EP2399565A1 - Dispositif pour reconstitution dosée et administration de solutions liquides contenant des substances actives disponibles sous forme séparée, en particulier en poudre ou en gel - Google Patents

Dispositif pour reconstitution dosée et administration de solutions liquides contenant des substances actives disponibles sous forme séparée, en particulier en poudre ou en gel Download PDF

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Publication number
EP2399565A1
EP2399565A1 EP20110170981 EP11170981A EP2399565A1 EP 2399565 A1 EP2399565 A1 EP 2399565A1 EP 20110170981 EP20110170981 EP 20110170981 EP 11170981 A EP11170981 A EP 11170981A EP 2399565 A1 EP2399565 A1 EP 2399565A1
Authority
EP
European Patent Office
Prior art keywords
bag
syringe
clamp
liquid solution
active substance
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Withdrawn
Application number
EP20110170981
Other languages
German (de)
English (en)
Inventor
Paolo Giuseppe Gobbi Frattini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GOBBI FRATTINI Ditta Paolo Giuseppe
Original Assignee
GOBBI FRATTINI Ditta Paolo Giuseppe
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 GOBBI FRATTINI Ditta Paolo Giuseppe filed Critical GOBBI FRATTINI Ditta Paolo Giuseppe
Publication of EP2399565A1 publication Critical patent/EP2399565A1/fr
Withdrawn legal-status Critical Current

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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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix 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
    • A61J1/2096—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
    • A61J1/1475—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
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting 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
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves

Definitions

  • the present invention relates to a device for dosed reconstitution and administration of liquid solutions containing active substances available in a separate form, in particular in powder or gel form.
  • liquid mixture that comprises, in addition to the active substance, a basic liquid solution that operates as a solvent.
  • this mixture and the delivery thereof into a bag intended for infusion or another administration method (for example for washing wounds) occurs in a closed-circuit environment in such a manner as to avoid both contamination of the active substance and harm to the medical and nursing staff that may arise from possible toxicity of the active substance if it is in drug form.
  • the drug or food to be administered can be reconstituted in a dosed manner, i.e. that the final liquid solution contains a variable dose of active substance to meet the variable treatment needs.
  • US-A-5899877 discloses a device for administrating medicines in accordance with the preamble to claim 1.
  • the object of the present invention is thus to make a device for dosed reconstitution and administration of liquid solutions containing active substances available in a separate form, in particular in powder or gel form, that meets the dual need of forming the mixture in a closed circuit and variable dosing of the quantity of active substance contained in the final solution to be administered to the patient.
  • this object is achieved with a device comprising the further features defined in the characterising part of claim 1.
  • the device according to the invention constitutes a closed circuit that does not allow contact of the active substance with the exterior and at the same time enables suitable dosing by the syringe of the quantity of active substance to be mixed with the basic liquid solution and thus pharmacological or nutritional loading of the mixture to be administered to the patient.
  • the device according to the present invention comprises a transparent flexible bag 1 that is provided with hooking windows 2, with a flexible administering tube 3 closed by a hermetic cap 4, for example of the perforable type, and with a flexible mixing tube 5.
  • the bag 1 is supplied to the medical facility filled with a basic solution or solvent 6.
  • the mixing tube 5 connects the bag 1 to a terminal 7 that is usable for hooking and perforating the perforable cap 8 of a bottle 9 that contains an active substance 10 in powder for (or gel form or other material) to be mixed with the basic solution 6 contained in the bag 1 ( figure 2 ).
  • the end 7 comprises a top plane 11, from which extend a perforating needle 12 with an axial hole 13 communicating with the internal passage of the tube 5 and two pairs of elastically deformable jaws 14 provided with an undercut 15 that is suitable for grasping and supporting the sealing collar 16 of the bottle 9.
  • the tube 5 provides internally a breakable closing cap 17 that can be broken and opened by manual action exerted on the outside of the tube 5.
  • the tube 5 has a flow deviator 18, shown in an enlarged section in figure 4 , which comprises a three-way passage 19 with a first way in communication with the bag 1, a second way in communication (via the breakable cap 17) with the terminal 7 and a third way in communication with a lateral mouth 20 with a valve device 21, that is normally closed by a screw cap 22.
  • the flow deviator 18 is completed by two clamps 23 and 24 of the type shown in a plan view in figure 3 , having a narrow part 25 that is suitable for tightening and closing the section of the tube 5 to which the opening and closing clamp is applied and a wide part 26 that is suitable for enabling the liquid to circulate freely inside the tube 5.
  • the device illustrated in figures 1-5 is usable as follows.
  • a bottle 9 containing an active substance 10 in powder form is applied to the terminal 7 in such a manner that the needle 12 perforates the cap 8 of the bottle and the jaws 14 with undercuts 15 hook and support the sealing collar 16 of the bottle.
  • the breakable cap 17 is broken, so the basic liquid solution, assisted by manual compression of the bag 1, starts to flow from the bag 1 to the bottle 9, where it mixes with the active substance in powder form, forming a liquid mixture composed of the active substance and of the basic solution ( fig. 6 ).
  • the mixture that is thus formed flows into the bag 1, after which at least one of the clamps 23 and 24 is moved to a closing position and the bag is thus ready for the infusion, which is performed by connecting the tube 3 to the patient by means of an intravenous tube with simultaneous or subsequent opening of the cap 4.
  • the device in figures 1-5 also enables the active substance to be delivered in a dosed quantity in the basic solution 6.
  • the cap 22 is unscrewed and the nozzle 30 of a syringe 31 is inserted into the side mouth 20 of the three-way passage 19 of the flow deviator 18 by pushing forwards and thus opening the valve device 21.
  • the piston 32 of the syringe fig. 8
  • a dosable quantity of the basic liquid solution present in the bag 1 is sucked into the internal chamber 33 of the syringe.
  • the subsequent advance of the piston 32 enables the dosed quantity of basic solution previously sucked by the syringe 31 to be transferred to the bottle 9, where it mixes with the active substance in powder form contained in the bottle ( figure 9 ).
  • a dosable quantity of the liquid mixture that is thus formed is subsequently sucked into the syringe 31 ( fig. 10 ) and, once the clamp 24 is closed and the clamp 23 is opened, is delivered to the bag 1 ( fig. 11 ).
  • valve device 21 By separating the syringe 31 from the mouth 20, the valve device 21 recloses automatically because of the pressure difference between the ends thereof.
  • Figure 12 shows a possible version of the device in figures 1-5 , which is completely similar to the previously disclosed one and also operates in a similar manner. The only difference is that the administering tube 3 is located at one end of the bag 1 that is opposite the one from which the mixing tube 5 extends.
  • Figures 13-18 in turn show a further variant of the device, which is distinguished from that of figures 1-5 by the fact that the flow deviator 18 consists of a three-way cock 40, in which three radial arms 41, 42, 43 provided with an indicating arrow are usable for rotating an internal valve 44 ( figure 14 ) and to alerting the user to the communications made each time.
  • the flow deviator 18 consists of a three-way cock 40, in which three radial arms 41, 42, 43 provided with an indicating arrow are usable for rotating an internal valve 44 ( figure 14 ) and to alerting the user to the communications made each time.
  • the basic solution 6 can flow into the bottle 9 and form a mixture with the active substance in powder form contained in the bottle 9 and then, by overturning the device, the mixture can be made to flow into the bag 1 in the manner disclosed with reference to figures 6 and 7 .
  • the cock 40 is rotated to the position in figure 16 and the nozzle of a syringe 31 is inserted into the mouth 20 by removal of the cap 22.
  • the piston 32 By retracting the piston 32, a dosed quantity of basic solution is sucked from the bag 1 to the syringe 31.
  • the cock 40 is then rotated to the position in figure 17 and the piston 32 is advanced to transfer the dosed quantity of basic solution previously sucked by the syringe 31 to the bottle 9, where a mixture in a dosed quantity is formed that then, after the cock 40 is rotated to the position in figure 18 , after the cap 22 is retightened and the device is overturned, flows into the bag 1.

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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP20110170981 2010-06-25 2011-06-22 Dispositif pour reconstitution dosée et administration de solutions liquides contenant des substances actives disponibles sous forme séparée, en particulier en poudre ou en gel Withdrawn EP2399565A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITMI2010A001154A IT1400708B1 (it) 2010-06-25 2010-06-25 Dispositivo per la ricostituzione dosata e la somministrazione di soluzioni liquide contenenti sostanze attive disponibili in forma separata, in particolare in polvere o gel.

Publications (1)

Publication Number Publication Date
EP2399565A1 true EP2399565A1 (fr) 2011-12-28

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP20110170981 Withdrawn EP2399565A1 (fr) 2010-06-25 2011-06-22 Dispositif pour reconstitution dosée et administration de solutions liquides contenant des substances actives disponibles sous forme séparée, en particulier en poudre ou en gel

Country Status (2)

Country Link
EP (1) EP2399565A1 (fr)
IT (1) IT1400708B1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3427781A3 (fr) * 2017-07-11 2019-05-01 Pharma Resources GmbH Médicament et système de dispositif pour des thérapies d'aérosol sous pression dans un espace creux d'un mammifère
KR20190114880A (ko) * 2018-03-30 2019-10-10 아디에네 파마 앤드 바이오테크 에스에이 주입 또는 주사에 의해 환자에게 투여될 의약의 또는 영양상 유체 물질의 투여분 재구성을 위한 압력 보상기가 구비된 멸균 가요성 패키지
IT201900002745A1 (it) 2019-02-26 2020-08-26 Adienne Pharma & Biotech Sa “Confezione sterile o sterilizzata per l’erogazione di sostanze medicinali o nutrizionali”
IT202000027669A1 (it) * 2020-11-18 2022-05-18 Paolo Gobbi Frattini S R L “insieme ad elementi connettibili e disconnettibili per la ricostituzione di farmaci e nutrimenti fluidi somministrabili a pazienti con sostanze attive in polvere o gel.”

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4408498A1 (de) * 1993-11-16 1995-05-18 Christian Eichler Umfülleinrichtung für die Medizin und die Pharmazie, z.B. eines Wirkstoffes in eine Lösung
US5899877A (en) 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US20020087118A1 (en) * 2000-12-29 2002-07-04 Duoject Medical Systems Inc. Pharmaceutical delivery system
WO2003079956A1 (fr) * 2002-03-26 2003-10-02 Carmel Pharma Ab Ensemble de transfert de fluide

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4408498A1 (de) * 1993-11-16 1995-05-18 Christian Eichler Umfülleinrichtung für die Medizin und die Pharmazie, z.B. eines Wirkstoffes in eine Lösung
US5899877A (en) 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US20020087118A1 (en) * 2000-12-29 2002-07-04 Duoject Medical Systems Inc. Pharmaceutical delivery system
WO2003079956A1 (fr) * 2002-03-26 2003-10-02 Carmel Pharma Ab Ensemble de transfert de fluide

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3427781A3 (fr) * 2017-07-11 2019-05-01 Pharma Resources GmbH Médicament et système de dispositif pour des thérapies d'aérosol sous pression dans un espace creux d'un mammifère
US20220133593A1 (en) * 2018-03-30 2022-05-05 Adienne S.A. Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutritional substances to be administered to patients by infusion or injection
JP2019181181A (ja) * 2018-03-30 2019-10-24 アディエンヌ ファーマ アンド バイオテック エスエイＡｄｉｅｎｎｅｐｈａｒｍａ ＆ Ｂｉｏｔｅｃｈ Ｓａ 点滴又は注射によって患者に投与される液状の薬剤又は栄養物質の投与量を再構成するための圧力補償器を含む滅菌フレキシブルパッケージ
US11141350B2 (en) 2018-03-30 2021-10-12 Adienne Pharma & Biotech Sa Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutritional substances to be administered to patients by infusion or injection
KR20190114880A (ko) * 2018-03-30 2019-10-10 아디에네 파마 앤드 바이오테크 에스에이 주입 또는 주사에 의해 환자에게 투여될 의약의 또는 영양상 유체 물질의 투여분 재구성을 위한 압력 보상기가 구비된 멸균 가요성 패키지
US12274671B2 (en) * 2018-03-30 2025-04-15 Adienne S.A. Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutritional substances to be administered to patients by infusion or injection
CN110314087A (zh) * 2018-03-30 2019-10-11 阿迪恩内制药和生物技术公司 用于通过输注或注射向患者施用的流体药用或营养物质的剂量重组的无菌柔性包装
JP7179660B2 (ja) 2018-03-30 2022-11-29 アディエンヌ ファーマ アンド バイオテック エスエイ 点滴又は注射によって患者に投与される液状の薬剤又は栄養物質の投与量を再構成するための圧力補償器を含む滅菌フレキシブルパッケージ
JP2023017988A (ja) * 2018-03-30 2023-02-07 アディエンヌ ファーマ アンド バイオテック エスエイ 点滴又は注射によって患者に投与される液状の薬剤又は栄養物質の投与量を再構成するための圧力補償器を含む滅菌フレキシブルパッケージ
KR102736491B1 (ko) 2018-03-30 2024-11-28 아디에네 파마 앤드 바이오테크 에스에이 주입 또는 주사에 의해 환자에게 투여될 의약의 또는 영양상 유체 물질의 투여분 재구성을 위한 압력 보상기가 구비된 멸균 가요성 패키지
US12097168B2 (en) 2019-02-26 2024-09-24 Adienne Pharma & Biotech Sa Sterile and sterilized package for administration of medicinal or nutritional substances
IT201900002745A1 (it) 2019-02-26 2020-08-26 Adienne Pharma & Biotech Sa “Confezione sterile o sterilizzata per l’erogazione di sostanze medicinali o nutrizionali”
EP4000588A1 (fr) * 2020-11-18 2022-05-25 Paolo Gobbi Frattini S.r.l. Ensemble avec éléments connectables et déconnectables pour la reconstitution de médicaments et de nutriments fluides avec des substances actives en poudre, liquides ou en gel, et procédé d'utilisation associé
US11865073B2 (en) 2020-11-18 2024-01-09 Paolo Gobbi Frattini S.R.L. Assembly with connectable and disconnectable elements for the reconstitution of fluid drugs and nutrients with active substances in powder, liquid or gel form, and related method of use
IT202000027669A1 (it) * 2020-11-18 2022-05-18 Paolo Gobbi Frattini S R L “insieme ad elementi connettibili e disconnettibili per la ricostituzione di farmaci e nutrimenti fluidi somministrabili a pazienti con sostanze attive in polvere o gel.”

Also Published As

Publication number Publication date
ITMI20101154A1 (it) 2011-12-26
IT1400708B1 (it) 2013-06-28

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