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
  • A61J1/20—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
• • 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
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • 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
  • A61J1/202—Separating means
  • A61J1/2037—Separating means having valve means
• • 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
  • A61J1/2068—Venting means
• • 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
  • A61J1/2079—Filtering means
  • A61J1/2082—Filtering means for gas filtration
• • 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
  • A61J1/2079—Filtering means
  • A61J1/2086—Filtering means for fluid filtration

Definitions

• the present invention relates to a connector device for connecting a first and a second fluid container.
• the connector device has an improved valve arrangement which permits fluid flow in two different directions.
• the substance consists of cytotoxic drugs, radio-labelled or allergy-inducing substances it is for safety reasons important that the transfer of such substances from the vial to a patient, possibly by way of an infusion bag, takes place under satisfactory conditions and also so that an air contamination imparted by the injection needle during the transfer is avoided.
• the bottle connector comprises a neck element to which an injector can be fixedly coupled, and second connection means to connect the bottle connector to the drug bottle.
• the connector has a hollow needle to penetrate a closure on the bottle.
• a fluid transfer channel is arranged within the hollow needle.
• the bottle connector further comprises a pressure compensating means comprising a flexible container and a gas channel within the hollow needle for transporting gas from the bottle to the flexible container or vice versa in order to allow fluid to be transferred via the fluid transfer channel.
• the gas channej includes a filter to prevent liquid passage into said flexible container as this may damage the flexible container.
• one drawback is that the filter can be blocked If the filter is blocked, the function of the flexible container is reduced and the pressure inside the bottle can instantly increase or decrease to levels which could cause difficulties with respect to handling
• pressure increases or decreases inside the bottle can be hazardous, since in theory, it could lead to an increased risk of leakage It therefore seems to be a need for additional improvements in this field
• the vial adaptor has a housing, an expandable chamber, a filter to prevent fluid from entering the expandable chamber A check valve is arranged in the proximity of the filter to enable a one way fluid flow
• the connector is however not very flexible in terms of handling nor does it provide any means by which the filter can be prevented form being obstructed, i e clogged
• the teaching of the publication is further 15 that it is preferable that the check valve has as low cracking pressure as possible
• the above mentioned drawbacks are at least partly solved by means of a connector device according to the present invention More precisely they are solved by a connector 0 device for establishing fluid communication after connecting with a first fluid container and a second fluid container
• the connector device comprises a housing which in turn comprises first connection means having a pierceable barrier member to connect the first fluid container, and second connection means, to connect the second fluid container, and a fluid transfer channel to enable fluid communication between the first and second fluid 5 containers after assembly
• the housing further comprises at least one pressure normalization channel arranged to normalize the pressure in the second fluid container during fluid transfer
• the at least one pressure normalization channel has an outlet opening, an inlet opening, a barrier filter and at least one valve arrangement 0
• the at least one valve arrangement is arranged to permit fluid to flow in a first and a second direction wherein the first direction is in a direction from the inlet opening towards the outlet opening and the second direction is from the outlet opening towards the inlet opening Furthermore, the at least one valve arrangement has a cracking pressure in the first direction
• the first check valve and its cracking pressure enable a build up of pressure in the pressure normalization channel which partly prevents fluid from the second fluid container to reach the barrier filter during administration if the assembly for instance is; shaken; held up side down; laid down on the side or; when an excessive amount of medicaments and possibly air are returned to the second fluid container.
• the at least one valve arrangement comprises a first and a second check valve to enable the fluid flow in the first and the second direction.
• the first and the second check valve are preferably arranged in opposite directions and/or substantially parallel of each other.
• the main function is however that the first and the second check valve enable a fluid flow in the first and the second direction.
• the cracking pressure of the first check valve is at least 0,04 atm, preferably between 0,04 - 0,5 atm.
• the cracking pressure of 0,04 atm is enough to provide for the clogging preventing function while at the same time not impart a cracking pressure which makes the handling uncomfortable or difficult for a user, when the user is administrating or retracting medicament from the second fluid container. It has been found that a to high cracking pressure can cause a user to use an excessive amount of force during which other accidents can occur such as the device can slip from the users hands.
• the second check valve has a cracking pressure in the second direction of less than 0,5 atm, preferably less than 0,25 atm, even more preferably less than 0,1 atm and most preferred of less than 0,02 atm It may optionally be between 0,02- 0,5 atm, 0,02-0,25 atm or 0,02-0,1 atm
• the at least one valve arrangement comprises a membrane having at least one slit Such a membrane provides for a cracking pressure in both the first and the second direction
• an expandable bladder is arranged at the outlet opening of the at least one pressure normalization channel and in communication with the at least one pressure normalization channel As such, gas which has passed through the barrier filter is not exposed to the environment but collected in the volume defined by the expandable bladder
• the expandable bladder is preferably connected with a parabolic formed disc
• the volume of the pressure normalization channel between the first check valve and the inlet opening of the pressure normalization channel is preferably relatively small
• the volume can be ⁇ 1 ml, preferably between 0,01 ml - 0,9 ml This enables a pressure build up inside the pressure normalization channel which effectively prevents parts of the fluid from reaching the barrier filter which thereby could cause clogging of the filter
• the present invention relates to a connector device to connect a first and a second fluid container, directly or indirectly
• the connector device exhibit a first and a second connection means, a pierceable barrier member, a piercing member, a fluid transfer channel and a pressure normalization channel
• the pressure normalization channel is arranged to normalize an increasing pressure inside second fluid container
• a valve arrangement permitting fluid to flow in a first and a second direction is arranged in the pressure normalization channel
• the valve arrangement exhibit a cracking pressure in at least the first direction
• the present invention provides for a connector device which reduces the risk of clogging the barrier filter
• the present invention can be said to provide a fluid barrier to the barrier filter by means of the check valve arrangement and preferably the first and the second check valve
• the check valve arrangement provides directly for a hurdle, but also indirectly due to the pressure build up in the fluid transfer channel, for the fluid while permitting gas to pass the check valve arrangement and at the same time permit gas and fluid to flow in both the first and the second direction
• the present invention also relates to a valve arrangement, as described above, for a medical device, preferably a connector device, having a fluid flow channel with an inlet opening and an outlet opening, such as a pressure normalization channel for reducing a pressure build up in a connected fluid container
• the valve arrangement comprises a first and a second check valve arranged in parallel with each other so that after assembly to the fluid flow channel, the valve arrangement is arranged to permit fluid to flow in a first and a second direction, wherein the first direction is in a direction from the inlet opening towards the outlet opening and the second direction is from the outlet opening towards the inlet opening, wherein at least the first check valve has a cracking pressure
• Both the first and the second check valves can be provided with a cracking pressure
• the valve arrangement is further described with reference to figures 1-5 below
• figure 1 shows a cross section of an embodiment of the connector device according to the present invention
• figure 2 shows a cross section of the connector device shown in figure 1 in which the expandable bladder is shown in its expanded state, i e filled with gas
• figure 3 shows a close up of the valve arrangement comprising a first and a second check valve as shown in figure 1 and 2
• figure 4 shows parts of a first fluid container connected to a piercing member protection device, which in turn is connected to the connector device, according to the present invention, and as shown in figure 1 and 2, which in turn is connected to a second fluid container, to establish a fluid communication there between
• figure 5a-5b shows the connector device shown in figures 1-4, as seen in perspective with expandable bladder in its un-expanded state respectively in its expanded state
• Figure 1 shows in a cross sectional view a connector device 10 for establishing fluid communication between a first container and a second container, according to one embodiment of the present invention
• the connector device 10 has a housing 1 1 to which a first and a second connection means 12, 13 are arranged
• the first connection means 12 is substantially formed by a neck element 14 having a first and a second guiding groove 15, 16 arranged therein
• the first and the second guiding groove 15, 16 is arranged to guide corresponding guiding protrusions on e g a piercing member protection device arranged to a first fluid container as shown in figure 4, to establish a firm attachment to the connector device 10 after which fluid communication can be established
• the first connection means 12 is formed integrally with the housing 1 1
• One type of connection means 12 which can be used on the connector device 10 is disclosed in the patent publication US 6,715,520 B2 which also discloses a piercing member protection device and an appropriate first fluid container connected thereto
• the second connection means 13 which is arranged at substantially the opposite end of the housing 1 1 of the connector device 10 and with respect to the first connection means 12, comprises a plurality of engaging hook elements 20
• Each hook element 20 comprises a flexible tongue 21 having a distal and a proximal end 22, 23 The proximal end exhibits a hook protrusion 24 arranged to engage a corresponding flange on the second container, as is shown in greater detail in figure 4
• One example of appropriate hook elements 20 and a coupling arrangement in the form of a neck element, for the hook elements 20 are disclosed in the patent publication of US 6,715,520 B2
• a fluid transfer channel 30 extends substantially between the first and the second connection means 12, 13
• the purpose of the fluid transfer channel 30 is to permit e g a needle to extend through the housing 11 of the connector device 10 and to thereby permit fluid to be transferred through the connector device 10
• the fluid transfer channel has a longitudinal direction with a first and a second end 31 , 32
• a pierceable barrier member 40 is arranged in the proximity of the first connection means 12 and at the first end 31 of the fluid transfer channel 30
• the pierceable barrier member 40 provides for a liquid and gas tight seal between a piercing member and the pierceable barrier member 40 during fluid transfer so to minimize leakage and thereby exposure of hazardous medicaments to a user
• a piercing member 50 Protruding out from the housing 11 is a piercing member 50
• the piercing member 50 has a proximal end 51 and a distal end 52
• the fluid transfer channel 30 extends inside of the piercing member 50 in this embodiment
• the proximal end 51 of the piercing member 50 is arranged in the proximity of the pierceable barrier member 40 and is supported by a supporting wall structure 41 of the housing 11
• the piercing member 50 extends in a direction substantially parallel with the plurality of hook elements 20 and serves the purpose of piercing the second fluid container during assembly, as is shown in greater detail in figure 3
• the second end 32 of the fluid transfer channel 30 is substantially at the distal end 52 of the piercing member 50, with the exception of a piercing tip 53 which extends slightly longer
• a pressure normalization channel 60 extends from the distal end 52 of the piercing member 50 and substantially parallel with the fluid transfer channel 30 inside the piercing member 50 Substantially at the supporting wall structure 41 of the housing 11 , the pressure normalization channel 60 diverts in a direction perpendicular to the fluid transfer channel 30
• the pressure normalization channel 60 has an inlet opening 61 arranged substantially at the distal end 52 of the piercing member 50 and an outlet opening 62
• the outlet opening 62 is furthermore positioned substantially at the centre of a parabolic disc 63 having an expandable bladder 64 In figure 1 the expandable bladder 64 is in its unexpanded state
• Figure 2 shows the connector device 10 shown in figure 1 but with the difference that the expandable bladder 64 is shown in its expanded state
• the pressure normalization channel 60 comprises a barrier filter 70 arranged to cover the outlet opening 62 of the pressure normalization channel 60
• the barrier filter 70 serves the purpose of preventing any fluid from reaching the expandable bladder 64 and the volume defined by the parabolic disc 63 and the expandable bladder 64
• the barrier filter 70 is preferably a hydrophobic filter which permits gas to pass but prevents liquid to pass Filters like the barrier filter 70 are know per se and will need no further description herein
• a valve arrangement 80 is positioned to intersect the fluid flow of the pressure normalization channel 60 In figure 1 and 2, and in one embodiment according of the present invention, the valve arrangement 80 is positioned in the proximity of the outlet opening 62 of the pressure normalization channel 60
• the main purpose of the valve arrangement 80 is to prevent clogging of the filter barrier 70 by providing a cracking pressure to the valve arrangement 80 for the fluid which flows in a direction from the inlet opening 61 to the outlet opening 62 of the pressure normalization channel 60 while permitting preferably a minimal cracking pressure in the opposite direction
• Figure 3 shows a part of the connector device 10 seen in greater detail More specifically, figure 3 shows part of the pressure normalization channel 60, the outlet opening 62 of the pressure normalization channel 60, parts of the supporting wall structure 41 , parts of the parabolic disc 63 and parts of the expandable bladder 64, the barrier filter 70 and the valve arrangement 80
• the valve arrangement 80 comprises a first and a second check valve 81 , 82
• valve arrangement 80 is positioned to snugly fit inside the pressure normalization channel 60 as a separate component This is done for manufacturing reasons, although it is possible that the valve arrangement 80 and the first and the second check valves 81 , 82 are integrated parts of the housing 11
• the valve arrangement 80 comprises a substantially cylindrical housing 83 with a longitudinal centre line A and a transverse centre line B
• the cylindrical housing 83 exhibits a first and a second end 84, 85 and an inner and outer surface 86, 87
• the outer surface 87 of the cylindrical housing 83 is positioned towards an inner surface 65 of the pressure normalization channel 60 so as to provide for a liquid and gas tight seal there between
• the outer surface 87 of the cylindrical housing 83 is further provided with a slightly tilting surface 88, which tilts towards the longitudinal centre line A of the cylindrical housing 83 so that a substantially wedge-like form is provided at least at the first end 84 of the cylindrical housing 83
• the inner surface 65 of the pressure normalization channel 60 is likewise tilted in a direction towards the longitudinal centre line A of cylindrical housing 83, to provide for a substantially funnel-like form and to receive the tilting surface 88 of the cylindrical housing 83
• the tilting surfaces provides for a secure attachment of the valve arrangement 80 to the pressure normalization channel 60
• the inner surface 65 of the pressure normalization channel 60 can further be provided with a recess 66 to receive the cylindrical housing 83 so that the inner surface 86 of the cylindrical housing 83 is aligned with the inside of the pressure normalization channel 60 which provides for a smooth transition there between
• the first and the second check valves 81 , 82 can be of any conventional type although some preferred are listen below
• the first and the second check valve 81 ,82 can be a ball check valve, in which the disc, the movable part to block the flow, is a spherical ball
• the ball can be spring-loaded to help keep it shut In the case of no spring load on the ball, reverse flow is required to move the ball towards the seat and create a seal
• the interior surface of the main seats of the ball check valves are more or less conically-tapered to guide the ball into the seat and form a positive seal when stopping reverse flow
• the ball can be replaced by a poppet energized by a spring
• the first and the second check valves 81 , 82 can optionally be a diaphragm check valve
• a diaphragm check valve Such check valve uses a flexing rubber diaphragm positioned to create a normally-closed valve Pressure on the upstream side must be greater than the pressure on the downstream side by a certain amount, known as the pressure differential, for the check valve to open allowing flow Once positive pressure stops, the diaphragm automatically flexes back to its original closed position
• a swing check valve is a butterfly-style check valve in which a disc, the movable part to block the flow, swings on a hinge or trunnion, either onto the seat to block reverse flow or off the seat to allow forward flow
• the seat opening cross-section may be perpendicular to the centerline between the two ports or at an angle
• a clapper valve be used having a hinged gate, preferably with a biasing spring to urge it shut
• lift check valves can be used Combinations of the above mentioned check valves are of course also possible
• the first and the second check valves 81 , 82 can optionally be replaced by a membrane having at least one slit This embodiment is however less preferable
• FIG 4 shows the connector device 10 shown in figures 1-3
• the connector device 10 is assembled via its first connection means 11 to a piercing member protection device 5, which in turn can be connected to a first fluid container 1 , e g a syringe, and via its second connection means 12 with a second fluid container 2
• a first fluid container 1 e g a syringe
• second connection means 12 with a second fluid container 2
• the distal end 52 and especially the piercing tip 53 of the piercing member 50 is pierced through a septum 3 arranged to cover the opening of the second fluid container 2
• the hook elements 20 fixedly connects the connector device 10 as the flexible tongues 21 having hook protrusions 24 engages the corresponding flange 4 on the second fluid container 2
• a user is enabled to insert fluid into the second container 2, or optionally to retract fluid
• the first check valve 81 has a cracking pressure, in the shown embodiment, of about 0,04 atm
• a relatively high counter pressure is quickly built up in the pressure normalization channel 60 between the inlet opening 61 and the first check valve 81
• the relatively high counter pressure efficiently reduces the amount of medicament which reaches the barrier filter 70 and thereby significantly reduces the risk of clogging the barrier filter 70 While at the same time, the cracking pressure of the first check valve 81 is low enough not to cause any inconvenience
• each check valve 81 , 82 By having a first and a second check valve 81 , 82 the cracking pressures of each check valve 81 , 82 can be customized, permitting a very flexible valve arrangement 80 which can be fitted to any connector device, independently of the size of the pressure normalization channel used for that specific connecter device
• the pressure normalization channel can comprise two individual channels in which the first check valve 81 is positioned in one channel and the second check valve 82 is positioned in another channel
• the two individual channels can have mutual inlet and openings
• Figure 5a-5b shows the connector device as shown in figures 1 -4
• Figure 5a shows the expandable bladder 64 before expansion
• figure 5b shows the expandable bladder after expansion, i e being filled with gas
• the first connection means 12 and the second connection means 13 is seen as being formed as an integrated part of the housing 1 1 of the connector device 10
• the hook elements 20 having the flexible tongues
• the pressure normalization channel 60 is in communication with the volume defined by the expandable bladder 64 and any fluid container connected to the connector device 10 by means of the second connection means 13
• the second fluid container 2 has a total volume of 120 ml (V tot ) but is only filled with 100 ml of a cytotoxic liquid (V
• 30 ml is intended to be aspired although 32 ml of liquid is actually aspired from the second fluid container 2, leaving 52 ml of gas inside the second container 2 Alternatively some air bubbles are aspired into the syringe so that for example 0,5 ml or air is inside the syringe and 51 ,5 ml is inside the second container 2
• the height of the liquid column is assumed in this case to be about 50 mm (although different diameter of the second fluid container would give a different liquid column), hence, p + p - p

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• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (1)

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• 2008
  • 2008-12-15 ES ES08875455T patent/ES2447303T3/es active Active
  • 2008-12-15 CA CA2747024A patent/CA2747024C/en active Active
  • 2008-12-15 CN CN200880132761.5A patent/CN102307556B/zh active Active
  • 2008-12-15 JP JP2011539906A patent/JP5457462B2/ja active Active
  • 2008-12-15 EP EP20080875455 patent/EP2358327B1/de active Active
  • 2008-12-15 WO PCT/EP2008/067522 patent/WO2010069359A1/en active Application Filing

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