OCT catheter with low refractive index optical material

Abstract

Embodiments of the present disclosure include devices, systems, and methods for catheters with a single element for imaging and intervention. The catheter can have a distal tip that is positionable within a patient (e.g., in a lumen of a blood vessel). The distal tip can have an optical component that includes a reflective surface and a tapered distal end. The reflective surface can redirect light (e.g., light received along an optical fiber of the catheter) into an imaging beam that can be directed to a blood vessel wall. The tapered distal end can be a crossing tool for crossing an occluded or partially occluded portion of a blood vessel. In some embodiments, the reflective surface and the tapered distal end can be the same surface of the optical component. A low refractive index optical filler can be provided to reduce image artifacts at the imaging interface with patient fluids and tissues.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 165,672, filed March 24, 2021, and U.S. Provisional Application No. 63 / 014,110, filed April 22, 2020, both of which are incorporated herein by reference in their entirety. This application also relates to U.S. Provisional Application No. 63 / 165,673, filed March 24, 2021, which is incorporated herein by reference in its entirety. Technical Field

[0003] The embodiments described herein generally relate to intravascular imaging, cross-blocking, and atherosclerotic plaque resection devices, and particularly to interferometric imaging devices, imaging and interventional systems, and methods of operation having single elements for intervention and imaging. Background Technology

[0004] Minimally invasive interventions have consistently demonstrated efficacy comparable to or greater than traditional open surgical interventions, while offering lower mortality rates. For many of these minimally invasive procedures, accurate tracking of the placement of instruments inserted into the patient's vascular system is crucial for surgeons and other medical professionals performing such interventions. Most minimally invasive surgeries involve the use of flexible guidewires and catheters guided to the target vascular site. However, guiding the guidewire to the target vascular site can be challenging and risky. For example, improper manipulation of the guidewire can lead to harmful vascular dissection, perforation, or thrombosis. While some of these risks can be mitigated by heparinization, increasing the use of such anticoagulants may increase the risk of surgical bleeding.

[0005] Furthermore, most wire-guided navigation is currently performed under X-ray fluoroscopy imaging. However, X-ray imaging often requires surgeons or other medical professionals to undergo long radiation cycles.

[0006] Therefore, there is a need for improved devices, systems, and methods for intravascular imaging that address the challenges faced by current devices on the market. Such solutions should reduce the risk of complications for patients and the risk of radiation exposure for operators. Furthermore, such solutions should be compatible with or easily adaptable to other minimally invasive surgical devices, such as atherosclerotic catheters. In addition, such solutions should reduce the complexity of current devices and save on manufacturing costs. Intravascular imaging devices, systems, and methods can also be configured to improve image quality and / or reduce various image artifacts. Summary of the Invention

[0007] Embodiments of this disclosure relate to devices, systems, and methods for catheters, guidewires, or interventional devices having a single element tip for imaging and intervention. The catheter may have a distal tip that can be positioned within a patient (e.g., within the lumen of a blood vessel). The distal tip may have components or blocks including optical and mechanical features for passing through and / or inserting into atherosclerotic plaques. The optical features may redirect light (e.g., light received along an optical fiber in the catheter) into an imaging beam that can be directed to the vessel wall, while the mechanical features are configured to facilitate passage through a occluded portion or a portion of an occluded portion of the vessel via the angled tip. The imaging components or assemblies may also be configured to reduce one or more imaging artifacts.

[0008] In one embodiment, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; and a first optical filler located between the distal end of the optical fiber and the reflective element, the first optical filler having a refractive index less than 1.40. The refractive index of the first optical filler may be in the range of 1.30 to 1.40 or 1.33 to 1.38. The optical filler may comprise an aliphatic polyurethane acrylate and an acrylic monomer. The percentage of the aliphatic polyurethane acrylate may be 30% to 70%, and the percentage of the acrylic monomer may be 70% to 30%, or the percentage of the aliphatic polyurethane acrylate may be 40% to 65%, and the percentage of the acrylic monomer may be 60% to 35%. The viscosity of the first optical filler can be in the range of 1000 to 3000 cps, 1500 to 3000 cps, or 2000 to 2500 cps. The imaging device further includes a lens located between the optical fiber and the reflecting element. The lens can be a Fresnel lens, a GRIN lens, a plano-convex lens, or a biconvex lens. The lens can be tilted from 0.1 to 2.0 degrees. The imaging device may also include an unclad optical fiber, with a GRIN lens following it between the optical fiber and the reflecting element. The first optical filler may be further located between the lens and the reflecting element. The imaging device may also include a second optical filler located between the optical fiber and the lens. The first and second optical fillers may comprise different materials, or may comprise the same composition but in different proportions, and wherein the refractive index of the first and second optical fillers is less than 1.50. The angular surface of the reflecting element may include a Fresnel diffraction pattern. The Fresnel diffraction pattern may include collimation or focusing capability varying along its major axis, minor axis, and between the major and minor axes. The imaging device may further include a lens located between the optical fiber and the reflective element. The lens may be a GRIN lens. The first optical filler may be located between the lens and the reflective element. The reflective element may further include a tapered distal end protruding from the lumen of the outer axis, wherein the tapered distal end is configured to penetrate tissue. The first optical filler comprises a UV-curable optical material. A collimating lens may be located between the optical fiber and the first optical filler. The collimating lens may be a GRIN lens, a plano-convex lens, a biconvex lens, or a Fresnel lens.

[0009] In another example, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; a beam collimating element between the optical fiber and a first optical filler, and the first optical filler being located between the distal end of the beam collimating element and the reflective element, the first optical filler having a refractive index less than 1.40. The return loss or reference signal at the interface between the beam collimating element and the first optical filler is between -15dB and -28dB, -20dB and -35dB, or -23dB and -40dB. The beam collimating element may be a Fresnel lens or a GRIN lens.

[0010] In another example, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; and a reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material, the reflective element has an angular surface configured for imaging a beam, a beam collimation section between the optical fiber and a first optical fiber filler, the beam collimation section comprising an unclad optical fiber and a GRIN lens, and a first optical filler between the GRIN lens and the reflective element, the first optical filler having a refractive index less than 1.40. The return loss or reference signal at the interface between the beam collimation element and the first optical filler can be between -15dB and -28dB, -20dB and -35dB, or -23dB and -40dB. The interface between the optical fiber and the unclad optical fiber, and the interface between the unclad optical fiber and the GRIN lens, can have reflection artifacts weaker than -40dB.

[0011] In another variant, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; a beam collimating section between the optical fiber and a first optical filler, the beam collimating section forming a GRIN lens; and a first optical filler between the distal end of the GRIN lens and the reflective element, the first optical filler having a refractive index less than 1.40. The return loss or reference signal at the interface between the beam collimating element and the first optical filler can be between -15dB and -28dB, -20dB and -35dB, or -23dB and -40dB.

[0012] In yet another variation, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflecting element disposed within the cavity of the outer shaft, wherein the reflecting element includes a diffraction pattern on a flat surface of an optical material, the reflecting element having an angular surface configured as an imaging beam; and a first optical filler between the optical fiber and the reflecting element, the first optical filler having a refractive index of less than 1.40. The imaging device may further include: a lens located between the optical fiber and the reflecting element. The lens may be a Fresnel lens, a plano-convex lens, or a biconvex lens. The lens may be tilted from 0.1 to 2.0 degrees. The lens may be a GRIN lens. The lens may include an unclad optical fiber following a GRIN lens.

[0013] In another embodiment, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflecting element disposed within the cavity of the outer shaft, wherein the reflecting element includes a diffraction pattern on a flat surface and has an angular surface configured for imaging a beam, the diffraction pattern having varying collimation and focusing capabilities between its major and minor axes; and a first optical filler between the optical fiber and the reflecting element, the first optical filler having a refractive index less than 1.40. The imaging device may further include: a lens located between the optical fiber and the reflecting element. The lens may be a Fresnel lens, a plano-convex lens, or a biconvex lens. The lens may be tilted from 0.1 to 2.0 degrees. The lens may also be a GRIN lens, or include an unclad optical fiber followed by a GRIN lens.

[0014] In another example, an imaging device is provided, comprising: an optical fiber; a reflective element having an angular surface configured for imaging a beam; a beam-collimating GRIN lens having a unit length of at least 0.75 pitch or more; and a first optical filler between the distal surface of the GRIN lens and the reflective element, the first optical filler having a refractive index less than 1.40. The interface between the optical fiber and the GRIN lens produces reflection artifacts stronger or weaker than -40 dB.

[0015] In another embodiment, an imaging device is provided, comprising: an optical fiber; a reflective element having an angular surface configured as an imaging beam; a beam collimating GRIN lens having a unit length of at least 0.75 spacing or greater, having a reflection artifact stronger than -40 dB at the interface between the optical fiber and the GRIN lens; and a first optical filler between the distal surface of the GRIN lens and the reflective element, the first optical filler having a refractive index of less than 1.40.

[0016] In another embodiment, an imaging device is provided, comprising: an outer shaft having a cavity; an optical fiber located within the cavity of the outer shaft; a reflective element disposed within the cavity of the outer shaft, wherein the reflective element includes a diffraction pattern on a flat surface and has an angular surface configured for imaging a beam, the diffraction pattern having varying collimation and focusing capabilities between its major and minor axes; a beam collimating element between the optical fiber and a first optical filler, and the first optical filler being located between the distal end of the beam collimating element and the reflective element, the first optical filler having a refractive index of less than 1.40. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of an imaging and intervention system according to some embodiments of the present disclosure.

[0018] Figure 2 This is a cross-sectional view of the distal end of an imaging penetration device according to some embodiments of the present disclosure.

[0019] Figure 3 This is a cross-sectional view of the distal end of another embodiment of an exemplary imaging penetration device.

[0020] Figure 4 This is a cross-sectional view of the distal end of another embodiment of the imaging penetration device.

[0021] Figure 5A and Figure 5B This is a schematic diagram of an exemplary imaging penetration device with an angled tip.

[0022] Figure 6A and Figure 6B This is a schematic cross-sectional and perspective view of another exemplary imaging penetration device.

[0023] Figures 7A to 7E They are Figure 6A and Figure 6B Side perspective view, side perspective view, rear perspective view, front perspective view, and top perspective view of the optical elements in the image.

[0024] Figure 8A and Figure 8B It is in the retracted position. Figure 6A and Figure 6B Schematic perspective and side view of the imaging penetration device in the image; Figure 8C and Figure 8D These are schematic perspective and side views of the image penetrating the device in its extended position.

[0025] Figure 9 This is a schematic longitudinal cross-sectional view of another exemplary embodiment of the imaging penetration device.

[0026] Figure 10 This is a schematic longitudinal cross-sectional view of another exemplary embodiment of the imaging penetration device.

[0027] Figure 11 This is a schematic longitudinal cross-sectional view of another exemplary embodiment of the imaging penetration device.

[0028] Figure 12A An exemplary guiding catheter configured for use with an imaging penetration device is depicted. Figure 12B yes Figure 12A A schematic diagram of the proximal hub and proximal shaft of the guiding catheter.

[0029] Figure 13 and Figure 14 Different variations of the marking strip that can be provided on the guiding catheter are illustrated schematically.

[0030] Figure 15 and Figure 16 This is a schematic side view of the different guide catheter tips that can be used.

[0031] Figure 17A and Figure 17B yes Figure 15 High view and perspective view of the proximal end of the guiding catheter tip.

[0032] Figures 18A to 18C These are OCT images that depict various types of artifacts that may be caused by refractive index mismatch between the imaging system and the surrounding body fluids and tissues.

[0033] Figures 19A to 19C This is a schematic cross-sectional view of a side-view OCT imaging system, depicting back reflections from different optical filler configurations. Figure 19D and Figure 19E This is a schematic cross-sectional view of a side-view OCT imaging system with an optical filler configuration that reduces back reflection.

[0034] Figures 20A to 20C It is an OCT image with reduced artifacts caused by low-refractive-index optical filler materials in the imaging system.

[0035] Figure 21A and Figure 21B These are schematic cross-sectional views of OCT imaging systems with and without an outer axis, respectively, featuring low-refractive-index optical fillers.

[0036] Figure 22A and Figure 22B These are schematic depictions of variations in OCT imaging components, including GRIN lenses, with and without unclad fiber segments. Figure 22C and Figure 22D An OCT imaging assembly with a GRIN lens configured to produce a collimated beam is schematically depicted. Figure 22E and Figure 22F An OCT imaging assembly with a GRIN lens configured to generate a focused beam is schematically depicted.

[0037] Figure 23A and Figure 23B This is a schematic depiction of other variations of the OCT imaging system with GRIN lenses.

[0038] Figure 24 It is a schematic depiction of variations in OCT imaging systems, including spherical or aspherical lenses with collimating light.

[0039] Figure 25 It is a schematic depiction of variations in OCT imaging systems, including spherical or aspherical lenses with collimated or decollimated light.

[0040] Figure 26A and Figure 26C An embodiment of an exemplary OCT imaging system with a Fresnel lens is schematically depicted; Figure 26B yes Figure 26A A perspective view of the Fresnel lens component in the image.

[0041] Figure 27A This is a schematic depiction of a Fresnel reflector in an exemplary OCT imaging system. Figures 27B to 27E It shows Figure 27A Various beam profiles of the OCT imaging system at various focal lengths and their corresponding equivalent radii of curvature. Figure 27F This is the superior perspective view of a Fresnel reflector.

[0042] Figure 28A This is an exemplary depiction of an exemplary OCT imaging system with a GRIN lens and a Fresnel reflector. Figure 28B and Figure 28C They are Figure 28A Schematic side and end views of the beam profile of an OCT imaging system. Figure 28D Depicting Figure 28A The beam profile of the OCT imaging system.

[0043] Figure 29A and Figure 29B The mechanical coupling between the optical fiber and the GRIN lens is schematically depicted. Detailed Implementation

[0044] The following description of certain embodiments is merely exemplary and is in no way intended to limit the scope of this disclosure or its application or use. In the following detailed description of embodiments of the systems and methods, reference is made to the accompanying drawings, which form a part of the present invention, and to the drawings illustrating specific embodiments in which the described systems and methods may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the systems and methods disclosed herein, and it will be understood that other embodiments may be utilized and structural and logical changes may be made without departing from the spirit and scope of this disclosure. Moreover, for clarity, detailed descriptions of certain features will not be discussed where they are obvious to those skilled in the art, so as not to obscure the description of embodiments of this disclosure. Therefore, the following detailed description should not be construed in a limiting sense, and the scope of this disclosure is defined only by the appended claims.

[0045] Minimally invasive medical interventions can involve inserting a catheter through the lumen of one or more of a patient's blood vessels. For example, during atherosclerosis resection, a catheter or guidewire may be advanced through the patient's blood vessels, and one or more interventional instruments may be inserted over the working lumen of the catheter or the guidewire to remove (or otherwise reduce its volume) atherosclerotic plaques. In some variations, the progress of catheter advancement through the patient may be monitored, for example, to reduce the risk of puncturing or cutting the vessel wall, and / or to monitor the progress of plaque or clot removal.

[0046] Imaging devices include optical components or elements that allow imaging of the wall of a blood vessel in which the imaging device is positioned. Typically, the imaging device can be coupled to an optical system that can guide light along the imaging device (e.g., along one or more optical fibers of the imaging device). A reflective surface can be located in a distal region of the imaging device and can redirect light to illuminate the lumen and wall of the blood vessel. The reflective surface can also redirect light received from the lumen and wall of the blood vessel back to the optical system along the imaging device. For example, the imaging device can be an interferometric imaging device that performs optical coherence tomography (OCT) by scanning light along the vessel wall, generating an interference pattern by combining light reflected (or scattered) from the vessel wall with light reflected from a reference surface, and imaging the vessel wall based on this interference pattern. The imaging device can also be configured to have an angular or conical geometry to facilitate penetration of obstructed vascular systems. This interventional feature and the reflective surface can be integrated together. Reducing the size and volume of the imaging device to increase its ability to penetrate relatively narrow or obstructed blood vessels can be useful. This can be achieved, for example, using optical structures that include a reflective surface and an angular or conical surface for penetrating the obstruction.

[0047] This disclosure relates to an interferometric imaging apparatus, an imaging and intervention system, and a method of operation thereof having a single element for intervention and imaging. The interferometric imaging apparatus includes an optical component at a distal end of the imaging apparatus. The optical component includes an imaging feature and a penetrating element. For example, the imaging feature may be a reflective surface of the optical component angled relative to the long axis of the imaging apparatus to redirect light between the long axis of the imaging apparatus and a side surface of the imaging apparatus. The optical component may also include a geometry that can be an angled, tapered, diced, or sharp surface to facilitate penetration or guidance through plaque, blockage, or clot as the imaging apparatus passes along a blood vessel. The mechanical geometry may also be configured with tissue contact surfaces to penetrate, cut, or abrade plaque. The tissue contact surface of the optical component may adjustably extend from an end or portion of the imaging apparatus. In some embodiments, the tissue contact surface forming a tapered distal end and the reflective surface forming a reflective surface may be the same surface of the optical component.

[0048] For example, the distal tip component can be a monolithic, optically transparent component or structure, wherein the optical feature is an angularly oriented internal reflective surface in the distal geometry of the structure. The structure may also include a tapered geometry to facilitate selective penetration and advancement through the occluded portion of the vascular system, and wherein the distal geometry region of the structure includes an angularly oriented external surface corresponding to the angularly oriented internal reflective surface. Corresponding internal and external points, surfaces, or regions on the structure can be opposing internal and external geometries, parallel internal and external geometries, and / or directly orthogonal or perpendicular internal and external points, surfaces, or regions. The distal geometry region and / or other surfaces of the structure may include a coating to enhance the reflectivity or other optical properties of the structure.

[0049] Figure 1 This is a schematic diagram of an imaging and interventional system according to some embodiments of the present disclosure. Imaging system 100 includes a guidewire, catheter, or imaging device 102, all or part of which can be inserted into a patient. The distal tip 104 of imaging device 102 can be used for imaging the patient's tissues and / or for one or more interventions in the patient. The proximal end of imaging device 102 is coupled to control unit 110, which can be used to perform imaging and / or interventions via imaging device 102. Optionally, computing device 130 can be coupled to control unit 110 to operate or interface with control unit 110, feed imaging data from optical units and human-machine interface devices / positioning units back to control unit 110, and / or record / store / interpret / enhance data (e.g., imaging data) generated by control unit 110. Control unit 110 may optionally include a graphics processing unit to use neural networks to enhance data received from optical units and human-machine interface devices / positioning units to improve physician visualization and image guidance via display 136.

[0050] Figure 1 The illustration depicts a schematic unfolded view of the distal tip 104 of the imaging device 102. The imaging device 102 includes an outer axis 108 and an internal component 105 including an optical element 106. The optical element 106 may include a reflective surface for imaging tissue 107 surrounding the distal tip 104 of the imaging device 102, and also includes a tapered distal end for performing one or more interventions. For example, the optical element 106 may include a penetrating element for penetrating a narrowing or blockage in a blood vessel, such as a complete or partial blockage 109. The tissue 107 may be the wall of the blood vessel where the distal tip 104 is located. For example, the tissue 107 may be the wall of a coronary artery.

[0051] The control unit 110 includes a position unit 120 and an optical unit 112. Although in Figure 1 The example is shown as a single control unit 110; however, it should be understood that in some embodiments, the human-machine interface device / position unit 120 and the optical unit 110 may be separate components of the system 100. The human-machine interface device / position unit 120 may be used to control and / or track the position of the imaging device 102 and / or one or more components of the imaging device 102 relative to the imaging device 102. The optical unit 110 may image the tissue 107 surrounding the distal tip 104 using light provided and received via the imaging device.

[0052] Optical unit 112 can be used to perform optical coherence tomography (OCT). Optical unit 112 includes a light source 116 that provides transmitted light Tx. Light source 116 can be a laser, a light-emitting diode (LED), an arc lamp, an incandescent light source, a fluorescent source, other light sources, or combinations thereof. Transmitted light Tx can have a relatively narrow bandwidth centered at a specific frequency and can be a broadband source (e.g., white light) or a combination thereof. In some embodiments, light source 116 can be a swept-frequency laser, and the center frequency of transmitted light Tx can vary over time. In some embodiments, the center frequency of the transmitted light can be selected to penetrate tissue. For example, the center frequency can be in the near-infrared (NIR) window, where the tissue has relatively low extinction (e.g., between approximately 800 nm and 1400 nm).

[0053] Optical unit 112 includes an interferometer 114 that receives transmitted light Tx and provides it along imaging device 102. For example, interferometer 114 may couple the transmitted light into an optical fiber extending along the length of imaging device 102. The interferometer may also receive light from imaging device 102 (e.g., light received along the optical fiber) and provide the received light to detector 118. The received light may include a portion of the received light Rx interacting with tissue 107 and a portion of the local oscillator LO of light reflected from a reference surface. Interferometer 114 may include a Faraday isolation device, such as a Faraday effect optical circulator, which may separate the optical paths of the returned received light Rx and local oscillator LO from the transmitted light Tx. The separated Rx and LO light may then be directed to detector 118. In some embodiments, optical unit 112 may include additional components (e.g., lenses, filters, etc.) that may improve the performance of optical unit 112 and / or add additional functionality.

[0054] In some embodiments, system 100 may be a common-path OCT system, and the reference surface may be the end of an optical fiber in component 104, wherein Fresnel reflection causes a portion of the transmitted light Tx to be reflected away from the end of the optical fiber, while another portion of the transmitted light exits from the optical fiber to interact with optical component 104 (and from there organization 107). In other embodiments, system 100 may include a reference arm serving as a reference surface, which is separate from the optical fiber in component 104.

[0055] The transmitted light Tx can interact with tissue 107, and a portion of the light can be redirected along the optical path (e.g., scattering, reflection, or a combination thereof), causing the redirected light to re-enter conduit 102 and return to optical unit 112 as received light Rx. Received light Rx can travel a longer distance than the LO light, and therefore frequency, phase, and / or time differences may exist between Rx and LO light. These differences can be used by detector 118 (and / or computing device 130) to determine the characteristics of tissue 107. For example, received light Rx and local oscillator LO light can interfere with each other to generate an interference pattern at detector 118. The interference pattern can be interpreted (e.g., by computing device 130) to extract information about the difference between the distance traveled by received light Rx and the distance traveled by LO light. In the case of a swept-frequency light source OCT, this difference can be encoded as a beat frequency heterodyne on the carrier reference beam.

[0056] Detector 118 can convert light incident on it (e.g., received light Rx and LO light) into electrical signals. For example, detector 118 can be an array detector (e.g., CCD or CMOS) that provides signals based on the amount and / or color of light incident on each pixel of the array.

[0057] The outer shaft 108 may be a long, flexible tube configured to allow components such as guidewires, imaging elements, drive shafts, sensor lines or optical fibers, imaging lines or optical fibers, fiber optic cables, protective sleeves, or combinations thereof to extend or pass through the imaging device lumen of the imaging device 102. The human-machine interface device / positioning unit 120 may track and control the position of the outer shaft 108 and the internal member 105 relative to the outer shaft 108. For example, the positioning unit 120 may extend / retract the internal member 105 relative to the outer shaft 108 and / or rotate the internal member 105 relative to the outer shaft 108.

[0058] The human-machine interface device / position unit 120 may include multiple electromechanical devices or sensors that convert translational or angular / rotational motions of the imaging device 102, internal components 105, or combinations thereof into digital signals or data. For example, the position unit 120 may include one or more linear encoders 122, rotary encoders 124, or combinations thereof. Human control and sensory feedback from the human-machine interface device / position unit 120 can be used to enhance image visualization by using and integrating with neural networks to provide improved guidance to physicians during surgery.

[0059] One or more linear encoders 122 may be optical linear encoders, mechanical linear encoders, magnetic linear encoders, inductive linear encoders, capacitive linear encoders, or combinations thereof. Linear encoders 122 may be absolute encoders, incremental encoders, or combinations thereof. One or more linear encoders 122 may track or encode longitudinal movement / translation or displacement of the imaging device 102 and / or internal components 105. For example, one or more linear encoders 122 may track or encode longitudinal movement / translation or displacement of the proximal segment of the internal component 105.

[0060] In these and other embodiments, the position unit 120 may also include one or more rotary encoders 124. The one or more rotary encoders 124 may be absolute rotary encoders, incremental rotary encoders, or combinations thereof. The one or more rotary encoders 124 may be optical rotary encoders, mechanical rotary encoders, magnetic rotary encoders, capacitive rotary encoders, or combinations thereof. The one or more rotary encoders 124 may track or encode the rotational or angular position of the imaging device 102 and / or internal components 105.

[0061] Positioning unit 120 may also include a motor and drive assembly 126. The motor and drive assembly 126 may be configured to translate the imaging device 102, internal member 105, or a combination thereof in a longitudinal direction (e.g., in a distal direction, a proximal direction, or a combination thereof). For example, the motor and drive assembly 126 may provide torque or rotation to the proximal segment of internal member 108 while the outer axis 108 remains fixed. This may rotate the optical component 106 and scan transmitted light Tx around the distal tip 104. Rotation of the internal member 108 relative to the outer axis 108 may also allow the tapered distal end of the optical component 106 to cut or otherwise “de-block” tissue to remove and / or penetrate obstructions or partial obstructions, such as partial obstruction 109.

[0062] While the imaging device 102 is typically described in terms of imaging and intervention (such as penetration), it should be understood that these operations may be only part of the functionality of the imaging device 102. For example, the internal components 105 and the external axis 108 may extend along one lumen of the imaging device 102, while other lumens are used for other tools or functions. For example, the imaging device 102 may also be used to deliver or otherwise introduce bodily fluids, pharmaceutical compositions including small molecules and biological agents, contrast agents, biomarkers, or combinations thereof into the distal tip 104, a target treatment site near the distal tip 104 (e.g., a target vascular site within a patient's body), or a combination thereof.

[0063] Control unit 110 may be coupled to computing device 130. In some embodiments, computing device 130 may be a component separate from control unit 110. In some embodiments, control unit 110 may be integrated with computing device 130. In some embodiments, control unit 110 may be configured as a handle or handheld unit. In other embodiments, control unit 110 may be configured as a control box or desktop unit. In some embodiments, computing device 130 may be a desktop computer, laptop computer, tablet device, or a combination thereof. Computing device 130 may include processor 132, such as a central processing unit (CPU), and memory 134. Processor 132 may have a 32-bit processor data bus or a 64-bit processor data bus. Processor 132 may be a dual-core, quad-core, or other multi-core processor. Processor 132 may operate at a speed of 3 GHz or higher. Memory 134 may include random access memory (RAM) and read-only memory (ROM). More specifically, memory cells may include dynamic RAM (DRAM), static RAM (SRAM), synchronous DRAM (SDRAM), dual data rate (DDR) SDRAM, dual data rate 2 (DDR2) SDRAM, or a combination thereof. Optional GPUs may include 8 GB or more of memory for implementing neural networks to analyze images in real time, thereby enhancing their visualization through machine or deep learning to produce more visually intuitive images, such as through warnings, markers, and augmented reality.

[0064] The computing device 130 can process and store images captured by the optical unit 112. The optical unit 112 and the computing device 130 can be combined with other devices to form part of an OCT imaging system. For example, the OCT imaging system can be a common-path OCT system, a time-domain OCT system, a spectral or frequency-domain OCT system, or a combination thereof. The computing device 130 can be coupled to the detector 118. The computing device 130 can receive signals, such as raw data, from the detector 118 and record a series of raw data over time in the memory 134. The processor 132 can perform one or more image processing steps to extract images from the raw data.

[0065] Processor 132 can work in conjunction with control unit 110 to image the wall of the blood vessel where the distal tip 104 is located. For example, positioning unit 120 can rotate internal member 105, which, in turn, can “scan” the field of view of the optical unit around the blood vessel wall as optical component 106 rotates. Raw data generated by detector 118 can be associated with a specific angular position of internal member 105 relative to outer axis 108 (e.g., as reported by rotary encoder 124). Processor 132 can use the angular information and raw data to reconstruct an angular view of the blood vessel wall that is larger than a single field of view of detector 118. In some embodiments, processor 132 can generate a 360-degree view of the blood vessel wall. In a similar manner, processor 132 can also work with positioning unit 120 to construct an image that extends along the longitudinal axis and is larger than a single field of view by moving internal member 105 in the proximal / distal direction during imaging.

[0066] In some embodiments, the images generated by processor 132 may be displayed by a user of system 100 (e.g., displayed on a screen). In some embodiments, processor 132 may generate the display images at a rate (e.g., video rate) that allows for “real-time” imaging of the vessel wall. In some embodiments, the use of the distal conus may be based on the generated images.

[0067] The computing device 130 can also be configured to perform image registration on images captured by the optical unit 112. For example, image registration may involve establishing correspondences between features in an image set and using one or more transformation models to infer correspondences of additional features that avoid such features. Imaging registration can also be referred to as image alignment. Image registration can also be performed to align or map images obtained from different imaging modalities (e.g., OCT using intravascular ultrasound (IVUS) or OCT using X-ray fluoroscopy).

[0068] Figure 2 This is a cross-sectional view of the distal end of an imaging penetration device according to some embodiments of the present disclosure. Imaging device 200 may represent the distal end of an imaging device that can be used as an imaging and interventional system (such as...). Figure 1 It is part of the imaging and interventional equipment 100.

[0069] Imaging device 200 includes an outer axis 220 and an internal element 210. The internal element 210 is rotatable relative to the outer axis 220 and can be used for imaging and intervention. The internal element 210 includes an optical element 202 comprising a tapered distal end 204 and a reflective surface 206. The reflective surface 206 can be configured to redirect light between one or more optical fibers 212 of the internal element 210 and an imaging target (e.g., field of view). Figure 2As shown in the example, the reflective surface 206 will receive light from the optical fiber 212 (e.g., Figure 1 The transmitted light (Tx) is redirected into an imaging beam 208, which extends beyond the periphery of the imaging device 200. The reflective surface 206 can also redirect the received light (e.g., Figure 1 The Rx) is redirected back into the fiber 212. The tapered distal end 204 may include one or more tissue contact surfaces (here, a tapered tissue contact surface) that may extend from the front surface of the outer shaft 220 up to a distance “d”.

[0070] The outer shaft 220 may be the external body of the imaging device 200. The outer shaft 220 may have an outer diameter of approximately 0.020 inches (0.508 mm) or less. In another embodiment, the outer shaft 220 may have an outer diameter of approximately 0.045 inches (1.143 mm) or less. The outer shaft 220 may be roughly the size of a guidewire. The outer shaft 220 may be fixed relative to the internal element 210 (e.g., fixed to a control or optical unit). Therefore, the outer shaft 220 may be a torque shaft that remains fixed as the internal element 210 rotates within the outer shaft 220.

[0071] The outer shaft 220 may have a body 222 and a cap 224. The cap 224 may be located at the distal end of the outer shaft 220. The cap 224 may allow light to pass from the outside of the outer shaft 220 to the lumen of the outer shaft 220 (e.g., may allow light to pass from the outside of the outer shaft 220 to the internal element 210). In some embodiments, the cap 224 may be a separate component attached to the end of the body 222. In some embodiments, the cap 224 may be integrated with the body 222, and the cap 224 may refer to the distal end of the body 222. The body 222 may be formed of a coil or a modified sodium hypotube. The body 222 and the cap 224 may be generally tubular components having a lumen in which the internal element 210 is disposed. In some embodiments, the body 222 and the cap 224 may have similar outer diameters and thicknesses. In some embodiments, the body 222 and the cap 224 may have different outer diameters and / or thicknesses from each other.

[0072] In some embodiments, the cap 224 may be made of an optically transparent material. For example, the cap 224 may be made of a different material than the body 222 of the outer shaft 220. In some embodiments, the cap 224 may include a window, such as a laser-cut window through the material of the cap 224. In some embodiments, the laser-cut window may include a cover made of an optically transparent material. In some embodiments, the window may be uncovered. In some embodiments, the body 222 of the outer shaft 220 may be made of an optically transparent material, and a separate cover 224 may not be necessary.

[0073] In some embodiments, the cap 224 may include a hard stop 226 that restricts movement of the inner member 210 relative to the outer body 220. The hard stop 226 may restrict longitudinal movement of the inner member 210 relative to the outer body 220 (e.g., movement along the long axis of the imaging device 200). For example, the inner diameter of the cap 224 at the hard stop 226 may be smaller than the outer diameter of the inner member 210. In some embodiments, the hard stop 226 may be a tapered portion of the cap 224 and / or a step on the inner wall of the cap 224.

[0074] The internal member 210 may be a generally cylindrical member disposed within a lumen of the outer shaft 222. The internal member 210 may have an outer diameter of about 0.010 inches (0.254 mm) or less. In another embodiment, the outer shaft 210 may have an outer diameter of about 0.018 inches (0.457 mm) or less. The internal member 210 may be movable relative to the fixed outer shaft 220. The internal member 210 may be extendable / retractable relative to the outer shaft 220 along the longitudinal axis of the imaging device 200 and may be rotatable relative to the outer shaft 220. For example, a motor / drive assembly (e.g., Figure 1 (126) can move the internal component 210 relative to the outer shaft 220.

[0075] Internal component 210 includes optical fiber 212. Optical fiber 212 can be coupled to an optical unit (e.g., at the proximal end of the imaging device 200) Figure 1 Optical fiber 212 transmits light between the optical fiber 212 and the distal end of imaging device 2101. Optical fiber 212 can be a single fiber or a multi-core fiber. Optical fiber 212 can be surrounded by cladding material 211, which can support optical fiber 212 and provide optical conditions (e.g., refractive index mismatch) enabling light transmission along optical fiber 212. Cladding material 211 can then be surrounded by fiber reinforcement 216. Fiber reinforcement 216 can support optical fiber 212 and cladding material 211. In some embodiments, fiber reinforcement 216 can be a coil or a modified hypotube. A portion of optical component 202 can extend beyond the distal end of fiber reinforcement.

[0076] The optical fiber 212 (and cladding material 211) may terminate at a reference surface 214. The reference surface 214 may be located at the distal end of the optical fiber. In some embodiments, the reference surface 214 may typically be a flat surface perpendicular to the long axis of the imaging device 200 (e.g., a slit in the optical fiber). The reference surface 214 may reflect a portion of the transmitted light along the optical fiber 212. The light reflected from the reference surface 214 may be a local oscillator (LO) portion of the light, which may be located in the optical unit (e.g., Figure 1 The optical unit 112) performs interference combination with the received light.

[0077] Internal component 210 includes optical component 202. Optical component 202 may be a single element including a reflective surface 206 and a tapered distal end 204. Optical component 202 may be a monolithic material having one or more surfaces shaped to form the reflective surface 206 and one or more surfaces shaped to form the tapered distal end 204. In an example embodiment of optical component 202, the reflective surface 206 and the tapered distal end 204 may be separate surfaces of optical component 202.

[0078] Optical component 202 may be a generally cylindrical element, a portion of which may be disposed within fiber reinforcement 216. Optical component 202 may be formed from a single material. For example, optical component 202 may be formed from alumina, zirconium oxide, silicon carbide, diamond, or a combination thereof. In some embodiments, optical component 202 may be a metal, such as SS304.

[0079] The distal tapered end 204 can be a tool for coronary intervention, such as a perforation tool. The distal tapered end 204 can be a tissue contact surface that extends a distance d from the distal tip of the outer axis 220 as the inner member 210 is extended to the hard stop member 226. In some embodiments, the distance d can be about 1 mm or less. The distal tapered end 204 can be formed along the distal end of the optical member 202. For example, the distal tapered end 204 can be a tapered surface extending to a point. In some embodiments, the point of the tissue contact surface can be along the long axis of the imaging device 200. In some embodiments, the point of the tapered surface can be offset from the long axis of the imaging device 200.

[0080] The reflective surface 206 of the optical component 202 may be a reflective surface that redirects light from an optical axis typically aligned with the long axis of the optical fiber and an optical axis pointing towards one side of the imaging device 200. For example, the reflective surface 206 may redirect light at approximately a right angle. The reflective surface 206 may be a sloping surface at the proximal end of the optical component 202. The angle of the optical element 206 relative to the long axis of the imaging device 200 may be selected based on the desired deflection of light reflected from the reflective surface 202. For example, in some embodiments, the reflective surface 206 may have an angle of approximately 45 degrees. In some embodiments, the reflective surface 206 may be coated with a reflective material. For example, the reflective surface of the reflective surface 206 (e.g., the proximal surface of the optical component 202) may be gold-plated.

[0081] As illustrated by the example rays of imaging beam 208, transmitted light passing through fiber 212 can diverge as it exits fiber 212 at reference surface 214. The diverging rays of imaging beam 208 can then be redirected by reflective surface 206 such that imaging beam 208 forms a diverging cone of transmitted light extending from one side of imaging device 200. Fiber reinforcement 216 may include a window (and / or be made of a transparent material) to allow imaging beam 208 to pass through internal member 210 (and thereafter through imaging device 200).

[0082] Therefore, when the internal member 210 rotates relative to the outer axis 220, the imaging beam 208 can sweep around the periphery of the imaging device 200. The internal member 210 can also be movable relative to the outer axis 220 along the longitudinal axis of the imaging device 200. The field of view represented by the imaging beam 208 can sweep around the imaging device 200 in a 360-degree arc and can be moved longitudinally along the imaging range L relative to the position of the imaging device. The imaging range can be defined by the furthest extension of the internal member 210 within the outer axis 220 (e.g., when the internal member 210 is adjacent to the hard stop 226) and the length of the transparent portion of the outer axis 220 (e.g., the transparent portion of the cap 224). In some embodiments, the imaging range L can be about 5-25 mm.

[0083] Imaging beam 208 can interact with the environment surrounding imaging device 200. For example, when imaging device 200 is in a blood vessel, the imaging beam can illuminate a portion of the vessel wall surrounding imaging device 200. As internal component 210 rotates, imaging beam 208 can sweep around to illuminate the annulus of the vessel wall. Light can return from the illuminated tissue to imaging device 200. For example, a portion of the illumination light can be scattered and / or reflected by one or more parts and structures of the tissue. Some illumination light can penetrate a distance into the tissue before returning to imaging device 200. A portion of the returned light can follow an optical path reflected from imaging tool 206 and coupled to optical fiber 212. The returned light coupled to the optical fiber can form receiving light (e.g., Figure 1 The receiving light (Rx).

[0084] Internal component 210 may include a filler material 218 between the distal end of optical fiber 212 (e.g., reference surface 214) and the proximal surface of optical component 202 (e.g., reflective surface 206). Since reference surface 214 and reflective surface 206 may be at different angles relative to the long axis of imaging device 200, a gap may exist between reference surface 216 and optical component 202. The filler material 218 may be an optically transparent material to allow imaging beam 208 (and receiving light) to propagate through the filler material 216. In some embodiments, the filler material 218 may have a refractive index selected to match the refractive index of optical fiber 212 to prevent light refraction at the fiber / filler interface. For example, the refractive index of the filler material may be about 1.55. In other examples, the refractive index of the filler material may be in the range of 1.40 to 1.80, 1.50 to 1.60, or 1.55 or 1.65. In some embodiments, the filler material 218 may be an adhesive and may help couple the optical component 202 to the optical fiber 212 and the cladding 211. In some embodiments, the filler material 218 may also fill a window in the optical fiber reinforcement 216.

[0085] Figure 3 This is a cross-sectional view of the distal end of an imaging penetration device according to some embodiments of the present disclosure. Imaging device 300 may represent the distal end of an imaging device that can be used as an imaging and interventional system (such as...). Figure 1 It is part of the imaging and interventional device 100. The imaging device 300 may include [equipment / devices / etc.]. Figure 2 The imaging device 200 shares many similar features. For brevity, regarding... Figure 3 The imaging device 300 will no longer repeat the features and operations previously described with respect to the imaging device 200.

[0086] Imaging device 300 includes an optical component 302 comprising a single distal surface 304 that acts as a reflective surface and a tapered distal end. The optical component 302 may be generally cylindrical with a generally trapezoidal longitudinal cross-section. The optical component 302 may be formed of an optically transparent material (e.g., sapphire), and light can propagate through a proximal surface 307 and enter the material of the optical component 302. The proximal surface 307 may be angled (relative to the major axis of imaging device 300) to minimize light reflection as light is transmitted from the filler material 318 into the material of the optical component 302.

[0087] The distal surface 304 of the optical component 302 extends a distance d from the distal tip of the outer axis 320. The distal surface 304 may be a generally flat surface at an angle relative to the major axis of the imaging device 300. The distal surface 304 may reach points beyond the distance d of the outer axis 320, which may act as a penetrating tool. Light from the optical fiber 312 may be reflected from the distal surface 304 within the optical component 302. In some embodiments, the distal surface 304 may be angled to establish a total internal reflection (TIR) ​​condition at the distal surface 302. In some embodiments, the distal surface 304 may be coated with a reflective material (e.g., gold). Thus, the optical component 302 has a single surface (e.g., the distal surface 304) that acts as a tapered distal and reflective surface.

[0088] Figure 4 This is a cross-sectional view of the distal end of an imaging penetration device according to some embodiments of the present disclosure. Imaging device 400 may represent the distal end of an imaging device that can be used as an imaging and interventional system (such as...). Figure 1 It is part of the imaging and interventional device 100. The imaging device 400 may include [equipment / devices / etc.]. Figure 2 Imaging equipment 200 and Figure 3 The imaging device 300 shares many similar features. For the sake of brevity, we will no longer discuss... Figure 4 The imaging device 400 repeats the previous information about Figure 3 The features and operation described in the imaging device 200 and / or imaging device 300.

[0089] Similar to Figure 3 The imaging device 400 includes an optical component 402, which includes a distal surface 404 that is tapered at the distal end and a reflective surface. The imaging device 400 also includes a lens 409 disposed between a reference surface 414 of the optical fiber 412 and a proximal surface 407 of the optical component 402. The lens 409 can shape an imaging beam 408. For example, the lens 409 can focus the imaging beam 408 such that the imaging beam 408 is focused at a focal point. The focal length of the lens 409 can be selected to focus the imaging beam 408 at or within a focal region of the blood vessel wall (e.g., based on a desired distance from the imaging device 400 to the blood vessel wall). In some embodiments, the lens 409 may be a gradient refractive index (GRIN) lens. In the imaging device 400, the reference surface 414 may be located at the distal end of the lens 409.

[0090] In this and other variations of the exemplary embodiments described herein, lens 409 may be, but is not limited to, a Fresnel lens, a spherical lens, an aspherical lens, or a deformable lens. Lenses may also be selected to focus light at a selected distance from the outer exit surface of the imaging beam, such as... Figure 22E and Figure 22FThe depicted lens, or alternatively, can be used to provide a collimated beam profile, such as Figure 22C and Figure 22D The depicted lens may be selected to produce different degrees of focusing capability, including collimation at different angular orientations across the beam. Lens 409 may also include a lens assembly having two or more lenses. Additional features of lenses in OCT imaging systems are provided later below.

[0091] Figure 5A and Figure 5B This is a schematic diagram of an exemplary imaging device having a curved or angular region according to some embodiments of the present disclosure. Figure 5A and Figure 5B Imaging devices 502 and 504 are depicted, each including a pre-shaped bend that can facilitate penetration via a tapered distal end. Imaging device 502 can be an imaging device such as... Figure 3 Imaging equipment 300 and Figure 4 Imaging device 400, wherein the optical components have a single surface that serves as both a conical distal end and a reflective surface. Imaging device 504 can be an imaging device, such as... Figure 2 An imaging device 200, wherein the optical components have a first surface that acts as a reflective surface and a second surface that acts as a conical distal end.

[0092] Figure 6A and Figure 6B This is a schematic diagram of another embodiment of the imaging penetration device 600, including a shaped or molded optical element 602. The molded optical element 602 may include one or more structures 604 and 606 configured to facilitate handling, manipulation, and / or alignment of the optical element 604 during manufacturing and / or use. The device 600 may also include an optical fiber 608 to transmit light between a near-end light source or optical receiver and the optical element 602. The optical fiber 608 may be a single-mode or multimode fiber. A lens 610 may be provided to optically couple the optical fiber 608 and the optical element 602. The lens 610 may be, for example, a gradient refractive index lens, fused to the distal end of the optical fiber 608 at its near end 612, and configured to collimate or focus light from the light source and the optical fiber 608 onto the reflective surface 614 of the optical element 602. The optical fiber 608, lens 610, and optical element 602 may be housed in a phreatic tube 616 of the device 600. The device 600 may be used in conjunction with a conduit 618. Figure 6A and Figure 6BIn the specific example depicted, the thiopanle 616 has an outer diameter of 0.010”, 0.017”, or 0.022”, but in other examples, the outer diameter of the thiopanle ranges from 0.009” to 0.022” or 0.012” to 0.020”. The conduit 618 may have an inner diameter ranging from 0.010” to 0.013”, 0.018” to 0.020”, or 0.020” to 0.024”, or the diameter of the thiopanle 616 otherwise configured with the receiving device 600. The outer diameter of the conduit 618 may range from 0.016” to 0.020”, or 0.016” to 0.017” or 0.018” to 0.045”. The inner and / or outer surfaces of the thiopanle 616 and the conduit 618 may include a lubricating coating to facilitate rotational or longitudinal movement of the device 600 or the conduit 618.

[0093] Still referencing Figure 6A and Figure 6B Optical element 602 includes a first protruding flange or structure 604 and a second protruding flange or structure 606. The protruding structures 604 and 606 can be used to grip and manipulate optical element 602 while reducing the risk of damaging the optical properties of optical element 604, and / or can be used to facilitate alignment. In this particular example, structure 604 includes a smaller cross-sectional shape than structure 606, having a smaller lateral width and / or longitudinal length than the other structure 606. In some examples, however, structures 604 and 606 may be located at and adjacent to the proximal end 620 of optical element 602. These structures 604 and 606 may be sized and shaped to facilitate insertion and alignment of optical element 602 with the submersible tube 616. Reference Figures 8A to 8D The hysteresis tube 616 includes: an inner cavity 622 for receiving an optical fiber 608 and an optical element 602; and a proximal opening (not shown) and a distal opening 623 through which the optical element 602 can partially protrude. The hysteresis tube 616 also includes an insertion opening 626 through which the optical element 602 can be inserted into the inner cavity 622. The insertion opening 626 may be configured to be long enough to receive the optical element 602 such that the distal end of the optical element 602 can protrude from the distal opening 624 of the hysteresis tube 616, and that structure 604 is located in an alignment recess opening 628 opposite to the insertion opening 626. The alignment opening 628 and the protruding structure 604 may be configured to receive the protruding structure 602 or to form a complementary engagement between the opening 628 and the structure 604. When the optical element 602 is fully located in the hysteresis tube 616, the distal surface 630 of the protruding structure 606 may abut against the distal surface 632 of the insertion opening 626. The protruding structures 604 and 606 may also include cylindrical circular side surfaces 634 and 636, which can be aligned with the outer diameter of the hysteresis tube 616 when the optical element 602 is fully fixed. Figure 6A As depicted, lens 610 can be pushed distally to abut and couple to the proximal surface of optical element 602.

[0094] Now for reference Figures 7A to 7E The optical element 602 may include an inner core 700 and an outer molded housing 702. The material for the inner core 700 may be a high-refractive-index polymer, such as, but not limited to, polyurethane, polyvinylpyrrolidone, polystyrene, polycarbonate, amorphous polyolefin, or NAS-21, and the material for the outer molded housing 702 may be the same as the material of the inner core 700 or the optical polymer (such as, but not limited to, polymethyl methacrylate (PMMA), photosensitive resin, or cellulose). The refractive index of the inner core 700 may be about 1.55, but in other examples, the refractive index may be in the range of 1.40 to 1.80, or 1.50 to 1.60, or 1.55 to 1.65. The length of the optical element may be about 500 micrometers, but in other examples, it may be in the range of 400 to 800 micrometers, or 500 to 600 micrometers, or 450 to 550 micrometers. Optical element 602 includes a cylindrical body 706 with a diameter of approximately 150 micrometers, but in other embodiments, it can range from 140 to 200 micrometers or from 140 to 160 micrometers. The distal end of the cylindrical body 706 may include a reflective surface 708 oriented at 45 degrees relative to the longitudinal optical axis 710 of the optical element 602. The cylindrical body 706 may also include a side interface surface 712 from which light reflected from the reflective surface 708 exits the optical element 602 and from which light reflected back from surrounding tissue structures is received. The side interface surface 712 may be formed or oriented at an angle of 5 to 8 degrees from the outer radial direction of the cylindrical body 706, and its maximum width can be approximately 60 micrometers and its length 135 micrometers. In other examples, the width can range from 40 to 80 micrometers, and the length can range from 100 to 180 micrometers. Figure 7E The depicted side interface surface 712 includes a planar configuration with a parabolic shape, having a vertex 714 adjacent to the distal edge 716 located at the proximal end of the optical element 602. The side interface surface 712 and the reflective surface 708 may share a common edge 720, as... Figure 7D As shown.

[0095] The inner core 702 may comprise a generally cylindrical shape having an orthogonal proximal surface 722 and an angular distal surface 724 aligned with the reflective surface 708. In other examples, however, the core may comprise a distally flat surface. The diameter of the inner core 702 may range from 100 micrometers to 150 micrometers or from 110 micrometers to 130 micrometers. In some variations, the inner core 702 may have a variable diameter or lateral shape. Figure 7C and Figure 7D For example, the inner core 702 may have a diameter of about 110 micrometers at its proximal end and about 125 micrometers at its distal end.

[0096] Protruding structures 604 and 606 are located on opposite sides of the cylindrical body 706. Structures 604 and 606 may protrude from the surface of the cylinder 706 by the same or different distances. In some variations, the total protrusion distance may be approximately 100 micrometers, or in the range of 90 to 120 micrometers. Individually, the protrusion distance of each structure 604 and 606 may be in the range of 40 to 60 micrometers or approximately 50 to 55 micrometers.

[0097] like Figure 6A As depicted, light traveling through optical fiber 608 is collimated or focused by lens 610 onto the reflective surface 708 of optical element 602. Reflective surface 708 is an inner surface of the optical element, opposite or complementary to the outer surface 726 of the tapered or angled distal end 728. In some variations, the outer surface 726 may also include a reflective material, such as a gold or other metallic coating, to promote reflection. To promote coating adhesion, the surface may be mechanically or chemically treated to roughen it and enhance adhesion.

[0098] However, in other examples, the reflective surface of the optical element may include an external reflective surface. Figure 9 Another example of an imaging penetration device 900 is depicted, including an optical element 902 and a reflective surface 906. The optical element 902 has a cylindrical body 904 with a length ranging from 500 micrometers to 1000 micrometers. The reflective surface 906 is located at the proximal end of the optical element 904 and spaced apart from the tapered or angled penetrating distal end 908 of the optical element 900. In this embodiment, the device 900 also includes a hysteresis tube 908, an optical fiber 910, and a lens 912, but wherein the hysteresis tube 918 includes an imaging cavity 914 filled with an optically transparent polymer or adhesive 916. The lens 912 is configured to collimate or focus light from the optical fiber 910 onto surrounding tissue at different focal lengths, because... Figure 6A and Figure 6B Compared to the more distant reflective surfaces in device 600, the reflective surface 906 in device 900 is located closer together. The reflective surface 906 may also be treated and / or coated with a reflective material as described for the reflective surface 708 of device 600. In embodiments including an outer reflective surface, the material of the optical element does not need to be optically transparent and may include metals such as steel, and may include polished reflective surfaces, or materials such as ceramics or glass, including sapphire or sapphire optical fibers.

[0099] Many optical adhesives or curable materials that can be used as optically transparent polymers, adhesives, or fillers have a refractive index greater than 1.5, but this results in a significant refractive index mismatch with saline, blood, and / or plasma, whose refractive indices can range from 1.33 to 1.38. This leads to visible artifacts, including ghosting images, light streaks, and / or rings. For example, Figure 18A An OCT image was depicted, which has annular artifact 1802 from interface mismatch and light stripe artifact 1804 caused by strong refractive index mismatch that saturates the detector. Figure 18B This is another exemplary OCT image with ring artifact 1812 and light stripe 1814. Figure 18C This is another exemplary OCT image with ring artifact 1816 and ghost image 1818. To potentially improve these artifacts, the profile of the filler material can be modified from a cylindrical shape to a concave or convex shape along the length of the filler material during manufacturing to reflect refractive index mismatch signals from the detector. Figure 19A The back reflection 1902 is depicted from the mismatched filler / fluid interface 1904 between the optical filler 1806 and the surrounding body fluid / tissue 1906, while Figure 19B and Figure 19C The concave interface 1914 and the convex interface 1924, centered on the transverse optical axis, are depicted respectively. Figure 19D and Figure 19E The concave interface 1934 and the convex interface 1944 are depicted, which are close to or off the transverse optical axis, and reduce back reflections 1932 and 1942.

[0100] In some variations, optically transparent polymers, adhesives, or filler materials with a refractive index less than or equal to 1.5 can be selected. For example, aliphatic polyurethane acrylates with acrylic monomers can be used, for instance, with a refractive index in the range of 1.30 to 1.40. Such materials can improve manufacturing tolerances, process repeatability, and manufacturability because they are less sensitive to reflection variations caused by meniscus concave / convex shapes and interfaces with high refractive index mismatches, thereby minimizing or eliminating undesirable detector saturation and ghosting images.

[0101] In some variations, the filler material can be a UV-curable optical adhesive comprising a mixture of aliphatic polyurethane acrylate and acrylic monomers. Examples include Norland Optical Adhesives 133 and 13775 (Norland products, Cranbury, NJ). NOA 133 has a refractive index of 1.33 and a pre-cured viscosity of 15 cps, and comprises a mixture of 1-15% aliphatic polyurethane acrylate and 85-99% acrylic monomers, while NOA 13775 has a refractive index of 1.3775 and a pre-cured viscosity of 4000 cps, and comprises a mixture of 80-99% aliphatic polyurethane acrylate and 1-20% acrylic monomers. In some variations, the choice of filler material can be based on the desired refractive index and manufacturing properties such as viscosity. For example, a viscosity of 15 cps may be too thin to be easily manufactured, while 4000 cps may be too thick or too viscous to be controlled in a small volume. In some variations, for example, the viscosity of the filler material can range from 1000 to 3000 cps, 1500 to 3000 cps, or 2000 to 2500 cps. While aliphatic polyurethane acrylates and acrylic monomers are used, other polymeric materials with a refractive index in the range of 1.30 to 1.40, a pre-cured viscosity between 1000 and 3000 cps, and a post-cured Shore D hardness higher than 30 may also be suitable. Another example of a low-refractive-index polymeric material or filler is a combination of hexafluoroacetone and 3-aminopropyltriethoxysilane.

[0102] While the viscosity of the filler material can be further selected or modified, for example, by choosing materials with different relative amounts of aliphatic polyurethane acrylate and acrylic monomer, the optical properties may or may not exhibit a linear relationship based on the relative percentages or proportions of the components. For example, a mixture comprising 50% by volume NOA 133 and 50% by volume NOA 13775 (40% to 57% aliphatic polyurethane acrylate and 43% to 60% acrylic monomer) has a refractive index of 1.274 at 1310 nm, while a mixture comprising 40% by volume NOA 133 and 60% by volume NOA 13775 (48% to 65% aliphatic polyurethane acrylate and 35% to 52% acrylic monomer) has a refractive index of 1.345 at 1310 nm. In other variants, the percentage of aliphatic polyurethane acrylate ranges from 30% to 70% and the percentage of acrylic monomer ranges from 70% to 30%, while in yet other variants, the percentage of aliphatic polyurethane acrylate ranges from 40% to 50% and the percentage of acrylic monomer ranges from 60% to 50%.

[0103] Two or more mixtures of optical adhesives with different refractive indices can be combined before curing to achieve a desired refractive index or optical refractive index. For example, a mixture comprising 50% by volume NOA 133 and 50% by volume NOA 13775 (40% to 57% aliphatic polyurethane acrylate and 43% to 60% acrylic monomer) has a refractive index of 1.274 at 1310 nm, while a mixture comprising 40% by volume NOA 133 and 60% by volume NOA 13775 (48% to 65% aliphatic polyurethane acrylate and 35% to 52% acrylic monomer) has a refractive index of 1.345 at 1310 nm. The mixing ratio to achieve the desired refractive index can be linear or proportional, or it can be non-linear or proportional. The pre-cured refractive index and the post-cured refractive index can be different or the same. A cured refractive index of 1.33 to 1.35 can match the refractive index of water, salt water and fluids, while a cured refractive index of 1.37 to 1.40 can match the refractive index of soft tissue.

[0104] Figures 20A to 20C Various OCT images from an imaging system using a UV-cured filler material comprising a mixture of 40% NOA 133 and 60% 13775 are depicted. As depicted, with... Figures 18A to 18C Compared to the signal intensity in [previous data], the signal intensity of the ring artifacts originating from the filler / fluid interface in 2002, 2006, 2010, and 2012 was significantly reduced. Besides reducing the occurrence of ghosting images, this further reduced [the occurrence of other artifacts]. Figure 18A and Figure 18B The detector saturation and corresponding light stripes were found in the image.

[0105] The low-refractive-index filler materials described herein can be used with any of a variety of OCT imaging devices and systems, whether in an aqueous or biological environment, and are not limited to the various exemplary OCT imaging embodiments described herein. For example, the low-refractive-index filler materials described herein can be used in OCT imaging probes that may or may not include the cut tips or distal tapered ends or edges of 204, 304, 404, 716, or 1004 described herein.

[0106] Figure 21AThis is a cross-sectional view of an exemplary distal end of an OCT imaging device 2100 having a low-refractive-index filler material 2118, located between the distal end of an optical fiber 2114 and the reflective surface 2106 of a tip structure 2102. The imaging device 2100 may include an internal core 2110 located within a lumen 2115 of an outer tubular axis 2120. The internal core 2110 may be configured to rotate relative to the outer axis 2120 and includes an optical fiber 2112 that transmits light from a light source and receives optical signals returned from a target structure. Light from the light source travels distally through the optical fiber 2112 and exits from the end 2114 of the optical fiber 2112, passing through the optical filler 2118 before being reflected from the reflective surface 2106 of the tip structure 2102 to redirect the imaging beam 2108 to the target structure.

[0107] The outer diameter of the outer shaft 2120 may be about 0.020 inches or less, 0.045 inches or less, or may include a diameter determined according to common guidewire dimensions, including 0.014 inches, 0.018 inches, and 0.35 inches. The outer shaft 2120 may include a one-piece design, or may include a body 2122 and a cap 2124 joined during the manufacturing process. The body 2122 may be formed from a coil or a hypotube. The body 2122 and the cap 2124 may have similar or different outer diameters and wall thicknesses. As with other variations described herein, the cap 2124 may include different materials, such as optically transparent materials, to facilitate light transmission through the cap 2124. In some embodiments, the cap 2124 may include a window, such as a laser-cut window through the material of the cap 2124. In some embodiments, the laser-cut window may include a cover made of an optically transparent material. In some embodiments, the window may be uncovered. In some embodiments, the body 2122 of the outer shaft 2120 may be made of an optically transparent material, and a separate cap 2124 may not be necessary.

[0108] The internal core 2110 may be a generally cylindrical member disposed within a cavity 2115 of the outer shaft 2120. The outer diameter of the internal core 2110 may be approximately 0.010 inches (0.254 mm) or less. The internal core 2110 may be extendable / retractable relative to the outer shaft 2120 along the longitudinal axis of the imaging device 2100, and may be rotatable relative to the outer shaft 2120. For example, a motor / drive assembly (e.g., Figure 1 (126) The inner core 2110 can be moved relative to the outer axis 2120. This can facilitate the movement of the imaging region without requiring the movement of the outer axis 2120.

[0109] Fiber 2112 is configured as an optical unit (e.g., at the proximal end of the imaging device 2100) coupled to the imaging device 2100. Figure 1The optical fiber 2112 transmits light between the distal end of the imaging device 2101 and the optical fiber 2112. The optical fiber 2112 can be a single fiber or a multi-core fiber. The optical fiber 2112 can be surrounded by a cladding material 2111, which can support the optical fiber 2112 and provide optical conditions (e.g., refractive index mismatch) that facilitate light transmission along the optical fiber 2112. The cladding material 2111 can then be surrounded by an optical fiber reinforcement 2116. The optical fiber reinforcement 2116 can support the optical fiber 2112 and the cladding material 2111. In some embodiments, the optical fiber reinforcement 2116 can be a coil or a modified hypotube.

[0110] The end 2114 of the optical fiber 2114 (and the cladding material 2111) can be a flat surface perpendicular to the long axis of the imaging device 2100 (e.g., a cut in the optical fiber), but in other variations, it may include a non-orthogonally oriented surface. Some light traveling distally through the optical fiber 2112 can be reflected back at the end 2114 of the optical fiber 2112 to serve as a local oscillator (LO) portion of the light, which in the optical unit (e.g., Figure 1 The optical unit 112) performs interference combination with the received light.

[0111] The reflective surface 2106 of the tip structure 2102 is configured to redirect light from the optical axis, which is typically aligned with the long axis of the optical fiber 2112 and points towards one side of the imaging device 2100. For example, the reflective surface 2106 may redirect the light at approximately a right angle. The reflective surface 2106 may be a sloping surface at the proximal end of the tip structure 2102. The angle of the reflective surface 2106 relative to the long axis of the imaging device 200 may be configured based on the desired deflection of the light reflected from the reflective surface 2102. For example, in some embodiments, the angle of the reflective surface 2106 may be 45 degrees. In some embodiments, the reflective surface 2106 may be coated with a reflective material, such as gold. Figure 21A As depicted herein, the low-refractive-index filler material 2118 is located between the end 2114 of the optical fiber 2112 (or a lens located at the end 2114 of the optical fiber 2112) and the reflective surface 2106 of the tip structure 2102. Due to the low-refractive-index material used, the refractive index mismatch between the outer surface 2130 of the filler material 2118 and the surrounding body fluid or tissue, along with image artifacts, is reduced.

[0112] In other variations, such as Figure 21B As depicted, since the imaging device 2150 is configured for insertion and use within the lumen of a catheter or other instrument to provide OCT imaging, it does not provide or require an external tubular axis, but can otherwise be used with... Figure 21A The internal core structure of the imaging device 2100 is similar to that of 2110.

[0113] refer to Figure 22AIn other variations, the OCT imaging system 2200 may include an optical fiber 2202, a lens 2204, a mirror or reflector 2206, and a low-refractive-index filler material 2208 between the lens 2204 and the reflector 2204. As described elsewhere, the optical fiber 2202 may be a single-mode fiber, but in other variations it may be a multimode fiber. The distal surface 2210 of the optical fiber 2202 and the proximal surface 2212 of the lens 2204 may be mechanically spliced ​​or fused together. Surfaces 2210 and 2212 are cut or diced into complementary geometries and then mechanically aligned. This may be a flat surface, each perpendicular to the axis of the optical fiber 2202, but in other variations it may include a non-flat surface or a surface not perpendicularly oriented. Figure 29A An example of an OCT imaging system 2900 is depicted, which is mechanically spliced ​​with an optical fiber 2902 having a flat distal surface 2904 and including a 90-degree orientation relative to the longitudinal axis of the optical fiber 2902. This surface 2904 abuts against a corresponding proximal surface 2906 of a lens 2908, wherein surface 2906 is also flat and includes a 90-degree orientation. Figure 29A As further depicted, the distal region 2910 of optical fiber 2902 can have its sheath 2912 removed. In some further variations, such as Figure 29B As depicted, after splicing, fiber 2902 and lens 2204 can be recoated and partially or completely re-wrapped, which can improve light streaks, rings, ghosting images, and other image artifacts. In further variations, an optical adhesive with a refractive index similar to that of fiber 2902 and / or lens 2904 can be used, or fiber 2202 and lens 2204 can be fused or welded together. This fusion may result in a loss of single-mode coupling and form an intermediate region 2914 for optical functionality between fiber 2902 and lens 2904.

[0114] Return to reference Figure 22A Lens 2204 may be a GRIN lens. In this particular embodiment, the length of the GRIN lens corresponds to one-quarter of the full sinusoidal path or pitch of lens 2204, but in other variations it may include any odd multiple equal to or corresponding to one-quarter pitch, such as a 3 / 4 pitch length, or a 1 1 / 4 pitch length 2300. Figure 23A ), 1 3 / 4 pitch length 2302 ( Figure 23B One potential benefit of increasing the length is that it reduces the ring artifacts (e.g., those generated by the reflection interfaces between fiber 2304 and GRIN lens 2308, and fiber 2306 and GRIN lens 2310) respectively. Figure 20A , 20BThe artifacts in 2004, 2008, and 2012 (and in 20C) will exhibit an increased diameter in the image, allowing the ring artifact to be magnified to a size that lies outside the effective field of view. This reflection artifact is typically stronger or greater than -40 dB.

[0115] like Figure 22A As depicted, the GRIN lens 2204 outputs a collimated beam 2220 through the low-refractive-index material 2208, and is reflected as if by a mirror or reflector 2206. The beam diameter can be configured nominally in the range of 20 μm to 200 μm. The distal surface 2214 of the GRIN lens 2204 and the polymer material 2208 can also form a 90-degree surface angle relative to the axis of the fiber 2202. This ensures that any light reflected at the lens / polymer interface will have the same partially reflected path, which can provide improved consistency / reproducibility during manufacturing and provide stable and optimal return loss (RL) or reference signal. In some variations, for example, the RL at the lens / polymer interface can be in the range of -14 dB to -28 dB, or -15 dB to -35 dB, or -20 dB to -40 dB.

[0116] For example, Figure 22C and Figure 22D A general and close-up schematic diagram of an example OCT imaging assembly 2260 configured with a collimated beam 2270 is depicted. The OCT imaging assembly includes a single-mode fiber 2262, a GRIN lens 2264, a low-refractive-index polymer material 2266, and a mirror 2268. The beam 2270 exits from the single-mode fiber 2262 and is collimated by the GRIN lens 2262, but partial reflection of the collimated beam 2270 occurs at the interface between the GRIN lens 2262 and the low-refractive-index polymer 2266, resulting in an RL (reflection resistance) typically in the range of -14 dB to -35 dB at the interface. Depending on the specific design, RL ranges of -14 dB to -40 dB, or -15 dB to -35 dB, or -20 dB to 35 dB, or -25 dB to -35 dB can be achieved. As the reflected beam 2272 travels back toward the fiber 2262, the GRIN lens 2264 focuses the reflected beam back into the single-mode fiber core 2274, whose dimensions may be, for example, 10 μm or smaller, 9 μm or smaller, or 8 μm or smaller. This can result in high RL (reference link) for the reference signal. This high RL is achieved at a local maximum of the optimal GRIN length for beam collimation, which can be found at or near 0.5 pitch unit length, 0.75 pitch unit length, 1.25 pitch unit length, 1.75 pitch unit length, etc., which can be beneficial for improving manufacturability and repeatability, allowing for a tolerance of + / - 10% regarding the optimal GRIN unit length.

[0117] In contrast, the OCT imaging module 2280 is equipped with a focused beam 2290, such as Figure 22E and Figure 22F As shown, it includes a single-mode fiber 2282, a GRIN lens 2284, a low-refractive-index polymer material 2286, and a reflector 2288. When the beam 2290 exits from the single-mode fiber 2282, it is partially focused by the GRIN lens 2284 and then partially reflected at the junction of the GRIN lens 2284 and the low-refractive-index polymer material 2286. This partial reflection 2292 can result in a low RL in the range of -35 dB to -60 dB. However, when the reflected beam returns toward the fiber 2282, it is not refocused back into the fiber core 2294, resulting in a low and lossy, invalid RL for the reference signal. As a reflection reference, when the GRIN length is configured for focusing the beam, it is centered away from the local maximum of the optimal GRIN length for beam collimation, which leads to unpredictable RL and reduced manufacturability.

[0118] The GRIN lenses in the exemplary OCT imaging system described herein may be coated or uncoated. Their lengths may range from 500 μm to 700 μm, 600 μm to 800 μm, or 700 μm to 1100 mm, or 800 μm to 5000 μm; their diameters may range from 65 μm to 130 μm, 100 μm to 200 μm, or 125 μm to 500 μm; and their pitch lengths may range from 0.500 mm to 1.200 mm, 0.600 mm to 1.500 mm, or 0.700 mm to 2.000 mm (e.g., at wavelengths in the range of 750 nm to 1380 nm).

[0119] Reflector 2206 may include a mechanically and / or electropolished surface typically oriented at a 45-degree angle relative to the longitudinal axis of the optical fiber. The angle may intentionally vary between 35 and 65 degrees. Reflector 2206 may include a layer of gold, silver, tin, nickel-chromium, aluminum, dielectric, or multilayer dielectric or other coating, wherein the coating process includes chemical vapor deposition, physical vapor deposition, sputtering, electroplating, etc. The coating thickness may be between 50 nm and 300 nm, or 100 nm and 250 nm, or 100 nm and 200 nm. The base material for the reflector may be optical glass, ceramic, semiconductor material, or polymer.

[0120] Figure 24Another embodiment of the OCT imaging system 2400 is depicted, wherein the optical fiber 2402 includes a distal end or surface 2404 that is cut or configured at an angle not orthogonal to the longitudinal axis of the optical fiber 2402, and instead includes surface angles at an angle of at least 8, 10, 12, 15 or more degrees to an orthogonal orientation, which can reduce or eliminate reflection artifacts. A spherical or aspherical lens 2406 may be spaced apart from the distal end surface 2404 of the optical fiber 2402 to receive and collimate the beam 2408. The beam 2408 then continues through a low-refractive-index material 2410 and is reflected by a mirror or reflector 2412 out of the material 2410 and out of the imaging system 2400. The refractive index of the spherical or aspherical lens 2406 can be, for example, in the range of 1.50 to 1.85, and it has a plano-convex configuration with a convex near-end surface 2414 and a flat far-end surface 2416 with a radius of curvature in the range of 0.20 to 1.00 mm. The RL or reference signal at the interface between the lens and the polymer material 2410 can be in the range of -14 dB to -40 dB, or -15 dB to -35 dB, or -20 dB to 35 dB, or -25 dB to -35 dB. The cavity or space between the optical fiber 2402 and the lens 2406 can be filled with the same material as 2410 or a different material, such as a polymer material with a higher refractive index in the range of 1.45 to 1.48, 1.40 to 1.50, or 1.5 to 1.85, or a different low refractive index material, for example, in the range of 1.30 to 1.48. The refractive index of the material in the space between the optical fiber 2402 and the lens 2406 should be lower than the refractive index of the lens 2406. The distance between the end of the optical fiber and the lens can be, for example, in the range of 0.1 mm to 4.0 mm, or 0.3 mm to 3.0 mm, or 0.5 mm to 2.00 mm. The distance between the distal surface of the lens and the center of the reflector can be, for example, in the range of 0.025 mm to 0.250 mm, 0.050 mm to 0.500 mm, 0.1 mm to 3.0 mm, or 0.2 mm to 2.0 mm, or 0.3 mm to 2.00 mm.

[0121] In addition to providing a biconvex lens 2502 to replace the plano-convex lens, Figure 25 Depicting something similar to Figure 24This is another variant of the OCT imaging system 2500 of the OCT imaging system 2400. The radius of curvature of the proximal convex surface 2504 can also be in the range of 0.20 mm to 1.00 mm, and the refractive index can be in the range of 1.50 to 1.85. In this particular example, the lens tilt 2506 of the lens 2502 can be in the range of 0.10 degrees to 2.00 degrees. This tilt minimizes or eliminates reflection artifacts by deflecting any interface reflections from the lens 2502 away from the fiber. In this embodiment, return loss or reference signals are collected from the interface between the fiber and the polymer material between the fiber and the lens 2502 in the range of -14 dB to -40 dB, or -15 dB to -35 dB, or -20 dB to 35 dB, or -25 dB to -35 dB. The lens 2502 can be configured to provide a non-collimated beam 2508, such as Figure 25 The depicted or collimated beam. In non-collimated embodiments, the focal length of the OCT system can be from 0.250 mm to 4.00 mm from the longitudinal axis of the OCT imaging system 2500 or the center of the mirror or reflector 2510.

[0122] Figure 26A and Figure 26C Additional exemplary embodiments of the OCT imaging systems 2600 and 2650 are depicted, wherein a Fresnel lens 2602 is provided instead of a GRIN lens or a spherical / aspherical lens. The Fresnel lens 2602 may be configured with a grating or diffraction pattern with a radius of curvature of 0.20 mm to 1.00 mm, optically equivalent to a convex lens. As in some other embodiments described herein, the Fresnel lens 2602 may be spaced apart from the ends 2604 and 2652 of the optical fibers 2606 and 2654, for example, in the range of 0.1 mm to 4.00 mm, 0.2 mm to 3.00 mm, or 0.5 mm to 2.5 mm. The gaps or cavities 2608 and 2656 between the ends 2604 and 2652 of the optical fibers 2606 and 2654 and the Fresnel lens 2602 may be filled with polymer materials 2608 and 26056. In some further variations, polymer materials 2608 and 2656 may be, for example, low refractive index materials with n < 1.50 or in the range of 1.30 to 1.48. The polymer material 2610 between lens 2602 and reflector 2612 may be in the range of 1.30 to 1.40, or between 1.30 to 1.48, or between 1.30 to 1.30, or between 1.32 to 1.38, and may be the same as or different from the near-end polymer materials 2608 and 2656. In some variations, polymer material 2610 may be a higher refractive index in the range of 1.50 to 1.70 or 1.52 to 1.65. The interface between optical fibers 2606 and 2654 and the near-end polymer materials 2608 and 2656 may be flat and may be in a position such as... Figure 26AThe 90-degree angle depicted, or that can be offset from a 90-degree angle, such as... Figure 26C As described in the text, it is offset from the orthogonal orientation by at least 8, 10, 12, 15 or more degrees. Figure 26A Embodiments are depicted having RL or reference signals from interface 2604 within the range of -14 dB to -40 dB, or -15 dB to -35 dB, or -20 dB to 35 dB, or -25 dB to -35 dB; preferably, the refractive indices of the Fresnel lens and the distal polymer material 2610 are matched or similar. Figure 26C An embodiment is depicted having an RL or reference signal from the interface between the Fresnel lens and the distal polymer material 2610; preferably, the refractive index mismatch or difference of the distal polymer material 2610 is such that the RL is in the range of -14dB to -40dB, or -15dB to -35dB, or -20dB to 35dB, or -25dB to -35dB. Figure 26B Depicting what can be used Figure 26A and Figure 26C An exemplary Fresnel lens 2602 in an OCT imaging system is shown. Lens 2602 may include a circular lens body having a plurality of concentric gratings or gratings 2660. In this particular example, lens 2602 is radially symmetrical with respect to a first axis 2662 and a second axis 2664, wherein both axes 2662, 2664 are transverse to the longitudinal axes of optical fibers 2606, 26054 and orthogonal to each other. In other variations, however, the configuration of the diffraction grating pattern may differ along the two axes 2662, 2664 to produce different focusing capabilities, or combinations of beam focusing and collimation. This can provide the ability to adjust the beam profile to ensure a confocal beam without requiring the use of a deformable lens.

[0123] exist Figure 27AIn another depicted embodiment, the OCT imaging system 2700 may be without lenses, but includes a reflector 2702 on its reflective surface with a Fresnel diffraction grating formed or etched thereon. Like the mirrors or reflectors described herein, the Fresnel reflector 2702 may comprise layers of gold, silver, tin, nickel-chromium, aluminum, dielectric, or multilayer dielectrics or other coatings. Between the distal end 2704 of the optical fiber 2706 and the Fresnel reflector 2702, a low-refractive-index polymer 2708, as described herein, and as described elsewhere herein, may be provided. As the light beam 2710 exits the optical fiber 2706 and travels through the polymer material 2708, the light is reflected and collimated by the diffraction pattern of the Fresnel reflector 2702, and then exits from the polymer material 2708 to the target imaging location. The Fresnel reflector 2702 can be configured with an equivalent radius of curvature (R) ranging from -0.25 mm to -2.00 mm (concave) or from -0.20 mm to -1.00 mm (concave); an ineffective pitch angle ranging from 0 degrees to 75 degrees; a pitch frequency of 20 degrees or greater (pitch / mm); and a focal length (f) between the fiber and the reflector surface ranging from 200 μm to 1000 μm. For example... Figure 27F As shown, like Figure 26B Like a Fresnel lens, reflector 2702 may comprise a circular reflector body having a plurality of concentric circular gratings, gratings, or diffraction patterns 2760. In this particular example, reflector 2702 is radially symmetrical with respect to its major axis 2762 and minor axis 2764, but in other variations discussed below, the configuration of the grating patterns may differ along the two axes 2762, 2764. The orientation of the major axis 2762 lies in the same plane as the longitudinal axis of fiber 2706 and reflected beam 2712, while the minor axis 2764 is transverse and orthogonal to the major axis 2762 and the longitudinal axis of fiber 27. This can be provided to adjust the beam profile to ensure a confocal beam or beam waist without requiring the use of a deformable lens with a concave reflective surface. In embodiments of Fresnel reflector 2702, the diffraction grating pattern, imprinted on a flat surface, having parameters including but not limited to ineffective pitch angles and pitch frequencies, may gradually vary from the major axis 2762 to the minor axis 2764 to ensure a confocal beam waist. In another embodiment of the Fresnel reflector 2702, the diffraction grating pattern embossed on the flat surface can be asymmetrical and elliptical, wherein the major axis of the elliptical pattern matches the major axis 2762 and the minor axis of the elliptical pattern matches the minor axis 2764 to match the cross-section of the incident beam 2710 in the Fresnel reflector 2702.

[0124] Figures 27B to 27E Depicting Figure 27A Various cross-sectional beam profiles of beam 2710 in the image. Figure 27B and Figure 27CThe beam profiles 2712 and 2714 are depicted at a focal length of 200 μm (distance from fiber to reflector surface) and a radius of curvature of -0.4 mm (concave), and at a focal length of 250 μm and a radius of curvature of -0.5 mm (concave), respectively. Figure 27D The beam profile 2716 at a focal length of 300 μm and a radius of curvature of -0.6 mm was depicted, while... Figure 27E The beam profile at a focal length of 500 μm and a radius of curvature of -1.1 mm was depicted 2718.

[0125] Figure 28A Another embodiment of an OCT imaging system 2800, including a GRIN lens 2802 and a Fresnel reflector 2804, is depicted. In this example, the light beam 2814 emanating from the fiber 2806 is then collimated by the GRIN lens 2802, and then enters a low-refractive-index polymer material 2808, and is then reflected by the Fresnel reflector 2804 before exiting from the low-refractive-index polymer material 2808 and reaching the target position. As described with respect to other embodiments herein, the end 2812 of the fiber 2806 may be a flat surface having an orientation of 90 degrees to the longitudinal axis of the fiber 2806, or may be offset. The diameter of the collimated beam 2816 can range from 20 μm to 200 μm, and the RL at the interface between the GRIN lens 2802 and the low refractive index material can range from -14 dB to -28 dB, -14 dB to -40 dB, or -15 dB to -35 dB, or -20 dB to 35 dB, or -25 dB to -35 dB.

[0126] Depending on the desired configuration, the Fresnel reflector 2804 can be configured with an equivalent radius of curvature ranging from -0.25 mm to -30 mm to provide a focused beam, or an equivalent radius of curvature ranging from -30 mm to infinity to collimate the beam. As previously mentioned, the diffraction pattern of the Fresnel reflector 2804 can be configured with a radially symmetrical or asymmetrical pattern. Regardless of whether the beam from the GRIN lens is converging (focused), diverging, collimated, or sufficiently collimated, as... Figure 27A and Figure 28A The depicted Fresnel reflectors 2702 or 2804, positioned at a 45-degree angle, will both introduce astigmatism, exhibiting a deviation or offset in beam focusing, or a combination of beam collimation / focusing along the major axis 2762 and the minor axis 2764. In variations where some correction to the astigmatic beam is desired, elliptical or asymmetric diffraction patterns can be provided. Depending on the axis of astigmatism, the major or minor axis of the Fresnel reflector 2804 can be adjusted to provide an elliptical diffraction pattern to compensate for astigmatism, matching the incident beam when the reflector 2804 is tilted at a 45-degree angle. Figure 28B and Figure 28CThese are schematic side and end views of reflector 2804 and the outline of reflected beam 2816, wherein... Figure 28D An exemplary astigmatic beam profile 2818 is depicted. To compensate for the asymmetric profile 2818, as shown... Figure 27F As depicted, the major axis 2762 and minor axis 2764 of reflector 2702 can be adjusted to an elliptical shape to compensate for any astigmatism in the incident beam, such that the reflected beam is sufficiently collimated, or, if it is a focused beam, confocal. Alternatively, a diffraction grating pattern imprinted on a flat surface, having parameters including but not limited to ineffective pitch angles and pitch frequencies, can be gradually varied from the major axis 2762 to the minor axis 2764 to ensure a confocal beam waist. The use of Fresnel reflectors 2702 or 2804 avoids the need for anamorphic lenses with concave reflective surfaces.

[0127] Figure 10 Another variant of the imaging penetration device 1000, similar to device 900, is depicted, but in which the optical element 1002 includes a tapered distal end 1004 having an enlarged diameter body 1006 outside the hysteresis tube 1008, and a smaller diameter proximal rod 1010 having a proximal reflective surface 1012. The proximal reflective surface 1012 may be at a 45-degree angle, or deviate from 45 degrees, such as 48 degrees, but not exceeding 45 + / - 5 degrees. As with device 900, a hysteresis tube 1014, an optical fiber 1016, a lens 1018, and an adhesive 1020 are provided.

[0128] Figure 11 Another embodiment of the imaging penetration device 1100 is depicted, wherein the optical element 1102 includes a proximal angular surface 1104 on the rod 1106 of the enlarged cutting head 1108, but with a prism 1110 inserted between the lens 1112 and the proximal angular surface 1104. The prism 1110 includes an orthogonal proximal surface 1114 optically coupled to the lens 1112, and a 45-degree angular distal end 1116 coupled to the proximal angular surface 1104 of the rod 1106, wherein the prism has a longest dimension not exceeding 255 μm. The angular distal end (or bevel) 1116 of the prism 1110 may be coated or coupled to the rod 1106 using an aluminum or other metal reflective coating.

[0129] In use, the imaging penetration device described herein can be used in conjunction with conventional guiding catheters to access desired target locations for diagnostic assessment and / or therapeutic procedures. In other variations of the imaging penetration device, dual-lumen guiding catheters may be used. Reference Figure 12A The guiding catheter 1200 may include a proximal hub 1202, a catheter body 1204, and a distal tip 1206. (Reference) Figure 12BThe proximal hub 1204 may include one or more proximal openings 1206, which communicate with two or more catheter body lumens 1208, 1210 of the catheter body 1204. For example... Figure 12B As depicted, the catheter body 1204 is partially located within the distal lumen 1212 and distal opening 1214 of the hub 1202. The hub may also include an optional flushing port 1216, which may be configured to be in fluid communication with one or both of the catheter body lumens 1208, 1210. In some variations, the catheter body 1204 may include a separate tubular body for each catheter body lumen 1208, 1210, located within an outer sheath 1218, such as... Figure 12B As depicted. In these variations, the flushing port may be in fluid communication within the tubular lumen of the outer sheath 1218, but outside the main body lumen 1208, 1210. The tubular lumens 1208, 1210 may have the same or different diameters. Figure 12B In the specific examples depicted, catheter lumen 1208 includes a smaller diameter of 0.016'' for use with a guidewire, and catheter lumen 1210 includes a larger diameter of 0.022'' or 0.025'' for receiving an imaging penetration device. Variations of the distal embodiments of dual-lumen catheters 1300 and 1400 are also depicted. Figure 13 and Figure 14 In the first embodiment, the last 2 to 6 inches (50.8 to 152.4 mm) at the distal end comprises an optically transparent material. In another embodiment, the 3 to 5 inches (76.2 to 127.0 mm) at the distal ends 1300 and 1400 comprise an optically transparent material.

[0130] The distal end 1220 of the catheter body 1204 can be attached to the catheter tip 1220. (Reference) Figure 15 The catheter tip 1220 may include a cylindrical base 1222 having a proximal surface 1224 and corresponding openings for tip lumens 1226 and 1228, the tip lumens being configured in fluid communication with catheter body lumens 1208 and 1210. In this particular catheter tip 1220, the tip lumen 1226 extends distally from the proximal surface 1224 along an extension tube 1230 projecting distally from the cylindrical base 1222 a greater distance than the tip lumen 1228. One or more angled transition surfaces 1232 may be provided on the outer surface of the cylindrical base 1222 to provide a smooth transition from the extension tube 1230.

[0131] In some variations of the guiding catheter used with imaging penetration devices, one or more lateral openings may be provided along the catheter body and / or catheter tip, allowing a guidewire to be manipulated to exit proximally from the guiding catheter at the distal opening 1334 of the guidewire tip lumen 1228. Figure 16For example, a side opening 1602 is provided in the catheter tip 1600. This can be in addition to the provided catheter body opening, for example at 20 cm, 40 cm and / or 60 cm along the catheter body as measured from the hub.

[0132] like Figure 15 and Figure 16 As shown, in some variations, guidewire tip lumens 1226 and 1604 may include a generally linear configuration, wherein the lumen extends axially without any angle or deviation from the longitudinal axis. However, in other examples, or in the case of imaging penetration device tip lumens 1228 and 1606, lumens 1228 and 1606 may be provided with angular regions to guide the inserted device away from the extension tube 1230 at an outward angle. This may help facilitate the diagnosis or treatment of anatomically eccentric lesions. However, in other examples, lumens 1228 and 1606 may have a straight orientation.

[0133] Figure 13 and Figure 14 Additional features of the guiding catheters 1300 and 1400 are depicted, which may include radiopaque marking bands 1302 and 1402 positioned along the catheter bodies 1304 and 1404, respectively. Marking band 1302 includes a loop configuration with uniform length, while marking band 1402 includes an asymmetrical configuration, which may facilitate assessment of catheter orientation and / or position.

[0134] The operation of an optical system is typically described in terms of the light emitted by the optical system toward a target area. However, those skilled in the art will understand that, since optical paths can often be reversible, a beam path can also represent the field of view “seen” by the optical system (e.g., reaching the receiver of the optical system). Therefore, an imaging beam emitted by an optical fiber can also represent the path along which (all or part) the received light can return to the optical fiber.

[0135] This document describes certain materials based on their interactions with light (e.g., opacity, reflection, transmission, refraction, etc.). These descriptors may refer to the interaction of the material with one or more wavelength ranges emitted by the system and / or one or more wavelength ranges sensitive to the receiver. Those skilled in the art will understand that the properties of a given material vary at different wavelength ranges, and different materials may be desirable for different wavelength ranges. The description of a particular example material is not intended to limit this disclosure to the wavelength range in which that particular example material has the desired optical properties. Similarly, the description of a particular wavelength is not intended to limit the system to those wavelengths. The term "light" can be used to refer to electromagnetic radiation across the entire spectrum and is not intended to limit this disclosure to electromagnetic radiation within the visible spectrum. The term "light" can refer to electromagnetic radiation of any wavelength.

[0136] Of course, it will be understood that any of the examples, embodiments, or processes described herein may be combined with one or more other examples, embodiments, and / or processes, or may be separated and / or performed in the middle of a separate device or device portion according to the system, device, and method.

[0137] Finally, the above discussion is intended to be illustrative only and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments. Therefore, while the system has been described in particular detail with reference to exemplary embodiments, it should be understood that many modifications and alternative embodiments can be devised by those skilled in the art without departing from the broader and contemplated spirit and scope of the system as set forth in the following claims. Consequently, this specification and drawings are to be viewed in an illustrative manner and are not intended to limit the scope of the appended claims.

Claims

1. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; A lens, located between the optical fiber and the reflective element, wherein the lens is tilted from 0.1 to 2.0 degrees; and A first optical filler is disposed between the distal end of the optical fiber and the reflective element, the first optical filler having a refractive index of less than 1.

40.

2. The imaging device according to claim 1, wherein, The refractive index of the first optical filler is in the range of 1.30 to 1.

40.

3. The imaging device according to claim 1, wherein, The refractive index of the first optical filler is in the range of 1.33 to 1.

38.

4. The imaging device according to claim 1, wherein, The first optical filler comprises aliphatic polyurethane acrylate and acrylic monomer.

5. The imaging device according to claim 4, wherein, The percentage of the aliphatic polyurethane acrylate is 30% to 70%, and the percentage of the acrylic monomer is 70% to 30%.

6. The imaging device according to claim 5, wherein, The percentage of the aliphatic polyurethane acrylate is 40% to 65%, and the percentage of the acrylic monomer is 60% to 35%.

7. The imaging device according to claim 4, wherein, The viscosity of the first optical filler is in the range of 1000 to 3000 cps.

8. The imaging device according to claim 7, wherein, The viscosity of the first optical filler is in the range of 1500 to 3000 cps.

9. The imaging device according to claim 7, wherein, The viscosity of the first optical filler is in the range of 2000 to 2500 cps.

10. The imaging device according to claim 1, wherein, The lens is a Fresnel lens.

11. The imaging device according to claim 1, wherein, The lens is a plano-convex lens or a biconvex lens.

12. The imaging device according to claim 1, wherein, The lens is a GRIN lens.

13. The imaging device according to claim 1, further comprising: An unclad optical fiber, with a GRIN lens following it between the optical fiber and the reflective element.

14. The imaging device according to claim 1, wherein, The first optical filler is further located between the lens and the reflective element.

15. The imaging device according to claim 1, further comprising: A second optical filler is located between the optical fiber and the lens.

16. The imaging device according to claim 15, wherein, The first optical filler and the second optical filler comprise different materials.

17. The imaging device according to claim 15, wherein, The first optical filler and the second optical filler comprise the same components but in different proportions, and wherein the refractive index of both the first optical filler and the second optical filler is less than 1.

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18. The imaging device according to claim 1, wherein, The angular surface of the reflective element includes a Fresnel diffraction pattern.

19. The imaging device according to claim 18, wherein, The Fresnel diffraction pattern includes collimation or focusing capability along its major axis, minor axis, and varying between the major and minor axes.

20. The imaging device according to claim 1, wherein, The lens is a GRIN lens.

21. The imaging device according to claim 1, wherein, The first optical filler is located between the lens and the reflective element.

22. The imaging device according to claim 1, wherein, The reflective element further includes a tapered distal end that protrudes from the lumen of the outer shaft, wherein the tapered distal end is configured to penetrate tissue.

23. The imaging device according to claim 1, wherein, The first optical filler includes a UV-curable optical material.

24. The imaging device according to claim 1, wherein, The collimating lens is located between the optical fiber and the first optical filler.

25. The imaging device according to claim 24, wherein, The collimating lens is a GRIN lens, a plano-convex lens, a biconvex lens, or a Fresnel lens.

26. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; A beam collimating element is positioned between the optical fiber and the first optical filler, wherein the beam collimating element is tilted between 0.1 and 2.0 degrees. A first optical filler is disposed between the distal end of the beam collimating element and the reflecting element, the first optical filler having a refractive index of less than 1.

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27. The imaging device according to claim 26, wherein, The return loss or reference signal at the interface between the beam collimating element and the first optical filler is between -15 dB and -28 dB.

28. The imaging device according to claim 26, wherein, The return loss or reference signal at the interface between the beam collimating element and the first optical filler is between -20 dB and -35 dB.

29. The imaging device according to claim 26, wherein, The return loss or reference signal at the interface between the beam collimating element and the first optical filler is between -23 dB and -40 dB.

30. The imaging device according to claim 26, wherein, The beam collimating element is a Fresnel lens.

31. The imaging device according to claim 26, wherein, The beam collimating element is a plano-convex lens or a biconvex lens.

32. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; A beam collimation section, located between the optical fiber and the first optical filler, comprising an unclad optical fiber and a GRIN lens, wherein the GRIN lens is tilted from 0.1 to 2.0 degrees; and A first optical filler is disposed between the distal end of the GRIN lens and the reflective element, the first optical filler having a refractive index of less than 1.

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33. The imaging device according to claim 32, wherein, The return loss or reference signal at the interface between the collimated beam section and the first optical filler is between -15 dB and -28 dB.

34. The imaging device according to claim 32, wherein, The return loss or reference signal at the interface between the collimated beam section and the first optical filler is between -20 dB and -35 dB.

35. The imaging device according to claim 32, wherein, The return loss or reference signal at the interface between the collimated beam section and the first optical filler is between -23 dB and -40 dB.

36. The imaging device according to claim 32, wherein, The interface between the optical fiber and the unclad optical fiber, and the interface between the unclad optical fiber and the GRIN lens, produces reflection artifacts weaker than -40dB.

37. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises an optical material and has an angular surface configured for imaging a beam; A beam collimation section, located between the optical fiber and the first optical filler, forms a GRIN lens, wherein the GRIN lens is tilted from 0.1 to 2.0 degrees; and A first optical filler is disposed between the distal end of the GRIN lens and the reflective element, the first optical filler having a refractive index of less than 1.

40.

38. The imaging device according to claim 37, wherein, The return loss or reference signal generated at the interface between the collimation section of the beam and the first optical filler is between -15 dB and -28 dB.

39. The imaging device according to claim 37, wherein, The return loss or reference signal generated at the interface between the collimated beam section and the first optical filler is between -20 dB and -35 dB.

40. The imaging device according to claim 37, wherein, The return loss or reference signal generated at the interface between the collimated beam section and the first optical filler is between -23 dB and -40 dB.

41. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element disposed within the cavity of the outer shaft, wherein the reflective element comprises a diffraction pattern on a flat surface of an optical material having an angular surface configured for imaging a beam; A lens, located between the optical fiber and the reflective element, wherein the lens is tilted from 0.1 to 2.0 degrees; and A first optical filler is disposed between the optical fiber and the reflective element, the first optical filler having a refractive index of less than 1.

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42. The imaging device according to claim 41, wherein, The lens is a Fresnel lens.

43. The imaging device according to claim 41, wherein, The lens is a plano-convex lens or a biconvex lens.

44. The imaging device according to claim 41, wherein, The lens is a GRIN lens.

45. The imaging device according to claim 41, wherein, The lens includes an unclad optical fiber followed by a GRIN lens.

46. ​​An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element is disposed within the cavity of the outer shaft, wherein the reflective element includes a diffraction pattern on a flat surface and has an angular surface configured for imaging a beam, the diffraction pattern having varying collimation and focusing capabilities between its major and minor axes. A lens, located between the optical fiber and the reflective element, wherein the lens is tilted from 0.1 to 2.0 degrees; and A first optical filler is disposed between the optical fiber and the reflective element, the first optical filler having a refractive index of less than 1.

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47. The imaging device according to claim 46, wherein, The lens is a Fresnel lens.

48. The imaging device according to claim 46, wherein, The lens is a plano-convex lens or a biconvex lens.

49. The imaging device according to claim 46, wherein, The lens is a GRIN lens.

50. The imaging device according to claim 46, wherein, The lens includes an unclad optical fiber followed by a GRIN lens.

51. An imaging device, comprising: optical fiber; A reflective element having an angular surface configured as an imaging beam; A beam-collimating GRIN lens having a unit length of 0.75 pitch or more, wherein the GRIN lens is tilted from 0.1 to 2.0 degrees; as well as A first optical filler is disposed between the distal surface of the GRIN lens and the reflective element, the first optical filler having a refractive index of less than 1.

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52. The imaging device according to claim 51, wherein, The interface between the optical fiber and the GRIN lens produces a reflection artifact stronger than -40dB.

53. The imaging device according to claim 51, wherein, A reflection artifact weaker than -40dB is generated at the interface between the optical fiber and the GRIN lens.

54. An imaging device, comprising: The outer shaft has a cavity; An optical fiber, which is located within the cavity of the outer shaft; A reflective element is disposed within the cavity of the outer shaft, wherein the reflective element includes a diffraction pattern on a flat surface and has an angular surface configured for imaging a beam, the diffraction pattern having varying collimation and focusing capabilities between its major and minor axes. A beam collimating element is positioned between the optical fiber and the first optical filler, wherein the beam collimating element is tilted between 0.1 and 2.0 degrees; and A first optical filler is disposed between the distal end of the beam collimating element and the reflecting element, the first optical filler having a refractive index of less than 1.40.

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