WO1999053988A1 - Fil-guide pour catheter - Google Patents

Fil-guide pour catheter Download PDF

Info

Publication number
WO1999053988A1
WO1999053988A1 PCT/JP1999/002083 JP9902083W WO9953988A1 WO 1999053988 A1 WO1999053988 A1 WO 1999053988A1 JP 9902083 W JP9902083 W JP 9902083W WO 9953988 A1 WO9953988 A1 WO 9953988A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide wire
dlc
catheter
organ
blood
Prior art date
Application number
PCT/JP1999/002083
Other languages
English (en)
Japanese (ja)
Inventor
Atsushi Shimada
Original Assignee
Getz Bros. Co., Ltd.
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 Getz Bros. Co., Ltd. filed Critical Getz Bros. Co., Ltd.
Publication of WO1999053988A1 publication Critical patent/WO1999053988A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a guide wire for a catheter for percutaneously introducing a catheter into an organ and a lesion through a blood vessel, and particularly to a guide wire for a catheter having improved biocompatibility and antithrombotic properties.
  • a method of percutaneously guiding a tubule called a catheter from outside a patient through a blood vessel and diagnosing organs and lesions through this catheter, and a method of treating the organs and lesions have become widespread.
  • a wire called a guidewire which is smaller in diameter than a catheter, is introduced percutaneously into the blood vessel, and after the tip reaches the target organ and lesion, the catheter is removed from the guidewire.
  • After fitting percutaneously penetrate the blood vessel and guide the distal end in the same way, then remove the guide wire from the catheter, and then apply a forceps or a linear treatment device equipped with a female needle at the distal end.
  • treatment ⁇ Insert a diagnostic catheter into the catheter to diagnose organs and lesions, inject drugs, and cut the affected area.
  • This method of diagnosis and treatment can be performed with catheteride under local anesthesia, even for procedures requiring surgery under general anesthesia, which can greatly reduce invasiveness to patients and is expected to become more widespread in the future. You.
  • biocompatibility Since the guide wire is pulled out after guiding the catheter to the organs and lesions, its indwelling time in the body is short, so its compatibility with blood and living tissue (hereinafter referred to as “biocompatibility”) is taken into account.
  • metal such as stainless steel was mostly processed into a linear shape.
  • guiders are more likely to have biocompatibility, even temporarily, because they come into contact with the blood vessel walls and internal organ surfaces, and treatment using this catheter is particularly promising.
  • the guidewire causes a new source of blood clots and organ damage, and guidewires have better antithrombotic properties and biocompatibility Is desired.
  • guidewires coated with silicone resin-polyurethane resin to impart antithrombotic properties and biocompatibility have been used.
  • the present invention has been made in view of the above circumstances, and an object of the present invention is to provide a guidewire for a catheter having further improved antithrombotic properties and biocompatibility. Disclosure of the invention
  • the above object of the present invention is attained by a guide wire for guiding a catheter to a diseased part through a blood vessel, wherein the outer peripheral surface of the guide wire is coated with a diamond-like carbon film. .
  • DLC Diamond-like carbon
  • FIG. 1 is a cross-sectional view of a main part of a guide wire for a catheter of the present invention.
  • FIG. 2 is a schematic view showing an example of a film forming apparatus for manufacturing the guide wire for a catheter of the present invention.
  • the figure is a partial cross-sectional view showing a guide wire through hole formed in a column of a drum jig of the film forming apparatus of FIG. BEST MODE FOR CARRYING OUT THE INVENTION
  • FIG. 1 is a schematic sectional view of a main part showing a guide wire for a catheter of the present invention (hereinafter, simply referred to as “guide wire”).
  • the guide wire 10 is formed by uniformly coating the outer peripheral surface of the linear base material 12 with the DLC film 13.
  • the substrate 12 may be the same as a conventional guide wire, and is formed by processing a corrosion-resistant metal such as stainless steel into a linear shape.
  • the thickness of the DLC film 13 is not particularly limited, it is practically acceptable if it is in the range of 150 A to 150 A, preferably 150 A to 25 0 0 A is good.
  • the distal end of the guide wire 10 is formed in a hemispherical shape so as not to damage the blood vessel wall.
  • a catheter 11 indicated by a dashed line in the figure is externally fitted to the guidewire 10.
  • the DLC film 13 is formed on the substrate 12 using, for example, a film forming apparatus 20 shown in FIG.
  • the film forming apparatus 20 is roughly composed of a vapor deposition chamber 21 in which a base material 12 is wound around a drum jig 22 and accommodated, and a plasma generator 23 for generating a carbon source.
  • a force source 24 is provided at an upper portion thereof, and an anode 25 is provided at a bottom portion thereof so as to face the force source 24.
  • Do 25 is made of, for example, stainless steel plate.
  • An opening 26 for passing plasma toward the vapor deposition chamber 21 is formed substantially at the center of the anode 25, and a part of the upper surface is covered with an insulator 27. Thereby, the density of the plasma is increased near the anode 25.
  • a gas introduction hole 28 for introducing a raw material gas serving as a carbon source together with a carrier gas is connected to an appropriate position of the plasma generation section 23.
  • a raw material gas a hydrocarbon-based gas such as methazine acetylene is used, and as a carrier gas, an inert gas such as nitrogen gas or argon is used.
  • a magnetic coil 29 is provided around the plasma generating section 23. The magnetic coil 29 forms a magnetic field of several hundred gauss and increases the path length of the plasma.
  • a grid 30 is arranged at an upper portion in the vapor deposition chamber 21 so as to face the anode 25 at a predetermined interval.
  • An opening 31 communicating with the opening 26 of the anode 25 is formed substantially at the center of the grid 30. Further, the grid 30 has a potential higher by a predetermined voltage than the anode 25, and the plasma passing through the opening 26 of the anode 25 is supplied to the drum jig 22 through the opening 31. It is configured to lead to the base material 12 above.
  • the drum jig 22 is formed by connecting a pair of metal disks 32 facing each other with a plurality of columns 33.
  • Each pillar 3 3 has through holes 34 at predetermined intervals through which the base material 12 passes along the longitudinal direction thereof, and the base material 12 circulates in parallel with the disk 3 2. Is wound around the drum jig 22.
  • the through-hole 34 of the support post 33 is cut into a tapered shape at the opening side edge portion 34 a as shown in FIG.
  • the drum jig 22 is accommodated in the vapor deposition chamber 21 such that the column 33 is located substantially immediately below the opening 31.
  • the drum jig 22 is connected to a motor (not shown), and is rotated along the circumferential direction of the disk 32 during film formation.
  • the drum jig 22 is provided with a motor 35 also serving as a chuck member of the substrate 12, and rotates the substrate 12 about its axis during the film forming process.
  • a motor 35 also serving as a chuck member of the substrate 12, and rotates the substrate 12 about its axis during the film forming process.
  • the entire outer peripheral surface of the substrate 12 is uniformly exposed to the plasma, and together with the rotation of the drum jig 22 itself, the entire outer peripheral surface of the substrate 12 is formed in a single film forming process.
  • the DLC film 13 is formed with an appropriate thickness.
  • the film forming apparatus 20 naturally includes heating means, vacuum evacuation means, exhaust means, high-frequency power supply, source gas supply source, etc. which are usually provided in a general PVD (Physical 1 Vapor Deposition) apparatus. Have.
  • PVD Physical 1 Vapor Deposition
  • an example of the film forming conditions of the DLC film 13 using the above-described film forming apparatus 20 is shown below. • Deposition temperature: 150-250
  • the formation of the DLC film 13 on the substrate 12 is not limited to the PVD method described above, but may be performed by an IVD (Ion Vapor Deposition) method, an ion beam evaporation method, or a sputtering method.
  • a film forming method such as a plating method, an arc-type ion plating method, or a plasma CVD method can be performed using the drum jig 22 described above.
  • methane gas as a source gas is supplied to the plasma generating section 23 at a rate of 200 cc / in, and a high-frequency output of 200 W is applied.
  • generating a plasma Te deposition chamber 2 1 a of the ultimate vacuum 2 X 1 0 - 6 T orr , 3 in vacuum the deposition X 1 0 3 T 0 rr, deposition temperature 2 0 0 ° C, the drum Osamu
  • the tool 22 was subjected to a treatment for 20 minutes under the condition of a rotation speed of 60 rpm, and a DLC film of 2000 persons was formed on a stainless steel wire to form a guide wire.
  • C 3 C 5 and C were measured 3 days, 7 days and 14 days after test sample implantation
  • test plate A a stainless steel (SUS304) plate having a surface area of 1 cm 2 and a thickness of 0.2 mm, and a test plate having a 500 A DLC film formed on the stainless steel plate.
  • B was immersed in lactic acid for 1 week and in 1N hydrochloric acid for 1 hour, and then the eluted metal ions were analyzed using a plasma emission spectrometer (ICP). Sa Sampling was performed with four types of iron, chromium, nickel and manganese. The results are shown in Tables 3 and 4.
  • Table — 3 _ lactic acid for one week
  • a stainless steel (SUS316L) plate having a surface area of 7.6 cm 2 (test plate C) and a test plate D having a 500 A DLC film formed on the stainless steel plate were used. It was exposed for 30 minutes at room temperature in human Bok platelet solution (3 3 3 X 1 0 9 platelets / L) using a sustained exposure apparatus. Thereafter, each test plate was taken out, washed with saline, the platelets adhered to the test plate surface were fixed, and the number of platelets adhered was measured using a scanning electron microscope. The measurement was performed at five locations with an area of 1 cm 2 on each test plate.
  • Example 5 The following shaking and immersion tests were performed.
  • a 0.5 mm diameter stainless steel wire (SUS316L; test wire A) and a test wire B obtained by forming a 500-OA DLC film on the stainless wire were each used for human fresh blood.
  • Each unit was separately immersed in each experimental cell filled with 5 ml of heparinized fresh blood containing 1 unit of parin per 1 ml.
  • the length of each test wire was adjusted such that the ratio (SZV) of the surface area (S) of the test wire to the volume of heparinized fresh blood (V) was 7 or more.
  • each cell was shaken and immersed in a constant temperature bath at 37 ° C for 3 hours while rotating, and the test wire was taken out, and the following items were measured for blood in the experimental cell.
  • only blood was placed in an experimental cell and subjected to the same shaking to serve as a control group for the following items. The measurement was performed for each of the three samples, and the results are shown in Table 5.
  • an ETFE with an outer diameter of 3.69 mm, an inner diameter of 3.19 mm, and a length of 250 mm
  • the tubing is immersed in physiological saline in a curved shape with a radius of 88 mm, and a silicone tube (outside diameter: 1.9 Omm, inside diameter: 1.25 mm) and this cylinder are placed in this tube.
  • a silicone tube outside diameter: 1.9 Omm, inside diameter: 1.25 mm
  • Each tube through which a 1 ⁇ m DLC membrane was provided was passed through a cone tube, and the resistance was measured. The measurement was performed three times each.
  • a catheter wire for cathether which has excellent biocompatibility and antithrombotic properties, and further has excellent slidability is provided. can get.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un fil-guide pour cathéters dont la face extérieure est revêtue de carbone cristallisé sous la forme diamant (DLC), ce qui lui confère une biocompatibilité élevée et de bonnes propriétés antithrombotiques. En raison de son activité chimique extrêmement réduite, le DLC n'entraîne qu'une faible coagulation sanguine et n'exerce que peu d'effet sur les tissus vitaux lorsqu'il est mis en contact avec le sang. Lorsque le fil-guide est introduit par voie percutanée dans un organe ou une lésion via les vaisseaux sanguins, il n'endommage pratiquement pas les parois internes des vaisseaux sanguins et de l'organe grâce aux excellentes propriétés lubrifiantes du DLC qui facilitent les opérations de passage et de manipulation. Les caractéristiques de la présente invention permettent de réduire le frottement entre un organe ou une lésion cible et le cathéter attaché au fil-guide.
PCT/JP1999/002083 1998-04-20 1999-04-20 Fil-guide pour catheter WO1999053988A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP10/109551 1998-04-20
JP10955198 1998-04-20

Publications (1)

Publication Number Publication Date
WO1999053988A1 true WO1999053988A1 (fr) 1999-10-28

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Family Applications (1)

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PCT/JP1999/002083 WO1999053988A1 (fr) 1998-04-20 1999-04-20 Fil-guide pour catheter

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WO (1) WO1999053988A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005061021A1 (fr) * 2003-12-19 2005-07-07 Keio University Fil-guide medical revetu d'un film de carbone
KR20180008427A (ko) * 2015-04-30 2018-01-24 에스아이오2 메디컬 프로덕츠, 인크. 열가소성 물품으로의 희석 생체분자 부착의 감소를 가져오는 비중합성 화합물을 이용한 플라즈마 처리
KR20180103040A (ko) * 2015-11-16 2018-09-18 에스아이오2 메디컬 프로덕츠, 인크. 생체분자 부착이 감소된 표면을 갖는 중합성 기재 및 이러한 기재의 열가소성 물품
WO2018195315A1 (fr) * 2017-04-21 2018-10-25 Medtronic Vascular, Inc. Fil-poussoir pour dispositif médical endoluminal
JP2019506198A (ja) * 2015-12-28 2019-03-07 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 抗血栓コーティングを有する医療装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01284243A (ja) * 1987-08-04 1989-11-15 Ion Tech Ltd 人体移植用部材
JPH04916A (ja) * 1990-04-18 1992-01-06 Fuji Electric Co Ltd Ａ／ｄ変換器のオフセットドリフト補正装置
JPH08141072A (ja) * 1994-11-15 1996-06-04 Alps Electric Co Ltd 血液回路弁
JPH10110257A (ja) * 1996-10-03 1998-04-28 Nissin Electric Co Ltd 医療用被覆材

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01284243A (ja) * 1987-08-04 1989-11-15 Ion Tech Ltd 人体移植用部材
JPH04916A (ja) * 1990-04-18 1992-01-06 Fuji Electric Co Ltd Ａ／ｄ変換器のオフセットドリフト補正装置
JPH08141072A (ja) * 1994-11-15 1996-06-04 Alps Electric Co Ltd 血液回路弁
JPH10110257A (ja) * 1996-10-03 1998-04-28 Nissin Electric Co Ltd 医療用被覆材

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005061021A1 (fr) * 2003-12-19 2005-07-07 Keio University Fil-guide medical revetu d'un film de carbone
KR20180008427A (ko) * 2015-04-30 2018-01-24 에스아이오2 메디컬 프로덕츠, 인크. 열가소성 물품으로의 희석 생체분자 부착의 감소를 가져오는 비중합성 화합물을 이용한 플라즈마 처리
KR102670650B1 (ko) 2015-04-30 2024-05-31 에스아이오2 메디컬 프로덕츠, 인크. 열가소성 물품으로의 희석 생체분자 부착의 감소를 가져오는 비중합성 화합물을 이용한 플라즈마 처리
KR20180103040A (ko) * 2015-11-16 2018-09-18 에스아이오2 메디컬 프로덕츠, 인크. 생체분자 부착이 감소된 표면을 갖는 중합성 기재 및 이러한 기재의 열가소성 물품
JP2018537556A (ja) * 2015-11-16 2018-12-20 エスアイオーツー・メディカル・プロダクツ・インコーポレイテッド 生体分子の付着が低減された表面を有するポリマー基材、及びそのような基材の熱可塑性物品
KR102701204B1 (ko) 2015-11-16 2024-08-30 에스아이오2 메디컬 프로덕츠, 인크. 생체분자 부착이 감소된 표면을 갖는 중합성 기재 및 이러한 기재의 열가소성 물품
JP2019506198A (ja) * 2015-12-28 2019-03-07 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 抗血栓コーティングを有する医療装置
WO2018195315A1 (fr) * 2017-04-21 2018-10-25 Medtronic Vascular, Inc. Fil-poussoir pour dispositif médical endoluminal
US11219744B2 (en) 2017-04-21 2022-01-11 Medtronic Vascular, Inc. Push wire for endoluminal medical device

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