Stent device with stent cover having multiple junction regions

Abstract

The stent device has a stent cover joined to the stent wires forming the stent body at a plurality of junctions distal to the intersection of the stent wires. By apportioning the junctions to the stent wires between the intersection portions, axial flexibility of the stent device is maintained. The stent cover joined by the disclosed junctions helps prevent luminal tissue from penetrating the stent body and occluding the stent, and placement of the junctions joining the stent cover to the stent device provides a change in positive outcomes for the covered stent device and the patient in which the stent device is placed.

Description

[0001] Related application data

[0002] This application is based upon and claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63 / 168,370, filed on March 31, 2021, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to stent devices, and more particularly to stent devices having a stent cover joined to a stent body by a plurality of joining regions, which helps to increase the axial flexibility of the stent device, particularly in the loops, interlocks and / or entanglements between the wires forming the stent body. Background Art

[0004] In the following discussion, reference is made to specific structures and / or methods. However, the following references should not be construed as an admission that these structures and / or methods constitute prior art. Applicants expressly reserve the right to demonstrate that such structures and / or methods do not conform to the prior art for the present invention.

[0005] Typically, stent devices are implanted in a patient's internal organs to push lesions and widen narrowed organs such as blood vessels, bile ducts, esophagus, duodenum, and small intestine. Stent devices can be covered or uncovered. On the one hand, in uncovered stent devices, restenosis may occur after implantation because luminal cells penetrate the mesh of the wire and enter the stent lumen ("ingrowth"). Although restenosis may help anchor the stent device and prevent the uncovered stent device from migrating (i.e., changing the stent position within the patient's body), restenosis may lead to the return of harmful medical conditions or new harmful medical conditions, such as luminal tissue proliferation on the lumen side of the stent body. On the other hand, as a measure to prevent restenosis, covered stent devices can be used. However, while the cover of a covered stent device prevents restenosis, the cover also reduces the axial flexibility of the stent device, which may be necessary when the stent device needs to be implanted in an internal organ with a complex shape and its lumen.

[0006] Figure 13 is a diagram of a covered stent device disclosed in the prior art (U.S. Patent Publication No. 2017 / 01434610A1). Figure 131 is a partial cross-sectional view illustrating the internal structure of a conventional covered stent 100. Conventional covered stent 100 includes a cylindrical stent body 52 and a stent covering formed of PTFE tape 10-1 and PTFE tape 10. The cylindrical stent body 52 is formed by alternating braids of different shape-memory alloy wires 1 and 2, and has multiple interlocking portions 3 and multiple intersecting portions 4, allowing the size of a diamond-shaped opening 5 to be changed under the action of an external force. For example, PTFE tape 10-1 is placed around the entire outer surface of the cylindrical stent body 52, and PTFE tape 10 is intermittently placed on the inner surface of the cylindrical stent body 52. ​​When heat and pressure are applied to the entire stent device, the PTFE tape 10-1 and PTFE tape 10 are bonded to each other at the diamond-shaped opening 5, while the PTFE tape 10-1, which is not bonded to the PTFE tape 10 due to the spacing of the PTFE tape 10, remains free relative to the cylindrical stent body 52. This configuration allows the conventional covered stent 100 to be completely covered from the outer surface by the PTFE tape 10 - 1 , preventing lesions from invading the cylindrical stent, while simultaneously enabling axial flexibility due to the bonding intervals between the PTFE tape 10 - 1 and the PTFE tape 10 . Figure 14 is a diagram from the same prior art (U.S. Patent Publication No. 2017 / 01434610A1), and is a photograph showing the bending characteristics of an actual product of the covered stent 100 of the prior art.

[0007] While conventional covered stents 100 possess a certain degree of flexibility and axial strength, the locations of the bending portions, fixed to the spacing of the PTFE tape 10, may not align with the locations within the lumen of an internal organ where bending is desired. Furthermore, if the covered stent includes a plurality of interlocking portions 3, where one or more wires are entangled, the covered stent may undesirably lose flexibility if the PTFE tape 10 covers the area including the specific interlocking portions 3. Consequently, due to the fact that conventional covered stents 100 do not conform to the shape of the lumen in which they are placed, the therapeutic effect may be reduced. Summary of the Invention

[0008] Therefore, there is a need for a covered stent device having a structure that, in view of practical use, substantially eliminates one or more of the problems caused by the limitations and disadvantages of the prior art covered stent devices. An object of the present disclosure is to provide an improved stent device having an efficient structure and practical management of the associated medical procedures. Furthermore, there is a need for an improved covered stent device that balances the risks of restenosis and migration while allowing the stent device to achieve the purpose of enlarging a stenotic organ at a treatment site by flexibly reaching the treatment site. At least one or some of the objects are achieved by the stent device disclosed herein.

[0009] In general, the disclosed structures and systems provide stents and stent covers that effectively inhibit ingrowth, such as those discussed above, and problems associated with the prior art. To address the problems, a stent cover structure is disclosed that engages the stent wires at locations other than the interlocking structure of the stent wires.

[0010] For example, the disclosed stent device has a stent cover that is joined to the stent body at portions of the stent wires (which come from the stent body) other than at portions of the interlocking structures of the stent wires (the interlocking structures of the stent wires are primary interlocking structures such as ring structures or secondary interlocking structures such as intersection structures, where the first wire crosses or passes over / under the second wire). The joining portion between the stent cover and the stent body is separated from the portion of the interlocking structure of the stent wires (whether the primary interlocking structure or the secondary interlocking structure), while maintaining the flexibility of the covered stent device, the growth and proliferation of luminal tissue is prevented from protruding into the inner cavity side of the stent device (which may cause obstruction of the stent device). The stent wires woven into the stent body of the stent device can be divided into two types, one being the stent wire that is closer to the inner cavity of the stent device, and the other being the stent wire that is closer to the outer space of the stent device. The stent wires for the stent cover to engage are based on the placement of the stent cover - the stent wires closer to the inner cavity of the stent device are engaged with the stent cover placed on the surface of the stent body toward the inner cavity of the stent device, and the stent wires closer to the outer space of the stent device are engaged with the stent cover placed on the outside of the outer surface of the stent body.

[0011] In some aspects, the stent cover and the stent wire can be joined at multiple locations along the length of the stent wire between the interlocking structures of the stent body. Depending on the level of flexibility to be maintained, the stent cover and the stent wire can be joined at different points or at specific lengths. The stent cover can be folded back and bonded together at both ends of the stent device to form a fixed portion for securely securing the stent cover to the stent device.

[0012] Embodiments of the disclosed stent device include: one or more stent wires forming a stent body that encloses an interior void and defines an endoluminal surface of the stent body; and a stent cover covering at least a portion of the stent body. The one or more stent wires of the stent body include intersections that form a plurality of open cells, wherein each open cell includes a perimeter defined by a portion of the one or more stent wires and enclosing the cell void. The stent cover and a first segment of a portion of the one or more stent wires are joined together at a junction, and the intersection and the junction are separated from each other by a second segment of a portion of the one or more stent wires, which is not joined to the stent cover.

[0013] Embodiments of the disclosed stent devices also include a single junction present on a first segment of a portion of one or more stent wires between adjacent intersections.

[0014] Embodiments of the disclosed stent devices also include a plurality of junctions present on a first segment of a portion of one or more stent wires between adjacent intersections.

[0015] Embodiments of the disclosed stent devices also include junctions, between adjacent intersection junctions, present over up to 80% of the total length of the first segment of a portion of one or more stent wires.

[0016] Embodiments of the disclosed stent device also include a stent cover positioned on the luminal surface of the stent body.

[0017] Embodiments of the disclosed stent devices also include a stent cover extending the entire axial length of the stent body.

[0018] Embodiments of the disclosed stent device also include a stent cover that is folded back to cover an end portion of the luminal surface of the stent body.

[0019] Embodiments of the disclosed stent device also include a junction portion located on an inner wire portion of the stent wire that is radially inward from the outer wire portion of the stent wire.

[0020] Embodiments of the disclosed stent apparatus also include a stent cover positioned on an outer surface of the stent body.

[0021] Embodiments of the disclosed stent devices also include a stent cover extending the entire axial length of the stent body.

[0022] Embodiments of the disclosed stent device also include a stent cover that is folded back to cover an end portion of the outer surface of the stent body.

[0023] Embodiments of the disclosed stent device also include a junction located on an outer wire portion of the stent wire that is radially outward from the inner wire portion of the stent wire.

[0024] Embodiments of the disclosed stent device further include a stent cover comprising a first stent cover portion located on the luminal surface of the stent body and a second stent cover portion located on the outer surface of the stent body.

[0025] Embodiments of the disclosed stent device also include at least one of a first stent cover portion and a second stent cover portion extending across the entire axial length of the stent body.

[0026] Embodiments of the disclosed stent device also include first and second stent cover portions extending throughout the entire axial length of the stent body.

[0027] Embodiments of the disclosed stent device also include a stent cover that is folded back to cover an end portion of the outer surface of the stent body.

[0028] Embodiments of the disclosed stent device also include first and second stent cover portions joined together at the plurality of open cells.

[0029] Embodiments of the disclosed stent device further include a junction comprising a first junction located at an inner wire portion of the stent wire and a second junction located at an outer wire portion of the stent wire, wherein the inner wire portion of the stent wire is radially inward from the outer wire portion of the stent wire.

[0030] Embodiments of the disclosed stent devices also include intersections having primary interlocking structures.

[0031] Embodiments of the disclosed stent devices also include intersections having secondary interlocking structures.

[0032] Embodiments of the disclosed stent device also include a stent delivery system comprising: a front end; a covered stent device; a double-layer sheath having an axial length and configured to carry the covered stent device from a first position along the axial length to a second position along the axial length; and a handle for removing the stent device from the double-layer sheath.

[0033] As used herein, the term "patient" includes any and all organisms and encompasses the term "subject." A patient can be human or animal.

[0034] Additional features and advantages will be set forth in the following description, and in part will be apparent from the description, or may be learned through practice of the invention. The objectives and other advantages of the disclosed stent device will be realized and obtained by the structures particularly pointed out in the written description and technical solutions as well as the accompanying drawings.

[0035] Upon inspection of the drawings and detailed description, other systems, methods, features and advantages will be or will become apparent to one skilled in the art. It is intended that all such additional systems, methods, features and advantages be included within this specification, be within the scope of the present disclosure, and be protected by the accompanying technical solutions. Nothing in this section should be construed as limiting these technical solutions. Further aspects and advantages are discussed below in conjunction with embodiments of the disclosed input device. It should be understood that the foregoing general description and the following detailed description of the disclosed input device are exemplary and illustrative, and are intended to provide further explanation of the disclosed bracket device as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The following detailed description of the preferred embodiments may be read in conjunction with the accompanying drawings, in which like numerals represent like elements, and in which:

[0037] Figure 1 An embodiment of a stent delivery system including a stent device is illustrated.

[0038] Figure 2A and Figure 2B Shown in collapsed state ( Figure 2A ) and expansion state ( Figure 2B ) is a schematic diagram of the bracket body.

[0039] Figure 3 and Figure 4 is an enlarged view of an embodiment of a stent body and illustrates aspects of the stent wires.

[0040] Figure 5 An example of a method of manufacturing a stent device is illustrated.

[0041] Figure 6 is an enlarged schematic diagram of an embodiment of a stent body and illustrates aspects of the stent wire.

[0042] Figure 7 A covered stent device with a stent cover is schematically illustrated, wherein the stent cover is attached at the lumen of the stent device and the excess stent cover is folded back and fused together.

[0043] Figures 8A to 8C is an enlarged schematic diagram of an embodiment of a stent body and illustrates aspects of the stent wire.

[0044] Figures 9A to 9C is an enlarged schematic diagram of an embodiment of a stent body and illustrates aspects of the stent wire.

[0045] Figures 10A to 10C is an enlarged schematic diagram of an embodiment of a stent body and illustrates aspects of the stent wire.

[0046] Figure 11 and Figure 12 Alternative stent devices are shown that may incorporate embodiments of the disclosed stent covers.

[0047] Figure 13 and Figure 14 A prior art stent arrangement is shown.

[0048] In all the drawings, for the sake of clarity, the sizes of the various components are appropriately adjusted. For ease of viewing, in some cases, only some named features in the drawings are marked with reference numerals. DETAILED DESCRIPTION

[0049] Figure 1 1 is a diagram of a stent device delivery system 101. The stent delivery system 101 includes a front end 102, a stent device 104, a sheath 106, two port hubs 108, side ports 110, a rotatable handle lock 112, and an inner handle 114. The sheath 106 has a two-layer structure of an inner sheath and an outer sheath, and has a stent device 104 with a reduced diameter held between the two layers at the front end 102. The front end 102 is connected to the inner sheath and the inner handle 114. The outer sheath is connected to the two port hubs 108 and the rotatable handle lock 112. After the stent delivery system 101 places the front end 102 and the stent device 104 at the desired position, by fixing the inner handle 110 and pulling the rotatable handle lock 112 toward the proximal side of the delivery system 101, the outer sheath at the front end 102 slides proximally, causing the stent device 104 to self-expand from the reduced diameter to the designed diameter. After the outer sheath has completely slid the entire length of the stent device 104, the delivery system 101 and the stent device 104 are separated, leaving the stent device 104 to be implanted in the patient.

[0050] In some procedures, the stent delivery system 101 implants a stent device 104 into the patient's body to open a stricture (e.g., a vascular (circulatory) stent), and in some embodiments, this procedure is combined with the use of an endoscope. For example, in the case of a bile duct stent implant, an endoscope is inserted through the mouth and advanced into the duodenum. The stent delivery system 101 is then passed through the endoscope's clamp channel and into the bile duct through the duodenal papilla. Finally, the stent device 104 is placed in the bile duct stricture using the visual imagery of the endoscope.

[0051] Figure 2A is a diagram of a stent device 104 with the stent body in its collapsed state. The degree of axial shortening that occurs when the stent body collapses depends on the interlocking structure of the stent wires. In order to deliver the stent device 104 through a patient's blood vessels and other confined spaces, the stent device is inserted into the stent delivery system 101 in its collapsed state. Figure 2B As disclosed, after the stent device 104 , which is a self-expanding stent, reaches the treatment site and is ejected from the stent delivery system 101 , the stent device 104 expands to a size designed for treating the treatment site.

[0052] Figure 3 The diagram shows a pattern of stent wires comprising the stent body of the stent device 104. Figure 3 As shown, the stent wires intersect with each other and form cells surrounded by the stent wires, such as stent cell 302. For example, by observing the positional relationship of stent wire 304 when it intersects with stent wires 306, 308, and 310, it can be seen that Figure 3 3. The interconnection or overlap of the stent wires is seen in FIG. 3. At intersection 312, stent wire 304 intersects stent wire 306 (where stent wire 304 passes under stent wire 306). Then, at intersection 314, stent wire 304 intersects stent wire 308 (where stent wire 304 passes over stent wire 308). Stent wire 304 then passes under stent wire 310 at the next intersection 316. Wire 304 is positioned alternately up and down relative to the intersecting wires at each intersection. Figure 3 Repeated throughout the body of the stent as shown.

[0053] Figure 4 Another pattern of stent wires comprising the stent body of the stent device 104 is shown. Figure 3 Similarly, the stent wires of the stent device 104 cross each other and form cells surrounded by the stent wires, such as stent cell 402. Figure 3 Compared with Figure 4 The interconnection or overlap of the stent wires in the stent body shown is more complex. For example, stent wires 404 and 406 cross each other at intersection 408, but stent wires 404 and 406 are each bent and interlocked with the corresponding other stent wire, such as stent wires 404 and 410 forming interlocking intersection 412. Because stent wires 404 and 410 can move independently of each other, stent wires 404 and 410 in the area of ​​interlocking intersection 412 can form interlocking stent cells 414.

[0054] The stent device 104 may be made by braiding NiTi alloy wires or other wires made of biocompatible materials. When the stent device 104 is expanded into a tubular shape, the tubular shape is memorized.

[0055] Figure 5 The diagram illustrates an example method for manufacturing a stent device. The method includes preparing a jig 500 having a cylindrical shaft 502 and braiding at least one stent wire 504, spirally wrapping around the longitudinal axis of the shaft 502 from its proximal end to its distal end. The jig 500 has multiple pins 506 attached to the outer circumference of the shaft 502, and holes are formed at turning points on the outer circumference of the shaft 502 for inserting the pins 506. The holes in the shaft 502 are located at the intersections of multiple circumferential dividing lines, which extend longitudinally of the shaft 502 and divide the circumference of the shaft 502 into multiple equal sections, and multiple length dividing lines, which extend circumferentially of the shaft 502 and divide the length of the shaft 502 into multiple equal sections. During the preparation of the jig 500, a pin 506 is attached to each hole in the shaft 502. The multiple pins 506 attached to the holes are arranged along a spiral path around the longitudinal axis of the shaft 502.

[0056] During the braiding process, one end of the stent wire 504 is fixed to the anchor pin 508, and the stent wire 504 extends from the anchor pin 508 to the starting pin 506a, which is the pin closest to the length dividing line. The stent wire 504 extends from the starting pin 506a in the circumferential direction of the shaft 502 and is wrapped around the longitudinal axis of the shaft 502 in a zigzag manner. This forms a plurality of wound stent wires 504. At this time, the stent wire 504 extends in a zigzag manner in the circumferential direction, while alternately passing through the pins 506 located in one length dividing line and the pins 506 located in another length dividing line adjacent to the distal end of the one length dividing line. This forms peaks on the pins 506 located in one length dividing line and valleys on the pins 506 located in the other length dividing line.

[0057] Figure 6 The figure shows the pattern of the stent wire constituting the stent body of the stent device 104. Figure 6 As shown, stent wires 602 may be alternately braided to form cells surrounded by the stent wires 602, such as stent cell 604. The stent wires 602 are entangled at interlocking structures 606 for alleviating axial forces, which are forces that serve to return the stent device 104 to its original straight position when the stent device 104 is bent. Figure 6 The interlocking structure 606 in FIG. Figure 4 The primary interlock structure is the same as the interlock 414 shown in FIG, but may alternatively be a primary interlock structure such as that shown in FIG. Figure 3 The intersection 314 shown in FIG is the same as the secondary interlocking structure of the intersection. Figure 6 , the area marked with diagonal lines represents a stent cover 608, which is connected to the stent wire 602 of the stent body of the stent device 104 by a junction 610. The junction 610 can be an inconspicuous location such as a round or square dot, or can be an extension such as a junction 612 having a length dimension that extends along the length of the stent wire 602. The extension of the junction 612 has the effect of increasing the fixation of the stent cover 608 to the stent wire 602, but can increase the axial force of the stent device 104. The extension of the junction 612 can cover 70% to 90% of one or more stent wires between adjacent interlocking structures 606. The junction 610 and junction 612 are located on the stent wire 602, away from the interlocking structure 606 and between the interlocking structures 606 (whether primary or secondary interlocking structures). Between the interlocking structures 606, there can be a single junction 610 or junction 612 (see, e.g., FIG. 2 ). Figure 6 ), or there may be multiple junctions 610 or junctions 612 (see e.g. Figure 6 region P in the .

[0058] The junction 610 and the junction 612 are located away from the interlock structure 606 to avoid locking the interlock structure 606 in place (which would result in an increase in axial force and also negatively affect the flexibility of the stent device 104). Because the junction 610 and the junction 612 are only located at a location of the stent wire 602 away from the interlock structure 606, the stent cover 608 and the stent wire 602 can move freely to provide flexibility during stent bending or when the stent device 104 is bent without the interlock structure 606 being locked or restricted in movement. In other words, because the stent wire 602 can move freely with the engaged stent cover 608, the sliding of the stent wire 602 at the interlock structure 606 is not hindered, resulting in continuous bending ability and flexibility of the stent device 104.

[0059] In addition, the junction 610 and the junction 612 are located on the portion of the stent wire 602 that is closer to the stent cover 608. Because the stent wire 602 is braided together by the interlocking structure 606, the stent wire 602 will be divided into a portion forming an inner wire structure 614 and a portion forming an outer wire structure 616. In terms of structure, when viewed in an axial cross-section, the portion forming the inner wire structure 614 and the portion forming the outer wire structure 616 are at different radial distances from the longitudinal axis of the stent device, wherein the portion forming the inner wire structure 614 is radially inward of the portion forming the outer wire structure 616. Figure 6 In the embodiment shown in FIG. 1 , because stent cover 608 is placed within the lumen of stent device 104, i.e., on the inner surface of stent device 104, inner wire structure 614 will be closer to stent cover 608. Thus, junction 610 and junction 612 will be located on inner wire structure 614. Conversely, if stent cover 608 is placed on the outer surface of stent device 104, outer wire structure 616 will be closer to stent cover 608. Thus, junction 610 and junction 612 will be located on outer wire structure 616.

[0060] Stent cover 608 can be made of PTFE membrane or other polymer membranes such as silicone or polyurethane, as well as composite membranes produced by lamination. In addition, porous ePTFE membrane can be used to increase the flexibility of the membrane, and the elasticity of the membrane may be more preferred depending on the application. Stent cover 608 and stent device 104 can be joined by heat welding. In addition to heat welding, adhesion, threading, sealing, and other joining methods compatible with stent cover 608 can also be used.

[0061] Figure 7The illustration shows a stent device 104 having a stent cover 608 attached from the lumen by a plurality of junctions 610 or junctions 612. Because the stent cover 608 is attached from the lumen of the stent device 104, the stent wire 602 is exposed to the space outside the stent device 104. The stent cover 608 covers the entire inner surface of the stent device 104, and the overhanging portion of the stent cover 608 (such as at location 702) can be folded back at both ends to cover the outer surface of the stent device 104. As a separate embodiment, another set of stent covers having the same diameter and a shorter length (e.g., 10 mm or less, preferably 3 to 5 mm) can be placed on the outer surface of the stent device 104 at both ends. The stent covers at both ends of the stent device 104 undergo the above-described junction process, directly attaching the inner stent cover to the outer stent cover at the stent cell 604 and surrounding the stent wire 602. So-called "full-surface fixation" can be used to securely fix the stent cover 608 to both ends of the stent device 104. The length of the full-surface fixation at both ends preferably extends 10 mm or less, more preferably 3 to 5 mm, in the longitudinal direction of the stent device 104. If present, the full-surface fixation can be at the same location (e.g., location 702) as the folded-back overhang at the end of the stent device 104. In addition, as an independent embodiment, the stent cover 608 may not cover the entire inner cavity or outer surface of the stent device 104, but may cover only specific portions of the inner cavity and / or outer surface of the stent device 104.

[0062] Although not shown in the figures, in an alternative embodiment, the stent cover 608 can cover the entire outer surface of the stent device 104, and the protruding portions of the stent cover 608 at both ends can be folded back to cover the inner lumen of the stent device 104. As a separate embodiment, another set of stent covers having the same diameter and a shorter length (e.g., 10 mm or less, preferably 3 to 5 mm) can be placed at the inner lumens of both ends of the stent device 104. The stent covers at both ends of the stent device 104 are subjected to the above-mentioned joining process, and the outer stent cover is directly attached to the inner stent cover at the stent cell 604 and surrounds the stent wire 602. The so-called "full-surface fixation" will be used to firmly fix the stent cover 608 to both ends of the stent device 104. The length of the full-surface fixation at both ends preferably extends 10 mm or less, more preferably 3 to 5 mm, along the longitudinal direction of the stent device 104.

[0063] Figure 8A is a schematic diagram of an enlarged portion of a stent body of a stent device 104 formed using stent wire 602, and showing interlocking structures 606 and joints 610 (represented by solid dots). Stent cover 608 (for clarity, not shown in FIG. Figure 8A(not shown) covers the entire enlarged portion of the stent body from the inner cavity side. Figure 8B and Figure 8C ), the stent wire 602 includes an inner wire portion 614 and an outer wire portion 616.

[0064] Figure 8B is Figure 8A A schematic diagram of a portion of an axial cross-sectional view taken from A to A' shown, Figure 8C is Figure 8A Schematic diagram of a portion of the cross-sectional view taken from B to B' shown. Figure 8B and Figure 8C As shown, a stent cover 608 is attached to the stent body of the stent device 104 from the inner lumen 802, and the stent wire 602 and the junction 610 are exposed to the exterior space 804 of the stent device 104. Stent wire 602a is part of an inner wire portion 614 and is located radially inward relative to stent wire 602b, which is part of an outer wire portion 616. As part of the inner wire portion 614, stent wire 602a is positioned at a first distance from the stent cover 608, and as part of the outer wire portion 616, stent wire 602b is positioned at a second distance from the stent cover 608, the second distance being greater than the first distance, meaning that stent wire 602b is further away from the stent cover 608 than stent wire 602a. Thus, the junction 610 is formed at the stent wire 602a of the inner wire portion 614 rather than at the stent wire 602b of the outer wire portion 616.

[0065] Figure 9A is a schematic diagram of an enlarged portion of a stent body of a stent device 104 formed using stent wire 602, and showing interlocking structures 606 and joints 610 (represented by solid dots). Stent cover 608 (for clarity, not shown in FIG. Figure 9A (not shown) covers the entire enlarged portion of the stent body shown from the outer surface. Figure 9B and Figure 9C ), the stent wire 602 includes an inner wire portion 614 and an outer wire portion 616.

[0066] Figure 9B is Figure 9A A schematic diagram of the axial cross-section at A to A' shown, Figure 9C is Figure 9A Schematic diagram of a portion of the cross-sectional view taken from B to B' shown. Figure 9B and Figure 9CAs shown, a stent cover 608 is attached to the stent body of the stent device 104 from the exterior space 804, and the stent wire 602 and the junction 610 are exposed to the interior lumen 802 of the stent device 104. Stent wire 602b is part of an outer wire portion 616 and is located radially outward relative to stent wire 602a, which is part of an inner wire portion 614. As part of the inner wire portion 614, stent wire 602a is positioned at a first distance from the stent cover 608, and as part of the outer wire portion 616, stent wire 602b is positioned at a second distance from the stent cover 608, the second distance being greater than the first distance, meaning that stent wire 602b is further away from the stent cover 608 than stent wire 602a. Consequently, the junction 610 is formed at the stent wire 602b of the outer wire portion 616 rather than at the stent wire 602a of the inner wire portion 614.

[0067] Figure 10A is a schematic diagram of an enlarged portion of a stent body of a stent device 104 formed using stent wire 602 and showing interlocking structures 606 and joints 610 (represented by solid dots). Figure 10A The stent device 104 is not shown in the figure and includes a first stent cover portion 608a covering the entire enlarged portion of the stent body from the inner cavity side and a second stent cover portion 608b covering the entire enlarged portion of the stent body from the outer surface of the stent device 104. Figure 10B and Figure 10C ), the stent wire 602 includes an inner wire portion 614 and an outer wire portion 616.

[0068] Figure 10B is Figure 10A A schematic diagram of a portion of an axial cross-sectional view taken from A to A' shown, Figure 10C is Figure 10A Schematic diagram of a portion of the axial cross-sectional view taken from B to B' shown. Figure 10B and Figure 10CAs shown, the stent cover 608 is attached to the stent body of the stent device 104 from both the inner lumen 802 and the outer space 804. Specifically, the first stent cover portion 608a is attached to the stent body of the stent device 104 from the inner lumen 802, and the second stent cover portion 608b is attached to the stent body of the stent device 104 from the outer space 804. The stent wire 602a, which is part of the inner wire portion 614, and the stent wire 602b, which is part of the outer wire portion 616, are both positioned adjacent to corresponding portions of the stent cover 608. Thus, the stent device 104 is joined to the respective stent covers 608a, 608b at the joining point 610 via the stent wire 602a of the inner wire portion 614 and the stent wire 602b of the outer wire portion 616. The engagement between the stent wire 602a as part of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the stent device 104 from the lumen 802 is similar to the engagement between the stent wire 602a as part of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the stent device 104 from the lumen 802. Figures 8A to 8C The same as shown and described. The engagement between the stent wire 602b as part of the outer wire portion 616 and the second stent cover portion 608b attached to the stent body of the stent device 104 from the exterior space 804 is the same as shown and described. Figures 9A to 9C Same as shown and described.

[0069] The embodiments of the stent covers disclosed herein can be used as stent covers in any of a variety of known stent devices. For example, Figure 11 A first alternative stent device, such as disclosed in the prior art (U.S. Patent No. 10,349,944, the entire contents of which are incorporated herein by reference), to which a stent cover may be attached is schematically illustrated. The attached stent cover may be consistent with the embodiments disclosed herein. In the first alternative stent device, a first stent wire A and a second stent wire B are braided around a clamp 1100, which includes an upper head forming member 1102 and a lower head forming member 1104. The braided stent device includes an upper head 1106, a body 1108, and a lower head 1110, and includes an intersecting portion 1112 and an annular portion 1114. In a manner substantially similar to Figures 8A to 8C 、 Figures 9A to 9C as well as Figures 10A to 10CIn the same manner, the stent cover 608 can be attached to the first alternative stent body of the stent device from one or both of the inner cavity and the outer space. For example, the first stent cover portion 608a is attached to the stent body of the first alternative stent device from the inner cavity, while the second stent cover portion 608b is attached to the stent body of the first alternative stent device from the outer space. The stent wire that is part of the equivalent of the inner wire portion 614 and the stent wire that is part of the equivalent of the outer wire portion 616 are both positioned near the corresponding portions of the stent cover 608, so that the first alternative stent device is joined to the corresponding stent cover by the equivalent of the joining point 610. The junction between the stent wire that is part of the equivalent of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the first alternative stent device from the inner cavity is similar to the junction between the stent wire that is part of the equivalent of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the first alternative stent device from the inner cavity and Figures 8A to 8C The engagement between the stent wire as part of the equivalent of the outer wire portion 616 and the second stent cover portion 608b attached to the stent body of the first alternative stent device from the exterior space is the same as shown and described. Figures 9A to 9C Same as shown and described. In alternative embodiments, when the stent cover is attached from one of the inner lumen and the outer space, the above description regarding attaching the stent cover from only one side is applicable.

[0070] For example, Figure 12 A second alternative stent device such as disclosed in the prior art (U.S. Patent No. 8,313,522, the entire contents of which are incorporated herein by reference) to which a stent cover may be attached is schematically illustrated. The attached stent cover may be consistent with the embodiments disclosed herein. In the second alternative stent device, a first superelastic shape memory alloy wire 1202 and a second superelastic shape memory alloy wire 1204 are woven to form a second alternative stent device including an intersecting portion 1206 and an interlocking portion 1208 and leaving a plurality of diamond-shaped spaces 1210 between the interlocking portions. In addition, the downward extension 1212 of the first wire 1202 is used to limit the longitudinal expansion and contraction of the second alternative stent device. In a manner substantially similar to Figures 8A to 8C 、 Figures 9A to 9C as well as 10A to 10CIn the same manner, the stent cover 608 can be attached to the second alternative stent body of the stent device from one or both of the inner cavity and the outer space. For example, the first stent cover portion 608a is attached to the stent body of the second alternative stent device from the inner cavity, while the second stent cover portion 608b is attached to the stent body of the second alternative stent device from the outer space. The stent wire that is part of the equivalent of the inner wire portion 614 and the stent wire that is part of the equivalent of the outer wire portion 616 are both positioned near the corresponding portions of the stent cover 608, so that the second alternative stent device is joined to the corresponding stent cover by the equivalent of the joining point 610. The junction between the stent wire that is part of the equivalent of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the second alternative stent device from the inner cavity is similar to the junction between the stent wire that is part of the equivalent of the inner wire portion 614 and the first stent cover portion 608a attached to the stent body of the second alternative stent device from the inner cavity and Figures 8A to 8C The same as shown and described. The engagement between the stent wire as part of the equivalent of the outer wire portion 616 and the second stent cover portion 608b attached to the stent body of the second alternative stent device from the exterior space is the same as shown and described. Figures 9A to 9C Same as shown and described. In alternative embodiments, when the stent cover is attached from one of the inner lumen and the outer space, the above description regarding attaching the stent cover from only one side is applicable.

[0071] While the present invention has been described in conjunction with the preferred embodiments thereof, those skilled in the art will appreciate that additions, deletions, modifications and substitutions not specifically described may be made without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A covered stent device comprising: One or more stent wires forming a stent body, the stent body comprising: forming a plurality of intersections of a plurality of interlocking open cells, wherein each open cell includes a perimeter defined by portions of the one or more stent wires and surrounding a cell void, and an inner wire structure formed from a first portion of the plurality of portions of the one or more stent wires and an outer wire structure formed from a second portion of the plurality of portions of the one or more stent wires; and at least one stent cover, wherein the first portion of the plurality of portions of the one or more stent wires forming the inner wire structure is located at a first radial distance from the longitudinal axis of the stent device, and the second portion of the one or more stent wires forming the outer wire structure is located at a second radial distance from the longitudinal axis of the stent device, the first radial distance being less than the second radial distance, The periphery of each opening unit cell includes a plurality of joint portions, and wherein a first stent covering of the at least one stent covering is located radially inwardly of the stent body and is attached to the stent body only at the plurality of junctions located on the inner wire structure, and A second stent cover of the at least one stent cover is located radially outward from the stent body and is attached to the stent body only at the plurality of junctions located on the outer wire structure.

2. The covered stent device according to claim 1, wherein: A single joining location among the plurality of joining locations is located between two adjacent intersections among the plurality of intersections.

3. The covered stent device according to claim 1, wherein: A plurality of the plurality of joining locations are located between two adjacent intersections among the plurality of intersections.

4. The covered stent device according to claim 2, wherein: Between two adjacent intersections among the plurality of intersections, the junction exists at 70% to 90% of the total length of the one or more stent wires.

5. The covered stent device according to claim 1, wherein: A first stent cover of the at least one stent cover is an inner stent cover, and the inner stent cover extends over the entire axial length of the stent body.

6. The covered stent device according to claim 1, wherein: A first stent cover of the at least one stent cover is an inner stent cover, and the inner stent cover is folded back to cover an end portion of an outer surface of the stent body.

7. The covered stent device according to claim 1, wherein: A second stent cover of the at least one stent cover is an outer stent cover, and the outer stent cover extends over the entire axial length of the stent body.

8. The covered stent device according to claim 1, wherein: A second stent cover of the at least one stent cover is an outer stent cover that is folded back to cover an end portion of the luminal surface of the stent body.

9. The covered stent device according to claim 1, wherein: Both the first stent cover and the second stent cover extend over the entire axial length of the stent body.

10. The covered stent device according to claim 1, wherein: The first bracket cover and the second bracket cover are joined together at the cell interstices of the plurality of interlocking open cells.

11. The covered stent device according to claim 1, wherein: The plurality of intersections comprises a primary interlocking structure.

12. The covered stent device according to claim 1, wherein: The plurality of intersections include a secondary interlocking structure.

13. The covered stent device of claim 1, wherein: The plurality of engagement locations includes a plurality of engagement points.

14. The covered stent device of claim 1, wherein: The plurality of engagement locations includes a plurality of engagement portions.

15. The covered stent device of claim 1, wherein: The plurality of joining locations include a plurality of joining points and a plurality of joining parts.

16. A stent delivery system comprising: front end; The covered stent device according to claim 1; a double-layer sheath having an axial length and configured to carry the covered stent device from a first position along the axial length to a second position along the axial length; and A handle is provided for removing the stent device from the double-layer sheath.

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