Blood flow guiding device

Abstract

The utility model discloses a blood flow guiding device, and belongs to the technical field of medical instruments. The blood flow guiding device comprises a dense net support, the whole dense net support is of a tubular structure and comprises a plurality of weaving wires which are arranged in a crossed mode, and the weaving wires are made of biodegradable materials. The woven filaments comprise a plurality of first woven filaments arranged in parallel, the dense net support is further provided with first fiber lines arranged between every two adjacent first woven filaments, and the first fiber lines are degradable high-molecular polymer workpieces. According to the utility model, the weaving wires for weaving the dense mesh stent are made of biodegradable materials, so that the dense mesh stent can be degraded, and complications such as vascular restenosis, endothelialization delay and thrombosis caused by long-term carrying of the stent are avoided. Meanwhile, due to the fact that the dense net stent is made of degradable woven filaments, anticoagulant medicine does not need to be taken for a long time; and the MRI or CT image effect is not influenced, and if the disease relapses, the subsequent treatment is not obviously hindered.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a blood flow guiding device. Background Art

[0002] Aneurysms are vascular tumor-like protrusions caused by abnormal changes in local arterial blood vessels. Subarachnoid hemorrhage is often caused by aneurysm rupture, and the mortality rate is very high. In the treatment of aneurysms, the blood flow diversion device effectively changes the hemodynamics at the neck of the aneurysm, thereby changing the direction of blood flow, reducing the blood flow impact pressure at the neck and wall of the aneurysm, and achieving the purpose of vascular remodeling. Compared with other treatment methods, the use of a blood flow diversion device (FD) is more advantageous in treating multiple, small, and adjacent intracranial aneurysms. The blood flow diversion device can induce reconstruction of the lumen of the tumor-bearing artery, without the need to send an additional microcatheter into the aneurysm cavity, reducing the risk of aneurysm rupture.

[0003] The principle of blood flow diversion device implantation is to form an interception barrier at the neck of the aneurysm in the blood vessel through the high surface tension between the meshes of the dense mesh stent, thereby reducing the speed of blood flowing into the aneurysm, changing the direction of blood flow, and further coagulating the blood in the aneurysm, finally forming an embolism, and endothelializing the surface of the dense mesh stent at the neck of the aneurysm, thereby achieving the effect of vascular reconstruction.

[0004] However, the dense mesh stent of the blood flow guidance device also has disadvantages and shortcomings. Because the stent is generally made of metal alloy materials mainly composed of nickel-titanium alloy, nickel-titanium alloy exists in the human body as a foreign body, which will weaken the MRI or CT images; and it is easy to cause intimal hyperplasia, which will eventually lead to restenosis of the lumen. Utility Model Content

[0005] The purpose of the utility model is to provide a blood flow guiding device to solve the deficiencies in the prior art, and to degrade the braided wire of the dense mesh stent, thereby avoiding complications such as vascular restenosis, delayed endothelialization and thrombosis caused by long-term carrying of the stent. At the same time, because the dense mesh stent uses degradable braided wire, there is no need to take anticoagulants for a long time, and it will not affect the MRI or CT imaging effect. If the disease recurs, there is no obvious obstacle to subsequent treatment.

[0006] The utility model provides a blood flow guiding device, comprising: a dense mesh stent, which is an overall tubular structure and comprises a plurality of braided wires arranged in an intersecting manner, and the braided wires are made of biodegradable materials; the braided wires comprise a plurality of first braided wires arranged in parallel, and the dense mesh stent also has a first fiber line arranged between two adjacent first braided wires, and the first fiber line is made of a degradable high molecular polymer.

[0007] Furthermore, the braided wires are made of biodegradable metal materials or biodegradable polymer materials.

[0008] Furthermore, the material of the biodegradable metal material product includes one of magnesium and magnesium-based alloys, iron and iron-based alloys, zinc and zinc-based alloys.

[0009] Furthermore, the material of the first fiber line includes one or more materials selected from the group consisting of L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid, glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride and polyphosphate.

[0010] Furthermore, a plurality of the first fiber lines are arranged between two adjacent first braided wires, the plurality of the first fiber lines are arranged in parallel to form a first wire structure, and an extending direction of the first fiber lines is parallel to the first braided wires.

[0011] Furthermore, the dense mesh stent also has a contrast agent coating arranged outside the braided wires and the first fiber wires.

[0012] Furthermore, the contrast agent coating includes an X-ray developer component, and the material between the X-ray developers includes one or more of diatrizoate, iopromide, diatrizoate meglumine, iohexol, iodixanol and iotalamic acid.

[0013] Furthermore, the first fiber wire is disposed between any two adjacent first braiding wires, so that the first wire structure and the first braiding wires are arranged in parallel and at intervals to form first braiding direction wires.

[0014] Furthermore, the braided wires further include a plurality of second braided wires arranged in parallel, and a plurality of the first braided wires and a plurality of the second braided wires are arranged crosswise;

[0015] The dense mesh stent also has a second wire structure arranged between two adjacent second braided wires, the second wire structure includes a plurality of second fiber wires arranged in parallel with the second braided wires, and the second wire structure and the second braided wires are arranged in parallel and spaced manner to form second braiding direction wires;

[0016] The first weaving direction threads and the second weaving direction threads are cross-woven to form a mesh structure.

[0017] Furthermore, the width of the plurality of first fiber threads in the first thread structure after arrangement is 1.5-50 times the diameter of the first braided thread.

[0018] Compared with the prior art, the utility model sets the braided wire of the woven dense mesh stent to a biodegradable material, which can make the dense mesh stent degrade, thereby avoiding complications such as vascular restenosis, delayed endothelialization and thrombosis caused by long-term carrying of the stent. At the same time, because the dense mesh stent uses degradable braided wire, there is no need to take anticoagulants for a long time; and it will not affect the MRI or CT imaging effect. If the disease recurs, there is no obvious hindrance to subsequent treatment; in addition, the braided wire parts are provided with degradable fiber lines, which ensure that the stent has sufficient support strength while also having better flexibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the blood flow guiding device disclosed in the embodiment of the utility model in use;

[0020] Figure 2 It is a structural schematic diagram of a dense mesh stent in a blood flow guiding device disclosed in an embodiment of the utility model;

[0021] Explanation of the reference numerals: 1 - dense mesh stent, 11 - braided wire, 111 - first braided wire, 112 - second braided wire, 12 - first wire structure, 120 - first fiber wire, 13 - second wire structure, 130 - second fiber wire, 100 - blood vessel, 200 - aneurysm. DETAILED DESCRIPTION

[0022] The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0023] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "parallel", "axial", "middle", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure.

[0024] It should be noted that the first weaving direction and the second weaving direction described in the embodiment of the present invention are not limited to one or two specific directions, that is, the first weaving direction and the second weaving direction are not parallel. In order to facilitate the description of the blood flow guidance device of the embodiment of the utility model, the "first weaving direction" is preferably a direction inclined from bottom to top and to the left, and the "second weaving direction" is preferably a direction inclined from bottom to top and to the right.

[0025] like Figure 1-2As shown, the utility model discloses a blood flow guiding device, comprising: a dense mesh stent 1, the dense mesh stent 1 is an overall tubular structure and comprises a plurality of braided wires 11 arranged crosswise with each other, and the braided wires 11 are made of biodegradable materials.

[0026] The braided wires in the prior art are generally made of stainless steel, titanium and its alloys, nickel-titanium alloys and other materials, but these materials have poor blood compatibility and are prone to cause thrombosis in the stent after implantation, with a potential risk of delayed pathological thrombosis; and these metals are non-degradable and permanently exist in the human body as foreign matter, which will weaken MRI or CT images; during the lifelong carrying process, long-term oral antiplatelet aggregation drug treatment is generally required, otherwise it will cause intimal hyperplasia and eventually lead to restenosis of the lumen.

[0027] In this embodiment, the braided wire 11 of the braided dense mesh stent 1 is set to a biodegradable material to enable the dense mesh stent 1 to degrade, thereby avoiding complications such as vascular restenosis, delayed endothelialization and thrombosis caused by long-term carrying of the stent. At the same time, because the dense mesh stent 1 uses degradable braided wire, there is no need to take anticoagulants for a long time; and it will not affect the MRI or CT imaging effect. If the disease recurs, there is no obvious obstacle to subsequent treatment.

[0028] In a specific embodiment, the braided wire 11 is made of a biodegradable metal material or a biodegradable polymer material.

[0029] Biodegradable metal materials refer to a type of metal material that gradually corrodes in the body until it is completely dissolved in the process of assisting and completing the repair of biological tissues. At the same time, the corrosion products of the material will not produce or produce a slight host reaction to the organism. Therefore, the main components of biodegradable metal materials should be basic metal elements that can be excreted from the body through metabolism and have a certain corrosion rate in the body.

[0030] In this embodiment, the braided wire 11 is preferably made of biodegradable metal material, and the biodegradable metal material mainly includes one or more of pure magnesium and magnesium-based alloys, pure iron and iron-based alloys, pure zinc and zinc-based alloys, tungsten and (calcium-based, zinc-based and silver-based) bulk amorphous alloys.

[0031] In other embodiments, the braided wire 11 can also be made of biodegradable polymer materials. The biodegradable polymer materials can degrade and absorb biological molecules and can fully function in the body for a period of time. After a period of time, they begin to degrade and lose their original functions. Their degradation products are absorbed or excreted from the body after metabolism.

[0032] The materials of the biodegradable polymer parts may include, but are not limited to, one or a copolymer or blend of at least two of polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polyethylene glycol, polyanhydride, polytyrosine, polycarbonate, polyorthoester, polysalicylic anhydride, polytrimethylene carbonate, polyamino acid-derived carbonate, copolymers of polylactic acid and polyglycolic acid.

[0033] In this embodiment, the braided wire 11 includes a plurality of first braided wires 111 arranged in parallel, and the dense mesh stent 1 further includes a first fiber wire 120 arranged between two adjacent first braided wires 111 , and the first fiber wire 120 is made of a degradable high molecular polymer.

[0034] This embodiment actually replaces part of the metal braided wire 11 with the non-metal first fiber wire 120, so that the braided wire 11 and the first fiber wire 120 are mixed and used to improve the transportation performance of the entire dense mesh stent 1. The first wire structure 12 composed of the first fiber wire 120 is arranged between the first braided wires 111, which can make the dense mesh stent 1 have better flexibility under the premise of ensuring sufficient support strength. Compared with the first braided wire 111 made of metal, the first fiber wire 120 has better flexibility, which can make the dense mesh stent 1 have better flexibility, thereby improving the transportation performance of the dense mesh stent 1. In addition, because the first fiber wire 120 is softer and more flexible, it can minimize the wear on the tissue, thereby protecting the user.

[0035] The metal braided wire 11 serves as the main skeleton to provide the main mechanical properties, so that the dense mesh stent 1 has a higher supporting strength. The first fiber wire 120 is filled between adjacent braided wires 11 to increase the coverage of the dense mesh stent 1, thereby enhancing the guiding effect of blood flow and accelerating the healing speed.

[0036] Furthermore, the first fiber line 120 is made of a degradable polymer material; the first fiber line 120 is also configured to be a degradable material to avoid the first fiber line 120 from remaining in the body, so that it can be cleared after use, avoiding various problems caused by long-term presence in the body.

[0037] Specifically, the first fiber line 120 includes one or more of L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid, glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride and polyphosphate.

[0038] A plurality of first fiber lines 120 are disposed between two adjacent first braided wires. The plurality of first fiber lines 120 are arranged in parallel to form a first wire structure 12 . The extending direction of the first fiber lines 120 is parallel to the first braided wires 111 .

[0039] In the present embodiment, a plurality of fiber threads 120 are arranged in parallel to form a first thread structure 12. The width of the first thread structure 12 can be changed by increasing or decreasing the number of fiber threads 120, thereby changing the coverage rate of the dense mesh bracket 1. The dense mesh bracket 1 can be adjusted according to the actual needs of the user to better meet the needs of the user.

[0040] like Figure 1 As shown, the dense mesh stent 1 is delivered to the human blood vessel 100 through a catheter, and finally located at the position of the aneurysm 200, so as to guide the blood flow and reduce the blood flow into the aneurysm 200. By adjusting the arrangement of the first fiber wire 120 on the dense mesh stent 1, the coverage of the sealed stent 1 can be changed, thereby changing the blood flow into the aneurysm 200. It is understandable that the coverage of the dense mesh stent 1 can also be adjusted by changing the number and arrangement of the braided wires 11.

[0041] The dense mesh stent 1 also has a contrast agent coating (not shown) disposed outside the braided wires 11 and the first fiber wires 120. The provision of the contrast agent coating can achieve the imaging performance of the dense mesh stent 1.

[0042] The contrast agent coating comprises an X-ray developer preparation, and the material of the X-ray developer preparation comprises one or more of diatrizoate, iopromide, diatrizoate meglumine, iohexol, iodixanol and iotalamic acid.

[0043] In the above embodiment, the contrast agent coating is formed simultaneously outside the braided wire 11 and outside the first fiber line 120. Of course, in other embodiments, the contrast agent coating can be formed only outside the braided wire 11 or only outside the first fiber line 120.

[0044] In other embodiments, when the first fiber line 120 is provided with a developing property, the first fiber line 120 may be copolymerized / blended with an X-ray developing component to form a composite fiber line. Similarly, when the braided wire 11 is provided with a developing property, the braided wire 11 may be copolymerized / blended with an X-ray developing component to form a composite metal wire.

[0045] As a preferred solution, a first wire structure 12 is provided between any two adjacent first braided wires 111 , so that the first wire structure 12 and the first braided wires 111 are arranged in parallel and at intervals to form first braiding direction wires.

[0046] The braided wire 11 further includes a plurality of second braided wires 112 arranged in parallel, and the plurality of first braided wires 111 and the plurality of second braided wires 112 are arranged crosswise;

[0047] The dense mesh stent 1 also has a second wire structure 13 arranged between two adjacent second braided wires 112, the second wire structure 13 includes a plurality of second fiber wires 130 arranged in parallel with the second braided wires 112, and the second wire structure 13 and the second braided wires 112 are arranged in parallel and spaced manner to form second braiding direction wires;

[0048] The first weaving direction threads are cross-woven with the second weaving direction threads to form a mesh structure.

[0049] It should be noted that the second fiber line 130 is made of the same material as the first fiber line 120. According to different needs, the first fiber line 120, the second fiber filament 130 and the braided wire 11 of appropriate specifications and sizes can be selected, and the number, proportion and arrangement of multiple braided wires 11 and multiple strands of the first fiber line 120 and multiple strands of the second fiber line 130, as well as the braiding angle can be adjusted to adjust different mechanical properties, flexibility and blood flow guiding effects.

[0050] The width of the first fiber lines 120 in the first wire structure 12 after arrangement is 1.5-50 times the diameter of the first braided wire 111. The number of first braided wires 111 in the first wire structure 12 can be set according to different coverage requirements, thereby changing the width of the first wire structure 12.

[0051] It can be understood that the second wire structure 12 has the same characteristics as the first wire structure 11 , and the width of the plurality of second fiber wires 130 in the second wire structure 13 after arrangement is also 1.5-50 times the diameter of the second braided wire 112 .

[0052] The above describes in detail the structure, features and effects of the utility model based on the embodiments shown in the drawings. The above is only a preferred embodiment of the utility model, but the utility model is not limited to the scope of implementation shown in the drawings. Any changes made in accordance with the concept of the utility model, or modifications to equivalent embodiments with equivalent changes, which still do not exceed the spirit covered by the description and the drawings, should be within the protection scope of the utility model.

Claims

1. A blood flow guiding device, characterized in that: include: A dense mesh stent, the dense mesh stent is an overall tubular structure and includes a plurality of woven wires arranged in an intersecting manner, the woven wires are made of biodegradable materials; the woven wires include a plurality of first woven wires arranged in parallel, the dense mesh stent also has a first fiber line arranged between two adjacent first woven wires, the first fiber line is made of a degradable high molecular polymer.

2. The blood flow guiding device according to claim 1, characterized in that: The braided wire is made of biodegradable metal material or biodegradable polymer material.

3. The blood flow guiding device according to claim 2, characterized in that: The material of the biodegradable metal material product includes one of magnesium and magnesium-based alloys, iron and iron-based alloys, zinc and zinc-based alloys.

4. The blood flow guiding device according to claim 1, characterized in that: A plurality of the first fiber lines are arranged between two adjacent first braided wires. The plurality of the first fiber lines are arranged in parallel to form a first wire structure. The extending direction of the first fiber lines is parallel to the first braided wires.

5. The blood flow guiding device according to claim 4, characterized in that: The dense mesh stent also has a contrast agent coating disposed outside the braided wires and the first fiber wires.

6. The blood flow guiding device according to claim 4, characterized in that: The first fiber wire is disposed between any two adjacent first braiding wires, so that the first wire structure and the first braiding wires are arranged in parallel and at intervals to form first braiding direction wires.

7. The blood flow guiding device according to claim 6, characterized in that: The braided wires further include a plurality of second braided wires arranged in parallel, and the plurality of the first braided wires and the plurality of the second braided wires are arranged crosswise; The dense mesh stent also has a second wire structure arranged between two adjacent second braided wires, the second wire structure includes a plurality of second fiber wires arranged in parallel with the second braided wires, and the second wire structure and the second braided wires are arranged in parallel and spaced manner to form second braiding direction wires; The first weaving direction threads and the second weaving direction threads are cross-woven to form a mesh structure.

8. The blood flow guiding device according to claim 4, characterized in that: The width of the plurality of first fiber threads in the first thread structure after arrangement is 1.5-50 times the diameter of the first braided thread.

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