Support Catheter

Abstract

A delivery device 100 can be provided with a low profile and high flexibility for navigating tortuous anatomical structures. The inner lumen 140 defined by the delivery device shaft 110 provides adequate space for the delivery device to target the anatomical structure. Additionally, the delivery device maintains luminal patency even when placed within tortuous anatomical structures. The turns of thread 132 forming the shaft coil 130 adjust their axial spacing relative to one another to avoid buckling that would otherwise narrow the inner lumen.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 886,229, entitled "SUPPORT CATHETER," filed on August 13, 2019, which is incorporated by reference in its entirety herein.

[0002] TECHNICAL FIELD This description relates generally to procedures within body vessels, and more particularly to catheters and methods of delivering devices within body vessels. [Background technology]

[0003] Various delivery devices can be used to deliver other interventional devices to desired treatment locations within a patient's body. Examples of such delivery devices include catheters that navigate within a body vessel and provide a lumen for the interventional device to navigate to reach a target location for treatment. Catheters can be advanced intravascularly within a patient's blood vessels to facilitate treatment at a target location therein. Interventional devices for use with such catheters can include guidewires, stents, implants, balloon devices, crossing devices, and the like.

[0004] The description provided in the Background section should not be deemed to be prior art merely because it is mentioned in or associated with the Background section. The Background section may include information that describes one or more aspects of the present technology. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International patent application PCT / US2010 / 047170 [Patent Document 2] U.S. Patent Publication No. 2017 / 100266 [Brief description of the drawings]

[0006] [Figure 1] FIG. 2 is a side view of a delivery device. [Diagram 2] FIG. 2 is a cross-sectional view of a distal portion of a delivery device. [Diagram 3] FIG. 1 is a cross-sectional view of a shaft of a delivery device. [Figure 4] FIG. 13 is another cross-sectional view of the shaft of the delivery device. [Diagram 5] FIG. 13 is a cross-sectional view of a thread in the shaft of a delivery device. [Figure 6] FIG. 1 is a cross-sectional view of a shaft of a delivery device. [Figure 7] FIG. 1 is a cross-sectional view of a shaft of a delivery device. [Figure 8] FIG. 13 is an exploded perspective view of a distal portion of the delivery device. [Figure 9] FIG. 13 is an exploded perspective view of a distal portion of the delivery device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] In one or more embodiments, not all of the components shown in each figure may be required, and one or more embodiments may include additional components not shown in the figures. The configuration and type of components may be changed without departing from the scope of the present disclosure. Additional, different, or fewer components may be utilized within the scope of the present disclosure.

[0008] The detailed description set forth below is intended as a description of various embodiments and is not intended to represent the only embodiments in which the present technology can be practiced. As will be understood by those skilled in the art, the described embodiments can be modified in a variety of different ways, all without departing from the scope of the present disclosure. Thus, the drawings and description should be regarded as illustrative in nature, and not restrictive.

[0009] The present technology relates generally to systems, methods, and devices for treating conditions within a patient's body, such as vascular conditions within a blood vessel. Specific details of several embodiments of the present technology are described herein with reference to Figures 1-9.

[0010] The devices described herein may be applied to treat a variety of conditions, including, but not limited to, (e.g., chronic total occlusions ("CTOs"), total occlusions, partial occlusions, occlusions resulting from thrombi, occlusions resulting from embolism, occlusions resulting from atherosclerosis, etc.). In addition, other embodiments of the technology may have different configurations, components, or procedures than those described herein. For example, other embodiments may include additional elements and features other than those described herein, or other embodiments may not include some of the elements and features shown and described herein.

[0011] Conventional support catheters are typically constructed with a polymer braided or multi-strand wire shaft with a polymer jacket, a radiopaque polymer tip, and a hub. Thus, as the support catheter is placed over the guidewire, it encounters increased tortuosity and an increased amount of sliding friction in the guidewire lumen. In some cases, complete snagging occurs. To reduce sliding friction between the catheter shaft ID and the guidewire, some devices include a smooth liner on the inner diameter of the other structure.

[0012] The embodiments of the present disclosure provide a delivery device that reduces sliding friction by including a lubricious coating in a configuration that also minimizes the contact surface of the catheter. This can be accomplished by coating the individual wires in a helical wound configuration instead of a traditional liner at the ID. The coated wires wind in a helical fashion and move relative to each other as needed to reduce snagging in tortuous anatomy.

[0013] 1, the system can include a delivery device 100 for delivering another device through its lumen. The delivery device 100 can include a connector 106 at and / or defining a proximal end portion 102 of the delivery device 100 and providing a handle, luer, connector, and / or hub. For example, the connector 106 can include mating and / or receiving features for securely connecting to other components. The connector 106 can include a touhy bourst seal configured to secure the position of one or more devices within the delivery device 100.

[0014] The delivery device 100 may further include a distal tip 190 at and / or defining the distal end portion 104 of the delivery device 100. The distal tip 190 may include a radiopaque distal tip (e.g., polymer, tungsten, barium, etc.). The delivery device 100 may further include a shaft 110 extending between the connector 106 and the distal tip 190. The connector 106 may be configured to be disposed at a location external to the patient, and the shaft 110 may be configured to place the distal tip 190 (e.g., intravascularly) at or near a total or partial occlusion within a blood vessel of the patient. The delivery device 100 may have an internal lumen extending from the connector 106 to the distal tip 190 and / or the side port 150. The delivery device 100 may receive one or more devices (e.g., a guidewire) through the distal tip 190 and into the internal lumen. The delivery device 100 can receive one or more devices, such as interventional devices (not shown), through the connector 106 and into the lumen. The delivery device 100 can include a strain relief element between the shaft 110 and another portion of the connector 106. For example, the strain relief element can surround or engage the shaft 110 at its proximal end.

[0015] Shaft 110 can be sized and shaped to enter a target site (e.g., a treatment site) within a patient's blood vessel. In one embodiment, for example, shaft 110 has a length of about 150 cm to about 180 cm and a suitable cross-sectional dimension for placement within the vasculature of a subject. The length of shaft 110 can be a working length, such as a length that can be placed within the vasculature of a subject. In some embodiments, for example, the working length is from about 70 cm to about 300 cm, from about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm.

[0016] 2-5, the shaft of the delivery device can provide a mechanism for providing great flexibility and reducing sliding friction.

[0017] As shown in FIG. 2 , the shaft 110 can be coupled to a distal tip 190. The distal tip 190 can define a distal end portion 104 of the delivery device 100. The lumen 140 can extend through both the shaft 110 and the distal tip 190. A distal portion of the distal tip 190 can extend beyond the shaft 110. The distal tip 190 can be radiopaque and can include markers to allow for its visualization during the procedure. Additionally or alternatively, other structures can be provided on, adjacent to, or between one or more of the shaft 110 and / or the distal tip 190 to facilitate visualization thereof.

[0018] The delivery device 100 may include a shaft 110 that extends along a substantial length thereof. For example, the shaft 110 may span a majority of the length of the entire delivery device 100. For example, the shaft 110 may span at least 50%, 60%, 70%, 80%, or 90% of the length of the entire delivery device 100. Along such a length, the delivery device 100 may optionally provide no structure other than the shaft 110. The shaft 110 may have a consistent and / or repeating pattern throughout its length. Thus, the shaft 110 may define a substantial portion of the entire delivery device 100, such that the features of the shaft 110 are provided along a substantial length of the entire delivery device 100.

[0019] As shown in FIG. 3, the shaft 110 may include a coil 130 formed by one or more threads 132 that extend helically along the length of the shaft 110. The winding pattern need not include a configuration in which the threads 132 cross (e.g., braid) each other. Thus, each of the threads 132 may be arranged with the same chirality (i.e., right-handed or left-handed) as all the other threads. Thus, the shaft need not include a thickness formed by crossed (e.g., braided) threads 132. The threads 132 may be conformal to each other, such that the threads 132 extend about the same axis 200 and differ only in translation along the axis 200. The threads 132 may have other characteristics in common, such as winding pitch angle, thread diameter, winding diameter, etc. It will be understood that any two threads 132 may have different characteristics, such as winding pitch angle, thread diameter, winding diameter, etc. It will be further understood that some characteristics may differ for different threads 132 while maintaining certain overall characteristics. For example, different threads 132 may have different thread diameters yet provide similar inner winding diameters, such that the resulting lumen defined by threads 132 is constant across multiple threads 132.

[0020] One or more threads 132 may be provided in a repeating pattern. For example, three threads 132A, 132B, and 132C are shown in FIG. 3. It will be understood that any number of threads may be provided in a repeating pattern. For example, shaft 110 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 threads wound around one another in a repeating pattern. When only one thread 132 is included, the single thread 132 defines the size of lumen 140 extending through coil 130.

[0021] As further shown in FIG. 3, the shaft 110 may further include one or more jackets 120 extending over the threads 132 of the coil 130 and / or the windings of the thread or threads 132. The jacket 120 may extend along a radially outer portion of the thread 132 defined relative to an axis 200 about which the thread 132 is helically wound. The jacket 120 may include a material (e.g., a polymer, polyurethane, polyimide, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, Pebax® (polyether block amide), etc.) that wraps around the threads 132 of the coil 130 and a shape that provides flexibility to allow axially adjacent turns of the thread or threads 132 to move toward and / or away from each other. The jacket 120 may be directly coupled to the threads 132 of the coil 130 (e.g., a reflowed thermoplastic or a heat activated shrink wrap).

[0022] For example, as shown in Figure 3, some portions of the covering 120 may be coupled to a radially outer portion of the thread 132. Other portions of the covering 120 may extend radially inward to fill spaces between axially adjacent turns of one or more threads. The covering 120 may extend radially inward only partially, such that the thread 132, and not the covering 120, defines the innermost boundary of the lumen 140. The covering 120 may include a first material and an optional coating thereon (e.g., PTFE, a hydrophilic layer, etc.).

[0023] It will be appreciated that the coating 120 may be secured to the coil 130 by fusion or the like. For example, the coating 120 may be fused to the coil 130 at the contact areas. The respective materials of the coating 120 and the coil 130 (e.g., their outer layers) may facilitate such fusion, for example, using compatible polymers. Additionally or alternatively, the coating 120 may be loosely disposed on the coil 130 to allow the coating and the coil 130 (or portions thereof) to slide, rotate, or otherwise move relative to one another.

[0024] The covering 120 can define an outermost dimension of the shaft 110. The covering 120 can be directly coupled to the threads 132 of the coil 130. The threads 132 can define an innermost dimension of the shaft 110 at the lumen 140. The lumen 140 can thus be defined by the inner edges of the threads 132 of the coil 130, where such threads 132 are axially separated from one another to form discontinuities along the path taken through the lumen 140.

[0025] The shaft 110 may consist only of the threads 132 (including coating) of the coil 130 on the radially inner surface of the shaft 110, and only of the covering 120 (including coating) on ​​the radially outer surface of the shaft 110. The delivery device 100 may consist only of the shaft 110 along a substantial length thereof (e.g., between the proximal end of the shaft 110 and the distal end of the shaft 110 connected to the distal tip 190). Thus, optionally, no other structure may be provided between the proximal end of the shaft 110 and the distal end of the shaft 110 (e.g., at the distal tip 190).

[0026] As shown in FIG. 4, the covering 120 can bend, stretch, and / or flex to allow adjacent turns of one or more threads 132 of the coil 130 to move toward and / or away from one another. Such flexibility allows the shaft 110 to bend while navigating through tortuous anatomy. It will be appreciated that such flexibility is multidirectional, such that the shaft 110 can deflect in any radial direction away from its central axis. For example, the spacing between adjacent turns of the threads 132 can be adjusted to facilitate bending, stretching, and / or bending of the shaft 110. Such flexibility can be enhanced by omitting additional structures that would otherwise limit the flexibility of the overall assembly.

[0027] Each of the yarns 132 of the coil 130 can have a composition and assembly that provides the performance characteristics described herein. As shown in FIG. 5, any given yarn 132 can include a core 134 and an outer layer 136.

[0028] The core 134 can provide structural support to retain a particular (e.g., helical) shape. For example, the core 134 can include a metal such as a shape memory alloy (e.g., Nitinol). The core 134 can be shape-set into a particular (e.g., helical) shape for assembly to a shaft. Although the core 134 is shown as forming a circular (e.g., round) cross-sectional shape, the core 134 can have one or more other cross-sectional shapes (e.g., rectangular, square, polygonal, elliptical, etc.).

[0029] The core 134 may be shape set by one or more of a variety of techniques. For example, the core 134 may be initially formed as a wire and then heat set (e.g., annealed) into a particular (e.g., helical) shape. By way of further illustration, the core 134 may be shape set by annealing along with resistive heating, hot working, cold working, milling, forging, rolling, drawing, extrusion, and / or combinations thereof. It will be appreciated that the core 134 may be held in a desired shape during such processes or may be manipulated into a desired shape. Thus, appropriate tools (e.g., mandrels, casts, molds, rollers, guides, etc.) may be used to obtain the desired shape.

[0030] The outer layer 136 may be provided as a coating over the outer periphery of the core 134. Thus, the outer layer 136 of the thread 132 can define the innermost dimension of the shaft at the lumen. The outer layer 136 can include a material (e.g., PTFE, a hydrophilic layer, etc.) that allows for low friction with devices passing through the lumen of the assembled shaft.

[0031] The outer layer 136 may be provided on the outer surface of the core 134 by one or more of a variety of techniques. For example, the outer layer 136 may be deposited on the core 134. By way of further example, the outer layer 136 may be deposited on the core 134 by dipping, spraying, vapor deposition (e.g., physical vapor deposition and / or chemical vapor deposition), and / or combinations thereof.

[0032] It will be appreciated that the outer layer 136 may include one or more layers. For example, a primer coat (e.g., a carbonaceous material) may be deposited over the core 134 and a top coat (e.g., a hydrophilic polymer) may be deposited over the primer coat.

[0033] The outer layer 136 may be thin enough so that adjacent turns of thread 132 do not contact one another and so that thread 132 defines a sufficiently wide shaft lumen while having a narrow profile.

[0034] One or more threads 132 may be arranged in a helical configuration as described herein and provided with a covering 120 to define shaft 110. Threads 132 may be prepared for assembly by performing the operations described herein in any one order or in various orders, with examples provided below, where it will be understood that in each example, additional or fewer operations may be performed at any stage.

[0035] Assembly of the yarn may include the operations of (in order): (1) shaping each yarn (e.g., core) into its respective helical shape, (2) coating each of the yarns in its entirety with an outer layer, and (3) combining multiple yarns into a multi-yarn helical winding configuration.

[0036] Assembly of the yarns may include (in order): (1) shaping each yarn (e.g., core) into its respective helical shape; (2) combining multiple yarns into a multi-yarn helical winding configuration; and (3) coating each of the yarns in its entirety with an outer layer.

[0037] Assembly of the yarn may include the operations of (in order): (1) coating each of the yarns (e.g., cores) in their entirety with an outer layer; (2) shaping each yarn into its respective helical shape; and (3) combining multiple yarns into a multiple yarn helical winding configuration.

[0038] Assembly of the yarn may include the operations of (in order): (1) coating each of the yarns (e.g., cores) in their entirety with an outer layer; (2) combining multiple yarns into a multiple-yarn helical winding configuration; and (3) shape-setting each yarn into its respective helical shape.

[0039] Assembly of the yarn may include the operations of (in order): (1) combining multiple yarns into a multiple yarn helical winding configuration, (2) shape-setting each yarn into its respective helical shape, and (3) coating the entirety of each of the yarns (e.g., core) with an outer layer.

[0040] Yarn assembly may include the operations of (in order): (1) combining multiple yarns into a multiple yarn helical winding configuration, (2) coating the entirety of each of the yarns (e.g., cores) with an outer layer, and (3) shape-setting each yarn into its respective helical shape.

[0041] As described herein, the coating 120 can define a radially outermost portion of the shaft 110 along its length, and the coil 130 can define a radially innermost portion of the shaft 110 along its length. Thus, the coil 130 (e.g., an outer layer 136 providing a lubricious coating) can define a lumen 140 extending through the shaft 110. There is no need to provide an intervening structure between the coating 120 and the coil 130. Thus, the coating 120 can directly contact and engage the coil 130.

[0042] 6 and 7, the shaft can include additional structures, where applicable, that provide support and desired mechanical properties. For example, the shaft 110 can include one or more additional layers that add structural support. As described herein, the shaft 110 can include only a jacket and coil, but alternatively, additional layers can be added to modify the structural properties and performance of the delivery device.

[0043] 6, the shaft 110 may include a support layer 160 that extends around the covering 120. The support layer 160 may include a braided and / or coiled configuration that provides mechanical support (e.g., column strength, etc.). The support layer 160 may surround and / or be coupled to the covering 120.

[0044] The support layer 160 may include one or more braided wires. The wires, or segments thereof, may cross each other at multiple locations according to a braiding pattern. Additionally or alternatively, the support layer 160 may include a coil formed by one or more wires wound in a helical shape. The chirality (i.e., right-handed or left-handed) of the coils of the support layer 160 may be the same as the coils 130 or may be reversed relative to the coils 130. For example, if the coils 130 have a certain winding direction (e.g., chirality), the coils of the support layer 160 may have the opposite chirality, such that a torque applied in either of the two directions may be in the same direction as one of the coils.

[0045] It will be appreciated that any number of layers may be provided with or as part of support layer 160. Such layers may be the same as one another or different. For example, multiple layers in support layer 160 may each include a coil, where each coil has the same or a different winding direction (e.g., chirality).

[0046] As further shown in FIG. 6, an outer jacket 180 may be provided about the support layer. The outer jacket 180 may define a radially outermost portion of the shaft 110 along its length. The outer jacket 180 may include a material (e.g., a polymer, polyurethane, polyimide, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, Pebax® (polyether block amide), etc.). The outer jacket 180 may include an optional coating thereon (e.g., PTFE, a hydrophilic layer, etc.).

[0047] 7, the shaft 110 can include an intermediate layer 170 that extends around the covering 120. The intermediate layer 170 can include a coil and / or braid configuration that provides mechanical support (e.g., column strength, etc.). The intermediate layer 170 can be disposed radially between the covering 120 and the coil 130.

[0048] The intermediate layer 170 may include a coil formed by one or more wires wound in a helical shape. The chirality (i.e., right-handed or left-handed) of the coils of the intermediate layer 170 may be the same as that of the coils 130 or may be reversed relative to the coils 130. For example, if the coils 130 have a certain winding direction (e.g., chirality), the coils of the intermediate layer 170 may have the opposite chirality, such that a torque applied in either of the two directions may be in the same direction as one of the coils. Additionally or alternatively, the intermediate layer 170 may include one or more braided wires. The wires, or segments thereof, may cross each other at multiple locations according to a braiding pattern.

[0049] It will be appreciated that any number of layers may be provided with or as part of intermediate layer 170. Such layers may be the same as one another or different. For example, multiple layers within intermediate layer 170 may each include a coil, where each coil has the same or a different winding direction (e.g., chirality).

[0050] 8 and 9, the delivery device can include a distal tip defining a distal end portion of the delivery device. The distal tip can form an extension of a lumen extending through the shaft and terminate in an opening of the lumen.

[0051] As shown in FIG. 8, the distal tip 190 may extend over and around at least a portion of the shaft 110 such that a distal portion of the shaft 110 resides within a portion of the distal tip 190. The distal portion of the distal tip 190 may be tapered and / or provide an atraumatic shape. The distal tip 190 may be a flexible material (e.g., a polymer) having a length that allows the distal tip 190 to bend to navigate tortuous anatomy. The distal tip 190 may be coupled to the coil and / or jacket of the shaft 110. For example, the polymer material of the distal tip 190 may be heat treated to melt over and / or with the coil and / or jacket of the shaft 110.

[0052] 9, the shaft 110 may extend over and around at least a portion of the distal tip 190 such that a proximal portion of the distal tip 190 resides within a portion of the shaft 110. The distal tip 190 may be a rigid material (e.g., metal) to apply force to a target (e.g., CTO). The distal tip 190 may have a sufficiently short length that allows the distal tip 190 to navigate through tortuous anatomy despite its rigidity.

[0053] Thus, the embodiments described herein provide a delivery device with a small profile and high flexibility to navigate through tortuous anatomical structures. The inner lumen provides adequate space for the delivery device to target the anatomical structures. In addition, the delivery device maintains patency of its lumen even when placed inside the tortuous anatomical structures. The shaft turns adjust their axial spacing relative to each other to avoid buckling that would otherwise narrow the inner lumen.

[0054] The delivery device 100 described herein can be used to place an interventional device. An example of such an interventional device is the crossing device disclosed in International Patent Application PCT / US2010 / 047170, entitled "SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS," filed August 30, 2010, which is incorporated herein by reference in its entirety. For example, an interventional device can be placed within the delivery device 100 and actuated (e.g., advanced, retracted, rotated, etc.) to provide a mechanism (e.g., blade, edge, cutting tool, etc.) to facilitate penetration or other action against a target anatomical structure (e.g., CTO, vessel wall, etc.).

[0055] The delivery device 100 described herein can be used to deploy a therapeutic or implantable device. An example of such a device is the expandable device disclosed in U.S. Patent Publication No. 2017 / 100266, entitled "Stents having protruding drug-delivery features and associated systems and methods," filed March 27, 2017, and incorporated herein by reference in its entirety. For example, the expandable device can be deployed with the delivery device 100 and can expand when deployed in the target anatomical structure (e.g., a vascular wall, etc.).

[0056] The vessels within which the delivery devices described herein may be sized and shaped for placement include arteries such as coronary arteries, peripheral arteries, carotid arteries, Circle of Willis, anterior cerebral arteries, middle cerebral arteries, posterior cerebral arteries, lenticulostriate arteries, renal arteries, femoral arteries, cerebral veins, saphenous veins, arteriovenous fistulas, or any other vessel that may contain a treatment site. Other vessels are envisioned as well, and the delivery device may be shaped and / or selected according to known destinations and / or travel routes within the patient's body.

[0057] Various examples of aspects of this disclosure are itemized below for convenience and are provided as examples and not as limitations of the technology.

[0058] Section A: A delivery device comprising: a proximal end, a distal tip, and a shaft defining a lumen and extending between the proximal end and the distal tip, the shaft comprising a coil comprising a thread extending helically about an axis to define the lumen, the thread comprising a metallic core and a polymeric outer layer coating the metallic core, and a jacket extending around the coil.

[0059] Section B: A delivery device comprising: a proximal end portion, a distal end portion, and a shaft defining an inner lumen and extending between the proximal end portion and the distal end portion, the shaft comprising a coil comprising a lubricious material, the lubricious material defining a surface of the coil, the lubricious material defining a radially innermost portion extending along the entirety of the shaft, and a covering extending around the coil.

[0060] Section C: A method of assembling a shaft for a delivery device, comprising coating a yarn core with an outer layer, shaping the yarn into a helical shape to form a coil winding about a lumen, and covering the coil with a coating extending longitudinally throughout the coil, the outer layer of the coil forming a radially innermost portion of the delivery device in the lumen.

[0061] One or more of the above clauses may include one or more of the features described below. It is noted that any of the following clauses may be combined with one another in any combination and placed into their own independent clauses, e.g., clauses A, B, or C.

[0062] Node 1: The thread is one of several threads that extend helically around an axis to form a coil.

[0063] Section 2: The coating defines a radially outermost portion of the shaft.

[0064] Section 3: The outer layer of the coil defines the radially innermost portion of the shaft.

[0065] Node 4: The coating extends partially radially inward between adjacent turns of the coil.

[0066] Section 5: The distal tip extends within the distal portion of the shaft.

[0067] Section 6: The distal tip extends around the distal portion of the shaft.

[0068] Node 7: A support layer that extends around the jacket, forming a coil or braid.

[0069] Node 8: Radial intermediate element between the coil and the jacket, forming a coil or braid.

[0070] Node 9: The coil comprises a plurality of threads extending helically around an axis.

[0071] Node 10: The coil further comprises a core, the core supporting a lubricious material that is coated onto the core.

[0072] Node 11: The jacket defines the radially outermost portion of the shaft.

[0073] Section 12: The shaft defines more than 50% of the overall length of the delivery device.

[0074] Section 13: Combining the yarns into a multi-yarn helical winding configuration to form a coil.

[0075] Section 14: Shaping the yarn includes cold working the core into a helical shape while the outer layer is coated onto the core.

[0076] Reference to an element in the singular is not intended to mean just one, unless specifically stated otherwise, but rather means one or more. For example, "a" module may refer to one or more modules. An element followed by "a," "an," "the," or "said" does not, without further constraints, exclude the presence of more of the same element.

[0077] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word exemplary is used to mean serve as an example or illustration. To the extent terms such as including, having, etc. are used, such terms are intended to be inclusive in a manner similar to the manner in which the term comprising is interpreted when used as a transitional term in the claims. Relative terms such as first and second may be used to distinguish one entity or act from another without necessarily requiring or implying an actual, such as a relationship or order, between the entities or acts.

[0078] Phrases such as "an aspect," "the aspect," "another aspect," "some aspects," "one or more aspects," "embodiment," "the embodiment," "another embodiment," "some embodiments," "one or more embodiments," "example," "the embodiment," "another embodiment," "an example," "one or more examples," "configuration," "the configuration," "another configuration," "some configurations," "one or more configurations," "the technology," "disclosure," "the disclosure," and other variations thereof, are used for convenience and do not imply that disclosure associated with such phrases is essential to the technology or that such disclosure applies to all configurations of the technology. Disclosure associated with such phrases may apply to all configurations, or to one or more configurations. Disclosure associated with such phrases may provide one or more examples. Phrases such as "an aspect" or "some aspects" may refer to one or more "aspects," and vice versa, which applies to the other aforementioned phrases as well.

[0079] The phrase "at least one" preceding a list of items, with the term "and" or "or" separating any of the items, modifies the entire list and not each member of the list. The phrase "at least one" does not require the selection of at least one item, but rather allows the phrase to mean including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, and C" or "at least one of A, B, or C" refers, respectively, to only A, only B, or only C, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0080] It is understood that the particular order or hierarchy of steps, operations, or processes disclosed is an example of an example approach. It is understood that the particular order or hierarchy of steps, operations, or processes may be performed in different orders unless otherwise specified. Some of the steps, operations, or processes may be performed simultaneously. Method claims in the appended claims present various steps, operations, or process elements in an example order, and are not meant to be limited to the particular order or hierarchy presented. They may be performed sequentially, serially, in parallel, or in different orders. It is understood that the instructions, operations, and systems described may generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0081] In one aspect, a term such as "coupled" may refer to being directly coupled. In another aspect, a term such as "coupled" may refer to being indirectly coupled.

[0082] Terms such as "top," "bottom," "front," "back," "side," "horizontal," and "vertical" refer to any frame of reference other than the usual gravitational frame of reference, and thus may refer to directions upward, downward, diagonal, or horizontal in a gravitational frame of reference.

[0083] In general, unless the context indicates otherwise, the terms "distal" and "proximal" in this disclosure refer to a location relative to an operator or an operator's control device. For example, "proximal" can refer to a location closer to the operator or an operator's control device, and "distal" can refer to a location farther away from the operator or an operator's control device.

[0084] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some cases, well-known structures and components are shown in block diagrams to avoid obscuring the concepts of the present technology. The present disclosure provides various examples of the present technology, but the present technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art. Also, the principles described herein may be applied to other aspects.

[0085] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or that later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under 35 U.S.C. ...

[0086] The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure and not as a limiting description. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. It will be further appreciated that in the detailed description, the description provides an illustrative example, and that various features have been grouped into various embodiments for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Instead, as the claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0087] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and include all legal equivalents. Nonetheless, none of the claims are intended to, and should not be construed to, cover subject matter that does not comply with the requirements of applicable patent law.

Claims

1. A proximal end portion; a distal tip; and a shaft defining an internal lumen and extending between the proximal end and the distal tip; Equipped with The shaft is a coil comprising a thread extending helically about an axis to define the lumen, the thread comprising a metal core and a polymeric outer layer coating the metal core; a coating extending around the coil; the coating extends partially radially inwardly between adjacent turns of the coil; the coating is disposed over the coil in a manner that allows the coating and the coil to slide relative to one another; Delivery device.

2. The delivery device of claim 1 , wherein the thread is one of a plurality of threads that extend helically around the axis to form the coil.

3. The delivery device of claim 1 , wherein the covering defines a radially outermost portion of the shaft.

4. The delivery device of claim 1 , wherein the outer layer of the coil defines a radially innermost portion of the shaft.

5. The delivery device of claim 1 , wherein the distal tip extends within a distal portion of the shaft.

6. The delivery device of claim 1 , wherein the distal tip extends around a distal portion of the shaft.

7. The delivery device of claim 1 , further comprising a support layer extending around the covering, the support layer forming a coil or braid.

8. The delivery device of claim 1 , further comprising an intermediate element radially between the coil and the covering, the intermediate element forming a coil or a braid.

9. a proximal end portion; A distal end portion; and a shaft defining an internal lumen and extending between the proximal end portion and the distal end portion; Equipped with The shaft is a coil comprising a lubricious material defining a surface of the coil, the lubricious material defining a radially innermost portion extending entirely along the shaft; a coating extending around the coil; the coating extends partially radially inwardly between adjacent turns of the coil; the coating is disposed over the coil in a manner that allows the coating and the coil to slide relative to one another; Delivery device.

10. The delivery device of claim 9 , wherein the coil comprises a plurality of threads extending helically around an axis.

11. The delivery device of claim 9 , wherein the coil further comprises a core, the core supporting the lubricious material coated thereon.

12. The delivery device of claim 9 , wherein the covering defines a radially outermost portion of the shaft.

13. The delivery device of claim 9 , wherein the shaft defines more than 50% of an overall length of the delivery device.

14. The delivery device of claim 9 , further comprising a support layer extending around the covering, the support layer forming a coil or a braid.

15. The delivery device of claim 9 , further comprising an intermediate element radially between the coil and the covering, the intermediate element forming a coil or a braid.

16. 1. A method of assembling a shaft for a delivery device, comprising: coating the yarn core with an outer layer; setting the thread into a helical shape to form a coil winding about a lumen; covering the coil with a coating extending longitudinally over the entire coil; Including, the outer layer of the coil forms a radially innermost portion of the delivery device in the lumen; the coating extends partially radially inwardly between adjacent turns of the coil; the coating is disposed over the coil in a manner that allows the coating and the coil to slide relative to one another; method.

17. The method of claim 16 , wherein the coil comprises a plurality of threads.

18. 20. The method of claim 17, further comprising combining the yarns in a multi-yarn helical winding configuration to form the coil.

19. 17. The method of claim 16, wherein the step of shaping the yarn comprises cold working the core into the helical shape while the outer layer is coated onto the core.

20. A proximal end portion, a distal tip; and a shaft defining an internal lumen and extending between the proximal end and the distal tip; Equipped with The shaft is a coil comprising a thread extending helically about an axis to define the lumen, the thread comprising a metal core and a polymeric outer layer coating the metal core; a first coating engaging the coil along a length of the coil; a support layer engaging the first coating along a length of the first coating, the support layer forming a coil or a braid; a second coating engaging the support layer along a length of the support layer. Delivery device.

21. The first coating, 21. The delivery device of claim 20, wherein the first covering and the coil are wound over the coil to allow the first covering and the coil to move relative to each other.

22. The delivery device of claim 20, wherein the polymeric outer layer has a lubricious coating.

23. The delivery device of claim 20, wherein the polymeric outer layer comprises polytetrafluoroethylene.

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