CN103561789A - Medical device comprising a wetted hydrophilic coating - Google Patents

Medical device comprising a wetted hydrophilic coating Download PDF

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Publication number
CN103561789A
CN103561789A CN201280025917.6A CN201280025917A CN103561789A CN 103561789 A CN103561789 A CN 103561789A CN 201280025917 A CN201280025917 A CN 201280025917A CN 103561789 A CN103561789 A CN 103561789A
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wetting agent
instruments
medical apparatus
coating
hydrophilic polymer
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约翰内斯·威廉默斯·贝尔特
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DSM IP Assets BV
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DSM IP Assets BV
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D81/00—Containers, 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
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • 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
    • A61L29/085—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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/04—Packaging single articles
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/10—Materials for lubricating medical devices

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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

The invention is directed to the use of a wetting agent having a boiling point higher than 100 DEG C and a viscosity lower than 500 mPa.s, wherein the wetting agent comprises 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, a method for the preparation of a medical device and a package comprising a medical device.

Description

The medical apparatus and instruments of the hydrophilic coating that comprises moistening
The present invention relates to have higher than the boiling point of 100 ℃ and lower than the wetting agent of the viscosity of 500mPa.s the purposes for lubricated hydrophilic polymer coating, wherein this wetting agent comprises water with the amount of the 0-4.9 % by weight based on wetting agent gross weight.The invention still further relates to the medical apparatus and instruments that comprises hydrophilic polymer coating, the packing of preparing the method for medical apparatus and instruments and comprising medical apparatus and instruments, this hydrophilic polymer coating is had higher than the boiling point of 100 ℃ with lower than the wetting agent moistening of the viscosity of 500mPa.s, and wherein this wetting agent comprises water with the amount of the 0-4.9 % by weight based on wetting agent gross weight.
Many medical apparatus and instruments such as seal wire, catheter and cardiovascular catheters, syringe and film all need to have lubricant application to outer surface and/or inner surface, to insert health and remove and/or promote the drain from the fluid of health from health.In order making to insert or remove rear soft tissue injury, to minimize, also to need greasy property.Especially, for lubricated object, this medical apparatus and instruments can have hydrophilic surface coating or layer, and it applied after a period of time with wetting fluid after moistening before apparatus inserts patient body, becomes and lubricates and obtain low friction performance.The coating that becomes lubricated after moistening or layer are hereinafter referred to as hydrophilic coating.The coating obtaining after moistening is hereinafter referred to as lubricant coating.Herein, " lubricate " to be defined as and there is smooth surface or sliding surface.
Following wetting fluid has been described in the prior art: water, also comprises the aqueous mixture of the component of one or more organic solvents and/or one or more dissolvings such as salt.According to prior art, wetting fluid can also be body fluid or the saline solution with (approximately) physiological osmotic pressure.
In principle, can face use before moistening medical apparatus and instruments (thereby becoming lubricated).Yet from user's angle, expectation can directly be used apparatus afterwards in the packing of opening storage apparatus.Consider this respect, introduced the medical apparatus and instruments with hydrophilic coating, it is by aseptic packaging in packing, and this packing has enough wetting fluids and keeps coating moistening (and therefore lubricated).
WO-0405909A1 discloses the purposes in the crosslinked hydrophilic coating of plasticizer hydrophilic polymer on base material.Plasticizer forms a part for the polymer solution that is coated on base material.After coating, polymer solution is dried and solidifies.Base material can be medical apparatus and instruments, for example conduit, seal wire or endoscope.Adopt the medical apparatus and instruments of hydrophilic coating coating to use water-wet before for patient.The effect that plasticizer has is that the hydrophilic coating that shows high-wearing feature and low-friction coefficient when moistening is provided.
EP-1809345A1 discloses the medical apparatus and instruments of the hydrophilic coating with moistening, and it comprises: the coating composition that comprises hydrophilic polymer and the wetting agent that contains water and one or more lubricants.Wetting agent comprises one or more lubricants with the total amount of 0.1-95 % by weight.This medical apparatus and instruments has low-friction surface, have the exsiccation of prolongation (dry-out) time and No drip type or have the dropping liquid of reducing tendency.
Above-mentioned hydrophilic coating has following shortcoming: make water lubricate hydrophilic coating.By making water as the key component in wetting agent, thereby hydrophilic coating can become dry and can be within a very long time lubricated.Remove 15 minute period after medical apparatus and instruments after moistening or from packing within, hydrophilic coating is conventionally no longer lubricated.
Now be surprisingly found out that and had higher than the boiling point of 100 ℃ and can be for hydrophilic polymer coating on lubricated base material lower than the wetting agent of the viscosity of 500mPa.s, wherein wetting agent comprises water with the amount of the 0-4.9 % by weight based on wetting agent gross weight, and the hydrophilic coating after lubricated on base material can keep surpassing 15 minutes lubricated.
Another advantage is lubricated hydrophilic coating No drip type.
Wetting agent have higher than 100 ℃, preferably higher than the boiling point of 200 ℃.Boiling point is under atmospheric pressure measured.
High boiling wetting agent is low from the amount of lubricated hydrophilic coating evaporation corresponding to wetting agent.This means that hydrophilic coating can keep the lubricated longer time.
Wetting agent can be the mixture of a kind of liquid or plurality of liquid.Wetting agent can comprise water, but only comprises a small amount of water.Gross weight based on wetting agent, the amount of water 4.9 % by weight at the most in wetting agent.The amount of water is preferably lower than 4 % by weight, more preferably lower than 1 % by weight.
Wetting agent has the viscosity lower than 500mPa.s.This is on viscometer, to measure at the temperature of 25 ℃ according to ASTM D445.The viscosity of water is 1mPa.s.The viscosity of wetting agent is preferably lower than 100mPa.s.The viscosity of wetting agent preferably higher than 1mPa.s, more preferably higher than 5mPa.s.Low viscous wetting agent is low corresponding to lubricated hydrophilic coating and other surperficial amount of friction.
Wetting agent preferably comprises at least one hydroxyl.More preferably, wetting agent can select the group that free glyceride, glycerin ether, glycol, diol ester and glycol ethers form.The example of wetting agent is glycerol, acetin, diacetine and diacetone alcohol.
Wetting agent is for lubricated hydrophilic polymer coating.Hydrophilic coating can be to comprise any coating that absorbs and/or adsorb the hydrophilic media of wetting agent.This can be any coating of comprising hydrophilic polymer, antimicrobial coatings, without dirty coating or drug eluting coatings.
Hydrophilic polymer coating comprises can be for coating provides hydrophilic hydrophilic polymer, and described polymer can be blend or copolymer that synthesize or biologically-derived and that can be both.Suitable hydrophilic polymer includes but not limited to gather (lactams) (for example polyvinyl pyrrolidone (PVP)), polyurethane, the homopolymer of acrylic acid and methacrylic acid and copolymer, polyvinyl alcohol, polyvingl ether, copolymer based on maleic anhydride, polyester, vinylamine, polymine, polyethylene glycol oxide, poly-(carboxylic acid), polyamide, poly-anhydride, polyphosphazene, cellulose family (methylcellulose for example, carboxymethyl cellulose, hydroxy methocel and hydroxypropyl cellulose), heparin, glucosan, polysaccharide (chitosan for example, hyaluronic acid, alginate, gelatin and chitin), polyester (polylactic acid for example, polyglycolide and polycaprolactone), polypeptide (collagen protein for example, fibrin, elastin laminin, albumin, oligopeptide, polypeptide, short-chain peptide, protein) and oligonucleotide.
Preferably, hydrophilic polymer comprises poly-(lactams) (for example polyvinyl pyrrolidone (PVP)), polyurethane, the homopolymer of acrylic acid and methacrylic acid and copolymer, polyvinyl alcohol, polyvingl ether, copolymer based on maleic anhydride, polyester, vinylamine, polymine or polyethylene glycol oxide.
More preferably, hydrophilic polymer comprises polyvinyl pyrrolidone (PVP).
Generally, the molecular weight of hydrophilic polymer arrives in the scope of about 5000000g/mol approximately 8000, preferably approximately 20000, in the scope of about 3000000g/mol and more preferably, approximately 200000, arrives in the scope of about 2000000g/mol.Gross weight based on dry coating, hydrophilic polymer can be for example, with the amount that is greater than 1 % by weight, is greater than 5 % by weight or is greater than 50 % by weight for coating.Gross weight based on dry coating, hydrophilic polymer can with 99 % by weight at the most or at the most 95% amount exist.
Hydrophilic polymer can be for example prepolymer, comprises one or more polymerizable groups, one or more free redical polymerization groups polymer of one or more vinyls for example particularly.
For cross-linked network is provided, especially suitable is the prepolymer that in per molecule, the average number of polymerizable groups is greater than 1.Preferably, the average number of reactive group is at least 1.2, more preferably at least 1.5, particularly at least 2.0.Preferably the average number of group be at the most 64, more preferably in 15 scope at the most, particularly at the most 8, more specifically at the most in 7 scope.
Yet, also can under the existence of light trigger, solidify not containing the hydrophilic polymer of this polymerizable groups, by being exposed to light time formation grafting (grafts) when filling a prescription, realize particularly.
Hydrophilic coating compositions can be the form of solution or the dispersion that comprises liquid medium.Can make hydrophilic coating formula be coated to lip-deep any liquid medium herein, all satisfies the demand.The example of liquid medium is alcohols (for example methanol, ethanol, propanol, butanols or corresponding isomer and their aqueous mixture) or acetone, methyl ethyl ketone, oxolane, dichloromethane, toluene and their aqueous mixture or emulsion.
According to hydrophilic coating compositions of the present invention, can additionally comprise various additives, comprise some conventional compositions, pigment for example, dyestuff, disperse and stabilizing agent (being generally surfactant or emulsifying agent), rheology control agent, flow improver additive, extender, defoamer, plasticizer, thickening agent, heat stabilizer, levelling agent, anticrater agent, filler, precipitating inhibitor, UV absorbent, antioxidant, organic cosolvent, wetting agent, antifungal, antibacterial, antifreezing agent, coalescents, wax etc., these any stages in production process introduce or are introducing thereafter.
Hydrophilic coating base material thereon can be coated with and a series of geometries and material can be selected from.Base material can have texture, for example porous, atresia, smooth, coarse, smooth or uneven.Substrate support hydrophilic coating in its surface.Hydrophilic coating can be on the All Ranges of base material or on selection area.Hydrophilic coating can be applied in various physical form, comprises film, sheet, rod, pipe, moulding part (rule or irregular shape), fiber, fabric and granule.Suitable surface is to provide the surface of following required character, required character such as porous, hydrophobicity, hydrophilic, coloring (colorisability), intensity, flexibility, permeability, percentage elongation, wearability and wear resistant.The example of appropriate surfaces is for example that it forms or comprise metal, plastics, pottery, glass and/or composite by metal, plastics, pottery, glass and/or composite as lower surface.Hydrophilic coating can directly be coated on described surface, or can be coated on pretreatment or applied surface.Design pretreatment and coating are in order to contribute to hydrophilic coating to be adhered on base material.
Preferably, hydrophilic polymer coating is applied on medical apparatus and instruments.Medical apparatus and instruments can be implantable apparatus or external apparatus.This apparatus can short-term temporarily use, or permanent implanted for a long time.In some embodiments, suitable apparatus is those apparatuses that are generally used for providing for heart rhythm disorders, heart failure, valvular disease, angiopathy, diabetes, sacred disease and deficiency disorder, plastic surgery, neurosurgery, oncology, ophthalmology and ENT operation medical treatment and/or diagnosis.
The suitable example of medical apparatus and instruments comprises, but be not limited to, support, stent graft, adapter coincide, synthetic paster, lead-in wire, electrode, pin, seal wire, conduit, sensor, surgical unit, angiopoiesis ball, wound drain, isocon (shunt), pipe, transfusion cover (infusion sleeve), intraurethral cannula, bead, implant, blood oxygenation generator, pump, vascular graft, vascular access port (vascular access port), cardiac valve, annuloplasty ring, stitching thread, surgical clips, operation nail, pacemaker, implantable defibrillator, nerve stimulator, plastic surgery apparatus, cerebrospinal fluid isocon, implantable Teat pipette, vertebra cage, artificial intervertebral disc, the alternative apparatus of vertebral pulp, syrinx, intra-ocular lens and any pipe using in Minimally Invasive Surgery.
Be particularly suitable for apparatus used in this invention and comprise medical apparatus and instruments or assembly, for example conduit such as intermittent catheters, seal wire, support, syringe, metal and plastic implant, contact lens and medical tube.
Hydrophilic polymer coating can be coated on base material by for example dip-coating.Other method applying comprises spraying, washcoated, vapour deposition, brushing, roller coat and other methods known in the art.
Hydrophilic polymer coating can have one or more layers.One deck can be for dope layer being adhered to the priming coat on medical apparatus and instruments.
The invention still further relates to the method for preparing medical apparatus and instruments, it comprises following steps:
-at least part of medical apparatus and instruments with the coating of hydrophilic polymer coating is provided,
-provide to have higher than the boiling point of 100 ℃ with lower than the wetting agent of the viscosity of 500mPa.s, wherein wetting agent can comprise water with the amount of the 0-4.9 % by weight based on wetting agent gross weight,
-by the part of the medical apparatus and instruments being coated with by hydrophilic polymer coating with wetting agent so that wetted dose of lubricated mode of hydrophilic coating contact,
-optionally, by sterilization of medical instrument.
Hydrophilic polymer coating on medical apparatus and instruments must wetted dose of moistening.Term " moistening " is known in the art, and in a broad sense, refers to " comprising wetting agent ".Particularly, this term is used for describing and comprises enough wetting agent and carry out lubricated coating in this article.Lubricated coating has the coefficient of friction (COF) lower than 0.15, coefficient of friction as defined belowFor the concentration of wetting agent, the dry weight based on coating, the coating of moistening comprises at least 10 % by weight, preferably at least 50 % by weight, the wetting agent of at least 100 % by weight more preferably conventionally.For example, in a concrete embodiment of the present invention, the wetting agent that absorbs about 300-500 % by weight is feasible.
Preferably, can obtain the lubricated coating that the exsiccation time surpasses 15 minutes, the exsiccation time is in the upper mensuration of Harland friction testing instrument (Harland Friction tester).In the context of the present invention, the exsiccation time is: after taking out the wetting agent that apparatus is stored to also moistening from it, or after taking out in the packing being stored under wetting conditions from it at apparatus, coating keeps the lubricated persistent period.The exsiccation time can be determined by measure the variation of coefficient of friction that is exposed to the function of airborne time as conduit on Harland friction testing instrument.The exsiccation time is that wherein coefficient of friction reaches 0.2 or higher or in stricter test 0.15 or higher time point.This scheme is shown in embodiment.
Preferably, can obtain coefficient of friction lower than 0.20 lubricated hydrophilic coating, coefficient of friction records on Harland friction testing instrument.If while measuring under the clamping force of 100g and the pulling rate of 1cm/s on Harland FTS Friction tester, coating have 0.20 or less, preferably 0.15 or less friction, coating is considered to lubricate.This scheme is shown in embodiment.
Optionally, medical apparatus and instruments is through sterilizing.Sterilizing can be by appropriately combined realization that adopts heat, chemistry and/or irradiate.
Heat sterilization can carry out in autoclave, and wherein steam is heated to 120-135 ℃.During chemosterilization, medical apparatus and instruments is contacted with for example ethylene oxide (EtO), ozone or hydrogen peroxide.Radiation sterilization can be undertaken by for example electron beam, x-ray or radiation gamma.
Hydrophilic coating and/or wetting agent can comprise additive, and additive protective finish is in case the adverse effect of formed free radical during sterilizing.These additives are for example aliphatic compounds, alicyclic compound and/or antioxidant.
In principle, can use on any aliphatic stable compound and/or alicyclic stable compound, especially physiology, allow and nontoxic any this stable compound during preferably with concentration used.
The stable compound with relatively low molecular weight is specially suitable, and for example molecular weight is lower than 1000g/mol, more specifically 800g/mol or less, preferably 600g/mol or less compound.With the Compound Phase ratio with higher molecular weight, the use of low molecular weight compound can have one or more following advantages:
Particularly preferred aliphatic series and/or alicyclic stable compound comprise alcohol, ether, aldehyde, ketone, amide, ester, mercaptan, thioesters, organic acid and their combination.It is highly preferred that (saturated) aliphatic compound, its choosing group that freely (saturated) aliphatic alcohol, ether, aldehyde, ketone, amide, ester, mercaptan, thioesters, organic acid and their combination form.
Preferred alcohol comprises aklylene glycol, for example diethylene glycol, triethylene glycol, TEG, propylene glycol, dipropylene glycol, tripropylene glycol, (low-molecular-weight) ethoxylation or propenoxylated alcohol and/or amine, as ethanolamine, diethanolamine, triethanolamine, Polyethylene Glycol (PEG), the Mw poly alkylene glycol of about 600g/mol at the most particularly, lower aliphatic alcohols (C particularly 1-C 8alcohol, C more specifically 2-C 4alcohol, for example isopropyl alcohol, ethanol, 1-propanol and n-butyl alcohol), and their combination.Adopt carbohydrate, monosaccharide, glucose more specifically particularly, further realized good result.
Preferred ether comprises poly alkylene glycol, for example PEG.
Suitable aldehyde comprises C1-C8 aldehyde.Preferred aldehyde comprises formaldehyde, acetaldehyde and butyraldehyde.
Suitable ketone comprises C3-C8 ketone.Preferred ketone comprises acetone and methyl ethyl ketone.
Suitable organic acid comprises C1-C8 organic acid.Preferred organic acid comprises formic acid.
The invention still further relates to the packing that comprises medical apparatus and instruments or medical apparatus and instruments parts, this medical apparatus and instruments or medical apparatus and instruments parts comprise lubricated hydrophilic coating, and its intermediate package is airtight.For example packing can be made by plastics or aluminium foil.Packing can comprise extra wetting agent.
Preferably, comprise the medical apparatus and instruments through sterilizing.
Now by following non-limiting example, illustrate the present invention.
Embodiment 1-5 and Comparative experiment A-H
Priming coat formula
By by following components dissolved in ethanol, prepare sole formula.
Figure BDA0000423914900000071
PTGL1000 (T-H) 2the synthetic of oligomer is described in WO2007/065722.
Hydrophilic coating formula
By by following components dissolved in the mixture (1:1, based on weight) of water/ethanol, prepare hydrophilic coating formula.
% by weight
Figure BDA0000423914900000081
Coating applies
On Harland PCX175/24 coating machine, be coated with the pvc pipe of diameter 14Fr, long 30cm.
First according to the impregnation solution of priming coat in table 1, with priming coat formula dip-coating pvc pipe curing.According to the impregnation solution of hydrophilic coating, apply hydrophilic coating formula and solidify subsequently.In coating, temperature and humidity is respectively 2 ℃ of 21 ℃ of +/-and 40%+/-15%.
On Harland PCX175/24 coating machine, be equipped with Harland Medical system UVM400 lamp.The light intensity average out to 60mW/cm of Harland PCX175/24 coating machine 2, and with being equipped with the Solatell Sola Sensor 1 of International Light detector SED005#989 to measure, input light: W#11521, light filter wbs320#27794.The IL1400A workbook that uses International Light, it can obtain from network: www.intl-liRht.com.For applied parameter in PCX coating machine referring to table 1.
To manage in imnersional wetting dose, flood 2 minutes, by the speed of 1cm/s, from wetting agent, take out thereafter.After removing, directly assess the coating of moistening from wetting agent.
All measurements are all carried out under the relative temperature of 40-50%.
The parameter adopting in table 1.PCX coating machine
Method of testing
Viscosity test
At the temperature of 25 ℃, according to ASTM D445, on viscometer, measure the viscosity of wetting agent.
Lubricity test
On Harland FTS5000 friction testing instrument (HTF), carry out lubricity test.The scheme of selecting arranges referring to the HFT of table 2.Friction testing instrument plate is used Harland Medical Systems, P/N102692, FTS5000 friction testing instrument plate, 0.125*0.5**0.125,60 durometers.
When activating " operation test " (" run test "), import needed test specification subsequently.Sample is fixed on specimen holder.The transmission system of tester is moved to desired position, and by carrying out activation scheme by " beginning " (" start ").Save data after completing.Specimen holder is removed from tester and subsequently conduit is removed from frame.
Table 2.HFT arranges
Transmission system moves (cm) 10
Chucking power (g) 100
Pulling rate (cm/s) 1
Acceleration time (s) 2
The coefficient of friction that use records (COF) is evaluated coating performance.COF be defined as the frictional force that records chucking power.
After dry 10,15 and 30 minutes, on sample, measure COF.Directly start from wetting agent remove at sample drying time.
Judge that COF<0.15 is as good.Judge COF between 0.15 and 0.20 as too high; COF>0.20 is for poor.
Table 3, the result of lubricity test
Figure BDA0000423914900000111
The resulting Bearing performance of glyceryl triacetate goes out high COF.According to observations, the not coated reduction of fractions to a common denominator of this compound absorbs.
The resulting Bearing performance of acetin and diacetine goes out low friction valve, and this value remains unchanged at the whole test period of 30 minutes.While even remeasuring sample after 16 hours in air, almost do not observe variation (COF is 0.12).
Contrast experiment C-F shows, and to adding coating that water can shorten moistening in wetting agent, removes rear coating keep the lubricated time from wetting agent.

Claims (13)

1. have higher than the boiling point of 100 ℃ and lower than the wetting agent of the viscosity of 500mPa.s the purposes for hydrophilic polymer coating on lubricated base material, wherein said wetting agent comprises water with the amount of the 0-4.9 % by weight based on described wetting agent gross weight.
2. purposes as claimed in claim 1, wherein said wetting agent comprises at least one hydroxyl.
3. purposes as claimed in claim 1 or 2, wherein said wetting agent is selected from the group that comprises glyceride, glycerin ether, glycol, diol ester and glycol ethers.
4. the medical apparatus and instruments that comprises hydrophilic polymer coating, described hydrophilic polymer coating is had higher than the boiling point of 100 ℃ with lower than the wetting agent moistening of the viscosity of 500mPa.s, and wherein said wetting agent comprises water with the amount of the 0-4.9 % by weight based on described wetting agent gross weight.
5. medical apparatus and instruments as claimed in claim 4, wherein said wetting agent is containing at least one hydroxyl.
6. the medical apparatus and instruments as described in claim 4 or 5, wherein said wetting agent is selected from the group that comprises glyceride, glycerin ether, glycol, diol ester and glycol ethers.
7. the medical apparatus and instruments as described in any one in claim 4-6, wherein said hydrophilic polymer coating is cross-linked.
8. the medical apparatus and instruments as described in any one in claim 4-7, wherein said hydrophilic polymer coating comprises polyvinyl pyrrolidone (PVP).
9. the medical apparatus and instruments as described in any one in claim 4-8, it has the exsiccation time that surpasses 15 minutes, and the described exsiccation time is measured on Harland friction testing instrument.
10. the medical apparatus and instruments as described in any one in claim 4-8, it has the coefficient of friction lower than 0.2, and described coefficient of friction is measured on Harland friction testing instrument.
The method of the medical apparatus and instruments of 11. preparations as described in any one in claim 4-10, it comprises following steps:
A., at least part of medical apparatus and instruments with the coating of hydrophilic polymer coating is provided,
B. provide and have higher than the boiling point of 100 ℃ with lower than the wetting agent of the viscosity of 500mPa.s, wherein said wetting agent comprises water with the amount of the 0-4.9 % by weight based on wetting agent gross weight,
C. by the part of the described medical apparatus and instruments by the coating of described hydrophilic polymer coating with described wetting agent so that the mode that described hydrophilic coating is lubricated by described wetting agent contact,
D. optionally, by described sterilization of medical instrument.
12. packings that comprise the medical apparatus and instruments as described in any one in claim 4-10, wherein said packing is airtight.
13. packings as claimed in claim 12, wherein said medical apparatus and instruments is through sterilizing.
CN201280025917.6A 2011-07-29 2012-07-27 Medical device comprising a wetted hydrophilic coating Pending CN103561789A (en)

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US201161513021P 2011-07-29 2011-07-29
EP11175951 2011-07-29
EP11175951.0 2011-07-29
US61/513,021 2011-07-29
PCT/EP2012/064820 WO2013017547A1 (en) 2011-07-29 2012-07-27 Medical device comprising a wetted hydrophilic coating

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