Apparatus and method for imaging vasculature

Abstract

A forward-viewing angioscope for insertion into cerebrovasculature includes a distal segment with an imaging sensor and illumination source arranged for forward viewing beyond a petrous segment of a carotid artery. The distal segment incorporates a bend orienting the imaging sensor at an acute angle relative to a longitudinal axis. A flexile sheath extends longitudinally from the distal segment, with electrical cabling disposed within the sheath. The cabling has greater flexibility along its length compared to the flexile sheath, enabling the cabling to conform to the sheath's shape during navigation through cerebrovasculature. This configuration enables controlled navigation and imaging within tortuous cerebrovascular anatomy while maintaining high image quality and minimizing trauma.

Description

APPARATUS AND METHOD FOR IMAGING VASCULATURECLAIM OF PRIORITY

[0001] This application claims priority to Canadian Provisional Patent Application Serial No. 3251752, filed on November 1, 2024, and US Provisional Patent Application Serial No. 63 / 819,140, filed on June 6, 2025, which are each incorporated by reference herein in their entirety and the benefit of priority of each of which is claimed herein.BACKGROUND

[0002] Cerebrovascular pathologies can include, among other things, a thrombus (blood clot) or an aneurysm (localized enlargement or weakening of a blood vessel). A cerebrovascular thrombus can be associated with ischemic stroke, which, in turn can cause damage to brain tissue. A cerebrovascular aneurysm can be associated with a risk of rupture and hemorrhagic stroke, which, in turn can also cause damage to brain tissue.

[0003] Certain angioscopy techniques can facilitate direct visualization of blood vessels and other anatomical structures through minimally invasive means. The cerebrovasculature presents unique challenges for imaging and navigation due to its complex network of vessels, including the petrous segment of the carotid artery and intracranial vessels. Certain imaging approaches for cerebrovascular procedures include fluoroscopy and computed tomography, which provide limited resolution for detailed tissue assessment.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0005] FIG. 1 A depicts an example of an angioscope for navigating cerebrovasculature.

[0006] FIG. IB depicts an example of an imaging processor for coupling with the angioscope of FIG. 1A.

[0007] FIG. 1C is a magnified view of a distal tip of the angioscope of FIG. 1 A.

[0008] FIG. 2A shows a scale of a distal portion of an angioscope, as compared with a coin.

[0009] FIG. 2B shows an example of a distal tip of an angioscope.

[0010] FIG. 2C shows an example of a distal tip of an angioscope.

[0011] FIG. 3 A is an example of an image obtained via optical-fiber angioscopy imaging.

[0012] FIG. 3B is an example of an image obtained via chip-on-tip angioscopy imaging.

[0013] FIG. 4A is a block diagram of an example of an angioscopy system for imaging cerebrovasculature.

[0014] FIG. 4B depicts an example of a user interface for imaging cerebrovasculature, including real time imaging via angioscopy.

[0015] FIG. 5A depicts an example of an encased distal portion of an angioscope.

[0016] FIG. 5B depicts an example of a distal tip of an angioscope.

[0017] FIG. 6A depicts an example of an unencased distal portion of an angioscope.

[0018] FIG. 6B depicts an example of a distal tip of an angioscope.

[0019] FIG. 7A depicts an example of a laser-cut hypotube of an angioscope.

[0020] FIG. 7B is a magnified view of the laser-cut hypotube of FIG. 7A.

[0021] FIG. 8A depicts an example of a cut pattern of a laser-cut hypotube.

[0022] FIG. 8B depicts an example of a cut pattern of a laser-cut hypotube.

[0023] FIG. 8C depicts an example of a cut pattern of a laser-cut hypotube.

[0024] FIG. 8D depicts an example of a cut pattern of a laser-cut hypotube.

[0025] FIG. 9A depicts a distal portion of an example of an angioscope, including a laser-cut hypotube.

[0026] FIG. 9B is a magnified view of a distal tip of the angioscope of FIG. 9A.

[0027] FIG. 10A depicts a transition portion of an example of a sheath of an angioscope.

[0028] FIG. 10B is a magnified view of the transition portion of FIG. 10A.

[0029] FIG. 11A depicts an example of an arrangement of an imaging sensor and an illumination source at a distal tip of an angioscope.

[0030] FIG. 1 IB depicts an example of an arrangement of an imaging sensor and an illumination source at a distal tip of an angioscope.

[0031] FIG. 11C depicts an example of an arrangement of an imaging sensor and an illumination source at a distal tip of an angioscope.

[0032] FIG. 12A is a cross-section view of an example of a distal portion of an angioscope, including an atraumatic tip.

[0033] FIG. 12B is a front view of the atraumatic tip of FIG. 12A.

[0034] FIG. 13 A is a flowchart showing an example of a process for image processing a signal received from an angioscope, including 3 dimensional (3D) reconstruction of patient anatomy.

[0035] FIG. 13B shows a processed image from a signal received from an angioscope, including 3- dimensional (3D) reconstruction of patient anatomy.

[0036] FIG. 14A depicts an example of a distal tip of an angioscope.

[0037] FIG. 14B depicts an example of a distal tip of an angioscope.

[0038] FIG. 15 depicts a cross section of an example of a laser-cut hypotube of an angioscope.

[0039] FIG 16 depicts an example of a laser-cut hypotube of an angioscope.

[0040] FIG. 17 depicts a transition portion of an example of a sheath of an angioscope.

[0041] FIG. 18A depicts a distal tip of an angioscope, formed of a flexile polymer.

[0042] FIG. 18B depicts a distal tip of an angioscope, formed of a flexile polymer.

[0043] FIG. 19 depicts a partially exploded view of a distal tip of an angioscope, exposing a manipulation element for establishing a specified angle of a bend of the angioscope.

[0044] FIG. 20 is a block diagram of a machine.DETAILED DESCRIPTION

[0045] Certain angioscopy techniques rely on X-ray imaging to navigate microcatheters and guidewires through complex, twisted blood vessels. X-rays present certain challenges, including poor soft tissue visibility, low contrast, and lack of depth perception with limiting resolutions around 250pm. Optical imaging, such as from within the blood vessels, can provide certain advantages over other imaging techniques. For example, optical fiber angioscopy can facilitate direct visualization inside blood vessels, or such as in neurosurgery for accessing brain ventricles, as well as in pulmonology and gastroenterology.

[0046] Neurovascular and ventricular segments in a human patient can be difficult to access internally via certain probes. For example, certain other devices for intravascular imaging include coherent fiber bundles which are inherently stiff and rigid, limiting their ability to navigate tortuous vasculature. The rigidity of conventional fiber optic bundles also involves challenges when attempting to redirect the viewing angle or navigate through complex anatomical structures, as the stiffness prevents the type offlexibility needed for controlled manipulation. Small-caliber, high-curvature segments in the intracranial vasculature of a human patient generally requires a great degree steerability and tip flexibility of a probe. Here, crossing unstable plaques or delicate vessels with certain fiber-based or side-facing probes, such as optical coherence tomography (OCT) or intravascular ultrasound (IVUS) can increase the risk of plaque rupture, thrombus dislodgement, or distal embolization. Likewise, accessing the ventricles of a human patient via a lumbar puncture approach would be clinically beneficial, but certain other endoscopes or fiberscopes are too stiff, have too large a diameter to reliably traverse the spine’s tight subarachnoid space without causing significant trauma, have too narrow of a field of view, or have limiting resolutions in the 22pm range which reduce the diagnostic utility of the imaging device.

[0047] The present disclosure relates to forward-viewing angioscopes for intravascular imaging, particularly suited for navigating and imaging within the cerebrovasculature, such as to facilitate minimally invasive diagnostic and therapeutic procedures. In particular, the present inventors have recognized the benefits of a chip-on-tip CMOS-based angioscope that leverages wafer-level optics for wide-field, high-resolution, direct color imaging of arteries, veins, and the cerebrospinal fluid (CSF) system (e.g., via lumbar puncture), such as to facilitate real-time visualization in anatomically challenging regions such as distal intracranial vessels or the spinal subarachnoid space.

[0048] In an example, distal segment of the angioscope can at least partially house an imaging sensor and illumination source, such as arranged to provide forward viewing capabilities beyond the petrous segment of the carotid artery. The distal segment can include a bend, the bend end user configurable at a specified angle such as to orient the imaging sensor at an acute angle relative to the longitudinal axis defined by the angioscope. The angioscope can also include a flexile sheath extending from the distal segment toward the proximal end, with electrical cabling disposed within. The cabling can have a greater flexibility along its length compared to the flexile sheath, allowing it to conform to the sheath's shape during navigation through cerebrovasculature. In an example, this can be achieved through an unencased or unshielded (e.g., using unshielded wires) cable design with a notably short rigid section of approximately less than 4 mm (e.g., about 1.68mm) at the distal tip. The flexile sheath can be implemented using various constructions, including laser-cut hypotubes with specialized cut patterns such as ring-and-bar or interrupted spiral patterns. These patterns can facilitate torque transmission (such as to transmit a twisting motion introduced at proximal end of the angioscope to a distal end of the angioscope, to change a viewing angle of the imaging sensor) while maintaining flexibility. In an example, the flexile sheath is constructed from at least one of superelastic shapememory materials (e.g., nitinol), stainless steel, nonmagnetic nickel-cobalt-chromium -molybdenum (MP35N).

[0049] In an example, the illumination source can include at least one of fiber optic illumination or board level LED-based emitters. For example, a fiber optic implementation can facilitate advantages in terms of wavelength flexibility, such as to enable various imaging modes including white light, infrared, and specific wavelengths for fluorescence imaging. This flexibility allows for advanced diagnostic capabilities such as plaque identification and blood clot characterization. Likewise, when a light emitting diode (LED) implementation, can facilitate emission of white light via controlled Red, Green, blue (RGB) LED operation. In an example, illumination source can also incorporate fluorescent dyes such as Evans blue, indocyanine green (ICG), Rhodamine, or Nile blue such as to enhance imaging capabilities.

[0050] In an example, the angioscope can be communicatively coupled with an imaging processor, such as to perform 3-dimensional (3D) reconstruction of internal patient anatomy via integration with pre-operative CT / MR imaging or co-regi strati on with single or bi-plane fluoroscopy and real-time image processing. Such image processing can enable an end user to create a detailed 3D model of the patient anatomy with significantly higher resolution than conventional CT or MR imaging, which can be particularly beneficial for procedures such as brain-computer interface electrode placement. While generally described herein with reference to navigating vasculature of a human patient (e.g., peripheral, pulmonary, renal, coronary and cerebrovasculature), devices described herein can also be useful for endocisternal navigation (e.g., subarachnoid space via lumber puncture), pulmonary interventions (e.g., airway, venous and arterial), or fetal / placental intervention.

[0051] FIG. 1A depicts an example of an angioscope for navigating cerebrovasculature. In an example, an angioscope 102 can include a flexile sheath 108, and a distal segment 106 including a distal tip 116 having an imaging sensor 124 and an illumination source. The flexile sheath 108 can establish at least a part of a proximal segment 104, which can extend to a transition coupling 110, which can be arranged as a bifurcated joint for breaking out imaging and power cabling to an illumination plug 112 and an imaging plug 114, respectively. The illumination plug 112 and the imaging plug 114 can each be removably coupled with an illumination receptacle 122 and an imaging receptacle 120, respectively, of an imaging processor 118 (as depicted in FIG. IB).

[0052] In an example, the angioscope 102 has a distal segment 106 with a diameter less than about 3.5 French (Fr) or less than about 0.045 inches (in) distal tip. Here, the distal segment 106 can have a greater largest diameter than that of the proximal segment 104, which can have a largest diameteralong its length (e.g., up to the transition coupling 110) of less than 3 Fr or less than about 0.039 in. In an example, the flexile sheath 108 can include a step down (e.g., at or near the distal segment 106 from a diameter of about 4 mm toward a diameter of about 3 Fr extending toward a proximal end. In an example, at least the proximal segment 104 and the distal segment 106 can be introduced to patient anatomy via a parent catheter or via balloon irrigation. For example, the angioscope 102 can be used with a parent catheter or other introducer system with an insertion portion width at least one millimeter (mm) wider in diameter than that of the distal segment 106, such as greater than about 2.5 Fr, greater than about 3 Fr, or greater than about 3.6 Fr.

[0053] In example, the proximal segment 104 and the distal segment 106 can have a combined length within a range of about 140 centimeters (cm) and about 185 cm. In an example, the flexile sheath 108 can be formed as a laser-cut hypotube. Alternatively or additionally, the flexile sheath 108 can formed of one or multiple waveguides (e.g., formed via strands of optical fiber), such as concurrently establishing the illumination source.

[0054] FIG. IB depicts an example of an imaging processor for coupling with the angioscope of FIG. 1A. In an example, a system for imaging cerebrovasculature can include the angioscope 102 and an imaging processor 118. The imaging processor 118 can include circuitry for providing power, image processing, and video output to the angioscope 102, such as via cabling disposed within the flexile sheath 108. In an example, the imaging processor 118 can including a housing having a front panel user interface, the imaging plug 114 for communicatively coupling with an imaging sensor 124 at the distal tip 116, and the illumination plug 112 for providing illumination via the illumination source. The user interface of the imaging processor 118 can include user controls, such as for triggering capture of a still image or capture of recorded video, such as in addition to toggling image processing settings. In an example, to promote sterility in an angiosuite environment, the imaging processor 118 can be fully draped with a covering 126 during operation and use.

[0055] In an example, the imaging processor 118 can including processing circuitry (e.g., a graphics processing unit (GPU), such as including real-time frame interpolation (e.g., such as NVIDIA DLSS4 or naive frame interpolation) for receiving an imaging signal via the imaging sensor 124 and displaying an image in real time and at a high definition (e.g., greater than about 480 vertical pixels or greater than about 720 vertical pixels and at a frame rate greater than about 24 frames per second (FPS) or greater than about 30 FPS). In an example, the processing circuitry of the imaging processor can convert an imaging signal received at a frame rate of about 30 FPS and convert the graphics to a frame rate of 60 FPS, such as using a machine learning model to construct synthetic frames fordisposing between actual captured frames. For example, the imaging processor 118 can have memory including instructions that, when executed by a system processor (e.g., a central processing unit (CPU) or GPU) to receive consecutive real image frames captured by the imaging sensor 124 and to predict and generate at least one synthetic frame inserted between the consecutive real image frames based on motion vectors and learned features. For example, the system processor can access a trained neural network model to analyze temporal and spatial features of the received image frames to predict motion. In an example, the processing circuitry of the imaging processor 118 can combine the synthetic frames with the real frames into a continuous video signal at a higher effective frame rate than the native frame rate of the imaging sensor 124. Such increased FPS can help facilitate better image analysis by the end user and allow for slowing down the video feed, such as to search for certain still images to aid in clinical decisions.

[0056] In another example, the image processor 118 can perform object detection to localize and classify objects of interest, such as other medical devices used in conjunction with the angioscope 102 and pathology observed. The image processor 118 can receive consecutive real image frames captured by the image sensor 124 and generate bounding boxes and masks of objects of interest, while also providing labels of the object using neural network models, in real time. Additionally, the classification of objects of interest can include pathological indicators and grading to provide users with greater information on the potential pathology observed and aid in clinical decisions. In an example, the image processor 118 can receive video data from the image sensor 124 and consolidate clinically relevant sections of video captured in vivo. For example, the image processor 118 can perform video frame thresholding (e.g., based on average pixel value), such as to facilitate rapid identification of frames to be removed. For example, if it is desirable for a certain procedure to remove sections of the video where it’s the user tracking the device and only blood (red) is in view, the image processor 118 can naively average all pixel values and use thresholding flag irrelevant frames for removal. Such image processing can be used to help construct clinical highlight videos, where relatively long (e.g., minutes) periods of mostly static video frames can be identified and removed by the image processor 118 such as to shorten the resulting clinical highlight video to only the clinically- relevant parts.

[0057] In an example, the image processor 118 can access a dataset of labelled pre-clinical data, such as an input to a cerebrovascular pathology detection or tracking model. Here, the dataset of labelled pre-clinical data can be used to train detection or tracking model, which can then uploaded and used by the image processor 118 for active object detection. For example, the image processor 118 canperform automated feature identification, e.g., using bounding box detection and segmentation techniques using a pre-trained model with the labelled pre-clinical data as an input. For example, the pre-trained model can include deep learning object detection architectures such as Faster R-CNN, Mask R-CNN, or Y0L0v9.

[0058] In an example, the image processor 118 can perform at least one of illumination correction or specular reflectance removal of images received by the imaging sensor 124. Specular reflectance removal generally can include, e.g., two models: a) a glare detection model (e.g. a deep learning segmentation model that detects glare spots) and b) an in-painting model (e.g. a deep learning inpainting model to fill the glare spots). For example, illumination correction, or white balancing can be performed (e.g., in realtime during image capture) to facilitate that colors being recorded and monitored are sufficiently accurate for end user (e.g., physician) detection of clinically relevant features in the cerebrovasculature. For example, the image processor 118 can perform gray -world, white patch, and ground truth white balance correction of images captured via the imaging sensor 124.

[0059] FIG. 1C is a magnified view of a tip of the angioscope of FIG. 1A. In an example, the 102 includes an imaging sensor 124 arranged at the distal tip 116 in a “chip-on-tip” configuration, such as allowing increased flexibility at the distal tip 116 compared to other fiberoptic imaging sensors including coherent fiber bundles. In an example, the imaging sensor 124 can include a Complementary Metal-Oxide-Semiconductor (CMOS) arranged to provide an imaging signal in full color, for facilitating forward viewing, imaging of a vessel into which the distal tip 116 has been inserted.

[0060] In an example, the distal segment 106 includes a relatively short (e.g., less than about 4 mm, such as having a rigid section of less than 4 mm (e.g., about 1.68 mm) at or near the distal tip 116). For example, the distal segment 106 can have a rigid section of less than about 3 mm, less than about 2mm, such as at about 1.68 mm. The distal segment 106 can include a flexible portion, adjacent and proximal to the rigid section, for promoting navigation of the distal segment 106 through certain tortuous vessels.

[0061] FIG. 2A shows a scale of a distal portion of an angioscope, as compared with a coin. In an example, the proximal segment 104 can have a maximum diameter less than about 2.7 Fr and the distal segment 106 can have a maximum diameter less than about 3 Fr. Here, the working portion (e.g., the distal segment 106 and the proximal segment 104 combined) can be introduced to the patient anatomy via a variety of different catheters or via a typical spinal needle (e.g., having a Gauge (G) between 18-20 G), such as to inspect subarachnoid spaces, ventricles, or other small cavities. In anexample, the distal segment 106, the proximal segment 104, or both can include a hydrophilic coating to aid in smooth passage of the angioscope 102 through the patient anatomy.

[0062] FIG. 2B and FIG. 2C each show an example of a distal tip of an angioscope. In an example, the imaging sensor 124 can provide an image having a field of view (FOV) greater than about 100°, such as greater than about 127°.

[0063] In an example, as depicted in FIG. 2B, the illumination source 202 includes a plurality of Red, Green, Blue (RGB) light emitting diodes (LED) or white LEDs, disposed adjacent to (e.g., surrounding) the imaging sensor. Such an arrangement can provide a reduced catheter diameter as compared with certain other light configurations involving separate light fibers and can improve illumination intensity or uniformity in close-up views. In an example, this can be achieved by reducing the cross-sectional area behind the camera module, where certain board level micro LED’s can use the same wires or communication busses as the camera module. Beyond modal control of R, G and B, certain regional modal control modalities can also be achieved by turning off LEDs disposed at or near vessel walls, such as to reduce glare and improve the dynamic range in the areas of interest. Similar regional modal control can also be used to send structured light patterns that can be used to create 3D reconstructions of the scene at the patient anatomy.

[0064] Alternatively or additionally, as depicted in FIG. 2C, the distal tip 116 can include the individual illumination fibers (e.g., each having a diameter of about ~30-microns and a numerical aperture greater than about 0.8), providing significantly greater flexibility compared to certain other ~280-micron coherent fiber bundles. The fiber optic illumination approach can offer advantages over certain LED-only solutions, such as reducing glare, expanding a field of illumination with a high numerical aperture, and facilitating a plurality of different illumination modes, such as red, green, blue, white light, and infrared capabilities. Such varied illumination can help facilitate specific wavelength selection for fluorescence imaging, plaque identification, and blood clot characterization. For example, the illumination source 202 includes optical fiber and a rotating assembly of various LEDs including at least one of red, green, blue, white, infrared, or ultraviolet (UV) light sources that can selectively be used for excitation, fluorescence, or hyper spectral fluorescence. Here, the optical fiber arrangement of the illumination source 202 (as depicted in FIG. 2C) can facilitate a variety of combinations of illumination, without requiring mounting the rotating assembly of various LEDs directly at the distal tip 116.

[0065] In an example, the imaging processor 118 can include processing circuitry to control the illumination source 202 and the imaging sensor 124 for at least one of excitation, fluorescence, orhyper spectral fluorescence. For example, the imaging sensor 124 can include a specialized CMOS sensor and the illumination source 202 can be varied (e.g., pulsed or scanned across different wavelengths) on a per-pixel or sub-array basis such as to detect fluorescence markers. Such a technique can be especially useful in certain vascular scopes that require high-sensitivity to certain dyes or biomarkers. In an example, the imaging sensor 124 can include or use an embedded color filter array configured to aid in image sensing of near infrared (NIR) or certain specific fluorescence wavelengths. For example, the illumination source 202 can include a fluorescent dye including at least one of Evans blue, indocyanine green (ICG), a Rhodamine, or Nile blue. In an example, the imaging processor 118 can control the data coming from each pixel, e.g., by monitoring the Serial Peripheral Interface (SPI) data output, to aid in saturating and white balancing. For example, the imaging processor 118 can control pixel -by-pixel data based on the SPI such as to minimize white saturation and enhancing the deep view by controlling the illumination fibers light output intensity at a “zone” level. Fluorescence images can then be overlay ed on real-time full color images to enhance fluoresced objects of interest.

[0066] In an example, the imaging processor 118 can include processing circuitry to control the RGB or white LEDs such that a white light is emitted from the distal segment. Here, as depicted in FIG. 2B, the illumination source 202 can include LED red, green, and blue emitters arranged around the imaging sensor 124, such that when each LED is activated, a perceived white light is emitted from the distal tip 116. Here, the LEDs of the illumination source 202 can be driven off of the same cabling of the imaging sensor 124 sensor. Alternatively or additionally to the aforementioned RGB / White modes, the imaging processor 118 can include processing circuitry to control the RGB LEDs such that, where the distal tip 116 is bumped against a vessel wall, a specified zone of LEDs (e.g., a quadrant, a row, etc.) can be turned off to mitigate or avoid over saturation and to allow the end user to selectively focus on a properly illuminated area of the patient anatomy. In an example, the imaging sensor 124 can be disposed inside the distal sheath such that the imaging sensor remains oriented at an angle away from a longitudinal axis defined by a rigid portion of the distal segment. In an example, the imaging sensor can extend at least partially out of a distal-most aperture of the distal flexile sheath 108. In an example, as depicted in each of FIG. 2B and FIG. 2C, the distal tip 116 can include the illumination source 202 and the imaging sensor 124, arranged relative to each other such that the atraumatic edge (e.g., a bevel, a chamfer, etc.) of the distal tip 116 widens a dispersion of light without significantly introducing image distortion to a lens over the imaging sensor 124.

[0067] FIG. 3A is an example of an image obtained via optical-fiber angioscopy imaging. Certain angioscopy techniques involving imaging via an optical fiber bundle can involve a challenge of a "honeycomb effect," which significantly reduces image resolution, such as to about 22 pm. In addition, the field of view of certain fiber bundle GRIN lens designs and certain scanning fiber designs are typically below 100 degrees, restricting the clinical utility of the images obtained, often unable to image the entire scene of an artery or ventricle. In addition, such fibers in the optical fiber bundle themselves are bulky, fragile, and can be cost-prohibitive to manufacture at scale. Most significantly, certain optical fiber bundle angioscopy devices are stiff and lack an appropriate flexibility to navigate certain small arteries, complex anatomical pathways, and procedures such as ventriculostomy for accessing the brain's ventricles. In an example, certain interpolation algorithms or CNN-based deep learning models can be used (e.g., by the image processor 118 of FIG. IB) to remove or clarify honeycomb effects.

[0068] FIG. 3B is an example of an image obtained via chip-on-tip angioscopy imaging. The present inventors have recognized the benefits of an angioscope (e.g., the angioscope 102 of FIG. 1A, FIG. 1C, FIG. 2A, FIG. 2B, and FIG. 2C), such as including a CMOS-based system providing resolution (about 10 pm) several orders of magnitude higher than certain other angioscopes relying on an optical fiber bundle. The increased square field of view of 127 degrees can allow for up to about five times greater area of view than certain other scopes (e.g., having a maximum field of view less than about 100 degrees), significantly increasing the likelihood of correctly imaging the area of interest when the imaging sensor is inserted into a vessel or ventricle. This can be incredibly beneficial in certain saline environments where field of views are can be decreased by about 30%, such as based on principles explained by Snell’s Law. Applicant's angioscopes, as described herein, can provide significant improvements in flexibility and torqueability, facilitating improved navigation of challenging patient anatomies.

[0069] FIG. 4A is a block diagram of an example of an angioscopy system for imaging cerebrovasculature. FIG. 4B depicts an example of a user interface for imaging cerebrovasculature, including real time imaging via angioscopy.

[0070] In an example, the imaging processor 118 can be communicatively coupled with to a user interface 406, such as to display images based on an imaging signal received from the angioscope 102. In an example, such real-time imaging can be transmitted to the user interface 406 from the imaging processor 118 via an DVI or HDMI output, providing integration with certain externalmonitors. In an example, the imaging processor 118 can include or use one or more USB ports for image and video storage, or alternatively or additionally include internal storage capabilities.

[0071] In an example, the imaging processor 118 can include processing circuitry 402 for receiving an imaging signal from the imaging sensor 124 of the distal tip 116, and displaying the image to an end user via the user interface 406 to aid in image analysis for at least one of stroke therapy, stent verification, cerebrospinal fluid (CSF) endoscopy, or neuroendoscopic guidance.

[0072] For example, the displayed image on the user interface 406 can aid an end user in distinguishing clot type (white vs. red) in acute ischemic stroke to optimize device selection (aspiration vs. stent retriever) and confirm full revascularization. For example, the displayed image can be provided at a sufficient resolution and framerate to assist an end user in identifying a red vs. white thrombus, the source of a stroke, plaque color or ulceration, and to see stent malapposition in real time. Here, the direct color vantage provided by the imaging sensor 124 can mitigate or avoid ambiguities of certain other grayscale modalities (e.g., fluoroscopy, intravascular ultrasound (IVUS) or blind spots of certain side-facing probes, e.g., optical coherence tomography (OCT)).

[0073] The displayed image on the user interface 406 can assist an end user in assessing stent or flow diverter coverage, apposition, and potential plaque protrusions or intimal tears in intracranial or extracranial settings. The displayed image on the user interface 406 can assist an end user in evaluating suspected subarachnoid hemorrhage, cystic lesions, or congenital anomalies minimally invasively through a small-gauge lumbar or cisternal approach. The displayed image on the user interface 406 can promote wide-angle, flexible navigation for procedures requiring direct visualization, e.g., inspection of shunt placements or intraventricular therapies.

[0074] In an example, a real-time image signal feed from the imaging sensor 124 can be viewed by an end user, via the user interface 406, in conjunction with fluoroscopy to aid in vascular interventions. A radiopaque marker band is positioned at the distal tip of the device. The device features a high- resolution video endoscope with a surrounding lighting system which provides real-time, high- resolution imaging inside blood vessels. This can facilitate accurate visualization of vascular structures and pathologies as well as physicians’ tools and devices in real-time, enabling precise interventions under real-time direct visualization. This can mitigate the drawbacks of non-real-time pull-back methods of systems such as IVUS and OCT which do not inform real time device placement.

[0075] In an example, the processing circuitry 402 can include, use, or be communicatively coupled with an image signal processor (ISP) 403. The ISP 403 can convert a raw image signal from theimaging sensor 124 to digital format and can provide image processing according to any combination of image processing blocks 405, 407, 409, 411, 413, 415, or 417.

[0076] For example, at the preprocessing block 405, the ISP 403 can facilitate preprocessing of images received from the image sensor such as to adjust any combination of the following parameters, according to a specified surgical scene or protocol: a. Demosaicing: e.g., converting a raw Bayer-patterned image data into full color image b. Brightness (e.g., exposure or gain) c. Saturation d. Hue e. Sharpness f. Gamma g. Auto-exposure / auto-gain h. Auto white balance

[0077] At the object detection block 407, the ISP 403 can facilitate object detection of images received from the image sensor using a machine learning model, e.g., trained for object detection or classification of objects. For example, the ISP 403 can receive frames from a video (e.g., every frame or at a sampling rate (e.g. 1 / 30 frames for latency)) into the machine learning model for inference. Here, for a plurality of frames, the ISP 403 can use the model to generate bounding boxes or masks of the objects of interests detected in respective frames. In an example, the ISP 403 can determine an indication of grading of plaque or thrombi based on the object detection.

[0078] At the reconstruction / navigation block 409, the ISP 403 can facilitate any of a gaussian splatting, deep learning mono-lens depth map reconstruction, or other 3D reconstruction algorithm or model such as to generate a 3D model of cerebrovasculature imaged via the imaging sensor 124. For example, such 3D reconstruction can be performed in real-time during the image capture, or alternatively as a post-procedure process. In an example, at least one of the processing circuitry 402 or the ISP 403 can receive bi-planar fluoroscopy data, corresponding with the imaged cerebrovasculature such as to help in mapping a location image captured via the imaging sensor 124.

[0079] At the sharpening block 411, the ISP 403 can facilitate sharpening of an individual image captured via the imaging sensor 124, e.g., via a high pass filter or via application of unsharp masking to such as to increase contrast along edges and to increase object definition.

[0080] At the denoising block 413, the ISP 403 can use one or more filters to such as de-noise an individual image (e.g., a Gaussian filter), or apply deep learning model to de-noise an individual image.

[0081] At the frame generation block 415, the ISP 403 can create one or more synthetic frames such as to simulate an increase in frames per second (FPS), such as to facilitate smoother video or to facilitate creation of a slow-motion video. Block 415 can involve any of the following interpolation techniques: a. Classical interpolation techniques i. Motion interpolation: calculates motion vectors to describe movement of pixels from one frame to another b. Deep learning (DL) techniques to estimate motion and create frames (less defined on method) i. Similar methods to motion interpolation, but instead performed with DL models

[0082] At the specular reflectance removal block 417, one or more deep learning models can be accessed or used via the ISP 403 such as to remove or otherwise mitigate glare in an image or video feed received from the imaging sensor 124. Such specular reflectance can involve segmentation to detect glare spots and in-painting, such as to remove the detected glare spots.

[0083] FIG. 5A depicts an example of an encased distal portion of an angioscope. FIG. 5B depicts an example of a distal tip of an angioscope. In an example, the distal segment 106 can include an imaging sensor and an illumination source, and the imaging sensor can be sized, shaped, or otherwise arranged to forwardly view and inspect a target location beyond a petrous segment of a carotid artery of the cerebrovasculature. As depicted in FIG. 5A, a cabling 504 connecting the imaging sensor and the illumination source can be encased, such as via a shielding material. As shown in FIG. 5B, in an example the distal tip can be square-shaped or rectangular- shaped.

[0084] FIG. 6A depicts an example of an unencased distal portion of an angioscope. FIG. 6B depicts an example of a distal tip of an angioscope. FIG. 6B depicts an example of a distal tip of an angioscope. By contrast with the cabling 504 depicted in FIG. 5 A and FIG. 5B, the cabling 504 as depicted in FIG. 6A and FIG. 6B can remain unencased, such that individual strands or wires are not bound via an encasement or shielding material other than the flexile sheath 108 (as depicted in FIG. 1A). The shielding is provided by the flexible sheath surrounding the imaging cables with metal reinforcementto reduce electromagnetic emissions and immunity. In an example, the cabling 504 is formed of material collectively having a greater flexibility, along a length of a cable, than a flexibility of the flexile sheath surrounding the cabling 504, such that the cabling 504 conforms to a shape of the flexile sheath as the flexile sheath passes through the cerebrovasculature. In an example, as depicted in FIG 6B, the cabling 504 can include no greater than six individual strands or wires for both the illumination source and the imaging sensor.

[0085] FIG. 7A depicts an example of a laser-cut hypotube of an angioscope. FIG. 7B is a magnified view of the laser-cut hypotube of FIG. 7A. In an example, depicted in FIG 7A, the distal segment can be disposed within by the flexile sheath 108. The distal segment (and the flexile sheath 108 surrounding the distal segment) can be formed including a bend 704 to orient the distal tip (including the imaging sensor) laterally at an acute angle (9) with respect to a proximal-distal longitudinal axis 708 defined by the angioscope. In an example, distal segment includes a pivot 714, located at or near the bend (e.g., slightly proximal to the bend), the pivot attached to a manipulation element 710. In an example, the manipulation element 710 can be end user-controllable to establish a specified angle 9 of the bend 704. In an example, the wherein the manipulation element can be at least a portion of the electrical cabling 504 (as depicted in FIG. 6A and FIG. 7A) disposed within the flexile sheath. Alternatively or additionally, the manipulation element 710 includes a pull wire or a guidewire. In an example, the manipulation element 710 includes at least a portion of a laser-cut hypotube (such as forming at least a portion of the flexile sheath 108 or a hypotube separate from the flexile sheath 108, disposed within the flexile sheath 108). For example, the manipulation element 710 can adjust a shape of the distal portion of the flexile sheath 108 to a j -shaped curve, an s-shaped curve, or toward about a 90-degree angle to enable side-viewing.

[0086] In an example, the flexile sheath 108 extends at least partially along a length of the angioscope, and the flexile sheath 108 has a rotational stiffness to translate rotational torque, applied at the proximal segment 104 (as depicted in FIG. 1A) to the distal segment 106 and control a direction of orientation at which the imaging sensor is pointed (by nature of the bend 704). For example, to provide such ability for rotational torque translation while remaining sufficiently flexible, at least a portion of the flexile sheath can be formed as a laser-cut hypotube. In an example, the hypotube can include at least one laser-cut pattern, such as an interrupted spiral cut pattern 802 (as depicted in FIG. 8A), a ring and bar cut pattern 804 (as depicted in FIG. 8B), or a brickwork cut pattern 806 (as depicted in FIG 8C), or a combination thereof. In an example, the laser-cut hypotube forming at least a portion of the flexile sheath 108 is formed of a superelastic material having shape memory, stainless steel,nonmagnetic nickel-cobalt-chromium-molybdenum (MP35N), or a combination thereof. For example, the flexile sheath 108 can be formed of a nitinol hypotube that is laser-cut with specific cell patterns and including a hydrogel coating to provide lubricity both inside and outside the flexile sheath 108. Here, the flexile sheath 108 can include, at the laser-cut hypotube, ultra-thin walls (such as less than about -0.002 in) while retaining flexibility and kink resistance during travel of the flexile sheath 108 through patient anatomy.

[0087] In an example, the laser-cut hypotube can be dip-coated in hydrogel while mounted on a mandrel. Here, the hydrogel can cure such that it provides both interior and exterior lubricity with a minimal wall profile, eliminating the need for separate liners or external coatings to achieve a desired level of lubricity. Such single hydrogel-coated laser-cut hypotube can replace certain other multi-layer catheter construction (e.g., involving PTFE, Pebax, etc.) to achieve ultra-thin walls with excellent navigability and fewer manufacturing steps.

[0088] In an example, the laser-cut hypotube of the flexile sheath 108 can be grounded at or near the proximal segment 104 (as depicted in FIG. 1A). Here, the laser-cut hypotube can acts as a faraday sleeve, such as to attenuate radiated emissions. This can provide an opportunity to arrange the cabling 504, within the flexile sheath 108, without a typical shielding as generally appropriate for certain chip- on-tip image sensors, which can provide additional flexibility. In an example, the laser-cut hypotube of the flexile sheath 108 includes at least 80% metal coverage and has a cutting pattern such that no slot has a width wider than 0.35mm, such as to provide an appropriate emission attenuation. In an example, the laser-cut hypotube of the flexile sheath 108 has a resistance less than about 50 milliohm (mOhm) to facilitate attenuation of emissions.

[0089] FIG. 8A, FIG. 8B, FIG. 8C, and FIG. 8D each depict an example of a cut pattern of a laser-cut hypotube. In an example, a hypotube can be cut in a specified cutting pattern to increase flexibility. For example, hypotube can be made more flexible by cutting it into a spiral, which allows for different bend radii based on a pitch of the cuts, establishing a continuous spiral cutting pattern. However, a full spiral can lack desired torque transmission, as twisting one end has little effect on the other. In an example, according to interrupted spiral cut pattern 802 of FIG 8 A, to improve torque and pushability without significantly reducing flexibility, the spiral can be broken so that the cuts do not go around the entire circumference.

[0090] Another technique for creating flexible hypotubes involves using straight lines that run partially around the circumference. This method provides better pushability and torquability but less flexibility than a pure spiral. To achieve multi -plane flexibility, such lines can be rotated, e.g., byabout 90 degrees. However, straight lines can cause certain hypotube materials (e.g., stainless steel) to crack under repeated flexing, especially at the tips where stress is highest. To mitigate this, I-shaped cuts can used, spreading the load and increasing durability, though this also increases manufacturing time and costs.

[0091] Brickwork Pattern Cut Hypotubes feature a design characterized by parallel lines of interrupted incisions that resemble the arrangement of stones in a brick wall. This unique pattern not only provides aesthetic appeal but also enhances the functional properties of the hypotube. The interrupted nature of the cuts contributes to improved torque transmission and pushability, as each section can flex independently.

[0092] Over the years, various intricate patterns have emerged for flexible tubes, with one standout design being the jigsaw cut, also known as the puzzle cut. In this method, different sections of the tube are entirely separate, connected by two D-shaped socket and ball joints, providing inherent flexibility. Similar to straight lines, movement can be restricted to a single plane. The jigsaw cut offers exceptional flexibility, torque, and pushability, ideally suited for thick wall sections to prevent dislocation. It can also be machined in thinner walls if care is taken.

[0093] In an example, as depicted in FIG. 8D, a laser-cut hypotube can include a plurality of differently-cut sections, such as in a first pattern 810, a second pattern 812, and a third pattern 814. As depicted, the laser-cut hypotube include different sections 810, 812, and 814, each with an interrupted spiral cut pattern 802 at a different pitch from one another. In an example, pitches of cutting pattern can be altered along a length of the flexile sheath 108, such as to promote increased flexibility or reinforced strength at certain points along the 108.

[0094] FIG. 9A depicts a distal portion of an example of an angioscope, including a laser-cut hypotube. FIG. 9B is a magnified view of a distal tip of the angioscope of FIG. 9A.

[0095] In an example, the distal segment 106 can be manufactured with pre-shaped tips formed of steam-shapeable materials to facilitate intraoperative customization. For example, the distal segment 106 can be manufactured or otherwise end user configurable (e.g., via the steam-shaping) such that the bend 704 is set at a specified acute angle (e.g., within a range about 25° and about 70°, such as about 30° or about 45°). The distal segment 106 can also be manufactured or otherwise end user configurable (e.g., via the steam-shaping) such that the bend 704 is set at a specified shape, such as a J-shaped curve or an S-shaped curve.

[0096] In an example, when inserting the cabling 504 (as depicted in FIG. 6A and FIG. 6B) within the flexile sheath 108 during assembly of the angioscope, friction can cause the cabling 504 to stickto inner walls of the flexile sheath 108. In an example, during assembly, ultrasonic or mechanical vibration can be applied to either the flexile sheath 108 or the cabling 504 to prevent sticking and allow gravity-assisted feeding, such as when the flexile sheath 108 is oriented vertically.

[0097] In an example, the image sensor can be disposed at the distal tip of the distal segment 106, such as flush with or countersunk (or similarly embedded into) a distal-most plane of the distal segment 106. Optionally, the imaging sensor can be covered via an optically-clear tip cover 950, e.g., formed substantially semispherical and attached via adhesive to the imaging sensor and / or the distal- most plane of the distal segment 106. For example, the tip cover 950 can be formed of glass, epoxy, silica, etc. In an example, one or more dopants can be infused with or otherwise added to the material forming the tip cover 950, such as to polarize / attenuate / diffuse light. The tip cover 950 can be formed as optically-clear, such as of a transparent or translucent polymers, and can be atraumatic when maneuvered through, e.g., tortuous segments of cerebrovasculature to facilitate vessel safety and desired navigation. In an example, the tip cover 950 can include a beveled edge while defining a flat, planar surface that extends from the distal-most plane of the distal segment 106. Here, the imaging sensor 124 can at least slightly protrude from the distal-most plane of the distal segment 106 (e.g., in a direction opposite to the counter-sunk direction as depicted in FIG. 9B, such as to be at or near flush with the planar surface defined by the tip cover 950 having the beveled edge.

[0098] FIG. 10A depicts a transition portion of an example of a sheath of an angioscope. FIG. 10B is a magnified view of the transition portion of FIG. 10 A. In an example, the flexile sheath includes a distal sheath portion 1006 formed of the superelastic material and a proximal sheath portion 1002 formed of at least one of stainless steel, nitinol, or MP35N. Here, the distal sheath portion 1006 has a length within a range of about 35 centimeters (cm) and about 50 cm, and the proximal sheath portion 1002 has a length within a range of about 100 cm and about 130 cm. In an example, the distal sheath portion 1006 and the proximal sheath portion 1002 can be fused to each other at a joint 1004, such as via at least one of a spot weld, a seam weld, rotary friction welding, swaging, or reflow lamination.

[0099] In an example, the distal sheath portion 1006 is formed of nitinol and the proximal sheath portion 1002 is formed of 304 stainless steel. In another example, each of the distal sheath portion 1006 and the proximal sheath portion 1002 are formed of 304 stainless steel, such as each having an inner diameter of about 0.045 in and an outer diameter of about 0.05 in. Here, the two stainless steel portions can be spot welded together at the joint 1004.

[0100] FIG. 11 A, FIG. 1 IB, and FIG. 11C each depict an example of an arrangement of an imaging sensor and an illumination source at a distal tip of an angioscope. In an example, the flexile sheath108 includes a housing lumen 1102 or a partial housing lumen 1104 for a guidewire having a diameter within a range of 0.0075 in and 0.015 in (e.g., a 0.008 in, 0.010 in, or 0.014 in guide wire). This housing lumen 1102 can be formed of a polymer, Stainless steel, nitinol can extend along a length of the angioscope (e.g., up to about 1.6 m), or rather extend partially along the proximal segment 104 and the distal segment 106 (as depicted in FIG. 1 A). As shown in FIG. 11 A, the housing lumen 1102 can be, along a majority of the length of the angioscope, “behind” the imaging sensor 124 and can curve around the imaging sensor 124 to provide the guidewire adjacent to the imaging sensor 124. Alternatively, as shown in FIG. 1 IB and FIG. 11C, the housing lumen 1102 (or partial housing lumen 1104) can extend along a majority of the angioscope alongside the imaging sensor 124 and its associated cabling.

[0101] In an example electrical cabling extending within the flexile sheath to be communicatively couple with the imaging sensor, can be formed of a material collectively having a greater flexibility, along a length of a cable, than a flexibility of the flexile sheath along its length, such that the cabling conforms to a shape of the flexile sheath as the flexile sheath passes through cerebrovasculature of a patient. In an example, the electrical cabling can be wrapped around or otherwise surround a spiral- patterned wire, such that the cabling conforms to the shape of the spiral -patterned wire. In an example, the spiral-patterned wire, the electrical cabling, or both can be formed of 304 stainless steel. Alternatively or additionally, the electrical cabling (e.g., not necessarily mutually exclusive to the example shown with respect to electrical cabling) can be arranged within the flexile sheath, and the flexile sheath can be formed as a laser-cut hypotube and define or manipulate a shape of the cabling therewithin.

[0102] FIG. 12A is a cross section of showing internal contents of a distal portion of an angioscope, including an atraumatic tip. FIG. 12B is a front view of the atraumatic tip of FIG. 12A. Certain chip- on-tip distal tips can be formed by attaching the imaging sensor 124 (e.g., a squared-off camera module), generally involving grinding and polishing to blend with the circular scope body. Here, illumination fibers 1206 can be placed with manual alignment, which can result in uneven light distribution at the distal tip.

[0103] In an example, the angioscope can include a molded tip 1202 disposed over the imaging sensor 124. The molded tip 1202 can include an edge 1204, such has having a tapered, beveled, or rounded transition. Here, embedding illumination fibers 1206 within epoxy of the molded tip 1202 can facilitate, even illumination around the imaging sensor 124. In an example, the molded tip 1202 can be formed of silicon or glass distal, sized and shaped to minimize trauma to vessel walls duringinsertion and steering of the angioscope through patient anatomy. Further, the molded tip 1202 can be formed of a material acting as a diffuser, such as to reduce illumination induced glare and improving color reproducibility of the system. In an example, the illumination fibers can be terminated proximal to the camera module and a clear heat shrink can be molded around the camera module act as a light guide around the camera module, such as to reduce a need for any additional sheathing and allowing for a reduced outer diameter of the flexile sheath..

[0104] FIG. 13 A is a flowchart showing an example of a process for image processing a signal received from an angioscope, including 3-dimensional (3D) reconstruction of patient anatomy. FIG. 13B shows a processed image from a signal received from an angioscope, including object detection and 3-dimensional (3D) reconstruction of patient anatomy.

[0105] In an example, the imaging processor 118 (as depicted in FIG. IB, FIG. 4A, can perform 3D reconstruction of vessel scenes, allowing an end user to remove the angioscope from the vessel and then virtually “fly through” with full color imaging inside of a patient vessel. Such 3D reconstruction of the vessel can help assist an end user to identify and visualize where lesions start, a location of thrombus, location of plaque, or a correlation with bi-planar fluoroscopy or 3D CT / MRI.

[0106] At 1302, pre-op CT can be performed such as to create an initial 3D point cloud model of the anatomy (e.g., considering that CT resolution is limited to -250 microns).

[0107] At 1304, the imaging sensor 124 can be manually moved around such as to image the vessel space from multiple angles. In addition, the position of the image sensor 124 can be tracked under procedural fluoroscopy during the operation due to the radiopaque marker near the distal tip of the angioscope 102.

[0108] In an example, at 1306, 3D Gaussian reconstruction can be performed. Here, the imaging processor 118 can determine a 3D point cloud of features captured from the image sensor 124 when moved around.

[0109] At 1308, the camera’s position can be correlated with the estimated 3D point cloud, generated for 3D construction, to establish a projection. In an example, the point cloud can be refined with the higher resolution (e.g., 15 micron) camera data, and color information can be added to identify, e.g., white, red, or yellow areas.

[0110] At 1310, a dynamic 3D image can be formed by applying the 3D reconstruction projection to the 3D model generated from the pre-op CT by co-registering the fluoroscopy and the 3D model of the anatomy of interest. As the image sensor 124 position within the 3D reconstruction projection and the 3D model is the same, the co-regi strati on allows for integration of the projection into the 3D modelof the anatomy of interest. For example, the imaging processor 118 can display the dynamic image 1310 on a user interface, such as to provide an end user with an input to manipulate the 3D model in the control room. For example, the end user can navigate, zoom, slicing, etc. to help identify important anatomical structures The 3D reconstruction capability can be particularly valuable in the ventricular space and back of the brain, such as for brain-computer interface procedures where physicians need to place electrodes in specific anatomical locations. The full color 3D reconstruction can provide an improved visualization as compared to certain other X-ray approaches.[OHl] FIG. 14A and FIG. 14B each depict an example of a distal tip of an angioscope. In an example, a distal tip 116 of an angioscope can include a flexile polymer 1402 (e.g., (25D-72D PEBAX®) defining a housing cavity for receiving an imaging sensor 124. In the example depicted in FIG. 14A, the imaging sensor 124 is included in an imaging module 1404. In an example, the imaging sensor 124 of the imaging module 1404 can provide an image having a field of view (FOV) greater than about 100°, such as greater than about 127°. In an example, the imaging module 1404 can also include the illumination source 202, e.g., including a plurality of Red, Green, Blue (RGB) light emitting diodes (LED) or Red, Green, Blue, White (RGB) LEDs, disposed adjacent to (e.g., surrounding) the imaging sensor 124. Such an arrangement can provide a reduced catheter diameter as compared with certain other light configurations involving separate light fibers and can improve illumination intensity or uniformity in close-up views.

[0112] FIG. 15 depicts an example of a hypotube of a steerable catheter. The laser-cut hypotube 1502 depicted in FIG. 15 can be similar to the hypotube illustrated and described with respect to FIGs. 7A- 9B, and can be similarly arranged with similar components and utilizations as described elsewhere herein. In an example, a manipulation element 710 can be formed in the laser cut hypotube (e.g., as a subcomponent thereof), such as to define a pull wire 1550. For example, prior to being coated with PFTE, Pebax®, or the like, to form the outer polymer layer, the hypotube 1502 can undergo a lasercutting step, e.g., using a fiber laser machine. This laser-cutting step can involve creating a precise pattern of slits and shaped voids 1554 in the wall of the hypotube 1502. The pattern of slits and shaped voids provides structural support and enhance steerability, replacing traditional coiling or braiding wires, or complementing them.

[0113] The pull wires 1550 can be formed integrally into an inner wall of the hypotube 1502 by lasercutting. In an exmaple, the pull wires 1550 can formed within the hypotube such as to be detaachable from a distal portion of the hypotube, such as via one or more frangible tabs 1552 located along the wall of the hypotube 1502. The frangible tabs 1552 are can be sized and shaped such as to break orshear off, releasing the pull wire 1550 from the wall of the hypotube 1502 when a sufficient pulling force is applied to the pull wire 1550 in the direction of arrow during the initial use of the angioscope by the operator. The one or more frangible tabs 1552 can be strategically weakened areas in the wall of the hypotube 1502, securing the pull wire 1550 at an initial construction or formation of the hypotube in the angioscope, and arranged, sized, and shaped such as to break under a controlled force.

[0114] In an example, pull wire 1550 is defined by a straight strip of the material from which the wall of the hypotube 1502 is constructed, such as stainless steel, nitinol, and nitinol alloys, left intact after the laser-cutting process. Such a metal strip can run longitudinally along the hypotube 1502.

[0115] In an example, an angioscope constructed including the above-described hypotube 1502 can maintain a substantially uniform, round cross-sectional shape due to the integration of the pull wire 1550 with the hypotube 1502. The cross-sectional shape of an outer, flexile sheath of the angioscope can be preserved even after the pull wire 1550 is pulled during the initial use of the angioscope by an end user, and the one or more frangible tabs 1552 break, detaching the pull wire 1550 from the wall of the hypotube 1502.

[0116] FIG 16 depicts an example of a laser-cut hypotube of an angioscope, including a metal scaffold located at a distal tip of the angioscope. Similar to that described with respect to FIG. 14A and FIG. 14B, in an example the distal tip 116 of an angioscope can be formed of a flexile polymer 1402. For example, the flexile polymer 1402 can form an expandable metal scaffold. Here, the distal tip 116 including the flexile polymer 1402 can form an atraumatic tip, such that the distal tip 116 may traverse the cerebrovasculature without causing significant damage to vessels, even when the flexile polymer 1402 moves toward an expanded position of the expandable metal scaffold. For example, the flexile polymer 1402 can include a high-performance thermoplastic elastomer, such as polyether block amid (PEBA) (e.g., 25-72D Pebax®). In an example, the flexile polymer 1402 can be formed at the distal tip 116 as a mold or die such as to encapsulate an imaging module or imaging sensor. In an example, the flexile polymer 1402 can be formed of a semi-transparent or translucent material, such as for diffusing light from an illumination source disposed therein.

[0117] In an example, the flexile sheath 108 can be formed including a bend 704 to orient the distal tip (including the imaging sensor) laterally at an acute angle (a) with respect to a proximal-distal longitudinal axis 708 defined by the angioscope. In the example depicted in FIG. 16, where the flexile polymer 1402 of the distal tip 116 forms an expandable stent, the distal tip 116 can travel at the bend such that the acute angle a has a maximum value within a range of about 10° and about 90°, such as a maximum value at or near about 60°. In an example, an angle of view can be further refined by 1offsetting the image sensor angle of view from within the outer flexible sheath from 0 to 10 degrees. Even when the sheath is a a 0 degree angle of orientation with respect to the longitudinal axis, this image sensor offset can provide a user an ability to torque the sheath and better observe their desired target, useful in orienting the image sensor away from a vessel wall. Such a pre-shaped tip can also, e.g., include a J curve such as for providing a view behind certain anatomy, an S curve for selecting off centered vessel ostium’s, or a gradual bend e.g., following a radius that self-centers the image sensor as they navigate through vessels. As explained with respect to FIG. 7A and further with respect to FIG. 19, the bend 704 can be user-controlled during an operation via a manipulation element. Alternatively or additionally, the bend 704 can be user-set, e.g., prior to a procedure, via steam setting or other similar approaches to reforming a shape of the distal tip 116. In an example, the bend 704 can also be laser cut in an angle, in many materials such as nitinol. In an example, the flexile polymer 1402 can form the expandable stent at a length L2 (e.g., extending from the distal tip 116 toward the bend 704), while an entire length LI stretches from the bend to the distal tip 116. In an example, a ratio between LI and L2 can be within a range of about 1.25: 1 and about 1.75: 1, such as at a ratio of LI to L2 being about 1.5: 1.FIG. 17 depicts a transition portion of an example of a sheath of an angioscope. In an example, the flexile sheath includes a distal sheath portion 1006 formed of the superelastic material and a proximal sheath portion 1002 formed of at least one of stainless steel, nitinol, or MP35N. Here, the distal sheath portion 1006 has a length within a range of about 35 centimeters (cm) and about 50 cm, and the proximal sheath portion 1002 has a length within a range of about 100 cm and about 130 cm. In an example, the distal sheath portion 1006 and the proximal sheath portion 1002 can be mechanically connected via at least one laser-cut interlocking feature 1702. Here, respective laser-cuts of the distal sheath portion 1006 and proximal sheath portion 1002 can each be sized and shaped to mechanically interface with each other. For example, such respective laser-cuts can be a mortise-and-tenon, a tongue-and-groove, dovetail features, finger joints, or other shape-complementary features. In an example, the distal sheath portion 1002 and proximal sheath portion 1006 can be forged together, such as either with or without the laser-cut interlocking feature 1702, via rotary friction welding, spot welding, seam welding, swaging, or reflow lamination.

[0118] FIG. 18A and FIG. 18B each depict a distal tip of an angioscope, formed of a flexile polymer. In an example, a distal segment 106 of an angioscope can include or house an imaging sensor and an illumination source, and the imaging sensor can be sized, shaped, or otherwise arranged to forwardly view and inspect a target location beyond a petrous segment of a carotid artery of thecerebrovasculature. As shown in FIG. 18B, in an example the distal tip can be substantially cylindrically-shaped, such as having a cross-sectional profile that is circular or oval-shaped.

[0119] In an example, the distal segment 106 (e.g., including a distal tip of the angioscope) can be formed of a flexile polymer for securing at least one of the imaging sensor or the illumination source within a cavity of the distal segment. For example, the flexile polymer can include a high performance thermoplastic elastomer, such as polyether block amid (PEBA) (e.g., 25-72D Pebax®). In an example, the flexile polymer can be formed at the distal portion 106 as a mold or die such as to encapsulate an imaging module or imaging sensor. In an example, the flexile polymer can also be used for atraumatic tip purposes (e.g., in a spherical or semi -spherical shape) and also, to diffuse the light for the illumination source to decrease or remove glare.

[0120] FIG. 19 depicts a partially exploded view of a distal tip of an angioscope, exposing a manipulation element for establishing a specified angle of a bend of the angioscope. In an example, the flexile sheath can include or define one or more channels 2202 for housing a corresponding manipulation element 710. In an example, the manipulation element 710 includes at least one pull wire. As shown in FIG. 19, an imaging sensor 124 can be communicatively coupled with electrical cabling 504, and the electrical cabling extend through a liner 2206. For example, the liner 2206 can be formed of polytetrafluoroethylene (PTFE) or another nonstick or coated polymer. One or more channels 2202 can be adjacently arranged and running parallel with the liner 2206. Each of the one or more channels 2202 can house a manipulation element 710 extending therethrough. In an example, a flexile sheath 108 can at least partially encapsulate or surround the one or more channels 2202, the liner 2206, and thus the manipulation element(s) 710, the electrical cabling 504, and the imaging sensor 124. In an example, the distal segment 106 formed of the flexile polymer 1402 can at least partially encapsulate or surround the flexile sheath 108, at least at or near the distal segment 106 or at or near the distal tip of the angioscope.

[0121] FIG. 20 illustrates generally an example of a block diagram of a machine 2001 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform in accordance with some examples. In alternative embodiments, the machine 2001 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 2001 may operate in the capacity of a server machine, a client machine, or both in serverclient network environments. In an example, the machine 2001 may act as a peer machine in peer-to- peer (P2P) (or other distributed) network environment. The machine 2001 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a webappliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0122] Examples, as described herein, may include, or may operate on, logic or a number of components, modules, or mechanisms. Modules are tangible entities (e.g., hardware) capable of performing specified operations when operating. A module includes hardware. In an example, the hardware may be specifically configured to carry out a specific operation (e.g., hardwired). In an example, the hardware may include configurable execution units (e.g., transistors, circuits, etc.) and a computer readable medium containing instructions, where the instructions configure the execution units to carry out a specific operation when in operation. The configuring may occur under the direction of the executions units or a loading mechanism. Accordingly, the execution units are communicatively coupled to the computer readable medium when the device is operating. In this example, the execution units may be a member of more than one module. For example, under operation, the execution units may be configured by a first set of instructions to implement a first module at one point in time and reconfigured by a second set of instructions to implement a second module.

[0123] Machine (e.g., computer system) 2001 may include a hardware processor 2002 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core (e.g., an image signal processor), or any combination thereof), a main memory 2003 and a static memory 2004, some or all of which may communicate with each other via an interlink (e.g., bus) 2005. The machine 2001 may further include a display unit 2006, an alphanumeric input device 2007 (e.g., a keyboard), and a user interface (UI) navigation device 2008 (e.g., a mouse). In an example, the display unit 2006, alphanumeric input device 2007 and UI navigation device 2008 may be a touch screen display. The machine 2001 may additionally include a storage device (e.g., drive unit) 2009, a signal generation device 2010 (e.g., a speaker), a network interface device 2011, and one or more sensors 2012, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 2001 may include an output controller 2016, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0124] The storage device 2009 may include a machine readable medium 2013 that is non-transitory on which is stored one or more sets of data structures or instructions 2014 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 2014 may also reside, completely or at least partially, within the main memory 2003, within static memory 2004, or within the hardware processor 2002 during execution thereof by the machine 2001. In an example, one or any combination of the hardware processor 2002, the main memory 2003, the static memory 2004, or the storage device 2009 may constitute machine readable media.

[0125] While the machine readable medium 2013 is illustrated as a single medium, the term “machine readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) configured to store the one or more instructions 2014.

[0126] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 2001 and that cause the machine 2001 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples may include solid-state memories, and optical and magnetic media. Specific examples of machine-readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0127] The instructions 2014 may further be transmitted or received over a communications network 2015 using a transmission medium via the network interface device 2011 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 2011 may include one or more physical jacks (e.g., Ethernet, coaxial, or phone j acks) or one or more antennas to connect to the communications network 2015. In an example, the network interface device 2011 may include a plurality of antennas to wirelessly communicateusing at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MEMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 2001, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.

[0128] The above Detailed Description can include references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0129] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that can include elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

[0130] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” can include “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that can include elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0131] The above description is intended to be illustrative, and not restrictive. For example, the abovedescribed examples (or one or more aspects thereof) can be used in combination with each other.Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is:

1. A forward-viewing angioscope for insertion into a cerebrovasculature of a human subject, the angioscope comprising: a distal segment including an imaging sensor and an illumination source, the distal segment arranged at a distal end of the angioscope, the imaging sensor sized, shaped, or otherwise arranged to forwardly view and inspect a target location beyond a petrous segment of a carotid artery of the cerebrovasculature, wherein the distal segment is formed including a bend to orient the imaging sensor laterally at an acute angle with respect to a proximal -distal longitudinal axis defined by the angioscope; a flexile sheath extending longitudinally from the distal segment toward a proximal end of the angioscope; and electrical cabling disposed within the flexile sheath and extending within the flexile sheath to communicatively couple the imaging sensor of the distal segment with an outlet at or near the proximal end of the angioscope; wherein the cabling is formed of material collectively having a greater flexibility, along a length of a cable, than a flexibility of the flexile sheath along its length, such that the cabling conforms to a shape of the flexile sheath as the flexile sheath passes through the cerebrovasculature.

2. The angioscope of claim 1, wherein the flexile sheath has a rotational stiffness to translate rotational torque, applied at the proximal end of the angioscope, to the distal segment and control a direction of orientation at which the imaging sensor is pointed.

3. The angioscope of claim 1, wherein the flexile sheath is at least partially formed as a laser cut hypotube including a ring and bar cut pattern.

4. The angioscope of claim 1, wherein the flexile sheath is at least partially formed as a laser cut hypotube including an interrupted spiral cut pattern.

5. The angioscope of claim 1, wherein the flexile sheath is at least partially formed as a laser cut hypotube including a continuous spiral pattern.

6. The angioscope of claim 1, wherein the at least one of electrical cabling is wrapped around a spiral patterned wire or arranged inside a laser cut hypotube of the flexile sheath.

7. The angioscope of claim 1, wherein the flexile sheath is formed of one or multiple waveguides, establishing the illumination source.

8. The angioscope of claim 1, wherein the flexile sheath is formed of at least one of a superelastic material having shape memory, stainless steel, or nonmagnetic nickel-cobalt-chromium- molybdenum (MP35N).

9. The angioscope of claim 8, wherein the flexile sheath includes a distal sheath portion formed of the superelastic material and a proximal sheath portion formed of at least one of the stainless steel or the MP35N.

10. The angioscope of claim 9, wherein the distal sheath portion has a length within a range of 25 centimeters (CM) and 50 cm, and the proximal sheath portion has a length within a range of 100 cm and 130 cm.

11. The angioscope of claim 10, wherein the distal and proximal sheath portions are fused to each other via at least one of a spot weld, a seam weld, swaging, or reflow lamination.

12. The angioscope of claim 9, wherein the distal and proximal sheath portions each include a lasercut interlocking feature, respective laser-cuts of the distal and proximal sheath portions sized and shaped to mechanically interface with each other.

13. The angioscope of claim 9, wherein the distal and proximal sheath portions are forged to each other via rotary friction welding.

14. The angioscope of claim 11, wherein the flexible sheath includes a full or a partial housing lumen for a guidewire having a diameter within a range of 0.0075 inches and 0.015 inches.

15. The angioscope of claim 1, wherein the distal segment has a diameter less than 3.5 French (Fr).

16. The angioscope of claim 1, wherein the distal segment is less than 4 mm in length.

17. The angioscope of claim 1, wherein the distal segment provides a field of view (FOV) greater than 100°.

18. The angioscope of claim 1, wherein the imaging sensor is disposed inside the distal sheath such that the imaging sensor remains oriented at an angle away from a longitudinal axis defined by a rigid portion of the distal segment.

19. The angioscope of claim 1, wherein the imaging sensor extends at least partially out of a distal- most aperture of the distal sheath.

20. The angioscope of claim 1, wherein the distal segment includes an atraumatic edge.

21. The angioscope of claim 20, wherein the distal segment includes an illumination source and imaging sensor arranged relative to each other such that the atraumatic edge widens dispersion of light without significantly introducing image distortion to a lens over the imaging sensor.

22. The angioscope of claim 21, wherein the illumination source includes an illuminator assembly including at least two of a Red, Green, Blue (RGB) point source, a white point source, an infrared source, or an ultraviolet (UV) source.

23. The angioscope of claim 22, comprising processing circuitry to control the illuminator assembly for at least one of excitation, fluorescence, or hyper spectral fluorescence.

24. The angioscope of claim 21, wherein the illumination source includes Red, Green, Blue (RGB) light emitting diodes (LED) or white LEDs disposed adjacent to the imaging sensor.

25. The angioscope of claim 24, comprising processing circuitry to control the RGB LEDs such that a white light is emitted from the distal segment.

26. The angioscope of claim 25, wherein the illumination source is configured to provide a waveform that excites a fluorescent dye including at least one of Evans blue, indocyanine green (ICG), a Rhodamine, or Nile blue.

27. The angioscope of claim 1, wherein the distal segment is formed of a flexile polymer for securing at least one of the imaging sensor or the illumination source at the distal tip and act as an atraumatic tip.

28. The angioscope of claim 27, wherein the flexile polymer includes at least one of 25-72D PEBAX or an adhesive including titanium dioxide microparticles or nanoparticles.

29. The angioscope of claim 1, wherein the distal segment includes a pivot, the pivot attached to a manipulation element, the manipulation element being end user-controllable to establish a specified angle of the bend.

30. The angioscope of claim 29, wherein the manipulation element is at least a portion of the electrical cabling disposed within the flexile sheath.

31. The angioscope of claim 30, wherein the manipulation element is formed as a subcomponent of the laser cut hypotube disposed within the flexile sheath.

32. The angioscope of claim 30, wherein the manipulation element includes at least one pull wire.

33. The angioscope of claim 32, wherein the flexile sheath includes or defines a channel for housing the at least one pull wire.

34. The angioscope of claim 30, wherein the manipulation element includes a laser cut hypotube.

35. The angioscope of claim 1, wherein at least one of the distal segment or the flexile sheath is at least partially coated with a hydrophilic or hydrophobic coating.

36. A forward-viewing angioscope for insertion into a cerebrovasculature of a human subject, the angioscope comprising:a distal segment including an imaging sensor and an illumination source, the distal segment arranged at a distal end of the angioscope, the imaging sensor sized, shaped, or otherwise arranged to forwardly view and inspect a target location beyond a petrous segment of a carotid artery of the cerebrovasculature, wherein the distal segment is formed including a bend to orient the imaging sensor laterally at an acute angle with respect to a proximal -distal longitudinal axis defined by the angioscope; a flexile sheath extending longitudinally from the distal segment toward a proximal end of the angioscope; and electrical cabling disposed within the flexile sheath and extending within the flexile sheath to communicatively couple the imaging sensor of the distal segment with an outlet at or near the proximal end of the angioscope; wherein the flexile sheath has a rotational stiffness to translate rotational torque, applied at the proximal end of the angioscope, to the distal segment and control a direction of orientation at which the imaging sensor is pointed.

37. The angioscope of claim 36, wherein the cabling is formed of material collectively having a greater flexibility, along a length of a cable, than a flexibility of the flexile sheath along its length, such that the cabling conforms to a shape of the flexile sheath as the flexile sheath passes through the cerebrovasculature.

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