WO2011140973A1 - Marqueur de visualisation apte à fabriquer une endoprothèse polymère clairement visible aux rayons x - Google Patents

Marqueur de visualisation apte à fabriquer une endoprothèse polymère clairement visible aux rayons x Download PDF

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Publication number
WO2011140973A1
WO2011140973A1 PCT/CN2011/073894 CN2011073894W WO2011140973A1 WO 2011140973 A1 WO2011140973 A1 WO 2011140973A1 CN 2011073894 W CN2011073894 W CN 2011073894W WO 2011140973 A1 WO2011140973 A1 WO 2011140973A1
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WO
WIPO (PCT)
Prior art keywords
stent
marker
mark
reserved hole
diameter
Prior art date
Application number
PCT/CN2011/073894
Other languages
English (en)
Chinese (zh)
Inventor
谢建
魏征
Original Assignee
上海微特生物技术有限公司
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 上海微特生物技术有限公司 filed Critical 上海微特生物技术有限公司
Publication of WO2011140973A1 publication Critical patent/WO2011140973A1/fr

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Classifications

    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0052—T-shaped
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers 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

Definitions

  • the utility model relates to a development mark which can make a polymer stent clearly visible under X-rays, and belongs to the field of medical instruments. technical background
  • vascular stents Minimally invasive placement of vascular stents is widely used as an effective intervention technique for the treatment of vascular stenosis.
  • long-term retention of metal stents in blood vessels can cause chronic damage of blood vessels, which can cause atrophy of the middle layer of blood vessels and formation of aneurysms.
  • reactive intimal hyperplasia ultimately leading to the occurrence of vascular restenosis (Rab ST, KiHgsB, Roubin GS, et al. Coronary aneurysms after stent Placement: a suggestion of altered vessel wall healing in the Presence of anti-inflammatory agents. J Am Coll Cardiol 1991, 18:1524).
  • the stent Since the stent is implanted into the blood vessel, it mainly plays a role in mechanical support of the blood vessel within a certain time of injury healing (for a coronary stent generally within half a year), so the ideal vascular stent should be given sufficient mechanical support and healing in the lesion segment. It is then gradually absorbed by the body (Colombo A, Karvouni E. Biodegradable stents: "fulilling the mission and stepping away”. Circulation, 2000, 102: 371-373).
  • biodegradable polymer scaffold materials that can be completely absorbed by the human body are all polymer plastic materials.
  • the materials used for biodegradable vascular scaffolds are polylactic acid (PL), L-polylactic acid (PLLA or LP).
  • LA Polyglycolic acid/polylactic acid (PGLA), polycaprolactone (PCL), polyhydroxylbutyrate valerate (PHBV), polyacetylglutamic acid , PAGA), polyorthoesters (POE) and polyethylene oxide/polybutylene terephthalate (PEO/PBTP).
  • transparent plastic-based stents evade X-ray detection during medical procedures and patient visits, making development difficult. Therefore, the difficulty of safely and accurately placing the stent in the lesion site during surgery is greatly increased, and the surgical failure rate is increased. Moreover, postoperative observation is difficult and cannot provide direct treatment and reoperation for different patients. in accordance with.
  • Patent 200620158386. X describes a method for increasing the development of a stent by coating a developing film with gold and silver powder on both ends of the stent.
  • the adhesion of the coated developing film to the stent substrate may be due to the matrix material. Different and different.
  • a developing film having poor adhesion has a great risk of falling off during and after implantation, resulting in an acute thrombus.
  • a developing film having a different coating composition at both ends may cause an artificial coating unevenness, posing a risk to the treatment.
  • Patent 200920095643. 3 Describes a metal bracket using a two-layer material.
  • the double-layer material has a thick wall, is difficult to manufacture and subsequent processing, is expensive, and can only be applied to a bracket of a metal matrix material.
  • the utility model aims to find a channel which is safely applied to the development of a degradable polymer stent.
  • a development mark capable of making a polymer stent clearly visible under X-rays wherein a reserved hole (3) is disposed on the polymer support (2), and a mark body (1) is embedded in the reserved hole (3).
  • the mark (1) is a development mark (4) on the outer surface of the reserved hole (3), and the mark (1) does not protrude on the inner surface of the support at the other end of the reserved hole (3) .
  • This radiopaque marker can be applied to any polymer stent to improve the development of X-rays.
  • the radiopaque marker capable of developing the polymer stent is to be embedded in the polymer holder to be embedded in the reserved hole (3).
  • any part of the bracket can be selected as needed.
  • the connecting ribs at both ends of the bracket are generally selected as the set points of the reserved holes.
  • the shape of the reserved hole may be any suitable shape such as a circle, a plum shape, a star shape, a cross shape, a hexagon shape, or the like.
  • the size of the outer hole of the bracket is between 0. 18 ⁇ 0. 24mm, and the diameter of the inner surface of the bracket is not larger than the diameter of the outer surface of the reserved hole.
  • the diameter of the outer surface of the stent is 0. 01mm.
  • Gold or titanium, platinum, etc.
  • this kind of precious metal has good biocompatibility and has been widely used for filling teeth and manufacturing human implants.
  • a good material for radiopaque development marks Thanks to the good ductility of the material, the metal pellets can be easily pressed into the reserved holes of the polymer holder, and the wells are well matched with the reserved holes, and the marking points are firm.
  • the radiopaque marker capable of developing the polymer stent is to embed the marker body (1) from the outer surface of the polymer stent (2) into the bracket reserved hole (3), and to reserve the hole a developing mark (4) having a larger diameter than the outer surface of the reserved hole is formed on one side of the outer surface of the support, and the developing mark (4) is protruded from the outer surface 0. 01 0. 05 preferably 0. 03
  • the entire metal ball forms a metal "T" mark (5 ) Tightly fixed in the reserved hole, the other end of the "T” mark (5) does not protrude from the inner surface of the bracket (6).
  • This design ensures that the outer surface of the stent is tightly attached to the inner wall of the blood vessel after implantation, and the marker is tightly sandwiched between the stent and the blood vessel wall, and can withstand long-term vasoconstriction and blood flow impact without falling off.
  • the whole stent is wrapped in the blood vessel wall by the new tissue.
  • the degradable stent is completely absorbed, and the metal marker with excellent compatibility will be completely wrapped in the vessel wall. The blood flow is blocked.
  • the utility model can be used for X-ray development of any polymer-based stent, including but not limited to the above-mentioned polylactic acid (PLA), L-polylactic acid (PLLA or LPLA), Polyglycolic acid/polylactic acid (PGLA), polycaprolactone (PCL), polyhydroxylbutyrate valerate (PHBV), polyacetylglutamic acid (polyhydroxylbutyrate valerate, PHBV) Polyacetylglutamic acid, PLGA), polyorthoesters (POE) and polyethylene oxide/polybutylene terephthalate (PE0/PBTP).
  • PLA polylactic acid
  • PLLA or LPLA Polyglycolic acid/polylactic acid
  • PCL polycaprolactone
  • PHBV polyhydroxylbutyrate valerate
  • PHBV polyacetylglutamic acid
  • PLGA polyorthoesters
  • PE0/PBTP polyethylene oxide/polybutylene
  • Figure 1 is a plan view showing the outer surface of the bracket connecting rib after a circular reserved hole is provided.
  • Figure 2 is a side view of the metal ball placed on the reserved hole of the bracket before being buried.
  • Figure 3 is a side view of the marker position bracket after the metal pellet is buried in the reserved hole.
  • Figure 4 is a top plan view of the outer surface of the marker position after the metal pellet is buried in the reserved hole.
  • Fig. 5 is a schematic view showing the shape of a "rivet" formed after the metal ball is buried in the reserved hole.
  • Figure 6 is a cross-sectional side view of the marker position bracket after the metal ball is buried in the reserved hole.
  • Fig. 7 is a plan view showing the outer surface of the bracket connecting rib after setting a plum-shaped reserved hole.
  • Fig. 8 is a plan view showing the outer surface of the bracket connecting rib after the provision of a cross-shaped reserved hole.
  • Figure 9 is a top plan view of the outer surface of the bracket connecting rib after setting a star-shaped reserved hole.
  • Fig. 10 is a plan view showing the outer surface of the bracket connecting rib after the hexagonal reserved hole is provided. detailed description
  • the present invention provides a development mark that enables a polymer stent to be clearly visible under X-rays.
  • the recording body is a medical pure gold material, and the pure gold ball (1) is manually pressed into the reserved hole (3) of the polymer support by the outer surface of the polymer support (2), and a diameter larger than the reserved hole of the polymer is formed on the outer surface.
  • the pure gold ball pressed into the reserved hole forms a "T" mark (5) under the action of an external force, and is firmly fixed in the reserved hole (3) of the polymer.
  • the bracket material is PGLA, and the reserved holes are arranged on the connecting ribs at both ends of the bracket, which are round holes, and the reserved holes at both ends (3) are center-symmetrical, the size is 0.22 mm, and the diameter of the pure gold ball is 0.23 mm.
  • a development mark (4) larger than the outer surface diameter of the reserved hole is formed on the outer surface of the reserved hole holder, and the development mark (4) protrudes from the outer surface 0.03.
  • the metal ball forms a pure gold "T" mark (5) that is tightly fixed in the reserved hole, and the other end of the "T” mark (5) does not protrude from the inner surface of the bracket (6).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Cardiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention porte sur un marqueur de visualisation apte à fabriquer une endoprothèse polymère clairement visible aux rayons X. Ce marqueur de visualisation est composé d'un corps de marqueur (1), et le matériau du corps de marqueur (1) est l'or, le titane ou le platine pour un usage médical, etc. Le corps de marqueur métallique (1) est incorporé manuellement dans un trou préparé (3) de l'endoprothèse à partir de la surface externe de l'endoprothèse polymère (2) et sur le côté du corps de marqueur (1) sur la surface externe du trou préparé (3) est formé un marqueur de visualisation (4) qui est plus grand que le diamètre de la surface externe du trou préparé et fait saillie à partir de la surface externe de l'endoprothèse afin de former un marqueur en forme de « T » (5) qui est fixé fermement dans le trou préparé. L'autre côté du marqueur en forme de « T » (5) ne fait pas saillie à partir de la surface interne de l'endoprothèse. Après l'implantation de l'endoprothèse, le marqueur est serré fermement entre l'endoprothèse et la paroi du vaisseau sanguin, de sorte que le marqueur peut résister à un mouvement du vaisseau sanguin de longue durée et à un bouchon de flux sanguin mais ne pas tomber. Le marqueur de visualisation a un bon effet de visualisation et est sans danger pour le corps humain.
PCT/CN2011/073894 2010-05-10 2011-05-10 Marqueur de visualisation apte à fabriquer une endoprothèse polymère clairement visible aux rayons x WO2011140973A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201020184367.0 2010-05-10
CN2010201843670U CN202027751U (zh) 2010-05-10 2010-05-10 一种能使聚合物支架在x射线下清晰可见的显影标记

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WO2011140973A1 true WO2011140973A1 (fr) 2011-11-17

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109984864A (zh) * 2017-12-29 2019-07-09 先健科技(深圳)有限公司 用于分支血管的支架
CN109984863A (zh) * 2017-12-29 2019-07-09 先健科技(深圳)有限公司 双层血管支架

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2692288T3 (es) * 2012-10-25 2018-12-03 Arterial Remodeling Technologies S.A. Marcador radiopaco para estents biorreabsorbibles
CN105457105B (zh) * 2015-07-24 2018-08-31 中国科学院金属研究所 一种可显影镁合金血管支架
CN107029306B (zh) * 2016-02-04 2020-05-15 中国科学院金属研究所 一种能使降解支架在x光下显影的标记及其制备方法
CN108464879B (zh) 2017-02-21 2020-04-10 上海微创医疗器械（集团）有限公司 支架
CN107596454B (zh) * 2017-10-18 2024-03-08 苏州恒瑞迪生医疗科技有限公司 一种可吸收血管内假体及其制备方法
CN107874843A (zh) * 2017-12-15 2018-04-06 泗洪县正心医疗技术有限公司 一种有空腔的体表显影件

Citations (7)

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Publication number Priority date Publication date Assignee Title
US6334871B1 (en) * 1996-03-13 2002-01-01 Medtronic, Inc. Radiopaque stent markers
US6464720B2 (en) * 1997-09-24 2002-10-15 Cook Incorporated Radially expandable stent
US20040167619A1 (en) * 2003-02-26 2004-08-26 Cook Incorporated Prosthesis adapted for placement under external imaging
US20070156230A1 (en) * 2006-01-04 2007-07-05 Dugan Stephen R Stents with radiopaque markers
US20070266542A1 (en) * 2006-05-08 2007-11-22 Cook Incorporated Radiopaque marker for intraluminal medical device
US7625398B2 (en) * 2003-05-06 2009-12-01 Abbott Laboratories Endoprosthesis having foot extensions
CN101621974A (zh) * 2007-02-09 2010-01-06 百乐仕医疗器械有限公司 支架

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6334871B1 (en) * 1996-03-13 2002-01-01 Medtronic, Inc. Radiopaque stent markers
US6464720B2 (en) * 1997-09-24 2002-10-15 Cook Incorporated Radially expandable stent
US20040167619A1 (en) * 2003-02-26 2004-08-26 Cook Incorporated Prosthesis adapted for placement under external imaging
US7625398B2 (en) * 2003-05-06 2009-12-01 Abbott Laboratories Endoprosthesis having foot extensions
US20070156230A1 (en) * 2006-01-04 2007-07-05 Dugan Stephen R Stents with radiopaque markers
US20070266542A1 (en) * 2006-05-08 2007-11-22 Cook Incorporated Radiopaque marker for intraluminal medical device
CN101621974A (zh) * 2007-02-09 2010-01-06 百乐仕医疗器械有限公司 支架

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109984864A (zh) * 2017-12-29 2019-07-09 先健科技(深圳)有限公司 用于分支血管的支架
CN109984863A (zh) * 2017-12-29 2019-07-09 先健科技(深圳)有限公司 双层血管支架
CN109984863B (zh) * 2017-12-29 2020-04-07 先健科技(深圳)有限公司 双层血管支架
CN109984864B (zh) * 2017-12-29 2020-07-17 先健科技(深圳)有限公司 用于分支血管的支架
US10993821B2 (en) 2017-12-29 2021-05-04 Lifetech Scientific (Shenzhen) Co., Ltd Double-layer blood vessel stent

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