CN113507904A - 植入物 - Google Patents

植入物 Download PDF

Info

Publication number
CN113507904A
CN113507904A CN202080018085.XA CN202080018085A CN113507904A CN 113507904 A CN113507904 A CN 113507904A CN 202080018085 A CN202080018085 A CN 202080018085A CN 113507904 A CN113507904 A CN 113507904A
Authority
CN
China
Prior art keywords
segment
section
strips
implant
segments
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202080018085.XA
Other languages
English (en)
Inventor
A.斯科夫
D.弗里克
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik AG
Original Assignee
Biotronik AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotronik AG filed Critical Biotronik AG
Priority to CN202310763579.6A priority Critical patent/CN116747061A/zh
Publication of CN113507904A publication Critical patent/CN113507904A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91583Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明涉及一种植入物,植入物具有镂空、中空圆柱形主体(10),其组装自多个镂空、中空圆柱形段(11、13),多个镂空、中空圆柱形段(11、13)在纵向方向(L)上连续地布置且彼此连接。段各自包括在纵向方向上布置在主体(10)的每端处的末端段(11)和在纵向方向(L)上布置在两个末端段(11)之间的至少一个内部段(13),其中每个段(11、13)具有多个条(21),多个条(21)一起形成具有最大点(25)和最小点(23)的迂曲结构,迂曲结构在圆周方向上延伸。主体(10)呈现压缩状态和膨胀状态。至少一个末端段(11)的迂曲结构具有比至少一个内部段(13)更少数量的最大点(25)和最小点(23),并且处于压缩状态或处于膨胀状态的该至少一个末端段(11)的内径和外径与处于相同状态的至少一个内部段(13)的内径和外径基本上相同。

Description

植入物
技术领域
本发明涉及一种具有镂空、中空圆柱形主体的植入物,该主体组装自多个镂空、中空圆柱形段,其在纵向方向上连续地布置且彼此连接,其中每个段具有多个条,多个条一起形成具有最小点和最大点的迂曲结构,迂曲结构在圆周方向上延伸。植入物或其主体可以呈现压缩状态和膨胀状态。
背景技术
用于宽范围的应用的多种医疗植入物(假体),尤其是冠状动脉内假体,是由现有技术已知的。
支架通常用作植入物且例如可以用于治疗狭窄(血管缩窄)。它们通常具有镂空、中空圆柱形(管状)主体,其在纵向方向(即,在纵向轴线的方向上)上的两端是开口的。该类植入物通常通过导管插入到要治疗的血管中并用于在相对长时间(数月到数年)内通过其主体支撑血管。血管中的窄的区域可以通过使用支架而变宽。
部分地或完全地由生物可降解材料制成的植入物(特别是支架)也是已知的。生物降解被理解为活体中的水解、酶解和其他代谢地诱导的分解过程,这首先都是由体液与植入物的可生物降解材料接触引起的,并导致含有可生物降解材料的植入物结构的逐渐分解。因为该过程,植入物在某一点失去其机械完整性。术语“生物腐蚀”通常与术语“生物降解”同义地使用。术语“生物再吸收”包含由活体后续重吸收降解产物。
文档EP 1 974 700 A1描述了支架形式的植入物,其具有径向地可膨胀主体,其中主体具有多个支撑段。每个段由迂曲支柱形成。文档EP 3 034 035 A1也描述了这样的植入物,其是柔性的且同时具有充分的径向刚度以支撑其所插入到的血管。
诸如上述那些的已知的植入物,其主体组装自多个段,该多个段在纵向方向上连续地布置,通常在每个段中具有多个支柱,支柱各自形成周向迂曲结构。出于此目的,支柱在结构的弓形最大点和最小点处彼此紧固或彼此过渡。迂曲结构具有交替的最小点和最大点,其中位于较接近于主体的第一端的弧被称为段的最小点,而位于较接近于主体的与第一端相对的端的其他弧被称为最大点。
在本申请的范围内,段理解为是指植入物的中空圆柱形部分。段由形成周向迂曲结构的多个支柱和弧构成。段在圆周方向上封闭,也就是说段的支柱和弧彼此连接,使得它们在圆周方向上形成封闭环。在支架的情况下,该类实施例通常称为环设计。
一方面,已知的植入物呈现上述压缩状态,该状态下,它们可以例如通过导管微创地引入到待治疗的患者的体内。另一方面,植入物例如通过球囊膨胀在治疗位点转换为膨胀状态,植入物将留在该治疗位点处。在膨胀状态下,植入物通过它们的主体支撑相关血管或锚定在相关器官或其他体腔中。在本申请的范围内,膨胀状态理解为是指植入物在例如通过球囊膨胀而膨胀之后提供的状态,其中个体植入位点(例如局部地不同的血管直径,刚度或与圆形截面的偏差)带来的个体且局部的外部影响不予考虑。因此,膨胀状态对应于敞开空间中膨胀之后的状态。
在以下解释的范围内,术语“血管”应包含全部血管、器官或其他体腔,特别是一般植入物可以插入以进行治疗的要治疗的患者的血管。
如果具有上述主体的植入物插入到血管中,该血管的体液从而流动通过该植入物。在没有植入物的血管与具有植入物的血管之间的过渡处,发生流率改变,这阻止体液的流动并可能潜在地导致该体液的内容物在该过渡区域中的不期望的沉积或结块。在移动的血管(例如血液血管)的情况下,特定血管的刚度也在插入的植入物的区域改变,因为治疗位点处存在的植入物也增加刚度。在可能的情况下的刚度的此改变不应是突然的。
因此,目标在于创建一种植入物,其实现在从没有植入物的血管到具有植入物的血管的过渡处的改善的流动过渡和刚度上的较小改变。此外,根据本发明的植入物应比可比的现有技术植入物可更好且更容易地植入。
发明内容
以上目标由具有权利要求1的特征的植入物实现。
特别地,根据本发明的植入物具有在纵向方向上连续地布置的多个镂空、中空圆柱形段,其具有上述的迂曲结构,其中段各自包括在纵向方向上布置在主体的每端处的末端段和至少一个内部段,至少一个内部段在纵向方向上布置在两个末端段之间。根据本发明,至少一个末端段的迂曲结构具有比至少一个内部段更少数量的最小点。
段优选地具有一样多的最小点和最大点。这优选地对末端段和内部段两者相等地适用。
该至少一个末端段的外径在膨胀状态下优选地基本上等于相同状态下的至少一个内部段的外径。换言之,当植入物膨胀时,产生外径在内部段和端部段之间不变的中空圆柱形主体。在本申请的范围内,“基本上相等的外径”理解为是指直径上的差异小于3%,优选地小于2%。
由于根据本发明的方案,创建植入物,其主体允许改善的植入过程。因为段的结构是迂曲的,末端段中的最小点的数量上的减少同时也表示最大点和条的数量上的对应的减少。这意味着,末端段可以被压缩为比内部段更小的直径。在植入时,植入物头先地插入到血管中。由于末端段的较小压缩直径,最小化了随着插入而末端段支出并碰到且损伤血管壁的风险。此外,由于末端段的区域中的更少数量的条,产生了改善的流动过渡。
在本发明的一个示例性实施例中,两个末端段都具有比至少一个内部段更少数量的最小点。
在其他示例性实施例中,一个末端段或两个末端段的最小点的数量比内部段的最小点的数量小1或2倍。如果内部段具有不同数量的最小点,则在一个特定实施例中,一个末端段或两个末端段的最小点的数量应比具有最小数量的最小点的内部段的最小点的数量小1或2倍。
例如,植入物具有内部段,内部段各自形成迂曲结构中的6个最小点。在该示例性实施例中,一个末端段或两个末端段例如具有4或5个最小点。由以上定义,也包含其他数量的最小点,其中最小点的数量是自然数。
在一个特定实施例中,在至少一个末端段的迂曲结构上提供用于布置由X射线不透明和/或辐射不透明材料构成的功能元件的至少一个孔眼,其中孔眼的内开口优选地具有椭圆形状。具有圆形的内开口或正方形形状或矩形形状或另外的形状的内开口的孔眼也是可以设想的。在根据本发明的植入物的情况下,布置与常规植入物相比相对大的X射线不透明和/或辐射不透明功能元件是可能的,因为通过减少最小点的数量并从而减少条的数量而创建了为此所需的空间,而不阻碍主体在该区域的压缩或膨胀。孔眼的外部长度(即,在纵向方向上的外尺寸)小于或等于此处末端段的宽度。此处,段的宽度(段宽度)视为在主体的纵向方向上的特定状态下的段的外部长度。在该实施例中,本发明与压缩状态下的小直径有关的优点尤其突出。由于最小点的数量减少,为功能元件创建了更多空间,使得植入物可以与功能元件一起作为整体压缩到较小的直径。功能元件不使压缩状态下的直径增大。这导致用于插入该类植入物的导管系统的小轮廓,并从而允许较简单且较小创伤的植入。
功能元件可以由例如来自以下组的一个或多个X射线不透明和/或辐射不透明元素或化合物制成,该组包括:铂、铱、金、钨、钼、铌、钽、钇、锆、镱或这些金属的合金。
在特定示例性实施例中,由X射线不透明和/或辐射不透明材料构成的功能元件布置在至少一个孔眼中。在此情况下,功能元件例如通过粘合结合紧固到孔眼。
在特定示例性实施例中,可以实现在具有植入物的血管与没有植入物的血管之间的刚度上的变化的进一步减小,因为至少一个末端段的段宽度大于至少一个内部段的段宽度。由于至少一个末端段的较大段宽度,其具有进一步减小的径向刚度。末端段的段宽度可以例如在1mm与2mm之间,优选地在1.1mm与1.6mm之间。内部段的段宽度可以在例如相似范围内。(一个或多个)内部段有利地具有较小的条宽度,其在0.01mm与0.3mm之间,优选地在0.01mm与0.2mm之间,特别优选地在0.07mm与0.12mm之间。
在其他示例性实施例中,末端段与相邻的内部段之间的距离大于两个相邻的内部段之间的距离。相关末端段的区域中的轴向刚度由此减小,并且因此产生了改善的刚度过渡。此处,两个段之间的距离理解为在连接一段的最小点的线与连接另一段的相对的最大点的线之间的纵向方向上的空白空间的最小长度。末端段与相邻的内部段在纵向方向上的之间的距离可以例如在0.10mm与0.13mm之间,优选地在0.11mm与0.12mm之间。两个相邻的内部段在纵向方向上的距离可以例如在0.08mm与0.12mm之间,优选地在0.09mm与0.11mm之间。
在其他示例性实施例中,至少一个末端段的条的宽度比至少一个内部段的条的宽度更小,和/或至少一个末端段的条的边缘比至少一个内部段的条的边缘圆化更强。由于段的条的该设计,产生了在植入物的内部的方向上的甚至更好的流动过渡,因为相关末端区域的区域中的材料厚度减小。另一方面,相关末端段的区域中的径向刚度进一步减小。条宽度理解为当在中空圆柱的圆周上延伸的主体在平面上铺展时产生的平面(铺展平面)中测量的条的宽度。此处,在该铺展平面中垂直于条的外面测量相关条的宽度,该条的外面垂直于铺展平面设置。可以例如通过该区域中的适当电抛光来实现末端段中的更小的条的宽度和/或边缘的更强圆化。末端段条宽度可以例如在0.135mm与0.155mm之间,优选地在0.140mm与0.150mm之间。内部段的条的宽度可以例如在0.145mm与0.160mm之间,优选地在0.150mm与0.155mm之间。边缘的更强圆化在本申请的范围内理解为是指具有较大半径的圆化的弧的圆化边缘。
在本发明的其他示例性实施例中,至少一个末端段的条的厚度比至少一个内部段的条的厚度更小。相似于条宽度的减小,条厚度的减小导致植入物内部的方向上的改善的流动过渡和径向刚度的减小,由此实现没有植入物的血管与具有植入物的血管之间的改善的过渡。在本申请的范围内,条厚度应理解为是指考虑到条垂直于条宽度的截面所得的条的壁厚度。同样可以通过适当电抛光实现相关末端元件中的较小的条宽度。末端段的条厚度可以例如比内部段的条厚度小5μm至15μm。
上述两个实施例优选地组合。在此优选组合中,至少一个末端段的条具有较小的宽度、较小的厚度和/或边缘的较强圆化。
在其他示例性实施例中,相邻的段通过连接条彼此连接,其中至少一个连接条的条宽度和/或条厚度比至少一个内部段的条的条宽度和/或条厚度和/或至少一个末端段的条的条宽度和/或条厚度更小。植入物从而有利地在整体上实现良好的轴向柔性和良好的弯曲柔性。连接条的条宽度可以例如在0.07mm与0.10mm之间,优选地在0.08mm与0.09mm之间,并且与段的条的宽度类似地测量。可以参考以上对至少一个末端段的条和至少一个内部段的条的示例性条宽度的描述。
根据本发明的植入物的主体可以整体地或部分地由生物可降解材料构成。该类生物可降解材料为金属生物可降解材料,特别是基于镁或镁合金,例如WE43、镁-锌-铝、镁-铝或镁-锌-钙。此处,优选地使用高纯度镁合金,诸如镁-锌-铝,其具有0-4%以重量计的Zn和2-10%以重量计的Al或具有1.5-7%以重量计的Zn和0.5-3.5%以重量计的Al;诸如镁-铝,其具有5-10%以重量计的Al,特别是5.5-7%以重量计的铝,特别优选地6.25%以重量计的铝;诸如镁-锌-钙,其具有3-7%以重量计的Zn和0.001-0.5%以重量计的Ca或0-3%以重量计的Zn和0-0.6%以重量计的Ca。该类高纯度镁合金,除前述合金元素之外,还包括小于0.006%以重量计的其他元素(杂质,诸如Fe、Cu、Co、Si等或稀土元素)。将此类高纯度镁合金用于植入物的主体的优点是,可以很好地控制分泌物的形成。通过控制分泌物的尺寸、体积和成分,植入物的降解行为进而可以被很精确地控制。植入物的降解行为设定为使得其支撑功能在植入到血管中后保持至少90天,并且植入物在大约一年的时间后几乎完全降解,也就是说分解。
合适的生物可降解聚合物化合物的示例是来自以下组的聚合物:纤维素、胶原、白蛋白、酪蛋白、多聚糖(PSAC)、聚丙交酯(PLA)、聚-L-丙交酯(PLLA)、聚乙二醇(PGA)、聚-D,L-丙交酯-共-乙交酯(PDLLA-PGA)、聚羟基丁酸(PHB)、聚羟基戊酸(PHV)、聚碳酸烷基酯、聚原酸酯、聚对苯二甲酸乙二醇酯(PET)、聚丙二酸(PML)、聚酐、聚磷腈、聚氨基酸及其共聚物和透明质酸。聚合物可以以纯净形式、衍生形式、混合物或作为共聚物的形式存在,取决于期望的性质。生物可降解材料也可以部分地由金属生物可降解材料且部分地由聚合物生物可降解化合物构成。
在替代实施例中,植入物的主体整体地或部分地由非生物可降解金属或金属合金形成,诸如不锈钢、钛、钴铬合金、镍-钛合金、铂或相似适当金属合金。
在其他优选实施例中,植入物包括至少部分地含活性成分的聚合物涂层,其中特别是整个主体均匀涂覆,即,端部段与内部段之间不存在涂层差异。上述聚合物,特别是聚丙交酯(PLA)或聚-L-丙交酯(PLLA),可以用作聚合物。
抗增殖、抗迁移、抗血管生成、抗炎、消炎、细胞抑制、细胞毒性和/或抗血栓形成活性成分、抗再狭窄活性成分、皮质激素、性激素、他汀类、埃坡霉素、前列环素、血管生成诱导剂可用作活性成分。特别优选紫杉醇及其衍生物或西罗莫司及其衍生物。
下文将基于示例性实施例并参考附图来解释本发明。此处,在附图中描述和/或示出的所有特征单独地或以任何组合形成本发明的主题,也独立于它们在权利要求中的概述或权利要求的从属引用。
附图说明
附图示意性地示出:
图1在俯视图中在铺展平面中示出的处于电抛光之后的状态的根据本发明的植入物的主体,
图2在放大视图中分开地示出的来自图1的细节D,
图3在放大视图中分开地示出的来自图1的细节C,
图4在放大视图中分开地示出的来自图1的细节B,以及
图5在侧视立体图中示出处于电抛光之后的状态的根据本发明的植入物。
具体实施方式
图1示出了根据本发明的植入物的示例性实施例的主体10,其为处于电抛光之后、压缩之前的支架的形式,其中,为了改善主体10(其具有布置为单独的段的带有多个条的镂空结构)的图示,其已经被铺展在卷起平面中。图5示出了当尚未铺展时的处于压缩状态的主体10的中空圆柱形状,而没有详细示出主体10的结构。
在电抛光之后的状态下,主体10的直径接近于膨胀的直径,但小于膨胀状态下的目标直径。主体的直径此处基本上对应于制造主体所用的管的直径。
主体10组装自多个段11、13,其中在图1中,完整示出了总共十一个段11、13。具有附图标记11的段形成末端段,因为它们设置在在纵向方向L(中空圆柱形主体10的纵向轴线的方向;见图5)上布置的主体10的端部处。其他段13形成内部段。
每个段11、13由两个连接条15连接到其相邻的段11、13。连接条15被在图1的主体10的细节F中突出。连接条15在所示示例性实施例中以弯曲或S形延伸,但也可以在它们的中间笔直延伸。在替代实施例中,可以提供仅单个连接条或多于两个连接条以用于相邻的段11、13的连接。
每个段11、13具有多个条,其基本上在纵向方向L上延伸或与之稍倾斜地延伸。图2和图4中提供的具有附图标记21的条可以笔直或弓形或弯曲延伸,其中可以在单个段中布置不同的笔直和弓形和弯曲的条。每两个相邻条21由弧连接,使得产生迂曲结构。弧各自形成迂曲结构的最小点23或最大点25(见图2和图4)。
在所示的示例性实施例中(特别是见图1和图2的细节A、D和E),内部段13各自具有十二个弯曲条21和十二个弧,其中这些弧中的六个弧形成最大点25且六个弧形成最小点23。相比之下,末端段11组装自十个条21和十个弧,其中五个弧形成最大点25且五个弧形成最小点23。孔眼27布置在末端段11的条21上,并且示出为图3中的放大尺度。此处,根据本发明的支架在电抛光之后的状态下在内部段13的区域中和在末端段11的区域中具有相同或基本上相同的外径,并且该外径由图5中的D指代。在膨胀状态,内部段13具有与端部段11相同或基本上相同的内径。由于内部段13和末端段11的不同机械特性,可能仅因为压缩之后或膨胀之后的不同回弹行为而产生末端段11与内部段13之间的外径D上的小差异。内部段13和末端段11的外径D是基本上相同的。
内部段中和末端段中的其他数量的最小点、最大点和条是同样可设想的,其中,根据本发明,末端段的最小点的数量比内部段的最小点的数量更小至少一个。
图3中详细示出的孔眼27用于在内连续开口28中布置由辐射不透明和/或X射线不透明材料构成的功能元件,从而确保支架在引入到身体中时的可见度。由于末端段中的最小点的减少,可以增大功能元件的体积或可见面积,使得支架的可见度改善。此处,孔眼27及其内开口28具有近似椭圆的形状,其具有与其他形状相比的较大面积。椭圆布置在主体10中,使得其主轴平行于主体的纵向方向L行进。此外,布置在两个末端段11上的两个孔眼27中的椭圆形开口28的主轴在圆周方向上偏移长度e(见图1)。孔眼27的开口28的主轴o1的长度为例如800μm,并且副轴o2的长度为例如350μm。孔眼27的条宽度s为例如100μm。
孔眼27的开口28的主轴o1的长度为例如800μm,并且副轴o2的长度为例如350μm。孔眼27的条宽度为例如100μm。
两个末端段11具有例如1.36mm的段宽度b11,而内部段13的段宽度b13为例如1.25mm(见图1)。其他段宽度也是可设想的,其中优选地:b11>b13。末端段11的径向刚度由此进一步减小。
段之间的距离在图1中示出。附图标记a11指代末端段11与相邻内部段13之间的距离,而a13指代两个内部段13之间的距离。为降低过渡区域中的轴向刚度,在所示的植入物的示例性实施例中,a11>a13,例如a11=115μm且a13=95μm。
如果末端段11的条宽度s11小于内部段的条宽度s13,则也实现从无支架的血管到有支架的血管的刚度上的更好的过渡,其中段可以具有段内的不同的条宽度s11、s13。例如,s11在135μm至149μm的范围内,并且s13在150μm至165μm的范围内。这对于末端段11的条与内部段13的条之间不同条厚度(未示出)也成立。
此外,在所示的植入物的示例性实施例中,为了确保支架或主体10的良好的轴向柔性和良好的弯曲柔性,连接条15的条宽度v小于内部段13的条的条宽度s13和末端段11的条宽度s11。例如,连接条15的条宽度v在80μm与90μm之间。
此外,末端段11的条21、最大点25和最小点23的边缘的圆化比内部段13的迂曲结构的相同元件的边缘更强。从而也降低了在到支架的过渡处对体液的流动的扰乱。
根据本发明的支架可以以已知的方式通过从管状半成品激光切割以及后续电抛光来制造。相似于孔眼的内开口28形成且由X射线不透明和/或辐射不透明材料制成的功能元件然后被插入到开口28中并例如通过粘合结合而紧固到孔眼27。
为了治疗患者,根据本发明的支架例如可以被卷曲到导管的球囊(未示出)上。支架然后可以通过导管被引入到患者体内,并且例如沿着血液血管推进到要治疗的点。支架然后被通过球囊膨胀,并且从而紧固到血管壁。支架被用于保持血管打开并对其支撑。导管在将支架锚定在血管中之后被移除。
支架的主体由高纯度镁-铝合金构成,其含有5.5-7%以重量计的铝(优选地6.25%以重量计的铝),至多0.006%以重量计的其他元素(杂质诸如Fe、Cu、Co、Si等或稀土元素)和镁作为其余组分。支架还具有含西罗莫司的PLLA涂层,其中支架的腔体侧(内侧)的涂层比支架的非腔体侧(外侧)(10-15μm)更薄(2-7μm)。

Claims (9)

1.一种植入物,其具有镂空的、中空圆柱形的主体(10),所述主体组装自多个镂空的、中空圆柱形的段(11、13),所述多个镂空的、中空圆柱形的段(11、13)在纵向方向(L)上连续地布置且彼此连接,其中所述段各自包括在所述纵向方向上布置在所述主体(10)的每端处的末端段(11)和至少一个内部段(13),所述至少一个内部段(13)在所述纵向方向(L)上布置在两个末端段(11)之间,其中每个段(11、13)具有多个条(21),所述多个条(21)一起形成具有最大点(25)和最小点(23)的迂曲结构,所述迂曲结构在所述圆周方向上延伸,其中所述主体(10)呈现压缩状态和膨胀状态,其特征在于,至少一个末端段(11)的迂曲结构具有比所述至少一个内部段(13)更少数量的最小点(23)。
2.根据权利要求1所述的植入物,其特征在于,处于所述膨胀状态下的至少一个末端段的外径对应于所述至少一个内部段的外径。
3.根据前述权利要求中任一项所述的植入物,其特征在于,两个末端段(11)都具有比所述至少一个内部段(13)更少数量的最小点(23)。
4.根据前述权利要求中任一项所述的植入物,其特征在于,在所述主体(10)的至少一个末端段(11)的迂曲结构上提供用于布置功能元件的至少一个孔眼(27),所述功能元件由X射线不透明和/或辐射不透明材料构成,其中所述孔眼(27)的内开口(28)优选地具有椭圆形状。
5.根据权利要求4所述的植入物,其特征在于,由X射线不透明和/或辐射不透明材料构成的功能元件布置在所述至少一个孔眼(27)中。
6.根据前述权利要求中任一项所述的植入物,其特征在于,所述至少一个末端段(11)的段宽度(b11)大于所述至少一个内部段(13)的段宽度(b13)。
7.根据前述权利要求中任一项所述的植入物,其特征在于,末端段(11)与相邻的内部段(13)之间的距离(a11)大于两个相邻的内部段(13)之间的距离(a13)。
8.根据前述权利要求中任一项所述的植入物,其特征在于,至少一个末端段(11)的条(21)的宽度(s11)和/或厚度比所述至少一个内部段(13)的条(21)更小,和/或所述至少一个末端段(11)的条(21)的边缘比所述至少一个内部段(13)的条(21)的边缘圆化更强。
9.根据前述权利要求中任一项所述的植入物,其特征在于,相邻的段(11、13)通过至少一个连接条(15)彼此连接,其中所述至少一个连接条(15)的条宽度(v)比所述至少一个内部段(13)的条(21)和/或至少一个末端段的条更小。
CN202080018085.XA 2019-03-15 2020-03-02 植入物 Pending CN113507904A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310763579.6A CN116747061A (zh) 2019-03-15 2020-03-02 植入物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP19163172.0 2019-03-15
EP19163172.0A EP3708129A1 (de) 2019-03-15 2019-03-15 Implantat
PCT/EP2020/055418 WO2020187550A1 (en) 2019-03-15 2020-03-02 Implant

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202310763579.6A Division CN116747061A (zh) 2019-03-15 2020-03-02 植入物

Publications (1)

Publication Number Publication Date
CN113507904A true CN113507904A (zh) 2021-10-15

Family

ID=66048986

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202310763579.6A Pending CN116747061A (zh) 2019-03-15 2020-03-02 植入物
CN202080018085.XA Pending CN113507904A (zh) 2019-03-15 2020-03-02 植入物

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN202310763579.6A Pending CN116747061A (zh) 2019-03-15 2020-03-02 植入物

Country Status (9)

Country Link
US (1) US20220142797A1 (zh)
EP (2) EP3708129A1 (zh)
JP (1) JP2022523174A (zh)
KR (1) KR20210139255A (zh)
CN (2) CN116747061A (zh)
AU (1) AU2020242879A1 (zh)
BR (1) BR112021018296A2 (zh)
SG (1) SG11202110125PA (zh)
WO (1) WO2020187550A1 (zh)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002060344A2 (en) * 2000-09-22 2002-08-08 Scimed Life Systems, Inc. Flexible and expandable stent
US6537311B1 (en) * 1999-12-30 2003-03-25 Advanced Cardiovascular Systems, Inc. Stent designs for use in peripheral vessels
US6981986B1 (en) * 1995-03-01 2006-01-03 Boston Scientific Scimed, Inc. Longitudinally flexible expandable stent
US20060036315A1 (en) * 2001-09-24 2006-02-16 Advanced Stent Technologies, Inc. Stent with protruding branch portion for bifurcated vessels
US20060224231A1 (en) * 2005-03-31 2006-10-05 Gregorich Daniel J Endoprostheses
US20080243230A1 (en) * 2007-03-31 2008-10-02 Biotronik Vi Patent Ag Stent having radially expandable main body
US20100131044A1 (en) * 2006-07-13 2010-05-27 Udayan Patel Stent
US20160106560A1 (en) * 2014-10-17 2016-04-21 Cerevatech Medical, Inc. Vascular implant for treating aneurysms
CN106456347A (zh) * 2014-03-18 2017-02-22 波士顿科学国际有限公司 减少肉芽和炎症的支架设计
US20170172768A1 (en) * 2015-12-17 2017-06-22 Abbott Cardiovascular Systems Inc. Thin-walled scaffolds having flexible distal end

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8070792B2 (en) * 2000-09-22 2011-12-06 Boston Scientific Scimed, Inc. Stent
JP7059182B2 (ja) * 2015-12-17 2022-04-25 アボット カーディオヴァスキュラー システムズ インコーポレイテッド 薄肉スキャフォールド
EP3578142B1 (en) * 2017-02-01 2022-03-23 Kake Educational Institution Okayama University Of Science Bioabsorbable stent

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6981986B1 (en) * 1995-03-01 2006-01-03 Boston Scientific Scimed, Inc. Longitudinally flexible expandable stent
US6537311B1 (en) * 1999-12-30 2003-03-25 Advanced Cardiovascular Systems, Inc. Stent designs for use in peripheral vessels
WO2002060344A2 (en) * 2000-09-22 2002-08-08 Scimed Life Systems, Inc. Flexible and expandable stent
US20060036315A1 (en) * 2001-09-24 2006-02-16 Advanced Stent Technologies, Inc. Stent with protruding branch portion for bifurcated vessels
US20060224231A1 (en) * 2005-03-31 2006-10-05 Gregorich Daniel J Endoprostheses
US20100131044A1 (en) * 2006-07-13 2010-05-27 Udayan Patel Stent
US20080243230A1 (en) * 2007-03-31 2008-10-02 Biotronik Vi Patent Ag Stent having radially expandable main body
CN106456347A (zh) * 2014-03-18 2017-02-22 波士顿科学国际有限公司 减少肉芽和炎症的支架设计
US20160106560A1 (en) * 2014-10-17 2016-04-21 Cerevatech Medical, Inc. Vascular implant for treating aneurysms
US20170172768A1 (en) * 2015-12-17 2017-06-22 Abbott Cardiovascular Systems Inc. Thin-walled scaffolds having flexible distal end

Also Published As

Publication number Publication date
EP3708129A1 (de) 2020-09-16
WO2020187550A1 (en) 2020-09-24
SG11202110125PA (en) 2021-10-28
KR20210139255A (ko) 2021-11-22
BR112021018296A2 (pt) 2021-11-23
AU2020242879A1 (en) 2021-09-16
EP3937859A1 (en) 2022-01-19
CN116747061A (zh) 2023-09-15
JP2022523174A (ja) 2022-04-21
US20220142797A1 (en) 2022-05-12

Similar Documents

Publication Publication Date Title
EP1768609B1 (en) Expandable medical device for the delivery of a beneficial agent
US8603155B2 (en) Stent having improved stent design
EP2429462B1 (en) Bioerodible endoprosthesis
JP5523331B2 (ja) 薬剤送達のためのらせん状チャンネルを有するステント
EP2398521B1 (en) Bioerodible endoprosthesis
EP2186492B1 (en) Stent and living organ dilator
KR20080044323A (ko) 생체 유치용 스텐트
US20110282428A1 (en) Biodegradable composite stent
US9427500B2 (en) Stent made of a cobalt alloy
US20160022450A1 (en) Bioresorbable stent
EP3134140B1 (en) Bioerodible stent
US20140144001A1 (en) Stent having function elements
US10864069B2 (en) Stent with deflecting connector
CN113507904A (zh) 植入物
US7914571B2 (en) Stent with radiopaque material

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40062244

Country of ref document: HK