Catheters with multiple coil layers and associated systems and methods

Abstract

Catheters having multiple coil layers and associated systems and methods are disclosed herein. In some embodiments, a catheter includes an inner liner, a plurality of wires on the inner liner, and an outer sheath over the wires. The filaments are wound about a longitudinal axis of the conduit in a first direction to form a first coil layer over the liner, and the filaments are wound about the longitudinal axis in a second direction opposite the first direction over the first coil layer to form a second coil layer over the first coil layer. The filaments each include a continuous / self-terminating end portion, wherein the filaments switch from the first direction to the second direction and transition from an inner coil layer to an outer coil layer.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 405,251, filed on September 9, 2022, and entitled “CATHETERS HAVING MULTIPLE COILLAYERS, AND ASSOCIATED SYSTEMS AND METHODS,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology generally relates to catheters having multiple coil layers, and more specifically to catheters having adjacent coil layers formed from the same wire, wherein the wire is (i) wound in a first direction to form an inner coil layer and (ii) wound in a second direction opposite to the first direction to form an outer coil layer above the inner coil layer. Background Art

[0004] Thromboembolic events are characterized by vascular obstruction. Thromboembolic diseases such as stroke, pulmonary embolism, heart attack, peripheral thrombosis, atherosclerosis, etc. affect many people. These diseases are the main causes of morbidity and mortality.

[0005] When an artery is blocked by a clot, tissue ischemia develops. If the blockage persists, the ischemia will progress to tissue infarction. If blood flow is quickly reestablished, the infarction will not develop or will be greatly limited. Failure to reestablish blood flow may result in limb loss, angina, myocardial infarction, stroke, or even death.

[0006] In the venous circulation, obstructive material can also cause serious harm. Blood clots can form in the large veins of the legs and pelvis, a common condition known as deep vein thrombosis (DVT). DVT most commonly occurs in situations where there is a tendency for blood to clot (e.g., long-distance air travel, inactivity, etc.) and blood to clot (e.g., cancer, recent surgery such as plastic surgery). DVT causes harm by (1) blocking the drainage of venous blood from the legs, causing swelling, ulcers, pain, and infection, and (2) acting as a reservoir for blood clots to travel to other parts of the body, including the heart, lungs, brain (stroke), abdominal organs, and / or extremities.

[0007] In the pulmonary circulation, unwanted substances can cause damage by blocking a pulmonary artery, a condition known as pulmonary embolism. If the blockage is upstream, in a main trunk or large branch pulmonary artery, it can severely impair total blood flow within the lungs, and therefore the entire body, as well as cause hypotension and shock. If the blockage is downstream, in a large to medium pulmonary artery branch, it can prevent a significant portion of the lungs from participating in the exchange of gases to the blood, leading to low blood oxygen and accumulation of blood carbon dioxide.

[0008] There are many existing techniques for reestablishing blood flow through blocked blood vessels. One common surgical technique, embolectomy, involves cutting open the blood vessel and placing a device with a balloon tip, such as a Fogarty catheter, at the site of the blockage. The balloon is then inflated at a point outside the clot and used to translate the blocking material back to the cutting point. The blocking material is then removed by the surgeon. Although such surgical techniques have been useful, exposing the patient to surgery can be traumatic and is best avoided when possible. Additionally, the use of a Fogarty catheter can be problematic because there can be a risk of damaging the inner lining of the blood vessel as the catheter is withdrawn.

[0009] Percutaneous methods are also used to reconstruct blood flow. Common percutaneous techniques are called balloon angioplasty, in which a catheter with a balloon tip is introduced into a blood vessel (e.g., typically by an introduction catheter). The catheter with the balloon tip is then advanced to the point of obstruction and inflated to dilate the stenosis. Balloon angioplasty is suitable for treating vascular stenosis, but it is usually not effective for treating acute thromboembolism because the obstructing material is not removed and the blood vessel will restenosis after dilation. Another percutaneous technique includes placing a catheter near the clot and injecting streptokinase, urokinase or other thrombolytic agents to dissolve the clot. Unfortunately, thrombolysis usually requires hours to days to be successful. In addition, thrombolytic agents can cause bleeding, and for many patients, the agent cannot be used at all.

[0010] Various devices exist for performing thrombectomy or removing other foreign bodies. However, such devices have been found to have highly complex structures, be traumatic to the vessel being treated, or lack adequate retaining structures and therefore may not be properly secured to the vessel to function adequately. In addition, many devices have highly complex structures, which leads to manufacturing and quality control difficulties and delivery issues when passing through tortuous or small diameter catheters. Less complex devices may allow the user to pull through the clot, particularly for inexperienced users, however such devices may not completely capture and / or collect all of the clot material. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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.

[0012] Figure 1 is a partially schematic side view of a clot management system including a catheter according to an embodiment of the present technology.

[0013] Figure 2 According to the implementation scheme of the present technology Figure 1 The line CC in Figure 1A side cross-sectional view of a catheter.

[0014] Figure 3A and Figure 3B According to the implementation scheme of the present technology Figure 1 An enlarged isometric view of a portion of a catheter.

[0015] Figures 3C to 3G According to the implementation scheme of the present technology Figure 1 A side view of an inner coil layer and an outer coil layer of a catheter at a distal portion of the catheter.

[0016] Figure 4 According to additional embodiments of the present technology Figure 1 An enlarged isometric view of a portion of a catheter.

[0017] Figure 5 According to additional embodiments of the present technology Figure 1 An enlarged isometric view of a portion of a catheter.

[0018] Figure 6 According to additional embodiments of the present technology Figure 1 The line CC in Figure 1 A side cross-sectional view of a catheter.

[0019] Figure 7 According to additional embodiments of the present technology Figure 1 The line CC in Figure 1 A side cross-sectional view of a catheter.

[0020] Figure 8 According to additional embodiments of the present technology Figure 1 The line CC in Figure 1 A side cross-sectional view of a catheter.

[0021] Fig. 9 According to an embodiment of the present technology, a method for manufacturing Figure 1 A flow chart of a process or method of catheterization.

[0022] Fig. 10A and Fig. 10B According to the implementation scheme of the present technology Figure 1 Side view of a distal portion of a catheter during a procedure for removing clotted material from within a patient's blood vessel BV. DETAILED DESCRIPTION

[0023] The present technology as a whole relates to catheters (e.g., suction catheters) having multiple coil layers and associated systems and methods. In some embodiments, a catheter configured according to the present technology includes an inner liner, a plurality of wires above the inner liner, and an outer sheath above the wires. The wires are wound around the longitudinal axis of the catheter in a first direction to form a first coil layer above the inner liner, and the wires are wound around the longitudinal axis in a second direction opposite to the first direction above the first coil layer to form a second coil layer above the first coil layer. The wires each include a continuous / self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer.

[0024] In some aspects of the present technology, the inner and outer coil layers can be configured to provide selected properties to the catheter over the entire length of the catheter or in selected areas of the catheter, such as selected flexibility, pushability, torquability, kink resistance, hoop strength, and / or other properties known in the catheter art. For example, the number of wires used to form the inner and outer coil layers and / or the spacing between the wires can vary.

[0025] In additional aspects of the present technology, the arrangement of the inner coil layer and the outer coil layer can enable the catheter to be turned and positioned in a difficult-to-reach (e.g., tortuous) area of ​​the patient's anatomical structure (e.g., venous anatomy) while still having a relatively large size (e.g., 20 French, 24 French, greater than 24 French). More specifically, the inner coil layer and the outer coil layer can give the catheter a torsionability and pushability similar to a conventional catheter including a braided structure (e.g., a braided mesh). Similarly, the inner coil layer and the outer coil layer can provide an annular strength and flexibility similar to or greater than a conventional catheter including a single filament coil structure, while also reducing kinks around a tight bending radius. In addition, the inner coil layer and the outer coil layer allow the catheter to have these characteristics without including a braided structure or other reinforcement structure, which allows the catheter to be manufactured with a relatively thin liner and / or outer sheath, and causes the catheter to have a thinner wall. This can enable the inner diameter of the catheter to be larger than other catheters marked with the same outer diameter French size. A larger inner diameter may be optimal for generating an aspiration flow rate (eg, increasing the aspiration flow rate) during a thrombectomy or embolectomy procedure, thereby resulting in more complete clot removal.

[0026] In the following description and in Figures 1 to 10BCertain 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. In addition, although primarily reference is made to aspiration catheters and catheters used for clot removal procedures, the catheters of the present technology may be other types of catheters and / or may be used for other types of medical procedures. However, one of ordinary skill in the art will recognize that the present technology may be practiced without one or more of the details set forth herein and / or with other structures, methods, components, etc.

[0027] 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.

[0028] 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, such as the position of the components and the details of certain precise connections between such components. Many details, sizes, angles and other features shown in the accompanying drawings are merely 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 the following description of some details.

[0029] 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.

[0030] As used herein, the terms "about," "approximately," "substantially," and the like, mean within ±10% of the stated value unless expressly indicated otherwise. If any material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls. The headings provided herein are for convenience only and should not be construed as limiting the disclosed subject matter.

[0031] I. Selected Embodiments of Clot Management Systems

[0032] Figure 1 is a partially schematic side view of a clot handling system 100 according to an embodiment of the present technology. The clot handling system 100 may also be referred to as an aspiration assembly, a clot removal system, and / or a thrombectomy system. In the illustrated embodiment, the clot handling system 100 includes a tubing assembly 110 fluidly coupled to a catheter 120 via a valve 102. In general, the clot handling system 100 (i) may include features that are substantially similar or identical to the features of the clot handling system described in detail in U.S. patent application Ser. No. 16 / 636,185, filed on Aug. 8, 2019, entitled “SYSTEM FOR TREATING EMBOLISMAND ASSOCIATED DEVICES AND METHODS,” the entirety of which is incorporated herein by reference, and / or (ii) may be used to treat / remove clotted material from a patient (e.g., a human patient) using any of the methods described in detail therein.

[0033] In the illustrated embodiment, the catheter 120 includes (i) a proximal region or portion 122, (ii) an intermediate region 124 adjacent to and distal to the proximal region 122, (iii) a distal region 126 adjacent to and distal to the intermediate region 124, and (iv) a distal tip region 128 adjacent to and distal to the distal region 126 (collectively, "regions 122, 124, 126, 128"). The catheter 120 also defines a lumen 121 extending completely therethrough from the proximal region 122 to the distal tip region 128. The proximal region 122 defines a proximal end 123 of the catheter 120, and the distal tip region 128 defines a distal end 125 of the catheter 120. In the illustrated embodiment, the distal tip region 128 includes a marker band 129, such as a radiopaque marker, which is configured to facilitate visualization of the position of the catheter 120 during a medical procedure (e.g., a clot removal procedure) in which the catheter 120 is used. In other embodiments, the marker band 129 may be omitted or positioned at a different location along the catheter 120 , and / or the catheter 120 may include additional marker bands to facilitate visualization of the catheter 120 .

[0034] In some embodiments, the proximal region 122 has a first length, the middle region 124 has a second length less than the first length, the distal region 126 has a third length greater than the second length but less than the first length, and the distal tip region 128 has a fourth length less than the first, second, and third lengths. For example, the first length can be between about 20.00 inches and 50.00 inches (e.g., about 22.0 inches), the second length can be between about 2.0 inches and 3.0 inches (e.g., about 2.50 inches), the third length can be between about 10.00 inches and 20.00 inches (e.g., about 16.00 inches), and the fourth length can be between about 0.10 inches and 0.50 inches (e.g., about 0.15 inches). In other embodiments, the lengths of one or more regions 122, 124, 126, 128 can be different. As used herein with respect to the first to fourth lengths, the term "about" means within ±0.50 inches of the lengths. In some embodiments, the conduit 120 may have different flexibility, shape, thickness, and / or other properties in / along various regions 122, 124, 126, 128, as described in more detail below. The lengths of the regions 122, 124, 126, 128 relative to each other in the figures may not be drawn to scale.

[0035] The valve 102 is fluidly coupled to the lumen 121 of the catheter 120 and may be integral with or coupled to a proximal region 122 of the catheter 120. In some embodiments, the valve 102 is a hemostatic valve configured to maintain hemostasis during a clot removal procedure by inhibiting or preventing fluid from flowing through the valve 102 in a proximal direction when various components such as a delivery sheath, a pull member, a guidewire, an interventional device, other aspiration catheters, etc. are inserted through the valve 102 to be delivered to a treatment site in a blood vessel through the catheter 120. The valve 102 includes a branch or side port 104 configured to fluidly couple the lumen 121 of the catheter 120 to the tubing assembly 110. In some embodiments, the valve 102 may be a valve of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed on August 30, 2018, entitled “HEMOSTASIS VALVES AND METHODS OF USE,” which is incorporated herein by reference in its entirety.

[0036] In the illustrated embodiment, the tubing assembly 110 fluidly couples the catheter 120 to a pressure source 106, such as a syringe. The tubing assembly 110 may 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 106 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 104 of the valve 102 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 can be externally operated by a user to regulate the flow of fluid therethrough, specifically, to regulate the flow of fluid from the lumen 121 of the catheter 120 to the pressure source 106. In some embodiments, the connector 116 is a quick release connector (eg, a quick disconnect fitting) that enables the conduit 120 and the fluid control device 114 to be quickly coupled / disconnected to / from the pressure source 106 .

[0037] II. Selected Embodiments of Catheters Having Self-Terminating Coils

[0038] Figure 2 According to the implementation scheme of the present technology Figure 1 0 is a side cross-sectional view of the catheter 120 taken along line CC in FIG. In the illustrated embodiment, the catheter 120 includes an outer sheath 230 and an inner liner 232 extending through / defining each of the regions 122, 124, 126, 128. The outer sheath 230 is positioned above the inner liner 232 (e.g., radially outward). The outer sheath 230 may also be referred to as an outer jacket, outer shaft, outer layer, etc., and the inner liner 232 may also be referred to as an inner layer, inner sheath, inner shaft, etc. In the illustrated embodiment, the catheter 120 also includes an inner coil layer 234 (e.g., a first coil layer) and an outer coil layer 236 (e.g., a second coil layer) extending above / around the inner coil layer 234. As described below with reference to Figures 3A to 3G Described in more detail, the inner coil layer 234 and the outer coil layer 236 (collectively referred to as "coil layers 234, 236") may include a plurality of individual wires wound around the liner 232. The coil layers 234, 236 may extend through each of the regions 122, 124, 126, 128 along the entire length of the catheter 120, or may only extend partially along the length of the catheter 120 (e.g., in the distal region 126 and the distal tip region 128). The coil layers 234, 236 may be collectively referred to as reinforcement structures or the like.

[0039] The outer sheath 230 may be formed of a plastic material, an elastomeric material, and / or a thermoplastic elastomer (TPE) material. In some embodiments, the outer sheath 230 may be formed of a TPE manufactured by Arkema SA of Colombes, France, such as a TPE manufactured under the trademark "Pebax". In some embodiments, the outer sheath 230 may have varying hardness (e.g., durometer), thickness, flexibility, rigidity, and / or other properties in one or more of the different regions 122, 124, 126, 128. For example, the outer sheath 230 may have a first hardness along the proximal region 122, a second hardness along the middle region 124 that is less than the first hardness, a third hardness along the distal region 126 that is less than the first hardness and the second hardness, and a fourth hardness greater than the third hardness in the distal tip region 128. In some embodiments, the first hardness and the fourth hardness may each be between about 65D and 75D (e.g., about 72D), the second hardness may be between about 45D and 60D (e.g., about 45D, about 50D), and the third hardness may be between about 25D and 40D (e.g., about 25D, about 30D, about 35D). As used herein with respect to the first to fourth hardnesses, the term "about" means within ±2D of the hardness. In other embodiments, one or more of the regions 122, 124, 126, 128 may have different hardnesses.

[0040] The liner 232 defines the lumen 121, and in some embodiments, the liner can be formed of a lubricating material that facilitates the movement of various components (such as delivery sheaths, traction members, guidewires, interventional devices, other aspiration catheters, etc.) through the lumen 121 (e.g., distal advancement, proximal retraction). In some embodiments, the liner 232 can be formed of a polymer material, a fluoropolymer material (e.g., polytetrafluoroethylene (PTFE)), and / or another material with a high degree of lubricity. The liner 232 defines the inner diameter D of the catheter 120. The thickness of the outer sheath 230, the liner 232, and the coil layers 234, 236 relative to each other and / or relative to the inner diameter D is Figure 223. The drawings may not be to scale. For example, one of ordinary skill in the art will appreciate that, for clarity, the thickness of these components is shown, but the catheter 120 may have a relatively thin wall (e.g., including the outer sheath 230, the liner 232, and the coil layers 234, 236) compared to the inner diameter D. In some embodiments, the inner diameter D is greater than about 6 French, greater than about 10 French, greater than about 16 French, greater than about 20 French, greater than about 24 French, or greater. In some embodiments, the inner diameter D is about 8 French, about 16 French, about 20 French, about 24 French, or about 26 French. As used herein with respect to the inner diameter D, the term "about" means within ±1 French of the diameter. In certain embodiments, the diameter D of the liner 232 is the same in each of the regions 122 , 124 , 126 , 128 , while in other embodiments, the inner diameter D may vary along one or more of the regions 122 , 124 , 126 , 128 .

[0041] In some embodiments, the inner liner 232 or the outer jacket 230 can be omitted. For example, the inner liner 232 can be omitted, and the coil layers 234, 236 can be coupled to (eg, fused to) the outer jacket 230.

[0042] Figure 3A and Figure 3B According to the implementation scheme of the present technology Figure 1 An enlarged isometric view of a portion of the catheter 120 is shown. Specifically, Figure 3A The portion of the catheter 120 shown is a portion of the catheter 120 proximal to the distal tip 125, and Figure 3B The portion of the catheter shown is a portion of the catheter 120 including the distal tip 125. For clarity, Figure 3A and Figure 3B The outer sheath 230 is not shown. Figure 2 ). Figure 3C and Figure 3D The coil layers 234, 236 according to an embodiment of the present technology are, for example, Figure 1 A side view of the distal region 126 and distal tip region 128 is shown. FIG. 3A to FIG. 3D , the coil layers 234, 236 include a plurality of individual threads 340 (eg, filaments, filaments, strands, etc.; each identified as a first thread 340a, a second thread 340b, a third thread 340c, and a fourth thread 340d). For clarity, Figure 3C In FIG. 1 , individual wires 340a, 340b, 340c and 340d are shown as having different patterns / fills and in FIG. Figure 3D In FIG. 1 , coil layers 234, 236 are shown as having different patterns / fills. In addition to the pattern / fill of wire 340, Figure 3C and Figure 3D are the same.

[0043] In the illustrated embodiment, the wire 340 is oriented in a first direction around the longitudinal axis L ( Figure 1 ) extends in a spiral or helical pattern around the liner 232 to form the inner coil layer 234, and the wire 340 extends at the distal end 342 ( FIG. 3B to FIG. 3D ) to extend in a second direction around the longitudinal axis L in a spiral or spiral pattern around the inner coil layer 234 to form the outer coil layer 236. More specifically, in the illustrated embodiment, the wire 340 is (i) wound / coiled in the inner coil layer 236 in the distal direction D around the liner 232 such that the spiral or spiral pattern of the wire 340 in the inner coil layer 234 has a first orientation (e.g., a left-hand orientation), and (ii) wound / coiled in the outer coil layer 234 in the proximal direction P around the inner coil layer 234 such that the spiral or spiral pattern of the wire 340 in the outer coil layer 236 has a second orientation opposite to the first orientation (e.g., a right-hand orientation).

[0044] Reference together FIG. 3B to FIG. 3D , the wires 340 each include a distal tip or distal end portion 342, at which the wires 340 switch direction and transition from the inner coil layer 234 to the outer coil layer 236. Thus, the wires 340 are disposed at the distal tip region 128 ( Figure 1 ) at the proximal region 122 of the catheter 120 ( Figure 1 In some aspects of the present technology, the wires 340 do not need to be glued, annealed, or otherwise secured together at the distal end portion 342 because the distal end portion 342 is self-terminating, thereby reducing the cost and complexity of manufacturing the catheter 120.

[0045] In addition, each of the wires 340 includes a first portion (e.g., a first half) that is wrapped around the liner 232 and forms the inner coil layer 234 and a second portion (e.g., a second half) that is wrapped around the inner coil layer 234 and forms the outer coil layer 236. A distal end portion 342 of each of the wires 340 separates the first portion from the second portion. In some embodiments, the coil layers 234, 236 are not fixed together, such that, for example, the first portion and the second portion of the wire 340 can move relative to each other. Referring together Figures 2 to 3D, such movement can be limited by the outer sheath 230 and / or the inner liner 232, which can couple / fix the coil layers 234, 236 together. That is, the outer sheath 230 and the inner liner 232 can fix the coil layers 234, 236 in place. In other embodiments, the coil layers 234, 236 are directly fixed together via adhesives, welding, etc.

[0046] Let’s refer to it again FIG. 3A to FIG. 3D , the first wire 340a is positioned between (e.g., adjacent to) the second wire 340b and the fourth wire 340d, the second wire 340b is positioned between the first wire 340a and the third wire 340c, the third wire 340c is positioned between the second wire 340b and the fourth wire 340d, and the fourth wire 340d is positioned between the third wire 340c and the first wire 340a. In the illustrated embodiment, the wires 340 are evenly spaced apart from each other at a first pitch P1 in the inner coil layer 234, and the wires 340 are evenly spaced apart from each other at a second pitch P2 in the outer coil layer 236. In some embodiments, the first pitch and the second pitch P2 are evenly spaced apart from each other. 1-2 The first and second spacings P may be the same along the entire length of the conduit 120. In other embodiments, as described in more detail below, the first and second spacings P may be the same along the entire length of the conduit 120. 1-2 The may be different and / or may vary along the length of the catheter 120 to provide different mechanical properties along the length of the catheter 120 .

[0047] In the illustrated embodiment, the catheter 120 includes four of the wires 340 that form the coil layers 234, 236. In other embodiments, the catheter 120 may include more or fewer wires 340 (e.g., 1 wire, 2 wires, 3 wires, 5 wires, 6 wires, 8 wires, 12 wires, or more than 12 wires). The wire 340 may be a flat wire (e.g., a rolled flat wire) having a generally rectangular cross-sectional shape, with a size of about 0.001 inches to 0.005 inches (e.g., about 0.003 inches) x about 0.002 inches to 0.025 inches (e.g., about 0.010 inches). In other embodiments, the wire 340 may have other cross-sectional shapes (e.g., circular). The wire may be formed of a metal or other material of suitable strength, such as a nickel-titanium alloy (e.g., nitinol), platinum, a cobalt-chromium alloy, stainless steel, tungsten, and / or titanium. In some embodiments, some or all of the wires 340 may include a shape memory material that is heat set or otherwise configured to have a predetermined shape. For example, some or all of the wires may be configured to deflect so that the catheter 120 has a pre-shaped portion (e.g., along some or all of the distal region 126 and / or the distal tip region 128), as described, for example, in U.S. patent application Ser. No. 17 / 529,018, filed on Nov. 17, 2021, entitled “CATHETERS HAVING SHAPED DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS,” which is incorporated herein by reference in its entirety.

[0048] Figures 3E to 3G The coil layers 234, 236 according to an embodiment of the present technology are, for example, Figure 1 Additional side views of the distal region 126 and distal tip region 128 are shown. In addition to the pattern / fill of the wire 340, Figures 3E to 3G and Figure 3C and Figure 3D For clarity, Figure 3E The inner coil layer 234 is shown with a single pattern / fill, and each of the first to fourth wires 340a-d in the outer coil layer 236 is shown with a different pattern / fill. That is, the second portion of the wire 340 forming the outer coil layer 236 is shown with a different pattern / fill. Figure 3F The outer coil layer 236 is shown with a single pattern / fill, and each of the first to fourth wires 340a-d in the inner coil layer 234 is shown with a different pattern / fill. That is, the first portion of the wire 340 forming the inner coil layer 234 is shown with a different pattern / fill. Figure 3GThe first to fourth wires 340a-d in (i) the inner coil layer 234 are shown with different patterns / fills and the first to fourth wires 340a-d in (ii) the outer coil layer 236 are shown with different patterns / fills. That is, the first and second portions of the wires 340, which form the coil layers 234, 236, respectively, are shown with different patterns / fills.

[0049] Reference together Figures 1 to 3G In some aspects of the present technology, the coil layers 234 , 236 may be configured to provide selected properties to the catheter 120 over the entire length of the catheter 120 or in selected areas of the catheter 120 . Such properties include flexibility (e.g., the ability of the catheter 120 to flex / bend laterally away from the longitudinal axis L), pushability (e.g., column strength; e.g., the ability of the catheter 120 to transmit longitudinal forces from the proximal region 122 to the distal region 126 and the distal tip region 128 along the length of the catheter 120), torsionalness (e.g., torque response; e.g., the ability of the catheter 120 to transmit rotational forces from the proximal region 122 to the distal region 126 and the distal tip region 128 along the length of the catheter 120), kink resistance (e.g., the ability of the catheter 120 to maintain its cross-sectional profile (such as the inner diameter D) during compressive deformation), circumferential strength (e.g., the ability of the catheter 120 to maintain its cross-sectional profile when a pressure differential exists between the lumen 121 of the catheter 120 and the environment surrounding the catheter 120, such as during aspiration of the lumen 121), and / or other properties known in the catheter art. For example, the number of wires 340 forming the coil layers 234, 236 and / or the spacing P between the wires 340 in the coil layers 234, 236 may be selected. 1-2 , to provide the desired flexibility, pushability, torsionability, kink resistance, hoop strength, etc.

[0050] More specifically, for example, the spacing P between the wires 340 is increased. 1-2 The flexibility of the catheter 120 can generally be reduced because the wires 340 extend more longitudinally (eg, less circularly) about the longitudinal axis L of the catheter 120, while also increasing the pushability of the catheter 120. Conversely, reducing the spacing P between the wires 340 1-2 The flexibility of the catheter 120 may generally be increased because the wires 340 extend more circularly around the longitudinal axis L of the catheter 120, while also decreasing the pushability of the catheter 120. Furthermore, increasing the number of wires 340 may increase pushability, torquability, kink strength, and hoop strength, while also decreasing the flexibility of the catheter 120. Conversely, decreasing the number of wires 340 may decrease pushability, torquability, kink strength, and hoop strength, while also increasing the flexibility of the catheter 120.

[0051] For example, Figure 4 and Figure 5According to additional embodiments of the present technology Figure 1 An enlarged isometric view of a portion of the catheter 120 is shown. Figure 4 and Figure 5 The outer sheath 230 is removed ( Figure 2 ). First refer to Figure 4 In the illustrated embodiment, the spacing P between the wires 340 is 1-2 Compare Figures 3A to 3G As described in detail above, the smaller the spacing P 1-2 The flexibility of the catheter 120 can be increased. Figure 5 In the illustrated embodiment, the spacing P between the wires 340 in the coil layers 234, 236 is 1-2 Different regions along the catheter 120, such as the distal region 526 and the proximal region 522, are different. For clarity, the spacing P 1-2 and coil layers 234, 236 in Figure 5 Not marked in Figures 2 to 4 For example, the spacing P 1-2 The distal region 526 is smaller than the proximal region 522. Therefore, as described in detail above, the catheter 120 can be relatively more flexible in the distal region 526 than in the proximal region 522, while the proximal region 522 can provide good pushability for the catheter 120. More generally, referring to Figures 1 to 5 , the spacing P between the wires 340 1-2 The spacing P may be varied one or more times along the length of the conduit 120 (eg, in regions 122, 124, 126, 128) to provide different flexibility and / or other properties along the length of the conduit 120, and / or the spacing P may be varied one or more times along the length of the conduit 120 (eg, in regions 122, 124, 126, 128). 1-2 The coil layers 234 , 236 may vary along the same area of ​​the catheter 120 , such that they impart different flexibility and / or other properties along the same area of ​​the catheter 120 .

[0052] More generally, in some aspects of the present technology, the arrangement of the coil layers 234, 236 can enable the catheter 120 to be turned and positioned in a difficult-to-reach (e.g., tortuous) area of ​​the patient's anatomical structure (e.g., venous anatomy) while still having a relatively large size (e.g., 20 French, 24 French, greater than 24 French). More specifically, the coil layers 234, 236 can give the catheter 120 the twistability and pushability similar to conventional catheters including a braided structure (e.g., a braided mesh) or other reinforcement structure. Similarly, the coil layers 234, 236 can provide annular strength and flexibility similar to or greater than conventional catheters including a single filament coil structure, while also reducing kinks around tight bend radii. In addition, the coil layers 234, 236 allow the catheter 120 to have these characteristics without including a braided structure or other reinforcement structure, which allows the catheter 120 to be manufactured with a relatively thin liner 232 and / or a thin outer sheath 230 and causes the catheter 120 to have a thin wall. This may enable the inner diameter D of the catheter 120 to be larger than other catheters labeled with the same outer diameter (OD) French size.

[0053] In some embodiments, catheter 120 may include more coil layers in addition to coil layers 234, 236. For example, Figure 6 According to additional embodiments of the present technology Figure 1 1 is a side cross-sectional view of the catheter 120 taken along line CC in FIG. In the illustrated embodiment, the inner coil layer 234 is a first inner coil layer 234 and the outer coil layer 236 is a first outer coil layer 236 (collectively referred to as "first coil layers 234, 236"), and the catheter 120 further includes a second inner coil layer 634 and a second outer coil layer 636 (collectively referred to as "second coil layers 634, 636"). The first inner coil layer 234 may be referred to as the first coil layer 234, the first outer coil layer 236 may be referred to as the second coil layer, the second inner coil layer 634 may be referred to as the third coil layer, the second outer coil layer 636 may be referred to as the fourth coil layer, and so on.

[0054] The second coil layers 634, 636 may be substantially similar or identical to the first coil layers 234, 236. For example, the second coil layers 634, 636 may include a plurality of individual wires, and the wires may (i) be arranged in a first direction around the longitudinal axis L ( Figure 1 ) extends in a spiral or spiral pattern around the first outer coil layer 236 to form a second inner coil layer 634, and (ii) extends in a spiral or spiral pattern around the second inner coil layer 634 in a second direction around the longitudinal axis L to form a second outer coil layer 636 above the second inner coil layer 634. In addition, the wires forming the second coil layers 634, 636 may be located at the distal tip region 128 ( Figure 1) as described in detail above. The second coil layers 634, 636 may extend through each of the regions 122, 124, 126, 128 along the entire length of the catheter 120 ( Figure 1 ), or may extend only partially along the length of the catheter 120 (e.g., in the distal region 126 and the distal tip region 128). That is, for example, (i) the second coil layers 634, 636 may self-terminate at the same location as the first coil layers 234, 236, such that the catheter 120 includes four coil layers (e.g., the first coil layers 234, 236 and the second coil layers 634, 636 thereabove) along its entire length, or (ii) the second coil layers 634, 636 may self-terminate at a different location than the first coil layers 234, 236, such that a portion of the catheter 120 includes four coil layers (e.g., the first coil layers 234, 236 and the second coil layers 634, 636 thereabove) and a portion of the catheter 120 includes two coil layers (e.g., the first coil layers 234, 246). In some embodiments, the wires used to form the first coil layer 234 , 236 and the second coil layer 634 , 636 may be thinner to maintain the same or similar inner diameter D of the lumen 121 of the catheter 120 .

[0055] In some embodiments, a single wire is used to form the first coil layer 234, 236 and the second coil layer 634, 636. In other embodiments, the same wire may be wrapped multiple times along the length of the catheter 120 to form the first coil layer 234, 236 and the second coil layer 634, 636. That is, for example, the same wire may be (i) wrapped distally along the liner 232 to form the first inner coil layer 234, (ii) wrapped back proximally along the first inner coil layer 234 to form the first outer coil layer 236, (iii) wrapped back distally along the first outer coil layer 236 to form the second inner coil layer 634, and then (iv) wrapped back proximally along the second inner coil layer 634 to form the second outer coil layer 636. In such embodiments, the wires may self-terminate at the distal junction between the first coil layers 234, 236, at the proximal junction between the first outer coil layer 236 and the second inner coil layer 634, and at the distal junction between the second coil layers 634, 636. Furthermore, the number of wires and / or the spacing between the wires in the first coil layers 234, 236 and the second coil layers 634, 636 may vary as described in detail above.

[0056] In some aspects of the present technology, the second coil layers 634, 636 can increase the pushability, torquability, hoop strength, and / or other aspects of the catheter 120. For example, referring to Figures 3A to 3G and Figure 6, twisting the catheter 120 in a first direction (e.g., clockwise) may force the first inner coil layer 234 to compress / close (e.g., for reducing the first spacing P1). Conversely, twisting the catheter 120 in the first direction may simultaneously force the first outer coil layer 236 to expand / open (e.g., for increasing the second spacing P2). Similarly, twisting the catheter 120 in a second direction opposite to the first direction (e.g., counterclockwise) may force the first inner coil layer 234 to expand / open while forcing the first outer coil layer 236 to compress / close. These opposing forces may produce an asymmetric torque on the catheter 120. The second coil layers 634, 636 may have similar torque responses, and in some aspects of the present technology, the torque response of the catheter 120 may be made more symmetrical by balancing the opposite torque responses of the first coil layers 234, 236.

[0057] Figure 7 According to additional embodiments of the present technology Figure 1 1. A side cross-sectional view of the catheter 120 taken along line CC in FIG. 1. In the illustrated embodiment, the catheter 120 further includes a third inner coil layer 734 and a third outer coil layer 736 (collectively referred to as "third coil layers 734, 736"). The third coil layers 734, 736 may be substantially similar or identical to the first coil layers 234, 236 and the second coil layers 634, 636. For example, the third coil layers 734, 736 may include a plurality of individual wires, and these wires may (i) be arranged in a first direction around the longitudinal axis L ( Figure 1 ) extends in a spiral or spiral pattern around the second outer coil layer 636 to form a third inner coil layer 734, and (ii) extends in a spiral or spiral pattern around the third inner coil layer 734 in a second direction around the longitudinal axis L to form a third outer coil layer 736 above the third inner coil layer 734. In addition, the wires forming the third coil layers 734, 736 may be located at the distal tip region 128 ( Figure 1 ) as described in detail above. The third coil layers 734, 736 may extend through each of the regions 122, 124, 126, 128 along the entire length of the catheter 120 ( Figure 1 ), or may extend only partially along the length of the catheter 120 (e.g., in the distal region 126 and the distal tip region 128). In some embodiments, the wires used to form the first coil layer 234, 236, the second coil layer 634, 636, and the third coil layer 734, 736 may be thinner to maintain the same or similar inner diameter D of the lumen 121 of the catheter 120. In other embodiments, the catheter 120 may include more than three coil layers (e.g., four or more coil layers), which may be formed from the same wire or separate wires.

[0058] In some embodiments, a separate wire is used to form the first coil layer 234, 236, the second coil layer 634, 636, and the third coil layer 734, 736. In other embodiments, the same wire can be used to form some or all of the coil layers. For example, the same wire can be wrapped multiple times along the length of the catheter 120 to form the first coil layer 234, 236, the second coil layer 634, 636, and / or the third coil layer 734, 736. That is, for example, the same wire may be (i) wound distally along the liner 232 to form a first inner coil layer 234, (ii) wound back proximally along the inner coil layer 234 to form a first outer coil layer 236, (iii) wound back distally along the first outer coil layer 236 to form a second outer coil layer 634, (iv) wound back proximally along the second inner coil layer 634 to form a second outer coil layer 636, (v) wound back distally along the second outer coil layer 636 to form a third inner coil layer 734, and then (vi) wound back proximally along the third inner coil layer 734 to form a third outer coil layer 736. In such embodiments, the wire may self-terminate at a distal junction between the first coil layers 234, 236, at a proximal junction between the first outer coil layer 236 and the second inner coil layer 634, at a distal junction between the second coil layers 634, 636, at a proximal junction between the second outer coil layer 636 and the third inner coil layer 734, and at a distal junction between the third coil layers 734, 736. Alternatively, for example, the same wire may be used to form the first coil layers 234, 236 and the second coil layers 634, 636 and a separate wire may be used to form the third coil layers 734, 736, or the same wire may be used to form the second coil layers 634, 636 and the third coil layers 734, 736 and a separate wire may be used to form the first coil layers 234, 236, etc. Furthermore, the number of wires and / or the spacing between wires in the first coil layer 234, 236, the second coil layer 634, 636, and the third coil layer 734, 736 may vary as described in detail above.

[0059] In some aspects of the present technology, the third coil layers 734, 736 can further increase the pushability, torquability, hoop strength, and / or other properties of the catheter 120. For example, the third coil layers 734, 736 can help make the torque response of the catheter 120 more symmetrical by balancing the opposing torque responses of the first coil layers 234, 236 and / or the second coil layers 634, 636.

[0060] In some embodiments, catheter 120 may include one or more lumens, pull wires, and / or other components. For example, Figure 8 According to additional embodiments of the present technology Figure 11. A side cross-sectional view of the catheter 120 taken along line CC in FIG. In the illustrated embodiment, the catheter 120 includes a first component 850 positioned between the coil layers 234, 236, a second component 851 positioned between the liner 232 and the inner coil layer 234, and a third component 852 positioned between the outer sheath 230 and the outer coil layer 236. The catheter 120 may include any number of components 850-852 positioned at different circumferential locations around the lumen 121.

[0061] One or more of the first to third components 850, 851, 852 ("components 850, 851, 852") can be a lumen through which other devices can be inserted and / or through which fluid can be injected or withdrawn (e.g., to inflate a balloon coupled to catheter 120). In some aspects of the present technology, where one or more of components 850, 851, 852 includes an inflation lumen, the coil layers 234, 236 can provide support for the inflation lumen while also allowing for improved (e.g., minimized) inflation / deflation times even when catheter 120 is positioned in a highly tortuous anatomical structure. In some embodiments, one or more of components 850, 851, 852 includes a lumen through which a contrast agent can be injected to facilitate a distal portion (e.g., Figure 1 126 and / or distal tip region 128). In such embodiments, components 850, 851, 852 may include tubes, extrusions, elongated members, etc. The lumen may have a Figure 8 The circular cross-sectional shape shown in FIG. 1 may have other cross-sectional shapes. For example, the first to third lumens 853a-c (eg, contrast agent injection lumens) are respectively located at Figure 8 120 as having a U-shaped cross-sectional shape. More specifically, the lumens 853a-c can extend partially or completely circumferentially around the longitudinal axis L of the catheter 120. In the illustrated embodiment, the first lumen 853a extends between the outer sheath 850 and the outer coil layer 856, the second lumen 853b extends between the coil layers 854, 856, and the third lumen 853c extends between the inner coil layer 854 and the liner 852.

[0062] In some embodiments, one or more of components 850, 851, 852 may include a pull wire configured to, for example, cause a portion of catheter 120 (e.g., Figure 1 For example, a pull wire may be secured to one or both of the coil layers 234, 236 at the distal end and may be withdrawn proximally to deflect the catheter 120. In some embodiments, the catheter 120 includes more than two of the illustrated coil layers 234, 236 (e.g., as described above with reference to Figure 6 and Figure 7 In the case of a plurality of coil layers (described in detail), one or more of components 850, 851, 852 may be positioned between different coil layers (e.g., adjacent coil layers) of the coil layer. For example, multiple inflation and / or fluid injection lumens may be positioned between different coil layers to facilitate inflation of multiple balloons.

[0063] In some aspects of the present technology, the first component 850 can be fixed in place between the coil layers 234, 236 during manufacturing by: (i) Figures 3A to 3G ) After being wound around the liner 232, the first component is positioned above the inner coil layer 234, and then (ii) the wire 340 is further wound over the first component 850 and the inner coil layer 234 to form the outer coil layer 236. In some aspects of the present technology, as described below with reference to Fig. 9 As further described in detail, the conduit 120 can be manufactured to include components 850, 851, 852 with a single machine setup due to the self-terminating ends of the coil layers 234, 236. In additional aspects of the present technology, the components 850, 851, 852 can be formed within the conduit 120 without increasing or substantially increasing the thickness T of the conduit 120 compared to conventional manufacturing methods.

[0064] III. Selected Embodiments of Methods of Making Catheters Having Self-Terminating Coils

[0065] Fig. 9 9 is a flow chart of a process or method 960 for manufacturing a catheter (eg, catheter 120) according to an embodiment of the present technology. Although for illustration purposes, the Figures 1 to 8 Certain features of method 960 are described in the context of the illustrated catheter 120 , but one skilled in the art will readily appreciate that method 960 may be performed to form other catheters described herein.

[0066] At block 961, method 960 may include positioning liner 232 along a mandrel, a hypotube, or another elongated member. In some embodiments, liner 232 is stretched along the mandrel to have a desired thickness.

[0067] At box 962, the method 960 may include winding / wrapping the wire 340 around the mandrel in a first direction (e.g., distal direction D) over the liner 232 to form the inner coil layer 234. As described in detail above, the number of wires 340 and / or the spacing P1 between the wires 340 may vary to provide the desired characteristics of the catheter 120. In some embodiments, when the wire 340 is wound over the liner 232, tension is applied to the wire so that the wire 340 is tightly wound around the liner 232. The wire 340 can be wound manually by a user or by a machine.

[0068] At frame 963, method 960 may include winding / wrapping the wire 340 around the mandrel in a second direction (e.g., a proximal direction P) opposite to the first direction over the inner coil layer 234 to form the outer coil layer 236. That is, the direction of winding may be reversed to form a distal end portion 342 of the wire 340 at, for example, the distal tip region 128 of the catheter 120. As described in detail above, the spacing P2 between the wires 340 may vary to provide the desired characteristics of the catheter 120. In some embodiments, when the wire 340 is wound over the inner coil layer 234, tension is applied to the wire so that the wire 340 is tightly wound around the inner coil layer 234.

[0069] At block 964, the method 960 may optionally include forming one or more additional inner and outer coil layers, such as the second coil layer 634, 636, the third coil layer 734, 736, and / or additional coil layers, over the coil layers 234, 236. As described in detail above, the additional inner and outer coil layers may be formed in the same manner as the coil layers 234, 236 (blocks 962 and 963), and may be formed using separate wires and / or the same wires used to form the wires 340 of the coil layers 234, 236.

[0070] At block 965, the method 960 may include positioning the outer jacket 230 over the liner 232 and the coil layers 234, 236 (and any additional coil layers). In some embodiments, the outer jacket 230 is stretched along the mandrel to have a desired thickness.

[0071] At block 966, the method 960 may include coupling the outer jacket 230, the coil layers 234, 236 (and any additional coil layers), and the inner liner 232 together to form the catheter 120. For example, the outer jacket 230 and the inner liner 232 may be heat shrunk, fused, laminated, or otherwise secured together with the coil layers 234, 236 located therebetween.

[0072] Finally, at block 967, method 960 may include removing catheter 120 from the mandrel. In some embodiments, method 960 may optionally include positioning one or more components (e.g., components 850-852) (such as lumens or pull wires) between any of the steps described in blocks 961-965 such that the components are integrally formed in the wall of catheter 120.

[0073] IV. Selected Embodiments of Methods of Clot Management

[0074] Fig. 10A and Fig. 10B1 is a side view of a distal region 126 of a catheter 120 of a clot management system 100 during a procedure for removing clot material CM (e.g., pulmonary embolism) from a blood vessel BV (e.g., a pulmonary vessel) of a patient (e.g., a human patient) in accordance with an embodiment of the present technology. As described above, in some embodiments, Fig. 10A and Fig. 10B The clot removal procedures exemplified in the present invention may be substantially similar or identical to any clot removal procedures disclosed in U.S. patent application Ser. No. 16 / 536,185, filed on Aug. 8, 2019, entitled “SYSTEM FOR TREATING EMBOLISM ANDASSOCIATED DEVICES AND METHODS,” which is incorporated herein by reference in its entirety.

[0075] Reference together Figure 1 and Fig. 10A , the catheter 120 can be advanced through the patient to bring the clot material CM into proximity with the blood vessel BV (e.g., to a treatment site within the blood vessel BV). In some embodiments, the catheter 120 is advanced through the blood vessel BV until the distal tip 125 of the catheter 120 is positioned proximal to the proximal portion of the clot material CM. The position of the distal tip 125 can be confirmed or located via visualization of a marker band 129 using fluoroscopy or another imaging procedure (e.g., a radiographic procedure). In other embodiments, the distal tip 125 can be at least partially positioned within or distal to the clot material CM.

[0076] In some aspects of the present technology, the catheter 120 is configured to flex / bend into a tortuous (e.g., difficult to reach) region of the vessel BV. For example, in the illustrated embodiment, the catheter 120 has been bent around a bend 1070 in the vessel BV, which may have a relatively small radius of curvature. Portions of the vessel BV distal to the bend 1070 may be difficult to reach due to the required entry angle, the varying anatomy of the vessel BV, and / or irregularities due to the patient's disease. In some embodiments, the vessel BV may be a portion of the left pulmonary artery, the temporal artery, the inferior vena cava, or the right atrium. In some embodiments, the clot material CM may be a clot transported in the right atrium (CIT).

[0077] Access to the pulmonary vasculature can be achieved through the patient's vasculature, for example, via the femoral vein. In some embodiments, the clot management system 100 may include an introducer (e.g., a Y-shaped connector with a hemostatic valve, not shown); which can be partially inserted into the femoral vein. A guidewire (not shown) can be introduced into the femoral vein through the introducer and navigated through the right atrium, the tricuspid valve, the right ventricle, the pulmonary valve, and into the main pulmonary artery. Depending on the location of the clot material CM, the guidewire can be guided to one or more branches of the right pulmonary artery and / or the left pulmonary artery. In some embodiments, the guidewire can extend completely or partially through the clot material CM. In other embodiments, the guidewire can extend to a position just proximal to the clot material CM. After positioning the guidewire, the catheter 120 can be placed over the guidewire and advanced to a location proximate to the clot material CM, such as Fig. 10A As illustrated. In some embodiments, the guidewire can then be retracted, while in other embodiments, the guidewire can be retained and can be used to guide other catheters (e.g., delivery catheters, additional suction guide catheters), interventional devices, etc. to the treatment site. However, it should be understood that other entry locations into the patient's venous circulatory system are also possible and consistent with the present technology. For example, the user can gain access through the jugular vein, subclavian vein, brachial vein, or any other vein that connects to or ultimately leads to the superior vena cava. It can also be advantageous to use other blood vessels that are closer to the right atrium of the patient's heart because this reduces the length of the instrument required to reach the clot material CM.

[0078] Reference together Figure 1 and Fig. 10B , the pressure source 106 is configured to generate (e.g., form, create, fill, accumulate) a vacuum (e.g., a negative relative pressure) and store the vacuum for subsequent application to the catheter 120. For example, after positioning the catheter 120 proximate the clot material CM, the user may first close the fluid control device 114 before generating a vacuum in the pressure source 106, such as by withdrawing the plunger of a syringe coupled to the connector 116. In this way, the pressure source 106 is filled with a vacuum (e.g., maintained at a negative pressure) before the pressure source 106 is fluidly connected to the lumen 121 of the catheter 120. In order to aspirate the lumen 121 of the catheter 120, the user may open the fluid control device 114 to fluidly connect the pressure source 106 to the catheter 120, thereby applying or releasing the vacuum stored in the pressure source 106 to the lumen 121 of the catheter 120.

[0079] 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. In particular, suction is applied at the distal tip region 128 of the catheter 120 to aspirate / draw at least a portion of the clotted material CM into the lumen 121 of the catheter 120, as shown in FIG. Fig. 10BIn one aspect of the present technology, pre-filling or storing vacuum in the pressure source 106 prior to applying vacuum to the lumen 121 of the catheter 120 is expected to produce greater suction and corresponding fluid flow rate at and / or near the tip region 128 of the catheter 120 than simply activating the pressure source while the pressure source 106 is fluidly connected to the catheter 120. In other embodiments, the pressure source 106 can be activated to aspirate the clot material CM when the fluid control device 114 is open.

[0080] Sometimes, such as Fig. 10B As shown, releasing the vacuum stored in the pressure source to draw the lumen 121 of the catheter 120 can remove substantially all (e.g., a desired amount) of the clot material CM from the blood vessel BV. That is, a single pulse of suction can adequately remove the clot material CM from the blood vessel BV. In other embodiments, a portion of the clot material CM may remain in the blood vessel BV. In this case, the user may wish to apply vacuum pressure again (perform a "suction pass") to remove all or a portion of the remaining clot material CM in the blood vessel BV. In this case, the pressure source 106 can be disconnected from the tubing assembly 110 and exhausted (e.g., the aspirated clot removal material is removed) before the pressure source 106 is reconnected to the tubing assembly 110 and activated again. After the desired amount of clot material CM is removed, the catheter 120 can be withdrawn from the patient.

[0081] In some aspects of the present technology, the relatively large flexibility and torquability of the catheter 120 (e.g., as provided by Figures 3A to 3G The coil layers 234, 236 (shown) allow the catheter 120 to be positioned in a hard-to-reach area of ​​the blood vessel BV (or elsewhere in the patient's vasculature) without reducing the size of the lumen 121. It is expected that the increased size of the lumen 121 will provide greater suction in a shorter period of time (e.g., will provide a larger vacuum pulse). In some embodiments, the greater suction can be beneficial in removing clot material from the patient's blood vessel, even in situations where the clot material is firmly embedded or adhered within the vessel (e.g., chronic clots). Thus, the catheter 120 can be used to generate greater suction forces to improve clot removal in hard-to-reach locations of the vasculature, as compared to conventional catheters. In additional aspects of the present technology, the coil layers 234, 236 ( Figures 3A to 3G ) can provide high annular strength along the distal region 126 of the catheter 120, which inhibits or even prevents kinking or other undesirable movement of the catheter 120 when the pressure source 106 is used to generate suction pulses at the distal region 126 of the catheter 120.

[0082] V. Additional Embodiments

[0083] Several aspects of the present technology are illustrated in the following examples:

[0084] 1. A catheter, comprising:

[0085] longitudinal axis;

[0086] a plurality of wires, wherein the wires are wound around the longitudinal axis in a first direction spaced apart from each other to form a first coil layer, and wherein the wires are wound around the longitudinal axis in a second direction opposite to the first direction spaced apart from each other over the first coil layer to form a second coil layer over the first coil layer; and

[0087] An outer sheath is over the plurality of wires.

[0088] 2. The catheter according to embodiment 1 further includes a liner, wherein the wire is wound above the liner.

[0089] 3. The catheter of Example 1 or Example 2, wherein the wires in the first coil layer have a helical arrangement with a first orientation, and wherein the wires in the second coil layer have a helical arrangement with a second orientation opposite to the first orientation.

[0090] 4. The catheter of any one of embodiments 1 to 3, wherein the wires each include a continuous end portion at which the wires switch from the first direction to the second direction and transition from the first coil layer to the second coil layer.

[0091] 5. The catheter of any one of embodiments 1 to 4, wherein the wires each include a self-terminating end portion at which the wires switch from the first direction to the second direction and transition from the first coil layer to the second coil layer.

[0092] 6. The catheter of any one of embodiments 1 to 5, wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are the same.

[0093] 7. The catheter of any one of embodiments 1 to 6, wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are different.

[0094] 8. The catheter of any one of Examples 1 to 7, wherein the wires have a first spacing in the first coil layer and a second spacing in the second coil layer, and wherein the first spacing and / or the second spacing varies along the longitudinal axis.

[0095] 9. A catheter according to any one of embodiments 1 to 8, wherein the wire is further (a) wound around the longitudinal axis in the first direction to form a third coil layer above the second coil layer, and (b) wound around the longitudinal axis in the second direction above the third coil layer to form a fourth coil layer above the third coil layer.

[0096] 10. A catheter according to Example 9, wherein the wires each include (a) a first self-terminating end portion, at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer, and (b) a second self-terminating end portion, at which the wire switches from the second direction to the first direction and transitions from the second coil layer to the third coil layer.

[0097] 11. The catheter of Example 10, wherein the first self-terminating end portion is positioned at a distal end portion of the catheter, and wherein the second self-terminating end portion is positioned at a proximal end portion of the catheter.

[0098] 12. The catheter of Example 10 or Example 11, wherein the first self-terminating end portion is located at a different position along the longitudinal axis relative to the second self-terminating end portion.

[0099] 13. The catheter of any one of Examples 9 to 12, wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis.

[0100] 14. The catheter of any one of Examples 9 to 12, wherein the third coil layer extends completely above the second coil layer along the longitudinal axis.

[0101] 15. A catheter according to any one of embodiments 1 to 8, wherein the wire is a first wire and also includes a plurality of second wires, wherein the second wires (a) are wound around the longitudinal axis in the first direction to form a third coil layer above the second coil layer, and (b) are wound around the longitudinal axis in the second direction above the third coil layer to form a fourth coil layer above the third coil layer.

[0102] 16. A catheter according to Example 15, wherein the first wires each include a first self-terminating end portion, at which the first wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer, and wherein the second wires each include a second self-terminating end portion, at which the second wire switches from the first direction to the second direction and transitions from the third coil layer to the fourth coil layer.

[0103] 17. The catheter of Example 16, wherein the first self-terminating end portion is positioned at the same position along the longitudinal axis relative to the second self-terminating end portion.

[0104] 18. The catheter of Example 17, wherein the first self-terminating end portion and the second self-terminating end portion are positioned at a distal end portion of the catheter.

[0105] 19. The catheter of Example 16, wherein the first self-terminating end portion is positioned at a different position along the longitudinal axis relative to the second self-terminating end portion.

[0106] 20. The catheter of any one of Examples 15 to 19 wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis.

[0107] 21. The catheter of any one of Examples 15 to 19, wherein the third coil layer extends completely above the second coil layer along the longitudinal axis.

[0108] 22. The catheter of any one of embodiments 1 to 21, wherein the wire has a rectangular cross-sectional shape.

[0109] 23. The catheter of any one of embodiments 1 to 22, wherein the plurality of wires comprises 4 wires.

[0110] 24. The catheter of any one of embodiments 1 to 22, wherein the plurality of wires comprises 12 wires.

[0111] 25. The catheter of any one of Examples 1 to 24, further comprising a liner defining a lumen, wherein the wire is wound over the liner, wherein the lumen has a diameter of 20 French or greater.

[0112] 26. The catheter of any one of Examples 1 to 25, further comprising a lumen extending between the inner coil layer and the outer coil layer.

[0113] 27. The catheter of any one of Examples 1 to 26, further comprising a lumen extending between the outer coil layer and the outer sheath.

[0114] 28. The catheter of any one of embodiments 1 to 27, further comprising:

[0115] a liner, wherein the filaments are wound over the liner; and

[0116] A lumen extends between the inner coil layer and the inner liner.

[0117] 29. A method of manufacturing a catheter, the method comprising:

[0118] winding a plurality of wires around a mandrel in a first direction to form an inner coil layer;

[0119] winding the wire around the mandrel in a second direction opposite to the first direction to form an outer coil layer over the inner coil layer;

[0120] positioning an outer sheath over the inner coil layer and the outer coil layer; and

[0121] The outer sheath is coupled to the inner coil layer and the outer coil layer.

[0122] 30. The method of embodiment 29, wherein the method further comprises positioning a liner over the mandrel, and wherein winding the wire in the first direction around the mandrel comprises winding the wire in the first direction over the liner to form the inner coil layer over the liner.

[0123] 31. The method of embodiment 30, wherein coupling the outer jacket to the inner coil layer and the outer coil layer comprises fusing the outer jacket and the inner liner together.

[0124] 32. The method of any one of embodiments 29 to 31, wherein the wires in the first coil layer have a helical arrangement with a first orientation, and wherein the wires in the second coil layer have a helical arrangement with a second orientation opposite to the first orientation.

[0125] 33. The method of any one of embodiments 29 to 32, wherein winding the wire around the mandrel in the first direction to form the inner coil layer includes changing a spacing between the wires in the first direction.

[0126] 34. The method of any one of embodiments 29 to 33, wherein winding the wires in the second direction around the mandrel to form the outer coil layer includes changing a spacing between the wires in the second direction.

[0127] 35. A method according to any one of embodiments 29 to 34, wherein the method also includes positioning a slender member above the inner coil layer, and wherein winding the wire around the core axis in the second direction to form the outer coil layer includes winding the wire above the slender member to fix the slender member between the inner coil layer and the outer coil layer.

[0128] 36. The method of embodiment 35, wherein the elongated member comprises a lumen.

[0129] 37. A method according to any one of embodiments 29 to 36, wherein winding the wire around the core shaft in the second direction includes forming a continuous end portion for each of the wires, at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer.

[0130] 38. The method of any one of embodiments 29 to 37, wherein winding the wires around the mandrel in the second direction comprises forming a self-terminating end portion of each of the wires at which the wires switch from the first direction.

[0131] 39. A catheter comprising:

[0132] longitudinal axis;

[0133] Multiple threads, including -

[0134] The wire is wound in a first direction around the longitudinal axis to form a first coil layer,

[0135] The wire is wound around the longitudinal axis in a second direction opposite to the first direction over the first coil layer to form a second coil layer over the first coil layer, and

[0136] The wires each include a continuous end portion where the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer; and

[0137] An outer sheath is over the plurality of wires.

[0138] 40. A catheter, comprising:

[0139] longitudinal axis;

[0140] Multiple threads, including -

[0141] The wire is wound in a first direction around the longitudinal axis to form a first coil layer,

[0142] The wire is wound around the longitudinal axis in a second direction opposite to the first direction over the first coil layer to form a second coil layer over the first coil layer, and

[0143] The wires each include a self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer; and

[0144] An outer sheath is over the wires.

[0145] VI. Conclusion

[0146] 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.

[0147] 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.

[0148] 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 catheter, comprising: longitudinal axis; a plurality of wires, wherein the wires are wound around the longitudinal axis in a first direction spaced apart from each other to form a first coil layer, and wherein the wires are wound around the longitudinal axis in a second direction opposite to the first direction spaced apart from each other over the first coil layer to form a second coil layer over the first coil layer; as well as An outer sheath is over the plurality of wires. 2 . The catheter of claim 1 , further comprising a liner, wherein the wire is wound over the liner.

3. The catheter of claim 1, wherein the wires in the first coil layer have a helical arrangement with a first orientation, and wherein the wires in the second coil layer have a helical arrangement with a second orientation opposite to the first orientation. 4 . The catheter of claim 1 , wherein the wires each include a continuous end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer.

5. The catheter of claim 1, wherein the wires each include a self-terminating end portion at which the wires switch from the first direction to the second direction and transition from the first coil layer to the second coil layer.

6. The catheter of claim 1, wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are the same.

7. The catheter of claim 1, wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and the second pitch are different.

8. The catheter of claim 1, wherein the wires have a first pitch in the first coil layer and a second pitch in the second coil layer, and wherein the first pitch and / or the second pitch varies along the longitudinal axis.

9. A catheter according to claim 1, wherein the wire is further (a) wound around the longitudinal axis in the first direction to form a third coil layer above the second coil layer, and (b) wound around the longitudinal axis in the second direction above the third coil layer to form a fourth coil layer above the third coil layer.

10. A catheter according to claim 9, wherein the wires each include (a) a first self-terminating end portion, at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer, and (b) a second self-terminating end portion, at which the wire switches from the second direction to the first direction and transitions from the second coil layer to the third coil layer.

11. The catheter of claim 10, wherein the first self-terminating end portion is positioned at a distal end portion of the catheter, and wherein the second self-terminating end portion is positioned at a proximal end portion of the catheter.

12. The catheter of claim 10, wherein the first self-terminating end portion is located at a different position along the longitudinal axis relative to the second self-terminating end portion.

13. The catheter of claim 9, wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis.

14. The catheter of claim 9, wherein the third coil layer extends completely above the second coil layer along the longitudinal axis.

15. The catheter of claim 1, wherein the wire is a first wire and further comprising a plurality of second wires, wherein the second wires (a) are wound around the longitudinal axis in the first direction to form a third coil layer above the second coil layer, and (b) are wound around the longitudinal axis in the second direction above the third coil layer to form a fourth coil layer above the third coil layer.

16. A catheter according to claim 15, wherein the first wires each include a first self-terminating end portion, at which the first wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer, and wherein the second wires each include a second self-terminating end portion, at which the second wire switches from the first direction to the second direction and transitions from the third coil layer to the fourth coil layer.

17. The catheter of claim 16, wherein the first self-terminating end portion is positioned at the same position along the longitudinal axis relative to the second self-terminating end portion.

18. The catheter of claim 16, wherein the first self-terminating end portion and the second self-terminating end portion are positioned at a distal end portion of the catheter.

19. The catheter of claim 16, wherein the first self-terminating end portion is positioned at a different position along the longitudinal axis relative to the second self-terminating end portion.

20. The catheter of Claim 15, wherein the third coil layer extends only partially over the second coil layer along the longitudinal axis.

21. The catheter of Claim 15, wherein the third coil layer extends completely above the second coil layer along the longitudinal axis.

22. The catheter of claim 1, wherein the wire has a rectangular cross-sectional shape.

23. The catheter of claim 1, wherein the plurality of wires comprises 4 wires.

24. The catheter of claim 1, wherein the plurality of wires comprises 12 wires.

25. The catheter of claim 1 further comprising a liner defining a lumen, wherein the wire is coiled over the liner, wherein the lumen has a diameter of 20 French or greater.

26. The catheter of claim 1, further comprising a lumen extending between the inner coil layer and the outer coil layer.

27. The catheter of Claim 1, further comprising a lumen extending between the outer coil layer and the outer sheath.

28. The catheter of claim 1, further comprising: a liner, wherein the filaments are wound over the liner; as well as A lumen extends between the inner coil layer and the inner liner.

29. A method of manufacturing a catheter, the method comprising: winding a plurality of wires around a mandrel in a first direction to form an inner coil layer; winding the wire around the mandrel in a second direction opposite to the first direction to form an outer coil layer over the inner coil layer; positioning an outer sheath over the inner coil layer and the outer coil layer; as well as The outer sheath is coupled to the inner coil layer and the outer coil layer.

30. The method of claim 29, wherein the method further comprises positioning a liner over the mandrel, and wherein winding the wire in the first direction around the mandrel comprises winding the wire in the first direction over the liner to form the inner coil layer over the liner.

31. The method of claim 30, wherein coupling the outer jacket to the inner coil layer and the outer coil layer comprises fusing the outer jacket and the inner liner together.

32. The method of claim 29, wherein the wires in the first coil layer have a helical arrangement with a first orientation, and wherein the wires in the second coil layer have a helical arrangement with a second orientation opposite the first orientation.

33. The method of claim 29, wherein winding the wires in the first direction around the mandrel to form the inner coil layer comprises varying a spacing between the wires in the first direction.

34. The method of claim 29, wherein winding the wires in the second direction around the mandrel to form the outer coil layer comprises varying a spacing between the wires in the second direction.

35. A method according to claim 29, wherein the method further includes positioning a slender member above the inner coil layer, and wherein winding the wire around the core shaft in the second direction to form the outer coil layer includes winding the wire over the slender member to secure the slender member between the inner coil layer and the outer coil layer.

36. The method of claim 35, wherein the elongated member comprises a lumen.

37. A method according to claim 29, wherein winding the wire around the core shaft in the second direction includes forming a continuous end portion of each of the wires, at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer.

38. A method according to claim 29, wherein winding the wire around the core shaft in the second direction includes forming a self-terminating end portion of each of the wires, at which the wire switches from the first direction to the second direction and transitions from the inner coil layer to the outer coil layer.

39. A catheter comprising: longitudinal axis; Multiple threads, including - The wire is wound in a first direction around the longitudinal axis to form a first coil layer, The wire is wound around the longitudinal axis in a second direction opposite to the first direction over the first coil layer to form a second coil layer over the first coil layer, and The wires each include a self-terminating end portion at which the wire switches from the first direction to the second direction and transitions from the first coil layer to the second coil layer; as well as An outer sheath is over the wires.

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