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
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/06—Ampoules or carpules
  • A61J1/065—Rigid ampoules, e.g. glass ampoules
• • 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
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • 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
  • A61J1/1475—Inlet or outlet ports
• • 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
  • A61J1/2006—Piercing means
  • A61J1/2013—Piercing means having two piercing ends
• • 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

Definitions

• the present invention relates to an ampoule for packaging and transferring a liquid or a powder for medical use in a container.
• the infusion bags are generally equipped with an injection site formed by a tube connected to the contents of the bag and closed by a perforable seal or by a valve device.
• Valve devices are generally housed at the bottom of a female LUER Lock cone. The valve opens automatically when a male LUER Lock is connected.
• the existing devices are intended to improve patient safety by reducing the risk of bacteriological contamination, and that of the operator by reducing the risk of bites and inhalation of toxic products.
• the existing devices are all in the form of a pre-assembled system intended to be clipped onto a glass bottle of standard size, provided with a perforable cap or not, depending on the devices.
• Document FR 2 791 254 in the name of the applicant describes an ampoule for packaging a liquid for medical use.
• This device comprises a hypodermic type needle the tip of which is directed towards a perforable membrane and the other end of which is fitted with means for connection to a medical syringe.
• This device can only be used in combination with a syringe.
• 35 graduations of the syringe is not necessary, especially when it comes to transfer the entire contents of one ampoule to an infusion bag.
• the object of the invention is therefore to provide an ampoule for packaging and transferring a liquid or a powder into a bag for medical use, which is sufficient in itself, and does not require the use of '' an intermediate syringe.
• the bulb according to the invention must be a bulb of simple structure, not requiring the use of means other than those contained in the bulb, and having perfect safety for patients and for operators, in particular avoiding that certain component parts of the ampoule cannot, during the transfer of the liquid or the powder, or after transfer of the liquid or the powder, contaminate the patients or the nursing staff.
• the bulb it relates to, comprising a tubular body of synthetic material having two chambers insulated in a sealed manner by a perforable membrane or a removable or ruptible wall, one of which contains the liquid or the powder, and of which the other is accessible from the outside to establish a connection during transfer, the membrane or perforable wall being disposed at the end of a tube integral with the bulb and opening into the chamber which can be placed in communication with the exterior, this tube containing a tubular element having a point-like end directed towards the membrane and being movable by a distance at least equal to that necessary for the perforation of the membrane, is characterized in that the tubular element and the tube comprise means preventing the separation of the tubular element and the tube after mounting one into the other.
• the bulb is made of synthetic material, the risk of breakage is excluded.
• the bulb integrates the transfer means towards a pocket, these means being constituted by the tubular element slidably mounted in the tube that the bulb comprises. The use of this bulb avoids any risk for medical personnel, since the tubular element cannot be detached from the tube, after mounting in the latter.
• the means preventing the separation of the tubular element and the tube are constituted by a shoulder formed at the periphery of the tubular element and at least one projecting part formed on the internal face of the tube.
• the tubular element and the tube are each equipped with a annular shoulder forming the means preventing separation.
• the annular shoulder of the tubular element also seals against the tube, after perforation of the membrane.
• This separation of the tubular element from the tube can be obtained before or after perforation of the membrane, the main thing being that the tubular element cannot be separated from the tube after transfer of the product.
• the part of the tubular element located on the side of the point is of frustoconical shape, complementary to that of the corresponding part of the tube, in which the tubular element is engaged in the perforated position of the membrane.
• the second end of the tubular element is also shaped as a point.
• the tubular element comprises, on the side of its second end, a part which, in the storage position, protrudes from the tube by a value at least equal to the value of the displacement of the tubular element.
• the second end of the tubular element is in the form of a connector, such as a male LUER cone.
• the tube has an internal thread for a threaded connection intended to be fixed with sealing on the second end of the tubular element.
• the tubular element and the tube have complementary anti-rotation fins.
• the zone of the tube situated on the side opposite to that equipped with the membrane is shaped as a female LUER type connector.
• this end of the tube has an external thread for an internally threaded connection intended to be fixed with sealing on the tube, and comprising an internal shaped part. of LUER cone, engaged in the tube and bearing against the end of the tubular element.
• the chamber containing no liquid or the powder is closed.
• This closure can be achieved by a peelable seal, or by a cap.
• the bulb is made of flexible synthetic material and the chamber containing the liquid or the powder is closed by flattening and heat sealing.
• the bulb is made of rigid synthetic material and the chamber containing the liquid or the powder is closed by an attached plug.
• the stopper can also be made in the form of a container for the drug. In this case, the weld will be shifted towards the middle part of the body.
• this end of the tube in the case where the end region of the tube opposite to that equipped with the membrane is shaped as a female LUER type fitting, this end of the tube has an external thread for an internally threaded fitting intended to be fixed with sealing on the tube, and comprising an internal part in the shape of a LUER cone, engaged in the tube and bearing against the end of the tubular element.
• Figure 1 is a longitudinal sectional view of a first bulb.
• Figures 2 to 5 are partial views, in longitudinal section of the same bulb during several successive phases of use.
• Figures 6 to 8 are three views of an alternative embodiment of the bulb of Figures 1 to 5, during three phases of use.
• Figures 9 to 13 are five views of another bulb during five phases of use.
• Figures 14 to 17 are four views in longitudinal section of another bulb, during four phases of use.
• the bulb shown in Figure 1 comprises a cylindrical tubular body 2 of synthetic material, having two chambers, a lower chamber 3 and an upper chamber 4, separated from each other by a partition 5 in the form of a disc.
• the chamber 3 contains a product such as a liquid or a powder 6, and is closed by a bottom 7 fixed for example by heat sealing.
• a tube 8 From the partition 5 extends a tube 8, which is closed near the partition 5 by a perforable membrane 9.
• the tube 8 comprises on its inner face and near the membrane 9, a frustoconical part 10, extended by a tubular part comprising an annular recess 12, limited near the free end of the tube by an annular shoulder 13.
• Au tube 8 is associated with a tubular element 14, comprising a front part 15 of frustoconical shape, complementary to the frustoconical part 10 of the tube and a peripheral annular shoulder 16 intended to bear with sealing in the annular recess 12, and to come into abutment against the shoulder 13 of the tube to prevent any risk of the tubular element leaving.
• This tubular element has two points 17 and 18 facing respectively towards the membrane and towards the outside. In the embodiment shown in the drawing, when the tip 17 is set back from the membrane 9, as shown in FIG. 1, the tubular element 14 cannot be extracted from the tube insofar as the shoulders 16 and 13 are resting against each other. Chamber 4 is closed by a peelable cover 19.
• a connection is intended to be made with a pocket 20 of which only a part is shown in the drawing ending in a tube 22 equipped with a filling site 23 provided with a perforable plug 24.
• the use of the bulb shown in Figures 1 to 5 is as follows:
• the cover 19 is torn off.
• the point 18 of the tubular element 14 is presented in the center of the plug 24 of the bag 20. If the plug of the injection site of the bag is easy to perforate, the point 18 will perforate it before the point 17 punctures the membrane 9 of the bulb. However, the liquid cannot flow outward due to the presence sealing means 16. The thrust being maintained, the end of the injection site 22, 23 will come close to the part of the tubular element 14 projecting from the tube 8. And the tubular element will pierce the membrane 9 to ensure communication between the two volumes. This is the position shown in Figure 4. The operator then exerts repeated pressure on the flexible bag which allows the flow of liquid from the bag to the bulb and the air contained in the bulb towards the pocket.
• the powder can thus be dissolved using the liquid collected.
• the operator turns the assembly over, the bulb being at the top and the bag at the bottom, and repeats the pumping action by successive pressures applied to the flexible bag.
• the liquid contained in the bulb passes into the pocket and is replaced by the air contained in the latter.
• the operation being completed the operator uncouples the bag and the bulb, the tubular element 14 remaining trapped in the bulb, which avoids any risk of contamination.
• the ampoule contains a medicine in liquid form, it suffices to carry out the second operation, to carry out the transfer of the liquid to the pocket.
• the tube 8 protrudes from the second chamber 4.
• the bulb In the non-use position, the bulb is closed by a cap 25.
• a second tube 26 is slidably mounted on the first tube 8. The end of this second tube 26 can be closed off by a plug 27.
• This bulb essentially aims to transfer the contents of the ampoule to a bottle 28 which is not equipped with a connection tube, but simply closed by a perforable cap 29.
• the operator after having removed the protective cap 25, applies the cap 27 against the cap 29 of the bottle.
• the bulb being held by the operator, a push is exerted towards the bottle 28 to slide the tube 26 on the tube 8, which allows the tip 18 to successively puncture the plugs 27 and 29 and the tip 17 to perforate the membrane 9.
• FIG. 7 The contents of the ampoule being in communication with the contents of the bottle or of the bag, the reconstitution can be carried out in the manner indicated above, the pumping action being carried out by the bulb.
• the operator pulls on the bulb body while holding the tube 26 fixed, which has the effect of covering the tip 18 by the tube 26 and then locking the latter by cooperation of 'a shoulder 30 of the tube 26 and a groove 32 of the tube 8, as shown in Figure 8.
• the needle is therefore protected after use.
• the membrane 27 is chosen from a self-sealing material, the chamber 3 is sealed in relation to the outside, which avoids harmful fumes when the medicament is dangerous for the nursing staff.
• the bulb includes protective means preventing access to the tip 18 by the user, so as to avoid any injury or contamination.
• the protection is effected by the tubular body 2 forming the second chamber 4, which surrounds and exceeds the point 18, even when the element 8 is in the high position and the shoulders 13 and 16 are in abutment against each other, as illustrated in FIG. 5.
• the protection means are formed by the protective tube 26 which covers the transfer element, in particular the tip 18 , at any time, except when a bottle or pocket is connected to the ampoule, as illustrated in Figures 6, 7 and 8.
• Figures 9 to 13 show another embodiment in which the same elements are designated by the same references as above.
• the end of the tubular element 14, opposite the tip 17, is constituted by a male LUER cone 35.
• the rear end of the tube 8 has a thread 36.
• the front end of the 'tubular element 14 comprises fins 37 complementary to fins 38 formed in the tube 8 near the membrane 9. These fins are intended to prevent rotation of the tubular element with respect to the tube in the perforated position of the membrane .
• a pocket 39 is equipped with a valve site 40 associated with a female LUER cone 42 intended to come to engage on the male LUER cone of the tubular element.
• this bulb is as follows: After tearing off the cover 19, the site 42 of the pocket 39 is engaged on the LUER cone 35 of the element 14, and screwed into the internal thread 36 of the tube 8. This connection movement is shown in Figure 2, in the case where the membrane is first perforated. It is also possible to envisage the case where the coupling between the bag and the tubular element is carried out before perforation of the membrane, as shown in FIG. 11.
• FIG. 12 shows the bulb and the bag in the connection position , position from which the transfer of liquid or powder from one container to another can be carried out as indicated above.
• FIGS. 14 to 17 represent a another embodiment of this bulb in which the same elements are designated by the same references as above.
• the outer end of the tube 8 is shaped as a female LUER cone 45, capable of sealingly receiving a male LUER cone 46 of a container 47 or of a syringe, coming to bear sealingly against the rear end of the tubular element 14.
• the tube 8 may include an external thread 48 onto which is screwed an internally threaded part 49 belonging to the neck of the container 47.
• FIG. 16 represents the end of the connection, from which the transfer can be made.
• the uncoupling is carried out by unscrewing, as shown in FIG. 17, the tubular element 14 remaining trapped in the tube 8.
• the invention brings a great improvement to the existing technique by providing a vial intended for the packaging and the transfer of a liquid or a powder to a bag or another container, of simple structure, integrating means of transfer, and retaining these after transfer, which avoids the risks of contamination for both the patient and the operator.
• the invention is not limited to the sole embodiments of this bulb, described above by way of examples, on the contrary it embraces all variants.
• the bulb could be made of a flexible synthetic material, and that the chamber 3 containing the liquid or the powder could not be closed by a bottom, but closed by pinching the material constituting the body and heat-sealing it. this, without departing from the scope of the invention.

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• Health & Medical Sciences (AREA)
• Hematology (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=8858598

Family Applications (1)

Country Status (8)

Families Citing this family (34)

Family Cites Families (20)

• 2001
  • 2001-01-08 FR FR0100193A patent/FR2819174B1/fr not_active Expired - Fee Related
  • 2001-12-20 CA CA002436934A patent/CA2436934A1/fr not_active Abandoned
  • 2001-12-20 WO PCT/FR2001/004129 patent/WO2002053086A1/fr not_active Application Discontinuation
  • 2001-12-20 BR BR0116656-5A patent/BR0116656A/pt not_active Withdrawn
  • 2001-12-20 AU AU2002226472A patent/AU2002226472B2/en not_active Ceased
  • 2001-12-20 EP EP01995750A patent/EP1349530A1/de not_active Withdrawn
  • 2001-12-20 US US10/450,199 patent/US7261707B2/en not_active Expired - Fee Related
  • 2001-12-20 JP JP2002554037A patent/JP2004520111A/ja active Pending

Non-Patent Citations (1)

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