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WO2009030974A1 - Dispositif médical et revêtement lubrifiant pour ce dispositif - Google Patents

Dispositif médical et revêtement lubrifiant pour ce dispositif Download PDF

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Publication number
WO2009030974A1
WO2009030974A1 PCT/IB2007/003339 IB2007003339W WO2009030974A1 WO 2009030974 A1 WO2009030974 A1 WO 2009030974A1 IB 2007003339 W IB2007003339 W IB 2007003339W WO 2009030974 A1 WO2009030974 A1 WO 2009030974A1
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WO
WIPO (PCT)
Prior art keywords
coating
medical device
piston
container
pistons
Prior art date
Application number
PCT/IB2007/003339
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/IB2007/003339 priority Critical patent/WO2009030974A1/fr
Publication of WO2009030974A1 publication Critical patent/WO2009030974A1/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

Definitions

  • the present invention relates in general to a medical device with a lubricant coating, for example a syringe, comprising two parts, for example a container and 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 with a lubricant coating for example a syringe
  • two parts for example a container and 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.
  • 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.
  • 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).
  • 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.
  • 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 dimer is vaporized under vacuum (1 mm of mercury for example) and at approximately 15O 0 C for example,
  • 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.
  • the coating thus obtained adheres to the part directly or indirectly. Because of its slip characteristics, the coating facilitates the relative movement between the two parts of the medical device. In addition, the elastic behaviour of the coating allows it in a resilient manner to accommodate the deformations and stresses imposed on the part provided with it, for example the piston, as it slides in the container. Thus, tightness in the region of contact between the piston and the container can be guaranteed to be maintained.
  • 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 polymer material coating of the poly(p-xylylene) type has a thickness ranging from 0.25 ⁇ m to 1 ⁇ m, it being possible for a coating thickness of 0.10 to 76 ⁇ m to be obtained in a single stage.
  • this thickness range seems inappropriate for most medical devices, particularly of the syringe type. This is because with this range of thicknesses, when the two parts of the medical device move relative to one another, the coating breaks, tears or breaks up.
  • Document US 5,000,994 devotes itself to medical devices, of the syringe type, comprising a part of the piston type consisting of a viscoelastic or elastomeric material and at least one contact region of which provides tightness with the container of the medical device, in this instance the syringe body. More specifically, that document is concerned with the automatic fitting of pistons into syringe bodies and with the circulation or transportation for that purpose of loose pistons, in contact with one another, in gravity-fed feeders, for example those with a vibrating bowl.
  • Such a thickness is undoubtedly suitable for reducing the coefficient of friction between pistons, outside the medical devices that incorporate them, in industrial processes where they are handled loose.
  • a coating as thin as this is unable to withstand the friction forces involved in the relative movement between two parts of a medical device, and is unable to generate a durable and mechanically strong seal therebetween, particularly once the medical device has been sterilized.
  • the thicknesses considered for the coating of a first part movable relative to a second part seem far too low.
  • a plastic or metal container is provided with a polyparaxylylene coating 0.25 to 25 ⁇ m thick-so-as to redticeHts- coefficient of friction. It is clearly evident from the foregoing explanations that a coating of the order of 0.25 ⁇ m thick is unsuitable for the application of the invention. Furthermore, a 25 ⁇ m coating would be too thick, making it more rigid and adversely affecting its elastic behaviour. The result would be an adverse effect on the desired function of tightness in the region of contact between the two moving parts. Furthermore, nothing in document US 5,354,286 is able to demonstrate that a narrower and better targeted range of values would provide an answer to the problems that the invention proposes to solve.
  • the viscoelastic material of which the piston of a medical device such as 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, for example the adhesion or friction with respect to one of the other parts of the medical device.
  • the mean thickness of the coating needs to range from 3 to 10 ⁇ m, preferably from 3 to 5 ⁇ m.
  • Such a thickness also 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.
  • a first aspect of the present invention is a medical device comprising at least a first part and a second part, said first and second parts being able to move one relative to the other and determining between them at least one contact region, at least one of said first and second parts being provided with at least one coating designed to at least encourage the relative sliding of said first and second parts one relative to the other and tightness in said contact region, and said coating consisting of at least one polymer material comprising polymer chains having the following repeat unit:
  • X represents a halogen, for example F, or a hydrogen
  • Y 1 , Y 2 , Y 3 , Y 4 each independently represent a halogen, for example Cl, or a hydrogen, characterized in that the mean thickness of said coating ranges from 3 to 10 ⁇ m.
  • 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 thickness range at the contact region between the piston and the container, allows the successful completion of these two relatively incompatible requirements.
  • distal end of a component or of a device means the end furthest away from the hand of the user and the proximal end means the end closest to the hand of the user.
  • proximal direction and proximally mean in the direction opposite to the direction of injection.
  • 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
  • the mean thickness of said coating ranges from 3 to 5 ⁇ m.
  • said first part is a container intended to accommodate a medical product and said second part is a piston movable in said container in order to vary the volume of said medical product contained in said container.
  • said second part consists of a viscoelastic material designed to encourage tightness at said contact region.
  • the first part is a container intended to accommodate a medical product, said medical device comprising a piston movable in said container, said second part being an intermediate part located between said container and said piston.
  • Said coating may be provided at least on said container. In another embodiment of the invention, said coating is provided at least on said piston.
  • said coating is provided at least on said intermediate part.
  • said coating is continuous and elastic.
  • Said 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).
  • said contact region further includes a lubricant other than said coating.
  • said coating provided on said container or on said piston 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.
  • said coating is designed to have at least one outer surface relative to which at least one of said first and second parts is intended to move, said outer surface having a mean roughness Ra of less than 2.5 ⁇ m, preferably less than 2 ⁇ m and, for example, of the order of 1.0 ⁇ m.
  • said polymer material consists of poly(p-meta-chloroxylene).
  • said first part is made out of glass.
  • said first part is a glass container.
  • the medical device includes an injection device.
  • a medical device 1 considered by the present invention for example a syringe, 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 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.
  • at least part of the developed surface of the piston 3, which corresponds to the contact region 10 is provided with a coating 8 which is continuous, intrinsically elastic and firmly secured to the piston 3.
  • the piston 3 comprises 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.
  • the contact region 10 between the container 2 and the piston 3 also determines a region of gliding contact between the piston 3 and the container 2.
  • 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 container 2.
  • the coating 8 may be formed of two individual coatings, one provided on the container 2 and one on the piston 3.
  • the coating is provided on one or on the two faces of an intermediate part located between the piston and the container.
  • 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 container 2. When the medical device 1 is in use, the coating 8 ensures the dynamic 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 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:
  • This coating 8 according to the invention is obtained by dry vacuum deposition/polymerization at ambient temperature, as described above.
  • the coating 8 according to the invention has a thickness ranging from 3 to 10 ⁇ m. Hence, when the contact region 10 is provided with two individual coatings 8, one provided on the container 2 and one on the piston 3, the thickness of the coating 8 of the medical device will therefore be the sum of the thicknesses of each individual coating 8.
  • the person skilled in the art will know how to deposit and control a predetermined thickness of the polymer material adopted, particularly by varying the time for which the part that is to be coated is exposed to the reactive monomer form of the poly(p-xylylene) chosen. Furthermore, a person skilled in the art knows that 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 3 to 10 ⁇ m and preferably from 3 to 5 ⁇ m.
  • Such a specific thickness range allows a smooth gliding of two complementary parts relative to each other while ensuring tightness at the contact region between said two complementary parts.
  • 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).
  • the coating 8 is important in giving the coating 8 the desired performance and function, and this, independently of the thickness of the coating 8, provided said thickness ranges from 3 to 10 ⁇ m as defined in the present invention.
  • the outer surface finish of the coating 8 has a mean roughness R 3 of less than 2.5 ⁇ m and preferably less than 2 ⁇ m and, more preferably still, less than 1.5 ⁇ m, for example of the order of 1.0 ⁇ m.
  • the roughness 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 roughness of less than 2.5 ⁇ m, measured as described hereinabove, for the coating 8 of a medical device of the invention allows a smooth gliding of a such coated part, like a piston, relative to a complementary part, like a container.
  • 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 4 inside the container 2.
  • the piston 3 is made of a viscoelastic material such as bromobutyl rubber by West Company, or chlorobutyl rubber by 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).
  • the coated pistons several thicknesses of coating 8, and several surface finishes or roughnesses of the exterior surface of this coating 8 were tested, as summarized in Table 1 below.
  • Table 1 configurations of pistons A, B1, B2, B3 and C
  • the surface finishes of the coatings 8 of the coated pistons 3 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.
  • Activation Gliding Force tests were performed to determine the necessary forces for moving each piston 3 with respect to the container 2 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 2 filled with 1 ml_ of demineralised water and each plugged with one piston 3 to be tested (coated or uncoated). Each container 2-piston 3 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 pistons 3 in the containers 2, a Gr ⁇ ninger 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.
  • the surface state of the pistons was observed before any functional test and before any ageing.
  • piston A which had no coating according to the invention, had a relatively rough surface finish with peaks and troughs.
  • the coatings 8 of the invention on pistons B1 and B2 had relatively smooth and uniform surface finishes, and the coating on the piston B3 had a relatively rough surface finish with various irregularities.
  • Pistons B1 and B2 with their coatings 8 according to the invention 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 4 ⁇ g per cm 2 ⁇ 1. No lubricant of the silicone type was added to the pistons B1 and B2.
  • the syringes 2 thus assembled were placed in an ageing chamber for one month at 40 0 C with a relative humidity RH of 75%.
  • 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.
  • tests are carried out in order to determine whether addition of various amounts of a silicone lubricant has an influence on the medical device 1 of the invention, in the case where said silicone lubricant is added both on the pistons 3 and on the internal surface of the containers 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 glass 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 3 and silicone on the internal surface of the container 2, and thus, to define the low limit for the silicone amount acceptable for functional testing (AGF test).
  • Table 5 Activation Gliding Forces, Pistons A, B2 and C, 3 months ageing
  • Table 6 Activation Gliding Forces, Pistons A and B2, 6 months ageing
  • Example 3 The test protocol of Example 3 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 Tables 7 and 8 below. Table 7 : Activation Gliding Forces, Pistons A, B1 and C
  • Example 2 The protocol of Example 2 was repeated using a different glass syringe body or glass container 2, which was not coated with an internal film of silicone oil. By contrast, a silicone oil was coated on the pistons prior to assembly or fitting.
  • Example 2 The protocol of Example 2 was repeated for both of the following scenarios: 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.
  • 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 3 and 10 ⁇ m and preferably from 3 to 5 ⁇ m.
  • containers 2 are syringe barrels made of glass.
  • the invention is not limited to glass containers and also includes containers made of plastic, polymer and any other suitable materials.
  • 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.
  • an adhesion-promoting layer that encourages the coating to bond with the container 2 may 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 un premier élément (2; 3) et un second élément (3; 2) mobiles l'un par rapport à l'autre, ainsi qu'un revêtement (8) présentant une région de contact (10) vis-à-vis de l'un de ces deux éléments (2; 3) et conçu pour favoriser le glissement relatif de ces premier et second éléments (2, 3) l'un par rapport à l'autre et assurer l'étanchéité dans la région de contact (10), ce revêtement (8) étant composé d'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 l'épaisseur moyenne dudit revêtement (8) est comprise entre 3 et 10 μm.
PCT/IB2007/003339 2007-09-03 2007-09-03 Dispositif médical et revêtement lubrifiant pour ce dispositif WO2009030974A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8512796B2 (en) 2009-05-13 2013-08-20 Si02 Medical Products, Inc. Vessel inspection apparatus and methods
US9272095B2 (en) 2011-04-01 2016-03-01 Sio2 Medical Products, Inc. Vessels, contact surfaces, and coating and inspection apparatus and methods
US9458536B2 (en) 2009-07-02 2016-10-04 Sio2 Medical Products, Inc. PECVD coating methods for capped syringes, cartridges and other articles
US9545360B2 (en) 2009-05-13 2017-01-17 Sio2 Medical Products, Inc. Saccharide protective coating for pharmaceutical package
US9554968B2 (en) 2013-03-11 2017-01-31 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
US9662450B2 (en) 2013-03-01 2017-05-30 Sio2 Medical Products, Inc. Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus
US9664626B2 (en) 2012-11-01 2017-05-30 Sio2 Medical Products, Inc. Coating inspection method
US9764093B2 (en) 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US9863042B2 (en) 2013-03-15 2018-01-09 Sio2 Medical Products, Inc. PECVD lubricity vessel coating, coating process and apparatus providing different power levels in two phases
US9878101B2 (en) 2010-11-12 2018-01-30 Sio2 Medical Products, Inc. Cyclic olefin polymer vessels and vessel coating methods
US9903782B2 (en) 2012-11-16 2018-02-27 Sio2 Medical Products, Inc. Method and apparatus for detecting rapid barrier coating integrity characteristics
US9937099B2 (en) 2013-03-11 2018-04-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
US10189603B2 (en) 2011-11-11 2019-01-29 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US10201660B2 (en) 2012-11-30 2019-02-12 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition on medical syringes, cartridges, and the like
US20210128800A1 (en) * 2019-11-04 2021-05-06 Alcon Inc. Irrigation sleeve for ophthalmic procedures
US11066745B2 (en) 2014-03-28 2021-07-20 Sio2 Medical Products, Inc. Antistatic coatings for plastic vessels
US11077233B2 (en) 2015-08-18 2021-08-03 Sio2 Medical Products, Inc. Pharmaceutical and other packaging with low oxygen transmission rate
US11116695B2 (en) 2011-11-11 2021-09-14 Sio2 Medical Products, Inc. Blood sample collection tube
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
US11624115B2 (en) 2010-05-12 2023-04-11 Sio2 Medical Products, Inc. Syringe with PECVD lubrication
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
US12257371B2 (en) 2012-07-03 2025-03-25 Sio2 Medical Products, Llc SiOx barrier for pharmaceutical package and coating process

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2735735A (en) * 1956-02-21 Syringe construction
US2842127A (en) * 1954-04-15 1958-07-08 S & R J Everett & Co Ltd Hypodermic syringes
US4973504A (en) * 1987-04-13 1990-11-27 The West Company Incorporated Pharmaceutical elastomeric coating
US5064083A (en) * 1990-03-08 1991-11-12 The West Company, Incorporated Closure device
WO2001027210A1 (fr) * 1999-10-11 2001-04-19 Ml Laboratories Plc Dispositif de diffusion de medicament a enrobage resistant a l'humidite
US20050010175A1 (en) * 2003-02-27 2005-01-13 Beedon Daniel E. Piston assembly for syringe
JP2005160888A (ja) * 2003-12-05 2005-06-23 Terumo Corp シリンジ用ガスケット、シリンジ及びシリンジ用ガスケットの製造方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2735735A (en) * 1956-02-21 Syringe construction
US2842127A (en) * 1954-04-15 1958-07-08 S & R J Everett & Co Ltd Hypodermic syringes
US4973504A (en) * 1987-04-13 1990-11-27 The West Company Incorporated Pharmaceutical elastomeric coating
US5064083A (en) * 1990-03-08 1991-11-12 The West Company, Incorporated Closure device
WO2001027210A1 (fr) * 1999-10-11 2001-04-19 Ml Laboratories Plc Dispositif de diffusion de medicament a enrobage resistant a l'humidite
US20050010175A1 (en) * 2003-02-27 2005-01-13 Beedon Daniel E. Piston assembly for syringe
JP2005160888A (ja) * 2003-12-05 2005-06-23 Terumo Corp シリンジ用ガスケット、シリンジ及びシリンジ用ガスケットの製造方法

Cited By (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10390744B2 (en) 2009-05-13 2019-08-27 Sio2 Medical Products, Inc. Syringe with PECVD lubricity layer, apparatus and method for transporting a vessel to and from a PECVD processing station, and double wall plastic vessel
US9545360B2 (en) 2009-05-13 2017-01-17 Sio2 Medical Products, Inc. Saccharide protective coating for pharmaceutical package
US9572526B2 (en) 2009-05-13 2017-02-21 Sio2 Medical Products, Inc. Apparatus and method for transporting a vessel to and from a PECVD processing station
US8512796B2 (en) 2009-05-13 2013-08-20 Si02 Medical Products, Inc. Vessel inspection apparatus and methods
US10537273B2 (en) 2009-05-13 2020-01-21 Sio2 Medical Products, Inc. Syringe with PECVD lubricity layer
US8834954B2 (en) 2009-05-13 2014-09-16 Sio2 Medical Products, Inc. Vessel inspection apparatus and methods
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
US11123491B2 (en) 2010-11-12 2021-09-21 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
US10577154B2 (en) 2011-11-11 2020-03-03 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US11116695B2 (en) 2011-11-11 2021-09-14 Sio2 Medical Products, Inc. Blood sample collection tube
US11148856B2 (en) 2011-11-11 2021-10-19 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US11724860B2 (en) 2011-11-11 2023-08-15 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US10189603B2 (en) 2011-11-11 2019-01-29 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US11884446B2 (en) 2011-11-11 2024-01-30 Sio2 Medical Products, Inc. Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus
US12257371B2 (en) 2012-07-03 2025-03-25 Sio2 Medical Products, Llc SiOx barrier for pharmaceutical package and coating process
US9664626B2 (en) 2012-11-01 2017-05-30 Sio2 Medical Products, Inc. Coating inspection method
US9903782B2 (en) 2012-11-16 2018-02-27 Sio2 Medical Products, Inc. Method and apparatus for detecting rapid barrier coating integrity characteristics
US10363370B2 (en) 2012-11-30 2019-07-30 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US10201660B2 (en) 2012-11-30 2019-02-12 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition on medical syringes, cartridges, and the like
US11406765B2 (en) 2012-11-30 2022-08-09 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US9764093B2 (en) 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US9662450B2 (en) 2013-03-01 2017-05-30 Sio2 Medical Products, Inc. Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus
US11344473B2 (en) 2013-03-11 2022-05-31 SiO2Medical Products, Inc. Coated packaging
US10016338B2 (en) 2013-03-11 2018-07-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
US9554968B2 (en) 2013-03-11 2017-01-31 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
US12239606B2 (en) 2013-03-11 2025-03-04 Sio2 Medical Products, Llc PECVD coated pharmaceutical packaging
US11298293B2 (en) 2013-03-11 2022-04-12 Sio2 Medical Products, Inc. PECVD coated pharmaceutical packaging
US10912714B2 (en) 2013-03-11 2021-02-09 Sio2 Medical Products, Inc. PECVD coated pharmaceutical packaging
US9937099B2 (en) 2013-03-11 2018-04-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
US10537494B2 (en) 2013-03-11 2020-01-21 Sio2 Medical Products, Inc. Trilayer coated blood collection tube with low oxygen transmission rate
US11684546B2 (en) 2013-03-11 2023-06-27 Sio2 Medical Products, Inc. PECVD coated pharmaceutical packaging
US9863042B2 (en) 2013-03-15 2018-01-09 Sio2 Medical Products, Inc. PECVD lubricity vessel coating, coating process and apparatus providing different power levels in two phases
US11066745B2 (en) 2014-03-28 2021-07-20 Sio2 Medical Products, Inc. Antistatic coatings for plastic vessels
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
US11077233B2 (en) 2015-08-18 2021-08-03 Sio2 Medical Products, Inc. Pharmaceutical and other packaging with low oxygen transmission rate
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
US12226613B2 (en) 2017-05-05 2025-02-18 Regeneron Pharmaceuticals, Inc. Auto-injector and related methods of use
US11865245B2 (en) * 2019-11-04 2024-01-09 Alcon Inc. Irrigation sleeve for ophthalmic procedures
US20210128800A1 (en) * 2019-11-04 2021-05-06 Alcon Inc. Irrigation sleeve for ophthalmic procedures
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

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