Self-expanding stent system with imaging

Abstract

In an exemplary example, methods and systems are disclosed herein for treating vascular disease by implanting a stent within a vessel and using intravascular imaging to determine and ensure that the stent is properly implanted and produces the desired and effective results. For example, a system can obtain optical shape sensing data and intravascular imaging data of a vessel. The system can process the optical shape sensing data and the intravascular imaging data to generate three-dimensional models and images of the vessel immediately before and after the stent is implanted in the vessel and make an exact comparison of the before and after images to ensure that the stent is properly implanted and will produce or is producing the desired and effective results. The exact comparison can be based on a derived diameter associated with the location of the stent placement in the vessel, which is based on the generated pre- and post- three-dimensional models.

Description

[0001] Cross-reference to related applications

[0002] none. Technical Field

[0003] The systems and apparatus described herein generally relate to the treatment and imaging of blood vessels. More specifically, this disclosure relates to implants, methods, and systems that involve implanting stents within blood vessels and using intravascular imaging to determine and ensure proper stent implantation and to produce desired and effective results for the treatment of vascular diseases. Background Technology

[0004] Intravascular ultrasound (IVUS) imaging is widely used as a diagnostic tool in interventional cardiology and peripheral vascular intervention to assess diseased vessels (e.g., arteries or veins) within the body to determine the necessity of treatment, guide intervention, and / or evaluate its effectiveness. An IVUS device, comprising one or more ultrasound transducers, is inserted into the tube and guided to the area to be imaged. The transducers emit ultrasound energy to form an image of the tube of interest. Ultrasound waves are reflected by discontinuities caused by tissue structures (e.g., different layers of the tube wall), red blood cells, and other features of interest. The echoes of the reflected waves are received by the transducers and transmitted to the IVUS imaging system. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the tube in which the device is placed.

[0005] Currently, there are two common types of IVUS catheters: rotary and solid-state. For a typical rotary IVUS catheter, a single ultrasound transducer element is located at the end of a flexible drive shaft that rotates within a plastic sheath inserted into the tube of interest. The transducer element is oriented such that the propagation of the ultrasound beam is substantially perpendicular to the axis of the device. The fluid-filled sheath protects the tube tissue from the rotating transducer and drive shaft while allowing the ultrasound signal to propagate from the transducer into the tissue and back. As the drive shaft rotates, the transducer is periodically excited with high-voltage pulses to emit short pulses of ultrasound. The same transducer then listens for the echoes reflected back from various tissue structures. The IVUS imaging system combines the pulse / acquisition cycle sequence occurring during a single rotation of the transducer to create a two-dimensional display of the tube cross-section.

[0006] In contrast, solid-state IVUS catheters incorporate an ultrasound scanner assembly comprising an array of ultrasound transducers distributed around the periphery of the device and connected to a set of transducer control circuitry. The transducer control circuitry selects individual transducers or combinations of transducers to emit ultrasound pulses and receive echo signals. By progressively traversing a series of transmitter-receiver pairs, the solid-state IVUS system can synthesize the effects of mechanically scanned transducer elements without moving parts. Because there are no rotating mechanical components, the transducer array can directly contact the blood and vascular tissue, minimizing the risk of vascular trauma. Furthermore, the interface is simplified due to the absence of rotating elements. Solid-state scanners can be directly connected to the imaging system using simple cables and standard detachable electrical connectors.

[0007] IVUS imaging can be used before, during, and / or after percutaneous coronary intervention (PCI) or peripheral vascular intervention. For example, IVUS imaging can be used for diagnosis and treatment planning to identify diseased portions of a vessel and determine the appropriate diameter and length of a stent to be positioned within the diseased portion of the vessel. In other words, the diameter and / or length of the vessel and stent can be obtained from intravascular imaging data (e.g., IVUS imaging and / or optical coherence tomography (OCT)).

[0008] IVUS imaging is typically performed using a separate intravascular device prior to stent implantation. After IVUS imaging, the intravascular device is removed from the blood vessel, and a stent delivery device is inserted to implant the stent. If the clinician wishes to view the stent after implantation, they must first remove the stent delivery device and then reinsert the IVUS intravascular device. Moreover, even after reinsertion, it is difficult to make an accurate comparison of the intravascular location of interest before and after stent implantation using the IVUS intravascular device, as the clinician cannot determine whether the IVUS intravascular device is in the correct position when attempting to make such a comparison. Furthermore, stent implantation is usually performed by the clinician viewing a two-dimensional view of the blood vessel, further complicating pre- and post-implantation comparisons. Therefore, it is desirable to provide one or more systems and / or methods to address these and other drawbacks. Summary of the Invention

[0009] In at least one exemplary example, a system is provided that includes one or more processors and a memory storing instructions. When the instructions are executed by one or more processors, the instructions cause the processors to generate three-dimensional synthetic images of the lesion or stenosis of the blood vessel immediately before and after stent placement, to perform an accurate comparison of the pre-placement and post-placement images, ensuring that the stent is properly placed and will produce or is producing the desired and effective results, including increased blood flow through the stenotic area where the stent is now placed.

[0010] In one example, a stent delivery system includes: a shape sensing line configured to generate shape sensing data representing a region of interest within a blood vessel of a subject; a stent delivery device disposed on the shape sensing line, wherein the stent delivery device includes a stent and an imaging element disposed distal to the stent, wherein the imaging element is configured to generate intravascular ultrasound imaging data representing the region of interest; and a computing system including: one or more processors; and a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: receive a plurality of first signals corresponding to the shape sensing data; receive a plurality of second signals corresponding to the intravascular ultrasound imaging data; and register the first and second signals. The system includes: processing a first and a second signal to generate a pre-deployment 3D model of the region of interest; determining the pre-deployment dimensional features of the region of interest based on the pre-deployment 3D model; receiving a stent deployment signal indicating stent deployment; receiving multiple third signals corresponding to shape sensing data after receiving the stent deployment signal; receiving multiple fourth signals corresponding to intravascular ultrasound imaging data after receiving the stent deployment signal; registering the third and fourth signals; processing the third and fourth signals to generate a post-deployment 3D model of the region of interest; determining the post-deployment dimensional features of the region of interest based on the post-deployment 3D model; calculating a comparison result between the pre-deployment and post-deployment dimensional features; and providing the comparison result to a monitor.

[0011] In another example, as described above in the stent delivery system, the stent delivery device includes a sensor that generates a stent deployment signal when the sheath retracts onto the stent delivery device.

[0012] In another example, such as the support delivery system described in any of the preceding paragraphs, the initial dimensional features and updated dimensional features are based on the derived diameter.

[0013] In another example, such as the support delivery system described in any of the preceding paragraphs, the derived diameter is based on the area, volume, or perimeter of the region of interest.

[0014] In another example, such as the stent delivery system described in any of the preceding paragraphs, the derived diameter is based on the area of ​​the region of interest.

[0015] In another example, such as the stent delivery system described in any of the preceding paragraphs, the derived diameter is based on the volume of the region of interest.

[0016] In another example, such as the support delivery system described in any of the preceding paragraphs, the derived diameter is based on the perimeter of the region of interest.

[0017] In another example, such as the support delivery system described in any of the preceding paragraphs, the derived diameter is based on at least two of the area, volume, and perimeter of the region of interest.

[0018] In another example, a stent delivery system as described in any of the preceding paragraphs, wherein the stent delivery system further includes a fluorescence fluoroscopic imaging device to generate fluorescence fluoroscopic image data corresponding to the region of interest.

[0019] In another example, a stent delivery system as described in any of the preceding paragraphs, wherein the memory stores instructions that, when executed by one or more processors, also cause one or more processors to register fluorescence perspectral image data with a first signal and a second signal, and process the fluorescence perspectral image data together with the first and second signals to generate a pre-deployment three-dimensional model of the region of interest.

[0020] In another example, a system includes: one or more processors; and a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: acquire a plurality of first signals corresponding to shape-sensing data of a region of interest within a blood vessel of a subject; acquire a plurality of second signals corresponding to intravascular ultrasound imaging data of the region of interest; register the first and second signals; process the first and second signals to generate a pre-deployment three-dimensional composite image of the region of interest; determine an initial blood volume capable of passing through the region of interest based on the pre-deployment three-dimensional composite image; receive a stent deployment signal indicating that a stent is deployed within the region of interest; after receiving the stent deployment signal, receive a plurality of third signals corresponding to the shape-sensing data; after receiving the stent deployment signal, receive a plurality of fourth signals corresponding to the intravascular ultrasound imaging data; register the third and fourth signals; process the third and fourth signals to generate a post-deployment three-dimensional composite image of the region of interest; determine an updated blood volume capable of passing through the region of interest based on the post-deployment three-dimensional model; calculate a comparison result between the initial blood volume and the updated blood volume; and provide a comparison signal indicating the comparison result.

[0021] In another example, a non-transitory computer-readable medium stores instructions for execution by one or more processors incorporated into a system, wherein the instructions, when executed by the one or more processors, cause the one or more processors to: acquire initial optical shape sensing data of a blood vessel; acquire initial intravascular imaging data of the blood vessel; register the initial optical shape sensing data and the initial intravascular imaging data; generate an initial three-dimensional model based on the initial optical shape sensing data and the initial intravascular imaging data; determine an initial derived diameter associated with a portion of the initial three-dimensional model; acquire subsequent intravascular imaging data of the blood vessel; register the initial optical shape sensing data and the subsequent intravascular imaging data; generate a subsequent three-dimensional model based on the initial optical shape sensing data and the subsequent intravascular imaging data; determine a subsequent derived diameter associated with a portion of the subsequent three-dimensional model; and provide a signal to a monitor representing a comparison result of the initial derived diameter and the subsequent derived diameter.

[0022] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both combined and separate in use. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” refers to a single A, a single B, a single C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element (e.g., X, Y, and Z) or a class of elements (e.g., X1-X), the meaning is different. n Y1-Y m and Z1-Z o When used, this phrase is intended to refer to a single element selected from X, Y, and Z, or a combination of elements selected from the same category (e.g., X1 and X2), or a combination of elements selected from two or more categories (e.g., Y1 and Z). o ).

[0023] The term "a" or "an" entity refers to one or more of the same entity. Therefore, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0024] The term “means” as used herein shall be given the broadest possible interpretation in accordance with Section 112(f) of 35 U.S.SC. Therefore, claims containing the term “means” shall cover all structures, materials, or actions set forth herein, and all their equivalents. Furthermore, structures, materials, or actions, and their equivalents, shall include all that is described in the summary, description of the drawings, detailed description, abstract, and claims.

[0025] It should be understood that each maximum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every lower numerical limit, as if such lower numerical limits were expressly stated herein. Each minimum numerical limit given throughout this disclosure is considered to include, as alternative to, every and every larger numerical limit, as if such larger numerical limits were expressly stated herein. Each numerical range given in this disclosure is considered to include, as if falling within that wider numerical range, every and every narrower numerical range, as if such narrower numerical ranges were all expressly stated herein.

[0026] The foregoing is a simplified summary of this disclosure, intended to provide an understanding of some aspects of it. This summary is neither extensive nor exhaustive; it is not intended to identify key or essential elements of the disclosure, nor to depict its scope, but rather to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description given below. As will be understood, other aspects, examples, and configurations of this disclosure may utilize one or more features described above or in detail below, individually or in combination. Attached Figure Description

[0027] The accompanying drawings are incorporated in and form part of this specification to illustrate various examples of the present disclosure. These drawings, together with the description, explain the principles of the present disclosure. The drawings simply illustrate preferred and alternative examples of how the present disclosure is made and used, and should not be construed as limiting the present disclosure to the examples shown and described. Other features and advantages will become apparent from the following more detailed description of various aspects, examples, and configurations of the present disclosure, as illustrated in the accompanying drawings with reference to them.

[0028] Figure 1 This is an exemplary block diagram illustrating a stent delivery system for imaging according to an example of the present disclosure.

[0029] Figure 2 This is an exemplary longitudinal schematic diagram of a support conveying device and an optical shape sensing line of a support conveying system according to an example of the present disclosure.

[0030] Figure 3 It is along Figure 2 The image shows an enlarged longitudinal side view of the distal portion of the support conveyor and the distal portion of the optical shape sensing line, taken from line AA, with the support attached to the shaft of the support conveyor.

[0031] Figure 4 It is along Figure 2 An enlarged longitudinal side view of the distal portion of the support conveyor and the distal portion of the optical shape sensing line, taken from line AA, wherein the support is separated from the shaft of the support conveyor.

[0032] Figure 5 This is an exemplary cross-sectional view of the proximal and distal portions of the support transport device and the optical shape sensing line of an example support transport system according to this disclosure.

[0033] Figure 6A This is an exemplary partial cross-sectional perspective view of a blood vessel with a narrow portion, according to an example of this disclosure.

[0034] Figure 6B This is an exemplary partial cross-sectional perspective view of a blood vessel having a stent placed adjacent to and restricting the stenosis, according to an example of this disclosure.

[0035] Figure 7-9 This is an exemplary flowchart describing a method for imaging blood vessels according to various aspects of this disclosure.

[0036] Figure 10 It is an exemplary IVUS image set that is stitched onto an image obtained from an optical shape sensing line.

[0037] It should be understood that the accompanying drawings are not necessarily drawn to scale. In some cases, details that are not necessary for understanding this disclosure or that make other details difficult to understand may be omitted. Of course, it should be understood that this disclosure is not limited to the specific examples shown herein. Detailed Implementation

[0038] Before explaining any examples of this disclosure in detail, it should be understood that this disclosure, in its application, is not limited to the details of the construction and component arrangement set forth in the following description or shown in the following figures. Other examples of this disclosure are possible and it can be implemented or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The terms "comprising," "including," or "having," and variations thereof, as used herein, are intended to cover the items listed thereafter and their equivalents, as well as any additional items.

[0039] refer to Figure 1An exemplary block diagram is illustrated, showing a system 100 capable of delivering and deploying stents. System 100 for deploying stents (e.g., self-expanding stents) uses navigation and imaging techniques to precisely measure the area of ​​interest within the tube and / or cannula and generate a three-dimensional image or model of it before stent implantation (e.g., a pre-deployment three-dimensional image or model), deploy the stent, and precisely measure the area of ​​interest within the tube and / or cannula and / or stent, generating a three-dimensional image or model of it after stent implantation (e.g., a post-deployment three-dimensional image or model). Navigation can be performed manually or robotically. System 100 may include a workstation or console 105 from which a clinician performs, supervises, and / or manages stent delivery operations. Workstation 105 preferably includes a computer system comprising one or more processors 110 and a memory 115 for storing programs and applications to perform the methods disclosed herein.

[0040] Memory 115 may store optical sensing module 120 and OSS processing module 125. Optical sensing module 120 may be configured to interpret optical feedback signals from one or more optical shape sensing (“OSS”) devices or lines 300 and generate intravascular optical shape sensing data. Optical sensing module 120 may also be configured to use optical signal feedback (and any other feedback, such as electromagnetic (EM) tracking) to reconstruct deformations, deflections, and other changes associated with a medical device or instrument via a placement device or system, such as stent placement device 200. OSS processing module 125 may be configured to generate three-dimensional (3D) OSS images at each of multiple locations across the entire region of interest based on the intravascular optical shape sensing data, and output the OSS images to a monitor (e.g., a display device and / or other type of user interface device) 150 to depict a 3D image of the tube and / or the region of interest of the tube.

[0041] The stent placement device 200 may include a tube or body 210 through which an OSS line 300, serving as a guide wire, passes. The OSS line 300 includes one or more optical fibers, which are then connected to a workstation 105. The OSS line 300 and the optical fibers are used to provide a visual representation of the placementable component, such as a stent. Although described in relation to stents, this principle can also be applied to other implantable devices.

[0042] In one example, the optical fiber of OSS line 300 is integrated within or passes through OSS line 300. OSS line 300 can be used for physical measurements. The measurements can be used for planning or placement of supports. For example... Figure 2 and Figure 3As shown, the support conveyor 200 is placed on the OSS line 300. Therefore, the handle 205 of the support conveyor 200 is connected to the OSS line 300. As will be discussed in detail below, the positioning and / or location of the support conveyor 200 relative to the OSS line 300 (including the positioning and / or relative position of the support 215) is registered in the registration module 140. That is, the relative positioning and / or location of the OSS line 300, the support conveyor 200, and the support 215 are registered in the registration module 140. Therefore, any movement of the support conveyor 200 and the support 215 is tracked relative to the OSS line 300.

[0043] While this principle can be applied to any interventional guidewire used in conjunction with a stent, this disclosure employs an OSS wire 300 as the guidewire. Therefore, the OSS wire 300 serves as a "delivery guide" for the stent delivery device 200, and passes along a dedicated guidewire lumen within the stent delivery device 200. Since the OSS wire 300 is physically located within the stent delivery device 200, the reconstructed shape of the OSS wire represents the shape of the stent delivery device 200. However, the OSS wire 300 can rotate and translate freely within the stent delivery device 200; therefore, the precise position and orientation of the stent delivery device 200 and / or the stent 215 can be determined.

[0044] The OSS line 300 may include a fiber Bragg grating sensor located within one or more optical fibers. A fiber Bragg grating (FBG) is a short section of optical fiber that reflects light of a specific wavelength and transmits light of all other wavelengths. This is achieved by introducing periodic variations in the refractive index into the fiber core, which produces an electron microscope for specific wavelengths. Therefore, fiber Bragg gratings can be used as inline optical filters to block certain wavelengths or as reflectors for specific wavelengths.

[0045] The fundamental principle behind the operation of a fiber Bragg grating (FBG) is Fresnel reflection at each interface where the refractive index changes. For some wavelengths, the reflected light at different times is in phase, resulting in constructive interference during reflection and destructive interference during transmission. The Bragg wavelength is sensitive to strain and temperature. This means that FBGs can be used as sensing elements in fiber optic sensors. In an FBG sensor, strain causes a shift in the Bragg wavelength.

[0046] One advantage of this technology is that various sensor elements can be distributed along the length of the optical fiber. By combining three or more fiber cores with various sensors (gauges) along the length of the fiber embedded in the structure, the three-dimensional form of the structure can be precisely determined, typically with an accuracy better than 1 mm. Numerous FBG sensors (e.g., three or more fiber sensing cores) can be placed at various locations along the length of the fiber. From the strain measurements of each FBG, the curvature of the structure at that location can be inferred. From the numerous measurement locations, the overall three-dimensional form can be determined.

[0047] As an alternative to fiber Bragg gratings, backscattering inherent in conventional optical fibers can be utilized. One such method utilizes Rayleigh scattering in standard single-mode communication fibers. Rayleigh scattering occurs due to random fluctuations in the refractive index within the fiber core. These random fluctuations can be modeled as Bragg gratings, with their amplitude and phase varying randomly along the grating length. By using this effect in three or more cores extending within a single-length multi-core fiber, the 3D shape and dynamics of the surface of interest can be tracked.

[0048] It should be understood that optical shape sensing can be performed in a variety of ways and is not limited to FBG or Rayleigh scattering techniques. For example, other techniques may include channels etched into the optical fiber, using quantum dots for reflection, using multiple individual optical fibers (e.g., three or more) instead of a single multi-core fiber, or other optical shape sensing techniques.

[0049] The OSS line 300 is registered using the registration module 140 in the memory 115 of workstation 105. (See again...) Figure 1 The registration module 140 is configured to register the OSS line 300 to the stent delivery device 200, the additional imaging system 160, intravascular physical structures (e.g., stenosis), other images, etc. For shape recognition registration, a unique shape or shape template can be used to obtain position and orientation information from the optical fiber. If the optical fiber takes a predefined and unalterable path, the curvature and shape information of that path can be used to identify an image (i.e., image 145) that is unique to the optical fiber transition and will be stored in memory 115, because the OSS processing module 125 can be configured to generate multiple 3D OSS images at each of multiple locations throughout the region of interest based on intravascular optical shape sensing data, which can be used for subsequent verification and comparison.

[0050] Image processing module 135 is configured to combine 3D OSS image 145 and position data of OSS line 300 for joint or separate display on display 150. OSS position data and image data (from preoperative or intraoperative image 145) can be registered and displayed jointly to assist in the placement of stents (or other implantable devices). Imaging system 160 may include a fluorescence fluoroscopy system (X-ray) for collecting real-time visualization information about instrument position or anatomical features. Image 145 collected using imaging device 160 can be registered together with OSS data from OSS line 300.

[0051] Navigation can be simplified by using the OSS line and / or a portion of the stent placement device 200, such as the handle 205, and the location of the stent 215 (or at least a relevant marker on the graft). Registered preoperative (e.g., CT) images can then be used for guidance. To introduce the use of optical shape sensing into interventional procedures, it is first necessary to integrate optical fibers into one or more devices / systems used in the intervention. By integrating optical shape sensing into the OSS line 300 used during stent placement and registering the stent 215 and stent placement device 200 to the OSS line 300 according to this principle, system 100 can be used with any type of stent and / or placement system with limited impact on the design of the stent or placement mechanism.

[0052] Workstation 105 may include a display 150 for viewing internal images of the subject (patient) 400, which may include images 145 (preoperative or intraoperative images) or OSS data as overlays or other renderings, registered together with OSS lines 300 in one or more components used during the surgery. Display 150 may also allow the user to interact with workstation 105 and its components and functions (e.g., touchscreen, graphical user interface, etc.), or any other element within system 100. This is further facilitated by interface 155, which may include a keyboard, mouse, joystick, haptic device, or any other peripheral or control to allow user feedback from and interaction with workstation 105.

[0053] One step in stent placement is the localization of X-ray visible (transmissive) markers. These markers are initially located as the stent 215 is advanced along the OSS line 300 to the approximate location of interest within the vessel 405 via the stent delivery device 200. If the stent 215 can be partially placed, the markers are reused to fine-tune the position of the stent 215. Placing a three-dimensional stent 215 within a three-dimensional anatomy is challenging and is typically performed under two-dimensional imaging guidance via X-ray fluoroscopy. Consequently, the operation time for stent 215 placement can become very long. The apparatus, system, and method of this disclosure potentially reduce operation time and provide immediate confirmation of the effectiveness of stent implantation.

[0054] refer to Figure 2 The stent placement device 200 may include one or more controls or stable handles 205, which, depending on the design, are used to perform multiple tasks, such as retracting the outer sheath 240 covering the stent 215 during introduction into the subject's blood vessels, advancing the shaft 210 carrying the stent 215, adjusting the OSS line 300, or any other useful function, depending on the design of the stent placement device 200 and the functions it needs to perform. Reference Figure 3 Draw along Figure 2 The image shows an enlarged longitudinal side view of the distal portion of the support deployment device 200 and the distal portion of the OSS line 300, taken from line AA, wherein the support 215 is attached to the shaft 210 of the support deployment device 200, at least in part because the outer sheath 240 holds the self-deployed support 215 in a retracted configuration. (Reference) Figure 4 The outer sheath 240 has been retracted proximally relative to the self-deployed bracket 215 and shaft 210 (or the shaft 210 and self-deployed bracket 215 have extended distally to the outer sheath 240), allowing the self-deployed bracket 215 to extend radially into an extended configuration. (Continue to refer to...) Figure 3 The outer sheath 240 includes a sensor 270 located at its distal end, and the shaft 210 of the stent delivery device 200 includes a sensor 275. When the outer sheath 240 retracts proximally relative to the self-deployed stent 215 and / or the shaft 210 (or when the shaft 210 and the self-deployed stent 215 extend distally to the outer sheath 240), the sensors 270 and 275 overlap, and one or both sensors send a signal to the workstation 105, wherein the sensor signal indicates that the stent 215 has been deployed into the blood vessel of the subject 400.

[0055] The stent placement device 200 is configured such that a handle 205 can be rigidly attached to the stent 215 in both axial and torsional directions. This allows the stent 215 to be reoriented during surgery, but can also be reused to maintain registration between the OSS line 300 and the stent placement device 200. This can be achieved in several different ways.

[0056] According to examples in this disclosure, a method and system are described to determine, identify, and / or derive tube diameter measurements (e.g., measurements of true / derived diameter) using intravascular imaging (e.g., by using IVUS and / or OCT imaging systems), which are used for tube and stent sizing procedures and / or surgeries. Exemplary IVUS systems are disclosed in U.S. Patent No. 7,930,014 (filed January 11, 2006, entitled “VASCULAR IMAGE CO-REGISTRATION”), U.S. Patent Application No. 14 / 594,599 (filed January 12, 2015, entitled “DETECTING ENDOLEAKSASSOCIATED WITH ANEURYSM REPAIR”), and U.S. Patent Application No. 14 / 798,218 (filed July 13, 2015, entitled “DEVICES, SYSTEMS, AND METHODS FOR IMPROVED ACCURACY MODEL OF VESSELANATOMY”), the entire disclosure of which is expressly incorporated herein by reference.

[0057] Figure 6A A tube 405 with a narrow section is shown. For example, Figure 6A This is a partial cross-sectional perspective view of tube 405. Tube 405 includes a proximal portion located on the left side of the figure and a distal portion located on the right side of the figure. Between the proximal and distal portions, a lumen 410 extends along the length of tube 405. In this respect, the lumen 410 allows fluid to flow through the tube. In some cases, tube 405 is a blood vessel. In some cases, tube 405 is a coronary artery, peripheral artery, or peripheral vein. In such cases, the lumen 410 is configured to facilitate blood flow through tube 405.

[0058] As shown in the figure, tube 405 includes a narrow portion 415 located between a proximal portion and a distal portion. The narrow portion 415 generally represents any obstruction or other structural arrangement that restricts fluid flow through the lumen 410 of tube 405. Examples of this disclosure are applicable to a variety of vascular applications, including coronary arteries, peripheral arteries (including, but not limited to, lower extremity, carotid, and neurovascular arteries), kidneys, and / or veins. When tube 405 is a blood vessel, the narrow portion 415 may be the result of plaque buildup, including but not limited to plaque components such as fibrous tissue, fibrinoids (fibrofatty substances), necrotic core, calcifications (dense calcium), blood, fresh thrombi, and mature thrombi. Generally, the composition of the narrow portion will depend on the type of tube being evaluated. In this respect, it should be understood that the concepts of this disclosure are applicable to virtually any type of obstruction or other narrowing of a tube that results in reduced fluid flow.

[0059] Continue to refer to Figure 6AThe lumen 410 of tube 405 has a diameter 420 proximal to the narrow portion 415 and a diameter 470 distal to the narrow portion. In some cases, diameters 420 and 470 are substantially equal to each other. In this respect, diameters 420 and 470 may represent healthy portions of the lumen 410, or at least portions that are healthier than the narrow portion 415. Therefore, these healthy portions of the lumen 410 are shown as having a substantially constant cylindrical profile, and thus the height or width of the lumen is referred to as the diameter. However, it should be understood that in many cases, these portions of the lumen 410 may also have plaque buildup, asymmetrical profiles, and / or other irregularities, but to a lesser degree than the narrow portion 415, and therefore will not have a cylindrical profile. In this case, diameters 420 and 470 are understood to represent the relative dimensions or cross-sectional areas of the lumen and do not imply a circular cross-sectional profile. In some examples, diameters 420 and 470 may not have equal diameters, but can still represent healthy portions (e.g., in the example where tube 405 is a vein). In other words, in such examples, healthy portions can also be represented by other criteria, such as area, plaque load, eccentricity (e.g., the mathematical eccentricity of a conical cross-section that uniquely characterizes its shape eccentricity based on a measurement of deviation from roundness), and so on.

[0060] like Figure 6A As shown, the stenosis 415 includes plaque deposits 425 that narrow the lumen 410 of the tube 405. In some cases, the plaque deposits 425 do not have a uniform or symmetrical profile, making the angiographic assessment of such stenosis unreliable. In the illustrated example, the plaque deposits 425 include an upper portion 430 and an opposing lower portion 435. In this respect, the lower portion 435 has an increased thickness relative to the upper portion 430, resulting in an asymmetrical and non-uniform profile relative to the proximal and distal portions of the lumen of the stenosis 415. As shown, the plaque deposits 425 reduce the available space for fluid flow through the lumen 410. Specifically, the cross-sectional area of ​​the lumen 410 is reduced due to the plaque deposits 425. At the narrowest point between the upper portion 430 and the lower portion 435, the lumen 410 has a height 440, which represents the reduced size or cross-sectional area relative to the diameters 420 and 470 of the stenosis 415. The narrow portion 415 may extend longitudinally between the proximal shoulder 450 and the distal shoulder 445. The shoulders 450 and 445 may be the starting / ending regions of the plaque deposit 425. The length of the narrow portion 415 may be defined by the length between the proximal shoulder 450 and the distal shoulder 445. It should be noted that the narrow portion 415 including the plaque deposit 425 is merely exemplary and should not be considered as restricting in any way. In this respect, it should be understood that the narrow portion 415 may have other shapes and / or compositions that restrict fluid flow through the lumen 410 in other cases. Although the tube 405 is in Figure 6AThe example is shown as having a single narrow section 415, and the following description of the example is primarily in the case of a single narrow section; however, it should be understood that the apparatus, system and method described herein have similar applications for tubes with multiple narrow sections.

[0061] In some examples, instead of plaque buildup 425, the lumen 410 of tube 405 may also be narrowed based on other factors. For example, in peripheral vessels (e.g., veins), narrowing of the lumen 410 may be caused by pressure from an external vessel (e.g., pressure from an external artery). Therefore, the methods described below can also be used to determine the outlet diameter of tube 405 that has been compressed due to an external vessel and / or other factors.

[0062] Treatment of the stenosis 415 may include positioning a stent 215 within the lumen 410. The stent 215 may be configured to restore normal or near-normal fluid flow through the lumen 410 by increasing its size or cross-sectional area. That is, refer to... Figure 6B The bracket 215 can increase the height 440' at the narrowest point between the upper part 430 and the lower part 435 to greater than Figure 6A The height is shown. In some examples, the diameter of stent 215 may be approximately equal to a diameter of 420 or 470. Stent 215 may extend between the proximal shoulder 450 and the distal shoulder 445. The length of stent 215 may be similar to the length of the stenosis. The proximal and distal ends of stent 215 may include stent struts that are well opposed to the lumen wall 450 when stent 215 is properly positioned within lumen 410. Stent struts may be positioned near the proximal shoulder 445 and the distal shoulder 450.

[0063] To determine an appropriate treatment plan for stent placement within tube 405, including determining the length and / or diameter of the stenosis and / or the appropriate length and / or diameter of the stent, a separate imaging system 160 may be used. The separate imaging system 160 may include endovascular devices such as catheters, guidewires, or guiding catheters. At a high level, the endovascular device may be a separate intravascular ultrasound (IVUS) device, such as a rotating IVUS device or a solid-state IVUS device. In this respect, the IVUS device can emit ultrasound energy from an imaging element or transducer element included in a scanner assembly mounted near the distal end of the IVUS device. A rotating IVUS device may include an imaging element or transducer element. A solid-state IVUS device may include an array formed of imaging elements or transducer elements.

[0064] Alternatively, refer to Figure 3 and Figure 4The endovascular device used to determine the length and / or diameter of the stenosis can be a stent delivery device 200 with included IVUS capabilities. For example, the stent delivery device 200 may include an array of transducer elements 225 positioned in a ring configuration around the longitudinal axis of the scanner. The emitted ultrasound energy is reflected by tissue structures in the medium surrounding the scanner assembly, and the ultrasound echo signal is received by the transducer elements 225. In some examples, the transducer elements may be positioned adjacent to the distal portion 220 of the stent delivery device 200. In this respect, the transducer elements 225 may be positioned at a distance of less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and / or less than 1 cm from the distal end of the stent delivery device 200. It should be understood that the transducer elements 225 may be positioned at any location along the stent delivery device 200, including any distance from the distal end. In some cases, the transducer elements 225 may be positioned at the distal end of the stent delivery device 200. However, preferably, as... Figure 3 As shown, when the support 215 is coupled to the shaft 210 in a retracted configuration, the transducer element 225 is positioned at the distal end of the support transport device 200 at a position distal to the axial position of the support 215. It should be understood that the support transport device 200 can be positioned distal to the narrow portion 415 in the tube 405, and before and after the deployment of the support 215, the support transport device 200 is pulled back manually or automatically to image the plaque deposit 425.

[0065] Scanner assembly 225 may include an integrated circuit controller chip configured to activate transmitter circuitry to generate electrical pulses to excite transducer elements and to receive amplified echo signals received from the transducer elements via an amplifier included on the integrated circuit controller chip. In an example where the support delivery device 200 includes a transducer array 225, the integrated circuit controller chip may be configured to select specific transducer array elements for transmission and / or reception. The processing architecture of the integrated circuit controller chip may resemble the structure described in U.S. Provisional Application No. 61 / 746,804, filed December 28, 2012, the entire contents of which are incorporated herein by reference. The frequency of the transmitted signal from the transducer elements may be controlled by the integrated circuit controller chip, the IVUS processing module 135 in the memory 115 of workstation 105, and / or another module in workstation 105.

[0066] An integrated circuit controller chip can be configured to excite transducer elements to emit ultrasonic energy at multiple frequencies during each A-scan. The transducer elements can be configured to emit various frequencies to optimize the collection of information about portions within tube 405, such as blood, plaque, outer membrane, calcium deposits, stent struts, etc. The various frequencies can interrogate the corresponding portions of tube 405 with improved accuracy. For example, a low-frequency A-array can be used to detect high-density objects (such as stents, calcium deposits) during low-gain reception and plaque / outer membrane during high-gain reception. Low-frequency A-scans can be in the range of approximately 5 MHz to approximately 30 MHz, approximately 5 MHz to approximately 25 MHz, approximately 10 MHz to approximately 30 MHz, and / or other suitable values. For example, a high-frequency A-array can detect fine details within tissue regions. High-frequency A-scans can be in the range of approximately 30 MHz to approximately 80 MHz, approximately 30 MHz to approximately 70 MHz, approximately 40 MHz to approximately 80 MHz, and / or other suitable values. Low-gain reception can be 10 dB to 40 dB lower than high-gain reception, depending on the system's dynamic range. While two frequency ranges—a high-frequency range and a low-frequency range—and two gain ranges—high-gain reception and low-gain reception—are described herein, it should be understood that any number of frequency ranges and / or gain ranges can be utilized. As described in U.S. Provisional Patent Application No. 61 / 740,822, filed December 21, 2012, the entire contents of which are incorporated herein by reference.

[0067] The stent delivery device 200 can be configured to detect blood flow within the tube 405. For example, an integrated circuit controller chip and / or IVUS processing module 135 can be configured to control the transducer element 225 to emit ultrasound energy at the same frequency for the same A-array in a discontinuous manner. For example, consecutive emissions at the same frequency (e.g., different samples from the same A-scan) can be separated in time. During this time, blood will have moved across the transducer element, while stationary tissue will not. Therefore, by separating the ultrasound emissions of the transducer element in time, blood can be identified at locations where movement is indicated by the IVUS imaging data, and tissue can be identified at locations where there is no movement. Samples can be separated into time intervals ranging from about 60 microseconds to about 150 microseconds, 70 microseconds to about 135 microseconds, 80 microseconds to about 120 microseconds, and / or other suitable values. The sampling period can be selected based on, for example, blood flow velocity. Changes in the IVUS imaging data during the time interval between two emissions can be analyzed to determine whether the change indicates blood flow within the wedge of the field of view associated with the A-scan. If the differences in the sample are greater than the expected noise or interference, then the IVUS imaging data can represent blood flow. Blood flow information can be extracted as described, for example, in U.S. Patent Application No. 13 / 974,757, filed August 23, 2013, the entire contents of which are incorporated herein by reference.

[0068] IVUS imaging data collected using multiple temporally separated frequencies and transmissions can be combined to generate a more accurate model of vascular anatomy. For example, blood can be identified as areas with little or no signal reception on low-frequency A-scans. Scaffolds and calcium deposits can be identified as areas with reasonable signal intensity on low-gain reception on low-frequency A-scans. While high-frequency A-scans can be used to image tissue regions, the model of vascular anatomy can incorporate information from all exposures (e.g., high-gain low-frequency, low-gain low-frequency, high-frequency, etc.) to generate a more accurate data representation or visualization of the tissue and reduce blood and / or tissue blotches.

[0069] Workstation 105 may include IVUS processing module 135, which facilitates signal communication between IVUS sensing module 130 and scanner components included in transducer 225. This communication may include, among other things, the following steps: (1) providing instructions to an integrated circuit controller chip; (2) providing a transmit trigger signal to the integrated circuit controller chip to activate transmitter circuitry, generating electrical pulses to excite transducer elements; and (3) receiving amplified echo signals received from the transducer elements via an amplifier included on the integrated circuit controller chip. In some examples, IVUS processing module 135 performs preliminary processing on the echo data before forwarding it to IVUS sensing module 130. For example, IVUS processing module 135 amplifies, filters, and / or summarizes the data. In some examples, PIM 304 also provides high-voltage and low-voltage DC power to support the operation of transducer 225. IVUS processing module 135 transmits (e.g., provides and / or forwards) the received echo signal to IVUS sensing module 130, where, among other things, the ultrasound image can be reconstructed and displayed on monitor or display 150.

[0070] IVUS processing module 135 can receive echo data from transducer 225 via IVUS sensing module 130 and process the data to reconstruct an image of tissue structures in the medium surrounding transducer 225. The echo data can be used to generate a mixed-mode IVUS image that includes both B-mode and flow information. The B-mode image represents the two-dimensional anatomical structure of tissue in a plane perpendicular to the longitudinal axis of transducer 225, with the brightness at any point in the image representing the intensity of the echo signal received from the corresponding location within the tissue. Flow data is associated with a visual representation of the movement of elements in the medium (e.g., blood flow) surrounding the scanner. B-mode data (e.g., using multi-frequency ultrasound transmission) and flow data (e.g., using time-separated ultrasound transmission) can be collected, processed, and / or combined as described herein. Computation system 306 can also output the mixed-mode image on a monitor or display 150.

[0071] Workstation 105 can generally represent any apparatus suitable for performing the processing and analysis techniques discussed in this disclosure. In some examples, workstation 105 includes at least one processor, random access memory, and / or storage medium. In this regard, in some cases, memory 115 is programmed to perform steps related to data acquisition and analysis as described herein. Therefore, it should be understood that any step relating to data acquisition, data processing, instrument control, and / or other processing or control aspects of this disclosure can be implemented by a computing system using corresponding instructions stored on or within a non-transitory computer-readable medium accessible by a computing device. In some cases, workstation 105 is a console device. In some cases, workstation 105 is similar to an S5™ imaging system or an S5i™ imaging system, each available from Volcano. In some cases, workstation 105 is portable (e.g., handheld, trolley-mounted, etc.). Furthermore, it should be understood that in some cases, workstation 105 includes multiple computing devices. In this regard, it should be particularly understood that the different processing and / or control aspects of this disclosure can be implemented individually or using multiple computing devices within a predetermined group. Any division and / or combination of the processing and / or control aspects described below across multiple computing devices is within the scope of this disclosure.

[0072] The additional imaging system 160 may include an angiography / fluorescence fluoroscopy imaging system configured to generate a two-dimensional representation of tube 405. The angiography / fluorescence fluoroscopy imaging system may include an X-ray source. For example, a reference image of tube 405 may be generated by the angiography / fluorescence fluoroscopy imaging system with radiopaque contrast agent injected into tube 405.

[0073] Angiography / fluorescence imaging data can be received at workstation 105. For example, the workstation may include a video capture card. The angiography / fluorescence imaging data can be output to a monitor or display 150. The angiography / fluorescence imaging data can be combined with IVUS imaging data to generate a high-precision model of tube 405. In some examples, IVUS imaging data and angiography / fluorescence imaging data can be collected simultaneously (e.g., during automatic or manual retraction of the stent delivery device 200). For example, IVUS imaging data and angiography / fluorescence imaging data can be registered, as described in, for example, U.S. Patent Application No. 13 / 632,916, filed October 1, 2012 and published as U.S. Patent Application Publication No. 2013 / 0030295 on January 31, 2013, and / or U.S. Patent Application No. 13 / 228,229, filed September 8, 2011 and published as U.S. Patent Application Publication No. 2012 / 0004537 on January 5, 2012, the entire contents of which are incorporated herein by reference. That is, using angiography / fluorescence imaging data, an IVUS image can be associated with the position of the stent 215 delivered by stent delivery device 200 within tube 405. Registration module 140 can be configured to perform processing steps related to the registration of IVUS imaging data and angiography / fluorescence imaging data.

[0074] refer to Figure 3 and Figure 4In some examples, the distal portion of the shaft 210 of the stent delivery device 200 may include one or more orientation marks 230. In some examples, the shaft 210 of the stent delivery device 200 may include multiple orientation marks 230. The orientation marks 230 may be made of a radiopaque material such that they are visible in angiographic / fluorescence imaging data. The orientation marks 230 may be used to determine the longitudinal position of the shaft 210 of the stent delivery device 200 along the tube 405 in the angiographic / fluorescence imaging data. The orientation marks 230 are used to determine the orientation, rotational position, and / or angular rotation of the intravascular device about its own longitudinal axis. Thus, the cross-section of the imaged tube 405 can be determined using the orientation marks 230 described herein. In some examples, the shaft 210 of the stent delivery device 200 may include three orientation marks 230 that are equidistantly spaced around the periphery of the shaft 210 of the stent delivery device 200. For example, three orientation marks 230 may be spaced approximately 120° apart around the periphery of the shaft 210 of the stent delivery device 200. In such an example, at least one of the three orientation marks 230 is visible in any angiographic / fluorescence fluoroscopy image data. In some examples, the orientation marks 230 themselves may be made of a radiopaque material. In some examples, the band around the periphery of the stent delivery device 200 may be made of a radiopaque material. The orientation marks may be notches or cuts in the radiopaque band. The orientation marks 230 may be positioned proximal to the transducer element 22 (e.g., ...). Figure 3 and Figure 4 (as shown) or distal side.

[0075] The orientation marker 230 can be asymmetrical, such as serrated. The serrated shape may include one side extending parallel to the longitudinal axis of the stent delivery device 200 and another side extending obliquely relative to the longitudinal axis. When the stent delivery device 200 rotates in a top-facing direction, the angled side will appear top-facing in the angiography / fluorescence imaging data. Similarly, when the stent delivery device 200 rotates in a bottom-facing direction, the angled side will appear bottom-facing. Therefore, the IVUS processing module 135 can determine whether the transducer device 225 is rotating towards the front or rear of the tube 405. The IVUS processing module 135 can measure the distance from the top or bottom of the stent delivery device 200 to the parallel side of the orientation marker 230 to determine the angle of rotation of the stent delivery device 200. Whether the stent delivery device 200 is rotating forward or backward and the angle of rotation can be used to determine the wedge shape of the cross-section of the tube 405 or the total field of view of the stent delivery device 200 being imaged. The serrated shape is a non-limiting example, and different shapes may be used in different examples.

[0076] The registered IVUS image can be rotated based on the rotation angle of the stent delivery device 200 determined using orientation marker 230. In some cases, the width or diameter 420, 470 of the lumen 410 can be measured in the angiography / fluorescence imaging data. In the registered IVUS image, the width or diameter 420, 470 of the lumen 410 is expected to be the same. The measured width provides a starting point for determining the location and contour of the lumen wall in the registered IVUS image. For example, the IVUS processing module 135 can be configured to use this information to perform a boundary detection algorithm. When using seed points (such as the width or diameter measured from the angiography / fluorescence imaging data), the boundary detection algorithm can potentially provide more accurate results, as opposed to when the boundary detection algorithm must first guess the starting point and then follow that boundary. Therefore, knowledge of the cross-section of the tube 405 imaged by the transducer, and knowledge of the position of the stent delivery device 200 within the tube 405, can be used to determine the diameter and cross-sectional area of ​​the tube 405 with high accuracy.

[0077] In some examples, the stent delivery device 200 includes features similar to those of a conventional rotary IVUS catheter, such as those available from Volcano. Catheter. In some examples, IVUS devices include features similar to conventional solid-state IVUS catheters, such as those available from Volcano. Catheters and those disclosed in U.S. Patent No. 7,846,101 (the entire contents of which are incorporated herein by reference). For example, stent delivery device 200 includes a scanner assembly 225 near its distal end and a transmission harness extending along the longitudinal body of stent delivery device 200. The transmission harness terminates at the proximal end of stent delivery device 200 to a Patient Interface Module (PIM) connector. The PIM connector electrically connects the transmission harness to the PIM and physically connects the stent delivery device 200 to the PIM. In one embodiment, stent delivery device 200 also includes a guidewire exit port 290. Thus, in some cases, stent delivery device 200 is a rapid-exchange catheter. Guidewire exit port 290 allows distal insertion of an OSS line 305 to guide stent delivery device 200 through tube 405.

[0078] In some examples, the stent delivery device 200 is configured to image within the tube 405 while being moved through the lumen 410. In some cases, the stent delivery device 200 is configured to move through the lumen 410 and across the stenosis 415. Therefore, IVUS imaging data can be collected at multiple locations across the entire region of interest of the tube 405. The region of interest may include the stenosis 415. In this regard, the stent delivery device 200 is positioned distal to the stenosis 415 and, in some cases, moved proximally (i.e., pulled back) across the stenosis to a position proximal to the stenosis. In other cases, the stent delivery device 200 is positioned proximal to the stenosis 415 and moved distally across the stenosis to a position distal to the stenosis. In some examples, the movement of the stent delivery device 200, whether proximal or distal, is manually controlled by a medical professional (e.g., a surgeon's hand). In other examples, the movement of the support delivery device 200, whether proximal or distal, is controlled by a movement control device (e.g., a pull-back device, such as the Trak available from Volcano). II) Automatic control of the device. In this respect, the movement control device controls the movement of the support conveyor 200 at a selectable known speed (e.g., 2.0 mm / s, 1.0 mm / s, 0.5 mm / s, 0.2 mm / s, etc.) in some cases. In some cases, the movement of the IVUS device 302 through the tube is continuous with each pull-back or push. In other cases, the support conveyor 200 is moved stepwise through the tube (i.e., repeatedly moving a fixed amount of distance and / or a fixed amount of time).

[0079] Figure 7 , Figure 8 and Figure 9 The flowcharts are respectively flowcharts of methods 700, 800 and 900 for imaging blood vessels according to various aspects of this disclosure. Figure 7This is a flowchart of method 700 for determining the dimensions of an imaged blood vessel and / or stenosis using geometric measurements (e.g., area, volume, and / or perimeter). The steps of method 700 may be performed by an OSS line 300, an IVUS portion of a stent delivery device 200, a separate IVUS device, an angiography / fluorescence imaging system shown as an additional imaging system 160, a computing system of workstation 405, and / or combinations thereof. In other examples, another invasive intravascular imaging (IVI) system or device, such as an optical coherence tomography (OCT) imaging system and / or a near-infrared spectroscopy (NIRS) system, may perform the steps of methods 700, 800, and / or 900. Furthermore and / or alternatively, a non-transitory computer-readable medium (e.g., memory within the computing system of workstation 105) may include instructions that, when executed by one or more processors (e.g., processors within the computing system), cause the processors to perform the steps of methods 700, 800, and / or 900.

[0080] refer to Figure 7 In operation, at step 702, a computing system (e.g., one or more processors) acquires fluorescence fluoroscopic image data of the region of interest within the blood vessel. The fluorescence fluoroscopic image data can be acquired using an X-ray source. In some examples, the fluorescence fluoroscopic image data can be acquired before and / or simultaneously with the acquisition of intravascular optical shape sensing data and / or IVUS imaging data. For example, a reference fluorescence fluoroscopic image can be acquired using a contrast agent before acquiring OSS data and / or IVUS imaging data. For example, the reference image can be used to roughly identify the region of interest. The computing system can generate a visual representation of the fluorescence fluoroscopic image data and output this visual representation separately from a visual representation of a model of the region of interest to display 150. The fluorescence fluoroscopic image data can also be acquired simultaneously with the acquisition of OSS data and / or IVUS imaging data. For example, fluorescence fluoroscopic image data can be acquired simultaneously with the acquisition of OSS data and / or IVUS imaging data during manual or automatic insertion and / or retraction of the OSS line 300 and / or stent delivery device 200 across the region of interest. As described herein, the fluorescence fluoroscopic image data and the OSS data and / or IVUS imaging data can be registered.

[0081] At step 704, the computing system acquires intravascular optical shape sensing data at multiple locations across the entire region of interest. The intravascular optical shape sensing data may be acquired by the OSS line 300. The region of interest may include obstructions (such as stenosis 415) and / or compressions (such as compression caused by pressure from an external artery) that restrict blood flow through the tube 405. In some examples, the OSS sensing module 120 and / or OSS processing module 125 of the computing system may generate OSS images at each of the multiple locations across the entire region of interest based on the intravascular optical shape sensing data, and output these OSS images separately from a visual representation of the model of the region of interest to a monitor (e.g., a display device and / or other type of user interface device) 150. Reference Figure 10 The diagram illustrates a composite 3D image 1000, which shows a 3D image 1010 of a vascular bundle generated from the OSS line 300 and a series of two-dimensional IVUS images 1020 superimposed on the 3DOSS image 1010.

[0082] Refer again Figure 7 At step 706, the computing system acquires IVUS imaging data at multiple locations across the entire region of interest. The IVUS imaging data can be acquired using IVUS components, such as transducer element 225 mounted on the stent delivery device 200 or a separate intravascular device (not shown) capable of acquiring IVUS imaging data. In some examples, the IVUS sensing module 130 and / or IVUS processing module 135 of the computing system can generate two-dimensional IVUS images at each of the multiple locations across the entire region of interest based on the IVUS imaging data, and output these IVUS images separately from a visual representation of a model of the region of interest to a monitor (e.g., a display device and / or other type of user interface device) 150. (Refer to again...) Figure 10 A series of two-dimensional IVUS images 1020 and 3D OSS images 1010 are registered using common and complementary coordinate sets (e.g., x, y, z coordinate systems), such that each IVUS image 1020 is superimposed and stitched onto the 3D OSS image 1010, thereby producing a synthetic 3D image 1000 that shows both OSS image data and IVUS image data in 3D format, thereby increasing clinicians' understanding and perception of areas of interest in the blood vessels and reducing interventional procedure time associated with such areas of interest.

[0083] IVUS imaging data at each of multiple locations may include multiple components corresponding to different frequencies of ultrasound emission. In some examples, the multiple components may include a first component corresponding to a first frequency of ultrasound emission, a second component corresponding to a second frequency with a first gain value, and a third component corresponding to the second frequency with a second gain value. While three components are described herein, it should be understood that more than three components may be used, corresponding to different frequencies and / or gain values. For example, the first frequency may be a relatively high frequency, while the second frequency may be a relatively low frequency. For example, the first gain value may be a relatively high gain value, while the second gain value may be a relatively low gain value. The first and second frequencies may be selected such that the ultrasound emission behaves differently in blood and tissue. For example, a low frequency may be selected such that the wavelength of the ultrasound emission is larger than that of blood cells. This may be beneficial for generating more accurate models of vascular anatomy, as soft plaques and blood behave similarly when interrogated by ultrasound energy. By selecting a low-frequency emission, only tissue, not blood, is imaged by the low-frequency emission. High-frequency and low-frequency emissions can be used to acquire information about tissue. In a similar manner, high-gain and low-gain values ​​may be selected to optimize the acquisition of IVUS imaging data. For example, low-frequency, low-gain emission can be used to identify stent struts and calcium deposits, both of which appear as saturated portions in IVUS images. IVUS imaging data associated with low-frequency, low-gain emission can be used to more easily identify stent placement, making it easier, for example, to determine the degree of stent repositioning relative to the lumen wall 410.

[0084] The successive ultrasound emissions, each associated with a different frequency, can be temporally separated. For example, the transducer element 230 of the stent delivery device 200 and / or another intravascular device can be controlled to transmit ultrasound energy in the following order: ultrasound emission associated with a first frequency, ultrasound emission associated with a second frequency having a first gain value, and ultrasound emission associated with a second frequency having a second gain value. While three ultrasound emissions are described herein, it should be understood that more than three ultrasound emissions, for example, ultrasound emissions associated with different frequencies and / or gain values, can be utilized. This can improve the efficiency of IVUS imaging data acquisition by interleaving emissions with different frequencies and / or gain values. For example, successive high-frequency emissions can be compared to extract blood flow information. The time between high-frequency emissions may include low-frequency emissions to extract information about tissue location and / or stents. The specific order disclosed herein is a non-limiting example, and other ultrasound emission algorithms can be implemented in different examples.

[0085] Refer again Figure 7At step 708, the computing system processes the fluorescence fluoroscopy image data, OSS data, and / or IVUS imaging data. At step 710, the computing system uses the fluorescence fluoroscopy image data, OSS data, and / or IVUS imaging data to generate a three-dimensional image and dimensions of the blood vessel (specifically, the region of interest), such as... Figure 10 As shown and discussed above. Reference method 800 ( Figure 8 This describes one or more sub-steps related to processing fluorescence perspectral image data, optical shape sensing data, and / or IVUS imaging data. (See reference) Figure 8 At step 802, the stent delivery device 200 is loaded into the subject's blood vessel on the OSS line 300, and the calculation system uses fluoroscopic image data to determine the position of the OSS line 300 and / or the position of the stent delivery device 200 relative to the X-ray source at each of multiple locations throughout the region of interest. For example, an orientation mark 230 placed on the stent delivery device 200 can be identified in the fluoroscopic image data. The calculation system can be configured to calculate the position of the stent delivery device 200 based on the position of the orientation mark 230 relative to the lumen boundary 410 in the fluoroscopic image data. This position can be the position of the stent delivery device 200 along the tube 405 and / or the rotational position of the stent delivery device 200 within the tube 405.

[0086] refer to Figure 5 This illustrates another example of determining the position of the support conveying device 200 (including support 215) relative to the OSS line 300. The support conveying device 200 may include multiple sets of sensors 250, 250', etc., along its longitudinal axis and / or axial length. For example, Figure 5 A set of sensors 250 in the handle 205 of the support conveyor 200 and another set of sensors 250' in the distal portion of the shaft 210 of the support conveyor 200 are illustrated. Although not shown, the support conveyor 200 may include additional sets of sensors between the handle 205 and the distal portion of the shaft 210. Each set of sensors may include multiple sensors 250a, 250b, 250c, etc. The OSS line may include multiple sets of sensors 310, 310', etc. along its longitudinal axis and / or axial length. For example, Figure 5 A set of sensors 310 at the distal portion of the OSS line 300 and another set of sensors 310' at the relatively proximal portion of the OSS line 300 are illustrated. Although not shown, the OSS line 300 may include additional sets of sensors between the distal and proximal sets of sensors. Each set of sensors may include multiple sensors 310a, 310b, 310c, etc.

[0087] When the OSS line 300 enters the lumen of the stent delivery device 200, and a set of sensors 310 in the OSS line passes a set of sensors 250 in the stent delivery device 200, corresponding signals indicating the positions of the stent delivery device 200 and the stent 215 relative to the OSS line 300 are transmitted from the stent delivery device 200 and / or the OSS line 300 to the computing system (including the registration module 140), and the relative positions of the stent delivery device 200 and the stent 215 relative to the OSS line 300 are registered. For example, a set of sensors 250 in the stent delivery device 200 may be axially located at the same position as the axial position of the stent 215. Alternatively, the axial position of the stent 215 on the stent delivery device 200 relative to one or more sets of sensors 250 may be stored in the memory 115. Furthermore, having multiple 250a, 250b, 250c, etc. in each group of sensors in the delivery device 200 and / or multiple 310a, 310b, 310c, etc. in each group of sensors in the OSS line 300 will allow the computing system to determine the direction of travel of the stent delivery device 200 (e.g., distal or proximal). For example, in a stent implantation procedure, the OSS line 300 may be inserted into the blood vessel first, and then the stent delivery device 200 is inserted into the blood vessel along the OSS line. When one or more groups of sensors 250 in the stent delivery device 200 are in the same axial position as one group of sensors 310 in the OSS line 300, the relative positions of the stent delivery device 200 and the stent 215 relative to the OSS line 300 will be registered, and the distal or proximal direction of travel of the stent delivery device 200 will be recorded and stored in memory.

[0088] Refer again Figure 8 At step 804, the calculation system, specifically registration module 140, registers the fluorescence fluoroscopy image data, OSS data, and / or IVUS imaging data. The simultaneously acquired fluorescence fluoroscopy image data, OSS data, and / or IVUS imaging data can be registered to identify the position of a specific OSS image and / or IVUS image frame along tube 405 within the fluorescence fluoroscopy image data. The OSS image and / or IVUS image frame can be appropriately rotated based on the determined position of the support delivery device 200, allowing for the determination of the position of the lumen wall 410 and the diameters of the lumens 420 and 470 with improved accuracy. (See again...) Figure 10A series of two-dimensional IVUS images 1020 are registered with 3D OSS images 1010, such that each IVUS image 1020 is superimposed and stitched onto the 3D OSS image 1010, thereby producing a synthesized 3D image 1000. This image displays both the OSS image data and the IVUS image data in 3D format, thereby increasing the clinician's understanding and perception of the area of ​​interest in the blood vessel and reducing interventional time associated with this area of ​​interest. Therefore, the synthesized 3D image 1000 can be rotated, allowing the clinician to better view the location of the stenosis 415, the stenosis region, the lumen wall 410, and the diameters of the lumens 420 and 470, as well as other anatomical features of the blood vessel 405 or its area of ​​interest.

[0089] In step 806, the calculation system generates and determines the size of the blood vessel, specifically in Figure 6A The dimension is shown at the obstruction or narrowing 415. This dimension can be generated using, for example, the defined location of the stent delivery device 200, registered fluorescence fluoroscopic image data, OSS image data, IVUS image data, composite image 1000, and / or any combination thereof. The dimension may include location information of the lumen boundary or wall 410 at each of multiple locations throughout the region of interest. The dimension may additionally include location information of one or more portions of the tube 405 (such as the narrowing 415). For example, the dimension may include multiple points within the tube 405 and / or around the lumen wall 410. These points may represent the location and / or contour of one or more portions of the tube 405. The dimension may additionally include length.

[0090] At step 808, the computational system generates a model of the region of interest. This model can be generated using, for example, the determined location of the stent delivery device 200, registered fluorescence fluoroscopic image data, OSS image data, IVUS image data, synthetic image 1000, and / or any combination thereof. The model of the region of interest can be a data or visual representation of one or more components of tube 405. The model may include location information of the lumen boundary or wall 410 at each of multiple locations throughout the region of interest. The model may additionally include location information of one or more portions of tube 405 (e.g., blood, plaque, adventitia, calcium, and stent struts). For example, the model may include multiple points within tube 405 and / or around the lumen wall 410. These points may represent the location and / or contour of one or more portions of tube 405. The model may additionally include feature data associated with each of these multiple points. This feature data can identify portions of tube 405. The data representation of the model can be automatically determined by the computational system before treatment, including the appropriate length and diameter of the stent and the appropriate positioning of the stent strut relative to the lumen wall 410.

[0091] In some examples, the model for generating the region of interest may include determining the boundary between blood and tissue within the vessel. The blood-tissue boundary can be determined using IVUS image data acquired with ultrasound emission, representing random variations of blood from frame to frame, and / or using different frequencies and / or gain values ​​that make the blood less visible. Boundary determination may also consider measurements from registered fluorescence fluoroscopy image data. Therefore, the computational system can calculate measurements such as the diameter, length, area, circumference, and / or volume of the lumen. Boundary determination may also consider the calculated rotational position of the intravascular device relative to the X-ray source, as indicated by catheter orientation markings visible in the fluorescence fluoroscopy image data. The computational system 306 may output an indication of the determined location of the blood-tissue boundary.

[0092] In some examples, generating a model of the region may include determining the boundary between the media and the surrounding adventitia of the vessel. The media-adventitia boundary can be determined based on the location of the defined blood and tissue boundaries of the vessel. Boundary determination may also consider IVUS image data. Specifically, IVUS image data associated with ultrasound emissions at frequencies penetrating the lumen (e.g., such that the media and adventitia are interrogated) can be used to determine the boundary. Boundary determination may also consider the location of the stent strut relative to the luminal boundary. The computational system can output an indication of the determined location of the media-adventitia boundary.

[0093] The visualization of the model may include optical shape-sensing images, IVUS images, fluorescence imaging images, and / or combinations thereof output to display 150. The visualization may be two-dimensional, but is preferably three-dimensional when viewed on display 150. The visualization may include the location and boundaries of one or more portions of tube 405 as described herein for improved accuracy. One or more portions of tube 405 may be colored differently to improve clarity (e.g., blood may be colored differently from tissue, plaque may be colored differently from tissue, etc.). The visualization may present registered fluorescence imaging data, optical shape-sensing data, and IVUS imaging data in an interactive manner. For example, selecting a location along a region of interest in tube 405 in a fluorescence imaging or optical shape-sensing image can recall the corresponding IVUS image frame. The OSS image and IVUS image frames of the model may be rotated based on the position of the stent delivery device 200.

[0094] In some examples, visualization may include generating synthetic OSS and IVUS images using optical shape sensing data and IVUS image data associated with different frequencies and / or different gain values. Synthetic OSS and IVUS images may be relatively clearer in terms of the location of blood, plaque, adventitia, calcification, stent struts, etc., compared to OSS images and IVUS images generated using a single frequency and / or gain value. Synthetic OSS and IVUS images can be generated on a pixel-by-pixel basis by calculating the features of each pixel in the IVUS image frame. The features and / or content of each pixel may be based on IVUS image data associated with different frequencies and / or different gain values. The features of each pixel may include numerical values ​​associated with the echo from the reflected ultrasound waves, whether the pixel corresponds to blood and / or tissue, what specific type of tissue the pixel corresponds to, etc. Synthetic pixel values ​​can be generated by combining information from IVUS image data associated with different frequencies and different gain values. Combining information in this way can advantageously provide optimal pixel values ​​to filter out noise, emphasize anatomical structures, and thus assist physicians in image interpretation. In some examples, the synthesized OSS and IVUS images may include overlay maps with color indicators that define the locations of blood-tissue boundaries, media-adventitia boundaries, and / or stent strut positions. The computational system can output the synthesized OSS and IVUS images.

[0095] In some examples, visualization may include generating a longitudinal representation of the region of interest. The longitudinal representation may be a longitudinal cross-section of the vessel at any angle, similar to the image longitudinal display (ILD) described in U.S. Patent Application No. 14 / 038,106, filed September 26, 2013 (the entire contents of which are incorporated herein by reference). This longitudinal representation may be generated using IVUS image data and / or synthesized IVUS images associated with different frequencies and different gain values. A computing system may output this longitudinal representation. In some examples, the longitudinal representation may include an overlay map with color indicators indicating defined locations such as blood-tissue boundaries, media-adventitia boundaries, and / or stent placement.

[0096] In some examples, the calculation system may determine the location of the minimum luminal area within the vessel. The minimum luminal area may occur at the location where the stenosis 415 results in the narrowest part of the vessel. The location of the minimum luminal area may be calculated based on the blood-tissue boundary. The longitudinal representation may include an indication of the location of the minimum luminal area. In some examples, the calculation system may provide an indication of the stenotic region adjacent to the minimum luminal area in the longitudinal representation. In some examples, method 700 may include determining the location of the vessel that is not stenotic and is closest to the stenotic region. The calculation system may use the generated model to calculate the area, diameter, and / or perimeter of the determined location. Additionally or alternatively, the calculation system may use the generated model to calculate the volume between two determined locations. The calculation system may calculate the stent length / diameter based on the calculated area, diameter, volume, and / or perimeter, as described below. The proposed stent diameter and length may extend the stenotic region to have a diameter similar to the vessel diameters proximal and distal to the stenotic region. The calculation system may output the proposed stent diameter and length.

[0097] As described herein, OSS images, IVUS images, and / or fluorescence perspectral image data can be displayed separately from the model or composite image of the region of interest. In some examples, composite images, OSS images, IVUS images, and / or fluorescence perspectral image data can be displayed at different times than the model of the region of interest (e.g., before and / or after scaffold deployment). In some examples, OSS images, IVUS images, and / or fluorescence perspectral image data are output to different portions of display 150, such as the composite image or model of the region of interest. For example, OSS images, IVUS images, and / or fluorescence perspectral image data can be positioned near the composite image or model of the region of interest.

[0098] Refer again Figure 7 and Figure 8 Methods 700 and 800 are executed by the computing system before the deployment of support 215. (See reference) Figure 3 When the support conveyor 200 is inserted into the tube 405 on the OSS line 300 ( Figure 6A In this configuration, the support 215 is connected to and mounted on the shaft 210 at the distal portion of the support conveying device 200, and the support 215 is axially aligned and positioned adjacent to the narrow portion 415. Figure 4 In the middle, the support 215 separates from the shaft 210 of the support conveying device 200 and extends adjacent to the narrow portion 415, such as Figure 6BAs shown. The outer sheath 240 includes a sensor 270 at its distal end, and the shaft 210 of the stent delivery device 200 includes a sensor 275. When the outer sheath 240 retracts proximally relative to the self-deployed stent 215, and the shaft 210 (or the shaft 210 and the self-deployed stent 215) extends distally to the outer sheath 240, sensors 270 and 275 overlap, and one or both sensors send a signal to workstation 105, wherein the sensor signal indicates that the stent 215 has been placed within the blood vessel of the subject 400, as shown. Figure 6B As shown. Therefore, this signal can be called the support deployment signal.

[0099] refer to Figure 9 This illustrates a method 900 for analyzing a region of interest in a blood vessel and comparing post-implantation data with pre-implantation data after stent 215 has been deployed. For example, step 902 includes receiving a signal indicating that stent 215 has been deployed within a region of interest in the blood vessel of subject 400. As described above, for stent deployment, the outer sheath 240 retracts proximally relative to the deployed stent 215, while the shaft 210 and OSS line remain substantially stationary or fixed. Therefore, immediately prior to stent 215 deployment, system 100 has recorded the relative positions of the OSS line 300 and the stent deployment device 200, calculated the dimensions of the region of interest in the blood vessel, and generated a three-dimensional model or a composite image thereof. Assuming that the OSS line 300 remains substantially stationary during the retraction of the outer sheath 240 and the expansion of the stent 215, step 904 includes accessing stored intravascular optical shape sensing data at multiple locations along the longitudinal axis of the region of interest (specifically, the stenotic area where stent 215 has been implanted). If the OSS line 300 translates or rotates during the retraction of the outer sheath 240 and the expansion of the stent 215, step 904 includes obtaining new intravascular optical shape sensing data at multiple locations along the longitudinal axis of the region of interest (specifically, the stenotic region where the stent 215 has been implanted).

[0100] Figure 9Step 906 of method 900 includes acquiring IVUS imaging data at multiple locations along the longitudinal axis of the region of interest (specifically, the narrow region where the stent 215 has been implanted). Step 908 includes processing OSS data and IVUS imaging data, including registering these data. Step 910 includes determining the dimensions of the vascular region where the stent 215 has been implanted and generating a three-dimensional model or synthetic image of the vascular region with the stent placed. Step 912 includes comparing the dimensions and model of the region of interest immediately before and after stent placement. Accurate comparison of dimensions, three-dimensional models, and synthetic images is made possible by using the OSS line 300, which remains within the vascular region (and is not removed), and the stent delivery device 200. That is, the OSS line 300 generates a three-dimensional image of the vascular region, and because the OSS line 300 remains within the vascular region during stent placement, the system can accurately determine the relative positions of the OSS line 300 and the stent delivery device 200, thereby ensuring the analysis and comparison of the same region of interest. For example, in response to user input received at the computing system, the system can output the determined length, diameter, circumference, and 2D or 3D shape of the stenosis 415 or stenotic region of the blood vessel exactly before and after stent placement, without requiring human interpretation of IVUS imaging data and / or fluorescence fluoroscopic image data.

[0101] For example, 3D synthetic images and models obtained before and after stent placement can be used to compare various measurements, dimensional features, and / or formulas associated with the stenosis region. For instance, synthetic 3D images or models can be used to calculate the distance between the proximal shoulder 450 and the distal shoulder 445. The length of the stent 215 can be determined to be substantially similar to, or slightly larger than, the distance between the proximal shoulder 450 and the distal shoulder 445. In various examples, different calculation methods can be performed using models of the generated region of interest to determine the length of the stenosis region and the stent. In another example, the calculation system can determine the diameter or height 440 of the lumen 410 at the stenosis region 415 within the vessel 405. The calculation system can also determine one or more formulas for calculating the derived diameter (e.g., intrinsic or true diameter) associated with the stenosis region within the vessel or the area where the stent is placed. For example, geometrically derived diameter measurements (e.g., true diameter measurements) provide a method for determining diameter measurements of a vessel profile, area, or volume, regardless of the profile shape (e.g., convex / concave) and without having to examine combinations of profile points to identify minimum / maximum diameters. This is particularly relevant to concave profile cases, which make it more difficult to obtain diameter measurements directly from the vessel profile.

[0102] In other words, based on at least one 2D or 3D cross-sectional image of the blood vessel 405 (e.g., from a generated model or synthetic image), the computational system determines the area, volume, and / or perimeter of a portion of the blood vessel (e.g., a cross-sectional region). For example, as previously described, the computational system can use boundary algorithms to determine (e.g., locate) the lumen boundary. After determining the location of the lumen boundary, the computational system can calculate the area (e.g., the number of pixels within the lumen boundary) and / or the perimeter (e.g., the number of pixels at the lumen boundary). Furthermore and / or alternatively, the computational system can use the generated model and / or multiple different cross-sectional images over the entire region of interest to determine the volume. For example, the computational system can calculate the area at multiple different regions (e.g., regions with stenosis and regions without stenosis). The computational system can then determine the length of the region of interest, including the length of regions with and / or without stenosis. Using this length and / or area, the computational system can calculate the volume 405 of the vessel.

[0103] In some examples, this portion of the blood vessel can be a cross-sectional area of ​​the vessel location with the smallest lumen area (e.g., a stenosis resulting in the narrowest part of the vessel and / or the location of the vessel's smallest cross-sectional area). This portion with the smallest lumen area can be... Figure 6A The location within the blood vessel, associated with a height of 440, is used for indication. In other examples, the calculation system determines the area, volume, and / or circumference of another portion of the blood vessel, such as the portion indicated by a location within the blood vessel associated with a diameter of 420 and / or 470.

[0104] After determining the area, volume, and / or perimeter, the calculation system determines one or more formulas (e.g., perimeter formula, area formula, and / or volume formula) to determine (e.g., calculate) the derived diameter of the blood vessel. The derived diameter is obtained before and after stent placement, and the calculation system suggests or recommends one or more diameters for comparison. In some examples, the calculation system and / or display 150 may include a user input device (e.g., keyboard, mouse, touchscreen). The calculation system can receive user input (e.g., from a physician) indicating a location within the blood vessel via interface 155. The calculation system can determine the area and / or perimeter of that portion (e.g., cross-section) of the blood vessel relative to the location indicated by the user input. In other words, a physician may wish to measure the area / perimeter of a cross-sectional area within the blood vessel, which may or may not be at a location with the minimum luminal area. The calculation system can then determine the area and / or perimeter at the indicated location. The calculation system can then determine how to calculate the derived diameter of the blood vessel using the area and / or perimeter formula.

[0105] In other examples, the calculation system may not accept user input and can automatically determine the derived diameter of the blood vessel. For instance, the calculation system can calculate the volume of the blood vessel, including both the portion with a narrow section and the portion without a narrow section. In some cases, the calculation system may only calculate the volume of the blood vessel with a narrow section.

[0106] In some examples, the computational system may determine one or more formulas (e.g., volume formulas for circles and / or ellipses) based on the ability to determine and / or ascertain the location (e.g., a portion) of the OSS and / or IVUS images acquired within the patient body. For example, based on OSS data and IVUS imaging data (e.g., generated models or synthetic images) and / or one or more formulas, the computational system determines the output diameter of a tube (e.g., associated with a stent). For example, computational system 306 may use one or more formulas determined at step 602 above to determine the output diameter. These one or more formulas may include:

[0107] P = 2πR (1)

[0108] A(circle) = πR 2 (2)

[0109] V(circle) = HA = HπR 2 (3)

[0110] A(ellipse)=πR1R2 (4)

[0111] V(ellipse)=πHR1R2 (5)

[0112] In the above formulas (1)-(5), P represents the perimeter, R represents the radius of the circle, R1 and R2 represent the minor and major axes of the ellipse, V represents the volume of the circle or ellipse, A represents the area of ​​the circle or ellipse, and H represents the height. Then, in some examples, given the length of the vessel profile (i.e., the perimeter P) and assuming the circular geometry of the tube and / or stent, the diameter D is derived. p It can be derived from formula (1):

[0113] D p =2R=P / π (6)

[0114] In other words, the calculation system 306 can use the above formula (6) to determine the derived diameter of the blood vessel based on the circumference measurement from the generated blood vessel model.

[0115] In other examples, given an area (e.g., A) enclosed by the vessel profile (e.g., the lumen or boundary of a blood vessel), and assuming the circular geometry of the tube and / or stent, the diameter D is derived. a It can be derived from formula (2) and / or formula (4).

[0116]

[0117] In other words, the calculation system 306 can use the above formula (7) to determine the derived diameter of the blood vessel based on the area measurement value from the generated blood vessel model.

[0118] In other examples, given a volume (e.g., V) surrounded by a stack of vessel contours (e.g., the lumen or boundary of a vessel) and assuming a circular geometry of the tube and / or stent, the diameter can be derived from formula (3) and / or formula (5).

[0119]

[0120] In other words, the computational system 306 can use the above formula (8) to determine the derived diameter of the blood vessel based on volume measurements from the generated blood vessel model. In some cases, Simpson's rule can be used to calculate the volume (e.g., V) of the stacked vessel contours. In this case, H is the length of the tube represented by the stacked contours (e.g., the length of the tube covered by the imaging frame from which the tube contour is obtained).

[0121] In some examples, the calculation system 306 may use additional and / or alternative formulas to determine the derived diameter of the blood vessel. For example, the calculation system 306 may determine the derived diameter by adding correction terms (e.g., error estimates) to one or more of the formulas described above (e.g., formulas (1)-(8)).

[0122] In some variations, due to imaging conditions and the difficulty of imaging at orthogonal sections, the intrinsic diameter based on the volume established from consecutive imaging sections can more readily represent the derived diameter measurement that can be associated with determining stent size. For example, OSS data and / or IVUS imaging data may include multiple distinct OSS data and / or IVUS images of the tube (e.g., consecutive slices). The calculation system can determine the diameter of each of these images using one or more formulas (e.g., area / perimeter formulas). The calculation system can then average them to determine the derived diameter. For example, the calculation system can use perimeter and / or area formulas to determine multiple distinct diameters. The calculation system can then average the multiple distinct diameters to determine the derived diameter. In some cases, the calculation system can determine the stent's derived diameter using the average diameter (e.g., from multiple distinct composite images) and the tube length.

[0123] In some examples, the calculation system may determine two or more formulas for calculating the derived diameter. For example, the calculation system may initially determine the derived diameter from the volume of the blood vessel (e.g., using formula (6) above). Additionally and / or alternatively, the calculation system may determine the derived diameter from the area and / or perimeter of the blood vessel (e.g., using formulas (5) and / or (6) above). For example, after determining the derived diameter from the volume, the calculation system 306 may receive user input indicating a portion of the blood vessel and / or indicating a formula for the derived diameter. Based on the user input, the calculation system may determine the derived diameter using the perimeter and / or area. In other examples, the calculation system may initially determine the derived diameter from the area. Subsequently, the calculation system may determine the derived diameter from the volume and / or perimeter based on the user input. In still other examples, the calculation system may initially determine the derived diameter from the perimeter. Subsequently, the calculation system may determine the derived diameter from the volume and / or area based on the user input.

[0124] In some variations, the derived diameters calculated for area, perimeter, and / or volume may differ. In such variations, the calculation system can determine a confidence interval or value for each of the derived diameters. The confidence interval can indicate the likelihood that the calculated derived diameter relates to the actual diameter of the blood vessel. In some cases, the calculation system can use more than one method to determine the derived diameter and then determine whether the different derived diameters are within acceptable tolerances (e.g., a pre-determined / pre-defined threshold). If so, the calculation system can use the derived diameter derived according to one of the methods. If not, the calculation system can repeat the above steps to determine a new derived diameter. For example, the calculation system can use geometric measurements (e.g., area, volume, and / or perimeter formulas) from two different angles (e.g., one from clockwise geometry and the other from counterclockwise geometry) to calculate the derived diameter. Furthermore and / or alternatively, the calculation system can use one or more geometric measurements, pixel counts, and / or user input (e.g., user-defined input regarding regions within a composite image) to determine the derived diameter.

[0125] In some cases, the calculation system can use a derived diameter from at least one of the area, perimeter, and / or volume formulas to determine the accuracy of the derived diameter (e.g., whether the derived diameter is an accurate representation of the tube's diameter). For example, if the derived diameters differ between the area, perimeter, and / or volume formulas, the calculation system can determine whether the derived diameters are within a predetermined range relative to each other. If not, the calculation system can determine a new derived diameter from the formulas. In other words, these formulas can be used as checks to determine whether they accurately represent the actual diameter of the blood vessel. If the differences between them exceed a predetermined range, the calculation system can determine a new derived diameter (e.g., from another cross-sectional area of ​​the tube) for use with a stent.

[0126] The natural tendency of a tube can be assumed to be circular, so the calculation system may apply formulas (6), (7), and / or (8) to calculate the derived diameter (e.g., the diameter of the tube). The assumption of a circular shape also applies to supports that are circular, and their dimensions are determined based on their diameter and length. The above methods and systems are particularly advantageous when the tube is deformed and / or its profile is not circular. In such cases, the profile perimeter, the area enclosed by the profile, and the volume enclosed by the stack of profiles can still be generated. Using any of these measurements, the derived diameter of the tube can be derived based on formulas (6), (7), and / or (8).

[0127] The foregoing discussion is provided for illustrative and descriptive purposes. It is not intended to limit this disclosure to the one or more forms disclosed herein. For example, see again... Figure 7 , Figure 8 and Figure 9 Methods 700, 800, and 900 are generally described in this disclosure as being performed by a computing system prior to stent placement 215, and method 900 being performed during and after stent placement. However, this disclosure envisions methods 700 and 800 being performed by the same stent delivery device 200, OSS line 300, and computing system before and after stent placement, wherein 3D images and dimensions of vessels are determined for the same region of interest (the same location within the same region of interest), wherein the region of interest does not include a stent before treatment, but includes a stent after treatment, since stent placement is treatment. In this case, method 900 would include step 902, step 904 would include accessing 3D images and dimensions of vessels in the so-called previously obtained pre-treatment and post-treatment regions of interest (with and without stents), and step 912 would include comparing the 3D images and dimensions of vessels at the region of interest before and after stent placement (pre-treatment and post-treatment) and outputting the comparison results.

[0128] In the foregoing summary section, for the purpose of simplifying this disclosure, various features of this disclosure have been combined in one or more aspects, examples, and / or configurations. Features of aspects, examples, and / or configurations of this disclosure may be combined in alternative aspects, examples, and / or configurations different from those discussed above. This disclosure approach should not be construed as reflecting an intention that the claims require more features than those expressly recited in each claim. Rather, as reflected in the following claims, the inventive aspect lies in fewer than all features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are incorporated herein by reference, and each claim stands independently as a separate preferred embodiment of this disclosure.

[0129] Furthermore, although the description has included descriptions of one or more aspects, examples, and / or configurations, as well as some variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure, for example, which, upon understanding this disclosure, may be within the skill and knowledge of a person skilled in the art. The aim is to obtain rights to alternative aspects, examples, and / or configurations included within the permitted scope, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps to be claimed, whether or not such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to publicly dedicate any patentable subject matter.

Claims

1. A support delivery system, comprising: Shape sensing lines are configured to generate shape sensing data representing the region of interest within the blood vessels of a subject. A stent delivery device is disposed on the shape sensing line, wherein the stent delivery device includes a stent and an imaging element disposed distal to the stent, the imaging element being configured to generate intravascular ultrasound imaging data representing the region of interest. A computing system, comprising: One or more processors; and A memory that stores instructions, which, when executed by the one or more processors, cause the one or more processors to: Receive a plurality of first signals corresponding to the shape sensing data; Receive multiple second signals corresponding to the intravascular ultrasound imaging data; Register the first signal and the second signal; The first and second signals are processed to generate a pre-deployment 3D model of the region of interest. Based on the pre-deployment 3D model, determine the pre-deployment size characteristics of the region of interest; Receive a support deployment signal indicating that the support is to be deployed; After receiving the bracket deployment signal, multiple third signals corresponding to the shape sensing data are received; After receiving the stent deployment signal, multiple fourth signals corresponding to the intravascular ultrasound imaging data are received; Register the third signal and the fourth signal; The third and fourth signals are processed to generate a post-deployment 3D model of the region of interest. Based on the deployed 3D model, determine the deployed size characteristics of the region of interest; Calculate the comparison results of the dimensional characteristics before deployment and the dimensional characteristics after deployment; and The comparison results are provided to the monitor.

2. The support conveying system according to claim 1, wherein, The support delivery device includes a sensor, wherein the sensor generates a support deployment signal when the sheath retracts onto the support delivery device.

3. The support conveying system according to claim 1, wherein, The initial and updated size features are based on the derived diameter.

4. The support conveying system according to claim 3, wherein, The derived diameter is based on the area, volume, or perimeter of the region of interest.

5. The support conveying system according to claim 4, wherein, The derived diameter is based on the area of ​​the region of interest.

6. The support conveying system according to claim 4, wherein, The derived diameter is based on the volume of the region of interest.

7. The support conveying system according to claim 4, wherein, The derived diameter is based on the perimeter of the region of interest.

8. The support conveying system according to claim 3, wherein, The derived diameter is based on at least two of the area, volume, and perimeter of the region of interest.

9. The support conveying system according to claim 1, wherein, The stent delivery system also includes a fluorescence fluoroscopic imaging device to generate fluorescence fluoroscopic image data corresponding to the region of interest.

10. The support conveying system according to claim 1, wherein, The memory stores instructions that, when executed by the one or more processors, also cause the one or more processors to register the fluorescence perspective image data with the first signal and the second signal, and process the fluorescence perspective image data together with the first signal and the second signal to generate the pre-deployment three-dimensional model of the region of interest.

11. A computing system, comprising: One or more processors; as well as A memory that stores instructions, which, when executed by the one or more processors, cause the one or more processors to: Multiple first signals are obtained corresponding to shape sensing data of the region of interest within the subject's blood vessels; Multiple second signals corresponding to intravascular ultrasound imaging data of the region of interest are obtained; Register the first signal and the second signal; The first signal and the second signal are processed to generate a pre-deployment three-dimensional composite image of the region of interest; Based on the pre-deployment 3D composite image, determine the initial blood volume that can pass through the area of ​​interest; Receive a bracket deployment signal indicating that the bracket is placed within the area of ​​interest; After receiving the bracket deployment signal, multiple third signals corresponding to the shape sensing data are received; After receiving the stent deployment signal, multiple fourth signals corresponding to the intravascular ultrasound imaging data are received; Register the third signal and the fourth signal; The third and fourth signals are processed to generate a post-deployment 3D composite image of the region of interest. Based on the three-dimensional composite image after deployment, determine the updated blood volume that can be obtained through the area of ​​interest; Calculate the comparison result between the initial blood volume and the updated blood volume; as well as A comparison signal is provided to indicate the comparison result.

12. A non-transitory computer-readable medium storing instructions for execution by one or more processors incorporated into a system, wherein, The instruction being executed by the one or more processors causes the one or more processors to: Obtain initial optical shape sensing data of blood vessels; Obtain initial intravascular imaging data of the blood vessel; Register the initial optical shape sensing data and the initial intravascular imaging data; An initial three-dimensional model is generated based on the initial optical shape sensing data and the initial intravascular imaging data; Determine the initial derived diameter associated with a portion of the initial 3D model; Obtain subsequent intravascular imaging data of the blood vessel; Register the initial optical shape sensing data and the subsequent intravascular imaging data; A subsequent 3D model is generated based on the initial optical shape sensing data and the subsequent intravascular imaging data. Determine the subsequent derived diameter associated with a portion of the subsequent 3D model; as well as A signal representing the comparison result between the initial derived diameter and the subsequent derived diameter is provided to the monitor.

Images