WO2021099829A2 - Système de flacon de médicament - Google Patents

Système de flacon de médicament Download PDF

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Publication number
WO2021099829A2
WO2021099829A2 PCT/IB2020/000921 IB2020000921W WO2021099829A2 WO 2021099829 A2 WO2021099829 A2 WO 2021099829A2 IB 2020000921 W IB2020000921 W IB 2020000921W WO 2021099829 A2 WO2021099829 A2 WO 2021099829A2
Authority
WO
WIPO (PCT)
Prior art keywords
safety system
liquid
conclusion
rubber stopper
case
Prior art date
Application number
PCT/IB2020/000921
Other languages
English (en)
Other versions
WO2021099829A3 (fr
Inventor
Tine DECOENE
Original Assignee
Decoene Tine
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Decoene Tine filed Critical Decoene Tine
Publication of WO2021099829A2 publication Critical patent/WO2021099829A2/fr
Publication of WO2021099829A3 publication Critical patent/WO2021099829A3/fr

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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
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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

Definitions

  • Vaccines such as vaccines must preferably be preserved and transported within a safe temperature range of between +2°Celsius and + 8°Celsius. Vaccines can be damaged when the temperature falls outside this temperature range, and the correct effect of such vaccines can be changed or, in other cases, the vaccine can become toxic by forming crystals, for example. Vaccine recipients can therefore be inoculated without the guarantee that the vaccine will have the necessary effect or that the vaccination is not toxic.
  • the VMM (Vaccine Vial Monitor) sticker manufactured by the company Temptime, is such an example.
  • the VMM sticker is affixed to the vaccine bottle and indicates when vaccines have been subjected to high temperatures for too long.
  • the Freeze Marker and the Freeze Watch Both products are indication stickers on the front of the secondary packaging.
  • the problem with such current products is that users and/or carers must interpret the stickers themselves. Interpretation and legibility differ according to which stakeholder is doing the interpreting and reading.
  • the sticker is in fact accompanied by a guideline, but users may still have their doubts regarding the meaning of the indication stickers. What is more, the existing products are only indicative. Therefore, these products do not provide an adequate solution for the goals set by the WHO.
  • This invention provides one single solution that makes it impossible to administer medicines that were exposed to temperatures falling outside the safety temperature range, such as the frequently occurring temperature range of between + 2°Celsius and + 8°Celsius.
  • the invention involves a working method and system to manage the access of a medicine in a medicine vial, preferably in a vaccine vial, which renders the needle entrance of the medicine vial to become inaccessible via the rubber stopper after the medicine has been subjected to incorrect temperatures and makes such process irreversible.
  • a safety system for the known medicine or vaccine vials such as the familiar vials or vaccine bottles.
  • the said vials are mostly provided with a rubber stopper through which a needle can be inserted.
  • the preferred design consists of an additional safety system that is placed over the existing rubber stopper.
  • the aim of this invention is to make vaccines or medicines that have been exposed to incorrect temperatures, heat and/or cold, inaccessible for use by not allowing the needle to be inserted into the rubber stopper of the vaccine vial. It is self-evident that in a preferred form, the safety system and the rubber stopper of the vaccine vial form a single integrated unit. It is therefore also a form of this invention where the rubber stopper is placed over the safety system as outlined here.
  • the invention concerns making medicines inaccessible and, more specifically, precisely those vaccines that become damaged by being exposed to incorrect temperatures and thereby no longer being fit for purpose, i.e. to be used.
  • the safety system will ensure that access is rendered impossible because the rubber stopper will no longer be able to be penetrated by a needle. Such a system meets the existing needs.
  • This invention provides a guarantee to the stakeholders (vaccine recipients, carers, care organisations, the authorities and the vaccine manufacturers) that only the vaccines that were not damaged by incorrect temperatures can be administered.
  • the safety system provides physical, visual and de facto feedback where the vaccine was exposed to incorrect temperatures.
  • vaccine recipients to be immunised with a vaccine will be given the certainty that they will be given an effectively functioning vaccine. There can no longer be any doubt whether the vaccine was exposed to incorrect temperatures, as a result of which it might have lost its effectiveness.
  • the invention will also help to work more efficiently with vaccines. Carers will be made aware of waste and will learn to handle vaccines differently, which, in the long term, will decrease costs. Vaccine manufacturers will be ensured that investing in improved (and expensive) vaccines will be worthwhile.
  • the invention will provide a security system for making inaccessible a rubber stopper of a medicine vial that contains a surface that can be penetrated by the prick of a needle; a system containing a covering plate, preferably with a hole, that can move between a neutral position and an activated position, where the covering plate will cover the surface normally to be pricked; a first liquid space containing the first liquid; a second liquid space containing the second liquid, where the volume of the first liquid and that of the second liquid increase if there is a change in the state of aggregation and where this activates the system.
  • the first liquid will change by increasing in volume upon the first temperature difference from the state of aggregation and the second liquid will change in state of aggregation with an accompanying increase in volume if there is a second and different temperature.
  • the invention provides a safety system to make inaccessible a rubber stopper where the first liquid increases in volume at a temperature that is lower than the bottom threshold of the safe temperature range to preserve the medicine; preferably the first liquid is water.
  • the invention provides a safety system to make inaccessible a rubber stopper where the second liquid increases in volume at a temperature that is higher than the top threshold of the safe temperature range to preserve the medicine; preferably the second liquid is ether.
  • the invention provides a safety system to make inaccessible a rubber stopper where the surface to be pricked forms a direct connection between the rubber stopper and the outside of the safety system.
  • the surface to be pricked forms a connection between the rubber stopper and the inside of the medicine vial. In such alternative form, the rubber stopper will be placed over the safety system.
  • the invention provides a safety system to make inaccessible a rubber stopper where the covering plate does not cover the surface to be pricked in the neutral position.
  • the invention provides a safety system to make inaccessible a rubber stopper, where the changed state of aggregation of the first liquid at a first temperature activates the system by moving the covering plate to the activated position.
  • the invention provides a safety system to make inaccessible a rubber stopper, where the changed state of aggregation of the second liquid at a second temperature that is different from the first temperature activates the system by moving the covering plate to the activated position.
  • the invention provides the use of a safety system to make inaccessible a rubber stopper of a medicine vial where the covering plate covers the surface to be pricked in the activated position.
  • the invention provides the use of a safety system to make inaccessible a rubber stopper of a medicine vial to render the rubber stopper inaccessible.
  • the invention provides a medicine vial containing a safety system to render a rubber stopper inaccessible.
  • the invention provides the use of a medicine vial (30) containing a safety system (1) to render a rubber stopper (3) inaccessible so that the medicine will be inaccessible in certain conditions.
  • the invention provides a medicine vial (30) containing a safety system (1) as outlined herein to render inaccessible a rubber stopper (3); more specifically, to render inaccessible the medicines in certain conditions, in which case the process of making the medicines inaccessible is irreversible.
  • Fig. 1 is a diagrammatic impression of a safety system according to a form of the current invention.
  • Fig. 2 is a cross section of a safety system according to a form of the current invention.
  • Fig. 3 is an exploded drawing of a safety system according to a form of the current invention.
  • Fig. 4 is the top view of a detailed view of a mechanism of a safety system according to a form of the current invention.
  • Fig. 5 is a diagrammatic drawing of a safety system according to a form of the current invention.
  • a product containing A and B may therefore not be restricted to a product that is made up exclusively of elements A and B. This means that the relevant elements of products are A and B present and that other elements such as C may be present in this invention.
  • one form or “a form” is referred to in these specifications, it means that a particular function or structure, or a particular property which relates to the form has been included in at least one form in this invention.
  • the phrase “in one form” or “in a form” is used in various places in these specifications, such phrase does not necessarily refer to the same form. What is more, certain functions, structures, steps or properties can be combined in any appropriate manner, as an ordinary expert in the field would regard that as appropriate in one or more forms.
  • “Making inaccessible a rubber stopper” as outlined in this document is understood to mean that the safety system in its activated position will ensure that a needle will no longer be able to be pricked into the typical rubber stopper to provide access to the medicine vial.
  • state of aggregation must be understood as the physical state in which a given amount of substance is to be found.
  • states of aggregation namely, solid, liquid and gas. Where it is stated that the state of aggregation of an element X has been changed, this must therefore be understood as a transition from the first state of aggregation (e.g. solid) to the second state of aggregation (e.g. liquid).
  • figure 1 reflects a diagrammatic impression of a safety system for a medicine vial according to a form of the current invention.
  • the safety system 1 is preferably positioned entirely over the rubber stopper 4 of the medicine vial 3.
  • the shape of the safety system 1 of figure 1 is not restrictive and can be shown in various ways.
  • Safety system 1 contains an outer encasing 5 and an inner encasing 6.
  • a lid, 20, is placed on the outer encasing 5, and a rubber ring, 19, is fitted for additional grip when holding the safety system 1 .
  • the outer encasing 5, and the inner encasing 6, are linked to one another. This can be done in various was, depending on the material chosen.
  • HDPE is the preferential synthetic material chosen for outer encasing 5 and inner encasing 6. This is especially because HDPE is a sustainable and inexpensive synthetic material that can be easily processed. It is self-evident that several synthetic materials can be used for this purpose.
  • the safety system 1 contains a small prick opening 17 with a diameter that is preferably between 1 and 5 millimetres and, at best, a diameter of 3 millimetres.
  • the said prick opening 17 runs from the outside of the safety system 1 through the outer encasing 5 and through the inner encasing 6 to the rubber stopper 4 of the medicine vial 3.
  • the said prick opening 17 is preferably in the centre of the safety system 1 and will allow a needle prick through the safety system 1 and the rubber stopper 4 of the medicine vial 3 solely and only if the safety system 1 is in the neutral position 15. When the safety system 1 is in the activated position 16, it is impossible to prick through the rubber stopper 4.
  • An upright ridge 18 is fitted on the outside of the inner encasing 6 so that the safety system 1 can be positioned over the rubber stopper 4 of the medicine vial 3.
  • the upright ridge 18 fits into cavity 2 of the medicine vial 3, causing the safety system 1 to be securely fitted on the medicine vial 3.
  • first liquid space 7A and second liquid space 7B will preferably contain first liquid space 7A and second liquid space 7B, with mechanism 10 next to them.
  • the liquid spaces 7A and 7B respectively contain first liquid 8A and second liquid 8B, and these liquids will expand at different temperatures, in particular, pursuant to a change in the state of aggregation.
  • the two liquid spaces 7 A and 7B are separated by a partition 27.
  • the first liquid 8A is preferably water and the second liquid 8B is preferably ether. This does not mean that other molecules having similar properties cannot be used.
  • the advantage of water is that it has a large expansion coefficient at temperatures below freezing point.
  • the advantage of ether is that it has a large expansion coefficient at warm temperatures.
  • Other options for the liquids can be combinations of water as first liquid 8A and a different substance having a large expansion coefficient as second liquid 8B.
  • the first liquid 8A and the second liquid 8B are sealed off by 2 small membranes 9, which separate the first liquid 8A and the second liquid 8B from mechanism 10.
  • the membranes 9 must also serve as a hatch between the first liquid 8A and the second liquid 8B, on the one hand, and mechanism 10, on the other hand.
  • the said membranes 9 must be flexible. Rubber is the preferred material to be used for this purpose. Various options are possible with regard to this component. Silicone rubber is used in this example. Synthetic foil could be another possible option.
  • Membranes 9 are positioned between openings 13 of the inner encasing 6.
  • Safety system 1 will preferably work as follows: when the first liquid 8A, e.g. water, is exposed to temperatures below freezing point, the first liquid 8A will expand and activate mechanism 10 in the safety system 1 , changing it from the neutral position 15 to the activated position 16, which will cause the prick opening 17 of the safety system 1 to be sealed off. In this way, the access to the rubber stopper of the medicine vial 3 will be blocked.
  • first liquid 8A e.g. water
  • the safety system 1 will contain a bi-metal and the mechanism 10.
  • the said bi-metal will react when it comes into contact with temperatures below freezing point and will thus activate mechanism 10. This action will cause cover plate 12 to be positioned in front of rubber stopper 4 and the prick opening 17 of the medicine vial 3 will become inaccessible for needles.
  • figure 4 reflects a detailed view of a mechanism 10 of a safety system I according to a form of the current invention.
  • the system of mechanism 10 of this non-exhaustive example contains a pre-stressed element
  • the cover plate 12 is preferably made from sturdy metal. A small aluminium plate was chosen in this example.
  • the pre-stressed element 11 in this design is elliptical, of which one side is bent more than the other. This element 11 must be made of a material that is both flexible and sturdy. Preference went out to synthetic material. The pre-stressed element 11 is clamped in the provided cavity 14 of the inner encasing 6.
  • the pre-stressed element 11 may be in one of 2 positions.
  • the first position is the neutral position 15, which puts the mechanism 10 in a non-activated position and the second position is the activated position 16, which puts the mechanism 10 in an activated position and fulfils its function.
  • the safety system 1 can no longer be returned to the neutral position 15 after it has reached the activated position 16. Activation of the safety system 1 to the activated position 16 is therefore an irreversible process.
  • temperatures below freezing point can cause the first fluid 8A to expand, and warm temperatures can cause the second fluid 8B to expand.
  • Expansion of the first liquid 8A and/or of the second liquid 8B causes the membranes 9 to become tense, which causes the membranes 9 to push the pre-stressed element 11 against the mechanism 10.
  • This causes the cover plate 12 to move a few millimetres and cover plate 12 to shift in front of the prick opening 17 of the safety system 1 .
  • Such shift is irreversible. Therefore, it is no longer possible for a needle to penetrate the prick opening 17 in the said activated position 16, and a needle can therefore no longer prick through the rubber stopper 4 of the medicine vial 3. This has the consequence that the medicine in the medicine vial 3 can no longer be used.
  • the rubber stopper 4 can be integrated in the safety system 1 by incorporating the pricking surface of rubber stopper 4, which is currently a rubber stopper, in the design of the safety system 1 .
  • the new inner encasing 23 thus formed, is then given a rubber underside or bottom 22, which can be clamped directly on the medicine vial. In this way, the integrated safety system 21 will replace the conventional rubber stopper 4 of the medicine vial 3, as it were.
  • the integrated safety system 21 also contains an outer encasing 5, a new inner encasing 23, an integrated mechanism 25, a first liquid space 7A, a second liquid space 7B and a first liquid 8A and a second liquid 8B.
  • the working method of the integrated mechanism 25 is similar to the safety system 1 discussed above. LIST OF PROPERTIES

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un procédé et un système de travail pour déterminer si une aiguille peut être insérée dans un flacon de médicament, de préférence un flacon de vaccin.
PCT/IB2020/000921 2019-11-22 2020-11-23 Système de flacon de médicament WO2021099829A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BE2019/5825 2019-11-22
BE201905825 2019-11-22

Publications (2)

Publication Number Publication Date
WO2021099829A2 true WO2021099829A2 (fr) 2021-05-27
WO2021099829A3 WO2021099829A3 (fr) 2021-09-02

Family

ID=68847903

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2020/000921 WO2021099829A2 (fr) 2019-11-22 2020-11-23 Système de flacon de médicament

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WO (1) WO2021099829A2 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190021954A1 (en) 2007-12-31 2019-01-24 Deka Products Limited Partnership Apparatus, System and Method for Fluid Delivery

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2976265B1 (fr) * 2011-06-08 2014-08-29 Biocorp Rech Et Dev Dispositif de bouchage et recipient equipe d'un tel dispositif

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190021954A1 (en) 2007-12-31 2019-01-24 Deka Products Limited Partnership Apparatus, System and Method for Fluid Delivery

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WO2021099829A3 (fr) 2021-09-02

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