Devices and methods for facilitating guidewire re-entry into the true lumen - Patents.com

Abstract

Apparatus and methods for facilitating guidewire re-entry into the true lumen may include an elongate shaft having a proximal end and a distal end, and an intravascular ultrasound (IVUS) catheter engagement region (e.g., capsule) coupled to the distal end of the elongate shaft. An IVUS imaging window may be disposed within a sidewall of the IVUS engagement region. The IVUS engagement region may be configured to receive an IVUS catheter such that the IVUS catheter can image through the window to image the blood vessel and assist in guiding and / or confirming guidewire re-entry into the true lumen of the blood vessel.

Description

[Technical Field]

[0001] Priority claims

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 483,477, entitled "DEVICES AND METHODS FOR FACILITATING GUIDEWIRE RE-ENTRY INTO A TRUE LUMEN," filed February 6, 2023, and U.S. Provisional Patent Application No. 63 / 497,160, entitled "DEVICES AND METHODS FOR FACILITATING GUIDEWIRE RE-ENTRY INTO A TRUE LUMEN," filed April 19, 2023, each of which is incorporated by reference in its entirety. [Background technology]

[0002]

[0002] There are thousands of percutaneous coronary interventions (PCIs) performed annually in the United States and worldwide to treat chronic total occlusions (CTOs) in coronary vessels. The vast majority of CTO procedures are performed in peripheral vessels. In coronary procedures, a guidewire may be used to span an intravascular blockage, and the guidewire may then serve as a rail over which other diagnostic or therapeutic devices may be delivered to the treatment site. However, many such procedures often fail due to the nature of the occlusion and the associated problems with controlling the guidewire. For example, inadvertent entry of the guidewire into the surrounding layers of the vessel wall may require a device to assist in re-entering the wire back into the true lumen of the vessel. Alternative procedures can be challenging to learn or perform. Therefore, improved devices and methods for treating occlusions are desirable. Summary of the Invention [Means for solving the problem]

[0003] Described herein are apparatuses, including methods, devices, and systems (e.g., reentry ultrasound engagement catheters), that may facilitate guidewire re-entry into the true lumen of a blood vessel. These apparatuses and methods are generally configured to interface with one or more guidewires and an intravascular ultrasound (IVUS) device. Referred to as reentry ultrasound engagement catheters, these devices may include an elongate body, e.g., a microcatheter body, that houses a first lumen for guiding the reentry guidewire. These devices may also incorporate an IVUS engagement region, which may be configured as a capsule or elongate body that includes an ultrasound window, allowing for proper orientation of the IVUS device relative to the remainder of the device, particularly the reentry guidewire exit port. This may allow visualization of the distal end of the elongate microcatheter body, particularly the first lumen, and thus the distal end of the reentry guidewire, through the ultrasound window. Additionally, the IVUS engagement region may be designed to accommodate or interact with a second guidewire, such as a subintimal wire (or IVUS guidewire). The IVUS engagement region may feature a distal opening for passage of a second guidewire, and may incorporate a channel or rapid exchange region for engaging a second guidewire and / or an IVUS device.

[0004] The methods described herein may be used as part of or in conjunction with antegrade, dissection, and reentry (ADR) procedures. In such procedures, which aim to span a stenotic lesion, the process typically involves creating an incision, advancing a wire subintimally across the lesion in the blood vessel, and then reintroducing a wire, typically a guidewire, from the subintimal space into the true lumen of the blood vessel. This maneuver establishes a pathway through which a diagnostic or therapeutic catheter may be passed to cross the occlusion, allowing for further evaluation or treatment of the occlusion. As noted above, ultrasound, including IVUS, can assist and guide this process. However, utilizing IVUS can be challenging, especially when simultaneously navigating and controlling both the guidewire and the IVUS device. Therefore, the methods and apparatus described herein offer a potentially simpler and more efficient solution.

[0005]

[0005] For example, described herein is a system for facilitating re-entry of a guidewire into a true lumen, the system comprising an elongate shaft having proximal and distal ends and a re-entry guidewire lumen extending through the proximal and distal ends, the re-entry guidewire lumen having an exit port at a distal end region of the elongate shaft, an intravascular ultrasound catheter (IVUS) engagement region configured as a capsule coupled to the distal end of the elongate shaft, and an IVUS imaging window disposed within a side wall of the capsule, the capsule configured to receive an intravascular ultrasound (IVUS) catheter and orient the IVUS catheter for imaging through the IVUS imaging window.

[0006] Any of these systems may include one or more guides within (and / or adjacent to) the exit port for deflecting the reentry guidewire laterally relative to the longitudinal axis of the elongate shaft. The guides may include ramps, channels, or deflectors. Any of these systems may optionally include a guidewire (e.g., a reentry guidewire) and / or an IVUS catheter.

[0007] The IVUS imaging window may be positioned laterally adjacent to the exit port. In some examples, the IVUS imaging window includes a cutout region.

[0008] The capsule may include a porous material. In some instances, the capsule includes a distal opening for an IVUS guidewire.

[0008]

[0009] Any of these devices may include one or more ultrasound markers on the distal end region of the elongate shaft and / or on the capsule. Alternatively or additionally, any of these devices may include one or more engagement features in the capsule configured to orient the IVUS catheter. In some instances, these devices may include one or more attachments for releasably securing the elongate body of the IVUS catheter to the elongate body.

[0009]

[0010] Also described herein are methods for using any of these devices to guide re-entry of a guidewire into the true lumen, such as a method for facilitating re-entry of a guidewire into the true lumen of a blood vessel, the method including advancing an elongate shaft having a capsule toward an occlusion within the blood vessel, advancing the capsule through the subintimal space of the blood vessel to position the capsule distal to the occlusion, disposing an intravascular ultrasound (IVUS) catheter within the capsule, and re-entering the guidewire from the subintimal space into the true lumen of the blood vessel while imaging the guidewire with the IVUS catheter to ensure that the guidewire is correctly positioned and advanced.

[0010]

[0011] In some examples, the IVUS engagement region may be an elongated region. For example, a system for facilitating guidewire re-entry into a true lumen includes an elongated shaft having a proximal end and a distal end, a reentry guidewire lumen extending between the proximal and distal ends and configured to slidably receive a reentry guidewire, an exit port fluidly connected to the reentry guidewire lumen at the distal end region of the elongated shaft, an intravascular ultrasound (IVUS) lumen extending between the proximal and distal ends of the elongated shaft and configured to slidably receive an IVUS catheter, and an IVUS imaging window disposed within a sidewall of the elongated shaft in communication with the IVUS lumen and distal to or adjacent to the exit port.

[0011]

[0012] Any of these systems may include a guide within or adjacent to the exit port to deflect the reentry guidewire laterally relative to the long axis of the elongate shaft. As mentioned, the guide may comprise a ramp, channel, or deflector.

[0012]

[0013] The IVUS imaging window may be positioned laterally adjacent to the exit port. In some examples, the IVUS imaging window comprises a cutout region. Any of these devices may include one or more ultrasound markers on the distal end region of the elongate shaft. The device may include one or more engagement features within the IVUS lumen configured to orient the IVUS catheter.

[0013]

[0014] As mentioned, also described are methods for facilitating re-entry of a guidewire into the true lumen of a blood vessel, including methods using the systems described above. For example, the method may include advancing an elongate shaft having a first lumen and a second lumen toward an occlusion in a blood vessel, advancing the elongate shaft over a guidewire disposed in the first lumen through a subintimal space of the blood vessel, advancing an intravascular ultrasound (IVUS) catheter through the second lumen, and advancing the re-entry guidewire through the first lumen to re-enter the re-entry guidewire from the subintimal space into the true lumen of the blood vessel while imaging the re-entry guidewire with the IVUS catheter to ensure that the re-entry guidewire is correctly positioned and advanced.

[0014]

[0015] All of the methods and apparatus described herein can be used in any combination to achieve the benefits contemplated and described herein.

[0016] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description and accompanying drawings that set forth illustrative embodiments. [Brief explanation of the drawings]

[0015] [Figure 1]

[0017] 1A is a diagram illustrating an example of a re-entry ultrasound engagement catheter that works with a separate IVUS catheter to facilitate re-entry of a wire into a vascular true lumen or other target location, showing the re-entry ultrasound engagement catheter engaged with an IVUS device (IVUS catheter), and FIG. 1B is a diagram illustrating an example of a re-entry ultrasound engagement catheter that works with a separate IVUS catheter to facilitate re-entry of a wire into a vascular true lumen or other target location, showing the re-entry ultrasound engagement catheter. [Figure 2]

[0018] FIG. 10 shows an example of a guidewire being advanced through the subintimal space and across a total occlusion. [Figure 3]

[0019] 3A is a diagram illustrating another example of a reentry ultrasound engaging catheter device similar to that shown in FIGS. 1A-1B, showing the reentry ultrasound engaging catheter engaged with an IVUS catheter and a reentry wire. FIG. 3B is a diagram illustrating another example of a reentry ultrasound engaging catheter device similar to that shown in FIGS. 1A-1B, showing the reentry ultrasound engaging catheter engaged with a reentry wire (without an IVUS catheter). [Figure 4]

[0020] 2 shows the re-entry ultrasound engagement catheter of FIG. 1 with the IVUS catheter in the subintimal space. [Figure 5]

[0021] FIG. 10 is a diagram showing an example of a reentry wire re-entering the vascular true lumen from the subintimal space. [Figure 6]

[0022] FIG. 10 shows an example in which a wire crosses an occlusion. [Figure 7]

[0023] 7A and 7B are diagrams illustrating examples of IVUS engagement regions that may be included as part of the devices described herein, showing a first example of a device including an IVUS engagement region configured as a capsule, and a second example of a device including an IVUS engagement region configured as a capsule, respectively. [Figure 8]

[0024] 8A and 8B illustrate examples of re-entry ultrasound engagement catheter devices configured to work with a separate IVUS catheter to facilitate re-entry of a wire into a vascular true lumen or other target location. [Figure 9]

[0025] 9A and 9B illustrate examples of re-entry ultrasound engagement catheter devices that work with a separate IVUS catheter to facilitate re-entry of a wire into a vascular true lumen or other target location. DETAILED DESCRIPTION OF THE INVENTION

[0016]

[0026] Described herein are methods and apparatus (e.g., devices, systems, etc., including reentry ultrasound engagement catheters) for facilitating guidewire reentry into the true lumen of a blood vessel. Generally, these apparatuses and methods are configured to engage one or more guidewires and an intravascular ultrasound device, e.g., an IVUS device. These devices may be referred to as reentry ultrasound engagement catheters. In some instances, these devices include an elongate body (e.g., a microcatheter body) with a first lumen for guiding the reentry guidewire, and an IVUS engagement region configured as a capsule or elongate body having an ultrasound window, the IVUS engagement region configured to orient the IVUS device so that the distal end of the elongate microcatheter body, particularly the distal end of the first lumen (and thus the reentry guidewire), is visualized through the ultrasound window. The IVUS engagement region may also be configured to pass or engage a second guidewire (e.g., a subintimal wire). In some cases, the IVUS engagement region may include a distal opening for passing the second guidewire. In some instances, the IVUS engagement region may include a channel and / or rapid exchange region for engaging a second guidewire and / or an IVUS device.

[0017]

[0027] The methods described herein may be used as part of or in conjunction with an antegrade, dissection, and reentry (ADR) procedure. An ADR procedure for spanning a stenotic lesion may involve creating an incision and advancing a wire subintimally across a lesion (e.g., an occlusion, a clot, etc.) within a blood vessel, and then reintroducing a wire (e.g., a guidewire) from the subintimal space into the vascular true lumen. This may provide a passageway through which a diagnostic or therapeutic catheter may be passed to cross the occlusion, allowing for further evaluation or treatment of the occlusion. As noted above, the process may be guided or assisted using ultrasound, including IVUS. Unfortunately, the use of IVUS can be challenging, especially when navigating and controlling the guidewire and IVUS device. Therefore, the methods and devices described herein may provide an easier and more efficient solution.

[0018]

[0028] In some examples, the methods and devices described herein may use a catheter, such as a reentry ultrasound engagement catheter, to help deliver a separate, discrete intravascular ultrasound (IVUS) catheter subintimally across the occlusion, which can then be used to monitor and help the physician guide the reentry wire from the subintimal space back into the vascular true lumen. The wire (reentry guidewire) can then be used as a rail over which other devices (e.g., angioplasty catheters or stent delivery systems) may be successfully delivered beyond the occlusion for further diagnosis and treatment. This example is not intended to be limiting, and the examples disclosed herein may have other uses. For example, in addition to facilitating true lumen re-entry from the intimal space, the devices described herein may also be used to facilitate wire entry from the true lumen of a blood vessel into a side branch ostium, or to direct a wire from the vessel lumen into the subintimal space to create an incision or enable drug delivery, or to puncture the vessel from the inside out toward a specific area, such as a nearby vein, or to create access to nearby healthy or unhealthy tissue, such as cancer. All of these procedures, which are not intended to be limiting, allow for more precise wire manipulation while under the visualization of an IVUS catheter.

[0019]

[0029] In general, an intravascular ultrasound catheter (IVUS) may be useful for guiding a subintimal guidewire to re-enter the true lumen. The re-entry ultrasound engagement catheters described herein may be configured to removably engage an IVUS catheter, particularly when transitioning between the subintimal space and the true lumen of a blood vessel, to enhance control for orienting and positioning the IVUS catheter.

[0020]

[0030] As such, the reentry ultrasound engagement catheter devices described herein may include an elongate body having or forming a lumen for the reentry guidewire, and an IVUS engagement region for the reentry guidewire lumen, which may extend distally from the exit port, configured to engage with the IVUS catheter to enable and enhance visualization of the reentry guidewire by the IVUS catheter as the reentry guidewire extends from the exit port. The reentry guidewire may be directed out of the reentry ultrasound engagement catheter device using one or more guides (e.g., ramps, channels, deflectors, etc.) of the reentry ultrasound engagement catheter device and / or using imaging from an IVUS catheter held in a predetermined position and / or orientation by the reentry ultrasound engagement catheter device.

[0021]

[0031] The elongate body of the reentry ultrasound engagement catheter device may be configured as an elongate, torqueable body. The elongate, torqueable body may be configured as a microcatheter body. The body may be reinforced to improve torqueability, for example, by including a mesh or braid. In some cases, the elongate microcatheter body may be a hypotube that is cut (e.g., laser cut) to increase flexibility while maintaining torqueability and / or column strength (pushability).

[0022]

[0032] The reentry guidewire lumen may be configured to extend along the length of the elongate body of the reentry ultrasound engagement catheter, or the reentry guidewire lumen may be configured in a rapid-exchange configuration at the distal end region of the elongate body. The reentry guidewire lumen may include an exit port at the distal end region of the elongate body. The elongate body may be configured to steer, guide, or direct the reentry guidewire off-axis relative to the elongate body, so that when the distal end region of the elongate body is outside the true lumen (e.g., the intima) of the blood vessel, the reentry guidewire may be directed laterally into the true lumen. Thus, in some examples, the reentry guidewire lumen and / or exit port may be configured to steer, guide, or direct the reentry guidewire into the true lumen, for example, laterally off-axis. For example, the distal end of the elongate body (including within the reentry guidewire lumen and / or the exit port for the reentry guidewire lumen and / or the region distal to the exit port) may include a guide (e.g., a ramp, channel, deflector, etc., also referred to as a "guide feature") configured to laterally direct the tip of the reentry guidewire. In some instances, the exit port for the reentry lumen may be lateral to the elongate body (e.g., on a side of the elongate body). In some cases, the exit port may be positioned relative to the IVUS engagement region so that the reentry guidewire can be steered and / or visualized as it exits the lumen so that reentry can be confirmed.

[0023]

[0033] In any of these devices, the IVUS engagement region may be coupled to and / or integral with the elongate body. In some cases, the IVUS engagement region is configured to extend distally of the elongate body, including distal to the exit port for the reentry guidewire lumen. In some instances, the IVUS engagement region is configured as a distal capsule extending partially along the distal end of the device. Alternatively, in some instances, the IVUS engagement region is configured as a proximally extending elongate body, including much of the length of the IVUS catheter.

[0024]

[0034] Generally, the IVUS engagement region includes at least a region that is ultrasound transmissive. For example, the IVUS engagement region may include an ultrasound (IVUS) window, e.g., an IVUS imaging window, through which ultrasound energy may be transmitted to re-enter the guidewire and / or image the blood vessel (e.g., an occlusion). In some examples, the IVUS imaging window is configured at the distal end region of the IVUS engagement region; the IVUS imaging window may be positioned opposite the re-entry lumen exit port. The IVUS imaging window may be configured as a discrete region; the IVUS imaging window may be configured as an oval, rectangular, square, teardrop, triangular, circular, or other shape. The shape may allow for orientation relative to the field of view. The IVUS imaging window may direct the user's attention. In some examples, a non-window region of the IVUS engagement region may be configured to reduce the intensity of ultrasound imaging by the IVUS catheter (e.g., to partially or completely occlude ultrasound imaging). In some cases, the IVUS imaging window may be a cutout region or an opening through a lateral region (e.g., side) of the IVUS engagement region. In some cases, the IVUS imaging window may be formed of a material that is transparent to ultrasound at the wavelength used for imaging. Optionally, in some cases, the entire IVUS engagement region (or most of it) may be formed of an ultrasound-transparent material. The IVUS engagement region may be configured to include one or more additional or alternative ultrasound-dense markers (fiducial markers). Optionally, in some examples, the device may include one or more markers (IVUS imaging markers), including at a location opposite and / or adjacent to the reentry catheter exit port.

[0025]

[0035] In variations that include an IVUS imaging window, the window may generally be positioned to allow imaging of the reentry wire as it leaves the reentry guidewire lumen and out of the elongate body (e.g., microcatheter). In some instances, the IVUS engagement region may extend distal to the distal end of the elongate body.

[0026]

[0036] In any of the IVUS engagement regions described herein, the engagement region may generally be configured to releasably secure the IVUS catheter distal end region and / or orient the IVUS catheter so that it images the occlusion and / or the reentry wire. For example, the IVUS engagement region may be configured to hold and / or orient the imaging portion of the IVUS catheter so that it images a relatively unoccluded blood vessel (including with a reentry ultrasound engagement catheter) and / or images the reentry guidewire to confirm and / or assist reentry into the true lumen.

[0027]

[0037] In some cases, the IVUS engagement region may include one or more engagement features. The engagement features may hold, position, and / or orient the IVUS catheter. For example, the distal IVUS engagement region may be configured to engage the distal end region of the IVUS catheter by including one or more notches, tapered regions, etc., which may position and / or orient the IVUS catheter imaging component(s). In some cases, the IVUS catheter may be configured to include a distal channel and / or opening (exit port) for an IVUS catheter guidewire (e.g., a "guidewire window"). Thus, in general, the IVUS engagement region may be configured for use with an IVUS catheter guidewire.

[0028]

[0038] The IVUS engagement region may be formed of any suitable material. For example, the IVUS engagement region may be formed of a mesh material. In some cases, the IVUS engagement region may be formed as a cylinder or tapered cylinder, a cone, or the like. The IVUS engagement region may be porous or closed along its sides. The IVUS engagement region may include a proximal opening for engaging / inserting an IVUS catheter and / or a guidewire that may be used with the IVUS catheter. In any of these devices, the inner diameter of the IVUS engagement region may be configured to retain the IVUS catheter (e.g., the IVUS engagement region may have an inner diameter greater than the maximum outer diameter of the IVUS device).

[0029]

[0039] In some cases, the elongate body and IVUS engagement region of the reentry ultrasound engagement catheter are formed as a single piece. For example, the elongate body of the reentry ultrasound engagement catheter may be integrated with the IVUS engagement region. Alternatively, the elongate body and the IVUS engagement region may be adjacent to each other but joined together at the distal end region. In some cases, the reentry ultrasound engagement catheter is configured to receive a rotating IVUS device. In some cases, the IVUS engagement region may be tandem with the elongate body, forming a lumen for the reentry wire.

[0030]

[0040] In variations in which the IVUS engagement region is coupled to the elongate body at a distal end region and does not extend completely proximally, the device may include one or more IVUS catheter engagement connectors along the length of the elongate body. For example, the elongate body may include one or more attachments for securing (or releasably securing) the body of the IVUS catheter. The engagement connectors may be configured as one or more of a snap, clip, loop, or the like. In general, the engagement connectors may be positioned along the length of the elongate body or simply at its distal end region.

[0031]

[0041] 1A and 1B show an example of an apparatus (e.g., a re-entry ultrasound engagement catheter apparatus) configured as a device that may be used with a separate IVUS catheter to facilitate re-entry of a wire into the true lumen of a blood vessel. In some instances, the re-entry ultrasound engagement catheter device itself does not include an ultrasound transducer; instead, the IVUS transducer is provided by a separate IVUS catheter. Alternatively, in some instances, the re-entry ultrasound engagement catheter may include an integrated IVUS catheter.

[0032]

[0042] In instances where an existing IVUS catheter (such as a phased array IVUS catheter or a rotational IVUS catheter) is used, the re-entry ultrasound engagement catheter may be configured to provide cost-effectiveness compared to using a re-entry device with an integrated ultrasound imaging transducer and then discarding the device after a single use.

[0033]

[0043] The reentry ultrasound engagement catheter 100 of FIGS. 1A and 1B includes an elongate body (e.g., shaft) 103 having an IVUS catheter engagement portion 109 configured as a capsule at the distal end of the shaft. The shaft may be a microcatheter, a single-lumen catheter, or a multi-lumen catheter, and may be formed from a polymer, metal, or other material known in the art. The shaft may be braided or have any desired stiffness to impart desired mechanical properties to the shaft (e.g., stiffness, column strength, torque transmission, etc.). The elongate shaft may have a lumen for a reentry wire (a “reentry guidewire lumen”), which may extend along the length of the elongate body or may be a rapid-exchange or over-the-wire lumen. In some cases where the lumen is a rapid exchange lumen, the distal exit port may be disposed at the most distal end of the shaft, and the proximal port may be disposed closer to the distal port than the most proximal end of the elongate shaft. In some instances, the lumen is an over-the-wire lumen, and the distal port may be disposed at the most distal end of the shaft (or optionally at a lateral side thereof), and the proximal port may be disposed at the most proximal end of the shaft. The wire lumen may be used to introduce a reentry wire, as discussed in more detail below. The proximal end of the shaft may include a hub with a luer connector to facilitate connection to other components such as tubing, syringes, etc. The shaft may have additional lumens, as needed, for other guidewires, fluid injection or removal, etc.

[0034]

[0044] As mentioned, the distal capsule 109 may be coupled to the distal end of the shaft 103, which may include a reentry guidewire lumen. The distal end of the reentry guidewire lumen may be disposed adjacent to the central portion and proximal edge of the IVUS window 107 on the capsule. A reentry wire may be advanced through the reentry guidewire lumen to exit the field of view of IVUS imaging (e.g., IVUS beam(s)) and then directed toward an area of ​​interest, including the true lumen, side branch, or vessel wall. The distal capsule 109 may include a distal aperture or port 115 through which a guidewire from the IVUS catheter may exit the capsule. In any of these examples, the IVUS catheter engagement region (e.g., the capsule) may be a radially expandable / collapsible cylindrical or conical structure having a central chamber configured to receive and accommodate the IVUS catheter. During delivery, the capsule may be in a collapsed configuration, and once delivered to the desired location, the capsule may expand to an expanded configuration. In other examples, the capsule may remain in the expanded configuration. The capsule may receive and carry the IVUS catheter during advancement through the blood vessel to the desired treatment area, or the IVUS catheter may be separately advanced over the guidewire into the capsule once the capsule has been delivered to the desired treatment area. In Figure 1A, a re-entry ultrasound engagement catheter 100 is shown engaged with an ultrasound catheter including an IVUS imaging array 113 at the distal end of the IVUS catheter shaft 105; an IVUS guidewire 111 is shown extending through the IVUS catheter.

[0035]

[0045] The IVUS catheter engagement region 109 has an IVUS window, which may be a cutout area in the capsule wall, allowing the IVUS catheter to image laterally or transversely through the capsule wall relative to the catheter's long axis. The IVUS catheter may be any IVUS catheter commercially available (e.g., phased array or rotational IVUS catheter) and used by practitioners. The IVUS catheter may have a guidewire lumen to receive a guidewire so that the IVUS catheter can be advanced over the guidewire to the target treatment area and into the capsule, or if the IVUS catheter is disposed within the capsule during delivery, both may be advanced together toward the treatment area, over the guidewire or without the guidewire. Upon delivery, the ultrasound transducer on the IVUS catheter may rotate to align the transducer on the IVUS catheter with the IVUS window in the capsule to enable imaging through the IVUS window.

[0036]

[0046] 7A-7B show several examples of IVUS catheter engaging regions configured as capsules 709, 709′. In any of the device examples disclosed herein, the IVUS catheter engaging region (sometimes referred to as a capsule or IVUS sleeve) can be open at the distal end, or the IVUS catheter engaging region may have a closed distal end including a wire opening at the distal tip. Both of the capsules shown include an open distal end 715 through which a guidewire (e.g., an IVUS guidewire) may be passed. The shaft 705 coupled to the IVUS catheter engaging region can rotate to orient to any area of ​​interest within the true lumen or vessel, such as the ostium of a side branch. The shaft 705 of the elongate body of the device may include radiopaque or echogenic markers at various locations to allow the operator to visualize the location of various device features during use. For example, the marker may be disposed at the distal end of the elongate shaft, adjacent to the proximal and / or distal ends of the IVUS window, adjacent to the proximal and / or distal ends of the capsule, adjacent to any of the lumen ports, etc.

[0037]

[0047] In instances where the IVUS field of view is 360° circumferentially around the capsule, the IVUS window 707 will facilitate visualization in one direction, while the other direction may be blocked by a reentry device. The shaft with the capsule, with or without simultaneous delivery of an IVUS catheter, may be advanced to the stenotic lesion and then further advanced past the occlusion using the antegrade, dissection, and reentry (ADR) technique discussed above. The IVUS catheter may then be used to image and ensure proper passage of the reentry wire from the subintimal space into the true lumen, or to help the operator know if repositioning is required. Other uses of the device are disclosed above.

[0038]

[0048] FIG. 2 shows a guidewire GW advanced distally through a blood vessel V, where an incision is made so that the wire can be advanced subintima across a lesion L and past the occlusion without re-entering the true lumen. FIGS. 3A-3B show that after the guidewire is positioned, the reentry ultrasound engagement catheter device described above may be advanced subintima over the guidewire. Optionally, an IVUS catheter (IVUS) may be delivered subintima simultaneously with the reentry ultrasound engagement catheter, or in another example, the IVUS catheter may be delivered and received within the reentry ultrasound engagement catheter after the reentry ultrasound engagement catheter has been delivered to the desired location. FIG. 3A is shown without the blood vessel surrounding the reentry ultrasound engagement catheter and IVUS catheter for ease of visualization.

[0039]

[0049] 3A, the re-entry ultrasound engagement catheter 300 is similar to the catheter shown in FIG. 1A and includes an elongate body 303 having a re-entry guidewire lumen (through which a re-entry guidewire 317 extends) and an IVUS engagement region 309 configured as a tapered capsule including a distal opening 315 for an IVUS guidewire 311. The IVUS catheter includes a shaft 305 and a distal IVUS sensor 313 (e.g., a transducer array).

[0040]

[0050] 3A, the elongated body 303 of the re-entry ultrasound engagement catheter device 300 also includes multiple (e.g., two are shown) fasteners 330, 330' for coupling the IVUS shaft 305 to the elongated body (not shown). The fasteners may radially secure the IVUS shaft while allowing it to slide axially, thereby navigating turns without inhibiting bending of the elongated body of the re-entry ultrasound engagement catheter. The capsule 309 includes an IVUS imaging window 307.

[0041]

[0051] FIG. 4 shows a reentry ultrasound engagement catheter and an IVUS catheter disposed within the subintimal space. Once the reentry ultrasound engagement catheter and IVUS catheter are properly positioned, for example, with the IVUS catheter 413 within the capsule 409 of the reentry ultrasound engagement catheter, the IVUS catheter may be rotated, for example, by rotating the IVUS catheter shaft 405 to align the ultrasound imaging transducer on the IVUS catheter with the imaging window 407 within the reentry ultrasound engagement catheter. A reentry wire may be advanced through the capsule shaft lumen and advanced distally so that the reentry wire exits the lumen at the distal end of the shaft, after which it can reenter the true vessel lumen or be directed to any other desired location, such as a side branch or vessel wall. The wire may exit the distal port of the elongated shaft at an angle of 0 to 135°, and the IVUS catheter may be oriented to facilitate visualization of the wire with the ultrasound beam. In FIG. 4, the vessel lumen 425 is occluded by an occlusion 422. A separate guidewire (eg, IVUS guidewire 411) may be used to position the IVUS catheter, including within the re-entry ultrasound engagement catheter.

[0042]

[0052] FIG. 5 shows re-entry performed while an IVUS catheter 513 images the advancement of a re-entry guidewire 517 to ensure proper positioning and advancement. The IVUS catheter helps guide the wire puncture from the subintimal space back into the true lumen 525 to help prevent the wire from exiting the vessel and / or dilating the incision. In FIG. 5, the re-entry ultrasound engagement catheter includes an elongate body (e.g., shaft) 503 having an IVUS engagement region (e.g., capsule) 509 coupled to a distal end region, which includes an IVUS imaging window 507 through which the IVUS device 513 may image. The IVUS catheter may be partially guided by an IVUS guidewire 511 and positioned on opposite sides of an occlusion 522 of the lumen; the lumen and occlusion may be imaged using the IVUS catheter.

[0043]

[0053] FIG. 6 shows that the capsule catheter, along with other devices, has been removed, leaving only the reentry wire RW 517 within the vessel V, providing a pathway across the lesion L (e.g., occlusion 522) within the vessel lumen 525 so that other devices can use the reentry wire as a rail to guide the other devices across the lesion. The reentry wire may equivalently be referred to as a guidewire or simply a wire. In some instances, the reentry wire may be replaced with another, more suitable wire using wire exchange techniques known in the art (e.g., using a microcatheter). An angioplasty or stenting or other diagnostic or therapeutic device may be advanced over the wire, and a procedure may then be performed to remove or otherwise treat the occlusion. Of course, those skilled in the art will recognize that the method described above may be modified in numerous ways and is therefore not intended to be limiting. Various steps may be substituted with other steps, and the order of the steps may be modified as needed by the operator.

[0044]

[0054] 8A-8B show another example of a re-entry ultrasound engagement catheter 800 that may be used to facilitate the use of a separate, discrete IVUS catheter during a re-acquisition procedure or other uses described herein. In this example, an IVUS engagement region 809 is coupled to and extends along the length of an elongated body 803, which may otherwise be similar or identical to the elongated bodies described above. In FIG. 8A, the IVUS engagement region includes an elongated lumen with a distal IVUS window region 807, and an IVUS catheter may be inserted proximally through the IVUS engagement region 809, either directly or over an IVUS guidewire (not shown). FIG. 8B shows a cross-section through the device of FIG. 8A.

[0045]

[0055] The reentry ultrasound engagement catheter 800 of FIG. 8A includes a first elongate body (shaft) 803, and the IVUS engagement region 809 is configured as a second elongate shaft. The two elongate shafts may be joined together so that a cross section taken perpendicular to the long axis of the catheter forms a figure-eight geometry, as seen in FIG. 8B. The shafts may be co-extruded to form a unified body, or the two shafts may be bonded together, or other techniques known in the art may be used to join the two shafts together. Either or both shafts may be braided to provide torque transmission. The first elongate shaft has a proximal end and a distal end. The proximal end may include a hub, such as a Luer connector, for securely or releasably coupling to other devices, such as fluid tubing, syringes, or other instruments. The distal end may have an exit port. The first elongate shaft may have one or more lumens extending between the proximal and distal ends. At least one lumen may be sized to receive a reentry wire that can be monitored and guided by an IVUS catheter disposed within a second elongate shaft having a proximal end and a distal end, and the at least one lumen extends between the proximal and distal ends to slidably receive the IVUS catheter. The second elongate shaft may also have a hub, such as a Luer connector, to allow the second elongate shaft to be coupled to other devices such as tubing, a syringe, a hemostatic valve, etc. In use, the device of FIG. 8 may be advanced over a wire already positioned within the subintimal space. The device may also be slidably advanced over a wire disposed within the lumen of the first elongate shaft. The lumen within the first elongate shaft may be configured as an over-the-wire lumen with a proximal port at the proximal end of the first elongate shaft and a distal port at the distal end of the first elongate shaft.Alternatively, the lumen in the first shaft may be configured as a monorail (rapid exchange) lumen, with the most distal wire exit port on the first elongate shaft at the most distal end of the first elongate shaft and the proximal wire port located at a proximal port on a second elongate shaft that is disposed closer to the distal end of the first elongate shaft than the proximal end of the first elongate shaft.

[0046]

[0056] Generally, the IVUS catheter may be a phased array IVUS catheter or a rotational IVUS catheter. The IVUS catheter may be preloaded into the lumen of the second elongate shaft when the reentry ultrasound engagement catheter device is advanced subintima toward and across the occlusion, or the IVUS catheter may be slidably advanced through the second elongate shaft after the reentry ultrasound engagement catheter device is positioned subintima. The IVUS lumen in the second elongate shaft may be configured as an over-the-wire lumen, as previously described above, or the IVUS lumen may be configured as a rapid-exchange lumen, as previously described above. Once the reentry ultrasound engagement catheter device and IVUS catheter are deployed at the desired location, the reentry ultrasound engagement catheter device is used in the same manner as in other examples disclosed herein. A reentry wire is advanced through the lumen of the first elongate shaft, and then the reentry wire is observed and guided to re-enter the true lumen using an IVUS catheter disposed within the second elongate shaft. Once the reentry wire has re-entered the true lumen, the reentry ultrasound engagement catheter device and IVUS catheter may be retracted, leaving behind the reentry wire, after which a further diagnostic or therapeutic device may be advanced across the occlusion using the reentry wire or another wire that replaces the reentry wire.

[0047]

[0057] 9A-9B show another example of a reentry ultrasound engagement catheter 900 that may be used to facilitate the use of a separate, discrete IVUS catheter during re-acquisition procedures or other uses described herein. In this example, a reentry guidewire lumen 918 is integrated into the same elongate body as an IVUS engagement region 909. The IVUS engagement region is formed as a second lumen extending parallel to the reentry guidewire lumen and extending further distally than the reentry guidewire lumen and exit port. An IVUS catheter may be inserted into the IVUS engagement region and, in some instances, may rotate within the IVUS engagement region. In FIG. 9A, the device may also include an IVUS imaging window 907 that may be distal to (and / or, in some instances, overlap with) the reentry guidewire exit port. This window may be open or made of an ultrasound-transparent material, as described above.

[0048]

[0058] Thus, the reentry ultrasound engagement catheter device 900 of FIG. 9A includes an elongate body (e.g., shaft) 903 having a proximal end and a distal end. The elongate shaft has at least two lumens extending between the proximal and distal ends. As mentioned, the first lumen is for a reentry guidewire, and the second lumen 909 is configured as an IVUS engagement region for a separate, discrete IVUS catheter 913. The proximal end of the catheter (not shown) may include one or more hubs, such as Luer connectors, to allow each lumen to be coupled to other devices such as tubing, syringes, hemostasis valves, etc. The first lumen may have an over-the-wire (OTW) or monorail (rapid exchange, RX) configuration. In an OTW configuration, the lumen has a proximal port at the proximal end of the catheter and a distal exit port at the distal end of the catheter. In the RX configuration, the lumen has a distal port at the distal end of the catheter, and a proximal port is closer to the distal end of the catheter than the proximal end of the catheter. Thus, there are several distal exit ports, including a distal exit port at the distal end of the catheter, or a distal port axially proximal to the distal end of the catheter for the first lumen when in the RX configuration. There may also be an exit port for the reentry wire adjacent to the RX distal port. In some instances, the reentry wire port and the RX port may be the same port. The IVUS engagement region may include a distal opening 915 for the IVUS guidewire to exit.

[0049]

[0059] The second lumen (e.g., the IVUS engagement region) may be sized and configured to slidably receive a separate and discrete IVUS catheter, such as a rotational IVUS catheter or a phased array IVUS catheter. The proximal port is at the proximal end of the catheter, and the distal port may be the same distal port as the first lumen distal port in an OTW configuration, although in alternative examples, the second lumen may be configured as a rapid exchange lumen.

[0050]

[0060] The cross section of the catheter may be as shown in Figure 9B, where the catheter is an outer circular shape with two circular lumens within the catheter wall. The catheter cross section and lumen cross section geometry may be circular, oval, elliptical, square, rectangular, or any other desired shape.

[0051]

[0061] In use, the device of Figures 9A-9B is advanced over a guidewire slidably disposed within a first lumen that has already been placed subintima to span the occlusion. In the RX configuration, the wire enters the catheter through the distal-most port and then exits the RX proximal port. An IVUS catheter, such as a rotational IVUS catheter, may be preloaded into the second lumen as the catheter is advanced subintima over the wire, or the IVUS catheter may be inserted into the second lumen after the catheter is properly positioned subintima. The IVUS catheter may then be used to visualize and guide a reentry wire, which is placed within the first lumen, to re-enter the true lumen. The reentry wire may exit a reentry port separate from the RX port, or the reentry wire port may be the same as the RX port. Once the reentry wire is properly advanced into the true lumen, the catheter is retracted, and another therapeutic or diagnostic device may be advanced over the reentry wire across the lumen.

[0052]

[0062] In the drawings, which are not necessarily drawn to scale, like numerals may describe like components in different views. Like numerals with different letter suffixes may indicate different instances of like components. The drawings generally illustrate various embodiments discussed in this document, by way of example, and not by way of limitation. Additionally, as explained, these figures may show a catheter that may be used in combination with a separate intravascular ultrasound (IVUS) catheter to facilitate wire re-entry from the subintimal space into the true lumen of a blood vessel during treatment of a blockage. The devices and methods disclosed herein may also be used to help direct a guidewire to a particular area, side branch, or lumen using an IVUS catheter. example

[0063] The following non-limiting examples detail particular aspects of the present subject matter to, among other things, solve the problems and provide the benefits discussed herein.

[0053]

[0064] Example 1 is a system for facilitating re-entry of a guidewire into a true lumen, comprising an elongate shaft having a proximal end and a distal end, a capsule coupled to the distal end of the elongate shaft, and a window disposed in a side wall of the capsule, the capsule configured to receive an intravascular ultrasound catheter (IVUS), and the IVUS catheter configured to image through the window.

[0054]

[0065] Example 2 is the system of Example 1 further comprising an IVUS catheter.

[0066] Example 3 is a method for facilitating re-entry of a guidewire into the true lumen of a blood vessel, the method including advancing an elongate shaft having a capsule toward an occlusion in the blood vessel, advancing the capsule through the subintimal space of the blood vessel, positioning the capsule distal to the occlusion, disposing an intravascular ultrasound catheter (IVUS) within the capsule, and re-entering the guidewire from the subintimal space into the true lumen of the blood vessel while imaging the guidewire with the IVUS catheter to ensure that the guidewire is correctly positioned and advanced. Example 4 is a system for facilitating re-entry of a guidewire into the true lumen, the system comprising an elongate shaft having proximal and distal ends, a first lumen extending between the proximal and distal ends, the first lumen configured to slidably receive a re-entry wire, and a second lumen extending between the proximal and distal ends, the second lumen configured to slidably receive an IVUS catheter.

[0055]

[0067] Example 5 is a method for facilitating re-entry of a guidewire into the true lumen of a blood vessel, the method comprising: advancing an elongate shaft having a first lumen and a second lumen toward an occlusion within the blood vessel; advancing the elongate shaft over a guidewire disposed within the first lumen through the subintimal space of the blood vessel; advancing an intravascular ultrasound catheter (IVUS) through the second lumen; and advancing the re-entry wire through the first lumen to re-enter the re-entry wire from the subintimal space into the true lumen of the blood vessel while imaging the re-entry wire with the IVUS catheter to ensure that the re-entry wire is correctly positioned and advanced.

[0056]

[0068] In Example 6, the apparatus or method of any one or any combination of Examples 1-5 may optionally be configured such that all listed elements or options are available for use or selection from.

[0057]

[0069] All publications and patent applications mentioned herein are 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. Furthermore, it should be recognized that all combinations of the above concepts, and additional concepts discussed in more detail below, are contemplated as part of the inventive subject matter disclosed herein (provided such concepts are not mutually inconsistent) and may be used to achieve the benefits described herein.

[0058]

[0070] Any of the methods (including user interfaces) described herein may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, a tablet, a smartphone, etc.) that, when executed by the processor, causes the processor to perform any of the steps, including, but not limited to, displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed at least in part by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium that stores a set of instructions for the process(es) of the method.

[0059]

[0071] Although various embodiments are described and / or illustrated herein in the context of a fully functional computing system, one or more of these example embodiments may be delivered as a program product in various forms, regardless of the particular type of computer-readable medium used to actually effect the delivery. The embodiments disclosed herein may also be implemented using software modules that perform particular tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or within a computing system. In some embodiments, these software modules may constitute a computing system that implements one or more of the example embodiments disclosed herein.

[0060]

[0072] As described herein, the computing devices and systems described and / or illustrated herein broadly refer to any type or form of computing device or system capable of executing computer-readable instructions, such as the instructions contained in the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0061]

[0073] The terms “memory” or “memory device,” as used herein, generally refer to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices include, without limitation, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, any variation or combination of one or more of the above, or any other suitable storage memory.

[0062]

[0074] Furthermore, the terms “processor” or “physical processor,” as used herein, generally refer to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the memory devices described above. Examples of physical processors include, but are not limited to, a microprocessor, a microcontroller, a central processing unit (CPU), a field-programmable gate array (FPGA) implementing a soft-core processor, an application-specific integrated circuit (ASIC), one or more predetermined portions of the above, one or more variations or combinations of the above, or any other suitable physical processor.

[0063]

[0075] Although shown as separate elements, the method steps described and / or illustrated herein may represent certain portions of a single application. Further, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as method steps.

[0064]

[0076] Further, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules listed herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0065]

[0077] The term "computer-readable medium," as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media such as carrier waves, and non-transitory-type media such as magnetic storage media (e.g., hard disk drives, tape drives, and floppy disks), optical storage media (e.g., compact disks (CDs), digital video disks (DVDs), and Blu-ray disks), electronic storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0066]

[0078] Those skilled in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and step sequences described and / or illustrated herein are given merely as examples and can be varied as needed. For example, although the steps illustrated and / or illustrated herein may be illustrated or discussed in a particular order, these steps do not necessarily have to be performed in the order illustrated or discussed.

[0067]

[0079] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or may include additional steps in addition to those disclosed. Furthermore, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0068]

[0080] The processors described herein may be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, the processor may be configured to combine one or more steps of one or more of the methods disclosed herein.

[0069]

[0081] When a feature or element is referred to herein as being "on" another feature or element, the feature or element can be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to herein as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, the feature or element can be directly connected, attached, or coupled to the other feature or element, or that intervening features or elements may be present. In contrast, when a feature or element is referred to herein as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Features and elements so described or illustrated, although described or illustrated with respect to one embodiment, may apply to other embodiments. It will also be recognized by those skilled in the art that references to structures or features disposed "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0070]

[0082] The terms used herein are merely for the purpose of describing particular embodiments and are not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0071]

[0083] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description to describe the relationship of one element or feature to another element(s) or feature(s) shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, elements described as being "under" or "beneath" the other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an over and an under orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptions used herein would be interpreted accordingly. Similarly, the terms "upwardly," "downwardly," "vertical," "horizontal," and similar terms are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0072]

[0084] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below could be referred to as a second feature / element, and similarly, a second feature / element discussed below could be referred to as a first feature / element, without departing from the teachings of the present invention.

[0073]

[0085] In general, any of the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, subcomponents, or substeps.

[0074]

[0086] As used in this specification and claims, including as used in the examples, and unless otherwise expressly specified, all numbers may be read as if preceded by the word "about" or "approximately," even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing magnitude and / or position to indicate that the stated value and / or position is within a reasonable expected range of value and / or position. For example, a numerical value may have a value that is + / - 0.1% (or range of values) of the stated value, + / - 1% (or range of values) of the stated value, + / - 2% (or range of values) of the stated value, + / - 5% (or range of values) of the stated value, + / - 10% (or range of values) of the stated value, etc. Any numerical value given herein should also be understood to include about or approximately that value unless the context dictates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges subsumed therein. When a value is disclosed, it is understood that "less than or equal to the value," "greater than or equal to the value," and possible ranges between values ​​are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It is also understood that throughout the application, data is provided in several different formats and that this data indicates endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than, less than, less than, and equal to 10 and 15, as well as between 10 and 15, are disclosed. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0075]

[0087] Although various illustrative embodiments are described above, any of several modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention, as that scope is set forth in the claims.

[0076]

[0088] The examples and illustrations contained herein illustrate, by way of illustration, not limitation, specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized and derived from the specific embodiments, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention," merely for convenience and without intending to intentionally limit the scope of this application to any single invention or inventive concept, if more than one is actually disclosed. Thus, although specific embodiments have been shown and described herein, any arrangements calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will become apparent to those skilled in the art upon reviewing the above description.

Claims

1. 1. A system for facilitating re-entry of a guidewire into a true lumen, comprising: an elongate shaft having proximal and distal ends and a reentry guidewire lumen extending through the proximal and distal ends, the reentry guidewire lumen having an exit port at a distal end region of the elongate shaft; an intravascular ultrasound catheter (IVUS) engagement region configured as a capsule coupled to the distal end of the elongate shaft; an IVUS imaging window disposed in a side wall of the capsule, the capsule configured to receive an intravascular ultrasound (IVUS) catheter and orient the IVUS catheter for imaging through the IVUS imaging window.

2. 10. The system of claim 1, The system further comprises a guide within or adjacent to the exit port for deflecting a re-entry guidewire laterally relative to the longitudinal axis of the elongate shaft.

3. 3. The system of claim 2, The system wherein the guide comprises a ramp, a channel, or a deflector.

4. 10. The system of claim 1, The system further comprises the reentry guidewire.

5. 10. The system of claim 1, The system wherein the IVUS imaging window is positioned laterally adjacent to the exit port.

6. 10. The system of claim 1, The system wherein the IVUS imaging window comprises a cutout area.

7. 10. The system of claim 1, The system, wherein the capsule comprises a porous material.

8. 10. The system of claim 1, The system wherein the capsule comprises a distal opening for an IVUS guidewire.

9. 10. The system of claim 1, The system further comprises one or more ultrasound markers on the distal end region of the elongate shaft and / or on the capsule.

10. 10. The system of claim 1, The system further comprises one or more engagement features in the capsule configured to orient the IVUS catheter.

11. 10. The system of claim 1, The system further comprises the IVUS catheter.

12. 10. The system of claim 1, The system further comprises one or more attachments for releasably securing the elongate body of the IVUS catheter to the elongate body.

13. 1. A method for facilitating re-entry of a guidewire into the true lumen of a blood vessel, comprising: advancing an elongate shaft having a capsule therein toward the occlusion within the blood vessel; advancing the capsule through the subintimal space of the blood vessel to position the capsule distal to the occlusion; disposing an intravascular ultrasound (IVUS) catheter within the capsule; and re-entering the guidewire from the subintimal space into the true lumen of the blood vessel while imaging the guidewire with the IVUS catheter to ensure that the guidewire is correctly positioned and advanced.

14. 1. A system for facilitating re-entry of a guidewire into a true lumen, comprising: an elongate shaft having a proximal end and a distal end; a reentry guidewire lumen extending between the proximal end and the distal end, the reentry guidewire lumen configured to slidably receive a reentry guidewire; an exit port fluidly connected to the re-entry guidewire lumen at a distal end region of the elongate shaft; an intravascular ultrasound (IVUS) lumen extending between the proximal end and the distal end of the elongate shaft, the IVUS lumen configured to slidably receive an IVUS catheter; an IVUS imaging window disposed within a sidewall of the elongate shaft in communication with the IVUS lumen and distal to or adjacent to the exit port.

15. 15. The system of claim 14, The system further comprises a guide within or adjacent to the exit port for deflecting a re-entry guidewire laterally relative to the longitudinal axis of the elongate shaft.

16. 16. The system of claim 15, The system wherein the guide comprises a ramp, a channel, or a deflector.

17. 15. The system of claim 14, The system further comprises the reentry guidewire.

18. 15. The system of claim 14, The system wherein the IVUS imaging window is positioned laterally adjacent to the exit port.

19. 15. The system of claim 14, The system wherein the IVUS imaging window comprises a cutout area.

20. 15. The system of claim 14, The system further comprises one or more ultrasound markers on the distal end region of the elongate shaft.

21. 15. The system of claim 14, The system further comprises one or more engagement features within the IVUS lumen configured to orient the IVUS catheter.

22. 15. The system of claim 14, The system further comprises the IVUS catheter.

23. 1. A method for facilitating re-entry of a guidewire into the true lumen of a blood vessel, comprising: advancing an elongate shaft having a first lumen and a second lumen toward the occlusion within the blood vessel; advancing the elongate shaft over a guidewire disposed within the first lumen through the subintimal space of the blood vessel; advancing an intravascular ultrasound catheter (IVUS) through the second lumen; and advancing the reentry guidewire through the first lumen and re-entering the reentry guidewire from the subintimal space into the true lumen of the blood vessel while imaging the reentry guidewire with the IVUS catheter to ensure that the reentry guidewire is correctly positioned and advanced.

Images