WO2013017547A1 - Dispositif médical comprenant un revêtement hydrophile mouillé - Google Patents

Dispositif médical comprenant un revêtement hydrophile mouillé Download PDF

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Publication number
WO2013017547A1
WO2013017547A1 PCT/EP2012/064820 EP2012064820W WO2013017547A1 WO 2013017547 A1 WO2013017547 A1 WO 2013017547A1 EP 2012064820 W EP2012064820 W EP 2012064820W WO 2013017547 A1 WO2013017547 A1 WO 2013017547A1
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WO
WIPO (PCT)
Prior art keywords
wetting agent
medical device
coating
hydrophilic polymer
hydrophilic
Prior art date
Application number
PCT/EP2012/064820
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English (en)
Inventor
Johannes Wilhelmus Belt
Original Assignee
Dsm Ip Assets B.V.
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 Dsm Ip Assets B.V. filed Critical Dsm Ip Assets B.V.
Priority to US14/115,920 priority Critical patent/US20140190846A1/en
Priority to EP12740180.0A priority patent/EP2736546A1/fr
Priority to CN201280025917.6A priority patent/CN103561789A/zh
Publication of WO2013017547A1 publication Critical patent/WO2013017547A1/fr

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/04Packaging single articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/10Materials for lubricating medical devices

Definitions

  • the invention is directed to the use of a wetting agent having a boiling point higher than 100 °C and a viscosity lower than 500 mPa.s, wherein the wetting agent can comprise water in an amount between 0 and 4.9 wt% based on the total weight of the wetting agent for the lubrication of a hydrophilic polymer coating.
  • the invention further relates to a medical device comprising a hydrophilic polymer coating that is wetted by a wetting agent having boiling point higher than 100 °C and a viscosity lower than 500 mPa.s, wherein the wetting agent can comprise water in an amount between 0 and 4.9 wt% based on the total weight of the wetting agent, a method for the preparation of a medical device and a package comprising a medical device.
  • cardiovascular catheters, syringes, and membranes need to have a lubricant applied to the outer and/or inner surface to facilitate insertion into and removal from the body and/or to facilitate drainage of fluids from the body.
  • Lubricious properties are also required so as to minimize soft tissue damage upon insertion or removal.
  • such medical devices may have a hydrophilic surface coating or layer which becomes lubricious and attains low-friction properties upon wetting, i.e. applying a wetting fluid for a certain time period prior to insertion of the device into the body of a patient.
  • a coating or layer which becomes lubricious after wetting is hereinafter referred to as a hydrophilic coating.
  • a coating obtained after wetting is hereinafter referred to as a lubricious coating.
  • lubricious is defined as having a smooth or slippery surface.
  • wetting fluids water, water- containing mixtures further comprising one or more organic solvents and/or one or more dissolved components, such as salts.
  • a wetting fluid can also be a body fluid or a saline solution having (approximately) physiological osmolarity.
  • the medical devices can be wetted (and thereby become lubricious) immediately prior to use.
  • medical devices with a hydrophilic coating have been introduced that are sterile-packaged in a package that contains enough wetting fluid to keep the coating wetted (and thus lubricious).
  • WO-0405909A1 discloses the use of plasticizers in a cross-linked hydrophilic coating of a hydrophilic polymer on a substrate. The plasticizers form part of the polymer solution that is applied to the substrate. After application the polymer solution is dried and cured.
  • the substrate can be a medical device, such as a catheter, guide wire or endoscope.
  • the medical devices that are coated with the hydrophilic coating are wetted with water before use on a patient.
  • the plasticizers have the effect that a hydrophilic coating is provided showing high abrasion resistance and low friction coefficient when wet.
  • EP-1809345A1 discloses a medical device having a wetted hydrophilic coating comprising a coating composition containing a hydrophilic polymer and a wetting agent comprising water and one or more lubricant(s).
  • the wetting agent comprises one or more lubricants in a total amount between 0.1 and 95 % by weight.
  • the medical devices have a low friction surface, have an extended dry-out period and do not drip or have a reduced tendency to drip.
  • hydrophilic coatings have the disadvantage that water is used for the lubrication of the hydrophilic coatings.
  • water By using water as the main component in a wetting agent the hydrophilic coating will dry out and will thus not be lubricous for a long time.
  • the hydrophilic coating will usually not be lubricous anymore within a time period of 15 minutes after wetting or after removal of a medical device from the package.
  • a wetting agent having a boiling point higher than 100 °C and a viscosity lower than 500 mPa.s wherein the wetting agent can comprise water in an amount between 0 and 4.9 wt% based on the total weight of the wetting agent can be used for the lubrication of a hydrophilic polymer coating on a substrate, where after the lubricious hydrophilic coating will stay lubricous for a time period that is much longer than 15 minutes.
  • a further advantage is that the lubricious hydrophilic coatings do not drip.
  • the wetting agent has a boiling point higher than 100 °C, preferably higher than 200 °C.
  • the boiling point is determined at ambient pressure.
  • a high boiling point of the wetting agent corresponds to a low amount of evaporation of the wetting agent from the lubricous hydrophilic coating. This means that the hydrophilic coating will remain lubricous for a longer time.
  • the wetting agent can be one liquid or a mixture of liquids.
  • the wetting agent can comprise water, but only in a minor amount.
  • the amount of water in the wetting agent is at most 4.9 weight% based on the total weight of wetting agent.
  • the amount of water preferably is lower than 4 weight%, more preferably lower than 1 weight%.
  • the wetting agent has a viscosity lower than 500 mPa.s. This is determined by at a temperature of 25 °C on a viscometer according to ASTM D445.
  • the viscosity of water is 1 mPa.s.
  • the viscosity of the wetting agent is preferably below 100 mPa.s.
  • the viscosity of the wetting agent is preferably higher than 1 mPa.s; more preferably higher than 5 mPa.s.
  • a low viscosity of the wetting agent corresponds to a low amount of friction between the lubricious hydrophilic coating and another surface.
  • the wetting agent preferably comprises at least one hydroxyl group. More preferably, the wetting agent can be chosen from the group consisting of glycerol esters, glycerol ethers, glycols, glycolesters and glycolethers. Examples of wetting agents are glycerol, monoacetin, diacetin and diacetone alcohol.
  • the wetting agents are used for the lubrication of a hydrophilic polymer coating.
  • the hydrophilic coating may be any coating which comprises a hydrophilic medium that absorbs and/or adsorbs the wetting agent. This can be any coating comprising hydrophilic polymers, an antimicrobial coating, a non-fouling coating or a drug eluting coating.
  • a hydrophilic polymer coating comprises a hydrophilic polymer capable of providing hydrophilicity to the coating, which polymer may be synthetic or bio-derived and can be blends or copolymers of both.
  • Suitable hydrophilic polymers include but are not limited to poly(lactams), for example polyvinylpyrollidone (PVP), polyurethanes, homo- and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinylethers, maleic anhydride based copolymers, polyesters, vinylamines, polyethyleneimines, polyethyleneoxides, poly(carboxylic acids), polyamides, polyanhydrides, polyphosphazenes, cellulosics, for example methyl cellulose, carboxymethyl cellulose, hydroxymethyl cellulose, and hydroxypropylcellulose, heparin, dextran, polysacharrides, for example chitosan, hyaluronic acid, alginates, gelatin, and chitin, polyester
  • polypeptides polypeptides, short chain peptides, proteins, and oligonucleotides.
  • the hydrophilic polymer coating comprises poly(lactams), for example polyvinylpyrollidone (PVP), polyurethanes, homo- and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinylethers, maleic anhydride based copolymers, polyesters, vinylamines, polyethyleneimines or polyethyleneoxides. More preferably the hydrophilic polymer coating comprises polyvinylpyrrolidone (PVP).
  • PVP polyvinylpyrollidone
  • the hydrophilic polymer has a molecular weight in the range of about 8,000 to about 5,000,000 g/mol, preferably in the range of about 20,000 to about 3,000,000 g/mol and more preferably in the range of about 200,000 to about 2,000,000 g/mol.
  • the hydrophilic polymer may be used in the coating in more than 1 wt%, for example more than 5 wt%, or more than 50 wt%, based on the total weight of the dry coating.
  • the hydrophilic polymer can be present up to 99 wt%, or up to 95 %, based on the total weight of the dry coating.
  • the hydrophilic polymer may for instance be a prepolymer, i.e. a polymer comprising one or more polymerisable groups, in particular one or more radically polymerisable groups such as one or more vinyl groups.
  • a prepolymer having an average number of polymerisable groups per molecule of more than 1 is in particular suitable.
  • the average number of reactive groups is at least 1 .2, more preferably at least 1 .5, in particular at least 2.0.
  • the average number of groups is up to 64, more preferably in the range of up to 15, in particular in the range of up to 8, more in particular up to 7.
  • polymerisable groups may be cured in the presence of a photo-initiator, in particular by the formation of grafts when the formulation is exposed to light.
  • the hydrophilic coating composition may be in the form of a solution or a dispersion comprising a liquid medium.
  • a liquid medium that allows application of the hydrophilic coating formulation on a surface would suffice.
  • liquid media are alcohols, like methanol, ethanol, propanol, butanol or respective isomers and aqueous mixtures thereof or acetone, methylethyl ketone, tetrahydrofuran, dichloromethane, toluene, and aqueous mixtures or emulsions thereof.
  • the hydrophilic coating composition according to the invention may additionally include various additives includes conventional ingredients like pigments, dyes, dispersing and stabilising agents (usually surfactants or emulsifiers), rheology control agents, flow-promoting agents, extenders, defoaming agents, plasticisers, thickeners, heat stabilisers, levelling agents, anti-cratering agents, fillers, sedimentation inhibitors, UV absorbers, antioxidants, organic co-solvents, wetting agents, fungicides, bacteriocides, anti-freeze agents, coalescents, waxes and the like introduced at any stage of the production process or subsequently.
  • the hydrophilic coating can be coated on a substrate which may be selected from a range of geometries and materials.
  • the substrate may have a texture, such as porous, non-porous, smooth, rough, even or uneven.
  • the substrate supports the hydrophilic coating on its surface.
  • the hydrophilic coating can be on all areas of the substrate or on selected areas.
  • the hydrophilic coating can be applied to a variety of physical forms, including films, sheets, rods, tubes, molded parts (regular or irregular shape), fibers, fabrics, and particulates.
  • Suitable surfaces are surfaces that provide the desired properties such as porosity, hydrophobicity, hydrophilicity, colorisability, strength, flexibility, permeability, elongation, abrasion resistance and tear resistance. Examples of suitable surfaces are for instance surfaces that consist of or comprise metals, plastics, ceramics, glass and/or composites.
  • the hydrophilic coating may be applied directly to the said surfaces or may be applied to a pretreated or coated surface. The pretreatment or coating can be designed to aid adhesion of the
  • hydrophilic coating to the substrate.
  • the hydrophilic polymer coating is coated on a medical device.
  • the medical device can be an implantable device or an extracorporeal device.
  • the devices can be of short-term temporary use or of long-term permanent
  • suitable devices are those that are typically used to provide for medical therapy and/or diagnostics in heart rhythm disorders, heart failure, valve disease, vascular disease, diabetes, neurological diseases and disorders, orthopedics, neurosurgery, oncology, ophthalmology, and ENT surgery.
  • Suitable examples of medical devices include, but are not limited to, a stent, stent graft, anastomotic connector, synthetic patch, lead, electrode, needle, guide wire, catheter, sensor, surgical instrument, angioplasty balloon, wound drain, shunt, tubing, infusion sleeve, urethral insert, pellet, implant, blood oxygenator, pump, vascular graft, vascular access port, heart valve, annuloplasty ring, suture, surgical clip, surgical staple, pacemaker, implantable defibrillator, neurostimulator, orthopedic device, cerebrospinal fluid shunt, implantable drug pump, spinal cage, artificial disc, replacement device for nucleus pulposus, ear tube, intraocular lens and any tubing used in minimally invasive surgery.
  • Devices that are particularly suited to be used in the present invention include medical devices or components such as catheters, for example intermittent catheters, guidewires, stents, syringes, metal and plastic implants, contact lenses and medical tubing.
  • the hydrophilic polymer coating can be applied to the substrate by for example dip-coating. Other methods of application include spray, wash, vapor deposition, brush, roller and other methods known in the art.
  • the hydrophilic polymer coating may have one or more layers.
  • One layer may be a primer layer useful for attaching the coating layer to the medical device.
  • the invention is further related to a method for the preparation of a medical device comprising the steps of:
  • wetting agent with a boiling point higher than 100 °C and a viscosity lower than 500 mPa.s, wherein the wetting agent can comprise water in an amount between 0 and 4.9 wt% based on the total weight of the wetting agent,
  • the hydrophilic polymer coating on the medical device must be wetted by the wetting agent.
  • the term "wetted” is generally known in the art and - in a broad sense - means "containing a wetting agent”. In particular the term is used herein to describe a coating that contains sufficient wetting agent to be lubricious.
  • a lubricious coating has a Coefficient of Friction (COF), as defined below, lower than 0.15.
  • COF Coefficient of Friction
  • concentration of the wetting agent usually a wetted coating contains at least 10 wt. % of wetting agent, based on the dry weight of the coating, preferably at least 50 wt. %, based on the dry weight of the coating, more preferably at least 100 wt. % based on the dry weight of the coating.
  • an uptake of wetting agent of about 300-500 wt. % is feasible.
  • a lubricious coating is obtained with a dry-out time longer than 15 minutes as determined on the Harland Friction tester.
  • the dry-out time is the duration of the coating remaining lubricious after the device has been taken out of the wetting agent wherein it has been stored and wetted or after the device has been taken out of the package wherein it has been stored in a wetted condition. Dry-out time can be determined by measuring the coefficient of friction as a function of time the catheter had been exposed to air on the Harland Friction tester. The dry-out time is the point in time wherein the coefficient of friction reaches a value of 0.2 or higher, or in a stricter test 0.15 or higher. The protocol is as indicated in the Examples.
  • a lubricious hydrophilic coating is obtained with a coefficient of friction lower than 0.20 as determined on the Harland Friction tester.
  • a coating is considered lubricious if it has a friction as measured on a Harland FTS Friction Tester of 0.20 or less at a clamp-force of 100 g and a pull speed of 1 cm/s, preferably of 0.15 or less.
  • the protocol is as indicated in the Examples.
  • the medical device is sterilized. Sterilization can be achieved by applying the proper combinations of heat, chemicals and/or irradiation.
  • Heat sterilization can be performed in an autoclave, wherein steam is heated to 120-135 °C.
  • the medical device is for instance contacted with ethylene oxide (EtO), ozone or hydrogen peroxide.
  • Sterilization by irradiation can, for instance, be performed by electron beam, x-ray or gamma ray irradiation.
  • the hydrophilic coating and or the wetting agent may comprise additives that protect the coating against a detrimental effect of radicals formed during sterilization.
  • additives are for example aliphatic compounds, alicyclic compounds and/or antioxidants.
  • any aliphatic stabilising compound and/or alicyclic stabilising compound may be used, in particular any such compound that is physiologically allowable and preferably non-toxic in the used concentration.
  • a stabilising compound with a relatively low molecular weight is particularly suitable, such as a compound with a molecular weight of less than
  • a low molecular weight compound may have one or more of the following advantages, compared to a compound having a higher molecular weight:
  • Particularly preferred aliphatic and/or alicyclic stabilising compounds include alcohols, ethers, aldehydes, ketones, amides, esters, thiols, thioesters, organic acids and combinations thereof.
  • Highly preferred are (saturated) aliphatic compounds selected from the group consisting of (saturated) aliphatic alcohols, ethers, aldehydes, ketones amides, esters, thiols, thioesters, organic acids and combinations thereof.
  • Preferred alcohols include alkylene glycols, such as diethyleneglycol, triethyleneglycol, tetraethyleneglycol, propyleneglycol, dipropyleneglycol,
  • triprolyeneglycol (low molecular) ethoxylated or propoxylated alcohols and/or amines like ethanolamine, diethanolamine, triethanolamine, polyethylene glycol (PEG), in particular polyalkylene glycols having a Mw up to about 600 g/mol lower aliphatic alcohols - in particular C1 -C8 alcohols, more in particular C2-C4 alcohol, such as isopropanol, ethanol, 1 -propanol and 1 -butanol - and combinations thereof. Good results have further been achieved with a carbohydrate, in particular a
  • monosaccharide more in particular glucose.
  • Preferred ethers include polyalkylene glycols, such as PEG.
  • Suitable aldehydes include C1 -C8 aldehydes.
  • Preferred aldehydes include formaldehyde, acetaldehyde and butanal.
  • Suitable ketones include C3-C8 ketones.
  • Preferred ketones include acetone and methylethylketone.
  • Suitable organic acids include C1 -C8 organic acids.
  • Preferred organic acids include formic acid.
  • the invention is further directed to a package containing a medical device or a part of a medical device comprising a lubricated hydrophilic coating, which package is impermeable to vapor.
  • the package can, for instance, be made of plastic or aluminum foil.
  • the package can contain additional wetting agent.
  • the package comprises a medical device that is sterilized.
  • the primer formulation was prepared by dissolving the components below in ethanol.
  • Irgacure 2959 (supplied by Sigma Aldrich) 0.20 % (w/w)
  • the hydrophilic coating formulation was prepared by dissolving the components below in a water/ethanol mixture 1 :1 based on weight. Weight%
  • PVC tubes with a diameter of 14 Fr and a length of 30 cm were coated on a Harland PCX coater 175/24.
  • the PVC tubes were first dip- coated with the primer coating formulation and cured according the dip protocol for the primer in table 1 . Subsequently the hydrophilic coating formulation was applied and cured according the dip protocol for the hydrophilic coating. Temperature and humidity during application were respectively 21 °C +1-2 °C and 40% +/- 15%.
  • the Harland PCX coater/175/24 was equipped with a Harland Medical systems UVM 400 lamp. Intensity of the lamps of the Harland PCX
  • coater/175/24 was on average 60 mW/cm 2 and was measured using a Solatell Sola Sensor 1 equipped with an International Light detector SED005#989, Input Optic:
  • the tubes were dipped in the wetting agent, immersed for 2 minutes and thereafter extracted from the wetting agent with a speed of 1 cm/s.
  • the wetted coatings were evaluated directly after removal from the wetting agent.
  • the viscosity of a wetting agent was determined on a viscometer according to ASTM D445 at a temperature of 25 °C. Lubricity test
  • HFT Harland FTS5000 Friction Tester
  • test description was inserted when "run test” was activated.
  • a sample was fastened in the sample holder..
  • the transport of the tester was moved to the desired position and the protocol was activated by pushing "start”.
  • the data were saved after finishing.
  • the sample holder was removed from the tester and subsequently the catheter was removed from the holder.
  • the measured coefficient of friction (COF) is used to rate the performance of the coating.
  • the COF is defined as the measured friction ⁇ clamp force.
  • the COF was determined on a sample after 10, 15 and 30 minutes of drying. The drying time started directly after removal of the sample from the wetting agent.
  • a C0FO.15 is judged as good.
  • a COF between 0.15 and 0.20 is judged as too high; a COF>0.20 is judged as bad.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Food Science & Technology (AREA)
  • Materials For Medical Uses (AREA)
  • Paints Or Removers (AREA)

Abstract

La présente invention concerne l'utilisation d'un agent humidifiant ayant un point d'ébullition supérieur à 100°C et une viscosité inférieure à 500 mPa.s, l'agent humidifiant comprenant de l'eau en une quantité comprise entre 0 et 4,9 % en poids en se basant sur le poids total de l'agent humidifiant, pour la lubrification d'un revêtement polymère hydrophile. L'invention concerne en outre un dispositif médical comprenant un revêtement polymère hydrophile qui est mouillé par un agent humidifiant, un procédé de préparation d'un dispositif médical et un emballage comprenant un dispositif médical.
PCT/EP2012/064820 2011-07-29 2012-07-27 Dispositif médical comprenant un revêtement hydrophile mouillé WO2013017547A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US14/115,920 US20140190846A1 (en) 2011-07-29 2012-07-27 Medical device comprising a wetted hydrophilic coating
EP12740180.0A EP2736546A1 (fr) 2011-07-29 2012-07-27 Dispositif médical comprenant un revêtement hydrophile mouillé
CN201280025917.6A CN103561789A (zh) 2011-07-29 2012-07-27 包含润湿的亲水性涂层的医疗器械

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201161513021P 2011-07-29 2011-07-29
US61/513,021 2011-07-29
EP11175951.0 2011-07-29
EP11175951 2011-07-29

Publications (1)

Publication Number Publication Date
WO2013017547A1 true WO2013017547A1 (fr) 2013-02-07

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PCT/EP2012/064820 WO2013017547A1 (fr) 2011-07-29 2012-07-27 Dispositif médical comprenant un revêtement hydrophile mouillé

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US (1) US20140190846A1 (fr)
EP (1) EP2736546A1 (fr)
CN (1) CN103561789A (fr)
WO (1) WO2013017547A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3281649A1 (fr) 2016-08-09 2018-02-14 Teleflex Lifesciences Formulation d'agent mouillant
WO2018136630A1 (fr) * 2017-01-20 2018-07-26 Hollister Incorporated Procédés de stérilisation d'un dispositif médical à revêtement hydrophile
EP4062952A1 (fr) * 2021-03-23 2022-09-28 Dentsply IH AB Ensemble cathéters urinaires hydrophiles réutilisables

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120042748A (ko) 2009-05-13 2012-05-03 씨브이 홀딩스 엘엘씨 코팅된 표면 검사를 위한 가스제거 방법
US9458536B2 (en) 2009-07-02 2016-10-04 Sio2 Medical Products, Inc. PECVD coating methods for capped syringes, cartridges and other articles
US11624115B2 (en) 2010-05-12 2023-04-11 Sio2 Medical Products, Inc. Syringe with PECVD lubrication
US9878101B2 (en) 2010-11-12 2018-01-30 Sio2 Medical Products, Inc. Cyclic olefin polymer vessels and vessel coating methods
US9272095B2 (en) 2011-04-01 2016-03-01 Sio2 Medical Products, Inc. Vessels, contact surfaces, and coating and inspection apparatus and methods
JP6095678B2 (ja) 2011-11-11 2017-03-15 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 薬剤パッケージ用の不動態化、pH保護又は滑性皮膜、被覆プロセス及び装置
US11116695B2 (en) 2011-11-11 2021-09-14 Sio2 Medical Products, Inc. Blood sample collection tube
EP2846755A1 (fr) 2012-05-09 2015-03-18 SiO2 Medical Products, Inc. Enrobage protecteur en saccharide pour conditionnement pharmaceutique
CA2890066C (fr) 2012-11-01 2021-11-09 Sio2 Medical Products, Inc. Procedes d'inspection de revetement
EP2920567B1 (fr) 2012-11-16 2020-08-19 SiO2 Medical Products, Inc. Procédé et appareil pour détecter des caractéristiques d'intégrité de revêtement de barrière rapide
WO2014085346A1 (fr) 2012-11-30 2014-06-05 Sio2 Medical Products, Inc. Corps creux comportant un revêtement intérieur
US9764093B2 (en) 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
EP2961858B1 (fr) 2013-03-01 2022-09-07 Si02 Medical Products, Inc. Seringue revetu.
CA2904611C (fr) 2013-03-11 2021-11-23 Sio2 Medical Products, Inc. Emballage muni d'un revetement
US9937099B2 (en) 2013-03-11 2018-04-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
EP2971227B1 (fr) 2013-03-15 2017-11-15 Si02 Medical Products, Inc. Procede de revetement.
US11066745B2 (en) 2014-03-28 2021-07-20 Sio2 Medical Products, Inc. Antistatic coatings for plastic vessels
EP3878484A1 (fr) 2015-04-16 2021-09-15 Hollister Incorporated Revêtements hydrophiles et leurs procédés de formation
CA2995225C (fr) 2015-08-18 2023-08-29 Sio2 Medical Products, Inc. Conditionnement pharmaceutique et autre presentant un faible taux de transmission d'oxygene
LT4088749T (lt) 2017-01-20 2023-12-27 Hollister Incorporated Sterilizuoto šlapimo kateterio formavimo būdas
LT3721910T (lt) 2017-02-21 2024-02-12 Hollister Incorporated Spinduliavimu aktyvuoti geliai, išskiriantys skysčius, ir juos talpinančos konstrukcijos
AU2019269674B2 (en) 2018-05-17 2024-04-18 Hollister Incorporated Hydrophilic medical products and hydration mediums for hydrating the same
CA3141410C (fr) * 2019-05-22 2023-03-07 Hollister Incorporated Dispositifs medicaux hydrophiles emballes
AU2020332172A1 (en) * 2019-08-21 2022-02-17 Terumo Kabushiki Kaisha Medical device and method for manufacturing same

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000030696A1 (fr) * 1998-11-20 2000-06-02 Coloplast A/S Procede de sterilisation d'un dispositif medical comportant un revetement hydrophile
WO2004005909A2 (fr) 2002-07-03 2004-01-15 Broadley Technologies Corporation Electrode de reference a elements de jonction a ecoulement liquide et de filtre
WO2006037321A1 (fr) * 2004-10-07 2006-04-13 Coloplast A/S Dispositif médical à revêtement hydrophile humidifié
WO2007065722A1 (fr) 2005-12-09 2007-06-14 Dsm Ip Assets B.V. Revêtement hydrophile comprenant un polyélectrolyte

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2870148B1 (fr) * 2004-05-12 2006-07-07 Snecma Moteurs Sa Procede de fonderie a cire perdue avec couche de contact
DK2156852T3 (da) * 2004-07-07 2011-08-08 Coloplast As Kateter omfattende Estane 58212
WO2006117372A1 (fr) * 2005-05-02 2006-11-09 Coloplast A/S Procede de sterilisation d'un dispositif medical comportant un revetement hydrophile
CN102006892B (zh) * 2008-05-16 2013-10-09 泰尔茂株式会社 具有亲水性聚合物涂层的医疗器械的放射线灭菌方法
WO2010003419A2 (fr) * 2008-06-16 2010-01-14 Coloplast A/S Milieux gonflants tamponnés destinés à irradier des revêtements hydrophiles stérilisés

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000030696A1 (fr) * 1998-11-20 2000-06-02 Coloplast A/S Procede de sterilisation d'un dispositif medical comportant un revetement hydrophile
WO2004005909A2 (fr) 2002-07-03 2004-01-15 Broadley Technologies Corporation Electrode de reference a elements de jonction a ecoulement liquide et de filtre
WO2006037321A1 (fr) * 2004-10-07 2006-04-13 Coloplast A/S Dispositif médical à revêtement hydrophile humidifié
EP1809345A1 (fr) 2004-10-07 2007-07-25 Coloplast A/S Dispositif medical a revetement hydrophile humidifie
WO2007065722A1 (fr) 2005-12-09 2007-06-14 Dsm Ip Assets B.V. Revêtement hydrophile comprenant un polyélectrolyte

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3281649A1 (fr) 2016-08-09 2018-02-14 Teleflex Lifesciences Formulation d'agent mouillant
WO2018028831A1 (fr) 2016-08-09 2018-02-15 Teleflex Lifesciences Formulation d'agent mouillant
WO2018029279A1 (fr) 2016-08-09 2018-02-15 Teleflex Lifesciences Procédé pour stériliser un dispositif médical
US11524096B2 (en) 2016-08-09 2022-12-13 Teleflex Life Sciences Pte. Ltd. Wetting agent formulation
WO2018136630A1 (fr) * 2017-01-20 2018-07-26 Hollister Incorporated Procédés de stérilisation d'un dispositif médical à revêtement hydrophile
EP3854427A1 (fr) * 2017-01-20 2021-07-28 Hollister Incorporated Procédés de stérilisation d'un dispositif médical à revêtement hydrophile
AU2018209944B2 (en) * 2017-01-20 2022-10-13 Hollister Incorporated Methods of sterilizing a hydrophilically coated medical device
EP4062952A1 (fr) * 2021-03-23 2022-09-28 Dentsply IH AB Ensemble cathéters urinaires hydrophiles réutilisables
WO2022200323A1 (fr) * 2021-03-23 2022-09-29 Dentsply Ih Ab Ensemble cathéter urinaire hydrophile réutilisable
EP4349390A3 (fr) * 2021-03-23 2024-07-03 Wellspect AB Ensemble catheter urinaire hydrophile reutilisable

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