Blocking crossing device

Abstract

A catheter system includes a catheter, the catheter including an outer shaft and a rotatable inner shaft with a drill tip. The catheter can be configured to bend laterally when the inner shaft rotates within another shaft to operate within a blood vessel, such as when the drill tip crosses an obstruction. The catheter bending can be actuated by translating the inner shaft relative to the outer shaft in a distal direction, a proximal direction, or both. The outer shaft can include a locking feature for rotatably locking the inner shaft and the outer shaft and allowing one-way lateral bending of the catheter. The inner shaft can include one or more imaging sensors for collecting images of the exterior of the catheter. For example, after crossing the obstruction, the inner shaft can be removed from the outer shaft to allow a guidewire or other device to be inserted into the outer shaft.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 923,347, filed on October 18, 2019, entitled “OCCLUSION-CROSSING DEVICE,” which is incorporated herein by reference in its entirety.

[0003] This application may be related to International Patent Application No. PCT / US2019 / 028415, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 19, 2019, which claims priority to U.S. Provisional Patent Application No. 62 / 768,769, entitled “OCCLUSION CROSSING DEVICES,” filed on November 16, 2018, and U.S. Provisional Patent Application No. 62 / 660,185, entitled “OCCLUSION CROSSING DEVICES,” filed on April 19, 2018, each of which is incorporated herein by reference in its entirety.

[0004] This application may also be related to U.S. Application No. 15 / 954,407, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 16, 2018, which is a continuation of U.S. Application No. 14 / 433,786, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 6, 2015, which is a 371st U.S. National Phase Application of PCT / US2013 / 064346, entitled “OCCLUSION-CROSSING DEVICES,” filed on October 10, 2013, which claims U.S. Provisional Patent Application No. 61 / 712,149, entitled “OCCLUSION-CROSSING DEVICES,” filed on October 10, 2012, and U.S. Provisional Patent Application No. 61 / 712,149, entitled “OCCLUSION-CROSSING DEVICES,” filed on March 15, 2013. U.S. Provisional Patent Application No. 61 / 799,505, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 6, 2015, is also a continuation-in-part of U.S. Patent Application No. 13 / 433,049, entitled “OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES,” filed on March 28, 2012 (now U.S. Patent No. 8,644,913), which claims priority to U.S. Provisional Patent Application No. 61 / 468,396, entitled “OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES,” filed on March 28, 2011, and U.S. Provisional Patent Application No. 61 / 468,396, entitled “OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES,” filed on October 17, 2011. ATHERECTOMYDEVICES" which are hereby incorporated by reference in their entirety.

[0005] This application may also be related to U.S. Patent Application No. 15 / 324,325, filed on January 6, 2017, entitled “HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES”, which is a 371st U.S. National Phase Application of International Patent Application No. PCT / US2015 / 039585, filed on July 8, 2015, entitled “HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES”, which claims U.S. Provisional Application No. 62 / 022,101, filed on July 8, 2014, entitled “HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES” and filed on October 31, 2014, entitled “HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES”. DEVICES"; each of the above patent applications is incorporated herein by reference in its entirety.

[0006] Incorporated by Reference

[0007] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0008] Catheters are described herein, and in particular, catheters that may include a rotating distal tip having both a directional cutting element and an OCT imaging sensor. Background Art

[0009] Peripheral artery disease (PAD) and coronary artery disease (CAD) affect millions of people in the United States alone. PAD and CAD are asymptomatic but dangerous conditions that can have devastating consequences if not treated promptly. CAD is one of the leading causes of death in the United States, while PAD is the leading cause of amputations in more than 50 states, accounting for approximately 160,000 amputations in the United States each year.

[0010] Coronary artery disease (CAD) and peripheral artery disease (PAD) are both diseases caused by the gradual narrowing of blood vessels, most commonly due to atherosclerosis, a buildup of plaque or fatty material along the lining of the artery walls. Over time, this material hardens and thickens, which may interfere with blood circulation to the arms, legs, stomach, and kidneys. This narrowing forms a blockage that completely or partially restricts flow through the arteries. Blood circulation to the brain and heart may be reduced, increasing the risk of stroke and heart attack.

[0011] Interventional treatments for CAD and PAD may include endarterectomy and / or atherectomy. Endarterectomy is the surgical removal of plaque from a blocked artery to restore or improve blood flow. Endovascular therapies such as atherectomy are typically minimally invasive techniques designed to open or widen an artery that has become narrowed or blocked. Other treatments may include angioplasty for opening an artery. For example, balloon angioplasty typically involves inserting a catheter into an artery in the leg or arm and positioning the catheter so that a balloon resides in the blockage. The balloon connected to the catheter is inflated to open the artery. The surgeon can then place a wire mesh tube called a stent in the blocked area to keep the artery open.

[0012] Such minimally invasive techniques (e.g., atherectomy, angioplasty, etc.) typically involve placing a guidewire across the obstruction. Using the guidewire, one or more interventional devices can be positioned to remove or displace the obstruction. Unfortunately, although placing a guidewire is critical for effective treatment, it may be difficult to achieve. In particular, when placing a guidewire across the obstruction, it may be difficult to pass the guidewire through the obstruction without damaging the artery. For example, it is often difficult to prevent the guidewire from extending from the lumen into the adventitia and surrounding tissue, thereby potentially damaging the vessel and hindering effective treatment of the obstruction.

[0013] Therefore, obstruction crossing devices have been developed to assist in traversing obstructions. However, many devices are not suitable for use with imaging, making guidewire placement cumbersome and difficult. In addition, many obstruction crossing devices are too large to be used in small diameter peripheral or coronary arteries. Furthermore, it has proven difficult to pass the device through the obstruction because the end of the device, particularly the end of a rotating device, may deviate from the obstruction and in some cases enter the vessel lumen wall, such as the adventitia. Generally, it may be desirable to avoid penetrating the lumen of a vessel.

[0014] Accordingly, described herein is an occluding transcatheter device designed to address some of these issues. Summary of the invention

[0015] The present invention relates to an occlusion traversing device (e.g., apparatus, system, etc.) having an outer shaft and an inner shaft, the inner shaft being movable within the outer shaft and being rotatable relative to the outer shaft to rotate a distal end region including an OCT imaging sensor. These devices can be configured as catheters including both the inner shaft and the outer shaft; the inner shaft can be removed from the outer shaft to open the lumen of the outer shaft so that other elements (such as a guidewire or guide catheter) can be inserted and passed through the outer shaft.

[0016] Therefore, these devices generally may include an outer shaft having a central channel or lumen, which opens distally and extends along the length of the shaft body, and the inner shaft can pass through and enter the shaft body so that the terminal region of the inner shaft can extend from the distal end of the outer shaft. The inner shaft and the outer shaft can be configured to limit the distal movement of the inner shaft relative to the outer shaft to prevent the outer shaft from extending beyond a predetermined distance from the distal opening of the outer shaft. Generally, the devices described herein can be configured as: (1) a guidewire support / placement device (such as a catheter); (2) a support / placement imaging device (such as a catheter); (3) a blocking traversing device (such as a catheter); or (4) a blocking traversing imaging device (such as a catheter). Any of these devices can include one or more elements described herein, and any of these device variations can be used to treat a condition, particularly peripheral arterial disease. The system can include an outer shaft and an inner shaft. In some variations, the device can also include one or more additional elements, such as a driver (e.g., for rotating the inner shaft and / or bending the outer shaft or inner shaft, and / or advancing the inner shaft and / or outer shaft). For convenience, in the following description, these devices may be referred to as occlusion traversal devices or occlusion traversal catheters.

[0017] In general, the devices described herein may include a flexible, elongated outer shaft, a proximal handle (or handle region), and a flexible, elongated outer shaft having a distal rotation tip. The distal rotation tip may have a spiral-like rotation tip having a distal central extension configured to guide the tip into the obstruction (e.g., to prevent tip deflection). The device may also or alternatively include a laterally offset distal-most tip (pointed or rounded) on the outer shaft (e.g., on one side of the outer shaft, such as within the region of the distal opening of the outer shaft).

[0018] Any device described herein may include one or more tissue dissecting cutting edges of a rotating distal end; these edges may be formed by a threaded (e.g., grooved) distal region. In some variations, the leading edge of the catheter includes one or more spiral edges that may be referred to as wedges. The spiral edge may be arranged at the distal end of the device. The edge may have a smaller diameter, particularly compared to the final diameter of the device. In one embodiment, the rotatable distal end includes a spiral groove terminating at a distal cutting surface. The distal cutting surfaces may be joined together at a sharp point that is configured to cut through tissue. The rotatable distal end may also include a distal protrusion that has a smaller diameter than a more proximal region that is cylindrical and may help center the end around the obstruction. Other end designs are also possible. For example, the end may include a grinding edge and / or paddles.

[0019] Any device variant described herein may include, for example, a central cavity through an outer shaft, after (for example, by retracting proximally) removing the inner shaft, a guide wire may be passed through the central cavity using a device, and placed across the obstruction. The central cavity generally extends to the distal end from the proximal end or the distal end region of the proximal end of the catheter along the length of the outer shaft. Therefore, the device may include a distal opening as described above. The opening may be angled, and / or may be tilted inwardly, so as to facilitate visualization (providing a reference point on the circumference of the outer shaft) and to facilitate the outer shaft to be centrally arranged, thereby centering the entire device in the blood vessel to prevent it from piercing the inner chamber wall. The central cavity of the outer shaft may also be referred to as a guide wire cavity. In some variations, the device is configured to pass through a lesion or obstruction (or one or more obstruction areas of a blood vessel), so that the device is arranged outside the obstruction before the guide wire passes through the outer shaft. The inner cavity may be any biological vascular lumen, such as an artery, a vein or a pipeline, such as a peripheral artery, a vein or a bile duct.

[0020] The device described herein can be configured to apply optical coherence tomography (OCT) to image tissue. Therefore, the device described herein can include an imaging sensor, such as an OCT imaging sensor. The OCT imaging sensor can include the distal end of an optical fiber and a reflector for importing / exporting light into / from the optical fiber. The optical fiber can be attached to a distal end structure. The imaging sensor can be oriented to image blood vessels in front of the device, perpendicular to the device and / or behind the end of the device. A reflector or reflector can be used to guide the light path entering and leaving the end of the optical fiber to fix the imaging direction of the device. For example, the optical fiber and the reflector can be fixed to the rotation distal end region and can be embedded in a transparent or translucent medium (including a transparent bonding agent or other fixing agent).

[0021] For example, described herein are blocking traversal devices, such as blocking traversal systems. Any of these systems may include any of the following: an outer shaft, the outer shaft defining an inner cavity and a distal opening, the distal opening being angled relative to the central axis of the outer shaft to form a distal-most end, and defining a first engagement region in the inner cavity; and an inner shaft, the inner shaft extending in the inner cavity and configured to rotate relative to the outer shaft, the inner shaft including a distal end having a slotted end, the slotted end being configured to extend through the distal opening, a lateral optical imaging window (e.g., for any imaging technique such as coherence tomography (OCT)) located on a lateral side of the inner shaft at the distal region of the inner shaft, and a second engagement region, the second engagement region being located on an outer surface of the inner shaft, configured to engage with the first engagement region to limit distal movement of the inner shaft within the outer shaft; wherein the distal-most end of the distal opening is configured to block the OCT imaging window at a defined rotational position when the inner shaft rotates relative to the outer shaft while the first engagement region engages with the second engagement region to provide a registration marker for OCT imaging.

[0022] In some variations, an occlusion traversing system may include an outer shaft defining an inner lumen and a distal opening, the distal opening being angled relative to a central axis of the outer shaft to form a distal-most tip, a first engagement region in the inner lumen, and a diaphysis region at a distal portion of the outer shaft, the diaphysis region being configured to bias a lateral bend of the distal portion within a plane including a midline of the central axis and also including the distal-most tip; and an inner shaft extending within the inner lumen and configured to rotate relative to the outer shaft, the inner shaft including a distal end having a slotted tip, the slotted tip being configured to extend through the traversing system. A lateral optical coherence tomography (OCT) imaging window is provided on the lateral side of the inner shaft at the distal end region of the inner shaft through the distal opening, and a second engagement region is provided, the second engagement region is provided on the outer surface of the inner shaft and is configured to engage with the first engagement region to limit the distal movement of the inner shaft within the outer shaft; wherein the farthest end of the distal opening is configured to block the OCT imaging window at a defined rotational position when the inner shaft rotates relative to the outer shaft and the first engagement region engages with the second engagement region to provide a registration mark indicating the bending direction for OCT imaging.

[0023] Any of the devices described herein may be bendable, for example, may include a bend or offset region as part of the outer shaft and / or the inner shaft. For example, any of these devices may include an outer shaft having a diaphysis region located at a distal portion of the outer shaft, the diaphysis region being configured to offset the lateral bend of the distal portion. In some variations, the offset direction may be fixed relative to the distal-most end of the outer shaft. For example, the device may be configured to bend in a plane including a midline of the central axis and the distal-most end.

[0024] As described above, the distal opening can be circumferentially inclined. For example, the distal opening can be inclined toward the inner cavity at an angle with the outside of the outer shaft (e.g., at an angle of about 5 to 80 degrees, about 10 to 70 degrees, about 12 to 60 degrees, about 15 to 50 degrees, etc.).

[0025] In any of these variations, the inner shaft can be configured to be removed from the outer shaft proximally, which may leave an open cavity through the outer shaft. At least on the proximal portion of the outer shaft (excluding the junction area on the inner and outer shafts), the inner shaft outer diameter is generally smaller than the outer shaft inner diameter.

[0026] Generally, the inner shaft can be configured to limit the distal motion outside the distal opening of the outer shaft. The distal motion can be limited by engaging the first engagement area on the inner wall of the outer shaft with the second engagement area on the outer surface of the inner member. For example, the second engagement area can be a ring (for example, a circular ring with a circular profile). In any one of these devices, the distal region of the outer member can have an inner diameter narrower than the more proximal end of the device. The inner member and / or the outer member can have a lip or rim (annular surface, annular lip, boss, ramp, etc.), and the lip or rim is wider than the outer diameter of the distal region of the inner shaft (for example, the distal region of the inner shaft), and has a wider diameter than the inner diameter of the distal region of the outer member, so that the first engagement area on the outer shaft (the region where the inner diameter narrows) engages with the second engagement area on the inner shaft (the region where the outer diameter becomes larger). The first engagement area and the second engagement area are configured so that the inner shaft can be against the outer shaft (for example, can rotate along the outer shaft) with very little friction. For example, one or both surfaces of the joining region may be configured to reduce friction and / or may be lubricated, or may include a lubricant. In some variations, the joining region (one or both) may include a diamond-like carbon (DLC) coating that forms a hard and smooth shell.

[0027] Furthermore, pushing the inner shaft distally so that the second engagement surface is driven distally against the first engagement surface of the outer shaft can cause the distal end of the device to bend in a predetermined direction established by the diaphyseal region as described in more detail below.

[0028] Any of the devices described herein may include visualization integrated into the device. For example, any of these devices may include an imaging window (which may include an imaging sensor or an optical fiber connected to an imaging sensor) located on one side of the distal region of the inner shaft. In some variations, the lateral imaging window is a lateral optical coherence tomography (OCT) imaging window. For example, any of these devices may include an inner shaft that includes an optical fiber coupled to the OCT imaging window and extending proximally through the inner shaft.

[0029] As described above, any of these devices may include a proximal attachment configured to couple the internal member to the rotational drive and the imaging subsystem. The proximal attachment may be a handle or a base. The proximal attachment may include a driver for driving the rotational movement of the inner shaft; the proximal attachment may alternatively or additionally be coupled to an imaging window (e.g., coupled to an optical fiber) for processing imaging.

[0030] The imaging (e.g., OCT imaging using the device) can be configured to image the blood vessel laterally and / or distally (or laterally and distally) in the distal region of the inner shaft in some variations. Because the imaging window can rotate with the end of the inner shaft (e.g., a drill bit or a grooved end), the imaging can provide a panoramic view of the lumen wall. In any one of these variations, when the inner shaft is pushed distally (to a stop position where the first engagement region and the second engagement region engage or are about to engage), the farthest end of the outer shaft can protrude into the field of view of the rotating imaging window. This protrusion may block a portion of the field of view of the rotating inner shaft (e.g., a field of view of about 0.5 degrees to 20 degrees, about 1 degree to 15 degrees, less than 15 degrees, less than 12 degrees, less than 10 degrees, etc.). Therefore, this obstruction of the outer shaft relative to the inner shaft can provide a reference (e.g., a benchmark) mark on the imaging to show the relative position of the outer shaft. This reference frame may be even more important when the device is configured to bend in a predefined direction relative to the fiducial (eg, toward or away from a fiducial marker), such as by driving an internal member distally, which may aid in steering the device.

[0031] Thus, the imaging window (e.g., OCT imaging window) can be a lateral imaging window located at or near the distal end of the inner shaft. For example, the lateral imaging window can be adjacent to the end of the slot. In some variations, the lateral (e.g., OCT) imaging window overlaps the end of the slot.

[0032] As described above, a distal region of a device (eg, a distal region of an outer shaft) can be configured to bend in a predetermined direction when a second engagement region of an inner member is driven distally against a first engagement region of an outer member.

[0033] Any device described herein can be configured to prevent the device from deviating from the obstruction (and potentially entering the cavity wall), and in particular, can be configured to allow the distal end of the inner shaft and / or outer shaft to remain centered relative to the target (e.g., obstruction) being passed through. At least two features briefly described above can be included (jointly or individually). For example, the distal end facing the distal end on the outer shaft can help prevent the outer shaft or the outer shaft and the inner shaft from deflecting. In any one of these variations, the distal opening (angled or vertical to the long axis of the outer member) can be tilted circumferentially inwardly from the outer surface of the outer shaft, as described above. The circumferential bevel extending from the outer surface of the outer shaft can also help prevent the deflection of the outer member and / or prevent the outer member from entering the adventitia of the vascular lumen. When the outer shaft has the distal end as described above, the bevel may be particularly effective.

[0034] Alternatively or additionally, any of these devices can include a projection on the threaded distal end of the inner shaft, the projection extending beyond the threaded and / or grooved distal end. The projection can extend sufficiently distally (e.g., extending from about 0.1 mm to about 7 mm, 0.2 mm to about 5 mm, about 0.5 mm to about 3 mm, greater than 0.1 mm, greater than about 0.2 mm, greater than about 0.3 mm, greater than about 0.4 mm, greater than about 0.5 mm, greater than about 0.6 mm, greater than about 0.7 mm, greater than about 0.8 mm, greater than about 0.9 mm, etc.). The diameter of the projection (over most of the projection length) can be less than about 75% (e.g., less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, etc.) of the diameter of the threaded and / or grooved region proximal to the projection.

[0035] For example, described herein is an occlusion traversal system comprising: an outer shaft defining an inner lumen and a distal opening, and a first engagement region in the inner lumen; and an inner shaft extending in the inner lumen and configured to rotate relative to the outer shaft, the inner shaft comprising: a distal end having a first slotted end region, the first slotted end region configured to extend through the distal opening, wherein the first slotted end region has a first diameter, a second end region extending from the first slotted end region, wherein the second end region has a diameter less than 60% of the first diameter. Any of these systems may also include a lateral optical coherence tomography (OCT) imaging window located on a lateral side of the inner shaft at the distal end region of the inner shaft, and a second engagement region located on an outer surface of the inner shaft configured to limit distal movement of the inner shaft within the outer shaft.

[0036] The blocking traversing system may include: an outer shaft, the outer shaft defining an inner cavity and a distal opening, the distal opening being angled relative to the central axis of the outer shaft to form a distal-most end, and defining a first engagement region in the inner cavity; and an inner shaft, the inner shaft extending in the inner cavity and configured to rotate relative to the outer shaft, the inner shaft comprising: a distal end having a first slotted end region, the first slotted end region being configured to extend through the distal opening, wherein the first slotted end region has a first diameter, a second end region extending from the first slotted end region, wherein the second end region has a diameter less than 60% of the first diameter, a lateral optical coherence tomography (OCT) imaging window located on a lateral side of the inner shaft at the distal end region of the inner shaft, and a second engagement region, the second engagement region being located on an outer surface of the inner shaft and configured to limit distal movement of the inner shaft within the outer shaft; wherein the distal-most end of the distal opening is configured to block the OCT imaging window at a defined rotational position when the inner shaft rotates relative to the outer shaft while the first engagement region engages with the second engagement region to provide a registration mark for OCT imaging.

[0037] The first diameter may be approximately the same as the diameter of the inner shaft in the region proximal to the grooved end region. The second end region may be a grooved and / or threaded region, and may be a grooved or threaded region with a different pitch, direction, or width (groove width) than the first end region. The second end region may extend to a certain point.

[0038] As described above, any of these devices can be configured to bend; for example, the outer shaft can include a stem region at a distal portion of the outer shaft, the stem region being configured to bias the lateral curvature of the distal portion. The distal region of the outer shaft can be configured to bend in a predetermined direction when the second engagement region of the inner member is driven distally against the first engagement region of the outer member.

[0039] As described above, the distal opening may be circumferentially inclined.The inner shaft may be configured to be proximally removed from the outer shaft.

[0040] In any variation of the devices including OCT imaging as described herein, the inner shaft can include an optical fiber coupled to the OCT imaging window and extending proximally through the inner shaft. As described above, any of these devices can include a proximal attachment configured to couple the inner member to the rotational drive and imaging subsystem, such as coupling the optical fiber to the OCT processing subsystem for OCT imaging. The lateral OCT imaging window can be adjacent to the end of the slot and / or can overlap the end of the slot.

[0041] The blocking traversing device may include: an outer shaft, the outer shaft defining an inner cavity and a distal opening, the distal opening being angled relative to the central axis of the outer shaft to form a distal-most end, wherein the distal opening is circumferentially inclined inward from the outer surface of the outer shaft, and further, wherein the distal portion of the outer shaft includes a stem extending longitudinally along at least a portion of the outer shaft, wherein the stem is configured to offset the lateral curvature of the distal portion; an inner shaft, the inner shaft extending in the inner cavity and configured to rotate relative to the outer shaft, the inner shaft including a distal end having a drill tip, the drill tip being configured to extend through the distal opening.

[0042] Any of these devices may include an imaging element coupled to the inner shaft and configured to rotate with the inner shaft. The imaging element may include an optical coherence tomography (OCT) imaging window, or a direct imaging element such as an imaging sensor (e.g., CCD, etc.). The imaging element may include an optical fiber within the inner shaft and extending substantially along the central axis of the inner shaft.

[0043] As described above, the distal-most tip may be configured to pass in front of the imaging element as the imaging element rotates, forming a registration mark.The devices also include a handle attached to the inner shaft and the outer shaft and configured to rotate the inner shaft.

[0044] The handle (eg, may be configured as a proximal attachment of the handle) may be configured to rotate the inner shaft, and thereby the drill tip (eg, a grooved or threaded distal end), at a speed greater than 500 rpm.

[0045] The backbone may be part of a selectively flexural support of the outer shaft that at least partially surrounds the flexible tubing of the outer shaft.

[0046] Generally, the outer shaft and / or the inner shaft may include a braided material. Specifically, the flexible conduit may include a braided material. The braided material may be made of a metallic material surrounded by a polymeric laminate material.

[0047] The outer shaft may include a circumferential cutout extending at least partially through a thickness of the outer shaft, wherein the stem is located between the circumferential cutouts. The outer shaft may include a plurality of stems. The inner shaft may be removably coupled to the outer shaft.

[0048] For example, the blocking traversing device may include: an outer shaft, including: a flexible tube, and a selective bending support at least partially surrounding the distal end of the flexible tube, the selective bending support including a backbone extending longitudinally along a portion of the flexible tube, wherein the backbone is configured to bias the lateral bend of the distal end of the outer shaft in a certain direction; and an inner shaft, the inner shaft extending within the outer shaft and configured to rotate relative to the outer shaft, the inner shaft having a drill tip extending through an opening at the distal end of the outer shaft. The selective bending support may include a plurality of ribs connected to the backbone and surrounding the flexible tube. For example, the selective bending support may include three or more ribs. The flexible tube may include a braided metal material, such as a braided metal material encapsulated in a laminate material to make the flexible tube substantially impermeable to fluids.

[0049] Any of these devices may include an optical fiber extending within and coupled to the inner shaft. The optical fiber may include an image sensor configured to sense image data from outside the obstruction crossing device.

[0050] In any of these devices, the drill tip may include a window to provide access to an image sensor for imaging outside the device that blocks traversal. The inner shaft may be removably coupled to the outer shaft via a connector. In some variations, the inner shaft moves longitudinally relative to the outer shaft when a force is applied to the inner shaft in a longitudinal direction to bend the distal end of the device in a direction toward the bone.

[0051] In any of the apparatus described herein, at least a portion of the selectively bendable support may radially overlap at least a portion of the drill bit tip.

[0052] Also described herein are methods of using any of these devices. For example, described herein are methods of traversing an obstruction in a blood vessel. In some variations, the method may include: inserting a catheter into a blood vessel, the catheter comprising an outer shaft and an inner shaft, the outer shaft having a distal opening angled relative to a central axis of the outer shaft to form a distal-most end, wherein the distal opening is circumferentially inclined inward from an outer surface of the outer shaft, and the inner shaft has a drill tip located at the distal end of the catheter; bending a distal portion of the catheter in a transverse direction relative to the central axis of the catheter, wherein the transverse direction is defined by a backbone extending longitudinally along at least a portion of the outer shaft; rotating the inner shaft relative to the outer shaft; moving the catheter distally to traverse the obstruction within the blood vessel; and removing the inner shaft from the outer shaft while maintaining the outer shaft within the blood vessel.

[0053] Any of these methods may include inserting a guide wire into the outer shaft after removing the inner shaft; the methods may also include performing an atherectomy procedure using the guide wire.

[0054] Any of these atherectomy procedures may include the use of one or more of balloons, stents, tubes, and drugs.

[0055] Generally, the devices described herein are configured so that the inner shaft can be rotated to rotate the grooved tip; the tip can be rotated clockwise or counterclockwise, and depending on the direction and configuration of the grooves or threads in the tip region, the tip can cut into tissue (blockage), or can be advanced against tissue (not necessarily cutting). This helps position the device and / or prevent the device from penetrating the vessel wall. For example, any of the methods described herein can include rotating the inner shaft in a first direction to cut through an obstruction while advancing and rotating the inner shaft in a second direction to advance without cutting.

[0056] For example, a method for traversing a blockage in a blood vessel may include: pushing an outer shaft distally into the blood vessel, thereby driving the outer shaft's distalmost end distally into the lumen of the blood vessel, the distalmost end being formed by an opening of the outer shaft that is angled relative to a central axis of the outer shaft, wherein the distal opening is circumferentially inclined inwardly from an outer surface of the outer shaft; pushing the inner shaft distally into the outer shaft until the grooved distal end of the inner shaft extends out of the opening, beyond the distalmost end to a stop position, in which the inner shaft is restricted from further distal extension from the outer shaft; rotating the inner shaft in a first direction relative to the outer shaft to cut the blocked tissue; and advancing the outer shaft and the inner shaft distally together to traverse the blockage.

[0057] For example, a method of traversing an obstruction in a blood vessel may include: advancing an outer shaft distally into the blood vessel, thereby driving a distal-most tip of the outer shaft distally into the lumen of the blood vessel, the distal-most tip being formed by an opening of the outer shaft that is angled relative to a central axis of the outer shaft, wherein the distal opening is circumferentially inclined inwardly from an outer surface of the outer shaft; advancing an inner shaft distally into the outer shaft until a grooved distal end of the inner shaft extends out of the opening beyond the distal-most tip to a stop position, at which the inner shaft is limited from further distal extension from the outer shaft, wherein the grooved distal end of the inner shaft includes a first grooved end region having a first diameter, and a second grooved end region extending distally from the first grooved end region, the second grooved end region having a second diameter that is less than 60% of the first diameter; rotating the inner shaft in a first direction relative to the outer shaft to cut obstructed tissue; rotating the inner shaft in a second direction relative to the outer shaft to reduce engagement with the blood vessel wall without cutting; and advancing the outer shaft and the inner shaft distally together to traverse the obstruction while rotating the inner shaft in the first direction. Generally, rotating the inner shaft relative to the outer shaft to cut tissue of the obstruction can include advancing the second grooved tip region into the obstruction before the remainder of the inner shaft is advanced into the obstruction to prevent the inner shaft from deflecting as it is advanced.

[0058] A method for traversing an obstruction in a blood vessel may include: pushing an outer shaft distally into the blood vessel, thereby driving the outer shaft's distalmost tip distally into the lumen of the blood vessel, the distalmost tip being formed by an opening of the outer shaft that is angled relative to a central axis of the outer shaft, wherein the distal opening is circumferentially inclined inwardly from an outer surface of the outer shaft; pushing the inner shaft distally into the outer shaft until the grooved distal end of the inner shaft extends out of the opening, beyond the distalmost tip to a stop position, at which the inner shaft is restricted from further distal extension from the outer shaft; imaging the lumen of the blood vessel through an imaging window on a lateral side of the inner shaft while rotating the inner shaft in a first direction relative to the outer shaft, such that when the inner shaft rotates relative to the outer shaft, the distalmost tip of the distal opening blocks the imaging window at a defined rotational position to provide a registration mark for imaging; and pushing the outer shaft and the inner shaft distally together to traverse the obstruction while rotating the inner shaft in the first direction.

[0059] According to some embodiments, the imaging device includes: an inner shaft, the inner shaft is operably connected to a rotational drive for rotating the inner shaft, the inner shaft includes a distal end with a drill tip, the drill tip is configured to pass through an obstruction within a blood vessel, the inner shaft also includes an optical coherence tomography (OCT) imaging element located at a distal region of the inner shaft, the imaging element is configured to collect images outside the catheter; an outer shaft, the outer shaft is removably connected to the inner shaft, the outer shaft includes: a first lumen, the first lumen accommodates the inner shaft so that the inner shaft can rotate and longitudinally translate within the outer shaft, the outer shaft includes a window or transparent material so that when the inner shaft rotates and translates in the first lumen, the OCT element can collect images through the outer shaft, wherein the distal end of the first lumen is closed to prevent the drill tip from translating through the distal end of the outer shaft, and a second lumen, the second lumen is parallel to the first lumen and extends longitudinally along at least a portion of the outer shaft, the second lumen is configured to accommodate a guide wire.

[0060] In some variations, the distal end of the outer shaft is tapered. The inner shaft can be configured to be removed from the outer shaft proximally. The second lumen can extend substantially along the entire length of the outer shaft. The rotary drive can be configured to rotate the inner shaft at a speed greater than 500 rpm. The imaging element can include an imaging fiber extending within the inner shaft. The distal region of the inner shaft can include an imaging window. The outer shaft can be rotatably coupled to the inner shaft at a connector of the proximal region of the inner shaft and the outer shaft. The connector can be part of the handle of the device. The rotary drive can be located at the handle of the device. The distal portion of the outer shaft can include a stem extending longitudinally along at least a portion of the outer shaft, wherein the stem is configured to offset the lateral bend of the distal portion along a plane. The second lumen can be radially aligned with the stem relative to the longitudinal axis of the device. The distal portion of the outer shaft can include a fluid flushing port configured to discharge fluid.

[0061] According to some embodiments, a catheter system includes: an inner shaft, the inner shaft is operatively connected to a rotational driver for rotating the inner shaft, the inner shaft includes a distal end having a drill tip, the drill tip is configured to pass through an obstruction in a blood vessel, the inner shaft also includes an optical coherence tomography (OCT) imaging element located at the distal region of the inner shaft, the imaging element is configured to collect images of the exterior of the catheter, wherein the inner shaft is configured to be interchangeably coupled to a first outer shaft and a second outer shaft, wherein: the first outer shaft includes a first lumen configured to accommodate the inner shaft, the first The outer shaft includes a window or transparent material so that the OCT element can collect images through the first outer shaft when the inner shaft rotates and translates in the first inner cavity, wherein the distal end of the first inner cavity is closed to prevent the drill tip from translating through the distal end of the first outer shaft; and the second outer shaft includes a central cavity and a distal opening to allow the drill tip to pass therethrough, wherein the bendable distal portion of the second outer shaft includes a stem configured to cause the bendable distal portion of the outer shaft and the inner shaft positioned therein to bend laterally when the inner shaft is pulled proximally relative to the second outer shaft.

[0062] In some variations, the first outer shaft includes a second lumen configured to accommodate a guide wire. The system may also include a handle with a connector, the connector being configured to rotatably lock the inner shaft to the second outer shaft, wherein when the inner shaft is rotatably locked to the first outer shaft or the second outer shaft, the connector allows the inner shaft to rotate relative to the first outer shaft or the second outer shaft. The connector may be configured to provide longitudinal movement between the inner shaft and the second outer shaft so that the inner shaft can be longitudinally translated a short distance to actuate the flexible distal portion. The connector may include one or more of a Luer lock, a valve connector, a connector fitting, and a washer connector. The handle may include a rotary drive. The distal portion of the outer shaft may include a fluid flushing port configured to discharge fluid.

[0063] According to some embodiments, an obstruction crossing device includes: an inner shaft, the inner shaft is operably connected to a rotational driver for rotating the inner shaft, the inner shaft includes a distal end having a drill tip, the drill tip is configured to pass through an obstruction within a blood vessel, the inner shaft also includes an optical coherence tomography (OCT) imaging element located at the distal region of the inner shaft, the imaging element is configured to collect images outside the device; an outer shaft, the outer shaft is removably connected to the inner shaft, the outer shaft includes an inner cavity for accommodating the inner shaft so that the inner shaft can rotate and longitudinally translate within the outer shaft; and an expandable bag connected to a distal portion of the outer shaft, the expandable bag including a cap portion and an opening, the opening being arranged to allow blood to flow distally along the outer shaft from a proximal position to enter the cap portion through the opening and expand the cap portion.

[0064] In some variations, the expandable bag is configured to contact the inner surface of the blood vessel when expanded to limit blood flow in the blood vessel to flow through the expandable bag distally. The expandable bag can be configured to collapse radially toward the outer shaft when the inner shaft is pulled proximally. The expandable bag may include one or more tethers extending from the edge of the cap portion and connecting the cap portion to the proximal portion of the expandable bag. The edge may at least partially define the opening of the expandable bag. The expandable bag may be at least partially located on a bendable portion at the distal portion of the outer shaft. The expandable bag may include a flexible polymer material that is configured to collapse against the outer surface of the outer shaft when the expandable bag is in a collapsed state. The expandable bag may include a collapsible cage structure having a plurality of rigid material filaments, wherein the cap portion is covered with a sheath that allows the cap portion to expand radially outward under the force of blood flowing into the cap portion. The distal end of the outer shaft may include one or more ports configured to discharge fluid at the distal portion of the device. The one or more ports may be connected to one or more channels to transport fluid to the one or more ports. The end region at the distal end of the outer shaft may be tapered. At least a portion of the end region may be configured to pass in front of the imaging element when the imaging element rotates, so that the end region serves as a registration mark. The distal portion of the outer shaft may include a diaphysis extending longitudinally along at least a portion of the outer shaft, wherein the diaphysis is configured to offset the lateral bend of the distal portion. The device may also include a handle attached to the inner shaft and the outer shaft, wherein the rotary drive is part of the handle. The rotary drive may be configured to rotate the drill end at a speed greater than 500 rpm. The outer shaft may include a circumferential cut extending at least partially through the thickness of the outer shaft. The outer shaft may include a first engagement region, the first engagement region is located on the inner surface of the outer shaft, and is configured to extend through the distal opening of the outer shaft, wherein the inner shaft includes a second engagement region, the second engagement region is located on the outer surface of the inner shaft, and is configured to engage with the first engagement region to limit the distal movement of the inner shaft in the outer shaft. The distal region of the inner shaft may include a lateral imaging window located on the lateral side of the inner shaft. The distal-most tip of the outer shaft may be configured to block an imaging window of the inner shaft at a defined rotational position when the inner shaft is rotated relative to the outer shaft to provide a registration marker for OCT imaging. The distal portion of the outer shaft may include a fluid flushing port configured to discharge fluid.

[0065] According to some embodiments, an obstruction crossing device includes: an inner shaft, which is operably connected to a rotary driver for rotating the inner shaft, the inner shaft includes a distal end having a drill end body, the drill end body is configured to pass through an obstruction in a blood vessel, and the inner shaft also includes an optical coherence tomography (OCT) imaging element located at the distal region of the inner shaft, the imaging element is configured to collect images outside the device; an outer shaft, which is removably connected to the inner shaft so that the inner shaft can rotate and longitudinally translate within the outer shaft in distal and proximal directions; and a collar, which is rotatably connected to the distal end of the outer shaft and has a central opening to accommodate the drill end body therein, wherein the drill end body and the collar include a locking feature, the locking feature is configured to lock the collar to the drill end body so that the collar and the drill end body can rotate together, wherein when the collar is locked with the drill end body: distal movement of the inner shaft relative to the outer shaft causes the obstruction crossing device to bend, and proximal movement of the inner shaft relative to the outer shaft causes the obstruction crossing device to straighten.

[0066] In some variations, the locking feature may be configured to unlock the collar from the drill end body by stopping the rotation of the drill end body and translating the drill end body proximally relative to the collar. Unlocking the collar from the drill end body may also include rotating the drill end body relative to the collar less than one full turn before translating the drill end body proximally relative to the collar. The locking feature may allow the drill end body and the inner shaft to be removed from the outer shaft. The drill end body may include a stopper that prevents the drill end body from fully extending through the central opening of the collar when the drill end body is translated in the distal direction. The stopper of the drill end body may be configured to press against the proximal edge of the collar to prevent the drill end body from fully extending through the central opening of the collar. The locking feature may include one or more keyways of the collar, the keyways configured to retain one or more keys of the drill end body to lock the collar and the drill end body. The collar may be configured to be longitudinally held in a position relative to the outer shaft when rotating relative to the outer shaft. The outer surface of the collar may include one or more abrasive surface features configured to cut tissue. The one or more abrasive surface features may include one or more protrusions, one or more notches, or adhered abrasive materials. The outer shaft may include a stem extending longitudinally along at least a portion of the outer shaft, wherein the stem may be configured to offset the lateral bending of the distal portion of the blocking traversing device along a plane. The blocking traversing device may also include a handle with a connector, the connector being configured to rotatably lock the inner shaft to the outer shaft, wherein, when the inner shaft is rotatably locked to the outer shaft, the connector may allow the inner shaft to rotate relative to the outer shaft. The connector may be configured to provide longitudinal movement between the inner shaft and the outer shaft, so that the inner shaft can be longitudinally translated a short distance to actuate the lateral bending of the stem. The connector may include one or more of a Luer lock, a valve connector, a connector fitting, and a washer connector. The outer shaft may include a stem, the stem being configured to bend the blocking traversing device when a thrust is applied to the inner shaft, wherein the blocking traversing device is configured to bend toward the stem in response to the thrust, so that the side of the outer shaft opposite to the stem expands. The blocking traverse device can be configured to straighten or bend away from the diaphragm when a pulling force is applied to the inner shaft. The optical window of the collar can be configured to align with the optical window of the drill end body when the collar and the drill end body are locked. The optical window of the collar can be longitudinally aligned with one or more optical windows of the outer shaft. The inner shaft is operatively coupled to a rotary drive configured to rotate the inner shaft relative to the outer shaft.

[0067] According to some embodiments, a method for operating a blocking traverse device is described, wherein the blocking traverse device includes an inner shaft and an outer shaft, the distal end of the inner shaft being attached with a drill end body, and the distal end of the outer shaft being rotatably connected to an axial collar, the method comprising: engaging locking features of the axial collar and the drill end body by translating the inner shaft and the drill end body distally within the outer shaft and rotating the inner shaft and the drill end body relative to the axial collar; rotating the inner shaft while locking the axial collar and the drill end body together so that the axial collar rotates together with the drill end body and the inner shaft; bending the blocking traverse device laterally in a first direction by applying a thrust force on the inner shaft when the axial collar and the drill end body are locked together; and straightening the blocking traverse device by applying a pulling force on the inner shaft when the axial collar and the drill end body are locked together.

[0068] In some variations, the method may further include removing the inner shaft from the outer shaft by stopping rotation of the inner shaft, the drill end body, and the collar; disengaging the locking features of the collar and the drill end body by rotating the inner shaft and the drill end body less than one full turn; and translating the inner shaft proximally relative to the outer shaft until the inner shaft is removed from the inner cavity of the outer shaft. The method may further include removing the inner shaft from the outer shaft by stopping rotation of the inner shaft, the drill end body, and the collar; and translating the inner shaft proximally relative to the outer shaft to disengage the locking features of the collar and the drill end body and remove the inner shaft from the outer shaft. The locking feature may include a key protruding from an outer surface of the drill end body, and a keyway located at a proximal end of the collar, wherein engaging the locking feature includes capturing the key in the keyway. Capturing the key in the keyway may include rotating the drill end body to align the key with a gap in the keyway, and translating the drill end body distally relative to the outer shaft so that the key enters the keyway. The method may also include aligning the key with the gap of the keyway by rotating the drill end body, removing the inner shaft from the outer shaft, and translating the drill end body toward the proximal side relative to the outer shaft so that the key leaves the keyway. The method may also include inserting a guide wire or a guide catheter into the outer shaft after removing the inner shaft from the outer shaft. Rotating the inner shaft and the drill end body relative to the collar may include rotating the inner shaft and the drill end body relative to the collar less than one full turn. The inner shaft, the drill end body and the collar may rotate in a clockwise direction or a counterclockwise direction. A thrust may be applied while the inner shaft and the drill end body are in motion. Applying the thrust may cause the blocking traversing device to bend toward the shaft of the outer shaft, wherein the shaft may extend longitudinally along at least a portion of the outer shaft. The method may also include bending the blocking traversing device laterally in a second direction opposite to the first direction by continuing to apply a pulling force on the inner shaft when the collar and the drill end body are locked together. The method may also include collecting an image of the outside of the blocking traversing device using an optical coherence tomography (OCT) imaging element coupled to the inner shaft. The blocking traverse device may include a handle having a connector configured to rotatably lock the inner shaft to the outer shaft, wherein the connector allows the inner shaft to rotate relative to the outer shaft when the inner shaft is rotatably locked to the outer shaft. The drill tip body may include a stopper that prevents the drill tip body from fully extending through the central opening of the collar when the drill tip body is translated distally within the collar.

[0069] According to some embodiments, a blocking traversing device includes: an outer shaft; a rotatable inner shaft, the rotatable inner shaft including a distal cutting end and an optical coherence tomography (OCT) imaging element; and an axle ring, the axle ring is rotatably attached to the outer shaft and is configured to removably connect the inner shaft within the outer shaft, wherein the axle ring includes a locking mechanism, the locking mechanism is configured such that: when the locking mechanism is engaged, the axle ring can rotate relative to the outer shaft together with the inner shaft, translation of the inner shaft relative to the outer shaft along a first axial direction causes the blocking traversing device to bend, and translation of the inner shaft relative to the outer shaft along a second axial direction causes the blocking traversing device to straighten; and when the locking mechanism is disengaged, the rotatable inner shaft can be removed from the outer shaft.

[0070] In some variations, the first direction may be a distal direction and the second direction may be a proximal direction. The blocking traversing device may be configured to bend and straighten when the inner shaft rotates. The locking mechanism may enable the inner shaft to translate less than 1 mm relative to the collar when engaged. The locking mechanism may be configured to disengage by translating the inner shaft proximally relative to the collar when the inner shaft is not rotating. The locking mechanism may also be configured to disengage by rotating the inner shaft less than one full turn relative to the collar before translating the inner shaft proximally relative to the collar. The distal cutting tip may include a spiral drill tip body. In the blocking traversing device, the inner shaft includes a stopper configured to engage with a proximal edge of the collar to limit distal translation of the inner shaft. The locking mechanism may include one or more keyways of the collar, the keyways configured to retain one or more keys of the drill tip body to lock the collar and the drill tip body. The one or more keyways may lock the collar and the drill tip body so that the inner shaft can translate relative to the outer shaft in a second axial direction to bend the blocking traversing device. The inner shaft may be translated in a first axial direction relative to the outer shaft to bend the blocking traversing device in a first transverse direction, and wherein the inner shaft may be translated in a second axial direction relative to the outer shaft to bend the blocking traversing device in a second transverse direction opposite to the first transverse direction. The one or more keyways may include an angled undercut edge configured to push the one or more keys out of the one or more keyways to unlock the collar and the drill end body. The one or more keyways may include an undercut edge configured to retain the one or more keys in the one or more keyways when the drill end body is rotated in a first rotational direction relative to the collar, and wherein the one or more keyways include a gap configured to allow the one or more keys to leave the one or more keyways when the drill end body is rotated in a second rotational direction relative to the collar and translated in a second axial direction relative to the outer shaft. The outer surface of the collar may include one or more abrasive surface features configured to cut tissue. The one or more abrasive surface features may include one or more protrusions, one or more recesses, or adhered abrasive material. The outer shaft may include a stem extending longitudinally along at least a portion of the outer shaft, wherein the stem is configured to offset the lateral bending of the distal portion of the blocking traversing device along a plane. The blocking traversing device may also include a handle with a connector, the connector being configured to rotatably lock the inner shaft to the outer shaft, wherein the connector allows the inner shaft to rotate relative to the outer shaft when the inner shaft is rotatably locked to the outer shaft. The connector may be configured to provide longitudinal movement between the inner shaft and the outer shaft so that the inner shaft can translate to actuate the lateral bending of the blocking traversing device. The connector may include one or more of a Luer lock, a valve connector, a connector fitting, and a washer connector. The outer shaft may include a stem, which is configured to bend the blocking traversing device when a thrust is applied to the inner shaft, wherein the blocking traversing device may be configured to bend toward the stem in response to the thrust so that the side of the outer shaft opposite to the stem expands.The blocking traversing device can be configured to straighten or bend away from the backbone when a pulling force is applied to the inner shaft. The cutting end can include an optical window configured to align with an OCT imaging element for imaging therethrough. The collar can also include an optical window configured to align with an optical window of the cutting end when the locking mechanism is engaged. The optical window of the collar can be longitudinally aligned with one or more optical windows of the outer shaft. The inner shaft can be configured to be operably coupled to a rotational drive to rotate the inner shaft relative to the outer shaft.

[0071] According to some embodiments, a method for operating a blocking traversing device is described, wherein the blocking traversing device includes an inner shaft with a cutting end attached and an outer shaft rotatably connected to a collar, the method including: placing the inner shaft within the outer shaft; engaging a locking feature of the collar to removably connect the outer shaft to the inner shaft; rotating the inner shaft when the locking feature is engaged so that the collar rotates with the inner shaft; bending the blocking traversing device laterally by translating the inner shaft relative to the outer shaft in a first axial direction when the locking feature is engaged; and straightening the blocking traversing device by translating the inner shaft relative to the outer shaft in a second axial direction when the locking feature is engaged.

[0072] In some variations, the method may further include, when the locking feature is engaged, laterally bending the blocking traversing device by continuing to translate the inner shaft relative to the outer shaft in a second axial direction. When the locking feature is engaged, one or more keyways of the collar may capture therein one or more keys of a drill tip body coupled to the inner shaft, such that the inner shaft can translate relative to the outer shaft in the second axial direction to bend the blocking traversing device. Translation of the inner shaft relative to the outer shaft in a first axial direction may cause the blocking traversing device to bend in a first lateral direction, and translation of the inner shaft relative to the outer shaft in a second axial direction may cause the blocking traversing device to bend in a second lateral direction opposite to the first lateral direction. The method may further include removing the inner shaft from the outer shaft by stopping rotation of the inner shaft; disengaging the locking feature by rotating the inner shaft less than one full turn; and translating the inner shaft relative to the outer shaft in the second axial direction until the inner shaft is removed from the inner cavity of the outer shaft. The method may further include removing the inner shaft from the outer shaft by stopping rotation of the inner shaft; and translating the inner shaft relative to the outer shaft in the second axial direction to disengage the locking feature and remove the inner shaft from the outer shaft. The locking feature can be engaged when the inner shaft is rotated in a first rotational direction, and the method further includes: rotating the inner shaft in a second rotational direction; and translating the inner shaft relative to the outer shaft in a second axial direction to remove the inner shaft from the inner cavity of the outer shaft. When the locking feature is engaged, one or more key slots can capture one or more keys therein. The method may also include separating the locking feature by releasing one or more keys from the one or more key slots. The one or more key slots may include an angled undercut edge, the undercut edge being configured to push the one or more keys out of the one or more key slots to separate the locking feature. The one or more key slots may include an undercut edge, the undercut edge being configured to hold the one or more keys in the one or more key slots when the inner shaft is rotated in a first rotational direction relative to the outer shaft, and wherein the one or more key slots may include a gap, the gap being configured to allow the one or more keys to leave the one or more key slots when the inner shaft is rotated in a second rotational direction relative to the outer shaft and translated in a second axial direction relative to the outer shaft. The method may also include capturing an image of the outside of the blocking traversal device using an optical coherence tomography (OCT) imaging element coupled to the inner shaft. One or more of the outer shaft, collar, and inner shaft may include windows to allow for capturing images of the exterior of the obstruction traversal device.

[0073] According to some embodiments, a blocking traversing device includes: an outer shaft; a rotatable inner shaft including a distal cutting end; and an axial collar, which is rotatably attached to the outer shaft and is configured to removably connect the inner shaft within the outer shaft, wherein the axial collar includes a locking feature, and the locking feature is configured so that: when the locking feature is engaged: the axial collar is capable of rotating relative to the outer shaft together with the inner shaft, translation of the inner shaft relative to the outer shaft along a first axial direction causes the blocking traversing device to bend along a first lateral direction, and translation of the inner shaft relative to the outer shaft along a second axial direction causes the blocking traversing device to bend or straighten along a second lateral direction opposite to the first lateral direction; and when the locking feature is disengaged, the inner shaft is capable of being removed from the outer shaft.

[0074] In some variations, the blocking traversing device may further include an optical coherence tomography (OCT) imaging element coupled to the inner shaft. One or more of the outer shaft, the collar, and the inner shaft may include a window to allow the capture of an image outside the blocking traversing device. The outer shaft may include a stem configured to bend the blocking traversing device when the inner shaft is translated with the locking feature engaged. The blocking traversing device may be configured to bend toward the stem when the inner shaft is translated in a first axial direction, and bend away from the stem when the inner shaft is translated in a second axial direction. The outer shaft may include a stop element that limits bending in the first transverse direction and the second transverse direction. The first axial direction may be in the distal direction, and the second axial direction may be in the proximal direction. The collar may include an undercut edge configured to engage with the inner shaft to limit the translation of the inner shaft in the second axial direction when the locking feature is engaged. The locking feature may be configured to separate by rotating the inner shaft less than one full turn relative to the outer shaft and translating the inner shaft relative to the outer shaft in the second axial direction. The locking feature can be configured to separate by stopping the rotation of the inner shaft and translating the inner shaft relative to the outer shaft in a second axial direction. The locking feature can be configured to engage when the inner shaft rotates in a first rotational direction, wherein the locking feature is configured to separate by rotating the inner shaft in a second rotational direction and translating the inner shaft relative to the outer shaft in a second axial direction. The blocking traversing device can also include a handle with a connector, the connector being configured to rotatably lock the inner shaft to the outer shaft, wherein when the inner shaft is rotatably locked to the outer shaft, the connector allows the inner shaft to rotate relative to the outer shaft. The connector can be configured to provide longitudinal movement between the inner shaft and the outer shaft so that the inner shaft can translate to actuate the lateral bending of the blocking traversing device. The connector can include one or more of a Luer lock, a valve connector, a connector fitting, and a washer connector. The inner shaft can include a stopper, which is configured to engage with the collar to limit the translation of the inner shaft in the first axial direction.

[0075] These and other aspects and advantages are described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Figures 1A to 3B An obstruction traversing device having a selective bending feature is shown.

[0077] Figures 4A to 5C A blocking traverse device is shown having separable inner and outer shafts.

[0078] Fig. 6A and 6B is an exemplary block diagram of a drive system for a catheter described herein.

[0079] Figures 7A to 7B An exemplary method for detecting the position of a drive shaft of a catheter is shown.

[0080] Figures 8A to 8B Articulation of an obstruction traversing device with selective bending features and separable inner and outer shafts is shown.

[0081] Fig. 9A and 9B Show Figures 8A to 8B The obstruction traverses the inner shaft of the device, which is disposed within the outer shaft for cutting and imaging.

[0082] Fig.10 Show Figures 8A to 8B The blocking traverses the outer shaft of the device, with the inner shaft removed.

[0083] Fig.11A and 11B Shown with Figures 8A to 8B An exemplary handle for use with a blocking crossing device.

[0084] Fig.12 and 13 Shown with Figures 8A to 8B Another exemplary handle for use with a blocking crossing device.

[0085] Figures 14A to 14C A distal portion of another embodiment of an occlusion crossing device is shown.

[0086] Fig.15 Shown is a single-track guidewire lumen Figures 1A to 3B Blocking crossing device.

[0087] Fig.16 An exemplary tip for use with an obstruction traversal device is shown.

[0088] Fig.17 Another exemplary tip for use with an obstruction traversal device is shown.

[0089] Fig.18 Another exemplary tip for use with an obstruction traversal device is shown.

[0090] Figures 19A to 19DAnother exemplary tip for use with an obstruction traversal device is shown.

[0091] Figures 20A to 20B Another exemplary tip for use with an obstruction traversal device is shown.

[0092] Figures 21A to 21B Another exemplary tip for use with an obstruction traversal device is shown.

[0093] Figures 22A to 22C Another exemplary occluder traverse device having selectively bendable supports is shown. Fig.22A A side view showing a blocking crossing device, Fig. 22B Shown is its perspective exploded view, Fig. 22C A longitudinal cross-sectional view thereof is shown.

[0094] Figures 23A to 23C Another exemplary occluder traverse device having selectively bendable supports is shown. Fig.23A A side view showing a blocking crossing device, Fig. 23B Shown is its perspective exploded view, Fig.23C A longitudinal cross-sectional view thereof is shown.

[0095] Figures 24A to 24C Another exemplary occluder traverse device having selectively bendable supports is shown. Fig.24A A side view showing a blocking crossing device, Fig. 24B Shown is its perspective exploded view, Fig.24C A longitudinal cross-sectional view thereof is shown.

[0096] Fig.25A and 25B Show that it can be replaced Figures 24A to 24C Different views of an exemplary collar of a collar blocking a traversing device are shown in FIG.

[0097] Figures 26A to 26C Another exemplary blocking traverse device having an angled outer shaft tip is shown. Fig.26A A side view showing a blocking crossing device, Fig.26B Shown is its perspective exploded view, Fig.26C A longitudinal cross-sectional view thereof is shown.

[0098] Fig. 27 Imaging using an occluded traversal device is shown.

[0099] Fig.28A and 28B A perspective view showing an exemplary selectively curved support for a blocking traverse device.

[0100] Fig.29A and 29B A perspective view of another exemplary selectively bendable support for a blocking traverse device is shown.

[0101] Fig. 30A and 30B A perspective view showing an exemplary selective bending feature for a blocking traverse device.

[0102] Fig.31A and 31B An example of a blocked crossing device is shown; Fig.31A a side perspective view showing the blocking traverse device in a bent configuration; Fig.31B Shown through Fig.31A A central cross section of the device.

[0103] Fig.32A is not used ( Fig.32A )Balloon and use( Fig.32B ) Example of a balloon blocking a transverse device, the balloon can help center the device and / or prevent blood from flowing around the device.

[0104] Figures 33A to 33C An example of an obstruction traversal device is shown, wherein deflection of the distal end of the device is shown; Fig.33A Slightly deflected, Fig.33B and 33C Respectively, gradually deflect more.

[0105] Figures 34A to 34D Left side, rear, right side, and front views, respectively, show the distal end of one example of a device (occluder traversing device) wherein the inner shaft extends distally to engage the outer shaft.

[0106] Fig.35 is a cross-sectional view through one example of an obstruction traversal device (system) showing an inner shaft having a grooved distal end and an outer shaft, the inner shaft being engaged with the outer shaft.

[0107] Fig.36 is with Fig.35 An exploded view of the distal portion of one example of a similar occluding crossing device showing the shaft portion of the outer shaft, the distal region of the outer shaft, the OCT imaging window, and the distal end of the inner shaft.

[0108] Figures 37A to 37D The front, right side, back, and left side views, respectively, illustrate one example of a distal end region of an outer shaft showing a distal opening angled relative to a central axis of the outer shaft to form a distal-most tip.

[0109] Fig.37E Showing downward viewing Figures 37A to 37D A top view of the distal region of the outer shaft of the blocking traverse device.

[0110] Figures 38A to 38DAn example of a distal region of an inner shaft is shown in right, rear, left, and front views, respectively.

[0111] Fig.38E yes Figures 38A to 38D A rear perspective view of the distal region of the inner shaft.

[0112] Figures 39A to 39D An example of a grooved distal end region of the inner shaft is shown from the rear, right, front and left sides, respectively.

[0113] Fig.39E Look down Figures 39A to 39D A top view of the grooved distal end region of the inner shaft.

[0114] Fig.40 One example of an occlusive traversing device having an outer shaft with a single track guidewire lumen is shown.

[0115] Fig.41A and 41B One example of a catheter device having an outer shaft suitable for collecting intravascular images is shown. Fig.41B Show Fig.41A Close-up of a part of.

[0116] Fig.42 An occlusion crossing device is shown having an expandable bag configured to expand as blood flows within a blood vessel.

[0117] Figures 43A to 43I Another variation of a catheter device is shown having a locking feature for rotating the collar with the drill tip body and inner drive shaft: Fig.43A showing a side view of the catheter device in an assembled state; Fig.43B showing an exploded side view of a catheter device; Fig.43C showing a perspective view of the collar showing surface features on the collar; Fig.43D showing another perspective view of the collar; Fig.43E showing a close-up view of a collar rotatably coupled to an outer shaft; Fig.43F showing a close-up of the distal portion of the outer shaft; Figure 43G a close-up view of the drill tip body showing the collar and guide tube arrangement; Figure 43H showing a close-up view of the drill bit tip body coupled to the collar; and Fig.43I A close-up view of the distal portion of the collar and outer shaft is shown, showing features for rotatably coupling the collar and outer shaft.

[0118] Fig.43J yes Figures 43A to 43I A flow chart of an exemplary method of using a catheter device is shown.

[0119] Figures 44A to 44I Yet another variation of a catheter device is shown having a locking feature for rotating the collar with the drill tip body and inner drive shaft: Fig.44A showing a side view of the catheter device in an assembled state; Fig.44B showing an exploded side view of a catheter device; Fig.44C showing a perspective view of the collar; Fig.44D showing a perspective view of the drill bit end body; Fig.44E another perspective view of the collar showing a keyway feature for rotatably coupling the collar to a drill tip body; Fig.44F A collar coupled to a drill bit tip body is shown; Figure 44G showing the collar and distal portion of the outer shaft, wherein features for rotatably coupling the collar and the outer shaft are shown; Figure 44H showing a collar rotatably coupled to an outer shaft; Fig.44I The distal portion of the outer shaft is shown.

[0120] Fig.44J yes Figures 44A to 44I A flow chart of an exemplary method of using a catheter device is shown.

[0121] Figures 45A to 45D Yet another variation of a catheter device is shown having a locking feature for rotating the collar with the drill tip body and inner drive shaft: Fig.45A showing a side view of the catheter device in an assembled state; Fig.45B showing an exploded side view of a catheter device; Fig.45C showing a perspective view of the collar; Fig.45D A perspective view showing a collar engaged with a drill bit tip body.

[0122] Fig.45E yes Figures 45A to 45D A flow chart of an exemplary method of using a catheter device is shown.

[0123] Figures 46A to 46D Yet another variation of a catheter device is shown having a locking feature for rotating the collar with the drill tip body and inner drive shaft: Fig.46A showing a side view of the catheter device in an assembled state; Fig.46B showing an exploded side view of a catheter device; Fig.46C showing a perspective view of the collar; Fig.46D A perspective view showing a collar engaged with a drill bit tip body.

[0124] Fig.46E yes Figures 46A to 46D A flow chart of an exemplary method of using a catheter device is shown.

[0125] Figures 47A to 47CShown is a mount configured for unidirectional bending: Fig.47A Shows the side of the mounting frame with the backbone; Fig.47B showing a side of the mounting frame opposite the backbone; and Fig.47C A close-up view showing the curved features of the mount.

[0126] Figures 48A to 48E Shown is a mount configured for bi-directional bending: Fig.48A a close-up view showing the curved features of the mounting bracket; Fig.48B showing the side of the mounting frame opposite the backbone when the mounting frame is bent toward the backbone; Fig.48C showing the side of the mounting frame with the backbone when the mounting frame is bent toward the backbone; Fig.48D showing a side of the mounting frame with the backbone as the mounting frame is bent away from the backbone; and Fig.48E The side of the mount opposite the backbone is shown as the mount is bent away from the backbone. DETAILED DESCRIPTION

[0127] Described herein is an obstruction traversing device (e.g., system and apparatus) having a low profile that can be used for small diameter arteries and coronary arteries (e.g., through a 5 French or smaller catheter). Generally, the device described herein can have onboard imaging, such as optical coherence tomography (OCT) imaging. The optical fiber used for OCT imaging can extend substantially along the central axis of the device, thereby reducing the profile of the device and allowing high-speed rotation. The device can also include a rotatable end to allow forward drilling. In some embodiments, the device can include an articulated distal end to enable the device to be turned.

[0128] For convenience, these devices may be collectively referred to as catheters or occlusion traversing catheters. It should be understood that these catheters may include an outer shaft and a concentrically arranged (and removable) inner shaft.

[0129] refer to Figures 1A to 3BIn one embodiment, the exemplary catheter 100 includes an outer shaft 122 connected to a distal drill tip 103 (also referred to herein as a tip body) and an inner shaft 131 (also referred to as an inner drive shaft). The inner shaft 131 can be configured to rotate relative to the outer shaft 122 to turn the drill tip 103. The elongated outer shaft 122 can be hollow and can have an inner diameter of about 1 mm and an outer diameter of about 1.5 mm. In some embodiments, at least a portion of the outer shaft 122 is flexible. For example, a portion of the outer shaft 122 can include a flexible tube. In some embodiments, at least a portion of the outer shaft 122 can have a coil structure, whereby the coil is wound by laying one coil on another coil. For example, the outer shaft 122 can include at least two coil layers. In addition, the coil layers can be reverse-wound, so that one coil layer (such as an inner coil layer) has a left-hand twist, and another layer (such as an outer coil layer) has a right-hand twist. The coil can provide a torque in the direction of tensioning the outer layer and tightening down on the inner layer. A third reverse-wound coil can be added to form torque in two directions. In another embodiment, at least a portion of the outer shaft 122 is made of a braided material (e.g., a wire or mesh). In yet another embodiment, at least a portion of the outer shaft 122 may be a laser cut tube. In some embodiments, the flexible portion is made of a variety of materials. For example, the flexible portion may include a metal support structure at least partially surrounded by a polymer material. The support structure (e.g., a coil, a braided and / or laser cut material) may be at least partially laminated (e.g., fused) with a polymer material. For example, the support structure (e.g., a coil, a braided and / or laser cut material) may be embedded in a laminate (e.g., substantially covered by a laminate). In some embodiments, the laminate (e.g., substantially) completely covers all surfaces of the support structure, making the flexible portion of the outer shaft (e.g., substantially) impermeable to fluids. In some embodiments, the outer shaft 122 includes a polymer liner located within the braided portion of the outer shaft to reduce friction with the rotating inner shaft 131. The outer shaft 122 may also include one or more imaging windows 144 located at its distal end, which will be described in detail below.

[0130] Bushing 124 (see Figure 1D ) can be attached to the outer shaft 122, for example, by a tab and slot mechanism 148. The bushing 124 can serve as a bearing surface relative to the inner shaft or drill bit end 103. In addition, the bushing 124 can include edges or lips 151, 152 on either side that are configured to interact with the inner drive shaft 131 or drill bit end 103, as discussed further below.

[0131] The drill tip 103 can be configured to separate, dissect, or mince tissue, for example. In some embodiments, the drill tip 103 can include a sharp spiral groove 113 that reaches a point in the center of the device. In addition, the groove 113 can be angled so that it has a sharper edge when rotated in one direction than when rotated in another direction. As a result, depending on the direction of rotation of the drill tip 103, the drill tip 103 with the groove 113 can have active and passive modes. In the passive mode, the drill tip 103 with the groove 113 can be less aggressive, providing blunt dissection of tissue. In the active mode, the drill tip 103 with the groove 113 can be more aggressive, providing cutting and drilling to pass through harder materials.

[0132] Inner drive shaft 131 (see Figure 1D ) can be connected to the distal drill tip 103 and can extend downward along the center of the outer shaft 122. The inner drive shaft 131 can be configured to rotate in a single direction or in a clockwise and counterclockwise direction, so that the drill tip 103 rotates in a single direction or in a clockwise or counterclockwise direction relative to the shaft 122 (around the bushing 124). Rings 174, 172 can be arranged around the distal portion of the inner drive shaft 131 and / or the drill tip 103. Rings 174, 172 can be arranged against the edges 151, 152 of the bushing 124. The annular bushing 124 can allow the inner drive shaft 131 to rotate relative to the bushing 124 while preventing its axial movement (and in some embodiments allowing articulation, as further described below). In some embodiments, the inner shaft 131 is configured to rotate only in a single direction. In some embodiments, the inner shaft 131 is configured to rotate in two directions. In some cases, the catheter device includes a control button (or other type of switch) to control the rotation direction of the inner shaft. In some embodiments, the control button is disposed on the handle.

[0133] The occlusion crossing device described herein may include at least one bendable portion to allow the occlusion crossing device to operate within a blood vessel before, during, and / or after traversing the occlusion. For example, the distal end of the occlusion crossing device may be configured to bend laterally in a controlled manner to guide the drill tip to a desired position within the blood vessel. In some cases, this bending is achieved by including an articulated feature of a backbone. The backbone can be a relatively rigid portion along the length of the device and biases the deflection of the device in one or more lateral directions. In some cases, the backbone can be a continuous rib that spans at least a portion of the length of the device. In some cases, the backbone is part of the outer shaft. The device may include one backbone or multiple backbones. In some designs, two or more backbones can provide greater lateral stability than one backbone.

[0134] exist Figures 1A to 3BIn an example of the present invention, the catheter 100 can include a selective bend feature 145 located at a distal portion of the selective bend feature of the outer shaft 122. The selective bend feature 145 can be configured to control lateral bending of the distal portion of the outer shaft. The selective bend feature 145 can be coupled to a flexible portion (e.g., a braided or coiled portion) of the outer shaft, which can include a support structure (e.g., a coil, braid, and / or laser cut material) as described herein. Figure 1A and 1B As shown, the selective bending feature 145 may include one or more stems 245a, 245b and a series of circumferential cuts 247. The circumferential cuts may extend circumferentially around the outer shaft partially between the one or more stems. In some embodiments, the circumferential cuts may be formed by laser cutting. In some cases, the circumferential cuts extend through the thickness of the outer shaft. In some cases, the circumferential cuts extend partially through the thickness of the outer shaft. When a force is applied longitudinally distally to the inner shaft 131, the one or more stems 245a, 245b may cause the outer shaft to bend laterally, preferably toward the stems 245a, 245b. The one or more stems may be disposed only on one side of the catheter (e.g., a span of less than 180 degrees, less than 150 degrees, or less than 90 degrees). In some embodiments, and as Figure 1A As shown, a series of small circumferential cutouts 295 may extend between the two diaphysis 245a, 245b to increase flexibility during bending. The circumferential cutouts 247, 295 may be configured as an incomplete ring or spiral around the outer shaft 122. Figure 1B In some embodiments, the circumferential rings 247 may include one or more splits 297a, 297b therein designed to provide additional tensile strength and compression resistance to the selective bending feature 145.

[0135] The selective bending feature 145 can be attached to the inner shaft 131 so that movement of the drive shaft 131 can actuate the selective bending feature. Figure 1C , 2B 3B) can be used to actuate movement of the inner drive shaft 131. In some embodiments, the handle 200 includes one or more actuators (e.g., buttons, levers, switches) for controlling the speed and / or direction of the inner drive shaft 131. In some cases, the handle 200 includes one or more actuators (e.g., buttons, levers, switches) for controlling the distal and proximal movement of the inner drive shaft 131 relative to the outer shaft 122.

[0136] See also Figures 2A to 2B When the drive shaft 131 is pushed distally, the ring 172 can be pushed distally on the proximal lip 152 of the bushing 124 (see Figure 1D), thereby expanding or opening the circumferential cutout 247 while the diaphysis 245a, 245b maintain their own length (and the circumferential cutouts 295 move toward each other). As a result, the selective bending feature 145 can bend toward the diaphysis 245a, 245b. Figure 2B As shown, the bending mechanism can be actuated on the handle 200, for example, by moving a ring 303 (also called a slider) distally and / or pushing or moving a button or lever.

[0137] Likewise, see Figures 3A to 3B As the drive shaft 131 is pulled proximally, the ring 174 can strike the distal lip 151 of the bushing 124. As the drive shaft 131 further applies distal force, the circumferential cutouts 247 can begin to move toward each other and / or the material between the cutouts 247 can overlap while the stems 245a, 245b maintain their own lengths (and the cutouts 295 move further apart). As a result, the selective bending feature 145 can bend toward the circumferential cutouts 247 and away from the stems 245a, 245b. Figure 3B As shown, the bending mechanism can be actuated on handle 200, for example, by moving ring 303 proximally and / or pushing or moving a button or lever.

[0138] When used in a blood vessel, the bending motion of the selective bending feature 145 can advantageously allow the device 100 to be manipulated, such as to re-enter a lumen if the drill tip protrudes out of an obstruction or lumen. In some embodiments, the catheter 100 can be configured to bend in only one direction by pushing or pulling the drive shaft 131, and to return to the original position by moving the drive shaft 131 in the opposite direction. Figure 1A Straight construction shown.

[0139] The catheter 100 may also include an imaging element 199 attached to the drive shaft 131 and configured to rotate with the drive shaft 131. The imaging element 199 may include one or more sensors for collecting image data (e.g., light). The imaging element 199 may be the distal end of an OCT fiber 119 extending down the center of the drive shaft 131. When the catheter 100 is used in a blood vessel, the imaging element 199 may provide imaging (through the window 144) to aid in traversal of an obstruction.

[0140] See also Fig.15, in some embodiments, a single-track guidewire lumen 1505 can extend along the outer shaft 122. The guidewire lumen 1505 can extend, for example, between the two backbones 245a, 245b, so as not to add additional stiffness to the flexible area with the circumferential cutout 247. In some embodiments, the outer shaft includes more than one guidewire lumen. Thus, the outer shaft can define at least two lumens: a main lumen for the inner shaft and one or more guidewire lumens for the guidewire. These configurations can allow the inner shaft to remain in the main lumen of the outer shaft 122 when the guidewire lumen is used with any interventional device (e.g., a balloon, stent, conduit, drug, and / or other angioplasty device). In some cases, the inner shaft can still be removed from the outer shaft so that the main lumen can also be used for the guidewire.

[0141] In some embodiments, the catheter 100 can be used with a sheath. The sheath can be hollow and include a hemostatic valve attached to the proximal end, with flushing ports provided on the side of the hemostatic valve to facilitate flushing through the sheath. The sheath can also facilitate placement of a guidewire at a target site, particularly for embodiments where the catheter 100 does not include a single-track guidewire lumen. That is, the catheter 100 can be used to traverse an obstruction, the sheath can be placed on the catheter, the device removed, and then the guidewire can be introduced.

[0142] In some embodiments, the catheter devices described herein can be used for procedures other than occlusion traversal. For example, the catheter device can be used for other atherectomy procedures, such as for placement of balloons, stents, conduits and / or drugs. In some cases, the catheter device can be used as an imaging device. For example, the drill tip can be replaced with a blunt tip (i.e., not designed for occlusion traversal). In some cases, the inner shaft is replaced with a guide wire or other interventional device.

[0143] Alternative drill tip designs for catheter 100 are also possible. In some embodiments, as described below with respect to Fig.14A and 14B As further described, the distal drill tip 103 may have a smooth angled surface without grooves.

[0144] Fig. 30A and 30BAn alternative selective bending feature 3045 is shown according to some embodiments. The selective bending feature 3045 can include a proximal end 3007, a distal end 3008, and a lumen 3020 for receiving an inner shaft (e.g., 113). The selective bending feature 3045 is similar to the selective bending feature 145 in that the selective bending feature 3045 can also be biased to bend toward the diaphysis 3055. That is, when a compressive load is applied to the selective bending feature 3045, the selective bending feature 3045 bends toward the straight diaphysis 3055. In contrast to the selective bending feature 145, the selective bending feature 3045 can include one diaphysis 3055. The selective bending feature 3045 can also include a cutout 3047 (e.g., a laser cutout) having a jigsaw pattern defining tongue elements 3065a, 3065b, 3065c opposite the diaphysis 3055. In some embodiments, the puzzle pattern includes holes 3075 where the cutouts 3047 terminate at the backbone 3055. The tongue elements 3065a, 3065b, 3065c can have a tapered structure that is configured to indicate the amount of deflection of the selective bend feature 3045 in two directions. For example, the tongue elements 3065a, 3065b, 3065c can force the selective bend features 3045 to lock relative to each other, thereby keeping the selective bend features 3045 aligned and resisting twisting under torque when deflected. This can also prevent the selective bend feature 3045 from over-bending. Fig. 30A and 30B As shown, the inner diameter of the selective bend feature 3045 can include an annular boss 3060 configured to mate with the end of the flexible portion of the outer shaft. The selective bend feature 3045 can be coupled to the flexible portion of the outer shaft using any technique, such as welding, adhesives, fasteners, or a combination thereof.

[0145] In addition, see Fig.16In some embodiments, a distal drill tip 1603 (e.g., for use in place of drill tip 103) may include a conical body 1660 having a sharp central extension 1616 extending distally from the drill tip 1603. The central extension 1616 may be disposed at the center of the drill tip 1603 (e.g., disposed along the central longitudinal axis of the drill tip 1603) and may be used to form a guide hole in the obstruction to guide the remainder of the drill tip 1603 therethrough. The diameter of the central extension 1616 may be substantially smaller than the diameter of the remainder of the drill tip 1603. For example, the diameter of the central extension 1616 may be 10% to 30%, such as 15% to 25%, of the diameter of the remainder of the drill tip 1603. Similarly, the length of the central extension 1616 may be 10% to 30%, such as 15% to 35%, of the total length L of the conical drill tip 1603. Central extension 1616 can be substantially cylindrical and have a pointed drill tip. The angle of the tip can extend from 15 to 75 degrees, such as 20 to 60 degrees, such as 30 to 45 degrees relative to the central longitudinal axis of drill tip 1603. In some embodiments, having a minimum angle of 30 degrees at the pointed drill tip ensures that drill tip 1616 does not cut into the side wall of the lumen when passing through a sharp curve (e.g., an aortic bifurcation). Conversely, in some embodiments, having a maximum angle of 45 degrees ensures that extension 1616 is able to drill into the obstruction (e.g., without deviating from the obstruction as a blunt tip would). Fig.16 As shown, the drill tip 1603 may also include two or more grooves 1662 extending axially along the conical body 1660 to form additional cutting edges when the drill tip 1603 is rotated through an obstruction. These grooves may continue into the extension 1616 to form side grooves therein.

[0146] Fig.17 Another exemplary distal drill tip 1703 similar to the distal drill tip 1603 is shown, except that the body 1760 is substantially bullet-shaped (or round, semicircular). In addition, the central extension 1716 can have a continuous taper from the distal tip to the body 1760, rather than having a cylindrical portion.

[0147] Fig.18 Another exemplary distal drill tip 1803 is shown that is similar to distal tip 1703 , except that body 1860 includes one or more helical grooves 1882 extending along body 1760 and extension 1816 .

[0148] The drill tip 103, 1603, 1703, 1803 may have a diameter of, for example, between 4 French and 8 French (between 1 and 1 / 3 mm and 2 and 2 / 3 mm).

[0149] See also Figures 4A to 5C In another embodiment, the exemplary catheter 300 includes an inner shaft 311, an outer shaft 322 and a distal drill bit end 303 connected to the inner shaft 311. In addition, the outer shaft 322 can be separated from the inner shaft 311. For example, the inner shaft 311 can include one or more connectors that allow the outer shaft 322 to be removably connected to the inner shaft 311. In some embodiments, the (one or more) connectors are Luer connectors, but other connectors such as valve connectors, connector fittings and / or gasket connectors can also be used. The (one or more) connectors can be located at any position along the catheter. In some embodiments, the (one or more) connectors are close to the proximal end, thereby allowing attachment and separation from the connector on the proximal end of the outer shaft 322, as described below with respect to the handle 900.

[0150] In some embodiments, the distal portion 313 of the outer shaft 322 can be transparent, such as made of clear plastic, to allow imaging therethrough. In some embodiments, the outer shaft 322 can also include a preformed bend 329 disposed therein to aid in device orientation or steering. Markings 315, such as metal markings, can extend within the distal portion 313 to indicate the relative orientation of the catheter 300 when in use. For example, as shown in FIG. Figure 4B As shown, the innermost portion of bend 329 may be aligned with marking 315 .

[0151] Furthermore, in some embodiments, the inner shaft 311 can be longitudinally moved within the hollow outer shaft 322 by slidingly connecting to a ring on a handle (such as handle 200) of the catheter 300 to allow exposure of the inner shaft 311 (such as Figures 4A to 4B as shown) or completely covers the inner shaft 311 (as shown Figures 5A to 5C ). In use, the inner shaft 311 can thus extend out of the outer shaft to help drill through an obstruction, and be pulled in when no dissection is required (or when only blunt dissection is required). In some embodiments, the inner shaft 311 can be configured to be fixed at different points relative to the outer shaft 322 to change the amount of exposure of the drill tip 103. In addition, the shaft 311 can be completely removed from the outer shaft 322 to allow a guide wire to be placed therethrough.

[0152] Additionally, device 300 may include an imaging element 399 similar to that described above with respect to device 100. Catheter 300 is configured for imaging using imaging element 399 when inner shaft 311 extends distally out of outer shaft 322 and inner shaft 311 is disposed within outer shaft 322 (through transparent distal portion 313).

[0153] The device 300 may include a drill tip 103 similar to any of the drill tips described above with respect to the device 100. However, the drill tip for the device 300 may have a smaller diameter to fit through the outer shaft 322. For example, the diameter of the drill tip may be less than or equal to 7 French (less than or equal to 2 1 / 3 mm), such as a diameter between 1 mm and 2 1 / 3 mm.

[0154] An exemplary drill tip 1903 for use with the device 300 is shown in FIG. Figures 19A to 19D Drill tip 1903 is similar to drill tip 1803, except that body 1960 is not continuously tapered, but includes a proximal cylindrical portion 1965 and a central tapered section 1967. Recess 1982 extends through cylindrical portion 1965, central tapered section 1967, and central extension 1916.

[0155] Figures 20A to 20B Another drill bit end 2003 is shown. Drill bit end 2003 is similar to drill bit end 1903, except that it does not include any grooves. Instead, drill bit end 2003 includes a cylindrical body 2060 from which a central extension 2016 extends.

[0156] Figures 21A to 21B Another drill tip 2103 is shown. Drill tip 2103 is similar to drill tip 1603, except that body 2160 is not continuously tapered, but rather includes a proximal cylindrical portion 2165 and a central tapered slot segment 2067. Additionally, extension 2116 is continuously tapered.

[0157] Device 300 may further or alternatively include any of the features, materials, and / or dimensions described above with respect to device 100 .

[0158] See also Figures 8A to 10 In another embodiment, the exemplary catheter 800 may include a separable inner shaft 811 and an outer shaft 822 , and a selective bending feature 845 at the distal end of the outer shaft 822 .

[0159] See also Figures 8A to 8B , the selective bending feature 845 may include a backbone 945 and a series of circumferential cutouts 947. In addition, as Fig. 9AAs shown, the outer shaft 822 can include a collar 860, which can be attached to the selective bending feature 845 of the outer shaft 822. The collar 860 can provide a shape for the distal end of the outer shaft 822 to facilitate the manipulation of the catheter in the blood vessel. For example, the collar 860 can have a tapered and / or curved outer surface. The collar can be considered as an extension of the outer shaft 822. For example, the collar can be considered as the distal end of the outer shaft, wherein the distal end (e.g., the collar) can include a hole for extending the drill tip 803 through. The collar can be a part of the outer shaft (e.g., formed integrally with the outer shaft), or it can be a separate part. In some embodiments, the collar is fixedly connected to the outer shaft (e.g., by welding, fasteners and / or adhesives). In some embodiments, the collar is removably connected to the outer shaft. In some embodiments, the collar engages with the outer shaft. In some cases, a portion of the collar radially overlaps another portion of the outer shaft (e.g., fits in the other portion). For example, the inner boss 862 of the collar 860 can fit within a distal portion of the selective bending feature of the outer shaft 822 .

[0160] As described herein, the outer shaft can cooperate with the inner shaft to provide an offset bend in the distal end of the catheter. Figures 8A to 10 In the example of , the inner shaft 811 can be configured to move longitudinally relative to the outer shaft 822. The outer shaft 822 can include an inner boss 862, which is configured to extend radially inward relative to the outer shaft 822. Similarly, the inner shaft 811 can include an annular member 872, such as a plastic bearing, and the diameter of the annular member 872 is larger than the rest of the inner shaft 811. Therefore, when the inner shaft 811 is pushed distally, the annular member 872 of the inner shaft 811 can push against the inner boss 862 of the outer shaft 822 (e.g., the collar 860). As a result, the outer shaft 822 can bend toward the backbone 945 at the cutout 947 (e.g., Fig. 9A 947). For example, the force applied to the inner shaft 862 can cause the cutout 947 to expand, causing the outer shaft 811 to bend preferentially toward the diaphysis 945. This is because the diaphysis 945 can be relatively rigid compared to the side of the outer shaft 811 having the cutout 947. If the outer shaft includes multiple diaphysis (e.g. Figures 1A to 3B ), the outer shaft can preferably be bent toward the side of the outer shaft having the backbone.

[0161] like Fig.10As shown, by pulling the inner shaft 811 proximally, the inner shaft 811 can be completely removed from the outer shaft 822 and the collar 860. In this way, the outer shaft 822 can be used as a sheath, for example, for guidewire placement. For example, after the inner shaft 811 with the drill end 803 is used to traverse (e.g., drill through) the obstruction, the inner shaft 811 (with the drill end 803) can be removed from the outer shaft 811 by pulling proximally. Then, the guidewire can be placed in the lumen of the outer shaft 811 where the inner shaft 811 was once provided (e.g., pushed through). In this way, the guidewire can be placed through the obstruction. If the guidewire has any interventional device (e.g., a balloon, a stent, a tube, a drug, and / or other angioplasty device), the interventional device can be used to treat the obstructed area of ​​the blood vessel. In some cases, the first guidewire is used to perform a first intervention and the second guidewire is used to perform a second intervention. In a specific example, the first guidewire can include a balloon to widen the blood vessel; then, the first guidewire can be removed and replaced with the second guidewire to insert the stent.

[0162] In addition, the inner shaft 811 can include an imaging element 877, which is similar to the elements described above with respect to devices 100 and 300 and can rotate with the inner shaft 811. The imaging element 877 can be imaged through the imaging window 866 in the collar 860. In addition, the inner boss 862 can also be used to properly align the imaging element 877 with the imaging window 866 when the inner shaft 811 is located within the outer shaft 822.

[0163] The inner shaft 811 may include a rotatable distal drill tip 803 that is similar to the drill tip described above with respect to devices 100 and 300 (e.g., may include any of the distal drill tip designs described with respect to devices 10 and 300). Likewise, the device 800 may alternatively or additionally include any of the materials and dimensions described above with respect to devices 100 and 300.

[0164] See also Figures 11A to 11B, the handle 900 can be used to operate the device 800. The handle 900 can include a connector 883, which is configured to connect and lock the inner shaft 811 and the outer shaft 822 longitudinally. In some embodiments, the connector 883 is a Luer lock, a valve connector, a joint fitting, or a gasket joint. The connector 883 can be configured to provide some relative longitudinal movement between the outer shaft 822 and the inner shaft 811, so that the inner shaft 811 can still move a short distance, such as about 0.125 inches to 0.2 inches, to actuate the selective bending feature 845. For example, the inner shaft 811 can include an accordion fold or elastic segment to provide additional relative movement. The actual displacement distance depends on the diameter of the outer shaft of the catheter, the desired bending degree, and the extension / compression of the outer shaft and the inner shaft, respectively. The larger the diameter of the outer shaft, the greater the desired bending degree, and the more compression / extension of the shaft, the greater the displacement required. In addition, the connector 883 can be configured to allow the inner shaft 811 to rotate freely within the outer shaft, thereby providing rotation of the sharp distal drill tip 803 connected to the inner shaft 811. The connector 883 can be configured to enable the outer shaft to rotate relative to the position of the handle. When the shaft is in the articulated position, the rotating outer shaft will guide the catheter around or towards an obstruction during use. If the connector 883 is disconnected, such as Fig. 11B As shown, the inner shaft 811 can be pulled out of the outer shaft 822 by the handle, leaving the outer shaft 822 in a suitable position, for example, for guidewire placement.

[0165] The handle 900 may also include a rod 885 or ring configured to control the axial movement of the inner shaft 811 (and thereby control the articulation of the device 800). In some embodiments, the rod 885 may include a locking mechanism that allows the device 800 to remain bent at a set angle. The handle 900 may also include a rotation element 893 attached to the outer shaft 822 and configured to rotate the outer shaft 822 (e.g., 360 degrees) to position the bending of the device 800 to a desired orientation.

[0166] Figures 12 to 13 Another exemplary handle 1000 is shown. Handle 1000 can include many of the features of handle 900. Sliding button 1085 can be used to control axial movement of the inner shaft. Rotation element 1093 can be configured to rotate outer shaft 822.

[0167] In addition, in some embodiments, the connection between the inner and outer shafts of the handle and the inner shaft can be configured so that the two shafts snap together, the proximal ends are axially fixed together, but allowed to rotate independently. In other embodiments, a third element can be used to key, link or bolt the two shafts together.

[0168] Although the features of handles 900 , 1000 are described as being used with catheter 800 , they may likewise be used with any of the catheters described herein.

[0169] Another embodiment of the catheter 1400 has a distal end at Figures 14A to 14B 14. The catheter 1400 is similar to the catheters 100, 300, 800, except that it includes a smooth distal drill tip 103 and a molded distal portion 1410. Thus, the distal tip 103 can have a smooth angled surface 1413 that is ungrooved and joins at a slightly convex distal point 1415 (i.e., the drill tip can be frustoconical). Fig.14A , 14B The distal drill tip 103 may advantageously provide a less invasive drilling procedure through an obstruction. Fig.14A and 14B The distal drill tip 103 of the catheter 100, 300, 800 can be used to replace any distal drill tip described with respect to the catheter 100, 300, 800. Similarly, the catheter 1400 may include a molded distal portion 1422. The molded distal portion 1412 may be similar to the distal end of the catheter 300, and may include a sleeve 1424, a transparent section 1422, and a selective bending support 1452 (also referred to as a mounting frame or chassis) of the outer shaft. The selective bending support 1452 may be disposed on at least a portion of the flexible portion (e.g., a braided or coiled portion) of the outer shaft. In addition, the imaging optical fiber 1499 may extend downward along the central axis of the device, as described above with respect to other embodiments. Any features of the catheters 100, 300, 800 may be used as a supplement or replacement for the features described with respect to the catheter 1400. Similarly, the catheter 1400 may be used with a handle having some or all of the features of the handle 200, 900, or 1000.

[0170] In some embodiments, the entire outer shaft of the catheter described herein or a portion thereof can be transparent to allow imaging therethrough. In addition, in some embodiments, the catheter described herein can include a balloon for occlusion for better imaging. The balloon can be a transparent balloon to allow imaging therethrough.

[0171] In some embodiments, the selective bending feature of the outer shaft is in the form of a selective bending support that fits over a flexible portion (e.g., a flexible tube) of the outer shaft and at least partially surrounds the flexible portion of the outer shaft. That is, at least a portion of the selective bending support can radially overlap the flexible portion of the outer shaft. This configuration provides another way to balance between providing flexibility (e.g., bendability) and allowing biased bending of the distal end of the catheter.

[0172] Figures 22A to 22CAn exemplary catheter 2200 with a selective bending support 2206 is shown. Similar to other catheters described herein, the catheter 2200 may include an outer shaft having a flexible portion 2204 (e.g., a flexible tube), an inner shaft 2205 configured to be removable from the outer shaft, and a terminal body 2210 coupled to the inner shaft 2205. The selective bending support 2206 may extend longitudinally along a portion of the length of the flexible portion 2204 of the outer shaft. In some embodiments, the length L of the selective bending support 2206 (and other selective bending supports described herein) may be in the range of about 0.125 inches to about 3 inches. The selective bending support 2206 may be configured to provide selective rigidity to the flexible portion 2204 of the outer shaft at the distal end of the catheter. The selective bending support 2206 may include a proximal portion 2207 and a distal portion 2208 coupled to each other via a backbone 2209. The proximal portion 2207 and the distal portion 2208 of the selectively curved support 2206 can respectively have a shape (e.g., cylindrical) defining an opening, and the opening is suitable for a portion of the flexible portion 2204 of the outer shaft to fit through. That is, the proximal portion 2207 and the distal portion 2208 can surround or surround at least a portion of the circumference of the flexible portion 2204. The proximal portion 2207 and the distal portion 2208 can be called a rib. The proximal portion 2207 and the distal portion 2208 can be spaced apart from each other so that the flexible portion 2204 of the outer shaft between the proximal portion 2207 and the distal portion 2208 is not covered by the selectively curved support 2206, thereby allowing the side of the outer shaft opposite to the backbone 2209 to have greater flexibility to expand. In some cases, the backbone 2209 has a surface shape corresponding to the outer surface of the flexible portion 2204 of the outer shaft. For example, the backbone 2209 can have a curved inner surface corresponding to the cylindrical flexible portion 2204.

[0173] In addition, the backbone 2209 can be configured to bias the lateral bending of the catheter 2200. That is, as described with respect to other embodiments herein, the removable inner shaft 2205 can be used to control the bending of the catheter 2200. For example, the tip body 2210 can include an annular lip 2282 that extends radially outward more than any component of the tip 2210 that is away from the annular lip 2282. When the inner shaft 2205 is inserted into the outer shaft 2204, the annular lip 2282 can abut against the proximal edge 2284 of the collar 2202. Further pushing the inner shaft 2205 distally can cause the catheter 2200 to bend preferentially in the direction of the backbone 2209 because the flexible portion of the outer shaft 2204 can be more flexible and / or stretchable than the backbone 2209. That is, the backbone 2209 can provide greater resistance to bending than the flexible portion of the outer shaft between the proximal portion 2207 and the distal portion 2208.

[0174] As with other embodiments described herein, the tip body 2210 can include one or more grooves 2212 (eg, helical grooves) that can help drive the tip body 2210 at least partially through an obstruction as the inner shaft 2205 and the tip body 2210 rotate.

[0175] In some embodiments, the imaging element support 2216 is used to support and / or position the imaging element in the catheter 2200. In some cases, the imaging element support 2216 (which may also be referred to as a "molded lens" in other cases) has a first surface 2220 (e.g., substantially) orthogonal to the rotation axis of the end body 2210, and a second surface 2218 that is not orthogonal to the rotation axis of the end body 2210. The first surface 2220 can be elongated to support, for example, an optical fiber. The second surface 2218 can be configured to support the distal end of the optical fiber located near the window 2214 of the end body 2210 and deflect the OCT signal into the tissue. Examples of such molded lenses are described in PCT / US2016 / 042152, entitled "MICRO-MOLDEDANAMORPHIC REFLECTOR LENS FOR IMAGE GUIDED THERAPETUIC / DIAGNOSTIC CATHETERS," filed on July 13, 2016, which is incorporated herein by reference in its entirety.

[0176] exist Figures 22A to 22C In the exemplary catheter 2200 of the present invention, the collar 2202 can have a distal outer surface 2222 that is round (i.e., convex) and tapered to give the collar 2202 a bullet-like shape. In some applications, this rounded tapered shape can allow the collar 2202 and the catheter 2200 to move more easily through an obstruction (e.g., compared to a non-round and / or non-tapered collar). The degree to which the collar 2202 is tapered can vary in part based on application requirements. In one embodiment, the collar 2202 can be tapered at an angle between 15 degrees and 120 degrees. In addition, the end can include a radius or a compound form, such as an ellipse, to form a tapered element without sharp corners.

[0177] In some embodiments, the end body 2210 may include a window 2214 configured to allow imaging access by an imaging element (e.g., one or more optical fibers) outside the catheter 2200 and into the blood vessel. The window 2214 may correspond to an opening in the wall of the end body 2210, which may be open or filled with a signal transparent (e.g., optically transparent) material. The end body 2210 may be configured to fit into the internal cavity (lumen) of the collar 2202 so that the window 2214 is axially aligned with one or more windows 2223 (e.g., three windows) in the selective bending support 2206. The one or more windows 2223 may also be separated by one or more markers 2224 (e.g., three markers). The inner shaft 2205 may be configured to rotate the end body 2210 relative to the selective bending support 2206 and the collar 2202 so that the markers 2224 periodically pass in front of the imaging element and are detected by the imaging element. The imaging element may be operably coupled to a computer (eg, a controller) configured to utilize periodic detection of the markers 2224 to determine the relative orientation of the catheter 2200 during use.

[0178] The distance along the length of the catheter 2200 between the tip 2211 of the tip body 2212 and the center of the window 2214 can be measured as distance D. The distance D can be, for example, 2.5 mm.

[0179] In some embodiments, the catheter includes a tip that allows the imaging device to be closer to the tip body (i.e., Fig.23C For illustration, Figures 23A to 23C An exemplary catheter 2300 is shown that is similar to catheter 2200 (including an outer shaft 2304, a removable inner shaft 2305, a rotatable distal body 2310 and a selectively bendable support 2306), except that at least a portion of the shaft ring 2302 is made of a material that allows signals (e.g., OCT signals) to be at least partially transmitted.

[0180] In some embodiments, the collar 2302 is at least partially transparent (optically transparent) to visible light wavelengths. In some embodiments, the collar 2302 is configured to allow at least partial transmission of signals having a wavelength of about 1310 nanometers. In some embodiments, the collar 2302 (or a portion thereof) is made of a signal transparent polymer material. The signal transparent collar 2302 can allow an imaging element to be at least partially covered by (overlapping with) the collar 2302 while still being able to detect signals from outside the catheter 2300. For example, see Fig.23C, at least a portion of the collar 2302 can axially overlap the distal end of the imaging element support 2316 (e.g., having the imaging element) and the imaging window 2314. This configuration can bring the imaging element closer to the rotating drill end 2311 than a configuration in which the imaging element is disposed more proximally. For example, see Fig.23C , the distance D between the drill tip 2311 and the center of the window 2314 of the tip body 2310 along the length of the catheter 2300 can be shortened. In some cases, the distance D is shortened by up to or at least about 1 millimeter compared to a configuration in which the imaging element does not overlap axially with the collar. In some cases, the distance D is shortened by up to or at least one-third compared to a configuration in which the imaging element does not overlap radially with the collar. For example, the distance D can be less than 2 mm. In this example, the drill tip includes a proximal grooved region extending distally, the proximal grooved region having a first diameter, the first diameter being greater than the diameter of a second region 2313, the second region 2313 extending distally from the proximal region and having a smaller diameter; the second region can be pointed and can be used to prevent the drill tip from deflecting from even hard (e.g., calcified) obstructions.

[0181] In some embodiments, the collar 2302 includes a proximal collar portion 2302a and a distal collar portion 2302b. The proximal collar portion 2302a can be configured to prevent light transmission (e.g., be opaque), while the distal collar portion 2302b can be configured to allow light to be transmitted therethrough (e.g., be transparent). In addition, the proximal portion 2302a can include a tab 2324 that is radially arranged around a central axis of the proximal collar portion 2302a and is configured to extend within the distal collar portion 2302b. In some embodiments, the distal collar portion 2302b and the tab 2324 can be axially aligned with the imaging element so that the tab 2324 can act as a marker when the imaging element is rotated. Referring to the above reference Figures 22A to 22B Like the markings 2224 described above on the selectively bendable support 2206 , the markings 2324 of the collar 2302 can be configured to periodically pass in front of the imaging element as the imaging element rotates to provide information regarding the relative orientation of the catheter 2300 .

[0182] In any blocking traversing device herein, the distal end of the outer shaft can include an asymmetrically tapered angled end. This asymmetry can be relative to the central axis of the device, such as the central axis of the outer shaft. This asymmetric shape can provide a smoother entry and / or navigation of the device in a blood vessel. This asymmetric shape can also allow the end to be used as a marker for an optical sensor (e.g., an OCT imaging sensor). The angled end can be a portion of the outer shaft, or a portion of the outer shaft. In some embodiments, the angled end is located on the collar of the device.

[0183] Figures 26A to 26CAn exemplary catheter 2600 is shown in which the collar has an asymmetric shape. Catheter 2600 is similar to catheter 2200 (including an outer shaft 2604, a removable inner shaft 2605, a rotatable distal tip body 2610, and a selectively bendable support 2606), except that a distal end 2624 of the collar 2602 can be asymmetrically tapered to form an angled surface for the distal end 2624 of the collar 2602. In some applications, the asymmetric tapered distal end 2624 can be used as a wedge or shovel, configured to facilitate pushing through an obstruction. In some cases, the asymmetric tapered distal end 2624 is configured to be used as a marker to facilitate determining the relative orientation of the catheter 2600 when in use. For example, as Fig.26C As shown, a first edge 2680 of the distal end 2624 of the collar 2602 can be configured to axially overlap with the imaging element (within the imaging element support 2316) and / or extend distally beyond the imaging element, while a second edge 2682 of the distal end 2624 of the collar 2602 can be configured not to axially overlap with the imaging element (i.e., be disposed proximal to the imaging element). When the imaging element rotates relative to the collar 2602, the first edge 2680 of the distal end 2624 of the collar 2602 can periodically pass in front of the imaging element, thereby serving as a marker to provide information about the relative orientation of the catheter 2600. One of the advantages of the collar configuration of the catheter 2600 can be that the imaging element can be disposed closer to the end 2611 of the distal body 2610 than in other embodiments. In some cases, the distance D (the distance between the end 2611 and the center of the imaging element and / or window 2614) can be less than 1.5 mm (e.g., about 1 mm). In some embodiments, there is no outer groove on the outer surface of the collar 2602. Additionally, in some embodiments, collar 2602 is not optically transparent.As described above in Figures 23 and 24, the distal end of the drill tip region can include a smaller diameter region 2613 to help prevent the drill tip from deflecting away from even hard obstructing materials.

[0184] Fig.28A and 28B An alternative selectively curved support 2806 is shown according to some embodiments. The selectively curved support 2806 can be used in conjunction with the selectively curved support 2206 ( Figures 22A to 22C) is similar to the selective bending support 2806 because it is configured to provide an offset bend of the distal end of the catheter. The selective bending support 2806 includes a backbone 2809 connected to a plurality of ribs: a proximal portion 2807, a distal portion 2808, and one or more intermediate ribs 2850. In some embodiments, the distal portion 2808 includes an engagement feature 2820 for engaging with, for example, a collar of an outer shaft. The intermediate rib 2850 can provide torsional strength. For example, the intermediate rib 2850 can provide lateral stability for the selective bending support 2806 (and the distal end of the catheter), thereby providing resistance to torsional forces when the catheter is winding through a blood vessel. Since these ribs are spaced apart, the selective bending support 2806 can still be flexible enough to bend laterally in the direction of the backbone 2809. The number, thickness, and spacing between the ribs can be changed to achieve a desired compromise between flexibility and torsional strength. In some cases, the spacing between the ribs is determined by the diameter of the shaft flexible portion (e.g., braided portion) of the outer shaft.

[0185] Fig.29A and 29B Another selectively flexed support 2906 is shown having similar features to the selectively flexed support 2806, except that the selectively flexed support 2906 has a different intermediate rib configuration. For example, the intermediate ribs 2950 are thinner than the intermediate ribs 2850. In addition, some of the intermediate ribs 2950 are connected by connectors 2960. In some embodiments, the connectors 2960 can be oriented parallel to the backbone 2909.

[0186] Any of the catheter variations described herein may include a guidewire lumen as part of or attached to the outer shaft for receiving a guidewire therein.

[0187] Any of the catheter variations described herein may include a balloon as part of or attached to the outer shaft.

[0188] Fig. 27 2700. As the imaging element (e.g., OCT fiber) rotates along a central axis of rotation, light can radiate from a distal region of the device 2700 on a circular path 2702. A first portion 2704 of the light can exit the device 2700, while a second portion 2706 of the light can be obstructed by one or more markers of the device 2700. Because the marker(s) can be fixed relative to the device 2700 (including the tip body 2708), the marker(s) can be used as a reference regarding the position of the device 2700 (including the tip body 2708).

[0189] In any occlusion crossing device herein, the imaging element can be configured to image a front view image (in the distal direction). This configuration can be used instead of or in addition to a side view image.

[0190] In some embodiments, the collar can be configured to rotate with the tip body. Figures 24A to 24C A catheter 2400 is shown that is similar to catheter 2200 (including an outer shaft 2404, a removable inner shaft 2405, a rotatable distal body 2410, and a selectively bendable support 2406), except that the collar 2402 includes a groove 2442 configured to rotate with the tip body 2410. The groove 2442 can have substantially the same pitch as the groove 2412 on the tip body 2410 to provide a substantially continuous cut when the tip body 2410 and the collar 2402 are rotated.

[0191] The collar 2402 can be engaged with the end body 2410 using a locking mechanism, for example. The locking mechanism can be any type of locking mechanism, such as a mechanical lock, a friction lock, or other coupling mechanism. For example, the end body 2410 can include a first keying member 2430, which is configured to align and engage with a corresponding second keying member 2432 of the collar 2402. In some embodiments, the first and second keying members 2430, 2432 correspond to tab and groove features, step features, and / or groove tongue features. The first and second keying members 2430, 2432 can be disposed at any position on the end body 2410 and the collar 2402. In some cases, the first and second keying members 2430, 2432 are located on an outer surface (e.g., outer wall) and / or an inner surface (e.g., inner wall) of the end body 2410 and / or the collar 2402. For example, the first keying member 2430 may correspond to a groove or recess on the outer surface of the tip body 2410, and the second keying member 2432 may correspond to a protrusion of the collar 2402, the shape of which is configured to align and match with the first keying member 2430, so that the inner surface of the second keying member 2432 engages with the outer surface of the tip body 2410. The rotational movement of the tip body 2410 can lock the collar 2402 with the tip body 2410, thereby causing the collar 2402 to rotate as well. When the tip body 2410 rotates and advances in the forward direction, the pressure generated between the tip body 2410 and the collar 2402 can further strengthen the engagement of the first keying member 2430 and the second keying member 2432.

[0192] In addition, the collar 2402 can include one or more windows 2434 configured to axially align with one or more windows 2414 of the tip body 2410 when engaged with the tip body 2410 to provide signaling access for imaging elements outside the catheter 2400. In some cases, the user can be automatically notified when the tip body 2410 and the collar 2402 are not properly aligned and engaged. For example, if the collar 2402 becomes misaligned with the tip body 2410 (e.g., if the tip 2411 is accidentally pushed proximally relative to the outer shaft 2404), the (one or more) windows 2434 of the collar 2402 can become misaligned with the (one or more) windows 2414 of the tip body 2410, which signal can be detected by the imaging element and sent as feedback to one or more controllers. The distal tip includes a region 2413 having a smaller diameter than the rest of the slotted distal tip.

[0193] In some embodiments, the selectively bendable support 2408 can also include distally extending markings 2424 that are configured to be axially aligned with the imaging windows 2414 , 2434 to provide information regarding the relative orientation of the catheter 2400 .

[0194] Additionally, in some embodiments, the collar 2402 may be light transmissive (with Figures 23A to 23C similar to the collar 2302).

[0195] In some embodiments, the tip body and the collar can be configured to reduce rotation of the tip body in response to a resistance force applied to the tip body. Fig.25A and 25BA collar 2502 is shown that can replace the collar 2402 of the catheter 2400. The collar 2502 can be similar to the collar 2402, except that the second keying member 2532 of the collar 2502 can have a different geometry than the second keying member 2432 of the collar 2402. The second keying member 2532 can have an angled wall 2590 that is configured to allow the collar 2502 to impart when subjected to a rotational resistance above a certain amount. For example, an edge (or lip) 2495 of the tip body 2410 can slide along one of the angled walls 2590 of the collar 2502 so that the first keying member 2430 can move out of the first keying member 2430 of the tip body 2410, causing the second keying member 2532 to separate from the first keying member 2430 (e.g., in some cases, causing the collar 2502 to move slightly laterally relative to the tip body 2410). In this way, when the limit of resistance is reached by rotating the tip body 2410 and the collar 2502, the locking mechanism may be broken, thereby allowing the tip body 2410 to rotate without the collar 2502. In some applications, this may advantageously prevent tissue bunching, which may otherwise occur, for example, in the adventitia. In some embodiments, the user may determine that the collar 2502 is not rotating and may be used to inform an action (e.g., stopping the rotation of the tip body 2410 to readjust the positioning of the catheter 2400).

[0196] As described above, any catheter described herein may include an imaging element. The imaging element may include an optical fiber, such as an optical coherence tomography (OCT) imaging fiber. The optical fiber may extend within a drive shaft or inner shaft to extend substantially along the central axis of the catheter over the entire length of the optical fiber. The optical fiber may be attached to the distal end and / or distal drill end of the drive shaft or inner shaft, but may also be freely floating within the drive shaft in other ways. The imaging fiber may transmit OCT signals for imaging a blood vessel in which the device is placed. In some embodiments, the imaging fiber may have a polyimide coating that coats the imaging fiber within the length of the drive shaft to support and protect the optical fiber as it rotates within the drive shaft. In addition, the handle described herein may be configured to accommodate a certain amount of slack in the optical fiber to facilitate telescoping of the drive shaft relative to the hollow shaft.

[0197] The imaging element may also include a reflector oriented at an angle (e.g., 30 to 60 degrees, such as 45 degrees) relative to the central axis of the optical fiber so that light from the optical fiber reflects from the reflector and enters adjacent tissue. The distal end of the optical fiber may be held in place with glue. The refractive index of the glue may be configured to be appropriately mismatched with the refractive index of the optical fiber, as described in U.S. Patent Application No. 12 / 790,703, entitled "OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICAL IMAGING" and published as US-2010-0305452-A1, filed on May 28, 2010; and International Patent Application No. PCT / US2013 / 031951, entitled "OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING", filed on March 15, 2013, both of which are incorporated by reference in their entirety. Additionally, the glue can have a meniscus shape along its outer edge, as described in International Patent Application No. PCT / US2013 / 031951, entitled "OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING," filed on March 15, 2013, which is incorporated herein by reference. The meniscus shape can advantageously ensure that the light reflected from the glue surface and returned into the optical fiber is significantly smaller than the reference light.

[0198] The drive shaft or inner shaft and thus the imaging element or optical fiber can be configured to rotate continuously at high speed in one or both directions, such as at a speed of greater than 500 rpm, greater than 600 rpm, greater than 700 rpm, greater than 800 rpm, greater than 900 rpm, or greater than 1000 rpm, such as between 500 and 1000 rpm, to provide OCT imaging around the inner circumference of the blood vessel. This high speed rotation in a single direction or different directions selected by the user (compared to the need to rotate alternately in two directions to manage the optical fiber) allows for faster acquisition of image data, thereby providing more accurate and up-to-date images during use of the device 100. For example, images can be generated at a rate of greater than 6 frames per segment (fps), such as greater than or equal to 8 fps or greater than or equal to 10 fps, such as approximately 16.67 fps. In an exemplary embodiment, the laser scanning rate (such as approximately 20 KHz) can be configured to be maintained at 16.67 frames per second, with approximately 1200 lines per frame.

[0199] Advantageously, because the optical fiber extends through the center of the catheter described herein, the diameter of the catheter can be relatively small. For example, the outer diameter of the catheter described herein can be less than 0.10", such as less than 0.08", such as less than 0.07", less than 0.06", or less than 0.05". Therefore, the catheter described herein can be advantageously used in small diameter peripheral arteries and coronary arteries.

[0200] In some embodiments, the catheter described herein can be configured to be attached to a drive system. The drive system can include a rotating optical joint configured to rotate an optical fiber. Exemplary drive systems that can be used with the device herein are described in U.S. Patent Application No. 13 / 654,357, entitled "ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATION MECHANISM FOR CATHETERS," filed on October 17, 2012, and International Patent Application No. PCT / US2013 / 032089, entitled "ATHERECTOMY CATHETER DRIVE ASSEMBLIES," filed on March 15, 2013, which are incorporated herein by reference in their entirety.

[0201] In some embodiments, the drive system can communicate with the control system via a communication bus, which in some embodiments can be a CAN bus 2.0B. Such communication can be used to transmit status, such as direction, speed, operating status, and other information to the control system or console. Such communication can also be used to send control information to the drive system, such as operating commands, speed, direction, and parameter settings for compensating for the mechanical characteristics of the catheter. See Fig. 6A In one embodiment, a drive processor 1601 serves as the main control element of the drive system. The drive processor 1601 controls the motor 1603 via a motor controller 1602, which receives commands from the drive processor 1601 and returns status to the drive processor 1601. In addition to simple speed and direction control, the drive processor 1601 can also implement algorithms to optimize catheter performance. The drive processor 1601 communicates with the control system (e.g., the console of the device) via a CAN controller 1604 to send and receive commands and status. In addition, in this embodiment, a switch 1605 on the housing of the drive processor 1601 allows local control of the operating state. The switch 1605 can be replaced with an alternative hardware input, such as a button, a toggle switch, or a knob.

[0202] Additionally, in some embodiments, the drive system can communicate with the catheter via NFC or RFID to obtain information about the catheter. For example, this information may include catheter type, optimal rotation speed and direction, serial number, and many possible parameters. See Figure 6B, the drive system communicates with the catheter via the NFC / RFID reader 1606 and the NFC / RFID tag 1607 in the catheter to obtain the information stored in the tag.

[0203] The drive system can be configured to allow the drive shaft and cutter to continuously rotate in a clockwise or counterclockwise direction depending on the user's preference. Thus, in some embodiments, the drive system can include a user-addressable switch, such as a toggle switch, to set the desired direction.

[0204] Additionally, in some embodiments, the drive system may include a mechanism for determining the amount of rotation of the drive shaft in a clockwise or counterclockwise direction. Fig. 6A and 6B In one embodiment, for example, the drive system can provide information related to the direction of the motor. The speed and direction can be sensed by a data line in the control cable of the control system (or console), which can be a dedicated line or a multiplexed signal. The dedicated line can carry analog or digital signals. In one embodiment, the dedicated voltage line carries six discrete rates (vector speed + direction) that are interpreted by the control system or console to infer the speed and direction of the catheter.

[0205] See also Figures 7A to 7B In one embodiment, the marker in the drive system may include an asymmetric design or asymmetric positioning of the marker around the motor (see Fig. 7A ). The controller can then sense the motor direction by detecting different series of mark gaps and / or widths, such as Figure 7B shown.

[0206] Additionally, in some embodiments, the drive system may be configured to rotate the drive shaft at multiple discrete rates, and / or include a knob to allow a user to select a continuously variable speed.

[0207] Any of the catheters described herein may be shape-fixed, or include shape-fixed features, to enhance trackability and navigability.

[0208] As used herein, an imaging element may include an OCT optical fiber, such as the distal end of the optical fiber, and a reflector and adhesive for holding the reflector and optical fiber in place.

[0209] As described above, the catheters described herein may include optical coherence tomography imaging, such as common-path OCT. This OCT system is described in U.S. patent application No. 12 / 829,267, filed on July 1, 2010, entitled “CATHETER-BASED OFF-AXISOPTICAL COHERENCE TO MOGRAPHY PHY IMAGING SYSTEM” and publication number US-2010-0021926-A1; U.S. patent application No. 12 / 790,703, filed on May 28, 2010, entitled “OPTICAL COHERENCE TO MOGRAPHY FOR BIOLOGICAL IMAGING” and publication number US-2010-0305452-A1; and international patent application No. PCT / US2013 / 031951, filed on March 15, 2013, entitled “OPTICAL COHERENCE TO MOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING,” all of which are incorporated by reference in their entirety. Alternatively, other types of imaging may also be used with the catheters described herein. For example, the devices described herein may be configured to work with infrared spectroscopy or ultrasound.

[0210] The catheters described herein can be used for traversal of occlusions within a blood vessel. Advantageously, the device can advantageously improve trackability through bending / turning, and high imaging speed during traversal.

[0211] Although the features of the conduits described herein are described with respect to specific examples, it should be understood that some or all of the features of the conduits herein may be combined with some or all of the features of one or more other conduits described herein. For example, any drill tip described herein with respect to one embodiment may replace any drill tip described with respect to another embodiment. In addition, any feature described with respect to a conduit may be combined or replaced with any feature described with respect to another conduit.

[0212] Example

[0213] Figures 31A to 31B An example of a blocking traversing device (e.g., blocking traversing system) including at least some of the features described above is shown. Fig.31A In the embodiment, the blocking traversing system 3100 includes an outer shaft 3101, and the outer shaft 3101 includes an inner cavity 3107 (in Fig.31B31). The outer shaft also includes a distal opening 3109 that is angled relative to the central axis of the outer shaft 3101 to form a distal-most end 3113. The device also includes an inner shaft 3103 that extends in the lumen and is configured to rotate relative to the outer shaft. The inner shaft includes a distal end having a slotted end 3133 that is configured to extend through the distal opening. The distal end of the inner shaft also includes a lateral optical coherence tomography (OCT) imaging window 3135 located on the lateral side of the inner shaft at the distal region of the inner shaft.

[0214] The distal-most end of the distal opening is configured to block the OCT imaging window at a defined rotational position when the inner shaft is rotated relative to the outer shaft while the first engagement region is engaged with the second engagement region to provide a registration mark for OCT imaging.

[0215] exist Fig.31B middle, Fig.31A The device is shown in a cross-sectional view through the midline of the device. Although the proximal end of the device is not shown, a proximal attachment may be included that is configured to couple the internal member with the rotational drive and imaging subsystem (eg, for OCT imaging).

[0216] The outer shaft in this example also includes a diaphysis region 3141 located at the distal end portion of the outer shaft, and the diaphysis region 3141 is configured to offset the lateral curvature of the distal end portion. The offset can be located in a plane including the midline of the central axis and the distal end; Fig.31B In , the plane is the plane of the cross section (e.g., the midline that bisects the farthest end and passes through the central axis 3111). Fig.31A and 31B , the distal end of the device is shown as being curved. In some variations, the distal region of the outer shaft can be configured to bend in a predetermined direction after the inner member is driven distally relative to the outer member beyond a stop position. Alternatively, the outer member and / or the inner member can be biased to bend in a relaxed configuration and can be controllably straightened, for example, by driving the inner member distally.

[0217] As will be described in greater detail below, the distal opening at the distal end of the outer shaft is circumferentially angled such that it presents a cut-away tapered region (cut at an angle to the midline of the central axis to form the distal-most tip).

[0218] In this example, the inner shaft is configured to be removed proximally from the outer shaft, for example, by proximally retracting the inner shaft and pulling the inner shaft out of the outer shaft (not shown). The inner shaft is prevented from further extending from the outer shaft by engagement between an area of ​​the outer shaft (the first engagement area) and the inner shaft (the second engagement area), which will be described in more detail below.

[0219] Fig.32A and 32BAnother example of a blocked crossing device (eg, a blocked crossing system) is shown, which is similar to Figures 31A to 31B The device shown in is similar to that shown in , but may also include a balloon 3215. The balloon may be attached to the outside of the outer shaft (e.g., over the entire diaphyseal region 3241 or a portion thereof). Fig.32A Middle, balloon is not inflated; Fig.32B The inflated balloon is shown. The balloon can be very large to occlude the vessel (prevent or restrict blood flow) and can be inflated with saline from the proximal end (not shown).

[0220] Figures 33A to 33C Shown with Figures 31A to 31B Similar blocking occurs across the bend of the device. The inner shaft 3305 and the outer shaft 3303 can bend together. In this example, the inner shaft can flexibly follow the bend of the outer shaft, which includes a backbone region 3317 (at Fig.33B ), the backbone region 3317 can guide bending within a defined plane (in this example, the plane of the paper).

[0221] Figures 34A to 34D Shown above Figures 31A to 31B A similar enlarged view of the distal end of the blocking traversing device. In this example, the distal end of the outer shaft is formed by a rigid collar 3406, which includes an opening at the distal end through which the grooved distal end of the inner shaft 3608 (e.g., the drill end of the inner member) extends. The grooved distal end extends from the distal opening until the internal stop is engaged. The distal opening of the distal end of the outer shaft (e.g., formed by the rigid collar) is inclined inwardly at an angle α, which is toward the inner cavity, such as Fig.34A As shown (e.g. the outer member is circumferentially inclined). Figures 34A to 34D In the embodiment, the bevel angle α is the same, but can be different near the periphery. In this example, the angle is between about 25 and 35 degrees (e.g., 30 degrees).

[0222] The threaded or grooved distal end 3410 of the inner shaft wraps around a region having a first diameter D1, and a second distal region 3412 having a second diameter D2 extends from the first region, as shown in FIG. Fig.32A shown. Figures 34B to 34D Shows views of different sides of the same distal tip. Fig.34B , a rear view shows the farthest end 3422 of the distal opening of the outer shaft.

[0223] Fig.34DAn example of a lateral optical coherence tomography (OCT) imaging window 3432 is shown. As shown in this example, the imaging window is below the height of the distal-most end 3422 of the outer shaft. In operation, the inner shaft rotates while imaging through the lateral window; therefore, for each rotation, the imaging window will be temporarily obscured by the distal-most end of the outer shaft. As described above, this provides an indication of the orientation of the device relative to the image (vascular lumen). This can be used both for raw image viewing and when processing images to reduce noise or drift.

[0224] Generally, the inner shaft can be rotated in a clockwise or counterclockwise direction relative to the outer shaft at any appropriate rate. The direction of rotation can be advantageously used to position the distal end of the device, because the grooved distal end of the inner shaft can be rotated in a first direction (e.g., counterclockwise) to engage the sharp wedge shape of the grooves to cut tissue, or can be rotated in a second direction (e.g., clockwise) that is less cutting / less invasive. Since imaging (e.g., OCT imaging) can occur while rotating, in some cases it may be desirable to rotate the grooved distal tip for imaging, even when cutting tissue is not desired.

[0225] Fig.35 Shown through such as Figures 34A to 34D An example of a cross section of the distal end of the device is shown. Fig.35 As shown, the inner shaft 3505 can be advanced distally within the outer shaft 3503 so that the grooved distal end 3508 extends from the distal opening of the outer shaft. The inner shaft can be advanced until an engagement region 3519 of the inner shaft (shown as an annular region having a larger outer diameter than the rest of the inner shaft) engages against an engagement region 3521 on the inner cavity of the outer shaft (shown here as an area of ​​narrowed diameter near the distal end of the outer shaft). In this example, the engagement region of the inner shaft can be rotated against the engagement region of the outer shaft so that the inner shaft can rotate freely relative to the outer shaft. The area may include a lubricant and / or may be coated or formed with a lubricating material. In some variations, one or both surfaces may include small channels or cut-out areas that form a fluid bearing. Although Fig.35 The engagement area of ​​the inner shaft is shown as a circular ring, but other configurations may be used, such as multiple discrete areas rather than a continuous ring. Fig.35 In the embodiment, the inner shaft also includes an optical fiber line 3526 extending downwardly along the length of the inner shaft, and the optical fiber line 3526 is connected to the OCT imaging window 3536 at the distal end and can form a part of the imaging window.

[0226] Fig.36 Show Figures 34A to 34D , including the shaft region of the outer shaft 3603, the distal region 3604 of the outer shaft including the farthest end, the OCT imaging window 3617, and the grooved distal region 3603 of the inner shaft. The distal region of the inner shaft also includes an annular engagement region 3619.

[0227] Figures 37A to 37D A rotated view of the distal end of the outer shaft is shown formed as a rigid collar 3706, which includes an opening at the distal end 3708 of the outer shaft and a circumferential bevel 3716, as described above. The distal end of the outer shaft also includes a distal-most tip 3719.

[0228] Figures 38A to 38D An example of a distal region of an inner shaft is shown, showing a slotted end region 3844 configured to extend through a distal opening of an outer shaft. The slotted end region includes a first slotted end portion 3847 having a first diameter D1, and a second end region 3845 extending from the first slotted end region. The diameter D2 of the second end region is less than 60% of the first diameter (in this example, less than 40% of D1). The distal end of the inner shaft also includes a lateral optical coherence tomography (OCT) imaging window 3814 located on the lateral side of the inner shaft at the distal region of the inner shaft. As shown, the imaging window can be located distally, such as adjacent to the slotted region or overlapping with the slotted region. In Figures 38A to 38D In the embodiment, the distal region of the inner shaft further includes an annular engagement region 3824 on the outer surface of the inner shaft, and when the annular engagement region 3824 engages with the inner engagement region of the outer shaft, the distal movement of the inner shaft within the outer shaft can be limited, as described above in Fig.35 Described in . Fig.38E Show Figures 38A to 38D A rear perspective view of the same distal region is shown.

[0229] Figures 39A to 39D Shown with Figures 38A to 38D Other details on the grooved distal region of the inner shaft are similar, including a more proximal grooved region and a distal protrusion of smaller diameter, in this example, being a point. Fig.39E Shown is a top view looking down at the grooved distal end of the inner shaft. Fig.39E The top view of shows the relative diameters of the first grooved region 3953 ( D1 ) and the second grooved region 3951 ( D2 ).

[0230] Any catheter device described herein may include an interchangeable inner shaft and outer shaft that are removably and rotatably coupled to each other. In some embodiments, the inner shaft and outer shaft are coupled by one or more connectors that are configured to allow the inner shaft to rotate relative to the outer shaft. The connector may be part of a handle (e.g., Fig.11A , 11B, 12 and 13), and may include any of a variety of connector types (e.g., Luer connectors, valve connectors, fittings, and / or gasket connectors). In some embodiments, the inner shaft can be configured to couple to more than one type of outer shaft. Similarly, the outer shaft can be configured to couple to more than one type of inner shaft. This versatility can allow a user to easily replace an inner shaft or outer shaft between intravascular procedures. For example, returning to Fig.32A and 32B , the outer shaft with the balloon 3215 can be separated from the inner shaft after one procedure and replaced with a different outer shaft without the balloon in a subsequent procedure.

[0231] Fig.40 Another example of a catheter device 4020 having a different variation of an outer shaft 4022 is shown. The outer shaft 4022 may include a first lumen 4030 for accommodating an inner shaft 4031, and a second lumen 4032 (also referred to as a guidewire lumen or a monorail guidewire lumen) for accommodating a guidewire. The outer shaft 4022 and the inner shaft 4031 may extend proximally and be rotatably coupled together by a connector at the handle region of the catheter device 4020. The monorail outer shaft 4022 configuration may be used for procedures where a guidewire may support placement of the catheter device 4020 within an appropriate blood vessel, such as with Fig.15 4020 . The diameter of the guidewire lumen 4032 can vary. In some embodiments, the diameter of the guidewire lumen 4032 is large enough to accommodate a standard guidewire (e.g., a guidewire with a diameter of 0.014 inches). The outer shaft 4022 may include or be used with the backbone 4035 to provide an offset bend as described herein. In some cases, the guidewire lumen 4032 is radially aligned with the backbone 4035 to allow for offset flexure of the catheter 4020. In some embodiments, the outer shaft 4022 does not include a circumferential cutout (see, e.g., Fig.15 ).

[0232] Inner shaft 4031 can include any inner shaft feature described herein, such as imaging element / optical fiber, drill body / end, collar and / or other inner shaft feature described herein. In some cases, outer shaft 4022 can be made of optically transparent material at least in part to allow imaging element in inner shaft 4031 to take images through outer shaft 4022. In other embodiments, outer shaft 4022 is made of optically opaque material. Guidewire cavity 4032 can extend distance 4041 along the length of outer shaft 4022. In some embodiments, the distance 4041 of guidewire cavity 4032 only extends along a portion of the length of outer shaft 4022. In some cases, distance 4041 is in the range of about 10 centimeters (cm) to about 50cm (e.g., about 10cm, 20cm, 25cm, 30cm, 45cm or 50cm). In other embodiments, the distance 4041 of guidewire cavity 4032 extends substantially along the entire length of outer shaft 4022. Therefore, distance 4041 can extend proximally to the handle or its vicinity. Generally, a longer guidewire lumen provides more support for the guidewire than a shorter guidewire lumen.

[0233] The catheter device 4020 can be used in any of a variety of ways. In one example, the inner shaft 4031 is placed in the first lumen 4030 of the outer shaft 4022, and the inner shaft and the outer shaft are connected together at the handle; and the guide wire is placed in the second lumen 4032. Then, the catheter device 4020 (wherein the inner shaft 4031 and the outer shaft 4022 are rotatably connected) can be placed in the patient's blood vessel. The imaging device (e.g., including an optical fiber) in the inner shaft 4031 can be used to guide the assembly to a target position in the blood vessel, such as an obstruction or its vicinity. For example, the optical fiber and the inner shaft 4031 can be rotated relative to the outer shaft 4022 to provide a panoramic view of the inner wall of the blood vessel during positioning. In some cases, the outer shaft 4022 can be configured to allow imaging to occur through the wall of the outer shaft 4022. For example, the wall of the outer shaft 4022 can be optically transparent and / or include one or more windows. The drill tip 4011 can be used to traverse the obstruction, and the guide wire can be guided through the obstruction site. After the occlusion crossing procedure is completed and the catheter 4020 is removed from the blood vessel (e.g., by pulling the catheter 4020 proximally), the outer shaft 4022 can be separated from the inner shaft 4031 at the handle. The inner shaft 4031 can then be rotatably coupled to a different outer shaft for use in other different intravascular procedures.

[0234] Fig.41A and 41BAnother catheter device 4120 of different variations with an outer shaft 4122 is shown, and the outer shaft 4122 can be removably connected to any inner shaft (e.g., 4131) described herein. The outer shaft 4122 may include a first lumen 4130 for accommodating the inner shaft 4131, and a second lumen 4132 (also referred to as a guidewire lumen or a single-track guidewire lumen) for accommodating a guidewire. Under this configuration, the outer shaft 4122 may be suitable for guiding the inner shaft 4131 through a blood vessel to take an image of at least a portion of the blood vessel. This configuration may be configured to not use the blocking traversing feature of the inner shaft 4131. The outer shaft 4122 may have a closed distal end 4135, which covers the end body 4110 of the inner shaft 4131, so that the drill tip of the end body 4110 does not advance outside the outer shaft 4122 when located in the blood vessel. In some embodiments, the inner shaft 4131 does not include the end body 4110. In some embodiments, the distal end 4135 of the outer shaft 4122 may have a tapered shape to facilitate manipulating the distal end 4135 through a blood vessel. In some embodiments, an imaging component or element (e.g., an imaging fiber) as part of an imaging system (e.g., OCT) may be included in the inner shaft 4131, and may be configured to rotate relative to the outer shaft 4122 with the inner shaft 4131 to take an image of the blood vessel. In some cases, the outer shaft 4122 may be at least partially made of an optically transparent material, or may include one or more windows to allow the imaging element in the inner shaft 4131 to take an image through the outer shaft 4122. In some cases, the distal portion of the outer shaft 4122 may include or be used with a backbone 4135, which is configured to provide a biased bend along a plane, as described herein. In some cases, the guidewire lumen 4132 is radially aligned with the backbone 4135 (e.g., relative to the longitudinal axis of the first lumen or the inner shaft) to allow biased flexure of the catheter 4120. In other embodiments, the distal portion of the outer shaft 4122 does not include the backbone. The guidewire lumen 4132 can extend a distance 4141 along the length of the outer shaft 4122. In some embodiments, the distance 4141 of the guidewire lumen 4132 extends only along a portion of the length of the outer shaft 4122. In some cases, the distance 4141 is in the range of about 10 centimeters (cm) to about 50cm (e.g., about 10cm, 20cm, 25cm, 30cm, 45cm or 50cm). In other embodiments, the distance 4141 of the guidewire lumen 4132 extends along the entire length of the outer shaft 4122. Therefore, the distance 4141 can extend proximally to the handle or its vicinity.

[0235] The catheter device 4120 can be used in any of a variety of ways. In one example, the inner shaft 4131 (which may or may not be attached with the end body 4110) is placed in the first lumen 4130 of the catheter device 4120 and is coupled to the first lumen 4130 at the handle; and the guide wire is placed in the second lumen 4132. The catheter device 4120 (where the inner shaft 4131 and the outer shaft 4122 are rotatably coupled) can be placed in the patient's blood vessel. The inner shaft 4131 can be guided along a certain length of the blood vessel by the guide wire, and the imaging device (e.g., including an optical fiber) in the inner shaft 4131 can be used to observe the image in the blood vessel. In some cases, the inner shaft 4131 translates a certain distance in the outer shaft 4131 to collect images along a specific segment of the blood vessel. The inner shaft of the optical fiber and the inner shaft 4131 can be rotated relative to the catheter device 4120 to provide a panoramic view of the inner wall of the blood vessel. The catheter device 4120 can be configured to allow imaging to occur through the wall of the catheter device 4120. For example, the wall of the catheter device 4120 can be optically transparent and / or include one or more windows. In this way, the catheter device 4120 can be used to visualize a section of a blood vessel before or after other different intravascular procedures. After imaging is completed and the catheter 4120 is removed from the blood vessel (e.g., by pulling the catheter 4120 proximally), the outer shaft 4122 can be separated from the inner shaft 4131. Then, the inner shaft 4131 can be rotatably coupled to a different outer shaft for use in other different intravascular procedures (e.g., occlusion traversal procedures).

[0236] As described herein, the outer shaft may include an expandable device, such as a balloon (e.g. Fig.32A and 32B ) to prevent or reduce blood flow during at least part of the procedure. Fig.42 Another example of a catheter device 4220 having a different expandable device is shown. In this case, the catheter 4220 includes an outer shaft 4222 having an expandable bag 4200 (also called a parachute), which can be used with any inner shaft described herein (e.g., 4231). The bag 4200 can include a cap portion 4255, a proximal connection region 4232, an opening 4260, and one or more tethers 4250. The bag 4200 can be configured to maintain an expanded state or a collapsed state, in which the diameter of the bag 4200 is much larger than the outer diameter of the catheter 4220 (e.g., as shown in FIG. 4B ). Fig.424260), in the collapsed state, the diameter of the bag 4200 approaches the outer diameter of the catheter 4220. The catheter 4220 can be inserted and oriented in a blood vessel so that blood flow primarily flows from a proximal position to a distal position along the outer axis 4222, and the cap portion 4255 is positioned distally along the catheter 4220 relative to the opening 4260. Blood flow through the opening 4260 can be collected in the cap 4255 and the cap 4255 expanded. In the expanded state, the outer surface of the cap 4255 can contact the inner surface of the blood vessel and restrict (e.g., reduce or prevent) blood flow within the blood vessel from flowing distally through the cap 4255. In some embodiments, the proximal connection region 4232 includes a ring surrounding the outer axis 4222. The proximal connection region 4232 can be connected to the cap 4255 via one or more tethers 4250. In some cases, the tethers 4250 extend from an edge 4261 of the cap 4255 that at least partially defines the opening 4260. In Fig.42 In the example shown, bag 4200 includes four tethers 4250; however, any number of tethers (e.g., 1, 2, 3, 4, 5, 6, 10, 20, or more tethers) may be used.

[0237] The expandable bag 4200 may have a similar function to a balloon (e.g. Fig.32A and 32B ). For example, bag 4200 can be used to reduce or prevent blood from flowing around the imaging portion of catheter 4220, thereby allowing better visualization within the vessel by an imaging device when catheter 4220 is manipulated within the vessel (e.g., before, during, and / or after an occlusion traversal procedure). In some cases, the expanded bag 4200 can be used to apply a substantially uniform radial outward force to radially center the drill tip of inner shaft 4231 within the vessel. This can prevent or reduce damage to the vessel wall when catheter 4220 is manipulated within the vessel. For example, keeping the drill tip substantially centered within the vessel can help prevent or reduce contact and possible damage to a portion of the vessel wall by the drill tip while catheter 4220 is advancing through the vessel to a target site and / or at a target site before, during, and / or after an occlusion traversal procedure.

[0238] In some embodiments, the bag 4200 is configured to expand and collapse passively. For example, the cap 4255 can be configured to expand only under the action of blood flow forces. To collapse the bag 4200, the catheter 4220 can be pulled proximally so that the vessel wall forces the tethers 4250 to collapse radially inward toward the catheter 4220. Blood collected in the cap 4255 will be forced to exit the cap from between the tethers 4250 through the openings 4262 until the cap 4255 assumes a substantially collapsed state against the outer shaft 4222 until the catheter 4220 is removed from the vessel.

[0239] Bag 4200 can be made of any of a variety of materials. In some embodiments, at least a portion of bag 4200 can be made of one or more flexible biocompatible materials, such as a flexible biocompatible polymer sheet. In other embodiments, bag 4200 includes a more rigid material, such as a metal (e.g., nitinol) and / or a rigid polymer material. For example, bag 4200 can have a mesh or cage structure formed by a plurality of rigid material filaments. In this case, at least cap 4255 can be covered by a sheath (e.g., a polymer and / or fabric) so that cap 4255 can adequately hold blood to expand.

[0240] The bag 4200 can be attached to any portion of the outer shaft 4222. In some embodiments, the bag 4200 is coupled to the offset curved portion 4265 at the distal region of the outer shaft 4222. Fig.42 In the example shown, the bag 4200 is coupled to a portion of the outer shaft 4222 proximate to the offset curved portion 4265. Alternatively, the bag 4200 may be partially located on the offset curved portion 4265. For example, the distal end 4230 of the bag 4200 may be coupled to the offset curved portion 4265, and the proximal connection region 4232 of the bag 4200 may be coupled to a region of the outer shaft 4222 proximate to the offset curved portion 4265.

[0241] The outer shaft 4222 can include one or more outer shaft features described herein. For example, the outer shaft 4222 can include a backbone 4235 to provide an offset bend of the outer shaft and catheter 4220. As another example, the outer shaft 4222 can include a circumferential cut that extends at least partially through the thickness of the outer shaft 4222. As another example, a terminal region at the distal end of the outer shaft can be tapered and configured to pass in front of the imaging element as the imaging element rotates, such that the terminal region serves as a registration mark. As another example, the outer shaft can include a first engagement region located on an inner surface of the outer shaft and configured to extend through a distal opening of the outer shaft, and the inner shaft can include a second engagement region located on an outer surface of the inner shaft and configured to engage with the first engagement region to limit distal movement of the inner shaft within the outer shaft (e.g., Fig.35 ).

[0242] Any catheter device described herein may include a fluid flushing feature, wherein a fluid (e.g., saline solution) is discharged around the distal portion of the catheter. The fluid pressure of the fluid may be high enough to at least partially stop (e.g., stop bleeding) or reduce the blood flow at the distal end of the catheter. This may enhance the visibility around the distal end of the catheter so that an imaging device may obtain a clear image in the blood vessel during at least part of the intravascular procedure. The fluid may be transported to the distal end of the catheter by extending from the proximal portion of the catheter to the distal portion of the catheter. In some cases, the passage may be a tube or sheath located in the lumen and / or inner shaft of the outer shaft, or attached to the lumen and / or inner shaft of the outer shaft. In some cases, the passage may be an elongated opening on the wall of the outer shaft and / or inner shaft, which at least partially spans the length of the outer shaft and / or inner shaft. The fluid may leave one or more ports at the distal portion of the catheter, which may be located in or on the outer shaft and / or inner shaft. One or more valves, pumps, and / or regulators at the proximal portion of the catheter may be used to control the fluid pressure leaving one or more ports. In some cases, fluid irrigation is used in conjunction with other hemostatic or blood flow reduction mechanisms. For example, a fluid irrigation catheter may include an inflatable balloon (e.g., Fig.32A and 32B ) or expandable bags (e.g. Fig.42 ). When fluid is expelled from a port at the distal end of the catheter, the balloon or bag can be inflated to at least partially block blood flow through the vessel.

[0243] As mentioned above, see for example Figures 24A to 24C and 25A-25B, the collar may be configured to rotate with the drill bit end and the inner shaft. Figures 43A to 43I A catheter device 2400 ( Figures 24A to 24C ) but with a different collar feature and optical window arrangement. Similar to catheter device 2400, collar 4302 is configured to rotate with drill tip body 4310, which is coupled to and rotates with the inner (drive) shaft. Rotation of collar 4302 during a cutting procedure can prevent collar 4302 from getting caught on tissue as device 4300 is advanced through a vessel, thereby increasing cutting efficiency and improving forward movement of catheter 4300.

[0244] In addition, if Fig.43C and 43DAs shown, the collar 4302 may include a surface feature configured to cut tissue (e.g., blockage) to facilitate forward movement through the tissue. In this example, the distal end of the collar 4302 includes one or more grooves 4350a, 4350b, 4350c, and 4350d, which define a plurality of cutting edges (e.g., 4355a1, 4355a2, 4355c1, and 4355c2) to engage with the tissue and cut the tissue when rotating, thereby further increasing forward movement. Compared with the spiral / helical grooves in other examples, the cutting edges (e.g., 4355a1, 4355a2, 4355c1, and 4355c2) may be non-helical (e.g., straight), and are arranged so that the cutting edges are substantially parallel to the axis of rotation. In the example shown, the collar 4302 includes four surface grooves 4350a, 4350b, 4350c, and 4350d, each of which defines two cutting edges. However, the collar may also have any number of grooves and cutting edges. In some examples, one or more outer surfaces 4360 may include abrasive surface features, such as one or more protrusions, one or more notches, and / or adhered abrasive material (e.g., diamond particles) to further improve the cutting efficiency of the collar 4302.

[0245] Device 4300 and Figures 24A to 24C Another difference of the device 2400 is that the collar 4302 may not include an optical window. Fig.43E and 43F As shown, the optical imaging window 4314 of the drill tip body 4310 can be configured to extend at least partially distally through the collar 4302, such that at least a portion of the window 4314 is located distally relative to the collar 4302, thereby allowing the imaging element to collect images from outside the device 4300. Compared to some other configurations, this configuration can allow the window 4314 to be closer to the distal end of the drill tip body 4310, thereby allowing images to be collected closer to the cutting area.

[0246] The apparatus 4300 may include Figures 24A to 24C A locking mechanism similar to the device 2400 is provided to allow the drill end body 4310 to engage and rotate with the collar 4302. Fig.43E and 43F As shown, the distal portion of the collar 4302 may include an edge 4317 that is configured to abut a stopper 4315 protruding from an outer surface of the drill tip body 4310 to prevent the tip body 4310 from completely passing through the collar 4302. Fig.43FThe drill tip body 4310 is shown translating distally within the collar 4302 such that the stopper 4315 engages (contacts) with the edge 4317 of the collar 4302, thereby preventing the drill tip body 4310 from extending distally all the way through the collar 4302. The outer surface of the drill tip body 4310 may include a first keying member located at a proximal region of the drill tip body 4310, the first keying member being configured to engage with a corresponding second keying member at a proximal region of the collar 4302. In this example, the first keying member may correspond to one or more notches 4320 extending laterally into the drill tip body 4310 and located within the semi-annular stopper 4315, thereby forming a flattened surface at the proximal region of the drill tip body 4310 at each notch 4320. The second keying member of the collar 4302 may include one or more rods 4322 protruding proximally and laterally from the proximal edge of the collar 4302. The protruding rod 4322 of the collar 4302 can be configured to enter the recess 4320 of the end body 4310 when the end body 4310 is translated distally within the collar 4302. When the drill end body 4310 is rotated in either direction (clockwise or counterclockwise), the walls 4324 on both sides of the recess 4320 can retain the rod 4322 in the recess 4320. When the end body 4310 is rotated to the extent that the wall 4324 engages with the corresponding rod 4322 disposed therein, the locking feature can be activated. In some cases, the collar 4302 is configured to rotate with the drill end body 4310 when the stopper 4315 of the drill end body 4310 contacts or nearly contacts the edge 4317 of the collar 4302. In some cases, the inner shaft and the drill end body 4310 are configured to rotate in clockwise and counterclockwise directions. This may be advantageous, for example, where rotation of the drill tip body 4310 in various directions provides differentiated cutting aggressiveness.

[0247] In the illustrated example, the collar 4302 includes two protruding rods 4322 located on opposite sides of the collar 4302, and the drill end body 4310 includes two recesses 4320 located on opposite sides of the drill end body 4310. However, the collar and the drill end body may include any number of rods and recesses (e.g., 1, 2, 3, 4, 5, 6, 8, 10, 20). To separate the drill end body 4310 from the collar 4302, for example, when removing the inner shaft from the device 4300 for inserting a guide wire or a guide catheter, the inner shaft (coupled with the drill end body 4310) can be translated proximally (e.g., toward the handle) to separate one or more rods 4322 from the corresponding recesses 4320.

[0248] Figures 43G to 43I4302 is shown how the collar 4302 can be configured to be held in position longitudinally relative to the outer shaft when rotated relative to the outer shaft. The collar 4302 can include an annular groove 4340 configured to receive one or more tabs 4342a, 4342b, 4342c, 4342d, 4342e, and 4342f of the outer shaft (e.g., a mounting bracket 4306 portion of the outer shaft) to hold the collar 4302 in position longitudinally relative to the outer shaft when the collar 4302 is rotated relative to the outer shaft. In this example, the tabs 4342a-4342f are located at a distal portion of the outer shaft and the groove 4340 is a proximal portion of the collar 4302. The tabs 4342a-4342f can be configured to bend (e.g., during assembly of the device 4300) so as to protrude radially within the annular groove 4340 (e.g., not contact the bottom surface of the groove 4340). In the example shown, the outer shaft (mounting frame 4306 portion of the outer shaft) includes six tabs 4342a to 4342f. However, the outer shaft (e.g., the mounting frame portion of the outer shaft) can have any number of tabs (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, or more). When disposed in the groove, the tabs 4342a to 4342f can contact the edge 4344 defining the annular groove 4340 when the collar 4302 is longitudinally translated, thereby holding the collar 4302 in position longitudinally relative to the outer shaft and preventing the collar 4302 from separating from the device 4300. The annular shape of the groove 4340 around the outer surface of the collar 4302 allows the collar 4302 to rotate freely relative to the outer shaft. In some cases, the mounting frame may not be configured to rotate (e.g., coupled to a handle so as not to rotate substantially).

[0249] Since the collar 4302 can be longitudinally (axially) held in position relative to the outer shaft (e.g., the selectively bendable support 4306 portion of the outer shaft), the catheter 4300 can be bent by applying a thrust against the collar 4302 to the drill tip body 4310. For example, once the stop 4315 is pressed against the proximal edge 4317 of the collar 4302, the inner shaft can be further pushed in the distal direction to apply a pressing force against the proximal edge of the collar 4302, thereby bending the bending area of ​​the catheter 4300. As described above, the translational movement can be regulated by a control mechanism at the proximal end, which provides a relatively small amount of translation between the inner shaft and the outer shaft (e.g., between about 0.125 inches and about 0.75 inches) while still allowing the collar 4302 to be rotationally coupled to the drill tip body 4310 (e.g., via a connector, such as a Luer lock). In some cases, the maximum translational movement provided by the control mechanism is about 0.75 inches. In some cases, the maximum translational movement provided by the control mechanism is about 0.50 inches. The control mechanism can be any mechanism that allows controlled translational movement of the inner shaft relative to the outer shaft. In some cases, the control mechanism can be part of the handle and include a slider (e.g., 303). See again Fig.43A and 43B , applying a pressing force can bend the stem 4325 (also called a selective bending support) of the mounting frame 4306 in a direction toward the stem 4325, so that the side of the mounting frame 4306 opposite the stem 4325 expands. As shown, the stem 4325 can correspond to a narrow solid band extending longitudinally along the outer axis.

[0250] Fig.43J 43 is a flow chart of an exemplary method of using the catheter device 4300. The locking features of the collar 4302 and the drill end body 4310 can be engaged (4371) by inserting the drill end body 4310 into the collar 4302 in the distal direction. The drill end body 4310 and the collar 4302 can be rotated (4373) in either direction (clockwise or counterclockwise), for example, to traverse an obstruction in a blood vessel. The device 4300 can be straightened (for example, if it is already in a curved configuration) or bent in a first direction (towards the backbone) by pushing the inner shaft (4375) while the drill end body 4310 and the collar 4302 are rotated. This bending can facilitate the navigation of the device 4300 in the blood vessel and through the obstruction. After traversing the obstruction, the inner shaft can be removed from the outer shaft by pulling the inner shaft (4377) while leaving the outer shaft in the blood vessel. Then, optionally, a guide wire or a guide catheter is inserted into the outer shaft (4379).

[0251] Figures 44A to 44IAn example catheter device 4400 is shown having similar features to the catheter device 4300, but the catheter device 4400 includes a different optical window configuration and locking features that allow the catheter device 4400 to be straightened and / or bidirectionally bent. In this example, the locking features of the collar 4402 and the drill end body 4410 can be configured to longitudinally hold the collar 4402 in place when a pulling force is applied to the inner shaft. This can allow the catheter device to be straightened or bent in a direction opposite to the diaphysis 4425 (and bent toward the diaphysis when a thrust is applied) when a pulling force is applied to the inner shaft. The collar 4402 can include a recess 4420 located at the proximal end of the collar 4402 and including one or more keyways 4424a and 4424b for limiting distal and proximal movement of the drill end body 4410. The keyways 4424a and 4424b can be configured to receive the keys 4422a and 4422b of the drill end body 4410, which protrude radially from the outer surface of the drill end body 4410. In this example, the collar 4402 includes two keyways 4424a and 4424b, and the drill end body 4410 includes two keys 4422a and 4422b. However, the devices described herein can have collars including any number of keyways (e.g., 1, 2, 3, 4, 5, 6, 8, 10, or more), and drill end bodies including any number of keys (e.g., 1, 2, 3, 4, 5, 6, 8, 10, or more).

[0252] like Figures 44C to 44F As shown, each keyway 4424a or 4424b can correspond to a T-shaped cutout with a gap (e.g., 4450) to allow the key 4422a or 4422b of the drill end body 4410 to enter and leave the keyway 4424a or 4424b when properly aligned. To engage the collar 4402 and the drill end body 4410, the drill end body 4410 is rotated until the keys 4422a and 4422b are axially aligned with the gap (e.g., 4450), and then translated distally (e.g., by pushing the inner shaft) until the keys 4422a and 4422b enter the corresponding cutouts. The keyway 4424b can have multiple edges for holding the key 4424a or 4424b therein. The distal edge 4417 in the recess 4420 of the collar 4402 can be configured to abut the key 4422b to prevent the end body 4410 from completely passing through the collar 4402. The transverse edges 4425a and 4425b can limit the axial movement of the key 4422a or 4422b when it is in the keyway 4424b. The rotational movement of the drill end body 4410 can cause the key 4422a and 4422b to contact one of the transverse edges (e.g., transverse edges 4425a and 4425b), such as Fig.44FIn this manner, collar 4402 can remain engaged with drill bit end body 4410 when drill bit end body 4410 is rotated in either direction (clockwise or counterclockwise).

[0253] If key 4422a or 4422b is not axially aligned with gap 4450, undercut edges 4430a and 4430b may prevent key 4422b from leaving recess 4420 when drill tip body 4410 is pulled proximally. Fig.44F The key 4422b is shown positioned within the keyway 4424b and not axially aligned with the gap 4450, such that when the drill tip body 4410 is pulled proximally, the undercut edge 4430b prevents the key 4422b from leaving the gap 4450. In this manner, the collar 4402 can remain coupled to the drill tip body 4410 when a translational force (pulling force) is applied to the drill tip body 4410 in a proximal direction (e.g., via an inner shaft). In addition, appropriate pulling force can be applied to the mounting bracket 4406 to straighten the device and, in some cases, bend the device in a direction opposite to the backbone 4425. Figures 47A to 47C and 48A to 48E further describe in detail how the mounting bracket 4406 can be configured for unidirectional and bidirectional bending, as well as controlling the degree of bending of the device.

[0254] To disengage the collar 4402 from the drill tip body 4410, the drill tip body 4410 may be rotated so that the keys 4422a and 4422b are again aligned with the gaps (e.g., 4450) of the collar 4402, and then the drill tip body 4410 may be translated proximally (e.g., by pulling the inner shaft) until the keys 4422a and 4422b are released from the cutouts 4424a and 4424b. Disengagement may involve stopping the rotation of the drill tip body 4410 and the inner shaft, rotating the drill tip body 4410 slightly (e.g., less than one full turn) to align the keys 4422a and 4422b with the corresponding gaps (e.g., 4450), and then pulling the inner shaft (attached to the drill tip body 4410) until the keys 4422a and 4422b are clear of the recesses 4420. Once separated from the collar 4402, the drill tip body 4410 and inner shaft can be removed from the catheter device to allow insertion of a guidewire or guide catheter.

[0255] The collar 4402 may include one or more optical imaging windows 4445a and 4445b configured to align with the optical imaging window 4446 of the drill end body 4410 to provide optical access to an imaging element coupled to the inner shaft. The drill end body 4410 may be configured to engage with the collar 4402 in a plurality of orientations. For example, the first key 4422a may be configured to be captured within the first notch 4424a or the second notch 4424b depending on the axial orientation of the drill end body 4410 relative to the collar 4402. If the first key 4422a is captured within the first notch 4424a, the imaging window 4446 of the drill end body 4410 may be aligned with the first imaging window 4445a of the collar 4402.

[0256] Figures 44G to 44I 4406 of the outer shaft. The collar 4402 can include an annular groove 4440 configured to receive one or more tabs 4442a, 4442b, 4442c, 4442d, 4442e, and 4442f of the outer shaft (e.g., the mounting bracket 4406 portion of the outer shaft) to longitudinally maintain the collar 4402 in a position relative to the outer shaft when the collar 4402 rotates relative to the outer shaft. The tabs 4442a-4442f can be bent radially inward (e.g., during assembly of the device 4400) so as to protrude radially within the annular groove 4440 (e.g., not contacting the bottom surface of the groove 4440). When disposed in the groove, tabs 4442a and 4442b can contact edge 4444 surrounding annular groove 4440 when collar 4402 is longitudinally translated, thereby maintaining collar 4402 in a longitudinal position relative to the outer shaft and preventing collar 4402 from separating from device 4400. In the example shown, the outer shaft (the mounting bracket 4406 portion of the outer shaft) includes six tabs.

[0257] One or more imaging windows 4445a and 4445b of the collar 4402 can be longitudinally aligned with one or more slots 4447a, 4447b and 4447c in the mounting bracket 4406 to provide optical access to the imaging element outside the catheter device. When the drill end body is engaged with the collar 4402 and rotates with the collar 4402, the window 4445 rotates relative to the mounting bracket 4406 so that the solid segments of the mounting bracket 4406 between the slots 4447a to 4447c (including the tabs 4442a to 4442f) periodically pass in front of the imaging element and are detected by the imaging element. These solid segments of the mounting bracket 4406 can be used as imaging markers to determine the relative orientation of the catheter 4400 when in use. The solid segment markers can be arranged to be at a predetermined radial distance from each other. In some cases, the solid segment markers are arranged radially equidistant from each other.

[0258] Fig.44J 4400. The drill tip body 4410 can be translated distally within the collar 4402 and the locking features (4471) of the drill tip body 4410 can be engaged by rotating the drill tip body 4410 in a clockwise or counterclockwise direction relative to the collar 4402. The drill tip body 4410 and the collar 4402 can be rotated in a clockwise or / and counterclockwise direction (4473), for example, to traverse an obstruction within a blood vessel. The device 4400 can be straightened (for example, if already in a bent configuration) or bent in a first direction (toward the bone) while the drill tip body 4410 and the collar 4402 are rotating by pushing the inner shaft (4475). The device 4400 can also be straightened or bent in a second direction (away from the backbone) by pulling the inner shaft (4477) while the drill end body 4410 and the collar 4402 are rotating. This bending and straightening can facilitate navigation of the device 4400 within the blood vessel and through the obstruction. After traversing the obstruction, the drill end body 4410 can be stopped from rotating (4479), for example, by using the inner shaft of the handle. The drill end body 4410 can be rotated slightly (e.g., rotated less than one full circle) to align the keys 4422a and 4422b with the corresponding gaps 4450 of the collar 4402 (4481). Once the keys 4422a and 4422b are aligned, the inner shaft can be removed from the outer shaft by pulling the inner shaft (4483) while leaving the outer shaft in the blood vessel. Then, optionally, a guide wire or guide catheter is inserted into the outer shaft (4485).

[0259] Figures 45A to 45DAnother example catheter device 4500 is shown having similar features to catheter device 4400, but catheter device 4500 includes a collar 4502 and a drill tip body 4510 having a different locking feature variation. Similar to device 4400, mounting bracket 4506 may include a backbone 4525 to control the bending of device 4500. In this example, collar 4502 has keyways 4524a and 4524b corresponding to the L-shaped cutout. One side of the L-shaped keyway 4524b has an undercut edge 4530 for holding the key 4522b of the drill tip body 4510 in the keyway 4524b when the drill tip body 4510 is pulled proximally, thereby allowing the catheter to straighten and, in some cases, bend in the opposite direction to the backbone (bidirectional bending). The other side of the L-shaped keyway 4524b includes a gap 4550 that allows the key 4522b to exit the keyway 4524b when the key 4522b is axially aligned with the gap 4550 and the drill tip body 4510 is pulled proximally. This can allow the inner shaft to be removed by rotating the drill tip body 4510 in a direction that aligns the key 4522b with the gap 4550. Note that the collar 4502 can engage and rotate with the drill tip body 4510 when the drill tip body 4510 is rotated in either direction (clockwise or counterclockwise). Thus, this locking feature variation can allow: (1) the drill tip body 4510 to bend toward the diaphysis when the drill tip body 4510 is rotated in either direction (due to the rotation of the inner shaft and the proximal force on the inner shaft); (2) the drill tip body 4510 to be pulled proximally so that it can be straightened (or bent in a direction away from the diaphysis) when the drill tip body 4510 is rotated in a clockwise direction 4595 due to engagement with the L-shaped keyway 4524b; and (3) the drill tip body 4510 to be removed when the rotation stops and the drill tip is slightly rotated in a counterclockwise direction 4596 (e.g., less than a full turn) to disengage from the L-shaped keyway. One advantage of this design over device 4400 is that the inner shaft can be removed more easily because the locking feature does not need to be aligned to remove the inner shaft. Note that in other examples, the (one or more) L-shaped key slots can be configured to lock the key when the (one or more) keys are rotated in a counterclockwise direction 4596, and unlock the key when the (one or more) keys are rotated in a clockwise direction 4595.

[0260] Fig.45E45 is a flow chart of an exemplary method of using the catheter device 4500. The locking features (4571) of the collar 4502 and the drill tip body 4510 can be engaged by translating the drill tip body 4510 distally within the collar 4502 and rotating (e.g., slightly) the drill tip body 4510 in a first direction (e.g., clockwise) relative to the collar 4502. The drill tip body 4510 and the collar 4502 can be rotated (4573) in a first direction (e.g., clockwise 4595) via the inner shaft, for example, to traverse an obstruction within a blood vessel. The device 4500 can be straightened (e.g., if already in a bent configuration) or bent in a first direction (toward the bone) by pushing the inner shaft (4575) while the drill tip body 4510 and the collar 4502 are rotated. The drill tip body 4510 and the collar 4502 can be rotated in a first direction (e.g., clockwise direction 4595) or a second direction (e.g., counterclockwise direction 4596), for example, to facilitate navigation through a vessel and / or an obstruction. When a pulling force is applied to the drill tip body 4510, the rotation in the first direction (e.g., clockwise direction 4595) can retain the key (e.g., 4522b) in the corresponding L-shaped keyway (e.g., 4524b) through the undercut edge (e.g., 4530). This can allow the catheter to be straightened or bent in a second direction (away from the bone) by pulling on the inner shaft (4577) while the drill tip body 4510 and the collar 4502 are rotated in the first direction (e.g., clockwise direction 4595). To remove the inner shaft, the inner shaft and drill tip body 4510 can be rotated (4579) in a second direction (e.g., counterclockwise direction 4596) to align the key (e.g., 4522b) against the lateral edge (e.g., 4525b) and with the gap (e.g., 4550) of the corresponding L-shaped keyway (e.g., 4524b). The inner shaft can then be pulled to remove the inner shaft (4583). Once the inner shaft (with drill tip body 4510) is removed, a guide wire or guide catheter can be optionally inserted into the outer shaft (4585).

[0261] Figures 46A to 46DAnother example catheter device 4600 is shown having similar features to catheter device 4400, but catheter device 4600 includes a collar 4602 and a drill tip body 4610 having a different locking feature variation. Similar to device 4400, mounting bracket 4606 may include a stem 4625 to control the bending of device 4600. In this variation, collar 4602 includes a keyway (e.g., 4624b) with tapered undercut edges (e.g., 4630a and 4630b) for adjusting the amount of pulling required to separate the drill tip body 4610 from collar 4602. For example, tapered undercut edges 4630a and 4630b may be angled to push key 4622b toward gap 4650 when drill tip body 4610 is pulled proximally (e.g., via an inner shaft). One advantage of this locking feature over the locking feature of device 4400 is that less alignment may be required to unlock the drill tip body 4610 from the collar 4602 because the tapered undercut edges 4630a and 4630b can help align the key 4622b for unlocking while still allowing rotation in clockwise and counterclockwise directions when the drill tip body 4610 is pulled proximally. As the drill tip body 4610 rotates, the rotational force can cause the key 4622b to abut against the lateral edge 4625a or 4625b so that the collar 4602 can rotate with the drill tip body 4610 while both are locked. Moreover, the undercut edge 4630a or 4630b (depending on the direction of rotation) can retain the key 4622b within the keyway 4624b while the drill tip body 4610 and the collar 4602 rotate. Thus, when the drill tip body 4610 is rotated, applying a pulling force to the drill tip body 4610 (e.g., via the inner shaft) can cause the conduit to straighten or bend in a direction opposite to the diaphragm 4625. When the drill tip body 4610 is not rotating and no rotational force is applied, the pulling force can cause the key 4622b to slide along the angled undercut edge 4630a or 4630b and eventually leave the gap 4650. In some cases, when a pulling force is applied to the drill tip body 4610, the angled undercut edge 4630a or 4630b can cause the drill tip body 4610 to rotate slightly and align the key 4622b with the gap 4650. The angles of the undercut edges 4630a and 4630b can be selected based on the desired pulling force required to separate the drill tip body 4610 from the collar 4602, with the larger the angle, the greater the force that pushes the key 4622b toward the gap 4650.

[0262] Fig.46E46 is a flow chart of an exemplary method of using catheter device 4600. The locking features (4671) of the collar 4602 and the drill tip body 4610 can be engaged by translating the drill tip body 4610 distally into the collar 4602 and rotating the drill tip body 4610 in a clockwise or counterclockwise direction relative to the collar 4602 (e.g., slightly rotating). The drill tip body 4610 and the collar 4602 can be rotated (4573) in a first direction (e.g., clockwise direction 4595) via the inner shaft, for example, to traverse an obstruction within a blood vessel.

[0263] The locking features of the collar 4602 and the drill tip body 4610 can be engaged (4671) by inserting the drill tip body 4610 into the collar 4602 and axially translating the drill tip body 4610 in the distal direction. The drill tip body 4610 and the collar 4602 can be rotated in either direction (4673) via the inner shaft, for example, to traverse an obstruction within a blood vessel. The device 4600 can be straightened (for example, if already in a bent configuration) or bent in a first direction (toward the bone) by pushing the inner shaft (4675) while the drill tip body 4610 and the collar 4602 are rotated. The device 4600 can also be straightened or bent in a second direction (away from the bone) by pulling the inner shaft (4677) while the drill tip body 4610 and the collar 4602 are rotated. To remove the inner shaft, the inner shaft, drill tip body 4610, and collar 4602 can be stopped from rotating (4679), and the inner shaft can be axially translated (pulled) in the proximal direction (4681). Once the inner shaft (with drill tip body 4610) is removed, a guide wire or guide catheter can be optionally inserted into the outer shaft (4683).

[0264] As mentioned above Figures 43A to 43J , 44A to 44J, 45A to 45E and 46A to 46E, when the locking features are engaged, the locking features of the collar and the drill bit end body can limit the translational movement of the drill bit end body / inner shaft relative to the collar. In some embodiments, the drill bit end body can be allowed to translate less than about 1 millimeter (mm) relative to the collar.

[0265] As described herein, the locking features of the drill tip body and the collar can be configured to allow pulling and / or pushing the drill tip body / inner shaft to bend the catheter device unidirectionally, to bend and straighten, or to bend bidirectionally. The bending direction of the catheter device can also depend on the configuration of the mounting bracket. Figures 47A to 47C 48A to 48E illustrate two exemplary mounting brackets showing how the mounting brackets can control directional bending of a catheter device, either of which may be implemented in any of the catheter devices described herein.

[0266] Figures 47A to 47C Features of an example mount 4706 configured for unidirectional bending are shown. Fig.47A One side of the mounting frame 4706 including the backbone 4725 is shown. Fig.47B The side of the mounting frame 4706 opposite the backbone 4725 is shown. The mounting frame 4706 may include a series of axial slits 4760 (also referred to as axial or circumferential cuts) arranged longitudinally along at least a portion of the mounting frame 4706. Fig.47B 4725. In the embodiment of the present invention, each slit 4760 can form a T-shaped segment 4762 within the mounting frame 4706 on the side of the mounting frame 4706 opposite the backbone 4725. When the mounting frame 4706 is bent toward the backbone 4725, the side of the mounting frame 4706 with the backbone 4725 contracts, while the side of the mounting frame 4706 opposite the backbone 4725 expands. When the mounting frame 4706 is bent away from the backbone 4725, the side of the mounting frame 4706 with the backbone 4725 expands, while the side of the mounting frame 4706 opposite the backbone 4725 contracts. The gap around the T-shaped segment 4762 can indicate how much the mounting frame 4706 can bend toward and away from the backbone 4725. In the example of the mounting frame 4706, the gap around the T-shaped segment 4762 allows bending toward the backbone 4725, but substantially does not allow bending away from the backbone 4725.

[0267] Fig.47CA close-up view of the side of the mounting frame 4706 opposite the backbone 4725 is shown, showing details of the gaps around the T-shaped segments 4762. The slits 4760 can be shaped to provide first gaps 4764a and 4764b on a first side (e.g., distal side) of each T-shaped segment 4762, and second gaps 4766 on a second side (e.g., proximal side) of each T-shaped segment 4762. The longitudinal width 4768 of the first gaps 4764a and 4764b (as measured along the longitude of the mounting frame 4706) can indicate how much the mounting frame 4706 can bend in a lateral direction toward the backbone 4725. The longitudinal width 4770 of the second gap 4766 (as measured along the longitude of the mounting frame 4706) can indicate how much the mounting frame 4706 can bend away from the backbone 4725 in a lateral direction. For example, the first gaps 4764a and 4764b allow space for a side of the mounting frame 4706 opposite the backbone 4725 so that when a longitudinal force is applied to the mounting frame 4706 in a distal direction (e.g., by pushing the drill tip body / inner shaft), the mounting frame 4706 expands from a straightened (neutral) configuration to a bent configuration toward the backbone 4725. Continued pushing of the drill tip body / inner shaft can cause the T-shaped segment 4762 to contact the first edge 4792 on the first side (e.g., distal side) of the T-shaped segment 4762, thereby preventing the mounting frame 4725 from further bending toward the backbone 4725. Thus, the first edge 4792 can act as a stop element to limit lateral bending of the mounting frame 4706 in a direction toward the backbone. The larger the longitudinal width 4768 of the first gaps 4764a and 4764b, the more the mounting frame 4706 bends in a direction toward the backbone 4725. A longitudinal force may be applied to the mount 4706 in the proximal direction (e.g., by pulling on the drill end body / inner shaft) to straighten the mount 4706 back to the straightened (neutral) position. Once the mount 4706 is in the straightened (neutral) position, further pulling on the drill end body / inner shaft may cause the T-segment 4762 to contact the second edge 4794 on the second side (e.g., proximal side) of the T-segment 4762, thereby preventing the mount 4706 from bending in a direction opposite to the backbone 4725. In this manner, the second edge 4794 may serve as a stop element to limit lateral bending of the mount 4706 in a direction away from the backbone. Since the longitudinal width 4770 of the second gap 4766 is very small, the side of the mount 4706 with the backbone 4725 may be prevented from contracting (preventing the mount 4706 from bending laterally away from the backbone 4725).

[0268] Figures 48A to 48E Shown with Figures 47A to 47C Example mounting bracket 4806 has similar features to mounting bracket 4706 in FIG. 4 , except that mounting bracket 4806 is configured for bi-directional bending. Fig.48AA close-up view of the side of the mounting frame 4806 opposite the backbone 4825 is shown, showing first gaps 4864a and 4864b located on a first side (e.g., distal side) and a second gap 4866 located on a second side (e.g., proximal side) of each T-shaped segment 4862. Figures 47A to 47C As with the mounting frame 4706 in FIG. 4 , the longitudinal width 4868 of the first gaps 4864a and 4864b can indicate how much the mounting frame 4806 can bend in the lateral direction toward the backbone 4825, and the longitudinal width 4870 of the second gap 4866 can indicate how much the mounting frame 4806 can bend in the lateral direction away from the backbone 4825. In this case, the second gap 4866 is large enough to allow the mounting frame 4806 to bend away from the backbone 4825.

[0269] For example, from the straightened (neutral) position of the mounting frame 4806, a longitudinal force is applied to the mounting frame 4806 in the distal direction (e.g., by pushing on the drill tip body / inner shaft), the first gaps 4864a and 4864b allow room for the side of the mounting frame 4806 opposite the backbone 4825 to expand (and for the side of the mounting frame 4806 with the backbone 4825 to contract), thereby allowing the mounting frame 4806 to flex toward the backbone 4825 (e.g., Fig.48B and Fig.48C Continuing to push the drill tip body / inner shaft can cause the T-segment 4862 to contact the first edge 4892 on a first side (e.g., distal side) of the T-segment 4862, thereby preventing further bending of the mounting bracket 4825. Thus, the first edge 4892 can act as a stop element to limit lateral bending of the mounting bracket 4806 in a direction toward the diaphysis. A longitudinal force can be applied to the mounting bracket 4806 in a proximal direction (e.g., by pulling on the drill tip body / inner shaft) to straighten the mounting bracket 4806 back to the straightened (neutral) position. As longitudinal force continues to be applied to the mounting frame 4806 in the proximal direction (e.g., by pulling on the drill end body / inner shaft), the gap 4866 on the second side (e.g., the proximal side) of the T-shaped segment 4862 can allow the side of the mounting frame 4806 with the backbone 4825 to expand (and the side of the mounting frame 4806 opposite the backbone 4825 to contract), thereby causing the mounting frame 4806 to bend away from the backbone 4825 (e.g., Fig.48D and Fig.48E Further pulling on the drill tip body / inner shaft may cause the T-segment 4862 to contact a second edge 4894 on a second side (e.g., distal side) of the T-segment 4862, thereby preventing the mounting bracket 4825 from bending further away from the vertebra 4825. In this manner, the second edge 4894 may act as a stop element to limit lateral bending of the mounting bracket 4806 in a direction away from the vertebra.

[0270] It should be understood that any elements or features described herein with respect to one embodiment may be combined with or substituted for any elements or features described herein with respect to another embodiment.

[0271] As used in the application and claims, including in the examples, unless otherwise expressly stated, all numbers may be read as beginning with the word "about" or "approximately", even if the term is not expressly presented. The word "about" or "approximately" may be used when describing a size and / or position to indicate that the value and / or position is within a reasonably expected range of values ​​and / or positions. For example, a numerical value may have a value of + / -0.1% of the stated value (or numerical range), + / -1% of the stated value (or numerical range), + / -2% of the stated value (or numerical range), + / -5% of the stated value (or numerical range), + / -10% of the stated value (or numerical range), etc. Any numerical value listed herein is intended to include all subranges contained therein.

[0272] Other details related to the present invention, including materials and manufacturing techniques, can be used within the level of a person skilled in the relevant art. This is also true for various aspects of the present invention based on methods, in terms of additional actions that are usually or logically adopted. In addition, it is conceivable that any optional features of the described variations of the present invention can be described and claimed independently or in combination with any one or more features described herein. Similarly, references to single items include the possibility of multiple identical items. More specifically, in this specification and the appended claims, the singular forms "one", "and", "above" and "said" all include plural numbers unless the context clearly indicates otherwise. It should also be noted that the claims can be written in a way that excludes any optional elements. Therefore, this statement is intended to be used as a reference basis for the use of exclusive terms such as "solely", "only" and the like in conjunction with the narration of the claim elements or the use of "negative" limitations. Unless otherwise expressly stated herein, all technical and scientific terms used herein have the same meaning as those generally understood by ordinary technicians in the field to which the present invention belongs. The scope of the present invention is not limited by the examples described herein, but only by the ordinary meaning of the claim terms used.

Claims

1. A blocking crossing device, comprising: an inner shaft operatively coupled to a rotational driver for rotating the inner shaft, the inner shaft comprising a distal end having a drill tip body configured to penetrate an obstruction within a blood vessel, the inner shaft further comprising an optical coherence tomography imaging element located at a distal region of the inner shaft, the imaging element configured to collect images external to the device; an outer shaft removably coupled to the inner shaft such that the inner shaft is rotatable and longitudinally translatable within the outer shaft in distal and proximal directions; as well as A collar rotatably coupled to the distal end of the outer shaft and having a central opening for receiving the drill tip body in the wherein the drill bit end body and the collar include locking features configured to lock the collar to the drill bit end body such that the collar and the drill bit end body can rotate together, wherein when the collar is locked with the drill bit end body: Distal movement of the inner shaft relative to the outer shaft causes the occlusion crossing device to bend, Proximal movement of the inner shaft relative to the outer shaft causes the occlusion crossing device to straighten; and The undercut edge of the locking feature is configured to prevent the collar from unlocking from the drill tip body when the inner shaft is pulled proximally.

2. The blocking crossing device according to claim 1, wherein: The locking feature is configured to unlock the collar from the drill tip body by stopping rotation of the drill tip body and translating the drill tip body proximally relative to the collar.

3. The blocking crossing device according to claim 2, wherein: Unlocking the collar from the drill tip body further includes rotating the drill tip body relative to the collar less than one full turn prior to translating the drill tip body proximally relative to the collar.

4. The blocking crossing device according to claim 1, wherein: The locking feature allows the drill tip body and the inner shaft to be removed from the outer shaft.

5. The blocking crossing device according to claim 1, wherein: The drill tip body includes a stop that prevents the drill tip body from fully extending through the central opening of the collar when the drill tip body translates in the distal direction.

6. The blocking crossing device according to claim 5, wherein: The stopper of the drill tip body is configured to press against a proximal edge of the collar to prevent the drill tip body from fully extending through the central opening of the collar.

7. The blocking crossing device according to claim 1, wherein: The locking feature includes one or more keyways of the collar configured to retain one or more keys of the drill tip body to lock the collar and the drill tip body.

8. The blocking crossing device according to claim 1, wherein: The collar is configured to be longitudinally maintained in a position relative to the outer shaft when rotated relative to the outer shaft.

9. The blocking crossing device according to claim 1, wherein: An outer surface of the collar includes one or more abrasive surface features configured to cut tissue.

10. The blocking crossing device according to claim 9, wherein: The one or more abrasive surface features include one or more protrusions, one or more indentations, or adhered abrasive material.

11. The blocking crossing device according to claim 1, wherein: The outer shaft includes a stem extending longitudinally along at least a portion of the outer shaft, wherein the stem is configured to bias a lateral curvature of a distal portion of the occlusion crossing device along a plane.

12. The obstruction traversing device of claim 11, further comprising a handle having a connector configured to rotatably lock the inner shaft to the outer shaft, wherein: The connector allows the inner shaft to rotate relative to the outer shaft when the inner shaft is rotationally locked to the outer shaft.

13. The blocking crossing device according to claim 12, wherein: The connector is configured to provide longitudinal movement between the inner shaft and the outer shaft such that the inner shaft can be longitudinally translated a short distance to actuate lateral flexion of the shaft.

14. The blocking crossing device according to claim 13, wherein: The connector includes one or more of a Luer lock, a valve connector, a fitting, and a washer connector.

15. The blocking traversing device according to claim 1, wherein: The outer shaft includes a stem configured to bend the blocking traversing device when a thrust is applied to the inner shaft, wherein the blocking traversing device is configured to bend toward the stem in response to the thrust such that a side of the outer shaft opposite the stem expands.

16. The blocking crossing device according to claim 15, wherein: The occluding traversing device is configured to straighten or bend away from the diaphysis when tension is applied to the inner shaft.

17. The blocking crossing device according to claim 1, wherein: The optical window of the collar is configured to align with the optical window of the drill bit tip body when the collar and the drill bit tip body are locked.

18. The blocking crossing device according to claim 17, wherein: The optical window of the collar is longitudinally aligned with the one or more optical windows of the outer shaft.

19. The blocking crossing device according to claim 1, wherein: The inner shaft is operatively coupled to a rotary drive configured to rotate the inner shaft relative to the outer shaft.

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