Medical device and its film sewing method

Abstract

The present invention relates to a medical device and a method for sewing a film. The method for sewing the film includes: covering a stent with a film; passing the middle part of a suture through the stent at least four times and through the film at least once to form a suture loop, and tying a first knot between the fixed end and the movable end of the suture; pulling the movable end of the suture to move it along the first knot to adjust the length of the suture loop and then locking the suture loop. The method for sewing the film combines a slip knot (i.e., the first knot) with a dead knot (i.e., the second knot) to cover the film on the stent, which is beneficial to controlling the sewing tightness of the film on the stent and can also avoid the defect that the length of the suture loop cannot be adjusted after tying a dead knot; and passing the middle part of the suture through the stent at least four times and through the film at least once can prevent the medical device from being deformed due to excessive force, resulting in inaccurate adjustment of the suture loop.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a medical device and a method for sewing a film thereof. Background Art

[0002] Atrial fibrillation is the most common persistent arrhythmia and has a risk of inducing stroke. Therefore, preventing atrial fibrillation is of great significance. Recent studies have shown that occluding the left atrial appendage can effectively prevent the occurrence of stroke events caused by atrial fibrillation. Currently, the most commonly used left atrial appendage occluder in clinical practice is the plug-type left atrial appendage occluder. In this type of occluder, the alloy stent can be expanded into an umbrella shape and fixed at the orifice of the left atrial appendage by relying on the self-expansion property of the alloy. The flow-blocking film of the occluder covers and completely wraps the outside of the alloy stent. After the metal stent is expanded, the film can completely occlude the orifice of the left atrial appendage, thereby playing a role in isolating thrombus in the left atrial appendage.

[0003] In clinical use, the left atrial appendage occluder is usually delivered to the orifice of the left atrial appendage through a delivery system. The occluder is contracted into a cylindrical shape in the delivery system and becomes a plug shape after the stent is released. Therefore, a large amount of deformation occurs during the process of releasing the occluder from the delivery system. During this process, the flow-blocking film moves synchronously with the deformation of the stent. Therefore, an appropriate method is needed to fix the film and the stent to avoid the film shifting after the occluder is released, resulting in incomplete occlusion or residual leakage. Currently, due to the soft and flexible characteristics of the suture, it is suitable for fixing the flow-blocking film and the stent in medical devices with large deformation amounts. Because after the suture is sewn, the flow-blocking film still has a certain displacement margin, so that it will not be fixed too tightly, which will prevent the deformation and movement of the stent. At the same time, the flow-blocking film will also be tightened by the suture, and the flow-blocking film will not move randomly under the action of the stent and blood flow and its position will shift.

[0004] The film sewing method will affect the performance of the left atrial appendage occluder. If the flow-blocking film is sewn too tightly, the suture may break or the movement form of the occluder may be hindered. If sewn too loosely, the suture cannot effectively tighten the film, and the occluder cannot effectively occlude the left atrial appendage, resulting in residual leakage, or the film on the occluding disc is wrinkled and uneven, forming device-related thrombus. Therefore, it is necessary to provide a film sewing method for a medical device to ensure that the sewing tightness between the flow-blocking film and the stent is appropriate. Summary of the Invention

[0005] Based on this, in view of the technical problem that the sewing between the flow-blocking film and the stent of the left atrial appendage occluder is too loose or too tight, it is necessary to provide a medical device and a method for sewing a film thereof.

[0006] A method for sewing a film of a medical device, the medical device includes a stent and a film, and the film sewing method includes:

[0007] Placing the film on the stent;

[0008] Thread the middle part of the suture through the stent at least four times and through the membrane at least once to form a suture loop, and tie a first knot between the fixed end and the moving end of the suture;

[0009] Pull the moving end of the suture to move it along the first knot to adjust the size of the suture loop and then lock the suture loop.

[0010] In one embodiment, tying the first knot between the fixed end and the moving end of the suture includes:

[0011] Form a first knotting loop at the fixed end of the suture, pass the moving end of the suture through the first knotting loop, and then tighten the first knotting loop.

[0012] In one embodiment, the suture membrane method further includes tying a second knot between the fixed end and the moving end of the suture to lock the suture loop, including:

[0013] Form a second knotting loop at the fixed end or the moving end of the suture, pass the moving end or the fixed end of the suture through the second knotting loop, and then tighten the second knotting loop.

[0014] In one embodiment, the stent includes a plurality of stent rods, adjacent stent rods enclose a plurality of mesh openings, pores are formed on the stent rods, and the suture is threaded through the pores and / or the mesh openings;

[0015] The middle part of the suture is threaded through the pores at least three times, and the middle part of the suture is threaded through the membrane and the mesh opening at least once.

[0016] In one embodiment, the suture loop is an "8"-shaped double-ring suture loop. One of the ring suture loops is formed by threading the suture through the membrane, the mesh opening and the pore, and the other ring suture loop is formed by threading the suture through the pore.

[0017] In one embodiment, threading the middle part of the suture through the stent at least four times and through the membrane at least once to form a suture loop includes:

[0018] At the first pore of the stent, pass the fixed end or the moving end of the suture from the first side of the stent through the mesh opening into the second side of the stent and then through to the membrane;

[0019] After the fixed end or the moving end of the suture passes through the membrane and enters the first side of the stent, at the first pore, pass the fixed end or the moving end of the suture from the first side of the stent into the second side of the stent;

[0020] At the second pore of the stent, insert the fixed end or the moving end of the suture from the second side of the stent into the first side of the stent. The first and second pores are sequentially distributed in a direction away from the membrane. The first and second sides of the stent respectively refer to the outer and inner sides or the inner and outer sides of the stent.

[0021] In one embodiment, the threading of the middle part of the suture through the stent at least four times and through the membrane at least once includes:

[0022] At the first pore of the stent, insert the fixed end or the moving end of the suture from the first side of the stent into the second side of the stent;

[0023] At the second pore of the stent, after inserting the fixed end or the moving end of the suture from the second side of the stent into the first side of the stent, thread it towards the membrane;

[0024] After the fixed end or the moving end of the suture passes through the membrane and enters the second side of the stent through the mesh opening, at the second pore, insert the fixed end or the moving end of the suture from the second side of the stent into the first side of the stent. The first and second pores are sequentially distributed in a direction close to the membrane. The first and second sides of the stent respectively refer to the outer and inner sides or the inner and outer sides of the stent.

[0025] In one embodiment, before tying the first knot between the fixed end and the moving end of the suture, the method of suturing the membrane further includes:

[0026] Tie a third knot in the middle of the suture to prevent the suture from falling off the stent after breaking, wherein the third knot and the second knot are located on different sides of the stent.

[0027] In one embodiment, the tying of the third knot in the middle of the suture includes:

[0028] Form a third knotting loop by crossing in the middle of the suture. Wrap the fixed end or the moving end of the suture around the non-knotting area in the middle of the suture and pass it through the third knotting loop, and then tighten the third knotting loop.

[0029] The above suture film method for medical devices can first tie a first knot with the suture to form a suture loop between the stent and the film. Then, by taking advantage of the characteristic that the moving end of the suture can move along the first knot, the length of the suture loop can be controlled during the suture film process, thereby controlling the suture tightness between the film and the stent. After the suture tightness between the film and the stent is appropriately controlled, a second loop can be tied with the suture to lock the suture loop, avoiding the defect that the length of the suture loop cannot be adjusted after tying a dead knot. It can be seen that this suture film method combines a slip knot (i.e., the first knot) and a dead knot (i.e., the second knot) to wrap the film around the stent, which is beneficial to controlling the suture tightness of the film on the stent and can also avoid the defect that the length of the suture loop cannot be adjusted after tying a dead knot. In addition, compared with the suture threading method in the prior art, where the suture first passes through the film and the stent once and then passes through the stent a second time to form a suture loop and is knotted and fixed at the mesh opening of the stent, the suture loop in this application passes through the stent at least four times and through the film at least once. This can not only increase the number of force points of the suture on the stent and the film, making the force more uniform during the locking process of the suture loop of the medical device to ensure the structural and morphological stability of the medical device, thereby avoiding inaccurate adjustment of the suture loop due to severe deformation of the medical device, resulting in the suture loop being too large or too small; but also reduce the distance between the fixed end and the moving end of the suture loop before knotting, facilitating the knotting of the fixed end and the moving end without the need to use excessive force to knot the fixed end and the moving end, and can also avoid inaccurate adjustment of the suture loop due to excessive force on the medical device causing deformation.

[0030] It can be seen that the suture film method provided in this application, on the one hand, combines a slip knot (i.e., the first knot) and a dead knot (i.e., the second knot) to wrap the film around the stent, which is beneficial to controlling the suture tightness of the film on the stent and can also avoid the defect that the length of the suture loop cannot be adjusted after tying a dead knot; on the other hand, the middle part of the suture passes through the stent at least four times and through the film at least once to form a suture loop, which can avoid inaccurate adjustment of the suture loop due to severe deformation of the medical device, resulting in the suture loop being too large or too small, so as to ensure that the suture tightness between the flow-blocking film and the stent is appropriate.

[0031] A medical device, the medical device includes: a stent and a film, and the film is sewn on the stent through a suture;

[0032] The middle part of the suture passes through the stent at least four times and through the film at least once to form a suture loop, and the fixed end and the moving end of the suture are connected by tying a first knot to lock the suture loop.

[0033] In one embodiment, the medical device further includes a second knot, and the fixed end and the moving end of the suture are connected by tying a first knot and a second knot in sequence, wherein the first knot is movable and the second knot is used to lock the suture loop.

[0034] In one embodiment, a first knotting loop is formed on the fixed end of the suture and the moving end of the suture passes through the knotting loop, and the first knotting loop forms the first knot after being tightened;

[0035] A second knotting loop is formed on the fixed end or the moving end of the suture and the moving end or the fixed end of the suture passes through the second knotting loop, and the second knotting loop forms the second knot after being tightened.

[0036] In one embodiment, both the fixed end and the moving end of the suture are located outside the medical device.

[0037] In one embodiment, the stent includes a plurality of stent rods, and adjacent stent rods enclose a plurality of mesh openings. Pores are formed on the stent rods, and the suture is threaded through the pores and / or the mesh openings.

[0038] In one embodiment, the distal end of the stent is folded inward or outward of the medical device so that the distal end of the stent forms a double-layer structure, and the double-layer structure has overlapping pores. The suture loop is formed by threading the suture through the overlapping pores, the mesh openings and the membrane.

[0039] In one embodiment, the suture loop is an "8"-shaped double-ring suture loop. One of the ring suture loops is formed by threading the suture through the membrane, the mesh opening and the overlapping pore, and the other ring suture loop is formed by threading the suture through the overlapping pore.

[0040] In one embodiment, a first threading hole and a second threading hole are spaced along a direction away from the membrane on the inner layer of the distal end of the stent, and a third threading hole and a fourth threading hole are spaced along a direction away from the membrane on the outer layer of the distal end of the stent. The third threading hole overlaps with the first threading hole and the fourth threading hole overlaps with the second threading hole to form the overlapping pore;

[0041] One of the ring suture loops is formed by threading the suture through the first threading hole, the third threading hole and the membrane, and the other ring suture loop is formed by threading the suture through the first threading hole, the third threading hole, the second threading hole and the fourth threading hole.

[0042] In one embodiment, a third knot is formed in the middle of the suture, and the third knot is used to prevent the suture from falling off the stent after breaking, wherein the third knot and the second knot are located on different sides of the stent.

[0043] In one embodiment, a third knotting loop is formed by crossing the middle parts of the suture, and the fixed end or the moving end of the suture winds around the non-knotting area in the middle of the suture for one circle and passes out through the third knotting loop, and the third knotting loop forms the third knot after being tightened.

[0044] For the above-mentioned medical device, the first knot can be tied on the suture first to form a suture loop between the stent and the film. Then, by utilizing the characteristic that the moving end of the suture can move along the first knot, the length of the suture loop can be controlled during the film sewing process, thereby controlling the sewing tightness between the film and the stent. After the sewing tightness between the film and the stent is controlled to be appropriate, the second knot can be tied on the suture to lock the suture loop, avoiding the defect that the length of the suture loop cannot be adjusted after tying a dead knot.

[0045] In addition, compared with the suture threading method in the prior art, the suture first passes through the film and the stent once and then passes through the stent twice to form a suture loop and is knotted and fixed at the mesh opening of the stent. In this application, the suture loop passes through the stent at least four times and passes through the film at least once. This can not only increase the number of force points of the suture on the stent and the film, making the force more uniform during the locking process of the suture loop of the medical device to ensure the structural and morphological stability of the medical device, so as to avoid the inaccurate adjustment of the suture loop due to severe deformation of the medical device, resulting in the suture loop being too large or too small; but also reduce the distance between the fixed end and the moving end of the suture loop before knotting, which is convenient for knotting the fixed end and the moving end, without the need to use too much force to knot the fixed end and the moving end, and can also avoid the inaccurate adjustment of the suture loop due to excessive force on the medical device causing deformation.

[0046] It can be seen that for the medical device provided in this application, on the one hand, a method combining a slip knot (i.e., the first knot) and a dead knot (i.e., the second knot) is adopted to wrap the film around the stent, which is beneficial to controlling the sewing tightness of the film on the stent and can also avoid the defect that the length of the suture loop cannot be adjusted after tying a dead knot; on the other hand, the middle part of the suture passes through the stent at least four times and passes through the film at least once to form a suture loop, which can avoid the inaccurate adjustment of the suture loop due to severe deformation of the medical device, resulting in the suture loop being too large or too small, so as to ensure that the sewing tightness between the flow-blocking film and the stent is appropriate. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 is a schematic flowchart of a film sewing method for a medical device provided by an embodiment of the present invention;

[0048] Figure 2 Schematic structural diagram of a medical device provided by an embodiment of the present invention before suturing;

[0049] Figure 3 Schematic diagram of the movement direction of the moving end of the suture when the stent provided by an embodiment of the present invention is a single-layer structure under pulling;

[0050] Figure 4 First schematic diagram of the movement direction of an 8-shaped double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with a mesh opening;

[0051] Figure 5 First schematic diagram of the movement direction of an 8-shaped double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with pores;

[0052] Figure 6 Second schematic diagram of the movement direction of an 8-shaped double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with pores;

[0053] Figure 7 Second schematic diagram of the movement direction of an 8-shaped double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with a mesh opening;

[0054] Figure 8 First schematic diagram of the movement direction of a wound double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with pores;

[0055] Figure 9 Second schematic diagram of the movement direction of a wound double-ring suture coil provided by an embodiment of the present invention when passing through a single-layer structure stent with pores;

[0056] Figure 10 is Figure 2 Partial enlarged schematic diagram at A;

[0057] Figure 11 Schematic structural diagram of a suture coil provided by an embodiment of the present invention in the case of a double-layer structure stent;

[0058] Figure 12 Schematic structural diagram of a medical device provided by an embodiment of the present invention in the case of a double-layer structure stent;

[0059] Figure 13 First schematic diagram of the movement direction of a wound double-ring suture coil provided by an embodiment of the present invention when passing through a double-layer structure stent with pores;

[0060] Figure 14Schematic diagram of the second orientation of the wound double-ring suture coil provided by an embodiment of the present invention when passing through a stent with a double-layer structure and having pores;

[0061] Figure 15 Schematic diagram of the second orientation of the figure-eight double-ring suture coil provided by an embodiment of the present invention when passing through a stent with a double-layer structure and having pores;

[0062] Figure 16 Schematic diagram of the second orientation of the figure-eight double-ring suture coil provided by an embodiment of the present invention when passing through a stent with a double-layer structure and having mesh openings;

[0063] Figure 17 Schematic diagram of the structure of the first knot before being tightened provided by an embodiment of the present invention;

[0064] Figure 18 Schematic diagram of the structure of a medical device provided by another embodiment of the present invention in the case of a stent with a double-layer structure;

[0065] Figure 19 Schematic diagram of the orientation of the moving end of the suture thread when pulled provided by another embodiment of the present invention;

[0066] Figure 20 Schematic diagram of the structure of the second knot before being tightened provided by an embodiment of the present invention;

[0067] Figure 21 Schematic diagram of the structure of the second knot before being tightened provided by another embodiment of the present invention;

[0068] Figure 22 Schematic diagram of the structure of a medical device provided by another embodiment of the present invention in the case of a stent with a double-layer structure;

[0069] Figure 23 Schematic diagram of the structure of the third knot before being tightened provided by an embodiment of the present invention;

[0070] Figure 24 Schematic diagram after the third knot provided by an embodiment of the present invention is tightened.

[0071] Among them, the reference numerals in the drawings are explained as follows:

[0072] 100. Bracket; 100a. Network port; 110. Double-layer structure; 111. Outer layer; 111a. First wire-passing hole; 111b. Second wire-passing hole; 112. Inner layer; 112a. Third wire-passing hole; 112b. Fourth wire-passing hole; 130. Bracket rod; 130a. Porosity; 200. Coating film; 300. Suture; 310. Middle part; 311. Suture coil; 3111. Ring-shaped suture coil; 320. Fixed end; 330. Movable end; 340. First knot; 350. Second knot; 360. Third knot; 370. First knotting loop; 380. Second knotting loop; 390. Third knotting loop. Detailed implementation manners

[0073] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following will describe the detailed implementation manners of the present invention in conjunction with the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0074] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation to the present invention.

[0075] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0076] In the present invention, unless otherwise clearly specified or defined, the terms "mounted", "connected", "coupled", "fixed", etc. shall be construed in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0077] In the present invention, unless otherwise clearly specified or defined, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0078] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0079] As Figure 1 shown, an embodiment of the present invention provides a method for sewing a film for a medical device, wherein the medical device includes a stent 100 and a film 200, and the method for sewing the film includes:

[0080] S100, placing the film 200 on the stent 100;

[0081] S200, passing the middle portion 310 of the suture 300 through the stent 100 at least four times (such as four times, five times, six times, etc.) and through the film 200 at least once (such as once, twice, three times, etc.) to form a suture loop 311, and tying a first knot 340 between the fixed end 320 and the movable end 330 of the suture 300;

[0082] S300, pulling the movable end 330 of the suture 300 so that the movable end 330 of the suture 300 moves along the first knot 340 to adjust the size of the suture loop 311 and then lock the suture loop 311.

[0083] It should be noted that the wire knot in this article refers to a wire lump.

[0084] The film sewing method of the above-mentioned medical device is applicable to medical devices with a blocking function such as a left atrial appendage occluder. Preferably, the medical device includes a film 200 and a stent 100. Hereinafter, taking the left atrial appendage occluder as an example, the film sewing method of the medical device will be described. Among them, as Figure 2 shown, the left atrial appendage occluder includes a stent 100 and a film 200. The film 200 is covered on the distal end and the waist of the stent 100 through a suture 300. The material of the stent 100 can be a biocompatible and self-expanding alloy material such as nitinol or stainless steel. The material of the film 200 can be a polymer material such as PET (Polyethyleneterephthalate, polyester resin), PTFE (Poly tetra fluoroethylene, polytetrafluoroethylene), ePTFE (Expanded Polytetrafluoroethylene, expanded polytetrafluoroethylene), etc. The material of the suture 300 can be a polymer material such as PET, ePTFE, PP (Polypropylene, polypropylene), PA (Polyamide, polyamide), etc. The waist of the stent 100 refers to the part of the stent 100 between the proximal end and the distal end. The proximal end of the stent 100 refers to the end of the stent 100 close to the heart, and the distal end of the stent 100 refers to the end of the stent 100 far from the heart.

[0085] As Figure 3 shown, for the film sewing method of the above-mentioned medical device, a first wire knot 340 can be tied on the suture 300 to form a sewing coil 311 between the stent 100 and the film 200. Then, by using the characteristic that the moving end 330 of the suture 300 can move along the first wire knot 340, the size of the sewing coil 311 can be controlled during the film sewing process, and further the sewing tightness between the film 200 and the stent 100 can be controlled. After the sewing tightness between the film 200 and the stent 100 is controlled to be appropriate, the sewing coil 311 can be locked, avoiding the defect that the length of the sewing coil 311 cannot be adjusted after tying a dead knot. In addition, compared with the threading method of the suture 300 in the prior art, where the suture passes through the film and the stent once and then passes through the stent a second time to form a sewing coil and is tied and fixed at the mesh opening of the stent, the sewing coil of the present application passes through the stent at least four times and through the film at least once. For example, see Figure 3The threading method shown can increase the number of force points of the suture 300 on the stent 100 and the film 200, making the force more uniform during the locking process of the suture coil 311 of the medical device, so as to ensure the structural and morphological stability of the medical device, thereby avoiding inaccurate adjustment of the suture coil 311 due to severe deformation of the medical device, resulting in the suture coil 311 being too large or too small; it can also reduce the distance between the fixed end 320 and the moving end 330 of the suture coil 300 before knotting. This not only facilitates knotting the fixed end 320 and the moving end 330 without the need to use excessive force to knot the fixed end 320 and the moving end 330, but also can avoid inaccurate adjustment of the suture coil 311 due to deformation of the medical device caused by excessive force.

[0086] Regarding step S100, the film 200 can be wrapped around the proximal end and the waist of the stent 100.

[0087] Regarding step S200, the threading position of the suture 300 on the stent 100 is mainly related to the structure of the stent 200. Specifically, as Figure 2 shown, the stent 100 includes a plurality of stent rods 130, and a plurality of adjacent stent rods 130 enclose a plurality of mesh openings 100a. Pores 130a are formed on the stent rods 130 (see Figure 3 ), and the suture 300 is threaded through the pores 130a and / or the mesh openings 100a. It can be understood that the "threading" in this article means that the suture 300 passes from the inside of the stent 100 to the outside of the stent 100 or from the outside of the stent 100 to the inside of the stent 100. Specifically, holes can be drilled on the stent rods 130, and the suture 300 can pass through the pores 130a (see Figure 3 ), or can pass through the mesh openings 100a on the stent 100 (see Figure 4 ), or the suture 300 can also wind around the stent rods 130. It should be noted that in order to facilitate the description of how the middle part of the suture 300 passes through the mesh opening 100a, Figure 4 only one stent rod 130 and the adjacent parts of other intersecting stent rods 130 are retained.

[0088] Optionally, the middle part 310 of the suture 300 passes through the pores at least three times, and the middle part 310 of the suture 300 passes through the film 200 and the mesh opening 113a at least once. By utilizing the characteristic that the mesh opening 113a has a large area, the suture area overlapping with the mesh opening 113a in the film 200 can be increased, so that the suture position on the film 200 can be flexibly adjusted according to specific requirements; in addition, by utilizing the characteristic that the area of the gap 130a is small, it can play a limiting role on the suture 300 passing through it, thereby ensuring the morphological and structural stability of the medical device after suturing.

[0089] In addition, regarding the structure of the suture 300, two examples are given as follows:

[0090] The first example is as Figure 3 and Figure 4 shown. The suture loop 311 is an "8"-shaped double-loop suture loop. One loop suture 3111 is formed by the suture 300 passing through the film 200, the mesh opening 100a, and the pore 130a / mesh opening 100a, and the other loop suture 3111 is formed by the suture 300 passing through the pore 130a / mesh opening 100a. The "8"-shaped double-loop suture loop is not only convenient for knitting but also can firmly suture the film 200 to the stent 100.

[0091] Exemplarily, Figure 3 as shown, one loop suture 3111 of the suture loop 311 is formed by the suture 300 passing through the film 200, the mesh opening 100a, and the pore 130a, and the other loop suture 3111 is formed by the suture 300 passing through the pore 130a; Figure 4 as shown, one loop suture 3111 of the suture loop 311 is formed by the suture 300 passing through the film 200, the mesh opening 100a on the waist of the stent 100, and the mesh opening 100a on the distal end of the stent 100, and the other loop suture 3111 is formed by the suture 300 passing through the mesh opening 100a on the distal end of the stent 100.

[0092] Regarding the routing method of the "8"-shaped double-loop suture 3111, four examples are given as follows. For the convenience of description, the first two examples are described with the pore 130a provided on the stent rod 130 as an example, and the last two examples are described with the mesh opening 100a formed by the stent rod 130 surrounding as an example:

[0093] The first example (1.1) is as Figure 5 shown. This routing method includes:

[0094] Step a1: At the first pore of the stent 100, the fixed end 320 or the moving end 330 of the suture 300 is inserted from the first side of the stent 100 to the second side and then passes through the film 200;

[0095] Step b1: After the fixed end 320 or the moving end 330 of the suture 300 passes through the film 200 and enters the first side of the stent 100 through the mesh opening 100a, at the first pore, the fixed end 320 or the moving end 330 of the suture 300 is inserted from the first side of the stent 100 to the second side;

[0096] Step c1: At the second pore of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100, where the first and second pores are sequentially distributed in a direction away from the membrane 200. The first and second sides of the stent 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device including the membrane and the stent.

[0097] In the above steps, the first side of the stent 100 may refer to the outer side of the medical device, and the second side of the stent 100 may refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 5 The dotted arrow represents the running direction of the suture 300.

[0098] Example (1.2): As Figure 6 shown, this routing method includes:

[0099] Step a2: At the first pore of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100;

[0100] Step b2: At the second pore of the stent 100, after inserting the fixed end 320 or the movable end 330 of the suture 300 from the second side to the first side of the stent 100, thread it through the membrane 200;

[0101] Step c2: After the fixed end 320 or the movable end 330 of the suture 300 passes through the membrane 200 and enters the second side of the stent 100 through the mesh opening 113a, at the second pore, insert the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100, where the first and second pores are sequentially distributed in a direction close to the membrane 200. The first and second sides of the stent 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

[0102] In the above steps, the first side of the stent 100 may refer to the outer side of the medical device, and the second side of the stent 100 may refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 6 The dotted arrow represents the running direction of the suture 300.

[0103] Example (1.3): As Figure 4 shown, this routing method includes:

[0104] Step a3: At the first mesh opening of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100;

[0105] Step b3: At the second mesh opening of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the second side through the stent 100 to the first side, and then insert it through the first mesh opening to the second side of the stent 100;

[0106] Step c3: Pass the fixed end 320 or the movable end 330 of the suture 300 through the membrane 200 and enter the first side of the stent 100 through the third mesh opening, where the third, first, and second mesh openings are distributed in sequence in the direction away from the membrane 200. The first and second sides of the stent 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

[0107] In the above steps, the first side of the stent 100 can refer to the outer side of the medical device, and the second side of the stent 100 can refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 4 The dotted arrow represents the running direction of the suture 300.

[0108] The (1.4)th example is as follows Figure 7 As shown, this routing method includes:

[0109] Step a4: Pass the fixed end 320 or the movable end 330 of the suture 300 through the membrane 200 and enter the second side of the stent 100 from the first side of the stent 100 through the first mesh opening;

[0110] Step b4: At the second mesh opening of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100;

[0111] Step c2: At the third mesh opening of the stent 100, insert the fixed end 320 or the movable end 330 of the suture 300 from the first side of the stent into the second side of the stent 100, and then insert it through the third mesh opening to the first side of the stent 100, where the first, second, and third mesh openings are distributed in sequence in the direction away from the membrane 200. The first and second sides of the stent 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

[0112] In the above steps, the first side of the stent 100 can refer to the outer side of the medical device, and the second side of the stent 100 can refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 7 The dotted arrow represents the running direction of the suture 300.

[0113] Regarding the structure of the suture 300, the (2)nd example is given as follows:

[0114] As Figure 8 and Figure 9As shown, the suture coil 311 is a wound double-ring suture coil 3111. One of the ring suture coils 3111 is formed by passing the suture 300 through the covering film 200, the mesh opening 100a and the pore 130a / mesh opening 100a, and the other ring suture coil 3111 is formed by passing the suture 300 through the pore 130a / mesh opening 100a, and one of the ring suture coils 3111 surrounds the outside of the other ring suture coil 3111.

[0115] Regarding the routing method of the wound double-ring suture coil 3111, the following (2) examples are given. For the convenience of description, taking the pore 130a provided on the support rod 130 as an example, these 2 examples are described as follows:

[0116] The first (2.1) example, as Figure 8 shown, the routing method includes:

[0117] Step a5: At the first pore of the support 100, insert the fixed end 320 or the moving end 330 of the suture 300 from the first side of the support 100 to the second side of the support 100;

[0118] Step b5: At the second pore of the support, insert the fixed end 320 or the moving end 330 of the suture 300 from the second side of the support to the first side of the support;

[0119] Step c5: Pass the fixed end 320 or the moving end 330 of the suture 300 through the covering film 200 and enter the second side of the support 100 through the mesh opening 100a, and then pass through the second pore and enter the first side of the support. The first and second pores are distributed in sequence along the direction away from the covering film 200. The first and second sides of the support 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

[0120] In the above steps, the first side of the support 100 can refer to the outer side of the medical device, and the second side of the support 100 can refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 8 the dotted arrow represents the routing direction of the suture 300.

[0121] The second (2.2) example, as Figure 9 shown, the routing method includes:

[0122] Step a5: At the first pore, insert the fixed end 320 or the moving end 330 of the suture 300 from the first side of the support 100 to the second side of the support 100, and then pass through the covering film 200 and enter the first side of the support 100 through the mesh opening 100a;

[0123] Step b5: At the first pore, insert the fixed end 320 or the moving end 330 of the suture 300 from the first side of the stent 100 to the second side of the stent 100;

[0124] Step c5: At the second pore of the stent 100, insert the fixed end 320 or the moving end 330 of the suture 300 from the second side of the stent 100 to the first side of the stent 100, where the first and second pores are sequentially distributed along the direction close to the membrane 200, and the first and second sides of the stent 100 respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

[0125] In the above steps, the first side of the stent 100 can refer to the outer side of the medical device, and the second side of the stent 100 can refer to the inner side of the medical device. In this way, it is convenient to tie the first knot 340 with the fixed end 320 of the suture 300. It should be noted that Figure 9 The dotted arrow represents the running direction of the suture 300.

[0126] During application, the type and routing method of the suture coil 3111 can be selected according to the structure of the stent 100. For example, as Figure 10 shown, the distal end of the stent 100 is folded inward or outward of the stent 100, so that a double-layer structure 110 is formed at the distal end of the stent 100. The suture coil 311 is formed by passing the suture 300 through the distal end of the stent 100 and the membrane 200. Setting the distal end of the stent 100 as the double-layer structure 110 can not only ensure the mechanical properties of the stent 100, but also ensure the shape of the stent 100, so that the distal structure of the stent 100 matches the orifice of the left atrium of the heart, and thus can be more firmly attached to the orifice of the left atrium. The stent 100 with the above structure can either adopt the "8"-shaped double-ring suture coil 3111 provided in the above first example (see Figure 11 and Figure 12 ), or adopt the wound double-ring suture coil 3111 provided in the above second example (see Figure 13 and Figure 14 ), and is connected to the membrane 200.

[0127] Among them, as an example, pores 130a are provided on the double-layer structure 110 of the stent 100, and the "8"-shaped double-ring suture coil 3111 or the wound double-ring suture coil 3111 is passed through the pores 130a. Specifically, as Figure 10As shown, the inner layer 112 at the distal end of the stent 100 is provided with a first wire-passing hole 111a and a second wire-passing hole 111b at intervals in a direction away from the membrane 200. The outer layer 111 at the distal end of the stent 100 is provided with a third wire-passing hole 112a and a fourth wire-passing hole 112b at intervals in a direction away from the membrane 200. The third wire-passing hole 112a overlaps with the first wire-passing hole 111a, and the fourth wire-passing hole 112b overlaps with the second wire-passing hole 111b. Optionally, the first wire-passing hole 111a, the second wire-passing hole 111b, the third wire-passing hole 112a, and the fourth wire-passing hole 112b can be round holes, square holes, etc.

[0128] When the double-ring suture coil 3111 is adopted, as Figure 15 and Figure 16 shown, one of the ring suture coils 3111 is formed by passing the suture 300 through the first wire-passing hole 111a, the third wire-passing hole 112a, the mesh opening 130b, and the membrane 200. The other ring suture coil 3111 is formed by passing the suture 300 through the first wire-passing hole 111a, the third wire-passing hole 112a, the second wire-passing hole 111b, and the fourth wire-passing hole 112b. Among them, the double-ring suture coil 3111 can be threaded in the wire-passing mode provided by the above-mentioned first example (1.1). At this time, the first pore refers to the overlapping area of the first wire-passing hole 111a and the third wire-passing hole 112a, and the second pore refers to the overlapping area of the second wire-passing hole 111b and the fourth wire-passing hole 112b. The double-ring suture coil 3111 can be threaded in the wire-passing mode provided by the above-mentioned second example (1.2). At this time, the second pore refers to the overlapping area of the first wire-passing hole 111a and the third wire-passing hole 112a, and the first pore refers to the overlapping area of the second wire-passing hole 111b and the fourth wire-passing hole 112b.

[0129] When the wound double-ring suture coil 3111 is adopted, as Figure 12 and Figure 13As shown, one of the annular suture coils 3111 is formed by passing a suture 300 through a third thread-passing hole 112a, a fourth thread-passing hole 112b, a mesh opening 130b, and a film 200, and the other annular suture coil 3111 is formed by passing the suture 300 through a first thread-passing hole 111a, a third thread-passing hole 112a, a second thread-passing hole 111b, and a fourth thread-passing hole 112b. Among them, the double annular suture coil 3111 can be threaded according to the threading method provided in the above-mentioned example (1.5). At this time, the first pore refers to the overlapping area of the first thread-passing hole 111a and the third thread-passing hole 112a, and the second pore refers to the overlapping area of the second thread-passing hole 111b and the fourth thread-passing hole 112b; the double annular suture coil 3111 can be threaded according to the threading method provided in the above-mentioned example (1.6). At this time, the second pore refers to the overlapping area of the first thread-passing hole 111a and the third thread-passing hole 112a, and the first pore refers to the overlapping area of the second thread-passing hole 111b and the fourth thread-passing hole 112b.

[0130] In some embodiments of the present invention, as Figure 17 shown, the fixed end 320 and the moving end 330 of the suture 300 can be tied with a first knot 340 by the following method: a first knotting loop 370 is formed on the fixed end 320 of the suture 300, and the moving end 330 of the suture 300 is passed through the first knotting loop 370, and then the first knotting loop 370 is tightened. It can be understood that after the first knotting loop 370 is tightened, the moving end 330 of the suture 300 is in contact with the first knotting loop 370. When adjusting the length of the suture coil 311, only by pulling the end of the moving end 330 of the suture 300, the moving end 330 of the suture 300 will move along the first knotting loop 370 (see Figure 9 ), until the length of the suture coil 311 reaches the preset length. This kind of knotting method is easy to operate and reduces the difficulty of film suturing.

[0131] In some embodiments of the present invention, as Figure 18 shown, the film suturing method further includes: step S500, tying a second knot 350 between the fixed end 320 and the moving end 330 of the suture 300 to lock the suture coil 311. See Figure 19 . By utilizing the characteristic that the moving end 330 of the suture 300 can move along the first knot 340, the size of the suture coil 311 can be controlled during the film suturing process, and further the suturing tightness between the film 200 and the stent 100 can be controlled. After the suturing tightness between the film 200 and the stent 100 is controlled to be appropriate, the suture coil 311 can be locked by tying the second knot 350.

[0132] Optionally, as Figure 20As shown, the fixed end 320 and the moving end 330 of the suture 300 can be tied with a second knot 350 by the following method: a second knotting loop 380 is formed on the fixed end 320 or the moving end 330 of the suture 300, and the moving end 330 or the fixed end 320 of the suture 300 is passed through the second knotting loop 380, and then the second knotting loop 380 is tightened. As an example, a second knotting loop 380 is formed on the fixed end 320 of the suture 300, and the moving end 330 of the suture 300 is passed through the second knotting loop 380. As another example, a second knotting loop 380 is formed on the moving end 330 of the suture 300, and the fixed end 320 of the suture 300 is passed through the second knotting loop 380. This knotting method is convenient for operation and reduces the difficulty of suture film.

[0133] Regarding the number of the second knots 350, one or more can be set according to the length, thickness, length of the suture 300 and the requirement for the locking degree of the suture loop 311, such as 2, 3, 4, etc.

[0134] Of course, in some other embodiments of the present invention, other methods can also be used to form it, and the formed structure can be as Figure 21 shown.

[0135] In some embodiments of the present invention, as Figures 22 to 24 shown, before tying the first knot 340 between the fixed end 320 and the moving end 330 of the suture 300, the suture film method further includes: step S400, tying a third knot 360 in the middle 310 of the suture 300 to prevent the suture 300 from falling off the stent 100 after breaking, wherein the third knot 360 and the second knot 350 are located on different sides of the stent 100. Knot locking structures (i.e., the second knot 350 and the third knot 360) are formed on both the inner and outer sides of the stent 100, so that even if the suture 300 breaks, it cannot fall off the stent 100. As an example, the second knot 350 is located on the outer side of the stent 100, the third knot 360 is located on the inner side of the stent 100, and the maximum outer diameter of the third knot 360 is greater than the pore diameters of the first threading hole 111a, the second threading hole 111b, the third threading hole 112a, and the fourth threading hole 112b, to prevent the third knot 360 from passing through the first threading hole 111a, the second threading hole 111b, the third threading hole 112a or the fourth threading hole 112b and passing out from the inner side of the stent 100 to the outer side of the stent 100.

[0136] Specifically, in some embodiments of the present invention, as Figure 23As shown in the figure, the third knot 360 is formed in the following way: at the middle 310 of the suture 300, a third knotting loop 390 is formed by crossing. The fixed end 320 or the moving end 330 of the suture 300 is wound around the non-knotting area of the middle 310 of the suture 300 for one circle and passes out through the third knotting loop 390, and then the third knotting loop 390 is tightened. The knot formed by this kind of method has the characteristic of large volume, making the knot unable to pass through the stent 100 smoothly. It should be noted that the third knot 360 is a dead knot. Of course, in some other embodiments of the present invention, the third knot 360 can also be formed in other ways, and its formed structure can be as Figure 21 shown.

[0137] It can be seen that for the suture film method provided by the present application, on the one hand, a method combining a slip knot (i.e., the first knot 340) and a dead knot (i.e., the second knot 350) is adopted to wrap the film 200 on the stent 100, which is beneficial to controlling the stitching tightness of the film 200 on the stent 100, and can also avoid the defect that the length of the suture loop 311 cannot be adjusted after tying a dead knot; on the other hand, the middle 310 of the suture 300 passes through the stent 100 at least four times and passes through the film 200 at least once to form a suture loop 311, which can avoid the inaccurate adjustment of the suture loop 311 caused by serious deformation of the medical device, resulting in the suture loop 311 being too large or too small, so as to ensure that the stitching tightness between the flow-blocking film and the stent is moderate.

[0138] Another embodiment of the present invention provides a medical device, as Figure 3 shown. The medical device includes: a stent 100 and a film 200, and the film 200 is sewn on the stent 100 through a suture 300; the middle 310 of the suture 300 passes through the stent 100 at least four times and passes through the film 200 at least once to form a suture loop 311, and the fixed end 320 and the moving end 330 of the suture 300 are connected by tying a first knot 340 to lock the suture loop 311.

[0139] The above-mentioned medical device is applicable to medical devices with a blocking function such as left atrial appendage occluders, which include a film and a stent.

[0140] As Figure 3As shown, for the above-mentioned medical device, a first knot 340 can be tied on the suture 300 first to form a suture loop 311 between the stent 100 and the membrane 200. Then, by utilizing the characteristic that the moving end 330 of the suture 300 can move along the first knot 340, the size of the suture loop 311 can be controlled during the membrane suturing process, thereby controlling the suturing tightness between the membrane 200 and the stent 100. After the suturing tightness between the membrane 200 and the stent 100 is appropriately controlled, the suture loop 311 can be locked, avoiding the defect that the length of the suture loop 311 cannot be adjusted after tying a dead knot. In addition, compared with the threading method of the suture 300 in the prior art, where the suture passes through the membrane and the stent once and then passes through the stent a second time to form a suture loop and is tied and fixed at the mesh opening of the stent, the suture loop in this application passes through the stent at least four times and through the membrane at least once. For example, refer to Figure 3 the threading method shown, which can not only increase the number of force-bearing points of the suture 300 on the stent 100 and the membrane 200, making the force more uniform during the locking process of the suture loop 311 of the medical device to ensure the structural and morphological stability of the medical device, so as to avoid inaccurate adjustment of the suture loop 311 due to severe deformation of the medical device, resulting in the suture loop 311 being too large or too small; but also reduce the distance between the fixed end 320 and the moving end 330 of the suture loop 300 before knotting, which not only facilitates tying the fixed end 320 and the moving end 330 without the need to use excessive force to tie the fixed end 320 and the moving end 330, but also can avoid inaccurate adjustment of the suture loop 311 due to excessive force on the medical device causing deformation.

[0141] In some embodiments of the present invention, as Figure 18 shown, the medical device further includes a second knot 350. The fixed end 320 and the moving end 33 of the suture 300 are connected by tying the first knot 340 and the second knot 350 in sequence, where the first knot 310 can move, and the second knot 350 is used to lock the suture loop 311. For this medical device, a first knot 340 can be tied on the suture 300 first to form a suture loop 311 between the stent 100 and the membrane 200. Then, by utilizing the characteristic that the moving end 330 of the suture 300 can move along the first knot 340, the length of the suture loop 311 can be controlled during the membrane suturing process, thereby controlling the suturing tightness between the membrane 200 and the stent 100. After the suturing tightness between the membrane 200 and the stent 100 is appropriately controlled, a second knot 350 can be tied on the suture 300 to lock the suture loop 311.

[0142] In some embodiments of the present invention, as Figure 20As shown, a second knotting loop 380 is formed on the fixed end 320 or the moving end 330 of the suture 300, and the moving end 330 or the fixed end 320 of the suture 300 passes through the second knotting loop 380, and the second knotting loop 380 can be tightened to form a second knot 350. This type of second knot 350 has a simple structure and is easy to operate. Of course, in some other embodiments of the present invention, the second knot 350 can also adopt other structures, such as Figure 21 the structure shown.

[0143] In some embodiments of the present invention, such as Figure 19 , Figure 20 and Figure 22 shown, both the fixed end 320 and the moving end 330 of the suture 300 are located outside the stent 100. In this way, it is convenient to tie the first knot 340 and the second knot 350 for the fixed end 320 and the moving end 330 of the suture 300.

[0144] In some embodiments of the present invention, such as Figure 17 shown, a first knotting loop 370 is formed on the fixed end 320 of the suture 300, and the moving end 330 of the suture 300 passes through the first knotting loop 370, and the first knotting loop 370 can be tightened to form a first knot 340 after being tightened. This type of first knot 340 has a simple structure and is easy to operate.

[0145] In some embodiments of the present invention, such as Figure 2 shown, the stent 100 includes a plurality of stent rods 130, and adjacent stent rods 130 enclose a plurality of mesh openings 113a. Pores are formed on the stent rods 130, and the suture 300 is threaded through the pores 130a and / or the mesh openings 100a. In this way, according to the thickness of the stent rods 130, it can be considered whether to form pores on the stent rods 130, so as to determine whether the suture 300 is threaded through the pores or through the mesh openings 113a.

[0146] Specifically, in some embodiments of the present invention, the middle portion 310 of the suture 300 passes through the pores at least three times, and the middle portion 310 of the suture 300 passes through the film 200 and the mesh opening 113a at least once. By using the characteristic that the mesh opening 113a has a large area, the suture area overlapping with the mesh opening 113a in the film 200 can be increased. In this way, the suture position on the film 200 can be flexibly adjusted according to specific requirements; in addition, by using the characteristic that the gap area is small, it can play a limiting role on the suture 300 passing through it, so as to ensure the shape and structure stability of the medical device after suturing.

[0147] Among them, the specific threading method of the middle portion 310 of the suture 300 is mainly related to the distal structure of the stent 100. In some embodiments of the present invention, such as Figure 2 and Figure 10As shown, the distal end of the stent 100 is folded inward or outward of the stent 100, so that a double-layer structure 110 is formed at the distal end of the stent 100. The double-layer structure has overlapping pores. The suture coil 311 is formed by passing the suture 300 through the overlapping pores, the mesh opening 113a and the membrane 200. It should be noted here that threading holes are provided at the same position on the inner and outer layers of the double-layer structure 100, and at least a part of these two threading holes overlaps. The overlapping part is called the "overlapping pores". Setting the distal end of the stent 100 as the double-layer structure 110 can not only ensure the mechanical properties of the stent 100, but also ensure the shape of the stent 100, so that the distal structure of the stent 100 matches the orifice of the left atrium of the heart, and thus can be more firmly attached to the orifice of the left atrium.

[0148] Regarding the distal end of the stent 100 with the above structure, as Figure 11 and Figure 12 shown, in the embodiment of the present invention, the suture coil 311 is an "8"-shaped double-ring suture coil 3111. One of the ring suture coils 3111 is formed by passing the suture 300 through the membrane 200, the mesh opening 113a and the overlapping pores, and the other ring suture coil 3111 is formed by passing the suture 300 through the overlapping pores. The "8"-shaped double-ring suture coil can not only sew the membrane 200 on the stent 100, but also fix the inner and outer layers at the distal end of the stent 100 to make the two fastened, ensuring the stability of the structure of the stent 100. Of course, in some other embodiments of the present invention, the suture coil 311 can also be the wound double-ring suture coil 3111 provided in the above-mentioned (2) embodiment.

[0149] Among them, as an example, as Figure 11 shown, the inner layer 112 of the double-layer structure 110 is provided with a first threading hole 111a and a second threading hole 111b at intervals in the direction away from the membrane 200. The outer layer 111 of the double-layer structure 110 is provided with a third threading hole 112a and a fourth threading hole 112b at intervals in the direction away from the membrane 200. The third threading hole 112a overlaps with the first threading hole 111a and the fourth threading hole 112b overlaps with the second threading hole 111b to form overlapping pores; one of the ring suture coils 3111 is formed by passing the suture 300 through the first threading hole 111a, the third threading hole 112a, the mesh opening 113a and the membrane 200, and the other ring suture coil 3111 is formed by passing the suture 300 through the first threading hole 111a, the third threading hole 112a, the second threading hole 111b and the fourth threading hole 112b. Optionally, the first threading hole 111a, the second threading hole 111b, the third threading hole 112a and the fourth threading hole 112b can be round holes, square holes, etc.

[0150] In some embodiments of the present invention, the middle portion 310 of the suture 300 passes through the stent 100 at least twice, and the middle portion 310 of the suture 300 passes through the membrane 200 at least once. In this way, it can be ensured that the fixed end 320 and the moving end 330 of the suture 300 are both on the side of the stent 100 after the middle portion of the suture 300 passes through the membrane 200 and the stent 100, rather than one end being on the side of the membrane 200 and the other end being on the side of the stent 100, which is convenient for tying the first knot 340 between the fixed end 320 and the moving end 330 of the suture 300, and can also avoid excessive pulling of the membrane 200 during the process of adjusting the length of the suture loop 311, thereby preventing the membrane 200 from being torn off the stent 100. Regarding the specific number of times the middle portion 310 of the suture 300 passes through the stent 100 and the membrane 200, it is mainly related to the passing method of the middle portion 310 of the suture 300. For example, as Figure 19 shown, the middle portion 310 of the suture 300 passes through the stent 100 three times and the middle portion 310 of the suture 300 passes through the membrane 200 once according to the "8"-shaped route.

[0151] Among them, the passing method of the middle portion 310 of the suture 300 is mainly related to the distal structure of the stent 100. In some embodiments of the present invention, as Figure 10 shown, the distal end of the stent 100 is folded inward or outward of the stent 100 so that a double-layer structure 110 is formed at the distal end of the stent 100, and the suture loop 311 is formed by the suture 300 passing through the distal end of the stent 100 and the membrane 200. Setting the distal end of the stent 100 as a double-layer structure 110 can not only ensure the mechanical properties of the stent 100, but also ensure the shape of the stent 100, so that the distal structure of the stent 100 matches the orifice of the left atrium, and thus can be more firmly attached to the orifice of the left atrium.

[0152] For the distal end of the stent 100 with the above structure, as Figure 11 shown, in the embodiments of the present invention, the suture loop 311 is an "8"-shaped double-ring suture loop. One of the ring suture loops 3111 is formed by the suture 300 passing through the membrane 200 and the stent 100, and the other ring suture loop 3111 is formed by the suture 300 passing through the stent 100. The "8"-shaped double-ring suture loop can not only sew the membrane 200 on the stent 100, but also fix the inner and outer layers at the distal end of the stent 100 to make the two fastened, ensuring the stability of the structure of the stent 100. Among them, as an example, as Figure 10 and Figure 11As shown, the inner layer 112 at the distal end of the stent 100 is provided with a first wire threading hole 111a and a second wire threading hole 111b at intervals in a direction away from the membrane 200. The outer layer 111 at the distal end of the stent 100 is provided with a third wire threading hole 112a and a fourth wire threading hole 112b at intervals in a direction away from the membrane 200. The third wire threading hole 112a corresponds to the first wire threading hole 111a, and the fourth wire threading hole 112b corresponds to the second wire threading hole 111b. One of the annular suture coils 3111 is formed by passing a suture 300 through the first wire threading hole 111a, the third wire threading hole 112a and the membrane 200. The other annular suture coil 3111 is formed by passing the suture 300 through the first wire threading hole 111a, the third wire threading hole 112a, the second wire threading hole 111b and the fourth wire threading hole 112b. Optionally, the first wire threading hole 111a, the second wire threading hole 111b, the third wire threading hole 112a and the fourth wire threading hole 112b can be round holes, square holes, etc.

[0153] In some embodiments of the present invention, as Figure 22 and Figure 24 shown, a third knot 360 is formed in the middle 310 of the suture 300. The third knot 360 is used to prevent the suture 300 from falling off the stent 100 after breaking, and the third knot 360 and the second knot 350 are located on different sides of the stent 100. Knot locking structures (i.e., the second knot 350 and the third knot 360) are formed on both the inner and outer sides of the stent 100, so that even if the suture 300 breaks, it cannot fall off the stent 100. As an example, the second knot 350 is located on the outer side of the stent 100, the third knot 360 is located on the inner side of the stent 100, and the maximum outer diameter of the third knot 360 is greater than the aperture diameters of the first wire threading hole 111a, the second wire threading hole 111b, the third wire threading hole 112a, and the fourth wire threading hole 112b, to prevent the third knot 360 from passing through the first wire threading hole 111a, the second wire threading hole 111b, the third wire threading hole 112a or the fourth wire threading hole 112b and piercing from the inner side of the stent 100 to the outer side of the stent 100.

[0154] Specifically, in some embodiments of the present invention, as Figure 23 shown, the middle 310 of the suture 300 intersects to form a third knotting loop 390, and the fixed end 320 or the moving end 330 of the suture 300 winds around a non-knotting area of the middle 310 of the suture 300 for one circle and passes out through the third knotting loop 390. The third knotting loop 390 can form a third knot 360 after being tightened. The knot of this type of structure has the characteristic of large volume, so that the knot cannot pass through the stent 100 smoothly. It should be noted that the third knot 360 is a dead knot. Of course, in some other embodiments of the present invention, the third knot 360 can also adopt other structures, such as Figure 21 shown in the structure.

[0155] It can be seen that for the medical device provided by the present application, on the one hand, a method combining a slip knot (i.e., the first wire knot 340) and a dead knot (i.e., the second wire knot 350) is adopted to wrap the membrane 200 around the stent 100, which is beneficial to controlling the stitching tightness of the membrane 200 on the stent 100 and can also avoid the defect that the length of the stitching coil 311 cannot be adjusted after tying a dead knot. On the other hand, the middle part 310 of the suture 300 is passed through the stent 100 at least four times and through the membrane 200 at least once to form the stitching coil 311, which can avoid inaccurate adjustment of the stitching coil 311 due to severe deformation of the medical device, resulting in the stitching coil 311 being too large or too small, so as to ensure that the stitching tightness between the flow-blocking membrane and the stent is appropriate.

[0156] In the present invention, a left atrial appendage occlusion stent is taken as an example. However, those of ordinary skill in the art should know that the stent can be other medical devices with an open or closed structure such as a large artery stent, a filter stent, a venous stent, etc.

[0157] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0158] The above-described embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed. However, it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. A method for sewing a film on a medical device, the medical device comprising a stent and a film Characterized in that The film sewing method includes: Placing the film on the stent; Threading the middle part of the suture through the stent at least four times and through the film at least once to form a suture loop, and tying a first knot between the fixed end and the moving end of the suture, wherein the first knot is a slip knot; Pulling the moving end of the suture to move it along the first knot to adjust the size of the suture loop; Tying a second knot between the fixed end and the moving end of the suture to lock the suture loop, wherein the second knot is a dead knot; Wherein, the stent includes a plurality of stent rods, adjacent stent rods enclose a plurality of mesh openings, pores are formed on the stent rods, and the suture is threaded through the pores and the mesh openings; the middle part of the suture is threaded through the pores at least three times, and the middle part of the suture is threaded through the mesh openings at least once.

2. The film sewing method according to claim 1 Characterized in that The tying of the first knot between the fixed end and the moving end of the suture includes: Forming a first knotting loop on the fixed end of the suture, threading the moving end of the suture through the first knotting loop, and then tightening the first knotting loop.

3. The film sewing method according to claim 1 Characterized in that The tying of the second knot between the fixed end and the moving end of the suture to lock the suture loop includes: Forming a second knotting loop on the fixed end or the moving end of the suture, threading the moving end or the fixed end of the suture through the second knotting loop, and then tightening the second knotting loop.

4. The film sewing method according to claim 1 Characterized in that The suture loop is an "8"-shaped double-ring suture loop, one of the ring suture loops is formed by threading the suture through the film, the mesh opening and the pore, and the other ring suture loop is formed by threading the suture through the pore.

5. The film sewing method according to claim 4 Characterized in that The threading of the middle part of the suture through the stent at least four times and through the film at least once to form a suture loop includes: At the first pore of the stent, threading the fixed end or the moving end of the suture from the first side of the stent into the second side of the stent and then threading it towards the film; After the fixed end or the moving end of the suture passes through the film and enters the first side of the stent through the mesh opening, threading the fixed end or the moving end of the suture from the first side of the stent into the second side of the stent at the first pore; At the second pore of the stent, threading the fixed end or the moving end of the suture from the second side of the stent into the first side of the stent, the first and second pores are sequentially distributed in a direction away from the film, and the first and second sides of the stent respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

6. The film sewing method according to claim 4 Characterized in that The threading of the middle part of the suture through the stent at least four times and through the film at least once includes: At the first pore of the stent, the fixed end or the moving end of the suture is inserted from the first side of the stent to the second side of the stent; At the second pore of the stent, after the fixed end or the moving end of the suture is inserted from the second side of the stent to the first side of the stent, it penetrates towards the film covering; After the fixed end or the moving end of the suture penetrates through the film covering and enters the second side of the stent through the mesh opening, at the second pore, the fixed end or the moving end of the suture is inserted from the second side of the stent to the first side of the stent. The first and second pores are sequentially distributed along the direction close to the film covering. The first and second sides of the stent respectively refer to the outer and inner sides or the inner and outer sides of the medical device.

7. The film sewing method according to claim 3, wherein, Before tying the first knot between the fixed end and the moving end of the suture, the film sewing method further includes: Tying a third knot in the middle of the suture to prevent the suture from falling off the stent after breaking, wherein the third knot and the second knot are located on different sides of the stent.

8. The film sewing method according to claim 7, wherein, Tying the third knot in the middle of the suture includes: Forming a third knotting loop by crossing in the middle of the suture, winding the fixed end or the moving end of the suture around the non-knotting area in the middle of the suture for one circle and passing through the third knotting loop, and then tightening the third knotting loop.

9. A medical device, wherein, The medical device includes: a stent and a film covering, and the film covering is sewn on the stent through a suture; The middle part of the suture penetrates through the stent at least four times and penetrates through the film covering at least once to form a suture loop. The fixed end and the moving end of the suture are connected in sequence by tying a first knot and a second knot. The first knot is a slip knot and is used to adjust the size of the suture loop. The second knot is a dead knot and is used to lock the suture loop; Wherein, the stent includes a plurality of stent rods, adjacent stent rods enclose to form a plurality of mesh openings, pores are formed on the stent rods, and the suture passes through the pores and the mesh openings; the middle part of the suture penetrates through the pores at least three times, and the middle part of the suture penetrates through the mesh openings at least once.

10. The medical device according to claim 9, wherein, The medical device further includes a second knot. The fixed end and the moving end of the suture are connected by tying the first knot and the second knot in sequence. The first knot can move, and the second knot is used to lock the suture loop.

11. The medical device according to claim 10, wherein, A first knotting loop is formed on the fixed end of the suture and the moving end of the suture passes through the first knotting loop. The first knotting loop can be tightened to form the first knot; A second knotting loop is formed on the fixed end or the moving end of the suture and the moving end or the fixed end of the suture passes through the second knotting loop. The second knotting loop can be tightened to form the second knot.

12. The medical device according to claim 9, wherein, Both the fixed end and the moving end of the suture are located outside the medical device.

13. The medical device according to claim 9, wherein, the distal end of the stent is folded inward or outward of the medical device so that a double-layer structure is formed at the distal end of the stent, the double-layer structure has overlapping pores, and the suture coil is formed by the suture passing through the overlapping pores, the mesh opening and the film.

14. The medical device according to claim 13, wherein, the suture coil is an "8"-shaped double-ring suture coil, one of the ring suture coils is formed by the suture passing through the film, the mesh opening and the overlapping pores, and the other ring suture coil is formed by the suture passing through the overlapping pores.

15. The medical device according to claim 14, wherein, the inner layer of the double-layer structure is provided with a first threading hole and a second threading hole at intervals in a direction away from the film, the outer layer of the double-layer structure is provided with a third threading hole and a fourth threading hole at intervals in a direction away from the film, the third threading hole overlaps with the first threading hole and the fourth threading hole overlaps with the second threading hole to form the overlapping pores; one of the ring suture coils is formed by the suture passing through the first threading hole, the third threading hole, the mesh opening and the film, and the other ring suture coil is formed by the suture passing through the first threading hole, the third threading hole, the second threading hole and the fourth threading hole.

16. The medical device according to claim 10, wherein, a third knot is formed in the middle of the suture, and the third knot is used to prevent the suture from falling off the stent after breaking, and the third knot and the second knot are located on different sides of the stent.

17. The medical device according to claim 16, wherein, the middle of the suture crosses to form a third knotting loop, and the fixed end or the moving end of the suture winds around the non-knotting area in the middle of the suture and passes out through the third knotting loop, and the third knotting loop can be tightened to form the third knot.

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