Support catheter

Through the combination of single wire coating and sheath arranged in spiral windings, the problem of sliding friction and restraint of traditional catheters when bending in the blood vessel is solved, achieving low friction and high flexibility of the catheters in the blood vessels, maintaining the unobstructed lumen. .

CN114616013BActive Publication Date: 2024-12-31REFLOW MEDICAL INC
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Patent Information

Application Number
CN202080071894.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-08-13
Filing Date
2020-08-13
Publication Date
2024-12-31
Estimated Expiration
2040-08-13

AI Technical Summary

Technical Problem

The amount of sliding friction increases when the traditional support catheter encounters bending within the blood vessel, resulting in a constraint between the catheter shaft ID and the guidewire. The prior art is difficult to effectively reduce sliding friction and maintain lumen patency.

Method used

A single wire coating arranged in a spiral winding is used to move the wires spirally wound relative to each other, reducing constraints in the tortuous anatomy and providing flexibility to reduce friction through a combination of sheath and coils.

Benefits of technology

It realizes reducing sliding friction in the tortuous anatomy, maintaining lumen patency, and reducing the binding between the catheter and the guidewire, improving the stability and flexibility of the catheter in the blood vessel.

✦ Generated by Eureka AI based on patent content.

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Abstract

A delivery device (100) can have a low outer profile and high flexibility for use in traversing tortuous anatomical structures. An internal lumen (140) defined by a shaft (110) of the delivery device provides sufficient space for the delivery device to reach a target anatomical structure. Furthermore, the delivery device maintains the patency of its lumen even when positioned in a tortuous anatomical structure. The turns of a wire (132) of a coil (130) forming the shaft adjust their axial spacing relative to each other to avoid bends that would otherwise cause the internal lumen to narrow.
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Description

[0001] Cross-application of related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 886,229, filed on August 13, 2019, entitled “SUPPORT CATHETER,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to procedures within body vessels and, more particularly, to catheters and methods for delivering devices within body vessels. Background Art

[0004] A variety of delivery devices can be used to deliver other interventional devices to a desired treatment location in a patient's body. Examples of such delivery devices include catheters that travel within a body vessel and provide a lumen for the travel of the interventional device to reach the target location for treatment. The catheter can travel within a patient's blood vessel to facilitate treatment at a target location therein. The interventional devices used with such catheters can include guidewires, stents, implants, balloon devices, crossing devices, and the like.

[0005] The descriptions provided in the Background section should not be admitted to be prior art merely by virtue of being mentioned in or associated with the Background section.The Background section may include information describing one or more aspects of the subject technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 A side view of the delivery device is shown.

[0007] Figure 2 A cross-sectional view of a distal portion of the delivery device is shown.

[0008] Figure 3 A cross-sectional view of the shaft of the delivery device is shown.

[0009] Figure 4 Another cross-sectional view of the shaft of the conveying device is shown.

[0010] Figure 5 A cross-sectional view of a linear object of the shaft of the delivery device is shown.

[0011] Figure 6 A cross-sectional view of the shaft of the delivery device is shown.

[0012] Figure 7 A cross-sectional view of the shaft of the delivery device is shown.

[0013] Figure 8 A perspective exploded view of the distal portion of the delivery device is shown.

[0014] Fig. 9 A perspective exploded view of the distal portion of the delivery device is shown.

[0015] In one or more embodiments, all components shown in each figure may not be required, and one or more embodiments may include additional components not shown in the figures. The arrangement and type of components may be changed without departing from the scope of the subject disclosure. Additional components, different components, or fewer components may be used within the scope of the subject disclosure. DETAILED DESCRIPTION

[0016] The detailed description set forth below is intended as a description of various embodiments, and is not intended to represent the only embodiment in which the subject technology can be practiced. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways, all without departing from the scope of the present disclosure. Therefore, the drawings and description are considered to be illustrative in nature, rather than restrictive.

[0017] The present technology generally relates to systems, methods and devices for treating conditions within a patient's body (eg, vascular conditions within a blood vessel). Figure 1-9 Specific details of several embodiments of the present technology are described.

[0018] The devices described herein can be used to treat a variety of conditions, including, but not limited to (e.g., chronic total occlusion ("CTO"), total occlusion, partial occlusion, thrombotic occlusion, embolic occlusion, atherosclerotic occlusion, etc.). In addition, other embodiments of the present technology may have different configurations, components, or processes than those described herein. For example, other embodiments may include additional elements and features in addition to those described herein, or other embodiments may not include several of the elements and features shown and described herein.

[0019] Conventional support catheters are typically constructed of a polymer braided shaft or a multi-wire shaft with a polymer sheath, a radiopaque polymer tip, and a hub. When such support catheters are placed over a guidewire and encounter increased curvature, the amount of sliding friction in the guidewire lumen increases. In some cases, complete binding can occur. To mitigate sliding friction between the catheter shaft ID and the guidewire, some devices include lubricating pads on the inner diameter of other structures.

[0020] Embodiments of the present disclosure provide a delivery device with reduced sliding friction by including a lubricious coating in a construction that also minimizes the contact surface of the catheter. This can be achieved by coating a single wire in a helical winding arrangement in the ID instead of a traditional liner. The coated wires are helically wound and moved relative to each other as needed to reduce binding in tortuous anatomy.

[0021] like Figure 1 As shown, the system may include a delivery device 100 for delivering another device through its lumen. The delivery device 100 may include a connector 106 located at and / or defining a proximal end portion 102 of the delivery device 100 and providing a handle, a Luer connector, a connector and / or a hub. For example, the connector 106 may include a mating feature and / or a receiving feature for securely coupling to other components. The connector 106 may include a Touhy Bourst seal configured to secure the position of one or more devices within the delivery device 100.

[0022] The delivery device 100 may further include a distal tip 190 located 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 positioned at a location outside the patient's body, and the shaft 110 may be configured to position the distal tip 190 (e.g., within a blood vessel) at or near a complete or partial occlusion within a blood vessel of the patient. The delivery device 100 may have a lumen and / or side port 150 extending from the connector 106 to the distal tip 190. The delivery device 100 may receive one or more devices (e.g., a guidewire) into the lumen through the distal tip 190. The delivery device 100 may receive one or more devices (e.g., an interventional device, not shown) into the lumen through the connector 106. The delivery device 100 can include a strain relief element between the shaft 110 and another portion at the connector 106. For example, the strain relief element can surround or otherwise engage the shaft 110 at its proximal end.

[0023] The size and shape of shaft 110 can be set to the target site (e.g., treatment site) for intravascular access to the patient. In some embodiments, for example, shaft 110 has a length of about 150 cm to about 180 cm and a suitable cross-sectional size for positioning in the subject's vascular system. The length of shaft 110 can be a working length, such as a length that can be positioned in the subject's vascular system. In some embodiments, for example, the working length is about 70 cm to about 300 cm, 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.

[0024] Reference now Figure 2-5 , the shaft of the conveyor may provide features that impart firm flexibility and reduce sliding friction.

[0025] like Figure 2 As shown, 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 the shaft 110 and the distal tip 190. The distal portion of the distal tip 190 can extend beyond the shaft 110. The distal tip 190 can be radiopaque or include markings to provide visualization thereof during the procedure. Additionally or alternatively, other structures can be disposed at one or more of the shaft 110 and / or the distal tip 190, adjacent to one or more of the shaft 110 and / or the distal tip 190, or between the shaft 110 and the distal tip 190 to facilitate visualization thereof.

[0026] The delivery device 100 may include an axis 110 extending along a significant length thereof. For example, the axis 110 may span a majority of the length of the entire delivery device 100. For example, the axis 110 may span at least 50%, 60%, 70%, 80%, or 90% of the length of the entire delivery device 100. Along this length, the delivery device 100 may optionally provide no structure other than the axis 110. The axis 110 may have a consistent and / or repeating pattern throughout its length. Thus, the axis 110 may define a significant portion of the entire delivery device 100, such that the features of the axis 110 are provided throughout the significant length of the entire delivery device 100.

[0027] like Figure 3 As shown, the shaft 110 may include a coil 130 formed by one or more threads 132 extending spirally along the length of the shaft 110. The winding pattern does not need to include an arrangement in which the threads 132 cross each other (e.g., braided). Therefore, each thread 132 can be arranged with the same chirality (i.e., right-handed or left-handed) as each other thread. Therefore, the shaft does not need to include a thickness formed by crossing (e.g., braiding) the threads 132. The threads 132 may be consistent with each other so that they extend around the same axis 200 and have different translations along the axis 200. The threads 132 may have other common properties, such as winding pitch angles, thread diameters, winding diameters, etc. It should be understood that any two threads 132 may have different properties, such as winding pitch angles, thread diameters, winding diameters, etc. It will be further understood that certain properties between different threads 132 may be different while maintaining consistent aggregation characteristics. For example, different wires 132 may have different wire diameters but provide similar inner winding diameters such that the resulting lumen defined by the wires 132 is consistent across the plurality of wires 132 .

[0028] One or more threads 132 may be provided in a repeating pattern. Figure 3 , three threads 132A, 132B, and 132C are shown. It should 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 threads wound together in a repeating pattern. In the case of only one thread 132, the only thread 132 defines the size of the lumen 140 extending through coil 130.

[0029] like Figure 3 As further shown, the shaft 110 may also include one or more sheaths 120 extending over the plurality of wires 132 of the coil 130 and / or over the plurality of windings of the one or more wires 132. The sheath 120 may extend along a radially outer portion of the wires 132 defined relative to the axis 200, and the wires 132 are helically wound around the axis 200. The sheath 120 may include a material (e.g., a polymer, polyurethane, polyimide, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, (polyether block amide), etc.) and a shape that provides coverage of the wire 132 of the coil 130 and flexibility that allows axially adjacent turns of one or more of the wires 132 to move toward and / or away from each other. The sheath 120 can be directly coupled to the wire 132 of the coil 130 (e.g., a reflowed thermoplastic or heat activated shrink wrap).

[0030] For example, Figure 3 As shown, a portion of the sheath 120 can be coupled to a radially outer portion of the thread 132. Other portions of the sheath 120 can extend radially inward to fill the space between axially adjacent turns of one or more threads. The sheath 120 can only partially extend radially inward so that the thread 132 (rather than the sheath 120) defines the innermost boundary of the lumen 140. The sheath 120 can include a first material and an optional coating thereon (e.g., PTFE, a hydrophilic layer, etc.).

[0031] It should be understood that the sheath 120 can be fixed to the coil 130 by fusion or the like. For example, the sheath 120 can be fused to the coil 130 at the contact area. The material of each of the sheath 120 and the coil 130 (e.g., the outer layer thereof) can facilitate such fusion, for example, by compatible polymers. Additionally or alternatively, the sheath 120 can be loosely positioned on the coil 130 to allow the sheath and the coil 130 (or portions thereof) to slide, rotate, or otherwise move relative to each other.

[0032] The sheath 120 can define the outermost dimension of the shaft 110. The sheath 120 can be directly coupled to the wires 132 of the coil 130. The wires 132 can define the innermost dimension of the shaft 110 at the lumen 140. Thus, the lumen 140 can be defined by the inner edges of the wires 132 of the coil 130, wherein such wires 132 are axially spaced apart from each other to form discontinuities along a path across the lumen 140.

[0033] The shaft 110 may include only the wire 132 (including the coating) of the coil 130 on the radially inner side of the shaft 110 and the sheath 120 (including the coating) on ​​the radially outer side of the shaft 110. The delivery device 100 may include only 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).

[0034] like Figure 4 As shown, sheath 120 can be bent, stretched and / or flexed to allow adjacent turns of one or more thread-like objects 132 of coil 130 to move toward and / or away from each other. Such flexibility allows shaft 110 to bend when traveling through tortuous anatomical structures. It should be understood that this flexibility is multi-directional so that shaft 110 can deflect in any radial direction away from its central axis. For example, the spacing between adjacent turns of thread-like object 132 can be adjusted to be convenient to the bending, stretching and / or flexing of shaft 110. This flexibility can be enhanced by omitting additional structures, otherwise the additional structures can limit the flexibility of the entire assembly.

[0035] Each thread 132 of the coil 130 may have a composition and assembly that provides the performance characteristics described herein. Figure 5 As shown, any given thread 132 may include a core 134 and an outer layer 136 .

[0036] The core 134 can provide structural support to maintain a specific (e.g., spiral) shape. For example, the core 134 can include a metal, such as a shape memory alloy (e.g., Nitinol). The core 134 can be formed into a specific (e.g., spiral) shape for assembly into a shaft. Although the core 134 is shown as providing a circular (e.g., annular) cross-sectional shape, the core 134 can have one or more other cross-sectional shapes (e.g., rectangular, square, polygonal, elliptical, etc.).

[0037] The core 134 can be formed by one or more of a variety of techniques. For example, the core 134 can be initially formed into a wire, and then heat-set (e.g., annealed) into a specific (e.g., spiral) shape. As a further example, the core 134 can be formed by annealing using resistance heating, hot working, cold working, milling, hammering, rolling, stretching, extrusion, and / or a combination thereof. It should be understood that in this process, the core 134 can be maintained or manipulated into a desired shape. Therefore, the desired shape can be obtained using appropriate tools (e.g., mandrels, castings, molds, rollers, guide rails, etc.).

[0038] The outer layer 136 can be provided as a coating covering 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 provides low friction to the device passing through the lumen of the assembled shaft.

[0039] The outer layer 136 can be disposed on the outer surface of the core 134 by one or more of a variety of techniques. For example, the outer layer 136 can be deposited on the core 134. As a further example, the outer layer 136 can 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.

[0040] It should be understood that the outer layer 136 can include one or more layers. For example, a primer layer (eg, a carbonaceous material) can be deposited on the core 134, and a top coating layer (eg, a hydrophilic polymer) can be deposited on the primer layer.

[0041] The outer layer 136 may be thin enough so that adjacent turns of the wire 132 do not contact each other and the wire 132 defines a sufficiently wide lumen of the shaft while providing a small outer profile.

[0042] One or more threads 132 may be arranged in a spiral arrangement as described herein and provided with a sheath 120 to define an axis 110. The threads 132 may be prepared for assembly by performing the operations described herein in any one or more sequences, as exemplified below. It should be understood that in each example, additional or fewer operations may be performed at any stage.

[0043] Assembly of the wires may include the following operations (in order): (1) forming each wire (e.g., core) into its corresponding spiral shape, (2) coating the entirety of each wire with an outer layer, and (3) combining multiple wires into a multi-wire spiral winding arrangement.

[0044] Assembly of the wires may include the following operations (in order): (1) forming each wire (e.g., core) into its corresponding spiral shape, (2) combining multiple wires into a multi-wire spiral winding arrangement, and (3) coating the entirety of each wire with an outer layer.

[0045] Assembly of the wires may include the following operations (in order): (1) coating the entirety of each wire (e.g., core) with an outer layer, (2) forming each wire into its corresponding spiral shape, and (3) combining multiple wires into a multi-wire spiral winding arrangement.

[0046] Assembly of the wires may include the following operations (in order): (1) coating the entirety of each wire (e.g., core) with an outer layer, (2) combining multiple wires into a multi-wire spiral winding arrangement, and (3) forming each wire into its corresponding spiral shape.

[0047] Assembly of the wires may include the following operations (in order): (1) combining multiple wires into a multi-wire spiral winding arrangement, (2) forming each wire into its corresponding spiral shape, and (3) coating the entirety of each wire (e.g., core) with an outer layer.

[0048] Assembly of the wires may include the following operations (in order): (1) combining multiple wires into a multi-wire spiral winding arrangement, (2) coating the entirety of each wire (e.g., core) with an outer layer, and (3) forming each wire into its corresponding spiral shape.

[0049] As described herein, the sheath 120 can define a radially outermost periphery of the shaft 110 along the length of the shaft, and the coil 130 can define a radially innermost periphery of the shaft along the length of the shaft 110. Thus, the coil 130 (e.g., the outer layer 136 providing a lubricious coating) can define a lumen 140 extending through the shaft 110. No intervening structure need be disposed between the sheath 120 and the coil 130. Thus, the sheath 120 can directly contact and engage the coil 130.

[0050] Reference now Figure 6 and Figure 7 , the shaft may include additional structures to provide support and desired mechanical properties (where applicable). For example, the shaft 110 may include one or more additional layers to increase structural support. Although as described herein, the shaft 110 may include only a sheath and a coil, alternatively, additional layers may be added to change the structural features and performance of the delivery device.

[0051] For example, Figure 6As shown, shaft 110 may include a support layer 160 extending around sheath 120. Support layer 160 may include an arrangement of braids and / or coils that provide mechanical support (eg, column strength, etc.). Support layer 160 may surround sheath 120 and / or be coupled thereto.

[0052] Support layer 160 may include one or more braided wires. Wires or sections thereof may cross each other at multiple locations according to a braiding pattern. Additionally or alternatively, support layer 160 may include a coil formed by one or more spirally wound wires. The chirality (i.e., right-handed or left-handed) of the coil in support layer 160 may be the same or opposite to coil 130. For example, where coil 130 has a winding direction (e.g., chirality), the coil in support layer 160 may have an opposite chirality, so that a torque applied in either direction may be in the same direction as one of the coils.

[0053] It should be understood that any number of layers may be provided with or as part of the support layer 160. The layers may be the same or different from each other. For example, multiple layers within the support layer 160 may each include a coil, wherein the coils have the same or different winding directions (e.g., chirality).

[0054] like Figure 6 As further shown, an outer sheath 180 can be disposed around the support layer. The outer sheath 180 can define a radially outermost periphery of the shaft along the length of the shaft 110. The outer sheath 180 can include a material (e.g., a polymer, polyurethane, polyimide, high density polyethylene (HDPE), polytetrafluoroethylene, silicone, (polyether block amide), etc.) The outer sheath 180 may include an optional coating thereon (eg, PTFE, a hydrophilic layer, etc.).

[0055] like Figure 7 As shown, the shaft 110 may include an intermediate layer 170 extending around the sheath 120. The intermediate layer 170 may include an arrangement of coils and / or braids that provide mechanical support (eg, column strength, etc.). The intermediate layer 170 may be positioned radially between the sheath 120 and the coil 130.

[0056] The middle layer 170 may include a coil formed by one or more spirally wound wires. The chirality (i.e., right-handed or left-handed) of the coil in the middle layer 170 may be the same or opposite to the chirality of the coil 130. For example, where the coil 130 has a winding direction (e.g., chirality), the coil in the middle layer 170 may have an opposite chirality so that a torque applied in either direction may be in the same direction as one of the coils. Additionally or alternatively, the middle layer 170 may include one or more braided wires. The wires or sections thereof may cross each other at multiple locations according to a braiding pattern.

[0057] It should be understood that any number of layers may be provided with or as part of the intermediate layer 170. The layers may be the same or different from each other. For example, multiple layers within the intermediate layer 170 may each include a coil, wherein the coils have the same or different winding directions (e.g., chirality).

[0058] Reference now Figure 8 and Fig. 9 The delivery device may include a distal tip defining a distal end portion of the delivery device. The distal tip may provide a continuation of a lumen extending through the shaft and terminate at an opening of the lumen.

[0059] like Figure 8 As shown, the distal tip 190 can extend on and around at least a portion of the shaft 110 so that the distal portion of the shaft 110 is located within the portion of the distal tip 190. The distal portion of the distal tip 190 can be tapered and / or provide an atraumatic shape. The distal tip 190 can be a flexible material (e.g., a polymer) having a length that allows it to bend to pass through a tortuous anatomical structure. The distal tip 190 can be coupled to the coil and / or sheath of the shaft 110. For example, the polymer material of the distal tip 190 can be heat treated to melt onto and / or melt with the coil and / or sheath of the shaft 110.

[0060] like Fig. 9 As shown, the shaft 110 can extend over and around at least a portion of the distal tip 190, such that a proximal portion of the distal tip 190 is located within a portion of the shaft 110. The distal tip 190 can be a rigid material (e.g., metal) for applying force to a target (e.g., a CTO). The distal tip 190 can have a sufficiently short length to allow it to pass through tortuous anatomical structures despite its rigidity.

[0061] Thus, the embodiments described herein provide a delivery device having a low outer profile and high flexibility for traversing tortuous anatomical structures. Its internal lumen provides sufficient space for the delivery device to the target anatomical structure. In addition, the delivery device maintains the patency of its lumen even when placed in a tortuous anatomical structure. The turns of the thread of the shaft adjust their axial spacing relative to each other to avoid buckling, which would otherwise cause narrowing of the internal lumen.

[0062] The delivery device 100 described herein can be used to position an interventional device. An example of such an interventional device is a crossing device disclosed in International Patent Application No. PCT / US2010 / 047170, entitled "SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS," filed on August 30, 2010, which is incorporated herein by reference in its entirety. For example, an interventional device can be positioned with the delivery device 100 and actuated (e.g., advanced, retracted, rotated, etc.) and provide features (e.g., blades, edges, cutting tools, etc.) to facilitate penetration or other actions relative to a target anatomical structure (e.g., a CTO, a vessel wall, etc.).

[0063] The delivery device 100 described herein can be used to position a therapeutic or implantable device. An example of such a device is an expandable device disclosed in U.S. Patent Publication No. 2017 / 100266, filed on March 27, 2017, entitled "Stents having protruding drug-delivery features and associated systems and methods," the entire contents of which are incorporated herein by reference. For example, the expandable device can be positioned with the delivery device 100 and can expand when positioned in a target anatomical structure (e.g., a blood vessel wall, etc.).

[0064] The delivery devices described herein are sized and shaped to be placed in vessels including arteries (e.g., coronary arteries, peripheral arteries, carotid arteries, Willis circle, anterior cerebral arteries, middle cerebral arteries, posterior cerebral arteries, any lenticulostriate arteries, renal arteries, femoral arteries), veins (e.g., cerebral veins, saphenous veins, arteriovenous fistulas), or any other vessels that may contain a treatment site. Other vessels are also contemplated, and delivery devices may be formed and / or selected based on known destinations and / or paths of travel within the patient's body.

[0065] For convenience, various examples of various aspects of the present disclosure are described as clauses below. These are provided only as examples and do not limit the subject technology.

[0066] Item 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 around an axis to define the lumen, the thread comprising a metal core and a polymer outer layer coating the metal core; and a sheath extending around the coil.

[0067] Item B: A delivery device comprising: a proximal end portion; a distal end portion; and a shaft defining a lumen and extending between the proximal end portion and the distal end portion, the shaft comprising: a coil comprising a lubricating material defining a surface of the coil, the lubricating material defining a radially innermost portion extending along the entirety of the shaft; and a sheath extending around the coil.

[0068] Item C: A method of assembling the shaft of a delivery device, the method comprising: coating the core of a thread with an outer layer; forming the thread into a helical shape to form a coil wrapped around a lumen; and covering the coil with a sheath extending longitudinally over the coil, wherein the outer layer of the coil forms the radially innermost portion of the delivery device at the lumen.

[0069] One or more of the above clauses may include one or more of the following features. It should be noted that any of the following clauses may be combined with each other in any combination and placed into their own independent clauses, such as clause A, B or C.

[0070] Clause 1: The thread is one of a plurality of threads extending helically about an axis to form a coil.

[0071] Clause 2: The sheath defines the radially outermost portion of the shaft.

[0072] Clause 3: The outer layer of the coil defines the radially innermost portion of the shaft.

[0073] Clause 4: The sheath extends partially radially inwardly between adjacent windings of the coil.

[0074] Item 5: The distal tip extends within the distal portion of the shaft.

[0075] Item 6: The distal tip extends around the distal portion of the shaft.

[0076] Item 7: A support layer extending around the sheath, the support layer forming a coil or braid.

[0077] Clause 8: An intermediate element radially between the coil and the sheath, said intermediate element forming a coil or a braid.

[0078] Clause 9: The coil comprises a plurality of wires extending helically about an axis.

[0079] Clause 10: The coil further comprises a core supporting a lubricating material coated on the core.

[0080] Clause 11: The sheath defines a radially outermost portion of the shaft.

[0081] Clause 12: The shaft defines more than 50% of the total length of the conveying device.

[0082] Item 13: Combining wires into a multi-wire helical winding arrangement to form a coil.

[0083] Item 14: Shaping the wire comprises cold working a core into a helical shape while an outer layer is applied to the core.

[0084] Unless otherwise specified, an element in the singular form does not refer to one or only one, but to one or more. For example, "a" module may refer to one or more modules. Without further limitation, an element beginning with "a", "a", "the" or "said" does not exclude the presence of additional identical elements.

[0085] The use of headings and subheadings, if any, is for convenience only and does not limit the invention. The word "exemplary" is used to mean serving as an example or illustration. To the extent that the terms "including," "having," and the like are used as transitional terms in the claims, such terms are intended to be inclusive in a manner similar to the term "comprising" being interpreted. Relational terms such as first and second, etc. may be used to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.

[0086] For example, an aspect, this aspect, another aspect, some aspects, one or more aspects, an embodiment, this embodiment, another embodiment, some embodiments, one or more embodiments, an example, this example, another example, some examples, one or more examples, a construction, this construction, another construction, some constructions, one or more constructions, subject technology, this disclosure, the present disclosure, other variations and similar variations are all for convenience and do not mean that the disclosure associated with the phrase is necessary for subject technology, or that the disclosure is applicable to all constructions of subject technology. The disclosure associated with such phrases can be applicable to all constructions, or one or more constructions. The disclosure associated with such phrases can provide one or more examples. For example, a phrase of an aspect or some aspects can refer to one or more aspects, and vice versa, and this is similarly applicable to other aforementioned phrases.

[0087] The phrase "at least one" preceding a series of items, with the terms "and" or "or" separating any of the items, modifies the list as a whole, rather than each member of the list. The phrase "at least one" does not require selection of at least one of the items; rather, the phrase permits a meaning that includes at least one of any one item, 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, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers to A only, B only, or C only; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0088] It should be understood that the specific order or hierarchy of the disclosed steps, operations or processes is an illustration of an exemplary method. Unless otherwise expressly stated, it should be understood that the specific order or hierarchy of steps, operations or processes can be performed in different orders. Some steps, operations or processes can be performed simultaneously. The attached method claims (if any) present the elements of various steps, operations or processes in an exemplary order and are not meant to be limited to the specific order or hierarchy presented. These can be performed in serial, linear, parallel or different orders. It should be understood that the instructions, operations and systems described can generally be integrated in a single software / hardware product, or packaged in multiple software / hardware products.

[0089] In one aspect, the term coupled, etc. may refer to a direct coupling. In another aspect, the term coupled, etc. may refer to an indirect coupling.

[0090] Terms such as top, bottom, front, back, side, horizontal, and vertical refer to an arbitrary frame of reference other than the ordinary gravitational frame of reference. Thus, such terms can extend upward, downward, diagonally, or horizontally in a gravitational frame of reference.

[0091] Generally, unless the context indicates otherwise, the terms "distal" and "proximal" in this disclosure refer to a position relative to an operator or an operator's controls. For example, "proximal" may refer to a position closer to an operator or an operator's controls, and "distal" may refer to a position farther from an operator or an operator's controls.

[0092] 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 diagram form to avoid blurring the concept of the subject technology. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the principles described herein may be applied to other aspects.

[0093] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in a claim. No claim element is to be construed under the provisions of 35 U.S.C. §112, paragraph 6, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “for the step of.”

[0094] The title, background, brief description of the drawings, abstract, and drawings are incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as limiting descriptions. This application is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and that various features are combined together in various implementations in order to simplify the disclosure. The disclosed method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than those expressly stated in each claim. On the contrary, as reflected in the claims, the inventive subject matter lies in less than all the features of a single disclosed construction or operation. The claims are thereby incorporated into the detailed description, and each claim stands alone as a separately claimed subject matter.

[0095] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are intended to include subject matter that does not satisfy applicable patent law requirements and should not be interpreted in such a manner.

Claims

1. A conveying device, comprising: proximal end; distal tip; as well as 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 metal core and a polymer outer layer coating the metal core, the polymer outer layer comprising a lubricious coating; and A sheath extends around the coil, wherein the sheath extends partially radially inwardly between adjacent windings of the coil, the sheath being positioned over the coil to allow the sheath and coil to slide relative to each other.

2. The conveying device according to claim 1, wherein: The wire is one of a plurality of wires that extend helically around the axis to form the coil.

3. The conveying device according to claim 1, wherein: The jacket defines a radially outermost portion of the shaft.

4. The conveying device according to claim 1, wherein: The outer layer of the coils defines a radially innermost portion of the shaft.

5. The conveying device according to claim 1, wherein: The distal tip extends within a distal portion of the shaft.

6. The conveying device according to 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 sheath, 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 sheath, the intermediate element forming a coil or a braid.

9. A conveying device comprising: Proximal end ; distal end portion; as well as a shaft defining a lumen and extending between the proximal and distal end portions, the shaft comprising: a coil including a lubricating material defining a surface of the coil, the lubricating material defining a radially innermost portion extending along the entirety of the shaft, wherein the coil further includes a core supporting the lubricating material coated on the core; and A sheath extends around the coil, wherein the sheath extends partially radially inwardly between adjacent windings of the coil, the sheath being positioned over the coil to allow the sheath and coil to slide relative to each other.

10. The conveying device according to claim 9, wherein: The coil includes a plurality of wires extending helically around an axis.

11. The conveying device according to claim 9, wherein: The jacket defines a radially outermost portion of the shaft.

12. The delivery device according to claim 9, wherein: The shaft defines more than 50% of the overall length of the delivery device.

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

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

15. A method of assembling a shaft of a conveying device, the method comprising: Coating a core of a thread with an outer layer, the outer layer comprising a lubricious coating, the core supporting the lubricious coating coated on the core; shaping the wire into a helical shape to form a coil wound around the lumen; and covering the coil with a sheath extending longitudinally over the coil, wherein an outer layer of the coil forms a radially innermost portion of the delivery device at the lumen, and wherein the sheath extends partially radially inwardly between adjacent windings of the coil, the sheath being positioned over the coil to allow the sheath and the coil to slide relative to each other.

16. The method according to claim 15, wherein: The coil includes a plurality of wire-shaped objects.

17. The method of claim 16, further comprising combining the wires into a multi-filar helical winding arrangement to form the coil.

18. The method according to claim 15, wherein: Shaping the wire includes cold working the core into a helical shape while the outer layer is applied to the core.