WO2010090097A1 - Cathéter antibactérien et son procédé de fabrication - Google Patents

Cathéter antibactérien et son procédé de fabrication Download PDF

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Publication number
WO2010090097A1
WO2010090097A1 PCT/JP2010/050957 JP2010050957W WO2010090097A1 WO 2010090097 A1 WO2010090097 A1 WO 2010090097A1 JP 2010050957 W JP2010050957 W JP 2010050957W WO 2010090097 A1 WO2010090097 A1 WO 2010090097A1
Authority
WO
WIPO (PCT)
Prior art keywords
main body
antibacterial agent
antibacterial
catheter
tip
Prior art date
Application number
PCT/JP2010/050957
Other languages
English (en)
Japanese (ja)
Inventor
直人 竹村
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2010549437A priority Critical patent/JPWO2010090097A1/ja
Publication of WO2010090097A1 publication Critical patent/WO2010090097A1/fr

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Classifications

    • 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
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir

Definitions

  • JP-A-5-220216 (Claims 1 to 4)
  • JP-A-11-290449 (Claims 1 to 5)
  • the antibacterial catheter according to claim 3 further includes a tube-like distal end portion that is joined to the distal end side of the main body portion and is more flexible than the main body portion in the antibacterial catheter,
  • the tip portion is made of a polymer material containing an antibacterial agent, and the antibacterial agent exists substantially uniformly from the inner surface to the outer surface of the tip portion.
  • the amount of the antibacterial agent eluted from the main body part at the time of use can be reduced at the initial stage. Is maintained at a high level for a long time.
  • the polymer material constituting the tip portion is swollen by the swellable organic solvent, and the swollen tip portion (polymer material) is impregnated with the antibacterial agent.
  • the impregnation part of the antibacterial agent in the tip part from the inner surface to the outer surface, the antibacterial agent exists substantially uniformly from the inner surface to the outer surface of the tip part.
  • the growth or infection of bacteria that have entered the body through the skin piercing portion and lumen of the catheter can be suppressed over a long period of time, and the antibacterial activity of the catheter can be maintained at a high level over a long period of time. Moreover, antithrombogenicity is imparted to the catheter.
  • a catheter that does not deform at the tip is manufactured.
  • a catheter is manufactured that is unlikely to have a site with insufficient antibacterial properties, that is, that does not cause unevenness in antibacterial properties.
  • a catheter provided with antithrombogenicity is manufactured.
  • the polymer material used for the main body 2 a polymer material conventionally used for catheters can be used.
  • various resins such as polyvinyl chloride, polyurethane, polyamide, polyolefin, polyester, silicon resin, or a resin composition obtained by combining two or more of these can be used.
  • the polymer material may contain a contrast agent for the purpose of ensuring the contrast in the body of the main body 2.
  • the contrast agent inorganic compounds such as barium sulfate, barium carbonate, bismuth oxide, bismuth subcarbonate and tungsten are used.
  • the amount of the antibacterial agent 3 eluted from the main body 2 is long-term.
  • the antibacterial properties of the catheter 1 can be maintained at a high level over a long period of time.
  • the elution amount in the initial stage of the antibacterial agent 3 eluted from the main body 2 and the distal end portion 4 can be reduced, the elution amount can be maintained at a high level for a long time, and the antibacterial property of the catheter 1 can be maintained at a high level for a long time.
  • the catheter 1 according to the present invention may be one in which the outer surfaces of the main body 2 and the distal end 4 are coated with an antithrombotic material.
  • the antithrombogenic material coated on the main body portion 2 and the tip portion 4 is made of a biological material or a non-biological material mentioned as the antithrombogenic material coated on the main body portion 2.
  • the same kind of antithrombogenic material may be used for the tip 2 and the tip portion 4, or different kinds of antithrombotic materials may be used.
  • the main body 2 is immersed in an antibacterial agent solution, and the inner surface vicinity 2a and the outer surface vicinity 2b of the main body 2 are impregnated with the antibacterial agent 3, whereby the inner surface vicinity 2a of the main body 2 and the outer surface A predetermined amount of the antibacterial agent 3 is unevenly distributed in the vicinity of the surface 2b.
  • the amount of the antibacterial agent 3 eluted from the main body 2 is maintained at a high level over a long period of time, and the antibacterial property of the catheter 1 can be maintained at a high level over a long period of time.
  • a method of coating a solution in which the antithrombotic material is dissolved by a dipping method, a spray method, or the like is used.
  • the solvent that dissolves the antithrombotic material include organic solvents such as acetone, methanol, ethanol, isopropanol, tetrahydrofuran, N, N-dimethylformamide, N, N-dimethylacetamide, and cyclohexanone.
  • the hub 6, the connection tube 7 and the outer surface of the connector 8 may be coated with an antithrombotic material.
  • the main body 2 and the tip 4 are separately immersed in the antibacterial agent solution.
  • the immersion conditions for example, the kind of antibacterial agent solution, immersion time
  • tip part 4 comprised more flexibly than the main-body part 2 are not influenced by the immersion conditions of the main-body part 2, in other words, the main-body part 2 and The tip portion 4 can be immersed in the antibacterial agent solution under different immersion conditions.
  • the immersion condition of the distal end portion 4 does not become excessive, and the distal end portion 4 does not swell excessively and lacks flexibility, so that deformation of the distal end portion 4 (catheter 1) can be prevented.
  • the inner needle is removed, the guide wire is introduced into the blood vessel with the mantle remaining, and the guide wire is removed after the mantle is removed.
  • a central venous catheter is inserted and the guide wire is removed (Seldinger method).
  • any method can be preferably used.
  • the catheter according to the present invention can be preferably used not only for central venous catheters but also for catheters inserted and placed in the body, such as urethral catheters and gastric tube catheters.

Abstract

L'invention concerne un cathéter antibactérien (1) qui est caractérisé en ce qu'il comprend un corps principal en forme de tube (2) composé d'un matériau polymère contenant un agent antibactérien (3), l'agent antibactérien (3) étant situé à proximité de la surface intérieure et à proximité de la surface extérieure du corps principal (2). L'invention concerne également un procédé de fabrication du cathéter antibactérien (1), qui est caractérisé en ce qu'il comprend : une première étape de dispersion de l'agent antibactérien (3) dans un solvant organique gonflable pour préparer une solution d'agent antibactérien ; et une seconde étape d'immersion du corps principal (2) dans la solution d'agent antibactérien pour imprégner la proximité de la surface intérieure et la proximité de la surface extérieure du corps principal (2) avec l'agent antibactérien (3).
PCT/JP2010/050957 2009-02-09 2010-01-26 Cathéter antibactérien et son procédé de fabrication WO2010090097A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2010549437A JPWO2010090097A1 (ja) 2009-02-09 2010-01-26 抗菌性カテーテルおよびその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2009-027150 2009-02-09
JP2009027150 2009-02-09

Publications (1)

Publication Number Publication Date
WO2010090097A1 true WO2010090097A1 (fr) 2010-08-12

Family

ID=42542000

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2010/050957 WO2010090097A1 (fr) 2009-02-09 2010-01-26 Cathéter antibactérien et son procédé de fabrication

Country Status (2)

Country Link
JP (1) JPWO2010090097A1 (fr)
WO (1) WO2010090097A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011118680A1 (fr) * 2010-03-26 2011-09-29 テルモ株式会社 Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03503375A (ja) * 1987-11-23 1991-08-01 コロラド　バイオメディカル　インコーポレイテッド 抗菌活性作用を行う医用装置、それに抗菌剤を注入する方法及び抗菌性組成物
JPH0564660A (ja) * 1991-05-21 1993-03-19 Sumitomo Bakelite Co Ltd 医療用カテーテルおよびその作製方法
JP2003506511A (ja) * 1999-07-30 2003-02-18 ヨット・ペーター・グッゲンビヒラー 改良された長期効能を有する抗菌性プラスチック体の製造法
JP2004523267A (ja) * 2000-12-22 2004-08-05 ザ トラスティース オブ コロンビア ユニバーシティ イン ザ シティ オブ ニューヨーク 抗菌性医用装置
JP2008508321A (ja) * 2004-07-30 2008-03-21 アクリメッド インコーポレイテッド 抗菌銀組成物

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4185226B2 (ja) * 1999-11-19 2008-11-26 テルモ株式会社 湿潤時に表面が潤滑性を発現する医療用具およびその製造方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03503375A (ja) * 1987-11-23 1991-08-01 コロラド　バイオメディカル　インコーポレイテッド 抗菌活性作用を行う医用装置、それに抗菌剤を注入する方法及び抗菌性組成物
JPH0564660A (ja) * 1991-05-21 1993-03-19 Sumitomo Bakelite Co Ltd 医療用カテーテルおよびその作製方法
JP2003506511A (ja) * 1999-07-30 2003-02-18 ヨット・ペーター・グッゲンビヒラー 改良された長期効能を有する抗菌性プラスチック体の製造法
JP2004523267A (ja) * 2000-12-22 2004-08-05 ザ トラスティース オブ コロンビア ユニバーシティ イン ザ シティ オブ ニューヨーク 抗菌性医用装置
JP2008508321A (ja) * 2004-07-30 2008-03-21 アクリメッド インコーポレイテッド 抗菌銀組成物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, vol. 141, 2004, Columbus, Ohio, US; abstract no. 124925E *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011118680A1 (fr) * 2010-03-26 2011-09-29 テルモ株式会社 Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien

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