Dilator for vascular access system, and associated devices and methods

Abstract

Dilators for vascular access systems, and associated devices and methods, are disclosed herein. In some embodiments, the dilator includes an elongate body having a diameter that is substantially constant or uniform along the length of the body. The diameter may be sized to correspond to a catheter of a vascular access system such that the dilator may be positioned within the catheter with little or no gap or spacing between the dilator and the interior of the catheter. Additionally or alternatively, the body of the expander may include a plurality of body regions, each region having one or more respective mechanical properties. In these and other embodiments, the dilator may be configured to engage with at least a portion of the vascular access system. For example, the dilator may include one or more notches configured to couple the dilator to a vascular access system via a valve of the vascular access system.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 338,266 filed on May 4, 2022 and U.S. Patent Application No. 63 / 397,649 filed on August 12, 2022, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology generally relates to dilators for use in vascular access systems, and associated devices and methods. Background Art

[0004] Thrombosis is the local coagulation or coagulation of blood in a part of the circulatory system, and thrombus is a blood clot formed in situ in the vascular system. Venous thrombosis is a blood clot formed in a vein. Common types of venous thrombosis are deep vein thrombosis (DVT), which is a blood clot formed in a deep vein (e.g., mainly in the leg). Nonspecific signs of thrombosis can include pain, swelling, redness, fever, and congestion of superficial veins.

[0005] If a blood clot breaks off (embolizes) and travels to the lungs, it can become a life-threatening pulmonary embolism (PE) (e.g., a blood clot in the lung). In addition to the loss of life that can result from PE, DVT can also cause serious health problems, such as post-thrombotic syndrome, which can cause chronic swelling, pressure, pain, and ulcers due to valve and blood vessel damage. In addition, DVT can lead to significant medical expenses, either directly or indirectly, through treatment-related complications and the patient's inability to work.

[0006] Existing methods for treating DVT and PE typically involve treating DVT or PE with a catheter system that is advanced through the patient's vasculature, such as along a venous access path. Such catheter systems, especially those with large sizes (e.g., greater than 16 Fr), typically include a navigation component, such as a smaller catheter or dilator, that can be used to dilate the patient's vasculature and guide the larger catheter to the target treatment site. For example, a larger catheter can be inserted over the navigation component, using the navigation component as a "guide" to guide the larger catheter to the target treatment site.

[0007] However, during advancement of the catheter through the vasculature, the navigation component and / or the catheter may be subject to considerable force or resistance from the patient's vasculature. In some cases, this may cause the physician to inadvertently over-advance the large catheter along the navigation component and injure the patient. In addition, the forces acting on the navigation component may cause the navigation component to move or slide back relative to the catheter. If the navigation component bends or flexes relative to the catheter, the physician's ability to advance the navigation component and catheter together through the patient's vasculature may be impeded. If the navigation component slides back far enough through the catheter, the edge of the catheter may be exposed, thereby potentially causing damage to the patient's percutaneous access site or vasculature. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Many aspects of the present invention may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0009] Figure 1 is a partial schematic side view of a vascular access system constructed in accordance with the present teachings.

[0010] Figure 2A and Figure 2B 2 are a side view and a side cross-sectional view, respectively, of a dilator constructed in accordance with an embodiment of the present technology.

[0011] Figure 2C According to the embodiment of the present invention Figure 2A An enlarged perspective view of region 2C of the dilator is shown.

[0012] Figure 3A and Figure 3B The embodiment according to the present invention is located in Figure 1 Vascular access valves FIG. 2A to FIG. 2C Side cross-sectional view of the dilator.

[0013] Figure 4A and Figure 4B The embodiment according to the present invention is located in Figure 1 Blood vessels entering the system FIG. 2A to FIG. 2C Perspective view of the dilator. DETAILED DESCRIPTION

[0014] The present technology as a whole relates to navigation components ("dilators") for vascular access systems, and associated devices and methods. In some embodiments, the dilator includes an elongated body having a diameter that is substantially constant or uniform along the length of the body. The diameter can be sized to correspond to a catheter of a vascular access system so that the dilator can be positioned within the catheter with little or no gap or spacing between the dilator and the interior of the catheter. In these and other embodiments, the body of the dilator can include multiple body regions, each having one or more corresponding mechanical properties. In at least some embodiments, for example, the dilator includes a first body region having a first flexible profile and a second body region having a second flexible profile greater than the first flexible profile, such that the second body region is more flexible than the first body region. The second body region can be distal to the first body region, such that the less flexible / more rigid first body region can provide a portion of the dilator to which force can be applied to advance the dilator through the patient's vasculature; and the less rigid / more flexible second body region can provide improved navigation response and / or control when advancing the dilator through the patient's vasculature.

[0015] Existing dilators may be tapered or angled to provide flexibility. For example, the diameter of the tapered dilator may decrease toward the distal head of the tapered dilator, wherein the reduced diameter provides increased flexibility toward the distal head. However, these tapered dilators may be difficult to fix relative to a vascular access device (such as a catheter). For example, when the tapered dilator is positioned within a catheter, the tapered shape of these dilators may create a gap or spacing between the tapered dilator and the catheter, which may allow the tapered dilator to bend or flex within the catheter during use. Such bending or flexing may reduce the control and / or navigation accuracy in the surgical procedure. Compared to current angled dilators, the dilators of the present technology may have a substantially constant or uniform diameter, which improves the fit of these dilators within the vascular access device and / or may reduce or prevent these dilators from experiencing undesirable flexing or bending during the surgical procedure. Additionally or alternatively, corresponding mechanical properties of the dilator body region may be selected to improve the flexibility of these dilators.

[0016] Additionally or alternatively, the dilator can be configured to engage at least a portion of the vascular access system. In some embodiments, the dilator includes one or more notches. Each of these notches can extend at least partially or completely around the longitudinal axis of the dilator body and can be configured to connect the dilator to the vascular access system via a valve of the vascular access system. For example, the valve can include one or more internal components or tethers configured to open and / or close a path through the valve. When the dilator is positioned within the valve and one of the notches is aligned with the tether, the tether can be at least partially inserted into the notch, thereby generating a resistance or interference fit that inhibits or prevents further movement of the dilator relative to the valve (and / or movement of the valve relative to the dilator). Each notch can be spaced along the length of the dilator so that when connected via the valve, each notch can be associated with a different position of the dilator relative to the vascular access system and / or a different length of the dilator extending beyond the vascular access system. Because each notch can inhibit further movement of the dilator and / or the vascular access system relative to each other, the position of one or more notches can be configured to inhibit or prevent over-insertion of the dilator and / or can increase user control over the amount that the dilator extends beyond the vascular access system.

[0017] In the following description and in Figures 1 to 4B Certain details are set forth in order to provide a thorough understanding of various embodiments of the present technology. In other cases, well-known structures, materials, operations, and / or systems that are typically associated with intravascular procedures, clot removal procedures, catheters, etc. are not shown or described in detail in the following disclosure to avoid unnecessarily obscuring the description of various embodiments of the present technology. However, one of ordinary skill in the art will recognize that the present technology can be practiced without one or more of the details set forth herein and / or with other structures, methods, components, etc.

[0018] The terminology used below should be interpreted in its broadest reasonable manner, even though it is used in conjunction with the detailed description of certain examples of the embodiments of the present disclosure. In fact, certain terms may even be emphasized below; however, any term intended to be interpreted in any limited manner will be openly and specifically defined in this detailed description section.

[0019] The accompanying drawings depict embodiments of the present technology, and are not intended to limit their scope unless explicitly stated. The sizes of the various depicted elements are not necessarily drawn to scale, and these various elements may be amplified to improve readability. Component details may be separated in the drawings to exclude these details when it is not necessary to fully understand how to make and use the present technology in details such as the position of the components and certain precise connections between such components. Many details, sizes, angles and other features shown in the drawings are only specific embodiments of the present disclosure. Therefore, without departing from the present technology, other embodiments may have other details, sizes, angles and features. In addition, it will be appreciated by those of ordinary skill in the art that other embodiments of the present technology may be implemented without some details described below.

[0020] With respect to the terms "distal" and "proximal" in this specification, unless otherwise specified, these terms may guide the relative position of the various parts of the tube system with respect to the operator and / or the position in the vasculature. In addition, as used herein, the designations "rearward," "forward," "upward," "downward," etc. are not intended to limit the referenced components to a particular orientation. It should be understood that such designations refer to the orientation of the referenced components as shown in the accompanying drawings; the systems of the present technology may be used in any orientation suitable for the user.

[0021] Figure 11 is a partial schematic side view of a vascular access system 100 ("system 100") constructed in accordance with an embodiment of the present technology. System 100 may also be referred to as an aspiration assembly, a clot handling system, a clot removal system, a thrombectomy system, an introducer sheath assembly, etc. In the illustrated embodiment, system 100 includes a tubing assembly 110 fluidly coupled to a catheter 120 via a valve 130. In some embodiments, catheter 120 is an elongated member configured to be inserted into and through the vasculature of a patient and used, for example, to treat clotted material therein. In other embodiments, catheter 120 may be an introducer sheath configured to be inserted through the skin and tissue tract of a patient to provide an access site through which other components (e.g., other catheters for treating clotted material) may be passed to easily access vascular structures. Thus, catheter 120, when referred to as "catheter 120," may include an introducer sheath, an access sheath, and / or another type of elongated member configured to be inserted through the skin and tissue tract and / or configured to traverse the vasculature of a patient. In general, system 100 (i) may include features substantially similar or identical to the features of the clot handling system described in detail in U.S. patent application Ser. No. 16 / 536,185, filed on August 8, 2019, entitled “SYSTEM FOR TREATING EMBOLISM ANDASSOCIATED DEVICES AND METHODS,” which is incorporated herein by reference in its entirety, and / or (ii) may use any of the methods described in detail therein for treating / removing clotted material from a patient (e.g., a human patient).

[0022] In the illustrated embodiment, the catheter 120 includes a proximal region or portion 122a, and a distal tip region or portion 122b opposite the proximal region 122a. The proximal region 122a may include a proximal end 126a of the catheter 120, and the distal tip region 122b may include a distal end 126b of the catheter 120. The catheter 120 also defines an inner cavity 124 ( Figure 1 The lumen 124 and / or the conduit 120 may at least partially define a longitudinal axis X of the system 100 .

[0023] The valve 130 is fluidly coupled to the lumen 124 of the catheter 120 and can be integral with or coupled to the proximal region 122a of the catheter 120 so that these components move together. In some embodiments, the valve 130 is a hemostatic valve that is configured to maintain hemostasis during a clot removal procedure by preventing fluid from flowing through the valve 130 in the proximal direction P when various components (such as dilators, delivery sheaths, pull members, guidewires, interventional devices, other aspiration catheters, etc.) are inserted through the valve 130 to be delivered to a treatment site in a blood vessel through the catheter 120. The valve 130 can include a branch or side port 102 that is configured to fluidly couple the lumen 124 of the catheter 120 to the tubing assembly 110. In some embodiments, the valve 130 can be a valve of the type disclosed in U.S. patent application Ser. No. 16 / 117,519, filed on Aug. 30, 2018, entitled “HEMOSTASIS VALVES AND METHODS OF USE,” which is incorporated herein by reference in its entirety.

[0024] In the illustrated embodiment, the tubing assembly 110 fluidly couples the conduit 120 to a pressure source 104, such as a syringe. The pressure source 104 can be configured to generate (e.g., form, generate, fill, accumulate) a vacuum (e.g., a negative relative pressure) and store the vacuum for subsequent application to the conduit 120. The tubing assembly 110 can include one or more tubing segments 112 (each labeled as a first tubing segment 112a and a second tubing segment 112b), at least one fluid control device 114 (e.g., a valve), and at least one connector 116 (e.g., a Toomey head connector) for fluidly coupling the tubing assembly 110 to the pressure source 104 and / or other suitable components. In some embodiments, the fluid control device 114 is a stopcock that (i) is fluidly coupled to the side port 102 of the valve 130 via the first tubing segment 112a, and (ii) is fluidly coupled to the connector 116 via the second tubing segment 112b. The fluid control device 114 is externally operable by a user to regulate the flow of fluid therethrough, and in particular, to regulate the flow of fluid from the lumen 124 of the conduit 120 to the pressure source 104. In some embodiments, the connector 116 is a quick release connector (e.g., a quick disconnect fitting) that enables the conduit 120 and the fluid control device 114 to be quickly coupled to / disconnected from the pressure source 104.

[0025] During the clot handling procedure, at least a portion of the system 100, such as the distal end 126b and / or the distal head region 122b of the catheter 120, can be inserted through the vascular system of the patient. In some embodiments, the system 100 is inserted through an introducer sheath that traverses the patient's skin and tissue to provide an access site. When the catheter 120 is positioned at a desired location relative to the clot material (e.g., pulmonary embolism, deep vein thrombosis) in the patient, the user can first close the fluid control device 114 before generating a vacuum in the pressure source 104, such as by withdrawing the plunger of a syringe connected to the connector 116. In this way, before the pressure source 104 is fluidly connected to the inner cavity 124 of the catheter 120, the pressure source 104 is filled with a vacuum (e.g., maintaining a negative pressure). In order to aspirate the inner cavity 124 of the catheter 120, the user can open the fluid control device 114 to connect the pressure source 104 fluid to the catheter 120, thereby applying or releasing the vacuum stored in the pressure source 104 to the inner cavity 124 of the catheter 120. Opening the fluid control device 114 instantaneously or nearly instantaneously applies the stored vacuum pressure to the tubing assembly 110 and the catheter 120, thereby generating a suction pulse throughout the catheter 120 that can draw the clotted material into the catheter 120. Specifically, suction is applied at the distal tip region 122b of the catheter 120 to aspirate / draw at least a portion of the clotted material proximate the distal tip region 122b into the lumen 124 of the catheter 120. Additionally or alternatively, the catheter 120 can function as an introducer sheath and can be inserted through the patient's skin and tissue and then partially inserted into a blood vessel to provide an access point through which other medical devices can be delivered and / or otherwise used to treat the patient.

[0026] Figure 2A and Figure 2B 2 and 3 are side elevation and side cross-sectional views, respectively, of a navigation member or expander 240 constructed in accordance with an embodiment of the present technology. Figure 1The dilator 240 is inserted and advanced together with the catheter 120 of the vascular access device. The dilator 240 includes a generally elongated body 242 having a proximal region or portion 242a, a distal head region or portion 242b opposite the proximal region 242a, and one or more body segments or regions 244 (identified as a first body region 244a and a second body region 244b, respectively) extending at least partially between the proximal region 242a and the distal head region 242b. The dilator 240 may also include a head end 246 (e.g., an atraumatic head end) in or near the distal head region 242b, a coupling component 248 in or near the proximal region 242a, and one or more notches 250 (e.g., insertion positioning features). The coupling component 248 may include a twist-lock connector, a Luer connector, and / or another suitable coupling component, and may be configured to couple or lock the dilator 240 to a valve of a vascular access system, such as Figure 1 The valve 130 of the system 100. In the illustrated embodiment, the head end 246 is located distally of the second body region 244b, and the connecting member 248 is located proximal to the first body region 244a. In other embodiments, the second body region 244b may include all or a portion of the head end 246, and / or the first body region 244a may include all or a portion of the connecting member 248 and / or be positioned within all or a portion of the connecting member. Figure 2C The notch 250 is described in further detail.

[0027] In some embodiments, the body 242, the head end 246 and / or the coupling member 248 may be hollow, such as Figure 2B As shown, a guide wire (not shown) can be positioned within the dilator 240 and used to assist in its navigation. In such an embodiment, each body region 244 can have a respective thickness T, Figure 2B The first thickness T a and the second thickness T b The first thickness and the second thickness T a-b can be the same or different, and / or each thickness T a-b The length along all or part of a respective body region 244a-b may be constant or variable.

[0028] The first body region 244a, the second body region 244b, the head end 246 and / or the coupling member 248 can each be formed of one or more polymers and / or other suitable materials. For example, the first body region and the second body region 244a-b can be formed of the same or different materials.

[0029] Each of the body regions 244a-b can have a respective outer dimension or diameter D, respectively denoted as a first diameter D aand the second diameter D b In some embodiments, the diameter D of the body region 244a-b is a-b The first and second body regions 244a-b and / or one or more portions thereof may have different diameters. In the illustrated embodiment, the first and second diameters D a-b 240, such that the body 242 of the expander 240 has a substantially uniform diameter. In these and other embodiments, the diameter D a-b One or more of the dimensions may correspond to and / or be smaller than an inner dimension of a catheter, such as an inner diameter of the lumen 124 of the catheter 120 ( Figure 1 Thus, the dilator 240 can be positioned within the catheter 120 (e.g., via the valve 130) with at least a portion of the head end 246 extending distally beyond the distal tip 126b of the catheter 120 ( Figure 1 ).

[0030] Each of the main body regions 244 can have one or more corresponding mechanical properties, such as hardness, rigidity, hardness, flexibility, rigidity, Young's modulus, density, and / or similar properties. Mechanical properties (e.g., varying hardness) can give different flexible profiles to the main body regions 244. In some embodiments, each of the main body regions 244 can include one or more coils, braids, and / or be configured to, for example, increase or reduce other structures of the flexible profile relative to one or more other main body regions 244. In at least some embodiments, the first main body region 244a has a first flexible profile, and the second main body region 244b has a second flexible profile greater than the first flexible profile, so that the second main body region 244b is less rigid / flexible than the first main body region 244a. For example, in the illustrated embodiment, the first main body region 244a has a first hardness, and the second main body region 244b has a second hardness less than the first hardness (e.g., less rigid / flexible). In some aspects of the present technology, the less stiff second body region 244b can improve the navigability of the dilator 240 as it is advanced through the vasculature, while the more stiff first body region 244a can improve the control of the dilator 240 and / or the transfer of force to the dilator (e.g., the "pushability" and / or column strength of the dilator) as the dilator 240 is navigated through the vasculature. Figure 2A and Figure 2BThe expander 240 shown in the figure includes two body regions 244a-b, but in other embodiments, the expander 240 can include more body regions 244, and each of the body regions 244 can have one or more corresponding mechanical properties greater than, equal to, or less than one or more of the other body regions 244. Therefore, in some embodiments, the expander 240 includes two or more body regions 244 having the same diameter but different stiffness, hardness, flexibility, etc.

[0031] Figure 2C According to the embodiment of the present invention Figure 2A 2C. In the illustrated embodiment, the recess 250 defines / includes a recessed area that extends at least partially or completely around the body 242 of the expander 240, such as circumferentially around the longitudinal axis Y of the body 242. Thus, the recess 250 can define a third diameter D of the expander 240. c , the third diameter may be smaller than the first diameter D a and / or the second diameter D b In the illustrated embodiment, the notch 250 is positioned between the first body region 244a and the second body region 244b. In other embodiments, the notch 250 can be at least partially positioned within one or both of the body regions 244a-b. In these and other embodiments, the expander 240 can include a plurality of notches 250, each of which can be at least partially positioned between the first body region 244a and the second body region 244b, at least partially positioned within the first body region 244a, at least partially positioned within the second body region 244b, or positioned at another suitable location along the expander 240.

[0032] Figure 3A and Figure 3B is a side cross-sectional view of a dilator 240 positioned within a valve 130 in accordance with an embodiment of the present technology. Figure 3A In the embodiment, the expander 240 is in a first position within the valve 130, and in Figure 3B , the dilator 240 has been moved (e.g., distally) to a second position within the valve 130, as indicated by arrow A. Figure 3A and Figure 3B , dilator 240 includes a notch 250 ("first notch 250") and an additional second notch 350 positioned proximal to first notch 250. Second notch 350 can be at least substantially similar or identical to first notch 250 in structure and / or function.

[0033] See together Figure 3A and Figure 3B, the valve 130 includes a first or distal hole 332a, a second or proximal hole 332b, and a central lumen 334 extending therebetween. The distal hole 332a can be fluidly coupled to a catheter, such as Figure 1 The valve 130 also includes a thin wire or tether 336, which is operably connected to one or more actuators or buttons 338 (in Figure 3A and Figure 3B The tether 336 can be configured to open and / or close the central lumen 334 of the valve 130, for example, to form a substantially fluid-impermeable seal that inhibits or prevents fluid communication between the distal and proximal apertures 332a-b. In the illustrated embodiment, for example, the button 338 is actuated by a spring 339 (in Figure 3A and Figure 3B The first spring 339a and the second spring 339b are respectively indicated in the figure to bias outward to Figure 3A When the buttons 338a-b are in the first position, the buttons 338a-b pull the raised tether 336, tightening and sealing the central lumen 334. The user can press the button 338 to overcome the biasing force of the spring 339. Figure 3B 30, 2018, which is hereby incorporated by reference in its entirety, and / or (ii) may use any of the methods described in detail therein for treating / removing clotted material from a patient (e.g., a human patient).

[0034] In some embodiments, the tether 336 is configured to releasably couple the dilator 240 to the valve 130 by engaging one of the notches 250, 350. For example, in the illustrated embodiment, when the buttons 338a-b are in the first position, the tether 336 tightens around the central lumen 334, such as Figure 3A Thus, when the expander 240 is inserted through the proximal aperture 332b, the first notch 250 can be positioned to align with the tether 336, thereby allowing at least a portion of the tether 336 to be driven toward and / or into the first notch 250, thereby creating a resistance / interference fit that couples the expander 240 to the valve 130. The resistance / interference fit inhibits or prevents further movement of the expander 240 relative to the valve 130 (e.g., proximally and / or distally).

[0035] like Figure 3B As shown, the dilator 240 can be decoupled from the valve 130 by actuating / pressing one or more of the buttons 338 to move the tether 336 radially outward away from the longitudinal axis of the central lumen 334 and radially outward / radially outward away from the first recess 250. Pressing one or more of the buttons 338 can thus allow the dilator 240 to move further relative to the valve 130 (e.g., proximally and / or distally). In some embodiments, the resistance / interference fit can be overcome by applying an increased force to the dilator 240 and / or valve 130, for example, to displace the tether 336 from the first recess 250 and allow the dilator 240 and / or valve 130 to move further relative to each other without pressing one or more of the buttons 338. Figure 3B , the dilator 240 has passed through the valve 130 from the proximal position ( Figure 3A ) is further distally moved to a more distal position. In some embodiments, the expander 240 can be further distally advanced until the second notch 350 is positioned to align with the tether 336. When the second notch 350 is aligned with the tether 336, the tether 336 can be radially driven into the second notch 350, as previously described with reference to the first notch 250, thereby again coupling the expander 240 to the valve 130.

[0036] See together Figures 1 to 3B , the dilator 240 can be inserted distally through the valve 130 (e.g., via the proximal hole 332b) and fully extended through the lumen 124 past the distal end 126b of the catheter 120, such that the head end 246 of the dilator 240 is positioned beyond the distal end 126b of the catheter 120. The notch 250 can be configured to control the position of the dilator 240 relative to the catheter 120 (e.g., during insertion). For example, when the dilator 240 is inserted into the catheter 120 through the valve 130 (e.g., distally), the notch 250 can engage with the tether 336 (e.g., releasably coupled to the tether), thereby creating a resistance or interference fit that at least inhibits or prevents further movement (e.g., proximally and / or distally) of the dilator 240 relative to the catheter 120. The size of the resistance / interference fit between the notch 250 and the valve 130 (e.g., the tether 336) can correspond to the third diameter D c Another diameter of the main body region of the expander 240 (such as the first diameter D of the first main body region 244a) a and / or the second diameter D of the second body region 244b b ) in size.

[0037] Generally speaking, the third diameter D cThe diameter of the main body region located proximal to the notch 250 (eg, the first diameter D of the first main body region 244a) is greater than the diameter of the main body region 244a. a ) can be associated with a resistance / interference fit that inhibits or prevents further distal movement of the dilator 240 through the system 100 (e.g., through the catheter 120) and / or further proximal movement of the system 100 over the dilator 240. c The diameter of the main body region located distal to the notch 250 (eg, the second diameter D of the second main body region 244b) is greater than the diameter of the main body region located distal to the notch 250 (eg, the second diameter D of the second main body region 244b). b ) can be associated with a resistance / interference fit that inhibits or prevents further proximal movement of the dilator 240 through the system 100 and / or further distal movement of the system 100 over the dilator 240. For example, if the third diameter D c With the first diameter D a 336) is between about 0.1 mm and about 0.5 mm, the resistance / interference fit can be relatively slight and partially prevent further (distal) movement of the dilator 240 and / or further (proximally) movement of the system 100. In such embodiments, the resistance / interference fit can provide a tactile indication or feeling associated with the relative position of the dilator 240 and the system 100 (e.g., a user-perceivable "click" sound or feeling), and any resistance / interference to further movement can be overcome by applying an increased force to the dilator 240 and / or the system 100 to disconnect the notch 250 and the valve 130 (e.g., the tether 336). For another example, if the third diameter D c With the first diameter D a , the resistance / interference fit can be relatively large and completely prevent further (distal) movement of the dilator 240 and / or further (proximally) movement of the system 100. In such embodiments, the resistance / interference fit can be overcome by actuating one or more of the buttons 338 of the valve 130 to release the dilator 240. A dilator with a larger diameter can include a recess having a larger depth (e.g., corresponding to the third diameter D) than a dilator with a relatively smaller depth recess. c With the first diameter D a and / or the second diameter D b The larger difference between the notches is expected to provide an increased resistance / interference fit with a larger notch depth than a smaller notch depth.

[0038] In some embodiments, the magnitude of the resistance force / interference fit is based at least in part on the spring force applied by valve 130 (e.g., via springs 339a-b) to expander 240. For example, a spring having a relatively high spring constant is expected to provide a greater resistance force than a spring having a relatively low spring constant.

[0039] When the dilator 240 is positioned within the catheter 120, the dilator 240 and the catheter 120 can be inserted together into a patient (e.g., a human patient) during a clot treatment procedure. For example, the dilator 240 and the catheter 120 can be inserted together into a patient's blood vessel and advanced through the patient's blood vessel to a target location in the blood vessel. In some embodiments, after the dilator 240 has been inserted through the catheter 120, since the dilator 240 and the catheter 120 can move relative to each other, the catheter 120 can be advanced (e.g., distally, telescopically, etc.) over the dilator 240, for example, using the dilator 240 as a guide or "rail" to position the catheter 120 at or near the target location. When the catheter 120 is positioned at or near the target location, the dilator 240 can then be retracted through the catheter 120 (e.g., proximally) to allow other intravascular medical devices to be introduced into the patient via the catheter 120 and / or for aspiration of the catheter 120.

[0040] In some aspects of the present technology, it is desirable that the uniform diameter and varying stiffness of the dilator 240 improve the control and propulsion characteristics of the dilator 240 and the catheter 120. For example, it is desirable that the uniform diameter of the dilator 240 better matches the internal dimensions of the lumen 124 of the catheter 120, which in turn can reduce or eliminate the gaps or spaces between the dilator 240 and the catheter 120. Reducing / eliminating these gaps can at least partially inhibit or prevent the dilator 240 from flexing or buckling within the catheter 120 when navigating through the patient's vasculature, which can improve the control of the dilator's movement during the procedure. Additionally or alternatively, it is desirable that the uniform diameter of the dilator 240 improves the durability (e.g., compression resistance) of the catheter 120 when the dilator 240 is positioned within the catheter 120. For example, reducing / eliminating these gaps can also reduce or completely eliminate the size of one or more crush zones associated with the gaps or spaces between the dilator 240 and the catheter 120 and in which the catheter 120 can be crushed or collapsed during use. In addition, the variable mechanical properties of the body regions 244a-b of the dilator can improve the dilator's flexibility and / or response to forces applied to the dilator 240 during a procedure (e.g., by a physician and / or from the catheter 120). In these and other embodiments, it is desirable that the notch 250 further improves the control and propulsion characteristics of the dilator 240 and / or the system 100. For example, the size of the resistance / interference fit between the notch 250 and the valve 130 (e.g., the tether 336) can be configured to inhibit or prevent over-insertion of the dilator 240, which could damage the patient's vasculature. Additionally or alternatively, the tactile feedback or feel provided by the interference fit between the notch 250 and the valve 130 can provide (e.g., to a user) an indication of the relative position of the dilator 240 within the system 100.

[0041] Figure 4A and Figure 4B is a perspective view of expander 240 positioned within system 100 according to an embodiment of the present technology. More specifically, Figure 4A The expander 240 is shown in a first position or state 401a, Figure 4B The expander 240 is shown in a second position or state 401b. Figure 4A and Figure 4B In the embodiment, the coupling member 248 of the expander 240 includes one or more Luer coupling features 452 (in Figure 4A and Figure 4BThe stop features 454 may include one or more luer coupling features 452a and one or more luer coupling features 452b (identified as first and second luer coupling features 452a and 452b, respectively) and / or one or more stop features 454 (identified as first and second stop features 454a and 454b, respectively). The stop features 454 may each be spaced apart from one or more of the luer coupling features 452 and / or positioned proximal to one or more of the luer coupling features.

[0042] See also Figure 4A , the dilator 240 can be inserted through the system 100 until the dilator 240 is coupled to the valve 130 via the notch 250 ( FIG. 2A to FIG. 3B ), as previously referenced in this article Figure 3A and Figure 3B As described. When the dilator 240 and the system 100 are in the first state 401a, the first length L1 of the dilator 240 can extend distally beyond the distal end 126b of the catheter 120. In the illustrated embodiment, the first length L1 includes the head end 246 and a portion of the body 242. Additionally or alternatively, the first length L1 can extend beyond the distal end 126b by about 1 cm to about 5 cm. In the first state 401a, the dilator 240 and the catheter 120 can be in a "standard" or "vascular access" mode or configuration, in which the catheter 120 and the dilator 240 can be inserted into the patient's vasculature and / or used to navigate through the patient's vasculature, for example, to reach a target location, as previously described herein. The dilator 240 can then be removed from the catheter 120 so that the system 100 can be used to treat and / or remove clotted material within the patient.

[0043] See also Figure 4B, the dilator 240 can be advanced from the first state 401a to the second state 401b by advancing the dilator 240 distally through the system 100 and / or retracting the system 100 proximally over the dilator 240. In the second state 401b, the second length L2 of the dilator 240 can extend distally beyond the distal end 126b. The second length L2 can be greater than the first length L1. In at least some embodiments, for example, the second length L2 is between about 5 cm and about 20 cm, such as at least 15 cm, or another suitable length therebetween. In the second state 401b, the dilator 240 and the catheter 120 can be in a "guide rail" or "telescopic delivery" mode or configuration, in which the catheter 120 can be advanced into and / or through the patient's vascular system while sliding along the dilator 240 and / or otherwise moving over the dilator (e.g., telescopically moving over it). In at least some embodiments, telescopically inserting the catheter 120 over the dilator 240 may include moving from the second state 401b to the first state 401a and / or from the second state toward the first state ( Figure 4A ). In these and other embodiments, once the dilator 240 and / or catheter 120 are positioned at or near the target location, the dilator 240 can be removed from the catheter 120 so that the system 100 can be used to treat and / or remove clotted material from the patient.

[0044] In some embodiments, one or more of the Luer coupling features 452 ( Figure 4A ) can be coupled to the valve 130 in the second state 401b, for example, to at least partially or completely prevent the catheter 120 and / or the dilator 240 from further movement (e.g., unintended movement) relative to each other. Additionally or alternatively, in the second state 401b, one or more of the stop features 454 can contact or abut the valve 130, thereby inhibiting or preventing (i) the dilator 240 from further distal movement relative to the system 100, and / or (ii) the system 100 from further proximal movement relative to the dilator 240.

[0045] As described in detail above, the expander 240 may include more than one notch (e.g., including Figure 3A and Figure 3B 1 and 2. Each notch can be spaced apart along the length of the dilator 240 such that, when coupled via the valve 130, each notch can be associated with a different position of the dilator 240 relative to the system 100 and / or a different length (e.g., between the first length L1 and the second length L2) of the dilator 240 extending beyond the distal tip 126b. For example, see FIG. 3A to FIG. 4B, the second notch 350 is positioned proximal to the first notch 250 such that when the valve 130 is coupled to (eg, locked to) the dilator 240 at the second notch 350 , the dilator extends further beyond the distal tip 126 b of the catheter 120 .

[0046] Because each notch can inhibit further movement of the expander 240 and / or the system 100 relative to each other, the location of one or more notches can be configured to inhibit or prevent over-insertion of the expander 240 and / or can increase the user's control over the amount that the expander 240 extends beyond the distal end 126b. In addition, when the expander 240 includes multiple notches, the expander 240 can be configured to transition between more than the two states 401a-b shown in the illustrated embodiment. For example, the expander 240 can be configured to transition between at least three, four, five, or more different states.

[0047] Example

[0048] Several aspects of the present technology are illustrated in the following examples:

[0049] 1. A dilator, comprising:

[0050] Head end;

[0051] Connecting parts;

[0052] a first body region between the head end and the coupling member, wherein the first body region has a first flexible profile; and

[0053] A second body region is interposed between the first body region and the head end, wherein the second body region has a second flexible profile greater than the first flexible profile, wherein the first body region and the second body region have the same diameter.

[0054] 2. The expander of Example 1, wherein the first body region has a first stiffness, wherein the second body region has a second stiffness, and wherein the first stiffness is greater than the second stiffness.

[0055] 3. The expander of Example 1 or Example 2, wherein the first body region has a first hardness, wherein the second body region has a second hardness, and wherein the second hardness is less than the first hardness.

[0056] 4. The dilator of any one of embodiments 1 to 3, wherein the first body region comprises a first material, and wherein the second body region comprises a second material different from the first material.

[0057] 5. The dilator according to any one of embodiments 1 to 4 further includes a third body region between the head end and the connecting member, wherein the third body region has a third flexible profile different from the first flexible profile or the second flexible profile.

[0058] 6. The dilator of any one of embodiments 1 to 5, further comprising a notch positioned between the head end and the coupling member.

[0059] 7. The dilator of Example 6, wherein the recess is positioned between the first body region and the second body region.

[0060] 8. The dilator according to Example 6 or Example 7, wherein the notch is a first notch, and the dilator further comprises a second notch positioned on a proximal side or a distal side of the first notch.

[0061] 9. A vascular access system comprising:

[0062] a valve having a proximal end and a distal end;

[0063] a catheter defining a lumen and coupled to the valve; and

[0064] a dilator configured to be positioned within the lumen through the valve, wherein the dilator comprises

[0065] a first body region having a first flexible profile; and

[0066] a second body region having a second flexible profile that is smaller than the first flexible profile,

[0067] wherein the first body region and the second body region have the same diameter. 10. The vascular access system of embodiment 8, wherein the first body region has a

[0068] A stiffness, wherein the second body region has a second stiffness, and wherein the first stiffness is greater than the second stiffness.

[0069] 11. The dilator of Example 9 or Example 10, wherein the first body region has a first hardness, wherein the second body region has a second hardness, and wherein the second hardness is less than the first hardness.

[0070] 12. The vascular access system of any one of embodiments 9 to 11, wherein the first body region comprises a first material, and wherein the second body region comprises a second material different from the first material.

[0071] 13. A vascular access system according to any one of Examples 9 to 12, wherein the dilator further includes a recess configured to extend at least partially around a longitudinal axis of the dilator, wherein the valve is configured to releasably couple to the dilator via the recess.

[0072] 14. The vascular access system of Example 13 wherein the notch defines a concave region of the dilator, the concave region having a notch diameter that is smaller than a diameter of the first body region and the second body region.

[0073] 15. The vascular access system of Example 13 or Example 14, wherein the valve includes a tether, and wherein the tether is configured to be at least partially positioned within the recess to releasably couple the dilator to the valve.

[0074] 16. A vascular access system according to Example 15, wherein the tether is biased in a first direction to releasably connect the dilator to the valve, and the valve further includes a button that is operably connected to the tether and is configured to move the tether in a second direction opposite to the first direction so that the tether releases the connection between the dilator and the valve.

[0075] 17. The vascular access system of any one of Examples 13 to 16, wherein the notch is a first notch, and wherein the dilator further comprises a second notch positioned on a proximal or distal side of the notch.

[0076] 18. The vascular access system of embodiment 17, wherein the catheter comprises a distal tip, wherein when the first notch is coupled to the valve, a first length of the dilator extends beyond the distal tip, and wherein when the second notch is coupled to the valve, a second length of the dilator extends beyond the distal tip.

[0077] 19. The vascular access system of embodiment 18, wherein the second length is greater than the first length.

[0078] 20. A method of treating clotted material in a patient, the method comprising:

[0079] positioning a dilator within a vascular access system such that a valve of the vascular access system releasably engages a notch of the dilator to inhibit further movement of the dilator relative to the vascular access system;

[0080] actuating a button of the valve to release the notch from the valve, thereby allowing further movement of the dilator relative to the vascular access system; and

[0081] The dilator is moved relative to the vascular access system and / or the vascular access system is moved relative to the dilator.

[0082] 21. The method of embodiment 20, wherein moving the dilator relative to the vascular access system comprises advancing the dilator through the vascular access system to increase the length of the dilator extending beyond the distal end of the vascular access system.

[0083] 22. The method of embodiment 20, wherein moving the vascular access system relative to the dilator comprises advancing the vascular access system over the dilator to reduce the length of the dilator extending beyond the distal tip of the vascular access system.

[0084] 23. The method of any one of embodiments 20 to 22, wherein the recess is a first recess, the method further comprising:

[0085] positioning the dilator within the vascular access system such that the valve releasably engages a second notch of the dilator; and

[0086] A force is applied to the dilator and / or the vascular access system to release the second notch from the valve.

[0087] 24. The method of embodiment 23, wherein applying the force to release the second notch from the valve comprises applying the force to release the second notch from the valve without actuating the button.

[0088] 25. A vascular access system comprising:

[0089] a dilator extending along a longitudinal axis, wherein the dilator has a varying flexibility profile at least partially along the longitudinal axis, and wherein the dilator defines a recess extending at least partially circumferentially about the longitudinal axis;

[0090] a valve having a proximal end and a distal end; and

[0091] a catheter coupled to the valve and defining a lumen;

[0092] wherein the valve is configured to releasably couple to the dilator via the notch to inhibit movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter.

[0093] 26. The vascular access system of embodiment 25, wherein the dilator comprises a body region having a diameter, and wherein the notch comprises a recessed region of the dilator having a notch diameter that is less than the diameter of the body region.

[0094] 27. The vascular access system of Example 25 or Example 26 wherein the valve comprises a tether, and wherein the tether is configured to be at least partially positioned within the recess to releasably couple the dilator to the valve.

[0095] 28. A vascular access system according to embodiment 27, wherein the tether is biased in a first direction to releasably connect the dilator to the valve, and the valve further includes a button, which is operably connected to the tether and is configured to move the tether in a second direction opposite to the first direction to at least partially move the tether out of the recess, thereby releasing the connection between the dilator and the valve.

[0096] 29. A vascular access system according to any one of Examples 25 to 28, wherein the recess is a first recess, wherein the portion of the dilator is a first portion, wherein the dilator further defines a second recess extending at least partially circumferentially around the longitudinal axis, and wherein the valve is configured to releasably couple to the dilator via the second recess to inhibit movement of the dilator relative to the catheter when at least a second portion of the dilator is inserted through the valve into the inner cavity of the catheter.

[0097] 30. The vascular access system of embodiment 29, wherein the catheter comprises a distal tip, wherein when the first notch is coupled to the valve, a first length of the dilator extends beyond the distal tip, and wherein when the second notch is coupled to the valve, a second length of the dilator extends beyond the distal tip.

[0098] 31. The vascular access system of embodiment 30, wherein the second length is greater than the first length.

[0099] 32. A vascular access system according to any one of embodiments 25 to 31, wherein the dilator includes a proximal body region having a first flexible contour and a distal body region having a second flexible contour greater than the first flexible contour, wherein the recess is at least partially positioned between the proximal body region and the distal body region.

[0100] 33. The vascular access system of claim 25, wherein the dilator has a varying stiffness at least partially along the longitudinal axis.

[0101] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, those skilled in the relevant art will recognize that various equivalent modifications may be made within the scope of the present technology. For example, although the steps are given in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0102] From the above, it should be understood that the specific embodiments of the technology have been described herein for illustrative purposes, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0103] In addition, unless the word "or" is expressly limited to mean only a single item in a list involving two or more items that excludes other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" refers to at least including the mentioned features from beginning to end, so that any greater number of the same features and / or other types of features are not excluded. It should also be understood that specific embodiments have been described here for illustrative purposes, but various modifications can be made without departing from the present technology. In addition, although the advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to belong to the scope of the present technology. Therefore, the present disclosure and related technologies may include other embodiments not explicitly shown or described herein.

Claims

1. A dilator, comprising: Head end; Connecting parts; a first body region, the first body region being between the head end and the coupling member, wherein the first body region has a first flexible profile; and a second body region, the second body region being between the first body region and the head end, wherein the second body region has a second flexible profile that is greater than the first flexible profile, The first body region and the second body region have the same diameter.

2. The dilator of claim 1, wherein the first body region has a first stiffness, wherein the second body region has a second stiffness, and wherein the first stiffness is greater than the second stiffness.

3. The dilator of claim 1, wherein the first body region has a first hardness, wherein the second body region has a second hardness, and wherein the second hardness is less than the first hardness.

4. The dilator of claim 1, wherein the first body region comprises a first material, and wherein the second body region comprises a second material different from the first material.

5. The dilator of claim 1, further comprising a third body region between the tip and the coupling member, wherein the third body region has a third flexible profile different from the first flexible profile or the second flexible profile.

6. The dilator of claim 1, further comprising a notch positioned between the head end and the coupling member.

7. The dilator of claim 6, wherein the notch is positioned between the first body region and the second body region.

8. The dilator of claim 6, wherein the notch is a first notch, the dilator further comprising a second notch positioned on a proximal side or a distal side of the first notch.

9. A vascular access system comprising: a valve having a proximal end and a distal end; a catheter defining a lumen and coupled to the valve; and a dilator configured to be positioned within the lumen through the valve, wherein the dilator comprises-- a first body region having a first flexible profile; and a second body region having a second flexible profile that is smaller than the first flexible profile, The first body region and the second body region have the same diameter.

10. The vascular access system of claim 9, wherein the first body region has a first stiffness, wherein the second body region has a second stiffness, and wherein the first stiffness is greater than the second stiffness.

11. The vascular access system of claim 9, wherein the first body region has a first hardness, wherein the second body region has a second hardness, and wherein the second hardness is less than the first hardness.

12. The vascular access system of claim 9, wherein the first body region comprises a first material, and wherein the second body region comprises a second material different from the first material.

13. The vascular access system of claim 9, wherein the dilator further comprises a notch configured to extend at least partially around a longitudinal axis of the dilator, wherein the valve is configured to releasably couple to the dilator via the notch.

14. The vascular access system of claim 13, wherein the notch defines a concave region of the dilator, the concave region having a notch diameter that is smaller than a diameter of the first and second body regions.

15. The vascular access system of claim 13, wherein the valve comprises a tether, and wherein the tether is configured to be positioned at least partially within the recess to releasably couple the dilator to the valve.

16. A vascular access system according to claim 15, wherein the tether is biased in a first direction to releasably connect the dilator to the valve, and the valve further includes a button, which is operably connected to the tether and is configured to move the tether in a second direction opposite to the first direction so that the tether releases the connection between the dilator and the valve.

17. The vascular access system of claim 13, wherein the notch is a first notch, and wherein the dilator further comprises a second notch positioned on a proximal or distal side of the notch.

18. The vascular access system of claim 17, wherein the catheter comprises a distal tip, wherein when the first notch is coupled to the valve, a first length of the dilator extends beyond the distal tip, and wherein when the second notch is coupled to the valve, a second length of the dilator extends beyond the distal tip.

19. The vascular access system of claim 18, wherein the second length is greater than the first length.

20. A method of treating clotted material in a patient, the method comprising: positioning a dilator within a vascular access system such that a valve of the vascular access system releasably engages a notch of the dilator to inhibit further movement of the dilator relative to the vascular access system; actuating a button of the valve to release the notch from the valve, thereby allowing further movement of the dilator relative to the vascular access system; and The dilator is moved relative to the vascular access system and / or the vascular access system is moved relative to the dilator.

21. The method of claim 20, wherein moving the dilator relative to the vascular access system comprises advancing the dilator through the vascular access system to increase the length of the dilator extending beyond the distal tip of the vascular access system.

22. The method of claim 20, wherein moving the vascular access system relative to the dilator comprises advancing the vascular access system over the dilator to reduce the length of the dilator extending beyond the distal tip of the vascular access system.

23. The method of claim 20, wherein the notch is a first notch, the method further comprising: positioning the dilator within the vascular access system such that the valve releasably engages a second notch of the dilator; as well as A force is applied to the dilator and / or the vascular access system to release the second notch from the valve.

24. The method of claim 23, wherein applying the force to release the second notch from the valve comprises applying the force to release the second notch from the valve without actuating the button.

25. A vascular access system comprising: a dilator extending along a longitudinal axis, wherein the dilator has a varying flexibility profile at least partially along the longitudinal axis, and wherein the dilator defines a recess extending at least partially circumferentially about the longitudinal axis; a valve having a proximal end and a distal end; and a catheter coupled to the valve and defining a lumen; wherein the valve is configured to releasably couple to the dilator via the notch to inhibit movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter.

26. The vascular access system of claim 25, wherein the dilator comprises a body region having a diameter, and wherein the notch comprises a concave region of the dilator having a notch diameter that is less than the diameter of the body region.

27. The vascular access system of claim 25, wherein the valve comprises a tether, and wherein the tether is configured to be positioned at least partially within the recess to releasably couple the dilator to the valve.

28. The vascular access system of claim 27, wherein the tether is biased in a first direction to releasably couple the dilator to the valve, the valve further comprising a button operably coupled to the tether and configured to move the tether in a second direction opposite to the first direction to at least partially move the tether out of the recess, thereby releasing the coupling of the dilator from the valve.

29. A vascular access system according to claim 25, wherein the recess is a first recess, wherein the portion of the dilator is a first portion, wherein the dilator further defines a second recess extending at least partially circumferentially around the longitudinal axis, and wherein the valve is configured to releasably couple to the dilator via the second recess to inhibit movement of the dilator relative to the catheter when at least a second portion of the dilator is inserted through the valve into the inner cavity of the catheter.

30. The vascular access system of claim 29, wherein the catheter comprises a distal tip, wherein when the first notch is coupled to the valve, a first length of the dilator extends beyond the distal tip, and wherein when the second notch is coupled to the valve, a second length of the dilator extends beyond the distal tip.

31. The vascular access system of claim 30, wherein the second length is greater than the first length.

32. The vascular access system of claim 25, wherein the dilator comprises a proximal body region having a first flexible profile and a distal body region having a second flexible profile greater than the first flexible profile, wherein the recess is at least partially positioned between the proximal body region and the distal body region.

33. The vascular access system of claim 25, wherein the dilator has a varying stiffness at least partially along the longitudinal axis.

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