Vessel diameter determination based on intraluminal images and associated devices, systems, and methods

Abstract

Disclosed is an intraluminal imaging system comprising: an intraluminal imaging catheter or guidewire configured to be positioned within an anatomical structure of a patient; and a processor circuit in communication with the imaging catheter or guidewire, wherein the processor circuit is configured to receive a plurality of cross-sectional images of the anatomical structure from the imaging catheter or guidewire. The processor is further configured to: calculate a value of the anatomical structure using image processing of at least one of the cross-sectional images; estimate a cross-sectional shape of the anatomical structure as circular; calculate a diameter of the anatomical structure based on the calculated value and the estimated circular shape; and output the diameter of the anatomical structure to a display.

Description

Technical Field

[0001] The subject matter described herein relates to systems for intraluminal medical imaging. In particular, the disclosed systems provide systems for calculating geometrically derived vascular measurements in real time or near real time based on intravascular ultrasound (IVUS) images or other intraluminal images acquired during a pullback procedure. Background Technology

[0002] Various types of intraluminal (also known as intravascular) imaging systems are used in the diagnosis and treatment of diseases. For example, intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for visualizing blood vessels within a patient's body. This can aid in assessing diseased blood vessels (e.g., arteries and veins) within the body to determine treatment needs, optimize treatment, and / or evaluate the effectiveness of procedures such as angioplasty and stent placement, IVC filter retrieval, and EVAR and FEVAR (which are similar in abdominal features) plaque excision. Different diseases, implants, and medical procedures produce physical characteristics with varying sizes, structures, densities, water content, and imaging sensor accessibility. For example, deep vein thrombosis (DVT) produces clots of blood cells, while post-thrombotic syndrome (PTS) creates webbing or other residual structural effects in the vessel that are compositionally similar to the vessel wall itself and therefore difficult to distinguish from it. Stents are dense (e.g., metallic) objects that can be placed in a blood vessel or lumen to keep the vessel or lumen open to a specific diameter. Compression occurs when an external anatomical structure impacts a blood vessel or lumen, causing it to constrict. A thrombus forms when a blood clot forms within the lumen of a blood vessel. Both compression and thrombosis are examples of narrowing (e.g., blood vessel narrowing). Narrowing can also occur when other materials (e.g., plaque) accumulate within the lumen of a blood vessel.

[0003] In some cases, intraluminal imaging devices (e.g., IVUS catheters including one or more ultrasound transducers) are used to perform intraluminal medical imaging. The IVUS catheter is delivered into the blood vessel and guided to the area to be imaged. The transducer emits ultrasound energy and receives the ultrasound echoes reflected from the blood vessel. The ultrasound echoes are processed to create cross-sectional images of the blood vessel at one or more regions of interest. The images of the blood vessel may include one or more lesions or blockages, implants, and other geometric features within the vessel. For example, a stent may be placed within the blood vessel to treat or correct a blockage, and intraluminal imaging can be performed to see how the stent is positioned within the vessel. Other types of treatment include thrombectomy, ablation, angioplasty, drug administration, etc.

[0004] In vascular procedures, vascular measurements are used to facilitate clinical decisions, such as stent size design. Stent size is defined by stent diameter and stent length. Vascular measurements can be obtained from intraluminal imaging data (IVUS or OCT). In some respects, obtaining accurate vascular measurements can be challenging or problematic because stenosis (e.g., compression, thrombosis) can cause complex cross-sectional shapes, including concave vessel geometry within stenotic regions, leading to inaccurate vascular size measurements and consequently, inaccurate stent size design.

[0005] The information included in the background section of this specification (including any references cited herein and any descriptions or discussions thereof) is included for technical reference purposes only and should not be considered as the subject matter defining the scope of this disclosure. Summary of the Invention

[0006] What is disclosed are systems, methods, and associated apparatuses for advantageously calculating geometrically derived vascular measurements in real-time or near real-time based on intravascular ultrasound images or other image types acquired during a pullback procedure. In particular, the present disclosure provides systems and methods for deriving vascular diameter measurements (hereinafter referred to as “intrinsic diameter” measurements) based on the identification and quantification of vascular geometric features (e.g., luminal boundaries, cross-sectional area, and / or volume). This method is applicable to all vascular geometries, but can be associated with and represents substantial improvements for concave (e.g., bean-shaped) luminal cross-sections, where direct diameter measurement can be challenging. This system may be referred to as a luminal intrinsic diameter measurement system.

[0007] The lumen inherent diameter measurement system disclosed herein has specific, but not exclusive, use in endoluminal ultrasound imaging procedures. In one embodiment, the lumen inherent diameter measurement system includes an endoluminal imaging system comprising: an endoluminal imaging catheter or guidewire configured to be positioned within a patient's anatomical structure; and processor circuitry communicating with the endoluminal imaging catheter or guidewire, wherein the processor circuitry is configured to: receive multiple cross-sectional images of the anatomical structure from the endoluminal imaging catheter or guidewire; calculate values ​​of the anatomical structure using image processing of the cross-sectional images from the multiple cross-sectional images; estimate the cross-sectional shape of the anatomical structure as circular; calculate the diameter of the anatomical structure based on the calculated values ​​and the estimated circular cross-sectional shape; and output the diameter of the anatomical structure to a display communicating with the processor circuitry. Other examples of this embodiment include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, all configured to perform the actions of the method.

[0008] Implementations may include one or more of the following features: In the endoluminal imaging system, the value includes the perimeter of the anatomical structure. In the endoluminal imaging system, the value includes the cross-sectional area of ​​the anatomical structure. In the endoluminal imaging system, the value includes the volume of the anatomical structure. In the endoluminal imaging system, the value includes at least two of the perimeter, cross-sectional area, or volume of the anatomical structure. In the endoluminal imaging system, the processor circuitry is further configured to calculate a stent diameter equal to the calculated diameter of the anatomical structure multiplied by a scaling factor. The endoluminal imaging system also includes a user interface communicating with the processor circuitry, wherein the user interface is configured to accept input from a user, and wherein the processor circuitry is further configured to perform the following operations in response to receiving input from the user interface: calculate the stent diameter; and output the stent diameter to the display; calculate the stent length based on the multiple cross-sectional images; and output the stent length to the display. In the endoluminal imaging system, the anatomical structure is a blood vessel. Implementations of the technology may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0009] One embodiment includes a method for calculating a lumen diameter for an endoluminal medical procedure, the method comprising: receiving, by processor circuitry, multiple cross-sectional images of a patient's anatomical structure, wherein the multiple cross-sectional images are obtained by an endoluminal imaging catheter or guidewire positioned within the anatomical structure; calculating a value for the anatomical structure using image processing of the cross-sectional images from the multiple cross-sectional images by the processor circuitry; estimating the cross-sectional shape of the anatomical structure as circular; calculating the diameter of the anatomical structure based on the calculated value of the anatomical structure and the estimated circular cross-sectional shape; and outputting the diameter of the anatomical structure to a display in communication with the processor circuitry. Other examples of this embodiment include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, all configured to perform the actions of the method.

[0010] Implementations may include one or more of the following features: In the method, the value includes the perimeter of the anatomical structure. In the method, the value includes the cross-sectional area of ​​the anatomical structure. In the method, the value includes the volume of the anatomical structure. In the method, the value includes at least two of the perimeter, cross-sectional area, or volume of the anatomical structure. The method further includes: calculating a stent diameter equal to the calculated diameter of the anatomical structure multiplied by a scaling factor. The method further includes: responding to input received from a user interface by performing the following operations: calculating the stent diameter; and outputting the stent diameter to the display; calculating a stent length based on the multiple cross-sectional images; and outputting the stent length to the display. In the method, the anatomical structure is a blood vessel. Implementations of the technology may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0011] One embodiment includes a system for intravascular imaging, the system comprising: an intravascular imaging catheter or guidewire; and processor circuitry in communication with the intravascular imaging catheter or guidewire, wherein the processor circuitry is configured to: receive multiple cross-sectional images of a blood vessel captured by the intravascular imaging catheter or guidewire; calculate an inherent diameter associated with the blood vessel based on the multiple cross-sectional images; calculate a stent diameter based on the inherent diameter; and output the stent diameter to a display in communication with the processor circuitry. Other examples of this embodiment include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, all configured to perform the actions of the method.

[0012] Implementations may include one or more of the following features. In the system, the processor circuitry is configured to calculate the inherent diameter associated with the blood vessel based on at least one of a lumen circumference measurement, a lumen area measurement, or a lumen volume measurement, and an estimate of the circular cross-section of the blood vessel. Implementations of the technology may include hardware, methods, or processes, or computer software on a computer-accessible medium.

[0013] This abstract is provided to present selected concepts in a simplified form, which are further described in the detailed embodiments below. This abstract is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The written description of various embodiments of this disclosure below provides a broader presentation of the features, details, uses, and advantages of the lumen inherent diameter measurement system as defined in the claims, and this presentation is illustrated in the accompanying drawings. Attached Figure Description

[0014] Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0015] Figure 1 This is an illustrative schematic diagram of an intraluminal imaging system based on various aspects of this disclosure.

[0016] Figure 2 It is a longitudinal cross-sectional view of a narrowed blood vessel according to various aspects of this disclosure.

[0017] Figure 3 It is a longitudinal cross-sectional view of a blood vessel containing a narrowed vessel and opened by a stent 340, according to various aspects of this disclosure.

[0018] Figure 4 These are IVUS images of radial or axial cross-sections of a blood vessel captured during an intravascular imaging procedure, according to various aspects of this disclosure.

[0019] Figure 5 It is a flowchart of the bracket size design process based on various aspects of this disclosure.

[0020] Figure 6a It is a cross-sectional view of a blood vessel with a calculated minimum and maximum diameter, wherein the vessel wall comprises a convex, nearly circular geometry, according to various aspects of this disclosure.

[0021] Figure 6b It is a cross-sectional view of a blood vessel with a calculated minimum and maximum diameter, wherein the vessel wall comprises a complex partially concave geometry, according to various aspects of this disclosure.

[0022] Figure 6c It is a cross-sectional view of a blood vessel having a calculated minimum and maximum diameter, wherein the vessel wall includes a concave cross-section, according to various aspects of this disclosure.

[0023] Figure 7a This is a flowchart of the bracket sizing design process based on various aspects of this disclosure.

[0024] Figure 7b The illustrations are based on various aspects of this disclosure, as shown in the diagrams. Figure 7a The flowchart shows the various aspects of the bracket size design process.

[0025] Figure 8a This is a flowchart of the bracket sizing design process based on various aspects of this disclosure.

[0026] Figure 8b The illustrations are based on various aspects of this disclosure, as shown in the diagrams. Figure 8a The flowchart shows the various aspects of the bracket size design process.

[0027] Figure 9a This is a flowchart of the bracket sizing design process based on various aspects of this disclosure.

[0028] Figure 9b The illustrations are based on various aspects of this disclosure, as shown in the diagrams. Figure 9a The flowchart shows the various aspects of the bracket size design process.

[0029] Figure 10 This is a schematic diagram of the processor circuitry according to various aspects of this disclosure. Detailed Implementation

[0030] This disclosure generally relates to intraluminal medical imaging, including imaging associated with a patient's body lumen using an intraluminal imaging device. In some instances, intraluminal imaging is performed using an IVUS device comprising one or more ultrasound transducers. The IVUS device can be delivered into the blood vessel and the IVUS catheter can be guided to the area to be imaged. The transducer emits ultrasound energy and receives ultrasound echoes reflected from the blood vessel. The ultrasound echoes are processed to create an image of the vessel of interest. The image of the vessel of interest may include one or more lesions or blockages in the vessel. Stents can be placed within the vessel to treat these blockages, and intraluminal imaging can be performed to view the placement of the stent within the vessel. Other types of treatment include thrombectomy, ablation, angioplasty, drug administration, etc.

[0031] As described above, intraluminal imaging can be used to obtain vascular measurements in order to select a stent whose dimensions (e.g., diameter, circumference) are suitable for the vascular cross-section to which the stent will be placed. One method for obtaining vascular measurements may include: measuring the distance between all combinations of points along the vascular profile passing through the center of the lumen, identifying the minimum and maximum diameters of the lumen, and estimating the average diameter as the average of the minimum and maximum diameters. However, this method may assume convex profiles (e.g., vessels with substantially elliptical cross-sections) and may not take into account complex and / or concave vascular geometries (e.g., vessels with bean-shaped cross-sections).

[0032] This disclosure provides systems, methods, and apparatus for advantageously calculating geometrically derived vascular measurements in real-time or near real-time based on intravascular images (e.g., IVUS, optical coherence tomography (OCT), radiography, etc.) acquired during a pullback procedure. In particular, the present disclosure provides systems, apparatus, and methods for deriving vascular diameter measurements based on the identification and quantification of vascular geometric features, including luminal boundaries, cross-sectional area, and volume. In this regard, the inherent vascular diameter (hereinafter referred to as "inherent diameter") can be derived from measurements of vascular profile, perimeter, area, and / or volume using the mathematical formulas described herein and the assumption of a circular vascular geometry. In some cases, the inherent diameter can be used to select the stent diameter.

[0033] This disclosure provides algorithms, relationships, and mathematical formulas for deriving vessel diameter measurements, which can then be used for vessel and stent sizing purposes. The disclosure also provides apparatus and systems for capturing the required precursor measurements and reporting the results to the user. In some aspects, geometrically derived diameter (“intrinsic diameter”) calculations allow for reliable vessel diameter measurements and / or stent sizing for vessels with various shapes, profiles, or cross-sections without having to examine all combinations of profile points to identify minimum and maximum diameters. Embodiments of this disclosure may be particularly relevant to vessels with concave cross-sections, which make it difficult to obtain measurements directly from the vessel profile. According to embodiments of this disclosure, these algorithms predict based on the assumption that the vessel has a circular cross-section rather than any other shape, and in particular, do not exclude the possibility of circular stents expanding within the vessel. Therefore, assuming a circular vessel geometry to extract diameter measurements from profile, perimeter, area, or volume measurements is a practical means of performing vessel measurements, resulting in more accurate stent sizing, which can be associated with improved clinical outcomes. This method is applicable to all geometries, but it is particularly relevant to concave (e.g., bean-shaped) lumen cross sections (where direct diameter measurement can be challenging) and represents a substantial improvement over concave (e.g., bean-shaped) lumen cross sections. In some respects, the system may be referred to below as a lumen intrinsic diameter measurement system.

[0034] The lumen inherent diameter measurement system provides a quantitative output, namely the inherent diameter, which can be used to select, for example, the stent diameter that will optimally dilate the blood vessel without stretching it.

[0035] The apparatus, system, and method described herein can include one or more features described in the following documents: U.S. Provisional Application US 62 / 750983 (Representative File No. 2018PF01112-44755.2000PV01) (filed October 26, 2018), U.S. Provisional Application US 62 / 751268 (Representative File No. 2018PF01160-44755.1997PV01) (filed October 26, 2018), U.S. Provisional Application US 62 / 751289 (Representative File No. 2018PF01159-44755.1998PV01) (filed October 26, 2018), and U.S. Provisional Application US... The following are references: US 62 / 750996 (Representative File No. 2018PF01145-44755.1999PV01) (filed October 26, 2018), US Provisional Application US 62 / 751167 (Representative File No. 2018PF01115-44755.2000PV01) (filed October 26, 2018), and US Provisional Application US 62 / 751185 (Representative File No. 2018PF01116-44755.2001PV01) (filed October 26, 2018). Although this paper does not fully elaborate on the above-mentioned documents, each of the above documents is incorporated into this paper in its entirety through citation.

[0036] The apparatus, system, and method described herein may also include one or more features described in the following documents: U.S. Provisional Application US 62 / 642847 (Agency File No. 2017PF02103) (filed March 14, 2018) (and its non-provisional application US Serial No. 16 / 351175, filed March 12, 2019), U.S. Provisional Application US 62 / 712009 (Agency File No. 2017PF02296) (filed July 30, 2018), U.S. Provisional Application US 62 / 711927 (Agency File No. 2017PF02101) (filed July 30, 2018), and U.S. Provisional Application US 62 / 643366 (Agency Case No. 2017PF02365) (filed on March 15, 2018 (and from its non-provisional application with U.S. Serial No. US16 / 354970 filed on March 15, 2019), although the above-mentioned documents are not fully described herein, each of the above-mentioned documents is incorporated herein by reference in its entirety.

[0037] Embodiments of this disclosure essentially assist clinicians in determining the stent diameter that achieves optimal vascular dilation (e.g., maximum dilation without stretching) by providing a geometrically derived value for an idealized vessel diameter (e.g., the diameter of the vessel if it is circular). When implemented on a medical imaging console (e.g., an IVUS imaging console) that communicates with medical imaging sensors (e.g., intraluminal ultrasound sensors), the lumen intrinsic diameter measurement system disclosed herein can save time and improve the accuracy of stent sizing. The disclosed embodiments can provide a quantitative, repeatable process involving fewer and simpler steps for clinicians or other users. This process occurs, for example, in situations where there is no usual daily need to identify the narrowest point of a vessel, at which the minimum and maximum diameters of the vessel lumen are measured, and the minimum and maximum diameters are averaged to produce an estimated diameter. This unconventional approach improves the functional operation of medical imaging consoles and sensors by outputting a single quantitative value (intrinsic diameter), in some cases where the intrinsic diameter can be directly used as the stent diameter.

[0038] A lumen inherent diameter measurement system can be implemented as a set of computer program instructions, logical branches, and / or mathematical operations, the output of which can be viewed on a display and operated by a control process running on a processor that accepts user input from a user interface (e.g., a keyboard, mouse, or touchscreen interface) and communicates with one or more medical imaging sensors (e.g., an intraluminal ultrasound sensor). In this respect, the control process performs certain operations in response to different inputs or selections made by the user at the start of the imaging procedure, and can also respond to inputs made by the user during the procedure.

[0039] These descriptions are provided for illustrative purposes only and should not be considered as limiting the scope of the inherent diameter measurement system for the lumen. Features may be added, deleted, or modified without departing from the spirit of the subject matter for which protection is sought.

[0040] To facilitate an understanding of the principles of this disclosure, reference will now be made to embodiments illustrated in the accompanying drawings, and these embodiments will be described using specific language. However, it should be understood that this disclosure is not intended to limit its scope. Any changes and further modifications to the described devices, systems, and methods, as well as any further applications of the principles of this disclosure, are fully contemplated and included within this disclosure, as will commonly conceived by those skilled in the art to which this disclosure pertains. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. Furthermore, while the following embodiments are specifically directed to intravascular ultrasound (IVUS) imaging devices and procedures, this disclosure also contemplates other types of imaging devices, systems, and procedures, including but not limited to OCT, TEE, angiography / venography, external ultrasound imaging, and combinations thereof. However, for the sake of brevity, numerous iterative forms of these combinations will not be described separately.

[0041] Figure 1 This is an illustrative schematic diagram of an intraluminal imaging system including a system for measuring the inherent diameter of the lumen, according to various aspects of this disclosure. In some embodiments, the intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system. The intraluminal imaging system 100 may include an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, and an external imaging system 132, which may include angiography, ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging techniques, instruments, and methods. The intraluminal device 102 may be designed in size and shape and / or otherwise structurally arranged to be positioned within a patient's body lumen. For example, in various embodiments, the intraluminal device 102 can be a catheter, guidewire, guiding catheter, pressure guidewire, and / or flow guidewire. In some cases, the system 100 may include additional components and / or may be available without them. Figure 1 The system is implemented with one or more of the components shown. For example, system 100 may omit the external imaging system 132.

[0042] The intraluminal imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use in a patient's lumen or vascular system. In some embodiments, the intraluminal imaging system 100 is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, the intraluminal imaging system 100 may include a system configured for imaging modalities such as forward-looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), optical coherence tomography (OCT), and / or other suitable imaging modalities.

[0043] It should be understood that system 100 and / or device 102 can be configured to acquire any suitable intraluminal imaging data. In some embodiments, device 102 may include imaging components of any suitable imaging modality (e.g., optical imaging (OCT), photography, etc.). In some embodiments, device 102 may include any suitable non-imaging components, including pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, radio frequency (RF) electrodes, conductors, and / or combinations thereof. Typically, device 102 can include imaging elements to acquire intraluminal imaging data associated with lumen 120. Device 102 may be designed and shaped (and / or configured) for insertion into a patient's blood vessel or lumen 120.

[0044] System 100 can be deployed in a catheterization laboratory, for example, with a control room. Processing system 106 can be located in the control room. Optionally, processing system 106 can be located elsewhere, such as within the catheterization laboratory itself. The catheterization laboratory may include a sterile site, while its associated control room may be sterile or non-sterile depending on the procedure to be performed and / or the healthcare facility. The catheterization laboratory and control room can be used to perform any number of medical imaging procedures, such as angiography, fluorescein imaging, CT, IVUS, virtual histology (VH), forward-looking IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, fractional flow reserve (FFR) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intraluminal palpation imaging, transesophageal echocardiography, fluorescein imaging, and other medical imaging modalities or combinations thereof. In some embodiments, the device 102 can be controlled from a remote location (e.g., a control room), so that the operator does not need to be close to the patient.

[0045] Intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 can be directly or indirectly communicatively coupled to processing system 106. These components can be communicatively coupled to medical processing system 106 via wired connections (e.g., standard copper or fiber optic links) and / or via wireless connections (using IEEE 802.11 Wi-Fi, Ultra-Wideband (UWB), FireWire, Wireless USB, or another high-speed wireless networking standard). Processing system 106 can be communicatively coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other embodiments, different protocols can be utilized, such as Synchronous Optical Network (SONET). In some cases, processing system 106 can be communicatively coupled to a wide area network (WAN). Processing system 106 can utilize network connectivity to access various resources. For example, processing system 106 can communicate via network connectivity with a Medical Digital Imaging and Communication (DICOM) system, a Picture Archiving and Communication (PACS) system, and / or a Hospital Information System (HIS).

[0046] An intraluminal ultrasound imaging device 102 emits ultrasonic energy at a high level from a transducer array 124 included in a scanner assembly 110, which is mounted near the distal end of the intraluminal device 102. The ultrasonic energy is reflected by tissue structures in the medium surrounding the scanner assembly 110 (e.g., lumen 120), and the transducer array 124 receives the ultrasonic echo signals. The scanner assembly 110 generates one or more electrical signals representing the ultrasonic echoes. The scanner assembly 110 can include one or more individual ultrasonic sensors and / or transducer arrays 124 in any suitable configuration (e.g., planar array, curved array, circular array, ring array, etc.). For example, in some instances, the scanner assembly 110 can be a one-dimensional or two-dimensional array. In some instances, the scanner assembly 110 can be a rotating ultrasound device. The active region of the scanner assembly 110 can include one or more segments (e.g., one or more rows, columns, and / or one or more orientations) of one or more transducer materials and / or ultrasonic elements that can be uniformly or independently controlled and activated. The active region of the scanner assembly 110 can be patterned or structured on a variety of basic or complex geometries. The scanner assembly 110 can be configured for a side-view orientation (e.g., ultrasonic energy emitted perpendicular to and / or orthogonal to the longitudinal axis of the intraluminal device 102) and / or a front-view orientation (e.g., ultrasonic energy emitted parallel to and / or along the longitudinal axis). In some instances, the scanner assembly 110 is structurally arranged to emit and / or receive ultrasonic energy in a proximal or distal direction at an angle relative to the longitudinal axis. In some embodiments, the ultrasonic energy emission can be electronically redirected by selectively triggering one or more transducer elements of the scanner assembly 110.

[0047] The ultrasonic sensors(s) of the scanner assembly 110 can be piezoelectric micromechanical ultrasonic transducers (PMUTs), capacitive micromechanical ultrasonic transducers (CMUTs), single crystals, lead zirconate titanate (PZT), PZT composites, other suitable transducer types, and / or combinations thereof. In embodiments, the ultrasonic transducer array 124 can include any suitable number of individual transducer elements or acoustic elements (between 1 and 100,000 acoustic elements), for example, 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, 1,000 acoustic elements, 5,000 acoustic elements, 10,000 acoustic elements, 65,000 acoustic elements, and / or more and fewer acoustic elements.

[0048] The received echo signal is transmitted from PIM 104 to processing system 106, where the ultrasound image (including flow information) is reconstructed and displayed on monitor 108. The console or processing system 106 may include a processor and memory. Processing system 106 is capable of operating features that facilitate the intraluminal imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a transient tangible computer-readable medium.

[0049] PIM 104 facilitates signal communication between processing system 106 and scanner assembly included in in-lumen device 102. This communication may include: providing commands to one or more integrated circuit controller chips within in-lumen device 102; selecting one or more specific elements on transducer array 124 for transmission and reception; providing a transmission trigger signal to one or more integrated circuit controller chips to activate transmitter circuitry to generate electrical pulses that excite the selected one or more transducer array elements; and / or receiving echo signals received from the selected one or more transducer array elements via amplifiers included on one or more integrated circuit controller chips. In some embodiments, PIM 104 performs preliminary processing on the echo data before relaying the data to processing system 106. In examples of such embodiments, PIM 104 performs amplification, filtering, and / or aggregation of the data. In embodiments, PIM 104 also supplies high-voltage and low-voltage DC power to support the operation of in-lumen device 102, including circuitry within scanner assembly 110.

[0050] Processing system 106 receives echo data from scanner assembly 110 via PIM 104 and processes the data to reconstruct an image of tissue structures in the medium surrounding scanner assembly 110. Typically, device 102 can be used within any suitable anatomical structure and / or body lumen of the patient. Processing system 106 outputs image data such that an image of a blood vessel or lumen 120, e.g., a cross-sectional IVUS image of lumen 120, is displayed on monitor 108. Lumen 120 can represent naturally fluid-filled or fluid-surrounded structures and artificial fluid-filled or fluid-surrounded structures. Lumen 120 can be within the patient's body. Lumen 120 can be a blood vessel, e.g., an artery or vein of the patient's vascular system (including the cardiac vascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumen within the body). For example, device 102 can be used to examine any number of anatomical locations and tissue types, including but not limited to organs (including the liver, heart, kidneys, gallbladder, pancreas, and lungs), ducts, intestines, nervous system structures (including the brain, dura mater, spinal cord, and peripheral nerves); the urinary tract; and valves within the blood vessels, chambers, or other parts of the heart and / or other systems of the body. In addition to natural structures, device 102 can also be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0051] The controller or processing system 106 may include processing circuitry having one or more processors that communicate with memory and / or other suitable tangible computer-readable storage media. The controller or processing system 106 may be configured to perform one or more aspects of this disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated into a single component. For example, system 100 may include a touchscreen device, including a housing with a touchscreen display and a processor. System 100 may include any suitable input device (e.g., a touchpad or touchscreen display, keyboard / mouse, joystick, buttons, etc.) for a user to select options displayed on the monitor 108. The processing system 106, monitor 108, input devices, and / or combinations thereof may be referred to as the controller of system 100. This controller is capable of communicating with device 102, PIM 104, processing system 106, monitor 108, input devices, and / or other components of system 100.

[0052] In some embodiments, the intraluminal device 102 includes features similar to those of conventional solid-state IVUS catheters (e.g., EagleEye® catheters available from Royal Philips and those disclosed in U.S. Patent 7,846,101, which is incorporated herein by reference in its entirety). For example, the intraluminal device 102 may include a scanner assembly 110 near the distal end of the intraluminal device 102 and a transmission harness 112 extending along the longitudinal body of the intraluminal device 102. The cable or transmission harness 112 may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors.

[0053] The transmission harness 112 terminates in a PIM connector 114 at the proximal end of the intraluminal device 102. The PIM connector 114 electrically couples the transmission harness 112 to the PIM 104 and physically couples the intraluminal device 102 to the PIM 104. In embodiments, the intraluminal device 102 also includes a guidewire outlet 116. Thus, in some instances, the intraluminal device 102 is a quick-change catheter. The guidewire outlet 116 allows distal insertion of a guidewire 118 to guide the intraluminal device 102 through the lumen 120.

[0054] Monitor 108 may be a display device, such as a computer monitor or other type of screen. Monitor 108 can be used to display optional prompts, instructions, and visualizations of imaging data to a user. In some embodiments, monitor 108 can be used to provide a user with a process-specific workflow to complete an intraluminal imaging procedure. This workflow may include performing pre-stent placement planning to determine lumen status and stent potential, and may also include post-stent placement checks to determine the status of the stent that has been positioned in the lumen. This can be achieved through any of a variety of different displays or visualizations (e.g., below). Figure 4 The monitor (400) presents the workflow to the user.

[0055] External imaging system 132 can be configured to acquire X-ray images, radiographic images, angiographic images (e.g., with contrast), and / or fluorescence examination images (e.g., without contrast) of a patient's body (including blood vessels 120). External imaging system 132 can also be configured to acquire computed tomographic images of a patient's body (including blood vessels 120). External imaging system 132 may include an external ultrasound probe configured to acquire ultrasound images of the patient's body (including blood vessels 120) when positioned outside the body. In some embodiments, system 100 includes other imaging modalities (e.g., MRI) to acquire images of the patient's body (including blood vessels 120). Processing system 106 can combine intraluminal images acquired by intraluminal device 102 to utilize images of the patient's body.

[0056] Figure 2 The illustration shows a longitudinal cross-sectional view of a blood vessel 200 including a stenosis 230. The stenosis 230 can occur inside the vessel wall 210 (e.g., a thrombus, clot, or plaque) or outside the vessel wall 210 (e.g., compression), and can restrict blood flow through the lumen 220. Compression can be caused by other anatomical structures outside the blood vessel 200, including but not limited to tendons, ligaments, or adjacent lumens. As mentioned above, the presence of a stenosis 230 within the blood vessel 200 causes a non-circular luminal cross-section or profile. For example, in some aspects, the stenosis 230 creates a partially concave region within the blood vessel 230 (if no partially concave region exists, the blood vessel 230 may include a convex or predominantly convex region).

[0057] Figure 3 The illustration shows a longitudinal cross-section of a vessel 200 with a stenosis 230 and a stent 340 positioned within the vessel 200 to dilate or open the narrowed area of ​​the vessel caused by the stenosis 230. The stent 340 replaces and blocks the stenosis 230, pushing the vessel wall 210 outward, thereby reducing the flow restriction on blood through the lumen 220. In some aspects, the dimensions of the stent 340 (e.g., diameter, circumference, cross-sectional area) compel the vessel wall 210 to assume a circular or substantially circular cross-section for the area of ​​the stenosis 230. The stent 340 may be selected such that its dimensions correspond to the dimensions of the lumen 220 of the vessel 200 within the area of ​​the stenosis 230, and are assumed to have a circular cross-section. Other treatment options for relieving the blockage may include, but are not limited to, thrombectomy, ablation, angioplasty, and drug administration. However, in many cases, accurate and timely intravascular imaging of the affected area and accurate and detailed knowledge of the location, orientation, length, and volume of the affected area before, during, or after treatment are desirable.

[0058] Figure 4 This is an IVUS image 400 capturing a radial or axial cross-sectional view (i.e., a cross-section perpendicular to the longitudinal axis) of the vessel 200 during the intravascular imaging procedure. The radial cross-sectional view is associated with an imaging plane perpendicular to the longitudinal axis of the vessel 200. The intraluminal imaging probe 102, vessel wall 210, lumen 220, and compression 230 are visible. The perimeter 410 of the vessel wall 210 has been identified and labeled. Depending on the implementation, this can be done manually via a user interface (e.g., drawn on a touchscreen) or automatically via an algorithm as discussed below. The perimeter 410 includes a non-circular cross-sectional profile, including concave or partially concave portions within the area of ​​compression 230.

[0059] Figure 5This is a flowchart 500 of the stent sizing design process based on the relevant field. In step 510, an intraluminal imaging probe captures an image of the lumen. In step 520, the clinician manually identifies the lumen boundary or automatically identifies it using an algorithm. In step 530, the center of the lumen is identified, and in steps 540 and 550, the minimum lumen diameter (e.g., the shortest line connecting any two points on the lumen boundary through the lumen center) and the maximum lumen diameter (e.g., the longest line connecting any two points on the lumen boundary through the lumen center) are identified. In step 560, the average lumen diameter is estimated as the average of the minimum and maximum diameters. In step 570, the clinician selects the stent diameter based on the average lumen diameter of healthy tissue proximal and distal to the narrowest point of the vessel. Clinicians typically select a stent diameter that is an "empirical factor" that increases the average lumen diameter by 1-2 mm. In step 580, the clinician selects the stent length based on a visual perception of the length of the diseased segment of the vessel (e.g., the narrowed portion of the vessel that needs to be stented).

[0060] This process is time-consuming and has limited accuracy, so there is a need to improve tools and processes in this field.

[0061] Figures 6a-6c The process of discovering the minimum and maximum lumen diameters for different blood vessel cross sections according to various aspects of this disclosure is illustrated.

[0062] Figure 6a The minimum and maximum diameters of a blood vessel 200 having a vessel wall 210 with an assumed convex, nearly circular geometry are shown according to various aspects of this disclosure. The lumen boundary 410 has been identified (e.g., by image recognition). The minimum diameter 610 is the shortest line connecting any two points on the lumen boundary 410 through the lumen center 630. The maximum diameter 620 is the longest line connecting any two points on the lumen boundary 410 through the lumen center 630. In this example, the minimum and maximum diameters have similar values ​​and are separated by a substantial angle. As a result, the average of the minimum and maximum diameters can provide a reasonable approximation of the effective lumen diameter.

[0063] Figure 6bThe minimum and maximum diameters of a vessel 200 with a vessel wall 210 having a presumably complex, partially concave cross-section are shown according to various aspects of this disclosure. The minimum and maximum diameters are calculated as described above. However, in this example, there is a substantial difference between the minimum and maximum diameters. The lines representing the minimum and maximum diameters are also separated by only a relatively small angle, thus providing little information about the situation elsewhere around the vessel. In this case, the average of the minimum and maximum diameters may not be an accurate measure of the effective lumen diameter. Therefore, stent sizing designs based on the average diameter may be inaccurate.

[0064] Figure 6c The minimum and maximum diameters of a vessel 200 having a vessel wall 210 with a presumed concave (e.g., bean-shaped) cross-section are shown according to various aspects of this disclosure. The minimum and maximum diameters are calculated as described above. However, in this example, there is a significant difference between the minimum and maximum diameters (e.g., a difference of two or more times). In this case, the average of the minimum and maximum diameters will significantly underestimate the actual flow-carrying capacity of the vessel when it is stretched into a circular shape, and therefore the stent diameter selected based on this average is likely to be smaller than the stent diameter that the vessel can actually support.

[0065] General Reference Figures 6a-6c It should be understood that in some cases, using the described maximum and minimum diameter methods to determine vessel and / or stent dimensions may not be reliable. For example, while estimating vessel dimensions using the maximum and minimum diameter methods is generally reliable, it is not always reliable. Figure 6a The blood vessels in the image can provide a reasonable approximation of the lumen diameter (and the corresponding stent diameter), but for other blood vessel shapes (e.g., as shown in the image), the diameter of the vessel can be less accurately approximated. Figure 6b and Figure 6c The vessel shapes shown may not be entirely reliable. Therefore, it may be advantageous to employ methods for determining vessel size and / or stent size that do not rely on multiple maximum and minimum vessel diameters determined with respect to the vessel center. In this regard, this disclosure describes methods and associated systems and apparatus for determining vessel size and / or stent size by calculating or measuring the non-diameter geometry of the vessel (e.g., perimeter, cross-sectional area, volume) and using a circularization assumption to calculate the vessel size.

[0066] Figure 7aA flowchart 700 is shown for a stent sizing design process using a defined vessel circumference. In step 710, an intraluminal imaging catheter or guidewire captures an intraluminal image. The intraluminal image is then transmitted to and received by the processor circuitry of the intraluminal imaging system. It should be understood that in some embodiments, the intraluminal imaging catheter or guidewire captures or acquires multiple intraluminal images, which are subsequently received by the processor circuitry.

[0067] In step 720, the system identifies the lumen boundary or blood vessel boundary 410 through image processing and image recognition algorithms. Examples of boundary detection, image processing, image analysis, and / or pattern recognition include: U.S. Patent 6,200,268 (titled "VASCULAR PLAQUE CHARACTERIZATION", granted March 13, 2001, inventors D. Geoffrey Vince, Barry D. Kuban, and Anuja Nair), U.S. Patent 6,381,350 (titled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM", granted April 30, 2002, inventors Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar), U.S. Patent 7,074,188 (titled "SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE", granted July 11, 2006, inventors Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban), and U.S. Patent US... US Patent No. 7175597 (titled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD", granted February 13, 2007, inventors: D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith), US Patent No. 7215802 (titled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION", granted May 8, 2007, inventors: Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince), and US Patent No. 7359554 (titled "SYSTEM AND METHOD FORIDENTIFYING A VASCULAR BORDER", granted April 15, 2008, inventors: Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D.Kuban), and U.S. Patent US 7,463,759 (titled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," granted December 9, 2008, by Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince), the teachings of which are incorporated herein by reference in their entirety. In some embodiments, manual identification of the luminal boundaries can be performed at this step (e.g., by a clinician using a touchscreen interface).

[0068] In step 730, the system calculates values ​​for anatomical structures, such as geometric values. For example, the system can calculate geometric values ​​associated with any suitable anatomical structure or body lumen, including blood vessels, vascular lumens, esophagus, Eustachian tubes, urethra, fallopian tubes, intestines, colons, and / or any other suitable anatomical structure or body lumen. In the illustrated embodiment, the geometric value includes the perimeter of the luminal boundary of the blood vessel. This can be accomplished, for example, by counting pixels and converting them to distance at a known ratio (e.g., based on a field of view (FOV) setting of 0.05 mm per pixel). In some embodiments, the geometric value includes the outer perimeter of the blood vessel wall. In some embodiments, the geometric value includes the perimeter determined or calculated at the center region of the plaque in the blood vessel corresponding to the center of the plaque thickness around the lumen.

[0069] In step 740, the system calculates the inherent diameter for an anatomical structure (e.g., a lumen or vessel) based on the measured perimeter, which represents the diameter that the perimeter would have if the vessel were assumed or estimated to be circular (e.g., expanded to a circular cross-section). Therefore, in some embodiments, calculating the inherent diameter for an anatomical structure involves assuming or estimating the shape of the anatomical structure as circular. For example, assuming or estimating the shape of a vessel lumen as circular may involve using a perimeter measured or calculated as if it were a circle. Given a calculated length of the vessel perimeter profile (P) and assuming or estimating a circular geometry for the vessel and / or stent, the perimeter-based inherent diameter can be derived according to the following formula. :

[0070] Once the inherent diameter of the current frame has been calculated, the run returns to step 710 unless the pullback sequence is completed, in which case the run will continue to step 750. In some instances, circularization estimation involves transforming a non-circular shape into a circular shape and then measuring that circular shape. This transformation can be a mathematical transformation (e.g., a transformation matrix) or a conceptual transformation (e.g., assuming or estimating the perimeter of a non-circular shape as the perimeter of a circular shape). In other instances, circularization estimation is performed as described above without any transformation of the vessel shape. In some instances, the difference between the actual vessel shape and the assumed or estimated circular shape is not significant because the vessel may already exhibit a substantially circular cross-section. In other instances, the difference between the actual vessel shape and the assumed or estimated circular shape is very significant because the vessel may exhibit a concave or bean-shaped cross-section. Therefore, circularization estimation transforms the actual perimeter of the lumen into a circular shape to varying degrees. In some embodiments, the inherent diameter represents the diameter of the vessel's lumen. In some embodiments, the inherent diameter represents the inner diameter of the vessel (which may be the diameter defined by the vessel wall). In some embodiments, the inherent diameter represents the diameter from plaque center to plaque center in the blood vessel, corresponding to the center of the plaque thickness around the lumen.

[0071] In step 750, the system optionally recommends a stent diameter based on the inherent diameter of the determined circumference to a clinician or other user. In some embodiments, the recommended stent diameter may be equal to the inherent diameter of the healthy tissue of the vessel based on its circumference, proximal and distal to the point of the vessel's narrowest point (e.g., minimum circumference). In other instances, the recommended support diameter may be a fixed ratio or percentage (e.g., 95% or 105% of the inherent diameter based on the circumference) compared to the inherent diameter based on the circumference. It is also possible for clinicians to optionally modify it with additional factors.

[0072] It should be noted that the circularity assumption is itself an approximation; ideally, an expanded support could have a circular cross-section, but the axial and radial forces acting on the support would cause slightly asymmetrical expansion, thus deviating its cross-section from a perfect circle. Nevertheless, the circularity assumption can provide a reliable estimate of the correct support dimensions.

[0073] In step 760, the system recommends a stent length based on the determined inherent diameter based on circumference. For example, this could be equal to the following calculation: the number of narrow tissue frames indicated by the image recognition algorithm multiplied by the pull-back speed and divided by the frame rate, plus a fixed safety margin (e.g., 2 mm).

[0074] Figure 7b This is a diagram illustrating various aspects of method 700. Figure 7b An irregular blood vessel with a luminal circumference of 660 is shown. The luminal circumference 660 can be calculated using, for example, the boundary detection and quantification techniques referenced above. The luminal circumference 660 is transformed into, or assumed or estimated to be, a circle 662 of equal circumference. Thus, in the case of assuming a circular shape, the circle 662 of circumference 660 is determined to have a diameter 664, which is the diameter that the irregular blood vessel would have when assumed to be circular. Therefore, the diameter 664 of circle 662 can be used as the circumference-based intrinsic diameter of the blood vessel lumen.

[0075] Figure 8a A flowchart 800 is shown illustrating a stent sizing design process using a defined lumen area, according to at least one embodiment of the present disclosure. In step 810, an intraluminal imaging probe 102 captures an intraluminal image.

[0076] In step 820, the system identifies the lumen boundary or blood vessel boundary 410 through image processing and image recognition algorithms.

[0077] In step 830, the system calculates geometric values ​​associated with anatomical structures (e.g., blood vessels or lumens). In the illustrated embodiment, the geometric values ​​include the cross-sectional area of ​​the blood vessel lumen. This can be achieved, for example, by counting pixels and converting them to an area at a known ratio (e.g., 0.0025 mm per pixel based on the field of view setting). 2 This is done using [a method called] . In some embodiments, the geometric value may be the cross-sectional area including the blood vessel wall.

[0078] In step 840, the system calculates the area-based intrinsic diameter for the lumen or vessel, which represents the diameter the vessel would have if it were expanded to a circular cross-section. Given the area A enclosed by a given vessel profile (e.g., the lumen or vessel boundary) and an estimated circular geometry for the vessel and / or stent, the area-based intrinsic diameter can be derived according to the following formula. :

[0079] Once the inherent diameter of the current frame has been calculated, the run will return to step 810 unless the pullback sequence is completed, in which case the run will continue to step 850.

[0080] In step 850, the system determines a stent diameter based on the determined area-based intrinsic diameter and recommends such a stent diameter to a clinician or other user. In some embodiments, the recommended stent diameter may be equal to the area-based intrinsic diameter of healthy tissue of the vessel proximal and distal to the point of the vessel's narrowest point (e.g., minimum cross-sectional area). In other instances, the recommended support diameter may be a fixed ratio or percentage (e.g., 95% or 105% of the area-based inherent diameter) compared to the area-based inherent diameter. related.

[0081] In step 860, the system recommends a stent length. For example, this could be equal to the following calculation: the number of narrow tissue frames indicated by the image recognition algorithm multiplied by the pull-back speed and divided by the frame rate, plus a fixed safety margin (e.g., 2 mm).

[0082] Figure 8b This is a diagram illustrating various aspects of method 800. Figure 8b An irregular blood vessel with a lumen area of ​​670 is shown. The lumen area 670 can be calculated using, for example, the boundary detection and quantification techniques cited above. The lumen area 670 is transformed, or assumed or estimated, to have a circle with an area 672 equal to the area 670. Thus, in the case of assuming a circular shape, a circle with a cross-sectional area 672 that is the same as the cross-sectional area 670 of the irregular lumen is determined to have a diameter 674, which is the diameter that the irregular blood vessel would have when assumed to be circular. Therefore, the diameter 674 of this circle can be used as the inherent diameter of the blood vessel lumen based on its cross-sectional area.

[0083] Figure 9a A flowchart 900 is shown illustrating a stent sizing design process using a defined lumen volume, according to at least one embodiment of the present disclosure. In step 910, an intraluminal imaging probe 102 captures an intraluminal image.

[0084] In step 920, the system identifies the lumen boundary or blood vessel boundary 410 through image processing and image recognition algorithms.

[0085] In step 930, the system calculates geometric values ​​associated with anatomical structures (e.g., blood vessels or lumens). In the illustrated embodiment, the geometric values ​​include the volume of a lumen of a given length. As part of the pullback process, the above operations can be performed by obtaining a sequence or set of intraluminal images at different longitudinal locations with the lumen, and generating a three-dimensional volumetric image or dataset based on the sequence or set of intraluminal images.

[0086] In step 940, the system calculates the volume of a region of blood vessels in a healthy area closely proximal or distal to the region where the stent is to be placed (e.g., five to ten successive frames). This can be done, for example, by multiplying a known or measured distance between multiple frames by the cross-sectional area of ​​each frame in which a narrowing is detected.

[0087] In step 950, the system calculates the volume-based intrinsic diameter for a lumen or vessel, which represents the diameter the lumen or vessel would have if expanded to a circular cross-section. Given a volume V enclosed by a stack of vessel profiles (e.g., the lumen or vessel boundary of a vessel) and an estimated circular geometry for the vessel and / or stent, the volume-based intrinsic diameter can be derived according to the following formula. :

[0088] The Simpson rule can be used to calculate the volume of the stacked vascular profiles. In this instance, The length of the vessel is represented by a stack of contours (i.e., the length of the vessel covered by the imaging frames from which the vessel contours are obtained). Due to imaging conditions and the difficulty of imaging at orthogonal cross-sections, the intrinsic diameter based on the volume constructed from successive imaging cross-sections can more realistically represent the actual intrinsic diameter measurement that can be related to stent size design. However, since it requires geometric information from multiple frames simultaneously, The computation does not have to be performed on a per-frame basis, but and It can be calculated individually for each frame.

[0089] The calculation of the inherent vessel diameter relies on the tendency or ability to assume a circular shape for the vessel. This circular shape assumption also applies to stents, which are typically circular and sized based on their diameter and length. Volume-based inherent diameters can be particularly relevant to scenarios where the vessel is deformed and its profile is neither circular nor convex. Even in such scenarios, the profile perimeter, the area enclosed by the profile, and / or the volume enclosed by the profile stack can still be generated. By using any of these measurements, the inherent diameter of the vessel can be derived using the algorithms and relationships shown above.

[0090] In step 960, the system recommends a stent diameter based on the inherent volume diameter to clinicians or other users. In some embodiments, the recommended stent diameter may be equal to the inherent volume diameter. In other instances, the recommended stent diameter may be a fixed ratio or percentage (e.g., 95% or 105% of the inherent diameter based on volume) compared to the inherent diameter based on volume. related.

[0091] In step 970, the system recommends a stent length. For example, this can be equal to the following calculation: the number of narrow tissue frames shown by the image recognition algorithm multiplied by the pull-back speed and divided by the frame rate, plus a fixed safety margin (e.g., 2 mm).

[0092] In some embodiments, in addition to automated measurements based on multiple intravascular images, or instead of automated measurements based on multiple intravascular images, the desired stent length can also be calculated based on automated measurements performed using co-registered external images (e.g., fluorescence examination images). In some embodiments, inter-frame local differences in the diameter, area, or volume measurements of the vessel or lumen can be smoothed or averaged to provide an average measurement result.

[0093] Figure 9b This is a diagram illustrating various aspects of method 900. Figure 9b An irregular blood vessel with a lumen volume of 680 is shown. The lumen volume 680 can be calculated using, for example, the boundary detection and quantification techniques referenced above, based on multiple cross-sectional images obtained at different longitudinal locations within the vessel. The lumen volume 680 is transformed into a cylinder with a volume 682 equal to the volume 680. Thus, by estimating the cylindrical shape, a cylinder with the same length and volume 682 as the irregular lumen is determined to have a diameter 684, which is the diameter the irregular blood vessel would have if assumed to be cylindrical. Therefore, the diameter 684 of the cylinder can be used as the inherent diameter of the blood vessel lumen based on its cross-sectional volume.

[0094] Figure 10 This is a schematic diagram of a processor circuit 1050 according to an embodiment of the present disclosure. The processor circuit 1050 can be implemented in an ultrasound imaging system 100 or other device or workstation (e.g., a third-party workstation, network router, etc.) that must implement one or more of the methods disclosed herein (including methods 500, 700, 800, and / or 900). As shown, the processor circuit 1050 may include a processor 1060, a memory 1064, and a communication module 1068. These components can communicate directly or indirectly with each other (e.g., via one or more buses).

[0095] Processor 1060 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of the following: a general-purpose computing device, a reduced instruction set computing (RISC) device, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other related logic devices (including mechanical computers and quantum computers). Processor 1060 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 1060 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a combination of multiple microprocessors, one or more microprocessors used in conjunction with a DSP core, or any other such configuration.

[0096] Memory 1064 may include cache memory (e.g., cache memory of processor 1060), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In embodiments, memory 1064 includes a non-transient computer-readable medium. Memory 1064 may store instructions 1066. Instructions 1066 may include instructions that, when executed by processor 1060, cause processor 1060 to perform the operations described herein (including one or more steps of methods 500, 700, 800, and / or 900). Instructions 1066 may also be referred to as code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, flows, etc. "Instructions" and "codes" can include a single computer-readable statement or many computer-readable statements.

[0097] The communication module 1068 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between the processor circuitry 1050 and other processors or devices. In this regard, the communication module 1068 can be an input / output (I / O) device. In some instances, the communication module 1068 facilitates direct or indirect communication between the processor circuitry 1050 and / or the various components of the ultrasound imaging system 100. The communication module 1068 can communicate within the processor circuitry 1050 using various methods or protocols. Serial communication protocols may include, but are not limited to, US SPI, I... 2 C. Serial communication may be transmitted via RS-232, RS-485, CAN, Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged by UART, USART, or other suitable subsystems.

[0098] External communication (including, but not limited to, software updates, firmware updates, preset sharing between the processor and a central server, or readings from an ultrasound device) can be accomplished using any suitable wireless or wired communication technology, such as cable interfaces (e.g., USB, Micro USB, Lightning, or FireWire), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections (e.g., 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G). For example, Bluetooth Low Energy (BLE) radios can be used to establish connections with cloud services for data transfer and to receive software patches. The controller can be configured to communicate with a remote server or local device (e.g., a laptop, tablet, or handheld device) or may include a display capable of showing status variables and other information. Information can also be transferred over a physical medium (e.g., a USB flash drive or memory stick).

[0099] The examples and embodiments described above can be varied in many ways. For example, in addition to the systems described, a lumen intrinsic diameter measurement system can be used in anatomical systems within the body, or it can be used to image other disease types, object types, or process types besides those described. The techniques described herein can be applied to various types of intraluminal imaging sensors, whether currently existing or developed in the future. In arterial and venous imaging, the system can be used in conjunction with IVUS for coronary arteries and peripheral vessels, for example, Philips' IGT-D device and IVUS console software. In some embodiments, the intrinsic diameter can be calculated using several different methods, and the most suitable (e.g., the most conservative) value can be selected. In other embodiments, the user can choose which method to use in calculating the vessel diameter.

[0100] Therefore, the logical operations constituting embodiments of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these can occur or be performed in any order unless the order is otherwise expressly defined or a particular order is inherently required by the language of the claims. All directional references (e.g., up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal) are used only for identification purposes to assist the reader in understanding the claimed subject matter and do not impose limitations, particularly regarding the location, orientation, or use of the inherent diameter measurement system of the lumen. Connection references (e.g., attachment, coupling, connection, and engagement) will be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements, unless otherwise stated. Therefore, connection references do not necessarily imply that two elements are directly connected and have a fixed relationship. The term "or" should be interpreted as meaning "and / or" rather than "exclusive or". Unless otherwise stated in the claims, the values ​​recorded should be interpreted as illustrative only and should not be considered limiting.

[0101] The foregoing description, examples, and data provide a complete description of the structure and use of exemplary embodiments of the lumen inherent diameter measurement system as defined in the claims. While various embodiments of the claimed subject matter have been described above to some degree or with reference to one or more individual embodiments, many modifications can be made to the disclosed embodiments by those skilled in the art without departing from the spirit or scope of the claimed subject matter. Other embodiments are also contemplated. All subject matter contained in the foregoing description and shown in the accompanying drawings is intended to be illustrative of particular embodiments only and not to be limiting. Changes may be made to details or structure without departing from the essential elements of the subject matter as defined in the claims.

Claims

1. An intraluminal imaging system, comprising: Intraluminal imaging catheters or guidewires are configured to be positioned within the patient's anatomical structures. The processor circuit communicates with the intraluminal imaging catheter or guidewire. The processor circuit is configured as follows: Receive multiple cross-sectional images of the anatomical structure from the intraluminal imaging catheter or guidewire; The values ​​of the anatomical structures are calculated using image processing of the cross-sectional images from the multiple cross-sectional images; The diameter of the anatomical structure is calculated based on the calculated values ​​of the anatomical structure and the assumed circular cross-sectional shape of the anatomical structure. Calculate the stent diameter, which is equal to the calculated diameter of the anatomical structure multiplied by a scaling factor; and The diameter of the bracket is output to a display that communicates with the processor circuitry.

2. The intraluminal imaging system according to claim 1, wherein, The value includes the perimeter of the anatomical structure.

3. The intraluminal imaging system according to claim 1, wherein, The value includes the cross-sectional area of ​​the anatomical structure.

4. The intraluminal imaging system according to claim 1, wherein, The value includes the volume of the anatomical structure.

5. The intraluminal imaging system according to claim 1, wherein, The value includes at least two of the perimeter, cross-sectional area, or volume of the anatomical structure.

6. The intraluminal imaging system according to claim 1 further includes a user interface communicating with the processor circuit, wherein, The user interface is configured to accept input from a user, and the processor circuitry is further configured to perform the following operations in response to receiving input from the user interface: Calculate the diameter of the support; and The diameter of the bracket is output to the display.

7. The intraluminal imaging system according to claim 1, wherein, The processor circuit is also configured to: The length of the support structure is calculated based on the multiple cross-sectional images; and The length of the bracket is output to the display.

8. The intraluminal imaging system according to claim 1, wherein, The anatomical structure in question is a blood vessel.

9. A method for calculating the diameter of a lumen in an intraluminal medical procedure, the method comprising: The processor circuit receives multiple cross-sectional images of the patient's anatomical structures, wherein the multiple cross-sectional images are obtained by an intraluminal imaging catheter or guidewire positioned within the anatomical structures; The values ​​of the anatomical structures are calculated using image processing of the cross-sectional images from the plurality of cross-sectional images by the processor circuitry. The diameter of the anatomical structure is calculated based on the calculated values ​​of the anatomical structure and the assumed circular cross-sectional shape of the anatomical structure. Calculate the stent diameter, which is equal to the calculated diameter of the anatomical structure multiplied by a scaling factor; and The diameter of the bracket is output to a display that communicates with the processor circuitry.

10. The method according to claim 9, wherein, The value includes the perimeter of the anatomical structure.

11. The method according to claim 9, wherein, The value includes the cross-sectional area of ​​the anatomical structure.

12. The method according to claim 9, wherein, The value includes the volume of the anatomical structure.

13. The method according to claim 9, wherein, The value includes at least two of the perimeter, cross-sectional area, or volume of the anatomical structure.

14. The method of claim 9, further comprising: Perform the following actions in response to input received from the user interface: Calculate the diameter of the support; and The diameter of the bracket is output to the display.

15. The method of claim 9, further comprising: The length of the support structure is calculated based on the multiple cross-sectional images. and The length of the bracket is output to the display.

16. The method according to claim 9, wherein, The anatomical structure in question is a blood vessel.

17. A system for intravascular imaging, the system comprising: Intravascular imaging catheters or guidewires; and A processor circuit that communicates with the intravascular imaging catheter or guidewire, wherein the processor circuit is configured to: Receive multiple cross-sectional images of the blood vessel captured by the intravascular imaging catheter or guidewire; Calculate the value of the blood vessel; The inherent diameter associated with the blood vessel is calculated based on the calculated value of the blood vessel and the assumed circular cross-sectional shape of the blood vessel; Calculate the support diameter, which is equal to the calculated inherent diameter multiplied by a scaling factor; and The diameter of the bracket is output to a display that communicates with the processor circuitry.

18. The system according to claim 17, wherein, The value includes at least one of the following: lumen perimeter measurement result, lumen area measurement result, or lumen volume measurement result.

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