JP7471119B2 - Medical long body - Google Patents
Medical long body Download PDFInfo
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- JP7471119B2 JP7471119B2 JP2020050915A JP2020050915A JP7471119B2 JP 7471119 B2 JP7471119 B2 JP 7471119B2 JP 2020050915 A JP2020050915 A JP 2020050915A JP 2020050915 A JP2020050915 A JP 2020050915A JP 7471119 B2 JP7471119 B2 JP 7471119B2
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- Prior art keywords
- coating layer
- core material
- guidewire
- layer
- elongated body
- Prior art date
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- 239000011247 coating layer Substances 0.000 claims description 76
- 239000011162 core material Substances 0.000 claims description 48
- 229920001709 polysilazane Polymers 0.000 claims description 22
- 239000010410 layer Substances 0.000 claims description 21
- 125000000547 substituted alkyl group Chemical group 0.000 claims description 9
- 125000004435 hydrogen atom Chemical group [H]* 0.000 claims description 7
- 239000010935 stainless steel Substances 0.000 claims description 5
- 229910001220 stainless steel Inorganic materials 0.000 claims description 5
- 125000005017 substituted alkenyl group Chemical group 0.000 claims description 4
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- 239000000463 material Substances 0.000 description 13
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- QWTDNUCVQCZILF-UHFFFAOYSA-N isopentane Chemical compound CCC(C)C QWTDNUCVQCZILF-UHFFFAOYSA-N 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- CRSOQBOWXPBRES-UHFFFAOYSA-N neopentane Chemical compound CC(C)(C)C CRSOQBOWXPBRES-UHFFFAOYSA-N 0.000 description 2
- BKIMMITUMNQMOS-UHFFFAOYSA-N nonane Chemical compound CCCCCCCCC BKIMMITUMNQMOS-UHFFFAOYSA-N 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 230000002940 repellent Effects 0.000 description 2
- 239000005871 repellent Substances 0.000 description 2
- 125000001424 substituent group Chemical group 0.000 description 2
- 125000003396 thiol group Chemical group [H]S* 0.000 description 2
- 125000004973 1-butenyl group Chemical group C(=CCC)* 0.000 description 1
- 125000006017 1-propenyl group Chemical group 0.000 description 1
- 125000004974 2-butenyl group Chemical group C(C=CC)* 0.000 description 1
- 125000003903 2-propenyl group Chemical group [H]C([*])([H])C([H])=C([H])[H] 0.000 description 1
- 125000004975 3-butenyl group Chemical group C(CC=C)* 0.000 description 1
- 125000000590 4-methylphenyl group Chemical group [H]C1=C([H])C(=C([H])C([H])=C1*)C([H])([H])[H] 0.000 description 1
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical group [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 description 1
- WKBOTKDWSSQWDR-UHFFFAOYSA-N Bromine atom Chemical group [Br] WKBOTKDWSSQWDR-UHFFFAOYSA-N 0.000 description 1
- 239000004215 Carbon black (E152) Substances 0.000 description 1
- 229910000531 Co alloy Inorganic materials 0.000 description 1
- 229910017518 Cu Zn Inorganic materials 0.000 description 1
- 229910000881 Cu alloy Inorganic materials 0.000 description 1
- 229910017752 Cu-Zn Inorganic materials 0.000 description 1
- 229910017943 Cu—Zn Inorganic materials 0.000 description 1
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 description 1
- 241000283070 Equus zebra Species 0.000 description 1
- NHTMVDHEPJAVLT-UHFFFAOYSA-N Isooctane Chemical compound CC(C)CC(C)(C)C NHTMVDHEPJAVLT-UHFFFAOYSA-N 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 229910001260 Pt alloy Inorganic materials 0.000 description 1
- 125000003277 amino group Chemical group 0.000 description 1
- 229920001400 block copolymer Polymers 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000001273 butane Substances 0.000 description 1
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- 238000006243 chemical reaction Methods 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 125000001309 chloro group Chemical group Cl* 0.000 description 1
- QRJOYPHTNNOAOJ-UHFFFAOYSA-N copper gold Chemical compound [Cu].[Au] QRJOYPHTNNOAOJ-UHFFFAOYSA-N 0.000 description 1
- TVZPLCNGKSPOJA-UHFFFAOYSA-N copper zinc Chemical compound [Cu].[Zn] TVZPLCNGKSPOJA-UHFFFAOYSA-N 0.000 description 1
- JVSWJIKNEAIKJW-UHFFFAOYSA-N dimethyl-hexane Natural products CCCCCC(C)C JVSWJIKNEAIKJW-UHFFFAOYSA-N 0.000 description 1
- 238000003618 dip coating Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 125000003700 epoxy group Chemical group 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 125000001153 fluoro group Chemical group F* 0.000 description 1
- 125000000524 functional group Chemical group 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- DMEGYFMYUHOHGS-UHFFFAOYSA-N heptamethylene Natural products C1CCCCCC1 DMEGYFMYUHOHGS-UHFFFAOYSA-N 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 150000002430 hydrocarbons Chemical class 0.000 description 1
- KHYBPSFKEHXSLX-UHFFFAOYSA-N iminotitanium Chemical compound [Ti]=N KHYBPSFKEHXSLX-UHFFFAOYSA-N 0.000 description 1
- 229910052740 iodine Inorganic materials 0.000 description 1
- 239000001282 iso-butane Substances 0.000 description 1
- 125000000959 isobutyl group Chemical group [H]C([H])([H])C([H])(C([H])([H])[H])C([H])([H])* 0.000 description 1
- 125000001972 isopentyl group Chemical group [H]C([H])([H])C([H])(C([H])([H])[H])C([H])([H])C([H])([H])* 0.000 description 1
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- FPYJFEHAWHCUMM-UHFFFAOYSA-N maleic anhydride Chemical compound O=C1OC(=O)C=C1 FPYJFEHAWHCUMM-UHFFFAOYSA-N 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
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- 125000005641 methacryl group Chemical group 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- IJDNQMDRQITEOD-UHFFFAOYSA-N n-butane Chemical compound CCCC IJDNQMDRQITEOD-UHFFFAOYSA-N 0.000 description 1
- 125000004108 n-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 125000003136 n-heptyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 125000001280 n-hexyl group Chemical group C(CCCCC)* 0.000 description 1
- 125000000740 n-pentyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 125000004123 n-propyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 125000001971 neopentyl group Chemical group [H]C([*])([H])C(C([H])([H])[H])(C([H])([H])[H])C([H])([H])[H] 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- TVMXDCGIABBOFY-UHFFFAOYSA-N octane Chemical compound CCCCCCCC TVMXDCGIABBOFY-UHFFFAOYSA-N 0.000 description 1
- 125000000962 organic group Chemical group 0.000 description 1
- 125000003854 p-chlorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1Cl 0.000 description 1
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 239000001294 propane Substances 0.000 description 1
- 229920005604 random copolymer Polymers 0.000 description 1
- 125000002914 sec-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
- 125000005372 silanol group Chemical group 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- 125000000999 tert-butyl group Chemical group [H]C([H])([H])C(*)(C([H])([H])[H])C([H])([H])[H] 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Composite Materials (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials Engineering (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
本発明は、医療用長尺体に関する。 The present invention relates to a medical elongated body.
ガイドワイヤに代表される医療用長尺体は、体腔内に導入して用いられる。例えば、ガイドワイヤは、カテーテル等の医療用器具を人体の所定の目的部位を安全かつ確実に誘導するために、体腔内に導入して用いられる。このようにして用いられるガイドワイヤには、摺動性が求められ、また、体腔内の湾曲部の通過や手元操作のために折り曲げをさせるために、折曲性が求められる。従来のガイドワイヤにおいては、目的部位への体腔内への導入のために摺動性を確保する必要があるので、表面層としてポリテトラフルオロエチレン(PTFE)層が設けられることがある。しかしながら、PTFE層を備えるガイドワイヤは、摺動性が良好であるもののPTFE層の割れおよび脱離が生じやすいために、折曲性に問題がある。 Medical elongated bodies, such as guidewires, are introduced into body cavities for use. For example, guidewires are introduced into body cavities to safely and reliably guide medical instruments, such as catheters, to a specific target site in the human body. Guidewires used in this manner are required to have slidability, and also bendability so that they can pass through curved parts in the body cavities and bend for manual operation. In conventional guidewires, a polytetrafluoroethylene (PTFE) layer is sometimes provided as a surface layer since it is necessary to ensure slidability for introduction into the body cavity to the target site. However, guidewires with a PTFE layer have good slidability, but have problems with bendability because the PTFE layer is prone to cracking and detachment.
本発明は上記従来の課題を解決するためになされたものであり、その目的とするところは、摺動性と折曲性とを有する医療用長尺体を提供することにある。 The present invention was made to solve the above-mentioned problems, and its purpose is to provide a medical elongated body that has sliding and bending properties.
本発明の医療用長尺体は、芯材と、該芯材の表面の少なくとも一部を覆う被覆層とを備え、該被覆層が、有機ポリシラザンを含む。
1つの実施形態においては、上記有機ポリシラザンが、一般式(1)で表される構成単位を含む。
1つの実施形態においては、上記芯材が、ステンレス鋼から形成されている。
1つの実施形態においては、上記被覆層が形成された部分の長さが、400mm~2800mmである。
1つの実施形態においては、上記被覆層の厚みが、2μm以下である。
1つの実施形態においては、上記芯材の一部に上記被覆層が形成され、該被覆層が形成されていない部分において、親水層が形成されている。
The medical elongated body of the present invention comprises a core material and a coating layer that covers at least a portion of the surface of the core material, and the coating layer contains an organic polysilazane.
In one embodiment, the organic polysilazane contains a constitutional unit represented by general formula (1).
In one embodiment, the core is formed from stainless steel.
In one embodiment, the length of the portion on which the coating layer is formed is 400 mm to 2800 mm.
In one embodiment, the coating layer has a thickness of 2 μm or less.
In one embodiment, the coating layer is formed on a part of the core material, and a hydrophilic layer is formed in the part where the coating layer is not formed.
本発明によれば、有機ポリシラザンを含む被覆層を形成することにより、摺動性と折曲性とを併せもつ医療用長尺体を提供することができる。 According to the present invention, by forming a coating layer containing organic polysilazane, it is possible to provide a medical elongated body that has both sliding properties and bendability.
図1は、本発明の1つの実施形態による医療用長尺体を説明する概略図である。図1においては、医療用長尺体の代表例としてガイドワイヤが示されている。また、図2は、本発明の1つの実施形態による医療用長尺体の概略部分縦断面図である。以下、ガイドワイヤを例に取り上げて、医療用長尺体について説明する。ガイドワイヤ100は、芯材10と、芯材10の表面の少なくとも一部を覆う被覆層20とを備える。被覆層20は、有機ポリシラザンを含む。
Figure 1 is a schematic diagram illustrating a medical elongated body according to one embodiment of the present invention. In Figure 1, a guidewire is shown as a representative example of a medical elongated body. Also, Figure 2 is a schematic partial longitudinal sectional view of a medical elongated body according to one embodiment of the present invention. Below, the medical elongated body will be described using a guidewire as an example. The
1つの実施形態においては、芯材10は、基端(近位端)から先端(遠位端)に向けて細くなる形状であり得る。1つの実施形態においては、ガイドワイヤ100は、芯材10の先端に配置するコイル体30を備える。芯材10は、その先端においてコイル体30に内挿され得る。コイル体30を備えることにより、体腔内に押し込みやすく、また、座屈し難いガイドワイヤを得ることができる。なお、本明細書において、先端とは体腔内の治療領域に到達させる側の端部を意味し、基端とは先端とは反対側の端部を意味する。
In one embodiment, the
本発明のガイドワイヤは、本発明の効果が得られる限り図1に示す実施形態に限定されず、芯材の形状、コイル体の有無を含めた先端の形状等は、任意の適切な形状とすることができる。 The guidewire of the present invention is not limited to the embodiment shown in FIG. 1 as long as the effects of the present invention can be obtained, and the shape of the core material, the shape of the tip including the presence or absence of a coil body, etc. can be any appropriate shape.
1つの実施形態においては、芯材10のコイル体30に内挿されていない部分において、芯材10の表面に被覆層20が形成されている。
In one embodiment, a
上記のようなガイドワイヤは、作業者が手元部(芯材の基端部近傍)を操作することで、体腔内に挿入される。挿入されたガイドワイヤは、カテーテル等の医療器具を体腔内所定位置に誘導するように機能する。本発明によるガイドワイヤは、特に、カテーテル等の医療器具に対する摺動性に優れ、当該ガイドワイヤを用いれば、作業性よく当該医療器具を誘導することができる。また、手元部に被覆層を形成する場合、挿入作業する者による取り扱い性が向上したガイドワイヤとすることができる。本発明の医療用長尺体は、上記のような構成のガイドワイヤに限ることなく、外周に摺動面を有する長尺体に好適に用いることができる。外周面が医療用器具や生体組織と摺動する際に、摩擦抵抗が少ないために本発明の医療用長尺体の操作をすることができる。上記被覆層は、少なくとも一部が最外層として形成され、外部に露出した状態として形成されている。 The above-mentioned guidewire is inserted into a body cavity by the operator manipulating the proximal portion (near the base end of the core material). The inserted guidewire functions to guide a medical instrument such as a catheter to a predetermined position in the body cavity. The guidewire according to the present invention has excellent sliding properties, particularly with respect to medical instruments such as catheters, and the medical instrument can be guided with good workability by using the guidewire. In addition, when a coating layer is formed on the proximal portion, the guidewire can be made easier to handle by the person performing the insertion work. The medical elongated body of the present invention is not limited to the guidewire having the above-mentioned configuration, and can be suitably used for an elongated body having a sliding surface on the outer periphery. When the outer periphery surface slides against a medical instrument or biological tissue, frictional resistance is small, so that the medical elongated body of the present invention can be operated. At least a part of the coating layer is formed as the outermost layer and is formed in a state exposed to the outside.
さらに、本発明においては、上記被覆層が有機ポリシラザンから構成されていることにより、芯材の折曲性が低下し難く、折曲性に優れる医療用長尺体(例えば、ガイドワイヤ)を提供することができる。上記のガイドワイヤは、所望の経路(例えば、血管)に沿って、容易に挿入され得る。また、有機ポリシラザンから構成された被覆層は、芯材に対する密着性に優れ、脱離し難いという特徴を有する。本発明の医療用長尺体は、湾曲時においても被覆層が脱離し難いという点でも有利である。 Furthermore, in the present invention, since the coating layer is made of organic polysilazane, the bendability of the core material is unlikely to decrease, and a medical elongated body (e.g., a guidewire) with excellent bendability can be provided. The guidewire can be easily inserted along a desired path (e.g., a blood vessel). In addition, the coating layer made of organic polysilazane has the characteristic of having excellent adhesion to the core material and being difficult to come off. The medical elongated body of the present invention is also advantageous in that the coating layer is difficult to come off even when curved.
(芯材)
上記芯材の構成材料としては、金属材料が好ましく用いられる。芯材の構成材料としては、例えば、ステンレス鋼、Ni-Ti系合金、Cu-Zn系合金、コバルト系合金等が挙げられる。なかでも好ましくは、ステンレス鋼である。芯材は、材料が異なる複数種の線材を連結して構成されていてもよい。
(Core material)
As the constituent material of the core material, a metal material is preferably used. Examples of the constituent material of the core material include stainless steel, Ni-Ti alloy, Cu-Zn alloy, cobalt alloy, etc. Among them, stainless steel is preferable. The core material may be formed by connecting a plurality of types of wires made of different materials.
上記芯材の長さは、代表的には、1000mm~3000mmである。なお、1つの実施形態においては、芯材の長さは医療用長尺体の長さに相当し得る。 The length of the core material is typically 1000 mm to 3000 mm. In one embodiment, the length of the core material may correspond to the length of the medical elongated body.
上記芯材の直径は、代表的には0.1mm~1.5mmである。 The diameter of the core material is typically 0.1 mm to 1.5 mm.
(被覆層)
上記のとおり、被覆層は、有機ポリシラザンから構成される。有機ポリシラザンとは、-Si-N-を基本構造単位として有し、かつ、当該構造単位中に有機基を有するポリマーである。
(Covering layer)
As described above, the coating layer is made of an organic polysilazane, which is a polymer having —Si—N— as a basic structural unit and having an organic group in the structural unit.
有機ポリシラザンとしては、例えば、一般式(1)で表される構成単位を含むポリマーが挙げられる。
無置換若しくは置換基を有するアルキル基のアルキル基としては、例えば、メチル基、エチル基、n-プロピル基、イソプロピル基、n-ブチル基、イソブチル基、sec-ブチル基、t-ブチル基、n-ペンチル基、イソペンチル基、ネオペンチル基、n-ヘキシル基、n-ヘプチル基、n-オクチル基等の炭素数1~10のアルキル基が挙げられる。 Examples of the alkyl group of the unsubstituted or substituted alkyl group include alkyl groups having 1 to 10 carbon atoms, such as methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, t-butyl, n-pentyl, isopentyl, neopentyl, n-hexyl, n-heptyl, and n-octyl.
無置換若しくは置換基を有するアルケニル基のアルケニル基としては、例えば、ビニル基、1-プロペニル基、2-プロペニル基、1-ブテニル基、2-ブテニル基、3-ブテニル基等の炭素数2~10のアルケニル基が挙げられる。 Examples of the alkenyl group of the unsubstituted or substituted alkenyl group include alkenyl groups having 2 to 10 carbon atoms, such as vinyl, 1-propenyl, 2-propenyl, 1-butenyl, 2-butenyl, and 3-butenyl.
アルキル基およびアルケニル基の置換基としては、フッ素原子、塩素原子、臭素原子、ヨウ素原子、アルコキシシリル基、ヒドロキシル基、チオール基、エポキシ基、グリシドキシ基、(メタ)アクリロイルオキシ基、フェニル基、4-メチルフェニル基、4-クロロフェニル基等が挙げられる。 Examples of substituents for the alkyl and alkenyl groups include a fluorine atom, a chlorine atom, a bromine atom, an iodine atom, an alkoxysilyl group, a hydroxyl group, a thiol group, an epoxy group, a glycidoxy group, a (meth)acryloyloxy group, a phenyl group, a 4-methylphenyl group, and a 4-chlorophenyl group.
1つの実施形態においては、有機ポリシラザンは、一般式(2-1)で表される構成単位、(2-2)で表される構成単位および(2-3)で表される構成単位を含む。
式(2-2)中、R2-1およびR2-2はそれぞれ独立して、無置換若しくは置換基を有するアルキル基である。
式(2-3)中、R3-1は、水素原子または無置換若しくは置換基を有するアルキル基である。R3-2は、無置換若しくは置換基を有するアルキル基である。R3-3は、無置換若しくは置換基を有するアルキル基であり、良好な密着性を得るために、置換基として-Si(OR)3で表されるアルコキシシリル基(Rは1~20)を含んでいてもよい。これらの官能基は、芯材を構成する金属材料に対応させて適宜選択することができる。
In one embodiment, the organic polysilazane contains a constitutional unit represented by the general formula (2-1), a constitutional unit represented by the general formula (2-2), and a constitutional unit represented by the general formula (2-3).
In formula (2-2), R 2-1 and R 2-2 each independently represent an unsubstituted or substituted alkyl group.
In formula (2-3), R 3-1 is a hydrogen atom or an unsubstituted or substituted alkyl group. R 3-2 is an unsubstituted or substituted alkyl group. R 3-3 is an unsubstituted or substituted alkyl group, and may contain an alkoxysilyl group represented by -Si(OR) 3 (R is 1 to 20) as a substituent in order to obtain good adhesion. These functional groups can be appropriately selected in accordance with the metal material constituting the core material.
式(2-1)~(2-3)中、x、yおよびzは正の整数である。x、yおよびzの比は、(5~90):(5~90):(5~90)である。 In formulas (2-1) to (2-3), x, y, and z are positive integers. The ratio of x, y, and z is (5 to 90):(5 to 90):(5 to 90).
上記有機ポリシラザンは、ランダム共重合体であってもよく、ブロック共重合体であってもよい。 The organic polysilazane may be a random copolymer or a block copolymer.
有機ポリシラザンの数平均分子量は、好ましくは500~4500である。このような範囲であれば、摺動性および折曲性に優れる医療用長尺体を得ることができる。 The number average molecular weight of the organic polysilazane is preferably 500 to 4500. Within this range, a medical elongated body with excellent sliding properties and bendability can be obtained.
上記被覆層の厚みは、各種物性を満たすものであれば、好ましくは10μm以下、より好ましくは5μm以下、さらに好ましくは2μm以下とすることで折曲性に優れた医療用長尺体を得ることができる。上記被覆層の厚みは、公知の方法により層形成を行う場合には、例えば、好ましくは0.1μm~10μmであり、より好ましくは0.5μm~5μmであり、さらに好ましくは1μm~2μmである。このような範囲であれば、折曲性に優れる医療用長尺体を得ることができる。 As long as the thickness of the coating layer satisfies various physical properties, it is preferable that the thickness be 10 μm or less, more preferably 5 μm or less, and even more preferably 2 μm or less, so that a medical elongated body with excellent bendability can be obtained. When the layer is formed by a known method, the thickness of the coating layer is, for example, preferably 0.1 μm to 10 μm, more preferably 0.5 μm to 5 μm, and even more preferably 1 μm to 2 μm. If it is within such a range, a medical elongated body with excellent bendability can be obtained.
上記被覆層が形成された部分の長さは、好ましくは400mm~2800mmであり、より好ましくは1300mm~2000mmである。また、被覆層が形成された部分の長さは、芯材の長さに対して、好ましくは8%~100%であり、より好ましくは8%~60%であり、さらに好ましくは10%~50%であり、特に好ましくは15%~40%である。なお、被覆層が形成された部分においては、芯材の全周にわたり被覆層が形成されていることが好ましい。また、被覆層が形成されていない部分においては、芯材の表面に親水層が形成されていてもよい。親水層の詳細は後述する。 The length of the portion where the coating layer is formed is preferably 400 mm to 2800 mm, more preferably 1300 mm to 2000 mm. The length of the portion where the coating layer is formed is preferably 8% to 100% of the length of the core material, more preferably 8% to 60%, even more preferably 10% to 50%, and particularly preferably 15% to 40%. In the portion where the coating layer is formed, it is preferable that the coating layer is formed over the entire circumference of the core material. In the portion where the coating layer is not formed, a hydrophilic layer may be formed on the surface of the core material. Details of the hydrophilic layer will be described later.
上記被覆層は、任意の適切な方法により形成することができる。1つの実施形態においては、有機ポリシラザンを含む被覆層形成用組成物を、芯材の所定の領域に塗工することにより、被覆層が形成される。上記被覆層形成用組成物は、有機ポリシラザンを所定の溶媒に溶解して調製され得る。 The coating layer can be formed by any suitable method. In one embodiment, a coating layer is formed by applying a coating layer-forming composition containing an organic polysilazane to a predetermined area of the core material. The coating layer-forming composition can be prepared by dissolving an organic polysilazane in a predetermined solvent.
上記溶媒としては、有機ポリシラザンを溶解させ得る限り、任意の適切な溶媒が用いられる。当該溶媒としては、例えば、プロパン、ブタン、イソブタン、ペンタン、2-メチルブタン、ネオペンタン、シクロペンタン、ヘキサン、2-メチルペンタン、3-メチルペンタン、ヘプタン、2-メチルヘキサン、3-メチルヘキサン、シクロヘキサン、オクタン、イソオクタン、ノナン、イソノナン、デカン等が挙げられる。 As the above-mentioned solvent, any suitable solvent can be used as long as it can dissolve the organic polysilazane. Examples of the solvent include propane, butane, isobutane, pentane, 2-methylbutane, neopentane, cyclopentane, hexane, 2-methylpentane, 3-methylpentane, heptane, 2-methylhexane, 3-methylhexane, cyclohexane, octane, isooctane, nonane, isononane, decane, etc.
上記被覆層形成用組成物における有機ポリシラザンの濃度は、好ましくは5重量%~40重量%であり、このような範囲であれば、均一性よく好ましい厚さの被覆層を形成することができる。 The concentration of the organic polysilazane in the coating layer-forming composition is preferably 5% to 40% by weight. Within this range, a coating layer of a uniform thickness can be formed.
上記被覆層形成用組成物の粘度は、コーティング可能な粘度であれば特に限定されるものではない。被覆層形成用組成物の粘度を適切に調整することにより、良好な被覆層を形成することができる。 The viscosity of the coating layer-forming composition is not particularly limited as long as it is a coating-compatible viscosity. By appropriately adjusting the viscosity of the coating layer-forming composition, a good coating layer can be formed.
上記被覆層形成用組成物の塗布方法としては、任意の適切な方法が採用される。代表的には、ディップコート法、スプレーコート法や流し塗り法などが採用される。 Any suitable method may be used to apply the coating layer-forming composition. Typically, a dip coating method, a spray coating method, or a flow coating method may be used.
医療用長尺体は、好ましくは、被覆層形成用組成物を芯材に塗布した後、加熱処理が行われる。加熱処理により、溶剤が揮発し、また、塗布層が硬化して、芯材に密着した被覆層が形成される。 The medical elongated body is preferably subjected to a heat treatment after the coating layer forming composition is applied to the core material. The heat treatment causes the solvent to volatilize and the coating layer to harden, forming a coating layer that adheres closely to the core material.
上記のようにして形成される被覆層は、芯材のOH基と有機ポリシラザンのSiH基との脱水反応;芯材のOH基と有機ポリシラザンのNH基との脱アンモニア反応;または有機ポリシラザンのSiN基が加水分解(例えば、雰囲気中の水分による加水分解)した後、芯材のOH基と加水分解により生じたシラノール基との脱水反応;等の作用により、芯材に密着し得る。 The coating layer formed as described above can adhere to the core material by the action of a dehydration reaction between the OH groups of the core material and the SiH groups of the organic polysilazane; a deammonia reaction between the OH groups of the core material and the NH groups of the organic polysilazane; or, after the SiN groups of the organic polysilazane are hydrolyzed (for example, hydrolysis due to moisture in the atmosphere), a dehydration reaction between the OH groups of the core material and the silanol groups generated by hydrolysis.
被覆層の形成に際しては、芯材に任意の適切な表面処理を行ってもよい。例えば、芯材をカップリング処理した後に、被覆層形成用組成物を該芯材に塗工してもよい。カップリング処理に用いられるカップリング剤としては、例えば、エポキシ末端カップリング剤、アミノ基含有カップリング剤、メタクリル基含有カップリング剤、チオール基含有カップリング剤等が挙げられる。 When forming the coating layer, the core material may be subjected to any suitable surface treatment. For example, the core material may be subjected to a coupling treatment, and then the composition for forming the coating layer may be applied to the core material. Examples of coupling agents used in the coupling treatment include epoxy-terminated coupling agents, amino group-containing coupling agents, methacryl group-containing coupling agents, and thiol group-containing coupling agents.
上記被覆層形成用組成物をSUS304板に塗工して塗工層を形成した際の該塗工層の純水に対する接触角は、好ましくは100°~120°であり、より好ましくは105°~115°である。このような塗工層を形成し得る被覆層形成用組成物を用いて被覆層を形成すれば、摺動性に優れる医療用長尺体を得ることができる。 When the above-mentioned coating layer forming composition is applied to a SUS304 plate to form a coating layer, the contact angle of the coating layer with pure water is preferably 100° to 120°, and more preferably 105° to 115°. If a coating layer is formed using a coating layer forming composition capable of forming such a coating layer, a medical elongated body with excellent sliding properties can be obtained.
上記被覆層形成用組成物をSUS304板に塗工して塗工層を形成した際の該塗工層の静摩擦係数は、好ましくは0.05~0.15である。このような塗工層を形成し得る被覆層形成用組成物を用いて被覆層を形成すれば、摺動性に優れる医療用長尺体を得ることができる。 When the above-mentioned coating layer forming composition is applied to a SUS304 plate to form a coating layer, the static friction coefficient of the coating layer is preferably 0.05 to 0.15. If a coating layer is formed using a coating layer forming composition capable of forming such a coating layer, a medical elongated body with excellent sliding properties can be obtained.
上記被覆層形成用組成物をSUS304板に塗工して塗工層を形成した際の該塗工層の動摩擦係数は、好ましくは0.01~0.12である。このような塗工層を形成し得る被覆層形成用組成物を用いて被覆層を形成すれば、摺動性に優れる医療用長尺体を得ることができる。 When the above-mentioned coating layer forming composition is applied to a SUS304 plate to form a coating layer, the coating layer preferably has a dynamic friction coefficient of 0.01 to 0.12. By forming a coating layer using a coating layer forming composition capable of forming such a coating layer, a medical elongated body with excellent sliding properties can be obtained.
上記被覆層形成用組成物をSUS304板に塗工して塗工層を形成した際の該塗工層の鉛筆硬度は、例えば、6B未満である。鉛筆硬度が良好であることにより、摺動性に優れる医療用長尺体を得ることができる。さらに、摺動性を維持しつつも、被覆層が脱離し難い医療用長尺体を得ることができる。 When the coating layer is formed by applying the above-mentioned coating layer forming composition to a SUS304 plate, the pencil hardness of the coating layer is, for example, less than 6B. By having a good pencil hardness, a medical elongated body having excellent sliding properties can be obtained. Furthermore, a medical elongated body in which the coating layer is difficult to come off while maintaining sliding properties can be obtained.
(親水層)
1つの実施形態においては、上記のとおり、芯材の被覆層が形成されていない部分には、該芯材の表面に親水層が形成される。また、医療用長尺体(例えば、ガイドワイヤ)がコイル体を有する場合、コイル体の表面に親水層が形成されていてもよい。親水層を形成することにより、体腔内での摺動性(特に治療領域近傍での摺動性)に優れる医療用長尺体(例えば、ガイドワイヤ)を得ることができる。
(Hydrophilic Layer)
In one embodiment, as described above, a hydrophilic layer is formed on the surface of the core material in the portion where the coating layer is not formed. In addition, when the medical elongated body (e.g., guidewire) has a coil body, a hydrophilic layer may be formed on the surface of the coil body. By forming a hydrophilic layer, a medical elongated body (e.g., guidewire) having excellent slidability in a body cavity (especially slidability near a treatment area) can be obtained.
親水層は、任意の適切な親水性材料を芯材に塗工して形成することができる。親水性材料としては、例えば、セルロース系、ポリエチレンオキサイド系、無水マレイン酸系、アクリルアミド系等の高分子材料が挙げられる。 The hydrophilic layer can be formed by coating the core with any suitable hydrophilic material. Examples of hydrophilic materials include polymeric materials such as cellulose-based, polyethylene oxide-based, maleic anhydride-based, and acrylamide-based materials.
上記親水層が形成された部分の長さは、好ましくは100mm~1000mmであり、より好ましくは200mm~600mmである。また、親水層が形成された部分の長さは、芯材の長さに対して、好ましくは40%~92%であり、より好ましくは50%~90%であり、さらに好ましくは60%~85%である。 The length of the portion where the hydrophilic layer is formed is preferably 100 mm to 1000 mm, and more preferably 200 mm to 600 mm. The length of the portion where the hydrophilic layer is formed is preferably 40% to 92% of the length of the core material, more preferably 50% to 90%, and even more preferably 60% to 85%.
(コイル体)
上記コイル体は、任意の適切な構造であり得る。コイル体は、例えば、任意の適切な線材を巻回して構成され得る。コイル体を構成する線材の材料は、特に限定されず、放射線造影材でもよく、放射線非造影材でもよい。放射線造影材としては、白金、白金合金(例えばPt/Ir=93/7)、金、金-銅合金、タングステン、タンタルなどのX線に対する造影性が良好な材料が挙げられる。放射線非造影材としては、ステンレス(例えばSUS316、SUS304)など等が挙げられる。コイル体には、親水処理が施されていてもよい。
(Coil body)
The coil body may have any suitable structure. The coil body may be formed, for example, by winding any suitable wire. The material of the wire constituting the coil body is not particularly limited, and may be a radiopaque material or a non-radiopaque material. Examples of radiopaque materials include materials with good contrast properties to X-rays, such as platinum, platinum alloys (e.g., Pt/Ir=93/7), gold, gold-copper alloys, tungsten, and tantalum. Examples of non-radiopaque materials include stainless steel (e.g., SUS316, SUS304), and the like. The coil body may be subjected to a hydrophilic treatment.
本発明の医療用長尺体は、金属表面を有する医療用具に用いることができ、特に、摺動性と折曲性とが要求されるガイドワイヤや穿刺針などの、湾曲が可能とされた体内挿入部または湾曲部を有する体内挿入部を有する医療用具に好適である。 The medical elongated body of the present invention can be used in medical devices with a metal surface, and is particularly suitable for medical devices with a curved or bendable internal insertion portion, such as guidewires and puncture needles, which require slidability and bendability.
以下、実施例によって本発明を具体的に説明するが、本発明はこれら実施例によって限定されるものではない。また、実施例において、特に明記しない限り、「部」および「%」は重量基準である。 The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples. In the examples, "parts" and "%" are by weight unless otherwise specified.
[実施例1]
SUS304から構成される線材を芯材として用い、下記構造式(3-1)~(3-3)で表される構造単位を有する有機ポリシラザンを含む炭化水素系溶剤に溶解して調製された被覆層形成用組成物A(有機ポリシラザン濃度:約20重量%)を該芯材に塗布し、約110~130℃で約2時間加熱して、芯材表面に厚さ1μmの被覆層を形成させてガイドワイヤを想定した評価サンプル(1)を作製した。評価サンプル(1)について、下記の評価方法により、防汚性、鉛筆硬度、および折曲性を評価した。結果を表1に示す。
塗工層に油性インク(ZEBRA社製、商品名「ハイマッキー赤」)を連続5回塗り込み、インクの弾き性を目視及びマイクロスコープで確認した。
また、上記塗り込み後1分間経過した後に、ワイパーにより、インクが拭き取り可能であるかを確認した。
弾き性については、連続5回の重ね塗り後のインクの塗り跡に、塗布位置よりもインキが収縮するなどの、インキの弾きが見られたものを○とし、インキの弾きがないものを×とした。
<鉛筆硬度>
JIS K 5400-5-4に準じて、塗工層の鉛筆硬度を測定した。鉛筆硬度が6B以下のものを○とし、鉛筆硬度が6Bより硬いものを×とした。
<折曲性>
評価サンプル(1)を任意の一か所から折り曲げて、二つ折り状となるように、約180°に1回折り曲げた。折り曲げた状態で放置後、折り曲げた部位の被膜状態を市販のマイクロスコープで拡大して、被膜の割れや剥離の有無を目視により観察した。
[Example 1]
A wire made of SUS304 was used as a core material, and a coating layer-forming composition A (organic polysilazane concentration: about 20% by weight) was prepared by dissolving an organic polysilazane having structural units represented by the following structural formulas (3-1) to (3-3) in a hydrocarbon solvent. The core material was then coated with the coating layer-forming composition A and heated at about 110 to 130° C. for about 2 hours to form a coating layer having a thickness of 1 μm on the surface of the core material, thereby preparing an evaluation sample (1) intended as a guidewire. The evaluation sample (1) was evaluated for antifouling properties, pencil hardness, and bendability by the following evaluation methods. The results are shown in Table 1.
An oil-based ink (manufactured by ZEBRA, product name "Hi-Mackie Red") was applied to the coating layer five times in succession, and the ink repellency was confirmed visually and with a microscope.
After one minute had elapsed since the ink was applied, it was confirmed whether the ink could be wiped off with a wiper.
Regarding repellency, a case in which the ink was repellent, such as the ink shrinking from the applied position at the ink application site after five consecutive applications, was marked with an ◯, and a case in which the ink was not repellent was marked with an ×.
<Pencil hardness>
The pencil hardness of the coating layer was measured according to JIS K 5400-5-4. Pencil hardness of 6B or less was marked as ◯, and pencil hardness of more than 6B was marked as ×.
<Bendability>
The evaluation sample (1) was folded at an arbitrary position, and folded once at about 180° so as to be folded in half. After leaving it in the folded state, the coating state of the folded portion was magnified with a commercially available microscope, and the presence or absence of cracks or peeling of the coating was visually observed.
また、実施例1で用いた被覆層形成用組成物AをSUS板(市販品)に塗布して、評価サンプル(1)と同様の被膜形成を行い、評価サンプル(2)を得た。得られた評価サンプル(2)について、下記の評価方法により、接触角(純水)と摩擦係数とを測定した。結果を表2に示す。
<接触角(純水)>
協和界面科学社製の商品名「DropMaster500」を用いて、純水(液量2μL)の接触角を測定した。
<摩擦係数>
新東化学株式会社製の「表面性測定機トライボステーション TYPE:32」を用い、下記の条件にて、塗工層の静摩擦係数および動摩擦係数を測定した。
(摩擦係数測定条件)
荷重:100g
圧子:平面圧子(10mm×10mm)
移動速度:30mm/min(静摩擦係数)、600mm/min(動摩擦係数)
In addition, the composition A for forming a coating layer used in Example 1 was applied to a SUS plate (commercially available product) to form a coating similar to that of the evaluation sample (1), to obtain an evaluation sample (2). The contact angle (pure water) and friction coefficient of the obtained evaluation sample (2) were measured by the following evaluation method. The results are shown in Table 2.
<Contact angle (pure water)>
The contact angle of pure water (liquid volume: 2 μL) was measured using a product name "DropMaster 500" manufactured by Kyowa Interface Science Co., Ltd.
<Coefficient of friction>
The static friction coefficient and dynamic friction coefficient of the coating layer were measured under the following conditions using a "Surface Property Measuring Instrument Tribostation Type: 32" manufactured by Shinto Chemical Co., Ltd.
(Friction coefficient measurement conditions)
Load: 100g
Indenter: flat indenter (10 mm x 10 mm)
Movement speed: 30 mm/min (static friction coefficient), 600 mm/min (dynamic friction coefficient)
〔比較例〕
被覆層としてPTFE層を備える市販のガイドワイヤを入手し、評価サンプル(1)と同様に、防汚性、鉛筆硬度、および折曲性を評価した。結果を表1に示す。
Comparative Example
A commercially available guidewire having a PTFE layer as a coating layer was obtained, and the antifouling property, pencil hardness, and bendability were evaluated in the same manner as in the evaluation sample (1). The results are shown in Table 1.
[結果]
実施例1で得られた評価サンプル(1)は、折り曲げ箇所を目視およびマイクロスコープにて観察したところ、被覆層の割れ、脱離は確認されず、被覆層は優れた密着性で形成されていることが分かった。また、評価サンプル(1)は、防汚性と鉛筆硬度も良好であった。これに対して、比較例1の市販品は、防汚性と鉛筆硬度が良好であったが、折り曲げ箇所の被覆層が剥がれてしまい、折曲性は不良であった。
実施例1の被覆層形成用組成物Aについては、評価サンプル(2)について、接触角(純水)も108°と優れた撥水性を有し、静摩擦係数が0.095、動摩擦係数0.057と優れた摺動性を有していた。つまり、実施例1の被覆層形成用組成物Aより得られた医療用長尺体は、体腔内での挿入性に優れていることがわかる。
このような被覆層形成用組成物により被覆層を形成すれば、防汚性および鉛筆硬度が優れ、更に折曲性にも優れた医療用長尺体を得ることができる。本発明の医療用長尺体は、PTFEにより被覆された医療用長尺体と同等あるいは同等以上の摺動性および防汚性を有しながら、実施例1で示すように、被覆層の割れ、脱離等なく折曲性に優れる点で有利である。
[result]
When the bending portion of the evaluation sample (1) obtained in Example 1 was observed visually and with a microscope, no cracks or detachment of the coating layer was confirmed, and it was found that the coating layer was formed with excellent adhesion. In addition, the evaluation sample (1) also had good antifouling properties and pencil hardness. In contrast, the commercially available product of Comparative Example 1 had good antifouling properties and pencil hardness, but the coating layer at the bending portion peeled off, and the bending property was poor.
Regarding the composition A for forming a coating layer in Example 1, the evaluation sample (2) had excellent water repellency with a contact angle (pure water) of 108°, and had excellent sliding properties with a static friction coefficient of 0.095 and a dynamic friction coefficient of 0.057. In other words, it is found that the medical elongated body obtained from the composition A for forming a coating layer in Example 1 has excellent insertability in a body cavity.
By forming a coating layer using such a composition for forming a coating layer, a medical elongated body having excellent antifouling properties and pencil hardness, as well as excellent bendability, can be obtained. The medical elongated body of the present invention has the same or better sliding properties and antifouling properties as a medical elongated body coated with PTFE, and is advantageous in that it has excellent bendability without cracking or detachment of the coating layer, as shown in Example 1.
10 芯材
20 被覆層
30 コイル体
100 医療用長尺体(ガイドワイヤ)
10
Claims (8)
該被覆層が、有機ポリシラザンを含む、
ガイドワイヤ。 The core material has a coating layer that covers at least a part of a surface of the core material.
The coating layer comprises an organic polysilazane.
Guidewire .
式(1)中、R1、R2およびR3はそれぞれ独立に水素原子、無置換若しくは置換基を有するアルキル基、無置換若しくは置換基を有するアルケニル基を表し、R1、R2、R3のいずれか1つは水素原子以外であり、nは正の整数である。 The guidewire according to any one of claims 1 to 6 , wherein the organic polysilazane contains a constitutional unit represented by general formula (1):
In formula (1), R1, R2, and R3 each independently represent a hydrogen atom, an unsubstituted or substituted alkyl group, or an unsubstituted or substituted alkenyl group, one of R1, R2, and R3 is other than a hydrogen atom, and n is a positive integer.
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