STENT HAVING ENHANCED DEPLOYMENT CHARACTERISTICS - Patent application

Abstract

A stent having enhanced deployment characteristics to prevent kinking of the stent during delivery or deployment. The stent may include a first wire segment and a second wire segment coupled to one another by at least one connector. The first wire segment may be rotatably connected to a first side of the at least one connector, and the second wire segment may be rotatably connected to a second side of the at least one connector. The at least one connector may include an elongated body having at least two passageways including a first passageway for receiving the first wire segment and a second passageway for receiving the second wire segment. The first and / or second wire segments may include enlargements to prevent the wire segments from being pulled out of the passageways.

Description

[Technical field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 227,946, filed July 30, 2021, entitled Stent With Enhanced Deployment Characteristics, which is incorporated by reference herein in its entirety. [Background technology]

[0002] Stents are used in many different medical applications, advantageously deployed within a patient's blood vessels. While some vascular regions are relatively straight, many vascular regions have some type of curvature associated with their structure, which can vary from relatively shallow curves to highly tortuous curves that bend in one or more directions.

[0003] Generally, most stents are easiest to deploy in relatively straight or gently curved regions of a vessel. These regions allow the stent to radially expand uniformly throughout its length and, hopefully, become fixed relative to the vessel's inner surface. However, highly tortuous regions of a vessel can cause the stent to bend and twist in several different directions. This bending and twisting can be particularly difficult for stents braided from one or more wires, as the bending and twisting of the braided wires relative to each other can cause pressure and friction against each other, which can prevent them from moving relative to each other. This lack of movement of the braided wires relative to each other can then cause the stent not to fully radially expand and become fixed within the patient's vessel.

[0004] Thus, there is a need for improved stent deployment so that stents may be more uniformly and consistently deployed in highly tortuous regions of blood vessels. Summary of the Invention

[0005] Disclosed herein is a stent that is configured to radially expand and deploy more uniformly in tortuous regions of a vessel. This improved expansion and deployment can be achieved, in part, by reducing or eliminating twisting of the individual wires of a braided stent that can occur when deployed in particularly tortuous vessel regions.

[0006] In one embodiment, one or more anti-twist connectors are used to reduce or eliminate twisting of the stent and / or its braided wires. More specifically, a stent may include one or more anti-twist connectors that connect at least two segments of wires together longitudinally and allow the segments to rotate or turn relative to each other.

[0007] In one embodiment, the anti-kink connector includes a body having two adjacent passages that extend partially or completely through the body and are each sized to accommodate the diameter of one of the braided stent wires that make up the stent. A distally extending stent wire segment extends into and engages one passage, and a proximal extending stent wire segment extends into and engages a second passage. Both wire segments can be engaged with the passages such that the segments can rotate relative to one another. Thus, a wire that would otherwise extend uninterrupted between the proximal and distal ends of the stent is instead replaced by at least two wire segments connected by the anti-kink connector to allow rotation relative to one another.

[0008] A stent may include a single anti-kink connector, or may include multiple anti-kink connectors, all located at the same longitudinal position along the length of the stent (e.g., about one-quarter, one-half, or two-thirds of the length of the stent), or the multiple anti-kink connectors may be located at several different positions along the length of the stent (e.g., about one-quarter, one-half, and / or two-thirds of the length of the stent).

[0009] When a stent having one or more anti-kink connectors is deployed in a tortuous vessel, its body and constituent wires may begin to twist and thus resist uniform radial expansion. However, the anti-kink connector or connectors relieve this torsional tension by allowing their connected wire segments to rotate relative to one another. Thus, the stent can expand in a more uniform and reliable manner.

[0010] The stent may include a first wire segment, a second wire segment, and at least one connector for coupling the first wire segment with the second wire segment. The first wire segment may be connected to a first side of the at least one connector and the second wire segment may be connected to a second side of the at least one connector to reduce kinking between the first and second wire segments when the stent is deployed in or delivered through a tortuous blood vessel.

[0011] In some exemplary embodiments, the first wire segment can be rotatably connected to a first side of the at least one connector, and the second wire segment can be rotatably connected to a second side of the at least one connector.

[0012] In some exemplary embodiments, a first side of the at least one connector may include a first opening for receiving a first wire segment, and a second side of the at least one connector may include a second opening for receiving a second wire segment.

[0013] In some exemplary embodiments, the first side or the second side of at least one connector may include a third opening for receiving the first wire segment or the second wire segment.

[0014] In some exemplary embodiments, at least one connector may include a first passage for receiving a first wire segment and a second passage for receiving a second wire segment.

[0015] In some exemplary embodiments, the first wire segment may extend completely through the first passage, and the second wire segment may extend completely through the second passage.

[0016] In some exemplary embodiments, the first wire segment may be rotatable within the first passage and the second wire segment may be rotatable within the second passage.

[0017] In some exemplary embodiments, the first wire segment and / or the second wire segment may include a lubricious coating to reduce friction.

[0018] In some exemplary embodiments, a tip of a first wire segment may include a first enlarged portion and a tip of a second wire segment may include a second enlarged portion, the first and second enlarged portions functioning as stops.

[0019] In some exemplary embodiments, the first enlarged portion may include a first collar attached to the first wire segment and the second enlarged portion may include a second collar attached to the second wire segment.

[0020] In some exemplary embodiments, the first wire segment can include a third enlarged portion spaced proximally from the first enlarged portion, and the second wire segment can include a fourth enlarged portion spaced proximally from the second enlarged portion.

[0021] In some exemplary embodiments, the first and fourth enlargements may be disposed on a second side of the at least one connector, and the second and third enlargements may be disposed on a first side of the at least one connector.

[0022] In some exemplary embodiments, the stent may include a laser cut stent.

[0023] In some exemplary embodiments, the stent may include a braided stent.

[0024] In some exemplary embodiments, the at least one connector may include a first hypotube and a second hypotube, each of the first hypotube and the second hypotube extending between a first side and a second side of the at least one connector.

[0025] In some exemplary embodiments, a first wire segment may be rotatably connected within a first hypotube and a second wire segment may be rotatably connected within a second hypotube.

[0026] A connector for connecting a first wire segment and a second wire segment of a stent may include an elongate body including a first side and a second side, a first passage on the first side of the elongate body for receiving the first wire segment of the stent, and a second passage on the second side of the elongate body for receiving the second wire segment of the stent.

[0027] In some exemplary embodiments, a first bearing may be connected within the first passageway for receiving a first wire segment of the stent, and a second bearing may be connected within the second passageway for receiving a second wire segment of the stent.

[0028] In some exemplary embodiments, the connector may include a third passageway on the first side or the second side of the elongate body.

[0029] In some exemplary embodiments, each of the first and second passageways may extend only partially through the elongate body.

[0030] The stent may include a first wire segment, a second wire segment, and at least one connector means for reducing twisting between the first and second wire segments, The first wire segment may be rotatably connected to a first side of the at least one connector means, and the second wire segment may be rotatably connected to a second side of the at least one connector.

[0031] In some exemplary embodiments, the at least one connector means may be comprised of an elongate body including a first passage for receiving a first wire segment and a second passage for receiving a second wire segment. [Brief description of the drawings]

[0032] These and other aspects, features and advantages, with which embodiments of the invention are possible, will become apparent and elucidated from the following description of embodiments of the invention, taken in conjunction with the accompanying drawings.

[0033] [Figure 1A] FIG. 1A is a side view of a stent having one or more anti-kink connectors, according to one embodiment.

[0034] [Figure 1B] FIG. 1B is a side view of the stent of FIG. 1A in a curved position.

[0035] [Diagram 2] FIG. 2 is a side view of a stent having one or more anti-kink connectors, according to one embodiment.

[0036] [Diagram 3] FIG. 3 is a side view of a stent having one or more anti-kink connectors, according to one embodiment.

[0037] [Figure 4] FIG. 4 is a side view of a stent having one or more anti-kink connectors, according to one embodiment.

[0038] [Diagram 5] FIG. 5 is a perspective view of an anti-twist connector, according to one embodiment.

[0039] [Figure 6] FIG. 6 is a perspective view of an anti-kink connector connecting two wire segments of a stent, according to one embodiment.

[0040] [Figure 7] FIG. 7 is a perspective view of an anti-kink connector connecting two wire segments of a stent, according to one embodiment.

[0041] [Figure 8] FIG. 8 is a perspective view of an anti-kink connector connecting two wire segments of a stent, according to one embodiment.

[0042] [Figure 9] FIG. 9 is a perspective view of an anti-kink connector connecting multiple wire segments of a stent, according to one embodiment.

[0043] [Figure 10]FIG. 10 is a perspective view of an anti-kink connector connecting multiple wire segments of a stent, according to one embodiment.

[0044] [Figure 11] FIG. 11 is a perspective view of an anti-kink connector connecting multiple wire segments of a stent, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Hereinafter, specific embodiments of the present invention will be described with reference to the drawings. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the drawings, like numbers refer to like elements. Although different embodiments are described, the features of each embodiment may be used interchangeably with other embodiments described. In other words, any of the features of each of the embodiments may be mixed and matched with each other, and the embodiments should not necessarily be strictly construed as including only the features shown or described.

[0046] Disclosed herein is a stent configured to radially expand and deploy more uniformly in tortuous regions of a vessel. This improved expansion and deployment can be achieved, in part, by reducing or eliminating twisting of the individual wires of a braided stent that can occur when deployed in particularly tortuous vessel regions.

[0047] Each of the exemplary embodiments shown and described herein are merely examples of configurations for reducing or eliminating kinking of elongated, tubular medical devices, such as stents and / or their braided / laser-cut wires, and it is to be understood that such exemplary embodiments are not meant to be limiting in scope.

[0048] Although stents are primarily discussed herein and shown in the drawings, it is to be understood that the systems and methods shown and / or described herein may be utilized in connection with a variety of other elongated tubular medical devices delivered through the vasculature. Accordingly, it is to be understood that the term "stent" as used herein may be interpreted to encompass a wide range of elongated tubular medical devices, such as flow diverters.

[0049] Although the stents may be described herein as specifically including braided or laser-cut stents, it should be understood that the systems and methods shown and described herein may be equally applicable to both braided and laser-cut stents, as well as other configurations of stents known in the art. Thus, any reference to a "braided stent" or a "laser-cut stent" should not be construed as being limited to a particular type of stent, but instead should be construed as encompassing any and all types of stents known in the art, including stents that may not be braided or laser-cut.

[0050] As non-limiting examples, the systems and methods shown and / or described herein may be utilized in connection with any of the stents shown and / or described in U.S. Patent Nos. 10,898,203, 10,617,544, 10,543,113, 10,463,515, 10,039,655, 9,867,725, 9,439,791, 8,998,679, 8,872,062, 8,562,667, and U.S. Patent Publication Nos. 2020 / 0138609 and 2006 / 0287706, all of which are incorporated herein by reference.

[0051] Various elongated tubular medical devices, such as stents, flow diverters, etc., may have a tendency to kink when traversing tortuous vasculature, such as, but not limited to, the carotid artery. Such tendency to kink may be particularly pronounced in longer stents. Kinking during delivery may make such medical devices difficult to open (e.g., expand). This may require the operator to withdraw or retract the medical device from the body and start again, which may result in additional anesthesia time, costs, complications, or adverse patient outcomes in a medical emergency or situation where time is of the essence. The use of anti-kink connectors may help reduce or eliminate the possibility of such stents kink when deployed or delivered to a target location in a patient.

[0052] The present invention generally relates to a stent having two or more segments that may be interconnected with one another via one or more anti-kink connectors. The two or more segments of the stent may be substantially similar (e.g., may have the same or similar braid, laser cut pattern, length, width, and / or other characteristics) or may be different from one another (e.g., may have different braids, laser cut patterns, lengths, widths, and / or other characteristics).

[0053] Generally, twisting may occur throughout the length of the stent, such as, but not limited to, approximately in the middle of the stent's length. Thus, the present invention may utilize one or more anti-twist connectors that connect a pair of segments of a stent of equal length to one another. However, it should be understood that various other locations along the length of the stent may be utilized for the anti-twist connectors. For example, it may be desirable to place at least one anti-twist connector closer to the distal or proximal end of the stent. As a further example, for longer stents, it may be desirable to divide the stent into three or more segments, each of which is interconnected by one or more anti-twist connectors.

[0054] The number of anti-kink connectors may vary depending on the characteristics of the stent, including the length, width, type, configuration, etc. of the stent. For example, a single anti-kink connector may be utilized. However, additional anti-kink connectors may be utilized to improve the functionality of the present invention. Such anti-kink connectors may be positioned radially around the circumference of the stent. The anti-kink connectors may be aligned radially about the stent or offset with respect to each other.

[0055] The anti-kink connector may include an elongate body having a first side (e.g., a proximal side) and a second side (e.g., a distal side). The elongate body may have a generally curved profile to avoid any sharp edges or corners. One or more wires of a first segment of the stent may be connected to the first side of the anti-kink connector, and one or more wires of a second segment of the stent may be connected to the second side of the anti-kink connector.

[0056] The anti-kink connector may include one or more passageways on each side. For example, the anti-kink connector may include a single passageway on its first side for receiving a wire from a first segment of the stent and a single passageway on its second side for receiving a wire from a second segment of the stent. However, the number of passageways on each side of the anti-kink connector may vary. As an example, the first side of the anti-kink connector may have a single passageway for receiving a single wire from the first segment of the stent and the second side of the anti-kink connector may have a pair of passageways for receiving a pair of wires from the second segment of the stent, or vice versa. The present invention may also utilize more than two passageways on one or both sides of the anti-kink connector to allow even more wires from segments on one or both sides of the stent to be connected thereto.

[0057] The manner in which the wires of the stent are connected to the anti-kink connector may vary. The wires may be fixed in the anti-kink connector, may pass through the anti-kink connector, or may be rotatably connected in the anti-kink connector. The anti-kink connector may include a passageway made up of an opening through which the wires may extend fully or partially (e.g., the wires may extend completely through the anti-kink connector or may terminate within it). The anti-kink connector may include various tubular devices, such as bearings, into which the wires may be inserted. The wires may rotate relative to the anti-kink connector, or the wires may be fixed to such a tubular device such that the tubular device itself rotates relative to the anti-kink connector.

[0058] One or more enlargements may be connected to or formed on the wires to prevent the wires from advancing too far through the anti-twist connector or from being pulled out and disconnected from the anti-twist connector. The one or more enlargements may include separate structures, such as beads, secured to the wires. As another example, the one or more enlargements may include balls of adhesive, metal, alloy, plastic, etc. Each wire may include an enlargement at its terminal tip. Additionally or alternatively, each wire may include an enlargement inserted (e.g., spaced) from its terminal tip.

[0059] A portion of the wire may be coated with various coatings to reduce friction of the wire as it rotates within the anti-kink connector. Various coatings, such as lubricious coatings, known in the art may be utilized. For example, the end of the wire may be coated with a lubricious coating before being inserted into the passage of the anti-kink connector to reduce friction as the wire rotates within the passage. Alternatively or additionally, such a lubricious coating may be introduced into the passage of the anti-kink connector prior to inserting the wire therein. The coating may include a layer of a polymer or fibrous material, such as PTFE or Teflon, disposed around the wire and / or within the inner diameter of the passage to reduce friction.

[0060] Specific exemplary embodiments are further described below. However, it should be understood that any features from any embodiment can be mixed and matched with each other in any combination. Therefore, the present invention should not be limited to only these embodiments, but any broader combination thereof.

[0061] In one embodiment, one or more anti-kink connectors are used to reduce or eliminate twisting of the stent and / or its braided wires. More specifically, a stent may include one or more anti-kink connectors 100 that connect at least two separate segments of wire together to form a single elongated wire strand and allow the segments to rotate or turn relative to one another.

[0062] Generally, each of the anti-kink connectors 100 connects to one end of a proximal extending wire segment and another end of a distal extending wire segment. In this regard, the anti-kink connectors 100 connect two wire segments into one single wire. The proximal extending wire segment and the distal extending wire segment are preferably connected to the anti-kink connectors 100 such that they are rotatable relative to one another. Thus, when portions of the stent twist relative to one another during deployment in tortuous vessels, the wire segments rotate relative to one another, reducing tension caused by twisting and thereby allowing for a more uniform radial expansion of the stent.

[0063] 1A-3 show exemplary embodiments of a stent 10, each having a plurality of anti-kink connectors 100 connecting a proximal region 10A including a proximal wire segment 12A and a distal region 10B including a distal wire segment 12B. FIGURES 1A-1B show a first exemplary embodiment of a braided stent 10 having a uniform braid across both the regions 10A, 10B and the wire segments 12A, 12B.

[0064] 2 illustrates an exemplary embodiment of a braided stent 10 having different braids across both regions 10A, 10B and across both wire segments 12A, 12B. More specifically, in FIG. 2, it can be seen that distal region 10B, which includes distal wire segment 12B, may include more braids than proximal region 10A, which includes proximal wire segment 12A. It should be understood that the reverse configuration may also be utilized in some exemplary embodiments (e.g., proximal region 10A, which includes proximal wire segment 12A, may include more braids than distal region 10B, which includes distal wire segment 12B).

[0065] Figure 3 illustrates an exemplary embodiment of a laser-cut stent 10 that includes at least one anti-kink connector 100 connecting a proximal region 10A to a distal region 10B. Although Figure 3 illustrates an embodiment in which the proximal and distal regions 10A, 10B are substantially similar, it should be understood that the proximal and distal regions 10A, 10B may differ in various respects in different embodiments.

[0066] Each of Figures 1A-3 illustrates an exemplary embodiment in which one or more anti-kink connectors 100 are disposed approximately in the middle of the length of the stent 10. Thus, in such an embodiment, the length of the proximal region 10A may be approximately equal to the length of the distal region 10B. However, in some embodiments, the one or more anti-kink connectors 100 may not be disposed in the middle of the length of the stent 10. For example, in some exemplary embodiments, the anti-kink connectors 100 may be connected closer to the proximal or distal ends of the length of the stent 10.

[0067] 1A-3 show an exemplary embodiment in which only two separate regions of stent 10 are connected by anti-kink connector 100, it should be understood that in some embodiments, more than two regions of stent 10 may be connected together. For example, FIG. 4 shows an exemplary embodiment in which it can be seen that multiple anti-kink connectors 101A, 101B, 101C may be connected at various locations along the length of an exemplary embodiment of stent 10. Thus, in the embodiment shown in FIG. 4, stent 10 may be separated into four regions: a first region connected to a second region by anti-kink connector 101A, a second region connected to a third region by anti-kink connector 101B, and a third region connected to a fourth region by anti-kink connector 101C.

[0068] It should be understood that various other configurations not shown in Figures 1A-4 may be supported by the methods and systems described herein. For example, in an exemplary embodiment, three regions of the stent 10 may be connected by anti-kink connectors 100. In other exemplary embodiments, five or more regions of the stent 10 may be connected by anti-kink connectors 100.

[0069] It should also be understood that the respective lengths of each region of the stent 10 separated by anti-kink connectors 100 may vary in different embodiments. The figures show various embodiments in which the lengths of each of the regions 10A, 10B are approximately equal. For example, FIGS. 1A-3 show an embodiment in which the first region 10A is approximately equal in length to the second region 10B. FIG. 4 shows an embodiment in which the stent 10 is separated into four regions having approximately equal lengths. However, in some embodiments, one or more regions of the stent 10 may be longer than the other regions.

[0070] Thus, the anti-twist connector 100 need not necessarily be equally spaced as shown in the figures. For example, with respect to the embodiment illustrated in FIG. 1A, the first region 10A may in some embodiments be longer than the second region 10B, or vice versa. As a further example, with respect to the embodiment illustrated in FIG. 4, one or more regions may be longer than one or more other regions such that the anti-twist connector 100 is not equally spaced as shown.

[0071] The number, placement, and orientation of anti-kink connectors 100 connecting each region of the stent 10 may also vary in different embodiments. In the exemplary embodiment shown in the figure, it can be seen that the anti-kink connectors 100 may be substantially aligned along a vertical axis that bisects the stent 10. However, in some embodiments, the anti-kink connectors 100 may not be aligned vertically as shown in the figure. In addition, the number of anti-kink connectors 100 connecting each region of the stent 10 may vary in different embodiments and thus should not be construed as limited by the exemplary figures. Depending on various characteristics of the stent 10 (e.g., width, material), the application in which the stent 10 is being used, the vasculature through which the stent 10 passes, and / or other considerations, more or fewer anti-kink connectors 100 than shown in the figures may be utilized.

[0072] 1A and 1B show one exemplary stent 10 having multiple anti-kink connectors 100 connected to proximal wire segments 12A from region 10A and distal wire segments 12B from region 10B. As shown in FIG. 2, when the stent 10 is deployed in a tortuous vessel, one portion of the stent 10 may twist relative to another portion (e.g., proximal region 10A relative to distal region 10B). However, the anti-kink connectors 100, here located near the center of the stent 10, allow one or more wire segments in the proximal region 10A to rotate relative to one or more wire segments in the distal region 10B to relieve tension or friction caused by twisting that may prevent the stent 10 from radially expanding in a desired manner.

[0073] In one embodiment, the stent 10 is formed from multiple (e.g., 64) separate wires braided together into a tubular shape. In another embodiment, the stent is first braided from a single wire to form a tubular shape, and then the connector 100 is added later at the desired location. This may involve first braiding a single wire, then cutting it into two sub-segments at the desired location, and then reattaching them together via the connector 100. In yet another embodiment, the stent may be a laser cut stent having multiple struts as shown in FIG. 3. In any of these embodiments, the wire or strut segments represent portions of the wires or struts that extend only partially between the proximal and distal ends of the stent 10. Thus, multiple wire / strut segments may be connected to extend completely between the proximal and distal ends of the stent 10.

[0074] 1A shows that the proximal and distal wire segments 12A, 12B connected to the kink-proof connector 100 may be of approximately equal length (i.e., the connector 100 may be located approximately in the middle of the stent 10). However, as shown in FIG. 4, one or more connectors 100 may be located at one or more locations along the length of the stent 10. For example, one or more connectors may be located at approximately 25% (101A), 50% (101B), and / or 75% (101C) of the length of the stent 10. In that regard, the entire length of the wire strand between the proximal and distal ends of the stent 10 may be divided into two, three, four, or more wire segments that are all connected by kink-proof connectors 100.

[0075] In addition to connectors 100 being positioned at different locations along the length of stent 10, connectors can be used to connect all wires at a particular cross-sectional location (e.g., all wires that intersect at a central / 50% location on stent 10), or less than all wires at a particular cross-sectional location. For example, when looking at a cross-section of stent 10 at a given location and moving clockwise, connectors can be used with every other wire, every third wire, every fourth wire, every fifth wire, or a similar pattern (i.e., a wire here means two connected wire segments). In other words, connectors may only be positioned on wires at certain circumferential angles, such as 0 degrees and 180 degrees, when looking at a cross-section of stent 10.

[0076] In another example, each wire (i.e., extending between the proximal and distal ends of the stent 10) may have one or more connectors 100 arranged at alternating longitudinal positions along the stent 10. For example, from a cross-sectional clockwise perspective, a first connector may be placed on a first wire at 25% of the stent length, a second connector may be placed on a second adjacent wire at 75% of the stent length, a third connector may be placed on a third adjacent wire at 25% of the stent length, and so on. The order of connections between one wire segment with anti-kink connectors 100 and the strands of the other segment in a braided stent may depend on the level of torquing freedom (i.e., how much the stent 10 must twist) required when deploying the stent in a patient's long and / or tortuous vessels.

[0077] In another example, the longitudinal location of the connectors 100 along the length of the stent can also be varied in combination with the cross-sectional or circumferential angular location of the connectors 100. For example, four connectors 100 may be positioned at different locations along the length of the stent 10, each offset 90 degrees from one another. Such connector placement affects how the anti-kink aspect of the stent 10 functions, and in this manner, the stent 10 can be tuned to achieve specific performance characteristics.

[0078] The anti-twist connector 100 can have many different embodiments that primarily allow the two connected wire segments to rotate relative to one another, and in a preferred embodiment, the connector 100 may be connected to the wire segments in a manner that prevents longitudinal or translational movement of the connector and / or the wire segments relative to one another.

[0079] 5-11 illustrate various exemplary embodiments of anti-twist connectors 100 that may be utilized to connect two or more regions 10A, 10B of a stent 10 so as to prevent twisting of the stent 10 during delivery or deployment. As shown throughout the figures, the anti-twist connector 100 may include an elongate body 120 having a first side 120A and a second side 120B. Generally, one or more first wire segments 12A may be connected to the first side 120A of the anti-twist connector 100, and one or more second wire segments 12B may be connected to the second side 120B of the anti-twist connector 100.

[0080] The shape of the anti-twist connector 100, including the shape of the elongated body 120 of the anti-twist connector 100, may vary in different embodiments and therefore should not be construed as limited in scope by the exemplary embodiment shown in the figures. In some embodiments, the elongated body 120 may be substantially rectangular. Generally, the elongated body 120 has curved edges as shown in the figures to avoid any sharp points that may injure the patient. However, in some embodiments, the elongated body 120 may include one or more corners.

[0081] 5 illustrates a first side 120A of an exemplary embodiment of a twist-proof connector 100. As illustrated, the first side 120A of the elongated body 120 of the twist-proof connector 100 may include a pair of wire passages 122A, 122B configured to receive the wire segments 12A, 12B, respectively. As described in more detail below, each of the wire passages 122A, 122B may, in some embodiments, pass completely through the elongated body 120 of the twist-proof connector 100 (e.g., pass from the first side 120A to the second side 120B), or in other embodiments, each of the wire passages 122A, 122B may terminate within the elongated body 120 of the twist-proof connector 100.

[0082] In general, each passageway 122A, 122B may include an opening that extends partially or completely through the elongated body 120 of the twist-resistant connector 100. The shapes and dimensions of the passageways 122A, 122B may vary in different embodiments and thus should not be construed as limited by the exemplary embodiments shown in the figures.

[0083] For example, while the figures show each of the passages 122A, 122B consisting of a circular opening, it should be understood that a variety of other shapes may be utilized in different embodiments. As a further example, while the passages 122A, 122B are shown in some embodiments as passing completely through the elongated body 120 (e.g., between the first side 120A and the second side 120B of the elongated body), the passages 122A, 122B may in some embodiments terminate within the elongated body 120 and thus not pass completely through it.

[0084] The dimensions (e.g., diameters) of the passages 122A, 122B may vary to accommodate different types and sizes of wire segments 12A, 12B. Generally, the inner diameter of each passage 122A, 122B may be slightly larger than the outer diameter of the wire segment 12A, 12B to be inserted therein. However, in some embodiments, the inner diameter of each passage 122A, 122B may be larger than the outer diameter of the wire segment 12A, 12B.

[0085] The number of passages 122A, 122B of the twist-proof connector 100, and therefore the number of wire segments 12A, 12B connected to the twist-proof connector 100, may vary in different embodiments and therefore should not be construed as limited by the exemplary illustrations. FIGS. 7-8 and 10-11 show exemplary embodiments in which each side 120A, 120B of the elongated body 120 of the twist-proof connector 100 includes a pair of passages 122. FIG. 9 shows an exemplary embodiment in which the first side 120A of the elongated body 120 of the twist-proof connector 100 includes a pair of first passages 122A and the second side 120B of the elongated body 120 of the twist-proof connector 100 includes a single passage 122B. The reverse configuration may be utilized in other embodiments. Additionally, in some embodiments, one or both sides 120A, 120B of the elongated body 120 of the twist-proof connector 100 may include three or more passages 122.

[0086] 5-11 show an exemplary embodiment of a kink-resistant connector 100 including an elongated body 120 having first and second wire passages 122A, 122B each dimensioned to allow ends of wire segments 12A, 12B to be disposed therein. Depending on how the wire segments 12A, 12B are engaged with the connector 100, the passages 122 may extend partially through the elongated body 120 or completely through the elongated body, as previously described.

[0087] The elongate body 120 can take the form of a variety of different shapes and sizes depending on the size of the stent 10 in which it is to be deployed and / or the wire diameter size of the stent. For example, the elongate body can form a rectangular cuboid, a square cube, an ellipse, a sphere, or a variety of other shapes. Thus, the shapes shown in the exemplary embodiments in the figures should not be construed as limiting in scope.

[0088] It should be understood that the anti-twist connector 100, including its elongated body 120, may be constructed from various types of materials known in the art. As an example, the elongated body 120 of the anti-twist connector 100 may be constructed from various biocompatible materials, including metals, alloys, polymers, and the like. The elongated body 120 may be constructed from a metal or alloy (e.g., Nitinol), or a flexible material, such as a polymer or silicone, to further increase the movement of the wire segments relative to one another. In some embodiments, the elongated body 120 may include two or more materials that are bonded (e.g., fused) together. For example, the elongated body 120 may include a core constructed from a first material and an outer layer (e.g., plating) constructed from a second material. Also, the stiffness of the elongated body 120 may vary in different embodiments. Thus, the elongated body 120 may be constructed from a rigid, semi-rigid, flexible, and / or elastic material.

[0089] It should also be understood that the relative placement of the wire passages 122A, 122B may vary in different embodiments. The first wire passage 122A and the second wire passage 122B may be positioned approximately parallel to one another as shown in the figures, or may be positioned at various non-parallel angles to the axis of each passage (e.g., 5, 10, 15, 20, or 25 degrees relative to one another). In some embodiments, the first wire passage 122A and the second wire passage 122B may be directly aligned with one another.

[0090] In one example, the connector can be formed by placing two hypotubes adjacent to one another and then welding the two hypotubes together. Alternatively, the hypotubes can be welded to an existing body structure. In some examples, hypotubes may not be necessary and the first and second wire passages 122A and 122B are made directly into the elongated body structure (e.g., by drilling, laser cutting, or various other methods known to introduce openings into a structure).

[0091] The manner in which the wire segments 12A, 12B, such as the ends of the wire segments 12A, 12B, are connected to the kink-resistant connector 100 may vary in various embodiments. By way of example and not limitation, the wire segments 12A, 12B may be fixed within the passage 122, rotatably connected within the passage 122, or may pass freely through the passage 122.

[0092] In some embodiments, separate structures or devices may be fixed or rotatably connected within the passageway 122 of the kink-resistant connector 100. As a non-limiting example, tubular members such as bearings, tubes, etc. may be fixedly or rotatably connected via the kink-resistant connector 100. In such embodiments, the wire segments 12A, 12B may rotate relative to such tubular members, or such tubular members may themselves rotate within the passageway 122, with the wire segments 12A, 12B fixed within the tubular members such that they rotate with them. Thus, in embodiments in which such tubular members are utilized, the wire segments 12A, 12B may alternatively be fixed to such tubular members, rotatably connected to such tubular members, or may pass freely through such tubular members.

[0093] 7 and 9 show exemplary embodiments in which the wire segments 12A, 12B do not extend completely through the passage 122, but instead terminate therein. As previously mentioned, the passage 122 may comprise an opening in the elongated body 120 of the kink-proof connector 100, or in some embodiments, a separate structure or device, such as, but not limited to, a tubular member or a bearing, may be fixedly or rotatably connected to the passage 122. FIG. 7 shows an embodiment in which the passage 122 extends between the first side 120A and the second side 120B of the elongated body 120. FIG. 9 shows an embodiment in which the passage 122 does not terminate either on the exterior surface of the kink-proof connector 100 or within the elongated body 120.

[0094] 8 and 10-11 illustrate exemplary embodiments in which the wire segments 12A, 12B pass completely through the elongated body 120 of the twist-proof connector 100. In such embodiments, an enlarged portion 123 is formed on or attached to the wire segments 12A, 12B to prevent the wire segments 12A, 12B from being pulled out of or advanced away through the elongated body 120 of the twist-proof connector 100, as described in more detail below.

[0095] 11, the orientation (e.g., entry angle) of the wire segments 12A, 12B relative to the twist-proof connector 100 may vary in different embodiments. In some exemplary embodiments, each of the wire segments 12A, 12B may include a 90 degree rotation before entering the twist-proof connector 100. In other exemplary embodiments, the wire segments 12A, 12B may be oriented in a straight line before entering the twist-proof connector 100. In still other exemplary embodiments, a variety of other entry angles may be utilized for one or both of the wire segments 12A, 12B.

[0096] In one connection example, each end of the wire segments 12A, 12B may be secured to or within the passageway 122, such as by welding, adhesive bonding, or other methods. For example, the exemplary embodiment shown in Figures 7 and 9 may utilize such a connection method. This connection method may prevent rotation of the wire segments relative to the connector 100, while the position of the elongate body 120 relative to the wire segments (e.g., perpendicular to the axis of the stent 10) provides greater relative movement of the wire segments relative to one another.

[0097] 7 and 9, the ends of the wire segments may have enlarged portions 123 that are engaged by grooves or similar structures in the passages 122. Such a configuration may allow the ends of the wire segments to be retained in the passages 122 while also allowing rotation of the wire segments relative to the connector 100 and relative to each other.

[0098] In yet another example connection that may be utilized in the exemplary embodiment shown in Figures 7 and 9, a bearing (not shown) may be positioned within each passage 122A, 122B and an end of the wire segment 12A, 12B may be connected within each bearing such that the wire segment 12A, 12B may rotate with or relative to each bearing, or each wire segment 12A, 12B may rotate about a fixed axis, or the anti-kink connector 100 may rotate relative to each wire segment 12A, 12B.

[0099] In another example connection shown in Figures 8 and 10-11, each of the wire segments 12A, 12B may be positioned completely through the passages 122A, 122B, and the wire segments 12A, 12B are held in place by an enlargement 123 in the diameter of the wire segments 12A, 12B on one or both sides 120A, 120B of the passage 122. In this regard, the wire segments 12A, 12B may be prevented from being pulled out of the passages 122A, 122B or pushed further through the passages 122A, 122B, thereby retaining their longitudinal or translational positions relative to one another. In addition, such a connection method may allow each of the wire segments 12A, 12B to rotate freely relative to the connector 100.

[0100] The shape, size, type and number of the extensions 123 may vary in different embodiments and therefore should not be construed as limited in scope by the exemplary embodiment shown in the figures.

[0101] The figure shows the enlarged portion 123 comprised of a flat disk shape. However, a variety of other shapes may be utilized, including square, rectangular, spherical, hemispherical, and various other shaped enlarged portions 123. In some embodiments, one or more of the enlarged portions 123 may comprise a bead having an opening through which the wire segments 12A, 12B may extend, the bead being secured to the wire segments 12A, 12B by adhesive, welding, or the like. However, in some embodiments, the enlarged portion 123 may "float" along at least a portion of the length of the wire segments 12A, 12B.

[0102] The size of the enlargements 123 may vary and should not be construed as limiting by the illustration. Generally, each enlargement 123 should be at least slightly larger than the opening of the passageway 122 to prevent the enlargement 123 from entering or passing through the passageway 122.

[0103] The number of enlargements 123 utilized per wire segment 12A, 12B and / or twist-proof connector 100 may also vary and should not be construed as limited by the figures. Figures 8 and 11 show an embodiment in which each wire segment 12A, 12B includes two enlargements 123, i.e., a first enlargement at the tip of the wire segment 12A, 12B and a second enlargement that is set back (e.g., plugged in) relative to the first enlargement. Thus, in an embodiment as shown in Figures 8 and 11, the first enlargement 123 may be disposed on the second side 120B of the twist-proof connector 100 and the second enlargement 123 may be disposed on the first side 120A of the twist-proof connector 100.

[0104] 9 shows an embodiment in which each wire segment 12A, 12B includes only a single enlarged portion 123 located at its terminal tip on the second side 120B of the kink-proof connector 100. Although not shown, in some embodiments, each wire segment 12A, 12B may instead include only a single enlarged portion 123 on the first side 120A of the kink-proof connector 100.

[0105] Enlarged portion 123 may be formed after placing wire segments 12A and 12B through passages 122A and 122B. For example, a collar, tube, or C-shaped structure may be placed over the wires and welded in place. Alternatively, only additional welds may be required. Alternatively, spot welds may be used to enlarge the ends of the wire segments, thereby forming enlarged portion 123.

[0106] As best shown in Figures 5-11, the length of the body 120 of the connector 100 is oriented generally perpendicular to the longitudinal axis of the stent 10, while the wire segments 12A, 12B can be curved or bent so that they extend longitudinally parallel to the axis of the stent 10.

[0107] Passages 122A and 122B can be positioned at various distances from one another, including but not limited to within the inclusive range of 0.001 inch and 0.05 inch. Passages 122A, 122B can generally be sized slightly larger than wire segments 12A and 12B, such as wires having diameters within the inclusive range of about 0.0005 inch and 0.02 inch.

[0108] The connectors 100 described herein can be used with a wide variety of different stent 10 types and sizes. For example, the connectors 100 can provide performance characteristics useful for neurovascular stents 10, which often have expanded diameters in the inclusive range of about 2 mm to 10 mm, and expanded lengths in the inclusive range of about 5 mm to 100 mm.

[0109] In one embodiment, the stent 10 can be made by first braiding single or multiple strands of wire into the desired shape of the stent 10. The connectors 100 can then be incorporated by cutting the wire of the stent 10 into first and second segments 12A, 12B at desired locations along its length (e.g., at various lengths including, but not limited to, any of the lengths previously described herein).

[0110] A distal end of at least one strand of the first stent region 10A may then be connected with a first passageway 122A on the first side 120A of the connector 100, and a proximal end of another strand of the second stent region 10B may be connected with a second passageway 122B on the second side 120B of the connector 100. Connection to the connector 100 may be performed in any of the manners previously described (e.g., by welding or forming proximal and distal enlargements on a wire segment, or various other methods). Additional stent wires may be cut and connected in a similar manner at desired locations.

[0111] In a particular example, a woven stent can be cut at 75% of its length into a first region 10A and a second region 10B. A distal end of one or more strands in the first region 10A can be connected to a proximal end of one or more strands in the second region 10B with one or more connectors 100, thereby connecting the first stent region 10A of the stent 10 to the second stent region 10B of the stent 10 via the one or more connectors 100.

[0112] In yet another example, a woven stent can be cut into a first region 10A and a second region 10B at 50% of its length. A distal end of one or more strands in the first region 10A can be connected to a proximal end of one or more strands in the second region 10B using one or more connectors 100. According to another example, a braided or woven stent can be cut into a first region 10A and a second region 10B at 25% of its length. A distal end of one or more strands in the first region 10A can be connected to a proximal end of one or more strands in the second region 10B using one or more connectors 100.

[0113] Alternatively, the wire segments can be connected to one another via connectors prior to braiding, so that the stent can be braided after connecting each of the desired connectors.

[0114] In use, the stent 10 may be delivered to and deployed within the vasculature using a wide range of methods known in the art for delivering and deploying the stent 10. As shown in FIG. 1A, when the stent 10 is in a linear configuration (e.g., the stent 10 is arranged or extends along a straight or nearly straight line), the first wire segment 12A may be aligned with the second wire segment 12B. As shown in FIG. 1B, when the stent 10 is in a non-linear configuration (e.g., the stent 10 is bent, twisted, or curved), the connector 100 may reduce the relative twist between the first wire segment 12A and the second wire segment 12B compared to any relative twist of the stent 10. In this way, the risk of difficult problems during deployment in a tortuous vasculature (e.g., the stent 10 may not be able to fully expand) may be reduced or eliminated.

[0115] item

[0116] Exemplary embodiments are described in the following numbered items:

[0117] Item 1. A method of adding a connector to a stent may include braiding the stent with a plurality of strands, cutting the stent along its length to form a plurality of stent segments, connecting a distal end of at least one strand of a first stent segment with a first passage on the connector, and connecting a proximal end of at least one strand of a second stent segment with a second passage on the connector, thereby connecting the first segment of the stent with the second segment of the stent.

[0118] Item 2. The method according to item 1 may include cutting the stent to form three stent segments, connecting a distal end of at least one strand of the second connector to a first passageway of the second connector, and connecting a proximal end of at least one strand of the third stent segment to a second passageway of the second connector.

[0119] Item 3. A method of adding a connector to a stent may include braiding the stent with a plurality of strands, cutting the stent along its length to form a plurality of stent segments, connecting a distal end of a first strand of a first stent segment to a first passage on a first side of a connector, connecting a distal end of a second strand of the first stent segment to a second passage on the first side of the connector, and connecting a proximal end of the first strand of the second stent segment to the first passage on the second side of the connector.

[0120] Item 4. A method of adding a connector to a stent may include braiding the stent with a plurality of strands, cutting the stent along its length to form a plurality of stent segments, connecting a distal end of a first strand of a first stent segment to a first passage on a first side of the connector, connecting a proximal end of a first strand of a second stent segment to the first passage on a second side of the connector, and connecting a proximal end of a second strand of the second stent segment to the second passage on the second side of the connector.

[0121] Item 5. A method of adding a connector to a stent may include laser cutting a first tubular stent segment and a second tubular stent segment, connecting a distal end of a first wire of the first tubular stent segment to a first passage on a first side of the connector, and connecting a proximal end of the first wire of the second tubular stent segment to the first passage on a second side of the connector.

[0122] Item 6. The method according to item 5 may include connecting a distal end of a second wire of the first tubular stent segment to a second passageway on the first side of the connector.

[0123] Item 7. The method according to items 5 or 6 may include connecting a proximal end of a second wire of a second tubular stent segment to a second passageway on a second side of the connector.

[0124] Item 8. The method according to any of the preceding items may include the step of coating any end or tip of the strands or wires with a lubricious coating to reduce friction.

[0125] Item 9. The method according to any of the preceding items may include coating the interior of one or more passageways with a lubricious coating to reduce friction.

[0126] Item 10. The method according to any of the preceding items may include inserting either the strand or wire completely through the anti-kink connector.

[0127] Item 11. The method according to any of the preceding items may include terminating either the strands or the wires in a kink-resistant connector.

[0128] Item 12. The method according to any of the preceding items may include the step of connecting a first enlarged portion to an end of either the strand or wire to act as a stopper.

[0129] Item 13. The method according to any of the preceding items may include the step of connecting the second enlarged portion to either a strand or a wire spaced proximally from the first enlarged portion.

[0130] Item 14. The method according to any of the preceding items may include forming one or more enlargements in either the strands or wires by forming enlarged areas, such as balls, with adhesive, solder, or the like.

[0131] Although the present invention has been described with respect to specific embodiments and applications, those skilled in the art will be able to create additional embodiments and modifications in light of the present teachings without departing from the spirit or beyond the scope of the claimed invention. It is therefore to be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting its scope.

Claims

1. A first wire segment; A second wire segment; at least one connector for connecting the first wire segment and the second wire segment, the first wire segment is connected to the at least one connector and the second wire segment is connected to the at least one connector; the first wire segment is aligned with the second wire segment when the stent is in a linear configuration; A stent characterized in that when the stent is in a nonlinear configuration, the at least one connector reduces a relative twist between the first wire segment and the second wire segment compared to a relative twist of the stent.

2. The stent of claim 1 , wherein each of the first and second wire segments is rotatably connected to the at least one connector.

3. 2. The stent of claim 1, wherein a first side of the at least one connector includes a first opening for receiving the first wire segment and a second side of the at least one connector includes a second opening for receiving the second wire segment.

4. The stent of claim 3 , wherein the first side or the second side of the at least one connector includes a third opening for receiving the first wire segment or the second wire segment.

5. 2. The stent of claim 1, wherein the at least one connector includes a first passage and a second passage, the first wire segment extending completely through the first passage and the second wire segment extending completely through the second passage.

6. The stent of claim 5, wherein the first wire segment is rotatable within the first passageway and the second wire segment is rotatable within the second passageway.

7. The stent of claim 1 , wherein the at least one connector includes a lubricious coating to reduce friction caused by movement of the first wire segment and / or the second wire segment.

8. The stent of claim 1 , wherein a distal end of the first wire segment includes a first enlarged portion and a distal end of the second wire segment includes a second enlarged portion.

9. 9. The stent of claim 8, wherein the first enlarged portion includes a first collar attached to the first wire segment and the second enlarged portion includes a second collar attached to the second wire segment.

10. 9. The stent of claim 8, wherein the first wire segment includes a third enlargement spaced proximally from the first enlargement and the second wire segment includes a fourth enlargement spaced proximally from the second enlargement.

11. 11. The stent of claim 10, wherein each of the first wire segment and the second wire segment extends completely through the at least one connector, each of the first enlarged portion and the fourth enlarged portion is disposed on a second side of the at least one connector, and each of the second enlarged portion and the third enlarged portion is disposed on a first side of the at least one connector.

12. The stent of claim 1 , wherein the stent comprises a laser cut stent or a braided stent.

13. 2. The stent of claim 1, wherein the at least one connector comprises a first hypotube and a second hypotube, each of the first hypotube and the second hypotube extending between a first side and a second side of the at least one connector.

14. The stent of claim 1 , wherein the at least one connector is located approximately midway along the length of the stent.

15. The stent of claim 1 , wherein the at least one connector is disposed closer to a proximal or distal end of the stent.

16. A connector for connecting a first wire segment and a second wire segment of a stent, comprising: an elongate body including a first side and a second side; a first opening on the first side of the elongate body, and the first wire segment of the stent is disposed within the first opening; a second opening on the second side of the elongate body, the second wire segment of the stent being disposed within the second opening.

17. 17. The connector of claim 16, further comprising a first bearing connected within the first opening and a second bearing connected within the second opening, the first wire segment of the stent being disposed within the first bearing and the second wire segment of the stent being disposed within the second bearing.

18. 17. The connector of claim 16, further comprising a third opening on the first side or the second side of the elongate body, a third wire segment of the stent disposed within the third opening.

19. The connector of claim 16 , wherein each of the first opening and the second opening extends only partially through the elongate body.

20. A first wire segment; a second wire segment, A stent including at least one connector means for reducing twisting between said first and second wire segments when said stent is in a non-linear configuration.

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