WO2018090576A1

WO2018090576A1 - Flow blocking membrane and implanted medical device

Info

Publication number: WO2018090576A1
Application number: PCT/CN2017/083719
Authority: WO
Inventors: 刘香东
Original assignee: 先健科技(深圳)有限公司
Priority date: 2016-11-15
Filing date: 2017-05-10
Publication date: 2018-05-24
Also published as: CN108066047B; CN108066047A

Abstract

Disclosed are a flow blocking membrane (12, 12a, 12b) and a medical device (100) comprising the flow blocking membrane (12, 12a, 12b). The flow blocking membrane (12, 12a, 12b) comprises a membrane body (13, 15a, 13b, 15b) and an enhancement layer (17, 17a, 17b, 17c) arranged on the surface of the membrane body or inside the membrane body, with the tensile strength of the enhancement layer (17, 17a, 17b, 17c) being greater than the tensile strength of the membrane body (13, 15a, 13b, 15b). The enhancement layer (17, 17a, 17b, 17c) can prevent a needle or a suture from scratching the flow blocking membrane (12, 12a, 12b) to form a large hole, thereby improving the suturing strength and healing rate of the flow blocking membrane (12, 12a, 12b).

Description

Resisting membrane and implanted medical device

Technical field

The invention relates to the field of implanted medical device technology, in particular to a flow blocking film and an implanted medical device having the same.

Background technique

With the continuous development of interventional medical devices and interventional procedures, transcatheter implantation of various occluders, artificial vascular stents and prosthetic valves and other medical devices has become a treatment for valvular disease, hemangioma and vascular stenosis, and congenital heart defects. Important method.

Common occluder devices for the treatment of congenital heart defects such as atrial septal defect, ventricular septal defect and patent foramen ovale generally include the left and right discs, the waist connecting the left and right discs, and the two discs and/or the waist. A choke film to increase the plugging effect. The patent ductus arteriosus occluder includes a disc-like structure and a columnar waist and a baffle film disposed in the disc-like structure and/or the columnar waist. The split left atrial appendage occluder generally includes a occlusion disk and a fixing frame for implanting the occlusion disk in the left atrial appendage in the left atrial appendage, and a choke membrane disposed in the occlusion disk. The flow-blocking film may be made of polyester fiber for enhancing the plugging effect.

Both the prosthetic valve and the artificial blood vessel stent comprise a stent graft, and the stent graft generally comprises a bare metal stent and a flow blocking membrane made of a polytetrafluoroethylene membrane covering the metal stent. The mechanical strength of the above-mentioned baffle film is relatively low, especially when a prosthetic valve is fabricated, if the leaflet is sutured to the choke film on the bare metal support by a stitching process, the choke film is easily drawn by the suture. The hole makes it difficult to fix the choke film on the bare metal bracket, and the stitching yield is low. And the implanted medical device including the choke membrane, such as a congenital heart defect occluder, a left atrial appendage occluder, a prosthetic valve and an artificial blood vessel stent, are implanted in the human body, and the spoiler is sutured under the continuous impact of blood flow. It is easy to tear, and the tearing choke film easily falls off the stent or the occluder, shortening the service life of the medical device.

Summary of the invention

Based on this, it is necessary to provide a barrier film that is not easy to tear and an implant doctor having the barrier film. Therapeutic devices to increase the life of implanted medical devices.

The flow blocking film provided by the technical solution is to add a reinforcing layer on the existing flow blocking film, which comprises a film body provided with a reinforcing region and a reinforcing layer disposed in the reinforcing region. The tensile strength of the reinforcing layer is greater than the tensile strength of the film body. The reinforcing region may be provided on a surface of the film body, that is, a reinforcing layer is provided on a surface of the film body. When the film body comprises two sets of opposite films, the reinforcing regions may be disposed on opposite surfaces of the two sets of films, and the baffle film is sandwiched between the two sets of films, that is, the reinforcing layer is disposed inside the film body .

The reinforcing layer may have the same shape and size as the film body, and a reinforcing layer may be disposed in a partial region of the film body according to actual needs. For example, the enhancement zone can be located at the edge of the baffle, by way of example, for a choke membrane in a congenital heart defect occluder or a split left atrial appendage occluder, the baffle can be rounded and reinforced The zone may be an annular region disposed at the edge of the baffle membrane. For the stented stent, the barrier film may have a cylindrical shape having the same shape and size as the lumen stent body, that is, the barrier film is completely covered and covered. The inner or outer surface of the membranous lumen stent coincides.

The reinforcing layer in the baffle film may include a plurality of reinforcing members staggered to form a reinforcing mesh having a cross structure; or all of the reinforcing members are parallel to each other; or a part of the plurality of reinforcing members The reinforcing members are staggered to form a reinforcing mesh having a cross structure, and the other portions of the reinforcing members are parallel to each other. The reinforcing mesh refers to a mesh structure in which meshes are formed between the cross structures, and may also refer to a structure in which the cross structures are closely arranged without meshes. The tensile strength of the reinforcement is greater than the tensile strength of the film body.

The mesh of the reinforcing mesh ranges from 50 mesh to 120 mesh. The reinforcement has a diameter ranging from 0.05 mm to 0.6 mm. The thickness of the baffle film ranges from 0.06 mm to 0.72 mm.

The technical solution further includes providing an implantable medical device comprising the instrument body and the aforementioned flow blocking film, wherein a portion of the baffle film provided with the reinforcing layer is coupled to the instrument body.

The instrument body may be a device having a mesh-shaped plug disk such as a congenital heart defect occluder and a left atrial appendage occluder. The baffle film is located in the occlusion disk, the reinforcement layer is located at the edge of the baffle film, and the reinforcement layer is sewn on the occlusion disk.

The instrument body may also include a lumen stent having a plurality of corrugated annular structures, the lumen stent having a hollow between at least two adjacent corrugated annular structures, the obturator membrane covering the At least one surface of the lumen support, such as an inner or outer surface, or both inner and outer surfaces, or may cover all of the aforementioned surface or only a portion of the inner or outer surface, ie, uncovered The surface is exposed to a partial hollow, and correspondingly, the hollow of the covered surface of the lumen support is covered by the choke film.

When the reinforcing member forms the reinforcing mesh, a distance between two points farthest from each other on the mesh of the reinforcing mesh is smaller than two farthest points on the annular structure having the smallest area The distance between the at least one portion of the baffle film corresponding to the hollow covered by the baffle film contains a portion of the reinforcing layer.

When the choke membrane covers only one surface of the stent lumen stent, such as the inner surface of the cavity, the lumen stent may further include a membrane covering the other surface of the lumen stent, that is, the outer surface, the membrane It is connected to the choke film at the hollow.

When the instrument body is a prosthetic valve, it further includes a leaflet covering the inner surface or the outer surface of the lumen stent, the leaflet being disposed in the lumen of the lumen stent, and Connected to the reinforcement layer in the baffle at the hollow.

The flow blocking film of the present invention includes a reinforcing member having a tensile strength higher than that of the film body. When the reinforcing members cooperate with each other to form a mesh, the suture can be directly passed through the mesh to suture the choke film to the instrument body at the hollow of the instrument body, for example, suturing the edge of the choke membrane to the congenital heart defect. The mesh of the occluder is closed on the disc; or the choke film may be first covered on the instrument body having a hollow, such as a blood vessel support, and the reinforcement layer is correspondingly located at the hollow of the instrument body, and then the other components are passed through the suture Stitching onto the reinforcing layer of the baffle, such as suturing the leaflets to the baffle of the inner wall of the prosthetic valve stent. The reinforcing member can restrict the suture sliding. Even if the reinforcing layer has no mesh, the suture passes through the reinforcing layer and is restricted from sliding due to the tensile strength of the reinforcing member itself, thereby preventing the chordal film from being drawn by the suture. Large openings to increase stitching yield and tensile strength at the seam.

DRAWINGS

1 is a schematic view showing the structure of a medical device of the present invention.

Figure 2 is an enlarged view of A in Figure 1.

3 is a schematic view showing the film of the medical device of FIG. 1 partially cut away.

4 is a schematic view of the metal lumen stent of FIG. 3.

FIG. 5 is a partial schematic view of a flow blocking film according to another embodiment of the present invention.

FIG. 6 is a schematic diagram of a flow blocking film according to still another embodiment of the present invention.

FIG. 7 is a schematic diagram of a flow blocking film according to still another embodiment of the present invention.

detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

It should be noted that the interventional medical device of the present invention is exemplified by a mitral valve artificial heart valve, and the inventive concept can also be applied to an artificial blood vessel stent, a left atrial appendage occluder, and a congenital heart defect occluder. And other interventional medical devices. It should be noted that the heart valve tissue according to the present invention refers to any one of heart tissue such as an annulus, a leaflet, a chordae, and a papillary muscle, or a combination of several tissues.

All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, unless otherwise defined. The terminology used in the description of the present invention is for the purpose of describing particular embodiments and is not intended to limit the invention. The term "and/or" used herein includes any and all combinations of one or more of the associated listed items.

Referring to FIG. 1 to FIG. 3 together, the interventional medical device 100 of the present embodiment includes a covered lumen stent 10 and a leaflet 20 disposed in the lumen of the stented stent 10. The stented stent 10 is a hollow tubular structure comprising a metal lumen stent 11 and a baffle film 12 disposed on the inner wall of the metal lumen stent 11. The stented stent 10 in this embodiment is the main body frame of the prosthetic valve. After the at least two closable flaps 20 are disposed in the lumen of the stented stent 10, the interventional medical device 100 is formed, that is, artificial. Heart valve. The artificial valve is radially compressed and implanted into the damaged valve of the human body via a catheter to replace the damaged valve to realize the physiological function of the damaged valve. It can be understood that the stented stent 10 can also be part of a medical device or a medical device implanted in a human body. For example, the stented stent 10 can also be a vascular stent for treating a hemangioma.

Referring to FIG. 4, the metal lumen stent 11 is a support body of the stented stent 10 for expanding the stented stent 10 and adhering to the wall of the human body. The metal lumen support 11 has a hollow tubular shape and includes a plurality of corrugated rings, and the metal lumen support 11 has an integral structure. The "integral structure" in the present invention means that the metal lumen support 11 is formed by laser cutting and heat setting of a metal tube, or the metal lumen support 11 is composed of a plurality of components fixedly connected, such as a metal lumen support 11 Two components are welded to form. a plurality of hollows 111 are provided on the side of the metal lumen support 11 to make the metal lumen support 11 The side is hollowed out.

The metal lumen support 11 is made of a metal material having superelasticity or shape memory function, such as Nitinol, Nitinol, Nitinol or an alloy thereof. In the present invention, the metal lumen support 11 is cut by a nickel-titanium tube, and the outer diameter of the nickel-titanium tube is preferably 5 mm to 12 mm, and the wall thickness of the nickel-titanium tube is preferably 0.2 mm to 0.6 mm. First, the plurality of hollows are cut by laser on the nickel-titanium tube; then, the cut nickel-titanium tube is expanded under heat treatment conditions to a diameter suitable for a human damaged valve to obtain a metal lumen support 11 In the present invention, it is preferred to expand the outer diameter of the nickel-titanium tube to 25 mm to 35 mm. It can be understood that the metal lumen support 11 can also be woven with nickel-titanium wire.

It can be understood that the metal lumen support 11 can also be composed of a plurality of separate components. At this time, the metal lumen support 11 is no longer an integral structure. For example, the metal lumen support 11 can be composed of a plurality of separated metal wave-shaped annular structures. Aligning the axes of the plurality of separate metal-wave-shaped annular structures and sequentially arranging them along the axis, for example, by a soldering process or by connecting two adjacent metal-wave-shaped annular structures with a connecting member The metal corrugated annular structure is combined to form a hollow tubular metal lumen support 11 at which time each of the metal rings may include the hollow, or each two adjacent metal corrugated annular structures may cooperate to form the Hollowed out.

Referring again to FIG. 3, the stented stent 10 includes an inner membrane body 13 covering the inner surface of the metal lumen stent 11, an outer membrane body 15 covering the outer surface of the metal lumen stent 11, and an inner membrane. A reinforcing mesh 17 between the body 13 and the outer film body 15. Wherein, the surface of the inner film body 13 is provided with a reinforcing region having the same shape and size as the outer surface, the reinforcing mesh 17 is located in the reinforcing region, and covers the inner surface of the metal lumen support 11, the inner film body 13 and the reinforcement The mesh 17 constitutes the flow blocking film 12. In the manufacturing process of the laminar tube stent 10, the inner film body 13 and the reinforcing mesh 17 may be first formed into a whole body, that is, a baffle film, and then fixed to the metal tube by a conventional process such as stitching, bonding or thermocompression bonding. The inner surface of the cavity holder 11; the reinforcing mesh 17 may be directly covered to the inner surface of the metal lumen support 11, the inner film body 13 is covered on the reinforcing mesh 17, and the outer film body 15 is covered on the metal lumen support. The outer surface of the elbow 11 is then fixed to the metal lumen support 11 by a hot press synthesis. The inner film body 13, the outer film body 15, and the reinforcing mesh 17 are integrally joined to each other at the hollow portion 111 of the metal lumen support 11. It can be understood that in other embodiments, the metal lumen support 11, the inner film body 13, the outer film body 15 and the reinforcing mesh 17 may also be bonded together by an adhesive or stitched by suture stitching. As one.

The inner membrane body 13 and the outer membrane body 15 are used to form the stent lumen 10 to form a side-sealed lumen, so that blood flow only flows through the lumen of the stented stent 10 without covering the membrane The side of the lumen support 10 seeps out. The thickness of the inner film body 13 and the outer film body 15 may be between 0.01 and 0.06 mm, and the sum of the thicknesses of the inner film body 13, the outer film body 15 and the reinforcing layer, that is, the thickness of the flow blocking film is 0.06. From millimeters to 0.72 mm, so that the stented stent 10 has a smaller outer diameter, the inner membrane body 13 and the outer membrane body 15 can also effectively prevent blood from flowing from the inside of the stent lumen stent 10 The exterior of the membrane lumen stent 10. In the present embodiment, the thickness of the inner film body 13 and the outer film body 15 are both 0.01 mm, and the inner film body 13 and the outer film body 15 are both ePTFE (expanded polytetrafluoroethylene). Thus, the inner film body 13 and the outer film body 15 are respectively coated on the inner and outer surfaces of the metal lumen support 11, thereby reducing the possibility of metal ion release from the metal lumen support 11, and reducing the metal lumen support. The possibility of surface oxide layer detachment of 11 ensures the safety of the stented stent 10 after implantation into the body.

It can be understood that in other embodiments, the inner film body 13 and the outer film body 15 may also each be formed by superposing a plurality of layers of ePTFE single layer film, thereby forming two sets of opposing films.

The reinforcing mesh 17 is formed by staggering a plurality of reinforcing members having a mesh number ranging from 50 mesh to 120 mesh. The plurality of reinforcing members may be arranged in a staggered arrangement in which the two sets of reinforcing members are vertically intersected to form a "ten" word mesh structure or a "ten" structure having no mesh, or directly formed on a large reinforcing cloth. A plurality of "cross" structures, or a mesh structure by knitting. Each set of reinforcements includes a plurality of mutually parallel reinforcements. The reinforcing mesh may be a knitted mesh or a woven mesh having a thickness ranging from 0.1 mm to 0.6 mm. The reinforcing member can be made of a polymer material such as PTFE, PET or ultra high molecular weight polyethylene. The reinforcing member is a wire-like structure having a circular cross section or a strip-shaped structure having a flat cross section, and the diameter or the maximum sectional size preferably ranges from 0.05 mm to 0.6 mm. When the diameter of the reinforcing wire or the maximum cross-sectional dimension of the reinforcing mesh 17 is less than 0.05 mm, the toughness and strength of the reinforcing mesh 17 may be poor, and the tear resistance and the anti-scratching ability are poor, when the laminar stent is implanted After entering the body, the baffle 12 may still be damaged by blood flow or by the suture; when the diameter or maximum cross-sectional dimension of the mesh of the reinforcing mesh 17 is greater than 0.6 mm, the radial compression of the stent graft 10 The size is significantly increased, so that the stent graft 10 can not be loaded into the delivery catheter with a smaller inner diameter after being radially compressed, so that it cannot be implanted into the body through a delivery catheter having a smaller inner diameter, or the stented stent 10 is in the delivery catheter. The pushing force inside is increased to make it difficult to use. In this embodiment, the reinforcing mesh 17 forms a tubular structure around the metal lumen support 11; the reinforcing mesh 17 is made of PTFE Made of (polytetrafluoroethylene), and the reinforcing member (i.e., the mesh) of the reinforcing net 17 has a diameter of 0.3 mm; the plurality of meshes of the reinforcing net 17 have the same size and shape. Thus, the staggered network wires in the baffle film 12 can not only improve the toughness and strength of the baffle film 12, but also prevent the suture film 12 from being sutured when sutured through the mesh through the mesh to the metal lumen stent. Needles or sutures draw larger holes in the baffle film 12, particularly the inner film body 13, thereby improving the tear resistance and resistance to puncturing of the baffle film 12. Moreover, the reinforcing net 17 has a plurality of meshes, a plurality of mesh lines surrounding the mesh, and a plurality of bumps formed by intersections of the two intersecting mesh lines (ie, intersections of two lines in the "ten" structure), when enhanced When the net 17 is located on the surface of the membrane body, the roughness of the obstruction membrane 12 can be increased, the friction between the stent lumen 10 and the lumen wall of the stent can be increased, and the stent lumen 10 can be reduced in the lumen. The risk of shifting. In addition, in the hollow portion 1111 of the metal lumen support 11, the inner film body 13, the outer film body 15 and the reinforcing mesh 17 are bonded together, so that the choke film 12 and the choke film 12 are filled in the hollow portion 1111. The mesh of the inner reinforcing mesh 17 becomes an obstacle for blocking the movement of the metal lumen support 11 in the choke film 12, thereby preventing the risk of the metal lumen support 11 moving in the choke film 12, and the choke film 12 is improved. The bonding strength with the metal lumen stent 11 reduces the risk of the choke membrane 12 falling off the metal lumen stent 11 after implantation in the human body. In addition, the reinforcing mesh 17 has a mesh hole for allowing blood to pass through; if blood is infiltrated somewhere in the inner film body 13, the blood can be dispersed in the mesh, thereby preventing blood from being concentrated in the blood infiltration, reducing the blood. The pressure at the blood infiltration of the inner membrane body 13 prevents the cracks in the blood infiltration of the inner membrane body 13 from continuing to expand, prolonging the service life of the stent lumen stent 10.

Preferably, the distance between the two most distant points on any of the meshes of the reinforcing mesh 17 is less than the distance between the two most distant points on the annular structure 112 having the smallest area of the metal lumen support 11. . That is, each cutout corresponds to at least a portion of the reinforcing mesh, such as at least one mesh structure. As such, when it is desired to suture the leaflets at the hollow 111 of the metal lumen support 11, the reinforcing mesh 17 can better and more effectively improve the tear resistance and puncturing resistance of the flow blocking film 12.

It should be noted that the leaflet 20 in this embodiment can be connected to the stented stent 10 by suture through the mesh through the mesh; since the choke membrane 12 of the stented stent 10 has a mesh line therein, When the leaflet 20 is sewn to the stented stent 10 through the needle with the suture attached, since the tensile strength of the reinforcing member itself is higher than the tensile strength of the membrane body, the needle is not easily drawn on the blocking membrane 12 The large through hole, and the reinforcement forming the mesh, restricts the sliding of the suture, reducing the wind that the leaflet 20 falls off the laminar lumen support 10. The risk extends the life of the medical device 100.

It can be understood that, in other embodiments, the reinforcing mesh 17 can also be disposed between the outer film body 15 and the inner film body 13 piece by piece according to actual needs, and needs to improve tear resistance and anti-hole drilling performance. position. It will also be appreciated that in other embodiments, the reinforcement of the reinforcing mesh 17 may also be in the form of a flat strip. It can also be understood that in other embodiments, the cross section of the filament-shaped reinforcing member may also have other shapes such as a triangle, a quadrangle, a pentagon or the like.

It can be understood that when it is required to suture other components to the outer surface of the lumen stent 11, the baffle film 12 can be covered on the outer surface of the lumen stent 11, and the outer membrane body 15 in this embodiment is placed on the tube. The inner surface of the cavity holder 11.

It can be understood that, in other embodiments, if the medical device is a woven mesh-shaped heart defect occluder or a left atrial appendage occluder with a woven mesh plug structure, the edge of the choke film 12 is also stitched by a wire. Provided inside the occluder and connected to the mesh structure of the occluder; at this time, the flow blocking film 12 includes a film body and a reinforcement located in the reinforcing region of the film body, and the reinforcing region may be located at the edge of the film body It is also possible to match the shape and size of the film body, that is, the reinforcing layer may be provided only at the edge of the film body, or the reinforcing layer may be provided on the entire surface of the film body. Since the choke film 12 has a mesh line, when the choke film 12 is sewn into the inside of the occluder by a needle connected with a suture, the needle or the suture is difficult to draw a large through hole on the choke film 12, The risk of the choke film 12 falling off the occluder is reduced, and the life of the occluder is prolonged. In addition, the inside of the choke film 12 has a mesh line, and the toughness and strength of the choke film 12 are also strong, and it is not easily torn under the impact of blood flow, thereby improving the plugging effect and service life of the occluder.

It can be understood that, in other embodiments of the present invention, the reinforcing member may be disposed on the surface of the film body in other forms. For example, the reinforcing member may have only one piece, which is annularly disposed on the edge portion of the film body or is threaded. The pattern is disposed on the surface of the film body, or is woven by the root reinforcement to form a mesh having a plurality of meshes.

Referring to Fig. 5, a flow blocking film 12a according to a second embodiment of the present invention includes an outer film body 15a and a reinforcing mesh 17a provided in the outer film body 15a. In this embodiment, the outer film body 15a includes an inner sub-layer 151a and an outer sub-layer 153a, and the two opposite surfaces of the inner sub-layer 151a and the outer sub-layer 153a are provided with reinforcing regions having shapes and sizes matching the two surfaces. The reinforcing mesh 17a is disposed between the inner sub-layer 151a and the outer sub-layer 153a and located in the enhanced region. Preferably, in the present embodiment, the reinforcing mesh 17a is preliminarily disposed between the inner sub-layer 151a and the outer sub-layer 153a by means of hot pressing. Thus, the reinforcing mesh 17a and the outer layer There is a strong bonding force between the film bodies 15a, and it is difficult for the reinforcing mesh 17a to be detached from the outer film body 15a. Furthermore, if the implanted medical device further has the inner layer membrane body as described in the first embodiment, and the implanted medical device comprises a metal lumen stent, the outer membrane body 15a having the reinforcing mesh 17a can be further subjected to hot pressing The method and the inner membrane body are respectively disposed on the outer surface and the inner surface of the lumen support, and are combined at the hollowed out portion. Thus, the reinforcing mesh 17a is subjected to two hot pressing processes and the inner film body and the outer film body. Bonding makes it more difficult to detach from the inner film body and the outer film body.

It can be understood that, in other embodiments, if the medical device is an occluder, the baffle film 12a can be directly placed inside the occluder, and the reinforcing layer located at the edge region thereof is directly connected to the occluding body.

Referring to FIG. 6, the stented stent 10b of the third embodiment of the present invention is substantially the same as the stented stent 10, and includes a metal lumen stent 11b and a baffle film 12b disposed on the metal lumen stent 11b. . The covered lumen stent 10b is different from the stented stent 10 in that the membrane 12b includes an inner membrane body 13b disposed on the inner surface of the metal lumen stent 11b, and is disposed on the outer surface of the metal lumen stent 11b. The outer film body 15b and the plurality of reinforcing members 17b between the inner film body 13b and the outer film body 15b. The surface of the outer film body 15b is covered with a reinforcing member 17b, and the reinforcing member 17b and the outer layer film body 15b constitute a flow blocking film. The reinforcing member 17b may be made of PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), PE (polyethylene), nylon, glass fiber, carbon fiber, ultra high molecular weight polyethylene or stainless steel. Its diameter ranges from 0.05 mm to 0.6 mm.

Preferably, in the embodiment, the reinforcing member 17b is a wire-like structure having a circular cross section; each reinforcing member 17b forms an annular structure surrounding the metal lumen bracket 11b, and the plurality of reinforcing members 17b are parallel to each other; adjacent The distance between the two reinforcing members 17b in the axial direction of the metal lumen bracket 11b is smaller than the distance between the two most distant points on the annular structure having the smallest area of the metal lumen bracket 11b. Thus, when it is required to suture the leaflets at the hollow portion 111b of the metal lumen support 11b, the reinforcing member 17b can improve the overall tear resistance and puncturing resistance of the film body composed of the inner film body 13b and the outer film body 15b. .

The plurality of reinforcing members 17b can not only improve the toughness and strength of the outer layer membrane body 15b, but also block the suture needle from drawing a large hole in the choke membrane, and the reinforcing member can not only improve the tear resistance of the choke membrane, but also The anti-cratering ability of the choke film can be improved. Moreover, the plurality of reinforcing members 17b are parallel to each other and have a gap between the adjacent two reinforcing members 17b, so that the roughness of the choke film can be increased, and the laminar lumen stent 10b and the lumen wall of the implantation can be improved. Friction between the lowering of the stent lumen 10b in the lumen The risk of internal shifting. In addition, in the hollow portion 111b of the metal lumen support 11b, the inner film body 13b, the outer layer film body 15b and the reinforcing member 17b are bonded together, so that the choke film and the choke film filled in the hollow portion 111b are The mesh of the reinforcing member 17b acts as an obstacle to block the movement of the metal lumen support 11b in the choke membrane, thereby preventing the risk of the metal lumen support 11b moving within the choke membrane, and improving the choke membrane and the metal lumen stent. The bonding strength between 11b reduces the risk of the choke film falling off the metal lumen stent 11b after implantation in the human body. In addition, there is a gap between the adjacent two reinforcing members 17b to allow blood to pass through; if blood is infiltrated somewhere in the inner film body 13b, the blood can be dispersed in the gap, thereby preventing blood from being concentrated in the blood. At this point, the pressure at the blood infiltration site of the inner membrane body 13b is lowered, and the crack at the blood infiltration site of the inner membrane body 13b is prevented from continuing to expand, prolonging the service life of the stent lumen stent 10b.

It can be understood that, in other embodiments, some of the plurality of reinforcing members 17b are parallel to each other, and the remaining reinforcing members are alternately arranged to form a mesh structure having a mesh or a "ten" reinforcing pad structure having no mesh. . It will also be understood that in other embodiments, a portion of the plurality of reinforcing members 17b has an annular structure, and the remaining reinforcing members have a longitudinal direction parallel to the axial direction of the metal lumen support 11b.

Referring to FIG. 7, the stented stent holder 10c according to the fourth embodiment of the present invention is substantially the same as the stented stent stent 10b, except that the plurality of reinforcing members 17c of the stented stent stent 10c are staggered. Forming a reinforcing mesh having a plurality of meshes having different sizes and shapes, and the distance between the two points farthest from each of the meshes is smaller than the distance between the hollows 112c having the smallest area of the metal lumen support 11c The distance between the two points. Thus, when it is required to suture the hollow 111c of the metal lumen support 11c, the staggered reinforcing members 17c can improve the tear resistance and the puncturing resistance of the film in multiple directions.

It is precisely because of the staggered arrangement of the mesh line in the barrier film of the reinforcing mesh not only can improve the toughness and strength of the choke film, but also can block the suture needle and the suture to draw a larger hole in the choke film. The reinforcing member not only improves the tear resistance of the choke film, but also improves the anti-cratering ability of the choke film. The reinforcing net has a plurality of meshes, a plurality of mesh wires surrounding the mesh holes, and a plurality of bumps formed by intersections of the two intersecting mesh wires, so that the roughness of the choke film having the reinforcing mesh can be increased, and the The friction between the stented stent of the baffle and the wall of the lumen of the implant reduces the risk of displacement of the stented stent with the baffle in the lumen. In addition, in the hollow of the metal lumen stent of the stented stent, the inner membrane body, the outer membrane body and the reinforcing mesh are bonded together, so that the choke membrane and the resistance filled in the hollow portion are blocked. The mesh of the reinforcing mesh in the flow film becomes an obstacle to block the movement of the metal lumen bracket in the choke membrane, thereby preventing the risk of the metal lumen stent moving in the choke membrane, and improving the choke membrane and the metal lumen. The strength of the bond between the stents reduces the risk of the choke membrane falling off the metal lumen stent after implantation in the human body. In addition, the reinforcing mesh has a mesh to allow blood to pass through; if blood is infiltrated in a certain part of the inner film body, the blood can be dispersed in the mesh, thereby preventing blood from being concentrated in the blood infiltration and reducing the inside. The pressure at the place where the blood is infiltrated into the film body prevents the crack of the blood infiltration portion of the inner film body from continuing to expand, prolonging the service life of the film tube stent having the flow blocking film.

The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.

The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

A flow blocking film, comprising: a film body, wherein the flow blocking film further comprises a reinforcing layer disposed on a surface of the film body or inside the film body, wherein the reinforcing layer has a tensile strength greater than that of the film body tensile strength.
The baffle film according to claim 1, wherein the film body comprises two sets of opposing films, and the reinforcing layer is interposed between the two sets of films.
The baffle film according to claim 1, wherein the reinforcing layer comprises a plurality of reinforcing members staggered to form a reinforcing mesh; or all of the reinforcing members are parallel to each other; or A portion of the reinforcements of the plurality of reinforcements are staggered to form a reinforcing mesh, and the other portions of the reinforcement are parallel to each other.
The flow-blocking film according to claim 3, wherein the reinforcing member has a tensile strength greater than a tensile strength of the film body.
The flow blocking film of claim 1 wherein said reinforcing layer is located at an edge of said film body.
The baffle film according to claim 1, wherein the reinforcing layer is in weight with the film.
The flow-blocking film according to claim 3, wherein the reinforcing mesh has a mesh number ranging from 50 mesh to 120 mesh.
The baffle film according to claim 3, wherein the reinforcing member has a diameter ranging from 0.05 mm to 0.6 mm.
The baffle film according to claim 1, wherein the flow blocking film has a thickness ranging from 0.06 mm to 0.72 mm.
An implantable medical device comprising a device body and a flow blocking film according to any of claims 1-9, wherein the portion of the baffle film containing the reinforcing layer is coupled to the instrument body.
The implantable medical device according to claim 10, wherein said instrument body comprises a lumen support having a plurality of corrugated annular structures, at least partially adjacent of said corrugated annular structures having a hollow, said resistance The flow film is located on at least one surface of the lumen support and covers at least a portion of the hollow.
The implantable medical device of claim 11 wherein at least one of the hollows corresponds to a portion of the reinforcement layer.
The implantable medical device according to claim 11, wherein said lumen stent is further The film is covered, and the film and the flow blocking film are disposed on opposite surfaces of the lumen holder, and the film is connected to the flow blocking film at a hollow.
The implantable medical device according to claim 12, wherein the instrument body further comprises a leaflet disposed in the lumen of the lumen stent and in the hollow with the obstruction membrane The inner reinforcement layers are connected.