WO2012005396A1 - Cathéter et procédé de fabrication de celui-ci - Google Patents

Cathéter et procédé de fabrication de celui-ci Download PDF

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Publication number
WO2012005396A1
WO2012005396A1 PCT/KR2010/004474 KR2010004474W WO2012005396A1 WO 2012005396 A1 WO2012005396 A1 WO 2012005396A1 KR 2010004474 W KR2010004474 W KR 2010004474W WO 2012005396 A1 WO2012005396 A1 WO 2012005396A1
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WO
WIPO (PCT)
Prior art keywords
catheter
present
photosensitizer
photosensitive agent
porphyrin
Prior art date
Application number
PCT/KR2010/004474
Other languages
English (en)
Korean (ko)
Inventor
김용록
정석훈
왕강균
김다희
김봉진
Original Assignee
연세대학교 산학협력단
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 연세대학교 산학협력단 filed Critical 연세대학교 산학협력단
Priority to CN2010800679722A priority Critical patent/CN103068432A/zh
Priority to PCT/KR2010/004474 priority patent/WO2012005396A1/fr
Publication of WO2012005396A1 publication Critical patent/WO2012005396A1/fr

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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
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • 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

  • the present invention relates to a catheter and a method of manufacturing the same, and more particularly, having excellent physical properties such as stability against temperature change and pH change and high photophysical properties, and activity generated by excitation of a photosensitive agent according to light energy irradiation.
  • the present invention relates to a photofunctional autosterilization catheter capable of autoclaving through oxygen and preventing biofilm formation by bacteria, and a method of manufacturing the same.
  • catheters In general, catheters (catheter) is used for medical purposes and refers to a comprehensive reference to all means that are directly inserted into the body, it is used for various purposes such as vascular injection, urethral insertion, airway insertion, laparoscopic surgery.
  • various external chemicals are used to clean and reuse the outer surface and the inside of the body using various chemicals to prevent a body infection that may be caused by insertion of a portion of the tubular body into a blood vessel of the body. Doing.
  • washing liquid has a problem that it is very difficult to wash the inside of the main body through the washing liquid even if it is harmless to the human body, and there is a problem that the cost required for washing is large.
  • urinary catheter causes an ascending infection of pathogens colonized in the catheter inserted into the urethra.
  • urethral catheter The insertion of urethral catheter is the cause of pathogenic urinary tract infection (nosocomial UTI). Specifically, the insertion of short-term urethral catheter is associated with fever and acute pyelonephritis. It is known to cause complications such as chronic renal inflammation.
  • Escherichia coli is the most common causative agent of urinary tract infections.
  • Pseudomonas aeruginosa is the most common causative bacterium .
  • Enterococcus spp. Staphylococcus aureus is also a common causative agent.
  • isolates of urinary tract infections are resistant to various antibacterial agents such as penicillin, narrow and wide range cephalosporin, carbapenem, fluoroquinolone, aminoglycoside, and Gram-negative bacillus such as E. coli and P. aeruginosa .
  • ESBL metallo- ⁇ -lactamase and other mechanisms are commonly resistant to a wide range of cephlosporin, carbapenem.
  • the present invention is to solve the above problems, the object of the present invention is excellent physical properties such as stability against temperature changes and pH changes and high photophysical properties, by excitation of a photosensitive agent according to light energy irradiation Self-sterilization can be performed through the generated active oxygen, and to provide a photo-functional self-sterilization catheter and a manufacturing method thereof that can prevent the biofilm formation by bacteria.
  • a catheter that includes a photosensitizer supported on an inner circumferential surface of the body.
  • the body is preferably formed of silicone, latex and mixtures thereof, and the photosensitive agent is selected from the group consisting of porphyrin (H 2 TTP), phthalocyanine, dye (dye), porphyrin substituent and phthalocyanine substituent. It is preferably at least one selected.
  • a method of manufacturing a catheter comprising a main body and a photosensitive agent supported in the main body
  • a catheter manufacturing method comprising the step of supporting the photosensitive agent solution on the inner wall of the catheter body.
  • the catheter and its manufacturing method according to the present invention has excellent physical properties such as stability against temperature change and pH change and high photophysical properties, and is generated by excitation of a photosensitive agent according to light energy irradiation. Active oxygen can autoclave and prevent biofilm formation by bacteria.
  • FIG. 1 is a conceptual diagram showing a manufacturing process of the catheter according to an embodiment of the present invention.
  • Figure 2 is a conceptual diagram showing the autoclaving process of the catheter according to an embodiment of the present invention.
  • Figure 3 is a photograph using a confocal microscope of the catheter according to an embodiment of the present invention.
  • Figure 4 is a graph showing the absorption (left) / fluorescence (right) spectrum of the catheter according to an embodiment of the present invention.
  • 5 is a graph showing the decomposition efficiency of organics according to the concentration of porphyrin constituting the catheter according to an embodiment of the present invention.
  • Figure 6 is a graph showing the photocatalytic effect of the pH change of the catheter according to an embodiment of the present invention.
  • Figure 7 is a graph showing the photocatalytic effect of the temperature change of the catheter according to an embodiment of the present invention.
  • Figure 8 is a graph showing the stability of the catheter when tested in vivo similar conditions according to an embodiment of the present invention.
  • FIG. 9 is a graph showing the stability of the catheter according to an embodiment of the present invention.
  • FIG. 10 is a graph showing the antibacterial effect of E. coli catheter according to an embodiment of the present invention.
  • 11 is a graph showing the antibacterial effect of the catheter according to Staphylococcus aureus according to an embodiment of the present invention.
  • FIG. 12 is a graph showing the antibacterial effect of Pseudomonas aeruginosa of the catheter according to an embodiment of the present invention.
  • Figure 13 is a graph showing the antibacterial effect of the catheter on Candida albicans according to an embodiment of the present invention.
  • Figure 14 is a photograph showing the antibacterial effect of the catheter Escherichia coli according to an embodiment of the present invention.
  • 15 is a photograph showing the antibacterial effect of Staphylococcus aureus of the catheter according to an embodiment of the present invention.
  • 16 is a photograph showing the antibacterial effect of Pseudomonas aeruginosa of the catheter according to an embodiment of the present invention.
  • Figure 17 is a photograph showing the antibacterial effect of the catheter for Candida albicans according to an embodiment of the present invention.
  • the present invention relates to a catheter comprising a tubular body and a photosensitizer carried on the inner circumferential surface of the body.
  • the main body may be formed of silicone, latex, and mixtures thereof, and the photosensitive agent is selected from the group consisting of porphyrin (H 2 TTP), phthalocyanine, dye (dye), porphyrin substituent and phthalocyanine substituent. There may be more than one.
  • the catheter according to an embodiment of the present invention may be used for various purposes, such as for vascular injection, urethra insertion, airway insertion, laparoscopy, etc., but the catheter according to an embodiment of the present invention may be used for convenience of description.
  • the photosensitive agent constituting the catheter according to an embodiment of the present invention will be described as an example of porphyrin.
  • FIG. 1 is a conceptual diagram showing a catheter manufacturing process according to an embodiment of the present invention
  • Figure 2 is a conceptual diagram showing a self sterilization process of the catheter according to an embodiment of the present invention.
  • the urethral catheter according to an embodiment of the present invention includes a tubular body and porphyrin (H 2 TPP) supported on the inner circumferential surface of the body.
  • H 2 TPP porphyrin
  • the main body is not limited thereto, but may be formed of, for example, silicon, a silicon-latex mixture, or latex, and has a flow surface of a fluid having an inner surface and an outer surface and therein for injecting drugs therein. Is formed.
  • the porphyrin H 2 TPP is a photosensitive material, and when light energy is irradiated, active oxygen is generated through electron transfer or energy transfer to oxygen.
  • Such active oxygen can be classified into radical oxygen by electron transfer and singlet oxygen by energy transfer, and have different active efficiency and energy characteristics.
  • the urethral catheter according to an embodiment of the present invention by irradiating the light energy to porphyrin to different active efficiency of radical oxygen and singlet oxygen Therefore, various bacteria can be sterilized.
  • porphyrin is an organic compound and has good adhesion to the inner wall of the body of the catheters.
  • FIG. 3 is a photograph through a confocal microscope of a catheter according to one embodiment of the present invention. (Bright field, fluorescence, merged picture from the left)
  • the photosensitizer is uniformly introduced into the inner wall of the catheter. Through this, the photosensitizer is uniformly introduced into the inner wall of the catheter to induce the generation of active oxygen in the entire inner wall.
  • Figure 4 is a graph showing the absorption (left) / fluorescence (right) spectrum of the catheter according to an embodiment of the present invention.
  • the optical functional catheter introduced with a photosensitive agent is respectively Hitachi's U-2800 UV / Vis spectrophotometer and Jasco's V550 Reflectance UV /
  • the steady-state absorption spectrum was measured using a Vis spectrophotometer, and the B-band (400 nm) and Q-band (510, 530, 580, 630 nm), the intrinsic absorption wavelength peaks of porphyrin, showed porphyrin It was confirmed that the same appears in the absorption spectrum of the introduced catheter.
  • the absorption peak of the steady-state absorption spectrum of the porphyrin is preferably present at a wavelength of 350 nm to 700 nm, preferably 400 nm to 650 nm, and according to one embodiment of the present invention, according to the broad steady state absorption wavelength of the porphyrin.
  • the catheter can utilize the light energy of a wide visible light region, it can self-sterilize through the active oxygen generated by excitation of the photosensitizer according to the light energy irradiation, and can prevent the biofilm formation by bacteria have.
  • a photo-functional catheter in which a photosensitive agent (H 2 TPP) was introduced was measured using a F-4500 spectrophotometer manufactured by Hitachi (steady-state fluorescence spectrum) (excitation wavelength: 510 nm). As a result, it was confirmed that an intrinsic fluorescence peak appeared at 650 and 720 nm.
  • photoluminescence of the porphyrin is performed through a phosphorescence process, which can induce high active oxygen generation efficiency by having a relatively long life time.
  • the fluorescence peak of the fluorescence spectrum of the porphyrin may be present at a wavelength of 600 nm to 750 nm, and the generation of active oxygen through phosphorescence may maintain photophysical properties even in a long lifetime. .
  • 5 is a graph showing decomposition efficiency of organic materials according to the concentration of porphyrin constituting the catheter according to an embodiment of the present invention.
  • the concentration of the porphyrin constituting the catheter according to an embodiment of the present invention is 6.5 * 10 -8 mol / mL to 2.4 * It is preferred that it is 10-6 mol / mL.
  • the present invention provides a method for producing a catheter comprising a main body and a photosensitive agent supported in the main body, comprising: preparing a photosensitive solution by dissolving the photosensitive agent in a solvent; And supporting the photosensitive agent solution on an inner wall of the catheter body.
  • the method of preparing a porphyrin solution by dissolving 0.4 mg porphyrin (photosensitive agent) in 1 mL dichloromethane (solvent) and swelling of the body using the porphyrin solution using a syringe or the like Introducing the inner wall of the.
  • the concentration of the porphyrin solution may be 6.5 * 10 -8 mol / mL to 2.4 * 10 -6 mol / mL, and then, after heating to a temperature of 25 °C to 135 °C, solvent removal and dewelling
  • the catheter may be manufactured by performing a process) and washing the catheter with an ultrasonic cleaner.
  • FIG. 6 is a graph showing the photocatalytic effect of the catheter according to the pH change according to an embodiment of the present invention
  • Figure 6 is a graph showing the photocatalytic effect of the temperature change of the catheter according to an embodiment of the present invention
  • Figure 7 Is a stability diagram of the catheter according to an embodiment of the present invention
  • Figure 8 is a graph showing the stability of the catheter when tested in vivo similar conditions according to an embodiment of the present invention.
  • the catheter according to an embodiment of the present invention can be seen that there is a photocatalytic effect by the active oxygen even under various pH conditions, referring to Figure 7, the catheter sterilization temperature conditions (about 135 °C) treatment It can be confirmed that the photocatalytic efficiency is maintained afterwards, and thus the stability of the photocatalyst is maintained.
  • FIG 8 is a graph showing the dissolution of the photosensitizer from the catheter introduced with the photosensitizer under similar conditions in vivo (pH 6.8, 37 °C, 27 hours), the catheter according to an embodiment of the present invention is similar in vivo It was confirmed to have stability under the conditions.
  • FIG. 9 is a graph illustrating photophysical properties before and after decomposing an organic material using a catheter introduced with a photosensitizer.
  • the catheter according to an embodiment of the present invention has the same photophysical properties before and after decomposition of an organic material. It was confirmed that.
  • Escherichia coli which is the main contaminant of biofilm formation in silicone urinary tracts
  • 3 other bacteria Staphylococcus aureus ( Staphylococcus aureus ATCC 25923- Figures 11 and 15)
  • Pseudomonas aeruginosa Pseudomonas . Aeruginosa ATCC 27853-FIGS. 12 and 16
  • Candida albicans Candida albicans
  • the bacteria were incubated in BHI broth (Brain Heart Infusion broth (Oxoid)) at 37 ° C. and at least 24 hours of aerobic conditions. Suspensions of four bacteria cultured overnight were diluted in PBS to 2.0 x 10 5 cfu.
  • BHI broth Brain Heart Infusion broth (Oxoid)
  • MAC Mac Conkey agar
  • the urethral catheter according to an embodiment of the present invention is inserted into a patient, and after a micro laser (laser point, etc.) is brought into close contact with an extracorporeal end (exposed part) of the catheter, periodic laser (light energy) irradiation is performed. Induce the generation of reactive oxygen by a micro laser (laser point, etc.) is brought into close contact with an extracorporeal end (exposed part) of the catheter, periodic laser (light energy) irradiation is performed. Induce the generation of reactive oxygen by
  • the laser irradiated into the catheter is guided along the catheter inner wall to reach the distal end of the catheter.
  • the energy supply procedure is very simple and does not require additional equipment or devices.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un cathéter et un procédé de fabrication de celui-ci. Plus particulièrement, le cathéter selon la présente invention comprend: un corps tubulaire et un photosensibilisateur inclus dans la surface cylindrique interne du corps. Le cathéter selon la présente invention possède d'excellentes propriétés mécaniques, telles qu'une stabilité à la température et au pH et des caractéristiques optophysiques élevées. De plus, ce cathéter peut être autostérilisé par génération d'une espèce d'oxygène actif par l'excitation du photosensibilisateur due à l'énergie d'une lumière incidente, ce qui permet de prévenir la formation d'un biofilm par des bactéries.
PCT/KR2010/004474 2010-07-09 2010-07-09 Cathéter et procédé de fabrication de celui-ci WO2012005396A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN2010800679722A CN103068432A (zh) 2010-07-09 2010-07-09 导液管及其制造方法
PCT/KR2010/004474 WO2012005396A1 (fr) 2010-07-09 2010-07-09 Cathéter et procédé de fabrication de celui-ci

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR2010/004474 WO2012005396A1 (fr) 2010-07-09 2010-07-09 Cathéter et procédé de fabrication de celui-ci

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WO2012005396A1 true WO2012005396A1 (fr) 2012-01-12

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020260560A1 (fr) 2019-06-28 2020-12-30 Universidad Complutense De Madrid Dispositif médical photo-stérilisable

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108607151B (zh) * 2018-05-21 2021-06-01 青岛杰圣博生物科技有限公司 一种抗菌导尿管及其制备方法

Citations (4)

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US5456661A (en) * 1994-03-31 1995-10-10 Pdt Cardiovascular Catheter with thermally stable balloon
US20010006618A1 (en) * 1992-05-06 2001-07-05 Milton David Goldenberg Intraoperative, intravascular and endoscopic tumor and lesion detection, biopsy and therapy
US20020095197A1 (en) * 2000-07-11 2002-07-18 Lardo Albert C. Application of photochemotherapy for the treatment of cardiac arrhythmias
US20040024349A1 (en) * 1999-03-26 2004-02-05 Flock Stephen T. Catheter for delivering electromagnetic energy for enhanced permeation of substances

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US9597067B2 (en) * 2002-10-04 2017-03-21 Ethicon, Inc. Packaged antimicrobial medical device and method of preparing same
CN101237883A (zh) * 2005-04-07 2008-08-06 照片诊断设备（Pdd）有限公司 光敏剂和核磁共振(mir)增强剂
KR101549238B1 (ko) * 2006-02-28 2015-09-03 벡톤 디킨슨 앤드 컴퍼니 카테테르 잠금을 위한 항미생물성 조성물 및 방법
CN101023945B (zh) * 2007-02-16 2010-04-07 福州大学 非周边取代的酞菁金属配合物的用途
CN101012234B (zh) * 2007-02-16 2010-10-13 福州大学 非周边取代的酞菁金属配合物及其制备方法
CN101260110B (zh) * 2008-04-11 2010-06-02 福州大学 α-(8-喹啉氧基)单取代酞菁锌及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010006618A1 (en) * 1992-05-06 2001-07-05 Milton David Goldenberg Intraoperative, intravascular and endoscopic tumor and lesion detection, biopsy and therapy
US5456661A (en) * 1994-03-31 1995-10-10 Pdt Cardiovascular Catheter with thermally stable balloon
US20040024349A1 (en) * 1999-03-26 2004-02-05 Flock Stephen T. Catheter for delivering electromagnetic energy for enhanced permeation of substances
US20020095197A1 (en) * 2000-07-11 2002-07-18 Lardo Albert C. Application of photochemotherapy for the treatment of cardiac arrhythmias

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020260560A1 (fr) 2019-06-28 2020-12-30 Universidad Complutense De Madrid Dispositif médical photo-stérilisable

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