip (e.g., at least a portion of distal tip 119 is malleable). Imaging probe 100 can be rotated (e.g., via connector 180) to adjust the directionof a non-linear shaped portion of distal tip 119 (e.g., to adjust the trajectory of distal tip 119 in the vasculature of the patient). Alternatively or additionally, distal tip 119 can comprise a cap, plug, and / or other element configured to seal the distal opening of window 130. In some embodiments, distal tip 119 can comprise a radiopaque marker configured to increase the visibility of imaging probe 100 under a fluoroscope or other X-ray device. In some embodiments, distal tip 119 can comprise a relatively short luminal guidewire pathway to allow “rapid exchange” translation of imaging probe 100 over a guidewire of system 10 (guidewire not shown).

[0124] In some embodiments, at least the distal portion of imaging probe 100 (e.g., the distal portion of shaft 120 surrounding optical assembly 115) comprises an outer diameter of no more than 0.030”, such as no more than 0.025”, no more than 0.020”, and / or no more than 0.016”.

[0125] In some embodiments, imaging probe 100 can be constructed and arranged for use in an intravascular neural procedure (e.g., a procedure in which the blood, vasculature, and / or other tissue proximate the brain are visualized, and / or devices positioned temporarily or permanently proximate the brain are visualized). An imaging probe 100 configured for use in an intravascular neural procedure (also referred to herein as a “neural procedure”) can comprise an overall length of at least 150 cm, such as a length of approximately 300cm. Alternatively or additionally, imaging probe 100 can be constructed and arranged for use in an intravascular cardiac procedure (e.g., a procedure in which the blood, vasculature, and other tissue proximate the heart are visualized, and / or devices positioned temporarily or permanently proximate the heart are visualized). An imaging probe 100 configured for use in an intravascular cardiac procedure (e.g., also referred to as a “cardiac procedure” or “cardiovascular procedure” herein) can comprise an overall length of at least 120cm, such as an overall length of approximately 280cm (e.g., to allow placement of the proximal end of imaging probe 100 outside of the sterile field). In some embodiments, such as for placement of the proximal end of probe 100 outside of the sterile field, imaging probe 100 can comprise a length greater than 220 cm, such as a length of at least 220cm but less than 320cm.

[0126] In some embodiments, imaging probe 100 comprises an element, FPE 1500 shown, which can be configured as a fluid propulsion element and / or a fluid pressurization element (“fluid pressurization element” herein). FPE 1500 can be configured to prevent and / or reduce the presence of bubbles within gel 118 proximate optical assembly 115. FPE 1500 can be fixedly attached to optical core 110, where rotation of optical core 110 in turn rotates FPE 1500, such as to generate a pressure increase within gel 118 that is configured toreduce presences of bubbles from locations proximate optical assembly 115. Such one or more fluid pressurization elements FPE 1500 can be constructed and arranged to: reduce the likelihood of bubble formation within gel 118, reduce the size of bubbles within gel 118, and / or move any bubbles formed within gel 118 away from a location that would adversely impact the collecting of image data by optical assembly 115 (e.g., move bubbles away from optical assembly 115). In some embodiments, a fluid propulsion element FPE 1500 of imaging probe 100 comprises a similar construction and arrangement to a fluid propulsion element described in applicant’s co-pending United States Patent Application Serial Number 17 / 600,212 (Docket No. GTY-011-US), titled “Imaging Probe with Fluid Pressurization Element”, filed September 30, 2021.

[0127] In some embodiments, delivery catheter 80 comprises an elongate shaft, shaft 81 shown, which includes a lumen 84 therethrough and a connector 82 positioned on its proximal end. Connector 82 can comprise a Touhy or other valved connector, such as a valved connector configured to prevent fluid egress from the associated delivery catheter 80 (with and / or without a separate shaft positioned within the connector 82). Connector 82 can comprise port 83, such as one or more ports constructed and arranged to allow introduction of fluid into delivery catheter 80 and / or for removing fluids from delivery catheter 80. In some embodiments, a flushing fluid, such as is described herein, is introduced via one or more ports 83, such as to remove blood or other undesired material from locations proximate optical assembly 115 (e.g., from a location proximal to optical assembly 115 to a location distal to optical assembly 115). Port 83 can be positioned on a side of connector 82 and can include a luer fitting and a cap and / or valve. Shafts 81, connectors 82, and ports 83 can each comprise standard materials and be of similar construction to commercially available introducers, guide catheters, diagnostic catheters, intermediate catheters and microcatheters used in interventional procedures today. Delivery catheter 80 can comprise a catheter configured to deliver imaging probe 100 to an intracerebral location, an intracardiac location, and / or another location within a patient.

[0128] Delivery catheter 80 can comprise two or more delivery catheters, such as three or more delivery catheters. Delivery catheter 80 can comprise at least a vascular introducer, and other delivery catheters that can be inserted into the patient (e.g., through the vascular introducer, after the vascular introducer is positioned through the skin of the patient). Delivery catheter 80 can comprise sets of two or more delivery catheters collectively comprising sets of various inner diameters (IDs) and outer diameters (ODs) such that a firstdelivery catheter 80 slidingly receives a second delivery catheter 80 (e.g., the second delivery catheter OD is less than or equal to the first delivery catheter ID), and the second delivery catheter 80 slidingly receives a third delivery catheter 80 (e.g., the third delivery catheter OD is less than or equal to the second delivery catheter ID), and so on. In these configurations, the first delivery catheter 80 (e.g., its distal end) can be advanced to a first anatomical location, the second delivery catheter 80 (e.g., its distal end) can be advanced through the first delivery catheter to a second anatomical location distal or otherwise remote (hereinafter “distal”) to the first anatomical location, and so on as appropriate, using sequentially smaller diameter delivery catheters. In some embodiments, delivery catheter 80 can be of similar construction and arrangement to the similar components described in applicants co-pending United States Patent Application Serial Number 18 / 425,104 (Docket No. GTY-002-US- CON4), titled “Imaging System Includes Imaging Probe and Delivery Devices”, filed January 29, 2024.

[0129] In some embodiments, delivery catheter 80 comprises a guide extension catheter, such as a catheter including a coil -reinforced hollow shaft, and a push wire attached to the proximal end of the shaft. The shaft can include a skived (partial circumferential) proximal portion for ease of insertion of a separate device (e.g., a treatment device and / or probe 100) through the shaft.

[0130] Rotation assembly 210 operably attaches to connector assembly 150 of imaging probe 100. Rotation assembly 210 can comprise one or more rotary joints, optical connectors, rotational actuators (e.g., motors), and / or linkages, configured to operably attach to, allow the rotation of, and / or cause the rotation of optical core 110. Connector assembly 150 can be constructed and arranged to removably attach to rotation assembly 210, and to allow a rotating connection between proximal end 1101 and a rotating fiber optic joint (such as a fiber optic rotary joint or FORI). Rotation assembly 210 can be of similar construction and arrangement to similar components described in applicant’s co-pending United States Patent Application Serial Number 18 / 144,462 (Docket No. GTY-003-US-CON1), titled “Imaging System”, filed May 8, 2023, and applicant’s co-pending United States Patent Application Serial Number 17 / 276,500 (Docket No. GTY-004-US), titled “Imaging System with Optical Pathway”, filed March 16, 2021. Rotation assembly 210 can be configured to rotate optical core 110 at speeds of at least 100 rotations per second, such as at least 200 rotations per second or 250 rotations per second, or at speeds between 20 rotations per second and 1000 rotations per second. Rotation assembly 210 can comprise a rotational actuator selected from the group consisting of a motor; a servo; a stepper motor (e.g., a stepper motorincluding a gear box); an actuator; a hollow core motor; and combinations thereof. In some embodiments, rotation assembly 210 is configured to rotate optical assembly 115 and optical core 110 in unison.

[0131] Retraction assembly 220 operably attaches to imaging probe 100, such as to retract imaging probe 100 relative to a patient access site. A retraction element 2210 can operably attach to retraction assembly 220 and imaging probe 100, such as to transfer a retraction force from retraction assembly 220 to imaging probe 100. Retraction element 2210 can comprise a conduit 2211, surrounding a linkage 2212, slidingly received therein. Retraction element 2210 can comprise a connector 2213 that operably attaches to retraction assembly 220, such that retraction assembly 220 can retract linkage 2212 relative to conduit 2211. In some embodiments, conduit 2211 comprises a connector 2214 that operably attaches to a reference point near the patient access site, for example to connector 82 of delivery catheter 80, such as to establish a reference for retraction of imaging probe 100 relative to the patient. Connector 2214 can attach to a reference point such as by attaching to a patient introduction device, surgical table, and / or another fixed or semi fixed point of reference. Linkage 2212 releasably attaches to connector 180 of imaging probe 100. Retraction assembly 220 retracts at least a portion of imaging probe 100 (e.g., the portion of imaging probe 100 distal to the attached connector 180) relative to the established reference by retracting linkage 2212 relative to conduit 2211 (e.g., retract a portion of linkage 2212 exiting a portion of conduit 2211, as shown). In some embodiments, retraction assembly 220 is configured to retract at least a portion of imaging probe 100 (e.g., at least optical assembly 115 and a portion of shaft 120) at a rate of between 5mm / sec and 200mm / sec, or between 5mm / sec and lOOmm / sec, such as a rate of approximately 60mm / sec. Additionally or alternatively, a pullback procedure can be performed during a time period of between 0.5sec and 25sec, for example approximately 20sec (e.g., over a distance of 100mm at 5mm / sec). Service loop 185 of imaging probe 100 can be positioned between connector 180, and rotation assembly 210, such that imaging probe 100 can be retracted relative to the patient while rotation assembly 210 remains stationary (e.g., attached to the surgical table and / or to a portion of console 300).

[0132] Retraction assembly 220 further comprises a motive element configured to retract linkage 2212. In some embodiments, the motive element comprises a linear actuator, a worm drive operably attached to a motor, a pulley system, and / or other linear force transfer mechanisms. Linkage 2212 can be operably attached to the motive element via one or more linkages and / or connectors. Retraction assembly 220 can be of similar construction andarrangement to similar components described in applicant’s co-pending United States Patent Application Serial Number 18 / 144,462 (Docket No. GTY-003-US-CON1), titled “Imaging System”, filed May 8, 2023.

[0133] In some embodiments, PIU 200 can comprise a single discrete component (e.g., a single housing) which can contain both rotation assembly 210 and retraction assembly 220. Alternatively or additionally, PIU 200 can comprise two or more discrete components (e.g., two or more housings), such as a separate component for each of rotation assembly 210 and retraction assembly 220. In some embodiments, connector assembly 150, service loop 185, retraction element 2210, and connector 2213 are included in a single discrete component (e.g., housed within a single housing) and configured to operably attach to both rotation assembly 210 and retraction assembly 220 (e.g., such as when rotation assembly 210 and retraction assembly 220 are housed within a single housing or otherwise included in a single discrete component).

[0134] In some embodiments, system 10 includes a supplementary imaging device (e.g., in addition to imaging probe 100), second imaging device 15. Second imaging device 15 can comprise an imaging device such as one or more imaging devices selected from the group consisting of an X-ray; a fluoroscope such as a single plane or biplane fluoroscope; a CT Scanner; an MRI; a PET Scanner; an ultrasound imager; and combinations of one or more of these. In some embodiments, second imaging device 15 comprises a device configured to perform rotational angiography.

[0135] In some embodiments, system 10 includes a device configured to treat the patient (e.g., provide one or more therapies to the patient), treatment device 16. Treatment device 16 can comprise an occlusion treatment device and / or other treatment device selected from the group consisting of a balloon catheter constructed and arranged to dilate a stenosis or other narrowing of a blood vessel; a drug eluting balloon; an aspiration catheter; a sonolysis device; an atherectomy device; a thrombus removal device such as a stent retriever device; a Trevo™ stentriever; a Solitaire™ stentriever; a Revive™ stentriever; an Eric™ stentriever; a Lazarus™ stentriever; a stent delivery catheter; a microbraid implant; an embolization system; a WEB™ embolization system; a Luna™ embolization system; a Medina™ embolization system; and combinations of one or more of these. In some embodiments, imaging probe 100 and / or another component of system 10 is configured to collect data related to treatment device 16 (e.g., treatment device 16 location, orientation and / or other configuration data), after treatment device 16 has been inserted into the patient.

[0136] System 10 can further comprise one or more devices that are configured to monitor one, two, or more physiologic and / or other parameters of the patient, such as patient monitor 17 shown. Patient monitor 17 can comprise one or more monitoring devices selected from the group consisting of: an ECG monitor; an EEG monitor; a blood pressure monitor; a blood flow monitor; a respiration monitor; a patient movement monitor; a T-wave trigger monitor; and combinations of these.

[0137] System 10 can further comprise one or more fluid injectors, injector 20 shown, each of which can be configured to inject one or more fluids, such as a flushing fluid, an imaging contrast agent (e.g., a radiopaque contrast agent, hereinafter “contrast”) and / or other fluid, such as injectate 21 shown. Injector 20 can comprise a power injector, syringe pump, peristaltic pump or other fluid delivery device configured to inject a contrast agent, such as radiopaque contrast, and / or other fluids. In some embodiments, injector 20 is configured to deliver contrast and / or other fluid (e.g., contrast, saline, and / or dextran). In some embodiments, injector 20 delivers fluid in a flushing procedure, such as is described herein. In some embodiments, injector 20 delivers contrast or other fluid through delivery catheter 80 comprising an ID of between 5Fr and 9Fr, a delivery catheter 80 comprising an ID of between 0.53” to 0.70”, or a delivery catheter 80 comprising an ID between 0.0165” and 0.027”. In some embodiments, contrast or other fluid is delivered through a delivery catheter as small as 4Fr (e.g., for distal injections). In some embodiments, injector 20 delivers contrast and / or other fluid through the lumen of delivery catheter 80, while one or more smaller delivery catheters 80 also reside within the lumen of delivery catheter 80. In some embodiments, injector 20 is configured to deliver two dissimilar fluids simultaneously and / or sequentially, such as a first fluid delivered from a first reservoir and comprising a first concentration of contrast, and a second fluid from a second reservoir and comprising less or no contrast.

[0138] Injectate 21 can comprise fluid selected from the group consisting of: optically transparent material; saline; visualizable material; contrast; dextran; an ultrasonically reflective material; a magnetic material; and combinations thereof. Injectate 21 can comprise contrast and saline. Injectate 21 can comprise at least 20% contrast. During collection of image data (e.g., during a pullback), a flushing procedure can be performed, such as by delivering one or more fluids, (e.g., injectate 21 as propelled by injector 20 or other fluid delivery device), to remove blood or other somewhat opaque material (hereinafter nontransparent material) proximate optical assembly 115 (e.g., to remove non-transparent material between optical assembly 115 and a delivery catheter and / or non-transparentmaterial between optical assembly 115 and a vessel wall), such as to allow light distributed from optical assembly 115 to reach and reflectively return from all tissue and other objects to be imaged. In these flushing embodiments, inj ectate 21 can comprise an optically transparent material, such as saline. Inj ectate 21 can comprise one or more visualizable materials, as described herein.

[0139] As an alternative or in addition to its use in a flushing procedure, inj ectate 21 can comprise material configured to be viewed by second imaging device 15, such as when inj ectate 21 comprises a contrast material configured to be viewed by a second imaging device 15 comprising a fluoroscope and / or other X-ray device; an ultrasonically reflective material configured to be viewed by a second imaging device 15 comprising an ultrasound imager; and / or a magnetic material configured to be viewed by a second imaging device 15 comprising an MRI.

[0140] System 10 can further comprise an implant, such as implant 31, which can be implanted in the patient via a delivery device, such as an implant delivery device 30 and / or delivery catheter 80. Implant 31 can comprise an implant (e.g., a temporary or chronic implant) for treating, for example, a vascular occlusion and / or an aneurysm. In some embodiments, implant 31 comprises one or more implants selected from the group consisting of: a flow diverter; a Pipeline™ flow diverter; a Surpass™ flow diverter; an embolization coil; a stent; a Wingspan™ stent; a covered stent; an aneurysm treatment implant; and combinations of one or more of these.

[0141] Implant delivery device 30 can comprise a catheter and / or other tool used to deliver implant 31, such as when implant 31 comprises a self-expanding or balloon expandable portion. In some embodiments, system 10 comprises imaging probe 100, one or more implants 31 and / or one or more implant delivery devices 30. In some embodiments, imaging probe 100 is configured to collect data related to implant 31 and / or implant delivery device 30 (e.g., implant 31 and / or implant delivery device 30 anatomical location, orientation and / or other configuration data), after implant 31 and / or implant delivery device 30 has been inserted into the patient.

[0142] In some embodiments, one or more system 10 components, such as second imaging device 15, treatment device 16, patient monitor 17, injector 20, implant delivery device 30, delivery catheter 80, imaging probe 100, PIU 200, rotation assembly 210, retraction assembly 220, and / or console 300, further comprise one or more functional elements (“functional element” herein), such as functional elements 99a, 99b, 99c, 99d, 99e, 89, 199, 299, 219, 229, and / or 399, respectively, each as shown. Each functional element cancomprise at least two functional elements. Each functional element can comprise one or more elements selected from the group consisting of: sensor; transducer; and combinations thereof. The functional element can comprise a sensor configured to produce a signal. The functional element can comprise a sensor selected from the group consisting of: a physiologic sensor; a pressure sensor; a strain gauge; a position sensor; a GPS sensor; an accelerometer; a temperature sensor; a magnetic sensor; a chemical sensor; a biochemical sensor; a protein sensor; a flow sensor such as an ultrasonic flow sensor; a gas detecting sensor such as an ultrasonic bubble detector; a sound sensor such as an ultrasound sensor; and combinations thereof. The sensor can comprise a physiologic sensor selected from the group consisting of: a pressure sensor such as a blood pressure sensor; a blood gas sensor; a flow sensor such as a blood flow sensor; a temperature sensor such as a blood or other tissue temperature sensor; and combinations thereof. The sensor can comprise a position sensor configured to produce a signal related to a vessel path geometry (e.g., a 2D or 3D vessel path geometry). The sensor can comprise a magnetic sensor. The sensor can comprise a flow sensor. The system can further comprise an algorithm configured to process the signal produced by the sensor-based functional element. Each functional element can comprise one or more transducers. Each functional element can comprise one or more transducers selected from the group consisting of: a heating element such as a heating element configured to deliver sufficient heat to ablate tissue; a cooling element such as a cooling element configured to deliver cryogenic energy to ablate tissue; a sound transducer such as an ultrasound transducer; a vibrational transducer; and combinations thereof.

[0143] In some embodiments, imaging probe 100 comprises an overall length of at least 120cm, such as at least 160cm, such as approximately 280cm. In some embodiments, imaging probe 100 comprises an overall length of no more than 350cm. In some embodiments, imaging probe 100 comprises a length configured to be inserted into the patient (“insertable length” herein) of at least 90cm, such as at least 100cm, such as approximately 145cm. In some embodiments, imaging probe 100 comprises an insertable length of no more than 250cm, such as no more than 200cm. In some embodiments, distal tip119 comprises a spring tip with a length of at least 5mm, such as at least 25mm, such as approximately 15mm. In some embodiments, distal tip 119 comprises a spring tip with a length of no more than 75mm, such as no more than 30mm. In some embodiments, a distal portion of shaft 120 (e.g., window 130) comprises an outer diameter of less than 2Fr, such as less than 1.4Fr, such as approximately l. lFr. In some embodiments, a distal portion of shaft120 (e.g., window 130) comprises an outer diameter of at least 0.5Fr, such as at least 0.9Fr.In some embodiments, shaft 120 comprises one or more materials selected from the group consisting of: polyether ether ketone (PEEK); nylon; polyether block amide; nickel -titanium alloy; and combinations of these.

[0144] In some embodiments, at least a portion of imaging probe 100 (e.g., the most flexible portion) is configured to safely and effectively be positioned in a radius of curvature as low as 5mm, 4mm, 3mm, 2mm, and / or 1mm. In some embodiments optical core 110 comprises an optical fiber with a diameter of less than 120pm, such as less than 100pm, such as less than 80pm, such as less than 60pm, such as approximately 40pm. In some embodiments, optical core 110 comprises a numerical aperture of one or more of 0.11, 0.14, 0.16, 0.17, 0.18, 0.20, and / or 0.25. In some embodiments, optical assembly 115 comprises a lens selected from the group consisting of: a GRIN lens; a molded lens; a shaped lens, such as a melted and polished lens; a lens comprising an axicon structure, (e.g., an axicon nanostructure); and combinations of these. In some embodiments, optical assembly 115 comprises a lens with an outer diameter of less than 200pm, such as less than 170pm, such as less than 150pm, such as less than 100pm, such as approximately 80pm. In some embodiments optical assembly 115 comprises a lens with a length of less than 3mm, such as less than 1.5mm. In some embodiments, optical assembly 115 comprises a lens with a length of at least 0.5mm, such as at least 1mm. In some embodiments, optical assembly 115 comprises a lens with a focal length of at least 0.5mm and / or no more than 5.0mm, such as at least 1.0mm and / or no more than 3.0mm, such as a focal length of approximately 0.5mm. In some embodiments, optical assembly 115 can comprise longer focal lengths, such as to view structures outside of the blood vessel in which optical assembly 115 is inserted. In some embodiments, optical assembly 115 has a working distance (also termed depth of field, confocal distance, or Rayleigh Range) of up to 1mm, such as up to 5mm, such as up to 10mm, such as a working distance of at least 1mm and / or no more than 5mm. In some embodiments, optical assembly 115 comprises an outer diameter of at least 80pm and / or no more than 200pm, such as at least 150pm and / or no more than 170pm, such as an outer diameter of approximately 150pm. In some embodiments, system 10 (e.g., retraction assembly 220) is configured to perform a pullback of imaging probe 100 at a speed of at least lOmm / sec and / or no more than 300mm / sec, such as at least 50mm / sec and / or no more than 200mm / sec, such as a pullback speed of approximately lOOmm / sec. In some embodiments, system 10 (e.g., retraction assembly 220) is configured to perform a pullback for a distance of at least 25mm and / or no more than 200mm, such as at least 25mm and / or no more than 150mm, such as a distance of approximately 50mm. In some embodiments, system 10 (e.g.,retraction assembly 220) is configured to perform a pullback over a time period of at least 0.2 seconds and / or no more than 5.0 seconds, such as at least 0.5 seconds and / or no more than 2.0 seconds, such as a time period of approximately 1.0 second. In some embodiments, system 10 (e.g., rotation assembly 210) is configured to rotate optical core 110 at an angular velocity of at least 20 rotations per second and / or no more than 1000 rotations per second, such as at least 100 rotations per second and / or no more than 500 rotations per second, such as an angular velocity of approximately 250 rotations per second. In some embodiments, delivery catheter 80 comprises an inner diameter of at least 0.016” and / or no more than 0.050”, such as at least 0.016” and / or no more than 0.027”, such as an inner diameter of approximately 0.021”.

[0145] In some embodiments, console 300 comprises imaging assembly 320 that can be configured to provide light to optical assembly 115 (e.g., via optical core 110) and collect light from optical assembly 115 (e.g., via optical core 110). Imaging assembly 320 can include a light source 325. Light source 325 can comprise one or more light sources, such as one or more light sources configured to provide one or more wavelengths of light to optical assembly 115 via optical core 110. Light source 325 is configured to provide light to optical assembly 115 (via optical core 110) such that image data can be collected comprising cross- sectional, longitudinal and / or volumetric information related to a patient site or implanted device being imaged. Light source 325 can be configured to provide light such that the image data collected includes characteristics of tissue within the patient site being imaged, such as to quantify, qualify or otherwise provide information related to a patient disease or disorder present within the patient site being imaged. Light source 325 can be configured to deliver broadband light and have a center wavelength in the range from 350nm to 2500nm, from 800nm to 1700nm, from 1280 nm to 1310nm, or approximately 1300nm (e.g., light delivered with a sweep range from 1250nm to 1350nm). Light source 325 can comprise a sweep rate of at least 20kHz. In some embodiments, light source 325 comprises a sweep rate of at least lOOKHz, such as at least 200Khz, 300KHz, 400KHz, and / or 500KHz, for example approximately 200kHz. These faster sweep rates provide numerous advantages (over similar systems comprising slower sweep rates), such as to provide a higher frame rate, as well as being compatible with rapid pullback and rotation rates. For example, the higher sweep rate enables the requisite sampling density (e.g., the amount of luminal surface area swept by the rotating beam) to be achieved in a shorter time, advantageous in most situations and especially advantageous when there is relative motion between the probe and the surface / tissue being imaged such as arteries in a beating heart. Light source 325 bandwidthcan be selected to achieve a desired resolution, which can vary according to the needs of the intended use of system 10. In some embodiments, bandwidths are about 5% to 15% of the center wavelength, which allows resolutions of between 20qm and 5qm. Light source 325 can be configured to deliver light at a power level meeting ANSI Class 1 (“eye safe”) limits, though higher power levels can be employed. In some embodiments, light source 325 delivers light in the 1.3 pm band at a power level of approximately 20mW. Tissue light scattering is reduced as the center wavelength of delivered light increases, however water absorption increases. Light source 325 can deliver light at a wavelength approximating 1300nm to balance these two effects. Light source 325 can be configured to deliver shorter wavelength light (e.g., approximately 800nm light) to traverse patient sites to be imaged including large amounts of fluid. Alternatively or additionally, light source 325 can be configured to deliver longer wavelengths of light (e.g., approximately 1700nm light), such as to reduce a high level of scattering within a patient site to be imaged. In some embodiments, light source 325 comprises a tunable light source (e.g., light source 325 emits a single wavelength that changes repetitively over time), and / or a broad-band light source. Light source 325 can comprise a single spatial mode light source or a multimode light source (e.g., a multimode light source with spatial filtering).

[0146] Light source 325 can comprise a relatively long effective coherence length, such as a coherence length of greater than 10mm, such as a length of at least 50mm, at all frequencies within the bandwidth of the light source. This coherence length capability enables longer effective scan ranges to be achieved by system 10, as the light returning from distant objects to be imaged (e.g., tissue) must remain in phase coherence with the returning reference light, in order to produce detectable interference fringes. In the case of a swept- source laser, the instantaneous linewidth is very narrow (i.e. as the laser is sweeping, it is outputting a very narrow frequency band that changes at the sweep rate). Similarly, in the case of a broad-bandwidth source, the detector arrangement must be able to select very narrow linewidths from the spectrum of the source. The coherence length scales inversely with the linewidth. Longer scan ranges enable larger or more distant objects to be imaged (e.g., more distal tissue to be imaged). Current systems have lower coherence length, which correlates to reduced image capture range as well as artifacts (ghosts) that arise from objects outside the effective scan range.

[0147] In some embodiments, light source 325 comprises a sweep bandwidth of at least 30nm and / or no more than 250nm, such as at least 50nm and / or no more than 150nm, such as a sweep bandwidth of approximately lOOnm. In some embodiments, light source 325comprises a center wavelength of at least 800nm and / or no more than 1800nm, such as at least 1200nm and / or no more than 1350nm, such as a center wavelength of approximately 1300nm. In some embodiments, light source 325 comprises an optical power of at least 5mW and / or no more than 500mW, such as at least lOmW and / or no more than 50mW, such as an optical power of approximately 20mW.

[0148] System 10 can comprise one or more operably-connecting cables or other conduits, bus 58 shown. Bus 58 can operably connect PIU200 to console 300, rotation assembly 210 to console 300 (as shown), retraction assembly 220 to console 300, and / or rotation assembly 210 to retraction assembly 220. Bus 58 can comprise one or more optical transmission fibers, wires, traces, and / or other electrical transmission cables, fluid conduits, and combinations of one or more of these. In some embodiments, bus 58 comprises at least an optical transmission fiber that optically couples rotation assembly 210 to imaging assembly 320 of console 300. Additionally or alternatively, bus 58 comprises at least power and / or data transmission cables that transfer power and / or drive signals to one or more of motive elements of rotation assembly 210 and / or retraction assembly 220.

[0149] Console 300 can include processing unit 310, which can comprise a module (e.g., an electronics module) that can be configured to perform and / or facilitate one or more functions of system 10, such as one or more processes, energy deliveries (e.g., light energy deliveries), data collections, data analyses, data transfers, signal processing, and / or other functions of system 10 (“functions” herein). Processing unit 310 can include one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations of one, two, or more of these. For example, processing unit 310 can include at least one processor and at least one memory storge component, such as processor 312, memory 313, each shown. Memory 313 can be coupled to processor 312, and memory 313 can store instructions used by processor 312 to perform one or more algorithms of system 10. For example, system 10 can comprise one or more algorithms, algorithm 315 shown, that are performed by processor 312 and / or another similar arrangement of a processor and instructions stored in memory (e.g., processors and memory of processing unit 410 described herein). Algorithm 315 can comprise one or more machine learning, neural net, and / or other artificial intelligence algorithms (“Al algorithm” herein). All or a portion ofalgorithm 315 can be integrated into (e.g., stored in the memory of) one, two, or more of the various components of system 10, such as a server (e.g., server 400 described herein), a device or other component of system 10 comprising a processor, and / or a console of system 10 (e.g., console 300). System 10 can include an interface, user interface 350, for providing and / or receiving information to and / or from an operator of system 10. User interface 350 can be integrated into console 300 as shown. In some embodiments, user interface 350 can comprise a component separate from console 300, such as a display separate from, but operably attached to, console 300. User interface 350 can include one, two, or more user input and / or user output components. For example, user interface 350 can comprise a joystick, keyboard, mouse, touchscreen, and / or another human interface device, user input device 351 shown. In some embodiments, user interface 350 comprises a display (e.g., a touchscreen display), such as display 352, also shown. In some embodiments, processor 312 can provide a graphical user interface, GUI 353, to be presented on and / or provided by display 352. Algorithm 315 can be configured to perform one or more software routines that enable user control of one or more functions of system 10. The one or more software routines performed by algorithm 315 can comprise a graphical user interface, such as GUI 353. User interface 350 can include an input and / or output device selected from the group consisting of: a speaker; an indicator light, such as an LED indicator; a haptic feedback device; a foot pedal; a switch such as a momentary switch; a microphone; a camera, for example when processor 312 enables eye tracking and / or other input via image processing; and combinations of these.

[0150] In some embodiments, system 10 includes a data storage and processing device, server 400. Server 400 can comprise an “off-site” server (e.g., outside of the clinical site in which patient image data is recorded), such as a server owned, maintained, and / or otherwise provided by the manufacturer of system 10. Alternatively or additionally, server 400 can comprise a cloud-based server. Server 400 can include processing unit 410 shown, which can be configured to perform one or more functions of system 10, such as one or more functions described herein. Processing unit 410 can include one or more algorithms, algorithm 415. Processing unit 410 can comprise a memory (not shown) storing instructions for performing algorithm 415. Server 400 can be configured to receive and store various forms of data, such as: image data, diagnostic data, planning data and / or outcome data described herein, data 420. In some embodiments, data 420 can comprise data collected from multiple patients (e.g., multiple patients treated with system 10), such as data collected during and / or after clinical procedures where image data was collected from the patient viasystem 10. For example, image data can be collected via imaging probe 100, recorded by processing unit 310 of console 300, and sent to server 400 for analysis. In some embodiments, console 300 and server 400 can communicate over a network, for example, a wide area network such as the Internet. Alternatively or additionally, system 10 can include a virtual private network (VPN) through which various devices of system 10 transfer data.

[0151] As described herein, the one or more functions of system 10 performed by processing unit 310 and / or 410 can be performed by either or both processing units. For example, in some embodiments, image data is collected and preprocessed by processing unit 310 of console 300. The preprocessed image data can then be transferred to server 400, where the image data is further processed. The processed image data can then be transferred back to console 300 to be displayed to the operator (e.g., via GUI 353). In some embodiments, a first set of one or more images (“image” herein) that is based on a first set of image data (e.g., an image processed locally via processing unit 310) is displayed to the operator following the collection of the image data (e.g., in near-real-time), and a second image based on the first set of image data (e.g., an image processed remotely via processing unit 410) is displayed to the operator subsequently (e.g., when the first image was displayed while the second image was processed).

[0152] In some embodiments, algorithm 315 is configured to adjust (e.g., automatically and / or semi -automatically adjust) one or more operational parameters of system 10, such as an operational parameter of console 300, imaging probe 100 and / or a delivery catheter 80. Additionally or alternatively, algorithm 315 can be configured to adjust an operational parameter of a separate device, such as injector 20 and / or implant delivery device 30 described herein. In some embodiments, algorithm 315 is configured to adjust an operational parameter based on one or more sensor signals, such as a sensor signal provided by a sensorbased functional element of the present inventive concepts as described herein. Algorithm 315 can be configured to adjust (e.g., automatically adjust and / or recommend the adjustment of) an operational parameter selected from the group consisting of: a rotational parameter such as rotational velocity of optical core 110 and / or optical assembly 115; a retraction parameter of shaft 120 and / or optical assembly 115 such as retraction velocity, distance, start position, end position and / or retraction initiation timing (e.g., when retraction is initiated); a position parameter such as position of optical assembly 115; a line spacing parameter such as lines per frame; an image display parameter such as a scaling of display size to vessel diameter; an imaging probe 100 configuration parameter; an inj ectate 21 parameter such as asaline to contrast ratio configured to determine an appropriate index of refraction; a light source 325 parameter such as power delivered and / or frequency of light delivered; and combinations of one or more of these. In some embodiments, algorithm 315 is configured to adjust (e.g., automatically adjust and / or recommend the adjustment of) a retraction parameter such as a parameter triggering the initiation of the pullback, such as a pullback that is initiated based on a parameter selected from the group consisting of lumen flushing (the lumen proximate optical assembly 115 has been sufficiently cleared of blood or other matter that would interfere with image creation); an indicator signal is received from injector 20 (e.g., a signal indicating sufficient flushing fluid has been delivered); a change in image data collected (e.g., a change in an image is detected, based on the image data collected, that correlates to proper evacuation of blood from around optical assembly 115); and combinations of one or more of these. In some embodiments, algorithm 315 is configured to adjust a system 10 configuration parameter related to imaging probe 100, such as when algorithm 315 identifies (e.g., automatically identifies via an RF or other embedded ID) the attached imaging probe 100 and adjusts a system 10 parameter, such as an optical path length parameter, a dispersion parameter, a catheter-type parameter, an “enabled-feature” parameter (e.g., a parameter that locks and / or unlocks the use of a feature of system 10), a calibration parameter (such as an optical length to physical length conversion parameter), and / or other parameter as listed above. In some embodiments, console 300 is configured to record one or more metrics associated with the performance of imaging probe 100, such as a brightness score. These metrics can be encoded onto probe 100 during use (e.g., encoded into an onboard memory of probe 100, such as onto a writeable RFID tag). Additionally or alternatively, fault information can be encoded onto probe 100 (e.g., written onto an RFID tag), such as when a fault occurs and / or is detected by system 10. For example, fault information can include date and time of image loss, and / or other diagnostic information, such as inability to calibrate.

[0153] In some embodiments, algorithm 315 is configured to trigger the initiation of a pullback based on a time-gated parameter. In some embodiments, a T-wave trigger (e.g., provided by a separate device) can be provided to console 300 to begin pullback when the low-motion portion of the heart cycle is detected. As an alternative to a T-wave trigger, or in addition to it, motion patterns (e.g., relative motion patterns) can be tracked (e.g., using angiography) between one or more portions (e.g., components or other features) of imaging probe 100 and relatively stable (e.g., non-moving) portions of the patient’s anatomy (e.g., ribs, sternum and / or spinal column).

[0154] In some embodiments, system 10 comprises one, two or more calibration instruments, calibration tool 50 shown. Calibration tool 50 can be configured to detect and / or analyze light. Calibration tool 50 can comprise one or more robotic manipulators, such as to manipulate one or more tools and / or components of probe 100 during a closed-loop calibration process.

[0155] When a console 300 of system 10 is first installed at a clinical site (e.g., a catheter lab), a calibration routine can be performed (e.g., performed by and / or using calibration tool 50) 50), such as a calibration routine used to establish the latency between an angiographic system (e.g., second imaging device 15) of the clinical site and other components of system 10. Essentially, an imaging probe 100 is provided, an angiographic system at the clinical site is engaged, and an angiographic image feed is provided to console 300 (e.g., using any standard video connection, analog or digital). Angiographic system-provided video frames are registered according to a clock of console 300, which is used as a reference time frame. A pullback (e.g., in a patient or in a non-patient simulation mode) of imaging probe 100 is initiated (also coordinated by the console 300 clock) and captured by angiography (e.g., device 15). A trained operator (e.g., a clinician and / or technician) can review the angiographic image frames and designate the first frame in which motion was detected. This process establishes the associated latency according to the console 300 clock. The motion detection can also be automated, for example using a neural network or other algorithm (e.g., of algorithm 315 and / or 415) trained to recognize imaging probe 100 movement (e.g., movement of a marker band of imaging probe 100) under angiography.

[0156] In some embodiments, a calibration procedure (e.g., as performed by and / or using calibration tool 50) configured to establish the latency between an angiographic system (e.g., second imaging device 15) and other components of system 10, and an imaging procedure performed during relatively low motion of a heart cycle, includes the following steps. In a first step, angiography is initiated once probe 100 has been inserted into the patient and deployed into the target anatomy. In a second step, system 10 analyzes the relative motion between one or more portions of imaging probe 100 (e.g., motion of a marker band or other imaging probe 100 portion which follows the beating heart of the patient) and more stable features in the image, such as images of the sternum or spinal column. Once a cardiac rhythm has been established and the low motion portion identified (typically 5-10 heart cycles are used for this analysis, which can be velocity vector analysis, neural network analysis, and the like), an indicator is provided, and a system 10 “metronome” is started. System 10 can reference the output of the metronome, such as at the time that radiopaqueflushing material is injected to clear the blood from the target area to be imaged, since the one or more portions of imaging probe 100 (e.g., one or more marker bands) can become radioinvisible during this flushing period (e.g., radiopaque portions of probe 100 cannot be differentiated from the flushing material). In an alternative embodiment, a non-radiopaque flushing material can be used (e.g., dextran). In a third step, flushing is started, such as by an operator or in an automated way controlled by system 10. The flushing continues over several heart cycles, such as 3-5 heart cycles. In a fourth step, clearing of the vessel to be imaged is detected by system 10 analyzing one or more of the images produced by system 10. In a fifth step, at the low motion part of the metronome (e.g., a predicted low motion portion of the heart cycle), and accounting for the latency between system 10 components and the angiographic system previously established, a pullback starts. In some embodiments, the pullback will finish in about one-half of a heart cycle or less, such as to cause capture of all or a portion of image data to remain within the low motion portion of the heart cycle. System 10 can be configured to provide a pullback speed of at least 50mm / sec, such as at least lOOmm / sec, or 200mm / sec. In a sixth step, the pullback sequence of images, which include minimal motion artifact, can be provided to the operator and / or used for: CFD calculations (described herein), implant (e.g., stent) length measurements, and the like. The use of image capture during low motion, as described herein, avoids or at least reduces errors associated with motion artifacts, notably longitudinal motion artifacts.

[0157] In some embodiments, algorithms 315 and / or 415 (“algorithm 315 / 415” herein) are configured to perform various image processing of the image data produced by system 10. Algorithm 315 / 415 can comprise one, two, or more artificial intelligence algorithms configured to perform the various image processing and / or other calculations, as described herein. For example, algorithm 315 / 415 can comprise neural networks implemented using features of DDNet and / or UNet methodologies, such as features tailored for the processing and segmentation of intravascular image data.

[0158] Algorithm 315 / 415 can comprise one or more algorithms that are configured to perform one or more image processing applications selected from the group consisting of: an image quality assessment; procedural device segmentation, such as guide catheter and / or guidewire segmentation; implant segmentation, such as segmentation of endovascular implants such as stents and / or flow-diverters; lumen segmentation, such as segmentation of a vascular lumen; segmentation of side-branches; tissue characterization, such as a characterization of atherosclerotic versus normal; detection of thrombus; and combinations of these.

[0159] In some embodiments, algorithm 315 / 415 comprises various signal and / or image processing algorithms configured to process and / or analyze image data collected by system 10. Using these algorithms, system 10 can be configured to perform an automated quantification of one or more parameters, such as one or more patient parameters (e.g., parameters relating to the health of the patient), one or more image parameters (e.g., parameters relating to the quality of the image data), one or more treatment parameters (e.g., parameters relating to the clinical efficacy and / or technical proficiency of a treatment performed), and combinations of these. For example, system 10 can comprise a metric (e.g., a variable), data metric 525 shown, which can comprise a calculated result that is calculated using, and / or otherwise based on an analysis (e.g., a mathematical analysis) of these various parameters.

[0160] Data metric 525 can represent a quantification of the quality of image data, such as a quantification determined by an automated process of system 10. In some embodiments, data metric 525 can comprise a “confidence metric” that represents the quality of the results of an image processing step (e.g., a segmentation process). A data metric 525 comprising a confidence metric can represent a calculated level of accuracy of the image data as determined by system 10 (i.e. the level of “confidence” with which an operator of system 10 can have in the data being presented). In some embodiments, when data metric 525 comprises a confidence metric below a first threshold value (e.g., a value indicating low confidence), system 10 alerts the operator, such as via an indicator displayed to the operator via GUI 353. Additionally or alternatively, system 10 can be configured to not display any image data if a confidence metric related to that image data is below a second threshold value (e.g., a value indicating less confidence than the first threshold value). In some embodiments, system 10 can be configured to display to the operator an alert (e.g., a low confidence data warning) and / or prompt the operator to allow the display of the low confidence image data.

[0161] In some embodiments, data metric 525 comprises a quantification of one or more characteristics (e.g., level of apposition or amount of protrusion) describing the interaction between the patient’s anatomy and a treatment device (e.g., implant 31) that has been implanted in the patient. For example, system 10 can be configured to analyze image data collected prior to, during, and / or after implantation of an implant, and to determine one or more values of data metric 525 that represent (e.g., correspond to) the interaction between the implant and patient tissue (e.g., the vessel wall, the ostium of one or more side-branches, and / or the neck of one or more aneurysms).

[0162] In some embodiments, data metric 525 comprises a metric relating to the healing proximate an implantation site, for example when system 10 is used to collect image data from an implantation site in a follow-up procedure, such as a procedure performed at least one month, at least six months, or at least one year from the implant procedure.

[0163] In some embodiments, data metric 525 comprises a metric relating to a predicted outcome of an interventional procedure, such as a metric whose value is calculated and / or updated during the interventional procedure, after the interventional procedure, or both. For example, data metric 525 can be used to provide guidance to the operator by indicating the predicted outcomes of intended (e.g., future) and / or already performed interventions (e.g., based on an analysis of the potential efficacy of the intervention), such as interventions configured to treat brain aneurysms and / or ischemic strokes. For example, the mesh density of a flow diverter covering the neck of an aneurysm can be estimated by system 10 (e.g., based on automated image processing described herein). The mesh density can be used to predict the outcome of the intervention (e.g., long-term dissolution of the aneurysm). Additionally or alternatively, the geometry of the mesh can be used to estimate the angle of optical assembly 115 relative to the surface of the mesh, and to correct the mesh density accordingly. For example, in a bend, the light exiting optical assembly 115 (e.g., the beam of light being transmitted from optical assembly 115) may be along an oblique angle to the mesh surface normal. In this scenario, the mesh pattern will be elongated in the plane of incidence (e.g., the plane defined by the surface normal and the light beam) according to the angle of the light beam. Correcting this elongation to achieve a symmetric pattern can provide the angle of the light beam, and this angle information can be used by system 10 to correct the calculated density of the mesh.

[0164] In some embodiments, data metric 525 comprises a metric that informs (e.g., its value is used to recommend or otherwise inform) the patient’s clinician to potentially perform an additional (e.g., second) therapeutic procedure on the patient, such as to optimize or at least improve the therapeutic treatment in which at least a first procedure (e.g., an interventional procedure) has already been performed. The additional therapeutic procedure can comprise an interventional procedure selected from the group consisting of: an adjustment to a device (e.g., treatment device 16) implanted in the patient in a previous procedure, such as an adjustment comprising a repositioning, expansion, contraction, and / or other adjustment to the implant; implantation of a device (e.g., device 16) into the patient, whether or not a previous device had been implanted in the patient; a vessel dilation procedure; an atherectomy procedure and / or other procedure in which occlusive material isremoved; a coiling or other procedure in which undesired space within the vascular system is occluded; a drug-delivery procedure; and combinations of these.

[0165] In some embodiments, system 10 can identify if a myocardial bridge exists over a portion of an imaged vessel. For example, system 10 can automatically detect the presence of a myocardial bridge (e.g., via algorithm 315 / 415), and / or the data presented to the operator of system 10 can indicate the presence of a myocardial bridge (e.g., such that the operator can draw conclusions based on the data presented). In some embodiments, image data can be collected by system 10 during a pullback procedure in which imaging probe 100 is retracted at a speed in which multiple heart cycles are captured during the pullback, such that the strain on the imaged vessel (e.g., strain caused by motion of the heart) can be analyzed throughout the heart cycle. In some embodiments, system 10 is configured to identify a myocardial bridge by analyzing image data to detect an artifact in the image data indicating the presence of a myocardial bride (e.g., a signature artifact, similar to an echolucent “halo” that can be seen when imaging a myocardial bridge using intravascular ultrasound).

[0166] In some embodiments, system 10 is configured to quantify the quality of image data, such as a quantification determined by an automated process of system 10, such as is described herein. In some embodiments, if the quality of the image data is below a threshold, one or more analytic processes of system 10 (e.g., image analysis described herein) may be disabled, such that the process is not performed on poor quality image data. For example, if image data is analyzed and it is determined (e.g., by system 10 and / or an operator of system 10) that optical assembly 115 started and / or ended within a stent during a pullback procedure, system 10 can be configured to disable subsequent CFD or other calculations described herein based on that poor image data. In some embodiments, system 10 can assess the quality of a purge procedure based on the quality of the image data. For example, system 10 can assess image quality to identify blood ingress into delivery catheter 80, and indicate the need to purge. This analysis can be used for providing feedback to the operator in real-time during imaging, such as by displaying a warning message (e.g., “purge catheter”). Similarly, after an image acquisition is completed, system 10 can analyze the image data and display a warning to the operator if catheter purge was incomplete. In some embodiments, system 10 can analyze image data to identify blood residuals in the lumen, and to display a warning to the operator as well as indicate to the operator areas where blood clearance is incomplete. If blood clearance is incomplete in the region of high interest for CFD calculation (such as obscuring frame of reference or a stenosis), a warning can be provided about insufficientimage quality for a CFD calculation.

[0167] In some embodiments, system 10 is configured to perform various computational fluid dynamics (CFD) and / or optical flow ratio (OFR) calculations using high-resolution image data (e.g., OCT image data) to accurately simulate blood flow in a stenosed artery (e.g., a coronary artery), and to estimate pressure drops through one or more lesions, such as is described herein. These methods provide the operator (e.g., interventionalists) with a combined and simultaneous measurement of arterial anatomy and vessel hemodynamic conditions (e.g., “Physio- Anatomy”) in high-resolution, that can be used to better characterize and diagnose the significance of stenosed coronary arteries pre-intervention, as well as following intervention (e.g., post-intervention). This information can be used to provide informed guidance and / or to optimize intervention steps as detailed herein.

[0168] Traditional clinical practice is limited to the use of either intravascular imaging (e.g., OCT or IVUS imaging) or physiology measurements (e.g., FFR, iFR, RFR, etc.) at one time, as imaging and physiology measurements can only be acquired using separate instruments (e.g., single purpose catheters). System 10 can be configured to enable capture (e.g., in a single “pullback acquisition”) of both vessel anatomy and physiology. This combined solution has the key advantage of providing intrinsically co-registered anatomy and physiology data (e.g., data captured with a single device), that can be used to better plan and optimize coronary interventions than any of these tools alone.

[0169] In some embodiments, CFD simulations performed by system 10 are designed to closely simulate hyperemic conditions, for example as it is done for the acquisition of fractional flow reserve data using a pressure wire. Alternatively or additionally, CFD methods can be used to simulate non-hyperemic conditions, for example similar to the way iFR or RFR catheters are used to collect vessel hemodynamic data. FFR devices typically make a single FFR measurement from a single location distal to all lesions. Using CFD methods of system 10 described herein, blood flow and pressure drops can be more easily evaluated for the entire coronary segment imaged with OCT.

[0170] Traditional FFR methodologies suffer from a major limitation due to lesion crosstalk. For example in the case of serial lesions, an FFR acquisition is unable to discern the individual contribution of each lesion. The CFD methods of system 10 described herein will be able to determine the contribution of each lesion, indicating which of the imaged lesions is more significant and which to treat.

[0171] System 10 can be configured to achieve a CFD simulation and pressure drop evaluation of a whole arterial segment (e.g., 100mm or more) in a few seconds (e.g., less than 20 sec) using a simplified quasi-2D and / or 2D solver. If compared to a “full” 3D solver (e.g., a solver configured to implement Navier Stokes equations), a quasi-2D and / or 2D solver allows for an order of magnitude or more reduced computational time, retaining sufficient accuracy for coronary pressure drop evaluation.

[0172] In some embodiments, CFD simulations heavily rely on the segmentation of image data (e.g., OCT image data). Segmentation can be obtained through traditional image processing algorithms and / or Al methodologies (e.g., machine learning, deep learning, neural network, and / or other artificial intelligence methodologies). In some embodiments, these methodologies include the various steps to analyze image data sets (e.g., OCT image data sets) to quantify blood flow and / or pressure drops.

[0173] In some embodiments, system 10 comprises a graphical user interface, such as GUI 353 described herein. In some embodiments, the GUI is configured to provide the clinician or other operator with an easy and immediate way to obtain and use OCT images and / or simulated physiology data to diagnose coronary stenoses, plan, and optimize coronary interventions. In some embodiments, OCT-FFR “Physio- Anatomy” data can be registered to coronary angiography data to provide a comprehensive tool for interventionalists to accurately plan and guide coronary procedures. Additionally or alternatively, OCT-FFR simulations can be used to create a virtual stenting tool that allows the operator of system 10 (e.g., an interventionalist) to simulate the effect of stents of different lengths and diameters over different vessel locations to optimize stent sizing and selection and devise an optimal intervention strategy.

[0174] In some embodiments, Physio- Anatomy data can be quantified (e.g., by system 10) by the means of several metrics. For example, these metrics can be used to quantify the effect of the treatment pre-intervention vs. post-intervention (e.g., a “gain” quantification).

[0175] In some embodiments, system 10 is configured to ensure data quality and suitability for CFD calculations. For example, system 10 can be configured to ensure confidence of segmentation results (e.g., side-branch and / or lumen segmentation), by determining a “confidence metric”, such as is described herein. The goal of a confidence metric is to inform the operator about potential images with reduced quality where segmentation results are uncertain, allowing for a quick visual review and correction (if needed). In some embodiments, system 10 can be configured to ensure that a complete pullback has been acquired, from a location distal to a lesion to the tip of the guide catheter.In some embodiments, a complete pullback can be defined as: a pullback that captured the entire disease; a pullback that did not start and / or end on a diseased vessel segment; and, if a stent is present, it is imaged in its entirety. If a pullback starts and ends on diseased vessel segments, system 10 can be configured to recover from this situation and provide an accurate CFD measurement. For example, in this scenario, system 10 can identify (e.g., via one or more methodologies described herein) healthy vessel segments and can be configured to use branching laws to estimate vessel diameters and / or areas in proximal and / or distal reference frames.

[0176] In some embodiments, system 10 is configured to perform an assessment of image quality comprising an assessment of the presence of significant blood residuals in the vessel lumen during a pullback, for example blood that obscures one or more portion of the vessel. In some embodiments, system 10 is configured to assess blood that is trapped with a portion of a catheter that is configured to be imaged through (e.g., a portion of a catheter that is configured to be purged with saline before and / or during a pullback), where the trapped blood degrades the image quality. One or more algorithms of system 10 can be configured to automatically detect degradation in image quality as well as the degree of quality loss, and to warn the operator about the poor image quality and potential need to repeat acquisition (e.g., to repeat the pullback). In some embodiments, system 10 is configured to capture one or more angiography images. Analysis of angiography data performed by system 10 can reveal the presence of major collateral vessels. In this case, FFR and CFD calculations might be inaccurate (e.g., false low FFR in the “donor artery” and / or false high FFR in the “recipient artery”). In some embodiments, a warning message can be displayed to the operator to inform about presence of collateral vessels before a CFD calculation is performed by system 10 and / or before the results are displayed by system 10 to the operator.

[0177] In some embodiments, system 10 is configured to use various image processing techniques (e.g., as described herein) to help prevent incomplete and / or low-quality image data that can reduce the accuracy of CFD simulations for pressure-drop calculations. An automated determination of image data quality can warn the operator of system 10 about potential issues, can help the operator in correcting some issues where possible (e.g., help and / or enable the operator to fix inaccurate segmentation results), and / or can indicate to the operator when a new image data acquisition might be necessary. Automated assessment of data quality can warn and / or provide guidance to the operator about moderate quality images and facilitate corrections. Alternatively or additionally, a severe loss of image data quality that cannot be recovered can be displayed to the operator, and system 10 can provideguidance on how to improve the image quality (e.g., direct the operator to better purge the catheter, and / or to better engage the coronary ostium with the guide catheter) and perform an additional image acquisition.

[0178] In some embodiments, system 10 can determine reference diameters (e.g., proximal and distal reference diameters) as well as the size of side-branches and can use this information to calculate an “ideal” and / or “reference” vessel profile to better guide intervention and / or to quantify “stent expansion”. An ideal vessel profile is a metric that can inform a more accurate stent sizing. Stent expansion is a metric that can inform additional steps to optimize stent implantation procedures.

[0179] Information collected and / or analyzed by system 10 can be used to provide various functions in a clinical environment. For example, system 10 can be used as a tool to provide training, such as training to a clinician or other operator of system 10, and / or can provide equipment diagnostics information in a clinical setting, such as self-diagnostic information and / or diagnostic information related to equipment in the clinical setting that is not a part of system 10. When used in a training scenario, system 10 can be configured to perform an initial and / or periodic assessment of the operator of system 10, for example by comparing determinations made by the operator (e.g., based on image data gathered by system 10 and input into system 10), to determinations made by system 10 (e.g., by algorithm 315 / 415) based on similar data (e.g., the same data). For example, system 10 can perform an automated image assessment (e.g., to determine if blood is present during imaging, if a guide catheter is properly positioned during imaging, and / or if a catheter lumen was sufficiently purged during imaging). Based on the automated assessment, system 10 can provide feedback to the operator based on the operator’s operation of system 10 and / or the operators interpretation of the data. For example, system 10 can suggest IQ improvement, provide considerations based on the image quality assessment, and / or provide an overall pullback review. In some embodiments, system 10 is configured to operate in a training mode, for example when GUI 353 enables use of one or more training modes of system 10.

[0180] When used in a diagnostic scenario, system 10 can perform an image quality assessment, and infer (e.g., via algorithm 315 / 415) from the image quality if a component of system 10 may be the cause of poor image quality. For example, system 10 can detect serviceable issues such as a failing imaging assembly 320 (e.g., from dim image data), poorly connected and / or broken connectors, and / or poor image registration (e.g., caused by NURD or other physical conditions of the catheter). In some embodiments, system 10 is configured to track the usage of various components of the system, for example the number of pullbacksfor which an imaging probe 100 and / or an imaging assembly 320 has been used. In some embodiments, system 10 is configured to analyze a first set of image data collected by system 10, as well as a second set of image data from another imaging device (e.g., second imaging device 15), and to analyze (e.g., via algorithm 315 / 415) the image quality of the second set of image data, such as to provide a diagnostic report of the second imaging device (e.g., to determine if the second device is working properly or is in need of service and / or calibration).

[0181] In some embodiments, system 10 is configured to perform an automated review of image data gathered by the system to ensure the image quality is sufficient to perform subsequent calculations based on the image data (e.g., FFR calculations described herein). System 10 can be configured to identify various issues from image data, such as issues selected from the group consisting of: blood in the image, such as caused by inadequate blood clearing; reduced lumen wall confidence; image distortion, such as distortion caused by NURD; lack of guide catheter visualization; insufficient pullback distance, such as less than 40mm; improper beginning and / or ending points of image data (e.g., starting and / or ending within a stent); and combinations of these.

[0182] In some embodiments, system 10 is configured to analyze image data to determine if the patient meets any exclusion criteria (e.g., such that the patient would be excluded from further treatment and / or diagnosis by system 10). Exclusion criteria identified by system 10 can include: presence of a chronic total occlusion (CTO) in the target vessel; severe diffuse disease in the target vessel (e.g., defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree); presence of myocardial bridge (MB); target lesion involves the Left Main (e.g., stenosis >50%); an artifact observed in a pre-PCI OCT image for the target lesion or in the event of multiple target lesions; an artifact observed in a pre-PCI OCT image for all target lesions; presence of a target lesion that will need to go through any preparation (including but not limited to balloon dilatation, atherectomy, and the like) prior to pre-PCI OCT imaging and physiology measurement, or in case of multiple target lesions, all target lesions that will need to go through any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT imaging and physiology measurement; target lesion and / or significant coronary artery disease (CAD) beyond 60mm from coronary ostium (e.g., inability to image lesion with OCT in one pullback); incorrect and / or otherwise unsuccessful catheter purge and / or contrast flush; presence of plaque rupture and / or intravascular hematoma in target vessel (visual % diameter stenosis > 40%); and combinations of these.

[0183] In some embodiments, system 10 is configured to analyze angiography image data to identify a vessel within which imaging probe 100 is positioned (e.g., which vessel image data collected by system 10 represents). In some embodiments, one or more algorithms of system 10 (e.g., algorithm 315 / 415) is modified based on the vessel being imaged (e.g., automatically modified based on the identification of the vessel being imaged from angiography image data). In some embodiments, system 10 is configured to perform motion correction of OCT image data by analyzing velocity vectors of angiographic image data collected simultaneously with the OCT image data.

[0184] In some embodiments, the image processing methodologies of system 10 described herein are configured to automatically perform a process selected from the group consisting of identify normal and diseased segments of an imaged vessel; identify ideal reference frames for vessel sizing (e.g., to avoid placing a reference segment in a diseased area); optimize scaling laws by avoiding diseased segments as reference diameters; optimize vessel size estimation; and combinations of these.

[0185] In some embodiments, as described herein, system 10 is configured to capture image data (e.g., via imaging probe 100) prior to, during, and / or after an implant (e.g., implant 31) has been implanted at a patient site. For example, system 10 can capture image data from a patient site where an implant 31 comprising a stent-like flow diverter (or other aneurysm treatment device, such as coils and intrasaccular devices) has been implanted to treat an aneurysm at the patient site. Image data collected by system 10 can be analyzed, such as manually analyzed when the image data is presented to the clinician, and / or automatically or semi-automatically analyzed by an algorithm of system 10, such as is described herein. Analysis of the image data from the patient site comprising implant 31 can determine one or more implant metrics, for example, stent apposition and / or stent expansion. In some embodiments, if stent apposition or expansion is determined to be incomplete, system 10 can be configured to allow the clinician to adjust and / or replace implant 31, for example to reposition and / or further expand implant 31 (e.g., via implant delivery device 30) to improve the apposition of implant 31 to the tissue. In some embodiments, additional image data can be collected and analyzed following an implant adjustment.

[0186] In some embodiments, system 10 is configured to measure apposition of a stent, flow diverter, and / or other implant. In these embodiments, system 10 can be configured to improve apposition of such an implant. In some embodiments, system 10 is configured to improve the likelihood of achieving sufficient apposition of a stent, flow diverter, and / or other implant (e.g., via images provided by system 10), such as to improve the likelihood ofsufficient apposition being achieved, such as to a likelihood greater than 70% (e.g., a level of incomplete apposition that is less than 30%) , such as when system 10 achieves a likelihood of sufficient apposition of greater than 75%, 80%, 85%, 90%, 92%, 94%, or 96%.

[0187] In some embodiments, algorithm 315 is configured to analyze image data collected via one or more imaging devices of system 10, for example OCT data collected via imaging probe 100 and angiography data, such as angiography data collected via a second imaging device 15 comprising a fluoroscope, as described herein. In some embodiments, one or more vessel measurements, such as side branch diameter and / or aneurysm diameter measurements performed by algorithm 315 can be derived from angiography data collected by system 10. Algorithm 315 can be configured to analyze one or more measurements derived from angiography data in conjunction with OCT image data collected via imaging probe 100 to assess and / or predict the clinical effectiveness (e.g., to predict the clinical outcome) of the implantation of implant 31, such as implant 31 comprising a flow diverter that is configured to occlude an aneurysm. In some embodiments, the use of system 10 can achieve a likelihood of clinical efficacy (e.g., a successful procedure) of greater than 70%, such as when system 10 achieves a likelihood of clinical efficacy of greater than 75%, 80%, 85%, 90%, 92%, 94%, or 96%.FIRST-IN-HUMAN FEASABILITY STUDY

[0188] Endovascular interventions are rapidly emerging as the preferred method for the treatment of stroke arising from neurovascular diseases, such as brain aneurysms, ischemic occlusions, arterial dissections, and atherosclerotic disease (ICAD). Advances in endovascular techniques allow for the treatment of previously inoperable patients and expansion to new therapeutic indications. Nevertheless, challenges persist in accurately diagnosing specific intracranial arterial wall diseases and identifying perioperative events that may contribute to complications. Neuroendovascular interventions rely on sophisticated, multi-modality imaging guidance, utilizing x-ray techniques such as digital subtraction angiography (DSA), computed tomography (CT), and cone beam CT (CBCT), along with magnetic resonance imaging (MRI), to assess arterial wall disease, neurovascular implant placement, and procedural outcomes during follow-up examinations. Preclinical studies have linked proper neurovascular implant apposition to the arterial wall and optimal coverage of the aneurysm neck with improved rates of aneurysm occlusion and more favorable patient outcomes. This finding suggests that insufficient apposition may require adjunctive measures to improve aneurysm occlusion rates. Similarly, a more detailed assessment of arterial walldisease, its characteristics, and the presence of residual thrombus and anatomical landmarks (e.g., location of perforating arteries) could better inform device selection and placement for more accurate procedural steps in endovascular stroke procedures. However, accurate imaging assessment using current clinical modalities is challenging due to limited spatial resolution, imaging contrast, and metal-induced artifacts. Interpreting these images can often be ambiguous and insufficient for reaching a conclusive diagnosis. Accurate diagnosis of the underlying pathology and a detailed, artifact-free, depiction of the arterial wall interaction with neurovascular devices are important for an effective procedural decision-making process. However, the interpretation of these non-invasive images can often be ambiguous and insufficient for a conclusive diagnosis. Causes leading to complications are not always readily identifiable, and optimal patient management remains indeterminate. Applicant believes that to address these limitations, an imaging modality that can accurately depict both tissue and metallic devices in high-resolution is required.

[0189] Intravascular optical coherence tomography (OCT) offers high sensitivity, high dynamic range, and high-resolution imaging capabilities enabling detailed in situ volumetric microscopy. It has become an essential diagnostic tool for the treatment of myocardial infarction with non-obstructive coronary disease and has led to significant advances in the understanding of in vivo vascular biology. However, state-of-the-art coronary imaging catheters are not suitable for safe navigation and reliable imaging into tortuous intracranial arteries. Their size is incompatible with neurovascular microcatheters, the delivery method of choice for neuroendovascular interventions, and are too stiff for dependable navigation into tortuous cerebrovascular anatomies. Furthermore, their construct does not ensure artifact-free imaging (e.g., rotational distortions) in tortuous conditions. The limited field-of- view is also insufficient to comprehensively characterize large neurovascular arteries and aneurysms, and to visualize the subarachnoid space located beyond the vessel wall. For these reasons, the use of coronary imaging devices has been mostly limited to the non-tortuous intracranial circulation.

[0190] To address these limitations, applicant has developed a system 10 comprising a flexible, miniaturized, endoscopic imaging probe 100, combined with high-frequency optical coherence tomography (HF-OCT) imaging components, both specifically ideated for the human cerebrovasculature. Applicant hypothesizes that this intravascular imaging probe 100 can overcome the limitations of existing imaging catheters, enabling reliable, safe, and effective use in brain arteries for the first time. Applicant further hypothesizes that in situ optical microscopy provided by HF-OCT can provide unique insights into the treatment ofbrain aneurysms, ischemic stroke, and atherosclerotic intracranial artery disease by revealing details (e.g., microstructure) of the vessel wall and the exact device configuration in vivo that remain hidden from non-invasive modalities (e.g., x-ray, MRI). Clinical use of system 10 will advance the understanding of cerebrovascular artery disease and uncover new mechanisms for optimizing neurointerventional surgery and achieve individualized patient management.

[0191] To assess these hypotheses, and as described hereinbelow, applicant utilized system 10 in a first-in-human feasibility study in a series of 32 patients undergoing neurovascular catheterization procedures.MATERIALS AND METHODSNeuro Optical Coherence Tomography (nOCT) provided by system 10

[0192] Imaging assembly 320 of console 300 can comprise a swept source laser constructed and arranged to capture neuro optical coherence tomography (“nOCT” herein) data at a high speed. For example, in some embodiments, the laser comprises a central wavelength of approximately 1300 nm and the laser is swept 200,000 times per second, thereby generating an equivalent number of A-lines. In some embodiments, the axial resolution in tissue (with a refractive index of -1.45) can comprise at least 15pm, such as at least 10pm. In some embodiments, imaging assembly 320 comprises a high-velocity rotary joint that is combined with the imaging probe 100 optics to allow for high-speed rotation, collecting at least 200 cross-sectional images per second (e.g., 250 cross-sectional images per second), enabling rapid scanning of a long arterial segment (e.g., at least 40mm, or at least 50mm) in no more than 4 seconds, or 3 seconds, such as approximately 2 seconds.

[0193] Applicant has conducted studies to investigate the rapid scanning of arterial segments having a length of at least 50mm or 75mm via imaging assembly 320 as described herein. For 50mm long segment acquisitions, the longitudinal cross-sectional spacing comprises approximately 0.1mm. For 75mm long segment acquisitions, the longitudinal cross-sectional spacing comprises approximately 0.15mm.

[0194] As described in reference to the studies conducted by applicant, system 10 and / or imaging probe 100 comprises a field of view of approximately 14.4mm in diameter, and is configured to allow for the imaging of arteries and aneurysms up to approximately 7mm with imaging probe 100 positioned in an eccentric lumen position. Imaging probe 100 comprises a maximum diameter of approximately 0.0155” (390pm), configured to allow for navigation and imaging of distal arteries with a small diameter. Imaging probe 100 comprises a flexibledesign configured to allow for navigating elevated tortuosity. Imaging probe 100 further comprises a miniaturized optical assembly 115 constructed and arranged to focus and / or collect light from the arterial wall and intraluminal objects. Imaging probe 100 comprises wire-like characteristics. Additionally, imaging probe 100 can be used in combination with a 0.021” microcatheter for placement in the target vasculature.

[0195] In three clinical cases, imaging probe 100 was navigated through the vasculature supported by a distal access catheter. The light collected by imaging probe 100 is transferred to console 300 using a miniaturized optical core 110 encompassing the entire length of probe 100. Optical assembly 115 of imaging probe 100 is configured to provide consistent image quality (e.g., brightness) at locations several millimeters away from probe 100.

[0196] To ensure smooth rotation of optical core 110 and optical assembly 115, resulting in artifact-free stable images in elevated tortuosity conditions, imaging probe 100 can use a distal rotational control element (e.g., gel 118 described herein).

[0197] Console 300 operates a high-speed digitizer, interferometry techniques, and balanced optical detectors to measure and digitize the amplitude and location of the backscattered light received from probe 100, generating high-resolution, real-time cross- sectional images of the vessel wall (e.g., arterial wall) and intraluminal objects.Data acquisition and analysis

[0198] Applicant attempted a total of 78 acquisitions (e.g., scans) in 57 unique arteries. Three scans were affected by a procedural error or by an incomplete acquisition and were discarded; two scans were repeated. Of the three incomplete scans, one was due to an incorrect contrast injection (procedural error). In the second case, the scan was incomplete as the internal optical fiber was damaged during probe pullback. The acquisition was repeated using a second probe 100. In the third case, a different procedural error occurred (i.e., the torque device used to connect the probe 100 to the automated pullback device was not secured correctly by the operator) and it was repeated reusing the same probe. Most patients were placed under general anesthesia during the acquisitions; three patients were placed under sedation during the acquisitions.

[0199] A total of 75 scans were completed and were available for analysis, including 37,799 individual cross-sectional images. Of the 75 completed scans, three scans include data that was collected while the operator (an interventionalist) retracted the imaging probe 100 manually and slowly over a short arterial segment (e.g., a segment of no more than 15mm, such as no more than 10mm) of interest. The remaining 72 scans were performed byhaving console 300, via retraction assembly 220, automatically retract imaging probe 100 at a constant speed. Scans were acquired in both native untreated arteries (n=24, of which 22 were acquired through automated retraction) and after interventions or at follow-up (n=51 of which 50 were acquired through automated imaging probe 100 retraction). The maximum number of scans in a single procedure was equal to seven. Additionally, in 14 cases, three or more scans were collected from the same patients during the same procedure.

[0200] Using established criteria, the clear length (e.g., clear image length, CIL herein) of the scans was measured in all 72 pullbacks and were acquired automatically (and for which the scan acquisition speed was known). Applicant considered a cross-sectional image to be clear if at least 270 degrees of the image (as measured from the center of the arterial lumen) provided a diagnostic-quality depiction of the lumen, arterial wall, implanted devices, and other intraluminal objects without significant artifacts. CIL was calculated as the length of the data set that showed clear images and was expressed in millimeters (mm). Additionally, for all the 75 completed acquisitions (i.e., both manual and automated imaging probe 100 retraction), CIL was also reported as a percentage (%) relative to the captured total length of the artery. To calculate the total length, applicant considered the nominal length of the scan (e.g., 50mm or 75mm) and subtracted the length of the segment captured inside the microcatheter or distal access catheter (which obscured the image field of view). Applicant also disregarded distally repeated frames (e.g., due to catheter slack and tortuous anatomy) from CIL and the total length calculation.

[0201] Applicant analyzed the cross-sectional images for the presence of common artifacts, such as sew-up lines larger than 0.30mm and NURD, which could arise because of elevated tortuosity and mechanical optical core 110 rotation instability. Applicant determined the minimum thickness of the aneurysm wall by measuring the thinnest part observed in the entire aneurysm. System 10 (e.g., console 300) can be configured to automatically identify and segment the arterial wall for each cross-sectional image and can be further configured to quantify the lumen area and average diameter using deep learning image processing techniques. Additionally, the tracing of the lumen can be checked visually by the operator and adjusted as needed.

[0202] Applicant performed image interpretation according to established criteria that is commonly used for intracoronary OCT. Applicant identified the smallest lumen area observed in each dataset as the minimum lumen area (MLA). Applicant defined the shortest and / or longest diameter through the center of mass of the lumen as the minimum and / or maximum lumen and stent diameters, respectively.

[0203] Applicant defined communicating malapposition as a device malapposition (e.g., implant 31 malapposition) in the parent artery proximal to the aneurysm that continues into the neck of the aneurysm.

[0204] Applicant observed the normal arterial wall presents a layered structure, consisting of a thin bright layer (intima), a darker layer (media), and a signal-rich, bright thin layer (adventitia). In cases of intimal thickening, applicant further observed the intimal layer to appear thicker, but the media and adventitia remained visible.

[0205] Applicant observed fibrotic plaques to appear as a focal mass with high backscattering and homogeneous tissue appearance, with the media often visible. Applicant further observed lipid plaques to exhibit a strong signal drop-off due to high backscattering and optical attenuation. The fibrotic plaque can be visualized in its entirety and appears signal-rich and bright, while only the luminal surface of the lipid core is observable. The external elastic lamina (EEL) is no longer visible.

[0206] Applicant observed macrophage regions to appear as punctate, signal-rich areas, often found within atherosclerotic plaques. Applicant further observed macrophage regions strongly attenuated infrared light, resulting in a shadow effect on the underlying tissue.

[0207] Applicant observed cholesterol crystals to be visible as thin structures with high signal intensity, often exhibiting two reflections for their front and back.

[0208] Applicant observed thrombus to appear as a mass floating within the lumen or attached to the luminal surface. Applicant further observed red blood cell-rich thrombus to show high backscattering and high attenuation, whereas white (e.g., platelet-rich) thrombus displays lower backscattering and attenuation.

[0209] Applicant typically observed ruptured plaques and ulcerations in lipid plaque types, further appearing as a cavity or recess in the plaque. Applicant observed calcific plaques to exhibit sharply delineated borders and further appear as signal-poor, darker, heterogeneous regions within the arterial wall. Applicant observed both macro and micro calcifications present this appearance.

[0210] Applicant observed stent and flow-diverter struts, as well as other metallic device features, to be opaque to light, and further observed only the inner surface to be visible. Applicant observed the high-resolution capabilities of nOCT provided by system 10 to enable differentiation of neointimal tissue rich in smooth muscle cells versus fibrin-rich, immature, inflamed tissue coverage. Applicant observed uncovered struts can be identified by the lack of tissue coverage. Applicant characterized stent restenosis by significant tissue growth covering the stent, displaying either a layered or non-layered appearance.

[0211] Applicant obtained tortuosity quantifications using three-dimensional CT angiography (e.g., as provided by second imaging device 15), which was available for all patients except one (n=31) (i.e., an acute thrombectomy case where collection of CT data is not clinically routine). A total of 71 nOCT scans were acquired automatically. For anterior anatomy cases, applicant segmented the internal carotid artery to generate a smooth 3D volumetric structure, and which was further divided into two segments: the petrous segment and the segment between the cavernous ICA and the MCA. For posterior anatomy cases, applicant generated a single segment from the intradural segment of the vertebral basilar system (i.e., from the beginning of V4 segment to the basilar tip). For each segment, applicant extracted centerlines using a previously developed methodology. Applicant further resampled the centerlines at a resolution of 0.1mm and quantified two metrics: 1) tortuosity, which measures the ratio of the path length to the straight distance between the two ends of the segment; and 2) the minimum radius of curvature, which represents the minimum value of the arc length of the derivative of the path with respect to the tangential angle.RESULTSOVERVIEW OF APPROACH

[0212] As described herein, system 10 comprises a wire-like, endovascular imaging probe 100 that can provide neuro optical coherence tomography (nOCT) imaging of blood vessels and other structures in cerebrovascular anatomy. System 10 includes a probe 100 that achieves a high level of miniaturization and mechanical flexibility combined with alternative rotational control mechanisms to obtain images that are relatively free of artifacts in the tortuous vascular conditions encountered intracranially. Imaging probe 100 can comprise a maximum outer diameter of .0155” (0.39mm), an insertable length of at least 180cm, or 190 cm, and can include a distal, shapeable, a-traumatic spring tip (e.g., a spring tip with a length of at least 8mm, 10mm, 12mm, and / or 15mm). Imaging probe 100 can be equipped with a reduced size, rotating optical core 110 and optical assembly 115 which are protected inside a transparent plastic sheath and hypo tube. While rotating optical core 110 and optical assembly 115 at high speed, imaging probe 100 can be retracted through the vessel creating a spiral-shaped pattern to comprehensively image the arterial wall, as is shown and described herein below in reference to Figs. 2A-D. Optical assembly 115 is configured to focus near infrared light to illuminate the tissue, and the backscattered light is collected and transmitted to console 300 of system 10 for analysis and reconstruction of HF-OCT imaging data, as described herein. Console 300 can collect at least 200 cross-sectional images per second(e.g., approximately 250 cross-sectional images per second), with an axial resolution of at least 20 microns (e.g., approaching 10 microns), and can display the images in near real time (“real time” herein). The image field of view can be at least 10mm in diameter (e.g., approximately 14.4mm in diameter), making it suitable for imaging small and large intracranial arteries and the surrounding extravascular structures (i.e., veins, arteries, and other structures located outside of the vessel in which probe 100 is located).CLINICAL IMAGING

[0213] In this study, applicant utilized nOCT provided by system 10 in 32 patients as a complementary diagnostic examination alongside state-of-the-art x-ray imaging techniques (as provided by second imaging device 15 comprising an x-ray device). Fig. 1A shows a summary of the patient and imaging characteristics.

[0214] As in routine neuroendovascular procedures, imaging probe 100 was navigated and delivered through a neurovascular microcatheter with an inner diameter size of .021” and in combination with a standard 6-F, distal access catheter. In three cases, imaging probe 100 was advanced to a distal location on its own, supported by a 5-F distal access catheter. As red blood cells scatter and attenuate near infrared light, a brief injection of contrast media is needed to displace the arterial blood from the vessel lumen during the imaging scan performed using system 10. Building on previous evaluations in bench models, applicant hypothesized that similar protocols to the ones used in clinical routine for x-ray angiography would provide sufficient blood clearance to collect imaging data in cerebrovascular vessels. As such, undiluted contrast was injected by an automated pump, applying flushing at rates between 4ml / sec to 5ml / sec, similar to standard rotational angiography protocols. High- resolution imaging data from arterial segments up to 75mm in length were obtained in no more than 3 seconds (e.g., in 2 seconds), collecting at least 400 (e.g., 500) equally spaced cross-sectional images. Applicant applied nOCT provided by system 10 to a broad range of conditions and interventional procedures, with the goal of obtaining an enhanced diagnosis and evaluation of treatments’ efficacy in brain aneurysms, ischemic stroke, and intracranial atherosclerotic disease in both acute and chronic settings. System 10 can be configured to image blood vessels as small as 1.0mm, or smaller, in diameter, and blood vessels as large as 5.5mm, 7mm, or larger, in diameter. A total of 78 acquisitions (scans) were attempted in 57 unique arteries, ranging approximately from 1.0mm to 5.5mm in diameter, in both theanterior and posterior circulations, including distal segments of the middle cerebral and the posterior cerebrovascular arteries, as shown in Fig. 1 A. In three instances, a scan was repeated, resulting in the successful completion of 75 scans, with a success rate of 96.2%. Of the 75 completed scans, three were performed with operators (e.g., interventionalists) slowly retracting the probe manually during acquisition, while the remaining 72 were conducted with the console automatically retracting the probe at a constant speed. Partially occluded arteries, with a minimum lumen area as small as 0.3mm2, were also included (system 10 can be configured to provide an image with a minimum lumen area as small as 0.3mm2). Data was collected during the treatment of unruptured, ruptured, and recurring aneurysms, as well as during interventions for intracranial atherosclerotic artery diseases and vascular dissections, and in acute ischemic stroke cases.

[0215] The maximum number of scans in a single procedure was seven. In 14 cases, three or more scans were collected from the same patients during different steps of the procedure. No vasospasms related to the procedures were observed. Additionally, no adverse events linked to the use of imaging probe 100 were noted in this study, highlighting its safety and tolerability in clinical practice.Efficacy in human cerebrovasculature

[0216] On average, the captured arterial segments measured 47.4mm ± 14.4mm in length (n=72, automated scans). Within these segments, the CIL, representing the scan length without any blood shadowing artifacts, spanned 46.3mm ± 14.7mm (n=72). When applicant compared the CIL to the total length of the scans (n=75, including both automated and manual scans), applicant found that 92% of the scans (n=69) displayed a CIL of 90% or greater, 5.3% (n=4) fell within the range of 80-89%, and 2.7% (n=2) were below 80%. Statistical analysis revealed no significant difference between the CIL in scans taken in untreated arteries and those from treated arteries (n=72) (t-test, p=0.37). For each scan, applicant administered an average of 21.2ml ± 4.0ml of contrast. However, based on initial experiences, applicant elected to cap the total contrast injection volume at 20ml for the last 16 cases. In this second group of patients (n=72), applicant achieved an equivalent CIL (t-test, p=0.67) with a reduced contrast volume of 17.7ml ± 1.6ml. Additionally, applicant observed consistent image quality throughout the different anatomies encountered, irrespective of the level of arterial tortuosity (n=71, linear regression, p=0.31) and the minimum radius of curvature (p=0.49), both not significantly associated with CIL (mm). The smallest radius of curvature encountered in this study was 1.95mm, indicative of severe vascular tortuosity.Applicant further analyzed the data to identify additional factors affecting image quality. A very limited number of the cross-sectional images (0.20%) were affected by stitch-up line artifacts and applicant did not observe any presence of non-uniform rotational distortion (NURD). No adverse events related to the use of imaging probe 100 were reported in this study, illustrating its safety and tolerability in clinical practice. System 10 can be configured to perform a successful nOCT procedure in which no more than 20ml of contrast or other flushing fluid is used, for example as described hereabove and otherwise herein. System 10 can be configured to perform a successful nOCT procedure in blood vessels including a radius of curvature as low as 1.95mm or lower (e.g., imaging probe 100 is configured to translate and gather the first set of image data when positioned in a blood vessel with a radius of curvature as low as 1.95mm), for example as described hereabove and otherwise herein.Aneurysm treatment procedures

[0217] System 10 can be configured to provide images related to diagnosis and / or treating a brain aneurysm, for example as described herebelow and otherwise herein. In applicant’s studies, neuro-intravascular imaging was performed using system 10 on 17 patients undergoing aneurysm treatment. Applicant evaluated recurring aneurysms to refine guidance for additional procedures (n=7) and assessed the treatment of native unruptured (n=8) and ruptured (n=2) aneurysms. Applicant performed nOCT in an unruptured, previously coiled, recurrent right posterior communicating artery aneurysm that was treated with a 4.5mm by 12mm Surpass Evolve flow diverter (Stryker Neurovascular) deployed in the right internal carotid artery (ICA) supraclinoid segment. Applicant observed communicating malapposition and presence of acute clots, not detectable by x-ray techniques, covering approximately 90 degrees of the device at the level of the posterior communicating artery, as shown and described herein below in reference to Fig. 3 A, with a maximum clot thickness of approximately 150pm. Applicant believes this information can better inform pharmacological therapy, specifically, the use of GP Ilb / IIIa platelet inhibitor that is continued for 24-hour post procedure. In another case, as is shown and described herein below in reference to Fig. 3B, a previously coiled aneurysm located at the level of the anterior communicating artery was re-treated with a flow-diverting stent due to incomplete occlusion. Following implantation, nOCT performed using system 10 showed device malapposition over the parent artery wall but confirmed complete apposition over the aneurysm wall, as well as presence of acute thrombus on the flow-diverter struts covering theaneurysm neck, which was treated by a single intravascular injection of a GB Ilb / IIIa platelet inhibitor.

[0218] System 10 can be configured to provide images related to diagnosis and / or treating large aneurysms, such as large aneurysms in the posterior cerebral artery, for example as described herebelow and otherwise herein. A ruptured, large aneurysm in the posterior cerebral artery had initially been treated with stent-assisted coiling (implant 31 comprising coils and at least one stent). However, due to aneurysm recurrence and rapid regrowth, further intervention became necessary, involving the addition of overlapping flowdiverting stents. Despite this second procedure, persistent residual filling and aneurysm growth were observed. Before undertaking a third procedure, the utilization of nOCT provided by system 10 revealed incomplete apposition between the two previously implanted flow-diverting stents. This lack of complete contact, not discernible through X-ray imaging but shown in images created using probe 100, shed light on the mechanism underlying the ineffective treatment and the ongoing growth of the aneurysm, as is shown and described herein below in reference to Fig. 3C.

[0219] Based on these findings, angioplasty was performed, and a third overlapping flow diverter was deployed over the aneurysm neck. Subsequent post-treatment imaging provided by probe 100 confirmed a positive apposition between the newly implanted devices and the existing ones. A follow-up magnetic resonance angiography (MRA), performed 7 days later, showed complete occlusion of the aneurysm. System 10 can be configured to provide OCT images that are used in a first clinical procedure in a patient’s brain (e.g., an aneurysm treatment procedure in which one or more devices are implanted to treat the aneurysm), where analysis of the images (e.g., automatically by system 10, manually by a clinician, or both) is used to determine that a second clinical procedure should be performed (e.g., a procedure in which one or more additional devices are implanted to further treat the aneurysm).

[0220] System 10 can be configured to provide images related to diagnosis and / or treating a small saccular, unruptured aneurysm in the right middle cerebral artery (MCA) , for example as described herebelow and otherwise herein. Applicant evaluated a patient with a small saccular, unruptured aneurysm in the right middle cerebral artery (MCA), incidentally discovered through an MRA, to investigate the aneurysm wall conditions and risk of rupture. Images provided by system 10 revealed that the concerning irregular aneurysm dome included sections as thin as 30pm, as is shown and described herein below in reference to Fig. 4A, indicative of a hypocellular wall and a higher risk of rupture. Applicant observeddisruption of the internal elastic lamina throughout the entire aneurysm wall. No clots were found inside the aneurysm and the parent artery displayed a normal, three-layered appearance. The cerebrospinal fluid (CSF) surrounding the aneurysm appeared transparent, indicating absence of blood, consistent with an unruptured aneurysm presentation. These complementary findings provided a more comprehensive characterization of the aneurysm, including the assessment of some of the properties that have been linked to both aneurysm pathology progression and rupture in histological studies. Treatment included a 3.5mm by 20mm flow diverting stent. Post-intervention imaging showed procedural results that were deemed satisfactory, as is shown and described herein below in reference to Fig. 4A, and no further manipulation was performed.

[0221] System 10 can be configured to provide images related to diagnosis and / or treating a patient with multiple comorbidities associated with the brain, for example as described herebelow and otherwise herein. A patient with multiple comorbidities (i.e., vestibular migraine and family history of hemorrhagic stroke) was diagnosed with multiple intracranial aneurysms through MRA, including a saccular 5mm aneurysm located in the left ICA bifurcation. When evaluated with nOCT provided by system 10, this aneurysm exhibited a regular appearance. However, it also showed a minimum wall thickness of 60pm and disruption of the internal elastic lamina throughout the aneurysm wall, as is shown and described herein below in reference to Figs. 4A and B. Following intervention with a 4mm by 20mm flow diverting stent, cone-beam CT showed satisfactory procedural results, however, nOCT revealed suboptimal expansion. Using a microwire, the stent was further opened and a third and last nOCT scan confirmed an improved degree of expansion over the neck.

[0222] Applicant further observed two aneurysms that were both treated with intrasaccular devices, as is shown and described herein below in reference to Figs. 9A and B. A first aneurysm comprising a 7mm MCA bifurcation aneurysm was treated with a Contour device (Cerus Endovascular). A second aneurysm comprising a berry-shaped right posterior communicating aneurysm was treated using a 4mm by 2mm WEB SL. In both cases, nOCT provided by system 10 offered detailed visualization of the device coverage of the aneurysm neck confirming proper deployment.Intracranial atherosclerotic disease

[0223] System 10 can be configured to provide images related to diagnosis and / or treating intracranial atherosclerotic disease (ICAD), for example as described herebelow and otherwise herein. In applicant’s studies, nOCT provided by system 10 was utilized for assessing and managing cases (n=6) of intracranial atherosclerotic disease (ICAD).Applicant evaluated a patient with a symptomatic plaque in the right vertebral artery who had undergone angioplasty and intracranial stenting, as is shown and described herein below in reference to Fig. 5. Follow-up CT scans showed heterogeneous images and progressive restenosis starting 3 months after the treatment. At the 9-month time point, further restenosis progression was observed, and nOCT follow-up imaging revealed eccentric restenotic tissue over the stented segment, presenting a multi-layered appearance. A regular luminal layer with a bright and homogeneous appearance suggested the presence of smooth muscle cells, while a darker, deeper layer with heterogeneous appearance indicated inflammation and fibrin deposition, consistent with recent treatment. A large cholesterol crystal, a known sign of inflammation, was also observed. Micro vessels or luminal clots were not present. A moderate lumen stenosis characterized by a large eccentric lipid core plaque, just proximal to the stented segment, was also observed. Since the restenotic segment exhibited stable remodeling, the patient was placed under conservative medical management, and no further intervention was performed.

[0224] System 10 can be configured to provide images related to diagnosis and / or treating a patient that has had a stroke, such as a left hemisphere stroke, for example as described herebelow and otherwise herein. Applicant observed a procedure conducted on a patient who recently suffered a left hemisphere stroke presenting an 80% stenosis in the cavernous segment of the left ICA, and as is shown and described herein below in reference to Figs. 6A-D. System 10 provided nOCT images that were used to investigate arterial wall disease characteristics and plaque composition before intervention. Across the stenotic segment, the scan revealed a minimum lumen area (MLA) of 2.3mm2, a site of plaque ulceration, and an eccentric lipid plaque covered by a fibrotic cap, as is shown and described herein below in reference to Fig. 6A, showing characteristics of arterial wall inflammation (i.e., macrophage accumulations). Vascular disease was observed for a long portion of the artery extending beyond the stenotic area, including a fibrotic plaque at the MCA level and small calcifications in the distal ICA. The stenotic segment was treated using balloon angioplasty followed by the placement of a 4.5mm by 20mm self-expanding stent (Wingspan Stent, Stryker Neurovascular). After angioplasty, nOCT revealed a large iatrogenic dissection and rupture of the plaque, as is shown and described herein below in reference toFig. 6B. After stenting, applicant observed incomplete device expansion over the plaque, as is shown and described herein below in reference to Fig. 6C, and severe under-expansion of the distal stent edge, a recognized factor associated with complications and unfavorable outcomes and which was not initially detected with high-resolution contrast-enhanced cone beam CT. To address this issue, a 5mm by 30mm flow diverting stent (Pipeline Vantage, Medtronic) was deployed to cover the plaque and the distal stent segment, followed by additional balloon angioplasty. A final imaging scan confirmed optimal stent and luminal expansion, as is shown and described herein below in reference to Fig. 6D.Thrombectomy for ischemic stroke

[0225] Applicant utilized nOCT to investigate the etiology and underlying arterial wall conditions in two ischemic stroke patients. In the first case, a 40-year-old patient with fever and decreased level of consciousness presented with right-side hemiplegia, raising suspicion of vasculitis or cardiac emboli of ischemic or septic origin. A CT angiogram revealed a left MCA occlusion. System 10 provided nOCT images were used to assess the arterial wall and clot within the MCA before any thrombectomy attempt. Pre-intervention imaging unveiled the presence of a thrombus primarily composed of red blood cells (high optical attenuation), as is shown and described herein below in reference to Fig. 7A. A normal three-layered appearance was observed excluding arterial wall disease (e.g., atherosclerosis or vasculitis) as the cause of the ischemic event. Successful thrombectomy and removal of the thrombus was achieved in two passes (Solitaire stent retriever, Medtronic), resulting in a mTICI 2c (Modified Thrombolysis in Cerebral Infarction) score. A final scan revealed limited thrombus residuals without any visible intimal damage related to the thrombectomy, as is shown and described herein below in reference to Fig. 7A.

[0226] In a second case, nOCT was utilized to assess the outcomes of a thrombectomy MCA procedure. After four thrombectomy passes, the intervention achieved a TICI 2a score and X-ray angiography showed a residual MCA stenosis potentially necessitating intracranial stenting, prompting further investigation. At 6-day follow-up, nOCT showed no evidence of ICAD, dissections, or intimal damage, as is shown and described herein below in reference to Fig. 7B. A non-occlusive residual thrombus was seen adhered to the vessel wall, characterized by a white, fibrin-rich appearance (i.e., low optical attenuation). No additional intervention was performed, and the patient’s management included single antiplatelet medical therapy. System 10 can be configured to provide images related to diagnosis and / or treating thrombus, for example as described hereabove and otherwise herein.Intervention follow-up imaging

[0227] System 10 can be configured to provide images related to assessment or other diagnosis of a previously performed neurovascular treatment, such as a treatment performed at least 3 months prior, for example as described herebelow and otherwise herein. Patients undergoing neurovascular treatment often receive one or more invasive diagnostic examinations within 3 to 12 months of the index procedure. Applicant utilized nOCT provided by system 10 as part of the follow-up diagnostic examinations in additional n=9 cases. In one such case, applicant had treated a small choroidal ICA aneurysm in a symptomatic female patient using a 4mm by 15mm flow-diverting stent. Subsequent followup MRA revealed a progressive in-stent stenosis complication at the treated site, worsening at 3, 4, and 8 months. At the 8-month mark, DSA showed moderate restenosis and device deformation, despite favorable device deployment at the initial procedure which prompted further investigation, as is shown and described herein below in reference to Fig. 8A. System 10 provided nOCT images that revealed eccentric intimal hyperplasia co-localized with device compression for a 6mm long arterial segment, showing a minimum lumen area of2.1mm2, and a minimum stent diameter of 2.0mm. At the level of the restenosis, the neointimal tissue microstructure showed a layered appearance consisting of a bright, thick layer overlying a thinner, darker layer located on top of the device struts. The luminal tissue appeared smooth and regular with no signs of thrombus. A limited number of struts at the device edges showed lack of tissue coverage. Proximally, the flow diverting stent covered the ostium of the ophthalmic artery. System 10 provided nOCT images showed tissue growth, but also highlighted the presence of open channels that feed the ophthalmic artery. No further intervention was deemed necessary and based on these findings the patient will remain on dual antiplatelet therapy and be closely surveilled.

[0228] A patient with multiple prior strokes underwent treatment for a severe stenosis observed over the Ml segment. Applicant utilized a 1.5mm by 15mm paclitaxel coated balloon (Elutax, Aachen Resonance) to prepare the lesion. A self-expanding 4.5mm by 21mm metallic stent (Pegasus, Phenox) with antithrombogenic covered the entire diseased segment, between the Ml and distal ICA, and also covering the ostium of the anterior cerebral artery. At regularly scheduled 6 months follow-up, X-ray angiography revealed the presence of a restenotic segment prompting further investigation. Behind the stent, nOCT images provided by system 10 showed a thickened arterial wall without any signs of calcifications or lipid accumulations, as is shown and described herein below in reference toFig. 8B. No restenotic tissue nor thrombus was seen covering the stent. Limited tissue growth was observed over the distal edge of the stent. A delayed neointimal tissue growth is consistent with the use of drug-eluting devices and given that the segment with stenotic appearance showed no intimal hyperplasia or restenosis, and the moderate luminal narrowing was caused by thickened arterial wall, applicant avoided re-intervention.Subarachnoid space and other findings

[0229] System 10 can be configured to provide images of extravascular structures (i.e., veins, arteries, and other structures located outside of the vessel in which probe 100 is located) when imaging from an artery or vein of the brain, for example as described herebelow and otherwise herein. In some embodiments, system 10 is configured to provide images of an implant positioned outside of the blood vessel in which probe 100 is positioned, such as an implanted device in another blood vessel of the brain or in another brain location. In anatomical regions where arteries are surrounded by cerebrospinal fluid (CSF), a transparent medium for near-infrared light, nOCT was capable of visualizing the extravascular structures located around the main artery. Images captured at the level of the MCA (as is shown and described herein below in reference to Fig. 9A) and the posterior circulation (as is shown and described herein below in reference to Figs 10A and B), including the basilar and posterior cerebral arteries, showed the ability to visualize small perforating arteries, meningeal layers, bony structures surrounding the artery, parenchyma, subarachnoid trabeculae, and the transition between intracranial and extracranial ICA location. These structures can be located several millimeters away from imaging probe 100, such as when located at least 3mm, 5mm, and / or 7mm from imaging probe 100, and / or when located at least 1mm, 3mm, and / or 5mm from the wall of the blood vessel in which imaging probe 100 is located.

[0230] System 10 can be configured to provide images related to diagnosis and / or treating of a ruptured aneurysm, for example as described herebelow and otherwise herein. A ruptured aneurysm was imaged, which is shown and described herein below in reference to Fig. 9B. In this case, the cerebrospinal fluid around the artery appeared opaque, suggesting potential mixing with blood. Furthermore, in another case of a recently ruptured aneurysm, nOCT visualized a vasospasm at the level of the MCA artery, illustrating its capability to identify such pathological changes in cerebral vasculature in vivo, as is shown and described herein below in reference to Fig. 13C.

[0231] As described herein, system 10 can be configured to provide images related to diagnosis and / or treating of an aneurysm, such as when a stenosis is present, for example as described herebelow and otherwise herein. Additionally in applicant’s studies, nOCT provided by system 10 was utilized in a patient undergoing MCA aneurysm treatment to investigate a stenosis at the bifurcation between the common carotid artery and the ICA, as is shown and described herein below in reference to Fig. 11. During the examination, a calcified nodule (29) was incidentally discovered. The fibrotic cap appeared ruptured, with a red thrombus overlaying the nodule, necessitating endovascular treatment with a 7mm by 40mm closed-cell carotid stent (Wallstent). Other instances of arterial calcifications were identified using system 10 in additional cases of ICAD investigated in this study, as is shown and described herein below in reference to Fig. 12.DISCUSSION

[0232] As described herein, applicant has acquired data using system 10 in a first-inhuman study that translates the application of a dedicated high-resolution, neuro intravascular imaging technology, nOCT, to the examination of the cerebrovascular circulation. Applicant has demonstrated successful navigation of imaging probe 100 through standard microcatheters and acquisition of relatively free-from-artifacts, high-resolution images from long segments of small and large intracranial arteries across a diverse range of anatomical variations, tortuosity, implantable devices, and underlying conditions. System 10 was used to capture images of small distal vessels, such as the M2 segment of the MCA and the posterior cerebral artery, alongside larger vessels like the internal carotid, basilar, and vertebral arteries, including cases with severe arterial tortuosity. Probe 100 navigation was performed through standard microcatheters, seamlessly integrating with existing procedural workflows. Applicant observed complete blood clearance in both the anterior and posterior circulations using contrast injection protocols consistent with those used in routine clinical rotational angiography. The procedure takes approximately two seconds and needs approximately 16ml to 18ml of contrast per scan, and was safe and well-tolerated, even in cases involving multiple consecutive imaging runs. No use of additional medications was required and patients who were awake also participated in this study.

[0233] System 10 provided nOCT effectively imaged the microstructure of the wall of intracranial arteries and brain aneurysms, providing morphological details comparable to histological techniques. System 10 provided data (e.g., image data and / or other data) was used to successfully assess aneurysm dome shape, thickness, and the presence of arterial wallpathologies, such as disruption of the internal elastic lamina, which informed treatment. Similarly, data provided by system 10 offered the capability to evaluate the cerebrospinal fluid (CFS) appearance in the perivascular space, offering an opportunity to detect potential presence of blood and hemorrhage. Following treatment, nOCT provided by system 10 offered quantifiable insights into the device's interaction with the aneurysm wall and the aneurysm neck, including identifying coverage gaps and communicating malapposition, which, based on existing pre-clinical evidence, could predict occlusion. Furthermore, the use of nOCT provided by system 10 for analysis of recurrent aneurysms offered unique insights into the mechanisms behind incomplete healing or other complications, elucidating retreatment options.

[0234] Similarly, in patients with atherosclerotic disease, system 10 generated image data provided a detailed characterization of plaque composition and anatomy, including inflammation markers (e.g., macrophage accumulations and cholesterol crystals), which are not discernible using existing clinical modalities. This information enabled precise stent sizing and placement by evaluating the extent of the disease, stenoses, and vessel dimensions. During interventions, data provided by system 10 (e.g., image data and / or other data) was used to detect procedure-related iatrogenic effects, such as dissections and plaque rupture resulting from balloon angioplasty. Following stent implantation, data provided by system 10 provided valuable insights into the interaction between the stent and the plaque, including stent edge apposition, degree of expansion, and luminal size gain, which could guide the need for balloon angioplasty and optimal medical therapy.

[0235] During acute stroke thrombectomy interventions, data provided by system 10 (e.g., image data and / or other data) shed light on the underlying vascular pathology, enabling clear identification of normal artery appearances versus pathologic conditions (e.g., ICAD, dissections, and vasculitis). Moreover, system 10 data allowed for the unequivocal detection of residual thrombus or occluded branches after initial passes, as well as differentiation between predominantly red clots and white clots or clots with mixed appearances, thereby guiding the treatment course.

[0236] Additionally, system 10 can be configured to provide data (e.g., image data and / or other data) such that an implants’ healing progression can be closely monitored, including cases where stenting over the ostium of other arteries cannot be avoided, potentially addressing clinical questions related to thromboembolic events and complications following treatments, and informing the refinement of medical therapies (e.g., antiplatelet administration) and interventional techniques. The utility of data provided by system 10 isnot limited to assessing the arterial wall and intraluminal objects; it can also visualize blood and extravascular structures in the subarachnoid space, such as small perforating arteries, veins, brain parenchyma, cranial nerves, and membranes in remarkable detail. The data provided by system 10 offered a high-resolution snapshot of the subarachnoid space in vivo, which was previously inaccessible to state-of-the-art imaging modalities.

[0237] In this FIH study, applicant utilized brief contrast injections to clear the blood from the image field of view during nOCT datasets acquisitions, following established practices. Acquisitions were successfully conducted with a limited contrast volume, approximately 16ml to 18ml per scan. System 10 can be configured to perform nOCT dataset acquisitions with contrast volume injections of less than 20ml. This requirement aligns with protocols routinely employed in neurovascular x-ray angiography, and the overall increase in contrast usage in applicant’s studies was only marginal. Moreover, a recent coronary study showed that, with the use of OCT imaging, fewer angiography views were needed, leading to decreased radiation exposure and no difference in contrast amount utilization. However, a limited subset of patients undergoing neurovascular procedures may be deemed at higher risk when exposed to high contrast media amounts, including contrast-associated kidney injury and other rare adverse reactions, such as contrast-induced encephalopathy and contrast induced neurotoxicity. In these cases, alternative methods may be necessary to reduce or eliminate the use of contrast for nOCT acquisitions. In some embodiments, use of system 10 can include the use of balloon occlusion to momentarily reduce or halt blood flow, facilitating a small saline injection during data acquisition. While saline alone may not suffice for optimal clearing due to its lower viscosity compared to blood, when combined with a brief balloon occlusion, it could yield satisfactory results for nOCT imaging. Alternatively, system 10 can include other flush media for neurovascular imaging.

[0238] System 10 provided nOCT has proven to be an effective diagnostic tool for intracranial arteries, enabling volumetric, high-resolution characterization of cerebrovascular disease and implanted devices. When other imaging techniques yielded inconclusive results, nOCT offered additional information that complemented the decision-making process, providing a clearer picture. Furthermore, the enhanced resolution of nOCT has the potential to facilitate research on the limitations of existing therapeutic devices and techniques, thereby helping to refine current interventional practices and support the development of newer generations of neuroendovascular devices. Similarly, it can assist in evaluating vascular pathology reactions to novel pharmacological treatments and investigating related biological mechanisms. Applicant’s studies have demonstrated the efficacy and safety of system 10provided nOCT in an initial cohort of 32 patients with various presentations and a wide range of neurovascular anatomies and conditions.

[0239] Additionally, applicant has identified system 10 provided nOCT can be utilized to image through the spine to identify cerebrospinal fluid (CSF) leaks from a dural / vein fistula, which can be challenging to detect on conventional anatomic imaging (i.e., imaging signs of CSF can be subtle).

[0240] Referring now to Figs. 2A-D, various views of neuro intravascular imaging are illustrated, consistent with the present inventive concepts. As represented in the figures, imaging probe 100 is deployed through a microcatheter with an inner diameter of 0.021” into the arterial segment of interest (e.g., the M2 segment of the middle cerebral artery, as depicted in this figure). Once in position, the microcatheter is retracted, and imaging probe 100 is exposed to the neurovasculature. Contrast media is injected using standard neurovascular protocols through a distal access catheter (6-F) at a rate of approximately 4.5ml / sec for 4 seconds. While the inner optics is rotating at high velocity (i.e., 250 times per second), imaging probe 100 is automatically retracted at a constant speed generating an helicoidal scan, capturing images of up to 75mm of length of the artery and its surrounding structures in 2 seconds. This process generates 500 cross-sectional images, leading to a high- resolution volumetric acquisition. Referring specifically to Fig. 2B, a three-dimensional rendering of a scan that started from the M2 segment of the MCA and ended in the distal internal carotid artery is illustrated. With a spatial resolution provided by system 10 approaching 10pm, these images provide excellent details of the vessel wall microstructure and intraluminal objects (e.g., devices and thrombus). In the case presented here, the artery appears normal, with a three-layered appearance (as depicted in the cross-sectional images at the bottom). A dark layer representing the tunica media can be seen between the tunica intima and the adventitia. The cerebrospinal fluid (CSF) is optically transparent, allowing visualization of extravascular structures (i.e., veins, arteries, and other structures located outside of the vessel in which probe 100 is located), such as branching arteries, perforators, veins, and brain tissue. Surrounding arteries can be further distinguished from veins because their lumen appears black due to the contrast medium filling them. Conversely, veins remain filled with blood for a longer time, and their lumens appear opaque. In the cross-sectional images, the size of the perforating arteries was found to be between 0.06mm and 0.20mm.

[0241] Referring now to Figs. 3A-C, images of various treatments of recurrent aneurysms are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 3 A, a previously coiled recurring aneurysm that was re-treated with a flow-diverting stent is illustrated. Imaging using system 10 revealed acute clot formations at the level of the posterior communicating artery (inset). These clot formations uniformly covered the stent between approximately 8 o’clock and 1 o’clock, with a maximum thickness of 150pm. This potential thromboembolic complication was treated with intraarterial glycoprotein Ilb / IIIa inhibitors that was continued systemically for 24 hours.

[0242] Referring specifically to Fig. 3B, a recurring aneurysm re-treated with a flow diverting stent is illustrated. Imaging post-stent placement showed malapposition between 7 o’clock and 11 o’clock, with a maximum distance of 0.3mm between the arterial wall and the stent struts. Additionally, clot formations were observed in the images provided by system 10, the formations located on the surface of the device struts over the aneurysm neck. The clot formations were subsequently treated by a single intravascular injection of a GB Ilb / IIIa platelet inhibitor.

[0243] Referring specifically to Fig. 3C, a recurrent aneurysm in the posterior cerebral artery previously treated with multiple flow-diverting stents is illustrated. System 10 provided nOCT imaging shows unintended separation between the overlapping stents at the level of the neck, which impeded the healing process. To address this issue identified through the use of system 10, a third flow diverter was implanted over the neck of the aneurysm. Acute post-intervention imaging provided by system 10 confirmed the proper apposition of the newly implanted device, achieving the desired porosity and coverage.

[0244] Referring now to Figs. 4A and 4B, images of various treatments of native brain aneurysms are illustrated, consistent with the present inventive concepts. Referring specifically to Fig, 4A, a small, 2mm, saccular aneurysm located at the level of the distal Ml segment of the right middle cerebral artery is illustrated. Pre-intervention imaging shows an irregular aneurysm wall with varying thickness, with a minimum wall thickness of 30pm (inset). Imaging provided by system 10 after intervention shows satisfactory device expansion and coverage of the aneurysm neck.

[0245] Referring specifically to Fig. 4B, a left internal carotid artery terminus aneurysm showing a regular appearance and minimum wall thickness of 60pm (inset) is illustrated. Imaging provided by system 10 shows disruption of the internal elastic lamina (IEL), with arrowheads indicating the transition between a normal, three-layered vessel architecture andthe aneurysm wall (inset). After initial treatment, suboptimal device expansion was observed in the image data provided by system 10, and the flow diverter underwent further manipulation with a microwire to further open it. A third scan was performed using system 10, and confirmed improved expansion.

[0246] Referring now to Fig. 5, various images of intracranial in-stent restenosis are illustrated, consistent with the present inventive concepts. In images provided by system 10, the site of in-stent restenosis (Wingspan Stent, Stryker Neurovascular) is indicated by (i) and is visible with a minimum lumen area of 1.8mm2. The restenosis is eccentric and has a layered appearance. The luminal layer is regular and bright, suggesting the presence of organized smooth muscle cells indicating a stable remodeling. The darker, heterogeneous layer under the new smooth muscle cell layer indicates potential tissue inflammation. The site of a cholesterol crystal is indicated by (ii) and visible between the 5 o’clock and 6 o'clock positions, (arrow), (iii) a stenotic lesion in a more proximal vessel location is also present, due to an eccentric plaque with lipid accumulations, (iv) orthogonal (longitudinal) projection of the scan displayed from distal (top) to proximal (bottom). Scale bars shown are equal to 1mm.

[0247] Referring now to Figs. 6A-D, various images of intracranial atherosclerotic disease are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 6A, pre-intervention imaging provided by system 10 reveals a significant plaque burden over the stenosed segment. As shown in (i), the ML A is severely compromised by an eccentric plaque, measuring 2.3mm2. As shown in (ii), a site of plaque ulceration is observed. As shown in (iii), the plaque appearance indicates the presence of lipids. As shown in (iv), signs of inflammation is observed, such as macrophage accumulations. As shown in (v), distally, a non-stenotic, fibrotic plaque is observed at the level of the middle cerebral artery (Ml segment), indicative of extensive arterial disease.

[0248] Referring specifically to Fig. 6B, imaging provided by system 10 after balloon angioplasty reveals significant plaque disruption and an iatrogenic dissection, as a result of the intervention.

[0249] Referring specifically to Fig. 6C, following angioplasty, a 4.5x20mm selfexpanding metallic stent (Wingspan) was placed over the stenotic segment. Severe stent underexpansion is observed over the distal segment, as observed in images provided by system 10, which could compromise treatment safety and efficacy.

[0250] Referring specifically to Fig. 6D, because of the stent underexpansion, a flow diverter was subsequently deployed to improve lumen expansion. Imaging provided by system 10 shows improved arterial lumen diameter, demonstrating successful device expansion.

[0251] Referring now to Figs. 7A and B, various images of thrombectomy procedures in the middle cerebral artery are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 7A, prior to performing the thrombectomy procedure and using system 10, applicant conducted imaging in acute settings to investigate the underlying causes of the ischemic stroke. The images provided by system 10 captured both the Ml and M2 segments of the middle cerebral artery (MCA). Applicant observed a large, red thrombus that covered a long arterial segment. The imaging probe 100 was positioned between the thrombus and the arterial wall, and the entire scan displayed excellent blood clearance and image quality, despite the narrow lumen. Furthermore, the artery exhibited a normal, threelayered appearance, which indicated the absence of intracranial atherosclerotic disease (ICAD), dissections, or other conditions such as vasculitis (i, ii, and iii).

[0252] Two thrombectomy passes with different-size Solitaire™ stent retrievers were employed for thrombectomy. The first pass successfully removed the clot from the main artery, and the second pass with a smaller device addressed a clot occluding a side branch. Post-intervention imaging was performed twice, following each pass. Imaging data after the second pass displayed successful clot removal in the main artery with minor clot debris still visible (iv and v, arrows), and there was no significant intimal damage. Similarly, the clot was effectively removed from the side branch, with limited clot debris visible at the level of the ostium (vi, arrow).

[0253] Referring specifically to Fig. 7B, a stent retriever thrombectomy for an M2 occlusion was previously performed. Six days after the procedure, imaging was conducted using system 10, revealing non-occlusive residual thrombus at the M2 segment level. A mixed and white clot appearance (i.e., homogeneous appearance with lower optical absorption) was detected. There was no significant arterial wall damage, such as intimal tears or dissections and ICAD was ruled out.

[0254] Referring now to Figs. 8A and B, various images of neurovascular intervention follow-ups are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 8 A, a follow-up imaging procedure performed using system 10 of a leftsmall choroidal aneurysm previously treated with a 4mm by 15mm flow-diverter is illustrated. As shown in (i-iv), variations in device diameters are observed between the stent distal edge and the mid-portion of the stent, indicating underexpansion and device shrinkage. As shown in (iii), significant intimal hyperplasia is seen at the level of the minimum lumen area. As shown in (iv), the minimum stent diameter was found to be equal to 2.04mm. The restenotic tissue is eccentric and shows a layered appearance, with a brighter homogeneous layer covering a thinner darker layer located on top of the struts. The tissue appears smooth and without signs of thrombus. As shown in(v), imaging at the level of the ophthalmic artery (inlets show adjacent cross-sections), shows the device struts and the tissue covering its ostium. Some open channels are observed, connecting the lumen of the main artery to the ophthalmic.

[0255] Referring specifically to Fig. 8B, MCA stenosis treated with a 4.5mm by 21mm metallic stent and a drug-eluting balloon is illustrated. System 10 provided nOCT imaging was performed at 6 months follow-up. As shown in (i), the distal edge on the Ml portion of the MCA, and as shown in (ii), an angiographic visible stenosis distal to the Al segment of the anterior cerebral artery. A thickened arterial wall is observed behind the stent, presenting uncovered struts. As shown in (iii), the stent struts covering the Al segment do not show tissue growth over their surface, and as shown in (iv), a well-expanded proximal device edge.

[0256] Referring now to Figs. 9A and B, various images of two aneurysms treated with intrasaccular devices are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 9A, imaging of a Contour device providing quantifiable details of its coverage of the aneurysm neck is shown. As shown in (i), a small gap is present between device and aneurysm neck following device placement. The device detachment point is shown in (ii).

[0257] Referring specifically to Fig. 9B, imaging of a posterior communicating aneurysm treated with a WEB device is shown. Imaging provided by system 10 further shows proper placement of the device, good coverage of the aneurysm neck with protrusion into the parent artery but without occluding the posterior communicating artery ostium, as indicated by the asterisk.

[0258] Referring now to Figs. 10A and B, various images of the subarachnoid space are illustrated, consistent with the present inventive concepts. Referring specifically to Fig. 10A, imaging provided by system 10 at the level of the posterior cerebral artery and the basilarartery is shown. The CSF is optically transparent and permits imaging of the extravascular structures, including the parenchyma, bones, perforators as small as 0.05mm, veins, membranes, and the subarachnoid trabeculae.

[0259] Referring specifically to Fig, 10B, images provided by system 10 that were collected at the level of the middle cerebral artery are illustrated, showing several surrounding perforating arteries.

[0260] Referring now to Fig. 11, various images of a calcified nodule are illustrated, consistent with the present inventive concepts. Specifically, in images provided by system 10, a calcified nodule is observed at the level of the ICA bifurcation between the common carotid and the internal carotid arteries. Thrombus overlying the nodule can also be seen, as well as the degree of calcified nodule protrusion.

[0261] Referring now to Fig. 12, various images of intracranial artery calcifications are illustrated, consistent with the present inventive concepts. The images shown were produced using system 10. Specifically, the left image shows an example of a macro calcification (between approximately 2 and 5 o’clock) located in the distal internal carotid artery. Calcium appearance is characterized by a sharply defined homogeneous region with a darker appearance. Specifically, the right image shows an example of a small calcification located in the basilar artery.

[0262] Referring now to Figs. 13A-C, various images of structures surrounding the middle cerebral artery, a ruptured aneurysm, and a vasospasm are illustrated, respectively, consistent with the present inventive concepts.

[0263] Referring specifically to Fig. 13 A, system 10 produced images of various structures surrounding the middle cerebral artery are shown. As shown, the cerebrovascular fluid surrounding the middle cerebral artery is optically transparent and permits imaging of various extravascular structures, including the parenchyma, bones, veins, and perforators (in this example as small as 0.05mm).

[0264] Referring specifically to Fig. 13B, system 10 produced images of a ruptured aneurysm are shown. As shown, the space surrounding the artery shows an opaque appearance, suggesting potential presence of blood mixed with the cerebrovascular fluid (as indicated by the arrows).

[0265] Referring specifically to Fig. 13C, system 10 produced images of a vasospasm at the level of the middle cerebral artery are shown. Intravascular imaging shows the vessel’s appearance in high-resolution. A normal three-layered architecture is observed (i.e., endothelium, internal elastic lamina (IEL), and external elastic lamina (EEL)). The tunica media is visible as a layer with a darker appearance with respect to the tunica intima and the tunica externa. Due to the vasospasm, the artery appears folded several times. The scale bar on the cross-sectional image is equal to 1mm.

[0266] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which is defined in the accompanying claims.

Claims

WHAT IS CLAIMED IS:

1. A method of performing a medical procedure on a patient, the method comprising: selecting an imaging system for a patient, the imaging system comprising: an imaging probe, comprising: a first elongate shaft comprising a proximal end, a distal portion, a distal end, and a lumen extending at least between the proximal end and the distal portion; a second elongate shaft comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, wherein at least a portion of the second elongate shaft is positioned within the lumen of the first elongate shaft; a rotatable optical core comprising a proximal end and a distal end, wherein at least a portion of the rotatable optical core is positioned within the lumen of the second elongate shaft; and an optical assembly positioned proximate the distal end of the rotatable optical core, wherein the optical assembly configured to direct light to tissue to be imaged and to collect reflected light from the tissue to be imaged; a console comprising: an imaging assembly constructed and arranged to optically couple to the imaging probe, wherein the imaging assembly is configured to emit light into the imaging probe and to receive the reflected light collected by the optical assembly; and an implant device for implantation at a location within the brain of the patient, and using the system to produce a first set of image data of the patient’s brain prior to, during, and / or after the implantation of the implant device.

2. The method according to claim 1 and / or any one or more other claims herein, wherein the implant device comprises an aneurysm treatment device.

3. The method according to claim 1 and / or any one or more other claims herein, wherein the implant device comprises one, two, or more devices selected from thegroup consisting of: a flow diverter; an embolization coil; a stent; a covered stent; an aneurysm treatment implant; and combinations thereof.

4. The method according to claim 1 and / or any one or more other claims herein, further comprising analyzing the first set of image data.

5. The method according to claim 4 and / or any one or more other claims herein, wherein the analysis is performed by the system, by an operator, or both.

6. The method according to claim 1 and / or any one or more other claims herein, wherein the first set of image data comprises one or more vessel measurements.

7. The method according to claim 6 and / or any one or more other claims herein, wherein the one or more vessel measurements comprises side branch diameter measurements, aneurysm diameter measurements, or both.

8. The method according to claim 1 and / or any one or more other claims herein, further comprising determining one or more implant metrics based on the first set of image data.

9. The method according to claim 8 and / or any one or more other claims herein, wherein the one or more implant metrics comprises a stent apposition assessment, a stent expansion assessment, or both.

10. The method according to claim 8 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of successful stent apposition to a level of at least 70%.

11. The method according to claim 10 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of successful stent apposition to a level of at least 75%, 80%, 85%, 90%, 92%, 94%, and / or 96%.

12. The method according to claim 8 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of clinical efficacy to a level of at least 70%.

13. The method according to claim 12 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of clinical efficacy to a level of at least 75%, 80%, 85%, 90%, 92%, 94%, or 96%.

14. The method according to claim 8 and / or any one or more other claims herein, wherein the system further comprises a second imaging device, wherein the method further comprises: producing a second set of image data using the second imaging device, and determining one or more implant metrics based on both the first set of image data and the second set of image data.

15. The method according to claim 14 and / or any one or more other claims herein, wherein the second imaging device comprises a fluoroscope, and wherein the second set of image data comprises angiography data.

16. The method according to claim 14 and / or any one or more other claims herein, wherein the one or more implant metrics comprises a stent apposition assessment, a stent expansion assessment, or both.

17. The method according to claim 14 and / or any one or more other claims herein, wherein the first set of image data and / or the second set of image data comprises one or more vessel measurements.

18. The method according to claim 17 and / or any one or more other claims herein, wherein the one or more vessel measurements comprises side branch diameter measurements, aneurysm diameter measurements, or both.

19. The method according to claim 14 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of successful stent apposition to a level of at least 70%.

20. The method according to claim 19 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of successful stent apposition to a level of at least 75%, 80%, 85%, 90%, 92%, 94%, and / or 96%.

21. The method according to claim 14 and / or any one or more other claims herein, wherein the system and / or the method is configured to improve likelihood of clinical efficacy to a level of at least 70%.

22. The method according to claim 21 and / or any one or more other claims herein, wherein the system and / or the method isconfigured to improve likelihood of clinical efficacy to a level of at least 75%, 80%, 85%, 90%, 92%, 94%, or 96%.

23. The method according to claim 1 and / or any one or more other claims herein, wherein the system is configured to produce the first set of image data using no more than 20ml of flushing fluid.

24. The method according to claim 1 and / or any one or more other claims herein, wherein the imaging probe is configured to translate and gather the first set of image data when positioned in a blood vessel with a radius of curvature as low as 1.95mm.

25. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to diagnose and / or treat a brain aneurysm using the first set of image data.

26. The method according to claim 25 and / or any one or more other claims herein, wherein brain aneurysm comprises a large aneurysm.

27. The method according to claim 25 and / or any one or more other claims herein, wherein the brain aneurysm comprises an aneurysm in the posterior cerebral artery.

28. The method according to claim 25 and / or any one or more other claims herein, wherein the brain aneurysm comprises a small, unruptured aneurysm in the right middle cerebral artery.

29. The method according to claim 25 and / or any one or more other claims herein, wherein the brain aneurysm comprises a ruptured aneurysm.

30. The method according to claim 25 and / or any one or more other claims herein, wherein a stenosis is present proximate the brain aneurysm.

31. The method according to claim 1 and / or any one or more other claims herein, wherein the first set of image data is collected in a first clinical procedure, and wherein a second clinical procedure is performed based on an analysis of the first set of image data.

32. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to diagnose and / or a treat a patient with multiple comorbidities associated with the patient’s brain.

33. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to diagnose and / or treat intracranial atherosclerotic disease of the patient.

34. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to diagnose and / or treat a patient with a left hemisphere stroke and / or other stroke.

35. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to diagnose and / or treat a patient with presence of thrombus in a blood vessel of the patient’s brain.

36. The method according to claim 1 and / or any one or more other claims herein, wherein the first set of image data comprises data related to a previously performed neurovascular treatment.

37. The method according to claim 1 and / or any one or more other claims herein, wherein the first set of image data comprises images of structures located outside of the blood vessel in which the imaging probe is positioned.

38. The method according to claim 37 and / or any one or more other claims herein, wherein the structures comprise one, two, or more structures selected from the group consisting of an artery; a vein; one or more structures in the subarachnoid space; one or more small perforating arteries; a meningeal layer; a bony structure; parenchyma; subarachnoid trabeculae; the transition between intracranial and extracranial ICA location; and combinations thereof.

39. The method according to claim 37 and / or any one or more other claims herein, wherein the structure comprises an implanted device that has been planted at a location outside of the blood vessel in which the imaging probe is positioned.

40. The method according to claim 37 and / or any one or more other claims herein, wherein the structure comprises a structure that is located at least 3mm, 5mm, and / or 7mm from the imaging probe when the first set of image data is produced.

41. The method according to claim 37 and / or any one or more other claims herein, wherein the structure comprises a structure that is located at least 1mm, 3mm, and / or 5mm from the wall of the blood vessel in which the imaging probe is positioned when the first set of image data is produced.

42. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to assess a parameter selected from the group consisting of aneurysm dome shape; aneurysm dome thickness; aneurysm thickness; presence of arterial wall pathologies, such as disruption of the internal elastic lamina; and combinations of these.

43. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to evaluate cerebrospinal fluid appearance in the perivascular space.

44. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to assess the interaction between an implanted device and the wall and / or neck of an aneurysm.

45. The method according to claim 44 and / or any one or more other claims herein, wherein the assessment comprises identifying coverage gaps and / or communicating malapposition of the device with the aneurysm.

46. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to assess healing of a treated aneurysm.

47. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to characterize plaque composition and / or anatomy.

48. The method according to claim 47 and / or any one or more other claims herein, wherein the characterization comprises a characterization of macrophage accumulations; cholesterol crystals; and / or other inflammation marker.

49. The method according to claim 47 and / or any one or more other claims herein, wherein the system and / or the method are configured to determine stent sizing, stent placement, or both.

50. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to be used in an angioplasty procedure and to detect: a dissection; a plaque rupture; and / or other procedure related iatrogenic effect.

51. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to assess: stent apposition;stent edge apposition; stent degree of expansion; luminal size gain; and / or other stent-plaque interaction.

52. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method is configured to assess healing progression related to implantation of a stent or other implantable device.

53. The method according to claim 52 and / or any one or more other claims herein, wherein the stent and / or other implantable device is positioned at least partially over an ostium of a blood vessel.

54. The method according to claim 1 and / or any one or more other claims herein, wherein the system and / or the method are configured to assess one, two, or more of a wall of an artery; an intraluminal implant or other intraluminal material; a structure in the subarachnoid space such as small perforating arteries, veins, brain parenchyma, cranial nerves, and membranes; and combinations of these.

55. The method according to claim 1 and / or any one or more other claims herein, wherein the system is configured to deliver light into the patient’s spine, wherein the first set of image data comprises data related to the patient’s spine.

56. The method according to claim 55 and / or any one or more other claims herein, wherein the system and / or the method are configured to identify cerebrospinal fluid leaks, such as cerebrospinal fluid leaks from a dural / vein fistula.

57. The method according to claim 1 and / or any one or more other claims herein, wherein the system further comprises: a user interface comprising a display; and a processing unit comprising a processor and a memory storage component coupled to the processor, wherein the memory storage component stores instructions for the processor to perform an algorithm, wherein the algorithm is configured to assess at least the first set of image data.

58. The method according to claim 57 and / or any one or more other claims herein, wherein the algorithm is further configured to assess a second set of image data comprising angiography and / or other data.

59. The method according to claim 1 and / or any one or more other claims herein, wherein the system is configured to rotate the rotatable optical core at a rotational rate of at least 200 rotations per second, and / or at least 250 rotations per second.

Images