Imaging system

Abstract

Provided herein is an imaging system for a patient, comprising an imaging probe and an imaging assembly. The imaging probe comprises a first elongate shaft, a second elongate shaft disposed within a lumen of the first elongate shaft, a rotatable optical core disposed within a lumen of the second elongate shaft, and an optical assembly disposed near a distal end of the rotatable optical core. The optical assembly directs light at and collects reflected light from the tissue to be imaged. The imaging assembly illuminates light into the imaging probe and receives reflected light collected by the optical assembly.

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Application No. 63 / 416,170 (Docket No. GTY-023-PR1), entitled "Imaging System," filed October 14, 2022, the contents of which are incorporated by reference in their entirety.

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 532,223 (Docket No. GTY-025-PR1), entitled "Enhanced Imaging System," filed August 11, 2023, the contents of which are incorporated by reference in their entirety.

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 542,279 (Docket No. GTY-026-PR1), entitled "Imaging System," filed October 3, 2023, the contents of which are incorporated by reference in their entirety.

[0004] This application is related to U.S. Provisional Application No. 62 / 148,355, entitled "Micro-Optic Probes for Neurology," filed April 16, 2015 (Docket No: GTY-001-PR1), the contents of which are incorporated by reference in their entirety.

[0005] This application is related to U.S. Provisional Application No. 62 / 322,182, entitled "Micro-Optic Probes for Neurology," filed April 13, 2016 (Docket No. GTY-001-PR2), the contents of which are incorporated by reference in their entirety.

[0006] This application is related to International PCT Patent Application No. PCT / US2016 / 027764 (Docket No. GTY-001-PCT), entitled "Micro-Optic Probes for Neurology," filed April 15, 2016, and Publication No. WO2016 / 168605, published October 20, 2016, the contents of which are incorporated by reference in their entireties.

[0007] This application is related to U.S. Patent Application No. 15 / 566,041 (Docket No. GTY-001-US), entitled "Micro-Optic Probes for Neurology," filed October 12, 2017, and U.S. Patent No. 11,278,206, published March 22, 2022, the contents of which are incorporated by reference in their entirety.

[0008] This application is related to U.S. Patent Application No. 17 / 668,757, entitled "Micro Optic Probes for Neurology," filed February 10, 2022 (Docket No. GTY-001-US-CON1), and U.S. Publication No. 2022-0218206, published July 14, 2022, the contents of which are incorporated by reference in their entirety.

[0009] This application is related to U.S. Provisional Application No. 62 / 212,173 (Docket No. GTY-002-PR1), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed August 31, 2015, the contents of which are incorporated by reference in their entirety.

[0010] This application is related to U.S. Provisional Application No. 62 / 368,387 (Docket No. GTY-002-PR2), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed July 29, 2016, the contents of which are incorporated by reference in their entirety.

[0011] This application is related to International PCT Patent Application No. PCT / US2016 / 049415 (Docket No. GTY-002-PCT), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed August 30, 2016, and Publication No. WO2017 / 040484, published March 9, 2017, the contents of which are incorporated by reference in their entireties.

[0012] This application is related to U.S. patent application Ser. No. 15 / 751,570 (Docket No. GTY-002-US), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed February 9, 2018, and U.S. Patent No. 10,631,718, published April 28, 2020, the contents of which are incorporated by reference in their entirety.

[0013] This application is related to U.S. patent application Ser. No. 16 / 820,991 (Docket No. GTY-002-US-CON1), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed on March 17, 2020, and U.S. Patent No. 11,064,873, published on July 20, 2021, the contents of which are incorporated by reference in their entirety.

[0014] This application is related to U.S. Patent Application No. 17 / 350,021 (Docket No. GTY-002-US-CON2), entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed June 17, 2021, and Publication No. 2022-0142464, published May 12, 2022, the contents of which are incorporated by reference in their entirety.

[0015] This application is related to U.S. patent application Ser. No. 18 / 096,678, entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed on January 13, 2023 (Docket No. GTY-002-US-CON3), published on _________ under Publication No. _________, the contents of which are incorporated by reference in their entirety.

[0016] This application is related to U.S. Provisional Application No. 62 / 591,403 (Docket No. GTY-003-PR1), entitled "Imaging System," filed November 28, 2017, the contents of which are incorporated by reference in their entirety.

[0017] This application is related to U.S. Provisional Application No. 62 / 671,142 (Docket No. GTY-003-PR2), entitled "Imaging System," filed May 14, 2018, the contents of which are incorporated by reference in their entirety.

[0018] This application is related to International PCT Patent Application No. PCT / US2018 / 062766 (Docket No. GTY-003-PCT), entitled "Imaging System," filed November 28, 2018, and Publication No. WO2019 / 108598, published June 6, 2019, the contents of which are incorporated by reference in their entireties.

[0019] This application is related to U.S. Patent Application No. 16 / 764,087 (Docket No. GTY-003-US), entitled "Imaging System," filed May 14, 2020, and Publication No. 2020-0288950, published September 17, 2020, the contents of which are incorporated by reference in their entirety.

[0020] This application is related to U.S. Patent Application No. 18 / 144,462, entitled "Imaging System," filed May 8, 2023 (Docket No. GTY-003-US-CON), published on ___________ under Publication No. _________, the contents of which are incorporated by reference in their entirety.

[0021] This application is related to U.S. Provisional Application No. 62 / 732,114 (Docket No. GTY-004-PR1), entitled "Imaging System with Optical Pathway," filed September 17, 2018, the contents of which are incorporated by reference in their entirety.

[0022] This application is related to International PCT Patent Application No. PCT / US2019 / 051447 (Docket No. GTY-004-PCT), entitled "Imaging System with Optical Pathway," filed September 17, 2019, and Publication No. WO2020 / 061001, published March 26, 2020, the contents of which are incorporated by reference in their entireties.

[0023] This application is related to U.S. Patent Application No. 17 / 276,500 (Docket No. GTY-004-US), entitled "Imaging system with Optical Pathway," filed March 16, 2021, and Publication No. 2021-0267442, published September 2, 2021, the contents of which are incorporated by reference in their entirety.

[0024] This application is related to U.S. Provisional Application No. 63 / 017,258 (Docket No. GTY-005-PR1), entitled "Imaging System," filed April 29, 2020, the contents of which are incorporated by reference in their entirety.

[0025] This application is related to International PCT Patent Application No. PCT / US2021 / 29836 (Docket No. GTY-005-PCT), entitled "Imaging System," filed April 29, 2021, and Publication No. WO2021 / 222530, published November 4, 2021, the contents of which are incorporated by reference in their entirety.

[0026] This application is related to U.S. Patent Application No. 17 / 919,809 (Docket No. GTY-005-US), entitled "Imaging System," filed October 19, 2022, and Publication No. 2023-0181016, published June 15, 2023, the contents of which are incorporated by reference in their entirety.

[0027] This application is related to U.S. Provisional Application No. 62 / 840,450 (Docket No. GTY-011-PR1), entitled "Imaging Probe with Fluid Pressurization Element," filed April 30, 2019, the contents of which are incorporated by reference in their entirety.

[0028] This application is related to International PCT Patent Application No. PCT / US2020 / 030616 (Docket No. GTY-011-PCT), entitled "Imaging Probe with Fluid Pressurization Element," filed April 30, 2020, and Publication No. WO2020 / 223433, published November 5, 2020, the contents of which are incorporated by reference in their entireties.

[0029] This application is related to U.S. Patent Application No. 17 / 600,212 (Docket No. GTY-011-US), entitled "Imaging Probe with Fluid Pressurization Element," filed September 30, 2021, and Publication No. 2022-0142462, published May 12, 2022, the contents of which are incorporated by reference in their entirety.

[0030] This application is related to U.S. Provisional Application No. 62 / 850,945 (Docket No. GTY-013-PR1), entitled "OCT-Guided Treatment of a Patient," filed May 21, 2019, the contents of which are incorporated by reference in their entirety.

[0031] This application is related to U.S. Provisional Application No. 62 / 906,353 (GTY-013-PR2), filed September 26, 2019, and entitled "OCT-Guided Treatment of a Patient," the contents of which are incorporated by reference in their entirety.

[0032] This application is related to International PCT Patent Application No. PCT / US2020 / 033953 (Docket No. GTY-013-PCT), entitled "Systems and Methods for OCT-Guided Treatment of a Patient," filed on May 21, 2020, and Publication No. WO2020 / 237024, published on November 26, 2020, the contents of which are incorporated by reference in their entireties.

[0033] This application is related to U.S. Patent Application No. 17 / 603,689 (Docket No. GTY-013-US), entitled "Systems and Methods for OCT-Guided Treatment of a Patient," filed on October 14, 2021, and Publication No. 2022-0061670, published on March 3, 2022, the contents of which are incorporated by reference in their entirety.

[0034] This application is related to U.S. Provisional Application No. 63 / 154,934 (Docket No. GTY-021-PR1), entitled "Optical Imaging System," filed March 1, 2021, the contents of which are incorporated by reference in their entirety.

[0035] This application is related to U.S. Patent Application No. 17 / 682,197 (Docket No. GTY-021-US), entitled "Optical Imaging System," filed February 28, 2022, and Publication No. 2023-0000321, published January 5, 2023, the contents of which are incorporated by reference in their entirety.

[0036] This application is related to U.S. Provisional Application No. 63 / 298,086 (Docket No. GTY-022-PR1), entitled "Imaging System for Calculating Fluid Dynamics," filed January 10, 2022, the contents of which are incorporated by reference in their entirety.

[0037] This application is related to International PCT Patent Application No. PCT / US2023 / 010508 (Docket No. GTY-022-PCT), entitled "Imaging System for Calculating Fluid Dynamics," filed January 10, 2023, and Publication No. WO2023 / 133355, published July 13, 2023, the contents of which are incorporated by reference in their entireties.

[0038] The present invention relates generally to imaging systems, and more particularly to intravascular imaging systems that include an imaging probe and a delivery device. [Background technology]

[0039] Imaging probes have been commercially available for imaging various locations within a patient's body, such as intravascular probes for imaging a patient's heart. Current imaging probes are limited in their ability to reach certain anatomical locations due to their size and stiffness. Current imaging probes are also inserted over guidewires, which can lead to unstable probe placement and limit the use of one or more delivery catheters through which the imaging probe is inserted. Therefore, there is a need for imaging systems that include smaller diameter, more flexible imaging probes, and systems that include one or more delivery devices that are compatible with these improved imaging probes. Summary of the Invention

[0040] In accordance with one aspect of the present inventive concept, an imaging system for a patient includes an imaging probe including a first elongate shaft having a proximal end, a distal end, and a lumen extending at least between the proximal and distal ends; a second elongate shaft having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the second elongate shaft being at least partially disposed within the lumen of the first elongate shaft; a rotatable optical core having a proximal end and a distal end, the rotatable optical core being at least partially disposed within the lumen of the second elongate shaft; and an optical assembly disposed proximate the distal end of the rotatable optical core. The optical assembly is configured to direct light toward and collect reflected light from tissue to be imaged. The system further includes an imaging assembly constructed and arranged to be optically coupled to the imaging probe. The imaging assembly is configured to direct light toward the imaging probe and receive reflected light collected by the optical assembly.

[0041] In some embodiments, the distal portion of the first elongate shaft is transparent to light emitted by the imaging assembly, and the second elongate shaft is not transparent to light emitted by the imaging assembly.

[0042] In some embodiments, the system may further include a probe interface unit configured to be operably attached to the imaging probe. The probe interface unit may be configured to retract the second elongated shaft and the rotatable optical core. The probe interface unit may be configured to rotate the rotatable optical core without rotating either the first elongated shaft or the second elongated shaft. The imaging probe may further include a connector assembly configured to operably connect at least the rotatable optical core and the second elongated shaft to the probe interface unit. The rotatable optical core may further include an optical connector, and the connector assembly may include a stabilization assembly configured to engage the optical connector to inhibit relative movement between the second elongated shaft and the optical connector. The movement may include relative rotational movement. The movement may include relative axial movement. The stabilization assembly may be configured to release the optical connector when the connector assembly is attached to the probe interface unit. The stabilization assembly may be resiliently biased toward the optical connector to inhibit movement when in a rest position. The stabilization assembly may be resiliently biased away from the optical assembly to allow movement when in a rest position. The connector assembly may further include an outer shell configured to bias the stabilization assembly toward the optical connector.

[0043] In some embodiments, the optical assembly is disposed within the lumen of the first elongate shaft distal to the distal end of the second elongate shaft. The system may further include a viscous damping material disposed within the distal portion of the second elongate shaft and surrounding the rotatable optical core. The imaging probe may be configured to prevent the viscous damping material from exiting the second elongate shaft into the first elongate shaft.

[0044] In some embodiments, the rotatable optical core extends beyond the distal end of the second elongate shaft, and the optical assembly is disposed within the lumen of the first elongate shaft. An outer diameter of the optical assembly may be greater than an inner diameter of the second elongate shaft. The optical assembly may be disposed in air within the lumen of the first elongate shaft. The lumen of the first elongate shaft may be filled with air proximal and distal to the optical assembly.

[0045] In some embodiments, the optical assembly includes a reflector disposed distal to the distal end of the rotatable optical core. The optical assembly further includes a housing, which may be fixedly attached to the reflector and the distal end of the rotatable optical core. The rotatable optical core and the optical assembly may rotate together. The optical assembly further includes a space between the reflector and the distal end of the rotatable optical core, which may be filled with air. Light emitted from the distal end of the rotatable optical core may expand within the space. The reflector may include a concave reflective surface configured to collimate the expanded light.

[0046] The technology described herein, together with its attributes and attendant advantages, will be best understood by considering the following detailed description in conjunction with the accompanying drawings, in which representative embodiments are set forth by way of example.

[0047] (Incorporated by reference) 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 contents of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes. [Brief explanation of the drawings]

[0048] [Figure 1]1 is a schematic diagram of a diagnostic system including an imaging probe and one or more algorithms for processing image data consistent with the concepts of the present invention; [Figure 2] 1 is a perspective view of an imaging probe consistent with the concepts of the present invention; [Figure 2A] 1 is a cross-sectional view of a portion of an imaging probe consistent with the concepts of the present invention; [Figure 2B] 1 is a cross-sectional view of a portion of an imaging probe consistent with the concepts of the present invention; [Figure 3] 1 is a perspective view of an optical assembly consistent with the concepts of the present invention; [Figure 3A] 1 is a cross-sectional view of an optical assembly consistent with the concepts of the present invention; [Figure 4A] 1 is a perspective view of a reflector consistent with the concepts of the present invention; [Figure 4B] 1 is a perspective view of an assembly tool consistent with the concepts of the present invention; [Figure 4C] 1 is a perspective view of an optical assembly consistent with the concepts of the present invention; [Figure 5] 1 is a perspective view of an assembly tool consistent with the concepts of the present invention; [Figure 6] 1A-1D are various views illustrating one embodiment of a reflector consistent with the concepts of the present invention. [Figure 6A] FIG. 2 is an end view of a portion of a reflector consistent with the concepts of the present invention. [Figure 6B] FIG. 1 is a side view of a portion of a reflector consistent with the concepts of the present invention. [Figure 7] 1 is a side view of a distal end of an optical fiber consistent with the concepts of the present invention; [Figure 8] 1 is a partially transparent perspective view of a distal end of an imaging probe consistent with the concepts of the present invention; [Figure 9A] 1 is a side cross-sectional view of the distal end of an imaging probe consistent with the concepts of the present invention. [Figure 9B] 1 is a top cross-sectional view of the distal end of an imaging probe consistent with the concepts of the present invention; [Figure 10A] FIG. 10 shows optical modeling images consistent with the concepts of the present invention. [Figure 10B]10 is a chart of optical modeling results consistent with the concepts of the present invention. [Figure 11A] 1A-1D are anatomical cross-sectional side views illustrating steps of an imaging method consistent with the concepts of the present invention. [Figure 11B] 1A-1D are anatomical cross-sectional side views illustrating steps of an imaging method consistent with the concepts of the present invention. [Figure 11C] 1A-1D are anatomical cross-sectional side views illustrating steps of an imaging method consistent with the concepts of the present invention. [Figure 11D] 1A-1D are anatomical cross-sectional side views illustrating steps of an imaging method consistent with the concepts of the present invention. [Figure 11E] 1A-1D are anatomical cross-sectional side views illustrating steps of an imaging method consistent with the concepts of the present invention. [Figure 12] 1 is a side view of a portion of an imaging probe consistent with the concepts of the present invention; [Figure 12A] 1 is a side view of a portion of an imaging probe consistent with the concepts of the present invention; [Figure 13] 1 is a cross-sectional view of the distal end of an imaging probe consistent with the concepts of the present invention. [Figure 14] FIG. 1 is a side view of a lens assembly consistent with the concepts of the present invention. [Figure 14A] 1 is a side view of a distal end of an optical fiber consistent with the concepts of the present invention; [Figure 14B] 1 is a side view of a lens assembly disposed at the distal end of an optical fiber consistent with the concepts of the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0049] Reference will now be made in detail to the present embodiments of the present technology, as illustrated in the accompanying drawings. Like reference numerals are used to refer to like elements. However, this specification is not intended to limit the disclosure to the particular embodiments, but should be construed to include various modifications, equivalents, and / or alternatives to the embodiments described herein.

[0050] It will be understood that the terms "comprising" (and any form of comprising, such as "comprising" 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"), as used herein, imply the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0051] Furthermore, although terms such as "first," "second," and "third" may be used herein to describe various limitations, components, components, regions, layers, and / or sections, it will be understood that these limitations, components, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one limitation, component, component, region, layer, or section from another limitation, component, component, region, layer, or section. Thus, a first limitation, component, component, region, layer, or section described below may also be referred to as a second limitation, component, component, region, layer, or section without departing from the teachings of the present application.

[0052] Furthermore, when a component is referred to as being "on," "mounted," "connected," or "coupled" to another component, it will be understood that the component may be directly on or above the other component, or connected or coupled to the other component, or that there may be one or more intervening components. Conversely, when a component is referred to as being "directly on," "directly mounted," "directly connected," or "directly coupled" to another component, there are no intervening components. Other language used to describe the relationship between components should be interpreted similarly (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.).

[0053] Furthermore, when a first component is referred to as being "in," "on," and / or "within" a second component, it will be understood that the first component may be disposed within an interior space of the second component, within a portion of the second component (e.g., within a wall of the second component), on an exterior and / or interior surface of the second component, or a combination of one or more of these.

[0054] As used herein, when the term "proximate" is used to describe a first component or location being proximate to a second component or location, it is intended to include one or more locations near the second component or location, as well as locations within, on, and / or inside the second component or location. For example, a component positioned proximate to an anatomical location (e.g., a location of a target tissue) is intended to include not only a component positioned adjacent to the anatomical location, but also a component positioned within, on, and / or inside the anatomical location.

[0055] Spatially relative terms such as "beneath," "below," "lower," "upper," and the like are used to describe the relationship of a component and / or feature to another component and / or feature, for example, as illustrated in the figures. Furthermore, it will be understood that the spatially relative terms are intended to encompass different orientations of the device during use and / or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, components described as "below" and / or "below" other components or features would now be oriented "above" the other components or features. The device may be otherwise oriented (e.g., rotated 90 degrees or at another orientation), and the spatially relative descriptors used herein would be interpreted accordingly.

[0056] As used herein, the terms "reduce," "reducing," "reduction," and the like are intended to include a reduction in an amount, including a reduction to zero. Reducing the likelihood of occurrence is intended to include prevention of occurrence. Correspondingly, the terms "prevent," "preventing," and "prevention" are intended to include the acts of "reduce," "reducing," and "reduction," respectively.

[0057] As used herein, the term "and / or" should be construed as specifically disclosing each of the two specified features or components with or without the other feature or component. For example, "A and / or B" should be construed as specifically disclosing (i) A, (ii) B, and (iii) each of A and B, as if each were individually set forth herein.

[0058] As used herein, the term "one or more" may mean 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more, up to any number.

[0059] As used herein, the terms "and combinations thereof" and "and combinations thereof" may be used after a list of items that are to be included singly or collectively, respectively. For example, components, processes, and / or other items selected from the group consisting of A, B, C, and combinations thereof, shall include a set of one or more components consisting of 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.

[0060] In this specification, unless otherwise specified, "and" can mean "or," and vice versa. For example, if a feature is described as having A, B, and C, the feature may have A, B, C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature may have only one or two of A, B, and C.

[0061] As used herein, when a quantifiable parameter is described as being "between" a first value X and a second value Y, it is intended to include parameters having values ​​at least X, less than or equal to Y, and / or at least X and less than or equal to Y. For example, a value between 1 and 10 is intended to include a value of at least 1 (including values ​​of 10 and greater), a value less than 10 (including values ​​less than 1), and / or a value greater than 1 and less than 10.

[0062] The expression "configured (or set) for" used in this disclosure may be used interchangeably with, for example, "suitable for," "capable of," "designed for," "adapted for," "made for," or "capable of," depending on the context. Furthermore, the expression "configured (set) for" does not only mean "specially designed to" in terms of hardware. Depending on the context, the expression "device configured for" may also mean that the device is "capable of" operating with other devices or components.

[0063] As used herein, the term "about" or "approximately" is intended to refer to ±5% of the stated value.

[0064] As used herein, the term "threshold" refers to a maximum level, a minimum level, and / or a range of values ​​associated with a desired or undesirable condition. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range, and / or outside a threshold range to produce a desired effect (e.g., effective treatment) and / or prevent or otherwise reduce (hereinafter "prevent") an undesirable event (e.g., adverse device and / or clinical event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to produce a desired therapeutic effect on tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, the thresholds are determined to have a safety margin, taking into account patient variability, system variability, tolerances, etc. As used herein, "above a threshold" refers to a parameter being above a maximum threshold, below a minimum threshold, within a threshold range, and / or outside a threshold range.

[0065] As used herein, "room pressure" is intended to mean the pressure of the environment surrounding the systems and devices of the present inventive concept. Positive pressure includes pressures above room pressure or simply pressures greater than other pressures, such as a positive pressure differential across a fluid path component such as a valve. Negative pressure includes pressures equal to or less than room pressure or pressures less than other pressures, such as a negative pressure differential across a fluid path component such as a valve. Negative pressure may also include a vacuum, but does not mean a pressure below a vacuum. As used herein, the term "vacuum" is used to refer to a full or partial vacuum or any negative pressure described herein.

[0066] As used herein, the term "diameter" when used to describe a non-circular geometric shape should be interpreted as the diameter of an imaginary circle that approximates the geometric shape being described. For example, when describing a cross-section, such as a cross-section of a component, the term "diameter" shall refer to the diameter of an imaginary circle having the same cross-sectional area as the cross-section of the component being described.

[0067] As used herein, the terms "major axis" and "minor axis" of a component refer to the length and diameter, respectively, of an imaginary cylinder of minimum volume that can completely enclose the component.

[0068] As used herein, the term "functional component" should be interpreted to include one or more components configured and arranged to perform a function. A functional component may include a sensor, a transducer, or both. In some embodiments, a functional component is configured to deliver energy, provide a therapeutic treatment, and / or perform other functions. Alternatively or additionally, a functional component (e.g., a functional component comprising a sensor) may be configured to record one or more parameters, such as patient physiological parameters, patient anatomical parameters (e.g., tissue shape parameters), patient environmental parameters, and / or system parameters. In some embodiments, a sensor or other functional component is configured to perform a diagnostic function (e.g., collect data used to perform a diagnosis). In some embodiments, a functional component is configured to perform a therapeutic function (e.g., deliver therapeutic energy and / or a therapeutic agent). In some embodiments, the functional component comprises one or more components configured and arranged to perform a function selected from the group consisting of: supplying energy, extracting energy (e.g., cooling a component), delivering a drug or other agent, manipulating a system component or patient tissue, recording or otherwise sensing a parameter, such as a patient physiological parameter or a system parameter, and one or more combinations thereof. The functional component comprises a fluid and / or a fluid delivery system. The functional component may comprise a reservoir, such as an expandable balloon or other fluid-holding reservoir. A "functional assembly" may include an assembly configured and arranged to perform a function, such as a diagnostic function and / or a therapeutic function. The functional assembly may comprise an expandable assembly. The functional assembly may comprise one or more functional components.

[0069] As used herein, the term "transducer" should be interpreted to include a component or combination of components that receives energy or any input and produces an output. For example, a transducer may 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, the 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 piezoelectric transducer configured to deliver ultrasound energy), pressure (e.g., applied pressure or force), thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer comprising a motor or solenoid), magnetic energy, and / or a different electrical signal (e.g., a signal different from the input signal to the transducer). Alternatively or additionally, the transducer may convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. The transducer may comprise any component configured to deliver energy and / or agents to tissue, such as, for example, a transducer configured to deliver electrical energy (e.g., a transducer comprising one or more electrodes), optical energy (e.g., a transducer comprising a laser, a light emitting diode, and / or an optical component such as a lens or prism), mechanical energy (e.g., a transducer comprising a component that manipulates tissue), sonic energy (e.g., a transducer comprising a piezoelectric transducer), chemical energy, electromagnetic energy, magnetic energy, and one or more combinations thereof.

[0070] As used herein, the term "fluid" refers to any flowable material such as a liquid, gas, gel, or material that can be propelled through a lumen and / or opening.

[0071] As used herein, the term "material" refers to a single material or a combination of two, three, four, or more materials.

[0072] It will be understood 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 subcombination. For example, it will be understood that all features (whether independent or dependent) recited in any claim can be combined in any manner.

[0073] It should be understood that at least some of the drawings and descriptions of the inventive concepts have been simplified to focus on components relevant to a clear understanding of the inventive concepts, but that other components that one skilled in the art would understand may form part of the inventive concepts have been omitted for clarity, although such components are well known in the art and do not necessarily facilitate a better understanding of the inventive concepts, and therefore a description of such components will not be provided herein.

[0074] The terms defined in this disclosure are used only to describe specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in the singular are intended to include the plural, unless the context clearly indicates otherwise. All terms used in this specification, including technical or scientific terms, have the same meaning as commonly understood by those skilled in the relevant art, unless otherwise defined herein. Terms defined in commonly used dictionaries, unless explicitly defined herein, should be interpreted as having the same or similar meaning as in the context of the relevant art, and should not be interpreted as having an abstract or exaggerated meaning. In some cases, the terms defined in this disclosure should not be interpreted to exclude embodiments of the present disclosure.

[0075] Provided herein is a system for diagnosing and / or treating a patient, such as for use in a medical procedure including a diagnostic procedure, a therapeutic procedure (also referred to as a "treatment procedure"), or both. The system of the present inventive concept includes an imaging probe and an imaging assembly. The imaging probe includes an elongate shaft, a rotatable optical core, and an optical assembly. The elongate shaft has a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The rotatable optical core has a proximal end and a distal end. At least a portion of the rotatable optical core is disposed within the lumen of the elongate shaft. The optical assembly is disposed proximate the distal end of the rotatable optical core and is configured to direct light to tissue and collect reflected light from the tissue. The imaging system includes one or more algorithms configured to enhance performance of the system.

[0076] Imaging systems of the present concepts may be used to provide image data representative of arteries, veins, and / or other body conduits and to image one or more devices inserted into those conduits. The imaging system may 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 system may provide image data related to healthy tissue as well as diseased tissue, such as blood vessels containing stenoses, myocardial bridges, and / or other vascular narrowings (herein "lesions" or "stenoses") and / or blood vessels containing aneurysms. The system may also be configured to provide treatment information (e.g., suggesting treatment steps to be performed). For example, the treatment information may be used by an operator (e.g., a patient's clinician) to plan treatment and / or predict treatment outcomes.

[0077] 1, there is shown a schematic diagram of a diagnostic system including an imaging probe and one or more algorithms for processing image data consistent with the concepts of the present invention. System 10 is configured as a diagnostic system configured to record image data from a patient and generate one or more images based on the recorded data. System 10 is further configured to analyze the recorded data and / or the generated images (either or both, hereinafter referred to as "image data") to provide, for example, diagnostic data related to a disease or condition of the patient, planning data related to the planning of a therapeutic procedure to be performed on the patient, and / or outcome data related to the effectiveness and / or technical outcome of the therapeutic procedure.

[0078] System 10 is 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 includes high-frequency OCT (HF-OCT) data. System 10 includes imaging probe 100, a catheter-based probe, and probe interface unit PIU 200, configured to be operably attached to imaging probe 100. PIU 200 may include a rotation assembly 210 and / or a retraction assembly 220, each of which is operably attached to imaging probe 100 to rotate and / or retract at least a portion of imaging probe 100, respectively. System 10 includes console 300 operably attached to imaging probe 100, such as via PIU 200. Imaging probe 100 is introduced into a conduit, such as a blood vessel, of a patient using (e.g., through) one or more delivery catheters (e.g., delivery catheter 80 shown). Additionally or alternatively, the imaging probe 100 is introduced through an introduction device such as an endoscope, arthroscope, balloon dilator, etc. In some embodiments, the imaging probe 100 is configured to be introduced into a patient's ducts and / or other internal patient site selected from the group including an artery, a vein, an artery in or near the heart, a vein in or near the heart, an artery in or near the brain, a vein in or near the brain, a peripheral artery, a peripheral vein, an internal patient site accessed through a natural body orifice such as the esophagus, an internal patient site accessed through a surgically created opening such as a duct or other site in the abdomen, and a combination of one or more of these.

[0079] In some embodiments, imaging probe 100 and / or other components of system 10 may be configured and arranged similarly to the components described in applicant's co-pending U.S. patent application Ser. No. 17 / 668,757, filed February 10, 2022, and entitled "Micro-Optic Probes for Neurology" (Docket No. GTY-001-US-CON1). Imaging probe 100 may be configured 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 patient's vascular system. In some embodiments, system 10 may be configured and arranged similarly to the systems and methods of use described in applicant's co-pending U.S. patent application Ser. No. 18 / 096,678, filed January 13, 2023, and entitled "Imaging System Includes Imaging Probe and Delivery Devices" (Docket No. GTY-002-US-CON3).

[0080] The imaging probe 100 has an elongate body comprising one or more elongate shafts and / or tubes, herein shaft 120. The shaft 120 comprises a proximal end 1201, a distal end 1209, and a lumen 1205 extending therebetween. In some embodiments, the lumen 1205 comprises multiple coaxial lumens within the one or more elongate shafts of the shaft 120, with one or more lumens (e.g., axially aligned lumens) abutting each other to define the single lumen 1205. In some embodiments, at least a portion of the shaft 120 comprises a torque shaft. In some embodiments, a portion of the shaft 120 has a braided structure. In some embodiments, a portion of the shaft 120 comprises a helically cut tube (e.g., the shaft 120 comprises a helically cut metal tube). In some embodiments, the pitch of the helical cut may vary along the length of the cut to vary the stiffness of the shaft 120 along its length. The portion of the shaft 120 may comprise a tube constructed of a nickel-titanium alloy. The shaft 120 operably surrounds the optical core 110, which is a rotatable optical fiber (e.g., the optical core 110 is disposed within a lumen 1205). The optical core 110 has a proximal end 1101 and a distal end 1109. The optical core 110 comprises a dispersion-shifted optical fiber, such as a depressed cladding dispersion-shifted fiber (e.g., a non-zero dispersion-shifted (NZDS) fiber). The shaft 120 further comprises a distal portion 1208 having a transparent window 130 (e.g., a window that is relatively transparent to one or more frequencies of light transmitted through the optical core 110). The optical assembly 115 is operably attached to the distal end 1109 of the optical core 110. The optical assembly 115 is disposed within the window 130 of the shaft 120. The optical assembly 115 comprises a GRIN lens optically coupled to the distal end 1109 of the optical core 110.The optical assembly 115 may have a configuration and arrangement similar to the optical assembly 115 described in Applicant's co-pending U.S. patent application Ser. No. 18 / 144,462, entitled "Imaging System," filed May 8, 2023 (Docket No. GTY-003-US-CON1), and Applicant's co-pending U.S. patent application Ser. No. 17 / 276,500, entitled "Imaging System with Optical Pathway," filed March 16, 2021 (Docket No. GTY-004-US). In some embodiments, the optical core 110 comprises a single continuous length of optical fiber with zero seams along its length. In some embodiments, the imaging probe 100 has a single optical seam, such as a seam between the optical assembly 115 and the distal end 1109 of the optical core 110 (e.g., zero seams along the length of the optical core 110).

[0081] The connector assembly 150 is disposed at the proximal end of the shaft 120. The connector assembly 150 operably attaches the imaging probe 100 to the rotation assembly 210. In some embodiments, the connector assembly 150 comprises an optical connector fixedly attached to the proximal end of the optical core 110. The imaging probe 100 comprises a second connector, connector 180, positionable on the shaft 120. The connector 180 is removably attached and / or adjustably positioned along the length of the shaft 120. The connector 180 is positioned along the shaft 120 adjacent the proximal end of the delivery catheter 80, such as by a clinician, technician, and / or other user of the system 10 (herein referred to as a “user” or “operator”), after the imaging probe 100 has been inserted into a patient via the delivery catheter 80. The shaft 120 comprises a portion configured to provide and / or accommodate slack in the shaft 120, a service loop 185, between the connector assembly 150 and the positioning of the connector 180.

[0082] In some embodiments, shaft 120 has a multi-piece structure, 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 may comprise polyethylene terephthalate (PET) tubing. For example, a PET tube may surround a junction between two axially arranged tubes (e.g., two portions of shaft 120) to form a junction between the two tubes. In some embodiments, one or more PET tubes are placed under tension after assembly (e.g., the tubes are longitudinally stretched when shaft 120 is assembled) 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 are provided with a coating that includes one or more materials and / or surface modification processes to provide a hydrophilic or 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) to improve adhesion of the coating to that portion of shaft 120.

[0083] The imaging probe 100 includes one or more visible markers along its length (e.g., along the shaft 120), indicated by marker 131. The marker 131 may be one or more markers selected from the group including a radiopaque marker, an ultrasound-reflective marker, a magnetic marker, a ferrous material, and one or more combinations thereof. In some embodiments, the marker 131 is positioned at a location along the imaging probe 100 selected to assist an operator of the system 10 in performing a pullback procedure (herein a “pullback procedure” or “pullback”). For example, the marker 131 is positioned approximately one pullback length from the distal end 1209 of the shaft 120 such that after pullback, the distal end 1209 is no more proximal than the starting position of the marker 131. In some embodiments, prior to pullback, the operator may place the marker 131 at a location distal to the proximal end of the implant so that access to the implant is maintained after pullback is completed (e.g., so that the imaging probe 100 can be safely advanced through the implant after pullback).

[0084] In some embodiments, the imaging probe 100 includes a gel 118, which is a viscous damping material. The gel 118 is disposed within the shaft 120 surrounding the distal portion of the optical core 110 (e.g., a gel injected or otherwise applied during manufacturing). In some embodiments, the gel 118 surrounds a portion of the optical assembly 115. Alternatively, the gel 118 does not surround a portion of the optical assembly 115, for example, when the optical assembly 115 is configured to operate in air, as described below with reference to FIGS. 2 and 3. The gel 118 may be a non-Newtonian fluid, such as a shear-thinning fluid. In some embodiments, the gel 118 has 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 the static viscosity to the shear viscosity of the gel 118 may be between 1.2:1 and 100:1. In some embodiments, the gel 118 is injected (e.g., during manufacturing) through the distal end of the window 130. In some embodiments, gel 118 is a gel that is visualized (e.g., visualized under UV light, such as by including one or more materials that fluoresce under UV light). In some embodiments, during the manufacturing process in which gel 118 is injected into shaft 120 through window 130, shaft 120 is monitored while gel 118 is visualized (e.g., illuminated with UV light) to control the injection process (e.g., stopping injection once gel 118 has sufficiently penetrated shaft 120). The gel 118 may be a gel as described with reference to the applicant's co-pending U.S. patent application Ser. No. 17 / 668,757 (Docket No. GTY-001-US-CON1) titled "Micro-Optic Probes for Neurology" filed on February 10, 2022, and the applicant's co-pending U.S. patent application Ser. No. 18 / 144,462 (Docket No. GTY-003-US-CON1) titled "Imaging System" filed on May 8, 2023.

[0085] The imaging probe 100 includes a distal tip 119. In some embodiments, the distal tip 119 includes a spring tip configured to improve the "navigability" of the imaging probe 100 (e.g., improve the "trackability" and / or "steerability" of the imaging probe 100), for example, when the probe 100 is translated through a tortuous path (e.g., through the vasculature of the brain or heart, which have tortuous paths). In some embodiments, the distal tip 119 has a length between 5 mm and 100 mm (e.g., a spring having a length between 5 mm and 100 mm). In some embodiments, the distal tip 119 may be a user-shapeable spring tip (e.g., at least a portion of the distal tip 119 may be malleable). The imaging probe 100 may be rotated (e.g., via a connector 180) to adjust the orientation of the non-linear portion of the distal tip 119 (e.g., to adjust the trajectory of the distal tip 119 within the patient's vasculature). Alternatively or additionally, distal tip 119 may comprise a cap, plug, and / or other component configured to seal the distal opening of window 130. In some embodiments, distal tip 119 may comprise a radiopaque marker configured to enhance visibility of imaging probe 100 under a fluoroscope or other x-ray device. In some embodiments, distal tip 119 may comprise a relatively short lumen guidewire pathway to enable "quick exchange" translation of imaging probe 100 over a guidewire of system 10 (guidewire not shown).

[0086] In some embodiments, at least the distal portion of the imaging probe 100 (e.g., the distal portion of the shaft 120 surrounding the optical assembly 115) has an outer diameter of 0.030 inches or less, such as 0.025 inches or less, 0.020 inches or less, and / or 0.016 inches or less.

[0087] In some embodiments, the imaging probe 100 may be configured and arranged for use in an intravascular neurological procedure (e.g., a procedure in which blood, vasculature, and / or other tissues adjacent to the brain are visualized, and / or a procedure in which a device placed temporarily or permanently adjacent to the brain is visualized). An imaging probe 100 configured for use in an intravascular neurological procedure (also referred to herein as a "neural procedure") may have an overall length of at least 150 cm, e.g., about 300 cm. Alternatively or additionally, the imaging probe 100 may be configured and arranged for use in an intravascular cardiac procedure (e.g., a procedure in which blood, vasculature, and other tissues adjacent to the heart are visualized, and / or a procedure in which a device placed temporarily or permanently adjacent to the heart is visualized). An imaging probe 100 configured ... also referred to herein as a cardiac procedure or cardiovascular procedure) may have an overall length of at least 120 cm, e.g., about 280 cm (e.g., to allow the proximal end of the imaging probe 100 to be placed outside of a sterile field). In some embodiments, such as to position the proximal end of the probe 100 outside the sterile field, the imaging probe 100 may have a length greater than 220 cm, such as at least 220 cm but less than 320 cm.

[0088] In some embodiments, the imaging probe 100 includes a component, designated FPE 1500, configured as a fluid propulsion element and / or fluid pressurizing element (herein "fluid pressurizing element"). The FPE 1500 is configured to prevent and / or reduce the presence of air bubbles in the gel 118 proximate the optical assembly 115. The FPE 1500 is fixedly attached to the optical core 110, and rotation of the optical core 110 rotates the FPE 1500 to create a pressure increase in the gel 118 configured to reduce the presence of air bubbles from locations proximate the optical assembly 115. Such one or more fluid pressurizing elements FPE 1500 are configured and arranged to reduce the likelihood of air bubbles forming in the gel 118, reduce the size of air bubbles in the gel 118, and / or relocate any air bubbles formed in the gel 118 away from locations that would adversely affect the collection of image data by the optical assembly 115 (e.g., relocate air bubbles away from the optical assembly 115). In some embodiments, the fluid propulsion element FPE1500 of the imaging probe 100 may have a configuration and arrangement similar to the fluid propulsion element described in the applicant's co-pending U.S. patent application Ser. No. 17 / 600,212 (Docket No. GTY-011-US), entitled "Imaging Probe with Fluid Pressurization Element," filed on September 30, 2021.

[0089] In some embodiments, delivery catheter 80 comprises an elongate shaft, shown as shaft 81. Shaft 81 comprises a lumen 84 therethrough and a connector 82 disposed at its proximal end. Connector 82 may be a Touhy or other valved connector, such as a valved connector configured to prevent the evacuation of fluid from the associated delivery catheter 80 (with or without a separate shaft disposed within connector 82). Connector 82 may comprise ports 83, such as one or more ports configured and arranged to allow the introduction and / or removal of fluid from delivery catheter 80. In some embodiments, a jet of fluid, as described herein, is introduced through one or more ports 83 to remove blood or other undesirable material from a location proximal to optical assembly 115 (e.g., to a location distal to optical assembly 115). Port 83 is disposed on a side of connector 82 and comprises a luer fitting and a cap and / or a valve. The shaft 81, connector 82, and port 83 are each constructed of standard materials and have a configuration similar to commercially available introducers, guide catheters, diagnostic catheters, mid-catheters, and microcatheters used in current interventional procedures. The delivery catheter 80 may be a catheter configured to deliver the imaging probe 100 to intracerebral, intracardiac, and / or other locations within a patient.

[0090] The delivery catheter 80 may comprise two or more delivery catheters, e.g., three or more delivery catheters. The delivery catheter 80 may comprise at least a vascular introducer and another delivery catheter that is inserted into the patient (e.g., through the vascular introducer after the vascular introducer has been positioned through the patient's skin). The delivery catheter 80 may comprise a set of two or more delivery catheters collectively comprising a set of different inner diameters (ID) and outer diameters (OD), such that a first delivery catheter 80 slidably receives a second delivery catheter 80 (e.g., the outer diameter of the second delivery catheter is equal to or smaller than the inner diameter of the first delivery catheter), and the second delivery catheter 80 slidably receives a third delivery catheter 80 (e.g., the outer diameter of the third delivery catheter is equal to or smaller than the inner diameter of the second delivery catheter). In these configurations, a first delivery catheter 80 (e.g., its distal end) may be advanced to a first anatomical location, and a second delivery catheter 80 (e.g., its distal end) may be advanced through the first delivery catheter to a second anatomical location distal or otherwise separated (hereinafter "distal") from the first anatomical location, with successively smaller diameter delivery catheters being used as appropriate. In some embodiments, the delivery catheter 80 may have a similar configuration and arrangement as described in applicant's co-pending U.S. patent application Ser. No. 18 / 096,678, entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed Jan. 13, 2023 (Docket No. GTY-002-US-CON3).

[0091] In some embodiments, the delivery catheter 80 comprises a guide extension catheter, such as a catheter having a coil-reinforced hollow shaft, and a push wire attached to the proximal end of the shaft, the shaft having a skived (partially circumferential) proximal portion to facilitate insertion of a separate device (e.g., a treatment device and / or probe 100) therethrough.

[0092] The rotation assembly 210 is operably attached to the connector assembly 150 of the imaging probe 100. The rotation assembly 210 comprises one or more rotary joints, optical connectors, rotary actuators (e.g., motors), and / or linkages operably attached to the optical core 110 and configured to enable rotation of and / or cause rotation of the optical core 110. The connector assembly 150 is removably attached to the rotation assembly 210 and is constructed and arranged to enable a rotational connection between the proximal end 1101 and a rotary fiber optic joint (such as a fiber optic rotary joint or FORJ). Rotating assembly 210 may have a configuration and arrangement similar to the components described in applicant's co-pending U.S. patent application Ser. No. 18 / 144,462 (Docket No. GTY-003-US-CON1), entitled "Imaging System," filed May 8, 2023, and applicant's co-pending U.S. patent application Ser. No. 17 / 276,500 (Docket No. GTY-004-US), entitled "Imaging System with Optical Pathway," filed March 16, 2021. Rotating assembly 210 is configured to rotate optical core 110 at a speed of at least 100 revolutions per second, e.g., at least 200 revolutions per second or 250 revolutions per second, or between 20 revolutions per second and 1000 revolutions per second. The rotation assembly 210 may comprise a rotation actuator selected from the group including a motor, a servo, a stepper motor (e.g., a stepper motor with a gearbox), an actuator, a hollow core motor, and combinations thereof. In some embodiments, the rotation assembly 210 is configured to rotate the optical assembly 115 and the optical core 110 in unison.

[0093] The retraction assembly 220 is operably attached to the imaging probe 100 to retract the imaging probe 100 relative to the patient access site. The retraction element 10 is operably attached to the retraction assembly 220 and the imaging probe 100 to transmit a retraction force from the retraction assembly 220 to the imaging probe 100. The retraction element 10 includes a conduit 2211 surrounding a linkage 2212 slidably received therein. The retraction element 10 includes a connector 2213 operably attached to the retraction assembly 220 such that the retraction assembly 220 can retract the linkage 2212 relative to the conduit 2211. In some embodiments, the conduit 2211 includes a connector 2214 that operably attaches to a reference point near the patient access site, such as the connector 82 of the delivery catheter 80, to establish a reference for retraction of the imaging probe 100 relative to the patient. The connector 2214 can be attached to a reference point, such as a patient introduction device, a surgical table, and / or other fixed or semi-fixed reference point. The linkage 2212 is releasably attached to the connector 180 of the imaging probe 100. The retraction assembly 220 retracts at least a portion of the imaging probe 100 (e.g., the portion of the imaging probe 100 distal to the connector 180) relative to the established reference by retracting the linkage 2212 relative to the conduit 2211 (e.g., retracting the portion of the linkage 2212 that exits a portion of the conduit 2211, as shown). In some embodiments, the retraction assembly 220 is configured to retract at least a portion of the imaging probe 100 (e.g., at least a portion of the optical assembly 115 and the shaft 120) at a rate of between 5 mm / sec and 200 mm / sec, or between 5 mm / sec and 100 mm / sec, e.g., about 60 mm / sec. Additionally or alternatively, the pullback procedure may be performed for a time between 0.5 seconds and 25 seconds, for example about 20 seconds (eg, at 5 mm / sec over a distance of 100 mm).The service loop 185 of the imaging probe 100 is positioned between the connector 180 and the rotating assembly 210, allowing the imaging probe 100 to be retracted relative to the patient while the rotating assembly 210 remains stationary (e.g., attached to a portion of the operating table and / or console 300).

[0094] Retraction assembly 220 further comprises a power element configured to retract linkage 2212. In some embodiments, the power element comprises a linear actuator, a worm drive operably attached to a motor, a pulley system, and / or other linear force transmission mechanism. Linkage 2212 is operably attached to the power element via one or more linkages and / or connectors. Retraction assembly 220 may have a configuration and arrangement similar to components described in applicant's co-pending U.S. patent application Ser. No. 18 / 144,462, entitled "Imaging System," filed May 8, 2023 (Docket No. GTY-003-US-CON1).

[0095] In some embodiments, the PIU 200 may comprise a single, separate component (e.g., a single housing) that includes both the rotating assembly 210 and the retracting assembly 220. Alternatively or additionally, the PIU 200 may comprise two or more separate components (e.g., two or more housings), such as separate components for each of the rotating assembly 210 and the retracting assembly 220. In some embodiments, the connector assembly 150, the service loop 185, the retracting element 2210, and the connector 2213 comprise a single, separate component (e.g., housed in a single housing) and are configured to be operably attached to both the rotating assembly 210 and the retracting assembly 220 (e.g., the rotating assembly 210 and the retracting assembly 220 are housed in a single housing or are included in a single, separate component).

[0096] In some embodiments, system 10 includes a second imaging device 15 that is an ancillary imaging device (e.g., in addition to imaging probe 100). Second imaging device 15 comprises an imaging device such as one or more imaging devices selected from the group including 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 one or more combinations thereof. In some embodiments, second imaging device 15 includes an apparatus configured to perform rotational angiography.

[0097] In some embodiments, system 10 includes a treatment device 16, which is an apparatus configured to treat a patient (e.g., provide one or more therapies to a patient). Treatment device 16 may be an occlusion treatment device and / or other treatment device selected from the group consisting of a balloon catheter, a drug-eluting balloon, an aspiration catheter, a sonolysis device, an atherectomy device, a clot removal device such as a stent retraction device, a Trevo® stent retraction device, a Solitaire® stent retraction device, a Revive® stent retraction device, an Eric® stent retraction device, a Lazarus® stent retraction device, a stent delivery catheter, a microblade implant, an embolization system, a WEB® Embolization System, a Luna® Embolization System, a Medina® Embolization System, and combinations of one or more thereof, configured and arranged to dilate a stenosis or other restriction in a blood vessel. In some embodiments, the imaging probe 100 and / or other components of the system 10 are configured to collect data related to the treatment device 16 (e.g., the position, orientation, and / or other configuration data of the treatment device 16) after the treatment device 16 is inserted into the patient.

[0098] System 10 may further include one or more devices configured to monitor one, two, or more physiological and / or other parameters of the patient, such as the illustrated patient monitor 17. Patient monitor 17 may include 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 respiratory monitor, a patient motion monitor, a T-wave trigger monitor, and combinations thereof.

[0099] System 10 may further include one or more fluid injectors, such as the illustrated injector 20. Each of these injectors is configured to inject one or more fluids, such as an injection fluid, an imaging contrast agent (e.g., a radiopaque contrast agent, hereinafter "contrast agent"), and / or other fluids, such as the illustrated injectate 21. Injector 20 may be a power injector, syringe pump, peristaltic pump, or other fluid delivery device configured to inject an imaging agent, such as a radiopaque contrast agent, and / or other fluids. In some embodiments, injector 20 is configured to deliver contrast agent and / or other fluids (e.g., contrast agent, saline, and / or dextran). In some embodiments, injector 20 delivers fluids in an injection procedure as described herein. In some embodiments, the injector 20 delivers contrast or other fluids through a delivery catheter 80 having an ID between 5 Fr and 9 Fr, a delivery catheter 80 having an ID between 0.53 inches and 0.70 inches, or a delivery catheter 80 having an ID between 0.0165 inches and 0.027 inches. In some embodiments, the contrast or other fluids are delivered through a delivery catheter as small as 4 Fr (e.g., for distal injection). In some embodiments, the injector 20 delivers contrast and / or other fluids through the lumen of the delivery catheter 80, while one or more smaller delivery catheters 80 reside within the lumen of the delivery catheter 80. In some embodiments, the injector 20 is configured to deliver two different fluids simultaneously and / or sequentially, such as a first fluid from a first reservoir having a first concentration of contrast and a second fluid from a second reservoir having little or no contrast.

[0100] The injectate 21 may be a fluid selected from the group consisting of an optically transparent material, saline, a visible material, a contrast agent, dextran, an ultrasound-reflective material, a magnetic material, and combinations thereof. The injectate 21 may be a contrast agent and saline. The injectate 21 may contain at least 20% contrast agent. During image data collection (e.g., during pullback), a jetting procedure may be performed, such as delivering one or more fluids (e.g., injectate 21 propelled by the injector 20 or other fluid delivery device) to remove blood or other somewhat opaque material (hereinafter, non-transparent material) adjacent to the optical assembly 115 (e.g., to remove non-transparent material between the optical assembly 115 and the delivery catheter and / or between the optical assembly 115 and a blood vessel wall) so that light dispensed from the optical assembly 115 reaches and reflects back to all tissues and other objects being imaged. In these jetting procedures, the injectate 21 may be an optically transparent material, such as saline. Infusate 21 may be one or more visible materials, as described herein.

[0101] As an alternative or in addition to use in a spray procedure, the injectate 21 may be a material configured to be seen by the second imaging device 15, such as, for example, the injectate 21 being a contrast agent configured to be seen by the second imaging device 15 comprising a fluoroscope and / or other X-ray device, an ultrasound reflective material configured to be seen by the second imaging device 15 comprising an ultrasound imaging device, and / or a magnetic material configured to be seen by the second imaging device 15 comprising an MRI.

[0102] System 10 may further include an implant 31. The implant may be implanted into a patient via a delivery device, such as implant delivery device 30 and / or delivery catheter 80. Implant 31 may be, for example, an implant (e.g., a temporary or chronic implant) for treating a vascular occlusion and / or an aneurysm. In some embodiments, implant 31 is one or more implants selected from the group including a flow diverter, a Pipeline® flow diverter, a Surpass® flow diverter, an embolic coil, a stent, a Wingspan® stent, a covered stent, an aneurysm treatment implant, and combinations of one or more of these.

[0103] The implant delivery device 30 may include a catheter and / or other tools used to deliver the implant 31 if the implant 31 has a self-expanding or balloon-expandable portion. In some embodiments, the system 10 includes an imaging probe 100, one or more implants 31, and / or one or more implant delivery devices 30. In some embodiments, the imaging probe 100 is configured to collect data related to the implant 31 and / or implant delivery device 30 (e.g., the anatomical position, orientation, and / or other configuration data of the implant 31 and / or implant delivery device 30) after the implant 31 and / or implant delivery device 30 has been inserted into a patient.

[0104] In some embodiments, one or more components of system 10, 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 include one or more functional components (referred to herein as "functional components"), such as functional components 99a, 99b, 99c, 99d, 99e, 89, 199, 299, 219, 229, and / or 399, as shown. Each functional component may include at least two functional components. Each functional component may be one or more components selected from the group including a sensor, a transducer, and combinations thereof. A functional component may be a sensor configured to generate a signal. The functional component may be a sensor selected from the group including a physiological sensor, a pressure sensor, a strain gauge, a position sensor, a GPS sensor, an acceleration sensor, 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 detection sensor such as an ultrasonic bubble detector, a sound sensor such as an ultrasonic sensor, and combinations thereof. The sensor may be a physiological sensor selected from the group including a pressure sensor such as a blood pressure sensor, a flow sensor such as a blood gas sensor or a blood flow sensor, a temperature sensor such as a blood or other tissue temperature sensor, and combinations thereof. The sensor may be a position sensor configured to generate a signal related to the shape of the vascular pathway (e.g., the shape of the vascular pathway in 2D or 3D). The sensor may be a magnetic sensor. The sensor may be a flow sensor. The system may further comprise an algorithm configured to process the signal generated by the sensor-based functional component. Each functional component may comprise one or more transducers. Each functional component may comprise one or more transducers selected from the group including a heating element, such as a heating element configured to provide sufficient heat to ablate tissue, a cooling element, such as a cooling element configured to provide cryogenic energy to ablate tissue, a sound transducer, such as an ultrasound transducer, a vibration transducer, and combinations thereof.

[0105] In some embodiments, the imaging probe 100 has an overall length of at least 120 cm, e.g., at least 160 cm, e.g., about 280 cm. In some embodiments, the imaging probe 100 has an overall length of no more than 350 cm. In some embodiments, the imaging probe 100 has a length configured for insertion into a patient (referred to herein as an "insertable length") of at least 90 cm, e.g., at least 100 cm, e.g., about 145 cm. In some embodiments, the imaging probe 100 has an insertable length of no more than 250 cm, e.g., no more than 200 cm. In some embodiments, the distal tip 119 is a spring tip having a length of at least 5 mm, e.g., at least 25 mm, e.g., about 15 mm. In some embodiments, the distal tip 119 is a spring tip having a length of no more than 75 mm, e.g., no more than 30 mm. In some embodiments, the distal portion of the shaft 120 (e.g., the window 130) has an outer diameter of less than 2 Fr, e.g., less than 1.4 Fr, e.g., about 1.1 Fr. In some embodiments, the distal portion of shaft 120 (e.g., window 130) has an outer diameter of at least 0.5 Fr, such as at least 0.9 Fr. In some embodiments, shaft 120 is constructed from one or more materials selected from the group including polyetheretherketone (PEEK), nylon, polyether block amide, nickel titanium alloy, and combinations thereof.

[0106] In some embodiments, at least a portion (e.g., the most flexible portion) of the imaging probe 100 is configured to be safely and effectively positioned with a radius of curvature as low as 5 mm, 4 mm, 3 mm, 2 mm, and / or 1 mm. In some embodiments, the optical core 110 comprises an optical fiber having a diameter of less than 120 μm, e.g., less than 100 μm, e.g., less than 80 μm, e.g., less than 60 μm, e.g., about 40 μm. In some embodiments, the optical core 110 has 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, the optical assembly 115 comprises a lens selected from the group including a shaping lens, such as a GRIN lens, a molded lens, a fused-polished lens, a lens with an axicon structure (e.g., an axicon nanostructure), and combinations thereof. In some embodiments, the optical assembly 115 includes lenses having an outer diameter of less than 200 μm, e.g., less than 170 μm, e.g., less than 150 μm, e.g., less than 100 μm, e.g., about 80 μm. In some embodiments, the optical assembly 115 includes lenses having a length of less than 3 mm, e.g., less than 1.5 mm. In some embodiments, the optical assembly 115 includes lenses having a length of at least 0.5 mm, e.g., at least 1 mm. In some embodiments, the optical assembly 115 includes lenses having a focal length of at least 0.5 mm and / or 5.0 mm or less, e.g., at least 1.0 mm and / or 3.0 mm or less, e.g., about 0.5 mm. In some embodiments, the optical assembly 115 may have a longer focal length, such as for viewing structures outside the blood vessel into which the optical assembly 115 is inserted. In some embodiments, the optical assembly 115 has a working distance (also referred to as depth of field, confocal length, or Rayleigh range) of up to 1 mm, e.g., up to 5 mm, e.g., up to 10 mm, e.g., at least 1 mm and / or 5 mm or less. In some embodiments, the optical assembly 115 has an outer diameter of at least 80 μm and / or 200 μm or less, e.g., at least 150 μm and / or 170 μm or less, e.g., about 150 μm.In some embodiments, the system 10 (e.g., the retraction assembly 220) is configured to perform retraction of the imaging probe 100 at a retraction speed of at least 10 mm / sec and / or not more than 300 mm / sec, e.g., at least 50 mm / sec and / or not more than 200 mm / sec, e.g., about 100 mm / sec. In some embodiments, the system 10 (e.g., the retraction assembly 220) is configured to perform retraction over a distance of at least 25 mm and / or not more than 200 mm, e.g., at least 25 mm and / or not more than 150 mm, e.g., about 50 mm. In some embodiments, the system 10 (e.g., the retraction assembly 220) is configured to perform retraction over a time period of at least 0.2 seconds and / or not more than 5.0 seconds, e.g., at least 0.5 seconds and / or not more than 2.0 seconds, e.g., about 1.0 second. In some embodiments, the system 10 (e.g., the rotation assembly 210) is configured to rotate the optical core 110 at an angular velocity of at least 20 revolutions per second and / or not more than 1000 revolutions per second, e.g., at least 100 revolutions per second and / or not more than 500 revolutions per second, e.g., about 250 revolutions per second. In some embodiments, the delivery catheter 80 has an inner diameter of at least 0.016 inches and / or not more than 0.050 inches, e.g., at least 0.016 inches and / or not more than 0.027 inches, e.g., about 0.021 inches.

[0107] In some embodiments, console 300 includes an imaging assembly 320 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 may include a light source 325. Light source 325 may be one or more light sources configured to provide light of one or more wavelengths to optical assembly 115 via optical core 110. Light source 325 is configured to provide light to optical assembly 115 (via optical core 110) and collect image data including cross-sectional, longitudinal, and / or volumetric information related to the patient region or implant device being imaged. Light source 325 may be configured to provide light such that the collected image data includes characteristics of tissue within the patient region being imaged, e.g., to quantify, qualify, or otherwise provide information related to a patient disease or disorder present within the patient region being imaged. The light source 325 may be configured to provide broadband light having a center wavelength in the range of 350 nm to 2500 nm, 800 nm to 1700 nm, 1280 nm to 1310 nm, or approximately 1300 nm (e.g., light provided in a sweep range of 1250 nm to 1350 nm). The light source 325 may have a sweep rate of at least 20 KHz. In some embodiments, the light source 325 has a sweep rate of at least 100 KHz, such as at least 200 KHz, 300 KHz, 400 KHz, and / or 500 KHz, e.g., approximately 200 KHz. Such fast sweep rates offer many advantages, including providing higher frame rates (over similar systems with slower sweep rates) and accommodating faster pullback and rotation speeds. For example, a faster sweep rate allows the required sampling density (e.g., the amount of lumen surface area swept by the rotating beam) to be achieved in a shorter time. This is advantageous in most situations, and is particularly advantageous when there is relative motion between the probe and the surface / tissue being imaged, such as the arteries of a beating heart. The bandwidth of the light source 325 can be selected to achieve the desired resolution and can be varied depending on the needs of the intended use of the system 10.In some embodiments, the bandwidth is approximately 5%-15% of the central wavelength, enabling a resolution of 20 μm-5 μm. Light source 325 may be configured to emit light at a power level that meets ANSI Class 1 ("eye-safe") limits. Higher power levels may also be employed. In some embodiments, light source 325 emits light in the 1.3 μm band at a power level of approximately 20 mW. Tissue light scattering decreases as the central wavelength of the irradiated light increases, while water absorption increases. To balance these two effects, light source 325 may emit light with a wavelength closer to 1300 nm. Light source 325 may be configured to emit light with a shorter wavelength (e.g., approximately 800 nm) to traverse a region of the patient to be imaged that contains a large amount of fluid. Alternatively or additionally, light source 325 may be configured to emit light with a longer wavelength (e.g., approximately 1700 nm) to reduce high levels of scattering within the region of the patient being imaged. In some embodiments, light source 325 is a tunable light source (e.g., light source 325 emits light of a single wavelength that varies repeatedly over time) and / or a broadband light source. Light source 325 may be a single spatial mode light source or a multimode light source (e.g., a multimode light source with spatial filtering).

[0108] The light source 325 may have a relatively long effective coherence length, e.g., greater than 10 mm, e.g., at least 50 mm, at all frequencies within the source bandwidth. This coherence length capability enables the system 10 to achieve a longer effective scan range because light returning from a distant imaging object (e.g., tissue) must remain phase coherent with the returning reference light to produce detectable interference fringes. For swept-source lasers, the instantaneous linewidth is very narrow (i.e., when the laser is sweeping, it outputs a very narrow frequency band that changes at the sweep rate). Similarly, for broadband light sources, the detector geometry must be able to select a very narrow linewidth from the source spectrum. The coherence length is inversely proportional to the linewidth. A longer scan range allows for imaging larger or more distant objects (e.g., imaging more distant tissue). Current systems have short coherence lengths, resulting in a reduced imaging range and artifacts (ghosts) arising from objects outside the effective scan range.

[0109] In some embodiments, light source 325 has a sweep bandwidth of at least 30 nm and / or 250 nm or less, e.g., at least 50 nm and / or 150 nm or less, e.g., about 100 nm. In some embodiments, light source 325 has a center wavelength of at least 800 nm and / or 1800 nm or less, e.g., at least 1200 nm and / or 1350 nm or less, e.g., about 1300 nm. In some embodiments, light source 325 has an optical intensity of at least 5 mW and / or 500 mW or less, e.g., at least 10 mW and / or 50 mW or less, e.g., about 20 mW.

[0110] System 10 may include a bus 58, shown as one or more operably connected cables or other conduits. Bus 58 may operably connect PIU 200 to console 300, rotating assembly 210 to console 300 (as shown), retracting assembly 220 to console 300, and / or rotating assembly 210 to retracting assembly 220. Bus 58 may be comprised of one or more optically transmitting fibers, wires, traces, and / or other electrical transmitting cables, fluid conduits, and one or more combinations thereof. In some embodiments, bus 58 includes at least an optically transmitting fiber that optically connects rotating assembly 210 to imaging assembly 320 of console 300. Additionally or alternatively, bus 58 may include at least power and / or data transmitting cables that transmit power and / or drive signals to one or more motion elements of rotating assembly 210 and / or retracting assembly 220.

[0111] The console 300 may include a processing unit 310. The processing unit 310 is configured to perform and / or facilitate one or more functions of the system 10, such as one or more processes, energy supply (e.g., optical energy supply), data collection, data analysis, data transfer, signal processing, and / or other functions (referred to herein as "functions"). The processing unit 310 may include a processor 312, a memory 313, and / or an algorithm 315, each as shown. The memory 313 stores instructions for executing the algorithm 315 and may be connected to the processor 312. The system 10 may include a user interface 350, which is an interface for providing and / or receiving information to and / or from an operator of the system 10. The user interface 350 may be integrated into the console 300, as shown. In some embodiments, the user interface 350 may comprise a component separate from the console 300, such as a display operably attached to the console 300. User interface 350 may include one, two, or more user input components and / or user output components. For example, user interface 350 may include user input device 351, as shown, which may be a joystick, keyboard, mouse, touchscreen, and / or another human interface device. In some embodiments, user interface 350 may include display 352 (e.g., a touchscreen display), as shown. In some embodiments, processor 312 may include GUI 353, which is a graphical user interface displayed on and / or provided by display 352. User interface 350 may include input and / or output devices selected from the group including a speaker, indicator lights such as LED indicators, haptic feedback devices, foot pedals, switches such as momentary switches, microphones, cameras (e.g., if processor 312 enables eye-tracking and / or other input via image processing), and combinations thereof.

[0112] In some embodiments, system 10 includes a server 400, which is a data storage and processing device. Server 400 may be an “off-site” server (e.g., located outside the clinical site where 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 may be a cloud-based server. Server 400 may include a processing unit 410, as shown, configured to perform one or more functions of system 10, such as one or more functions described herein. Processing unit 410 may include one or more algorithms 415. Processing unit 410 may include a memory (not shown) that stores instructions for executing algorithms 415. Server 400 may be configured to receive and store various forms of data 420, such as image data, diagnostic data, planning data, and / or outcome data described herein. In some embodiments, data 420 is data collected from multiple patients (e.g., multiple patients treated with system 10), such as data collected during and / or after a clinical procedure in which image data was collected from patients via system 10. For example, image data may be collected via the imaging probe 100, recorded by the processing unit 310 of the console 300, and transmitted to the server 400 for analysis. In some embodiments, the console 300 and the server 400 may communicate over a network, for example a wide area network such as the Internet. Alternatively or additionally, the system 10 may include a virtual private network (VPN) through which various devices of the system 10 transfer data.

[0113] As described herein, one or more functions of system 10 performed by processing unit 310 and / or 410 may be performed by either or both processing units. For example, in some embodiments, image data is collected and pre-processed by processing unit 310 of console 300. The pre-processed image data is then transferred to server 400 for further processing. The processed image data may be transferred to console 300 and displayed to an operator (e.g., via GUI 353). In some embodiments, a first set of one or more images (referred to herein as “images”) based on a first set of image data (e.g., images processed locally via processing unit 310) is displayed to the operator following collection of the image data (e.g., in near real time), and a second image (e.g., images processed remotely via processing unit 410) based on the first set of image data is subsequently displayed to the operator (e.g., as the first image is displayed during processing of the second image).

[0114] In some embodiments, algorithm 315 is configured to adjust (e.g., automatically and / or semi-automatically adjust) one or more operating parameters of system 10, such as operating parameters of console 300, imaging probe 100, and / or delivery catheter 80. Additionally or alternatively, algorithm 315 may be configured to adjust operating parameters 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 the operating parameters based on one or more sensor signals, such as sensor signals provided by sensor-based functional components of the inventive concepts as described herein. The algorithm 315 may be configured to adjust (e.g., automatically perform or recommend adjustments to) operating parameters selected from the group including rotational parameters such as the rotational speed of the optical core 110 and / or optical assembly 115, retraction parameters of the shaft 120 and / or optical assembly 115 such as retraction speed, distance, start position, end position and / or retraction start timing (e.g., when retraction is initiated), positional parameters such as the position of the optical assembly 115, line spacing parameters such as lines per frame, image display parameters such as scaling of display size relative to vessel diameter, configuration parameters of the imaging probe 100, injectate 21 parameters such as a ratio of saline to contrast agent configured to determine an appropriate refractive index, light source 325 parameters such as the irradiated power and / or frequency of the irradiated light, and combinations of one or more thereof.In some embodiments, the algorithm 315 is configured to adjust (e.g., automatically or recommend) pullback parameters that trigger the initiation of pullback, such as pullback initiated based on parameters selected from the group including lumen ejection (the lumen proximate the optical assembly 115 is sufficiently clear of blood or other material that interferes with image generation), an indicator signal received from the injector (e.g., a signal indicating that sufficient ejection fluid has been delivered), a change in the collected image data (e.g., a change in the image associated with adequate ejection of blood from around the optical assembly 115 is detected based on the collected image data), and one or more combinations thereof. In some embodiments, the algorithm 315 is configured to identify the attached imaging probe 100 (e.g., automatically via RF or other embedded ID) and adjust system 10 configuration parameters associated with the imaging probe 100, such as when the algorithm 315 adjusts system 10 parameters such as optical path length parameters, dispersion parameters, catheter type parameters, “enablement” parameters (e.g., parameters that lock and / or unlock use of features of the system 10), calibration parameters (e.g., optical length to physical length conversion parameters, etc.), and / or other parameters as listed above. In some embodiments, the console 300 is configured to record one or more metrics related to the performance of the imaging probe 100, such as a brightness score. These metrics may be encoded into the probe 100 during use (e.g., encoded into on-board memory of the probe 100, such as a writable RFID tag). Additionally or alternatively, fault information may be encoded into the probe 100 (e.g., written to an RFID tag), such as when a fault occurs and / or is detected by the system 10. For example, the failure information may include the date and time of the image loss and / or other diagnostic information such as failure to calibrate.

[0115] In some embodiments, the algorithm 315 is configured to trigger the initiation of pullback based on a time-limited parameter. In some embodiments, a T-wave trigger (e.g., provided by a separate device) is provided to the console 300 to initiate pullback when a low-motion portion of the cardiac cycle is detected. As an alternative or in addition to a T-wave trigger, motion patterns (e.g., relative motion patterns) between one or more parts (e.g., components or other features) of the imaging probe 100 and relatively stable (e.g., non-moving) parts of the patient's anatomy (e.g., ribs, sternum, spine) may be tracked (e.g., using angiography).

[0116] In some embodiments, system 10 includes one, two, or more calibration instruments, shown as calibration tools 50. Calibration tool 50 may be configured to detect and / or analyze light, as described herein with reference to FIG. 5. Calibration tool 50 may include one or more robotic manipulators, such as for manipulating one or more tools and / or components of probe 100 during a closed-loop calibration process.

[0117] When the console 300 of the system 10 is initially installed in a clinical site (e.g., a catheter lab), a calibration routine may be executed (e.g., performed by and / or using the calibration tool 50) used to establish latency between the clinical site's angiography system (e.g., second imaging device 15) and other components of the system 10. Essentially, the imaging probe 100 is provided, the clinical site's angiography system is engaged, and an angiography image feed is provided to the console 300 (e.g., using any standard video connection, analog or digital). The video frames provided by the angiography system are registered according to the console 300's clock, which is used as a reference time frame. Pullback of the imaging probe 100 (e.g., in patient or non-patient simulation mode) is initiated (coordinated by the console 300's clock) and an angiogram (e.g., device 15) is captured. A trained operator (e.g., a clinician and / or technician) can reference the angiography image frames and designate the first frame in which motion was detected. This process establishes the associated latency according to the console 300's clock. Motion detection may be automated, for example, using a neural network or other algorithm (e.g., algorithms 315 and / or 415) trained to recognize motion of the imaging probe 100 (e.g., motion of the marker bands on the imaging probe 100) under angiography.

[0118] In some embodiments, a calibration procedure (e.g., performed by and / or using calibration tool 50) configured to establish latency between the angiography system (e.g., second imaging device 15) and other components of system 10, and an imaging procedure performed during the relatively low motion of the cardiac cycle, includes the following steps: In a first step, an angiogram is initiated once probe 100 is inserted into the patient and deployed to the target anatomical structure. In a second step, system 10 analyzes the relative motion between one or more portions of imaging probe 100 (e.g., the motion of a marker band or other portion of imaging probe 100 that follows the patient's beating heart) and more stable features in the image, such as an image of the sternum or spine. Once the cardiac rhythm is established and the low motion portion is identified (typically, this analysis takes 5-10 cardiac cycles and uses velocity vector analysis, neural network analysis, etc.), an indicator is provided and the "metronome" of system 10 is initiated. The system 10 can reference the output of the metronome when a radiopaque injection substance is injected to clear blood from the target area being imaged, since one or more portions of the imaging probe 100 (e.g., one or more marker bands) may become radiopaque during this injection period (e.g., the radiopaque portions of the probe 100 are indistinguishable from the injection substance). In another embodiment, a non-radiopaque injection substance (e.g., dextran) may be used. In a third step, injection is initiated, such as by an operator or an automated method controlled by the system 10. Injection continues for multiple cardiac cycles, such as three to five cardiac cycles. In a fourth step, clearing of the vessel being imaged is detected by analyzing one or more images generated by the system 10. In a fifth step, pullback is initiated at a low motion portion of the metronome (e.g., a predicted low motion portion of the cardiac cycle), accounting for latency between the components of the system 10 and the previously established angiography system. In some embodiments, the pullback ends about one-half or less of the cardiac cycle to capture all or part of the image data within the low motion portion of the cardiac cycle.System 10 may be configured to provide a pullback speed of at least 50 mm / sec, e.g., at least 100 mm / sec, or 200 mm / sec. In a sixth step, a pullback sequence of images containing minimal motion artifacts is provided to the operator and / or used for CFD calculations (described herein), implant (e.g., stent) length measurements, etc. As described herein, using image capture during low motion can avoid or at least reduce errors associated with motion artifacts, particularly longitudinal motion artifacts.

[0119] In some embodiments, algorithms 315 and / or 415 (herein "algorithms 315 / 415") are configured to perform various image processing of image data generated by system 10. Algorithms 315 / 415 may comprise one, two, or more artificial intelligence algorithms configured to perform various image processing and / or other calculations, as described herein. For example, algorithms 315 / 415 may comprise neural networks incorporating DDNet and / or UNet techniques, with features tuned for processing and segmentation of intravascular image data. In some embodiments, algorithms 315 / 415 comprise one or more algorithms similar in configuration to the algorithms described herein with reference to FIG. 2.

[0120] Algorithms 315 / 415 may include one or more algorithms configured to perform one or more image processing applications selected from the group including image quality assessment, treatment device segmentation such as guide catheter and / or guidewire segmentation, implant segmentation such as endovascular implant segmentation such as stent and / or flow diverter segmentation, lumen segmentation such as vessel lumen segmentation, side branch segmentation, tissue characterization such as distinguishing between atherosclerosis and normal atherosclerosis, thrombus detection, and combinations thereof.

[0121] In some embodiments, algorithms 315 / 415 include various signal and / or image processing algorithms configured to process and / or analyze image data collected by system 10. Using these algorithms, system 10 is configured to perform automated quantification of one or more patient parameters (e.g., parameters related to the patient's health), one or more image parameters (e.g., parameters related to the quality of the image data), one or more treatment parameters (e.g., parameters related to the clinical effectiveness and / or technical proficiency of a administered treatment), and combinations thereof. For example, system 10 may provide metrics (e.g., variables), such as illustrated data metrics 525, that include results calculated using analysis (e.g., mathematical analysis) of these various parameters and / or otherwise calculated based on the analysis.

[0122] Data metrics 525 can represent quantifications of the quality of the image data, such as quantifications determined by an automated process of system 10. In some embodiments, data metrics 525 include a "confidence metric" that represents the quality of the results of an image processing step (e.g., a segmentation process). Data metrics 525, including a confidence metric, represent a calculated level of accuracy of the image data determined by system 10 (i.e., the level of "confidence" an operator of system 10 has in the presented data). In some embodiments, if data metrics 525 include a confidence metric below a first threshold (e.g., a value indicating low confidence), system 10 alerts the operator, for example, via an indicator displayed to the operator via GUI 353. Additionally or alternatively, system 10 may be configured to not display any image data if the confidence metric associated with the image data is equal to or less than a second threshold (e.g., a value indicating less confidence than the first threshold). In some embodiments, the system 10 is configured to display a warning to the operator (eg, a low confidence data warning) and / or prompt the operator to allow the display of low confidence image data.

[0123] In some embodiments, the data metrics 525 include a quantification of one or more characteristics (e.g., level of force or amount of protrusion) that describe the interaction between the patient's anatomy and a treatment device (e.g., implant 31) implanted in the patient. For example, the system 10 may be configured to analyze image data collected before, during, and / or after implantation of the implant to determine one or more values ​​of the data metrics 525 that are representative of (e.g., correspond to) the interaction between the implant and patient tissue (e.g., a blood vessel wall, the periosteum of one or more side branches, and / or the neck of one or more aneurysms).

[0124] In some embodiments, the data metrics 525 include metrics related to healing near the implantation site, for example, when the system 10 is used to collect image data from the 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 after the implantation procedure.

[0125] In some embodiments, data metrics 525 include metrics related to predicted outcomes of an interventional procedure, e.g., metrics whose values ​​are calculated and / or updated during an interventional procedure, after an interventional procedure, or both. For example, data metrics 525 may be used to provide guidance to an operator by indicating predicted outcomes of intended (e.g., future) and / or already performed (e.g., based on an analysis of the potential effectiveness of) an interventional procedure, such as an interventional procedure configured to treat a cerebral aneurysm and / or ischemic stroke. 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 interventional procedure (e.g., long-term dissolution of the aneurysm). Additionally or alternatively, the shape of the mesh may be used to estimate the angle of optical assembly 115 relative to the surface of the mesh and correct the mesh density accordingly. For example, at a bend, light exiting the optical assembly 115 (e.g., a light ray transmitted from the optical assembly 115) may be along an oblique angle relative to the normal to the mesh surface. In this scenario, the mesh pattern elongates in the plane of incidence (e.g., the plane defined by the surface normal and the ray) depending on the angle of the ray. Correcting for this elongation to achieve a symmetrical pattern can provide the angle of the ray. This angle information can be used by the system 10 to correct the calculated density of the mesh.

[0126] In some embodiments, data metrics 525 include metrics that inform the patient's clinician (e.g., whose values ​​are used to provide recommendations or other information) that an additional (e.g., second) therapeutic procedure may be administered to the patient to optimize or at least improve upon at least a first (e.g., interventional) therapeutic procedure already administered. Additional therapeutic procedures include interventional procedures selected from the group including adjustments to a device (e.g., therapeutic device 16) implanted in the patient in a previous procedure, such as adjustments including implant repositioning, expansion, contraction, and / or other adjustments; implantation of a device (e.g., device 16) in the patient, regardless of whether the device was previously implanted in the patient; vasodilation procedures; thrombectomy procedures; and / or other procedures to remove occlusive material; coiling or other procedures to occlude undesirable spaces in the vasculature; drug delivery procedures; and combinations thereof.

[0127] In some embodiments, system 10 can identify whether a myocardial bridge is present in a portion of the imaged vessel. For example, system 10 can automatically detect the presence of a myocardial bridge (e.g., via algorithm 315 / 415) and / or data presented to an operator of system 10 indicates the presence of a myocardial bridge (e.g., allowing the operator to draw conclusions based on the presented data). In some embodiments, image data can be collected by system 10 during a pullback procedure in which imaging probe 100 is retracted at a rate that captures multiple cardiac cycles during pullback, thereby allowing strain on the imaged vessel (e.g., strain caused by cardiac motion) to be analyzed across cardiac cycles. In some embodiments, system 10 is configured to identify a myocardial bridge by analyzing the image data to detect artifacts in the image data that indicate the presence of a myocardial bridge (e.g., a signature artifact similar to the hypoechoic “halo” that can be seen when imaging a myocardial bridge using intravascular ultrasound).

[0128] In some embodiments, the system 10 is configured to quantify the quality of the image data, such as quantification determined by an automated process of the system 10 as described herein. In some embodiments, if the quality of the image data falls below a threshold, one or more analysis processes (e.g., image analysis described herein) of the system 10 can be disabled to prevent processing on the poor-quality image data. For example, if the image data is analyzed and it is determined (e.g., by the system 10 and / or an operator of the system 10) that the optical assembly 115 started and / or ended within the stent during the pullback procedure, the system 10 is configured to disable subsequent CFD or other calculations described herein based on the poor image data. In some embodiments, the system 10 evaluates the quality of the purging procedure based on the quality of the image data. For example, the system 10 can evaluate the image quality to identify blood infiltration into the delivery catheter 80, indicating the need for purging. This analysis can be used to provide real-time feedback to the user during imaging, such as displaying a warning message (e.g., "Please Purge Catheter"). Similarly, after image acquisition is complete, system 10 may analyze the image data and display a warning to the user if catheter purging was incomplete. In some embodiments, system 10 analyzes the image data to identify blood remaining in the lumen and display a warning to the user, indicating areas of incomplete blood clearance. Incomplete blood clearance in areas of high interest for the CFD calculations (such as an unclear frame of reference or a stenosis) can alert the user to insufficient image quality for the CFD calculations.

[0129] 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 within a stenotic artery (e.g., a coronary artery) and estimate pressure drop through one or more lesions, as described herein. These methods provide a user (e.g., an interventionalist) with multiple and simultaneous measurements of high-resolution arterial anatomy and vascular hemodynamics (e.g., "physical anatomy") that can be used to better characterize and diagnose pre- and post-intervention (e.g., post-intervention) stenotic coronary arteries. This information is used to provide informed guidance and / or optimize interventional steps, as described further herein.

[0130] Conventional clinical practice is limited to using either intravascular imaging (e.g., OCT or IVUS imaging) or physiological measurements (e.g., FFR, iFR, RFR) at the same time, with imaging and physiological measurements acquired only using separate instruments (e.g., single-purpose catheters). System 10 may be configured to capture both vascular anatomical and physiological structures (e.g., in a single "pullback acquisition"). This combined solution provides a significant advantage over either tool alone in that it inherently co-registers anatomical and physiological data (e.g., data captured by a single device) and can be used to plan and optimize coronary interventions.

[0131] In some embodiments, the CFD simulations performed by system 10 are designed to closely simulate hyperemic conditions, as is done, for example, for obtaining fractional flow reserve data using pressure wires. Alternatively or additionally, CFD methods may be used to simulate unheated conditions, similar to how vascular hemodynamic data is collected, for example, using an iFR or RFR catheter. FFR devices typically perform a single FFR measurement from a single location distal to all lesions. Using the CFD methods of system 10 described herein, blood flow and pressure drop can be more easily assessed across an entire coronary artery segment imaged with OCT.

[0132] Conventional FFR techniques suffer from significant limitations due to lesion crosstalk. For example, when lesions are contiguous, FFR techniques cannot distinguish the individual contribution of each lesion. The CFD method of the system 10 described herein can determine the contribution of each lesion and indicate which of the imaged lesions is more critical and should be treated.

[0133] System 10 may be configured to achieve CFD simulation and pressure drop assessment of an entire arterial segment (e.g., 100 mm or longer) in a few seconds (e.g., less than 20 seconds) using simplified quasi-2D and / or 2D solvers. When compared to a full 3D solver (e.g., a solver configured to implement the Navier-Stokes equations), quasi-2D and / or 2D solvers can reduce computational time by an order of magnitude or more while maintaining sufficient accuracy for coronary artery pressure drop assessment.

[0134] In some embodiments, the CFD simulation relies heavily on segmentation of image data (e.g., OCT image data). The segmentation can be obtained by conventional image processing algorithms and / or AI techniques (e.g., machine learning, deep learning, neural networks, and / or other artificial intelligence techniques). In some embodiments, these techniques include various steps of the method 1000 described with reference to FIG. 5 herein for analyzing an image dataset (e.g., an OCT image dataset) to quantify blood flow and / or pressure drop.

[0135] In some embodiments, system 10 includes a graphical user interface, such as GUI 353 described herein with reference to FIGS. 3A-3C. In some embodiments, the GUI is configured to provide a user with an easy and immediate way to acquire and use OCT images and / or simulated physiological data for diagnosing coronary artery stenosis and planning and optimizing coronary interventions. In some embodiments, registering OCT-FFR "physical anatomy" data to coronary angiography data can provide an interventionist with a comprehensive tool for accurately planning and guiding coronary procedures. Additionally or alternatively, OCT-FFR simulations may be used to create virtual stent tools that allow a user of system 10 (e.g., an interventionist) to simulate the effects of stents of different lengths and diameters across different vascular locations to optimize stent sizing and selection and devise optimal intervention strategies.

[0136] In some embodiments, the physical therapy anatomical data can be quantified (e.g., by system 10) by several metrics. For example, these metrics can be used to quantify the effectiveness of treatment before and after an intervention (e.g., quantifying "gain").

[0137] In some embodiments, the system 10 is configured to ensure data quality and suitability for CFD calculations. For example, the system 10 is configured to ensure the reliability of segmentation results (e.g., side branch and / or lumen segmentation) by determining a “confidence metric” as described herein. The goal of the confidence metric is to alert the user to images where the segmentation results are uncertain and may be of poor quality, allowing for quick visual confirmation and correction (if necessary). In some embodiments, the system 10 is configured to verify that a complete pullback is acquired from the distal location of the lesion to the tip of the guide catheter. In some embodiments, a complete pullback is defined as a pullback that captures the entire lesion, a pullback that does not start and / or end on the vessel segment of the lesion, and a stent, if present, that is imaged in its entirety. If the pullback starts and ends on the vessel segment of the lesion, the system 10 may be configured to recover from this situation and perform accurate CFD measurements. For example, in this scenario, system 10 may be configured to identify healthy vessel segments (e.g., by one or more techniques described herein) and use bifurcation rules to estimate the vessel diameter and / or area in proximal and / or distal reference frames, e.g., as described with reference to Figures 4A-4D herein.

[0138] In some embodiments, the system 10 is configured to perform an image quality assessment, including assessing the presence of significant residual blood in the lumen of the blood vessel during pullback, e.g., blood obscuring one or more portions of the vessel. The system 10 may be configured to perform such assessments as described with reference to FIGS. 7A-7D herein. In some embodiments, the system 10 is configured to assess blood trapped in a portion of the catheter configured to be imaged through (e.g., a portion of the catheter configured to be purged with saline before and / or during pullback), which degrades image quality. An example of an incomplete catheter purge and its effects is shown in FIG. 13 herein. One or more algorithms of the system 10 may be configured to automatically detect image quality degradation as well as the extent of the degradation and alert the user to the degradation in image quality and the potential need to repeat imaging (e.g., repeat pullback). In some embodiments, the system 10 is configured to capture one or more angiographic images. Analysis of the angiographic data performed by the system 10 can reveal the presence of major collateral vessels. This can result in inaccurate FFR and CFD calculations (e.g., a falsely low FFR in the "donor artery" and / or a falsely high FFR in the "recipient artery.") In some embodiments, a warning message is displayed to the user informing them of the presence of collateral vessels before the CFD calculations are performed by system 10 and / or before the results are displayed to the user by system 10.

[0139] 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 could degrade the accuracy of CFD simulations for pressure drop calculations. Automated determination of image data quality can alert a user of system 10 to potential problems, help the user correct some issues where possible (e.g., by helping and / or enabling the user to correct inaccurate segmentation results), and / or indicate to the user when new image data acquisition may be necessary. Automated data quality assessment can provide warnings and guidance to the user about images of moderate quality to facilitate correction. Alternatively or additionally, severe loss of image data quality that cannot be recovered may be indicated to the user, and system 10 may provide guidance on how to improve image quality (e.g., by instructing the user to better purge the catheter and / or better engage the guide catheter with the coronary artery periosteum) and perform additional image acquisition.

[0140] In some embodiments, system 10 can use this information to determine reference diameters (e.g., proximal and distal reference diameters) and side branch size (e.g., as described with reference to Figures 4A-4D herein) and calculate an "ideal" and / or "reference" vessel profile to better guide intervention and / or quantify "stent expansion." The ideal vessel profile is a metric that aids in more accurate stent sizing. Stent expansion is a metric that aids in additional steps to optimize the stent implantation procedure.

[0141] The 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 for clinicians or other users of system 10, and / or to provide device diagnostic information in a clinical environment, such as self-diagnostic information and / or diagnostic information related to devices in the clinical environment that are not part of system 10. When used in training scenarios, system 10 may be configured to perform initial and / or periodic evaluations of a user of system 10 by comparing decisions made by the user (e.g., based on image data collected by and input into system 10) with decisions made by system 10 (e.g., algorithms 315 / 415) based on similar data (e.g., the same data). For example, system 10 may perform automated image evaluations (e.g., determining whether blood is present during imaging, whether a guide catheter is properly positioned during imaging, and / or whether the catheter lumen was sufficiently purged during imaging). Based on the automated evaluation, system 10 may provide feedback to the user based on the user's operation of system 10 and / or the user's interpretation of the data. For example, system 10 may suggest IQ improvements, provide insights based on image quality assessments, and / or provide an overall pullback review.

[0142] When used in diagnostic scenarios, system 10 may perform image quality assessments and infer from the image quality (e.g., via algorithms 315 / 415) whether components of system 10 may be the cause of image quality degradation. For example, system 10 may detect repairable issues such as a faulty imaging assembly 320 (e.g., from dim image data), loose connections 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, e.g., the number of pullbacks the imaging probe 100 and / or imaging assembly 320 have been used. In some embodiments, system 10 is configured to analyze the image quality of the second set of image data (e.g., via algorithms 315 / 415), such as analyzing a first set of image data collected by system 10 and a second set of image data from another imaging device (e.g., second imaging device 15) and providing a diagnostic report for the second imaging device (e.g., determining whether the second device is operating properly or requires repair or calibration).

[0143] In some embodiments, the system 10 is configured to perform an automated review of the image data collected by the system to ensure sufficient image quality to perform subsequent calculations (e.g., FFR calculations described herein) based on the image data. The system 10 may be configured to identify various problems from the image data, such as problems selected from the group including blood in the image, such as due to insufficient blood removal, poor lumen wall integrity, image distortion, such as distortion due to NURD, lack of visualization of the guide catheter, insufficient pullback distance, such as less than 40 mm, improper starting and / or ending points of the image data (e.g., starting and / or ending within a stent), and combinations thereof.

[0144] In some embodiments, system 10 is configured to analyze the image data to determine whether the patient meets any exclusion criteria (e.g., criteria that would exclude the patient from further treatment and / or diagnosis by system 10). Exclusion criteria identified by system 10 include the 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, continuous, gross luminal irregularities present in a large portion of the coronary artery tree), the presence of a myocardial bridge (MB), target lesion involving the left main (e.g., greater than 50% stenosis), artifacts observed in pre-PCI OCT images of the target lesion or multiple target lesions, or artifacts observed in pre-PCI OCT images of all target lesions, target lesions or multiple lesions that require some preparation prior to pre-PCI OCT images and physiological measurements, and the presence of a myocardial bridge (MB) in the target vessel. Presence of multiple target lesions (including but not limited to balloon dilation, thrombus, etc.), presence of any target lesions (including but not limited to balloon dilation, thrombus, etc.) that require any preparation prior to pre-PCI OCT imaging and physiologic measurements, target lesions more than 60 mm from the coronary ostium (e.g., lesion cannot be imaged by OCT in a single pullback) and / or significant coronary artery disease (CAD), inaccurate or failed catheter purge and / or contrast flush, presence of plaque rupture and / or intravascular hematoma in the target vessel (visual % diameter stenosis ≥ 40), and combinations thereof.

[0145] In some embodiments, system 10 is configured to analyze the angiographic image data to identify the vessel in which imaging probe 100 is positioned (e.g., the vessel represented by the vascular image data collected by system 10). In some embodiments, one or more algorithms of system 10 (e.g., algorithms 315 / 415) are modified based on the vessel being imaged (e.g., automatically modified based on the identification of the vessel being imaged from the angiographic image data). In some embodiments, system 10 is configured to perform motion correction of the OCT image data by analyzing velocity vectors of the angiographic image data collected simultaneously with the OCT image data.

[0146] In some embodiments, the image processing techniques of the system 10 described herein are configured to automatically perform operations selected from the group including distinguishing between normal and diseased segments of an imaged vessel, identifying an ideal reference frame for vessel sizing (e.g., to avoid placing reference segments in diseased regions), optimizing scaling laws by avoiding lesioned segments as reference diameters, optimizing vessel size estimation, and combinations thereof.

[0147] 2, 2A, and 2B, a perspective view of an imaging probe and two cross-sectional views of a portion of the imaging probe are shown, consistent with the concepts of the present invention. The imaging probe 100 of FIG. 2 has a similar configuration and arrangement to the imaging probe 100 described with reference to FIG. 1 and includes similar components to the imaging probe 100 described herein. In some embodiments, the imaging probe 100 includes a shaft, such as the illustrated outer shaft 140, having a lumen 141 within which another shaft, such as the illustrated shaft 120, is rotatably and / or slidably disposed. A connector assembly 150 includes a first housing, shell 151, fixedly attached to the proximal end of the outer shaft 140, and a second housing, inner shell 152, fixedly attached to the proximal end of the shaft 120. The illustrated connector 153 is an optical connector, fixedly and optically attached to the proximal end of the optical core 110, such that rotation of the connector 153 causes corresponding rotation of the optical core 110. The connector 153 is rotatably connected to the inner shell 152 such that the connector 153 can rotate relative to the inner shell 152 (e.g., when attached to a rotation assembly 210, not shown, but described herein with reference to FIG. 1 ). In some embodiments, the PIU 200 (not shown, but described herein with reference to FIG. 1 ) is configured to rotate the optical core 110. The PIU 200 may further be configured to retract the optical core 110, the shaft 120, or both (e.g., together) relative to the outer shaft 140. For example, the connector assembly 150, comprising the shell 151 and the inner shell 152, is constructed and arranged to operably connect to a mating connector of the PIU 200, within which the inner shell 152 and the connector 153 are housed. Thus, the shaft 120 can be retracted relative to the outer shaft 140 by the PIU 200.The PIU 200 is configured to be attached to and retracted from the inner shell 151 and shaft 120 without rotating the inner shell 151 and / or shaft 120 (e.g., without rotating the connector 153 and shaft 110 relative to the inner shell 152 and shaft 120, respectively).

[0148] In some embodiments, outer shaft 140 includes buckle assembly 145, which is an assembly that provides a place for shaft 120 to safely buckle when under compression. Buckle assembly 145 includes housing 146, which is an elongated structure disposed between two segments of shaft 140. Housing 146 includes one or more chambers, such as chamber 147 shown. In some embodiments, shaft 120 extends through chamber 147, which is a first segment of shaft 140, and continues into a second segment of shaft 140 such that shaft 120 is not supported within chamber 147. This provides a "buckle point" for shaft 120 (e.g., a location where shaft 120 can safely buckle). If shaft 120 encounters resistance as it advances through shaft 140 (e.g., if it is elastically compressed), chamber 147 allows shaft 120 to safely buckle so as to prevent or at least limit shaft 120 (and / or optical core 110) from puncturing shaft 140 and / or undesirably exiting shaft 140 (e.g., due to undesirable rapid advancement of shaft 120 due to accumulated compression within shaft 120).

[0149] In some embodiments, at least the distal portion of shaft 140 includes an optically transparent segment, such as the illustrated window 142. In some embodiments, window 142 is constructed of polyetheretherketone (PEEK) or other optically transparent material (e.g., a material that is at least partially transparent to light of the wavelengths produced by light source 325). Shaft 120 is configured to move within shaft 140 such that optical assembly 115 translates within window 142 (e.g., within all or a portion of window 142). In some embodiments, the distal portion of optical core 110 with optical assembly 115 is positioned within shaft 140 beyond the distal end of shaft 120 (as shown in FIG. 2B ). In some embodiments, gel 118 surrounds the distal portion of optical core 110 within shaft 120. Probe 100 may be configured such that gel 118 does not exit shaft 120 into shaft 140 (e.g., gel 118 remains within shaft 120), e.g., so that gel 118 does not enter the optical path of optical assembly 115. In some embodiments, outer shaft 140 has the illustrated tip 1191, which is a rapid exchange tip.

[0150] 3 and 3A, perspective and cross-sectional views of an optical assembly consistent with the concepts of the present invention are shown. The imaging probe 100 includes the optical assembly 115 of FIGS. 3 and 3A, which has a configuration and arrangement similar to the optical assembly 115 described with reference to FIG. 1. The optical assembly 115 includes a housing 1120, which is an elongated structure configured and arranged to maintain the positions of the various components of the optical assembly 115 as described herein. For example, as shown, the housing 1120 is fixedly attached to the distal portion of the optical core 110 and a reflector 1130, which is a reflective element. The distal end 1109 of the optical core 110 is rotatably disposed and axially positioned relative to a reflective surface 1131 of the reflector 1130, such as an angled reflective surface (e.g., a surface that is not orthogonal to the axis of the reflector 1130). In some embodiments, the reflector 1130 is an injection-molded part. In some embodiments, the reflective surface 1131 has a shape created during the molding process. Alternatively or additionally, the reflective surface 1131 may have a machined surface (e.g., a surface formed in a machining process after the body of the reflector 1130 is molded or otherwise formed) and / or a 3D printed surface (e.g., if the reflector 1130 is 3D printed). In some embodiments, the surface 1131 of the reflector 1130 has a reflective coating, such as gold plating. In some embodiments, the optical core 110 is fixedly attached to the housing 1120 using adhesive 1122 (as shown) and / or another attachment element (e.g., heat shrink tubing), etc. In some embodiments, the adhesive 1122 includes an adhesive configured to cure with ultraviolet light. In some embodiments, the housing 1120 includes a material configured to enhance the visibility of the optical assembly 115, for example, a radiopaque material configured to be imaged using fluoroscopy. This allows an operator of the system 10 to identify the location of the optical assembly 115 within a fluoroscopic image.

[0151] The surface 1131 of the reflector 1130 and / or the distal end 1109 of the optical core 110 each have a shape configured to direct the path of light emitted from the optical core 110 toward tissue and / or direct light reflected from the tissue toward the optical core 110 (either or both, herein "directed" light), as described herein. In some embodiments, the distal end 1109 has an angled surface (e.g., a surface that is not orthogonal to the axis of the core 110), as shown, for example, if the optical core 110 comprises a fiber with an angled cut fiber and / or an angled polish. The housing 1120 has an opening 1121 as shown. The surface 1131 and the distal end 1109 are configured to direct light through the opening 1121. Alternatively or additionally, the housing 1120 may include an optically transparent material (e.g., an optically transparent window segment) capable of directing light. In some embodiments, the optical assembly 115 is disposed within the shaft 140 and surrounded by air (e.g., surrounded by a gas such as atmosphere), so that the directed light travels through the air between the distal end 1109 and the wall of the outer shaft 140. The air gap between the distal end 1109 and the reflector 1130 expands the light, and the concave surface of the reflector 1130 collimates the light. Because the optical assembly 115 can be disposed within the shaft in air (e.g., atmosphere), there is no need to purge the shaft 140.

[0152] In some embodiments, as shown in FIG. 3A , the optical assembly 115 extends beyond the distal end of the shaft 120 and is rotatably and slidably disposed within the window 142 portion of the outer shaft 140, as described with reference to FIG. 2B . As shown in FIG. 3A , the outer shaft 140 has an inner diameter D1 and an outer diameter D4. The optical assembly 115 (e.g., the lens housing 1120) has an outer diameter D3. The lens housing 1120 has an inner diameter D2. The shaft 120 has an inner diameter D5. The optical assembly 115 has a length L1. In some embodiments, the diameter D3 of the optical assembly 115 is greater than the inner diameter D5 of the shaft 120 (e.g., because the optical assembly 115 is disposed distal to the distal end of the shaft 120).

[0153] In some embodiments, the imaging probe 100 comprises a 1.8F shaft, for example, where the dimensions of the optical assembly 110 are approximately: D1 has a diameter between 0.010 inches and 0.045 inches (e.g., D1 has a diameter of at least 0.010 inches and / or a diameter of no greater than 0.045 inches), e.g., about 0.018 inches; D2 has a diameter between 0.005 inches and 0.040 inches, e.g., about 0.012 inches; D3 has a diameter between 0.005 inches and 0.042 inches, e.g., about 0.014 inches; and D4 has a diameter between 0.012 inches and 0.050 inches, e.g., about 0.023 inches. In some embodiments, L1 has a length between 0.040 inches and 0.500 inches (e.g., a length of at least 0.040 inches and / or a length of no greater than 0.500 inches).

[0154] 4A-4C, perspective views of a reflector, assembly tool, and optical assembly consistent with the concepts of the present invention are shown. In some embodiments, reflector 1130 includes handle 1132, a protrusion configured to be used during the manufacturing process and eventually removed (e.g., removed and discarded). Handle 1132 extends from insert 1133, a functional portion of reflector 1130, which is inserted into housing 1120 during manufacturing of optical assembly 115. Surface 1131, as shown, is located at the proximal end of insert 1133. A distal portion of insert 1133 includes shoulder 1134, a radial protrusion that extends radially to a diameter greater than the inner diameter of housing 1120, to control (e.g., limit or establish) the depth to which insert 1133 can be inserted into housing 1120. Handle 1132 includes feature 1135, one or more alignment features including flats, as shown. In some embodiments, the system 10 includes an assembly tool, jig 70. Feature 1135 has a flat surface that slidingly mates with jig 70, such as surface 71 shown in FIG. 4B , which is the mating surface of jig 70. In some embodiments, alignment feature 1135 has a keyed or other shape configured to align handle 1132 with a mating feature of assembly jig 70. Alignment feature 1135 can be rotationally aligned with surface 1131. When handle 1132 is aligned with assembly jig 70, surface 1131 is oriented to properly mate with housing 1120. Assembly jig 70 includes alignment feature recess 72. Recess 72 is configured and arranged to slidingly receive housing 1120. This allows housing 1120 to slide over insert 1133, positioning surface 1131 within opening 1121. In some embodiments, recess 72 is configured and arranged to rotationally align housing 1120 with surface 71 (opening 1121 is rotatably positioned with respect to surface 1131, and light is directed to opening 1121 via surface 1131).Alternatively or additionally, opening 1121 may be configured to be manually (e.g., "eyeball") aligned with surface 1131. In some embodiments, insert 1133 is fixedly attached to housing 1120 using adhesive 1136 or the like, as shown in FIG. 4C.

[0155] Referring now to FIG. 5 , a perspective view of an assembly tool consistent with the concepts of the present invention is shown. The system 10 includes an assembly tool, fixture 75, constructed and arranged to assist a manufacturing assembler in rotationally aligning the optical core 110 (e.g., the distal end 1109 of the optical core 110) with the surface 1131 of the reflector 1130 within the housing 1120. An alignment feature 1135 of the reflector 1130 can mate with a flat surface 76 or the like of the fixture 75, and the reflector 1130 and the housing 1120 are rotatably fixed relative to the fixture 75. The fixture 75 includes a rotation tool, torque generator 77, removably attached to the optical core 110 to assist the manufacturing assembler in rotating the optical core 110 to align the distal end 1109 with the surface 1131 of the reflector 1130. Once alignment is complete, the optical core 110 can be secured (e.g., glued) to the housing 1120 using adhesive 1122. In manufacturing, after the insert 1133 is attached to the housing 1120 and the assembly of the insert 1133 and housing 1120 is attached to the distal portion of the optical core 110, the handle 1132 of the reflector 1130 can be removed (e.g., cut off and discarded), leaving the optical assembly 115 fully assembled, as shown in FIG.

[0156] In some embodiments, during the manufacturing process and while the optical core 110 is aligned with the housing 1120, the core 110 is attached to a light source (e.g., the proximal end of the core 110 is attached to a light source, such as the light sources described herein), and light exiting the distal end 1109 is reflected by the surface 1131 of the reflector 1130. The reflected light (i.e., the light emitted from the optical assembly 115) can be observed if the system 10 includes a calibration device (e.g., the calibration tool 50 described with reference to FIG. 1 ) configured to analyze the emitted light, and the alignment of the core 110 can be adjusted to optimize the emitted light, as described herein. In some embodiments, the torque generating unit 77 includes a robotic control component (e.g., via the robotic manipulator of the calibration tool 50) to adjust the axial and rotational position of the distal end 1109 of the core 110 in a closed-loop manner (e.g., the calibration tool 50 analyzes the emitted light and adjusts the alignment, robotically or otherwise, to optimize the light emitted from the optical assembly 115).

[0157] Referring now to Figure 6, various views of an embodiment of a reflector consistent with the concepts of the present invention are shown. Reflector 1130 includes a handle 1132 and an insert 1133, and is comprised of components configured and arranged as shown in Figure 6. Referring additionally to Figures 6A and 6B, end and side views, respectively, of a portion of a reflector consistent with the concepts of the present invention are shown. Insert 1133 in Figures 6A and 6B may be configured and arranged similarly to insert 1133 described with reference to Figure 3A and elsewhere herein.

[0158] Referring now to Figure 7, a side view of the distal end of an optical fiber consistent with the concepts of the present invention is shown. The optical core 110 of Figure 7 has a similar configuration and arrangement to the optical core 110 described with reference to Figure 1 and elsewhere herein. In some embodiments, the distal end 1109 of the optical core 110 has an angled surface, such as a surface having an angle α as shown. The angle α may be an angle of 0° to 20° (e.g., an angle of at least 0° and / or an angle of 20° or less), for example, an angle of 8° to 12° (e.g., an angle of at least 8° or less than 12°), for example, an angle of about 8°.

[0159] Referring now to FIG. 8 , a partially transparent perspective view of a distal portion of an imaging probe consistent with the concepts of the present invention is shown. The imaging probe 100 of FIG. 8 may be configured and arranged similarly to the imaging probe 100 described with reference to FIG. 1 and elsewhere herein. The optical assembly 115 is disposed at the distal end of the optical core 110 and may be disposed within the lumen 141 of the outer shaft 140, as shown. As described herein, light provided to the optical assembly 115 by a light source 325 (not shown) exits the distal end 1109 of the optical core 110 and is reflected off the surface 1131 of the reflector 1130, as shown. The emitted light is reflected off the reflector 1130 and passes through the window 142 (e.g., through the wall of the portion of the shaft 140 having the window 142). In some embodiments, the surface 1131 of the reflector 1130 is gold-plated, as described herein.

[0160] 9A and 9B, cross-sectional side and top views, respectively, of the distal end of an imaging probe consistent with the concepts of the present invention are shown. FIGS. 9A and 9B illustrate a nominal optical path and an offset optical path (e.g., a non-nominal optical path caused by misalignment between the reflector 1130 and the distal end 1109 of the optical core 110). The offset optical path shown represents an offset of approximately 50 μm. In some embodiments, the shape (e.g., curvature) of the surface 1131 is configured to prevent such offsets (e.g., offsets caused by manufacturing processes) from adversely affecting the focus of light exiting the optical core 110. Alternatively or additionally, the shape (e.g., curvature) of the surface 1131 is configured to avoid the generation of unwanted stray light.

[0161] 10A and 10B, optical modeling images and charts of results consistent with the concepts of the present invention are shown. Applicant has performed simulations involving optical modeling of the performance of the optical assembly 115 described herein. FIG. 10A shows the modeled path of light emanating from the distal end 1109 of the optical core 110 and reflecting off the surface 1131 to the focal point. The modeling results show that X1 / e 2 @focal point=30μ, Y1 / e 2 @Focus=31μ, X1 / e 2 <35 0-3.2mm, Y1 / e 2<35 μm (0.7-4.4 mm). Modeling showed that the X and Y diameters of the focal spot at the focal position were 30 μm and 31 μm, respectively. This result indicates good X and Y symmetry. Furthermore, modeling showed that the X diameter remained less than 35 μm up to 3.2 mm, and the Y diameter remained less than 35 μm up to 4.4 mm. The X and Y dimensions of the beam are perpendicular to the beam axis (approximately 80° from the axis of the probe 100) and are primarily perpendicular and parallel to the axis of the probe 100, respectively, as shown. Modeling also showed a coupling efficiency of 77%. Coupling showed a depth of focus ranging from 0 mm to 4.4 mm. Figure 10B is a graph showing the X and Y variation of the focal spot size for various alignment shifts between the optical core 110 and the reflector 1130. These results indicate that the structure and arrangement of the optical assembly 115 is sufficient to compensate for distortions caused by the window 142 (e.g., a 1.8 Fr sheath) and maintain focus over the entire range of potential manufacturing tolerances.

[0162] 11A-11E, there are shown anatomical side cross-sectional views of steps in an imaging method consistent with the concepts of the present invention. In FIG. 11A, a first delivery catheter, guide catheter 80, is inserted. G 11B, a wire 8001, which is a guidewire, is advanced into a blood vessel (e.g., a blood vessel in the brain or other part of the head of a patient) near the subject to be imaged (e.g., near the proximal end of the length of the target blood vessel to be imaged). G and advanced through the target vessel to (e.g., extending at least to) the distal end of the imaging target. In some embodiments, the wire 8001 is guided through the guide catheter 80 G The guide catheter 80 is inserted before G is inserted over the wire 8001.

[0163] In FIG. 11C, a second delivery catheter, microcatheter 80 M guide catheter 80G 11D, wire 8001 is removed and an imaging probe, such as imaging probe 100 described herein, is inserted into microcatheter 80. M In some embodiments, as shown, at least the distal portion of the optical probe 100, including the imaging assembly 115, is advanced through the microcatheter 80. M Also, for example, the microcatheter 80 M If the distal end of the imaging assembly 115 has a transparent segment through which the imaging probe 100 can image the target vessel (e.g., a transparent segment through which the imaging probe can transmit and receive light), the imaging assembly 115 can be inserted into the microcatheter 80. M In some embodiments, the imaging probe 100 may remain within the microcatheter 80. M until the distal end of the microcatheter 80 is approximately aligned with and / or beyond the distal end of the imaging probe 100, and then M The imaging probe 100 may be retracted to expose the imaging assembly 115 (e.g., while the imaging probe 100 is held in place). M The imaging probe 100 may be configured to have a spring tip or other features, shape, and / or flexibility configured to prevent or at least limit the potential for trauma to the target vessel when advanced beyond the distal end of the microcatheter 80. M The catheter may be configured to safely advance beyond the distal end of the catheter.

[0164] In FIG. 11E, the microcatheter 80 M and imaging probe 100 are simultaneously retracted during the pullback procedure. For example, retraction assembly 220 (not shown but described with reference to FIG. 1) retracts microcatheter 80. M and the imaging probe 100 are configured to retract simultaneously.

[0165] Referring now to FIG. 12, a side view of a portion of an imaging probe consistent with the concepts of the present invention is shown. The imaging probe 100 of FIG. 12 has a configuration and arrangement similar to the imaging probe 100 described with reference to FIG. 1 and elsewhere herein. A shaft 120, surrounding an optical core 110, is shown positioned adjacent to an outer shaft 140. Components of a connector assembly 150 are disposed at the proximal ends of the shafts 140 and 120. The shaft 120 is configured and arranged to be slidably received within the shaft 140, as described herein. The shaft 140 may include a buckle assembly 145, as described herein, that provides a safe buckling position for the shaft 120 when compressed (e.g., when the shaft 120 is disposed within the shaft 140 and buckle assembly 145). The connector 150 may include a housing, shell 151 (e.g., as described above), fixedly attached to the proximal end of the shaft 140, as shown.

[0166] In some embodiments, the connector 150 includes a stabilization assembly, shown as a wishbone 154. The wishbone 154 is fixedly attached to the proximal end of the shaft 120 and configured to frictionally engage with a connector 153, shown as an optical connector disposed at the proximal end of the optical core 110. The optical core 110 and connector 153 are rotatable relative to the shaft 120 and the wishbone 154. In some embodiments, the wishbone 154 frictionally engages (e.g., lockingly engages) with the connector 153 to prevent the connector 153 from moving (e.g., rotationally and / or axially relative to the shaft 120). In some embodiments, the wishbone 154 is rotated (e.g., rotated relative to the shell 151) to engage and / or disengage the connector 153, for example, as described below. The wishbone 154 includes one or more elongated members, shown as arms 1541 a, 1541 b. Arms 1541a and 1541b are resiliently biased inward toward connector 153. In the rest position, arms 1541a and 1541b face connector 153 to prevent undesired rotation of connector 153 (e.g., to maintain a desired rotational direction between shell 151 and connector 153). Arms 1541a and 1541b may also be resiliently biased away from connector 153. Thus, in the rest position, arms 1541a and 1541b are positioned away from connector 153, allowing connector 153 to rotate freely.

[0167] The connector 150 may be configured and arranged to operably attach to a PIU 200 (not shown but described herein). The PIU 200 may include a connector (e.g., optically, electrically, and / or mechanically) configured to operably attach to the connector 150. For example, the connector 153 may be connected to a rotation assembly 210 of the PIU 200. The rotation assembly 210 can rotate the connector 153 and the optical core 110. In some embodiments, the PIU 200 is configured to apply a force that separates the arms 1541 a, 1541 b from the connector 153 (e.g., a force that “opens” the wishbone 154) to allow the connector 153 to rotate. In some embodiments, attaching the shell 151 to the PIU 200 opens the wishbone 154. For example, the shell 151 is configured to rotate (e.g., rotate approximately 90°) to attach to the PIU 200 and / or to open the wishbone 154. In some embodiments, the shell 151 has an oval interior shape, such that rotating the wishbone 154 relative to the shell 151 rotates the arms 1541 a, 1541 b of the wishbone 154 from the short axis of the shell 151 to the long axis of the shell 151, allowing the arms 1541 a, 1541 b to expand to an open position (e.g., when the arms 1541 a, 1541 b are biased to the open position). In some embodiments, the wishbone 154 is configured to attach to the retraction assembly 220 of the PIU 200, such that the wishbone 154 and the connector 153, which are attached to the shaft 120 and the optical core 110, respectively, are retracted simultaneously (e.g., during a retraction procedure). In some embodiments, the arms 1541 a, 1541 b have one or more features (e.g., geometric features) configured to engage with the retraction assembly 220, such as the illustrated hooks 1542 a, 1542 b.

[0168] In some embodiments, shaft 120 includes a reinforced portion 1202. Portion 1202 may be as long as the maximum retraction distance of retraction assembly 220 (e.g., the maximum retraction distance provided by system 10), such as a distance of at least 15 cm. In some embodiments, portion 1202 has a stiffness greater than the stiffness of shaft 120 distal to portion 1202. Portion 1202 is configured to avoid buckling when subjected to a compressive load of 1.5 pounds or more. In some embodiments, a rotating portion of connector 150 (e.g., connector 153) has a mass of less than 3 g, e.g., less than 2 g, e.g., about 1.1 g, to reduce angular momentum of connector 153.

[0169] 12A, a side view of a portion of an imaging probe consistent with the concepts of the present invention is shown. During advancement of shaft 120 within outer shaft 140 (e.g., after a pullback procedure), buckling of shaft 120 can occur when the two shafts bind. Under compression, shaft 120 can buckle at locations L1, L2, and / or L3, as shown. The force required to buckle at location L1 between wishbone 154 and shaft 140 changes as shaft 120 advances, shortening the unsupported length of portion 1202. Buckling of shaft 120 at location L2 within shaft 140 does not prevent additional forces (e.g., axial forces) from being applied to shaft 120 distal to location L2 (e.g., additional forces that could damage probe 100 or cause patient injury due to undesired advancement of probe 100). Buckling at location L3 via buckle assembly 145 safely relieves the compressive force caused by the coupling of shaft 120 distal to assembly 145 and prevents associated undesired advancement (e.g., unintended and / or uncontrolled advancement) of the distal end of shaft 120.

[0170] In some embodiments, the wishbone 154 includes a tube 1543, which is a hollow tube extending between the wishbone 154 and the connector 153, as shown. The optical core 110 extends from the proximal end of the shaft 120 through the tube 1543 to the connector 153. The tube 1543 may be configured to support the optical core 110 between the shaft 120 and the connector 153 (e.g., prevent buckling of the optical core 110). In some embodiments, the tube 1543 is constructed of a thermoplastic material, such as PEEK. In some embodiments, the wishbone 154 is constructed of a polycarbonate material.

[0171] Referring to FIG. 13, a cross-sectional view of the distal end of an imaging probe consistent with the concepts of the present invention is shown. The imaging probe 100 of FIG. 13 has a similar configuration and arrangement to the imaging probe 100 described with reference to FIG. 1 and elsewhere herein. FIG. 13 illustrates an embodiment of an optical assembly 115 including a reflector (e.g., the illustrated reflector 1130) that provides a lens / air interface configured and arranged to reflect light directed from the optical core 110 toward tissue. In some embodiments, the reflector 1130 is located at the distal end of the optical core 110, as shown. The reflector 1130 includes a body 11301, which is a body portion having a recess that forms a chamber portion (e.g., chamber 1137) of the reflector 1130. The proximal surface of the chamber 1137 has a reflective surface 1131, as shown (e.g., the proximal surface of the reflective surface 1131 provides a reflective interface for internal reflection). In some embodiments, the reflector 1130 includes a cap or other sealing member (seal 1138 shown) surrounding the chamber 1137 to prevent fluids and / or other substances from entering the chamber 1137. Air and / or one or more other gases sealed within the chamber 1137 provide a lens / air interface for the reflective surface 1131, and the reflector 1130 is configured to reflect light from the core 110 by "total internal reflection" (TIR). In some embodiments, the seal 1138 includes an adhesive, such as a UV adhesive. In some embodiments, the reflective surface 1131 includes a coating, such as a sputter coating and / or a vapor deposition coating, e.g., a gold and / or aluminum coating. The coating may be applied to all or part of the reflector 1130. For example, the coating may be applied only to the reflective surface 1131, such as when the reflector 1130 is held by a fixture during the coating process. The fixture prevents the coating from being unnecessarily applied to other portions of the reflector 1130.In some embodiments, the distal end 1109 has an angled distal surface, such as a distal surface with an angle of less than 20°, 10°, and / or 5°, as shown. Alternatively or additionally, the distal end 1109 may have a flat (e.g., non-angled) surface, such as a surface perpendicular to the axis of the optical core 110. In some embodiments, the reflector 1130 and the optical core 110 may be composed of index-matched materials, e.g., two materials with matching reflective indices. In some embodiments, the reflector 1130 is fabricated on the optical core 110 using an overmolding process. Alternatively or additionally, the reflector 1130 may be bonded to the optical core 110, for example, when comprising a machined, molded, and / or otherwise constructed part that is bonded onto the optical core 110 during a manufacturing assembly process. The reflector 1130 may have a mating portion that is physically attached to the optical core 110, such as the recess 1139 shown. The recess 1139 can slidably accommodate the distal portion of the optical core 110 when the optical core 110 is inserted into and adhered to the reflector 1130. In some embodiments, the shape of the recess 1139 approximates (e.g., closely matches) the shape of the distal end of the optical core 110. For example, if the distal end of the optical core 110 has an angled surface, the distal face of the recess 1139 may have an angled surface that matches the angle of the optical core 110.

[0172] The reflective surface 1131 has an angle θ as shown. θ is measured relative to the longitudinal axis of the optical core 110. The angle θ may be at least 45°, such as at least 47°. The chamber 1137 may have a diameter Dy as shown. The diameter Dy may be at least 0.2 mm, such as no more than 0.8 mm. The reflective surface 1131 may be positioned at a distance Lx from the distal end 1109 of the optical core 110, as shown. The distance Lx may be at least 0.3 mm, such as no more than 1.40 mm. In some embodiments, the optical assembly 115 is configured to image a spot size having a diameter Dz. The diameter Dz may be approximately 30 μm.

[0173] In some embodiments, the imaging probe 100 has one or more markers, such as the illustrated marker 131. In some embodiments, the marker 131 has one or more openings, such as the illustrated opening 1311. The openings 1311 allow directed light from the optical core 110 to exit the shaft 120 (e.g., without being blocked by the marker 131). In some embodiments, the reflector 1130 is constructed from a polycarbonate material. In some embodiments, the top portion (with respect to the page) of the reflector 1130 (e.g., the portion of the reflector 1130 where directed light exits or enters the reflector 1130) has a flat surface, such as when the reflector 1130 is cylindrical in shape with a polished flat top portion.

[0174] 14, 14A, and 14B, there are shown a lens assembly, a distal end of an optical fiber, and a side view of the lens assembly disposed at the distal end of the optical fiber, respectively, consistent with the concepts of the present invention. The imaging probe 100 of FIGS. 14, 14A, and 14B has a configuration and arrangement similar to that of the imaging probe 100 described in FIG. 1 and elsewhere herein. FIG. 14 shows an embodiment of a reflector 1130, which is a shaped reflector. FIGS. 14A and 14B show steps for preparing a fiber for attachment to the reflector and assembling the reflector onto the prepared fiber. The reflector 1130 includes a recess 1139, shown, that slidably receives the distal portion of the optical core 110. In some embodiments, the optical core 110 includes one or more coatings, such as a protective coating. For example, as shown in FIG. 14A, a portion of the coating may be removed (e.g., peeled and / or otherwise removed) from the distal portion of the optical core 110 before insertion into the recess 1139. In some embodiments, the reflective surface 1131 has a lens / air interface, for example, when the reflector 1130 is disposed in air within the shaft 120 of the probe 110 (not shown but described herein), and the reflector 1130 provides total internal reflection. In some embodiments, for example, when the reflector 1130 provides total internal reflection, the reflective surface 1131 does not have a reflective coating.

[0175] In some embodiments, the reflector 1130 has a diameter of at least 200 μm. In some embodiments, the reflective surface 1131 has a shape with one or more curvatures, such as a compound curvature configured to compensate for astigmatism caused by the curvature of the shaft 120 and / or the outer surface of the reflector 1130. The reflective surface 1131 has a nominal polish angle of about 40° relative to the axis of the optical core 110 (e.g., a polish angle configured to provide total internal reflection). The reflector 1130 has a length Lx from the distal end 1109 of the optical core 110 to the distal end of the reflector 1130, as shown. The length Lx may be at least 0.3 mm, no more than 1.40 mm, or both.

[0176] It should be understood that the above-described embodiments serve only as illustrative examples, and further embodiments are contemplated. Any feature described herein in connection with any one embodiment may be used alone or in combination with other described features, or may be used in combination with one or more features of any other embodiment or combination of any other embodiment. Furthermore, equivalents and modifications not described above may be employed without departing from the scope of the inventive concept as defined in the appended claims.

Claims

1. 1. An imaging system for a patient, comprising: an imaging probe; an imaging assembly; The imaging probe comprises: a first elongate shaft having a proximal end, a distal end, a distal end, and a lumen extending at least between the proximal end and the distal end; a second elongate shaft having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the second elongate shaft being at least partially disposed within the lumen of the first elongate shaft; a rotatable optical core having a proximal end and a distal end, the rotatable optical core being at least partially disposed within the lumen of the second elongate shaft; an optical assembly disposed proximate a distal end of the rotatable optical core, the optical assembly configured to direct light at and collect reflected light from a tissue to be imaged; Equipped with the imaging assembly constructed and arranged to be optically coupled to the imaging probe and configured to illuminate light into the imaging probe and receive reflected light collected by the optical assembly; Imaging system.

2. The system of claim 1 , wherein a distal portion of the first elongate shaft is transparent to light emitted by the imaging assembly.

3. The system of claim 2 , wherein the second elongate shaft is not transparent to light emitted by the imaging assembly.

4. The system of any one of claims 1 to 3, further comprising a probe interface unit configured to be operatively attached to the imaging probe.

5. The system of claim 4 , wherein the probe interface unit is configured to retract the second elongate shaft and the rotatable optical core.

6. The system of claim 4 , wherein the probe interface unit is configured to rotate the rotatable optical core without rotating either the first elongated shaft or the second elongated shaft.

7. The system of claim 4 , wherein the imaging probe further comprises a connector assembly configured to operably connect at least the rotatable optical core and the second elongate shaft to the probe interface unit.

8. 8. The system of claim 7, wherein the rotatable optical core further comprises an optical connector, the connector assembly comprising a stabilization assembly configured to engage the optical connector and inhibit relative movement between the second elongated shaft and the optical connector.

9. The system of claim 8 , wherein the movement comprises a relative rotational movement.

10. The system of claim 8 , wherein the movement comprises a relative axial movement.

11. The system of claim 8 , wherein the stabilization assembly is configured to release the optical connector when the connector assembly is attached to the probe interface unit.

12. The system of claim 8 , wherein the stabilization assembly is resiliently biased toward the optical connector to inhibit the movement when in a rest position.

13. The system of claim 8 , wherein the stabilization assembly is resiliently biased away from the optical assembly to allow the movement when in a rest position.

14. The system of claim 8 , wherein the connector assembly further comprises an outer shell configured to bias the stabilization assembly toward the optical connector.

15. The system of any one of claims 1 to 14, wherein the optical assembly is disposed within the lumen of the first elongate shaft, distal to the distal end of the second elongate shaft.

16. The system of claim 15 , further comprising a viscous damping material disposed within a distal portion of the second elongate shaft and surrounding the rotatable optical core.

17. The system of claim 16 , wherein the imaging probe is configured to prevent the viscous damping material from exiting the second elongate shaft into the first elongate shaft.

18. 18. The system of claim 1, wherein the rotatable optical core extends beyond the distal end of the second elongate shaft and the optical assembly is disposed within the lumen of the first elongate shaft.

19. 20. The system of claim 18, wherein an outer diameter of the optical assembly is greater than an inner diameter of the second elongate shaft.

20. 20. The system of claim 18, wherein the optical assembly is disposed in air within a lumen of the first elongate shaft.

21. 21. The system of claim 20, wherein the lumen of the first elongate shaft is air-filled proximal and distal to the optical assembly.

22. The system of any one of claims 1 to 21, wherein the optical assembly comprises a reflector located distal to the distal end of the rotatable optical core.

23. 23. The system of claim 22, wherein the optical assembly further comprises a housing, the housing fixedly attached to the reflector and a distal end of the rotatable optical core.

24. 24. The system of claim 23, wherein the rotatable optical core and the optical assembly rotate in unison.

25. 23. The system of claim 22, wherein the optical assembly further comprises a space between the reflector and the distal end of the rotatable optical core, the space being filled with air.

26. 26. The system of claim 25, wherein light emitted from the distal end of the rotatable optical core expands in the space.

27. 27. The system of claim 26, wherein the reflector comprises a concave reflective surface configured to collimate the expanded light.

Images