Stent Device

Abstract

The stent device includes a first stent wire and a second stent wire forming a cylindrical stent body, the cylindrical stent body enclosing an interior void space, a primary connection structure, and a secondary connection structure. The primary connection structure includes a first loop formed from the first stent wire and defining a first loop opening, and a second stent wire passing through the first loop opening. The secondary connection structure includes the first stent wire and the second stent wire passing over each other. The first stent wire includes a first peak and a first valley, and the first loop is located at the first peak or the first valley of the first stent wire.

Description

[Technical Field]

[0001] The present invention relates generally to stent devices, and more particularly to stent devices in which stent wires are interlocked to prevent axial shortening when the stent device is bent and to achieve an ideal ratio of flexibility for the stent device. The calculated placement of stent wire interlocks can result in a variety of positive effects for the stent and the patient in whom the stent is placed.

[0002] This application is based on and claims priority to U.S. Provisional Application No. 63 / 154,181, filed February 26, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0003] FIG. 20 is a diagram of a stent device disclosed in related art (Patent Document 1). FIG. 20 shows stent wires 100a, 100b, 100c, and 100d, each having peaks 110a, 110b, 110c, and 110d and valleys 120a, 120b, 120c, and 120d. The peaks and valleys may be "captured" with one another. For example, at the position indicated by reference numeral 102 in FIG. 20, the peak 110b of the second stent wire 100b is captured by the valley 120a of the first stent wire 100a. On the other hand, the peaks and valleys may not be "captured" with one another. For example, at the position indicated by reference numeral 104 in FIG. 20, the peak 110b of the second stent wire 100b is not captured by the valley 120a of the first stent wire 100a. In the prior art, the number of peaks 110a, 110b, 110c, and 110d and the number of valleys 120a, 120b, 120c, and 120d are preferably set to a multiple of 3 so that the peaks 110a, 110b, 110c, and 110d that are captured by the valleys 120a, 120b, 120c, and 120d and the peaks 110a, 110b, 110c, and 110d that are not captured by the valleys 120a, 120b, 120c, and 120d are repeated in a ratio of 2:1. While a ratio of 3:1 or 2:2 is possible instead of 2:1, this reduces the number of connections between the stents 100a, 100b, 100c, and 100d, which may result in damage to the connections between the stent wires 100 when an external force is applied.

[0004] Figure 21 is a diagram of another stent device disclosed in related art (Patent Document 2). Figure 21 discloses a net 11' having a mesh pattern in which a mesh 12' is formed by filaments 13' and 14' (the terms "mesh" or "meshes" refer to the actual cord or wire network, not the space between them). The intersections 15' of filaments 13' and 14' in all cases form eyes 19, with only one filament looped around the other. The radial support strength is increased by the eyes 19, but shortening of the stent by axial compression is not possible due to the eyes 19.

[0005] Disadvantages of related art stent devices include axial shortening of the stent device caused by axial compression after insertion of the stent device into the human body. Axial shortening limits the extent to which the lumen of the stent device can be expanded within the human body. Disadvantages of related art stent devices also include the inability to axially shorten the stent device and a lack of flexibility due to loops formed at every intersection of the stent wires. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2013 / 0226282 [Patent Document 2] U.S. Patent No. 6,221,100 Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need to design a stent device having an efficient structure with practical use in mind, which would substantially avoid one or more problems due to limitations and drawbacks of stent devices of the related art.It is an object of the present disclosure to provide a stent device having an arrangement of looped and non-looped connecting regions. [Means for solving the problem]

[0008] An embodiment of the disclosed stent device includes first and second stent wires forming a cylindrical stent body enclosing an interior void space, a primary connection structure, and a secondary connection structure, the primary connection structure including a first loop formed from the first stent wire and defining a first loop opening; a first intersection and a second intersection formed from the first stent wire; a second loop formed from the first stent wire and defining a second loop opening, the second loop being positioned distally in an axial direction of the cylindrical stent body relative to the first loop by the first intersection and the second intersection; No. 2 and a second stent wire passing only once through the loop opening of the first stent wire, and the secondary connection structure includes the first stent wire and the second stent wire passing over each other. The first stent wire includes a first peak and a first valley, The aforementionedThe first loop is located at a first peak or a first valley of the first stent wire.

[0009] In embodiments of the disclosed stent device, the secondary connection structure may not include a loop.

[0010] In embodiments of the stent device of the present disclosure, in the secondary connection configuration, the first stent wire and the second stent wire may pass over each other without forming a loop.

[0011] In an embodiment of the disclosed stent device, the second stent wire can include a second peak and a second valley, the portion of the first stent wire forming the secondary connection structure can be the first peak, the portion of the second stent wire forming the secondary connection structure can be the second valley, and in the secondary connection structure, the first peak can be located in the second valley.

[0012] An embodiment of the disclosed stent device further includes a primary connection structure that includes a second loop.

[0013] In embodiments of the disclosed stent device, the second loop may be formed from a second stent wire and may define a second loop opening.

[0014] In embodiments of the disclosed stent device, a portion of the second stent wire forming the second loop opening may pass through the first loop opening.

[0015] In embodiments of the disclosed stent device, the second loop may be formed in a peak or valley of the second stent wire.

[0016] In embodiments of the disclosed stent device, the second loop may be formed from the first stent wire and may define a second loop opening, and the primary connection structure may include the second loop formed from the first stent wire.

[0017] In an embodiment of the disclosed stent device, the first loop and the second loop may be part of a double loop structure, and the first loop may be most distal of the first loop and the second loop.

[0018] In embodiments of the disclosed stent device, the primary connection structure may include a third loop.

[0019] In embodiments of the disclosed stent device, the third loop may be formed from one of the first stent wire and the second stent wire and may define a third loop opening.

[0020] In embodiments of the disclosed stent device, the primary connection structure may include a fourth loop.

[0021] In embodiments of the disclosed stent device, a fourth loop may be formed from one of the first stent wire and the second stent wire and may define a fourth loop opening.

[0022] In an embodiment of the disclosed stent device, the first loop, the second loop, the third loop and the fourth loop may form two double loop structures.

[0023] In embodiments of the disclosed stent device, the number of primary connection structures may be less than or equal to the number of secondary connection structures.

[0024] In embodiments of the disclosed stent device, the first stent wire may not include three consecutive loops along alternating peaks and valleys.

[0025] In an embodiment of the disclosed stent device, the first stent wire may include one loop between four consecutive alternating peaks and valleys.

[0026] Embodiments of the disclosed stent device further include that the first stent wire may include two loops between four consecutive alternating peaks and valleys.

[0027] Embodiments of the disclosed stent device may further include a stent delivery system including a sheath capable of carrying the stent device and a pusher for pushing the stent device out of the sheath. [Effects of the Invention]

[0028] The specific type of loop can vary, with non-looped connection regions contributing to the flexibility of the stent device and looped connection regions contributing to preventing axial shortening when the stent device is bent. The looped connection regions can be arranged continuously or discontinuously along the length of the stent device, i.e., in the axial direction, parallel to the longitudinal axis. In other embodiments, the looped connection regions are continuous across two or more, or even two to four, sequentially arranged looped connection regions. Such improved stent devices have an efficient structure and provide practical administration of the associated medical procedure. At least one or several of the objectives are achieved by the stent devices disclosed herein. [Brief explanation of the drawings]

[0029] [Figure 1] 1A-1C illustrate an embodiment of a stent device delivery system associated with a stent device. [Figure 2A] FIG. 1 shows a schematic diagram of a stent device in which the stent body is in a folded state. [Figure 2B] FIG. 1 shows a schematic diagram of a stent device with the stent body in an expanded state. [Figure 3] FIG. 1 is a close-up view of one embodiment of a stent body showing one aspect of a stent wire. [Figure 4] FIG. 1 is a close-up view of one embodiment of a stent body showing one aspect of a stent wire. [Figure 5A]1 is a schematic diagram of a stent device showing the placement of stent wires in the region of the stent body. [Figure 5B] 1 is a schematic diagram of a stent device in an enlarged view showing the placement of the stent wires in the region of the stent body. [Figure 5C] 1 is a schematic diagram of a stent device showing the placement of stent wires in the region of the stent body. [Figure 5D] 1 is a schematic diagram of a stent device in an enlarged view showing the placement of the stent wires in the region of the stent body. [Figure 6A] 1A-1C are schematic diagrams of a stent device deployed within a patient in straight and curved configurations. [Figure 6B] 1A-1C are schematic diagrams of a stent device deployed within a patient in straight and curved configurations. [Figure 6C] 1A-1C are schematic diagrams of a stent device deployed within a patient in straight and curved configurations. [Figure 7A] 1A-1C are schematic diagrams illustrating embodiments of a stent wire having different attachment mechanisms when the stent body is subjected to different force conditions. [Figure 7B] 1A-1C are schematic diagrams illustrating embodiments of a stent wire having different attachment mechanisms when the stent body is subjected to different force conditions. [Figure 8A] 1 is a table detailing different types of loops and their relative ranking with respect to axial shortening and bending. [Figure 8B] 1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 8C] 1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 9] 1 is a table detailing factors that may affect the functioning of each loop. [Figure 10A] 1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 10B] 1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 11A]1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 11B] 1 is a schematic diagram showing one embodiment of the structure of a connecting portion of a stent wire. FIG. [Figure 12] FIG. 1 is a schematic diagram showing the positions, distribution, and positional relationship of connecting portions in a stent device. [Figure 13] 1 is a schematic diagram illustrating the allocation of connections in a stent device, showing the details and placement of connection blocks in one embodiment. [Figure 14A] 10 is a schematic diagram illustrating the allocation of connections in a stent device, showing the details and placement of connection blocks in another embodiment. [Figure 14B] 10 is a schematic diagram illustrating the allocation of connections in a stent device, showing the details and placement of connection blocks in another embodiment. [Figure 15A] 1 is a schematic diagram of a connector and comparative photographs of an exemplary stent device. [Figure 15B] 1 is a schematic diagram of a connector and a comparative depiction of an exemplary stent device. [Figure 15C] 1 is a schematic diagram of a connector and a comparative depiction of an exemplary stent device. [Figure 15D] 1 is a schematic diagram of a connector and a comparative depiction of an exemplary stent device. [Figure 16A] 10A-10C are schematic diagrams of connectors showing the effect of different connectors on the flexibility of the stent device. [Figure 16B] 10A-10C are schematic diagrams of connectors showing the effect of different connectors on the flexibility of the stent device. [Figure 16C] 10A-10C are schematic diagrams of connectors showing the effect of different connectors on the flexibility of the stent device. [Figure 17] 10A-10C are schematic diagrams of connectors illustrating the effect of other connectors on the flexibility of the stent device. [Figure 18] 1A to 1C are diagrams illustrating an example of a method for manufacturing a stent device. [Figure 19] 1A to 1C are diagrams illustrating an example of a method for manufacturing a stent device. [Figure 20] 1A-1C show related art stent devices. [Figure 21] 1A-1C show related art stent devices. DETAILED DESCRIPTION OF THE INVENTION

[0030] In the following description, reference is made to certain structures and / or methods. However, the following references should not be construed as an admission that these structures and / or methods constitute prior art. Applicant expressly reserves the right to demonstrate that such structures and / or methods are not admitted as prior art against the present invention.

[0031] Additional features and advantages will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The objectives and other advantages of the disclosed stent device will be realized and attained by the structure particularly pointed out in the specification and claims hereof, as well as the appended drawings.

[0032] As used herein, the term "patient" includes any and all living organisms and subsumes the term "subject." A patient can be a human or an animal.

[0033] Other systems, methods, features, and advantages will be or become apparent to one of ordinary skill in the art upon examination of the following drawings and detailed description. All such additional systems, methods, features, and advantages are intended to be included within this description, be within the scope of the present disclosure, and be protected by the following claims. Nothing in this section should be construed as a limitation on the scope of those claims. Further aspects and advantages are described below in connection with embodiments of the disclosed input device. It should be understood that both the foregoing general description and the following detailed description of the disclosed input device are examples and illustrations and are intended to provide further explanation of the disclosed stent device as claimed.

[0034] The following detailed description of the preferred embodiments may be read in conjunction with the accompanying drawings, in which like numerals indicate like elements and in which:

[0035] Throughout the drawings, the dimensions of each component have been adjusted appropriately for clarity, and in some instances, only some of the named features in the figures are labeled with reference numerals for clarity.

[0036] The following detailed description of the preferred embodiments may be read in conjunction with the accompanying drawings, in which like numerals indicate like elements, and in which FIG. 1 is a diagram of a stent device delivery system 101. The stent delivery system 101 includes a tip section 102, a stent device 104, a sheath 106, a two-port hub 108, a side port 110, a rotatable handle lock 112, and an inner handle 114. The sheath 106 has a two-layer structure consisting of an inner sheath and an outer sheath. The sheath 106 has a collapsed stent device 104 held between the two layers at the tip section 102. The tip section 102 is connected to the inner sheath and the inner handle 114. The outer sheath is connected to the two-port hub 108 and the rotatable handle lock 112. After the stent delivery system 101 positions the tip section 102 and stent device 104 at the desired location, the outer sheath in the tip section 102 is slid proximally by fixing the inner handle 110 and pulling the rotatable handle lock 112 proximally of the delivery system 101, causing the stent device 104 to self-expand from its reduced diameter to its designed diameter. After the outer sheath has finished sliding the entire length of the stent device 104, the delivery system 101 and the stent device 104 are separated, and the stent device 104 is released for implantation into the patient's body.

[0037] FIG. 2A is a diagram of a stent device 104 with its stent body in a contracted state. The degree of axial shortening that occurs when the stent body contracts depends on the connection structure of the stent wire. The stent device 104 is inserted into a stent delivery system 101 in a contracted state so that the stent device 104 can be delivered through a patient's blood vessels and other narrow spaces. As shown in FIG. 2B, after the stent device 104, which is a self-expanding stent, reaches the treatment site and is pushed out of the stent delivery system 101, the stent body self-expands to the size the stent was designed to perform the treatment by expanding the treatment site.

[0038] FIG. 3 illustrates the pattern of stent wires forming the stent body of stent device 104. The stent wires form a cylindrical stent body (hereinafter "stent body"). The stent body includes an interior void space. The stent body defines the inner luminal side of the stent body. As shown in FIG. 3, the stent wires cross each other to form cells surrounded by the stent wires, such as stent cell 302. In FIG. 3, the interconnection or overlap of the stent wires can be seen, for example, by observing the positional relationship of stent wire 304 as it crosses stent wires 306, 308, and 310. Stent wire 304 crosses stent wire 306 at crossover 312, where stent wire 304 passes under stent wire 306. Stent wire 304 then crosses stent wire 308 at crossover 314, where stent wire 304 passes over stent wire 308. Stent wire 304 then passes under stent wire 310 at the next intersection 316. The alternating under and over position of stent wire 304 relative to the intersecting wire at each intersection is repeated throughout the stent body shown in FIG.

[0039] FIG. 4 illustrates another pattern of stent wires forming the stent body of stent device 104. Similar to FIG. 3, the stent wires of stent device 104 cross each other to form cells surrounded by the stent wires, such as stent cell 402. The interconnections or overlaps of the stent wires in the stent body illustrated in FIG. 4 are more complex than those in FIG. 3. For example, stent wires 404 and 406 cross each other at intersection 408, but each of stent wires 404 and 406 bends to form a connecting structure with a respective additional stent wire, such as stent wires 404 and 410, which form connecting intersection 412. Because stent wires 404 and 410 can move independently of each other, stent wires 404 and 410 in the region of connecting intersection 412 can form an interlocking stent cell 414.

[0040] 5A-5D illustrate the mechanism of axial shortening occurring in the stent device 104. FIG. 5B shows an enlarged view of region 502 of FIG. 5A, illustrating the stent wires of the stent body of the stent device 104 without axial shortening. In FIG. 5B, each stent wire is axially spaced (represented by arrow A in FIG. 5A) with the peaks 504 and valleys 506 of adjacent stent wires crossing each other, with the connections axially spaced farthest apart. Depending on the similarity of the structures of adjacent stent wires, the locations of the crossings 508 can be evenly distributed. FIG. 5D shows an enlarged view of region 502 of FIG. 5C, illustrating an example of axial shortening. In FIG. 5D, the peaks 504 and valleys 506 of adjacent stent wires no longer form crossings 508, and the stent wires are now more closely packed together, intermingling as the stent wires move toward an overlapping configuration. The axial shortening is evident by comparing distance D1 in FIG. 5A with distance D2 in FIG. 5C.

[0041] 6A-6C illustrate the benefits of the flexibility of stent device 204 after insertion into a patient's body. FIG. 6A shows stent device 204 inserted into treatment portion 530 of a patient. In FIG. 6A, stent device 204 is in a straight configuration. FIG. 6B shows stent device 204 inserted into treatment portion 530 and in a bent configuration. Sufficient flexibility allows stent device 204 to bend according to the bending angle of treatment portion 530. However, as shown in FIG. 6C, if the stent device lacks sufficient flexibility or is not flexible at all, it will not be able to bend according to the bending angle of treatment portion 530. Due to this lack of flexibility, advanced techniques are required to insert stent device 204 into treatment portion 530 to prevent contact between portion 532, shown in FIG. 6C, and stent device 204.

[0042] 7A and 7B show two types of interconnection structures for stent wires forming the stent body of a stent device. Stent wires typically form peaks and valleys (i.e., peaks 702 and valleys 704). The peaks and valleys of a given stent wire alternate around the circumference of the stent body. A first interconnection type 706 (also referred to as a secondary interconnection structure) is shown in FIGS. 7A and 7B. The first interconnection type 706 is formed by two stent wires that are interconnected by threading the first stent wire over the second stent wire. In particular, the first interconnection type 706 is characterized by threading the first stent wire over the second stent wire such that the peaks 702 of the first stent wire are positioned over and pass over the valleys 704 of the second stent wire when the stent device is axially expanded. This arrangement of the first and second stent wires in the first coupling pattern 706 results in the peaks 702 of one stent wire being located in the valleys 704 of the other stent wire. A second coupling pattern 708 (also referred to as a primary coupling structure) is also shown in Figures 7A and 7B and is formed by two stent wires coupled to each other by the first stent wire forming a loop over the second stent wire (so that the second stent wire passes through an opening formed by the loop in the first stent wire). The first coupling pattern 706 may also be formed without a loop.

[0043] As shown in Figure 7B, the two stent wires comprising the first linking type 706 can move relative to one another and relax, resulting in axial shortening when an axial force is applied to the stent device. For example, the crests 702 of one stent wire can move relative to the valleys 704 of the other stent wire, causing the crests 702 to disengage from the valleys 704, e.g., the crests 702 of one stent wire can move away from the valleys 704 of the other stent wire. In contrast, as also shown in Figure 7B, the stent wires forming the second linking type 708 are constrained from moving relative to one another by the loop structure, in that the stent wires forming the second linking type 708 do not disengage from each other, and a stent body having the structure of the second linking type 708 will not exhibit axial shortening even when an axial force is applied to the stent device. However, even if the stent wires forming the second coupling type 708 are not disengaged from one another, the first stent wire passing through the loop structure of the first stent wire can, in some embodiments, move circumferentially relative to the stent wire having the loop structure. Additionally, to the extent that the first stent wire has a structure with some axial positional variation (such as a pattern of peaks and valleys), the two stent wires can also have relative axial movement in some embodiments, although such axial movement is constrained by the peak-to-valley distance of each first stent wire passing through the loop structure. A combination of relative circumferential and relative axial movement can also occur in stent devices incorporating the second coupling type 708.

[0044] Generally speaking, a stent device can be made from multiple stent wires or from a single stent wire. Although a linking structure may seem to require two or more stent wires to intertwine with each other, a single stent wire can be used to construct the entire cylindrical stent structure by forming various linking structures with the single stent wire.

[0045] 8A is a diagram disclosing six exemplary types of links that can be used to form the second link-type 708 structure of the stent body. Each of the various exemplary types of second link-type 708 structures includes at least one loop using a stent wire. In some embodiments, the second link-type 708 structure includes one loop on only the first stent wire and no loops (i.e., no loops) on the other stent wire, while in other embodiments, the second link-type 708 structure includes a combination of one or more loops on one of two stent wires and zero or one or more loops on the other of the two stent wires.

[0046] Six exemplary types of connections are described below with reference to FIGS. 8A to 8C. The second connection type No. I is formed by a first stent wire forming a single loop and another stent wire not forming a loop. The second connection type No. I is also shown in FIGS. 7A and 7B. The second connection type No. II is formed by a first stent wire forming a double loop and another stent wire not forming a loop. The non-looped stent wire can pass through one or the other opening of the double loop, but typically, the non-looped stent wire passes distally of the two loops (as shown in FIG. 8A). FIG. 8B is a schematic diagram of the second connection type No. II. A double loop is formed between A and C, forming two intersections 802 and 804. Here, A to B is the "outward wire," and B to C is the "inward wire." In FIG. 8B, the outward wire passes under the inward wire at both intersections 802 and 804. Second connection type No. III is similar to second connection type No. II. FIG. 8C is a schematic diagram of second connection type No. III. A double loop is formed between A and C, forming two intersections 806 and 808. Here, A to B is the "outward wire" and B to C is the "inward wire." In FIG. 8C, the outward wire passes under the inward wire at intersection 802, and the outward wire passes over the inward wire at 804. In other words, in second connection type No. III, the stent wire that curves at intersection 806 is different from the stent wire that curves at intersection 808. Therefore, unlike second connection type No. II, second connection type No. III has a twisted outward and inward wires, making the double loop of second connection type No. III stronger than that of second connection type No. II. The unlooped stent wire can pass through one or the other opening of the double loop, but typically the unlooped stent wire passes distal to the two loops (as shown in FIG. 8A). The second link type, No. IV, is formed by two stent wires forming a single loop. The two single loops are interconnected to each other as shown in FIG. 8A.The second linked type No. V is formed by a first stent wire forming a double loop and another stent wire forming a single loop. The single loop is interconnected with the double loop by passing the wire of the single loop through one of the openings of one or the other of the double loops, but typically the single loop passes distally of the two loops (as shown in FIG. 8A). Finally, the second linked type No. VI is formed by two stent wires forming a double loop. The loop of the first stent wire is interconnected with the loop of the second stent wire, but typically the distal loops of both double loop structures pass through each other (as shown in FIG. 8A). As shown in FIG. 8C, to make the double loop structures of the second linked types No. V and No. VI more rigid compared to the structure disclosed in FIG. 8B, the entanglement of the outward and inward wires can be more complex (i.e., twisted).

[0047] Depending on the combination of no loops, single loops, and double loops on the two stent wires, the axial shortening and flexibility (bending) may vary. For example, as shown in Figure 8A, the level of axial shortening increases from second link type No. I to No. VI due to the number of loops involved, and the level of flexibility of the stent device increases from second link type No. VI to No. I.

[0048] FIG. 9 is a diagram disclosing four factors (Factors F1 to F4) that can affect the function of each loop included in various second connection types. Factor F1 is the size of the loop. Increasing the size of the loop increases the degree of freedom of the stent wire at the connection portion, improving the overall flexibility of the stent device. Factor F2 is the shape of the loop. An asymmetrical loop shape can cause uneven flexibility in the stent wire forming the loop, resulting in uneven flexibility at the connection portion. Factor F3 is the direction of loop rotation. Changing the direction of loop rotation can adjust the direction of increased or decreased flexibility of the stent wire that makes up the connection portion. Factor F4 is the rise of the loop. The rise of the loop structure creates an uneven surface of the stent device, which can minimize or prevent migration of the stent device within the treatment area of the patient.

[0049] 10A and 10B illustrate how loops are formed on two stent wires (i.e., second connector types No. IV, No. V, and No. VI) to prevent axial shortening of the stent device. FIG. 10A shows two stent wires forming a single second connector type No. I. When an axial force is applied to the stent device, the loop 1002 of the second connector type No. I can slide along the other stent wire, e.g., along a circumferential movement, reducing the (axial) distance between the stent wires and causing axial shortening of the stent device. In contrast, as shown in FIG. 10B, two stent wires form a single second connector type No. IV, with one loop formed on each stent wire. The loops 1004 formed on the two stent wires prevent the loops 1004 from sliding, helping to maintain the (axial) distance between the stent wires and preventing axial shortening of the stent device. The second connecting portions No. V and No. VI, in which both the first wire and the second wire form a loop, have the same effect as the second connecting portion type No. IV.

[0050] 11A and 11B illustrate how double loops are formed on two stent wires to prevent axial shortening of the stent device (i.e., second connector type No. IV). FIG. 11A shows two stent wires forming second connector type No. IV, with one loop formed on each stent wire. Contraction of the stent device, necessary for implanting a stent delivery system such as that depicted in FIG. 2A, applies a circumferential force to the stent wires. As shown in FIG. 11A, after the circumferential force is applied, the loop shape elongates axially (compare distance 1102a and distance 1102b), providing more space for axial shortening to occur when an axial force is applied. For example, the open space 1104 within each loop provides the stent wire with freedom of axial movement, as indicated by arrow M1 in FIG. 11A. In contrast, when two stent wires form a second link type No. VI in which both stent wires have double loops, as shown in FIG. 11B , the difference in axial distance between the loop configurations when a circumferential force is applied (right side of FIG. 11B ) and when no circumferential force is applied (left side of FIG. 11B ) (compare distance 1106a and distance 1106b) is significantly smaller than the configuration of FIG. 11A . While the overall axial length is related to the axial length of the double-loop structure, the open space 1108 within the interconnected loops provides room for the stent wires to have limited freedom of axial movement, as indicated by arrow M2 in FIG. 11B . Because distance M2 is less than distance M1, the double loop of FIG. 11B minimizes and prevents axial shortening when the stent device is placed in a contracted state or when an axial force is applied thereafter to a greater extent than the single-loop structure of FIG. 11A .

[0051] Figure 12 shows two variations of connectors within a stent device: first connectors and second connectors. The first connectors have connections between stent wires that conform to the first connector type disclosed herein, and the second connectors have connections between stent wires that conform to the second connector type disclosed herein. The schematic diagram on the right shows two different connector locations for a cylindrical stent device, which is shown as a sheet-like structure. White dots represent first connectors, e.g., structures without loops within the connector structure, and black dots represent second connectors, e.g., structures with at least one loop within the connector structure. In the embodiment of Figure 12, the second connectors are positioned axially linearly.

[0052] FIG. 13 illustrates the relationship of four adjacent links (circumferentially) that share a single stent wire 1302 to form a link block 1304. As disclosed in FIG. 13, a link block requires a stent wire to connect two adjacent stent wires to form four consecutive links. There are multiple such link blocks 1304 that extend circumferentially across the length of the stent device (e.g., the four link blocks 1304 in region 1300 shown in FIG. 13 form a row of link blocks 1304). There are multiple rows of such link blocks 1304 that extend axially. Within each row of link blocks 1304, the arrangement of the four adjacent links included within a link block 1304 varies. For example, each of connection blocks 1304a, 1304b, and 1304c in region 1300 has one second connection and three first connections (indicated by white dots (representing first connections) and black dots (representing second connections)), while connection block 1304d in region 1300 has no second connections. A close-up of connection block 1304d is shown in FIG. 13. In the close-up of connection block 1304d, a single stent wire 1302 is connected to two other stent wires at connections 1306, 1308, 1310, and 1312, with each of the four connections being a first connection.

[0053] As shown in FIG. 13 , the location of the second link of four adjacent links in any link block 1304 varies within the stent device depending on the circumferential position. Thus, in link block 1304a, the second link is in the second position, in link block 1304b, the second link is in the third position, and in link block 1304c, the second link is in the fourth position. The stent wires are interconnected in a repeating pattern. The first two consecutive crests of a first stent wire are captured by the first two consecutive valleys of an adjacent stent wire, and then a subsequent crest of the first stent wire is not captured by a subsequent valley of the adjacent stent wire. The first stent wire may be formed without three consecutive loops along alternating crests and valleys.

[0054] 14A is a schematic diagram of a stent body showing the alternating allocation (number and location) of first and second connectors. Connector block 1402 has two axially aligned connectors, one of which is a first connector and the other a second connector. Connector block 1404 has two axially aligned connectors, both of which are second connectors. Connector block 1404 has two or more second connectors arranged axially aligned. This allows for better prevention of axial shortening of the stent device than connector block 1402. The second connectors do not necessarily need to be arranged contiguously. Arranging multiple second connectors in the same axial direction contributes to preventing axial shortening of the stent device.

[0055] 14B is another schematic diagram of a stent body showing the alternating allocation (number and location) of first and second links. Link block 1406 discloses two consecutive second links aligned diagonally. In other words, in link block 1406, the second links are formed on consecutive peaks and valleys of the stent wire. The structure of link block 1406 prevents axial shortening of the stent device better than link block 1402. Link block 1408 discloses four consecutive second links aligned diagonally. This configuration of link block 1408 can prevent axial shortening of the stent device better than link block 1406. Arranging more second links diagonally than link block 1406 also contributes to preventing axial shortening of the stent device, but the number of second links does not have to be four.

[0056] Figures 15A-15D show various link blocks 1400 for practical implementation 1402 in a stent device. Figures 15A-15D show link blocks 1400a, 1400b, 1400c, and 1400d, each having two first link portions (i.e., no loops) (shown as white dots) and two second link portions (i.e., including at least one loop) (shown as black dots). Figures 15A-15D also show a second link portion 1402a in the form of a second link type No. VI, in which the two stent wires forming the link portion include a double loop.

[0057] 16A-16C illustrate the relationship between the allocation, e.g., number and location, of second links within a link block 1500 and the effect of such different allocations on the flexibility of the stent device. FIG. 16A discloses a link block having one second link (second link type No. I) (represented by a black dot) and three first links (first link type, i.e., no loops) (represented by white dots). The line diagram illustrates the relationship of the stent wires and how the second links interact with the first links. The line diagram illustrates that when a force is applied circumferentially to the stent device (arrow 1602 shown in FIG. 16A), the loosely linked first links provide room for the stent wires to intermingle, resulting in flexibility of the stent device (see, e.g., region P1 where the stent wires separate apart within the first link). However, the second links maintain their linkage relationship.

[0058] 16B and 16C disclose another example of a link block having two second links (second link type No. I) (represented by black dots) and two first links (first link type, i.e., no loops) (represented by white dots). The line diagram also shows that when force is applied circumferentially to the stent device (arrows 1604, 1606, 1608, and 1610 shown in FIGS. 16B and 16C), the loosely linked first links provide room for the stent wires to intermingle, resulting in flexibility of the stent device (see, e.g., regions P2 and P3 within the first links where the stent wires separate). However, the second links maintain their linkage.

[0059] The ratio of the number of second links to first links is ideally 1:3 or 2:2, or alternatively 0.15 to 0.60, 0.15 to 0.40, 0.15 to 0.30, 0.25 to 0.40, or 0.40 to 0.60.

[0060] 17 discloses a link block 1600 having three second links (second link type No. I) (represented by black dots) and one first link (first link type, i.e., no loop) (represented by white dots). The line diagram illustrates that in this embodiment, when force is applied circumferentially to the stent device (arrow 1702 shown in FIG. 17), the loosely linked first links do not allow the stent wires to intertwine, resulting in no flexibility of the stent device. This lack of flexibility is typically seen in link blocks that include three or more second links.

[0061] FIG. 18 shows an example of a method for manufacturing a stent device. The method for manufacturing the stent device includes the steps of preparing a jig 1800 having a cylindrical shaft 1802 and braiding at least one stent wire 1804, spirally winding it around the longitudinal axis of the shaft 1802 from the proximal end to the distal end of the shaft 1802. The jig 1800 has a plurality of pins 1806 attached to the outer periphery of the shaft 1802, and holes are formed at transition points on the outer periphery of the shaft 1802 for inserting the pins 1806. The holes in the shaft 1802 correspond to the white dots of the first connecting portion and the black dots of the second connecting portion shown in FIG. 12. The holes in the shaft 1802 are located at the intersections of a plurality of circumferential division lines extending in the longitudinal direction of the shaft 1802 and dividing the circumference of the shaft 1802 into multiple equal parts, and a plurality of length division lines extending in the circumferential direction of the shaft 1802 and dividing the length of the shaft 1802 into multiple equal parts. In preparing the jig 1800, a pin 1806 is installed in each hole of the shaft 1802. The pins 1806 installed in the holes are arranged along a helical path around the longitudinal axis of the shaft 1802.

[0062] During the braiding process, one end of the stent wire 1804 is fixed to an anchor pin 1808, and the stent wire 1804 extends from the anchor pin 1808 to the start pin 1806a, which is the nearest pin located on a length division line. The stent wire 1804 extends from the start pin 1806a in the circumferential direction of the shaft 1802 and is wound in a zigzag pattern around the longitudinal axis of the shaft 1802. This process forms multiple wound stent wires 1804. The stent wire 1804 extends in a zigzag pattern in the circumferential direction, alternately passing through pins 1806 on one length division line and pins 1806 on the other length division line adjacent to the first length division line. This forms peaks on the pins 1806 on one length division line and valleys on the pins 1806 on the other length division line.

[0063] Figure 19 further illustrates one example of a method for manufacturing a stent device. As shown in Figure 19, stent wire 1804a extends circumferentially, passing through pins 1806 in an alternating zigzag pattern, forming peaks 1902 and valleys 1904. Stent wire 1804b extends circumferentially, passing through pins 1806 in an alternating zigzag pattern, forming peaks 1906 and valleys 1908. Stent wire 1804b forms a loop around pin 1806 and can connect with stent wire 1804a to form loop 1910 in second valley 1908 of stent wire 1804b, which can be a single loop or multiple loops, forming various types of connections as described in the previous embodiments.

[0064] While the present invention has been described in connection with preferred embodiments thereof, those skilled in the art will appreciate that additions, deletions, modifications, and substitutions not specifically described may be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

[0065] Embodiments of the disclosed stent device further include a ratio of the number of primary connection structures to the number of secondary connection structures that is 0.15 to 0.60, alternatively 0.15 to 0.40, or 0.15 to 0.30, or 0.25 to 0.40, or 0.40 to 0.60.

[0066] An embodiment of the disclosed stent device further includes a stent cover, which covers at least a portion of the outer circumferential surface of the cylindrical stent body.

[0067] An embodiment of the disclosed stent device further includes a stent cover, which covers at least a portion of the inner circumferential surface of the cylindrical stent body.

[0068] An embodiment of the disclosed stent device further includes a stent cover, wherein a first portion of the stent cover covers at least a portion of the outer circumferential surface of the cylindrical stent body, and a second portion of the stent cover covers at least a portion of the inner circumferential surface of the cylindrical stent body.

[0069] In an embodiment of the disclosed stent device, the two loops may be arranged sequentially along alternating peaks and valleys.

[0070] An embodiment of the disclosed stent device further includes two loops that are not sequentially arranged along alternating peaks and valleys.

[0071] An embodiment of the disclosed stent device further includes two loops that connect with the second stent wire.

[0072] An embodiment of the disclosed stent device further includes a first loop that is asymmetric.

[0073] An embodiment of the disclosed stent device further includes a first loop that projects outwardly from the lumen of the stent device.

[0074] An embodiment of the disclosed stent device further includes the first stent wire and the second stent wire being a single wire. [Industrial Applicability]

[0075] The improved stent device has an efficient structure and provides practical administration of the associated medical treatment. [Explanation of symbols]

[0076] 101 Stent delivery system 104 Stent Device 706 First Link Type (Secondary Link Structure) 708 Second connection type (primary connection structure)

Claims

1. a first stent wire and a second stent wire forming a cylindrical stent body, the cylindrical stent body enclosing an interior void space; a primary connection structure; a secondary linking structure; Equipped with The primary linking structure is a first loop formed from the first stent wire and defining a first loop opening; a first intersection and a second intersection formed from the first stent wire; a second loop formed from the first stent wire, defining a second loop opening, and positioned distally of the first loop in an axial direction of the cylindrical stent body by the first intersection and the second intersection; the second stent wire passing only once through the second loop opening; Including, the secondary connection structure includes the first stent wire and the second stent wire passing over each other; A stent device, wherein the first stent wire includes a first peak and a first valley, and the first loop is located at the first peak or the first valley of the first stent wire.

2. The stent device of claim 1 , wherein the secondary connection structure does not include a loop.

3. The stent device of claim 1 , wherein in the secondary connection configuration, the first stent wire and the second stent wire pass over each other without forming a loop.

4. the second stent wire includes second peaks and second valleys, and the portions of the first stent wire that form the secondary connection structure are the first peaks and the portions of the second stent wire that form the secondary connection structure are the second valleys; The stent device of claim 2 , wherein in the secondary connection structure, the first peak is located in the second valley.

5. The stent device of claim 1 , wherein the size of the second loop is greater than the size of the first loop.

6. the first loop is disposed between the first intersection and the second intersection; The stent device of claim 1 , wherein the second loop is positioned axially distal to the first loop relative to the second intersection.

7. 2. The stent device of claim 1, wherein the first stent wire has an outward wire and an inward wire, the outward wire passing under the inward wire at the first intersection and the second intersection.

8. the first stent wire has an outward wire and an inward wire; 2. The stent device of claim 1, wherein the outward wire passes under the inward wire at the first intersection and over the inward wire at the second intersection.

9. The stent device of claim 6, wherein the second loops are formed in peaks or valleys of the first stent wire.

10. The stent device of claim 1 , wherein a third loop is formed from the second stent wire and defines a third loop opening.

11. The stent device of claim 10, wherein a fourth loop is formed from the second stent wire and defines a fourth loop opening.

12. The stent device of claim 11, wherein the first loop, the second loop, the third loop, and the fourth loop form two double loop structures.

13. The stent device of claim 1 , wherein the number of primary connection structures is less than or equal to the number of secondary connection structures.

14. The stent device of claim 1 , wherein the first stent wire does not include three consecutive loops along alternating peaks and valleys.

15. The stent device of claim 1 , wherein the first stent wire includes one loop of four consecutive alternating peaks and valleys.

16. The stent device of claim 1 , wherein the first stent wire includes two loops of four consecutive alternating peaks and valleys.

17. the stent device comprising: a sheath capable of carrying said stent device; a pusher for pushing the stent device out of the sheath; The stent device of claim 1 , comprising a stent delivery system comprising:

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