Stent apparatus and stent delivery system

Abstract

A support device includes one or more support wires forming a cylindrical support body surrounding an internal void space; and a support cover covering the cylindrical support body. The one or more support wires of the cylindrical support body form a plurality of open cell sections, wherein each open cell section includes a periphery defined by the support wires and surrounding the cell void space. The support cover includes one or more low-porosity regions and one or more high-porosity regions. The low-porosity regions of the support cover correspond in location to the open cell sections, while the high-porosity regions correspond in location to the one or more support wires.

Description

Technical Field

[0001] This invention relates to stent devices and stent delivery systems, and more particularly to stent devices having a stent cover with porous and non-porous portions, which helps maintain the effectiveness of the stent device for an extended period after placement in a patient. The calculated placement of the porous and non-porous portions of the cover provides a variation that positively impacts both the stent and the patient.

[0002] This application is based on and claims priority to U.S. Provisional Application No. 63 / 153,453, filed on February 25, 2021, the entire contents of which are incorporated herein by reference. Background Technology

[0003] In the following discussion, specific structures and / or methods are referenced. However, these references should not be construed as an admission that these structures and / or methods constitute prior art. The applicant expressly reserves the right to demonstrate that such structures and / or methods do not conform to prior art for the present invention.

[0004] Typically, stents are implanted into a patient's internal organs to move the lesion site and widen narrowed organs such as the bile ducts, esophagus, and intestines. Stents can be covered or uncovered. On the one hand, in uncovered stents, restenosis can occur after implantation because luminal cells can grow into the stent lumen through the mesh of the suture (“inward growth”). While restenosis may help anchor the stent and prevent migration of uncovered stents (i.e., stent displacement within the patient), it can lead to a return to or new harmful medical conditions, such as luminal tissue proliferation into the luminal side of the stent body. On the other hand, covered stents can be used as a measure to prevent restenosis. However, while the covering of a covered stent prevents restenosis, it also prevents inward growth that would cause the covered stent to become unanchored and prone to migration.

[0005] Figure 13 is a diagram of a support device disclosed in related technology (US Patent Publication No. 2002 / 0143384A1). Figure 13 is a perspective view showing a cylindrical support body 15 constructed by connecting multiple elastic wire members 16 to each other, the wires 16 being bent into a spiral shape, and the cut-out portion being formed by the gaps between the wire members.

[0006] Figure 14 is a diagram from the same related art, which discloses a support 1 including a support cover 100, wherein some portions of the support body 2 protrude from the support cover 100. The support cover 100 includes a porous membrane end portion 3, a non-porous membrane central portion 5, and a junction portion 4, at which the porous membrane end portion 3 and the non-porous membrane central portion 5 overlap each other.

[0007] Figure 15A is a cross-sectional view along line 20-20 in Figure 14, showing the inner and outer surfaces of the scaffold body 2 of the scaffold 1 covered by the central portion 5 of the non-porous membrane. Figure 15B is a cross-sectional view along line 30-30 in Figure 14, showing the inner and outer surfaces of the scaffold body 2 of the scaffold 1 covered by the end portion 3 of the porous membrane. The end portion 3 of the porous membrane is intended to act as a good anchor for promoting endothelialization of the scaffold 1. On the other hand, the central portion 5 of the non-porous membrane has low water permeability, thereby preventing cells from permeating from the body duct into the inner lumen side of the scaffold body, and preventing the growth and proliferation of luminal tissue that would cause obstruction of the inner lumen side of the scaffold body into the inner lumen side of the scaffold body.

[0008] Although conventional covered stent devices have a porous membrane stent cover at the end of the stent body, such conventional covered stent devices make only the end of the stent body available for restenosis, which may be insufficient to prevent effects such as stent displacement.

[0009] List of cited references

[0010] Patent documents

[0011] Patent Document 1: US Patent Publication No. 2002 / 0143384A1 Summary of the Invention

[0012] The problem the invention aims to solve

[0013] However, conventional connection structures between the clamp unit and the treatment tool body have shortcomings in one or more aspects. For example, when the clamp unit rotates, conventional connection structures lack sufficient strength to ensure the rotational movement of the clamp unit around the axis of the compression tube. Furthermore, conventional connection structures lack sufficient strength to ensure linear movement of the clamp unit in the axial direction of the compression tube when the clamp unit is pulled by the manipulating wire. As a result, the clamp unit may accidentally detach from the hook of the treatment tool body before the ligation procedure is successfully completed.

[0014] Therefore, there is a need to design a treatment device for ablation procedures, whose efficient structure, for practical application, will substantially eliminate one or more problems caused by the limitations and drawbacks of treatment devices in related technologies. The purpose of this disclosure is to provide an improved treatment device with an efficient structure and practical management for the associated medical procedure. At least one or more of these objectives are achieved by the treatment device disclosed herein.

[0015] Solution for solving the problem

[0016] The disclosed stent device includes one or more stent wires forming a cylindrical stent body, the cylindrical stent body surrounding an internal void space and defining an inner cavity side of the stent body; and a stent cover covering the cylindrical stent body. The one or more stent wires of the cylindrical stent body form a plurality of open cell units, each open cell unit including a periphery defined by the stent wires and surrounding the cell void space. The stent cover includes one or more low-porosity regions and one or more high-porosity regions, with the low-porosity regions of the stent cover corresponding in position to the open cell units, and the high-porosity regions corresponding in position to the one or more stent wires.

[0017] In the disclosed embodiment of the support device, the area of ​​the open cell that is not covered by the low porosity portion is covered by the high porosity portion.

[0018] In the disclosed embodiments of the support device, for at least one set of open cells, the ratio of the area covered by the low porosity portion in each open cell may be different.

[0019] In the disclosed embodiment of the support device, the ratio of the area covered by the low-porosity portion of the open cell located at the center of the cylindrical support body can be higher at the open cell located at the center of the cylinder than the area covered by the low-porosity portion of the open cell located at the cylindrical end of the support cover.

[0020] In the disclosed embodiments of the support device, the ratio of the area of ​​the open cell partially covered by the low porosity portion can be higher at one half of the support cover than at the other half of the support cover.

[0021] In the disclosed embodiments of the support device, the support cover can be arranged to be separate from the two cylindrical ends of the cylindrical support body.

[0022] In the disclosed embodiment of the support device, the area of ​​the open cell covered by the low porosity portion is zero at at least one cylindrical end of the cylindrical support body.

[0023] In the disclosed embodiments of the support device, the cylindrical support body may be composed of support wires that are interlocked with each other by bending portions.

[0024] In the disclosed embodiments of the support device, the support cover may consist of an outer cover that covers the cylindrical support body from the outside and an inner cover that covers the cylindrical support body from the inside.

[0025] In the disclosed embodiments of the support device, the outer cover may have a higher porosity compared to the inner cover.

[0026] The effects of the invention

[0027] Therefore, this disclosure relates to an endoscopic treatment apparatus and clamping unit that substantially eliminates one or more problems caused by the limitations and disadvantages found in conventional endoscopic treatment apparatuses and clamping units.

[0028] Generally, the disclosed structures and systems provide a stent and a stent cover that effectively suppress stent migration and inward growth problems such as those discussed above and in conjunction with related techniques. To address these problems, a structure is disclosed comprising a stent cover with higher porosity covering the stent wire and a stent cover with lower porosity (optionally no porosity) covering the stent opening cell portion of the stent. The stent cover with higher porosity near the stent wire allows luminal tissue to penetrate into the stent cover and associate itself with the stent wire, thereby achieving endothelialization that helps prevent stent migration. The stent cover with lower porosity covering the stent cell prevents inward growth that could lead to luminal obstruction of the stent device. The porosity of the stent cover can be adjusted in various ways to suit needs arising from luminal conditions and other patient requirements, including continuous and discontinuous gradients of porosity as a function of the longitudinal position of the stent device, or patterns of different porosities configured along the longitudinal position of the stent device. Attached Figure Description

[0029] [ Figure 1 ] Figure 1 An embodiment of a support delivery system including a support assembly is shown.

[0030] [ Figure 2A ] Figure 2A A schematic diagram of the stent body in a contracted state is shown.

[0031] [ Figure 2B ] Figure 2B A schematic diagram of the support body in an expanded state is shown.

[0032] [ Figure 3 ] Figure 3 This is an enlarged view of the bracket wires in an exemplary embodiment of the bracket body.

[0033] [ Figure 4 ] Figure 4 This is an enlarged view of the bracket wires in an exemplary embodiment of the bracket body.

[0034] [ Figure 5A ] Figure 5A This is a schematic diagram of a support device, including an embodiment of a support cover having a region with varying porosity at different locations on the support body.

[0035] [ Figure 5B ] Figure 5B This is a schematic diagram of a support device, including an embodiment of a support cover having a region with varying porosity at different locations on the support body.

[0036] [ Figure 5C ] Figure 5C This is a schematic diagram of a support device, including an embodiment of a support cover having a region with varying porosity at different locations on the support body.

[0037] [ Figure 6A ] Figure 6A This is a schematic diagram of a support device, including an embodiment of a support cover having a region with varying porosity at different locations on the support body.

[0038] [ Figure 6B ] Figure 6B This is a schematic diagram of a support device, including an embodiment of a support cover having a region with varying porosity at different locations on the support body.

[0039] [ Figure 7A ] Figure 7A This is a schematic diagram of a support device, which includes other embodiments of a support cover having a portion with varying porosity at different locations on the support body.

[0040] [ Figure 7B ] Figure 7B This is a schematic diagram of a support device, which includes other embodiments of a support cover having a portion with varying porosity at different locations on the support body.

[0041] [ Figure 7C ] Figure 7C This is a schematic diagram of a support device, which includes other embodiments of a support cover having a portion with varying porosity at different locations on the support body.

[0042] [ Figure 8A ] Figure 8A This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0043] [ Figure 8B ] Figure 8B This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0044] [ Figure 8C ] Figure 8C This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0045] [ Figure 8D ] Figure 8D This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0046] [ Figure 9A ] Figure 9A This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0047] [ Figure 9B ] Figure 9B This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0048] [ Figure 9C ] Figure 9C This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0049] [ Figure 9D ] Figure 9D This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0050] [ Figure 10A ] Figure 10A This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0051] [ Figure 10B ] Figure 10B This is a schematic diagram illustrating an embodiment of the structure of the bracket wires and the bracket cover.

[0052] [ Figure 11A ] Figure 11A This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0053] [ Figure 11B ] Figure 11B This is a schematic diagram illustrating an embodiment of the structure of the support wires and multiple support covers.

[0054] [ Figure 12A ] Figure 12A This is a schematic diagram illustrating an embodiment of the structure of the support wire and multiple support covers with different porosities.

[0055] [ Figure 12B ] Figure 12B This is a schematic diagram illustrating an embodiment of the structure of the support wire and multiple support covers with different porosities.

[0056] [Figure 13] Figure 13 shows the support device of the related technology.

[0057] [Figure 14] Figure 14 shows the support device of the related technology.

[0058] [Figure 15A] Figure 15A shows a cross-sectional view of the support device of the related technology shown in Figure 14.

[0059] [Figure 15B] Figure 15B shows a cross-sectional view of the support device of the related technology shown in Figure 14. Detailed Implementation

[0060] As used herein, the term "patient" includes any and all living organisms and includes the term "subject." A patient can be a human or an animal.

[0061] Additional features and advantages will be set forth in the following description and will be apparent in part from the description, or may be learned by practice of the invention. The objectives and other advantages of the disclosed support device will be realized and obtained by the written description and its technical solutions, as well as the structures particularly pointed out in the drawings.

[0062] Other systems, methods, features, and advantages will be or will become apparent to those skilled in the art upon review of the following figures and detailed description. All such additional systems, methods, features, and advantages are intended to be included within this specification, the scope of this disclosure, and protected by the appended solutions. Nothing in this section should be construed as limiting these 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 of the disclosed input device and the following detailed description are exemplary and illustrative, and are intended to provide a further explanation of the claimed disclosed support device.

[0063] The following detailed description of preferred embodiments can be read in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements.

[0064] For clarity, the dimensions of the various components have been appropriately adjusted in all the accompanying drawings. For ease of viewing, in some cases, only a few named features in the drawings are labeled with reference numerals.

[0065] Therefore, there is a need to design a stent device that, for practical use, possesses an effective structure that will substantially eliminate one or more problems caused by the limitations and drawbacks of stent devices of related technologies. The object of this disclosure is to provide an improved stent device with an effective structure and practical management for 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 function as a widening device for narrowed organs at the treatment site. At least one or more of these objectives are achieved by the stent device disclosed herein.

[0066] For example, the disclosed stent device includes a stent cover having a porous membrane portion extending throughout the stent body for promoting endothelialization as an anchoring point for the stent device. In one aspect, the stent cover of the disclosed covered stent device is a membrane comprising a first region and a second region having different affinities for endothelialization. For example, the first region of the membrane is non-porous (or low-porosity) that minimizes and / or prevents the growth and proliferation of luminal tissue and covers the stent device according to the region to prevent luminal tissue from protruding into the luminal side of the stent body and, for example, causing blockage of the stent device, while the second region of the membrane is porous for promoting restenosis sufficient for anchoring and preventing migration. In some aspects, the second region of the porous membrane is located corresponding to the wire structure of the stent body, while the first region of the non-porous membrane is located corresponding to the gaps between the wire structures, for example, open cell portions on the circumferential surface of the stent body, each open cell having a periphery defined by the wires of the wire structure of the stent body. In this way, endothelialization is directed to locations where the filament structure can be anchored, while endothelialization is minimized and / or prevented in locations without filament structures, because in such locations endothelialization would lead to tissue intrusion into the luminal side of the scaffold body, while otherwise contributing little or no to anchoring the scaffold device.

[0067] The following detailed description of the preferred embodiments can be read in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements, wherein: Figure 1 This is a diagram of a support device conveying system 101. The support device conveying system 101 includes a front end 102, a support device 104, a sheath 106, a dual-port hub 108, a side port 110, a rotatable handle lock 112, and an inner handle 114. The sheath 106 has a double-layer structure with an inner sheath and an outer sheath. The sheath 106 holds the support device 104 at the front end 102 between the two layers in a reduced diameter state. The front end 102 is connected to the inner sheath and the inner handle 114. The outer sheath is connected to the dual-port hub 108 and the rotatable handle lock 112. After the support device conveying system 101 has positioned the front end 102 and the support device 104 to the desired position, by fixing the inner handle 110 and pulling the rotatable handle lock 112 towards the proximal end of the conveying system 101, the outer sheath at the front end 102 slides towards the proximal end, causing the support device 104 to expand from a reduced diameter to the designed diameter. After the outer sheath has slid across the entire length of the stent device 104, the delivery system 101 and the stent device 104 separate, leaving the stent device 104 implanted in the patient's body.

[0068] Existing procedures include those that use only a stent delivery system 101 to implant a stent device 104 into a patient to open a stenosis (e.g., vascular stents and circulatory stents), as well as procedures that combine stent delivery with endoscopy. In the case of biliary stent implantation, an endoscope is inserted through the mouth and advanced into the duodenum. The stent delivery system 101 then passes through the forceps channel of the endoscope and through the duodenal papilla into the bile duct. Finally, the stent device 104 is placed in the stenosis of the bile duct with the support of visual feedback from the endoscope.

[0069] Figure 2A This is an illustration of a stent device 104 in its contracted state. In its contracted state, the stent device 104 is inserted into the stent delivery system 101 for delivery through the patient's blood vessels and other narrow spaces. Figure 2B As disclosed herein, after the stent device 104 reaches the treatment unit and is ejected from the stent delivery system 101, the stent device 104 expands to a size designed for treating the treatment unit.

[0070] Figure 3 A pattern of the support wire forming the support assembly 104 is shown. The support wire forms a cylindrical support body 1041 (hereinafter referred to as the "support body"). The support body 1041 includes an internal open space. The support body defines the inner cavity side of the support body 1041. Figure 3 As disclosed, the support wires of the support device 104 can alternately cross each other to form cells, such as support cell 302 (open cell), surrounded by the support wires. The alternating state of the support wires can be seen by careful observation of support wires 304, 306, 308, and 310. Support wire 304 intersects with support wire 306 at intersection 312, where support wire 304 is covered by support wire 306. Then, support wire 304 intersects with support wire 308 at intersection 314, where support wire 304 crosses over support wire 308, and then again covers support wire 310 at the next intersection 316. In this way, support wire 304 can alternately intersect with other support wires. The support wires define the perimeter of support cell 302.

[0071] Figure 4 Another pattern of the support wire forming the support assembly 104 is shown. (See diagram below.) Figure 3 As shown, the support wires of the support assembly 104 can alternately cross each other to form cells surrounded by the support wires, such as support cell 402 (open cell). With Figure 3 Compared to the stent in the middle, Figure 4The alternating states disclosed are more complex. For example, support wires 404 and 406 may bend and cross alternately at the intersection 408. The bent support wires, such as support wires 404 and 410, form an interlocking intersection 412, which in turn forms an interlocking support cell 414.

[0072] Figure 5A This is an illustration of a support assembly 104 having a support cover that covers the entire support body 1041. Support wires (e.g., support wire 502) of the support assembly 104 intersect with other support wires to form a plurality of support cells (open cells) surrounded by the support wires. The support cover covering the support assembly 104 comprises two parts: a wire cover portion (e.g., ... Figure 5A The attached reference numeral 504 and the cell overlay (as shown) Figure 5A (Ref. 506 in the attached figure), and the porosity of the wire cover portion 504 and the cell cover portion 506 may be different from each other.

[0073] For example, with a higher porosity (i.e., more pores) in the wire cover 504, the pores near the scaffold wire will allow luminal tissue to grow and proliferate into the luminal side of the scaffold and associate itself with the scaffold wire, thus providing a good anchoring for promoting endothelialization at locations where the wire cover 502 exists throughout the body of the scaffold 104. On the other hand, a lower porosity (i.e., fewer pores) in the cell cover 506 will result in low permeability and prevent cell penetration from the biological lumen into the luminal side of the scaffold, thereby preventing luminal tissue growth and proliferation into the cell portions of the scaffold body. The opposite structure (where the wire cover 504 has a lower porosity than the cell cover 506) could also be used to promote endothelialization and prevent cell penetration of the scaffold device 104, but it may be less effective because the penetrating luminal tissue may not associate itself with the scaffold wire 502, which is used to enhance endothelialization of the scaffold device 104.

[0074] The pore size of the cell cover can be less than 6 μm to prevent luminal cells from entering the lumen of the scaffold device. The pore size of the wire cover can be between 6 μm and 25 μm. Any biocompatible material can be used for the scaffold cover material, such as silicone resins, polyurethane resins, nylon resins, polyester resins, polyolefin resins (such as polypropylene and polypropylene), and fluorinated resins (such as polytetrafluoroethylene (PTFE) and tetrafluoroethylene vinyl ether copolymer (FEP)).

[0075] As examples of methods for preparing porosity, silicone-based resins, polyurethane-based resins, nylon-based resins, polyester-based resins, and polyolefin-based resins can be extracted by mixing a pore-forming agent and removing the pore-forming agent with a solvent after molding, or by mixing a foaming agent to create pores. Molding methods can also be used. Porosity can be controlled by controlling the pore-forming agent and the foaming agent. Furthermore, PTFE materials can be stretched to form a porous structure, known as ePTFE. The porosity of this ePTFE material can be freely changed by adjusting the stretching direction and the amount of stretching. For example, porous materials with suitable properties can be obtained, such as materials stretched in one direction and materials stretched bidirectionally in both the vertical and horizontal directions.

[0076] The thickness of the stent cover is preferably 100 μm or less, more preferably 30 μm to 10 μm, for the purpose of resisting inward growth and maintaining the flexibility of the stent device.

[0077] Figure 5B Another illustration shows a support assembly 104 having a support cover that covers the entire support body. (See illustration for example.) Figure 5A As shown, the porosity of the wire cover portion 504 and the cell cover portion 506 can be different. With a higher porosity in the wire cover portion 504, the pores near the stent wire will promote endothelialization, while the lower porosity in the cell cover portion 506 will reduce the risk of blockage of the stent body's lumen caused by luminal tissue penetrating into the cell portion of the stent body. The areas of the wire cover portion 504 and the cell cover portion 506 vary depending on the location of the wire and the cell. The area of ​​the wire cover portion 504 is smaller in the center of the stent cover and increases as the wire approaches the edge of the stent cover. Conversely, the area of ​​the cell cover portion 506 is larger in the center of the stent cover and decreases as the cell approaches the edge of the stent cover.

[0078] Figure 5C Another illustration shows a bracket assembly 104 with a bracket cover that covers the entire bracket body, where the areas of the wire cover 504 and the cell cover 506 of the bracket cover are different. Figure 5C In the middle, the cell covering part 506 is not present near the edge of the bracket cover, and the entire cell is covered by the wire covering part 504. Figure 5CThis configuration is preferred because the stent device 104 is placed in the narrow portion 508 within the patient's body, with the aim of directing the central portion of the stent device 104 to the location of the lesion (e.g., cancer) in the treatment portion 510 where luminal tissue may be concentrated. By placing the cell cover 506 with low porosity in the central portion of the stent device 104, the risk of inward growth and blockage of the stent device lumen is prevented. On the other hand, the wire cover 504 located at the edge of the stent device 104 promotes endothelialization, thereby preventing the stent device 104 from migrating.

[0079] Figure 6A This is an illustration of a bracket assembly 104 having a bracket cover that covers the entire bracket body. The areas of the wire cover 504 and the cell cover 506 of this bracket cover vary. Figure 5C As in the disclosed embodiment, the central portion 602 of the stent cover has a relatively low porosity compared to the adjacent edge portion 604. The edge portion 604, with its relatively high porosity, serves as an anchor to hold the stent assembly 104 in place by utilizing the higher porosity that promotes endothelialization. The central portion 602 serves to prevent luminal tissue that could potentially clog the stent assembly from penetrating the interior of the stent body. This configuration is effective because the medical operator's goal is to place the central portion 602 of the stent assembly directly onto the lesion in the treatment area where luminal tissue may be concentrated.

[0080] Figure 6B This is an illustration of a bracket assembly 104 having a bracket cover that covers the entire bracket body. The areas of the wire cover portion 504 and the cell cover portion 506 of the bracket cover vary. The central portion 606 of the bracket cover has a semi-cylindrical shape that covers the upper half of the central portion of the bracket assembly 104. The remaining portion 608 of the bracket cover covers the lower half of the central portion of the bracket assembly 104 and the area including the edge portions of the bracket assembly 104. Figure 6A As shown, the central portion 606 has a relatively low porosity to prevent inward growth, while the remaining portion 608 has a relatively high porosity to prevent the migration of the support device 104.

[0081] Figure 7A This is an illustration of a support cover 700 with a porosity that varies based on location. Figure 6AAs disclosed in the embodiments, the central portion 702 of the stent cover 700 has a lower porosity compared to the adjacent intermediate portion 704, and the intermediate portion 704 has an even lower porosity compared to the adjacent edge portion 706. The edge portion 706 serves as an anchor to hold the stent device 104 in place by utilizing the high porosity that promotes endothelialization. The central portion 702 serves to prevent inward growth that could lead to occlusion of the stent device. This configuration is effective because the medical operator aims to place the central portion 702 of the stent device directly onto a lesion (e.g., cancer) in the treatment area that may concentrate luminal tissue.

[0082] Figure 7B This is another schematic diagram of a stent cover 700 with different porosities. The central portion 702 of the stent cover 700 has a lower porosity compared to the adjacent intermediate portion 704, and the stent cover 700 terminates at an edge that does not reach the stent assembly 104. The area lacking the stent cover 700 (i.e., region 708) serves as a more robust anchor to maintain the stent assembly 104 in the proper position within the patient's treatment area by allowing luminal tissue to freely penetrate within the stent assembly 104 and associate with the stent wires, thus promoting endothelialization.

[0083] Figure 7C This is another illustration of a stent cover 700 with different porosities. The central portion 702 of the stent cover 700 has a lower porosity compared to the rest of the stent cover 700 (i.e., 710). The central portion 702 can be designed to optimize the location and size of the area according to the lumen tissue it is intended to cover. By targeting the precise location of the stent cover portion with low porosity to the lumen tissue, measures to prevent cell permeation of the stent device 104 can be minimized, and by optimizing the stent cover portion with higher porosity to cover areas of the treatment region with less concentrated lumen tissue, endothelialization of the stent device 104 can be maximized.

[0084] Figure 8A This is an illustration of a support device 104 with another pattern of porosity that varies based on location. (Compared to...) Figure 6B As in the disclosed embodiment, the central portion of the bracket cover 700 has a cell cover 506 concentrated on the upper side of the bracket device 104 and a remaining portion consisting of a wire cover 504. Figure 8B The relationship between the high porosity portion 804 and the low porosity portion 802 is shown. The high porosity portion 804 is mainly composed of the cell covering portion 506, while the low porosity portion 802 is entirely composed of the wire covering portion 504.

[0085] Figure 8CThis is an illustration of a support device 104 with another pattern of porosity that varies based on location. (Compared to...) Figure 8A As in the disclosed embodiment, the central portion of the support cover 700 has cell cover portions 506 concentrated on the upper side of the support device 104 and the remaining portion consisting of wire cover portions 504. The central portion of the support cover 700 has cell cover portions 506 with varying degrees of concentration, wherein the area covering each cell increases towards the center of the support device 104. Figure 8D The relationship between the high porosity portion 806, the medium porosity portion 804, and the low porosity portion 802 is shown. The high porosity portion 806 is mainly composed of cell covering portions 506, the medium porosity portion 804 is composed of cell covering portions 506 that cover cells with a smaller area, and the low porosity portion 802 is entirely composed of wire covering portions 504.

[0086] Figure 9A This is an illustration of a cell in a support cover 700 with varying porosity. The central portion 902 of the rhombus has a lower porosity compared to the remaining portion 904, which has a higher porosity. Figure 9B Also disclosed is a rhomboid central portion 902 with a lower porosity compared to the remaining portion 904, and a mesoporous portion 906 located between the central portion 902 and the remaining portion 904 with a porosity higher than that of the central portion 902 and lower than that of the remaining portion 904.

[0087] Figure 9C This is an illustration of a cell of a support cover 700 with varying porosity. The circular central portion 902 has a lower porosity compared to the remaining portion 904, which has a higher porosity. Figure 9D Also disclosed is a circular central portion 902 with a lower porosity compared to the remaining portion 904, and a medium-porosity portion 906 located between the central portion 902 and the remaining portion 904 with a porosity higher than that of the central portion 902 and lower than that of the remaining portion 904.

[0088] Support covers with varying porosity can be manufactured using the following method. This can be achieved by applying an adhesive to... Figure 9A and Figure 9C As shown in section 902, while the cover is joined to the following location, an adhesive is used to join a material with low porosity to that location where it is desired that the porosity is reduced and the adhesive fills the porous portion. Furthermore, as... Figure 9B and Figure 9DAs shown, when the porosity is stepped, portions 902, 904, and 906 can all be manufactured using bonding methods such as hot pressing. ePTFE materials can be bonded by rolling them above their melting point temperature, and by changing the pressure at the bond, the degree of crushing of the stretched pore structure changes, and the porosity changes as well. Figure 9B and Figure 9D As shown.

[0089] Figure 10A This is an illustration of an embodiment disclosing the structural relationship between the support wire 502 and the support cover 700. (See illustration for details.) Figure 10A As disclosed, the support cover 700 covers the support wire 502 of the support assembly 104 at the outer cavity 1004 (i.e., from the outside of the support assembly 104). Conversely, Figure 10B The disclosed embodiment shows a bracket cover 700 that covers the wire 502 of the bracket device 104 at the inner cavity 1002 (i.e., from inside the bracket device 104).

[0090] Figure 11A This is an illustration of an embodiment disclosing the structural relationship between the wires of the support device 104 and multiple support covers. The support cover 1102 covers the wires 502 of the support device 104 at the outer cavity 1004. In addition, the support cover 1104 covers the wires 502 of the support device at the inner cavity 1002, forming a gap 1106.

[0091] Figure 11B This is another illustration of an embodiment showing the structural relationship between the wires of the disclosed support device 104 and the multiple support covers. (See illustration for further details.) Figure 11A As disclosed, the bracket cover 1102 covers the wire 502 of the bracket device 104 at the outer cavity 1004, and the bracket cover 1104 also covers the wire 502 at the inner cavity 1002. Figure 11A Conversely, the support covers 1102 and 1104 adhere to each other at locations where the wire 502 is absent. The porosity of the adhered portion 1108 will be lower than that of the individual support covers 1102 and 1104 because the overlap of the support covers cancels out their pores. Therefore, the porosity of the adhered portion 1108 will be lower than that of the support covers covering the wire 502, namely the support cover 1102 at the outer cavity 1004 and the support cover 1104 at the inner cavity 1002. Furthermore, Figure 11B The structure allows the stent to bend flexibly because the wires and cover are not directly fixed. Therefore, when the stent assembly 104 is implanted into the biological lumen in a bent state, the load on the biological lumen can be reduced.

[0092] Figure 12AThis is an illustration of another embodiment of the structural relationship between the wires of the disclosed stent device 104 and multiple stent covers. Stent cover 1102 covers the wires 502 at the outer cavity 1004, and stent cover 1104 covers the wires 502 at the inner cavity 1002, forming a gap 1106. The porosities of stent cover 1102 and stent cover 1104 can be different. For example, stent cover 1102 can have a higher porosity than stent cover 1104, making it easier for luminal tissue to penetrate into stent cover 1102 and the gap 1106, associating itself with the stent wires 502, thereby leading to endothelialization. On the other hand, penetration will stop at stent cover 1104, which has a lower porosity, so that the inner cavity 1002 is less affected by blockage-related problems.

[0093] Figure 12B This is another illustration of an embodiment showing the structural relationship between the wires and multiple support covers of the disclosed support device 104. (See illustration for further details.) Figure 12A As disclosed, the support cover 1102 covers the support wire 502 at the outer cavity 1004, and the support cover 1104 also covers the support wire 502 at the inner cavity 1002. Figure 12A Conversely, the stent covers 1102 and 1104 adhere to each other at the location where the stent wire 502 is not present, and form an adhesive portion 1108 with low porosity, thereby effectively preventing luminal tissue from penetrating into the lumen 1002.

[0094] The porosities of stent cover 1102 and stent cover 1104 can differ. For example, stent cover 1102 can have a higher porosity than stent cover 1104, allowing luminal tissue to easily penetrate into stent cover 1102 and associate itself with stent wire 502, thereby effectively promoting endothelialization. On the other hand, in addition to the reduced porosity caused by the overlap of the two stent covers, penetration will stop at the adhesion portion 1108 due to the low porosity of stent cover 1104. Penetration will also stop at stent cover 1104 near stent wire 502, thus the lumen 1002 is less affected by luminal tissue penetration compared to the case where stent cover 1104 has the same porosity as stent cover 1102.

[0095] The method for manufacturing the support device 104 includes: (i) braiding NiTi alloy (superelastic alloy) wire to form a support; (ii) winding biaxially stretched PTFE (pore size: 10 μm, thickness: 40 μm) around the outer surface of a cylindrical core material, placing the support device on the cylindrical core material, and then winding biaxially stretched PTFE (pore size: 10 μm, thickness: 40 μm) around the support device; (iii) using a soldering iron adjusted to approximately 350°C, pressing the soldering iron against the central portion of the mesh (cell) of the support device to fuse and fix the PTFE to the outer and inner surfaces of the support device; and (iv) removing the support device from the cylindrical core material. The area of ​​the cell to which the soldering iron is applied should increase towards the cell located in the center of the support device and decrease towards both ends of the support device.

[0096] The aforementioned manufacturing method is not limited to brackets that are double-sided or double-layered, but can also be used to cover a bracket on the outer or inner surface of a bracket assembly using only a single bracket cover, provided that the bracket cover is fixed to the bracket assembly by adhesion, stringing, or wiring. Since the porosity can be arbitrarily reduced using a soldering iron, the porosity of each cell of the covered bracket can be varied according to the design and intended use of the covered bracket.

[0097] The above manufacturing method is not limited to covering the stent on both sides, but can also be used to cover the stent only on the surface of the stent cavity or only on the outer peripheral surface, as long as the stent is fixed by adhesion, wire binding or wire fastening, the porosity can be reduced, and stents covered with arbitrarily varying porosity can be manufactured.

[0098] Although the invention has been described in conjunction with preferred embodiments thereof, those skilled in the art will understand that additions, deletions, modifications and substitutions not specifically described may be made without departing from the spirit and scope of the invention as defined by the appended claims.

[0099] The disclosed embodiments of the support device also include: the region of the open cell covered by the low porosity portion has a circular shape.

[0100] The disclosed stent device embodiment also includes a stent delivery system comprising a front end, a stent device, a double-layered sheath supporting the stent device between two layers, and a handle for removing the stent device from the sheath. The stent device has one or more stent wires forming a cylindrical stent body surrounding an internal void space. The stent device defines the inner cavity side of the stent body and is covered by a stent cover. The one or more stent wires of the cylindrical stent body form a plurality of open cell sections, each of which includes a periphery defined by the stent wires and surrounding the cell void space. The stent cover includes one or more low-porosity regions and one or more high-porosity regions, with the low-porosity regions of the stent cover corresponding in position to the open cell sections and the high-porosity regions corresponding in position to the one or more stent wires.

[0101] The disclosed implementation of the stent delivery system further includes: the area of ​​the open cell not covered by the low porosity portion is covered by the high porosity portion.

[0102] The disclosed implementation of the support device further includes: for at least one set of open cells, the ratio of the area of ​​the open cells covered by the low porosity portion is different.

[0103] The disclosed embodiments of the support device further include: the ratio of the area covered by the low porosity portion of the open cell is higher at the open cell in the center of the cylinder than at the open cell located at the end of the cylindrical part of the support cover.

[0104] The disclosed embodiments of the support device further include: the ratio of the area of ​​the open cell covered by the low porosity portion is higher at one half of the support cover than at the other half of the support cover.

[0105] The disclosed implementation of the support device further includes: the support cover does not reach the two cylindrical ends of the cylindrical support body.

[0106] The disclosed implementation of the support device further includes: for open cells located at the end of the cylindrical shape, the ratio of the area of ​​the open cell covered by the low porosity portion is zero.

[0107] The disclosed embodiments of the support device also include: the region of the open cell covered by the low porosity portion has a circular shape.

[0108] The disclosed implementation of the support device also includes: the cylindrical support body is composed of support wires that are interlocked with each other by bending portions.

[0109] The disclosed implementation of the support device further includes: the support cover is composed of an outer cover that covers the cylindrical support body from the outside and an inner cover that covers the cylindrical support body from the inside.

[0110] The disclosed embodiments of the support device also include an outer cover having a higher porosity compared to the inner cover.

[0111] Explanation of reference numerals in the attached figures

[0112] 104: Support device

[0113] 302, 402: Support cell (open cell)

[0114] 700: Bracket Cover

[0115] 1041: Main body of cylindrical support

Claims

1. A support device, comprising: One or more support wires forming a cylindrical support body, wherein the cylindrical support body surrounds an internal open space; and A support cover that covers the cylindrical support body. The cylindrical support body comprises one or more support wires forming multiple open cell units, each of which includes a perimeter defined and surrounded by the support wires, forming a space within the cell. The support cover includes one or more low-porosity regions and one or more high-porosity regions; and The low porosity region of the bracket cover corresponds in location to the open cell, and the high porosity region corresponds in location to the one or more bracket wires.

2. The support device according to claim 1, wherein, The area of ​​the open cell not covered by the low-porosity portion is covered by the high-porosity portion.

3. The support device according to claim 2, wherein, For at least one set of open cells, the ratio of the area covered by the low porosity portion in each open cell is different.

4. The support device according to claim 3, wherein, The ratio of the area covered by the low-porosity portion of the open cell at the center of the cylindrical part is higher than the ratio of the area covered by the low-porosity portion of the open cell at the cylindrical end of the support cover.

5. The support device according to claim 4, wherein, The ratio of the area of ​​the open cell covered by the low porosity portion is higher at one half of the support cover than at the other half of the support cover.

6. The support device according to claim 4, wherein, The support cover is arranged to be separate from the two cylindrical ends of the cylindrical support body.

7. The support device according to claim 1, wherein, The ratio of the open cells covered by the low porosity portion is zero at at least one cylindrical end of the cylindrical support body.

8. The support device according to claim 1, wherein, The cylindrical support body is composed of support wires that interlock with each other through bent sections.

9. The support device according to claim 1, wherein, The support cover consists of an outer cover that covers the cylindrical support body from the outside and an inner cover that covers the cylindrical support body from the inside.

10. The support device according to claim 9, wherein, The outer cover has a higher porosity compared to the inner cover.

11. A support delivery system, comprising: Support structure; A double-layered sheath supports the bracket device between the two layers; as well as A handle for removing the support device from the sheath. The support device includes one or more support wires forming the main body of the cylindrical support. The cylindrical support body surrounds the internal open space. The bracket cover covers the cylindrical bracket body. The one or more support wires of the cylindrical support body form a plurality of open cell units, wherein each open cell unit includes a perimeter defined by the support wires and surrounding the empty space of the cell. The support cover includes one or more low-porosity regions and one or more high-porosity regions, and The low porosity region of the bracket cover corresponds in location to the open cell, and the high porosity region corresponds in location to the one or more bracket wires.

12. The support conveying system according to claim 11, wherein, The area of ​​the open cell not covered by the low-porosity portion is covered by the high-porosity portion.

13. The support conveying system according to claim 12, wherein, For at least one set of open cells, the ratio of the area covered by the low porosity portion in each open cell is different.

14. The support conveying system according to claim 13, wherein, The ratio of the area covered by the low porosity portion of the open cell at the center of the cylindrical section is higher than that of the open cell at the cylindrical end of the support cover.

15. The support conveying system according to claim 14, wherein, The ratio of the area of ​​the open cell covered by the low porosity portion is higher at one half of the support cover than at the other half of the support cover.

16. The support conveying system according to claim 14, wherein, The support cover is arranged to be separate from the two cylindrical ends of the cylindrical support body.

17. The support conveying system according to claim 11, wherein, The ratio of the open cells covered by the low porosity portion is zero at at least one cylindrical end of the cylindrical support body.

18. The support conveying system according to claim 11, wherein, The cylindrical support body is composed of support wires that interlock with each other through bent sections.

19. The support conveying system according to claim 11, wherein, The support cover consists of an outer cover that covers the cylindrical support body from the outside and an inner cover that covers the cylindrical support body from the inside.

20. The support conveying system according to claim 19, wherein, The outer cover has a higher porosity compared to the inner cover.

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