WO2019033342A1 - 可降解金属支架及其制造方法 - Google Patents

可降解金属支架及其制造方法 Download PDF

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WO2019033342A1
WO2019033342A1 PCT/CN2017/097866 CN2017097866W WO2019033342A1 WO 2019033342 A1 WO2019033342 A1 WO 2019033342A1 CN 2017097866 W CN2017097866 W CN 2017097866W WO 2019033342 A1 WO2019033342 A1 WO 2019033342A1
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Prior art keywords
degradable
metal stent
metal layer
degradable metal
layer
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PCT/CN2017/097866
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English (en)
French (fr)
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翁玉麟
石全
刘宝瑞
谷卓阳
蒋伟宁
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鼎科医疗技术（苏州）有限公司
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Priority to PCT/CN2017/097866 priority Critical patent/WO2019033342A1/zh
Priority to CN201780001182.6A priority patent/CN107820416A/zh
Publication of WO2019033342A1 publication Critical patent/WO2019033342A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Definitions

  • the present application relates to the field of medical devices, particularly medical implants, and more particularly, to a degradable metal stent and a method of manufacturing the same.
  • a degradable metal stent with a drug coating can be used to treat coronary vascular stenosis, which includes, for example, a stent made of an alloy of magnesium, aluminum, zinc, iron, or the like.
  • the drug is evenly coated on the surface of the stent.
  • Chinese Patent Publication No. CN104189963B provides a magnesium alloy vascular stent having an intermediate layer of a silane coupling agent between the body of the degradable metal stent and the drug layer for reducing the degradation rate of the degradable metal stent.
  • the object of the present invention is to solve or at least alleviate the problems existing in the prior art
  • a degradable metal stent such as a stent made of an alloy of magnesium, aluminum, zinc, iron, or the like;
  • a degradable metal stent comprising a degradable metal stent body and a drug layer, wherein the degradable metal stent further comprises a metal layer between the degradable metal stent body and the drug layer, The metal layer has a greater density than the degradable metal stent body.
  • the metal layer is disposed immediately between the degradable metal stent body and the drug layer.
  • the metal layer comprises gold, platinum, rhodium or titanium, or the metal layer consists of gold, platinum, rhodium or titanium or any combination thereof.
  • the outer surface of the metal layer is subjected to texturing treatment.
  • the metal layer has a thickness of less than 20 ⁇ m.
  • the metal layer is applied to the degradable metal stent body by molecular deposition or atomic deposition.
  • the drug layer comprises a polymer selected from the group consisting of PLA, PLGA or PVDF or any combination thereof and rapamycin.
  • the rapamycin is present on the surface of the stent in an amount of 5-15 ug/mm.
  • a method of producing a degradable metal stent comprising:
  • a drug layer is applied over the metal layer.
  • the metal layer comprises gold, platinum, rhodium or titanium, or the metal layer consists of gold, platinum, rhodium or titanium or any combination thereof.
  • the metal layer is applied to the degradable metal stent body by molecular deposition or atomic deposition.
  • the method further comprises subjecting the metal layer to a texturing treatment prior to applying the drug layer.
  • the step of applying a drug layer on the metal layer comprises applying a drug mixture to the metal layer by ultrasonic spraying.
  • FIG. 1 shows a cross-sectional view of a degradable metal stent in accordance with an embodiment of the present application
  • FIG. 2 illustrates a cross-sectional view of a degradable metal stent after application of a metal layer in accordance with an embodiment of the present application
  • FIG. 3 illustrates a surface texturing or surface coating of a degradable metal stent in accordance with an embodiment of the present application. Schematic diagram of the time.
  • top, bottom, left, right, front, back, front, back, top, bottom, etc. mentioned or may be mentioned in this specification are defined with respect to the configurations shown in the respective drawings, which are Relative concepts, so it is possible to change accordingly according to their different locations and different usage states. Therefore, these or other orientation terms should not be interpreted as restrictive terms.
  • FIG. 1 shows a cross-sectional view of a degradable metal stent in accordance with one embodiment of the present application.
  • the degradable metal stent may include, for example, a stent made of an alloy of magnesium, aluminum, zinc, iron, or the like.
  • the degradable metal stent comprises a degradable metal stent body 1 , a metal layer 2 adjacent to the outside of the degradable metal stent body 1 and a drug layer 5 adjacent to the outside of the metal layer 2 .
  • the degradable metal stent may also be included Degradable metal stent body 1, other layers between metal layer 2 and drug layer 5 or outside drug layer 5.
  • the degradable metal stent body 1 can be made substantially of a magnesium alloy material.
  • the characteristic of the degradable metal stent is that the standard electrode potential of magnesium is -2.37V, which is relatively low, and is easily degraded under the physiological environment of the human body containing chloride ions, and the degraded magnesium can be absorbed with the metabolism and does not cause damage to the human body. damage.
  • the drug stent body made of magnesium alloy has desired physical properties, it has good matching in a human tissue environment.
  • the metal layer 2 its function is on the one hand to improve the visibility of the degradable metal stent, and on the other hand, it can serve as a protective layer to reduce the degradation rate of the degradable metal stent.
  • the metal layer 2 is made of a metal material having a higher density than the degradable metal stent body 1, and has a better visibility under X-rays due to its greater density.
  • the metal layer 2 may comprise gold, platinum, rhodium or titanium, or consist of gold, platinum, rhodium or titanium or any combination thereof. These metal materials have both visibility under X-rays, compatibility with the human body, and controllability of the degradation rate of the degradable metal stent 1.
  • the thickness of the metal layer may be less than 20 ⁇ m, such as between 0 and 20 ⁇ m.
  • the thickness of the metal layer 2 can be selected to control the degradation time of the entire degradable metal stent.
  • the thickness of the metal layer 2 can also be selected for the rate of degradation of a particular metal layer.
  • the drug layer 5 it may include a polymer and an effective drug, and the polymer may be selected from PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer) or PVDF (polyfluorinated fluorine) Ethylene), etc., rapamycin can be used as an effective drug.
  • the application of the drug layer 5 can be by means of ultrasonic spraying or the like.
  • the destructurable metal stent body is fabricated, and the structure and manufacturing method of the degradable metal stent body can be performed in a manner conventional in the art, such as by laser cutting or the like.
  • the metal layer 2 is applied to the surface of the degradable metal stent body.
  • the metal layer 2 may be in the form of molecular deposition or atomic deposition.
  • the thickness of the metal layer 2 can be selected according to the material of the metal layer, the desired degradation time, etc. Generally, the thickness of the metal layer 2 can be in the range of 0-20 um, or in the range of 0-18 um, or In the range of 5-18um, or in the range of 10-18um. In order to balance the visibility, compatibility, degradation rate, and the like of the metal layer 2, the metal layer 2 may be selected from gold, platinum, rhodium, titanium, and the like. In some embodiments, after the application of the metal layer 2 is completed, the semi-finished degradable metal stent 10 may be subjected to texturing treatment, for example, by laser texturing or sand blasting, the semi-finished degradable metal stent 10, especially the outer surface thereof.
  • the semi-finished degradable metal stent 10 may be disposed on the rotating shaft 3 for texturing treatment, such as sand blasting, in which the spray head 4 is fixed, and the rotating shaft 3 is rotatable at a predetermined speed and The translation is such that the outer surface 6 of the semi-finished degradable metal stent 10 has a certain roughness.
  • the degradable metal stent 10 having a certain roughness promotes endothelialization and reduces endothelialization time.
  • a drug layer can be applied to the textured semi-finished degradable metal stent 10.
  • the drug layer can be applied by ultrasonic spraying on a device similar to that of Figure 3, with the need to replace the sandblasting nozzle 4 with a spray nozzle.
  • An effective drug such as rapamycin and a polymer such as PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer) or PVDF (polyvinylidene fluoride) and a solvent such as acetone may be first mixed and carried out in a certain ratio. Stir.
  • rapamycin, PLA (PLGA), and acetone may be mixed at a mass ratio of 2:8:5 and stirred for 30 minutes.
  • the medical fluid mixture is injected into the sprayer, the ultrasonic power is adjusted to, for example, 2 W, the appropriate stent rotation speed is adjusted to, for example, 60 rpm, the axial direction is reciprocated at a speed of 0-2 mm/s, and for example, one or Multiple axial reciprocating cycles.
  • the acetone is volatilized, a mixture of the polymer and the active drug will cover the surface of the stent to form a drug layer.
  • the effective drug is present on the surface of the stent at a level of from 5 to 15 ug/mm, which is the drug content per unit length of the stent.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

一种可降解金属支架及其制造方法，其中可降解金属支架包括可降解金属支架本体(1)和药物层(5)，其中，可降解金属支架还包括可降解金属支架本体(1)和药物层(5)之间的金属层(2)，金属层(2)具有比可降解金属支架本体(1)更大的密度。该可降解金属支架具有更佳的可视性。

Description

可降解金属支架及其制造方法 技术领域
本申请涉及医疗器械尤其是医疗植入物技术领域，更具体地，本申请涉及一种可降解金属支架及其制造方法。
背景技术
带有药物涂层的可降解金属支架可以用于治疗冠脉血管狭窄,其例如包括由镁、铝、锌、铁等合金制成的支架。通常，将药物均匀地涂布在支架表面，当支架在病变血管处撑开后，支架表面的药物均匀的分布在病变血管处，且可降解金属支架由于血液的冲刷，会在人体内快速的降解。
中国发明专利公开号CN104189963B提供了一种镁合金血管支架，其具有可降解金属支架本体和药物层之间的硅烷偶联剂的中间层，以用于降低可降解金属支架的降解速度。
发明内容
本发明的目的在于解决或至少缓解现有技术中所存在的问题；
根据一些方面，本发明的目的在于提高可降解金属支架的可视性，可降解金属支架例如包括镁、铝、锌、铁等合金制成的支架；
根据一些方面，本发明的目的在于促进可降解金属支架的内皮化；
根据一些方面，本发明的目的在于控制可降解金属支架的降解速度。
一方面，提供了一种可降解金属支架，其包括可降解金属支架本体和药物层，其中，所述可降解金属支架还包括所述可降解金属支架本体和药物层之间的金属层，所述金属层具有比所述可降解金属支架本体更大的密度。
可选地，在上述可降解金属支架中，所述金属层紧邻地设置在所述可降解金属支架本体和药物层之间。
可选地，在上述可降解金属支架中，所述金属层包括金，铂，铱或钛，或者所述金属层由金，铂，铱或钛或它们的任何组合组成。
可选地，在上述可降解金属支架中，所述金属层的外表面经毛化处理。
可选地，在上述可降解金属支架中，其特征在于，所述金属层的厚度小于20μm。
可选地，在上述可降解金属支架中，其特征在于，所述金属层通过分子沉积或原子沉积施加在所述可降解金属支架本体上。
可选地，在上述可降解金属支架中，所述药物层包括选自PLA，PLGA或PVDF或它们的任何组合的聚合物和雷帕霉素。
可选地，在上述可降解金属支架中，所述雷帕霉素在支架表面的含量为5-15ug/mm。
另一方面，提供了一种可降解金属支架的生产方法，所述方法包括：
制造可降解金属支架本体；
在所述可降解金属支架本体上施加金属层，所述金属层具有比所述可降解金属支架本体更大的密度；以及
在所述金属层上施加药物层。
可选地，在上述方法中，所述金属层包括金，铂，铱或钛，或者所述金属层由金，铂，铱或钛或它们的任何组合组成。
可选地，在上述方法中，所述金属层通过分子沉积或原子沉积施加在所述可降解金属支架本体上。
可选地，在上述方法中，所述方法还包括在施加所述药物层前，对所述金属层进行毛化处理。
可选地，在上述方法中，所述在所述金属层上施加药物层的步骤包括将药剂混合物通过超声喷涂施加至所述金属层上。
附图说明
参照附图，本发明的公开内容将变得更易理解。本领域技术人员容易理解的是：这些附图仅仅用于说明的目的，而并非意在对本发明的保护范围构成限制。此外，图中类似的数字用以表示类似的部件，其中：
图1示出了根据本申请的实施例的可降解金属支架的截面图；
图2示出了根据本申请的实施例的可降解金属支架在施加金属层后的截面图；以及
图3示出了根据本申请的实施例的可降解金属支架的表面毛化处理或表面喷涂处 理时的示意图。
具体实施方式
容易理解，根据本发明的技术方案，在不变更本发明实质精神下，本领域的一般技术人员可以提出可相互替换的多种结构方式以及实现方式。因此，以下具体实施方式以及附图仅是对本发明的技术方案的示例性说明，而不应当视为本发明的全部或者视为对本发明技术方案的限定或限制。
在本说明书中提到或者可能提到的上、下、左、右、前、后、正面、背面、顶部、底部等方位用语是相对于各附图中所示的构造进行定义的，它们是相对的概念，因此有可能会根据其所处不同位置、不同使用状态而进行相应地变化。所以，也不应当将这些或者其他的方位用语解释为限制性用语。
图1示出了根据本申请的一个实施例的可降解金属支架的截面图。可降解金属支架例如可包括镁、铝、锌、铁等合金制成的支架。可降解金属支架包括可降解金属支架本体1，紧邻可降解金属支架本体1外侧的金属层2以及紧邻金属层2外侧的药物层5，在备选实施例中，可降解金属支架还可包括在可降解金属支架本体1，金属层2和药物层5之间或药物层5外侧的其他层。可降解金属支架本体1可基本由镁合金材料制成。可降解金属支架的特点在于：镁的标准电极电位为-2.37V，相对较低，其在含氯离子的人体生理环境下容易降解，并且降解的镁可随新陈代谢被吸收且不会对人体造成损害。此外，由于镁合金制成的药物支架本体具有期望的物理性能，在人体组织环境中具有良好的匹配性。对于金属层2而言，其作用一方面在于提高可降解金属支架的可视性，另一方面，其可作为保护层来降低可降解金属支架的降解速度。金属层2由比可降解金属支架本体1密度更大的金属材料制成，由于具有更大的密度，其在X射线下具有更佳的可见性。在一些实施例中，金属层2的可包括金，铂，铱或钛，或由金，铂，铱或钛或它们的任何组合组成。这些金属材料兼顾在X射线下的可视性，与人体的兼容性以及可降解金属支架1的降解速度的可控性。在一些实施例中，为防止金属层2难以降解，金属层的厚度可小于20μm，例如0-20μm之间。金属层2的厚度可选择成控制整个可降解金属支架的降解时间。金属层2的厚度还可针对特定金属层的降解速度来选择。对于药物层5而言，其可包括聚合物和有效药物，所述聚合物可选自PLA(聚乳酸)，PLGA(聚乳酸-羟基乙酸共聚物)或PVDF(聚偏氟 乙烯)等，有效药物可选用雷帕霉素。药物层5的施加可借助于超声喷涂等方式。
现在结合图2和图3来描述根据本发明的实施例的可降解金属支架的制造方法。首先，制造可降解金属支架本体，可降解金属支架本体的结构和制造方法可依据本领域中常规的方式，例如通过激光切割等方式。在可降解金属支架本体制造完成后，对可降解金属支架本体的表面施加金属层2。在一些实施例中，为增加可降解金属支架本体1和金属层2的结合力，并为了减少对可降解金属支架本体的损伤，金属层2可采用分子沉积或原子沉积的方式。金属层2的厚度可根据金属层的材料，期望的降解时间等因素来选择，一般而言，金属层2的厚度可在0-20um的范围中，或在0-18um的范围中，或在5-18um的范围中，或在10-18um的范围中等。为兼顾金属层2的可视性，兼容性和降解速度等，金属层2可选自金、铂、铱、钛等。在一些实施例中，在金属层2施加完成后，可将半成品可降解金属支架10进行毛化处理，例如可通过激光毛化或喷砂等方式对半成品可降解金属支架10尤其是其外表面进行毛化处理。在一些实施例中，如图3所示，可将半成品可降解金属支架10布置在转轴3上进行毛化处理，如喷砂处理，其中喷头4固定，而转轴3可按预定的速度旋转和平移，以使得半成品可降解金属支架10的外表面6处具有一定粗糙度。具有一定粗糙度的可降解金属支架10可促进其内皮化，减少内皮化时间。随后，可对经毛化处理的半成品可降解金属支架10施加药物层。在一些实施例中，药物层可通过在图3类似的设备上进行超声喷涂来施加，仅需将喷砂喷头4替换成喷涂喷嘴。可首先将有效药物如雷帕霉素和聚合物，如PLA(聚乳酸)，PLGA(聚乳酸-羟基乙酸共聚物)或PVDF(聚偏氟乙烯)以及溶剂，如丙酮按一定比例混合并进行搅拌。在一些实施例中，可采用雷帕霉素、PLA(PLGA)和丙酮以质量比2:8:5的比例混合，搅拌30分钟。随后，将药液混合物注入到喷涂机中，调整超声功率至例如2W，调整适当的支架旋转速度至例如60转/分钟，轴向以0-2mm/S的速度往复运动，并例如喷涂一个或多个轴向往复运动周期。待丙酮挥发后，聚合物和有效药物的混合物将覆盖在支架表面上，形成药物层。在一些实施例中，有效药物在支架表面的含量为5-15ug/mm，该含量指支架的每毫米单位长度中的药物含量。
以上所描述的具体实施例仅为了更清楚地描述本发明的原理，其中清楚地示出或描述了各个部件而使本发明的原理更容易理解。在不脱离本发明的范围的 情况下，本领域的技术人员可容易地对本发明进行各种修改或变化。故应当理解的是，这些修改或者变化均应包含在本发明的专利保护范围之内。

Claims (12)

  1. 一种可降解金属支架，其包括可降解金属支架本体和药物层，其特征在于所述可降解金属支架还包括所述可降解金属支架本体和药物层之间的金属层，所述金属层具有比所述可降解金属支架本体更大的密度。
  2. 根据权利要求1所述的可降解金属支架，其特征在于，所述金属层包括金，铂，铱或钛，或者所述金属层由金，铂，铱或钛或它们的任何组合组成。
  3. 根据权利要求1或2所述的可降解金属支架，其特征在于，所述金属层的外表面经毛化处理。
  4. 根据前述权利要求中任一项所述的可降解金属支架，其特征在于，所述金属层的厚度小于20μm。
  5. 根据前述权利要求中任一项所述的可降解金属支架，其特征在于，所述金属层通过分子沉积或原子沉积施加在所述可降解金属支架本体上。
  6. 根据前述权利要求中任一项所述的可降解金属支架，其特征在于，所述药物层包括选自PLA，PLGA或PVDF或它们的任何组合的聚合物以及雷帕霉素。
  7. 根据前述权利要求中任一项所述的可降解金属支架，其特征在于，所述雷帕霉素在支架表面的含量为5-15ug/mm。
  8. 一种可降解金属支架的生产方法，所述方法包括：
    制造可降解金属支架本体；
    在所述可降解金属支架本体上施加金属层，所述金属层具有比所述可降解金属支架本体更大的密度；以及
    在所述金属层上施加药物层。
  9. 根据权利要求8所述的方法，其特征在于，所述金属层包括金，铂，铱或钛，或者所述金属层由金，铂，铱或钛或它们的任何组合组成。
  10. 根据前述权利要求中任一项所述的方法，其特征在于，所述金属层通过分子沉积或原子沉积施加在所述可降解金属支架本体上。
  11. 根据前述权利要求中任一项所述的方法，其特征在于，所述方法还包括在施 加所述药物层前，对所述金属层的外表面进行毛化处理。
  12. 根据前述权利要求中任一项所述的方法，其特征在于，所述在所述金属层上施加药物层的步骤包括：
    将药剂混合物通过超声喷涂施加至所述金属层上，所述药剂混合物包括选自PLA，PLGA或PVDF或它们的任何组合的聚合物，有效药物以及溶剂，以及等待所述溶剂挥发。
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