Systems, apparatuses, and methods for treating a carotid artery

Abstract

A coaxial catheter system for treating a carotid artery includes an inner catheter, an outer catheter, and a stent. The inner catheter is configured to be coaxial with a microwire and a guide catheter and includes one or more stent anchors and a balloon. The outer catheter is coaxial with the inner catheter and configured to be coaxial with the guide catheter. The stent is disposed between the inner catheter and the outer catheter.

Description

Attomev Docket No.: 2024P15111WO SYSTEMS, APPARATUSES, AND METHODS FOR TREATING A CAROTID ARTERYTECHNICAL FIELD

[0001] The present disclosure relates to systems, apparatuses, and / or methods for treating a carotid artery with a coaxial catheter system.BACKGROUND

[0002] Catheters (and other elongated medical devices) may be used for many minimally-invasive medical procedures for the diagnosis and treatment of diseases of various vascular systems, including neurovascular interventional (NVI) also known as neurointerventional or neuroendovascular surgery, percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vasculature, and via the guidewire advancing a working catheter to deliver therapy.SUMMARY

[0003] At least one example embodiment relates to a coaxial catheter system for treating a carotid artery. The coaxial catheter system may include an inner catheter, an outer catheter, and a stent. The inner catheter may be configured to be coaxial with a microwire and a guide catheter and may include one or more stent anchors and a balloon. The outer catheter may be coaxial with the inner catheter and configured to be coaxial with the guide catheter. The stent may be disposed between the inner catheter and the outer catheter.

[0004] In at least one example embodiment, the one or more stent anchors may be configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.Attorney Docket No.: 2024P15111WO

[0005] In at least one example embodiment, the inner catheter may be configured to extend beyond the outer catheter by at least a length of the balloon.

[0006] In at least one example embodiment, the inner catheter and the outer catheter may be coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.

[0007] Also described herein is a system for treating a carotid artery. The system may include a microwire and a coaxial catheter system. The microwire may be configured to extend from a proximal end of the system to a distal end of the system. The coaxial catheter system may include an inner catheter, an outer catheter, a stent, and a filter. The inner catheter may be coaxial with the microwire and a guide catheter and may include one or more stent anchors and a balloon. The outer catheter may be coaxial with the inner catheter and the guide catheter. The stent may be disposed between the inner catheter and the outer catheter. The filter may be configured to be deployed proximate to the distal end of the system.

[0008] In at least one example embodiment, the one or more stent anchors may be configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.

[0009] In at least one example embodiment, the inner catheter may be configured to extend beyond the outer catheter by at least a length of the balloon.

[0010] In at least one example embodiment, the filter may be coupled to the microwire approximately 5cm to 10cm from the distal end of the system.

[0011] In at least one example embodiment, the inner catheter and the outer catheter may be coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.Attorney Docket No.: 2024P15111WO

[0012] Also described herein is a method of treating a carotid artery. The method may include inserting a catheter system into the carotid artery. The catheter system may include an inner catheter, an outer catheter, and a stent. The inner catheter may be coaxial with the microwire and a guide catheter and may include a balloon. The outer catheter may be coaxial with the inner catheter and the guide catheter. The stent may be disposed between the inner catheter and the outer catheter. The method may further include advancing the microwire across a lesion of the carotid artery prior to advancing the inner catheter into the lesion of the carotid artery to place the balloon at a target location, inflating the balloon at the target location, advancing the inner catheter to a second target location to locate the stent at the target location, deploying the stent at the target location, and removing the catheter system from the carotid artery.

[0013] In at least one example embodiment, the catheter system further may include a filter at the distal end of the system. In at least one example embodiment, the method may further include advancing the microwire into the lesion of the carotid artery to a third target location and deploying the filter at the third target location. In at least one example embodiment, the deploying the filter at the third target location may include adjusting the microwire so it has a maximum amount of slack in the carotid artery to position the filter at the third target location. In at least one example embodiment, the method may further include pulling the filter from the third target location to a distal end of the inner catheter before removing the catheter system from the carotid artery.

[0014] In at least one example embodiment, the method may further include providing the guide catheter, the microwire, and the coaxial catheter system and loading the microwire into the coaxial catheter system before the inserting the catheter system into the carotid artery. In at least one example embodiment, the inserting the catheter system into the carotid artery may includeAttorney Docket No.: 2024P15111WO placing the guide catheter into the carotid artery and loading the coaxial catheter system including the microwire into the guide catheter after the guide catheter is placed within the carotid artery.

[0015] In at least one example embodiment, inflating the balloon at the target location may include inflating the balloon via a balloon inflation port of the inner catheter.

[0016] In at least one example embodiment, the method may further include maintaining a position of the inner catheter relative to the outer catheter until the deploying the stent at the second target location.

[0017] In at least one example embodiment, the deploying the stent at the target location may include retracting the outer catheter to unsheathe the stent from the catheter system.

[0018] Also described herein is a coaxial catheter system for treating a carotid artery. The coaxial catheter system may include an inner catheter, an outer catheter, and a stent. The inner catheter may be configured to be coaxial with a microwire and a guide catheter and may include one or more stent anchors. The outer catheter may be coaxial with the inner catheter and configured to be coaxial with the guide catheter and may include a balloon. The stent may be disposed between the inner catheter and the outer catheter.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The various features and advantages of the non-limiting embodiments herein may become more apparent upon review of the detailed description in conjunction with the accompanying drawings. The accompanying drawings are merely provided for illustrative purposes and should not be interpreted to limit the scope of the claims. The accompanying drawings are not to be considered as drawn to scale unless explicitly noted. For purposes of clarity, various dimensions of the drawings may have been exaggerated.Attorney Docket No.: 2024P15111WO

[0020] FIG. 1 is a perspective view of a robotic catheter-based procedure system.

[0021] FIG. 2 is a schematic block diagram of a portion of the robotic catheter-based procedure system shown in FIG. 1.

[0022] FIG. 3 is a perspective view of an example of the robotic drive shown in FIGS. 1 and 2.

[0023] FIG. 4 is a perspective view of a proximal portion of a system used to treat a carotid artery in accordance with at least one example embodiment.

[0024] FIG. 5 is a perspective view of a distal portion of the system used to treat a carotid artery in accordance with at least one example embodiment.

[0025] FIG. 6 is a perspective view of a stent anchor that may be included in an inner catheter of the system used to treat a carotid artery in accordance with at least one example embodiment.

[0026] FIG. 7 is a perspective view of a fdter that may be included in the system used to treat a carotid artery in accordance with at least one example embodiment.

[0027] FIG. 8 is a perspective view of system including the filter of FIG. 4 used to treat a carotid artery in accordance with at least one example embodiment.

[0028] FIG. 9 is a perspective view of a proximal portion of another system used to treat a carotid artery in accordance with at least one example embodiment.

[0029] FIG. 10 is a perspective view of a distal portion of the system of FIG. 9 used to treat a carotid artery in accordance with at least one example embodiment.

[0030] FIG. 11 is a flow chart of a method of treating a carotid artery in accordance with at least one example embodiment.

[0031] FIG. 12 is a block diagram of a system that may implement the various methods described herein according to at least one example embodiment.Attorney Docket No.: 2024P15111WO DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0032] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0033] Some detailed example embodiments are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing some example embodiments. Example embodiments may, however, be embodied in many alternate forms and should not be construed as limited to only example embodiments set forth herein.

[0034] Accordingly, while example embodiments are capable of various modifications and alternative forms, example embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit an example embodiment to the particular forms disclosed, but to the contrary, example embodiments are to cover all modifications, combinations, equivalents, and alternatives falling within the scope of an example embodiment. Like numbers refer to like elements throughout the description of the figures.

[0035] It should be understood that when an element or layer is referred to as being “on,” “connected to,” “coupled to,” or “covering” another element or layer, it may be directly on, connected to, coupled to, or covering the other element or layer or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly connected to,” or “directly coupled to” another element or layer, there are no intervening elements or layers present. Like numbers refer to like elements throughout the specification. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0036] It should be understood that, although the terms first, second, third, etc. may be used herein to describe various elements, regions, layers and / or sections, these elements, regions, layers,Attorney Docket No.: 2024P15111WO and / or sections should not be limited by these terms. These terms are only used to distinguish one element, region, layer, or section from another region, layer, or section. Thus, a first element, region, layer, or section discussed below could be termed a second element, region, layer, or section without departing from the teachings of example embodiment.

[0037] Spatially relative terms (e.g., “beneath,” “below,” “lower,” “above,” “upper,” and the like) may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0038] The terminology used herein is for the purpose of describing various example embodiment only and is not intended to be limiting of example embodiment. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “includes,” “including,” “comprises,” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, and / or elements, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements and / or groups thereof.Attorney Docket No.: 2024P15111WO

[0039] Example embodiments are described herein with reference to cross-sectional illustrations that are schematic illustrations of example embodiment. As such, variations from the shapes of the illustrations are to be expected. Thus, example embodiment should not be construed as limited to the shapes of regions illustrated herein but are to include deviations and variations in shapes.

[0040] When the words “about” and “substantially” are used in this specification in connection with a numerical value, it is intended that the associated numerical value include a tolerance of ±10% around the stated numerical value, unless otherwise explicitly defined. Moreover, when the terms “generally” or “substantially” are used in connection with geometric shapes, it is intended that precision of the geometric shape is not required but that latitude for the shape is within the scope of the disclosure. Furthermore, regardless of whether numerical values or shapes are modified as “about,” “generally,” or “substantially,” it will be understood that these values and shapes should be construed as including a manufacturing or operational tolerance (e.g., ±10%) around the stated numerical values or shapes.

[0041] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiment belong. It will be further understood that terms, including those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0042] Conventionally, a catheterization procedure starts by gaining access into the appropriate vessel, such as an artery or vein, with a sheath such as an introducer sheath. Then, a guide catheter or a guide sheath plus a select catheter and wire such as 0.035 inch wire may be inserted andAttorney Docket No.: 2024P15111WO navigated into carotid arteries. The physician or operator may use an imaging system (e.g., fluoroscope) to obtain a cine with a contrast injection and select a fixed frame for use as a roadmap to navigate the guidewire or catheter to the target location, for example a lesion. Contrast-enhanced images are also obtained while the physician delivers the guidewire or catheter device so that the physician can verify that the device is moving along the correct path to the target location. While observing the anatomy using fluoroscopy, the physician manipulates the proximal end of the guidewire or catheter to direct the distal tip into the appropriate vessels toward the lesion and avoid advancing into side branches.

[0043] During a neurological intervention, there may be times where treatment of the carotid artery is necessary. In at least one example embodiment, treatment of the carotid artery during a neurological intervention may occur when there is a tandem lesion where a patient with an ischemic stroke also has a lesion in the carotid artery that requires treatment. Another example of treatment of the carotid artery during a neurological intervention may occur if there is a complication in the carotid artery such as a dissection. Treatment of the carotid artery may involve use of a balloon and / or a stent. For example, a microcatheter and a microwire may be used to cross a lesion in the carotid artery. Then, the balloon and stent may be used to treat the lesion and the stent may optionally be post dilated with the balloon. Conventional neurological interventions may involve over-the-wire (OTW) procedures while treatment of a carotid artery is typically performed via a peripheral method that may involve removing an OTW microcatheter followed by deployment of a balloon and stent via rapid exchange. The systems, methods, and devices described herein utilize coaxial catheters to optimize treatment of a carotid artery during a neurological intervention. The systems, methods, and devices described herein enable treatment of a carotid artery with one set of devices rather than requiring exchange of devices that are eachAttorney Docket No.: 2024P15111WO configured to do one portion of the treatment of the carotid artery to improve treatment of a carotid artery. Thus, the entire system may be able to cross a lesion rather than just a microcatheter and a microwire. The systems, methods, and devices described herein remove the need for an indwelling wire exchange using a robotic system which may allow a less experienced operator to be present at the patient site during the procedure. While the systems, methods, and devices described herein have been described with respect to treatment of a carotid artery, the use of the systems, methods, and devices is not limited herein and may be used to treat other arteries of a patient.

[0044] FIG. 1 is a perspective view of an example catheter-based procedure system 10 in accordance with an embodiment. Catheter-based procedure system 10 may be used to perform catheter-based medical procedures, e.g., percutaneous intervention procedures such as a percutaneous coronary intervention (PCI) (e.g., to treat STEMI), a neurovascular interventional procedure (NVI) (e.g., to treat an emergent large vessel occlusion (ELVO)), peripheral vascular intervention procedures (PVI) (e.g., for critical limb ischemia (CLI), etc.). Catheter-based medical procedures may include diagnostic catheterization procedures during which one or more catheters or other elongated medical devices (EMDs) are used to aid in the diagnosis of a patient's disease. For example, during one embodiment of a catheter-based diagnostic procedure, a contrast media is injected onto one or more arteries through a catheter and an image of the patient's vasculature is taken. Catheter-based medical procedures may also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, clot removal, arterial venous malformation therapy, treatment of aneurysm, etc.) during which a catheter (or other EMD) is used to treat a disease. Therapeutic procedures may be enhanced by the inclusion of adjunct devices 54 (shown in FIG. 2 ) such as, for example, intravascular ultrasound (IVUS), optical coherence tomography (OCT), fractional flow reserve (FFR), etc. It should be noted, however, thatAttorney Docket No.: 2024P15111WO one skilled in the art would recognize that certain specific percutaneous intervention devices or components (e.g., type of guidewire, type of catheter, etc.) may be selected based on the type of procedure that is to be performed. Catheter-based procedure system 10 can perform any number of catheter-based medical procedures with minor adjustments to accommodate the specific percutaneous intervention devices to be used in the procedure.

[0045] Catheter-based procedure system 10 includes, among other elements, a bedside unit 20 and a control station (not shown). Bedside unit 20 includes a robotic drive 24 and a positioning system 22 that are located adjacent to a patient 12. Patient 12 is supported on a patient table 18. The positioning system 22 is used to position and support the robotic drive 24. The positioning system 22 may be, for example, a robotic arm, an articulated arm, a holder, etc. The positioning system 22 may be attached at one end to, for example, the patient table 18 (as shown in FIG. 1 ), a base, or a cart. The other end of the positioning system 22 is attached to the robotic drive 24. The positioning system 22 may be moved out of the way (along with the robotic drive 24) to allow for the patient 12 to be placed on the patient table 18. Once the patient 12 is positioned on the patient table 18, the positioning system 22 may be used to situate or position the robotic drive 24 relative to the patient 12 for the procedure. The position of the robotic drive in a position for the procedure is referred to herein as the robotic drive in-use position. In an embodiment, patient table 18 is operably supported by a pedestal 17, which is secured to the floor and / or earth. Patient table 18 is able to move with multiple degrees of freedom, for example, roll, pitch, and yaw, relative to the pedestal 17. Bedside unit 20 may also include controls and displays 46 (shown in FIG. 2 ). For example, controls and displays may be located on a housing of the robotic drive 24.

[0046] Generally, the robotic drive 24 may be equipped with the appropriate percutaneous interventional devices and accessories 48 (shown in FIG. 2 ) (e.g., guidewires, various types ofAttorney Docket No.: 2024P15111WO catheters including but not limited to balloon catheters, stent delivery systems, stent retrievers, embolization coils, liquid embolics, aspiration pumps, device to deliver contrast media, medicine, hemostasis valve adapters, syringes, stopcocks, inflation device, etc.) to allow a user or operator to perform a catheter-based medical procedure via a robotic system by operating various controls such as the controls and inputs located at the control station. Bedside unit 20, and in particular robotic drive 24, may include any number and / or combination of components to provide bedside unit 20 with the functionality described herein. The robotic drive 24 includes a plurality of device modules 32a-d mounted to a rail or linear member. Each of the device modules 32a-d may be used to drive an EMD such as a catheter or guidewire. For example, the robotic drive 24 may be used to automatically feed a guidewire into a diagnostic catheter and into a guide catheter in an artery of the patient 12. One or more devices, such as an EMD, enter the body (e.g., a vessel) of the patient 12 at an insertion point 16 via, for example, an introducer sheath. Each device module 32a-d include a drive module and cassette removably attached to the drive module. Each drive module is movable along the robotic drive longitudinal axis with a bracket or stage. While FIG. 1 illustrates four device modules it is contemplated that the number of device modules may be one or more.

[0047] Bedside unit 20 is in communication with the control station (not shown), allowing signals generated by the user inputs of the control station to be transmitted wirelessly or via hardwire to the bedside unit 20 to control various functions of bedside unit 20. As discussed below, control station 26 may include a control computing system 34 (shown in FIG. 2, also referred to as a controller) or be coupled to the bedside unit 20 through the control computing system 34. Bedside unit 20 may also provide feedback signals (e.g., loads, speeds, operating conditions, warning signals, error codes, etc.) to the control station, control computing system 34 (shown in FIG. 2 ), or both. Communication between the control computing system 34 and variousAttorney Docket No.: 2024P15111WO components of the catheter-based procedure system 10 may be provided via a communication link that may be a wireless connection, cable connections, or any other means capable of allowing communication to occur between components. The control station or other similar control system may be located either at a local site (e.g., local control station 38 shown in FIG. 2) or at a remote site (e.g., remote control station 42 shown in FIG. 2 ). Catheter procedure system 10 may be operated by a control station at the local site, a control station at a remote site, or both the local control station and the remote control station at the same time. At a local site, a user or operator and the control station are located in the same room or an adjacent room to the patient 12 and bedside unit 20. As used herein, a local site is the location of the bedside unit 20 and a patient 12 or subject (e.g., animal or cadaver) and the remote site is the location of a user or operator and a control station used to control the bedside unit 20 remotely. A control station (and a control computing system) at a remote site and the bedside unit 20 and / or a control computing system at a local site may be in communication using communication systems and services 36 (shown in FIG. 2 ), for example, through the Internet. In an embodiment, the remote site and the local (patient) site are away from one another, for example, in different rooms in the same building, different buildings in the same city, different cities, or other different locations where the remote site does not have physical access to the bedside unit 20 and / or patient 12 at the local site. In at least one example embodiment, the remote site may be in communication with the local site may be by conventional means known in the art. In at least one example embodiment, the local operator may be less sophisticated than the remote operator.

[0048] The control station generally includes one or more input modules 28 configured to receive user inputs to operate various components or systems of catheter-based procedure system 10. In the embodiment shown, control station allows the user or operator to control bedside unitAttorney Docket No.: 2024P15111WO 20 to perform a catheter-based medical procedure. For example, input modules 28 may be configured to cause bedside unit 20 to perform various tasks using percutaneous intervention devices (e.g., EMDs) interfaced with the robotic drive 24 (e.g., to advance, retract, or rotate a guidewire, advance, retract or rotate a catheter, inflate or deflate a balloon located on a catheter, position and / or deploy a stent, position and / or deploy a stent retriever, position and / or deploy a coil, inject contrast media into a catheter, inject liquid embolics into a catheter, inject medicine or saline into a catheter, aspirate on a catheter, or to perform any other function that may be performed as part of a catheter-based medical procedure). Robotic drive 24 includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of the components of the bedside unit 20 including the percutaneous intervention devices.

[0049] In one embodiment, input modules 28 may include one or more touch screens, joysticks, scroll wheels, and / or buttons. In addition to input modules 28, the control station 26 may use additional user controls 44 (shown in FIG. 2 ) such as foot switches and microphones for voice commands, etc. Input modules 28 may be configured to advance, retract, or rotate various components and percutaneous intervention devices such as, for example, a guidewire, and one or more catheters or microcatheters. Buttons may include, for example, an emergency stop button, a multiplier button, device selection buttons and automated move buttons. When an emergency stop button is pushed, the power (e.g., electrical power) is shut off or removed to bedside unit 20. When in a speed control mode, a multiplier button acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of input modules 28. When in a position control mode, a multiplier button changes the mapping between input distance and the output commanded distance. Device selection buttons allow the user or operator to select which of the percutaneous intervention devices loaded into the robotic drive 24 are controlled by inputAttorney Docket No.: 2024P15111WO modules 28. Automated move buttons are used to enable algorithmic movements that the catheterbased procedure system 10 may perform on a percutaneous intervention device without direct command from the user or operator. In one embodiment, input modules 28 may include one or more controls or icons (not shown) displayed on a touch screen (that may or may not be part of a display), that, when activated, causes operation of a component of the catheter-based procedure system 10. Input modules 28 may also include a balloon or stent control that is configured to inflate or deflate a balloon and / or deploy a stent. Each of the input modules 28 may include one or more buttons, scroll wheels, joysticks, touch screen, etc. that may be used to control the particular component or components to which the control is dedicated. In addition, one or more touch screens may display one or more icons (not shown) related to various portions of input modules 28 or to various components of catheter-based procedure system 10.

[0050] Catheter-based procedure system 10 also includes an imaging system 14. Imaging system 14 may be any medical imaging system that may be used in conjunction with a catheter based medical procedure (e g., non-digital X-ray, digital X-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, imaging system 14 is a digital X-ray imaging device that is in communication with the control station. In one embodiment, imaging system 14 may include a C-arm (shown in FIG. 1 ) that allows imaging system 14 to partially or completely rotate around patient 12 in order to obtain images at different angular positions relative to patient 12 (e.g., sagittal views, caudal views, anterior-posterior views, etc.). In one embodiment imaging system 14 is a fluoroscopy system including a C-arm having an X-ray source 13 and a detector 15, also known as an image intensifier.

[0051] Imaging system 14 may be configured to take X-ray images of the appropriate area of patient 12 during a procedure. For example, imaging system 14 may be configured to take one orAttorney Docket No.: 2024P15I11WO more X-ray images of the head to diagnose a neurovascular condition. Imaging system 14 may also be configured to take one or more X-ray images (e.g., real time images) during a catheterbased medical procedure to assist the user or operator of control station 26 to properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The image or images may be displayed on display 30. For example, images may be displayed on a display to allow the user or operator to accurately move a guide catheter or guidewire into the proper position.

[0052] In order to clarify directions, a rectangular coordinate system is introduced with X, Y, and Z axes. The positive X axis is oriented in a longitudinal (axial) distal direction, that is, in the direction from the proximal end to the distal end, stated another way from the proximal to distal direction. The Y and Z axes are in a transverse plane to the X axis, with the positive Z axis oriented up, that is, in the direction opposite of gravity, and the Y axis is automatically determined by righthand rule. As used herein the X axis extends along a longitudinal axis of the robotic drive 24. Since in an in-use position the robotic housing may be at an angle with respect to the horizontal plane perpendicular to the direction of gravity the X, Y and Z axes are defined by robotic drive 24. Referring to FIG. 1 , robotic drive 24 includes a housing having a top or first member 24a parallel to the X-Y plane; a bottom or second member parallel to and spaced from the first member 24a; a front or third member 24c substantially perpendicular and extending between first member 24a and the second member, the third member facing a user when robotic drive 24 is in the in-use position or orientation illustrated in FIG. 1 . A fourth member is spaced from and substantially parallel to third member 24c and perpendicular to first member 24a and the second member 24b. It is contemplated that other shapes of the robotic drive housing may be used. In which case first member 24a would be the upper member, the second member would be the lower or bottomAttorney Docket No.: 2024P15111WO member, front or third member 24c would be the portion facing a user in an in-use position during a surgical procedure, and the fourth member is the portion facing away from the user in the in-use position during a surgical procedure. Robotic drive 24 further includes a distal region 24e and a proximal region 24f. Where the distal region 24e is closer to the entry point of the patient through which the EMD will be introduced and the proximal region 24f is furthest from the entry point of the patient through which the EMD will be introduced.

[0053] FIG. 2 is a block diagram of catheter-based procedure system 10 in accordance with an example embodiment. Catheter-procedure system 10 may include a control computing system 34. Control computing system 34 may physically be, for example, part of a control station. Control computing system 34 may generally be an electronic control unit suitable to provide catheter-based procedure system 10 with the various functionalities described herein. For example, control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionality described herein, etc. Control computing system 34 is in communication with bedside unit 20, communications systems and services 36 (e.g., Internet, firewalls, cloud services, session managers, a hospital network, etc.), a local control station 38, additional communications systems 40 (e.g., a telepresence system), a remote control station and computing system 42, and patient sensors 56 (e.g., electrocardiogram (ECG) devices, electroencephalogram (EEG) devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). The control computing system is also in communication with imaging system 14, patient table 18, additional medical systems 50, contrast injection systems 52 and adjunct devices 54 (e.g., IVUS, OCT, FFR, etc.). The bedside unit 20 includes a robotic drive 24, a positioning system 22 and may include additional controls and displays 46. As mentioned above, the additional controls and displays may be located on a housing of the robotic drive 24.Attorney Docket No.: 2024P15111WO Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface to the bedside unit 20. In an embodiment, interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheter, OCT catheter, FFR wire, diagnostic catheter for contrast, etc.) which interface to their respective adjunct devices 54, namely, an IVUS system, an OCT system, and FFR system, etc.

[0054] In various embodiments, control computing system 34 is configured to generate control signals based on the user's interaction with input modules 28 (e.g., of a control station such as a local control station 38 or a remote control station 42) and / or based on information accessible to control computing system 34 such that a medical procedure may be performed using catheterbased procedure system 10. The local control station 38 includes one or more displays 30, one or more input modules 28, and additional user controls 44. The remote control station and computing system 42 may include similar components to the local control station 38. The remote 42 and local 38 control stations can be different and tailored based on their required functionalities. The additional user controls 44 may include, for example, one or more foot input controls. The foot input control may be configured to allow the user to select functions of the imaging system 14 such as turning on and off the X-ray and scrolling through different stored images. In another embodiment, a foot input device may be configured to allow the user to select which devices are mapped to scroll wheels included in input modules 28. Additional communication systems 40 (e.g., audio conference, video conference, telepresence, etc.) may be employed to help the operator interact with the patient, medical staff (e.g., angio-suite staff), and / or equipment in the vicinity of the bedside.

[0055] Catheter-based procedure system 10 may be connected or configured to include any other systems and / or devices not explicitly shown. For example, catheter-based procedure systemAttorney Docket No.: 2024P15111WO 10 may include image processing engines, data storage and archive systems, automatic balloon and / or stent inflation systems, medicine injection systems, medicine tracking and / or logging systems, user logs, encryption systems, systems to restrict access or use of catheter-based procedure system 10, etc.

[0056] As mentioned, control computing system 34 is in communication with bedside unit 20 which includes a robotic drive 24, a positioning system 22 and may include additional controls and displays 46 and may provide control signals to the bedside unit 20 to control the operation of the motors and drive mechanisms used to drive the percutaneous intervention devices (e.g., guidewire, catheter, etc.). The various drive mechanisms may be provided as part of a robotic drive 24.

[0057] Referring to FIG. 3 device module 32a includes a first drive module 60 and a first cassette 68. Device module 32b includes a second drive module 62 and a second cassette 70. Device module 32c includes a third drive module 64 and a third cassette 72. Device module 32d includes a fourth drive module 66 and a fourth cassette 74. In one implementation first cassette 68, second cassette 70, third cassette 72 and fourth cassette 74 are shipped together as a multi-unit cassette assembly. In one implementation the multi-unit cassette assembly 76 allows for each of the cassettes to be removably connected to their respective drive modules while slidably connected together. In one implementation each of the multiple device modules 3 a-d may be independently actuated to move linearly along a linear member within robotic drive 24. Each device module 32a-d may independently move relative to each other and the linear member in the robotic drive. The drive mechanism moves each device module along a longitudinal axis 78 of robotic drive 24, also referred to herein as the robotic drive longitudinal axis 78. Robotic drive longitudinal axis 78 may extend along the linear member such as a screw drive along which device modules move or mayAttorney Docket No.: 2024P15111WO be defined along another axis that is parallel to the linear member along which the device modules move. Referring to FIG. 3 each cassette 68-74 is generally vertically oriented in the XZ plane. Each cassette 68-74 has a length along the X axis or parallel to longitudinal axis 78 that is greater than the width of each cassette along the Y axis or perpendicular to the Y axis.

[0058] Having now described an example embodiment of a robotic catheter-based procedure system for implementation, systems and methods for treating a carotid artery will now be described. For example purposes, the following example embodiments will be described with regard to the example robotic catheter-based procedure system 10 shown in FIGS. 1-3. However, example embodiments should not be limited to these examples. Rather, example embodiments may be applicable to other elongated medical devices and / or other robotic medical device systems.

[0059] FIGS. 4 and 5 illustrate a system 100 for treating a carotid artery. In particular, FIG. 4 illustrates a proximal end 102 of the system 100 and FIG. 5 illustrates a distal end 104 of the system 100. In at least one example embodiment, the distal end 104 of the system 100 may be configured to extend into a patient via an introducer sheath 108 to treat a carotid artery while the proximal end 102 remains accessible to an operator and / or a robot such as the robotic catheterbased procedure system 10 configured to perform a procedure utilizing the system 100. In particular, the introducer sheath 108 may be configured to extend into a patient while a portion of the system from the introducer sheath 108 to the proximal end 102 is configured to remain accessible to the operator and / or the robot for performing a procedure using the system 100.

[0060] The system 100 includes a microwire 106 configured to extend from the proximal end 102 to the distal end 104 of the system 100. The system 100 also includes a coaxial catheter system 105 including an inner catheter 110, an outer catheter 112, and a stent 114. The system 100 may further include a guide catheter 116. The guide catheter 116 may be a guide and / or a guide sheathAttorney Docket No.: 2024P15111WO and the terms guide catheter 116, guide 116, and guide sheath 116 are used interchangeably herein. In at least one example embodiment, the inner catheter 110 may be coaxial with the microwire 106 and the guide catheter 116 and the outer catheter 112 may be coaxial with the inner catheter 110 and the guide catheter 116.

[0061] In at least one example embodiment, the stent 114 may be disposed between the inner catheter 110 and the outer catheter 112. The stent 114 may be a conventionally-deployed selfexpanding stent that may be known in the art. The stent 114 may be deployed by pulling back on the outer catheter 112 relative to the inner catheter 110 to keep the stent in position. Thus, before deployment, the stent 114 may be encapsulated by the outer catheter 112 as shown in FIG. 5.

[0062] In at least one example embodiment, the inner catheter 110 may include one or more stent anchors and a balloon 120. The one or more stent anchors may be located proximate to the outer catheter such that the stent 114 is unable to pass the one or more stent anchors. This may enable the system 100 to maintain a constant distance between the stent and the inner catheter 110 during deployment of the system 100. As used herein, a constant distance is a constant distance axially / longitudinally. The inner catheter 110 may also include a port 122 configured to enable inflation of the balloon 120.

[0063] In at least one example embodiment, the inner catheter 110 may be configured to extend beyond the outer catheter 112 by at least a length of the balloon 120. In particular, in an undeployed state, the inner catheter 110 may extend distally beyond the outer catheter 112 by at least the length of the balloon 120. This may enable the balloon to be part of the inner catheter 110 which may make it easier to navigate the balloon 120 through a lesion of the carotid artery based on the diameter of the inner catheter 110. In at least one example embodiment, the inner catheter 110 with the balloon 120 may be approximately a size of a microcatheter of existing systems used toAttorney Docket No.: 2024P15111WO cross lesions. Thus, the inner catheter 110 with the balloon 120 may be configured to cross a lesion in the carotid artery. In at least one example embodiment, rather than being located within the inner catheter 110, the balloon 120 may be disposed in the outer catheter 112. When the balloon 120 is disposed in the outer catheter 112, for more distal lesions the inner catheter 110 may be placed higher in the vasculature where there may be greater tortuosity, for example.

[0064] In at least one example embodiment, the inner catheter 110 and the outer catheter 112 may be coupled such that movement of the inner catheter 110 is tied to movement of the outer catheter 112 until the stent 114 is deployed within a carotid artery. For example, the inner catheter 110 may be maintained at a constant position relative to the outer catheter 112 until the stent 114 is deployed at a target location. This may help to ensure that the stent 114 is not accidentally deployed in an incorrect location. In at least one example embodiment, the inner catheter 110 and the outer catheter 112 may be coupled by tightening a valve 130 of the system 100. In at least one example embodiment, the valve 130 maybe a Tuohy-Borst valve. Further, the inner catheter 110 and the outer catheter 112 may be robotically coupled within a control mode that only allows for coupled or simultaneous movement of the inner catheter 110 and the outer catheter 112.

[0065] In at least one example embodiment, proximal ends of each of the inner catheter 110, the outer catheter 112, and the guide catheter 116 may include luer fittings or a fitting configured to interface with a robot consumable such as the cassettes of the robotic catheter-based procedure system 10 described above. Further details of the robotic catheter-based procedure system 10 and the cassettes of the robotic catheter-based procedure system 10 are described in International Patent Publication PCT / US2021 / 070038 and U.S. Patent Publication 2024 / 0207574, each of which are incorporated herein by reference in their entirety. As described above, each device module 32a-32d includes a cassette. Thus, the robotic catheter-based procedure system 10 includesAttorney Docket No.: 2024P15111WO the first cassette 68, the second cassette 70, the third cassette 72, and the fourth cassette 74. In at least one example embodiment, the guide catheter 116 may be inserted into the first cassette 68, the outer catheter 112 may be inserted into the second cassette 70, the inner catheter 110 may be inserted into the third cassette 72, and the microwire 106 may be inserted into the fourth cassette 74.

[0066] Each of the inner catheter 110, the outer catheter 112, and the guide catheter 116 may be conventional catheters that may include strain reliefs and other features that may be fit to a particular robot for use of the system 100. In at least one example embodiment, lengths of each of the inner catheter 110, the outer catheter 112, and the guide catheter 116 may be optimized for optimal vasculature reach. This may enable deployment of the stent 114 without hubbing out the inner catheter 110, the outer catheter 112, the guide catheter 116, or the microwire 106. As used herein, the term hubbing refers to a situation where additional catheter length is needed but the catheter cannot be moved because an adjacent catheter is preventing the necessary movement. Thus, desired movement of the catheters may not be possible if hubbing occurs. However, the systems and methods described herein may have optimal lengths to minimize and / or avoid hubbing of the system 100.

[0067] In at least one example embodiment, the system 100 may additionally include one or more radio-opaque marker bands 135. In particular, either or both of the inner catheter 110 and the outer catheter 112 may include the one or more radio-opaque marker bands 135 near the distal end 104 of the system 100. The one or more radio-opaque marker bands 135 may allow a physician or operator to clearly see key parts of the system 100 under fluoroscopy as a band of dark color. The one or more radio opaque marker bands 135 are shown at a distal end of the inner catheter 110 in FIG. 5. However, the one or more radio opaque marker bands 135 may be located at a distal endAttorney Docket No.: 2024P15111WO of the outer catheter 112, at the stent anchors, or within or proximal to the stent 114 (not visible) in at least one example embodiment. Further, the system 100 may include one or more fluoroscopy safe markers 140 placed closer to the proximal end 104 of the system 100. The one or more fluoroscopy safe markers 140 may be visual markers on an outside shaft of the system 100 that a physician or operator may observe as he or she inserts the system 100 into a patient. In at least one example embodiment, the one or more fluoroscopy safe markers 140 may provide a visual indication of a length of the system 100 that may be inserted into the patient without fluoroscopy on until the one or more fluoroscopy safe markers 140 enter the guide catheter 116. As shown in FIG. 4, a marker of the one or more fluoroscopy safe markers 140 is shown on a portion of a shaft of the outer catheter 112. Locations of the one or more fluoroscopy safe markers 140 are not limited herein and may be placed at different locations dependent on the particular use of the system 100.

[0068] FIG. 6 illustrates a stent anchor 302 according to at least one example embodiment. The stent anchor 302 may be cylindrical with a central aperture 304. As described above, one or more stent anchors 302 may be included in the inner catheter 110 to maintain a constant distance between the stent and the inner catheter 110 during deployment of the system 100. As described above, the constant distance may be a constant distance axially / longitudinally.

[0069] FIG. 7 illustrates a filter 402 that may be included in the coaxial catheter system 105 in at least one example embodiment. The filter 402 may include one or more struts 404 that may provide structure to the filter 402 and keep the filter 402 from being traumatic to vessel walls of the carotid artery during deployment of the stent 114, when being retracted into the coaxial catheter system 105, or in case of accidental movement of the filter 402. Further, the filter 402 may be a sock type filter in at least one example embodiment which may enable the filter 402 to be low friction to enable the microwire 106 to be configured to rotate normally without resistance due toAttorney Docket No.: 2024P15111WO the filter 402. The filter 402 may provide embolic protection during treatment of a carotid artery. For example, the filter 402 may catch plaque or other elements that could otherwise break free from a lesion and continue to flow distally through the artery which may result in smaller vessels being blocked which could cause micro-strokes.

[0070] FIG. 8 illustrates the distal end 104 of a system 500 that may be similar or analogous to the system 100 of FIGS. 1 and 2 but may also include the filter 402. The microwire 106, the inner catheter 110, the outer catheter 112, and the guide catheter 116 may be substantially as described above with respect to FIGS. 1 and 2. The filter 402 may be included in the coaxial catheter system 105 when the filter 402 is included in the system 500. In at least one example embodiment, the filter 402 may be configured to couple to the microwire 106 approximately 5cm to 10cm from the distal end 104 of the system 500.

[0071] FIGS. 9 and 10 illustrate a system 150 for treating a carotid artery with the balloon 120 located on the outer catheter 112 rather than the inner catheter 110. The system 150 may be similar or analogous to the system 100 of FIGS. 4 and 5 other than the location of the balloon 120 and the port 122. As described above, when the balloon 120 is disposed in the outer catheter 112, for more distal lesions, the inner catheter 110 may be placed higher in the vasculature where there may be greater tortuosity.

[0072] FIG. 11 is a flow chart of a method 600 of treating a carotid artery. The method 600 may begin at step S602 when a catheter system is inserted into the carotid artery. The catheter system may include the microwire 106 and the coaxial catheter system 105. The catheter system described herein may be the system used to treat the carotid artery. Additional catheter systems, not described herein and generally known in the art, may be used to navigate from the insertion point 16 to the carotid artery. The system used to navigate to the carotid artery may include theAttorney Docket No.: 2024P15111WO guide catheter 116. All components, besides the guide catheter 116, may be removed once the system has been used to navigate to the carotid artery to allow the catheter system, including the guide catheter 116, to treat the carotid artery. The coaxial catheter system 105 may be as described with respect to FIGS. 4 and 5 or FIG. 8. Thus, the filter 402 may be included in the coaxial catheter system 105 or may not be included in the coaxial catheter system 105.

[0073] As described above, the guide catheter 116 may be inserted into the first cassette 68, the outer catheter 112 may be inserted into the second cassette 70, the inner catheter 110 may be inserted into the third cassette 72, and the microwire 106 may be inserted into the fourth cassette 74. Prior to step S602, when a catheter system is used to navigate from the insertion point 16 to the carotid artery, the first cassette 68, the second cassette 70, and the third cassette 72 may be advanced to advance the guide catheter, a select catheter, and a 0.035” guidewire. As described herein, movement of one or more of the first cassette 68, the second cassette 70, the third cassette 72, and / or the fourth cassette 74 may occur at the same time or at different times to advance the necessary catheter or element within the system 100. Then, the outer catheter 112 may be inserted into the second cassette 70, the inner catheter 110 may be inserted into the third cassette 72, and the microwire 106 may be inserted into the fourth cassette 74 to perform the method 600 described herein.

[0074] At S604, the microwire 106 may be advanced across a lesion of the carotid artery. The catheter system may provide support to the microwire to enable the microwire to cross a lesion to enable treatment of the carotid artery with the coaxial catheter system 100. In at least one example embodiment, advancing the microwire 106 may involve advancing the fourth cassette 74. The second cassette 70 and the third cassette 72 may also be advanced to provide support for the microwire 106. In at least one example embodiment, the first cassette 68 may be advanced to assistAttorney Docket No.: 2024P15111WO with navigating the system 100 or to maintain a position of the guide catheter 116 or the system 100 based on movement of one or more of the inner catheter 110, the outer catheter 112, or the microwire 106 as the system 100 is advanced towards the carotid artery.

[0075] After the microwire 106 is advanced across the lesion, the inner catheter 110 may be advanced into the lesion to place the balloon at a target location at S606. As described above, the outer catheter 112 may move in conjunction with the inner catheter 110 to prevent early stent deployment. Thus, the second cassette 70 and the third cassette 72 may be advanced to adjust the position of the inner catheter 110 and the outer catheter 112. In at least one example embodiment, the target location may be a target location within the lesion. The target location may be determined based on the particular patient and lesion in at least one example embodiment.

[0076] In at least one example embodiment when the filter 402 is included in the system 500, before the balloon 120 is inflated and thus prior to angioplasty, the filter 402 may be deployed. In particular, once the balloon 120 is located at the target location, the inner catheter 110 may be advanced to a third target location for deployment of the filter 402. In at least one example embodiment, a distal end of the microcatheter should be disposed at the third target location to enable placement of the filter 402 at the third target location. The filter 402 may then be deployed at the third target location by advancing the inner catheter 110 to the third target location until the filter 402 is deployed. The microwire 106 should be adjusted to have a maximum amount of slack which will place the filter 402 in a position where it is least likely to move. The filter 402 may provide embolic protection as described above when it is deployed at the third target location. After the filter 402 is deployed, the inner catheter 110 may be navigated back to the position of the balloon 120 at the target location.Attorney Docket No.: 2024P15111WO

[0077] At S608, the balloon 120 is inflated at the target location. In at least one example embodiment, the balloon 120 may be inflated via the port 122 of the inner catheter 110. Inflating the balloon 120 may enable angioplasty. In at least one example embodiment, a size of the balloon 120 may be paired with a size of the stent 114 to prevent individual sizing of the balloon 120 and the stent 114. There is no movement of the cassettes 68, 70, 72, 74 at S608.

[0078] At S610, after the balloon 120 is inflated, the balloon 120 may be deflated which may then allow the inner catheter 110 and the outer catheter 112 to advance through the lesion to place the inner catheter at a second target location. In at least one example embodiment, the inner catheter 110 and the outer catheter 112 may be advanced until the stent 114 is located at the target location. The second cassette 70 and the third cassette 72 may be advanced to adjust the position of the inner catheter 110 and the outer catheter 112 as described above.

[0079] At S612, the stent 114 is deployed at the target location. The stent 114 may be deployed by retracting the outer catheter 112 to unsheathe the stent 114 from the outer catheter 112. In at least one example embodiment, the second cassette 70 may be pulled back with the outer catheter 112 to unsheathe the stent 114. The third cassette 72 with the inner catheter 110 may be advanced slightly to maintain a position of the stent 114 at the target location and to get the stent to fluff. This process is known in the art and may be referred to as “push and fluff’.

[0080] In at least one example embodiment, after the stent 114 is deployed, the fdter may be removed by pulling the filter 402 with the microwire 106 to a distal end of the inner catheter 110. Then, the filter 402 may be pulled inside the guide catheter 116.

[0081] At S614, the catheter system excluding the guide catheter 116 may be removed from the carotid artery. In at least one example embodiment, prior to removing the catheter system from the carotid artery, the stent 114 may be post dilated with the balloon 120. Removing the catheterAttorney Docket No.: 2024P15111WO system, excluding the guide catheter 116, from the carotid artery may involve retracting the second cassette 70, the third cassette 72, and the fourth cassette 74. The guide catheter 116 may remain in place to enable further treatment of the patient.

[0082] In at least one example embodiment, before inserting the catheter system into the carotid artery, the guide catheter 116, the microwire 106, and the coaxial catheter system 105 may be provided and the microwire 106 may be loaded into the coaxial catheter system 105. In at least one example embodiment, one or more imaging methods may be used to determine a size of a lesion to be treated which will be used to determine a size of the balloon 120 and stent 114 to be used with the coaxial catheter system 105. In at least one example embodiment, the guide catheter 116 may be inserted into the patient and a cine may be performed with all other primary access devices being removed from the guide catheter. Analysis of an image resultant from the cine may be analyzed to determine a size of a lesion of the carotid artery. Then, the size of the lesion of the carotid artery may be used to determine a size of the coaxial catheter system to be used. The guide catheter 116 may be placed within the carotid artery first or may already be placed within the carotid artery if imaging was previously performed to determine a size of the lesion. Then, the remainder of the system including the microwire 106 coupled with the coaxial catheter system 105 may be inserted into the guide catheter 116. In at least one example embodiment, loading the microwire 106 with the coaxial catheter system 105 before coupling with the guide catheter 116 may ensure that the microwire 106 and the coaxial catheter system 105 are optimally set up before inserting the components into the carotid artery.

[0083] In at least one example embodiment, software may be configured to improve the systems and methods described herein. For example, the software may be deployed by a robot such as the robotic catheter-based procedure system 10 and may include algorithms or functionsAttorney Docket No.: 2024P15111WO configured to ensure placement of the inner catheter 110 and the outer catheter 112. For example, the inner catheter 110 may be maintained at a constant position relative to the outer catheter 112 until the stent 114 is deployed at the second target location. This may help to ensure that the stent 114 is not accidentally deployed in an incorrect location. In at least one example embodiment, the distal position of the filter 402 may also be configured in an algorithm such to reduce trauma to vessel walls. Also related to the filter 402, algorithms may be configured to prevent the filter 402 from being deployed when the microwire 106 is being used for navigation and to limit rotation of the microwire 106 when the filter 402 is included. In at least one example embodiment, another algorithm that may be implemented by the robotic catheter-based procedure system 10 may advance the inner catheter 110 at a pre-determined ratio to the pull-back of the outer catheter 112 during deployment of the stent 114 to maintain the stent 114 at a centered location relative to the lesion during deployment.

[0084] FIG. 12 illustrates a system 700 that may implement the software and / or algorithms described above. In at least one example embodiment, the system 700 may be or may be in communication with one or more robots such as the robotic catheter-based procedure system 10 to carry out the methods described herein. In at least one example embodiment, the system 700 includes at least one processor 702, at least one memory 704, and at least one communication interface 706. The at least one memory 704 may be configured to store instructions that may be executed by the at least one processor 702 to cause the system 700 to perform one or more functions.

[0085] As will be appreciated, depending on the implementation of the system 700, the system 700 may include additional components. However, it is not necessary that all of these generally conventional components be shown in order to disclose the illustrative example embodiment. ForAttorney Docket No.: 2024P15111WO example purposes, the system 700 will be discussed with regard to the at least one processor 702. However, it should be understood that the system 700 may include one or more processors or other processing circuitry, such as one or more Application Specific Integrated Circuits (ASICs).

[0086] The at least one processor 702 may include, but is not limited to, a central processing unit (CPU), an arithmetic logic unit (ALU), a graphics processing unit (GPU), an application processor (AP), a digital signal processor (DSP), a microcomputer, a field programmable gate array (FPGA), and programmable logic unit, application-specific integrated circuit (ASIC), a neural network processing unit (NPU), an Electronic Control Unit (ECU), a quantum computer, and the like. In some example embodiments, the processing circuitry may include a non-transitory computer readable storage medium or device (e.g., memory), for example a solid state drive (SSD), storing a program of instructions, and a processor (e.g., CPU) configured to execute the program of instructions to implement the functionality and / or methods performed by some or all of the systems according to any of the example embodiments. In at least one example embodiment, the processor 702 may be or may include the controller 34.

[0087] The at least one memory 704 may be a computer readable storage medium that generally includes a random access memory (RAM), read only memory (ROM), and / or a permanent mass storage device, such as a disk drive. The at least one may also store an operating system and any other routines / modules / applications for providing the functionalities of the system 700 to be executed by the at least one processor 702. These software components may also be loaded from a separate computer readable storage medium into the at least one using a drive mechanism (not shown). Such separate computer readable storage medium may include a disc, tape, DVD / CD-ROM drive, memory card, or other like computer readable storage medium (not shown). In some example embodiments, software components may be loaded into the at least one memory 704 viaAttomev Docket No.: 2024P15111WO one of the at least one communication interface 706, rather than via a computer readable storage medium.

[0088] The at least one processor 702 or other processing circuitry may be configured to carry out instructions of a computer program by performing the arithmetical, logical, and input / output operations of the system. Instructions may be provided to the at least one processor 702 by the at least one memory 704.

[0089] The at least one communication interface 706 may be wired and may include components that interface the at least one processor 702 with the other input / output components. As will be understood, the at least one communication interface 706 and programs stored in the at least one memory 704 to set forth the special purpose functionalities of the system 700 will vary depending on the implementation of the system 700.

[0090] The at least one communication interface 706 may also include one or more user input devices (e.g., a keyboard, a keypad, a mouse, or the like) and user output devices (e.g., a display, a speaker, or the like).

[0091] As disclosed herein, the term “storage medium,” “computer readable storage medium” or “non-transitory computer readable storage medium” may represent one or more devices for storing data, including read only memory (ROM), random access memory (RAM), magnetic RAM, core memory, magnetic disk storage mediums, optical storage mediums, flash memory devices and / or other tangible machine-readable mediums for storing information. The term “computer-readable medium” may include, but is not limited to, portable or fixed storage devices, optical storage devices, and various other mediums capable of storing, containing or carrying instruction(s) and / or data.Attorney Docket No.: 2024P15111WO

[0092] Furthermore, example embodiments may be implemented by hardware, software, firmware, middleware, microcode, hardware description languages, or any combination thereof. When implemented in software, firmware, middleware or microcode, the program code or code segments to perform the necessary tasks may be stored in a machine or computer readable medium such as a computer readable storage medium. When implemented in software, a processor or processors will perform the necessary tasks. For example, as mentioned above, according to one or more example embodiments, at least one memory may include or store a computer program or computer program code, and the at least one memory and the computer program code may be configured to, with at least one processor, execute a method for treating a carotid artery to perform the necessary tasks. Additionally, the processor, memory and example algorithms, encoded as computer program code, serve as means for providing or causing performance of operations discussed herein. At least one other example embodiment may include a computer program including program segments or instructions that, when executed by at least one processor of a system, cause the system to perform a method for treating a carotid artery.

[0093] A code segment of a computer program may represent a procedure, function, subprogram, program, routine, subroutine, module, software package, class, or any combination of instructions, data structures or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing and / or receiving information, data, arguments, parameters or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable technique including memory sharing, message passing, token passing, network transmission, etc.

[0094] The systems, devices, and methods described herein provide improved catheter systems that require no exchanges with an indwelling wire. This may enable a less skilled operator toAttorney Docket No.: 2024P15111WO deploy a stent using the systems described herein. Further, the systems, devices, and methods described herein require at least two fewer exchanges than a typical carotid workflow which may enable procedures to be carried out faster than with previous systems. Further, because the systems described herein do not require exchanges with indwelling wires, existing over the wire robots may be utilized to perform the methods described herein.

[0095] Example embodiments have been disclosed herein, it should be understood that other variations may be possible. Such variations are not to be regarded as a departure from the spirit and scope of the present disclosure, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.NON-LIMITING ILLUSTRATIVE EMBODIMENTS

[0096] The following is a list of non-limiting illustrative embodiments disclosed herein:

[0097] Illustrative embodiment 1 includes a coaxial catheter system for treating a carotid artery, the coaxial catheter system comprises: an inner catheter configured to be coaxial with a microwire and a guide catheter, the inner catheter including one or more stent anchors and a balloon; an outer catheter coaxial with the inner catheter and configured to be coaxial with the guide catheter; and a stent disposed between the inner catheter and the outer catheter.

[0098] Illustrative embodiment 2 includes the coaxial catheter system of illustrative embodiment 1, wherein the one or more stent anchors are configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.Attorney Docket No.: 2024P15111WO

[0099] Illustrative embodiment 3 includes the coaxial catheter system of any one of illustrative embodiments 1 and 2, wherein the inner catheter is configured to extend beyond the outer catheter by at least a length of the balloon.

[0100] Illustrative embodiment 4 includes the coaxial catheter system of any one of illustrative embodiments 1, 2 and 3, wherein the inner catheter and the outer catheter are coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.

[0101] Illustrative embodiment 5 includes a system for treating a carotid artery, the system comprising: a microwire configured to extend from a proximal end of the system to a distal end of the system; and a coaxial catheter system including an inner catheter coaxial with a microwire and a guide catheter, the inner catheter including one or more stent anchors and a balloon, an outer catheter coaxial with the inner catheter and the guide catheter, a stent disposed between the inner catheter and the outer catheter, and a filter configured to be deployed proximate to the distal end of the system.

[0102] Illustrative embodiment 6 includes the system of illustrative embodiment 5, wherein the one or more stent anchors are configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.

[0103] Illustrative embodiment 7 includes the system of any one of illustrative embodiments 5 and 6, wherein the inner catheter is configured to extend beyond the outer catheter by at least a length of the balloon.Attorney Docket No.: 2024P15111WO

[0104] Illustrative embodiment 8 includes the system of any one of illustrative embodiments 5, 6, and 7, wherein the fdter is coupled to the microwire approximately 5cm to 10cm from the distal end of the system.

[0105] Illustrative embodiment 9 includes the system of any one of illustrative embodiments 5, 6, 7, and 8, wherein the inner catheter and the outer catheter are coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.

[0106] Illustrative embodiment 10 include a method of treating a carotid artery, the method comprising: inserting a catheter system into the carotid artery, the catheter system including a microwire configured to extend from a proximal end of the catheter system to a distal end of the catheter system, a coaxial catheter system including an inner catheter coaxial with the microwire and a guide catheter, the inner catheter including a balloon, an outer catheter coaxial with the inner catheter and the guide catheter, and a stent disposed between the inner catheter and the outer catheter; advancing the microwire across a lesion of the carotid artery prior to advancing the inner catheter into the lesion of the carotid artery to place the balloon at a target location; inflating the balloon at the target location; advancing the inner catheter to a second target location to locate the stent at the target location; deploying the stent at the target location; and removing the catheter system from the carotid artery.

[0107] Illustrative embodiment 11 includes the method of illustrative embodiment 10, wherein the catheter system further includes a filter at the distal end of the system.

[0108] Illustrative embodiment 12 includes the method of illustrative embodiment 11, further comprising advancing the microwire into the lesion of the carotid artery to a third target location; and deploying the filter at the third target location.Attorney Docket No.: 2024P15111WO

[0109] Illustrative embodiment 13 includes the method of illustrative embodiment 12, wherein the deploying the fdter at the third target location includes adjusting the microwire so it has a maximum amount of slack in the carotid artery to position the filter at the third target location.

[0110] Illustrative embodiment 14 includes the method of any one of illustrative embodiments 12 and 13, further comprising: pulling the filter from the third target location to a distal end of the inner catheter before removing the catheter system from the carotid artery.

[0111] Illustrative embodiment 15 includes the method of any one of illustrative embodiments 10, 11, 12, 13, and 14, further comprising: providing the guide catheter, the microwire, and the coaxial catheter system; and loading the microwire into the coaxial catheter system before the inserting the catheter system into the carotid artery.

[0112] Illustrative embodiment 16 includes the method of illustrative embodiment 15, wherein the inserting the catheter system into the carotid artery includes placing the guide catheter into the carotid artery and loading the coaxial catheter system including the microwire into the guide catheter after the guide catheter is placed within the carotid artery.

[0113] Illustrative embodiment 17 includes the method of any one of illustrative embodiments 10, 11, 12, 13, 14, 15, and 16, wherein inflating the balloon at the target location includes inflating the balloon via a balloon inflation port of the inner catheter.

[0114] Illustrative embodiment 18 includes the method of any one of illustrative embodiments 10, 11, 12, 13, 14, 15, 16, and 17, further comprising: maintaining a position of the inner catheter relative to the outer catheter until the deploying the stent at the second target location.

[0115] Illustrative embodiment 19 includes the method of any one of illustrative embodiments 10, 11, 12, 13, 14, 15, 16, 17, and 18, wherein the deploying the stent at the target location includes retracting the outer catheter to unsheathe the stent from the catheter system.Attorney Docket No.: 2024P15111WO

[0116] Illustrative embodiment 20 includes a coaxial catheter system for treating a carotid artery, the coaxial catheter system including: an inner catheter configured to be coaxial with a microwire and a guide catheter, the inner catheter including one or more stent anchors; an outer catheter coaxial with the inner catheter and configured to be coaxial with the guide catheter, the outer catheter including a balloon; and a stent disposed between the inner catheter and the outer catheter.

Claims

Attorney Docket No.: 2024P15111WOWE CLAIM:

1. A coaxial catheter system for treating a carotid artery, the coaxial catheter system comprising:an inner catheter configured to be coaxial with a microwire and a guide catheter, the inner catheter including one or more stent anchors and a balloon;an outer catheter coaxial with the inner catheter and configured to be coaxial with the guide catheter; anda stent disposed between the inner catheter and the outer catheter.

2. The coaxial catheter system of claim 1, wherein the one or more stent anchors are configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.

3. The coaxial catheter system of claim 1, wherein the inner catheter is configured to extend beyond the outer catheter by at least a length of the balloon.

4. The coaxial catheter system of claim 1, wherein the inner catheter and the outer catheter are coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.

5. A system for treating a carotid artery, the system comprising:a microwire configured to extend from a proximal end of the system to a distal end of the system;a coaxial catheter system includingan inner catheter coaxial with the microwire and a guide catheter, the inner catheter including one or more stent anchors and a balloon,an outer catheter configured to be coaxial with the inner catheter and the guide catheter, anda stent disposed between the inner catheter and the outer catheter; andAttorney Docket No.: 2024P15111WOa filter configured to be deployed proximate to the distal end of the system.

6. The system of claim 5, wherein the one or more stent anchors are configured to interact with the stent to maintain a constant distance between the stent and the inner catheter during deployment of the coaxial catheter system in the carotid artery.

7. The system of claim 5, wherein the inner catheter is configured to extend beyond the outer catheter by at least a length of the balloon.

8. The system of claim 5, wherein the filter is coupled to the microwire approximately 5cm to 10cm from the distal end of the system.

9. The system of claim 5, wherein the inner catheter and the outer catheter are coupled such that movement of the inner catheter is tied to movement of the outer catheter until the stent is deployed within the carotid artery.

10. A method of treating a carotid artery, the method comprising:inserting a catheter system into the carotid artery, the catheter system includinga microwire configured to extend from a proximal end of the catheter system to a distal end of the catheter system,a coaxial catheter system includingan inner catheter coaxial with the microwire and a guide catheter, the inner catheter including a balloon,an outer catheter coaxial with the inner catheter and the guide catheter, anda stent disposed between the inner catheter and the outer catheter; advancing the microwire across a lesion of the carotid artery prior to advancing the inner catheter into the lesion of the carotid artery to place the balloon at a target location;inflating the balloon at the target location;advancing the inner catheter to a second target location to locate the stent at the target location;Attorney Docket No.: 2024P15111WOdeploying the stent at the target location; andremoving the catheter system from the carotid artery.

11. The method of claim 10, wherein the catheter system further includes a filter at the distal end of the system.

12. The method of claim 11, further comprising:advancing the microwire into the lesion of the carotid artery to a third target location; and deploying the filter at the third target location.

13. The method of claim 12, wherein the deploying the filter at the third target location includes adjusting the microwire so it has a maximum amount of slack in the carotid artery to position the filter at the third target location.

14. The method of claim 12, further comprising:pulling the filter from the third target location to a distal end of the inner catheter before removing the catheter system from the carotid artery.

15. The method of claim 10, further comprising:providing the guide catheter, the microwire, and the coaxial catheter system; and loading the microwire into the coaxial catheter system before the inserting the catheter system into the carotid artery.

16. The method of claim 15, wherein the inserting the catheter system into the carotid artery includes placing the guide catheter into the carotid artery and loading the coaxial catheter system including the microwire into the guide catheter after the guide catheter is placed within the carotid artery.

17. The method of claim 10, wherein inflating the balloon at the target location includes inflating the balloon via a balloon inflation port of the inner catheter.Attorney Docket No.: 2024P15111WO18. The method of claim 10, further comprising:maintaining a position of the inner catheter relative to the outer catheter until the deploying the stent at the second target location.

19. The method of claim 10, wherein the deploying the stent at the target location includes retracting the outer catheter to unsheathe the stent from the catheter system.

20. A coaxial catheter system for treating a carotid artery, the coaxial catheter system comprising:an inner catheter configured to be coaxial with a microwire and a guide catheter, the inner catheter including one or more stent anchors;an outer catheter coaxial with the inner catheter and configured to be coaxial with the guide catheter, the outer catheter including a balloon; anda stent disposed between the inner catheter and the outer catheter.

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