EP2996661B1 - Kit a usage unique pour la préparation de principes actifs par dissolution et/ou chauffage - Google Patents
Kit a usage unique pour la préparation de principes actifs par dissolution et/ou chauffage Download PDFInfo
- Publication number
- EP2996661B1 EP2996661B1 EP14729401.1A EP14729401A EP2996661B1 EP 2996661 B1 EP2996661 B1 EP 2996661B1 EP 14729401 A EP14729401 A EP 14729401A EP 2996661 B1 EP2996661 B1 EP 2996661B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- handle
- bowl
- cup
- gripping means
- stabilizing tab
- 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.)
- Active
Links
Images
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
-
- 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
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/0015—Devices specially adapted for taking medicines
- A61J7/0023—Spoons
Definitions
- the present invention relates to the field of accessories for the preparation by dissolving and / or heating pharmaceutical, medicinal or other products, in the form of a solid, powder or paste, intended to be administered by intravenous self-injection.
- the invention is part of the reduction of the risk of transmission of pathologies by the blood for injecting drug users. More particularly, the invention relates to the development of sterile accessories for single use to ensure better hygiene and better safety of users.
- kits for the preparation of pharmaceutical, medicinal or other products including a cup, a filtering nozzle removing impurities and a syringe are known.
- French patent FR2841789 discloses a device for preparing a pharmaceutical or medicinal product comprising among others a metal container usable for the dissolution and heating of the product.
- Said container has a recess having a shape and dimensions corresponding to those of the suction head of the filter tip of the injection kit.
- This patent also discloses a removable sleeve for handling and handling the container intended to engage or hook on a radial tab of the container and being able to ensure the stability of the container placed on a support.
- French patent FR2924019 also discloses a metal container having a gripping sleeve and handling container, said sleeve comprising elastically deformable tabs for snapping the filter tip and support legs for ensuring the stability of the container placed on a support .
- the patent GB2291356 discloses a container pre-filled with sterile water of the overall shape of a soup spoon having a bulge of the size of the filter tip and holding arms.
- the patent US2009 / 0264829 presents an injection kit comprising inter alia a flat-bottom mixing cup with a projection handle drawing a downward angle with respect to the top rim of the cup and ending with a flat portion in the same plane as the flat bottom of the cup. cup.
- the French patent application FR2967895 discloses a device for preparing a pharmaceutical or medicinal product, comprising a metal container and a detachable gripping sleeve forcibly mounted on said container.
- solutions of the prior art can contain only a small volume of solution, the latter may be insufficient for users who must then multiply the preparations and therefore increase the risk of mishandling and contamination.
- thermo-insulating tip on the grip sleeve.
- the user before administering his dose may tremble or be in a state that makes it difficult for him to perform this minute task. It can also reverse the dose or soil the cup by putting your fingers on it.
- he forgets to dispose of this tip or if he positions it badly the risk of burns related the use of a lighter or a flame to heat the preparation are increased.
- thermo-insulating tip the large weight of the thermo-insulating tip relative to the low weight of the cup makes the assembly unstable and easily reversible, particularly when the latter is placed on an irregular surface.
- the object of the present invention is to overcome the disadvantages of the prior art by proposing a disposable kit consisting of a sterile package containing a device for the preparation of products, in particular pharmaceutical or medicinal products, by dissolving and heating, comprising at least one cup ( 1) extended by at least one handle (2).
- This kit can be used for the preparation of injectables, such as drugs or active ingredients in the form of a solid, powder or paste and requiring for their preparation stages of dissolution, especially in sterile water, and heating.
- injectables such as drugs or active ingredients in the form of a solid, powder or paste and requiring for their preparation stages of dissolution, especially in sterile water, and heating.
- the device comprises a cup (1) having a flat bottom (14) concave internal peripheral edges (15), said cup (1) being and of constant depth, and extended by at least one handle (2), said handle (2 ) having at least one stabilizing tongue (6) configured so that the bottom (14) of said cup (1) is inclined when the device rests on a flat surface and gripping means (7), said gripping means (7) further comprising thermal insulation means.
- the stabilizing tongue (6) effectively holds the device on the surface on which it is placed. Similarly, its height being slightly higher than the depth of the cup (1), the liquid flows by gravity to the opposite end, which allows i) the liquid not to stagnate in the center of the cup, ii) to recover all the liquid during the aspiration by the syringe.
- the inner peripheral edges (15) of the bottom (14) of the cup are curved, concave and not at right angles to promote and maximize the flow of the liquid.
- the shape of the cup may be in particular oval, ovoid, semi-circle, semi-oval or triangular.
- the cup (1) is of ovoid section.
- the radius of curvature of the cup (1) of ovoid section is decreasing towards the end opposite the handle (4) to accentuate the accumulation of liquid, so that the user can suck with the filter tip of its syringe the entire contents of the cup without leaving a droplet.
- the handle (2) of the device is disposed opposite, that is to say in the extension of the broad base of the ovoid (3).
- the device is embossed in an aluminum foil with a thickness of between 0.2 mm and 0.4 mm.
- the use of a thick enough aluminum foil makes it possible to stiffen and weigh down the device and consequently to improve its stability.
- the aluminum may be non-limiting of a thickness of 0.28 to 0.30 mm.
- aluminum allows a good flow of aqueous solutions. Therefore, liquid losses are zero during suction by the filter tip of the syringe.
- the stabilizing tongue (6) comes from the handle (2) by at least one cutout (8, 9, 10) and a fold line (11), said stabilizing tongue (6) being lowered to face said cup (1) at an angle between 70 ° and 110 °.
- said stabilizing tab (6) shields the heat source and protects the user.
- the stabilizing tab also serves as a screen flame and therefore protects the user's fingers. The risk of burns are reduced and in fact, the user will have better control of the device. This stabilizing tab therefore gives increased comfort and safety of use.
- the gripping means (7) of the handle comprise thermal insulation means integral with the handle.
- the thermal insulation means are made of an insulating material and compatible with aluminum, for example and without limitation, silicone. Furthermore, the thermal insulation means are integral with the handle and do not require prior manipulation by the user.
- the device is sterile and ready for use. This limits the risk of mishandling that can soil the device and typically leading to the annoyance of users and risks of non-use of the device.
- the gripping means (7) of the handle (2) comprise thermal insulation means having non-slip grooves (13).
- non-slip grooves (13) are parallel to the fold line (11) of the stabilizing tongue (6).
- the cup (1) has a capacity of between 4.5 ml and 6 ml.
- This capacity is greater than the conventional contents of this type of device and is therefore adaptable to users requiring higher injection volume. In addition, this volume is limited so as not to encourage the sharing of doses between users.
- edges (5) of said cup (1) are non-cutting.
- the device is packaged in a sterile package.
- the figure 1 presents the device according to the invention in plan view.
- the latter has the general shape of a spoon with a cup (1) and a handle (2).
- the cup (1) has a substantially ovoid shape with a single axis of symmetry passing through the middle of the broad base (3) of the ovoid and the middle of its opposite edge (4) having a radius of curvature less than that from the base (3).
- the cup (1) has a flat bottom (14) whose peripheral edges (15) are concave to maximize the flow and recovery of the liquid.
- the cup has a constant depth between 6 and 10 mm for a capacity between 4.5 mL and 6 mL, ideally 5.7 mL.
- the edges (5) of the cup are not sharp.
- the wide base (3) of the cup (1) is extended by a handle (2) in the same plane as the edges (5) of the cup.
- the handle (2) comprises a stabilizing tongue (6) and gripping means (7).
- the stabilizing tongue (6) is located between the wide base (3) of the cup and the gripping means (7) and comes from three cutting lines (8, 9, 10) and a folding line (11). ).
- the stabilizing tongue (6) is lowered at an angle of 80 ° with respect to its cutting plane in the handle (2), opening a slot (12) in the body of the handle (2).
- This stabilizing tongue (6) has a height greater than 1 mm greater than the depth of the cup (1) thus allowing a slight inclination of the device when it is placed on a support. By gravity, the liquid thus accumulates towards the opposite edge (4) to the wide base (3) of the cup (1).
- the handle (2) ends with gripping means (7) surrounding the end of the handle (2).
- gripping means (7) consist of a heat-insulating material compatible with the material of the device, silicone for example.
- the gripping means (7) also have non-slip grooves (13) parallel to the fold line (11) of the stabilizing tongue (6) to facilitate grip of the device, especially when the user has wet hands .
- the figure 2 presents a perspective view of the device according to the invention.
- this device is in the form of a kit in a sterile package consisting of two peelable sheets, one side of which is permeable to a sterilization gas such as ethylene oxide.
Landscapes
- 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)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL14729401T PL2996661T3 (pl) | 2013-05-13 | 2014-05-09 | Zestaw do jednorazowego użytku do przygotowywania substancji aktywnych przez rozpuszczanie i/lub podgrzewanie |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1354251A FR3005407B1 (fr) | 2013-05-13 | 2013-05-13 | Kit a usage unique pour la preparation de principes actifs par dissolution et/ou chauffage |
PCT/FR2014/051071 WO2014184467A1 (fr) | 2013-05-13 | 2014-05-09 | Kit a usage unique pour la préparation de principes actifs par dissolution et/ou chauffage |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2996661A1 EP2996661A1 (fr) | 2016-03-23 |
EP2996661B1 true EP2996661B1 (fr) | 2017-06-21 |
Family
ID=49274746
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14729401.1A Active EP2996661B1 (fr) | 2013-05-13 | 2014-05-09 | Kit a usage unique pour la préparation de principes actifs par dissolution et/ou chauffage |
Country Status (6)
Country | Link |
---|---|
EP (1) | EP2996661B1 (es) |
ES (1) | ES2642121T3 (es) |
FR (1) | FR3005407B1 (es) |
PL (1) | PL2996661T3 (es) |
PT (1) | PT2996661T (es) |
WO (1) | WO2014184467A1 (es) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR3083445A1 (fr) * | 2018-07-09 | 2020-01-10 | Apothicom Distribution | Procede de fabrication d'une cupule destinee a la preparation et l'auto-injection de compositions pharmaceutiques ou medicamenteuses et cupule obtenue par le procede |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR3034995A1 (fr) * | 2015-04-20 | 2016-10-21 | Safe | Filtre membranaire a usage unique et kit medical comprenant un tel filtre |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE867286C (de) * | 1951-05-17 | 1953-02-16 | Ernst Schweizer | Haushalt-Medikamenteneinnehmeloeffel |
DE29510889U1 (de) | 1994-07-18 | 1995-11-23 | B. Braun Medical AG, Emmenbrücke | Sterilisierbarer Set für die Drogen-Selbstinjektion |
FR2841789B1 (fr) | 2002-07-05 | 2005-03-18 | Elliot Imbert | Dispositif de preparation d'un produit pharmaceutique ou medicamenteux notamment injectable |
US20050028386A1 (en) * | 2003-08-07 | 2005-02-10 | Hughes W. Scott | Kitchen utensil with head supporting member |
GB0427507D0 (en) | 2004-12-16 | 2005-01-19 | Frontier Plastics Ltd | Improvements relating to injection syringes and needles |
FR2924019B1 (fr) | 2007-11-27 | 2010-11-05 | Elliot Imbert | Dispositif de preparation d'un produit pharmaceutique ou medicamenteux injectable |
GB0723307D0 (en) * | 2007-11-28 | 2008-01-09 | Frontier Plastics Ltd | Mixing pan and mat |
FR2967895B1 (fr) * | 2010-11-25 | 2012-12-28 | Elliot Imbert | Dispositif de preparation d'un produit pharmaceutique ou medicamenteux notamment injectable comprenant un manchon de prehension amovible ameliore |
-
2013
- 2013-05-13 FR FR1354251A patent/FR3005407B1/fr not_active Expired - Fee Related
-
2014
- 2014-05-09 EP EP14729401.1A patent/EP2996661B1/fr active Active
- 2014-05-09 PL PL14729401T patent/PL2996661T3/pl unknown
- 2014-05-09 ES ES14729401.1T patent/ES2642121T3/es active Active
- 2014-05-09 WO PCT/FR2014/051071 patent/WO2014184467A1/fr active Application Filing
- 2014-05-09 PT PT147294011T patent/PT2996661T/pt unknown
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR3083445A1 (fr) * | 2018-07-09 | 2020-01-10 | Apothicom Distribution | Procede de fabrication d'une cupule destinee a la preparation et l'auto-injection de compositions pharmaceutiques ou medicamenteuses et cupule obtenue par le procede |
Also Published As
Publication number | Publication date |
---|---|
PL2996661T3 (pl) | 2018-01-31 |
PT2996661T (pt) | 2017-10-02 |
WO2014184467A1 (fr) | 2014-11-20 |
ES2642121T3 (es) | 2017-11-15 |
FR3005407A1 (fr) | 2014-11-14 |
FR3005407B1 (fr) | 2015-08-21 |
EP2996661A1 (fr) | 2016-03-23 |
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