Providing guidance for treatment procedures for blocked blood vessels

A computer-implemented method analyzes CT data to recommend a suitable endovascular treatment device for occluded blood vessels, addressing the challenge of selecting the right device based on occlusion characteristics for effective treatment.

JP2025533085APending Publication Date: 2025-10-03KONINKLIJKE PHILIPS NV
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Patent Information

Application Number
JP2025519486
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-12-12
Filing Date
2023-10-10
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

Selecting an appropriate endovascular treatment device for occluded blood vessels is challenging due to variations in occlusion characteristics such as size, shape, and composition, affecting procedure ease and effectiveness.

Method used

A computer-implemented method analyzes computed tomography data to determine the characteristics of the occlusion and recommends a suitable endovascular treatment device based on these characteristics.

Benefits of technology

Ensures that the recommended treatment device is suitable for the occluded portion, leading to more effective treatment of the blood vessel.

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Abstract

A computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel is provided, the method including analyzing CT data to determine one or more characteristics of the occlusion in the blood vessel, determining a recommended endovascular treatment device for treating the occluded blood vessel based on the one or more characteristics, and outputting an indication of the recommended endovascular treatment device.
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Description

[Technical Field]

[0001] SUMMARY

[0002] A computer-implemented method, computer program product, and system are disclosed that provide guidance for treatment procedures for occluded blood vessels. [Background technology]

[0002] Blood vessels within the anatomy can become blocked or occluded for a variety of reasons. For example, occluded blood vessels can result from the buildup of plaque within the blood vessel or from a blood clot within the blood vessel, also known as thrombosis. Occlusions can occur in blood vessels in various parts of the anatomy, including the heart, brain, and peripheral regions such as the legs.

[0003] In some cases, the blockage is partial, limiting but not inhibiting blood flow within the blood vessel. For example, in the heart, a partial blockage of a coronary artery can result in the heart having to work harder to maintain blood flow. Subjects with a partial blockage of a coronary artery may experience chest pain or angina. However, in more severe cases, blood flow within the blood vessel can be completely inhibited by the blockage. Chronic total occlusion, or "CTO," is defined as a complete blockage of a blood vessel lasting for three months or longer. The lack of blood flow resulting from a coronary CTO can result in permanent damage to the heart muscle. CTO is typically caused by a combination of severe atherosclerosis and thrombosis. Atherosclerosis is a condition in which plaques, composed of fat, cholesterol, calcium, fibrin, and other substances, build up in the walls of arteries. These plaques harden and narrow the arteries, restricting blood flow and oxygen delivery. Over time, the plaques may open or rupture, forming a thrombus or clot that further restricts blood flow. Thrombosis, in combination with plaque, can completely block an artery, resulting in a CTO.

[0004] Blockages are often treated using a procedure known as atherectomy, a minimally invasive endovascular procedure used to remove atherosclerotic disease from blood vessels in the body, thereby restoring blood flow. Various types of endovascular treatment devices are available for treating blockages during atherectomy procedures. A review of such devices is disclosed in Dash, D., et al., "Contemporary treatment options for surmounting conundrum of calcified coronaries," Journal of Transcatheter Interventions, 2020;28:eA202007. Currently available types of endovascular treatment devices include laser atherectomy devices that emit laser radiation to disrupt plaque, directional atherectomy devices that include an inflatable balloon and a cutting window to remove obstructing material from the vessel wall, rotational atherectomy devices that include a burr that rotates to perform a rotary abrasion or cutting operation to disrupt plaque, orbital atherectomy devices that include an eccentrically mounted abrasive crown to perform an orbital abrasion operation to disrupt plaque, transluminal atherectomy devices that include a rotating blade and an aspirator to cut and aspirate atheroma, respectively, and IVL balloons that deliver shock wave pulses to the vessel to disrupt plaque.

[0005] An example of a commercially available laser atherectomy device is the Turbo-Elite Laser Atherectomy Catheter, marketed by Philips Healthcare, Best, The Netherlands. An example of a commercially available directional atherectomy device is the HawkOne Directional Atherectomy System, marketed by Medtronic, Minneapolis, USA. An example of a commercially available rotational atherectomy device is the RotaPro Rotational Atherectomy System, marketed by Boston Scientific, Massachusetts, USA. An example of a commercially available orbital atherectomy device is the Diamondback 360 Coronary Orbital Atherectomy System, marketed by Cardiovascular Systems Inc., Minneapolis, USA. An example of a commercially available transluminal atherectomy device is the AngioJet Thrombectomy System, marketed by Boston Scientific, Massachusetts, USA. An example of a commercially available IVL balloon is the Shockwave C2 Coronary IVL Catheter marketed by Shockwave Medical, Santa Clara, USA. Summary of the Invention [Problem to be solved by the invention]

[0006] However, there remains a need to provide improved guidance for occlusion treatment procedures. The characteristics of occlusions vary in terms of their size, shape, and composition, and therefore, available endovascular treatment devices for treating occlusions have different strengths with respect to these characteristics. Therefore, selecting a treatment device type for use in an occlusion treatment procedure can be difficult. The type of device used to treat an occlusion can affect factors such as the ease of performing the procedure, the effectiveness of the treatment, and its outcome. Furthermore, when selecting a treatment device for treating an occlusion, it can be difficult to determine the characteristics of the device to use for the procedure. Device characteristics, such as its stiffness and tip shape, can affect the effectiveness of the treatment and therefore its outcome. It can also be difficult to determine the values ​​of treatment parameters to use with the device. For example, if the device is a laser atherectomy catheter, the values ​​of parameters such as the fluence of the light radiation emitted by the device and its advancement speed in the artery may need to be adjusted to optimize the desired outcome. [Means for solving the problem]

[0007] According to one aspect of the present disclosure, there is provided a computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel, the method comprising: receiving computed tomography data representative of the occluded blood vessel; analyzing the computed tomography data to determine one or more characteristics of an occlusion in the blood vessel; determining a recommended endovascular treatment device for treating the occluded vessel based on the one or more characteristics; outputting an indication of the recommended endovascular treatment device; It has.

[0008] In the above method, the recommended intravascular treatment device is determined based on the characteristics / properties of the occluded portion determined from the CT data of the occluded blood vessel. As a result, it is ensured that the recommended intravascular treatment device is suitable for the occluded portion in the blood vessel. Therefore, more effective treatment of the occluded blood vessel can be achieved.

[0009] Further aspects, features, and advantages of the present disclosure will become apparent from the following description of exemplary embodiments that proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1] Schematic diagrams showing examples of various characteristics of CTOs according to some embodiments of the present disclosure: A) Size: Short length, B) Size: Long length, C) Shape: Greater than 45 degree bend at CTO entry, D) Shape: Greater than 45 degree bend along the CTO path, E) Entry shape: Tapered cap, F) Entry shape: Blunt cap, G) Composition: Calcification along the CTO. [Figure 2] 1A-1C are schematic diagrams illustrating examples of various endovascular treatment devices for treating occlusions, according to some aspects of the present disclosure: A) laser atherectomy, B) directional atherectomy, C) rotational atherectomy, D) orbital atherectomy, E) transluminal atherectomy, and F) IVL balloon. [Figure 3] 1 is a flowchart illustrating an example of a computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel, according to some aspects of the present disclosure. [Figure 4] 2 is a schematic diagram illustrating a first example of a system 200 for providing guidance for a treatment procedure for an occluded blood vessel, according to some embodiments of the present disclosure. FIG. [Figure 5] FIG. 2 is a schematic diagram illustrating a second example of a system 200 for providing guidance for a treatment procedure for an occluded blood vessel, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] Examples of the present disclosure are provided with reference to the following description and figures. In this description, for purposes of explanation, many specific details of several examples are set forth. Reference herein to an "example," "embodiment," or similar language means that a feature, structure, or characteristic described in connection with an example is included in at least one of the examples. It should also be appreciated that features described in connection with one example may also be used in other examples, and that for purposes of brevity, not all features are necessarily replicated in each example. For example, features described in connection with a computer-implemented method may be implemented in a corresponding manner in a computer program product and in a system.

[0012] The following description refers to an example of a computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel. In some embodiments, the occlusion in the blood vessel is a CTO. Accordingly, the methods disclosed herein may be used with occluded blood vessels where the occlusion is a CTO. However, it should be understood that the methods disclosed herein may also be used with occluded blood vessels where other types of occlusions are present. In other words, the methods may be used with occluded blood vessels in general.

[0013] Reference is also made herein to an example in which the method is used to provide guidance for a treatment procedure for an occluded blood vessel, where the blood vessel is a coronary artery. However, it should also be understood that the blood vessel may generally be any type of blood vessel in the anatomy. Thus, the blood vessel may be an artery or a vein, and the artery or vein may be located anywhere in the body, such as in the heart, brain, arms, legs, etc.

[0014] It should be noted that the computer-implemented methods disclosed herein may be provided as a non-transitory computer-readable storage medium storing computer-readable instructions that, when executed by at least one processor, cause the at least one processor to perform the method. In other words, the computer-implemented methods may be implemented in a computer program product. The computer program product may be provided by dedicated hardware or hardware capable of executing software in association with appropriate software. When provided by a processor, the functionality of the method features may be provided by a single dedicated processor, by a single shared processor, or by multiple individual processors, some of which may be shared. One or more functions of the method features may be provided by a processor shared within a networked processing architecture, such as, for example, a client / server architecture, a peer-to-peer architecture, the Internet, or the cloud.

[0015] Explicit use of the terms "processor" or "controller" should not be construed as exclusively referring to hardware capable of executing software, but can implicitly include, but is not limited to, digital signal processor "DSP" hardware, read-only memory "ROM" for storing software, random access memory "RAM," non-volatile storage, and the like. Furthermore, examples of the present disclosure can take the form of a computer-usable storage medium, or a computer program product accessible from a computer-readable storage medium, the computer program product providing program code for use by or in connection with a computer or any instruction execution system. For purposes of this description, a computer-usable storage medium or computer-readable storage medium can be any apparatus that can contain, store, communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system or device or propagation medium. Examples of computer-readable media include semiconductor or solid-state memory, magnetic tape, removable computer diskettes, random access memory "RAM," read-only memory "ROM," rigid magnetic disks, and optical disks. Current examples of optical disks include compact disk-read only memory "CD-ROM", compact disk-read / write "CD-R / W", Blu-Ray™, and DVD.

[0016] As discussed above, there remains a need to provide improved guidance for occlusion treatment procedures. The characteristics of occlusions vary in their size, shape, and composition, and therefore, endovascular treatment devices available for treating occlusions have different strengths with respect to these characteristics. As an example, FIG. 1 is a schematic diagram illustrating examples of various characteristics of a CTO according to some embodiments of the present disclosure: A) Size: Short Length; B) Size: Long Length; C) Shape: Greater than 45° Bend at CTO Entry; D) Shape: Greater than 45° Bend Along the CTO Path; E) Entry Shape: Tapered Cap; F) Entry Shape: Blunt Cap; and G) Composition: Calcification Along the CTO.

[0017] FIG. 2 is a schematic diagram illustrating various exemplary endovascular treatment devices for treating occlusions, according to some embodiments of the present disclosure: A) laser atherectomy, B) directional atherectomy, C) rotational atherectomy, D) orbital atherectomy, E) transluminal atherectomy, and E) IVL balloon. The laser atherectomy device shown in FIG. 2A emits laser radiation LI to destroy plaque by photoablation. The directional atherectomy device shown in FIG. 2B includes an inflatable balloon BA and a cutting window CW. The cutting window CW is rotated within the vessel and aligned with the occlusive material on the vessel wall. In this position, the inflatable balloon stabilizes the cutting window CW and expands to press it against the occlusive material. The cutting blade is then rotated and translated, which removes the occlusive material from the vessel wall and packs it into the device's nosecone NC so that the removed material can be removed from the vessel. The rotational atherectomy device shown in FIG. 2C includes a burr with a roughened surface. The burr is rotated to perform a rotary abrasive or cutting action that disrupts the plaque. The orbital atherectomy device shown in Figure 2D includes an eccentrically mounted abrasive crown that uses centrifugal force to perform an orbital sanding action that disrupts the plaque. The transluminal atherectomy device shown in Figure 2E includes a rotating blade RB and an aspirator AS that respectively cut and aspirate the atheroma. The IVL balloon shown in Figure 2F includes one or more shock wave emitters SWE positioned on a catheter CA. The IVL balloon operates by delivering shock wave pulses SWP from the shock wave emitter SWE to the vessel VE to disrupt the plaque. During use, the balloon BA is filled with a liquid, such as saline, to expand the balloon and provide acoustic impedance matching between the emitter EM and the vessel.

[0018] As can be seen from the range of occlusion characteristics shown in Figure 1 and the different means of action of the types of treatment devices for treating occlusions shown in Figure 2, the endovascular treatment devices available for treating occlusions have different strengths with respect to the characteristics of the occlusion. As a result, the treatment device type used to treat an occlusion can affect factors such as the ease of performing the procedure, the effectiveness of the treatment, and its results. Therefore, selecting a treatment device type for use in an occlusion treatment procedure can be difficult.

[0019] FIG. 3 is a flowchart illustrating an example of a computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel, according to some embodiments of the present disclosure. FIG. 4 is a schematic diagram illustrating a first example of a system 200 for providing guidance for a treatment procedure for an occluded blood vessel, according to some embodiments of the present disclosure. FIG. 5 is a schematic diagram illustrating a second example of a system 200 for providing guidance for a treatment procedure for an occluded blood vessel, according to some embodiments of the present disclosure. Systems 200, 300 each include one or more processors 210. It should be noted that operations described in connection with the method illustrated in FIG. 3 may also be performed by one or more processors 210 of systems 200, 300 illustrated in FIGS. 4 and 5. Similarly, operations described in connection with one or more processors 210 of systems 200, 300 may also be performed in the method described with reference to FIG. 3.

[0020] Referring to FIG. 3 , a computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel includes: receiving S110 computed tomography data representative of the occluded blood vessel 110; Step S120 of analyzing the computed tomography data to determine one or more characteristics of an occlusion 120 in the blood vessel; a recommended endovascular treatment device 130 for treating the occluded blood vessel 110 based on the one or more characteristics; 1..6a step S130 of determining The recommended intravascular treatment device 130 1..6 Step S140 of outputting an indication of It has.

[0021] In the above method, the recommended intravascular treatment device is determined based on the characteristics / properties of the occluded portion determined from the CT data of the occluded blood vessel. As a result, it is ensured that the recommended intravascular treatment device is suitable for the occluded portion in the blood vessel. Therefore, more effective treatment of the occluded blood vessel can be achieved.

[0022] Referring to the method shown in FIG. 3, in act S110, CT data 140 representing an occluded blood vessel is received.

[0023] In general, the CT data received in act S110 may represent a still image of the occluded vessel, or alternatively, may represent a temporal sequence of images of the occluded vessel. In the latter case, the temporal sequence of images may be generated in substantially real time, and the method described with reference to FIG. 3 may be performed in substantially real time. Thus, in one example, an indication of a recommended endovascular treatment device may be output in real time.

[0024] In general, the CT data received in act S110 may be raw data, i.e., data that has not yet been reconstructed into a volumetric or 3D image, or it may be image data, i.e., data that has already been reconstructed into a volumetric image. CT data is sometimes referred to as volumetric data. The CT data may be generated by a CT imaging system, or, as described more fully below, may alternatively be generated by rotating or stepping an X-ray source and X-ray detector of an X-ray projection imaging system around the blood vessel.

[0025] A CT imaging system generates CT data by rotating or stepping an X-ray source-detector device around an object to obtain X-ray attenuation data of the object from multiple rotational angles relative to the object. The CT data can then be reconstructed into a 3D image of the object. Examples of CT imaging systems that can be used to generate the CT data include a cone-beam CT imaging system, a photon-counting CT imaging system, a dark-field CT imaging system, and a phase-contrast CT imaging system. An example of a CT imaging system 220 that can be used to generate the CT data received in operation S110 is shown in FIG. 4. As an example, the CT data can be generated by a CT 5000 Ingenuity CT imaging system commercially available from Philips Healthcare, Best, The Netherlands.

[0026] As described above, the CT data received in operation S110 can alternatively be generated by rotating or stepping the X-ray source and X-ray detector of an X-ray projection imaging system around the blood vessel. X-ray projection imaging systems typically include a support arm, such as a so-called "C-arm," that supports the X-ray source and X-ray detector. Alternatively, an X-ray projection imaging system may include a support arm with a different shape than this example, such as an O-arm. In contrast to CT imaging systems, X-ray projection imaging systems generate X-ray attenuation data of an object in which the X-ray source and X-ray detector are stationary relative to the object. X-ray attenuation data is sometimes referred to as projection data, in contrast to the volumetric data generated by CT imaging systems. X-ray attenuation data generated by X-ray projection imaging systems is typically used to generate 2D images of the object. However, X-ray projection imaging systems can generate CT data, i.e., volumetric data, by rotating or stepping their X-ray source and X-ray detector around the object and acquiring projection data of the object from multiple rotational angles relative to the object. Image reconstruction techniques can then be used to reconstruct the projection data acquired from multiple rotation angles into a volumetric image in a manner similar to the reconstruction of a volumetric image using X-ray attenuation data acquired from a CT imaging system. Thus, the CT data received in operation S110 may be generated by a CT imaging system, or alternatively, may be generated by an X-ray projection imaging system. An example of an X-ray projection imaging system that may be used to generate the CT data is the Azurion 7 X-ray projection imaging system sold by Philips Healthcare of BEST, The Netherlands.

[0027] In some examples, the CT data received in act S110 is spectral CT data. The spectral CT data includes a plurality of different energy intervals DE 1..mdefines the X-ray attenuation of the object in m. Generally, there may be more than one energy interval, i.e., m is an integer, and m≧2. In this regard, the spectral CT data received in act S110 may be generated by a spectral CT imaging system or by a spectral X-ray projection imaging system. In the latter case, the spectral CT data may be acquired by rotating or stepping the X-ray source and X-ray detector of the spectral X-ray projection imaging system around the blood vessel, as described above. More generally, the spectral CT data received in act S110 may be generated by a spectral X-ray imaging system.

[0028] Wide variety of energy intervals DE 1..m The ability to generate X-ray attenuation data in a single energy interval distinguishes the spectral X-ray imaging system from conventional X-ray imaging systems that generate X-ray attenuation data in a single energy interval. Processing data from multiple different energy intervals allows for differentiation between media that have similar X-ray attenuation values ​​when measured within a single energy interval and are indistinguishable in X-ray attenuation data generated by conventional X-ray imaging systems. Examples of spectral X-ray imaging systems that can be used to generate the spectral CT data received in operation S110 include a cone-beam spectral X-ray imaging system, a photon-counting spectral X-ray imaging system, a dark-field spectral X-ray imaging system, and a phase-contrast spectral X-ray imaging system. One example of a spectral CT imaging system that can be used to generate the spectral CT data received in operation S110 is the Spectral CT 7500 sold by Philips Healthcare of BEST, The Netherlands.

[0029] In general, spectral CT data can be generated by a variety of different configurations of spectral X-ray imaging systems including an X-ray source and an X-ray detector. The X-ray source of the spectral X-ray imaging system can include multiple monochromatic sources or one or more polychromatic sources, and the X-ray detector of the spectral X-ray imaging system can include a common detector for detecting multiple different X-ray energy intervals or multiple detectors, each detector detecting a different X-ray energy interval DE. 1..m The detector may include a multi-layer detector in which X-rays having energies within different X-ray energy intervals are detected by corresponding layers, or a photon-counting detector that classifies detected X-ray photons into one of a plurality of energy intervals based on their individual energies. In a photon-counting detector, the associated energy interval can be determined for each received X-ray photon by detecting the pulse height induced by electron-hole pairs generated in response to absorption of the X-ray photon in the direct conversion material.

[0030] Using the various configurations of X-ray source and detector described above, various X-ray energy intervals DE 1..m Typically, discrimination between different X-ray energy intervals can be provided at the source by switching the X-ray tube potential of a single X-ray source in time, i.e., by "rapid kVp switching," or by switching or filtering the X-ray emission from multiple X-ray sources in time. The time switch allows for multiple different X-ray energy intervals DE within a rotation of the X-ray source detector device. 1..mAlternatively, X-ray attenuation data for an energy interval may be acquired for a specified number of gantry rotations before switching to another energy interval, and X-ray attenuation data for that energy interval may be acquired in the same manner. In such a setup, a common X-ray detector may be used to detect X-rays across multiple different energy intervals, and X-ray attenuation data for each energy interval may be generated in a time series. Alternatively, a multi-layer detector or photon-counting detector may be used to provide the detector with the ability to distinguish between different X-ray energy intervals. Such a detector may be used to detect X-rays across multiple X-ray energy intervals. 1..m X-rays from the X-ray source can be detected almost simultaneously, and therefore no time switching in the radiation source is required. In this way, a multi-layer detector, or a photon-counting detector, can be used in conjunction with a polychromatic source to detect X-rays from various X-ray energy intervals DE 1..m X-ray attenuation data can be generated.

[0031] Other combinations of the aforementioned X-ray sources and detectors can also be used to provide spectral CT data. For example, in a further configuration, the need to sequentially switch between different X-ray sources emitting X-rays at different energy intervals can be avoided by mounting the X-ray source-detector pairs on the gantry at rotationally offset positions about the axis of rotation. In this configuration, each source-detector pair operates independently and emits X-rays at different energy intervals DE 1..m The separation between the spectral CT data is facilitated by the rotational offset of the source-detector pair. In this setup, the energy interval DE is obtained by applying an energy selection filter to the X-ray detector to reduce the influence of X-ray scattering. 1..m Improved separation between the spectral CT data can be achieved.

[0032] In general, the CT data received in act S110 can be received via any form of data communication, including wired, optical, and wireless communication. As some examples, when wired or optical communication is used, the communication may be via signals transmitted over electrical or optical cables, and when wireless communication is used, the communication may be via, for example, RF or optical signals. The CT data received in act S110 can be received from a variety of sources. For example, the CT data may be received from an imaging system, such as one of the imaging systems described above. Alternatively, the CT data may be received from another source, such as, for example, a computer-readable storage medium, the internet, or the cloud.

[0033] In act S120, the CT data is analyzed to determine one or more characteristics of the occlusion 120 within the blood vessel. In this regard, the one or more characteristics of the occlusion 120 may include characteristics such as measurements of the occlusion's size, location of the occlusion, measurements of the occlusion's shape, measurements of the occlusion's entrance geometry, and the occlusion's composition. Such occlusion characteristics may influence the selection of an endovascular treatment device for treating the occlusion. Some examples of occlusion characteristics that may be determined in act S120 are shown in FIG. 1. Generally, measurements of the occlusion's size may include measurements of the occlusion's length, diameter, area, or volume. Examples of measurements of the occlusion's length are shown in FIGS. 1A and 1B. Generally, the occlusion's location may be defined in terms of the vessel in which the occlusion is located (e.g., the left coronary artery) or the occlusion's location within the vessel (e.g., proximal location, distal location, within a specified distance of a bifurcation, etc.). Generally, measurements of the occlusion's shape may represent the amount of tortuosity or "tortuosity" of the occlusion, or the occlusion's "entrance geometry," i.e., the shape of its cap. The amount of curvature can be defined in terms of curvature at the entry of the bite, as shown in FIG. 1C, or curvature along the path of the bite, as shown in FIG. 1D. Various examples of occlusion "entrance shapes" are shown in FIG. 1E, which shows a tapered cap to the occlusion, and FIG. 1F, which shows a blunt cap to the occlusion. In general, measuring the composition of an occlusion can indicate the presence or distribution of various components in the composition. For example, measuring the composition of an occlusion can indicate the presence of different components (e.g., calcium) present in the occlusion, or the presence of plaque types (e.g., calcified, soft plaque, hard plaque) in the occlusion, or the distribution of plaque types (e.g., patchy, elongated) in the occlusion, as shown in FIG. 1G.

[0034] Generally, the act of S120 of analyzing the CT data to determine one or more characteristics of the occlusion 120 in the blood vessel is performed based on differences in X-ray attenuation in the CT data using known image processing techniques. As described above, the CT data received in act S110 and subsequently analyzed in act S120 may be generated by various types of X-ray imaging systems, including conventional CT imaging systems and spectral CT imaging systems. Thus, the CT data may represent X-ray attenuation in a single energy interval, or may be spectral CT data representing X-ray attenuation in multiple different energy intervals.

[0035] X-ray attenuation data from conventional CT imaging systems is typically expressed in Hounsfield units. CT data representing X-ray attenuation in a single energy interval can be used to distinguish between occlusions and the surrounding medium based on their differences in attenuation. For example, blood in a blood vessel has a lower X-ray attenuation coefficient than occlusions, so the lumen of the unoccluded portion of the blood vessel, which contains blood, can be distinguished from occlusions. This facilitates the measurement of occlusion characteristics, such as the size, location, and shape of the occlusion. Furthermore, hard and soft plaques in the occlusion can be distinguished based on the difference in their X-ray attenuation coefficients, thereby facilitating the determination of the occlusion's composition.

[0036] In one embodiment, the CT data received in act S110 is spaced apart from a plurality of different energy intervals DE 1..mThe spectral CT data defines the X-ray attenuation of an occluded blood vessel in the CT image. In this example, the act of analyzing the CT image in S120 includes analyzing the spectral CT data to determine one or more characteristics of the occlusion 120 in the blood vessel. As described above, the use of spectral CT data facilitates differentiation between media that have similar X-ray attenuation values ​​when measured within a single energy interval and that are indistinguishable in X-ray attenuation data generated by conventional X-ray imaging systems. Thus, the use of spectral CT data in this example facilitates improved differentiation between X-ray attenuation resulting from the occlusion and X-ray attenuation resulting from other media, such as contrast agents, dense tissue, bone, and the like, that may also be represented in the spectral CT data.

[0037] In a related example, the one or more characteristics of the occlusion 120 determined in act S120 include the composition of the occlusion. In this example, the act of analyzing the spectral CT data in act S120 includes applying a material decomposition algorithm to the spectral CT data to determine the composition of the occlusion. In this example, the composition of the occlusion may indicate the presence of different materials or types of materials within the occlusion. As some examples, the composition of the occlusion may indicate the type of plaque in the occlusion, such as calcified plaque, soft plaque, or hard plaque. In this example, different material decomposition algorithms may be applied to the spectral CT data. One example of a material decomposition algorithm that may be used is disclosed in Brendel, B. et al., "Empirical, projection-based, basis, component decomposition method," Medical Imaging 2009, Physics of Medical Imaging, edited by Ehsan Samei and Jiang Hsieh, Proc. of SP, 7258, 72583Y. For another example of a material decomposition algorithm that can be used, see Roessl, E. and Proksa, R., "K-edge imaging in X-ray computed tomography using multi-bin photon counting detectors," Phys Med Biol. 2007 Aug 7, 52(15):4679-96. Another example of a material decomposition algorithm that can be used is disclosed in published PCT patent application WO / 2007 / 034359 A2.

[0038] In some examples, the operation S120 of analyzing the CT data includes reconstructing an image representing the occluded blood vessel 110. In these examples, the operation S120 of analyzing the CT data is performed using the reconstructed image.

[0039] Various known image reconstruction techniques can be used to reconstruct an image according to this example. The image may also be segmented to identify occlusions. Various known segmentation algorithms may be used for this purpose, including model-based segmentation, watershed-based segmentation, region growing, level setting, graph cuts, etc. A neural network may also be trained to segment the reconstructed image to identify occlusions.

[0040] In one example, occlusions are automatically identified in the reconstructed image. In this example, the method described with reference to FIG. segmenting the reconstructed image to identify the occlusion 120; automatically identifying occlusions in the reconstructed image; Including, A step S120 of analyzing the CT data to determine one or more characteristics of an occlusion 120 in a blood vessel is performed on the identified occlusion.

[0041] By automatically identifying the occlusion, this example facilitates a more rapid determination of a recommended endovascular treatment device in subsequent operation S130. The segmentation operation in this example may be performed using the segmentation techniques described above. The operation of automatically identifying the occlusion in the reconstructed image may be performed using various known image processing techniques. For example, a feature detector or neural network may be trained to identify the occlusion. The feature detector may, for example, identify the occlusion based on abnormal changes in the intensity of blood vessels in the reconstructed image. Such changes may be due to changes in attenuation due to the transition between blood vessels containing blood vessels and blood vessels containing occlusive material. If the CT data is acquired after the injection of a contrast agent, the magnitude of the transition is enhanced in the CT data, which facilitates improved identification of the occlusion. Alternatively, a neural network, such as a convolutional neural network (CNN), may be trained to identify the occlusion in the reconstructed image using training data that includes multiple reconstructed images representing various occlusions and is annotated with the corresponding ground truth locations of the occlusions.

[0042] In another example, occlusions are identified in the reconstructed image based on user input rather than being automatically identified in the reconstructed image. In this example, the method described with reference to FIG. outputting the reconstructed image to a display device 230, 330; receiving a user input identifying an occlusion 120 in the reconstructed image; Including, A step S120 of analyzing the CT data to determine one or more characteristics of an occlusion 120 in a blood vessel is performed on the identified occlusion.

[0043] In this example, the reconstructed image may be output to a display device. For example, the reconstructed image may be output to a monitor 230 shown in FIG. 4. A user may identify an occlusion 120 in the reconstructed image using various user input devices, such as a touch screen, a pointing device such as a mouse, a joystick, or a keyboard. For example, a user may identify an occlusion by drawing the occlusion using the user input device or by placing a bounding box around the occlusion.

[0044] Returning to the methodology shown in FIG. 3, in act S130, a recommended endovascular treatment device 130 for treating the occluded blood vessel 110 is selected. 1..6 is determined based on one or more characteristics of the occlusion in the blood vessel. The recommended endovascular treatment device determined in act S130 may be specified at various levels, including, for example, at the level of type of device, or at a lower level, such as model of type of device. Examples of different types of devices that may be determined according to this example include the devices shown in FIG. 2 , namely, laser atherectomy device, rotational atherectomy device, orbital atherectomy device, transluminal atherectomy device, and IVL balloon. Because the recommended endovascular treatment device is determined based on one or more characteristics of the occlusion, the treatment device is suited to the occlusion being treated. Thus, a more optimal selection of the treatment device may be made.

[0045] Operation S130 can be performed in a variety of ways, including using a deterministic rule set, a lookup table, and a neural network. In the first two of these approaches, one or more characteristics of the occlusion are matched to an endovascular treatment device using rules determined by an expert. Examples of such rules are described in the above-cited article by Dash, D. et al. In the third approach, such rules can be used to train a neural network to predict a recommended endovascular treatment device for a given set of one or more characteristics of the occlusion. As an example, the characteristics / characteristics of the occlusion can classify the occlusion as containing superficial calcium, deep calcium, or nodular calcium. Superficial calcium is typically defined as a calcified nodule located near the intima-lumen interface or lumen of the blood vessel. Deep calcium is typically defined as a calcified nodule located near the media / adventitia boundary or adventitia. Nodular calcium is typically defined as the presence of multiple calcified nodules within the occlusion. If deep calcium is present, the recommended type of endovascular treatment device may be a laser atherectomy device. In contrast, if superficial calcium is present, the calcium thickness exceeds 0.5 millimeters, the length exceeds 5 millimeters, and the rotation angle exceeds 180 degrees around the centerline of the vessel, the recommended type of endovascular treatment device may be an IVL balloon. If nodular calcium is present, the recommended type of endovascular treatment device may be an orbital atherectomy device or a rotational atherectomy device. Similar rules, dependent on these and other characteristics of the occlusion, may be defined for other types of endovascular treatment devices or for specific models of such devices.

[0046] In another embodiment, in S120, the CT data is analyzed to determine one or more characteristics of the intravascular occlusion 120, and in S130, a recommended intravascular treatment device 130 for treating the occluded blood vessel 110 is selected based on the one or more characteristics. 1..6Here, the CT data received in operation S110 is input to the neural network, and a recommended endovascular treatment device 130 for treating the occluded blood vessel is determined from the input CT data. 1..6 The neural network is trained to predict a recommended endovascular treatment device 130 using training data including multiple CT training images representing occluded blood vessels. 1..6 The neural network is trained to predict the occlusion size and shape. Each CT training image includes a corresponding ground truth recommended endovascular treatment device for the vessel depicted in the image. The ground truth recommended endovascular treatment device may be determined by an expert. The neural network may be implemented by various types of architectures, including, for example, convolutional neural networks (CNNs) and other architectures. In this example, characteristics such as the size and shape of the occlusion are inherently determined by the neural network during evaluation of the input CT data, but these features are not necessarily output by the neural network.

[0047] Returning to the method shown in FIG. 3, in S140, the recommended endovascular treatment device 130 1..6 An indication of the recommended endovascular treatment device is output. The output of the recommended endovascular treatment device provides guidance for the treatment procedure. The indication of the recommended endovascular treatment device may be output in any human-understandable format. In one example, the indication of the recommended endovascular treatment device is output in a visual format. For example, the indication of the recommended endovascular treatment device may be output on a display. The indication of the recommended endovascular treatment device may be output, for example, on display 230 shown in FIG. 4. The indication may be provided, for example, as a symbol or text corresponding to the recommended endovascular treatment device. The guidance information may alternatively be output in other ways, including, for example, audibly or to a printer.

[0048] Characteristics of the vessel may also influence the selection of an endovascular treatment device to treat the occlusion. For example, the diameter of the vessel, the tortuosity of the vessel, the amount of contrast agent in the vessel, the amount of calcium in the vessel, the type and shape of plaque in the vessel, and the type and shape of plaque in the vessel along the access path to the occlusion may also influence the selection of an endovascular treatment device. In one example, the method described with reference to FIG. Analyzing the CT data to determine one or more characteristics of the blood vessel. Including, A recommended endovascular treatment device 130 for treating an occluded blood vessel 110 1..6 The step S130 of determining is further based on one or more characteristics of the blood vessel.

[0049] Thus, in this example, a recommended endovascular treatment device is determined based on one or more characteristics of the blood vessel and one or more characteristics of the occlusion, thereby improving the suitability of the recommended treatment device. In this example, the determined one or more characteristics of the blood vessel may include one or more of a measurement of the size of the blood vessel (e.g., a measurement of the length of the blood vessel, a diameter of the lumen of the blood vessel, or an area of ​​the lumen of the blood vessel), a measurement of the shape of the blood vessel (e.g., a measurement of the tortuosity of the blood vessel path, or a measurement of the shape of the blood vessel lumen), a measurement of the amount of plaque in the blood vessel, a discriminant of the type of plaque in the blood vessel, a discriminant of the shape of plaque in the blood vessel, and a discriminant of the composition of plaque in the blood vessel. For example, the size of the blood vessel lumen proximal and / or distal to the occlusion affects its navigation within the blood vessel and may be used to determine a recommended endovascular treatment device.

[0050] Characteristics of blood vessels can be determined from the CT data in a manner similar to that described above for occlusions. Thus, in general, analyzing the CT data to determine one or more characteristics of blood vessels is performed based on differences in X-ray attenuation in the CT data using known image processing techniques. The CT data may represent X-ray attenuation data at a single energy interval, or the CT data may be spectral CT data that defines X-ray attenuation at multiple different energy intervals. The use of spectral CT data facilitates improved differentiation between blood vessels and other media, such as dense tissue and bone, that may also be represented in the spectral CT data. The spectral CT data may be analyzed using material decomposition algorithms, as described above.

[0051] In this embodiment, in S130, a recommended endovascular treatment device 130 for treating the occluded blood vessel 110 is selected based further on one or more characteristics of the blood vessel. 1..6 The act of determining the characteristics of the vessel can be performed in a manner similar to that described above for the characteristics of the occlusion. Thus, a deterministic set of rules, or a lookup table, or a neural network can be used. In the first two of these approaches, one or more characteristics of the vessel are used in addition to one or more characteristics of the occlusion, and a deterministic set of rules, or a lookup table, is used to find a matching endovascular treatment device. In the third of these approaches, rules can be used to train a neural network to predict a recommended endovascular treatment device from an input set of one or more characteristics of the vessel and one or more characteristics of the occlusion.

[0052] In a related example, operation S120 of analyzing the CT data includes reconstructing an image representing the occluded blood vessel 110, and operation S120 of analyzing the CT data is performed using the reconstructed image. A centerline of the blood vessel may also be identified in the reconstructed image. The centerline may be used to determine characteristics of the blood vessel, such as its size, shape, etc. The centerline may be determined by segmenting the lumen of the blood vessel in the reconstructed image and defining the centerline of the blood vessel as the centerline of the lumen. The centerline of the lumen can be considered to provide an accurate location of the centerline of the blood vessel, thus facilitating accurate measurement of blood vessel characteristics, such as the length of the blood vessel, the amount of tortuosity, etc. The centerline of the blood vessel may also be used to provide a more accurate measurement of characteristics of the occlusion, such as the length of the occlusion, the amount of tortuosity, etc.

[0053] In one embodiment, the recommended endovascular treatment device 130 1..6 is a recommended type of atherectomy device. With reference to FIG. 3, this embodiment illustrates a recommended endovascular treatment device 130 for treating an occluded blood vessel 110. 1..6 The operation of S130 to determine the type of atherectomy device to treat the occluded vessel includes determining the type of endovascular treatment device 130 to recommend. 1..6 The act of S140 of outputting an indication of the type of atherectomy device determined includes outputting an indication of the type of atherectomy device determined.

[0054] As mentioned above, after selecting a treatment device to treat an occlusion, it can be difficult to determine the characteristics of the device. Device characteristics, such as its stiffness and tip shape, can also affect the effectiveness of the treatment and therefore its outcome.

[0055] In one example, the method described with reference to FIG. Recommended Endovascular Devices130 1..6 determining a recommended value for one or more characteristics of the outputting an indication of a recommended value for the one or more characteristics; Includes.

[0056] Values ​​for various properties of the device may be recommended according to this example, including, for example, device size (e.g., device diameter, or length of plaque removal element), size of guide catheter for use with the device, device stiffness, device tip geometry, device tip load, device coating, etc. The recommended values ​​of the properties may be determined using a set of deterministic rules, by using a lookup table, or by using a neural network, in a manner similar to that described above in connection with operation S130. The recommended values ​​of the properties may be used to determine the recommended endovascular treatment device 130. 1..6 In this example, a recommended value of one or more characteristics may be determined for the treatment device so that the treatment device is better suited to the occlusion being treated, and therefore, a more effective treatment can be delivered.

[0057] As mentioned above, it can also be difficult to determine the values ​​of treatment parameters to use with a recommended device. For example, if the recommended device is a laser atherectomy catheter as shown in FIG. 2A, the values ​​of treatment parameters, such as the fluence of the light radiation emitted by the device and its rate of progression through the artery, may need to be adjusted to optimize the desired results. In one example, the method described with reference to FIG. Recommended Endovascular Devices130 1..6 determining recommended values ​​for one or more treatment parameters of outputting an indication of recommended values ​​for one or more treatment parameters; Includes.

[0058] In this example, values ​​for various treatment parameters can be determined depending on the type of endovascular treatment device recommended. By way of example, if the endovascular treatment device is a laser atherectomy catheter, the recommended treatment parameter values ​​can include one or more of the following: a position of the laser atherectomy catheter relative to the occlusion, an advancement speed of the laser atherectomy catheter, a fluence of the light radiation emitted by the laser atherectomy catheter, a repetition rate of the light pulses emitted by the laser atherectomy catheter, and a duty cycle of the light radiation emitted by the laser atherectomy catheter.

[0059] As another example, if the endovascular treatment device is a directional atherectomy device, the recommended treatment parameter values ​​may include one or more of the following: the position of the directional atherectomy device relative to the occlusion, the advancement speed of the directional atherectomy device, and the rotational speed of the cutting window of the directional atherectomy device.

[0060] As another example, if the endovascular treatment device is a rotational atherectomy device, the recommended treatment parameter values ​​may include one or more of the position of the rotational atherectomy device relative to the occlusion, the advancement speed of the rotational atherectomy device, and the rotational speed of the burr of the rotational atherectomy device.

[0061] As another example, if the endovascular treatment device is an orbital atherectomy device, the recommended treatment parameter values ​​may include one or more of the following: a position of the orbital atherectomy device relative to the occlusion; an advancement speed of the orbital atherectomy device; and a rotational speed of the orbital atherectomy device.

[0062] As another example, if the endovascular treatment device is a transluminal atherectomy device, the recommended treatment parameter values ​​may include one or more of the following: the position of the transluminal atherectomy device relative to the occlusion, the advancement speed of the transluminal atherectomy device, and the aspiration flow rate of the transluminal atherectomy device.

[0063] As another example, if the endovascular treatment device is an intravascular lithotripsy, IVL, balloon, the at least one parameter may include one or more of: a position of the IVL balloon relative to the occlusion; a number of shock wave pulses to deliver to the occlusion from one or more shock wave emitters in the IVL balloon; and an IVL balloon pressure to use during delivery of shock waves from the IVL balloon to the occlusion.

[0064] The recommended values ​​of the treatment parameters may be determined using a set of deterministic rules, or by using a look-up table, or by using a neural network, i.e., in a manner similar to that described above with respect to operation S130. The recommended values ​​of the treatment parameters are determined by the recommended endovascular treatment device 130. 1..6 By providing recommended values ​​for one or more treatment parameters of the endovascular treatment device, this example facilitates delivery of a more effective treatment to the occlusion.

[0065] In one embodiment, the recommended values ​​of the treatment parameters are transmitted to the endovascular treatment device 130. 1..6 This improves workflow by avoiding the need for time-consuming user adjustment of treatment parameters.

[0066] In one example, the value of a treatment parameter is synchronized with the subject's cardiac phase. For example, a treatment parameter, such as the fluence of light radiation emitted by a laser atherectomy catheter, may be synchronized with the cardiac phase so that the light radiation is emitted only during diastole. This improves the effectiveness of delivering treatment to the occlusion because the curvature of the blood vessel in which the occlusion is located is typically more variable during systole than during diastole. The subject's cardiac phase may be determined using a sensor. For example, an electrocardiogram (EKG) sensor may be used.

[0067] In another example, an indication of one or more recommended treatment steps to be performed using a recommended endovascular treatment device is output. In this example, the method described with reference to FIG. Recommended Endovascular Devices130 1..6 determining one or more recommended treatment steps to be performed using the outputting an indication of one or more recommended action steps; Includes.

[0068] Examples of recommended treatment steps that may be output in this example include "advance the treatment device at a (specific) speed," "withdraw the treatment device (specific distance)," "rotate the treatment device through a (specific) angle and re-advance the tool," "acquire intravascular ultrasound (IVUS) imaging data of the occluded vessel," etc. Recommended treatment steps may be determined according to the rules disclosed in the document Brilakis, E., et al., "Guiding Principles for Chronic Total Occlusion Percutaneous Coronary Intervention: A Global Expert Consensus document," Circulation, 2019; 140:420-433.

[0069] The recommended procedure steps include a recommended CTO crossing strategy, such as "Antegrade Wiring," "Antegrade Dissection and Re-entry," "Retrograde Wiring," or "Retrograde Dissection and Re-entry." The crossing strategy may be determined based on occlusion characteristics and / or vessel characteristics. This crossing strategy is disclosed in the publication by Brilakis, E., et al., "A percutaneous treatment algorithm for crossing coronary chronic total occlusions," JACC Cardiovasc Interv. 2012;5:367-379.

[0070] The recommended treatment steps may be determined in a manner similar to that described above to determine the type of atherectomy device to use, i.e., using a set of deterministic rules, or a lookup table, or a neural network.

[0071] In another example, the method described with reference to FIG. determining a value of an outcome metric for the treatment procedure; outputting an indication of the value of the result metric; Includes.

[0072] The value of the outcome metric may represent a variety of factors. For example, the value of the outcome metric may represent the probability of success or failure of the procedure, or the duration of the procedure, or the probability of a medical complication resulting from the procedure.

[0073] Outcome metrics can be evaluated in various ways. In one example, the so-called J-CTO score is used. The J-CTO score estimates the likelihood of successful antegrade guidewire crossing of the CTO within 30 minutes. The J-CTO score assessment is documented by Morino, Y., et al., "Predicting Successful Guidewire Crossing Through Chronic Total Occlusion of Native Coronary Lesions Within 30 Minutes: The J-CTO (Multicenter CTO Registry in Japan) Score as a Difficulty Grading and Time Assessment Tool," JACC: Cardiovascular Interventions, Volume 4, Issue 2, February 2011, Pages 213-221. The J-CTO score is assessed based on five criteria: the entry shape of the occlusion (tapered vs. blunt), the presence of calcification within the CTO, the presence of at least one bend greater than 45 degrees during CTO entry or bend along the CTO body, the length of the occlusion, and whether the current attempt is a repeat attempt. The J-CTO score can be evaluated from the characteristics of the occlusion site described above with reference to FIG.

[0074] In another example, the value of the outcome metric is determined from a database of historical procedures performed on occlusions using endovascular treatment devices and recording corresponding outcome metric values. The value of the outcome metric may be determined from the database based on the values ​​of the outcome metric for procedures performed using similar endovascular treatment devices and on similar occlusions. One or more outcome factors may also be used to determine similarity of the characteristics of the endovascular treatment devices used in the procedures or similarity of treatment parameters of the endovascular treatment devices used in the procedures. In this example, a similarity metric such as Mahalanobis distance may be used to calculate the similarity between procedures, devices, etc. In this example, the value of the outcome metric of the most similar historical procedure may be used as the value of the outcome metric for the current procedure.

[0075] In another example, the value of the outcome metric is determined using a geometric model generated from the CT data received in act S110. In this example, the act of determining the value of the outcome metric for the treatment procedure includes: extracting geometric data representing the vessel and the occlusion 120 from the CT data; generating a geometric model representing the vessel and occlusion 120 from the geometric data; determining an expected effect of a recommended endovascular treatment device on the occluded vessel 110 using the geometric model; Recommended Endovascular Treatment Devices for Occlusive Blood Vessels130 1..6 determining a numerical value of an outcome metric for the treatment procedure based on the expected effect of the Includes.

[0076] In this example, extraction of geometric data representing blood vessels and occlusions 120 from the CT data may be performed in a manner similar to that described above for analyzing the CT data in operation S120 to determine one or more characteristics of the occlusions 120 in the blood vessels. Thus, if CT data representing X-ray attenuation at a single energy interval is used, the CT data may be reconstructed into an image, and the image may be segmented to identify the blood vessels and occlusions. The geometric data may then be extracted from the reconstructed image using image processing techniques. If spectral CT data is used, a material decomposition algorithm may be applied to the spectral CT data to identify the blood vessels and occlusions during reconstruction of the image representing the blood vessels and occlusions. The geometric data may then be extracted from the reconstructed image using known image processing techniques.

[0077] After extracting the geometric data, a geometric model representing the vessel and occlusion 120 is then generated from the geometric data. The geometric model may be provided in the form of a finite element model. An example of such a finite element model is disclosed in Holzapfel, G., et al., "Computational approaches for mechanics of atherosclerotic plaques: A review," Journal of Biomechanics, Volume 47, Issue 4, 3 March 2014, Pages 859-869. The expected effect of a recommended endovascular treatment device on the occluded vessel 110 can then be determined using the geometric model by fitting the model with material removed by the treatment device as the treatment is delivered. The value of the outcome metric for the treatment procedure is then calculated based on the recommended endovascular treatment device 130 on the occluded vessel. 1..6 As one example, outcome metrics can be assessed based on the amount of increase in luminal diameter as a result of treatment, i.e., the so-called "luminal gain."

[0078] In a related example, the geometric model is a biomechanical model and the CT data represents a temporal sequence of images representing an occluded blood vessel 110. In this example, the method described with reference to Figure 3 includes determining one or more biomechanical parameters of the biomechanical model based on temporal changes to the shape of the blood vessel in the temporal sequence of images representing the occluded blood vessel.

[0079] In this example, the biomechanical parameters of the biomechanical model may represent mechanical parameters such as vessel stiffness and occlusion. The biomechanical model provides a more accurate characterization of vessel deformation and occlusion in response to treatment delivery. As a result, the biomechanical model provides a more accurate prediction of the effect of the endovascular treatment device. This facilitates the determination of more accurate values ​​for outcome metrics.

[0080] In another example, the method described with reference to Figure 3 is used in conjunction with an occlusion treatment procedure. In this example, the method described with reference to Figure 3 receiving x-ray projection data representative of an occluded blood vessel, the x-ray projection data being generated during a treatment procedure; registering the CT data to the X-ray projection data; outputting a graphical representation of the X-ray projection data and the CT data as an overlay image; Includes.

[0081] This example may be performed by system 300 shown in FIG. 5 and including an X-ray projection imaging system 320 for generating X-ray projection data. The X-ray projection data may represent a still image of the occluded vessel or a temporal sequence of images of the occluded vessel. In the latter case, the temporal sequence of images may represent the occluded vessel in substantially real time. The operations of receiving the X-ray projection data, registering the CT data to the X-ray projection data, and outputting a graphical representation of the X-ray projection data and CT data may be performed in substantially real time to provide live guidance during a treatment procedure. In this example, the X-ray projection data may be received by one or more processors 210 shown in FIG. 5.

[0082] In this example, the CT data is registered to the X-ray projection data using known image registration techniques. Registration may be performed using the known geometry of the X-ray projection imaging system and its orientation relative to the CT data. Examples of suitable image registration techniques include intensity-based registration techniques, feature-based registration techniques, rigid and non-rigid registration techniques, etc. Graphic representations of the X-ray projection data and CT data are then output as an overlay image. The registration is used to generate the overlay image. This operation may be performed using known image overlay techniques. For example, one image from the X-ray projection data and the CT data may be overlaid on the other image, with the overlaid image having a predetermined level of transparency. The graphic representation may be output in various ways, such as for display. For example, the graphic representation may be output to the display 330 shown in FIG. 5. The output overlay image provides guidance to the physician during the treatment procedure by providing three-dimensional context from the CT data to the planar representation of the occluded vessel from the X-ray projection data.

[0083] In a related example, the method described with reference to FIG. receiving input data representing delivery of treatment to the occlusion by the endovascular treatment device 130 during a treatment procedure; updating the overlay image based on the received input data; Including, The updating step includes including an indication of delivery of therapy to the occlusion in the overlay image.

[0084] This example can be implemented by tracking the position of an endovascular treatment device relative to X-ray projection data generated during a treatment procedure and displaying the tracked position of the endovascular treatment device in an overlay image for the time the treatment is delivered to the vessel. As an example, an indication of treatment delivery to the occlusion can indicate that a specific number of light pulses have been delivered to the occlusion by the laser atherectomy device shown in FIG. 2A. The indication of treatment delivery to the occlusion can be provided in the overlay image, for example, as a symbol at the relevant location. The tracked position of the treatment device can be determined in the X-ray projection data or using a separate tracking system. In the former case, the tracked position of the endovascular treatment device can be determined in the X-ray projection images using a feature detector trained to detect the shape of the endovascular treatment device. Alternatively, the feature detector can be trained to detect the shape of fiducial markers attached to the treatment device. In the latter case, various interventional device tracking techniques can be used to track the position of the endovascular treatment device. The position can be determined in the X-ray projection images by registering the coordinate system of the tracking system to the coordinate system of the X-ray projection imaging system 320 that generates the X-ray projection data. A variety of tracking systems can be used to track the position of an endovascular treatment device, including electromagnetic tracking systems and fiber optic-based tracking systems. An example of an electromagnetic tracking system is disclosed in U.S. Patent Application Publication No. 2020 / 397510. An example of a fiber optic-based tracking technique that uses strain sensors to determine the position of an interventional device is disclosed in U.S. Patent Application Publication No. 2012 / 323115.

[0085] In this example, the received input data may represent the location of delivery of the treatment to the occlusion. The act of updating the overlay image may include providing an indication of the location of delivery of the treatment to the occlusion in the overlay image. Alternatively, or additionally, the act of updating the overlay image may include providing an indication of the total number of treatments delivered to the occlusion in the overlay image. For example, the total number of light pulses delivered to the occlusion by the laser atherectomy device shown in FIG. 2A may be indicated in the overlay image. Thus, the overlay image provides a record of the treatments delivered to the occlusion.

[0086] In another example, a computer program product is provided that comprises instructions that, when executed by one or more processors, cause the one or more processors to perform a method for providing guidance for a treatment procedure on an occluded blood vessel 110, the method comprising: a step S110 of receiving computed tomography CT data representative of an occluded blood vessel 110; Step S120 of analyzing the CT data to determine one or more characteristics of an occlusion 120 in a blood vessel; A recommended endovascular treatment device 130 for treating the occluded blood vessel 110 based on one or more characteristics. 1..6 a step S130 of determining Recommended Endovascular Devices130 1..6 Step S140 of outputting an indication of Includes.

[0087] In another example, a system 200, 300 is provided for providing guidance for a treatment procedure on an occluded blood vessel 110. The system includes: a step S110 of receiving computed tomography data representative of an occluded blood vessel 110; Step S120 of analyzing the CT data to determine one or more characteristics of an occlusion 120 in a blood vessel; A recommended endovascular treatment device 130 for treating the occluded blood vessel 110 based on one or more characteristics. 1..6 a step S130 of determining Recommended Endovascular Devices130 1..6 Step S140 outputs The system includes one or more processors 210 configured to execute the

[0088] An example of a system 200 is shown in Figure 4. This example may be used to provide guidance for the planning phase of an occlusion treatment procedure. It should be noted that the system 200 shown in Figure 4 may also include one or more of a CT imaging system 220 for providing CT data 140, a display 230 for displaying a graphical representation of the CT data, output results of the method, such as characteristics of the occlusion 120, characteristics of the blood vessel, etc., a patient bed 240, and a user input device (not shown in Figure 4) configured to receive user input related to the method performed by the one or more processors 210, such as a keyboard, mouse, touch screen, etc.

[0089] Another example of system 300 is shown in Figure 5. This example may be used to provide guidance for treatment stages of an occlusion treatment procedure. It should be noted that system 300 shown in Figure 5 may also include one or more of: an X-ray projection imaging system 320 for providing X-ray projection data; a display 330 for displaying graphical representations of the X-ray projection data and CT data as overlaid images; and further output results of the method, such as characteristics of occlusion 120, characteristics of the vessel, etc.; a patient bed 340; and a user input device configured to receive user input (not shown in Figure 5) related to the method performed by one or more processors 210, such as a keyboard, mouse, touch screen, etc.

[0090] The above examples should be understood as illustrating, not limiting, the present disclosure. Further examples are contemplated. For example, examples described in connection with a computer-implemented method may also be provided by a corresponding computer program product, a corresponding computer-readable storage medium, or a corresponding system. It should be understood that features described with respect to any one embodiment may be used alone or in combination with other described features, and may be used in combination with one or more other features of the embodiment or with combinations of other embodiments. Furthermore, equivalents and modifications not described above may also be used without departing from the scope of the present invention as defined in the appended claims. In the claims, the word "comprising" does not exclude other elements or operations, and the indefinite articles "a" or "an" do not exclude a plurality. The mere fact that certain features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be advantageously used. Any reference signs in the claims should not be construed as limiting their scope.

Claims

1. 1. A computer-implemented method for providing guidance for a treatment procedure for an occluded blood vessel, the computer-implemented method comprising: receiving computed tomography data representative of the occluded blood vessel; analyzing the computed tomography data to determine one or more characteristics of an occlusion in the blood vessel; determining a recommended endovascular treatment device for treating the occluded vessel based on the one or more characteristics; outputting an indication of the recommended endovascular treatment device; 10. A computer-implemented method comprising:

2. 2. The computer-implemented method of claim 1, wherein the one or more characteristics of the occlusion include one or more of a measurement of the size of the occlusion, a location of the occlusion, a measurement of the shape of the occlusion, a measurement of the ingress shape of the occlusion, and a composition of the occlusion.

3. the computed tomography data comprises spectral computed tomography data defining x-ray attenuation of the occluded blood vessel at a plurality of different energy intervals; 3. The computer-implemented method of claim 1, wherein analyzing the computed tomography data comprises analyzing the spectral computed tomography data to determine one or more characteristics of an occlusion in the blood vessel.

4. the one or more characteristics of the occlusion include a composition of the occlusion; 4. The computer-implemented method of claim 3, wherein analyzing the spectral computed tomography data comprises applying a material decomposition algorithm to the spectral computed tomography data to determine a composition of the occlusion.

5. analyzing the computed tomography data includes: reconstructing an image representative of the occluded blood vessel. and wherein analyzing the computed tomography data is performed using the reconstructed image. A computer-implemented method according to any one of claims 1 to 4.

6. The computer-implemented method comprises: segmenting the reconstructed image to identify the occlusion; automatically identifying occlusions in the reconstructed image; and analyzing the computed tomography data to determine one or more characteristics of an occlusion in the blood vessel is performed on the identified occlusion.

6. The computer-implemented method of claim 5.

7. The computer-implemented method comprises: outputting the reconstructed image to a display device; receiving a user input identifying an occlusion in the reconstructed image; and analyzing the computed tomography data to determine one or more characteristics of an occlusion in the blood vessel is performed on the identified occlusion.

6. The computer-implemented method of claim 5.

8. The computer-implemented method comprises: analyzing the computed tomography data to determine one or more characteristics of the blood vessel. and determining a recommended endovascular treatment device for treating the occluded vessel is further based on one or more characteristics of the vessel; A computer-implemented method according to any one of claims 1 to 7.

9. 9. The computer-implemented method of claim 8, wherein the one or more characteristics of the blood vessel include one or more of a measurement of a size of the blood vessel, a measurement of a shape of the blood vessel, a measurement of an amount of plaque in the blood vessel, a type of plaque in the blood vessel, a shape of plaque in the blood vessel, and a composition of plaque in the blood vessel.

10. determining a recommended endovascular treatment device for treating the occluded vessel comprises determining a type of atherectomy device for treating the occluded vessel; and outputting an indication of the recommended endovascular treatment device comprises outputting an indication of the determined type of atherectomy device. A computer-implemented method according to any one of claims 1 to 9.

11. determining a recommended value for one or more characteristics of the recommended endovascular treatment device; outputting an indication of the recommended value of the one or more characteristics; The computer-implemented method of claim 10, further comprising:

12. determining recommended values ​​for one or more treatment parameters of the recommended endovascular treatment device; outputting an indication of the recommended values ​​of the one or more treatment parameters; 12. The computer-implemented method of claim 10 or 11, further comprising:

13. The computer-implemented method comprises: determining a value of an outcome metric for the treatment procedure; outputting an indication of the value of the resulting metric; The computer-implemented method of claim 1 , further comprising:

14. The computer-implemented method comprises: receiving x-ray projection data representative of the occluded blood vessel, the x-ray projection data being generated during the treatment procedure; registering the computed tomography data to the x-ray projection data; outputting a graphical representation of the X-ray projection data and the computed tomography data as an overlay image; 14. The computer-implemented method of claim 1, further comprising:

15. The computer-implemented method comprises: receiving input data representative of delivery of treatment to the occlusion by an endovascular treatment device during the treatment procedure; updating the overlay image based on the received input data; and the updating step includes including an indication of delivery of therapy to the occlusion in the overlay image.

15. The computer-implemented method of claim 14.