Stent delivery device

Abstract

A stent delivery device for preventing twisting and / or flattening of a stent when the stent is being delivered or deployed through tortuous anatomy, such as tight bends or curves in the vasculature. The stent delivery device may include a plurality of expandable elements; one or more of which may be positioned within a body of the stent to prevent such twisting and / or flattening. Two or more of the expandable elements may be spatially separated along an elongated element such as a core wire.

Description

STENT DELIVERY DEVICERELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63 / 567,735 filed March 20, 2024 entitled Stent Delivery Device, which is hereby incorporated herein by reference in its entirety.BACKGROUND

[0002] Implants, including expandable elements such as stents, are used for a wide range of medical procedures, including but not limited to treatment of various neurovascular conditions. Stents may in many cases be delivered through tortuous anatomy. Stents have been known to flatten or twist when traversing tight bends or curves. Flattening of a stent may impact the ability of the stent to open or to stay opened. Twisting of a stent may provide similar drawbacks. It would thus be preferable to prevent or reduce such flattening and / or twisting of a stent during delivery or deployment through tortuous anatomy.SUMMARY

[0003] A stent delivery device for preventing or reducing twisting and / or flattening of the stent, such as during deployment or delivery through tortuous anatomy.

[0004] In an example, the stent delivery device may comprise an elongated element and a plurality of mesh portions disposed over the elongated element.

[0005] In an example, the elongated element may comprise a core wire.

[0006] In an example, the plurality of mesh portions may each have a radially compressed configuration and a radially expanded configuration.

[0007] In an example, the plurality of mesh portions may comprise one or more mesh bulbs when in the radially expanded configuration.

[0008] In an example, the plurality of mesh portions may comprise a first mesh portion having a single bulb and a second mesh portion having a second bulb.

[0009] In an example, the first bulb may be spatially separated from the second bulb by at least a portion of a length of the elongated element.

[0010] In an example, the first mesh portion may be spatially separated from the second mesh portion by at least a portion of a length of the elongated element.

[0011] In an example, one or both of the aforementioned mesh portions may comprise multiple, interconnected bulbs.

[0012] In an example, one or more bulbs of the stent delivery device may radially expand against an interior of a stent.

[0013] In an example, one or more bulbs of the stent delivery device may minimize the stent from flattening, thus aiding in keeping the stent open.

[0014] In an example, one or more bulbs of the stent delivery device may provide filler in an interior of a crimp stent to prevent or reduce stent twisting.

[0015] In an example, one or more mesh portions of the stent delivery device may be independently movable with respect to one or more remaining mesh portions of the stent delivery device.

[0016] In an example, one or more mesh portions of the stent delivery device may be composed of a radiopaque material to aid in visualization.

[0017] In an example, one or more mesh portions of the stent delivery device may be composed of drawn filled tubing (DFT) wire.

[0018] In an example, one or more mesh portions of the stent delivery device may be composed of DFT, nitinol, a combination thereof, or various other materials.

[0019] In an example, one or more mesh portions of the stent delivery device may comprise an 8-wire braid, a 10-wire braid, a 12-wire braid, a 16-wire braid, a 20-wire braid, a 24-wire braid, or various other configurations.

[0020] In an example, a proximal end of one or more mesh portions of the stent delivery device may be fixed to the elongated element.

[0021] In an example, a distal end of one or more mesh portions of the stent delivery device may be movable with respect to the elongated element.

[0022] In an example, a first mesh portion of the stent delivery device may comprise a first wire braid and a second mesh portion of the stent delivery device may comprise a second wire braid that is different from the first wire braid.

[0023] In an example, the first wire braid may have a different number of wires than the second wire braid.

[0024] In some aspects, the techniques described herein relate to a stent delivery device, including: an elongated element; a first expandable element disposed on the elongated element; and a second expandable element disposed on the elongated element, the second expandable element being spatially separated from the first expandable element by at least a portion of a length of the elongated element.

[0025] In some aspects, the techniques described herein relate to a stent delivery device, wherein the second expandable element includes a plurality of interconnected bulbs.

[0026] In some aspects, the techniques described herein relate to a stent delivery device, wherein the second expandable element is distal with respect to the first expandable element.

[0027] In some aspects, the techniques described herein relate to a stent delivery device, wherein, in a radially expanded configuration, the first expandable element and / orthe second expandable element radially expand against an interior of a stent to prop open the stent.

[0028] In some aspects, the techniques described herein relate to a stent delivery device, wherein the first expandable element includes a first mesh portion and wherein the second expandable element includes a second mesh portion.

[0029] In some aspects, the techniques described herein relate to a stent delivery device, wherein the first mesh portion or the second mesh portion includes at least one drawn filled tubing (DFT) wire.

[0030] In some aspects, the techniques described herein relate to a stent delivery device, wherein the first mesh portion is expandable to form a single mesh bulb and wherein the second mesh portion is expandable to form a plurality of interconnected mesh bulbs.

[0031] In some aspects, the techniques described herein relate to a stent delivery device, wherein a proximal end of the first expandable element is fixed to the elongated element and wherein a distal end of the first expandable element is movable with respect to the elongated element.

[0032] In some aspects, the techniques described herein relate to a stent delivery device, wherein a proximal end of the second expandable element is fixed to the elongated element and wherein a distal end of the second expandable element is movable with respect to the elongated element.

[0033] In some aspects, the techniques described herein relate to a stent delivery device, wherein the first expandable element includes a first wire braid, wherein the second expandable element includes a second wire braid, and wherein the first wire braid has a different number of wires than the second wire braid.

[0034] In some aspects, the techniques described herein relate to a stent delivery device, wherein the first expandable element and the second expandable element each have a radially compressed configuration and a radially expanded configuration.

[0035] In some aspects, the techniques described herein relate to a method of delivering a stent to a target location, including: advancing a stent through a vasculature towards the target location; advancing a stent delivery device at least partially into an interior of the stent, the stent delivery device including an elongated element and a plurality of expandable elements disposed on the elongated element, wherein the plurality of expandable elements includes at least a first expandable element and a second expandable element, the first expandable element being spatially separated from the second expandable element by at least a portion of a length of the elongated element; and expanding at least one of the plurality of expandable elements; and applying a force against an interior wall of the stent by the at least one of the plurality of expandable elements.

[0036] In some aspects, the techniques described herein relate to a method, further including propelling open the stent by at least one of the plurality of expandable elements.

[0037] In some aspects, the techniques described herein relate to a method, further including applying the force against the interior wall of the stent as the stent traverses a tortuous vasculature to prevent twisting or flattening of the stent within the tortuous vasculature.

[0038] In some aspects, the techniques described herein relate to a method, further including propping open the stent by at least one of the plurality of expandable elements.

[0039] In some aspects, the techniques described herein relate to a method, wherein the first expandable element includes a single mesh bulb.

[0040] In some aspects, the techniques described herein relate to a method, wherein the second expandable element includes a plurality of interconnected mesh bulbs.

[0041] In some aspects, the techniques described herein relate to a method, wherein at least one of the plurality of expandable elements is expanded within the interior of the stent.

[0042] In some aspects, the techniques described herein relate to a method, further including advancing the stent delivery device with a pusher, the pusher being attached to a proximal end of the stent delivery device.

[0043] In some aspects, the techniques described herein relate to a stent delivery system, including: an expandable implant; an elongated element; a first expandable means for applying force against an interior wall of expandable implant, wherein the first expandable means is disposed on a first portion of the elongated element; and a second expandable means for applying force against the interior wall of the expandable implant, wherein the second expandable means is disposed over a second portion of the elongated element; and, wherein the first expandable means is spatially separated from the second expandable means by at least a portion of a length of the elongated element.BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The following figures are included to illustrate certain aspects of the present disclosure and should not be viewed as exclusive examples. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. Reference is being made to the accompanying drawings, in which:

[0045] Fig. 1 illustrates a side view of a stent delivery device in a radially expanded configuration and positioned within a deployed stent in accordance with an example.

[0046] Fig. 2 illustrates a side view of the stent delivery device of Fig. 1 attached to a distal end of a pusher in accordance with an example.

[0047] Fig. 3 illustrates a side view of an example of a stent delivery device in a radially expanded configuration partially within a deployed stent in accordance with an example.

[0048] Fig. 4 illustrates a side view of the stent delivery device of Fig. 3 attached to a distal end of a pusher in accordance with an example.

[0049] Fig. 5 illustrates a side view of a stent delivery device in a compressed configuration within a catheter in accordance with an example.

[0050] Fig. 6 illustrates a side view of a stent delivery device in use in a stent in accordance with an example.

[0051] Fig. 7 illustrates a side view of a stent delivery device in use in a stent in accordance with an example.

[0052] Fig. 8 illustrates a side view of a stent delivery device partially within a catheter in accordance with an example.

[0053] Fig. 9A illustrates a side view of a stent delivery device having a bulb in a first position in accordance with an example.

[0054] Fig. 9B illustrates a side view of a stent delivery device having a bulb in a second position in accordance with an example.

[0055] Fig. 10 illustrates a side view of a stent delivery device in use in accordance with an example.

[0056] Fig. 11 illustrates a side view of a stent delivery device in use in accordance with an example.DETAILED DESCRIPTION

[0057] Specific examples of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many differentforms and should not be construed as limited to the examples set forth herein; rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. The terminology used in the detailed description of the examples illustrated in the accompanying drawings is not intended to be limiting of the disclosure. In the drawings, like numbers refer to like elements.

[0058] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0059] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used and brought together in any combination. In other words, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of this disclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0060] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings are not to scale. Unless otherwise noted, the terms “about” or “approximately” are defined to mean plus- or-minus 10% of a stated value.

[0061] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician / clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician / clinician or handle / hub of a device).

[0062] Numerical ranges discussed in this specification should be interpreted as both inclusive numerical ranges and as covering / disclosing a plurality of numbers within the ranges. Specifically, a range should be considered to recite numbers that increment by two decimal places (hundredths) for the purposes of support in the claims (e.g., 0.01 , 0.02, 0.03, etc.). Any of these incremented numbers from a range should be understood to have significance and importance in the context of the present specification.

[0063] Aspects of examples of a stent delivery system are generally disclosed below and are intended to be described in an inclusive, holistic manner such that any of these aspects are interchangeable or may be used together in any combination or permutation. The figures describe specific example combinations of some of these aspects but should not be interpreted to limit the present disclosure to only those combinations.

[0064] While the term “stent” is used throughout, it should be appreciated that the stent delivery device may be utilized in combination with a wide range of implants and, in particular, expandable implants delivered through, to, or within a tortuous path such as a tortuous vasculature. Thus, the various examples disclosed herein should not be construed as limited to any particular implant, configuration of implant, or type of implant.

[0065] Disclosed herein are various examples of a stent delivery device for preventing or reducing twisting and / or flattening of a stent during deployment or delivery, such as through tortuous anatomy. The various examples of a stent delivery device disclosed herein may also or alternatively be utilized to aid in opening (e.g., by propelling open), propping open, and / or retaining an expanded configuration of a stent or other expandable implant.

[0066] In an example, the stent delivery device may comprise a plurality of mesh portions disposed over an elongated element. Each of the mesh portions may comprise a discrete mesh portion that may be independently expanded, collapsed, and / or otherwise adjusted (e.g., rotated, axially translated, etc.) with respect to the remaining mesh portions along the elongated element.

[0067] Each of the mesh portions may comprise at least one expandable element which may be expanded to form, e.g., a bulb, bulbous region, or the like. As an example, a first mesh portion may be expandable to form a single bulb and a second mesh portion may be expandable to form a pair of interconnected bulbs (e.g., the pair of interconnected bulbs may be formed from the same mesh portion). The first and second mesh portions in such an example may be discrete or, in other words, spatially separated along the elongated element such that at least a portion of the length of the expandable element separates the first mesh portion from the second mesh portion. In this manner, overall control of the shape, configuration, and dispensation of the stent may be more precisely controlled by individually adjusting the mesh portions.

[0068] In some examples, three or more discrete mesh portions may be utilized, and thus examples shown in the figures illustrating only a pair of mesh portions should not be construed as limiting in scope. Further, the number of expandable elements (e.g., bulbs) formed when each mesh portion is expanded may vary and thus should not be construed as limited in scope to one or two expandable elements as shown in the illustrated examples of the figures.

[0069] The stent delivery device may comprise an elongated element, such as a core wire, and a plurality of mesh portions disposed over the elongated element. Each mesh portion may have a radially compressed configuration and a radially expanded configuration. In the radially expanded configuration, each mesh portion may expand to form one or more expandable elements, such as bulbs. It thus should be appreciated that, while the term “bulb” or “bulbs” is utilized herein, the shape, size, and configuration of the bulbs should not be construed as limited in scope by the examples shown in the figures, as various other types of expandable elements may be utilized with the systems, devices, and / or methods which are shown and / or described herein.

[0070] Each mesh portion may expand to form a single bulb or a plurality of bulbs. In mesh portions having a plurality of bulbs, the bulbs may be interconnected to each other, such as by an interconnecting portion of the mesh portion have a smaller diameter thanthe bulbs themselves. Thus, a single mesh portion may be expandable to form a single expandable element or multiple expandable elements which may be interconnected with each other by the mesh portion. In examples having such multiple expandable elements formed from a single mesh portion, the single mesh portion may comprise a first expandable element, a second expandable element, and a reduced diameter portion of the mesh linking the first and second expandable elements.

[0071] Where multiple mesh portions are utilized, the bulb(s) of a first mesh portion may be spatially separated from the bulb(s) of a second mesh portion by at least a portion of a length of the elongated element such that the at least two of a plurality of mesh portions are not interconnected together.

[0072] Where multiple mesh portions are utilized, the number of bulbs of each discrete mesh portion may vary. As an example, a first mesh portion may comprise a single bulb and a second mesh portion may comprise two or more bulbs, with the single bulb being spatially separated from the two or more bulbs by at least a portion of the length of the elongated element. As discussed, the two or more bulbs of the second mesh portion may be interconnected with each other by a reduced diameter segment of the mesh forming the second mesh portion.

[0073] Each mesh portion may comprise a braid. The braid may be comprised of one or more wires. The one or more wires may be composed of various materials, including but not limited to radiopaque materials to aid in visualization. For example, the one or more wires may be composed of drawn filled tubing (DFT), nitinol, a combination thereof, or various other materials (either radiopaque or non-radiopaque materials).

[0074] The number of wires forming each braid may vary. By way of non-limiting example, each mesh portion may be comprise of an 8-wire braid, a 10-wire braid, a 12- wire braid, a 16-wire braid, a 20-wire braid, or a 24-wire braid. When there are multiple mesh portions, each of the mesh portions may comprise the same type of braid, or different mesh portions may comprise different types of braids. For example, a first meshportion may comprise a 12-wire braid and a second mesh portion may comprise a 24- wire braid. Any combination may be utilized.

[0075] The respective sizes of each mesh portion may vary in different examples. Thus, the first mesh portion may be longer and / or wider (e.g., of a greater diameter / width) than the second mesh portion, or vice versa. Alternatively, each of the mesh portions may comprise substantially the same size (e.g., length, width / diameter). Where three or more mesh portions are utilized, two of the mesh portions may comprise substantially the same size and the remaining mesh portion may be longer, shorter, wider, or narrower than the other mesh portions. Alternatively, each of the three or more mesh portions may comprise a different size (e.g., different length and / or width / diameter).

[0076] The respective sizes of each expandable element (e.g., bulb) of each mesh portion may also vary in different examples. In an example, a first mesh portion may be expandable to form a first bulb and a second mesh portion may be expandable to form a second bulb and a third bulb. The first mesh portion may be proximal to the second mesh portion, or vice versa. In such examples, each of the three bulbs may comprise substantially the same size (e.g., length, width / diameter). In other examples, one or more of the bulbs may be a different size (e.g., a different length and / or a different width / diameter) than one or more of the remaining bulbs. Thus, each bulb may comprise substantially the same size, some bulbs may comprise substantially the same size, or each bulb may comprise a different size.

[0077] Multiple such expandable elements may be spatially separated and function independently. One or more of the expandable elements may be adjustable in length, width / diameter, and / or shape. One or more of the expandable elements may be movable (e.g., axially, rotationally) with respect to the elongated element.

[0078] At least a portion of each mesh portion may be affixed (e.g., fixedly attached) to the elongated element. As an example, a proximal end of each mesh portion may be affixed to the elongated element, such as by crimping, adhesives, welding, clamps, or thelike. At least a portion of each mesh portion may be movable with respect to the elongated element. As an example, a distal end of each mesh portion may be movably attached to the elongated element (e.g., disposed around the elongated element). The opposite configuration (e.g., in which the proximal end if floating and the distal end if fixed) may also be utilized.

[0079] Such a configuration in which one end of each mesh portion may be fixed to the elongated element and the other end of each mesh portion may be movable with respect to the elongated element may aid in facilitating the mesh portion expanding or collapsing. Such a configuration may also allow for individual adjustment of each mesh portion so as to target specific areas of the stent to be supported (e.g., propped open), prevented from flattening or twisting, and / or propelled open. For example, if a proximal portion of the stent is found to be flattening, the corresponding proximal mesh portion may be expanded while the remaining mesh portions (e.g., distal mesh portions) may remain in a reduced state.

[0080] The stent delivery device may include one or more support coil(s). The support coil(s) may be positioned proximally with respect to a proximal end of one or more mesh portions of the stent delivery device. As an example, the support coil(s) may be proximally adjacent to the proximal end of a proximal-most mesh portion of the stent delivery device. The support coil(s) may be composed of a radiopaque material, such as but not limited to DFT, nitinol, combinations thereof, or various other materials.

[0081] The support coil(s) may be bonded to the elongated element, such as bonded such that the support coil(s) is disposed and / or fixed around at least a portion of the length of the elongated element. The proximal and distal ends of the support coil(s) may be affixed to the elongated element. The medial portion of the support coil(s) may be free- floating (e.g., not bonded to the elongated element) to allow for flexibility.

[0082] Various portions of the elongated element, such as a distal end and / or proximal end of the elongated element, may comprise a radiopaque marker for visualization. Theradiopaque marker may be composed of radiopaque materials (e.g., DFT, nitinol, combinations thereof, and / or other materials). The radiopaque marker may comprise a band, coil, elongated member, or the like. The mesh portions themselves may be formed partially or completely from a radiopaque material in addition to or in alternative to any radiopaque markers on the elongated element. In some examples, the elongated element itself may be formed at least partially from a radiopaque material.

[0083] The elongated element may be attached (removably or fixedly) to a distal end of a pusher which may be utilized to advance the stent delivery device to a target location. The distal end of the pusher may include a radiopaque marker for visualization. The pusher’s radiopaque marker may be composed of radiopaque materials (e.g., DFT, nitinol, combinations thereof, and / or other materials). The radiopaque marker may comprise a band, coil, elongated member, or the like.

[0084] The systems, devices, and / or methods shown and / or described herein may aid with stent opening. For example, the systems, devices, and / or methods shown and / or described herein may help with stent opening in situations where the stent may become flattened or twisted due to bends in a delivery path through the vasculature (e.g., around tight turns). The expandable elements may be designed to have sufficient radial strength to assist in propping up any flattened or twisted segments of the stent. The expandable elements may provide filler in the middle of the stent to prevent or eliminate such flattening or twisting. Opening the stent, or propping open an already opened stent, may be improved by minimizing or eliminating any such twisting / flattening of the stent during delivery.

[0085] The systems, devices, and / or methods shown and / or described herein may be utilized as a mechanical mechanism to aid in pushing open (e.g., propelling open) the stent. One or more features of the stent delivery system may be visible under fluoroscopy, such as by utilizing drawn filled tubing, Nitinol, or other radiopaque materials and / or markers.

[0086] Specific example examples are described further below. However, it should be understood that any of the features from any of the examples can be mixed and matched with each other in any combination. Hence, the present disclosure should not be restricted to only these examples, but any broader combination thereof.

[0087] It should be appreciated that the sizes and respective ratios of sizes of the stent delivery device 100, including its mesh portion(s) 110A, 110B, bulb(s) 115, 115A, 115B, and elongated element 105, the stent 160, and / or the pusher 150 may vary in different examples and should not be construed as limited in scope by any figures herein.

[0088] Fig. 1 illustrates a side view of a stent delivery device 100 in a radially expanded configuration and positioned within a deployed stent 160 in accordance with an example. Fig. 2 illustrates a side view of the stent delivery device 100 of Fig. 1 attached to a distal end of a pusher 150 in accordance with an example.

[0089] The stent delivery device 100 may include an elongated element 105 which may span all or part of the length of the stent delivery device 100. A proximal end of the elongated element 105 may be attached, removably or fixedly, to the pusher 150. In some examples, a distal end of the elongated element 105 may include a radiopaque marker 105A for visualization. The radiopaque marker 105A may, in some examples, comprise a coil, band, or other attachment composed of a radiopaque material. However, the positioning of the radiopaque marker 105A shown in Figs. 1 -2 should not be construed as limiting in scope, as the radiopaque marker 105A, or additional radiopaque markers, may be positioned at any point along a length of the elongated element 105.

[0090] In some examples, the stent delivery device 100 may be comprised of a plurality of mesh portions (e.g. , expandable elements) 110A, 110B, such as a first mesh portion 110A and a second mesh portion 110B. In some examples, the first mesh portion 110A, when radially expanded, may comprise a single bulb 115. In some examples, the second mesh portion 110B, when radially expanded, may comprise a pair of bulbs 115A, 115B. In some examples, second mesh portion 110B, when radially expanded, maycomprise a single bulb. Although the figures illustrate that the first mesh portion 110A having a single bulb 115 may be proximal, and that the second mesh portion 110B having multiple bulbs 115A, 115B may be distal, it should be appreciated that the reverse configuration, or any other configuration, may be utilized.

[0091] The number, arrangement, positioning, orientation, and / or spacing of the mesh portions 110A, 110B may vary, and thus should not be construed as limited in scope by the examples shown in the figures. While the figures illustrate an example having two mesh portions 110A, 11 OB, it should be appreciated that three or more mesh portions may be utilized in some examples.

[0092] While the figures illustrate an arrangement in which the first mesh portion 110A includes a single bulb 115 and the second mesh portion 11 OB includes a pair of bulbs 115A, 115B, it should be appreciated that other arrangements may be utilized. For example, the first mesh portion 110A may include multiple bulbs and / or the second mesh portion 11 OB may include a single bulb. One or more mesh portions 110A, 11 OB may comprise three or more bulbs in some examples.

[0093] With respect to positioning and spacing of the mesh portions 110A, 110B along the length of the elongated element 105, it should be appreciated that the figures are not meant to be limiting. The mesh portions 110A, 110B could be closer together than shown in the figures or could be further apart than shown in the figures. In an example, the first mesh portion 110A may be positioned such that, when in a compressed configuration, its leading distal end, which may float (e.g. , be axially movable along at least a portion of the elongated element 105), may move distally along the elongated element 105 so as to be near or adjacent to the proximal end of the second mesh portion 110B as discussed in more detail below. In this manner, the first and second mesh portions 110A, 110B may form a continuous, cylindrical mesh when compressed.

[0094] It should also be appreciated that the respective sizes (e.g., lengths, diameters) of the mesh portions 110A, 110B may vary in different examples. Thus, the first meshportion 110A may be longer than the second mesh portion 11 OB, or vice versa. Alternatively, in some examples, the first and second mesh portions 110A, 11 OB may comprise substantially the same length.

[0095] The diameter or width of the respective bulbs 115, 115A, 115B may also vary in different examples. For example, the bulb 115 of the first mesh portion 110A may have a greater or smaller diameter or width than one or more of the bulbs 115A, 115B of the second mesh portion 11 OB. Further, the sizes of the bulbs 115A, 115B of the second mesh portion 11 OB may vary with respect to each other. For example, a first bulb 115A of the second mesh portion 110B may have a greater diameter or width than the second bulb 115B of the second mesh portion 110B, or vice versa.

[0096] In the above regards, it should be appreciated that the example lengths and diameters of the respective mesh portions 110A, 110B and bulbs 115, 115A, 115B in the illustrated examples of the drawings should not be construed as limited in scope by the examples illustrated in the figures.

[0097] Continuing to reference Figs. 1-2, it can be seen that a second mesh portion 110B may be expandable to form at least two interconnected expandable elements (e.g., bulbs) 115A, 115B. In an example, when expanded, the second mesh portion may thus form a first increased diameter region (e.g., a first bulb 115A), a second increased diameter region (e.g., a second bulb 115B), and a reduced diameter region interconnected between (e.g., linking) the first and second increased diameter regions. In this manner, a continuous mesh portion may be expandable to form multiple discrete but interconnected bulbs. Although not illustrated, where three or more bulbs may be utilized, each adjacent pair of bulbs may be interconnected by a discrete reduced diameter region of mesh.

[0098] Fig. 3 illustrates a side view of an example of a stent delivery device 100 in a radially expanded configuration partially within a deployed stent 160 in accordance withan example. Fig. 4 illustrates a side view of the stent delivery device 100 of Fig. 3 attached to a distal end of a pusher 150 in accordance with an example.

[0099] In some examples, the stent delivery device 100 may comprise a support 125 positioned adjacent to a proximal end of the first mesh portion 110A. The proximal end of the first mesh portion 110A may be affixed to the elongated element 105 by a clamp 120A, though other devices or structures may be utilized to affix the proximal end of the first mesh portion 110A to the elongated element 105 (e.g., the proximal end of the first mesh portion 110A may simply be heat set to crimp onto the elongated element 105).

[0100] In some examples, a distal end of the support 125 may be affixed to the elongated element 105 by the clamp 120A. A proximal end of the support 125 may be affixed to the elongated element 105 by a clamp 125A. A medial portion of the support 125, between its proximal and distal ends, may be disposed around the elongated element 105 but not affixed thereto so as to allow the support 125 to flex around curves and the like. The support 125 may in some examples comprise a coil. The support 125 may be radiopaque so as to aid in visualization of the proximal end of the first mesh portion 110A.

[0101] The elongated element 105 may be fixedly or removably attached to a pusher 150 such as shown in Fig. 4. In examples in which the elongated element 105 may be removably attached to the pusher 150, various detachment mechanisms may be utilized to detach the elongated element 105 from the pusher 150, such as but not limited to mechanical, thermal, magnetic, electrolytic, and the like. In some examples, the distal end of the pusher 150 may include a radiopaque marker 150A, such as a coil, band, or the like, to aid in visualization of the position of the pusher 150 during delivery and / or deployment.

[0102] Fig. 3 illustrates a side view of a stent delivery system including a stent 160 and a stent delivery device 100. In use, the stent delivery device 100 may be utilized for at least the purposes of preventing twisting of a stent 160 and / or preventing flattening ofa stent 160, supporting (e.g., by propping open) the stent 160, and / or aiding in expanding the stent 160 (e.g., propelling open the stent 160).

[0103] Fig. 3 illustrates positioning of a stent delivery device 100 so as to prevent flattening of the stent 160 such as when traversing a tight bend, with a bulb 115 being positioned within the body of the stent 160 to prevent the stent 160 from compressing or fully flattening during delivery, such as upon traversing curves in the anatomy. While Fig. 3 illustrates the bulb 115 of the first mesh portion 110A being positioned within the body of the stent 160, it should be appreciated that any of the remaining bulbs 115A, 115B or mesh portions 110B may alternatively or additionally be utilized for this purpose.

[0104] It should be appreciated that the expanded diameter of the mesh portions 110A, 110B and their bulbs 115, 115A, 115B with respect to the diameter of the stent 160 may vary and should not be construed as limited by the example shown in the figures. For example, the expanded diameter of the bulb 115 of the first mesh portion 110A may be greater or less than is shown in Fig. 3.

[0105] Fig. 5 illustrates a side view of a stent delivery device 100 in a compressed or reduced configuration within a catheter 170 in accordance with an example. The catheter 170 may, in some examples, comprise a microcatheter having a lumen in which the stent delivery device 100, in its compressed configuration, may positioned during delivery of the catheter 170 to a target site. It should be appreciated that the shape, size, and orientation of the stent delivery device 100 when compressed within a catheter 170 may vary in different examples, and thus should not be construed as limited by the illustrated example of Fig. 5. For example, the illustrated example of Fig. 5 shows that, when compressed, the mesh portions 110A, 110B may retain bulbs 115, 115A, 115B. In some examples, however, the bulbs 115, 115A, 115B may fully flatten out (compress) when so inserted within a catheter 170.

[0106] Fig. 6 illustrates a side view of a stent delivery device 100 in use expanding a stent 160 in accordance with an example. In particular, Fig. 6 illustrates an example ofusage of the stent delivery device 100 to prevent twisting of the stent 160 during delivery or deployment through a tortuous anatomy, such as tight curves or bends in the vasculature.

[0107] A bulb 115A may be positioned within the proximal tapering portion of the stent 160 so as to prevent its twisting during delivery or deployment. Also illustrated in Fig. 6 is a catheter 170 which may be utilized to guide and introduce the stent delivery device 100 and / or stent 160. The catheter 170 may comprise various types of delivery devices such as but not limited to a microcatheter. While Fig. 6 illustrates the use of the first bulb 115A of the second mesh portion 110B for preventing twisting, it should be appreciated that the bulb 115 of the first mesh portion 110B, or the second bulb 115B of the second mesh portion 110B, may alternatively be used for this purpose.

[0108] Fig. 7 illustrates a side view of another stent delivery device 100 in use expanding a stent 160 in accordance with an example. Fig. 7 illustrates an example in which the elongated element 105 may extend through an entire length of the mesh portion(s) 110A, 110B. As can be seen, the distal end of the elongated element 105 may include a radiopaque marker 105A, such as a radiopaque tip composed of a radiopaque material (e.g., platinum or the like). Also shown is a cinch 130 which may be positioned over a distal portion of the mesh portion 110B so as to cinch together the wire(s) forming the mesh portion 110B.

[0109] Figs. 6 and 7 illustrate positioning of a mesh portion 110A within the proximal tapering portion of the stent 160 to prevent twisting or flattening during delivery or deployment. It should be appreciated, however, that in some examples, one or more mesh portion(s) 110A, 110B may be utilized to aid in opening or propping open a main body (as opposed to a proximal tapering end) of a stent 160. In such examples, the mesh portion(s) 110A, 1 10B may expand to an outer diameter that substantially matches, or is slightly greater than, an inner diameter of the stent 160 when expanded.

[0110] Fig. 8 illustrates a side view of a stent delivery device 100 partially within a catheter 170 in accordance with an example. It should be understood that a stent 160 may also be positioned within the same catheter 170 as the stent delivery device 100 but has been omitted in this view. As illustrated, it should be appreciated that the respective sizes of the mesh portions 110A, 110B and / or bulbs 115, 115A, 115B may vary in different examples. In the illustrated example of Fig. 8, it can be seen that a first mesh portion 110A having a first bulb 115 may be positioned within the catheter 170 at a first size and that a second mesh portion 110B having a pair of bulbs 115A, 115B may be positioned outside of the catheter 170 at a second, larger size.

[0111] Fig. 9A illustrates a side view of a stent delivery device 100 having a bulb in a first position in accordance with an example. Fig. 9B illustrates a side view of a stent delivery device 100 having a bulb in a second position in accordance with an example.

[0112] Figs. 9A-9B illustrate how the positioning, shape, and size of each mesh portion 110A, 110B and / or bulb 115, 115A, 115B may be adjusted. In the illustrated example, the proximal end of each mesh portion 110A, 110B may be fixed to the elongated element such that the respective proximal ends may not move (e.g., axial movement) with respect to the elongated element. The distal end of each mesh portion 110A, 110B may be movable (e.g., slidable) axially and / or rotationally with respect to the elongated element.

[0113] By moving (e.g. , sliding) the distal end of a mesh portion 110A, 110B, such as mesh portion 110A, the shape, size, and position of the mesh portion 110A, 110B may be adjusted.

[0114] Fig. 9A illustrates the mesh portion 110A in a first position in which the mesh portion 110A may be expanded to form a bulb 115. Fig. 9B illustrates that the distal end of the mesh portion 110A has been slid distally towards the mesh portion 110B, with the proximal end of the mesh portion 110A remaining fixed. The movement of only the distal end of the mesh portion 110A may result in the mesh portion 110A becoming elongated and decreasing in width / diameter as shown. By so adjusting the mesh portion 110A, itsoverall length, width / diameter, and shape may be adjusted as needed during use to accommodate different needs when delivering and / or deploying a stent 160. In some examples, one or more portions of the mesh portion 110A may be cinched such that multiple bulbs may be formed as the diameter of the mesh portion 110A is increased.

[0115] While Figs. 9A-9B illustrate adjustment by movement of the distal end and fixation of the proximal end of a mesh portion 110A, it should be appreciated that the reverse configuration may be utilized (e g., the distal end may be fixed and the proximal end may be movable). In some examples, both the proximal and distal ends may be so movable.

[0116] Fig. 10 illustrates a side view of a stent delivery device in use in accordance with an example. It can be seen that one or more of the expandable elements 115, 115A, 115B may apply a force against an interior wall of the stent 160 as the stent 160 traverses across a curve, bend, or turn in the vasculature 200. The application of such force by the expandable elements 115, 115A, 115B may prevent or reduce any flattening of the stent 160 when positioned within the curve, bend, or turn in the vasculature 200 as shown.

[0117] Fig. 11 illustrates a side view of a stent delivery device in use in accordance with an example. It can be seen that one or more of the expandable elements 115, 115A, 115B may apply a force against an interior wall of the stent 160 so as to push (e.g., propel) the stent 160 open within a vasculature 200. The presence of one or more of the expandable elements 115, 115A, 115B may also provide filler within an interior of the stent 160 to prevent the stent from flattening / twisting or otherwise collapsing structurally within the vasculature 200.

[0118] Clauses:

[0119] Examples are set out in the following numbered clauses:

[0120] Clause 1. A stent delivery device, comprising: an elongated element; a first expandable element disposed on the elongated element; and a second expandableelement disposed on the elongated element, the second expandable element being spatially separated from the first expandable element by at least a portion of a length of the elongated element.

[0121] Clause 2. The stent delivery device of clause 1 , wherein the second expandable element comprises a plurality of interconnected bulbs.

[0122] Clause 3. The stent delivery device of clause 2, wherein the second expandable element is distal with respect to the first expandable element.

[0123] Clause 4. The stent delivery device of clause 1 , wherein, in a radially expanded configuration, the first expandable element and / or the second expandable element radially expand against an interior of a stent to prop open the stent.

[0124] Clause 5. The stent delivery device of clause 1 , wherein the first expandable element is comprised of a first mesh portion and wherein the second expandable element is comprised of a second mesh portion.

[0125] Clause 6. The stent delivery device of clause 5, wherein the first mesh portion or the second mesh portion is comprised of at least one drawn filled tubing (DFT) wire.

[0126] Clause 7. The stent delivery device of clause 5, wherein the first mesh portion is expandable to form a single mesh bulb and wherein the second mesh portion is expandable to form a plurality of interconnected mesh bulbs.

[0127] Clause 8. The stent delivery device of clause 1 , wherein a proximal end of the first expandable element is fixed to the elongated element and wherein a distal end of the first expandable element is movable with respect to the elongated element.

[0128] Clause 9. The stent delivery device of clause 8, wherein a proximal end of the second expandable element is fixed to the elongated element and wherein a distal end of the second expandable element is movable with respect to the elongated element.

[0129] Clause 10. The stent delivery device of clause 1 , wherein the first expandable element comprises a first wire braid, wherein the second expandable element comprises a second wire braid, and wherein the first wire braid has a different number of wires than the second wire braid.

[0130] Clause 11. The stent delivery device of clause 1 , wherein the first expandable element and the second expandable element each have a radially compressed configuration and a radially expanded configuration.

[0131] Clause 12. A method of delivering a stent to a target location, comprising: advancing a stent through a vasculature towards the target location; advancing a stent delivery device at least partially into an interior of the stent, the stent delivery device comprising an elongated element and a plurality of expandable elements disposed on the elongated element, wherein the plurality of expandable elements includes at least a first expandable element and a second expandable element, the first expandable element being spatially separated from the second expandable element by at least a portion of a length of the elongated element; and expanding at least one of the plurality of expandable elements; and applying a force against an interior wall of the stent by the at least one of the plurality of expandable elements.

[0132] Clause 13. The method of clause 12, further comprising propelling open the stent by at least one of the plurality of expandable elements.

[0133] Clause 14. The method of clause 12, further comprising applying the force against the interior wall of the stent as the stent traverses a tortuous vasculature to prevent twisting or flattening of the stent within the tortuous vasculature.

[0134] Clause 15. The method of clause 12, further comprising propping open the stent by at least one of the plurality of expandable elements.

[0135] Clause 16. The method of clause 12, wherein the first expandable element comprises a single mesh bulb.

[0136] Clause 17. The method of clause 16, wherein the second expandable element comprises a plurality of interconnected mesh bulbs.

[0137] Clause 18. The method of clause 12, wherein at least one of the plurality of expandable elements is expanded within the interior of the stent.

[0138] Clause 19. The method of clause 12, further comprising advancing the stent delivery device with a pusher, the pusher being attached to a proximal end of the stent delivery device.

[0139] Clause 20. A stent delivery system, comprising: an expandable implant; an elongated element; a first expandable means for applying force against an interior wall of expandable implant, wherein the first expandable means is disposed on a first portion of the elongated element; and a second expandable means for applying force against the interior wall of the expandable implant, wherein the second expandable means is disposed over a second portion of the elongated element; and, wherein the first expandable means is spatially separated from the second expandable means by at least a portion of a length of the elongated element.

[0140] Although the disclosure has been described in terms of particular examples and applications, one of ordinary skill in the art, in light of this teaching, can generate additional examples and modifications without departing from the spirit of or exceeding the scope of the claimed disclosure. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the disclosure and should not be construed to limit the scope thereof.

Claims

AMENDED CLAIMS received by the International Bureau on 22 July 2025 (22.07.2025)1 . A stent delivery device, comprising: an elongated element; a first expandable element disposed on the elongated element, the first expandable element being expandable to form a plurality of interconnected bulbs; and a second expandable element disposed on the elongated element, the second expandable element being expandable to form at least one bulb; and, wherein the second expandable element is spatially separated from the first expandable element by at least a portion of a length of the elongated element.

2. The stent delivery device of claim 1 , wherein the second expandable element is distal with respect to the first expandable element.

3. The stent delivery device of claim 1 , wherein, in a radially expanded configuration, the first expandable element and / or the second expandable element radially expand against an interior of a stent to prop open the stent.

4. The stent delivery device of claim 1 , wherein the first expandable element is comprised of a first mesh portion and wherein the second expandable element is comprised of a second mesh portion.

5. The stent delivery device of claim 4, wherein the first mesh portion or the second mesh portion is comprised of at least one drawn filled tubing (DFT) wire.

6. The stent delivery device of claim 4, wherein the first mesh portion is expandable to form a single mesh bulb and wherein the second mesh portion is expandable to form the plurality of interconnected bulbs.

7. The stent delivery device of claim 1 , wherein a proximal end of the first expandable element is fixed to the elongated element and wherein a distal end of the first expandable element is movable with respect to the elongated element.

8. The stent delivery device of claim 7, wherein a proximal end of the second expandable element is fixed to the elongated element and wherein a distal end of the second expandable element is movable with respect to the elongated element.

9. The stent delivery device of claim 1 , wherein the first expandable element comprises a first wire braid, wherein the second expandable element comprises a second wire braid, and wherein the first wire braid has a different number of wires than the second wire braid.

10. The stent delivery device of claim 1 , wherein the first expandable element and the second expandable element each have a radially compressed configuration and a radially expanded configuration.

11. A method of delivering a stent to a target location, comprising: advancing a stent through a vasculature towards the target location; advancing a stent delivery device at least partially into an interior of the stent, the stent delivery device comprising an elongated element and a plurality of expandable elements disposed on the elongated element, wherein the plurality of expandable elements includes at least a first expandable element and a second expandable element, the first expandable element being expandable to form a plurality of interconnected bulbs and the second expandable element being expandable to form at least one bulb, and wherein the first expandable element is spatially separated from the second expandable element by at least a portion of a length of the elongated element; and expanding at least one of the plurality of expandable elements; and applying a force against an interior wall of the stent by the at least one of the plurality of expandable elements.

12. The method of claim 11 , further comprising propelling open the stent by at least one of the plurality of expandable elements.

13. The method of claim 11 , further comprising applying the force against the interior wall of the stent as the stent traverses a tortuous vasculature to prevent twisting or flattening of the stent within the tortuous vasculature.

14. The method of claim 11 , further comprising propping open the stent by at least one of the plurality of expandable elements.

15. The method of claim 11 , wherein at least one of the plurality of expandable elements is expanded within the interior of the stent.

16. The method of claim 11 , further comprising advancing the stent delivery device with a pusher, the pusher being attached to a proximal end of the stent delivery device.

17. A stent delivery system, comprising: an expandable implant; an elongated element; a first expandable means for applying force against an interior wall of expandable implant, wherein the first expandable means is disposed on a first portion of the elongated element, and wherein the first expandable means is expandable to form at least one bulb; and a second expandable means for applying force against the interior wall of the expandable implant, wherein the second expandable means is disposed over a second portion of the elongated element, and wherein the second expandable means is expandable to form a plurality of interconnected bulbs; and, wherein the first expandable means is spatially separated from the second expandable means by at least a portion of a length of the elongated element.

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