WO2009030976A1 - Dispositif médical et revêtement lisse pour ce dispositif - Google Patents

Dispositif médical et revêtement lisse pour ce dispositif Download PDF

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Publication number
WO2009030976A1
WO2009030976A1 PCT/IB2007/003435 IB2007003435W WO2009030976A1 WO 2009030976 A1 WO2009030976 A1 WO 2009030976A1 IB 2007003435 W IB2007003435 W IB 2007003435W WO 2009030976 A1 WO2009030976 A1 WO 2009030976A1
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WO
WIPO (PCT)
Prior art keywords
medical device
piston
container
coating
intended
Prior art date
Application number
PCT/IB2007/003435
Other languages
English (en)
Inventor
Laurence Boulange
Séverine DOMANGE
Jean-Bernard Hamel
Original Assignee
Becton Dickinson France
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 Becton Dickinson France filed Critical Becton Dickinson France
Priority to PCT/IB2007/003435 priority Critical patent/WO2009030976A1/fr
Publication of WO2009030976A1 publication Critical patent/WO2009030976A1/fr

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Classifications

    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B25/00—Layered products comprising a layer of natural or synthetic rubber
    • B32B25/04—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B25/08—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/322—Layered products comprising a layer of synthetic resin comprising polyolefins comprising halogenated polyolefins, e.g. PTFE
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2255/00—Coating on the layer surface
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/746—Slipping, anti-blocking, low friction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter

Definitions

  • the present invention relates in general to a medical device, for example a syringe, comprising at least one smooth coated part, , for example a container and/or a piston, said parts being able to move one relative to the other, for example translationally and/or rotationally, when the medical device is operated.
  • a medical device for example a syringe
  • at least one smooth coated part for example a container and/or a piston
  • said parts being able to move one relative to the other, for example translationally and/or rotationally, when the medical device is operated.
  • distal means the part furthest from the user's hand
  • proximal means the part closest to the user's hand.
  • distal direction means the direction of administration, i.e., towards the patient
  • proximal direction means direction opposite to the direction of administration, i.e., away from the patient.
  • the container is intended to accommodate a medical product in the liquid, gaseous, fluid, pasty or lyophilized phase, which may have a variable viscosity and is therefore able to flow, particularly because of the pressure exerted as a result of the movement of the piston relative to the container.
  • the piston is preferably made at least partially from a viscoelastic material so as to ensure tightness in the region of contact between the container and the piston.
  • the volume of the medical product contained in the medical device varies, for example decreases, according to the relative movement between the two parts of the medical device.
  • the present invention also relates to a part for a medical device, this part being intended to cooperate with a complementary part by moving relative to said complementary part when the medical device is operated, said part being provided with a coating.
  • X represents a halogen, for example F, or a hydrogen
  • Yi, Y 2 , Y 3 , Y 4 each independently represent a halogen, for example Cl, or a hydrogen.
  • the polymer material is chosen from the group consisting of poly(p-xylylene) polymers, which may or may not be substituted, and in particular, poly(p-xylylene), poly(p-meta-chloroxylylene), poly(p-ortho- chloro/meta-chloroxylylene) and poly(p-difluoroxylylene).
  • poly(p-xylylene) polymers which may or may not be substituted, and in particular, poly(p-xylylene), poly(p-meta-chloroxylylene), poly(p-ortho- chloro/meta-chloroxylylene) and poly(p-difluoroxylylene).
  • the latter four polymer materials are manufactured and sold by UNION CARBIDE CORPORATION, or by SPECIALTY COATING SYSTEMS, under the names Parylene N, Parylene C, Parylene D and Parylene AF 4 , respectively.
  • polystyrene foams have various properties, for example imperviousness to gases, for example oxygen, and to dry-lubricating liquids, for example water, which make them particularly attractive for use in numerous biomedical applications, particularly for certain medical devices.
  • a polymer material of the poly(p-xylylene) type is not employed by injection, dissolving or suspending in a solvent, but is used by depositing it onto the part by a direct dry vacuum deposition process using the following protocol:
  • the vaporized dimer is then pyrolized, still under vacuum but at a higher temperature, for example at 65O 0 C, in order to obtain the reactive monomer form corresponding to the aforementioned dimer and to the aforementioned chemical unit, and
  • the reactive monomer is deposited directly on the entire accessible developed surface of the part, both internal and external, and polymerized at ambient temperature under a low vacuum, in a method akin to the vacuum deposition of a thin metal layer, so as to obtain a continuous coating of (substituted or unsubstituted) poly(p-xylylene) of relatively uniform thickness, completely (with no discontinuity) covering the part of the medical device.
  • Adhesion between the coating and the part may be direct, particularly by means of chemical bonds formed at the time of deposition and polymerization of the reactive monomer, between said part and the polymer material, or indirect, by way of a tie layer or primer layer applied beforehand to the surface that is to be coated, if appropriate after that surface has been cleaned or prepared.
  • the viscoelastic material of which the piston of a medical device such as a syringe may be made is generally an elastomeric material which alters, in particular degrades chemically over time. This possible degradation is sometimes initiated by the processes used to sterilize the medical devices containing them, for example bringing them into contact with ionizing radiation. Such degradation alters the surface properties of the elastomeric material and may cause inadequate interactions with the medical product potentially present in the medical device. Such degradation may also affect other surface properties of the elastomeric material, for example the adhesion or friction with respect to one of the other parts of the medical device.
  • the mean roughness Ra that is to say the surface finish
  • the mean roughness Ra that is to say the surface finish
  • the roughness Ra is measured according the following method : roughness measurements done in triplicate are performed by using a profiler Wyko NT 1100 (Veeco Instruments Inc. Arlington USA) on scans 370 ⁇ m x 240 ⁇ m with a VSI mode (Vertical Scanning Interferometry). The calibration of the apparatus is performed following the procedure Wl 7.6-20 using measuring instruments traceable to the National Institute of Standards and Technology (NIST).
  • a first aspect of the present invention is a medical device comprising at least one first part coated with a coating having a composition comprising at least one polymer material comprising polymer chains having the following repeat unit:
  • X represents a halogen, for example F, or a hydrogen
  • Yi, Y 2 , Y 3 , Y 4 each independently represent a halogen, for example Cl, or a hydrogen, characterized in that the outer surface of said coating has a mean roughness Ra of less than 2.5 ⁇ m.
  • the medical device of the invention with at least one part coated with a coating having such a roughness allows the medical product intended to be present in the medical device to be preserved.
  • said mean roughness Ra is less than 2 ⁇ m, preferably less than 1.5 ⁇ m and, for example, of the order of 1.0 ⁇ m.
  • said one first part is chosen among a piston, the internal surface of a container intended to receive a medical product, or an intermediate part located between a piston and the internal surface of a container intended to receive a medical product.
  • the medical device further comprises at least one second part being intended to move relative to said first part in a sliding relationship when said medical device is operated, said first and second parts defining between them a contact region.
  • a roughness Ra equal or less than 2.5 ⁇ m for the outer surface of the coating of the medical device of the invention allows a smooth gliding of a first coated part, like a piston, relative to a second part, like a container.
  • the medical device of the invention allows to have decreased activation, sustainable and final forces for moving a first part relative to a second part, for example for moving a piston within the container in which it is lodged, without having to add a lubricant and while preserving the tightness at the contact region between said two parts.
  • the piston in a medical device such as a syringe, the piston must be able to be moved relative to the container or syringe body, through a gliding movement, while at the same time ensuring the tightness with said container, so that all of the product to be administered escapes only via the distal end of the container and does not leak out of said container via the piston at the proximal end of the container.
  • the medical device of the invention thanks to a specific coating having a specific roughness range at the contact region between the piston and the container, allows the successful completion of these two relatively incompatible requirements.
  • the medical device of the invention it is possible to decrease the total amount of lubricant, for example silicone oil, that is necessary in such a medical device.
  • the medical device of the invention allows to limit the risk of interaction between a lubricant, for example silicone oil, and the therapeutic molecules potentially stored in the container of the medical device prior to delivery to a patient.
  • a lubricant for example silicone oil
  • one of said first and second parts consists of a viscoelastic material designed to encourage tightness at said contact region.
  • said first part is a piston and said second part is the internal surface of a container intended to receive a medical product or an intermediate part located between said piston and the internal surface of a container intended to receive a medical product, said piston being movable within said container when said medical device is operated.
  • said first part is an intermediate part located between a piston and the internal surface of a container intended to receive a medical product
  • said second part is a piston or the internal surface of a container intended to receive a medical product, said piston being movable within said container when said medical device is operated.
  • said first part is the internal surface of a container intended to receive a medical product
  • said second part is a piston or an intermediate part located between a piston and the internal surface of a container intended to receive a medical product, said piston being movable within said container when said medical device is operated.
  • said second part is further coated with said coating at least in the contact region.
  • said coating is continuous and elastic.
  • said polymer material is chosen from the group consisting of poly(p-xylylene), poly(p-meta-chloroxylylene), poly(p-ortho-chloro/meta-chloroxylylene) and poly(p-difluoroxylylene).
  • said polymer material consists of poly(p-meta- chloroxylylene).
  • said coating has a mean thickness ranging from 2 to 10 ⁇ m, preferably, ranging from 3 to 10 ⁇ m, and more preferably ranging from 3 to 5 ⁇ m.
  • a thickness has the advantage of ensuring that, regardless of the profile, shape or surface characteristics of the coated part, at the end of the process of depositing/polymerizing the polymer material, the coating covers the entirety of the part over the desired region, namely at least the region corresponding to the contact region, with no discontinuity, and does so durably.
  • said contact region further includes a lubricant other than said coating.
  • said coating provided on said container and/or on said piston and/or on said intermediate part is at least partially covered with said lubricant.
  • said piston or said container or said intermediate part, not provided with said coating is at least partially covered with said lubricant.
  • said lubricant contains silicone.
  • the medical device includes an injection device.
  • a further aspect of the invention is a part for a medical device, the part being intended to cooperate in relative movement with respect to a complementary part in order to operate said medical device, said part comprising a coating consisting of at least one polymer material comprising polymer chains consisting of the following repeat unit:
  • said coating having a outer surface intended to move relative to said complementary part, characterized in that said outer surface of said coating has a mean roughness Ra of less than 2.5 ⁇ m.
  • said outer surface has a mean roughness Ra of less than 2 ⁇ m, preferably less than 1.5 ⁇ m and, for example, of the order of 1.0 ⁇ m.
  • Said coating may be continuous and elastic.
  • said polymer material is chosen from the group consisting of poly(p-xylylene), poly(p-meta-chloroxylylene), poly(p-ortho-chloro/meta- chloroxylylene), and poly(p-difluoroxylylene).
  • said polymer material consists of poly(p-meta-chloroxylene).
  • the mean thickness of said coating ranges from 2 to 10 ⁇ m, preferably from 3 to 10 ⁇ m, and more preferably from 3 to 5 ⁇ m.
  • said part comprises at least one of - a container intended to accommodate a medical product, and/or
  • FIG. 1 depicts, schematically and in cross section, a portion of a medical device considered by the present invention and according to a first embodiment thereof
  • FIG. 2 depicts, again schematically and in cross section, a portion of a medical device according to a second embodiment of the invention.
  • a medical device 1 considered by the present invention for example a syringe, comprises at least one first coated part.
  • the first coated part is the piston of a syringe.
  • the medical device is a vial, intended to receive a medical product, and that may be closed by a plug.
  • the first coated part may be either the plug or the internal surface of the vial.
  • the medical device 1 comprises a first and a second parts 2 and 3, one being complementary to the other, for example a piston 3 housed in a container 2, the piston 3 and the internal surface of the container 2 being in contact with one another via a contact region 10.
  • the piston 3 and the container 2 are able to move one with respect to the other in a predetermined gliding movement 4, for example translationally and/or rotationally.
  • the container 2 is intended to accommodate a medical product 6 in the liquid, gaseous or fluid phase, the volume of said product 6 varying according to the movement of the piston 3 with respect to the container 2.
  • the piston 3 is caused to move distally along arrow 4 of figure 1 in order to push the product 6 out of the container 2.
  • the piston 3 is designed to deform in order to tighten the contact region 10.
  • a coating 8 which is continuous, intrinsically elastic and firmly secured to the piston 3.
  • the piston 3 comprises an intermediate part, under the form of an independent seal 9 housed in a groove 11 made in the piston 3, which is made of viscoelastic material, for example of elastomer, encouraging deformation of the piston 3 and therefore tightening the contact region 10.
  • the seal 9 is also made out of a viscoelastic material, for example an elastomer, in order to ensure tightness at the contact region 10.
  • the seal 9 is provided with a coating 8.
  • the piston 3 is made in its entirety of a viscoelastic material, for example an elastomer. Irrespective of the embodiment considered, the contact region 10 between the internal surface of the container 2 and the piston 3 also determines a region of gliding contact between the piston 3 and the container 2.
  • the internal surface of the container 2 and the piston 3 determine a contact region 10 which is provided with a coating 8.
  • the coating 8 is provided on the piston 3.
  • the coating 8 is provided on the internal surface on the container 2.
  • the coating 8 may be formed of two individual coatings, one provided on the internal surface of the container 2 and one on the piston 3.
  • the coating 8 is provided on one or on the two faces of an intermediate part, such as the seal 9 shown on figure 1 , located between the piston 3 and the container 2.
  • the coating 8 of the medical device 1 of the invention encourages the gliding of the piston 3 relative to the container 2 at the time of administration of the product 6. Moreover, the coating 8 also ensures static and dynamic tightness at the contact region 10 of the two complementary parts, namely the piston 3 and the container 2. In particular, before use of the medical device 1 , for example during storage, the coating 8 ensures the static tightness between the piston 3 and the container 2 by preventing the leakage of the product 6 at the contact region 10 between the piston 3 and the internal surface of the container 2.
  • the coating 8 ensures the dynamic tightness between the piston 3 and the internal surface of the container 2 by preventing the leakage of the product 6 at the contact region 10 between the piston 3 and the container 2 while the piston 3 is moving relative to the container 2.
  • the coating 8 consists of at least one polymer material comprising polymer chains consisting of the following repeat unit:
  • Y 2 , Y3 and Y 4 each independently represent a halogen, for example Cl, or a hydrogen.
  • This coating 8 according to the invention is obtained by dry vacuum deposition/polymerization at ambient temperature, as described above.
  • the outer surface of the coating 8 has a mean roughness of less than 2.5 ⁇ m, preferably of less than 2 ⁇ m, more preferably of less than 1.5 ⁇ m, for example of the order of 1.0 ⁇ m.
  • the person skilled in the art knows that it is possible to control the surface finish, namely the roughness obtained, by intermingling the pistons 3 with one another during the CVP process, on the one hand, and by intermingling them with inserted elements (inert parts) mixed in with the pistons 3 while they are being intermingled.
  • the roughness Ra is measured according the following method : roughness measurements done in triplicate are performed by using a profiler Wyko NT 1100 (Veeco Instruments Inc. Arlington
  • a roughness of less than 2.5 ⁇ m, measured as described hereinabove, for the outer surface of a coating 8 of a medical device 1 of the invention allows a smooth gliding of a such coated part, like a piston 3, relative to a complementary part, like a container 2.
  • the coating 8 according to the invention has for example a thickness ranging from 2 to 10 ⁇ m. Hence, when the contact region 10 is provided with two individual coatings 8, one provided on the internal surface of the container
  • the thickness of the coating 8 of the medical device will therefore be the sum of the thicknesses of each individual coating 8.
  • the rate of deposition/ polymerization is directly proportional to the square of the reactive monomer concentration, and inversely proportional to the absolute temperature of the part exposed to the monomer, this information allowing him to modify and control the thickness of the coating deposited on the part.
  • the present invention considers various substrates or viscoelastic materials to be appropriate to the deposition of a coating 8 as previously defined, these being various natural or synthetic elastomers: silicones, nitrile- based elastomers, natural or synthetic rubber, fluorocarbon elastomers, polyurethanes. As a preference, the invention will devote itself to bromobutyl and chlorobutyl synthetic elastomers.
  • the mean thickness of the coating 8 ranges from 2 to 10 ⁇ m and preferably from 3 to 10 ⁇ m and, more preferably still, from 3 to
  • the polymer material is preferably chosen from the group consisting of poly(p-xylylene), poly(p-meta-chloroxylylene), poly(p-ortho- chloro/meta-chloroxylylene) and poly(p-difluoroxylylene).
  • the polymer material consists of poly(p-meta-chloroxylylene).
  • test protocol is performed on a medical device 1 of the syringe type, according to the second embodiment depicted in Figure 2 of the present application.
  • the container 2 is a glass syringe body accommodating a piston 3 able to move translationally along arrow 4 of figure 2 inside the container 2.
  • the piston 3 is made of a viscoelastic material such as bromobutyl rubber commercially available at West Company, or chlorobutyl rubber commercially available at West Company.
  • the coated pistons 3 were coated with a coating 8 as previously defined, in which the polymer material is poly(p-meta-chloroxylylene) (Parylene C).
  • the polymer material is poly(p-meta-chloroxylylene) (Parylene C).
  • Parylene C poly(p-meta-chloroxylylene)
  • Table 1 configurations of pistons A, B1 and C
  • the surface finishes of the coatings of the coated pistons were examined by enlarging them using a scanning electron microscope, observed on a scale of 10 to 20 ⁇ m.
  • Ra represents the mean roughness (the arithmetic mean of the various values of a roughness profile) and is expressed in ⁇ m.
  • Rt represents the maximum peak-to valley height in a roughness profile and is expressed in ⁇ m.
  • Tests were performed to determine the necessary forces for moving each piston with respect to the container in which it is housed. These tests were performed using a LLOYD-CB190 tensile testing machine dynamometer using NEXYGEN operating software, according to two test protocols outlined briefly below.
  • Activation Gliding Force (AGF) tests were applied on containers filled with 1 ml_ of demineralised water and each plugged with one piston to be tested (coated or uncoated). Each container-piston system was tested 32 times in order to ensure the reproducibility and to validate the results. To prepare the 32 syringes for a system, and particularly to insert the piston in the container, a Groninger machine was used.
  • the friction force B is the force required, under static conditions, to break the contact at the contact region 10 between the piston 3 and the container 2,
  • the friction force S is the force required, under dynamic conditions, for moving the piston 3 in the container 2.
  • the friction force S is measured half way of the piston travel.
  • the container 2 was used filled with water,
  • the friction force F is the force required, again in dynamic mode, to move the piston 3 when it reaches the end of its travel in the container 2.
  • the friction force F is measured with a container 2 empty of medical product 6 but initially filled with water.
  • samples undergo an accelerated aging in a climatic room.
  • the conditions of the Heraeus climatic room were a temperature of 4O 0 C and a humidity rate of 75%.
  • the systems under assessment were placed in the climatic room during 1 , 3 and 6 months.
  • piston A which had no coating according to the invention, had a relatively rough surface finish with peaks and troughs.
  • the coating 8 of the invention on piston B1 had relatively smooth and uniform surface finishes, and the coating on the comparative piston B2 had a relatively rough surface finish with various irregularities.
  • Pistons B1 (according to the invention) and B2 (comparative) with their coatings were fitted and assembled in a glass container 2, such as a syringe body, coated on its internal surface with a layer of silicone at a rate of
  • the friction forces B, S and F were measured by the protocol described before, using the aforementioned equipment, at a rate of travel of 380 mm/min. Each measurement of the friction force B, S and F was repeated 30 times. The results obtained are collected in Table 2 below. The bracketed values correspond to the standard deviation.
  • a coating 8 with a relatively smooth surface finish according to the invention is preferable in order to limit the friction and optimize the sliding of the piston 3 in the container 2.
  • the pistons A, B1 , B2 and C of example 1 were coated by spraying respectively various quantities, respectively 5 ⁇ g/cm 2 , 15 ⁇ g/cm 2 and 50 ⁇ g/cm 2 , of a silicone-based lubricant (with a viscosity of 1000 cst) and were assembled in containers 2 themselves coated on their internal surface with a 50 ⁇ g/cm 2 coating of silicone.
  • the silicone amount was measured prior to any AGF test. This measurement was done in order to quantify the silicone amount in the system, i.e. silicone on the piston and silicone on the internal surface of the container and thus, define the low limit for the silicone amount acceptable for functional testing (AGF test).
  • Example 2 The test protocol of Example 2 was repeated with pistons A, B1 , B2 and C, with various levels of lubrication thereof, these levels being expressed by weight of silicone employed. The results obtained are given in Table 5 below. Table 5 : Activation Gliding Forces, Pistons A, B1 and C
  • Example 2 The protocol of Example 2 was repeated using a different syringe body or container 2, which was not coated with an internal film of silicone oil. By contrast, a silicone oil was used on the pistons 3 prior to assembly or fitting. The results according to Table 6 were then obtained. Table 6
  • Scenario 1 a silicone lubricant was deposited and baked onto the internal surface of the syringe body 2, at a rate of 40 ⁇ g for a surface area of 10 cm 2 , but no silicone was used or sprayed on the pistons 3.
  • the optimum mean thickness for the coating 8 for the medical device 1 of the invention ranges between 2 and 10 ⁇ m and preferably from 3 to 10 ⁇ m and, more preferably still, from 3 to 5 ⁇ m.
  • the coating according to the invention is on the container rather than on the piston.
  • the piston may be provided with a coating of silicone to face the coating at the contact region.
  • the container 2 according to the invention may be made of any kind of material - glass, plastic, polymer.
  • an adhesion-promoting layer that encourages the coating to bond with the container 2 will be provided.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif médical (1) comprenant au moins un premier élément (2; 3) pourvu d'un revêtement (8) qui présente une composition comprenant au moins une matière polymère comprenant des chaînes polymères comportant l'unité de répétition (I), dans laquelle X représente un halogène, par exemple F, ou un hydrogène et dans laquelle Y1, Y2, Y3 et Y4 représentent chacun indépendamment un halogène, par exemple Cl, ou un hydrogène. L'invention se caractérise en ce que la surface extérieure dudit revêtement (8) présente une rugosité moyenne Ra inférieure à 2,5 μm. L'invention concerne également un élément (2; 3) pour un dispositif médical (1) destiné à coopérer avec un autre élément (3; 2) et pourvu d'un tel revêtement (8).
PCT/IB2007/003435 2007-09-03 2007-09-03 Dispositif médical et revêtement lisse pour ce dispositif WO2009030976A1 (fr)

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