EP2692324A1 - Adaptor for coupling with a medical container - Google Patents
Adaptor for coupling with a medical container Download PDFInfo
- Publication number
- EP2692324A1 EP2692324A1 EP20120305958 EP12305958A EP2692324A1 EP 2692324 A1 EP2692324 A1 EP 2692324A1 EP 20120305958 EP20120305958 EP 20120305958 EP 12305958 A EP12305958 A EP 12305958A EP 2692324 A1 EP2692324 A1 EP 2692324A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- adaptor
- septum
- vial
- elastomeric piece
- medical container
- Prior art date
- Legal status (The legal status 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 status listed.)
- Withdrawn
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Classifications
-
- 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
- A61J1/1406—Septums, pierceable membranes
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- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
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- 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
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
Definitions
- the present invention relates to an adaptor for coupling to a medical container such as a vial containing a pharmaceutical product, such as a vaccine, said adaptor allowing for multiple aseptic needle piercing with an injection device to be filled with part of the product contained in the medical container.
- the distal end of a component or apparatus must be understood as meaning the end furthest from the hand of the user and the proximal end must be understood as meaning the end closest to the hand of the user, with reference to the injection device intended to be used with said component or apparatus.
- the distal direction must be understood as the direction of injection with reference to the injection device, and the proximal direction is the opposite direction, i.e. the direction of the transfer of the product from the vial to the injection device.
- the cold chain be not interrupted from production of the drug at a pharmaceutical company to its administration to the patient.
- the most efficient vaccine packaging is the multidose container such as multidose vial, that is to say, vial that may contain up to 10, 100 or 1000 doses of vaccine, one dose being intended for one patient.
- multidose vial that is to say, vial that may contain up to 10, 100 or 1000 doses of vaccine, one dose being intended for one patient.
- These vials are usually closed by a septum.
- the user pierces the septum of the vial with the needle of an empty syringe, he then fills the syringe with one dose of vaccine and proceeds to the injection of the vaccine to the patient.
- multidose vials imply that the septum of the vial be pierced successively a high number of times, namely as many as the number of doses present in the vial.
- the sterility of the septum of the vial should be maintained during the whole time the vial is used.
- the multidose vials may be handled and manipulated at ambiant air.
- the septum of the vial may be contaminated either by the ambiant air, or, each time a dose of vaccine is removed, by the needle of the empty syringe used.
- the multidose vials may be maintained in cold conditions by simple contact with ice packs. As time goes by, part of the ice may melt and turn into water, and the septum of the multidose vials may be in contact with such water that may contaminate the septum of the vial.
- a multidose vial such as for example a 10-dose vial
- a multidose vial is opened and that only three doses are used, for vaccinating three patients only, the remaining content of the vial being wasted because not intended to be administered in a sufficiently short time after opening of the vial in order to guaranty the vaccine or drug sterility.
- Vaccination campaigns can therefore be made difficult in some regions and a significant proportion of vaccines may be wasted by the time they reach their target. This has an unacceptable cost to the health organizations in charge of immunization campaigns.
- immunization campaigns or pandemic, hundreds of patients need to be vaccinated in a very short time, in locations where it is difficult to maintain good hygienic conditions such as remote locations which are far from towns and from hospital facilities.
- a device that would allow several successive piercings of a multidose vial septum and that would guarranty that said piercings be carried out in aseptic conditions, in particular that the septum be made sterile at the time of injection act, or be maintained sterile during the lifetime of the multidose vial, and that would prevent wastage of the drug, even if the multidose vial is not stored in aseptic conditions.
- a first aspect of the present invention is an adaptor for coupling with a medical container having a collar closed by a septum, said septum having an outer surface directed towards the outside of the medical container, the adaptor comprising:
- the adaptor of the invention is intended to be mounted on a medical container, such as for example a conventional vial for storing pharmaceutical products, such as multidose vials for vaccines.
- a medical container such as for example a conventional vial for storing pharmaceutical products, such as multidose vials for vaccines.
- a vial 1 is shown on Figures 1A-1C and generally comprises a tubular barrel 2 having a longitudinal axis A, closed at an end and having a collar 3 at the opposite end, said collar 3 being closed by a septum 4.
- the septum 4 is fixedly attached to the collar 3 of the vial 1 by a peripheral band 5, said peripheral band 5 leaving a part of the septum 4, herein called outer surface 4a of the septum, directly facing the outside of the vial 1, namely the outside environment.
- the septum 4 is usually made of a material impermeable to gas and liquid and it seals hermetically the content of the vial 1.
- the septum 4 is also pierceable by the needle of an injection device intended to be filled with the product contained in the vial, said septum 4 being accessible to said needle via its outer surface 4a.
- pierceable means that the septum and the elastomeric piece of the adaptor may be pierced and traversed by the needle of an injection device such as a syringe, an auto-injector, or a reconstitution device, for example for administering a pharmaceutical product such as a drug or vaccine.
- the gripping member of the adaptor of the invention may be any member capable of securing the adaptor around on the medical container, and in particular around the collar of the medical container, either in a temporary or permanent way.
- the pierceable elastomeric piece of the adaptor of the invention has at least a part intended to be in contact with the outer surface of the septum when said adaptor is secured on said medical container: in other words, the elastomeric piece has a design, shape, and location on the adaptor, allowing a part of it to be in contact, in particular in close contact, with the outer surface of the septum when said adaptor is secured on said medical container.
- the adaptor of the invention allows piercing the septum of the medical container in good hygienic conditions multiple successive times. Indeed, when the user decides to fill in an empty syringe with a dose of drug contained in the medical container, he simply secures the adaptor of the invention on the medical container by means of the gripping member. Once the adaptor is secured on the medical container, the pierceable elastomeric piece of the adaptor is in contact, for example in tight contact, with the outer surface of the septum of the medical container. As a consequence, introducing the needle in the medical container implies that the needle pierces and traverses the elastomeric piece of the adaptor in the first place.
- the needle mechanically rubs against the material forming the elastomeric piece and it is naturally cleaned, as the potential bacteria are wiped out from the needle when said needle penetrates the elastomeric piece.
- the needle protrudes out of the elastomeric piece of the adaptor, it directly enters the septum of the medical container and may therefore not be contaminated by foreign elements.
- the user may repeat the piercing step with the needle of a new empty injection device until all the doses contained in the medical container are removed.
- the adaptor of the invention acts as a protection of the septum.
- the elastomeric piece is made of a gas and liquid impermeable material capable of flexing under pressure.
- the elastomeric piece has a thickness ranging from 1 to 8 mm, preferably from 2 to 4 mm.
- the elastomeric piece may show a hardness ranging from 10 to 100 Shore A, preferably from 40 to 70 Shore A, measured according to standard DIN 53505.
- Suitable materials for the pierceable elastomeric piece of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.
- the pierceable elastomeric piece is self-resealing.
- Self-resealing means in the present application that the elastomeric piece closes automatically and rapidly the hole produced by the piercing of the needle, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece.
- This automatic closure step may occur a high number of times, for example as many times as necessary for removing the numerous doses of products contained in the multidose medical container.
- This automatic obstruction restricts or prevents air and/or contaminants from entering inside the medical container, as well as at the interface between the elastomeric piece and the septum, and thus allows asepsis maintenance.
- the presence of the pierceable elastomeric piece of the adaptor of the invention gives time to the septum of the medical container to reseal, as the needle is still present in the pierceable elastomeric piece after it is removed from the septum.
- neither air nor contaminants may be introduced in the medical container or at the interface between the elastomeric piece and the septum, even if the medical container is maintained under negative pressure after the withdrawing of one or more doses of product.
- the septum of the medical container may itself be self-resealing.
- Suitable materials for self-resealing pierceable elastomeric piece of the adaptor of the invention include synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof.
- the pierceable elastomeric piece may further comprise a material including antiseptic agents, such as silver ions or copper ions.
- antiseptic agents such as silver ions or copper ions.
- silver salts or copper salts may be covalently linked to a polymer matrix of the pierceable elastomeric piece.
- silver salts or copper salts may be included as a load during the manufacturing of the polymer present in the material comprised in the pierceable elastomeric piece.
- the polymer matrix may be selected from silicone rubber, butyl rubber and/or halogenobutyl rubber.
- the pierceable elastomeric piece may be made in silicone rubber including silver ions : such products are commercially available from the company Momentive Performance Materials under the tradenames "Statsil®” or "Addisil®”. In embodiments, the pierceable elastomeric piece may consist in a silicone rubber including silver ions.
- Pierceable elastomeric pieces of the adaptor of the invention comprising a material including antiseptic agents, such as silver ions or copper ions, show antiseptic and hydrophobic properties.
- the growth of bacteria is therefore directly prevented at the surface of the pierceable elastomeric piece.
- the growth of bacteria is prevented at the interface between the elastomeric piece and the septum when the adaptor is positioned on the medical container.
- Moisture formation is also prevented, thereby further reducing the growth of bacteria.
- the pierceable elastomeric piece may comprise a coating comprising an antiseptic agent, such as chlorhexidine di-acetate.
- the pierceable elastomeric piece may comprise a butyl rubber or a halogenobutyl rubber coated with a coating comprising chlorhexidine di-acetate.
- a solution of chlorhexidine di-acetate may be applied on the pierceable elastomeric piece before being submitted to UV cross-linking.
- Such kind of coatings are very interesting as they have fast kinetic (within minutes) and therefore can clean a needle during its insertion within the pierceable elastomeric piece.
- the surface of said part of the pierceable elastomeric piece is complementary to the whole outer surface of the septum.
- the distal tip of the needle will directly pierce the septum after being passed through the pierceable elastomeric piece. Therefore, said distal tip is not in contact with ambient air or with other elements that would be trapped between the outer surface of the septum and the surface of the pierceable elastomeric piece.
- the outer surface of the septum and the complementary surface of the pierceable elastomeric piece match each other in such a way that they are in intimate contact together on their entire surface and lead to a closed interface.
- the adaptor further comprises a compressive member for pressing said pierceable elastomeric piece onto said outer surface of the septum, when said adaptor is secured on said medical container, said compressive member being capable to transition from an inactive state, in which it does not exert pressure on said pierceable elastomeric piece, to an active state, in which it exerts pressure.
- the distal pressure on the compressive member may be exerted by the user at the time he mounts the adaptor on the medical container.
- Such embodiments ensure that the outer surface of the septum and the complementary surface of the pierceable elastomeric piece are in tight contact together and that no ambient air is trapped between the outer surface of the septum and the complementary surface of the pierceable elastomeric piece.
- the distal tip of the needle may not enter in contact with other elements than the pierceable elastomeric piece and the septum.
- the adaptor further comprises a fixing system for preventing releasing of said gripping member and definitively securing the adaptor on said medical container.
- a fixing system for preventing releasing of said gripping member and definitively securing the adaptor on said medical container.
- the adaptor further comprises a transversal wall connected to said gripping member, said transversal wall having a hole in which is lodged said pierceable elastomeric piece.
- the gripping member and the transversal wall may be formed of one single piece.
- the transversal wall is proximally deflectable.
- the transversal wall may be proximally deflected by the collar of the medical container when the adaptor is mounted on the medical container, the transversal wall coming back to a non deflected position once the adaptor is correctly fitted on the collar of the medical container.
- the gripping member is provided with a plurality of first recesses with sloped distal faces and of second recesses
- the compressive member is provided with inner radial pegs, said inner radial pegs being engageable with said first recesses and/or second recesses.
- the gripping member may be a lateral clipping member comprising a U-shaped element intended to be engaged on said collar via the open part of the U-shaped element, the curved part of the U-shaped element partially surrounding the collar.
- the transversal wall may join together the two branches of the U of the U-shaped element.
- the gripping member is an axial clipping member capable of being axially mounted on the collar of said medical container.
- the axial clipping member may comprise a tubular element capable of being axially engaged on said collar.
- the transversal wall may then be a disk wall contained within the tubular element.
- the lateral clipping member is adapted to receive large diameter vials, with a collar having typically a diameter of 20 mm, and is therefore not compatible with small diameter vials having typically a collar with a diameter of 13 mm. Therefore, a vial collar ring may be provided to be used with small diameter vials in order to fit with the adaptor of the present invention.
- such vial collar ring is provided with two cylindrical portions: a top portion with a large diameter to enclose the vial septum and the peripheral band, and a bottom portion with a small diameter to enclose the vial collar.
- This vial collar ring may consist in two hemi-rings connected together for example by a hinge that can be plugged to each other on their free extremity by a snap-in lock.
- the snap-in lock may comprise a snap-in portion on the first ring and a recess on the second ring. With this snap-in lock, the vial collar ring can either be provided in an open state or in a closed state .
- the vial collar ring can be plugged onto a small diameter vial. Then, the adaptor of the present invention can be mounted on the small diameter vial having such vial collar ring.
- the adaptor further comprises a cleaning pad, said cleaning pad being configured to at least partially slide on said outer surface of said septum when the adaptor is being mounted on the medical container.
- a cleaning pad configured to at least partially slide on said outer surface of said septum when the adaptor is being mounted on the medical container.
- the cleaning pad may be any pad, such as fabric or sponge, for example out of cotton or any other porous material, and may be treated by a cleaning solution.
- the cleaning pad may comprise a disinfecting agent.
- the outer surface of the septum is therefore disinfected before the elastomeric piece of the adaptor comes in contact with it.
- the disinfecting agents may be selected from alcohols, such as ethanol or isopropanol, organic solvents, such as nitrofurane, toluene, phenol and derivatives thereof, derivatives of quinoline and acridine, salts such as sodium hypochlorite, sodium chlorite or sodium chlorate, chlorine dioxide, salts of iodine, mercury, silver, ammonium, or the like, or a combination thereof.
- the disinfecting agent may be selected according to the most common bacteria and viruses that may be found in the area of use of the medical container.
- the cleaning pad may be provided as a part of the adaptor, for example as a part of the transversal wall.
- the user has no additional operation or action to do than simply mounting the adaptor on the vial. Because of the location and configuration of the cleaning pad on the adaptor, the cleaning pad automatically slides on the outer surface of the septum, thereby wiping out potential bacteria or contamination agents present on said outer surface, when the user completes the step of mounting the adaptor on the collar of the vial.
- the lateral clipping member comprises a U-shaped element intended to be engaged on said collar via the open part of the U
- the curved part of the U partially surrounding the collar said transversal wall may be provided in the direction of the free ends of the U-shaped element, with a projection provided with said cleaning pad.
- the cleaning pad is located on the distal face of the projection.
- the cleaning pad slides on the outer surface of the septum, until it loses contact with said septum when the lateral clipping member reaches its position where it is secured on the collar. In this position, because of its location at the free ends of the U, the cleaning pad does not face the septum anymore and it does not prevent the piercing of the septum by the needle to take place.
- the sliding of the cleaning pad onto the outer surface of the septum has wiped out the bacteria and/or contamination elements potentially present on said outer surface. The outer surface of the septum is therefore decontaminated when the elastomeric piece of the adaptor comes in contact with it.
- the cleaning pad may be a breakable membrane attached to the inner wall of said tubular element, and located distally with respect to said transversal wall.
- the breakable membrane which is attached to the inner wall of the tubular element, becomes stretched out on the outer surface of the septum and finally breaks on said outer surface and is torn in several parts that slide on said outer surface while the axial clipping member reaches its position where it is secured on the collar. In this position, because it is now torn in several parts hanging along the inner walls of the tubular element, the membrane does not face the septum anymore and it does not prevent the piercing of the septum by the needle to take place.
- the sliding of the several torn parts of the breakable membrane on the outer surface of the septum has wiped out the bacteria and/or contamination elements potentially present on said outer surface.
- the outer surface of the septum is therefore decontaminated when the elastomeric piece of the adaptor comes in contact with it.
- the cleaning pad is located on a removable part of said adaptor.
- said removable part may be removed from said adaptor once said adaptor is secured on said medical container.
- Such embodiments allow extensive cleaning by healthcare workers of the medical container septum and/or of other surfaces such as injector needle or patient's skin, as well as prompt disposal of the cleaning pad after use, or may allow avoiding contamination with a harmful disinfecting agent.
- a tubular lodging extends from said transversal wall in the proximal direction, said tubular lodging being shaped and dimensioned for receiving an injection device.
- the tubular lodging may be capable of receiving an empty injection device to be filled with a dose of the drug contained in the medical container.
- a cavity filled with decontaminated atmosphere is provided in the tubular lodging, the needle of the injection device or syringe received in said tubular lodging being lodged in said cavity.
- the removable part on which the cleaning pad is located is a portion of a blister surrounding said adaptor in a storage state.
- said portion of said blister may remain on the adaptor while the adaptor is mounted on the collar and may be removed thereafter, once the cleaning pad has completed its function of decontaminating the outer surface of the septum.
- the blister is provided with front guiding projection.
- the adaptor further comprises an air inlet for allowing air entrance into the medical container, once the adaptor is secured on said medical container.
- an air inlet for allowing air entrance into the medical container, once the adaptor is secured on said medical container.
- the medical container is made of glass or polymeric materials the walls of which are not collapsible.
- the presence of an air inlet prevents the formation of vacuum in the medical container when medical fluid is withdrawn therefrom.
- the air inlet comprises a cannula extending from the adaptor in the distal direction and provided with a sharp distal tip, capable of piercing the septum of the medical container, the proximal end of the cannula protruding outside the adaptor in ambient atmosphere.
- the air inlet is provided with a filter to restrict, in embodiments to prevent, entry of particulates or bacteria from the ambient atmosphere into the medical container, in particular during the vaccine withdrawal process.
- this filter has a pore size of approximately 0.22 microns.
- This filter may also be provided with silver antimicrobial additive in order to obtain a supplementary protection of the vial sterility.
- this filter may be provided with a chlorhexidine coating.
- Such a filter is commercially available from Porex® under the tradename Barrier Technology TM .
- the adaptor further comprises a pierceable decontamination insert located proximally with respect to said elastomeric piece.
- the distal tip of the needle therefore first pierces the decontamination insert, in which it is decontaminated, then the pierceable elastomeric piece, in which it is submitted to a mechanical cleaning as explained above, before entering in contact with the outer surface of the septum of the vial.
- the pierceable decontamination insert may be a sterilizing gel.
- the adaptor further comprises a counting system.
- a counting system Such embodiments allow the user to be provided with information about how many doses of product have already been withdrawn from the medical container or how many doses of product remain in the medical container.
- the counting system may be manually actionable.
- Another aspect of the invention is an assembly comprising a medical container having a collar closed by a septum, said septum having an outer surface directed towards the outside of the medical container, and an adaptor as described above.
- the septum is self-resealing.
- an adaptor 10 in accordance with an embodiment of the invention, in a position for being mounted on a multidose vial 1 as shown on Figures 1A-1C .
- the adaptor 10 comprises a gripping member 20 intended to secure it onto the vial 1, and an elastomeric piece 30 which is pierceable by the needle of an injection device.
- the adaptor 10 also comprises a compressive member 40, for pressing the elastomeric piece 30 onto the outer surface 4a of the septum 4, when the adaptor 10 is secured on the vial 1.
- the compressive member 40 is capable to transition from an inactive state, in which it does not exert any pressure on the elastomeric piece 30, to an active state, in which it exerts such a pressure.
- parts of the gripping member 20 and of the compressive member 40 are also useful in combination for forming a fixing system for preventing the release of the gripping member 20 and definitively securing the adaptor 10 on the vial 10, as will be explained below.
- the gripping member 20 is a lateral gripping member and comprises a U-shaped body 21, having a partially tubular wall 22 showing a height suitable for surrounding the collar 3 of the vial 1 (see figures 9A-B ), with two free ends 22a corresponding to the ends of the branches of the U, the U-shaped body 21 therefore forming a clipping member.
- the tubular wall 22 is provided on its outer surface with a first recess 23, and with a second recess 24, distally spaced with respect to the first recess 23.
- First recesses 23 are provided with sloped distal faces 23a.
- the partially tubular wall 22 is further provided on its outer surface with a pair of first rear recesses 25, and with a pair of second rear recesses 26, distally spaced with respect to the pair of first rear recesses 25.
- First rear recesses 25 are provided with sloped distal faces 25a.
- the partially tubular wall 22 is further provided on its outer surface with a rear projection 29 located between the two second rear recesses 26, and on its inner surface with a forward projection 29a.
- Each free end 22a is further provided with a distal front projection forming a radial rim 27.
- the U-shaped body 21 is further provided at its proximal end with an inner annular rim 21 a, forming a central hole 28.
- the compressive member 40 comprises a cap 41, formed of a tubular wall 42 closed at its proximal end by a transversal wall 41 a.
- the cap 41 is sized and shape for receiving therein the gripping member 20.
- the transversal wall 41 a is provided with a central hole 43 for receiving the elastomeric piece 30 (see Figure 2B ).
- the tubular wall 42 is provided with an opening 44 on a part of its circumference, herein called “front part" of the compressive member 40, said opening 44 being intended to face and receive the free ends 22a of the gripping member 20 when the gripping member 20 and the compressive member 40 are assembled together to form the adaptor of Figures 2A-2D .
- the tubular wall 42 In its front part, on each side of the opening 44, the tubular wall 42 is provided with a flexible leg 45 having a distal free end having an inner radial peg 45a. In its rear part opposite its front part, the tubular wall 42 is provided with two rear flexible legs 46 having a distal free end having an inner radial peg 46a (see Figure 4A ).
- the pierceable elastomeric piece 30 On Figure 5 is shown the pierceable elastomeric piece 30.
- the pierceable elastomeric piece 30 has globally the shape of a flat cylinder.
- the pierceable elastomeric piece 30 is dimensioned and shaped so as to be received within central hole 43 of the transversal wall 41 a of the cap 41 with friction.
- the distal face of the pierceable elastomeric piece 30 has a plane surface 31 having a rounded shape.
- the pierceable elastomeric piece may have any suitable shape complementary to that of the central hole of the transversal wall, such as a cubic shape, etc...
- the pierceable elastomeric piece 30 is made of a material impermeable to gas and liquid capable of flexing under pressure.
- the elastomeric piece has a thickness ranging from 1 to 8 mm, preferably from 2 to 4 mm.
- the elastomeric piece may show a hardness ranging from 10 to 100 Shore A, preferably from 40 to 70 Shore A, measured according to DIN 53505.
- Suitable materials for the pierceable elastomeric piece 30 of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chlroro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.
- the elastomeric piece is self-resealing and it automatically seals the hole produced by the piercing of the needle, automatically and rapidly, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece.
- This automatic closure step may occur a high number of times, in particular as many times as necessary for removing the numerous doses of product initially present in the multidose vial 1.
- Suitable materials for self-resealing pierceable elastomeric piece of the adaptor of the invention include synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof.
- the pierceable elastomeric piece may further comprise a material including antiseptic agents, such as silver ions or copper ions.
- a material including antiseptic agents such as silver ions or copper ions.
- silver salt or copper salt may be covalently linked to a polymer matrix present in the material comprised in the pierceable elastomeric piece.
- silver salts or copper salts may be introduced as a load during the manufacturing of the polymer present in the material comprised in the pierceable elastomeric piece.
- the polymer matrix may be selected from silicone rubber, butyl rubber and/or halogenobutyl rubber.
- the perceable elastomeric piece comprises a material comprising a silicone rubber including silver ions : such products are commercially available from the company Momentive Performance Materials under the tradenames "Statsil®” or "Addisil®".
- the pierceable elastomeric piece may consist in a material including silver ions, such as silicone rubber including silver ions. In other embodiments, the pierceable elastomeric piece may consist in a material including copper ions.
- Pierceable elastomeric pieces of the adaptor of the invention comprising a material including antiseptic agents, such as silver ions or copper ions, show antiseptic and hydrophobic properties.
- the growth of bacteria is therefore directly prevented at the surface of the pierceable elastomeric piece.
- Moisture formation is also prevented, thereby further reducing the growth of bacteria.
- a needle pierces a pierceable elastomeric piece of the adaptor of the invention comprising a material including antiseptic agents, such as silver ions or copper ions, in view of entering a vial for removing a dose of product from said vial, the risk of contamination of the vial content is reduced.
- the pierceable elastomeric piece may comprise a coating comprising an antiseptic agent, such as chlorhexidine di-acetate.
- an antiseptic agent such as chlorhexidine di-acetate.
- the pierceable elastomeric piece may comprise a butyl rubber or a halogenobutyl rubber coated with a coating comprising chlorhexidine di-acetate.
- Such a coating may be obtained by UV cross-linking. The antiseptic action of such a coating may occur within minutes and such a coating may therefore be able to clean a contaminated needle during its insertion within the pierceable elastomeric piece.
- a solution of chlorhexidine di-acetate may be applied on the pierceable elastomeric piece before being submitted to UV cross-linking.
- Such kind of coatings are very interesting as they have fast kinetic (within minutes) and therefore can clean a needle during its insertion within the pierceable elastomeric piece.
- the adaptor 10 is provided to the user with the gripping member 20, the pierceable elastomeric piece 30 and the compressive member 40 assembled together in the inactive state of the compressive member 40 as shown on Figures 2A-2C , and packed in a blister 50 as shown on Figure 7 .
- the pierceable elastomeric piece 30 is lodged in the central hole 43 of the cap 41 in which it remains fixed by friction, with its plane and rounded distal face 31 protruding distally outside said central hole 43, and its proximal face 32 protruding proximally outside the central hole 43.
- the cap 41 is assembled on the U-shaped body 21 by means of inner radial pegs 46a ( Figure 4A ) being engaged in first rear recesses 25, and of inner radial pegs 45a being engaged in first recesses 23.
- the opening 44 of the tubular wall 42 faces the free ends 22a of the tubular wall 22 of the U-shaped element 21, and the central hole 43 with the elastomeric piece 30 faces the central hole 28 of the gripping member 20.
- the adaptor 10 is packed before use in a blister 50 surrounding the adaptor 10.
- the blister 50 comprises a shell 51 closed by a pellicle film 52.
- the shell 51 is provided with a front projection 51 a carrying a cleaning pad 60, and with front guiding projections 53 located distally with respect to said front projection 51 a.
- the cleaning pad 60 may be any pad, such as fabric or sponge, for example out of cotton or any other porous material, and may be imbibed with a cleaning solution or disinfecting composition.
- the cleaning pad 60 may comprise a disinfecting agent.
- the disinfecting agents may be selected from alcohols, such as ethanol or isopropanol, organic solvents, such as nitrofurane, toluene, phenol and derivatives thereof, derivatives of quinoline and acridine, salts such as sodium hypochlorite, sodium chlorite or sodium chlorate, chlorine dioxide, salts of iodine, mercury, silver, ammonium, or the like, or a combination thereof.
- the shell 51 remains on the adaptor 10 until the adaptor 10 is secured on the collar 3 of the vial 1.
- the shell 51 is removed thereafter, before piercing of the elastomeric piece 30 by the needle of the injection device.
- the whole blister 50 may be removed before mounting the adaptor 10 on the vial 1.
- the user then approaches the front part of the adaptor 10 with the shell 51 towards the collar 3 of vial 1, in order to mount laterally the adaptor 10 onto the collar 3 of the vial 1.
- the front guiding projections 53 of the shell 51 slide around the collar 3 so as to guide the adaptor 10 and ensure appropriate positioning and correct fitting of the gripping member 20 on the collar 3 of the vial 1.
- the cleaning pad 60 enters first in contact with an edge of the outer surface 4a of the septum 4.
- the cleaning pad 60 slides on the outer surface 4a of the septum 4, until it loses contact with said septum 4 when the clipping member 20 reaches its position where it is secured on the collar 3, by means of forward projection 29a and radial rims 27 surrounding the collar 3, as shown on Figure 9A .
- the sliding of the cleaning pad 60 onto the outer surface 4a of the septum 4 has wiped out bacteria and/or contamination elements potentially present on said outer surface 4a.
- the outer surface 4a of the septum 4 is therefore decontaminated when the elastomeric piece 30 of the adaptor 10 comes in contact with it.
- the lateral mounting of the clipping member 20 allows a compressive and precise positioning of the adaptor 10 onto the vial collar 3.
- the connection of the adaptor 10 on the vial 1 is straightforward for the user and can be performed easily, even with a single hand.
- the cleaning pad 60 is provided on a proximal front projection of a free end 22a, for example opposite the radial rims 27.
- the adaptor 10 is provided in a blister 50 without a cleaning pad.
- the pierceable elastomeric piece 30 is now compressed and flexes under the pressure exerted by the compressive member 40 on the gripping member 20.
- the distal face 31 of the elastomeric piece 30 has a surface which is complementary to that of the septum 4, and this surface is tightly and intimately in contact with the outer surface 4a of the septum 4 so that no foreign elements may be present between the distal face of the elastomeric piece 30 and the outer surface 4a now cleaned and disinfected.
- the adaptor 10 is thus secured on the collar 3 of the vial 1 in a two steps process.
- the lateral gripping member 20 is mounted on the collar 3 by a lateral movement allowing an appropriate positioning, like for example the correct axial alignment of the elastomeric piece 30 of the adaptor 10 regarding the central hole 43 of the septum 4, but also a perfect transversal alignment of the distal face 31 of the elastomeric piece 30 and the outer surface 4a of the septum 4.
- the adaptor 10 is still in an inactive state as there is no contact between the elastomeric piece 30 and the septum 4.
- the compressive member 40 is definitely secured on the collar 3 by a distal movement with respect to the gripping member 20.
- the adaptor is now in an active state with a close contact between the elastomeric piece 30 and the septum 4. Therefore, thanks to these two steps securing process, air-tightness between the elastomeric piece 30 and septum 4 is achieved avoiding any contamination.
- the forward projection 29a, radial rims 27 and the recesses (24, 26) of the gripping member 20 form, in combination with the pegs (45a, 46a) of the compressive member 40, a fixing system for preventing the releasing of the gripping member 20 and definitively securing the adaptor 10 on the vial 1.
- This fixing system allows the maintenance of a sufficient pressure between the distal face 31 of the elastomeric piece 30 and the outer face 4a of the septum 4 in order to ensure the air-tightness between these surfaces. Moreover, this fixing system is useful as it allows a very tight hermetic contact between the two pieces 30 and 4, even if the dimensions of the different parts of the adaptor are not always accurate due to the manufacturing tolerances which can be significant on all small plastic or elastomeric parts.
- this fixing system allows the free rotation of the vial 1 regarding to the adaptor 10 in order to let the user move the vial while maintaining the adaptor, for example when he needs to find the information he is looking for on a label present on the vial 1.
- the user removes the shell 51 of the blister 50 and the adaptor 10 is ready to receive the needle 5 of an injection device 100, as shown on Figures 10A and 10B . It is therefore possible to pierce the elastomeric piece 30 of the adaptor 10 with the needle 5 and then subsequently pierce the septum 4, as many times as necessary, as explained above, with desired hygienic conditions.
- the cleaning pad 60 is provided on the blister 50
- the cleaning pad once contaminated by the cleaning of the septum 4, is disposed with the blister and can not disturb the user in removing a dose from the vial 1.
- the user may remove the pad once contaminated in order to prevent any disturbance during the dose withdrawal.
- Figures 11A-15 show alternative embodiments of the adaptor 10 of Figures 1A-10B . References designating the same elements as in Figures 1A-10B have been maintained for Figures 11A-15 .
- the gripping member 120 is an axial clipping member comprising a tubular element 122 capable of being axially mounted on the collar 3 of the vial 1, by means of flexible radial pegs 123 engageable on the collar 3.
- the adaptor 10 is provided with a transversal wall 121 located within said tubular element 122, and the cleaning pad is a breakable membrane 160 attached to the inner wall of the tubular element 122, and located distally with respect to the transversal wall 121.
- the breakable membrane 160 enters in contact with the outer surface 4a of the septum 4. While the user continues to move the gripping member 120 distally so as to mount it on the collar 3 of the vial 1, the breakable membrane 160, which is attached to the inner wall of the tubular element 122, becomes stretched out on the outer surface 4a of the septum 4 and finally breaks on said outer surface 4a and is torn in several parts that slide on said outer surface 4a while the gripping member 120 reaches its position where it is secured on the collar 3.
- the adaptor of Figures 11A and 11B is packed before use in a blister comprising a shell closed at its distal end by a transversal pellicle film.
- the breakable membrane may be part of the blister and may be attached to the inner surface of the shell parallel to the distal transversal pellicle film.
- the adaptor 10 does not comprise any compressive member.
- the gripping member 220 is therefore releasingly secured on the collar 3 of the vial 1.
- the transversal wall 221 is deflectable after the adaptor is mounted, for release of the vial 1 if necessary.
- a pierceable decontamination insert 70 is located proximally with respect to the elastomeric piece 30.
- the decontamination insert 70 comprises a sterilizing gel 71.
- the needle 5 first traverse the sterilizing gel 71, in which it is sterilized, then the elastomeric piece 30, in which it is submitted to a mechanical cleaning, before it contacts the septum 4. The piercing is therefore completed in improved hygienic conditions.
- the adaptor 10 further comprises an air inlet 80 for allowing air entrance into the vial 1, once the adaptor 10 is secured on the vial 1.
- the air inlet 80 comprises a cannula 81 extending from the adaptor 10 in the distal direction and provided with a sharp distal tip 82, capable of piercing the septum 4 of the vial 1, the proximal end 83 of the cannula 81 protruding outside the adaptor 10 in outside environment.
- the air inlet 80 is provided with a filter 84 to restrict or prevent entry of contaminants such as particulates or bacteria from the ambient atmosphere into the vial 1, in particular during the vaccine withdrawal process.
- this filter 84 has a pore size of 0.22 microns like for example a filter with Pore X TM technology.
- a filter with Pore X TM technology Such embodiments are advantageous in the case the vial is made of glass or polymeric materials the walls of which are not collapsible. The presence of an air inlet prevents the formation of vacuum in the vial when medical fluid is withdrawn therefrom.
- FIG. 15 With reference to Figure 15 is shown another embodiment of the adaptor 10 of Figures 12A and 12B , in which a tubular lodging 90 extends from the transversal wall 221 in the proximal direction, the tubular lodging 90 being shaped and dimensioned for receiving an injection device 100.
- a cavity (not shown) filled with decontaminated atmosphere is provided in the tubular lodging 90, the needle of the injection device received in the tubular lodging 90 being lodged in said cavity.
- Such embodiments allow better hygienic and aseptic conditions for proceeding to the piercing of the outer surface 4a of the septum 4 of the vial 1, as the needle of the injection device does not enter in contact with outside environment before piercing.
- the compressive member 340 is formed of a cap 341 formed of a tubular wall 342 closed at its proximal end by a transversal wall 341 a provided with a central hole 343.
- the tubular wall 342 is provided with an opening 344 on a part of its circumference and on its whole height, herein called “front part" of the compressive member 340, the opening 344 comprising a transversal bridge 347 defining a proximal window 347a.
- the proximal face of the transversal wall 341 a is provided with an opening 341 b (see Figure 18A ) radially spaced with respect to the center of the transversal wall 341 a.
- the distal face of the transversal wall 341 a is provided with a distally extending collar 348 surrounding the central hole 343. In the distal region of the outer wall of the distally extending collar 348 are located two opposite outer ears 348a, only one of them being visible on Figure 16 .
- the distal face of the transversal wall 341 a is further provided with a plurality of circumferentially distributed recesses 349 located around the distally extending collar 348.
- the dose counter 91 is made of a flat cylinder 92 provided with a plurality of circumferentially distributed peripheral projections 93 extending radially outwardly.
- the flat cylinder 92 is further provided with a central hole 94 dimensioned and shaped so as to fit around the distally extending collar 348 of the distal face of the transversal wall 341 a of the compressive member 340, and so as to be snap-fitted thereon after overcoming the outer ears 348a of said distally extending collar 348.
- the flat cylinder 92 is snap-fitted on the collar 348 so that it is able to rotate with respect to said collar 348.
- the proximal face of the flat cylinder 92 is further provided with two proximal pegs 95 located around the central hole 94. As will be shown later, these two proximal pegs 95 are intended to cooperate with the recesses 349 of the distal face of the transversal wall 341 a of the cap 341 of the compressive member 340.
- the proximal face of the flat cylinder 92 is further provided with a plurality of circumferentially distributed information data 96, such as digits from "0" to "10" on the example shown.
- the flat cylinder 92 is snap-fitted onto the distally extending collar 348 of the distal face 341 a of the cap 341 and it is therefore received within said cap 341 with a part of it protruding outside via the window 347a.
- the flat cylinder 92 is capable of rotating with respect to the collar 348, therefore with respect to transversal wall 341 a.
- one of the information data for example digit "0" faces the opening 341 b of the transversal wall 341 a and it is therefore visible by the user.
- the proximal pegs 95 are each engaged in one of the plurality of circumferentially distributed recesses 349 located around the distally extending collar 348.
- the flat cylinder 92 therefore forms a dose counter for counting how many doses of product have already been withdrawn or remain from the medical container.
- the clipping member of the adaptor is adapted to receive large diameter vials, with a collar having typically a diameter of 20 mm, and is not compatible with small diameter vials having typically a collar with a diameter of 13 mm. Therefore, with reference to Figures 19A-20 , a vial collar ring 400 may be provided to be used on small diameter vials in order to fit with the adaptor of the present invention.
- a vial collar ring 400 is provided with two cylindrical portions: a top portion 401 with a large diameter capable of enclosing the vial septum 4 and the peripheral band 5 between the abutment 404 and 405, and a bottom portion 402 having a small diameter in order to enclose the vial collar 3.
- This vial collar ring 400 consists in two hemi-rings 410 and 411 connected together for example by a hinge 420 that can be plugged together on their free extremity by a snap-in lock 430.
- the snap-in lock comprises a recess 432 on the first hemi-ring 410 and a snap-in portion 431 on the second hemi-ring 411. Thanks to this snap-in lock 430 and the hinge 420, the vial collar ring 400 can either be provided in an open state ( Figure 19A ) or in a closed state ( Figures19B and 20 ).
- the vial collar ring can be plugged onto a small diameter vial. Then, the adaptor of the present invention can be mounted on the small diameter vial equipped with the vial collar ring 400.
- the adaptor of the present invention is provided with a time monitoring system.
- a time monitoring system can be added to the adaptor in order to monitor the elapsing time from the first dose withdrawing or to indicate to the user what is the time remaining before the 28 or 30 days deadline.
- This time monitoring system may be an electronic timer or a system based on the diffusion of ink into a circuit. For example, the elapsing or remaining time can be monitored by the kinetic of ink progression in a microfluidic circuit.
- Such systems are particularly attractive because they are small and reliable. For example some of them are commercially available under the trademark Timestrip®.
- the time monitoring system may be triggered either manually by the user or automatically.
- An automatic trigger could occur when the adaptor is mounted on the collar 3 of the vial 1 which assumes a first dose withdrawing shortly afterwards.
- time monitoring label, placed on an adaptor 10 could be triggered by an additional peg (not shown) placed into the blister 50 that comes in contact with the time monitoring system and therefore activates it when the user applies a distal pressure on the top of the shell 51.
- Such a system may prevent the injection of potentially expired vaccines or drugs to patients, but may also facilitate the supply chain or stock management in drugstores or even avoid wastage of valuable drugs and vaccines by encouraging the use of the first opened vials.
- the adaptor and assembly of the invention allow piercing the septum of a multidose vial yielding favorable hygienic and aseptic conditions multiple successive times.
- introducing the needle of an injection device into the septum of a vial entails the needle piercing and traversing the elastomeric piece of the adaptor in the first place.
- the needle mechanically rubbing against the material forming the elastomeric piece and it is cleaned, as potential bacteria are wiped from the needle when said needle penetrates the elastomeric piece.
- the needle protrudes out of the elastomeric piece of the adaptor, it directly enters the septum of the vial and may therefore not be contaminated by foreign elements.
- the user may repeat the piercing step with the needle of a new empty syringe until all the doses contained in the vial are removed.
- the adaptor of the invention acts as a protection of the septum of the vial.
- the pierceable elastomeric piece of the adaptor of the invention and the septum of the medical container are in contact, for example in tight contact, once the adaptor is secured onto the medical container.
- both the pierceable elastomeric piece of the adaptor of the invention and the septum of the medical container are self-resealing, no possibility of communication exist between the inside of the medical container and the outside environment at the time the needle of the injection device is removed from both the septum and the pierceable elastomeric piece, after withdrawal of a dose of product from the medical container.
- the adaptor of the invention thus allows a hermetic sealing of the contents of the medical container it is secured on, even during the removal of the needle.
- the inside of the medical container is kept in aseptic conditions before, during and after a withdrawal of a dose from the medical container.
Abstract
The present invention relates to an adaptor (10) for coupling with a vial (1) having a collar (3) closed by a septum (4), said septum having an outer surface directed towards the outside of the vial, the adaptor comprising:
- a gripping member (20) for securing the adaptor to the vial, said gripping member being capable of being laterally mounted on the collar of said vial and
- a pierceable elastomeric piece (30) having at least a part intended to be in contact with the outer surface of the septum when said adaptor is secured on said vial. The invention also relates to an assembly comprising such an adaptor and a vial.
- a gripping member (20) for securing the adaptor to the vial, said gripping member being capable of being laterally mounted on the collar of said vial and
- a pierceable elastomeric piece (30) having at least a part intended to be in contact with the outer surface of the septum when said adaptor is secured on said vial. The invention also relates to an assembly comprising such an adaptor and a vial.
Description
- The present invention relates to an adaptor for coupling to a medical container such as a vial containing a pharmaceutical product, such as a vaccine, said adaptor allowing for multiple aseptic needle piercing with an injection device to be filled with part of the product contained in the medical container.
- In this application, the distal end of a component or apparatus must be understood as meaning the end furthest from the hand of the user and the proximal end must be understood as meaning the end closest to the hand of the user, with reference to the injection device intended to be used with said component or apparatus. As such, in this application, the distal direction must be understood as the direction of injection with reference to the injection device, and the proximal direction is the opposite direction, i.e. the direction of the transfer of the product from the vial to the injection device.
- One of the ways to improve health is to immunize entire populations against a number of diseases. To date, injection administration is the most common method of administering vaccines.
- Each year, numerous drugs, for example vaccines, need to be prepared throughout the world by healthcare institutions. Many vaccine compositions are usually not stable at room temperature and they must be stored at rather specific cold temperatures. Indeed, due to their biological nature, vaccines are complex to handle and to store. Vaccines are usually temperature sensitive and typically need to be maintained and stored at all time between 2 and 8 degrees Celsius (°C). Some vaccines will be more sensitive to heat exposure and others will be sensitive to freezing. Therefore, maintaining and monitoring the appropriate temperatures during the storage and the handling of vaccines is a critical issue in order to sustain their efficacy. Overexposure to heat as well as overcooling may result in the destruction of the biological elements of the vaccines. Use of vaccines not stored in appropriate conditions may lead to not effective vaccination of the populations against diseases and would lead to expensive campaigns with limited results.
- Furthermore, it is critical that the cold chain be not interrupted from production of the drug at a pharmaceutical company to its administration to the patient.
- From a supply chain perspective, the most efficient vaccine packaging is the multidose container such as multidose vial, that is to say, vial that may contain up to 10, 100 or 1000 doses of vaccine, one dose being intended for one patient. These vials are usually closed by a septum. In preparation of an injection of a vaccine, the user pierces the septum of the vial with the needle of an empty syringe, he then fills the syringe with one dose of vaccine and proceeds to the injection of the vaccine to the patient.
- As such, multidose vials imply that the septum of the vial be pierced successively a high number of times, namely as many as the number of doses present in the vial. In order to ensure safe injections, the sterility of the septum of the vial should be maintained during the whole time the vial is used.
- Anyway, in locations where it is difficult to maintain good hygienic conditions such as remote locations which are far from towns and from hospital facilities, the multidose vials may be handled and manipulated at ambiant air. In such cases, the septum of the vial may be contaminated either by the ambiant air, or, each time a dose of vaccine is removed, by the needle of the empty syringe used.
- In addition, in regions where there is limited or potentially no supply of energy to power cooling equipment such as a refrigerator, the multidose vials may be maintained in cold conditions by simple contact with ice packs. As time goes by, part of the ice may melt and turn into water, and the septum of the multidose vials may be in contact with such water that may contaminate the septum of the vial.
- It may then happen that a multidose vial, such as for example a 10-dose vial, is opened and that only three doses are used, for vaccinating three patients only, the remaining content of the vial being wasted because not intended to be administered in a sufficiently short time after opening of the vial in order to guaranty the vaccine or drug sterility.
- Vaccination campaigns can therefore be made difficult in some regions and a significant proportion of vaccines may be wasted by the time they reach their target. This has an unacceptable cost to the health organizations in charge of immunization campaigns. In addition, it may happen that in case of vaccination campaigns, or pandemic, hundreds of patients need to be vaccinated in a very short time, in locations where it is difficult to maintain good hygienic conditions such as remote locations which are far from towns and from hospital facilities.
- Therefore, it would be desirable to provide a device that would allow several successive piercings of a multidose vial septum and that would guarranty that said piercings be carried out in aseptic conditions, in particular that the septum be made sterile at the time of injection act, or be maintained sterile during the lifetime of the multidose vial, and that would prevent wastage of the drug, even if the multidose vial is not stored in aseptic conditions.
- A first aspect of the present invention is an adaptor for coupling with a medical container having a collar closed by a septum, said septum having an outer surface directed towards the outside of the medical container, the adaptor comprising:
- a gripping member for securing the adaptor to the medical container, said gripping member being capable of being laterally mounted on the collar of said medical container,
- a pierceable elastomeric piece having at least a part intended to be in contact with the outer surface of the septum when said adaptor is secured on said medical container.
- The adaptor of the invention is intended to be mounted on a medical container, such as for example a conventional vial for storing pharmaceutical products, such as multidose vials for vaccines. Such a
vial 1 is shown onFigures 1A-1C and generally comprises atubular barrel 2 having a longitudinal axis A, closed at an end and having acollar 3 at the opposite end, saidcollar 3 being closed by aseptum 4. Usually, theseptum 4 is fixedly attached to thecollar 3 of thevial 1 by aperipheral band 5, saidperipheral band 5 leaving a part of theseptum 4, herein calledouter surface 4a of the septum, directly facing the outside of thevial 1, namely the outside environment. Theseptum 4 is usually made of a material impermeable to gas and liquid and it seals hermetically the content of thevial 1. Theseptum 4 is also pierceable by the needle of an injection device intended to be filled with the product contained in the vial, saidseptum 4 being accessible to said needle via itsouter surface 4a. - In the present application, "pierceable" means that the septum and the elastomeric piece of the adaptor may be pierced and traversed by the needle of an injection device such as a syringe, an auto-injector, or a reconstitution device, for example for administering a pharmaceutical product such as a drug or vaccine.
- The gripping member of the adaptor of the invention may be any member capable of securing the adaptor around on the medical container, and in particular around the collar of the medical container, either in a temporary or permanent way.
- The pierceable elastomeric piece of the adaptor of the invention has at least a part intended to be in contact with the outer surface of the septum when said adaptor is secured on said medical container: in other words, the elastomeric piece has a design, shape, and location on the adaptor, allowing a part of it to be in contact, in particular in close contact, with the outer surface of the septum when said adaptor is secured on said medical container.
- The adaptor of the invention allows piercing the septum of the medical container in good hygienic conditions multiple successive times. Indeed, when the user decides to fill in an empty syringe with a dose of drug contained in the medical container, he simply secures the adaptor of the invention on the medical container by means of the gripping member. Once the adaptor is secured on the medical container, the pierceable elastomeric piece of the adaptor is in contact, for example in tight contact, with the outer surface of the septum of the medical container. As a consequence, introducing the needle in the medical container implies that the needle pierces and traverses the elastomeric piece of the adaptor in the first place. During this step, the needle mechanically rubs against the material forming the elastomeric piece and it is naturally cleaned, as the potential bacteria are wiped out from the needle when said needle penetrates the elastomeric piece. In addition, once the needle protrudes out of the elastomeric piece of the adaptor, it directly enters the septum of the medical container and may therefore not be contaminated by foreign elements.
- The user may repeat the piercing step with the needle of a new empty injection device until all the doses contained in the medical container are removed. The adaptor of the invention acts as a protection of the septum.
- In embodiments, the elastomeric piece is made of a gas and liquid impermeable material capable of flexing under pressure. For example, the elastomeric piece has a thickness ranging from 1 to 8 mm, preferably from 2 to 4 mm. The elastomeric piece may show a hardness ranging from 10 to 100 Shore A, preferably from 40 to 70 Shore A, measured according to standard DIN 53505.
- Suitable materials for the pierceable elastomeric piece of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.
- In embodiments, the pierceable elastomeric piece is self-resealing. "Self-resealing" means in the present application that the elastomeric piece closes automatically and rapidly the hole produced by the piercing of the needle, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece. This automatic closure step may occur a high number of times, for example as many times as necessary for removing the numerous doses of products contained in the multidose medical container. This automatic obstruction restricts or prevents air and/or contaminants from entering inside the medical container, as well as at the interface between the elastomeric piece and the septum, and thus allows asepsis maintenance. Moreover, the presence of the pierceable elastomeric piece of the adaptor of the invention gives time to the septum of the medical container to reseal, as the needle is still present in the pierceable elastomeric piece after it is removed from the septum. As such, neither air nor contaminants may be introduced in the medical container or at the interface between the elastomeric piece and the septum, even if the medical container is maintained under negative pressure after the withdrawing of one or more doses of product. In addition, the septum of the medical container may itself be self-resealing.
- Suitable materials for self-resealing pierceable elastomeric piece of the adaptor of the invention include synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof.
- In embodiments, the pierceable elastomeric piece may further comprise a material including antiseptic agents, such as silver ions or copper ions. For example, silver salts or copper salts may be covalently linked to a polymer matrix of the pierceable elastomeric piece. Alternatively, silver salts or copper salts may be included as a load during the manufacturing of the polymer present in the material comprised in the pierceable elastomeric piece. For example, the polymer matrix may be selected from silicone rubber, butyl rubber and/or halogenobutyl rubber. In embodiments, the pierceable elastomeric piece may be made in silicone rubber including silver ions : such products are commercially available from the company Momentive Performance Materials under the tradenames "Statsil®" or "Addisil®". In embodiments, the pierceable elastomeric piece may consist in a silicone rubber including silver ions.
- Pierceable elastomeric pieces of the adaptor of the invention, comprising a material including antiseptic agents, such as silver ions or copper ions, show antiseptic and hydrophobic properties. The growth of bacteria is therefore directly prevented at the surface of the pierceable elastomeric piece. As a consequence, the growth of bacteria is prevented at the interface between the elastomeric piece and the septum when the adaptor is positioned on the medical container. Moisture formation is also prevented, thereby further reducing the growth of bacteria. As a consequence, when a needle pierces a pierceable elastomeric piece of the adaptor of the invention comprising a material including antiseptic agents, before entering a vial for withdrawing a dose of product from said vial, the risk of contamination of the vial content is highly reduced.
- Alternatively or in combination, the pierceable elastomeric piece may comprise a coating comprising an antiseptic agent, such as chlorhexidine di-acetate. For example, the pierceable elastomeric piece may comprise a butyl rubber or a halogenobutyl rubber coated with a coating comprising chlorhexidine di-acetate. For example, a solution of chlorhexidine di-acetate may be applied on the pierceable elastomeric piece before being submitted to UV cross-linking. Such kind of coatings are very interesting as they have fast kinetic (within minutes) and therefore can clean a needle during its insertion within the pierceable elastomeric piece.
- In embodiments, the surface of said part of the pierceable elastomeric piece is complementary to the whole outer surface of the septum. As such, whatever the piercing location of the pierceable elastomeric piece of the adaptor by the needle, the user is ensured that the distal tip of the needle will directly pierce the septum after being passed through the pierceable elastomeric piece. Therefore, said distal tip is not in contact with ambient air or with other elements that would be trapped between the outer surface of the septum and the surface of the pierceable elastomeric piece. In particular, in such embodiments, the outer surface of the septum and the complementary surface of the pierceable elastomeric piece match each other in such a way that they are in intimate contact together on their entire surface and lead to a closed interface.
- In embodiments, the adaptor further comprises a compressive member for pressing said pierceable elastomeric piece onto said outer surface of the septum, when said adaptor is secured on said medical container, said compressive member being capable to transition from an inactive state, in which it does not exert pressure on said pierceable elastomeric piece, to an active state, in which it exerts pressure. For example, the distal pressure on the compressive member may be exerted by the user at the time he mounts the adaptor on the medical container. Such embodiments ensure that the outer surface of the septum and the complementary surface of the pierceable elastomeric piece are in tight contact together and that no ambient air is trapped between the outer surface of the septum and the complementary surface of the pierceable elastomeric piece. The distal tip of the needle may not enter in contact with other elements than the pierceable elastomeric piece and the septum.
- In embodiments, the adaptor further comprises a fixing system for preventing releasing of said gripping member and definitively securing the adaptor on said medical container. Such embodiments ensure that the adaptor is not separated from the medical container and prevent any re-use of the adaptor on another medical container. The good hygienic conditions of the medical container are therefore maintained.
- In embodiments, the adaptor further comprises a transversal wall connected to said gripping member, said transversal wall having a hole in which is lodged said pierceable elastomeric piece. For example, the gripping member and the transversal wall may be formed of one single piece. In embodiments, the transversal wall is proximally deflectable. For example, the transversal wall may be proximally deflected by the collar of the medical container when the adaptor is mounted on the medical container, the transversal wall coming back to a non deflected position once the adaptor is correctly fitted on the collar of the medical container.
- In embodiments, the gripping member is provided with a plurality of first recesses with sloped distal faces and of second recesses, and the compressive member is provided with inner radial pegs, said inner radial pegs being engageable with said first recesses and/or second recesses.
- For example, the gripping member may be a lateral clipping member comprising a U-shaped element intended to be engaged on said collar via the open part of the U-shaped element, the curved part of the U-shaped element partially surrounding the collar. For example, the transversal wall may join together the two branches of the U of the U-shaped element.
- In other embodiments, the gripping member is an axial clipping member capable of being axially mounted on the collar of said medical container. For example, the axial clipping member may comprise a tubular element capable of being axially engaged on said collar. For example, the transversal wall may then be a disk wall contained within the tubular element.
- In embodiments, the lateral clipping member is adapted to receive large diameter vials, with a collar having typically a diameter of 20 mm, and is therefore not compatible with small diameter vials having typically a collar with a diameter of 13 mm. Therefore, a vial collar ring may be provided to be used with small diameter vials in order to fit with the adaptor of the present invention. For example, such vial collar ring is provided with two cylindrical portions: a top portion with a large diameter to enclose the vial septum and the peripheral band, and a bottom portion with a small diameter to enclose the vial collar. This vial collar ring may consist in two hemi-rings connected together for example by a hinge that can be plugged to each other on their free extremity by a snap-in lock. The snap-in lock may comprise a snap-in portion on the first ring and a recess on the second ring. With this snap-in lock, the vial collar ring can either be provided in an open state or in a closed state .The vial collar ring can be plugged onto a small diameter vial. Then, the adaptor of the present invention can be mounted on the small diameter vial having such vial collar ring.
- In embodiments, the adaptor further comprises a cleaning pad, said cleaning pad being configured to at least partially slide on said outer surface of said septum when the adaptor is being mounted on the medical container. Such embodiments allow the outer surface of the septum, where the distal tip of the needle is intended to penetrate, to be automatically cleaned before the adaptor is secured to the medical container.
- The cleaning pad may be any pad, such as fabric or sponge, for example out of cotton or any other porous material, and may be treated by a cleaning solution. For example, the cleaning pad may comprise a disinfecting agent. The outer surface of the septum is therefore disinfected before the elastomeric piece of the adaptor comes in contact with it. The disinfecting agents may be selected from alcohols, such as ethanol or isopropanol, organic solvents, such as nitrofurane, toluene, phenol and derivatives thereof, derivatives of quinoline and acridine, salts such as sodium hypochlorite, sodium chlorite or sodium chlorate, chlorine dioxide, salts of iodine, mercury, silver, ammonium, or the like, or a combination thereof. For example, the disinfecting agent may be selected according to the most common bacteria and viruses that may be found in the area of use of the medical container.
- In particular, the cleaning pad may be provided as a part of the adaptor, for example as a part of the transversal wall. The user has no additional operation or action to do than simply mounting the adaptor on the vial. Because of the location and configuration of the cleaning pad on the adaptor, the cleaning pad automatically slides on the outer surface of the septum, thereby wiping out potential bacteria or contamination agents present on said outer surface, when the user completes the step of mounting the adaptor on the collar of the vial.
- For example, in embodiments where the lateral clipping member comprises a U-shaped element intended to be engaged on said collar via the open part of the U, the curved part of the U partially surrounding the collar, said transversal wall may be provided in the direction of the free ends of the U-shaped element, with a projection provided with said cleaning pad. For example, the cleaning pad is located on the distal face of the projection. As such, when the user approaches the free ends of the U of the lateral clipping member towards the collar of the vial, the cleaning pad enters in contact with an edge of the outer surface of the septum. While the user continues to move the lateral clipping member towards the collar so as to mount it thereon, the cleaning pad slides on the outer surface of the septum, until it loses contact with said septum when the lateral clipping member reaches its position where it is secured on the collar. In this position, because of its location at the free ends of the U, the cleaning pad does not face the septum anymore and it does not prevent the piercing of the septum by the needle to take place. During the mounting step of the adaptor on the collar as described above, the sliding of the cleaning pad onto the outer surface of the septum has wiped out the bacteria and/or contamination elements potentially present on said outer surface. The outer surface of the septum is therefore decontaminated when the elastomeric piece of the adaptor comes in contact with it.
- In embodiments where the axial clipping member comprises a tubular element capable of being axially engaged on said collar, said transversal wall being located within said tubular element, the cleaning pad may be a breakable membrane attached to the inner wall of said tubular element, and located distally with respect to said transversal wall. As such, when the user approaches the distal free end of the tubular element of the axial clipping member towards the collar of the vial, the breakable membrane enters in contact with the outer surface of the septum. While the user continues to move the axial clipping member distally so as to mount it on the collar of the vial, the breakable membrane, which is attached to the inner wall of the tubular element, becomes stretched out on the outer surface of the septum and finally breaks on said outer surface and is torn in several parts that slide on said outer surface while the axial clipping member reaches its position where it is secured on the collar. In this position, because it is now torn in several parts hanging along the inner walls of the tubular element, the membrane does not face the septum anymore and it does not prevent the piercing of the septum by the needle to take place. During the mounting step of the adaptor on the collar as described above, the sliding of the several torn parts of the breakable membrane on the outer surface of the septum has wiped out the bacteria and/or contamination elements potentially present on said outer surface. The outer surface of the septum is therefore decontaminated when the elastomeric piece of the adaptor comes in contact with it.
- In embodiments, the cleaning pad is located on a removable part of said adaptor. For example, said removable part may be removed from said adaptor once said adaptor is secured on said medical container. Such embodiments allow extensive cleaning by healthcare workers of the medical container septum and/or of other surfaces such as injector needle or patient's skin, as well as prompt disposal of the cleaning pad after use, or may allow avoiding contamination with a harmful disinfecting agent.
- In embodiments, a tubular lodging extends from said transversal wall in the proximal direction, said tubular lodging being shaped and dimensioned for receiving an injection device. For example, the tubular lodging may be capable of receiving an empty injection device to be filled with a dose of the drug contained in the medical container. In embodiments, a cavity filled with decontaminated atmosphere is provided in the tubular lodging, the needle of the injection device or syringe received in said tubular lodging being lodged in said cavity. Such embodiments allow better hygienic conditions for proceeding to the piercing of the outer surface of the septum of the medical container.
- In embodiments, the removable part on which the cleaning pad is located is a portion of a blister surrounding said adaptor in a storage state. For example, said portion of said blister may remain on the adaptor while the adaptor is mounted on the collar and may be removed thereafter, once the cleaning pad has completed its function of decontaminating the outer surface of the septum. In embodiments, the blister is provided with front guiding projection.
- In embodiments, the adaptor further comprises an air inlet for allowing air entrance into the medical container, once the adaptor is secured on said medical container. Such embodiments are advantageous in the case the medical container is made of glass or polymeric materials the walls of which are not collapsible. The presence of an air inlet prevents the formation of vacuum in the medical container when medical fluid is withdrawn therefrom. For example, the air inlet comprises a cannula extending from the adaptor in the distal direction and provided with a sharp distal tip, capable of piercing the septum of the medical container, the proximal end of the cannula protruding outside the adaptor in ambient atmosphere. In embodiments, the air inlet is provided with a filter to restrict, in embodiments to prevent, entry of particulates or bacteria from the ambient atmosphere into the medical container, in particular during the vaccine withdrawal process. For example, this filter has a pore size of approximately 0.22 microns. This filter may also be provided with silver antimicrobial additive in order to obtain a supplementary protection of the vial sterility. Alternatively or in addition, this filter may be provided with a chlorhexidine coating. Such a filter is commercially available from Porex® under the tradename Barrier Technology™.
- In embodiments, the adaptor further comprises a pierceable decontamination insert located proximally with respect to said elastomeric piece. In such embodiments, the distal tip of the needle therefore first pierces the decontamination insert, in which it is decontaminated, then the pierceable elastomeric piece, in which it is submitted to a mechanical cleaning as explained above, before entering in contact with the outer surface of the septum of the vial. For example, the pierceable decontamination insert may be a sterilizing gel.
- In embodiments, the adaptor further comprises a counting system. Such embodiments allow the user to be provided with information about how many doses of product have already been withdrawn from the medical container or how many doses of product remain in the medical container. For example, the counting system may be manually actionable.
- Another aspect of the invention is an assembly comprising a medical container having a collar closed by a septum, said septum having an outer surface directed towards the outside of the medical container, and an adaptor as described above. In embodiments, the septum is self-resealing.
- The present invention will now be described in greater detail based on the following description and the appended drawings in which :
-
Figures 1A-1C are respectively a perspective view, a partial side view and a partial cross section view of a conventional vial on which the adaptor of the invention is to be mounted, -
Figures 2A-2B are perspective views of an adaptor in accordance with an embodiment of the invention, respectively from the top front and from the bottom front, in a position for being mounted on the collar of a vial :Figure 2C is a cross section view of the adaptor ofFigures 2A-2B , -
Figures 3A-3C are perspective views of the gripping member of the adaptor ofFigures 2A-2C , respectively from the top front, from the bottom front and from the rear;Figure 3D is a cross section view of the gripping member ofFigure 3C along line I-I', -
Figures 4A and 4B are perspective views of the compressive member of the adaptor ofFigures 2A-2C , respectively from the bottom front and from the top front, -
Figure 5 is a perspective view of the elastomeric piece of the adaptor ofFigures 2A-2C , -
Figures 6A-6B are perspective views of the adaptor ofFigures 2A-2C , respectively from the top front and from the bottom front, in a position where it is definitely secured on the collar of a vial (not shown);Figure 6C is a cross section view of the adaptor ofFigures 6A-6B , -
Figure 7 is a cross section view of the adaptor ofFigure 2C packed in a closed blister in a storage position, -
Figure 8 is a cross section view of the adaptor offigure 7 with the blister open, and of the proximal region of the vial onto which the adaptor is to be secured, -
Figure 9A and 9B are cross section views of the adaptor ofFigure 8 once it is mounted on the collar of the vial, and once it is definitively secured on the collar of the vial, with the blister partially surrounding the adaptor, -
Figure 10A is a partial cross section view of a needle of an injection device ready to pierce the elastomeric piece of the adaptor and assembly ofFigure 9B , once the blister has been fully removed, in order to remove a dose of product from the vial, -
Figure 10B is a side view of the injection device and assembly ofFigure 10A at a larger scale, -
Figures 11A and 11b are schematic cross section views of another embodiment of the adaptor and assembly of the invention, in which the clipping member is axial and the cleaning pad is a breakable membrane, -
Figures 12A and 12b are respectively a perspective view and a partial perspective section view of another embodiment of an assembly of the invention, -
Figure 13 is a cross section view of another embodiment of the adaptor and assembly of the invention, comprising a pierceable decontamination insert, -
Figure 14 is a cross view of another embodiment of the adaptor and assembly of the invention, comprising an air inlet, -
Figure 15 is a side view of another embodiment of the adaptor and assembly of the invention, comprising a tubular lodging shaped and dimensioned for receiving an injection device, -
Figure 16 is an exploded view of another embodiment of the adaptor of the invention, comprising a dose counter, -
Figure 17 is a top perspective view of the dose counter of the adaptor ofFigure 16 , -
Figures 18A and 18B are respectively a top perspective view and a bottom perspective view of the adaptor ofFigure 16 , -
Figures 19A and 19B are respectively a top perspective view of an opened vial collar ring and a bottom perspective view of a closed vial collar ring. -
Figure 20 is a cross view of a closed vial collar ring mounted onto a vial. - With reference to
Figures 2A-2C is shown anadaptor 10 in accordance with an embodiment of the invention, in a position for being mounted on amultidose vial 1 as shown onFigures 1A-1C . Theadaptor 10 comprises a grippingmember 20 intended to secure it onto thevial 1, and anelastomeric piece 30 which is pierceable by the needle of an injection device. Theadaptor 10 also comprises acompressive member 40, for pressing theelastomeric piece 30 onto theouter surface 4a of theseptum 4, when theadaptor 10 is secured on thevial 1. As will be shown from the description below, thecompressive member 40 is capable to transition from an inactive state, in which it does not exert any pressure on theelastomeric piece 30, to an active state, in which it exerts such a pressure. In the embodiment shown, parts of the grippingmember 20 and of thecompressive member 40 are also useful in combination for forming a fixing system for preventing the release of the grippingmember 20 and definitively securing theadaptor 10 on thevial 10, as will be explained below. - With reference to
Figures 3A-3D , the grippingmember 20 will now be described in detail. The grippingmember 20 is a lateral gripping member and comprises aU-shaped body 21, having a partiallytubular wall 22 showing a height suitable for surrounding thecollar 3 of the vial 1 (seefigures 9A-B ), with twofree ends 22a corresponding to the ends of the branches of the U, theU-shaped body 21 therefore forming a clipping member. Close to eachfree end 22a, thetubular wall 22 is provided on its outer surface with afirst recess 23, and with asecond recess 24, distally spaced with respect to thefirst recess 23. First recesses 23 are provided with slopeddistal faces 23a. In its circular portion, the partiallytubular wall 22 is further provided on its outer surface with a pair of firstrear recesses 25, and with a pair of second rear recesses 26, distally spaced with respect to the pair of first rear recesses 25. Firstrear recesses 25 are provided with slopeddistal faces 25a. Still in its circular portion, the partiallytubular wall 22 is further provided on its outer surface with arear projection 29 located between the two second rear recesses 26, and on its inner surface with aforward projection 29a. - Each
free end 22a is further provided with a distal front projection forming aradial rim 27. - The
U-shaped body 21 is further provided at its proximal end with an innerannular rim 21 a, forming acentral hole 28. - With reference to
Figures 4A and 4B , thecompressive member 40 will now be described in detail. Thecompressive member 40 comprises acap 41, formed of atubular wall 42 closed at its proximal end by atransversal wall 41 a. Thecap 41 is sized and shape for receiving therein the grippingmember 20. Thetransversal wall 41 a is provided with acentral hole 43 for receiving the elastomeric piece 30 (seeFigure 2B ). Thetubular wall 42 is provided with anopening 44 on a part of its circumference, herein called "front part" of thecompressive member 40, saidopening 44 being intended to face and receive the free ends 22a of the grippingmember 20 when the grippingmember 20 and thecompressive member 40 are assembled together to form the adaptor ofFigures 2A-2D . - In its front part, on each side of the
opening 44, thetubular wall 42 is provided with aflexible leg 45 having a distal free end having an innerradial peg 45a. In its rear part opposite its front part, thetubular wall 42 is provided with two rearflexible legs 46 having a distal free end having an innerradial peg 46a (seeFigure 4A ). - On
Figure 5 is shown the pierceableelastomeric piece 30. In the embodiment shown, the pierceableelastomeric piece 30 has globally the shape of a flat cylinder. As shown onfigures 2A-D and6A-D , the pierceableelastomeric piece 30 is dimensioned and shaped so as to be received withincentral hole 43 of thetransversal wall 41 a of thecap 41 with friction. As also shown from these Figures, the distal face of the pierceableelastomeric piece 30 has aplane surface 31 having a rounded shape. In embodiments not shown, the pierceable elastomeric piece may have any suitable shape complementary to that of the central hole of the transversal wall, such as a cubic shape, etc... - The pierceable
elastomeric piece 30 is made of a material impermeable to gas and liquid capable of flexing under pressure. For example, the elastomeric piece has a thickness ranging from 1 to 8 mm, preferably from 2 to 4 mm. The elastomeric piece may show a hardness ranging from 10 to 100 Shore A, preferably from 40 to 70 Shore A, measured according to DIN 53505. - Suitable materials for the pierceable
elastomeric piece 30 of the adaptor of the invention include natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chlroro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof. - Preferably, the elastomeric piece is self-resealing and it automatically seals the hole produced by the piercing of the needle, automatically and rapidly, for example in less than 0.5 seconds, once the needle is removed from the elastomeric piece. This automatic closure step may occur a high number of times, in particular as many times as necessary for removing the numerous doses of product initially present in the
multidose vial 1. Suitable materials for self-resealing pierceable elastomeric piece of the adaptor of the invention include synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof. - In embodiments, the pierceable elastomeric piece may further comprise a material including antiseptic agents, such as silver ions or copper ions. For example, silver salt or copper salt may be covalently linked to a polymer matrix present in the material comprised in the pierceable elastomeric piece. Alternatively, silver salts or copper salts may be introduced as a load during the manufacturing of the polymer present in the material comprised in the pierceable elastomeric piece. For example, the polymer matrix may be selected from silicone rubber, butyl rubber and/or halogenobutyl rubber. In embodiments, the perceable elastomeric piece comprises a material comprising a silicone rubber including silver ions : such products are commercially available from the company Momentive Performance Materials under the tradenames "Statsil®" or "Addisil®". In embodiments, the pierceable elastomeric piece may consist in a material including silver ions, such as silicone rubber including silver ions. In other embodiments, the pierceable elastomeric piece may consist in a material including copper ions.
- Pierceable elastomeric pieces of the adaptor of the invention, comprising a material including antiseptic agents, such as silver ions or copper ions, show antiseptic and hydrophobic properties. The growth of bacteria is therefore directly prevented at the surface of the pierceable elastomeric piece. Moisture formation is also prevented, thereby further reducing the growth of bacteria. As a consequence, when a needle pierces a pierceable elastomeric piece of the adaptor of the invention comprising a material including antiseptic agents, such as silver ions or copper ions, in view of entering a vial for removing a dose of product from said vial, the risk of contamination of the vial content is reduced.
- Alternatively or in combination, the pierceable elastomeric piece may comprise a coating comprising an antiseptic agent, such as chlorhexidine di-acetate. For example, the pierceable elastomeric piece may comprise a butyl rubber or a halogenobutyl rubber coated with a coating comprising chlorhexidine di-acetate. Such a coating may be obtained by UV cross-linking. The antiseptic action of such a coating may occur within minutes and such a coating may therefore be able to clean a contaminated needle during its insertion within the pierceable elastomeric piece.
- For example, a solution of chlorhexidine di-acetate may be applied on the pierceable elastomeric piece before being submitted to UV cross-linking. Such kind of coatings are very interesting as they have fast kinetic (within minutes) and therefore can clean a needle during its insertion within the pierceable elastomeric piece.
- The use of the
adaptor 10 in connection with a vial offigures 1A-1C will now be explained with reference tofigures 2A-10B . - The
adaptor 10 is provided to the user with the grippingmember 20, the pierceableelastomeric piece 30 and thecompressive member 40 assembled together in the inactive state of thecompressive member 40 as shown onFigures 2A-2C , and packed in ablister 50 as shown onFigure 7 . - With reference to
Figures 2A-2C , the pierceableelastomeric piece 30 is lodged in thecentral hole 43 of thecap 41 in which it remains fixed by friction, with its plane and roundeddistal face 31 protruding distally outside saidcentral hole 43, and itsproximal face 32 protruding proximally outside thecentral hole 43. Thecap 41 is assembled on theU-shaped body 21 by means of innerradial pegs 46a (Figure 4A ) being engaged in first rear recesses 25, and of inner radial pegs 45a being engaged infirst recesses 23. In this position, theopening 44 of thetubular wall 42 faces the free ends 22a of thetubular wall 22 of theU-shaped element 21, and thecentral hole 43 with theelastomeric piece 30 faces thecentral hole 28 of the grippingmember 20. - With reference to
Figure 7 , theadaptor 10 is packed before use in ablister 50 surrounding theadaptor 10. Theblister 50 comprises ashell 51 closed by apellicle film 52. Theshell 51 is provided with afront projection 51 a carrying acleaning pad 60, and withfront guiding projections 53 located distally with respect to saidfront projection 51 a. - The
cleaning pad 60 may be any pad, such as fabric or sponge, for example out of cotton or any other porous material, and may be imbibed with a cleaning solution or disinfecting composition. For example, thecleaning pad 60 may comprise a disinfecting agent. The disinfecting agents may be selected from alcohols, such as ethanol or isopropanol, organic solvents, such as nitrofurane, toluene, phenol and derivatives thereof, derivatives of quinoline and acridine, salts such as sodium hypochlorite, sodium chlorite or sodium chlorate, chlorine dioxide, salts of iodine, mercury, silver, ammonium, or the like, or a combination thereof. - Once the user is ready to proceed to the withdrawal of a dose of product contained in the
vial 1, he removes thepellicle film 52 in order to open theblister 50. In the embodiment shown, theshell 51 remains on theadaptor 10 until theadaptor 10 is secured on thecollar 3 of thevial 1. Theshell 51 is removed thereafter, before piercing of theelastomeric piece 30 by the needle of the injection device. In other embodiments, thewhole blister 50 may be removed before mounting theadaptor 10 on thevial 1. - With reference to
Figure 8 , the user then approaches the front part of theadaptor 10 with theshell 51 towards thecollar 3 ofvial 1, in order to mount laterally theadaptor 10 onto thecollar 3 of thevial 1. Thefront guiding projections 53 of theshell 51 slide around thecollar 3 so as to guide theadaptor 10 and ensure appropriate positioning and correct fitting of the grippingmember 20 on thecollar 3 of thevial 1. Thecleaning pad 60 enters first in contact with an edge of theouter surface 4a of theseptum 4. While the user continues to move laterally theshell 51 containing theadaptor 10, and thus thelateral clipping member 20 towards thecollar 3 so as to mount it thereon, thecleaning pad 60 slides on theouter surface 4a of theseptum 4, until it loses contact with saidseptum 4 when the clippingmember 20 reaches its position where it is secured on thecollar 3, by means offorward projection 29a andradial rims 27 surrounding thecollar 3, as shown onFigure 9A . - During the mounting step of the
adaptor 10 on thecollar 3 as described above, the sliding of thecleaning pad 60 onto theouter surface 4a of theseptum 4 has wiped out bacteria and/or contamination elements potentially present on saidouter surface 4a. Theouter surface 4a of theseptum 4 is therefore decontaminated when theelastomeric piece 30 of theadaptor 10 comes in contact with it. - Moreover, the lateral mounting of the clipping
member 20 allows a compressive and precise positioning of theadaptor 10 onto thevial collar 3. The connection of theadaptor 10 on thevial 1 is straightforward for the user and can be performed easily, even with a single hand. - In another embodiment (not shown), where the
blister 50 is fully removed before mounting theadaptor 10 on thevial 1, thecleaning pad 60 is provided on a proximal front projection of afree end 22a, for example opposite theradial rims 27. - In another embodiment (not shown), the
adaptor 10 is provided in ablister 50 without a cleaning pad. - Back to
Figure 9A , once theadaptor 10 is secured on thecollar 3 of thevial 1 by means of the grippingmember 20, the user applies a distal pressure on top of theshell 51 in order to make thecompressive member 40 transition from its inactive state to its active state, as shown onFigure 9B . Under this distal pressure, thecompressive member 40 has moved distally with respect to the gripping member 20 : the inner radial pegs 46a have been able to escape the first rear recesses 25 by overcoming distal sloped faces 25a, and have become engaged in second rear recesses 26. In the same manner, inner radial pegs 45a have been able to escapefirst recesses 23 by overcoming distal sloped faces 23a, and have become engaged insecond recesses 24, as shown onFigures 6A-6C and9B . - As shown from
Figure 9B , the pierceableelastomeric piece 30 is now compressed and flexes under the pressure exerted by thecompressive member 40 on the grippingmember 20. In addition, as is clear fromFigure 9B , thedistal face 31 of theelastomeric piece 30 has a surface which is complementary to that of theseptum 4, and this surface is tightly and intimately in contact with theouter surface 4a of theseptum 4 so that no foreign elements may be present between the distal face of theelastomeric piece 30 and theouter surface 4a now cleaned and disinfected. - In addition, by cooperation of the
forward projection 29a andradial rims 27 coming in abutment on thecollar 3 of thevial 1 and of the pegs (45a, 46a) of thecompressive member 40 being engaged in the recesses (24, 26) of the grippingmember 20, the adaptor is now secured on the collar in a permanent way and may not be removed. - In general, the
adaptor 10 is thus secured on thecollar 3 of thevial 1 in a two steps process. In the first step, thelateral gripping member 20 is mounted on thecollar 3 by a lateral movement allowing an appropriate positioning, like for example the correct axial alignment of theelastomeric piece 30 of theadaptor 10 regarding thecentral hole 43 of theseptum 4, but also a perfect transversal alignment of thedistal face 31 of theelastomeric piece 30 and theouter surface 4a of theseptum 4. Theadaptor 10 is still in an inactive state as there is no contact between theelastomeric piece 30 and theseptum 4. In the second step, thecompressive member 40 is definitely secured on thecollar 3 by a distal movement with respect to the grippingmember 20. The adaptor is now in an active state with a close contact between theelastomeric piece 30 and theseptum 4. Therefore, thanks to these two steps securing process, air-tightness between theelastomeric piece 30 andseptum 4 is achieved avoiding any contamination. - Indeed, once the
adaptor 10 is secured on thecollar 3 of thevial 1, various contaminations of theinside vial 1 are avoided, and this ensures that the contents of thevial 1 will not be polluted. - The
forward projection 29a,radial rims 27 and the recesses (24, 26) of the grippingmember 20 form, in combination with the pegs (45a, 46a) of thecompressive member 40, a fixing system for preventing the releasing of the grippingmember 20 and definitively securing theadaptor 10 on thevial 1. - This fixing system allows the maintenance of a sufficient pressure between the
distal face 31 of theelastomeric piece 30 and theouter face 4a of theseptum 4 in order to ensure the air-tightness between these surfaces. Moreover, this fixing system is useful as it allows a very tight hermetic contact between the twopieces - Additionally, this fixing system allows the free rotation of the
vial 1 regarding to theadaptor 10 in order to let the user move the vial while maintaining the adaptor, for example when he needs to find the information he is looking for on a label present on thevial 1. - Then, when the adaptor is definitively secured on the vial, the user removes the
shell 51 of theblister 50 and theadaptor 10 is ready to receive theneedle 5 of aninjection device 100, as shown onFigures 10A and 10B . It is therefore possible to pierce theelastomeric piece 30 of theadaptor 10 with theneedle 5 and then subsequently pierce theseptum 4, as many times as necessary, as explained above, with desired hygienic conditions. - In the embodiment where the
cleaning pad 60 is provided on theblister 50, the cleaning pad, once contaminated by the cleaning of theseptum 4, is disposed with the blister and can not disturb the user in removing a dose from thevial 1. - In the embodiment where the
cleaning pad 60 is provided on a removable part of the adaptor 10 (not shown), the user may remove the pad once contaminated in order to prevent any disturbance during the dose withdrawal. -
Figures 11A-15 show alternative embodiments of theadaptor 10 ofFigures 1A-10B . References designating the same elements as inFigures 1A-10B have been maintained forFigures 11A-15 . - With reference to
figures 11A and 11B is shown schematically another embodiment of theadaptor 10 of the invention, in which the grippingmember 120 is an axial clipping member comprising atubular element 122 capable of being axially mounted on thecollar 3 of thevial 1, by means of flexibleradial pegs 123 engageable on thecollar 3. In the embodiment shown, theadaptor 10 is provided with a transversal wall 121 located within saidtubular element 122, and the cleaning pad is abreakable membrane 160 attached to the inner wall of thetubular element 122, and located distally with respect to the transversal wall 121. - As such, when the user approaches the distal free end of the
tubular element 122 of the grippingmember 120 towards thecollar 3 of thevial 1, as shown onfigure 11A , thebreakable membrane 160 enters in contact with theouter surface 4a of theseptum 4. While the user continues to move the grippingmember 120 distally so as to mount it on thecollar 3 of thevial 1, thebreakable membrane 160, which is attached to the inner wall of thetubular element 122, becomes stretched out on theouter surface 4a of theseptum 4 and finally breaks on saidouter surface 4a and is torn in several parts that slide on saidouter surface 4a while the grippingmember 120 reaches its position where it is secured on thecollar 3. In this position, as shown onFigure 11B , because it is now torn in several parts (160a, 160b) hanging along the inner walls of thetubular element 122, themembrane 160 does not face theseptum 4 anymore and it does not prevent the piercing of theseptum 4 by the needle of an injection device (not shown). During the mounting step of theadaptor 10 on thecollar 3 as described above, the sliding of the several torn parts (160a, 160b) of thebreakable membrane 160 on theouter surface 4a of theseptum 4 has wiped out the bacteria and/or contamination elements potentially present on saidouter surface 4a. Theouter surface 4a of theseptum 4 is therefore decontaminated when theelastomeric piece 30 of the adaptor comes in contact with it, as shown onFigure 11B . - In embodiments not shown, the adaptor of
Figures 11A and 11B is packed before use in a blister comprising a shell closed at its distal end by a transversal pellicle film. In embodiments, the breakable membrane may be part of the blister and may be attached to the inner surface of the shell parallel to the distal transversal pellicle film. - With reference to
Figures 12A and 12B is shown another embodiment of theadaptor 10 of the invention, in which thecleaning pad 260 is part of the grippingmember 220. In this embodiment, the grippingmember 220 is a lateral clipping member comprising atransversal wall 221 provided with ahole 223 in which is lodged theelastomeric piece 30. Thetransversal wall 221 is proximally deflectable thanks to arear hinge member 221 a connecting thetransversal wall 221 to the grippingmember 220. Thetransversal wall 221 is provided with a frontdistal projection 224 bearing thecleaning pad 260. In this embodiment, theadaptor 10 does not comprise any compressive member. - When the
adaptor 10 ofFigures 12A-12B is mounted laterally on thecollar 3 of thevial 1, thetransversal wall 221 is pushed in a proximal direction when it contacts thecollar 3. Thecleaning pad 260 is therefore caused to slide onto theouter surface 4a of theseptum 4, thereby cleaning and decontaminating said surface. The correct positioning of theadaptor 10 on thevial 1 is obtained when thecollar 3 comes in abutment against the frontdistal projection 224 and thetransversal wall 221 comes back to its non deflected position, as shown onfigure 12B . In this position, the pierceableelastomeric piece 30 is in close contact with theseptum 4 of thevial 1. - The gripping
member 220 is therefore releasingly secured on thecollar 3 of thevial 1. Thetransversal wall 221 is deflectable after the adaptor is mounted, for release of thevial 1 if necessary. - With reference to
Figure 13 , is shown another embodiment of theadaptor 10 of the invention, in which apierceable decontamination insert 70 is located proximally with respect to theelastomeric piece 30. On the embodiment shown, thedecontamination insert 70 comprises a sterilizinggel 71. For proceeding to the withdrawal of a dose of product from thevial 1, theneedle 5 first traverse the sterilizinggel 71, in which it is sterilized, then theelastomeric piece 30, in which it is submitted to a mechanical cleaning, before it contacts theseptum 4. The piercing is therefore completed in improved hygienic conditions. - With reference to
Figure 14 , is shown another embodiment of theadaptor 10 of the invention, in which theadaptor 10 further comprises anair inlet 80 for allowing air entrance into thevial 1, once theadaptor 10 is secured on thevial 1. On the example shown, theair inlet 80 comprises acannula 81 extending from theadaptor 10 in the distal direction and provided with a sharpdistal tip 82, capable of piercing theseptum 4 of thevial 1, theproximal end 83 of thecannula 81 protruding outside theadaptor 10 in outside environment. Theair inlet 80 is provided with afilter 84 to restrict or prevent entry of contaminants such as particulates or bacteria from the ambient atmosphere into thevial 1, in particular during the vaccine withdrawal process. For example, thisfilter 84 has a pore size of 0.22 microns like for example a filter with PoreX TM technology. Such embodiments are advantageous in the case the vial is made of glass or polymeric materials the walls of which are not collapsible. The presence of an air inlet prevents the formation of vacuum in the vial when medical fluid is withdrawn therefrom. - With reference to
Figure 15 is shown another embodiment of theadaptor 10 ofFigures 12A and 12B , in which atubular lodging 90 extends from thetransversal wall 221 in the proximal direction, thetubular lodging 90 being shaped and dimensioned for receiving aninjection device 100. For example, a cavity (not shown) filled with decontaminated atmosphere is provided in thetubular lodging 90, the needle of the injection device received in thetubular lodging 90 being lodged in said cavity. Such embodiments allow better hygienic and aseptic conditions for proceeding to the piercing of theouter surface 4a of theseptum 4 of thevial 1, as the needle of the injection device does not enter in contact with outside environment before piercing. - With reference to
Figures 16-18B is shown another variant of theadaptor 10 ofFigures 2A-6B further comprising adose counter 91. The references designating the same elements as inFigures 2A-6B have been maintained, augmented of 300. - With reference to
Figures 16-18B , thecompressive member 340 is formed of acap 341 formed of atubular wall 342 closed at its proximal end by atransversal wall 341 a provided with acentral hole 343. Thetubular wall 342 is provided with anopening 344 on a part of its circumference and on its whole height, herein called "front part" of thecompressive member 340, theopening 344 comprising atransversal bridge 347 defining aproximal window 347a. The proximal face of thetransversal wall 341 a is provided with anopening 341 b (seeFigure 18A ) radially spaced with respect to the center of thetransversal wall 341 a. The distal face of thetransversal wall 341 a is provided with adistally extending collar 348 surrounding thecentral hole 343. In the distal region of the outer wall of thedistally extending collar 348 are located two oppositeouter ears 348a, only one of them being visible onFigure 16 . The distal face of thetransversal wall 341 a is further provided with a plurality of circumferentially distributedrecesses 349 located around thedistally extending collar 348. - The
dose counter 91 is made of aflat cylinder 92 provided with a plurality of circumferentially distributedperipheral projections 93 extending radially outwardly. Theflat cylinder 92 is further provided with acentral hole 94 dimensioned and shaped so as to fit around thedistally extending collar 348 of the distal face of thetransversal wall 341 a of thecompressive member 340, and so as to be snap-fitted thereon after overcoming theouter ears 348a of said distally extendingcollar 348. Theflat cylinder 92 is snap-fitted on thecollar 348 so that it is able to rotate with respect to saidcollar 348. - With reference to
Figure 17 , the proximal face of theflat cylinder 92 is further provided with twoproximal pegs 95 located around thecentral hole 94. As will be shown later, these twoproximal pegs 95 are intended to cooperate with therecesses 349 of the distal face of thetransversal wall 341 a of thecap 341 of thecompressive member 340. The proximal face of theflat cylinder 92 is further provided with a plurality of circumferentially distributedinformation data 96, such as digits from "0" to "10" on the example shown. - When the
adaptor 10 is assembled, as shown onFigures 18A and 18B , theflat cylinder 92 is snap-fitted onto thedistally extending collar 348 of thedistal face 341 a of thecap 341 and it is therefore received within saidcap 341 with a part of it protruding outside via thewindow 347a. Theflat cylinder 92 is capable of rotating with respect to thecollar 348, therefore with respect totransversal wall 341 a. Anyway, before use, one of the information data, for example digit "0" faces theopening 341 b of thetransversal wall 341 a and it is therefore visible by the user. In addition, in order to temporarily maintain theflat cylinder 92 in this position with respect to thetransversal wall 341 a, the proximal pegs 95 are each engaged in one of the plurality of circumferentially distributedrecesses 349 located around thedistally extending collar 348. - The user then uses the
adaptor 10 in the same way as described forfigures 1A-6B in order to withdraw a dose of product from a medical container. He then rotates theflat cylinder 92, for example manually by grasping one of the plurality of circumferentially distributedperipheral projections 93 extending radially outwardly, for example in the direction of thearrow 341 c shown onFigure 18A . With this rotational movement, the proximal pegs 95 overcome therecesses 349 in which they were engaged, and become engaged inadjacent recesses 349, in which position the digit "1" now appears throughopening 341 b of the proximal face of thetransversal wall 341 a. - The
flat cylinder 92 therefore forms a dose counter for counting how many doses of product have already been withdrawn or remain from the medical container. - In embodiments, the clipping member of the adaptor is adapted to receive large diameter vials, with a collar having typically a diameter of 20 mm, and is not compatible with small diameter vials having typically a collar with a diameter of 13 mm. Therefore, with reference to
Figures 19A-20 , avial collar ring 400 may be provided to be used on small diameter vials in order to fit with the adaptor of the present invention. OnFigures 19A, 19B and20 , avial collar ring 400 is provided with two cylindrical portions: atop portion 401 with a large diameter capable of enclosing thevial septum 4 and theperipheral band 5 between theabutment 404 and 405, and abottom portion 402 having a small diameter in order to enclose thevial collar 3. Thisvial collar ring 400 consists in two hemi-rings 410 and 411 connected together for example by a hinge 420 that can be plugged together on their free extremity by a snap-inlock 430. The snap-in lock comprises arecess 432 on the first hemi-ring 410 and a snap-inportion 431 on the second hemi-ring 411. Thanks to this snap-inlock 430 and the hinge 420, thevial collar ring 400 can either be provided in an open state (Figure 19A ) or in a closed state (Figures19B and20 ). - The vial collar ring can be plugged onto a small diameter vial. Then, the adaptor of the present invention can be mounted on the small diameter vial equipped with the
vial collar ring 400. - In embodiments, the adaptor of the present invention is provided with a time monitoring system. Indeed, such an adaptor is used to prevent contamination of the content of
vial 1 for a limited period of time, for example up to 28 to 30 days. Therefore, a time monitoring system can be added to the adaptor in order to monitor the elapsing time from the first dose withdrawing or to indicate to the user what is the time remaining before the 28 or 30 days deadline. - This time monitoring system may be an electronic timer or a system based on the diffusion of ink into a circuit. For example, the elapsing or remaining time can be monitored by the kinetic of ink progression in a microfluidic circuit. Such systems are particularly attractive because they are small and reliable. For example some of them are commercially available under the trademark Timestrip®.
- Furthermore, the time monitoring system may be triggered either manually by the user or automatically. An automatic trigger could occur when the adaptor is mounted on the
collar 3 of thevial 1 which assumes a first dose withdrawing shortly afterwards. For example, such time monitoring label, placed on anadaptor 10 could be triggered by an additional peg (not shown) placed into theblister 50 that comes in contact with the time monitoring system and therefore activates it when the user applies a distal pressure on the top of theshell 51. - Such a system may prevent the injection of potentially expired vaccines or drugs to patients, but may also facilitate the supply chain or stock management in drugstores or even avoid wastage of valuable drugs and vaccines by encouraging the use of the first opened vials.
- The adaptor and assembly of the invention allow piercing the septum of a multidose vial yielding favorable hygienic and aseptic conditions multiple successive times. Indeed, with the adaptor of the invention, introducing the needle of an injection device into the septum of a vial entails the needle piercing and traversing the elastomeric piece of the adaptor in the first place. During this step, the needle mechanically rubbing against the material forming the elastomeric piece and it is cleaned, as potential bacteria are wiped from the needle when said needle penetrates the elastomeric piece. In addition, once the needle protrudes out of the elastomeric piece of the adaptor, it directly enters the septum of the vial and may therefore not be contaminated by foreign elements.
- The user may repeat the piercing step with the needle of a new empty syringe until all the doses contained in the vial are removed. The adaptor of the invention acts as a protection of the septum of the vial.
- The pierceable elastomeric piece of the adaptor of the invention and the septum of the medical container are in contact, for example in tight contact, once the adaptor is secured onto the medical container. In embodiments where both the pierceable elastomeric piece of the adaptor of the invention and the septum of the medical container are self-resealing, no possibility of communication exist between the inside of the medical container and the outside environment at the time the needle of the injection device is removed from both the septum and the pierceable elastomeric piece, after withdrawal of a dose of product from the medical container. This therefore restricts or prevents the product contained in the medical container from being contaminated by outside contaminants such as bacteria, unpurified water, particles, viruses, etc...The adaptor of the invention thus allows a hermetic sealing of the contents of the medical container it is secured on, even during the removal of the needle. The inside of the medical container is kept in aseptic conditions before, during and after a withdrawal of a dose from the medical container.
Claims (20)
- An adaptor (10) for coupling with a medical container (1) having a collar (3) closed by a septum (4), said septum having an outer surface (4a) directed towards the outside of the medical container, the adaptor comprising:- a gripping member (20; 220) for securing the adaptor to the medical container, said gripping member being capable of being laterally mounted on the collar of said medical container,- a pierceable elastomeric piece (30) having at least a part (31) intended to be in contact with the outer surface of the septum when said adaptor is secured on said medical container.
- The adaptor (10) of claim 1, further comprising a compressive member (40) for pressing said pierceable elastomeric piece onto said outer surface of the septum, when said adaptor is secured on said medical container, said compressive member being capable to transition from an inactive state, in which it does not exert pressure on said pierceable elastomeric piece, to an active state, in which it exerts pressure.
- The adaptor (10) of one of claims 1 to 2, further comprising a fixing system (24, 26, 27, 29a, 45a, 46a) for preventing releasing of said gripping member and definitively securing the adaptor on said medical container.
- The adaptor (10) of any one of claims 1 to 3, further comprising a transversal wall (41 a, 121, 221) connected to said gripping member, said transversal wall having a hole in which is lodged said pierceable elastomeric piece.
- The adaptor (10) of claim 4, wherein said transversal wall (221) is proximally deflectable.
- The adaptor (10) of any one of claims 2 to 5, wherein the gripping member is provided with a plurality of first recesses (23, 25) with sloped distal faces (23a, 25a) and of second recesses (24, 26), and the compressive member is provided with inner radial pegs (45a, 46a), said inner radial pegs (45a, 46a) being engageable with said first recesses and/or second recesses.
- The adaptor (10) of any one of claims 1 to 6, wherein said gripping member is a lateral clipping member comprising a U-shaped element (21 ) intended to be engaged on said collar via the open part of the U-shaped element, the curved part of the U-shaped element partially surrounding the collar.
- The adaptor (10) of any one of claims 1 to 7, further comprising a cleaning pad (60, 160, 260), said cleaning pad being configured to at least partially slide on said outer surface of said septum when the adaptor is being mounted on the medical container.
- The adaptor (10) of claims 4, 7, and 8, wherein said transversal wall (221) is provided in the direction of free ends of the U-shaped element, with a projection provided with said cleaning pad (260).
- The adaptor (10) of any one of claims 8 to 9, wherein said cleaning pad (60) is located on a removable part of said adaptor.
- The adaptor (10) of claim 10, wherein said removable part is a portion (51) of a blister (50) surrounding said adaptor in a storage state.
- The adaptor (10) of claim 11, wherein the blister (50) is provided with front guiding projection (53).
- The adaptor (10) of any one of claims 1 to 12, further comprising a pierceable decontamination insert (70) located proximally with respect to said elastomeric piece.
- The adaptor (10) of any one of claims 1 to 13, wherein the pierceable elastomeric piece is self-resealing.
- The adaptor (10) of any one of claims 1 to 14, wherein the elastomeric piece is made of a material selected from synthetic polyisoprene, natural rubber, silicone rubber, thermo-plastic elastomers, or the like or a combination thereof.
- The adaptor (10) of any one of claims 1 to 15, wherein the pierceable elastomeric piece further comprises a material including antiseptic agents, such as silver ions or copper ions.
- The adaptor (10) of any one of claims 1 to 16, wherein the pierceable elastomeric piece comprises a coating comprising an antiseptic agent, such as chlorhexidine di-acetate.
- The adaptor (10) of any one of claims 10 to 17, wherein the cleaning pad comprises a disinfecting agent.
- Assembly comprising a medical container (1) having a collar closed by a septum, said septum having an outer surface directed towards the outside of the medical container, and an adaptor (10) according to any one of claims 1 to 18.
- The assembly of claim 19, wherein the septum is self-resealing.
Priority Applications (20)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20120305958 EP2692324A1 (en) | 2012-08-02 | 2012-08-02 | Adaptor for coupling with a medical container |
CN201380015515.2A CN104203194B (en) | 2012-02-02 | 2013-02-01 | For with the joining adapter of containers for medical use |
EP18152784.7A EP3342392B1 (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
AP2014007902A AP3940A (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
ES18152784T ES2743537T3 (en) | 2012-02-02 | 2013-02-01 | Adapter for coupling with a medical container |
SG10201800190QA SG10201800190QA (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
ES13704502.7T ES2681968T3 (en) | 2012-02-02 | 2013-02-01 | Adapter that couples with a medical container |
JP2014555531A JP6247228B2 (en) | 2012-02-02 | 2013-02-01 | Adapter for connecting to medical containers |
PCT/SG2013/000042 WO2013115728A1 (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
SG11201404436XA SG11201404436XA (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
MX2014009017A MX358074B (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container. |
CN201710658179.3A CN107468520A (en) | 2012-02-02 | 2013-02-01 | For with the joining adapter of containers for medical use |
US14/375,203 US9668939B2 (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
IN6930DEN2014 IN2014DN06930A (en) | 2012-02-02 | 2013-02-01 | |
EP13704502.7A EP2809293B1 (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
KR1020147024123A KR101986869B1 (en) | 2012-02-02 | 2013-02-01 | Adaptor for coupling with a medical container |
ARP130100339 AR089893A1 (en) | 2012-02-02 | 2013-02-04 | ADAPTER TO COUPLE A MEDICAL CONTAINER |
ZA2014/06308A ZA201406308B (en) | 2012-02-02 | 2014-08-27 | Adaptor for coupling with a medical container |
US15/493,477 US10751252B2 (en) | 2012-02-02 | 2017-04-21 | Adaptor for coupling with a medical container |
JP2017221308A JP6530472B2 (en) | 2012-02-02 | 2017-11-16 | Adapter for connecting with medical container |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20120305958 EP2692324A1 (en) | 2012-08-02 | 2012-08-02 | Adaptor for coupling with a medical container |
Publications (1)
Publication Number | Publication Date |
---|---|
EP2692324A1 true EP2692324A1 (en) | 2014-02-05 |
Family
ID=46724300
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20120305958 Withdrawn EP2692324A1 (en) | 2012-02-02 | 2012-08-02 | Adaptor for coupling with a medical container |
Country Status (1)
Country | Link |
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EP (1) | EP2692324A1 (en) |
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WO2015134431A1 (en) * | 2014-03-03 | 2015-09-11 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
US9950084B2 (en) | 2015-09-03 | 2018-04-24 | Magnolia Medical Technologies, Inc. | Apparatus and methods for maintaining sterility of a specimen container |
CN112790982A (en) * | 2020-12-31 | 2021-05-14 | 雷诺丽特恒迅包装科技(北京)有限公司 | Combined cover for liquid package |
US11786155B2 (en) | 2019-02-08 | 2023-10-17 | Magnolia Medical Technologies, Inc. | Devices and methods for bodily fluid collection and distribution |
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US20040199139A1 (en) * | 1998-09-15 | 2004-10-07 | Fowles Thomas A. | Sliding reconstitution device for a diluent container |
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WO1994000094A1 (en) * | 1992-06-22 | 1994-01-06 | Mary Therese Purcell | A reconstitution device |
US20040199139A1 (en) * | 1998-09-15 | 2004-10-07 | Fowles Thomas A. | Sliding reconstitution device for a diluent container |
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Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2015134431A1 (en) * | 2014-03-03 | 2015-09-11 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
US10123783B2 (en) | 2014-03-03 | 2018-11-13 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
EP3721854A1 (en) * | 2014-03-03 | 2020-10-14 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
US11589843B2 (en) | 2014-03-03 | 2023-02-28 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
EP4218708A3 (en) * | 2014-03-03 | 2023-08-16 | Magnolia Medical Technologies, Inc. | Apparatus and methods for disinfection of a specimen container |
US9950084B2 (en) | 2015-09-03 | 2018-04-24 | Magnolia Medical Technologies, Inc. | Apparatus and methods for maintaining sterility of a specimen container |
US10624977B2 (en) | 2015-09-03 | 2020-04-21 | Magnolia Medical Technologies, Inc. | Apparatus and methods for maintaining sterility of a specimen container |
US11786155B2 (en) | 2019-02-08 | 2023-10-17 | Magnolia Medical Technologies, Inc. | Devices and methods for bodily fluid collection and distribution |
CN112790982A (en) * | 2020-12-31 | 2021-05-14 | 雷诺丽特恒迅包装科技(北京)有限公司 | Combined cover for liquid package |
CN112790982B (en) * | 2020-12-31 | 2023-02-28 | 雷诺丽特恒迅包装科技(北京)有限公司 | Combined cover for liquid package |
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