Systems, devices, and methods for forward interlayer reentry

Abstract

An example catheter includes a housing having a catheter distal region configured to be at least partially disposed within a body and a catheter proximal region configured to be at least partially retained outside the body. The catheter may define an imaging device lumen configured to receive an imaging device, a guidewire lumen, an exit chute, and an indicator lumen configured to receive an indicator detectable by the imaging device. The guidewire lumen is configured to receive a guidewire and includes a distal region and a proximal region. The exit chute extends from the guidewire lumen at or near an intersection of the distal and proximal regions of the guidewire lumen. The catheter may also include one or more guidewire feeders configured to move the guidewire from the proximal section to the outlet chute.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the following documents: U.S. Provisional Patent Application No. 63 / 311,852, filed on February 18, 2022, entitled “METHODS AND SYSTEMS CONFIGURED TO DETERMINE AN ​​ORIENTATION OF A CATHETER”; U.S. Provisional Patent Application No. 63,311,871, filed on February 18, 2022, entitled “ROTATIONAL IMAGING DISTORTION CORRECTION”; and U.S. Provisional Patent Application No. 63 / 479,850, filed on January 13, 2023, entitled “SYSTEMS, DEVICES AND METHODS FOR ANTEGRADE DISSECTION AND REENTRY”, each of which is incorporated herein by reference in its entirety for all purposes. Summary of the invention

[0003] Anatomically complex chronic total occlusions (CTOs) often require the utilization of extraplaque or former “subintimal” spaces for successful CTO recanalization. Anterior dissection reentry (ADR) technology is an important component of the contemporary hybrid approach to percutaneous coronary intervention (PCI) for CTOs. However, despite the availability of dedicated reentry devices, the success rate of ADR is approximately 50-60% in large registries. This is often due to massive extraplaque hematoma formation, resulting in loss of distal vessel visibility, guidewire support, and maneuverability, making reentry challenging. Existing ADR and antegrade guidewire recanalization are both blind strategies due to the lack of real-time visual guidance from angiography, and they do not provide high precision in maneuvering and advancing the reentry device.

[0004] A plurality of embodiments relate to methods and systems configured to perform intravascular imaging and / or forward dissection reentry for treating chronic total occlusion of a blood vessel, including coronary and peripheral vascular systems. For example, a catheter may be configured to support and aim a steerable guidewire under guidance from parallel optical coherence tomography ("OCT") imaging. In some examples, the catheter may include a tip having a radiopaque marker, a torque shaft, a catheter rotator assembly, a guidewire introduction port, an imaging drive shaft with an optical fiber, an imager with longitudinal translation, and a housing. The tip of the catheter also includes two ports, one for axial loading of a guidewire and the other for radial withdrawal of the guidewire. The tip of the catheter may be optically transparent in the visible to infrared light spectrum. The catheter is configured to be attached to an imaging console and a slide assembly to perform OCT.

[0005] The method includes obtaining one or more images at one or more locations along the length of the catheter using an OCT imaging device. The method also includes detecting the position of a marker or feature that is fixed and constantly present relative to the center of the OCT imaging device, such as an eccentric edge of an indicator lumen or a catheter body. The method also includes applying a template including an exit ramp indicator to the one or more images. The exit ramp indicator is a two-dimensional graphic or a three-dimensional enhanced graphic. The exit ramp indicator is displayed as opaque or translucent on the one or more images.

[0006] Some embodiments also relate generally to image processing and, more particularly, to methods and apparatus for correcting non-uniform rotational distortion in catheter-based imaging systems.

[0007] There is a need to provide a solution to visualize cross-sectional views of anatomical lumens or cavities while providing clear interpretation of surrounding anatomical structures and tissues. Accurate imaging and positioning of the imaging system can help accurately orient interventional tools, which the operator can manipulate to stay within a desired path to a target location and / or avoid critical structures that may be damaged during a diagnostic or therapeutic procedure.

[0008] In one example, a computer-based method of correcting image distortion in an eccentric rotational imaging catheter system is provided that utilizes sinusoidal variations of the catheter wall to remove distortion in the final image.

[0009] In one example, a system for imaging a lumen is provided, comprising: an imaging catheter comprising a tubular body comprising a proximal segment, a distal segment, and a middle region; a lumen for an imaging device positioned along the proximal region, the middle region, and the distal region; a lumen for a common guidewire positioned along the proximal region, the middle region, and the distal region; a side ramp lumen located in the distal region and connected to the common guidewire lumen, the side ramp lumen comprising a distal opening in a side wall of the tubular body; a distal guidewire lumen located in the distal region and connected to the common guidewire lumen, the distal guidewire lumen comprising a distal opening at an end wall of the tubular body; and at least one guidewire biasing structure selected from A group comprising: a reduced diameter region at the junction of the distal guidewire lumen and the common guidewire lumen; an offset distance between the longitudinal axis of the common guidewire lumen and the longitudinal axis of the distal guidewire lumen; an angled wing at or near the junction of the distal guidewire lumen and the common guidewire lumen; a guidewire lumen ridge at or near the junction of the distal guidewire lumen and the common guidewire lumen; a proximal catheter assembly comprising a catheter housing coupled to the proximal region of the tubular body and a proximal optical connection interface; a first guidewire port in fluid communication with the common guidewire lumen; an imager port in fluid communication with the imaging device lumen; and an imaging optical fiber connected to the proximal optical connection interface and extending along the imaging device lumen. The system may also include a second guidewire port in fluid communication with the common guidewire lumen, wherein the second guidewire port has an interface different from that of the first guidewire port. The first guide wire port and the second guide wire port are located in a hub distal to the catheter assembly. The catheter housing may also include an imager actuator coupled to the imaging optical fiber and configured to longitudinally translate the imaging optical fiber relative to the imaging device lumen. The system may also include a catheter rotation actuator coupled to the tubular body and configured to rotate the tubular body relative to the proximal catheter housing assembly. The catheter rotation actuator may be rotatably coupled to the distal end of the catheter housing. The proximal catheter assembly may also include an optical cable between the catheter housing and the proximal optical connection interface. The proximal optical connection interface may be directly coupled to the catheter housing. The system may also include an imaging console, the imaging console comprising: a console housing; a power supply; a laser source including an output port; a slide interconnection interface; a touch screen interconnection interface; and a large display interconnection interface. The laser source output port may include an imaging port and an aiming beam port. The system may also include a slide assembly, the slide assembly comprising: a slide housing; a catheter interconnect; a slide power actuator; and a catheter separation actuator.The catheter interconnect may be a spring biased catheter interconnect and the catheter separation actuator is a catheter jet actuator. The sled powered actuator includes a lamp / light. The system may also include a touch screen with mounting accessories. The system may also include a large non-touch screen display. The sled housing may include a distal cavity configured to receive the catheter housing.

[0010] In another example, a method of preparing an imaging catheter is provided, comprising: attaching a first sterile drape to a sled assembly; coupling a catheter assembly to the sled assembly; activating the sled assembly; activating an aiming beam of the catheter assembly; deactivating the sled assembly; detaching the catheter assembly from the sled assembly; and closing a proximal end of the catheter assembly with a second sterile drape. Attaching the first sterile drape to the sled assembly comprises attaching the sterile drape to the sled assembly using an attachment cap. The method may also include cutting a folded corner of the first sterile drape to form a drape opening to be positioned between the sled assembly and the attachment cap.

[0011] In another example, a method of using an imaging catheter is provided, comprising: advancing an imaging catheter over a guidewire through a guide catheter to a target site; attaching the imaging catheter to a sled assembly; enabling the imaging catheter and imaging the target site; longitudinally imaging the chute lumen of the imaging catheter using a longitudinal adjustment interface on a proximal housing of the imaging catheter; advancing the imaging catheter toward and near a lesion at the target site; using the imaging catheter to identify the true lumen of the target site; rotating the imaging of the target site using a rotary actuator of the imaging catheter to orient the chute lumen toward the true lumen of the target site; withdrawing the guidewire from the distal guidewire lumen of the imaging catheter; advancing the guidewire through the chute lumen of the imaging catheter and into the true lumen of the target site; confirming reentry into the true lumen; and withdrawing the imaging catheter while keeping the guidewire positioned in the true lumen. The method may also include delivering a stent to the target site using the guidewire. The method also includes: enabling a ruler overlay for target site imaging, the ruler overlay depicting distance markings; and measuring vessel size using the ruler overlay. The method may also include opening a ramp overlay for target site imaging, the ramp overlay depicting guidewire direction markings on the target site imaging. The method may also include flushing the imaging catheter using a guidewire flush port of the imaging catheter. Confirming reentry to the true lumen using fluoroscopy and contrast agents. The method may also include: pre-connecting a catheter assembly and the sled assembly; and enabling the sled assembly. The method may also include attaching a first sterile drape to the sled assembly. The method may also include: enabling an aiming beam of the catheter assembly; and deactivating the sled assembly. The method may also include: separating the catheter assembly from the sled assembly; and closing the proximal end of the catheter assembly with a second sterile drape. Attaching the first sterile drape to the sled assembly may include attaching the sterile drape to the sled assembly using an attachment cap. The method may further include cutting a folded corner of the first sterile drape to form a drape opening to be positioned between the slide assembly and the attachment cap.

[0012] An image-guided interventional catheter, comprising: a housing having a distal region of the catheter, the distal region of the catheter comprising an imaging body and a catheter body, the distal region of the catheter defining: an imaging device lumen configured to receive an imaging device; a guidewire lumen configured to receive a guidewire, the guidewire lumen comprising a distal section, a proximal section, and one or more guidewire feeders, the one or more guidewire feeders comprising at least one of the following: a raised portion located in the proximal section near the intersection of the distal section and the proximal section; the distal section having a tapered region, the tapered region a maximum transverse dimension that increases with increasing distance from the intersection; a center of the distal segment offset relative to the center of the proximal segment; and an intersection of the distal segment and the proximal segment having a thin pierceable wall; an exit ramp extending from the guidewire lumen at or near the intersection of the distal segment and the proximal segment of the guidewire lumen, one or more guidewire feeders configured to cause the guidewire to extend from the guidewire lumen into the exit ramp; and an indicator lumen configured to receive an indicator that can be detected by an optical coherence tomography imaging device. The imaging device may include an optical coherence tomography imaging device. One or more guidewire feeders may include a ridge. The one or more guidewire feeders may include: the distal segment having a tapered region. The tapered region may extend from the intersection of the distal segment and the proximal segment. One or more guidewire feeders may include a center of the distal segment offset relative to the center of the proximal segment. The one or more guidewire feeders may include: an intersection of the distal section and the proximal section having a thin pierceable wall. The one or more guidewire feeders may also include a ramp at the intersection of the distal section and the proximal section. The distal region of the catheter may include one or more detectable structures, the one or more detectable structures indicating the distance from the distal tip of the distal region of the catheter, and the one or more detectable structures can be detected by the imaging device. The one or more detectable structures may include an annular or semi-annular base and one or more slender arms extending from the annular or semi-annular base, wherein at least the one or more longitudinal arms can be detected by the imaging device. The one or more longitudinal arms may include a plurality of longitudinal elements, at least some of the plurality of longitudinal elements having different lengths. The one or more detectable structures may include one or more holes formed in the housing of the distal region of the catheter. In some embodiments, a system is provided that includes the above-mentioned catheter, wherein: the shell includes a proximal region of the catheter, a shell is attached to the catheter, and the shell includes one or more actuators, and the one or more actuators are configured to achieve at least one of the following: rotating at least a portion of the catheter relative to the shell; and moving the imaging device in the lumen of the imaging device.The system may also include a display and a graphical user interface configured to display an image detected by the imaging device on the display, the graphical user interface including at least one icon that applies a template to the image displayed on the display. The template may include an exit ramp indicator indicating the direction in which the exit ramp extends from the guidewire lumen.

[0013] In another example, a method of determining the orientation of a catheter is provided, the method comprising: obtaining one or more images at one or more locations along the length of the catheter using an optical coherence tomography imaging device; excluding data from the one or more images; detecting a track / orbit of the catheter; detecting a location of a fixed and constantly present landmark or feature of the catheter relative to a center of the optical coherence tomography imaging device; applying a template including an exit ramp indicator to the one or more images, wherein the exit ramp indicator includes a two-dimensional graphic or a three-dimensional enhanced graphic, and the exit ramp is presented as an opaque portion or a semi-transparent portion on the one or more images. Detecting the track of the catheter may include detecting a track that falls within a catheter edge detection range from an edge of the one or more images. The fixed and constantly present landmark feature of the catheter may include an indicator lumen. Detecting the location of a fixed and constant marker or feature of the catheter relative to the center of the optical coherence tomography imaging device may include at least one of: detecting an indicator lumen that falls within a lumen detection range from an edge of the one or more images; and detecting an indicator lumen that falls within an indicator lumen angle range, wherein the indicator lumen angle range is separated from the detected trajectory by an angular offset. The template may include an indicator lumen circle placed on the indicator lumen.

[0014] In another example, a non-transitory computer-readable medium storing an image correction program is provided, the image correction program causing a computer device including the storage medium to perform functions, the functions including: receiving image frames of a sequence of images generated by an eccentric imaging catheter; identifying an imaged wall position in a sequence of images from a time period of the sequence of images; and modifying the sequence of images for the time period by making the imaged wall position of the sequence of images conform to a reference wall position of the sequence of images for the time period. Modifying the sequence of images for the time period may include deleting an intermediate sequence of images between the sequence of images and the reference wall position. The reference wall position may be from a series of reference wall positions corresponding to a reference sinusoidal pattern of wall positions. The reference sinusoidal pattern of the wall position may be derived from a geometric model of the eccentric imaging catheter. The reference sinusoidal pattern of the wall position may be determined by a calibration procedure of the eccentric imaging catheter. The image frames may be selected from a series of sequence of images generated by the eccentric imaging catheter. The image frames of the sequence of images may correspond to a 360-degree rotation of the eccentric imaging catheter, or to a fixed sequence number of the sequence of images. The non-transitory computer-readable medium may also include downsampling the series or the time period of the sequence of images. Downsampling may include deleting a portion of the sequence images from the series or the time period. The ratio of deleted sequence images to non-deleted sequence images may be greater than or equal to 20:1. Downsampling may include cropping each of the sequence images from the series or the time period, the cropping being performed at a fixed number of pixels or distance from the imager origin end of each of the sequence images. The non-transitory computer-readable medium may also include inferring at least one replacement sequence image from at least some of the deleted sequence images, wherein the at least one replacement sequence image is less in number than the number of deleted sequence images.

[0015] In another example, a non-transitory computer-readable medium storing an image correction program is provided, the image correction program causing a computer device including the storage medium to perform functions, the functions comprising: receiving image frames of a sequence of images generated by a variable wall distance imaging catheter; identifying an imaged wall position in a sequence of images from a time period of the sequence of images; and modifying the sequence of images for the time period by making the imaged wall position of the sequence of images conform to a reference wall position of the sequence of images for the time period. The variable wall distance imaging catheter may be an eccentric imaging catheter. The variable wall distance imaging catheter may be a concentric non-circular imaging catheter.

[0016] In another example, an imaging processing system for performing an image processing function is provided, comprising: a receiving unit configured to receive image frames of a sequence of images generated by an eccentric imaging catheter; an identification unit configured to identify imaging wall positions in a sequence of images from the time period; and a modification unit configured to modify the sequence of images of the time period by making the imaging wall positions of the sequence of images conform to a reference wall position of the sequence of images of the time period.

[0017] In yet another example, an image processing method is provided, comprising: receiving image frames of a sequence of images generated by an eccentric imaging catheter; identifying an imaging wall position in a sequence of images from a time period; and modifying the sequence of images for the time period by making the imaging wall position of the sequence of images conform to a reference wall position of the sequence of images for the time period.

[0018] In another example, a reentry catheter system is provided, comprising: an elongated catheter body, the catheter body comprising: a proximal end; a distal end; a common lumen extending from a proximal position at the proximal end to a distal position proximal to the distal end, the common lumen comprising a first longitudinal center axis; a distal lumen extending from a distal position of the common lumen to the distal end of the catheter body, wherein the distal lumen has a second longitudinal center axis parallel to the first longitudinal center axis and offset from the first longitudinal center axis; and a side lumen extending distally from the distal position of the common lumen to a sidewall position of the catheter body, wherein the sidewall position is located proximal to the distal end of the catheter body; a lumen for an imaging device extending from the proximal end of the catheter body; a proximal catheter handle connected to the proximal end of the catheter body, the handle comprising: a catheter body rotator knob, which is configured to rotate the catheter body relative to the proximal catheter handle; and an imaging catheter shift knob, which is configured to longitudinally shift an imaging catheter inserted into the catheter body relative to the catheter body. The side wall position of the side lumen may be located proximal to the closed distal end of the imaging device lumen. The distal end of the catheter body may be in an asymmetrically tapered cone shape. The catheter body may also include an indicator lumen. The average diameter of the indicator lumen may be smaller than the average diameter of the distal lumen, the average diameter of the distal lumen is smaller than the average diameter of the common lumen, and the average diameter of the common lumen is smaller than the average diameter of the imaging device lumen.

[0019] Features from any disclosed embodiment may be used in combination with each other without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals represent the same or similar elements or features in the different views or embodiments shown in the drawings.

[0021] Figure 1A is an isometric view of a portion of a catheter according to one embodiment.

[0022] Figure 1B and 1C They are respectively along Figure 1A Cross-sectional views of the catheter taken along planes 1B-1B and 1C-1C are shown.

[0023] Figure 2-6B It is a cross-sectional view of a catheter with different guidewire feeders according to different environments.

[0024] Figure 7 is a flow chart of an example method of providing an exit ramp indicator according to one embodiment.

[0025] Figure 8A-8HH is a schematic diagram according to one embodiment, showing locations on a catheter where images can be captured and examples of original images and ramp-overlay images captured at each location.

[0026] Fig. 9 According to one embodiment Figure 8HH Examples of waterfall images taken at the locations shown.

[0027] Figures 10A to 10D is a schematic diagram illustrating how moving an OCT imaging device within a lumen of the imaging device changes the position of various components of the catheter relative to the center of the OCT imaging device, according to one embodiment.

[0028] Fig.11 yes Fig. 9 , which is further annotated to indicate additional information shown thereon.

[0029] Fig.12 Shown is a template superimposed on an image according to one embodiment.

[0030] Fig.13 is a circular image according to one embodiment that can be used to find the trajectory of the catheter and indicator lumen.

[0031] Fig.14 is an isometric view of a detectable structure that may be disposed in or on a catheter (not shown) according to one embodiment.

[0032] Fig.15 is an isometric view of a catheter including a detectable structure according to one embodiment.

[0033] Figures 16A to 16D are side views, side cross-sectional views, top views, and top cross-sectional views of an exemplary proximal catheter assembly.

[0034] Fig.16E A variation of a catheter is depicted that includes a proximal cable between the catheter housing and the connector.

[0035] Fig.17 is a diagram of a system according to one embodiment.

[0036] Fig.18A and 18B is an image of an example graphical user interface that may be used with a touch screen according to one embodiment.

[0037] Fig. 18C and 18D Depicted are the ruler overlays on the OCT image for the touch screen and auxiliary display, respectively.

[0038] Fig.19 is a flow chart of general system operation during a reentry procedure.

[0039] Figures 20A to 20C Depicted are general, proximal, and distal plan views of another exemplary catheter system including a 4-Fr image-guided reentry catheter.

[0040] Figures 21A to 21E Fluorescent images depicting the treatment process.

[0041] Fig.22A and 22B OCT images of the same anatomical location but different rotational orientations are depicted.

[0042] Fig. 22C and 22D Depicted in Fig. 22B OCT and angiogram images of the same anatomical location and similar rotational orientation with the guidewire extending from the side port.

[0043] Fig.22E and 22F These are OCT and angiography images, respectively, confirming the reintroduction of the guidewire.

[0044] Figure 22G is an angiographic image after reentry and stent implantation.

[0045] Fig.23A is a schematic waterfall image of a 2D image captured from a concentric rotational imaging catheter system.

[0046] Fig. 23B Is from Fig.23A Schematic circumferential reconstruction of the waterfall image.

[0047] Fig.24A is a schematic waterfall image of a 2D image captured from a concentric rotational imaging catheter system with distortion due to rotational variations.

[0048] Fig. 24B Is from Fig.24A Schematic circumferential reconstruction of the waterfall image.

[0049] Fig.25A is a schematic waterfall image of a 2D image captured from an eccentric rotational imaging catheter system.

[0050] Fig.25B Is from Fig.25A Schematic circumferential reconstruction of the waterfall image.

[0051] Fig.26A is a schematic waterfall image of a 2D image captured from an eccentric rotational imaging catheter system with distortion due to rotational variations.

[0052] Fig.26B Is from Fig.26A Schematic circumferential reconstruction of the waterfall image.

[0053] Fig. 27 is an exemplary waterfall image from an eccentric OCT catheter system annotated with the imaged and predicted catheter edges and the corresponding image correction set.

[0054] Fig.28A is a schematic perspective view of an exemplary multi-lumen catheter having an eccentric imaging device lumen.

[0055] Fig.28B and 28C yes Fig. 27 Various cross-sectional views of the mid-tube.

[0056] Fig.29A and 29B They are respectively Fig.28A Example pre- and post-correction OCT images captured by an example catheter in FIG.

[0057] Fig.29C It comes from Fig.29A and 29B Reference OCT images of the same imaging position with limited or no significant rotational distortion.

[0058] Figures 30A to 30C is from Fig.28A Example pre-correction, post-correction, and reference OCT images captured by an example catheter in FIG.

[0059] Figures 31A to 31C is from Fig.28AExample pre-correction, post-correction, and reference OCT images captured by an example catheter in FIG.

[0060] Figures 32A to 32C is from Fig.28A Example pre-correction, post-correction, and reference OCT images captured by an example catheter in FIG.

[0061] Figures 33A to 33M Depicted are exemplary preparatory steps for using an OCT imaging system.

[0062] Figures 34A to 34F Depicted are exemplary OCT images acquired during use of an OCT imaging system.

[0063] Figure 34G A ruler superimposed on the OCT image is depicted. DETAILED DESCRIPTION

[0064] A plurality of embodiments relate to systems, devices and methods for positive dissection reentry. Such systems, devices and methods may include an image-guided interventional catheter ("catheter"), a system including the catheter and a method for using the catheter. An exemplary catheter includes a housing having a distal region of the catheter configured to be at least partially placed in the body and a proximal region of the catheter configured to be at least partially maintained outside the body. The distal region of the catheter includes an imaging body and a catheter body. The distal region of the catheter defines a plurality of lumens. The plurality of lumens may include a lumen for an imaging device, a lumen for a guidewire, an exit ramp and a lumen for an indicator. The lumen for the imaging device is configured to receive an imaging device (e.g., an optical coherence tomography imaging device). The lumen for the guidewire is configured to receive a guidewire and includes a distal region and a proximal region. The exit ramp extends from the lumen for the guidewire at or near the intersection of the distal region and the proximal region of the lumen for the guidewire. The lumen for the indicator is configured to receive an indicator that can be detected by an imaging device and a software algorithm. The catheter may also include one or more guidewire feeders. The guidewire feeder is configured to move the guidewire from the proximal section to the exit ramp. Examples of guidewire feeders may include a ridge, a distal section including a tapered region, a center offset of the distal and proximal sections of the guidewire lumen, or an intersection of the distal and proximal sections including a thin pierceable wall.

[0065] Catheter can be used to guide guide wire in the body. For example, the distal end of guide wire can be inserted into the body. The lumen in which the guide wire is placed may be blocked (for example, due to chronic total occlusion) and / or may branch into one or more additional lumens (for example, true lumen). In this case, the proximal end of the guide wire can be placed in the guide wire lumen via an opening formed on the distal region of the catheter of the catheter. The catheter can move along the guide wire and enter the body until the catheter is in a desired position (for example, at the blocked portion of the lumen or at the position where the additional lumen branches from it). At this point, the guide wire is placed in both the distal region and the proximal region of the guide wire lumen. Once the catheter is in the desired position, the guide wire can be retracted toward the catheter until the guide wire is no longer in the distal region of the catheter. Then, the guide wire can advance in the catheter, which makes the distal tip of the guide wire interact with the guide wire feeder. The interaction between the guide wire and the guide wire feeder causes the guide wire to move into the outlet ramp, rather than returning to the distal section of the guide wire lumen. The guidewire may exit the catheter via the exit ramp at an angle relative to the catheter that is different than if the guidewire exited the catheter via a distal section of the guidewire lumen.

[0066] During use, it may be difficult to determine the orientation of the exit ramp relative to the body. It may be necessary to know the orientation of the exit ramp to prevent a guidewire exiting the exit ramp from piercing the lumen of the body or a blood vessel, or moving in the wrong direction. An imaging device in combination with other elements of the catheter can be used to determine the orientation of the exit ramp at any given time. For example, a system including a catheter can be capable of detecting one or more elements of the catheter (e.g., an indicator placed in an indicator lumen). The orientation of the exit ramp can then be determined based on the known positional relationship between the imaging device, the one or more detected elements, and the known positional relationship between the imaging device, the detected element, and the exit ramp.

[0067] Figure 1A is an isometric view of a portion of a catheter 100 according to one embodiment. Figure 1B and 1C They are respectively along Figure 1A The catheter 100 is a cross-sectional view of the catheter 100 taken along planes 1B-1B and 1C-1C. The catheter 100 includes a housing 102. The housing 102 includes a distal region of the catheter (a portion of which is located at Figure 1A ) and the proximal region of the catheter (shown in Fig.16A). The catheter distal region includes at least a portion of the housing 102 that is disposed within the body, and the catheter proximal region includes at least a portion of the housing 102 that is not disposed within the body. For illustrative purposes, the catheter distal region of the housing 102 includes an imaging body 104 and a catheter body 106, where the imaging body 104 facilitates imaging of structures and / or tissues surrounding the catheter 100. The imaging body 104 may include a material that is at least partially transparent (e.g., at least partially optically transparent) to stimuli emitted and / or detected by an imaging device 109 (e.g., an optical coherence tomography imaging device ("OCT") or ultrasound) to reduce imaging opacity relative to the imaging device 109. The catheter body 106 may be opaque relative to the imaging device 109. However, note that the imaging body 104 may be opaque and / or the catheter body 106 may be at least partially transparent to the imaging device 109. The imaging body 104 may be integrally formed with the catheter body 106 or may be different from the catheter body 106.

[0068] In some examples, the catheter 100 is an over-the-wire support catheter or an extender catheter to assist in the placement and positioning of a guidewire in a blood vessel. In another example, the catheter 100 is an OCT-guided OTW support catheter or an extender catheter to assist in the placement and positioning of a guidewire in a blood vessel with real-time visualization. In some examples, the catheter 100 is an OCT-guided OTW reentry catheter that can be used with a guidewire. The catheter 100 may be 2.5F, 3F, 4F, 5F, 6F, 7F, 8F, 9F, or 10F, have a length ranging from 50 cm to 130 cm, 90 cm to 130 cm, 90 cm to 110 cm, 50 cm to 135 cm, or 90 cm to 135 cm, may optionally include a hydrophilic coating, have or not have a radiopaque tip, have or not have an inflatable or deflated balloon at the distal end of the catheter 104 on the side opposite the exit ramp exit 114, and may be straight or angled. The balloon may be at least partially transparent to the imaging device 109.

[0069] The housing 102 of the catheter 100 may define a plurality of lumens. For example, the housing 102 may define a lumen 108 for an imaging device, a lumen 110 for a guidewire, a lumen 112 for an indicator, and a lumen 113 for an imaging device. Figure 1C and 8A) and an exit ramp 114. One or more of the imaging device lumen 108, the guidewire lumen 110, or the indicator lumen 112 may extend generally parallel to the longitudinal axis of the catheter 100. Meanwhile, the exit ramp 114 is a lumen extending from the guidewire lumen 110 to the side edge 116 of the housing 102. In other words, at least a portion of the exit ramp 114 extends at a non-parallel angle relative to the longitudinal axis of the catheter 100.

[0070] The imaging device lumen 108 may be configured to receive an imaging device 109 (eg, Figure 1A 100 and / or its surroundings (e.g., an artery). The imaging device 109 may include any suitable device that can image the catheter 100 and / or its surroundings (e.g., an artery). In one example, the imaging device 109 may include at least one of an OCT, an ultrasound transceiver, or another imaging device. The imaging device lumen 108 may extend into the imaging body 104 of the housing 102, thereby allowing the imaging device 109 to image the environment surrounding the catheter 100.

[0071] The guidewire lumen 110 may be configured to receive a guidewire (not shown). The guidewire lumen 110 may extend to a distal end 111 of the housing 102 and form an opening 113 in the housing 102 to allow the guidewire to extend out of the catheter 100. The guidewire lumen 110 includes a distal section 119 and a proximal section 120 ( Figure 1B ). The distal segment 119 extends from the distal end 111 of the housing 102 to the proximal segment 120. The proximal segment 120 extends from the distal segment 119 toward (e.g., to) the proximal region of the catheter. In one embodiment, all or a majority of the distal segment 119 (e.g., 80% or more or 90% or more of its length) is within the imaging body 104 of the housing 102, and all or a majority of the proximal segment 120 (e.g., 90% or more or 95% or more of its length) is within the catheter body 106. In such an embodiment, an intersection 122 of the distal segment 119 and the proximal segment 120 is located at or near the intersection of the imaging body 104 and the catheter body 106. Disposing all or a majority of the distal segment 119 in the imaging body 104 allows the exit ramp 114 and the environment into which the exit ramp positions the guidewire to be imaged by the imaging device 109.

[0072] In some examples, the catheter 100 can be an OCT-guided OTW reentry catheter that can be used with a guide catheter and a guidewire. In such examples, the guidewire lumen 110 can be configured to receive the guidewire. The guidewire can be a 0.014-inch guidewire, but in some other variations, it can be a 0.009-inch or 0.010-inch guidewire, with or without a tapered tip. The guidewire can include a hydrophobic coating or a hydrophilic coating in one or more regions, and can have a length ranging from 150 cm to 300 cm, 150 cm to 200 cm.

[0073] The indicator lumen 112 can be configured to receive a material that can be detected by the imaging device 109. In one particular example, the material received by the indicator lumen 112 can be more easily detected by the imaging device 109 than the guidewire and / or imaging body 104. For example, the material received by the indicator lumen 112 can be more opaque or more reflective of stimuli emitted and / or detected by the imaging device 109 than the guidewire and / or imaging body 104. Additionally or alternatively, the indicator lumen 112 can provide a material discontinuity or interface between the medium inside the lumen and its surroundings, resulting in a difference in optical refractive index and partial reflectance, the interference signal of which can be detected by the imaging device 109 and used as a fixed marker. In one embodiment, the indicator lumen 112 can also be used for other functions, including but not limited to flushing blood to improve imaging clarity or injecting diagnostic or therapeutic agents into surrounding tissue. In such an embodiment, the indicator lumen 112 may also form an opening (not shown) in the housing 102 through which flushing fluid and / or diagnostic or therapeutic agents may be dispensed from the housing 102 .

[0074] As previously described, the exit ramp 114 extends from the guidewire lumen 110 to the side edge 116 of the housing 102 (e.g., the side edge of the imaging body 104). In this way, transferring the guidewire from the guidewire lumen 110 into the exit ramp 114 causes the guidewire to extend at an angle relative to the longitudinal axis of the catheter 100. The exit ramp 114 may extend from the guidewire lumen 110 at a location located at or near the intersection 122 between the distal section 119 and the proximal section 120. This location of the exit ramp 114 allows the guidewire to turn into the exit ramp 114 when the guidewire is retracted from the distal section 119. The exit ramp 114 may extend at an angle of about 10° to about 45° relative to the central axis of the guidewire lumen 110, the angle being, for example, in the range of about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, or about 35° to about 45°.

[0075] The guidewire lumen 110 and the outlet ramp 114 are configured to receive the guidewire. In this way, the guidewire lumen 110 and the outlet ramp 114 have a cross-sectional dimension (e.g., diameter or other maximum transverse dimension) large enough to accommodate the guidewire. In one embodiment, at least a portion of the guidewire lumen 110 extending from the distal end 111 and a portion of the outlet ramp 114 extending from the intersection 122 have a cross-sectional dimension (e.g., up to 5%, 10%, 20%, 25%, 50%, 75%, 100%, 150% or 200%) significantly larger than the guidewire cross-sectional dimension. The significantly larger cross-sectional dimension of the guidewire lumen 110 and the outlet ramp 114 facilitates the insertion of the guidewire into the guidewire lumen 110 and the outlet ramp 114. In addition, the cross-sectional dimension of the guidewire lumen 110 and / or the outlet ramp 114 can be reduced along at least a portion of its length. For example, the cross-sectional size of the guidewire lumen 110 may be reduced at a location distal to the distal end 111 and / or proximal to the intersection 122 and / or at the exit of the exit ramp 114. As will be discussed in more detail below, the reduction in the cross-sectional size of the guidewire lumen 110 may help redirect the guidewire from the guidewire lumen 110 (e.g., the proximal section 120) into the exit ramp 114. The reduced cross-sectional size of the guidewire lumen 110 and / or the exit ramp 114 also reduces movement of the guidewire therein and minimizes backflow of fluid from the body into the guidewire lumen 110.

[0076] During use, the guide wire can be inserted into the lumen of health, such as the artery of human body. In some cases, the lumen of health may be blocked, such as, blocked by plaque or atherosclerotic plaque. Usually, the guide wire can be used for moving, breaking or otherwise removing the obstruction. In one embodiment, such as when the obstruction is caused by chronic total occlusion, the guide wire may not be moved, broken or otherwise remove the obstruction. When the guide wire encounters an obstruction that cannot be moved, broken or otherwise removed, the guide wire can be placed in the guide wire lumen 110 (if not yet positioned in the guide wire lumen 110), thereby allowing the guide wire to guide the catheter 100 through the health. When the catheter 100 is located at or near the obstruction that cannot be moved, broken or otherwise removed, the guide wire can be retracted into the guide wire lumen 110, until the distal tip of the guide wire is spaced farther apart from the distal end 111 of the catheter 100 than the entrance of the outlet ramp 114 (i.e., the outlet ramp 114 near the opening of the guide wire lumen 110). For example, the distal tip of the guidewire can be retracted until the distal tip of the guidewire is located proximal to the bifurcation intersection between the guidewire lumen 110 and the exit ramp 114. The guidewire can then be advanced into the exit ramp 114. Advancing the guidewire into the exit ramp 114 changes the direction in which the guidewire extends, thereby allowing the guidewire to bypass or pass through the obstruction in the direction toward the true lumen / true cavity, which in turn allows the catheter 100 to bypass the obstruction. For example, after the guidewire extends out of the exit ramp 114, the catheter 100 can be removed, and as the guidewire is loaded back into the catheter 100 at the distal tip 111, the catheter 100 is reinserted into the lumen and bypasses the obstruction along the guidewire.

[0077] As previously described, the catheter 100 may include one or more guidewire feeders. The guidewire feeder is configured to redirect the guidewire in the proximal section 120 to the exit ramp 114 instead of the distal section 119 when the guidewire is advanced from the proximal section 120 to the distal section 119. The catheter 100 may include any number of guidewire feeders, such as one guidewire feeder, two guidewire feeders, three guidewire feeders, four guidewire feeders, or five or more guidewire feeders. Figure 1B In the illustrated embodiment, catheter 100 includes three guidewire feeders. However, it should be noted that Figure 1B Alternatively or in addition to the guidewire feeder shown, catheter 100 may also include multiple guidewire feeders.

[0078] In one embodiment, the guidewire feeder may include a ridge 124. The ridge 124 is a protrusion extending from the housing 102 into the guidewire lumen 110. The ridge 124 may have any suitable shape, such as a portion of a generally spherical shape, a generally cylindrical shape, or a wedge shape. The ridge 124 may be located at the intersection 122 or in the proximal section 120 at a position slightly spaced apart from the intersection 122 (e.g., spaced apart by about 5 mm or less, about 3 mm or less, or about 1 mm or less). The ridge 124 may be opposite to the entrance of the exit ramp 114. The ridge 124 may be formed as an obstacle that causes the guidewire to be diverted to the exit ramp 114 instead of the distal section 119. For example, as previously described, the guidewire may be retracted into the catheter 100 until the guidewire is no longer located in the distal section 119, or in other words, until the distal tip of the guidewire is located in the proximal section 120. Advancing the guidewire toward the distal tip / end 111 causes the distal tip of the guidewire to contact the protuberance 124. Contacting the guidewire against the protuberance 124 can divert the guidewire toward the exit ramp 114, rather than toward the distal section 119. The protuberance 124 can be an improvement over conventional mechanisms for transferring a guidewire between two channels. For example, the protuberance 124 does not need to be moved to transfer the guidewire, thereby avoiding problems associated with at least some conventional mechanisms for transferring a guidewire, such as conventional mechanisms breaking or getting stuck.

[0079] In one embodiment, the guidewire feeder may include a tapered region 126 formed in the distal segment 119. The tapered region 126 includes a region of the distal segment 119 where the transverse dimension (e.g., diameter) of the distal segment 119 is reduced. The transverse dimension of the tapered region 126 may decrease as it approaches the intersection 122. The tapered region 126 may reduce the transverse dimension of the distal segment 119 until the transverse dimension of the distal segment 119 is only slightly larger than the transverse dimension of the guidewire. The tapered region 126 may be spaced apart from the distal tip 111 so that the reduced transverse dimension of the tapered region 126 does not prevent the guidewire from being inserted into the guidewire lumen 110. For example, as shown, the tapered region 126 may extend from or near the intersection 122. The tapered region 126 reduces the transverse dimension of the distal segment 119 at the intersection 122 so that the transverse dimension of the distal segment 119 is smaller than the transverse dimension of the entrance of the exit ramp 114. The reduction in the transverse dimension of the distal segment 119 at the intersection 122 relative to the transverse dimension of the entrance of the exit ramp 114 reduces the likelihood that advancing the guidewire will cause the guidewire to enter the distal segment 119, and increases the likelihood that advancing the guidewire will cause the guidewire to enter the exit ramp 114. Likewise, the tapered region 126 can be an improvement over conventional mechanisms for transferring a guidewire between two channels, since the tapered region 126 does not need to be moved to turn the guidewire. In addition, as previously described, the reduction in the transverse dimension of the guidewire lumen 110 caused by the tapered region 126 inhibits fluid flow from reaching the guidewire lumen 110.

[0080] In one embodiment, the guidewire feeder includes offsetting / misaligning the distal segment 119 and the proximal segment 120 relative to each other. For example, the distal segment 119 may have a distal center axis 128 and the proximal segment 120 may have a proximal center axis 130. The distal center axis 128 may be offset relative to the proximal center axis 130. In other words, the distal center axis 128 and the proximal center axis 130 are not aligned. The distal center axis 128 and the proximal center axis 130 may be positioned such that the proximal center axis 130 is closer to the exit ramp 114 than the distal center axis 128. The offset between the distal axis 128 and the proximal axis 130 increases the likelihood that the guidewire is advanced from the proximal segment to the distal tip 111, resulting in the guidewire entering the exit ramp 114 instead of the distal segment 119.

[0081] The catheter 100 may include one or more additional features, such as a reinforcement structure 118 that reinforces the guidewire lumen 110 or another portion of the catheter 100. The catheter 100 may also include a helical reinforcement or a side slotted tube.

[0082] The catheter disclosed herein may include Figure 1B A guide wire feeder of the guide wire feeder shown. Figure 2-6B is a cross-sectional view of a catheter with different guidewire feeders according to different environments. In addition to the disclosure herein, Figure 2-6B The catheter shown may be the same or substantially similar to any catheter disclosed herein. For example, the catheter may include a housing defining a plurality of lumens. The plurality of lumens may include a guidewire lumen and an exit ramp. The guidewire lumen may include a distal segment and a proximal segment. Note that Figure 2-6B The guidewire feeder shown can be used in any of the catheter embodiments disclosed herein. In addition, it should be noted that Figure 2-6B Any of the guidewire feeders shown in may be used in combination with one or more of any other guidewire feeders disclosed herein.

[0083] refer to Figure 2 , the guidewire feeder of the catheter 200 may include a thin pierceable wall ("thin wall") 232. The thin wall 232 may be positioned at or near the intersection 222 of the distal section 219 and the proximal section 220 of the guidewire lumen 210. The thin wall 232 is configured to be pierced by a guidewire to form a hole therein. The size of the hole formed in the thin wall 232 may correspond to the size of the guidewire. In other words, piercing the thin wall 232 with a guidewire causes the thin wall 232 to have a hole as small as possible to fit the guidewire through / fit the guidewire passing through it. The small size of the hole reduces the possibility that the guidewire moves back through the thin wall 232 as it advances from the proximal section 220 to the distal tip 211.

[0084] The thin wall 232 may be formed of any suitable material. In one example, the thin wall 232 may be formed of the same material as the portion of the housing 202 that defines the intersection 222, which may facilitate the manufacture of the thin wall 232 compared to if the thin wall 232 is formed of a different material than the portion of the housing 202 that defines the intersection 222. In one example, the thin wall 232 formed of a different material than the portion of the housing 202 that forms the intersection 222 may allow the thin wall 232 to be formed of a material that is more advantageous than the material forming the housing 202 in at least one of the following aspects: easier to pierce, stronger, easier to manufacture into a thin film, and otherwise more advantageous.

[0085] In one embodiment, the thin wall 232 has a minimum thickness measured in a direction parallel to one or more central axes of the guidewire lumen 210, and the minimum thickness is about 1 μm or greater, about 5 μm or greater, about 10 μm or greater, about 25 μm or greater, about 50 μm or greater, about 100 μm or greater, about 150 μm or greater, about 200 μm or greater, about 300 μm or greater, about 400 μm or greater, about 500 μm or greater, about 600 μm or greater, about 700 μm or greater, about 800 μm or greater, about 1 mm or greater, about 1.25 mm or greater, about 1.5 mm or greater, about 2 mm or greater, or the minimum thickness is about 1.5 mm or greater. The length is in the range of 1 μm to about 10 μm, about 5 μm to about 25 μm, about 10 μm to about 50 μm, about 25 μm to about 100 μm, about 50 μm to about 150 μm, about 100 μm to about 200 μm, about 150 μm to about 300 μm, about 200 μm to about 400 μm, about 300 μm to about 500 μm, about 400 μm to about 600 μm, about 500 μm to about 700 μm, about 600 μm to about 800 μm, about 700 μm to about 900 μm, about 800 μm to about 1 mm, about 900 μm to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm.

[0086] The thin wall 232 is configured to be easily pierced. Whether the thin wall 232 is easily pierced depends on the material forming the thin wall 232 and the minimum thickness of the thin wall 232. In one embodiment, the thin wall 232 does not include a hole. In such an embodiment, a device (e.g., a needle or a probe) can be inserted into the guidewire lumen 210 via a proximal or distal guidewire lumen. The device inserted into the guidewire lumen 210 can puncture or otherwise pierce the thin wall 232 to form a small hole therein. The transverse dimension (e.g., diameter) of the small hole can be substantially equal to or more preferably less than the transverse dimension of the guidewire. Then, the device can be removed from the guidewire lumen 210, and then the guidewire is inserted into the guidewire lumen 210. The guidewire can extend through the small hole formed in the thin wall 232. After the guidewire is extended through the small hole, the transverse dimension of the small hole is substantially similar to the transverse dimension of the guidewire. In one embodiment, the thin wall 232 includes a small hole formed therein before use. In such an embodiment, the thin wall 232 does not need to be pierced by the device. However, forming a small hole in the thin wall 232 before use may prevent the catheter 200 from being used with a guidewire having a transverse dimension that is smaller than the transverse dimension of the small hole. In one embodiment, the thin wall 232 does not include a hole formed therein. In such an embodiment, the guidewire itself can be used to form the small hole in the thin wall 232, rather than using the device to form the hole before inserting the guidewire.

[0087] refer to Figure 3A and 3B , the catheter 300 includes a shell 302. The shell 302 defines a guidewire lumen 310 including a distal section 319 and a proximal section 320. The shell 302 defines a lateral opening 334 extending from the side edge 316 to the guidewire lumen 310 at the intersection 322 of the distal section 319 and the proximal section 320. The shell 302 also includes a biasing section 336 having a tubular shape that partially extends through the lateral opening 334. In other words, the biasing section 336 forms the intersection 322. When not constrained, the biasing section 336 has a curved shape, which allows the biasing section 336 to extend through the lateral opening 334. As Figure 3A As shown, when the guidewire 338 is placed in the proximal section 319 and the distal section 320 of the guidewire lumen 310, the portion of the guidewire lumen 310 defined by the biasing section 336 can be forced to align with the distal section 319 and the proximal section 320 of the guidewire lumen 310. Figure 3BAs shown, retracting the guidewire 338 from the proximal section 319 allows the biasing section 336 to have its curved shape, which in turn allows the biasing section 336 to form an exit ramp of the catheter 300. Advancing the guidewire 338 toward the distal tip 311 causes the guidewire 338 to follow the curved shape of the biasing section 336. The curved shape of the biasing section 336 may extend at an angle relative to the central axis of the guidewire lumen 310 in the range of about 10° to about 45°, such as in the range of about 10° to about 20°, in the range of about 15° to about 25°, in the range of about 20° to about 30°, in the range of about 25° to about 35°, in the range of about 30° to about 40°, or in the range of about 35° to about 45°.

[0088] refer to Figure 4 , the catheter 400 includes a housing 402. The housing 402 defines a guidewire lumen 410 including a distal section 419 and a proximal section 420. The housing defines a lateral opening 434 extending from a side edge 416 to the guidewire lumen 410 at the intersection of the distal section 419 and the proximal section 420. The catheter 400 also includes a ramp 440 that extends at least partially through the lateral opening 434. The ramp 440 may be different from the housing 402 (e.g., the housing 402 may be formed of a polymer and / or the ramp 440 may be formed of nitinol), or may be integrally formed with the housing 402 (e.g., the housing 402 and the ramp 440 may be formed of the same material and have an integral / single-piece structure). The ramp 440 may be configured to rotate or bend at or near the location where the ramp 440 and the housing 402 meet. The ramp 440 can be switched between a first state and a second state. When the ramp 440 is in the first state, the ramp 440 can extend approximately parallel to the central axis of the guidewire lumen 410. When the guidewire (not shown) is positioned in the distal section 419 and the proximal section 420, the ramp 440 can be in the first state. Removing the guidewire from the distal section 419 allows the ramp 440 to move toward the surface of the guidewire lumen 410 opposite to the lateral opening 434. Because the ramp 440 is biased or due to gravity, the ramp 440 can move toward the opposite surface of the guidewire lumen 410. When the ramp 440 is allowed to move toward the surface of the guidewire lumen 410 opposite to the lateral opening 434, the ramp 440 is in the second state. When the ramp 440 is in the second state, advancing the guidewire toward the distal tip 411 causes the guidewire to exit the guidewire lumen 410 at the lateral opening 434. In other words, ramp 440 forms at least a portion of the exit ramp of conduit 400. Note that where ramp 440 does not extend to side edge 416 of housing 402, housing 402 may include tapered surface 442 extending from or near ramp 440.

[0089] refer to Figure 5A and5B , the catheter 500 includes a housing 502. The housing 502 defines a guidewire lumen 510 including a distal section 519 and a proximal section 520. The housing 502 defines a lateral opening 534, which extends from a lateral edge 516 to the guidewire lumen 510 at the intersection 522 of the distal section 519 and the proximal section 520. The housing 502 also includes a hypotube 544 disposed in the guidewire lumen 510. The hypotube 544 is movable (e.g., slidable) relative to the guidewire lumen 510. The hypotube 544 is biased so that when the hypotube 544 is not constrained, at least a portion of the hypotube 544 is in a curved shape. The hypotube 544 can be switched between a first state and a second state. When in the first state, the hypotube 544 can be located in the distal section 519 and the proximal section 520 and extend across the lateral opening 536 (eg, Figure 5A 510 ). When the hypotube 544 is in the first state, the hypotube 544 may be in a shape corresponding to the shape of the proximal section 519 and the distal section 520 of the guidewire lumen 510. The hypotube 544 may be switched from the first state to the second state by retracting the hypotube 544 and the guidewire (not shown) so that the hypotube 544 and the guidewire are no longer located in the distal section 519 of the guidewire lumen 510. When the hypotube 544 is in the second state, the portion of the hypotube 544 adjacent to the lateral opening 534 can be bent to present its curved shape, thereby allowing the hypotube 544 to extend through at least a portion of the lateral opening 534. The curved shape of the hypotube 544 allows the hypotube 544 to form an exit ramp of the catheter 500. In this way, when the hypotube 544 is in the second state, advancing the guidewire toward the distal end 511 causes the guidewire to exit the catheter 500 from the lateral opening 534. In another embodiment, the hypotube 544 can be further retracted proximal to the lateral opening 534 so that it is straightened in the guidewire lumen 510; the hypotube 544 is then rotated 180 degrees and advanced again toward the distal end of the guidewire lumen 510. Doing so keeps the hypotube straight in the guidewire lumen 510 while the hypotube 544 is biased against the inner wall opposite to the lateral opening 534. The hypotube 544 can then be repositioned as shown in FIG. Figure 5A The initial state shown enables the guidewire to be advanced to the distal end of the guidewire lumen 510 .

[0090] refer to Fig. 6A and 6B, the catheter 600 includes a shell 602. The shell 602 defines a guidewire lumen 610 including a distal section 619 and a proximal section 620. The shell 602 defines a lateral opening 654 that extends from a side edge 616 to the guidewire lumen 610 at an intersection 622 of the distal section 619 and the proximal section 620. The catheter 600 also includes a biasing member 646 that is attached to at least a portion of the side edge 616 that is opposite to the portion of the shell 602 that defines the intersection 622. When the guidewire is placed in the distal section 619 and the proximal section 620 of the guidewire lumen 610, the catheter distal region of the catheter 600 can be substantially straight (e.g., Fig. 6A Retracting the guidewire 638 from the distal section 619 of the guidewire lumen 610 allows the biasing member 646 to bend a portion of the catheter distal region of the housing 602 (eg, Figure 6B ). After the biasing member 646 bends the housing 602, advancing the guidewire toward the distal tip 611 allows the distal segment 619 to bend the guidewire 638, thereby changing the direction in which the guidewire 638 extends. In other words, the biasing member 646 causes the distal segment 619 to form an exit ramp for the catheter 600.

[0091] Figure 1A-6B A variety of different guidewire feeders are shown. Note that any catheter disclosed herein may include one or more of the above disclosed guidewire feeders or any other conventional guidewire feeders, including combinations of any of the foregoing guidewire feeders.

[0092] Figure 7-8HH and the accompanying description illustrate exemplary methods of using the catheter. For simplicity and clarity, when discussing methods of using the catheter, reference will be made to Figures 1A-1C Catheter 100 is shown. However, it should be noted that the methods of using the catheter discussed below may be used with any suitable catheter, including any catheter discussed herein or any conventional catheter.

[0093] An individual (e.g., a surgeon) using the catheter 100 can use the OCT imaging device 109 to assist in changing the direction of guidewire extension using the exit ramp 114. In a particular embodiment, an individual using the catheter 100 can position the catheter 100 so that the exit ramp 114 faces the opposite side of the adventitia (e.g., the outermost tissue layer of the arterial wall) of the lumen, as perforation of the adventitia may result in bleeding into the pericardium. This positioning of the catheter 100 allows the exit ramp 114 to be aligned in the direction of the true lumen / real lumen when the individual wants to push the guidewire. However, it may be difficult for an individual using the catheter 100 to determine the directional direction of the exit ramp 114 using the OCT imaging device 109.

[0094] Thus, the methods and systems disclosed herein are configured to provide an exit ramp indicator 1202 (in the Fig.12 ). The exit ramp indicator 121 helps an individual identify the direction in which the exit ramp 114 should point and the user should drive the guidewire outward, which in this case is toward the true lumen or artery. The exit ramp indicator 121 is configured to be sufficiently accurate and clear to prevent confusion for an individual using the catheter 100.

[0095] Figure 7 700 is a flow chart of an example method 700 for providing an exit ramp indicator according to one embodiment. The method 700 may include one or more operations, functions, or actions as shown in one or more of blocks 705, 710, 715, 720, and 725. The operations described in blocks 705 to 725 may be performed (or caused to be performed) in response to the execution of computer executable instructions stored on a non-transitory memory.

[0096] Method 700 includes box 705, which includes obtaining one or more images at one or more locations along the length of catheter 100 using OCT imaging device 109. Method 700 may include box 710, which includes excluding data from the one or more images. Method 700 may include box 715, which includes detecting the trajectory of catheter 100. Method 700 may include box 720, which includes detecting the position of a marker or feature structure that is fixed and constantly present relative to the center of OCT imaging device 109. Method 700 may include detecting the trajectory using box 715, and detecting the position of a marker or feature structure that is fixed and constantly present relative to the center of OCT imaging device 109 using box 720, performing one or more iterations in a forward or backward order, which may be predetermined by an algorithm. Method 700 may include box 725, which includes applying a template including an exit ramp indicator to the one or more images (such as Fig.13 shown).

[0097] The blocks included in method 700 are for illustrative purposes. In one example, the blocks may be executed in the order listed or in a different order. In one example, one or more of blocks 705 to 725 may be removed, divided into multiple blocks, modified, or supplemented. In one example, two or more of blocks 705 to 725 may be combined into a single block. In one example, method 700 may include one or more additional blocks, such as modifying or otherwise editing the one or more images (e.g., changing the brightness or contrast of the images).

[0098] Block 705 includes obtaining one or more images at one or more locations along the length of the catheter 100 using the OCT imaging device 109. The OCT imaging device 109 may capture 1D images. Each 1D image may include hundreds to thousands of data points (i.e., pixels). The OCT imaging device 109 may capture multiple 1D images to create a 2D image. The 2D image created by the OCT imaging device 109 may be a waterfall image (e.g., Fig. 9 and 11 ) or fan-shaped non-waterfall images (such as Fig.8D , 8DD , 8F, 8FF, 8H, 8HH, 12 and 13).

[0099] In one embodiment, the OCT imaging device may capture a single 2D image at a certain location along the length of the catheter 100 , or may take multiple 2D images at different locations along the length of the catheter 100 . Figure 8A-8HH ] are examples of different locations on the catheter 100 and examples of circular non-waterfall images (sector / cross-sectional views) taken at each location. Fig. 8A The first image is shown to be taken at the location where the exit ramp 114 starts to branch off from the guidewire lumen 110, Figure 8B is an example of the first image in unlabeled form. To facilitate viewing of the first image, Figure 8BB Included are circles superimposed thereon indicating the edge of the catheter 100 (larger circle) and the indicator lumen 112 (smaller circle). Note that subsequent images include similar circles superimposed thereon. Figure 8C It shows that the second image can be Fig. 8A ) is taken closer to the distal end 111, wherein the exit ramp 114 is different from the guidewire lumen 110, Fig.8D and 8DD Examples of the second image in unlabeled and labeled form, respectively. Fig. 8E It shows that the third image can be compared with the second image ( Figure 8C ) is taken closer to the distal end 111, where the exit ramp 114 meets the side edge 116, and Figure 8F and 8FF Examples of the third image in unlabeled and labeled form, respectively. Figure 8G It is shown that the fourth image can be compared with the third image ( Fig. 8E ) is taken at a position closer to the distal end 111, which is located between the exit ramp 114 and the distal end 111, and Figure 8H and 8HH Note that the above positions are provided as examples only, and block 705 may include capturing 2D images at more or fewer positions and / or may include capturing 2D images at different positions on catheter 100.

[0100] Note that it is difficult or impossible to determine Figure 8B , Fig.8D , Figure 8F and Figure 8H For example, it may be difficult or impossible to determine in which direction the exit ramp 114 extends from the guidewire lumen 110, or in which direction the guidewire will extend from the exit ramp 114. Therefore, it is important to find the orientation of the catheter 100, particularly the exit ramp indicator 1202 ( Fig.12 The exit ramp 114 provided in FIG. 110 extends from the guidewire lumen 110 .

[0101] Box 710 includes excluding data from the one or more images. The information contained in the images is highly redundant and, in some locations, is highly unlikely to provide useful information in determining the orientation of the catheter 100. Thus, discarding data from the one or more images can reduce redundancy, noise, and the amount of data analyzed. The reduced redundancy, noise, and data make it faster to determine the orientation of the catheter 100, make it possible to determine the orientation of the catheter 100 in real time (from the perspective of the individual using the catheter 100), and make it more accurate to determine the orientation of the catheter 100 by reducing the likelihood that the computer system will misidentify features of the catheter 100.

[0102] Block 710 may include analyzing the waterfall image. Fig. 9 is an example of a waterfall image 900 captured at a location between the distal end 111 and the exit ramp 114 of the catheter 100 according to one embodiment. The waterfall image 900 includes a plurality of 1D images captured by the OCT imaging device 109. Each 1D image (or A-line in OCT, A-mode line in ultrasound imaging) may be arranged / arranged into columns in the waterfall image. That is, the waterfall images may be arranged in a horizontal direction over a time interval (or B-scan). The exemplary waterfall image 900 is also annotated to show a catheter edge detection range 904 starting from the imager origin 902, at which the detection of the side edge 116 of the catheter 100 is performed, which in turn is used to detect the peak 906 of the sine wave defined by the side edge 116 of the catheter 100. It has been found that in some applications, the peak 906 may be the most easily and / or most reliably detected feature of the catheter 100. A lumen detection range 908 is also depicted, in which the detection of the indicator lumen 112 is performed. Lumen detection range 908 reduces the likelihood that other features similar to indicator lumen 112 will be inadvertently detected and identified as indicator lumen 112 . Fig. 9The waterfall image shown in may include 5000 1D images, although it is noted that the waterfall image detected by the OCT imaging device 109 may include more or less than 5000 1D images. Block 710 may include reducing the number of 1D images in the waterfall image due to redundant information included in the 1D images. For example, block 710 may include excluding all images except every 1 / 10 to every 1 / 35 (e.g., every 1 / 27) 1D images from the waterfall image. In a specific example, block 710 may include reducing the number of 1D images to approximately 180 images.

[0103] Components of the catheter 100 may be within a threshold distance from the OCT imaging device 109, while anything else that is farther from the OCT imaging device 109 than the threshold distance may be a lumen or body part. Thus, only data contained within the threshold distance from the top of the waterfall image may contain data related to components of the catheter 100. Block 710 may include excluding data that is more than the threshold distance from the top of the waterfall image because such data is less likely to contain information related to components of the catheter 100. In other words, block 710 may include retaining data within the threshold distance from the top of the image. Fig. 9 In the particular example shown, block 710 may include excluding all data that is more than 200 data points (ie, pixels) from the top of the image because such data is unlikely to contain information related to components of catheter 100 .

[0104] As will be discussed in more detail below, blocks 715 and 720 include determining the position (e.g., distance and / or angle) of certain components, edges, or interfaces of the catheter 100 relative to the center of the OCT imaging device 109. Note that the position of these components of the catheter 100 relative to the center of the OCT imaging device 109 may vary for a variety of reasons. In one example, the position of these components of the catheter 100 relative to the center of the OCT imaging device 109 may depend on the particular catheter 100. In one example, the OCT imaging device 109 may be movable within the imaging device lumen 108, which may change the position of the components of the catheter 100 relative to the center of the OCT imaging device 109. FIG. 10A to FIG. 10D is a cross-sectional view of a catheter 100 according to one embodiment, illustrating how moving an OCT imaging device 109 within an imaging device lumen 108 changes the position of various components of the catheter 100 relative to the center of the OCT imaging device 109. In particular, FIG. 10A to FIG. 10DThe OCT imaging device 109 is shown located at the top region, bottom region, left region, and right region of the imaging device lumen 108, respectively. Depending on the position of the OCT imaging device 109 in the imaging device lumen 108, the distance from the center of the OCT imaging device 109 to the track of the catheter 100 (i.e., the side edge 116 of the catheter 100 closest to the center of the OCT imaging device 109) varies. In addition, depending on the position of the OCT imaging device 109 in the imaging device lumen 108, the angle measured between the shortest straight line extending from the center of the OCT imaging device 109 to the track of the catheter 100 and the straight line extending from the center of the OCT imaging device lumen 108 to the center of the indicator lumen 112 varies. Note that the position of the components of the catheter 100 relative to the center of the OCT imaging device 109 may also vary due to compressive forces applied to the catheter 100 from the lumen, bending of the catheter 100, and / or manufacturing defects. Blocks 715 and 720 will use ranges rather than precise positions to find the components of the catheter 100 to accommodate these changes.

[0105] Block 715 includes detecting the track / orbit of the catheter 100. As previously described, the track of the catheter 100 is the side edge 116 of the catheter 100 that is closest to the center of the OCT imaging device 109. Back to Reference Fig. 9 , the OCT imaging device 109 may not be located at the center of the catheter 100, and, thus, the distance from the center of the OCT imaging device 109 to the side edge 116 of the catheter 100 may vary. The varying distance between the center of the OCT imaging device 109 and the side edge 116 causes the side edge 116 to appear as a sine wave in the waterfall image. The sine wave is superimposed on Fig. 9 109 to more clearly show the side edge 116 of the catheter 100. The approximate distance from the center of the OCT imaging device 109 to the track of the catheter 100 is known, and any uncertainty is largely due to the fact that the OCT imaging device 109 is not in the center of the imaging device lumen 108. Two horizontally extending lines are used to limit the area in the waterfall image where the track of the catheter 100 may be located. These two lines correspond to the approximate distance from the center of the OCT imaging device 109 to the track of the catheter 100, and the space between the two rings accommodates the variation in the distance between the center of the OCT imaging device 109 and the track for the reasons discussed above. The system can limit or at least focus the search for the track of the catheter 100 to the space between the two lines. Note that limiting or focusing the search for the track of the catheter 100 between the two lines prevents or at least suppresses false positives. The track of the catheter 100 is the portion of the sine wave closest to the top of the waterfall image (i.e., the side edge 116 of the catheter 100). Fig.11 yes Fig. 9, which is further labeled to indicate additional information shown thereon, including indicating the orbit angle 920 of the catheter 100, which is the axis between the imager origin 902 and the closest distance to the catheter edge (e.g., the peak 906 of the sine wave). As will be discussed in more detail below, Fig.11 Also depicted is the indicator lumen angle 906, which is the axis between the imager origin 902 to the center of the detected indicator lumen 112. Detection of the indicator lumen 112 is facilitated by constraining the search based on a distance range 908 from the imager origin 902, but may also be constrained by an indicator lumen angle range 924. The angular distance 924 is based on the slope characteristic of a sine wave. Once the indicator lumen angle 906 is identified, the angular offset between the track angle 920 and the indicator lumen angle 906 may be determined.

[0106] In one embodiment, a search for the track / orbit of the catheter 100 is performed using an independent template search. As previously described, the independent template search looks for the track of the catheter 100 between two lines. The template search uses a template extracted from a typical simplified waterfall image, processed by Gaussian blur, and then rescaled. The template search includes the squared difference between the template and a small patch of the search area (the template slides over the search area), and the result is then normalized. The result of the template search is a determined image where hot spots indicate a high probability that a feature / feature structure exists at that location.

[0107] Block 720 includes detecting the location of a fixed and constantly present marker or feature relative to the center of the OCT imaging device 109. The fixed and constantly present marker or feature may be constantly present along at least a portion of the length of the catheter 100. For simplicity, the indicator lumen 112 is discussed as a fixed and constantly present marker feature. However, it should be noted that other components, edges, or interfaces of the catheter 100 may be fixed and constantly present marker features instead of or in addition to the indicator lumen 112.

[0108] In one embodiment, block 720 includes detecting a trajectory of the indicator lumen 112 relative to the center of the OCT imaging device 109. The trajectory of the indicator lumen 112 may refer to the portion of the indicator lumen 112 that is closest to and / or farthest from the center of the OCT imaging device 109. The approximate distance from the center of the OCT imaging device 109 (the top of the waterfall image) to the trajectory of the indicator lumen 112 is known, with much of the uncertainty being due to the OCT imaging device 109 not being centered in the imaging device lumen 108. The distance from the center of the OCT imaging device 109 to the trajectory of the indicator lumen 112 may be known, determined experimentally or empirically (e.g., using OCT images), or calculated based on the geometry of a particular catheter. Reference Fig.11 , one or more sets of two horizontally extending lines 908 are used to limit the area in the waterfall image where the track of the indicator lumen 112 may be located. The one or more sets of two lines correspond to the approximate distance from the center of the OCT imaging device 109 to the track of the indicator lumen 112, and the space between the two lines accommodates the variation in the distance between the center of the OCT imaging device 109 and the track of the indicator lumen 112 for the reasons previously described. Fig. 9 and 11 , two sets of two horizontally extending lines 908 are used, one set for limiting or concentrating the search for the trajectory of the indicator lumen 112 closest to the center of the OCT imaging device 109, and the other set for limiting or concentrating the search for the trajectory of the indicator lumen 112 farthest from the center of the OCT imaging device 109. Note that the two lines 908 used to limit or concentrate the search for the trajectory of the indicator lumen 112 closest to the center of the OCT imaging device 109 are the same as the two lines 904 used to find the trajectory of the catheter 100, although the two sets of lines do not need to be the same depending on the geometry of the catheter 100. Note that limiting or concentrating the search for the indicator lumen 112 between the two lines 908 prevents or at least suppresses false positives. For ease of viewing, the indicator lumen 112 is shown using superimposed circles in FIGS. 3 and 5.

[0109] In one embodiment, the position of the trajectory of the catheter 100 detected during block 715 can be used to detect the position of the indicator lumen 112 relative to the center of the OCT imaging device 109. For example, the approximate angle between a line extending from the center of the OCT imaging device 109 to the trajectory of the catheter 100 and a line extending from the center of the OCT imaging device 109 to the center of the indicator lumen 112 (hereinafter referred to as the "track / indicator angle") is known, with the uncertainty in the track / indicator angle primarily due to the OCT imaging device 109 not being at the center of the imaging device lumen 108. The track / indicator angle can be known, determined experimentally or empirically (e.g., using OCT images), or calculated based on the geometry of the particular catheter. Reference Fig.11, the angle offset 926 is the distance on the waterfall image corresponding to the minimum approximate track / indicator angle. The indicator lumen angle range 924 corresponding to the uncertainty of the track / indicator angle extends from the angle offset 926. At least a portion of the indicator lumen 112 (e.g., the track of the indicator lumen 112) is expected to be located within the indicator lumen angle range 924. Therefore, the search for the indicator lumen 112 can be limited or focused within the indicator lumen angle range 924. In a specific example, the search for the indicator lumen 112 can be limited or focused within the overlapping portion between the indicator lumen angle range 924 and the portion located between the one or more groups of two lines 908. Note that limiting or focusing the search for the indicator lumen 112 within the indicator lumen angle range 924 prevents or at least suppresses false positives.

[0110] Block 720 may use the trajectory of the indicator lumen 112 or other information detected during block 720 to detect the center of the indicator lumen 112 (using Fig.11 922 on the figure).

[0111] In one embodiment, a search for fixed and constantly present markers or characteristic structures is performed using an independent template search. As previously described, an independent template search looks for fixed and constantly present markers or characteristic structures between two lines. The template search uses a template extracted from a typical simplified waterfall image, processed by Gaussian blur, and then rescaled. The template search includes the squared difference between the template and a small block of the search area (the template slides over the search area), and the result is then normalized. The result of the template search is a determined image in which hot spots indicate a high probability that a characteristic structure exists at that location.

[0112] Typically, in a waterfall image, the trajectory of catheter 100 can be found more reliably than indicator lumen 112. As such, the trajectory of catheter 100 can be used to detect the trajectory / indicator angle. However, in some embodiments, indicator lumen 112 can be found with a very high degree of certainty (e.g., more reliably detected than the trajectory of catheter 100). In such embodiments, indicator lumen 112 can be used to detect the trajectory of catheter 100 using the techniques described above. For example, the location of indicator lumen 112 and the known approximate trajectory / indicator angle can be used to limit or at least focus the search for the trajectory of catheter 100 to a certain area (i.e., an angular offset can be measured from the center of indicator lumen 112, and an angular range extending from the angular offset is used to limit or focus the search).

[0113] In one embodiment, as previously described, block 705 may include detecting multiple images at different locations along the length of the catheter 100. In such an embodiment, blocks 710 to 720 may be performed for only one, some, or all of the multiple images. A confidence value may be detected for each image for which blocks 710 to 720 are performed. Only the image with the highest confidence value or the image with a confidence value above a threshold, if any, is used to determine the orientation of the catheter 100 and the direction in which the exit ramp 114 extends from the rest of the catheter 100.

[0114] Block 725 includes applying a template 1200 (eg, including an exit ramp indicator 1202) to one or more images. Fig.12 100 ). Preferably, block 725 applies the template 1200 to the one or more images in substantially real time, thereby allowing an individual using the catheter 100 to know the orientation of the catheter 100 and the direction in which the exit ramp 114 extends at any given time. As used herein, substantially real time refers to a time period that is small enough that any delay is not detectable by the individual using the catheter 100, or that any delay is unlikely to adversely affect the operation of the catheter 100. For example, substantially real time may allow for delays of about 5 seconds or less, more preferably about 1 second or less, or even more preferably less than about 0.5 seconds, or less than about 0.1 seconds.

[0115] The template 1200 includes the positions (e.g., angles) and relative distances between the imaging device lumen 108, the guidewire lumen 110, the indicator lumen 112, the direction of the exit ramp 114 (shown using the exit ramp indicator 1202), and the side edge 116 of the catheter 100. The template 1200 can be known, determined experimentally or empirically (e.g., using OCT images), or calculated on a per-catheter basis. For example, three parameters of the template 1200 can be known, determined, or calculated, including the angle between the center of the guidewire lumen 110 and the center of the indicator lumen 112, the radial distance between the center of the imaging device lumen 108 and the guidewire lumen 110, and the exit ramp angle direction relative to the vector from the center of the imaging device lumen 108 and the center of the guidewire lumen 110. The template 1200 may also make one or more assumptions, such as the diameter of the catheter 100, the diameter of the imaging device lumen 108, the diameter of the guidewire lumen 110, the diameter of the indicator lumen 112, the relative angles of the centers of the three lumens, and the relative positions of the three lumens in the catheter 100. The template 1200 may be aligned on the image so that the features of the catheter 100 detected during blocks 715 and 720 are aligned with corresponding portions of the template 1200.

[0116] Template 1200 is a visual template. That is, when superimposed on an image, template 1200 adds one or more visual indications. Fig.12 A template 1200 is shown superimposed on an image according to one embodiment. The template 1200 includes an exit ramp indicator 1202. The exit ramp indicator 1202 indicates the angular direction in which the exit ramp 114 extends relative to the catheter 100 (e.g., relative to the guidewire lumen 110). The exit ramp indicator 1202 also indicates the orientation of the catheter 100. In one embodiment, the exit ramp indicator 1202 may include a line indicating the approximate angular direction in which the exit ramp 114 extends relative to the rest of the catheter 100. In one embodiment, the exit ramp indicator 1202 may be a triangle, two lines extending from a point, a single line with an arrow, or other indicators indicating the approximate angular direction in which the exit ramp 114 extends relative to the rest of the catheter 100 and any uncertainty. In one embodiment, as shown, the exit ramp indicator 1202 may include a line and an indicator (e.g., a triangle) indicating uncertainty.

[0117] In one embodiment, the template 1200 may include at least one of an imaging device lumen circle 1204, a guidewire lumen circle 1206, an indicator lumen circle 1208, or a catheter edge circle 1210 that is displayed when the template 1200 is superimposed on an image. The imaging device lumen circle 1204 may correspond to the location, size, and shape of the imaging device lumen 108. The guidewire lumen circle 1206 may correspond to the location, size, and shape of the guidewire lumen 110. The indicator lumen circle 1208 may correspond to the location, size, and shape of the indicator lumen 112. The indicator lumen 112 provides a user of the catheter 100 with direct and real-time visual feedback on the accuracy of the exit ramp indicator 1202 in predicting the exit trajectory of the guidewire. For example, if the indicator lumen 112 is misaligned with the indicator lumen, the user can estimate the degree of deviation of the exiting guidewire relative to the exit ramp indicator 1202 accordingly. The catheter edge circle 1210 corresponds to the position, size, and shape of the side edge 116 of the catheter 100. The imaging device lumen circle 1204, the guidewire lumen circle 1206, the indicator lumen circle 1208, and / or the catheter edge circle 1210 provide a visual indication to an individual using the catheter 100 and help the individual understand what is shown in the image. The imaging device lumen circle 1204, the guidewire lumen circle 1206, the indicator lumen circle 1208, and / or the catheter edge circle 1210 also help indicate the orientation of the catheter 100 to an individual using the catheter 100. In one embodiment, the imaging device lumen circle 1204, the guidewire lumen circle 1206, the indicator lumen circle 1208, and / or the catheter edge circle 1210 can be selectively displayed. Note that the imaging device lumen circle 1204, the guidewire lumen circle 1206, the indicator lumen circle 1208, and / or the catheter edge circle 1210 may be slightly offset on the image, for example, due to compression of the catheter 100 during use or due to manufacturing defects. Any element of the display or template of the exit ramp indicator 1202 can be any color or suitable form or shape that makes it easy for the user to identify. Not all elements 1202, 1204, 1206, 1208, and 1210 need to be displayed. For example, the exit ramp indicator 1202 displayed with the indicator lumen circle 1208 will meet the need to indicate the direction or trajectory of the guidewire leaving the exit ramp 114 using a reference (indicator lumen circle) indicator related to the position of the fixed marker (indicator lumen 112) to enable the user to determine whether the exit ramp indicator 1202 is displayed correctly.

[0118] The method 700 may include one or more additional boxes in addition to boxes 705 to 725. In one example, the method 700 may include creating a template 1200 customized for each catheter. Calibrating and creating the template 1200 for each catheter may be cumbersome / tedious. In this way, software may be used to capture the variations / differences of each catheter 100. The software may include generating multiple different images of the catheter 100. The software may analyze the images and calibrate the template 1200 based on the multiple different images. For example, the software may detect one or more feature structures of the catheter 100 and calibrate the template 1200 based on the detected feature structures. In one embodiment, a user of the catheter 100 may examine the images to determine whether the software is accurately characterized, and may allow the user to modify the template to accommodate errors in detecting features.

[0119] In one example, the method 700 includes an optional box to copy a portion of the waterfall image before boxes 715 and 720. For example, if the indicator lumen 112 and / or the track of the catheter 100 are at least partially located at or near the side edge (e.g., the left edge or the right edge) of the waterfall image, the algorithm disclosed herein may have difficulty detecting the track of the indicator lumen 112 and / or the catheter 100 as discussed in boxes 720 and 715. As such, the method 700 may include copying a columnar portion of one edge (the right edge or the left edge) of the waterfall image and adding the copied columnar portion to another edge of the waterfall image. The copied columnar portion may include 5-30% (e.g., 15-25%) of the waterfall image. In a specific example, when the image includes 180 1D images, the first 40 1D images on the right may be copied and added to the left so that the waterfall image now has 220 1D images. Duplicating the cylindrical portion of the waterfall image and adding the cylindrical portion to the opposing edges of the waterfall image ensures that the indicator lumen 112 and the trajectory of the catheter 100 are not located at or near the side edges of the waterfall image.

[0120] In one example, the method 700 includes an optional block of detecting a certainty value of the indicator lumen 112 and the trajectory of the catheter 100 detected during blocks 720 and 715 to determine whether there is sufficient confidence to warrant displaying the exit ramp indicator 121. In such an example, the exit ramp indicator 121 may be displayed when the certainty value is above a predetermined threshold. Detecting the certainty value of the indicator lumen 112 and the trajectory of the catheter detected during blocks 720 and 715 prevents displaying erroneous results to an individual using the catheter 100, which may confuse the individual.

[0121] In one example, method 700 includes an optional box for editing the image. For example, method 700 may include adjusting the brightness of the image, adjusting the contrast of the image, or otherwise editing the image. Editing the image may help detect the trajectory of catheter 100 and / or detect indicator lumen 112. Editing the image may also make it easier for an individual using catheter 100 to understand and interpret the OCT image.

[0122] In one example, method 700 includes displaying the detected image to the individual as a catheter-centric view of catheter 100, as opposed to OCT imaging device 109 being centered on the image. In such an example, template 120 may be catheter-centric.

[0123] Note that a circular image may be used instead of a waterfall image to find the trajectory of the indicator lumen 112 and / or catheter 100. For example, according to one embodiment, Fig.13 is a circular image that can be used to find the trajectory of the indicator lumen 112 and / or catheter 100. Fig.13 It is not a waterfall image, so circular lines are added to the image instead of horizontal lines. The outer two lines 1352 may indicate the space where the track of the catheter 100 can be found. Line 1354 indicates the position of the track of the catheter 100. The inner two circular lines 1356 indicate the space where the track of the indicator lumen 112 is expected to be found. The oblique line 1358 is the indicator lumen angle range. The line 1360 inside the oblique line 1358 indicates the center of the indicator lumen 112.

[0124] In various other embodiments, the indicator lumen 112 may be placed outside of the detection range 304 to completely separate it from the track edge detection. The indicator lumen 112 may also be any shape other than circular and may be any size within the physical limitations of the catheter 100 to distinguish it from other features within the cross-section of the catheter 100.

[0125] In various other embodiments, the side edge 116 of the catheter 100 may include fixed features along the range of travel of the imaging device 109 in the catheter 100. Such features may include small transparent or opaque elongated objects or grooves that are placed and adhered / attached / attached along the range of travel of the imaging device 109.

[0126] As previously described, the imaging device of the catheter disclosed herein may detect an image of the catheter at one or more locations along the length of the housing. For example, the imaging device may detect one or more images by physically moving the imaging device along the length of the housing. During use, it may be difficult for the user of the catheter to know the location of the imaging device at any given time as well as the location of the catheter and the environment around the catheter that the imaging device is imaging. Therefore, any catheter disclosed herein may include a detectable structure that is configured to indicate the location of the imaging device along the length of the housing. Fig.14 is an isometric view of a detectable structure 1450 that may be disposed in or on a catheter (not shown) according to one embodiment. The detectable structure 1450 is configured to be disposed in or on the housing 102.

[0127] The detectable structure 1450 is configured to be detectable by the imaging device 109. As such, the detectable structure 1450 is formed of a material that is easily detectable by the imaging device. For example, the detectable structure 1450 may be formed of a material that is at least partially opaque to or reflective of a stimulus transmitted or received by the imaging device. In one example, when the imaging device is an OCT imaging device, the detectable structure 1450 may be formed of at least one material that is opaque to light (e.g., more opaque than the surrounding shell) or reflective of light. In one example, when the imaging device is an ultrasound device, the detectable structure 1450 may be formed of a material that is at least partially opaque to (e.g., more opaque than the surrounding shell) or reflective of ultrasound wavelengths.

[0128] The detectable structure 1450 is configured to indicate the position of the imaging device relative to the housing. For example, the detectable structure 1450 may indicate the distance to the distal tip, the intersection of the distal and proximal segments of the guidewire lumen, and / or the distance to the intersection of the catheter body and the imaging body of the housing. The detectable structure 1450 indicates the position of the imaging device relative to the housing because the detectable structure 1450 has a known position on the housing.

[0129] The detectable structure 1450 includes a base 1452. The base 1452 may have an annular or semi-annular shape because the housing 102 generally has a circular cross-sectional shape. The annular or semi-annular shape of the base 1452 also allows the lumen of the catheter to pass through the base 1452. In certain embodiments, the base may have a semi-annular shape that allows the imaging device to detect at least a portion of the environment surrounding the catheter when the imaging device is at least partially surrounded by the annular base 1452. The detectable structure 1450 also includes one or more elongated arms 1454 extending from the base 1452. The detectable base 1452 and the one or more elongated arms 1454 can be used to determine the position of the imaging device 109. For example, when the imaging device is adjacent to the base 1452 or within a volume defined by at least a portion of the base 1452, the imaging device can detect the base 1452, thereby indicating the position of the imaging device. Similarly, when the imaging device is adjacent to the one or more elongated arms 1454, the imaging device may detect the one or more elongated arms 1454, thereby indicating the position of the imaging device. In one embodiment, as shown, the detectable structure 1450 includes a plurality of elongated arms 1454 extending from the base 1452. Each of the plurality of elongated arms 1454 may extend from the base 1452 to a different length. The position of the imaging device 109 may be determined based on the number of elongated arms 1454 detected by the imaging device 109. For example, using Fig.14 The specific detectable structure 1450 shown, when the imaging device 109 detects four slender arms 1454, the imaging device 109 is located between the base 1452 and the end of the shortest slender arm 1454, and when the imaging device 109 detects one slender arm 1454, the imaging device 109 is located between the end of the second longest slender arm 1454 and the end of the longest slender arm 1454.

[0130] The catheter disclosed herein may include Fig.14 The detectable structure 1450 is shown as a detectable structure. For example, Fig.15 1 is an isometric view of a catheter 1500 including a detectable structure 1550 according to one embodiment. Unless otherwise disclosed herein, the catheter 1500 may be the same or substantially similar to any catheter disclosed herein. The catheter 1500 includes a housing 1502. For ease of illustration, the lumen defined by the housing 1502 is not shown. The housing 1502 defines one or more holes and / or pits. The holes and / or pits may be spaced along the longitudinal axis of the housing 1502. The relative position of each hole and / or pit on the housing 1502 is known. The holes and / or pits can be detected by an imaging device. In this way, the holes and / or pits form a detectable structure 1550. The position of the imaging device in the housing 1502 can be determined by counting the number of holes and / or pits that the imaging device passes through when the imaging device moves in the housing 1502.

[0131] Fig.16A 1 is a side view of a catheter 1600 according to one embodiment. Unless otherwise disclosed herein, the catheter 1600 is the same or substantially similar to any catheter disclosed herein. For example, the catheter 1600 includes a catheter distal region 1656 and a catheter proximal region 1658. The catheter distal region 1656 can be connected to the catheter proximal region 1658. Figure 1A-6B The catheter distal regions of the catheters shown are identical or substantially similar. The total length of the catheter 1600 from the end of the catheter distal region 1656 to the catheter proximal region 1658 can be about 1 m to about 3 m. The portion of the catheter 1600 formed in the catheter distal region 1656 and the catheter proximal region 1658 can have any suitable size, such as 4 French or less.

[0132] The catheter 1600 may include a hub 1660 attached to the distal end of the proximal region 1658 of the catheter. Fig.16A As shown, the hub 1660 may optionally taper / contract in the distal direction. The hub 1660 may be attached to the catheter proximal region 1658 using any suitable technique. For example, a portion of the catheter proximal region 1658 adjacent to its end may be disposed within the distal end of the hub 1660 attached thereto using an interference fit, or the catheter proximal region 1658 may be integrally formed with the hub 1660. The hub 1660 may include one or more openings therein that allow access to one or more lumens of a distal scratch of the catheter 1600. For example, the distal connector 1660 may include a guidewire flushing port 1662 that is configured to allow one or more fluids to flow into the guidewire lumen. The hub 1660 may also include a guidewire introduction port 1664 that allows a guidewire to be introduced into the catheter and / or the distal tip of the guidewire to extend out of the catheter 1600 as needed.

[0133] The catheter 1600 also includes a housing 1666. The housing 1666 is configured to be grasped and manipulated by a user of the catheter 1600. The housing 1666 may include one or more actuators that can be manipulated by a user of the catheter 1600, thereby allowing the user to operate the catheter 1600. For example, the housing 1666 may include a first actuator 1668 and a second actuator 1670, as well as one or more flanges 1676 and / or grooves 1678, so as to facilitate engagement or releasable attachment to other components, such as a slide assembly, an interconnect or handle socket or sterile cover for the housing 1666. The first and second actuators 1668, 1670 may include a knob (e.g., a rotatable knob) or any other suitable actuator. The first and second actuators 1668, 1670 may be configured to control one or more operations of the catheter 1600. In one example, the first actuator 1668 may be used to adjust the longitudinal position of an imaging device inserted and / or engaged to the housing 1666. In such an example, the first actuator 1668 may include a rotatable knob that utilizes a spiral thread interface to advance or retract an imaging device engaged to the interface. In other variations, the first actuator 1668 may include a mechanical slider or a rack and pinion assembly to move the imaging device. In one example, the second actuator 1670 is a catheter body rotation interface or adapter that contributes to the rotation of the catheter distal region and the catheter proximal region 1656, 1658 without requiring the rotation of the entire catheter 1600 and / or housing 1666. In this way, the rotation of the catheter outlet ramp of the catheter distal region 1656 does not cause the rotation of all catheter structures. When the actuator is configured as a part of the rotating catheter 1600, the housing 1666 may include a fiber optic rotary joint, such as those manufactured by Spinner (Munich, Germany), Princetel (Hamilton, New Jersey), and Moog (Elma, New York).

[0134] The housing 1666 may also include an optical connector 1672 (e.g., a standard 2.5 mm optical connector) disposed at the proximal end of the housing 1666 to connect the catheter 1600 to a standard superluminescent diode (SLED) light source or scanning laser source of an OCT system. Any of a variety of known ophthalmic or medical OCT control systems or components may be used (e.g., Zeiss (Carl Zeiss Meditec USA, Inc.; Dublin, CA) and EnFocus (Leica Microsystems Inc.; Deerfield, IL)). Housing 1666 may also include one or more ports. For example, housing 1666 may include image flushing port 1672 configured to allow one or more fluids to flow into a lumen for an imaging device.

[0135] Fig.16E Another embodiment of a catheter 1680 is depicted, which is similar to Figures 16A to 16D 1600, except that a fiber optic cable 1682 is provided between the catheter housing 1666 and the fiber optic connector 1674. In this embodiment, the catheter housing 1666 is manipulated by the user like a proximal catheter handle, rather than as a Figures 33A to 33M The combined guide tube / slide assembly shown is manipulated as shown in FIG. Fig.16A The catheter 1600 with the optical cable 1680 also allows the system to move the boundary between the sterile environment and the non-sterile environment proximally from the catheter housing 1666, which can simplify the connection between the catheter connector 1674 and the slide, so that a sterile drape is not required at the connection between the connector 1674 and the slide. For example, the length of the optical cable 1682 can range from 6 inches to 6 feet, or 12 inches to 4 feet, or 1 foot to 3 feet, or 18 inches to 3 feet. The imaging driver / slide assembly has a permanent component at the proximal end, wherein the handle or housing socket at the distal end is connected to Fig.16A The catheter 1600 in.

[0136] Fig.17 17 is a diagram of a system 1780 according to one embodiment. System 1780 includes catheter 1700. Catheter 1700 may include any catheter disclosed herein. System 1780 may also be configured to perform any method disclosed herein.

[0137] The system 1780 includes one or more components that facilitate the operation of the catheter 1700. For example, the system 1780 may include a bed 1782 or other structure on which the patient can place the catheter 1700 for use. The system 1780 may also include an external imaging device 1784 configured to image tissue and the catheter 1700 in the patient's body. The external imaging device 1784 may include, for example, a projection radiography device (e.g., an x-ray machine), a magnetic resonance imaging (MRI) machine, a computed tomography machine (e.g., a CT scanner), and an ultrasound device, or any other external imaging device. The system 1780 may also include an imaging display 1786 configured to provide data to a user of the system 1780 (e.g., a medical practitioner). The imaging display 1786 may display, for example, images detected by the imaging device of the catheter 1700 and / or images detected by the external imaging device 1784.

[0138] The system 1780 may include one or more components configured to operate and / or use data collected by the catheter 1700. For example, the system 1780 may include an imaging driver 1788. The imaging driver 1788 may be configured to connect to the catheter 1700, for example, an image interconnect 1674, such as a DMI fiber optic connector (Diamond SA; Losone; Switzerland). The imaging driver 1788 may also include software that allows the imaging device of the catheter 1700 to communicate with other components of the system 1780, such as at least one of the imaging display 1786, the console 1790, and the touch screen 1792. The imaging driver 1788 may be physically attached to the touch screen 1792, or the imaging driver 1788 may be located separately on the operating table inside or outside the sterile field.

[0139] The system 1780 may also include a console 1790 connected to or connectable to the catheter 1700. The console 1790 is configured to facilitate the operation of the catheter 1700. In one example, the console 1790 may perform at least one of the following: provide power to the catheter 1700; and provide light or other stimulation to the catheter 1700 when the imaging device requires light or other stimulation (e.g., via an optical cable). In one example, the console 1790 may also provide control of one or more operations of the catheter 1700, and may analyze any data generated by the catheter. In such an example, the console 1790 may also include a housing with a SLED light source or a swept laser source output, a graphics processing unit (GPU) for generating outputs to a touch screen and an optional larger non-touch screen display, and corresponding connection cable interfaces for the laser source output and the GPU output. The SLED light source or swept laser source output may include an imaging source interconnect and an interconnect for an optional aiming beam, which will be described elsewhere herein. The console 1790 may also include one or more power switches, a locking mechanism (key or keyless), and an emergency stop button or actuator.

[0140] As previously described, the system 1780 may include a touch screen 1792 (e.g., a tablet computer). The touch screen 1792 may allow the system 1780 to provide information or control options to a user of the system 1780 and allow the user to at least partially control the operation of the system 1780. The touch screen 1792 (or a device configured to provide images to the touch screen 1792 and receive input from the touch screen 1792) may include a graphical user interface that provides information to the user and allows the user to enter commands to the system 1780. Fig.18A and 18Bis an image of an example graphical user interface 1800 that can be used with a touch screen according to an embodiment. The user interface 1800 includes a command area 1802 that allows a user to interact with the user interface 1800 (e.g., enter commands into the user interface 1800) and a display portion 1804 that is configured to provide data or images to the user. For example, the display portion 1804 can provide an image generated by an imaging device of the catheter using the methods discussed previously.

[0141] refer to Fig.18A , the command area 1802 may include one or more icons displayed thereon that, when pressed by a user, change the image provided in the display portion 1804. Typically, the command area 1802 is displayed on the touch screen 1792 and the display portion 1804 is displayed on the imaging display 1786. In one example, the icons may include a pause icon 1806 that, when pressed by a user, causes the image provided in the display portion 1804 to show a live feed / real-time broadcast or a still frame of the live feed of an image detected by the imaging device. In one example, the icons may include one or more rotation icons 1808a and 1808b that, when pressed, cause the image provided in the display portion 1804 to rotate. The icons may also include a brightness icon 1810 and a contrast icon 1812 that are configured to change the brightness and contrast of the image, respectively, when manipulated by a user. The icons may include an instant replay icon 1813 that, when pressed by a user, causes the display portion 1804 to display a replay of previously displayed content. The icons may also include an expand icon 1814. Reference Fig.18B , when pressed, the expansion icon 1814 may cause the graphical user interface 1800 to display an expansion box 1816. The expansion box 1816 may include one or more additional icons (e.g., selectable circles). For example, the expansion box 1816 may include a ramp overlay icon 1818. When pressed, the ramp overlay icon 1818 may overlay a template on the image. The template may include any template disclosed herein and may show, for example, an exit ramp indicator 1820 and an indicator lumen circle 1822 (as shown). The expansion box 1816 may also include a ruler icon 1824, which, when pressed, overlays a ruler on the image. Fig. 18C and 18DAn exemplary ruler overlay 1840 is depicted that may be provided on a touch screen and an auxiliary display, respectively, including a crossed X-axis and Y-axis rulers having 0.5 mm and / or 1 mm incremental markings. In this particular example, each ring is 1 mm apart and the axis markings are 0.5 mm apart. In use, in addition to turning the ruler overlay 1840 on and off via the user interface icon 1824, the user interface may be moved relative to the OCT image using the touch screen or input device (e.g., keyboard, mouse, gesture tracker), which may facilitate measurement of a lumen or other anatomical structure when the catheter is not centrally located within the lumen or anatomical structure. The expansion box 1816 may also include a background subtraction icon 1826 that subtracts or at least reduces the background detected by the imaging device. Return to Reference Fig.18A , graphical user interface 1800 may include additional control icons, optionally including but not limited to a video recording start / stop icon 1828, a replay / recycle icon 1830 for replaying the last segment of the current video to allow the user to review the process, and brightness and contrast icon controls 1832 and 1834. The interface may also include an icon 1836 for turning aiming beam 3326 on and off (e.g., Fig.33H ), which can be used to confirm the functionality of a catheter, a light source, and the optical connection therebetween before the catheter is inserted into a patient.

[0142] Back to reference Fig.17 , the system 1780 may include one or more input and output devices, instead of or in addition to the touch screen 1788. In one example, as shown, the system 1780 may include an imaging display 1786. In one example, the system 1780 may include a keyboard, mouse, joystick, or other input device that allows a user to modify an image detected by the imaging device.

[0143] The catheter systems disclosed herein are generally used for coronary and other peripheral vasculature, including arterial and venous vasculature, but in other variations, reentry can be used for other non-vascular body lumens, such as the lymphatic system, biliary tree, etc., as well as brain or neurovascular structures. Although the catheter system includes an imaging device such as OCT or ultrasound, the system can also be used in conjunction with an external visualization or imaging system such as a fluoroscopic system in a catheterization laboratory or interventional radiology room.

[0144] In one example, a method of using a reentry catheter system is provided, such as Fig.19As shown. Typically, method 1900 includes console preparation 1902, slide preparation 1904, touch screen preparation 1906, and catheter preparation 1908. The catheter is then manipulated under fluoroscopic guidance to reach the lesion 1910. Using the imaging system of the catheter 1912 (including the imager position knob and the catheter rotation adapter), the surrounding anatomical structures are visualized. The catheter is advanced 1914 to get closer to the chronic total occlusion ("CTO"). If necessary or required, the catheter is flushed 1916 with saline, which is visible on OCT imaging. The catheter is then advanced 1918 to the CTO and its surroundings, into the subintimal space. Once through the CTO, OCT imaging is used to identify 1920 the true lumen pulsation area and the outer membrane fiber / honeycomb layer area. Using imaging overlap / coverage, the guidewire ramp indicator is then rotated 1922 toward the true lumen and away from the pericardium or outer membrane to avoid the risk of perforation. Before advancing the guidewire, confirm that the superimposed enhancement portion / layer of the flushing lumen circle is concentric with the OCT image of the flushing lumen 1924. The guidewire may then be advanced and reentry into the true lumen confirmed by OCT imaging 1926. Once the guidewire is positioned, the catheter is retracted 1928 while maintaining the position of the guidewire. Once the catheter is removed, the imaging system is turned off 1930. A stent may then be deployed 1932 over the guidewire or other procedures performed.

[0145] Exemplary detailed surgery

[0146] The patient and surgical area are prepared and covered with a drape in the usual sterile manner. A transparent sterile drape may also be used over the console's non-sterile touch screen. The touch screen drape may include a silicone adhesive, hook and loop interface, or snaps for ease of attachment. The sterile drape may also be used to grip the touch screen in a sterile manner for repositioning or attachment to the operating table or the rails of a fluoroscopy system.

[0147] Inspect the catheter 3300 for damage and remove it from its packaging using aseptic technique and transfer it to a sterile field for further inspection. Remove the protective cap 3302 ( Fig.33A and 33B ). The proximal fiber optic connector 3304 can be a standard 2.5 mm ferrule. The catheter housing 3306 and connector 3304 are then inserted through the cap 3308 into the slide 3310 ( Fig.33C ) until the catheter housing is fully attached through the circumferential recess 3312 ( Fig.33D). The interface between the catheter housing 3306 and the slide 3310 can be configured to provide visual, auditory and / or tactile feedback to indicate engagement by, for example, surface markings, latches, or changes in resistance. The catheter shaft is then hydrated in sterile saline for a period of time, such as 20 seconds to 120 seconds, 30 seconds to 60 seconds, or 30 seconds to 45 seconds. Using a syringe (e.g., 5cc or 10cc), the catheter 3300 can be flushed with sterile heparinized saline using the guidewire lumen flush port 3314 while blocking the guidewire introduction port 3316 and verifying the openness of saline outflow from the distal end 3320 of the catheter. Blockage of the guidewire introduction port 3318 can be performed using the user's finger. A hemostatic valve can optionally be attached to the guidewire lumen flush port and / or the guidewire introduction port to block or prevent leakage. The syringe 3318 is then attached to the imaging device lumen port 3320 and fluid is verified to also be present at the distal tip ( Fig.33E ).

[0148] After reconfirming that the console is turned on, test the catheter by selecting and entering case information on the touch screen. This may include catheter specific information such as a catheter identifier or serial number. The catheter user interface is then available. Various medical record information such as patient ID, case ID, site ID, catheter serial number, etc. may be entered and edited on the data entry screen. After this data entry, the catheter user interface may then change to the catheter control screen ( Fig.18A ), with various exemplary catheter control elements as described elsewhere herein. Before commencing the procedure, various catheter control and interface elements are tested and / or configured. To initiate imaging, an actuator on the slide 3310, such as button 3322 ( Fig.33F ), and the rotation of the imager within the catheter 3300 is confirmed by a sector view on the system display. In some variations, an indicator light is provided on the system or in the actuator button and may illuminate with a first color (e.g., white or green) if functioning properly, or may provide a warning (red or flashing light) if the sensor and / or image output itself detects a problem with the imager rotation. When a problem is detected, the imager may be deactivated by actuating the separation latches or buttons 3324a and 3324b ( Figure 33G ) to detach and release the catheter 3300 from the slide 3310 and then reconnect to retry and confirm proper installation and function. Tactile and / or audible feedback can be confirmed to ensure proper installation, and then activation of the imager can be restarted. By Fig.18A )'s aiming beam icon 1826 opens the aiming beam 3322 ( Fig.33H ) to check for visible light emission from the end region of the catheter 3300, the image quality and continuity of the light source at the end region of the catheter 3300 can be tested and confirmed. If the aiming beam 1826 is not visible or is very dim, the catheter 3300 may need to be replaced.

[0149] Prior to inserting the catheter 3300 into the patient, the slide button 3318 ( Fig.33F ) to close the slide 3310 and catheter 3300. The light on the slide button 3318 should turn off and the rotating mechanism within the slide should stop turning. The catheter 3300 is then separated from the slide 3310 using the separation button 3320a / 3320b. The exposed connector 3304 should be re-capped using the protective cap 3302. Because the proximal end of the catheter 3300 is no longer sterile and has come into contact with the slide 3310, the catheter 3300 will need to be covered to maintain or protect the sterile field. Figures 33I to 33K 33, the sterile probe cover package 3328 is opened, containing the plastic cover 3330 and the elastic or rubber band 3332. The sterile end 3334 of the cover 3330 is grasped and the cover 3330 is pushed onto the proximal end of the catheter 3300 ( Fig.33J Then, the cover 3330 is fixed to the conduit 3300 around the recess of the conduit 3300 by the rubber band 3332 ( Figure 33K ).

[0150] The catheter is then advanced into the patient's body through the inserted sheath and over the guidewire under visual guidance (e.g., fluoroscopy) to the target lesion. The guidewire lumen of the catheter is configured to accommodate a standard 0.014" guidewire, but in other variations, other guidewire sizes may be accommodated. In this example, the minimum guidewire length is 180 cm and is used with a 6F to 8F capture, a 7F sheath, and a 7F guide catheter (minimum 0.081"). In another example, if the guidewire is used with a guide extension catheter such as Paired guide extension catheter (Teleflex; Morrisville, NC), 8F The catheter should be used with an 8F sheath and an 8F guiding catheter. To guide the extension catheter, a 300-cm guidewire should be used to ensure the guidewire position.

[0151] As the catheter is advanced within the guide catheter inserted into the patient, the tip of the catheter can be visually observed by fluoroscopy. When the catheter tip is just near the end of the guide catheter, advancement is stopped. The sterile cover 3330 and protective cap 3302 are then removed from the connector 3304 so that the catheter 3300 can be reattached to the slide 3310, as shown in FIG. Fig.33F As shown. By using the slide button 3322 and the record icon 1828 ( Fig.18A ) re-enable the system. During surgery, the vasculature is visualized using imaging on a touch screen or a secondary display connected to the system. Figure 33LThe imager knob 3336 of the catheter 3300 in the catheter can be used to adjust the longitudinal position of the imager along the ramp around the nose cone to the catheter side port. The imager knob 3336 can also be used to advance or withdraw the imager to visualize the ramp and / or guidewire lumen. The knob or adapter 3338 on the catheter 3300 can also be used to rotate the catheter clockwise or counterclockwise to direct the guidewire and guidewire ramp toward the true lumen.

[0152] The catheter is then advanced over the guidewire toward the target CTO lesion. If the guidewire is advanced into the subintimal space, the user may feel or detect some tactile resistance. Use fluoroscopic visualization during advancement to confirm the catheter position and guidewire tip relative to the CTO lesion. Once the distal tip of the catheter is in the vicinity of the CTO lesion, it should also be close to the distal tip of the guidewire. Figure 33M As shown, the proximal end of the guidewire 3340 should protrude through the introduction port 3342 at the proximal region of the catheter 3300. Local irrigation in the imaging area can be performed through the guidewire lumen irrigation port 3344 adjacent to the guidewire introduction port 3342. When necessary, such as in larger blood vessels, larger volume irrigation can also be performed through the irrigation port of the guide catheter. Fig.34A Depicted are exemplary OCT images with blood in the field of view, which acts as an optically scattering medium at the operating wavelength of the OCT imaging system and thus appears as a general blur, turbidity, or haziness in the image. Fig.34B An exemplary OCT image depicting a reduction in the amount of blood in the field of view is depicted, which is caused by a saline flush through the guidewire with the lumen flush port. The vascular structures surrounding the catheter are more clearly visible. The saline flush itself can be confirmed by the starburst-like area 3360 in the OCT image, which is caused by the fluid dynamics around the catheter 3300. Fig.34B The subintimal anatomy from the catheter is also depicted, with the true lumen 3362 seen as a flattened pancake shape extending from the 5 o'clock to 9 o'clock areas of the image.

[0153] To reenter the true lumen from the subintimal space, the catheter is advanced toward the lesion. Prior to advancing the catheter, the catheter tip / chute orientation is visually confirmed. The user confirms the location of the true lumen and identifies the desired reentry location or path based on the OCT image. Reference Fig.34C Once the location of the true lumen 3362 is identified, the catheter 3300 is rotated using the rotation adapter to align the guidewire ramp 3364 with the true lumen 3362 and away from the pericardium 3366 and adventitia 3368 of the blood vessels. The direction of the guidewire trajectory 3370 can be determined by the axis between the guidewire lumen 3372 and the guidewire ramp 3364. This can also be based on its relative orientation relative to other visible structures of the catheter 3320 (such as the indicator lumen or the flushing lumen 3376) and confirmed by the orientation of the guidewire 3377 as it is advanced through the ramp 3364.

[0154] A circular indicator 3376 ( Fig.34D and 34E ) can be expanded by expanding the ramp indicator icon 1818 ( Fig.18B ) can be turned on and off. When on, three potential states may occur. If the system is not confident in identifying the catheter orientation, no overlay will be provided. If the system is confident in its determination of the catheter orientation, a circular indicator 3376 and a frustoconical ramp indicator overlay 3374 will appear on the OCT image ( Fig.34D and 34E ). However, if Fig.34D As shown, the system may be confident in displaying the predicted trajectory of the guidewire trajectory / guidewire ramp, but still be erroneous, as shown by the offset between the circular indicator 3376 and the flush or indicator lumen 3378, while Fig.34E A greater alignment between the circular indicator 3376 and the irrigation lumen 3378 is depicted, such that Fig.34E The ramp indicator 3374 in the embodiment may be more accurate. When using or relying on the ramp indicator 3374, the user should confirm the alignment between the circular indicator 3376 and the irrigation lumen 3378 and make a final and independent assessment of the guidewire trajectory before and during the guidewire is advanced.

[0155] Once the user has decided to deploy or advance the guidewire into the true lumen, the guidewire is retracted until the distal end of the guidewire is located in the common lumen of the catheter (which is located proximal to the bevel lumen) and then advanced through the bevel lumen and into the true lumen. Fig.34F An OCT image depicting successful reentry of the guidewire 3380 from the subintimal space into the true lumen 3362, wherein the guidewire 3380 is visible within the true lumen 3362. The user should confirm reentry via fluoroscopy, where contrast injection under fluoroscopy demonstrates arterial or collateral vessel reconstruction. Once the site and direction of reentry are determined, the user may also Figure 33M The guidewire introduction port 3342 in the catheter can be used to replace or exchange an existing guidewire, depending on the user's decision as to whether a guidewire of a different type and / or different stiffness is appropriate. If the guidewire becomes stuck in the catheter during advancement or retraction, the guidewire lumen can be flushed through the guidewire lumen flush port 3344. During the process of pulling the guidewire back or retracting the catheter, if any resistance is encountered, the user should stop the operation and evaluate the cause of the resistance. If flushing of heparinized saline through the guidewire lumen flush port 3344 does not free the guidewire, or if the guidewire appears to be sagging or kinked, the guidewire should not be pulled back, instead, the guidewire and catheter should be slowly and gently withdrawn together as a single unit or assembly under fluoroscopic guidance.

[0156] Once the guidewire is properly placed, the catheter should be withdrawn using standard catheterization laboratory procedures while leaving the guidewire in place to facilitate catheter removal or replacement. Fig.33F Once the catheter is withdrawn from the body, the actuator button 3322 on the slide 3310 is deactuated to stop imaging and turn off the motor, and according to Figure 33G , disconnect the catheter 3300 by actuating the disconnect latch or button 3324a / 3324b. Once the catheter is removed from the sterile field, the catheter is discarded according to standard disposal techniques. Alternatively, the operator may choose to activate / turn off the imaging and motor and disconnect the catheter from the slide 3310 before withdrawing the catheter while keeping the guidewire in place.

[0157] To determine the size of an artery or lumen, as indicated during surgery, select Fig.18B Click the ruler icon 1824 depicted in Fig. 18C , 18D FIG. 23G depicts a cross-hatched pattern overlaying an OCT image with 0.5 mm accuracy in a water / saline environment. As previously described, the ruler overlay 1840 includes annular indicators spaced 1 mm apart and axis markings in 0.5 mm increments. Figure 34G In the particular example shown, the scale overlay 1840 has an imager field of view with a radius / diameter greater than 3.5 mm and 7 mm, respectively. Typically, arteries are filled with optically scattering media, such as blood, which obscures the OCT signal outside the catheter cross section. Imaging resolution can be improved by flushing an optically transparent fluid (preferably using 50 / 50 saline / contrast media) through the guide catheter flush port and / or the guidewire with the lumen flush port to expose the surrounding arterial structure, thereby temporarily or temporarily displacing the surrounding blood. By flushing, image resolution can be improved, and the inner diameter of the artery or lumen can be more easily measured with the help of the scale overlay 1840.

[0158] Case Report

[0159] The first human case of a successful contemporary ADR using an exemplary OCT-guided reentry catheter utilizing real-time high-resolution visualization with image enhancement / deployment and precise manipulation and advancement of the guidewire. Figures 20A to 20C A catheter 2000 is depicted that includes a proximal housing 2066 and a catheter body 2002 having a distal end 2011. Fig. 20B , the proximal housing 2066 includes an imager position adjustment knob or actuator 2068, a flush port 2072, a catheter orientation knob or controller 2070, and a guidewire introducer 2064 into which the guidewire 2038 has been inserted. Fig. 20CAs shown, at the distal end 2011 of the catheter body 2002, a guidewire 2038 is shown extending from the side port 2014, with the imaging device 2009 visible in the imaging device lumen 1222. The easily maneuverable and torquable imaging catheter helps the operator guide and aim the 0.014 inch guidewire out of the side port in any continuous orientation with an accuracy of better than 5 degrees.

[0160] A 74-year-old man presented with CCS grade III angina due to a left anterior descending (LAD) CTO. Bicoronary angiography showed a mid-LAD ​​CTO with a conical proximal cap ( Fig.21A ), occlusion length>20mm, calcification in the CTO segment (J-CTO score of 2) ( Fig.21B The AWE strategy was initially used, but the polymer sheathed guidewire was found to be located in the extraplaque space ( Fig. 21C ), so the ADR technique was performed using the exemplary ADR catheter ( Fig.21D ). The catheter is A 12-gauge guidewire (Asahi Intecc USA; Irvine, CA) was passed through the distal cap to the reentry zone of the extraplaque space ( Fig.21E ). Retrograde contrast injection showed poor visualization of distal targets due to extraplaque hematoma formation.

[0161] Using enhanced real-time OCT image guidance, a pulsating artery with blood flow is visualized from the extraplaque space through the distal cap of the CTO at the 5 o'clock position of the OCT image / segment ( Fig.22A ). The ramp overlay / cover enhancement is depicted by the highlighted lines, indicating the side port orientation where the guidewire will be advanced between the two highlighted lines. Fig.22A The ramp overlay is pointed in the direction of the adventitia as marked by the region identifying the fibrous / honeycomb structure. The catheter is then twisted / rotated to redirect the exit ramp overlay enhancement away from the adventitia (10 o'clock to 1 o'clock in the OCT image) and toward the true lumen at 5 o'clock in the OCT image / segment ( Fig. 22B ). Then XS20 line (Asahi Intecc USA) advances through a dedicated reentry port exit ramp ( Fig. 22C and 22D ) to successfully reenter the true lumen of the left anterior descending artery. The position of the guidewire in the true lumen was confirmed by angiography and OCT imaging ( Fig.22E and 22F ). Figure 22G The final angiographic findings and restoration of blood flow after stent placement are shown, depicting complete recanalization of the LAD after stent placement.

[0162] The ADR catheter provides real-time OCT-based enhancement with information about the catheter's orientation relative to the displayed vessel morphology (e.g., true lumen, adventitia, calcified nodules, etc.), allowing the user to directionally control the coronary guidewire for reentry. This real-time image-guided reentry helps overcome the challenges presented by extraplaque hematoma formation and subsequent loss of distal vessel visibility. The high resolution provides clear morphological detail, combined with software enhancements for ease of use, represents a significant advancement over current device-based reentry methods and IVUS-guided technology.

[0163] Although some imaging systems utilize arrays of imaging elements to capture complete 2D images, other imaging systems may use image capture sensors that can be moved during image capture to obtain a series of images at different locations. These images can then be gathered into a single 2D image or a 3D image or model. Examples of such imaging systems include A-line images captured by an OCT imaging system, or A-mode linear images captured by an ultrasound imaging system. This type of imaging is particularly useful in miniaturized and slender imaging systems, for example, in catheter-based or endoscope-based imaging systems, in which space limitations do not allow a fixed array of imaging elements to capture a complete image. In catheter-based imaging systems, the imaging element can be rotated to capture continuous or consecutive images at different angular orientations of the imaging element. These images can then be gathered to provide a two-dimensional representation of the structures surrounding the imaging catheter. For example, such an imaging catheter can be inserted directly into a patient's body for imaging, or can be inserted into the lumen of another catheter, so that the catheter can provide other functions or procedures.

[0164] For example, Fig.23A Schematically illustrated is a composite collection of sequential line images on a vertical axis, arranged in a parallel manner in time order on a horizontal axis, referred to as a waterfall image 2300a, generated from an imaging catheter positioned within a larger catheter (e.g., a guide catheter or interventional catheter). The top line 2302a in image 2300a corresponds to the imager origin or starting position of the imaging element, followed by a rectangular interior region 2304a of the larger catheter, followed by an outer wall 2306a of the larger catheter. Beyond the wall, various structures 2308a, 2310a, and 2312a in the surrounding tissue or environment can be seen. In this particular example, because the imaging catheter is positioned within a concentric lumen of another catheter, the distance from the imaging source to the outer wall of the other catheter is nominally a constant distance, such that in the waterfall image 2300a, the outer wall 2306a has a generally linear shape.

[0165] refer to Fig. 23B, the composite set of identical continuous line images can also be arranged in time order in a radial manner to generate a circumferential image 2300b (or a sector view) around the imaging catheter. Due to this radial arrangement of the linear images, the starting position of the imaging element is a circle or point 2302b, rather than Fig.23A Likewise, the interior region 2304b of the larger conduit is now an annular region that better represents the actual geometry of the larger conduit, and the outer wall 2306b is now represented as a circle instead of Fig.23A The various structures 2308a, 2310a and 2312a are now depicted in different positions and orientations, namely 2308b, 2310b and 2312b, respectively, about the reference point 2302b of the imager origin.

[0166] One potential problem with waterfall or radial image reconstruction is that ideally, the rate of movement or rotation of the imaging element is nominally uniform or constant, thereby uniformly arranging a simple convergence of linear images into waterfall or radial images. However, if the rate of movement or rotation is variable, it may result in oversampling or undersampling at some image orientations, which will cause image distortion when converged. This is often referred to as non-uniform rotational distortion (NURD) of the image. This may be caused by frictional rotational drag, which may result in excessive velocity after the drag is overcome or reduced.

[0167] Fig.24A and 24B Schematically depicts some of the distortions that may occur. During the scanning of structure 2408a / 2408b, if the imaging element maintains a constant rotation rate, then Fig.23A and 23B The composite image of structure 2408a / 2408b may be relatively accurate and undistorted compared to structure 2308a / 2308b in FIG. However, if the rotation rate or scanning speed is higher than expected, certain areas may be undersampled and result in a compressed appearance, such as Fig.24A and 24B As shown in the structure 2410a / 2410b in Fig.23A and 23B They may appear as compressed ellipses compared to the circles 2310a / 2310b in FIG. If the rotation rate or scan speed in a particular area is slower than expected, it may be oversampled and result in a horizontally or circumferentially elongated appearance, such as Fig.24A and 24B As shown in structure 2412a / 2412b, it is presented as a rectangle instead of Fig.23A and 23BHowever, it is worth noting that since the scanning speed or rotation rate has no effect on the distance from the imager origin 2402a / 2402b to the outer wall 2406a / 2406b, the wall line and wall circle 2406a / 2406b may appear undistorted, where the imaging catheter is concentrically located within the other catheter.

[0168] To correct for this distortion, some imaging catheters will utilize sensors (e.g., encoders) and / or reference points on the catheter to detect speed changes and correct for them. For example, the sensor must be present at the distal end of the signal acquisition point, as well as the proximal end of the catheter or endoscope from which the imaging element rotates. Presumably, the proximal end is well controlled with a uniform or constant rotational speed, while the imaging element collecting the input signal at the distal end is experiencing unpredictable and uneven friction along the axis of rotation. If the angular displacement or rotational speed difference between these two ends can be measured, the distorted image caused by NURD can be corrected. Other image correction algorithms may rely on external reference points, such as the struts of a stent loaded in the catheter, or the struts of a stent deployed into the vessel by a catheter or a previous surgery. Others may also analyze the degree of unevenness of continuous line images to detect oversampling and delete line images that cause distortion. However, it may be difficult to distinguish oversampled line images from anatomical regions that lack anatomical variability along certain portions / sectors of the image. In other words, correction for image distortion requires the ability to detect external objects with predictability, known periodicity, or uniformity in all orientations, which is lacking in biological tissue anatomy, or requires integrating sensing devices into the construction of the catheter or endoscope.

[0169] refer to Fig.25A and 25B , however, if the imaging catheter is located in the imaging device lumen of a catheter in which the imaging device lumen and imaging element are positioned eccentrically, the catheter wall 2506a in the waterfall image 2500a will have a sinusoidal appearance, with the amplitude of the sine wave proportional to the eccentricity. For a perfectly cylindrical (circular cross-section) catheter with an eccentrically placed imaging element, the catheter wall appearance in the waterfall view must be a complete single-cycle sine wave. On the radial image 2500b, the outer wall 2506b still has a circular appearance in a circular catheter, but the outer wall 2506b will be offset from the imager origin 2502b. If a consistent movement or rotation rate / speed is maintained, if the catheter material is substantially transparent to OCT imaging, then the structures 2508a / b, 2510a / b, and 2512a / b will be largely unaffected by the eccentric position of the imaging catheter.

[0170] If the rotation rate changes during image acquisition, images from an eccentric imaging catheter will show deviations from the sinusoidal pattern of the larger catheter outer wall that are not normally seen in images of the wall lines from a concentric imaging catheter system. Fig.26A and 26B Peripheral structures 2608a / b, 2610a / b, and 2612a / b are depicted in the same manner as Fig.24A and 24B Here, however, the outer wall line 2606a may deviate from the predicted sinusoidal pattern 2614 on the waterfall image 2600a and may have a more excited wave pattern 2616 or a flatter sinusoidal pattern depending on the type of change that occurs. On the radial image 2600b, the outer wall 2606b may have an irregular closed shape or an oblong shape instead of an offset circular shape.

[0171] However, by utilizing a predicted or reference shape or line of the outer wall of the larger catheter, the outer wall position of the actual line image acquired can be adjusted to conform to the predicted or reference shape or line of the outer wall, thereby compensating for image distortion caused by the uniform distribution of the non-uniform line images in the waterfall image, which can then be used to construct a less distorted radial image.

[0172] Fig. 27 An exemplary waterfall image 2700 obtained from an OCT imaging catheter inserted into a lumen of an imaging device of a multi-lumen catheter is depicted. Solid line 2702 represents the outer wall of the multi-lumen catheter identified or detected in a series of line images collected from a set of 360 degree collected line images that constitute the waterfall image. Dashed line 2704 represents one period of the reference sinusoidal line pattern that would be expected if the imaging catheter maintained a uniform rotational speed. To correct for changes in rotational speed, one or more line images may be deleted from the waterfall image to shift the wall position of the remaining line images horizontally or temporally to a relative position within the period or time interval of the line images that matches the reference wall position in the reference sinusoidal line pattern. This horizontal shift is represented by arrow 2706. Because the density of A-lines is typically much higher than the pixel density of a high resolution display, deleting the line images to match the reference sinusoidal line pattern corrects the relative distortion without noticeable loss of image detail.

[0173] In one embodiment, in order to minimize processing time so that the corrected OCT image can be displayed during surgery with minimal time delay, only the line image is removed from the acquired image to reduce image distortion. However, in other variations, interpolation is applied to the undersampled areas to restore the lost data to some extent and maintain the overall image resolution. However, this may introduce additional processing time, resulting in a lag or delay in the display of the corrected image.

[0174] In another embodiment, the edge position of the catheter wall is located along each A-line in the waterfall view, and the resulting edge deviation is compared to a template sine wave aligned with a peak, valley, or any reference point along the template, and then all A-lines are realigned and moved so that the edge position is aligned with the template. The catheter wall and reference points can be detected using existing methods including traditional image processing and neural networks. A-line adjustment can be accomplished by various methods including brute force pick and place or matrix transformation. When reconstructed in the sector view, the image is now undistorted and corrected.

[0175] In another embodiment, a model characterizing the NURD is created, a remapping matrix that inverts the distortion is generated, and the matrix is ​​applied to the distorted waterfall image to produce a corrected waterfall image. The model constants can be inferred in real time by utilizing the catheter wall detection method previously described, and include properties such as acceleration and velocity of the imaging element. Alternatively, if the observed NURD is generalizable across devices, one or more fixed models can be used, thereby cutting computational cost and minimizing processing time at a slight cost in quality.

[0176] Figures 28A to 28C It is used to capture Fig. 27 and Figures 29A to 32C Various schematic diagrams of a multi-lumen catheter 2800 with OCT images in . The catheter 2800 includes a housing 2802. For illustrative purposes, the housing 2802 includes an imaging section 2804 that facilitates imaging of structures and / or tissue surrounding the catheter 2800, the imaging section being located at the distal end of a catheter body 2806. The imaging section 2804 may include an optically transparent material to reduce imaging opacity relative to a selected imaging modality (e.g., OCT or ultrasound). Note, however, that the imaging section 2804 may be opaque, transparent, or partially transparent. For example, for an optical imaging modality such as OCT, the imaging section 2804 may be optically transparent or partially transparent; for an ultrasound imaging modality, the imaging section may be transparent, partially transparent, or opaque, so long as the material provides acoustic coupling to the ultrasound. The change in optical index between the outer wall 2816 of the imaging section 2804 and the surrounding biological fluids and tissues will highlight the visibility of the outer wall 2816 on the image, as shown in FIG. Figures 29A to 32C shown.

[0177] The imaging body 2804 may be formed integrally with the catheter body 2806 or may be formed separately from the catheter body 2806. The catheter 2800 includes a lumen 2808 for an imaging device and a lumen 2810 for a guidewire. The lumen 2808 for the imaging device and the lumen 2810 for the guidewire may extend generally parallel to the longitudinal axis of the catheter 2800. The lumen 2808 for the imaging device may be configured to receive an optical coherence tomography ("OCT") imaging device. The lumen 2810 for the guidewire may be configured to receive a guidewire (not shown). The lumen 2810 for the guidewire may extend to a distal end 2814 of the catheter 2800, thereby allowing the guidewire to extend out of the catheter 2800. The catheter 2800 may also include a lumen 2812 for an indicator (partially obscured by the lumen 2810 for the guidewire). The lumen 2812 for the indicator may be configured to receive a material that can be detected by an OCT imaging device. In certain examples, material received by indicator lumen 2812 may be more easily or more reliably detected by an OCT imaging device and may be used as a fiducial / reference point to perform further image processing or distortion correction. Indicator lumen 2812 may also be used for other functions, including but not limited to flushing blood to improve imaging clarity, or injecting diagnostic or therapeutic agents into surrounding tissue.

[0178] The structure of the multi-lumen catheter 2800, such as the guidewire lumen 2810 and the indicator lumen 2812, together with the outer wall 2702, is Fig. 27 Visible on the image. Fig.29A , 30A , 31A, and 32A depict other exemplary unprocessed OCT images captured via an OCT imaging catheter positioned in catheter 2800. Fig.29B , 30B , 31B and 32B depict the corresponding processed images with the above-mentioned distortion correction. Fig.29C , 30C , 31C and 32C are reference images that generally represent ideal images with minimal inherent distortion, which are taken with catheter 600 at positions corresponding to the distorted and processed images.

[0179] If a uniform rotation rate can be maintained, the size and shape of the sinusoidal pattern can be predicted or derived from the model geometry of the imaging device lumen of the larger catheter. However, in addition to the variability in the rotation rate, such a reference sinusoidal pattern may be subject to additional variations. For example, if the imaging catheter is smaller than the inner diameter of the imaging device lumen of the larger catheter, there may be additional variations in the imager origin position, and the imager origin position may also change during imaging as the imaging catheter and / or the larger catheter bends or twists. Alternatively, under ideal conditions that minimize rotation rate variations, such as when the catheter is in a straight configuration without any bends, and / or in a fluid that reduces friction, a reference sinusoidal pattern can be obtained by obtaining a reference calibration image from the catheter assembly.

[0180] The image correction described herein can be used with OCT catheters and endoscope systems, ultrasound catheter systems, and can be used to image various anatomical structures, lumens or ducts of humans, mammals and non-mammals, including but not limited to vascular lumens such as arteries and veins, lymphatic vessels, nasal cavity, external ear, inner ear, esophagus, stomach, duodenum, small intestine, large intestine, rectum, bronchi, urethra, ureters, etc. The applications are not limited to biological imaging and can be used in industrial and other applications.

[0181] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are also contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and not limitation.

[0182] Terms of degree (e.g., "about," "substantially," "approximately," and the like) indicate insignificant changes in structure or function. In one example, when a term of degree is included in a term expressing a quantity, the term of degree is interpreted as referring to ±10%, ±5%, or ±2% of the term expressing the quantity. In one example, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, have curved edges instead of straight edges, have one or more protrusions extending therefrom, be oblong, be the same as the disclosed shape, and the like.

Claims

1. A system for imaging a lumen, the system comprising: An imaging catheter, the imaging catheter comprising: A tubular body, the tubular body comprising: proximal region; Distal regions; and Middle area; a lumen for an imaging device positioned along the proximal region, the intermediate region, and the distal region; a common guidewire lumen positioned along the proximal region, the middle region, and the distal region; a side ramp lumen located in the distal region and connected to the common guidewire lumen, the side ramp lumen including a distal opening in a sidewall of the tubular body; a distal guidewire lumen located in the distal end region and connected to the common guidewire lumen, the distal guidewire lumen comprising a distal opening at an end wall of the tubular body; At least one guidewire biasing structure, the at least one guidewire biasing structure selected from the group consisting of: a reduced diameter region at the junction of the distal guidewire lumen and the common guidewire lumen; an offset distance between the longitudinal axis of the common guidewire lumen and the longitudinal axis of the distal guidewire lumen; an angled tab at or near the junction of the distal guidewire lumen and the common guidewire lumen; a guidewire lumen protrusion at or near a junction of the distal guidewire lumen and the common guidewire lumen; a proximal catheter assembly including a catheter housing coupled to a proximal region of the tubular body and a proximal optical connection interface; a first guidewire port in fluid communication with the common guidewire lumen; an imager port in fluid communication with the imaging device lumen; and An imaging optical fiber is connected to the proximal optical connection interface and extends along the imaging device lumen.

2. The system of claim 1, further comprising a second guidewire port in fluid communication with the common guidewire lumen, wherein the second guidewire port has an interface different from an interface of the first guidewire port.

3. The system according to claim 2, wherein: The first guidewire port and the second guidewire port are located in a hub distal to the catheter assembly.

4. The system according to claim 1, wherein: The catheter housing also includes an imager actuator coupled to the imaging fiber and configured to longitudinally translate the imaging fiber relative to the imaging device lumen.

5. The system of claim 1, further comprising a catheter rotation actuator coupled to the tubular body and configured to rotate the tubular body relative to the proximal catheter housing assembly.

6. The system according to claim 5, wherein: The catheter rotation actuator is rotatably coupled to the distal end of the catheter housing.

7. The system according to claim 2, wherein: The proximal catheter assembly also includes a fiber optic cable located between the catheter housing and the proximal optical connection interface.

8. The system according to claim 2, wherein: The proximal optical connection interface is directly coupled to the catheter housing.

9. The system of claim 1 , further comprising an imaging console comprising: console housing; power supply; a laser source including an output port; Slide board interconnection interface; Touch screen interconnection interface; and Large display interconnect interface.

10. The system according to claim 9, wherein: The laser source output port includes an imaging port and an aiming beam port.

11. The system of claim 9, further comprising a slide assembly, the slide assembly comprising: Skateboard housing; catheter interconnects; skateboard powered actuator; and Catheter detachment actuator.

12. The system according to claim 11, wherein: The conduit interconnect is a spring biased conduit interconnect and the conduit separation actuator is a conduit ejection actuator.

13. The system according to claim 11, wherein: The skateboard powered actuator includes a light.

14. The system of claim 9, further comprising a touch screen having a mounting attachment.

15. The system of claim 9, further comprising a large non-touch screen display.

16. The system according to claim 11, wherein: The sled housing includes a distal cavity configured to receive the catheter housing.

17. A method of preparing an imaging catheter, comprising: attaching a first sterile drape to the slide assembly; Connecting the catheter assembly to the slide assembly; activating the skateboard assembly; enabling an aiming beam of the catheter assembly; deactivating the slide assembly; separating the catheter assembly from the slide assembly; and The proximal end of the catheter assembly is closed with a second sterile drape.

18. The method according to claim 17, wherein: Attaching the first sterile drape to the slide assembly includes attaching the sterile drape to the slide assembly using an attachment cap.

19. The method of claim 18, further comprising cutting a folded corner of the first sterile drape to form a drape opening to be positioned between the slide assembly and the attachment cap.

20. A method of using an imaging catheter, comprising: Advance the imaging catheter over the guidewire through the guiding catheter to the target site; attaching the imaging catheter to the slide assembly; activating the imaging catheter and imaging the target site; longitudinally imaging the chute lumen of the imaging catheter using a longitudinal adjustment interface on a proximal housing of the imaging catheter; advancing the imaging catheter toward a lesion at a target site and to the vicinity of the lesion; using the imaging catheter to identify the true lumen of the target site; rotating the imaging of the target site using a rotation actuator of the imaging catheter to orient the ramp lumen toward the true lumen of the target site; withdrawing the guidewire from the distal guidewire lumen of the imaging catheter; advancing the guidewire through the bevel lumen of the imaging catheter and into the true lumen of the target site; Confirm reentry into the true lumen; and The imaging catheter is withdrawn while maintaining the guidewire positioned in the true lumen.

21. The method of claim 20, further comprising delivering the stent to a target site using the guidewire.

22. The method according to claim 20, further comprising: a ruler overlay enabling imaging of the target site, the ruler overlay depicting distance markings; and Vessel dimensions were measured using the ruler overlay.

23. The method of claim 20, further comprising turning on a ramp overlay of the target site imaging, the ramp overlay depicting a guidewire direction marker on the target site imaging.

24. The method of claim 20, further comprising flushing the imaging catheter using a guidewire flush port of the imaging catheter.

25. The method according to claim 20, wherein: Fluoroscopy and contrast medium were used to confirm reentry into the true lumen.

26. The method of claim 20, further comprising: pre-connecting the catheter assembly and the slide assembly; and The skateboard assembly is enabled.

27. The method of claim 21, further comprising attaching a first sterile drape to the slide assembly.

28. The method of claim 22, further comprising: enabling an aiming beam of the catheter assembly; and The slide plate assembly is deactivated.

29. The method of claim 23, further comprising: separating the catheter assembly from the slide assembly; and The proximal end of the catheter assembly is closed with a second sterile drape.

30. The method of claim 22, wherein: Attaching the first sterile drape to the slide assembly includes attaching the first sterile drape to the slide assembly using an attachment cap.

31. The method of claim 25, further comprising cutting a folded corner of the first sterile drape to form a drape opening to be positioned between the slide assembly and the attachment cap.

32. An image-guided interventional catheter, comprising: A housing having a catheter distal region, the catheter distal region including an imaging body and a catheter body, the catheter distal region defining: an imaging device lumen configured to receive an imaging device; A guidewire lumen configured to receive a guidewire, the guidewire lumen comprising a distal section, a proximal section, and one or more guidewire feeders, the one or more guidewire feeders comprising at least one of: a ridge in the proximal section near the intersection of the distal section and the proximal section; the distal section comprising a tapered region having a maximum transverse dimension that increases with increasing distance from the intersection; a center of the distal segment offset relative to a center of the proximal segment; and said intersection of said distal section and said proximal section having a thin pierceable wall; an exit ramp extending from the guidewire lumen at or near the intersection of the distal and proximal sections of the guidewire lumen, one or more guidewire feeders configured to cause the guidewire to extend from the guidewire lumen into the exit ramp; as well as The indicator lumen is configured to receive an indicator detectable by an optical coherence tomography imaging device.

33. The catheter of claim 32, wherein: The imaging device includes an optical coherence tomography imaging device.

34. The catheter of claim 32, wherein: The one or more guidewire feeders include the protuberance.

35. The catheter of claim 32, wherein: The one or more guidewire feeders include: the distal section having the tapered region.

36. The catheter of claim 35, wherein: The tapered region extends from the intersection of the distal section and the proximal section.

37. The catheter of claim 32, wherein: One or more guidewire feeders include a center of the distal section that is offset relative to a center of the proximal section.

38. The catheter of claim 32, wherein: The one or more guidewire feeders include: the intersection of the distal section and the proximal section having a thin pierceable wall.

39. The catheter of claim 32, wherein: The one or more guidewire feeders also include a ramp at the intersection of the distal section and the proximal section.

40. The catheter of claim 32, wherein: The catheter distal region includes one or more detectable structures that indicate a distance from a distal tip of the catheter distal region, the one or more detectable structures being detectable by the imaging device.

41. The catheter of claim 40, wherein: The one or more detectable structures include an annular or semi-annular base and one or more elongated arms extending from the annular or semi-annular base, wherein at least the one or more longitudinal arms are detectable by the imaging device.

42. The catheter of claim 41, wherein The one or more longitudinal arms include a plurality of longitudinal elements, at least some of the plurality of longitudinal elements having different lengths.

43. The catheter of claim 40, wherein: The one or more detectable structures include one or more apertures formed in a housing at a distal region of the catheter.

44. A system comprising a catheter according to claim 32, wherein: The housing includes a proximal region of the catheter; A housing is attached to the catheter, the housing including one or more actuators, the one or more actuators being configured to achieve at least one of the following: rotating at least a portion of the conduit relative to the one housing; and The imaging device is moved in the imaging device lumen.

45. The system of claim 44, further comprising a display and a graphical user interface, the graphical user interface configured to display on the display an image detected by the imaging device, the graphical user interface comprising at least one icon, the at least one icon applying a template to the image displayed on the display.

46. ​​The system of claim 45, wherein: The template includes an exit ramp indicator that indicates the direction in which the exit ramp extends from the guidewire lumen.

47. A method of determining an orientation of a catheter, the method comprising: obtaining one or more images at one or more locations along the length of the catheter using an optical coherence tomography imaging device; excluding data from the one or more images; detecting a trajectory of the catheter; detecting the position of a fixed and constant marker or feature of the catheter relative to the center of the optical coherence tomography imaging device; A template including an exit ramp indicator is applied on the one or more images, wherein the exit ramp indicator includes a two-dimensional graphic or a three-dimensional enhanced graphic, and the exit ramp appears as an opaque portion or a semi-transparent portion on the one or more images.

48. The method of claim 47, wherein: Detecting the trajectory of the catheter includes detecting a trajectory that falls within a catheter edge detection range from an edge of the one or more images.

49. The method of claim 47, wherein: The fixed and constantly present landmark feature of the catheter includes an indicator lumen.

50. The method of claim 49, wherein: Detecting the position of a fixed and constant marker or feature of the catheter relative to the center of the optical coherence tomography imaging device comprises at least one of the following: detecting a lumen for an indicator that falls within a lumen detection range from an edge of the one or more images; and An indicator lumen that falls within an indicator lumen angle range is detected, wherein the indicator lumen angle range is spaced apart from the detected track by an angle offset.

51. The method of claim 17, wherein: The template includes an indicator lumen circle placed on the indicator lumen.

52. A non-transitory computer-readable medium storing an image correction program, the image correction program causing a computer device including the storage medium to perform functions, the functions comprising: receiving image frames of a sequence of images generated by an eccentric imaging catheter; identifying an imaged wall location in a sequence of images from the sequence of images for the time period; and The sequence of images for the time period is modified by making the imaged wall positions of the sequence of images conform to the reference wall positions of the sequence of images for the time period.

53. The non-transitory computer readable medium of claim 52, wherein: Modifying the sequence of images of the time period includes deleting intermediate sequence images between the sequence of images and the reference wall position.

54. The non-transitory computer readable medium of claim 52, wherein: The reference wall position is from a series of reference wall positions corresponding to a reference sinusoidal pattern of wall positions.

55. The non-transitory computer readable medium of claim 53, wherein: A reference sinusoidal pattern of the wall position is derived from a geometric model of the eccentric imaging catheter.

56. The non-transitory computer readable medium of claim 53, wherein: The reference sinusoidal pattern of wall position is determined by a calibration procedure of the eccentric imaging catheter.

57. The non-transitory computer readable medium of claim 52, wherein: The image frames are selected from a series of sequential images generated by the eccentric imaging catheter.

58. The non-transitory computer readable medium of claim 57, wherein: The image frames of the sequence of images correspond to a 360-degree rotation of the eccentric imaging catheter, or correspond to a fixed sequence number of the sequence of images.

59. The non-transitory computer readable medium of claim 57, further comprising downsampling the series or the time period of sequential images.

60. The non-transitory computer readable medium of claim 59, wherein: The down sampling includes deleting a portion of the sequence images from the series or the sequence images of the time period.

61. The non-transitory computer readable medium of claim 60, wherein: The ratio of the deleted sequence images to the non-deleted sequence images is greater than or equal to 20:

1.

62. The non-transitory computer readable medium of claim 59, wherein: The down sampling includes cropping each of the sequential images from the series or the time period, the cropping being performed at a fixed number of pixels or distance from an imager origin end of each of the sequential images.

63. The non-transitory computer readable medium of claim 60, further comprising inferring at least one replacement sequence image from at least some of the deleted sequence images, wherein the at least one replacement sequence image is less in number than the number of deleted sequence images.

64. A non-transitory computer-readable medium storing an image correction program, the image correction program causing a computer device including the storage medium to perform functions, the functions comprising: receiving image frames of a sequence of images generated by a variable wall distance imaging catheter; identifying an imaged wall location in a sequence of images from the sequence of images for the time period; and The sequence of images for the time period is modified by making the imaged wall positions of the sequence of images conform to the reference wall positions of the sequence of images for the time period.

65. The non-transitory computer readable medium of claim 64, wherein: The variable wall distance imaging catheter is an eccentric imaging catheter.

66. The non-transitory computer readable medium of claim 64, wherein: The variable wall distance imaging catheter is a concentric non-circular imaging catheter.

67. An imaging processing system for performing an image processing function, comprising: a receiving unit configured to receive image frames of a sequence of images generated by an eccentric imaging catheter; an identification unit configured to identify an imaged wall location in a sequence of images from the time period; and A modification unit is configured to modify the sequence of images of the time period by making the imaging wall positions of the sequence of images conform to the reference wall positions of the sequence of images of the time period.

68. An image processing method, comprising: receiving image frames of a sequence of images generated by an eccentric imaging catheter; identifying an imaged wall location in a sequence of images from the sequence of images for the time period; and The sequence of images for the time period is modified by making the imaged wall positions of the sequence of images conform to the reference wall positions of the sequence of images for the time period.

69. A reentry catheter system, comprising: An elongated catheter body, the catheter body comprising: proximal; remote; a common lumen extending from a proximal position at the proximal end to a distal position proximal to the distal end, the common lumen including a first longitudinal central axis; a distal lumen extending from a location distal to the common lumen to a distal end of the catheter body, wherein the distal lumen includes a second longitudinal center axis parallel to and offset from the first longitudinal center axis; and a side lumen extending distally from a distal location of the common lumen to a sidewall location of the catheter body, wherein the sidewall location is proximal to a distal end of the catheter body; a lumen for an imaging device extending from a proximal end of the catheter body; a proximal catheter handle coupled to the proximal end of the catheter body, the handle comprising: a catheter body rotator knob configured to rotate the catheter body relative to the proximal catheter handle; and The imaging catheter displacement knob is configured to enable the imaging catheter inserted into the catheter body to be longitudinally displaced relative to the catheter body.

70. The catheter system of claim 69, wherein: The side wall of the side lumen is located proximal to the closed distal end of the imaging device lumen.

71. The catheter system of claim 69, wherein: The distal end of the catheter body is in an asymmetrically tapered cone shape.

72. The catheter system of claim 69, wherein: The catheter body also includes an indicator lumen.

73. The catheter system of claim 72, wherein: The average diameter of the indicator lumen is smaller than the average diameter of the distal lumen, the average diameter of the distal lumen is smaller than the average diameter of the common lumen, and the average diameter of the common lumen is smaller than the average diameter of the imaging device lumen.

Images