EP4534064A1 - Beutel mit pharmakologischen fluid und entsprechenden kit - Google Patents

Beutel mit pharmakologischen fluid und entsprechenden kit Download PDF

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Publication number
EP4534064A1
EP4534064A1 EP24203621.8A EP24203621A EP4534064A1 EP 4534064 A1 EP4534064 A1 EP 4534064A1 EP 24203621 A EP24203621 A EP 24203621A EP 4534064 A1 EP4534064 A1 EP 4534064A1
Authority
EP
European Patent Office
Prior art keywords
container
package
pharmacological
solution
drug
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.)
Pending
Application number
EP24203621.8A
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English (en)
French (fr)
Inventor
Vittorio Pelloni
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.)
Guardant Srl
Original Assignee
Guardant Srl
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 Guardant Srl filed Critical Guardant Srl
Publication of EP4534064A1 publication Critical patent/EP4534064A1/de
Pending 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
    • A61J1/05—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
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • 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

Definitions

  • the present invention relates to a pharmacological package comprising a container of fluids which receives a solution containing a drug, a medical package comprising a container of fluids which receives a physiological solution, as well as a kit of parts comprising the two packages.
  • the preparation and dosage of pharmacological solutions at a wished concentration can be implemented exclusively by operating under a laminar flow flood, by manipulating manually the original solution and by mixing it with physiological solutions.
  • the preparation and the dosage of alkalinized local anaesthetic solutions requires to mix the original solution with sodium bicarbonate (NaHCOs).
  • the document US2015/306288A1 describes a system of bags provided with a bag for containing placental blood.
  • the bag comprises a first collection hose at the ends thereof there are sampling needles to take the placental blood, a second hose provided with collection element, and a third tube which, in case, can be provided at one end with a connector of Luer type for the connection with the other bag.
  • the document WO2017/140824A1 describes a container apt to preserve inside thereof a pharmaceutical substance, a cell culture and/or microorganisms.
  • the container preferably provides two or three attachments to connection tubes for filling-in or emptying the same.
  • the document EP0092528A1 describes a device for the endoperitoneal dialysis comprising a bag with two compartments for containing different substances, or solutions. Two tubular mouths are connected to one chamber, whereas only one tubular mouth is connected to the other chamber.
  • the document US2019/038887A1 describes a drainage unit which comprises a bag containing a physiological solution and provided on the lower side with two connectors, wherein one thereof is a connection connector of Luer Lock type which allows the connection with a drip chamber.
  • the technical problem underlying the present invention is then to provide a drug or active principle in adequate pharmaceutical form allowing to obviate the drawbacks just mentioned with reference to the known art.
  • the pharmacological package of the invention comprises a container implemented in form of bag containing a solution of a drug of interest, in particular an alkalinized local anaesthetic, advantageously with a connection element carrying at least an opening, distal from said container, to allow the introduction of a diluent fluid in the container or the extraction of the solution containing the drug from the container, and a collection element for the repeated withdrawal of the solution containing the drug by inserting temporarily and/or partially a needle, and by inserting in said solution, containing said drug and present in said containment compartment, an anaesthetic and/or additional drug.
  • a container implemented in form of bag containing a solution of a drug of interest, in particular an alkalinized local anaesthetic, advantageously with a connection element carrying at least an opening, distal from said container, to allow the introduction of a diluent fluid in the container or the extraction of the solution containing the drug from the container, and a collection element for the repeated withdrawal of the solution containing the drug
  • connection element and the collection element are defined by preferably flexible tubular elements.
  • the connection element has an opening at one end, distal from said container. At such end there is preferably a connection connector.
  • the collection element at one end, distal from said container has a self-sealing element apt to allow the repeated withdrawal of said solution by inserting a needle and, through the same, by inserting in said solution an anaesthetic and/or additional drug.
  • a self-sealing element at one end of the preferably flexible collection element is fundamental to allow an operator to perform in an easy and quick way, and in total safety, the procedures for preparing the pharmacological solution.
  • connection element of the pharmacological package carries a connector of male or female Luer Lock type at the opening, configured to allow the connection of the container with a system for inserting the diluent fluid or extracting the solution from the container, in particular with a medical package according to the present invention.
  • the self-sealing element can be associated removably to the end of the collection element.
  • the self-sealing element can comprise, or can consist of, a removable plug provided with one or more elastomeric membranes, in case arranged in sequence.
  • the medical package of the invention comprises a container implemented shaped as a bag, which contains a predefined volume of physiological solution suitable for diluting the drug at a specific concentration, wherein said physiological solution is an alkalinized physiological solution, in particular comprising sodium bicarbonate.
  • the container of the medical package carries a connection element having at least an opening, distal from the container, for the extraction of the alkalinized physiological solution from the container or for the insertion, into the above-mentioned container, of the drug solution present in the pharmacological package according to the invention.
  • the medical package comprises a collection element in tubular shape which extends from the container and puts said internal containment compartment in communication with the outside of the container, which collection element is provided with a self-sealing element, at one end distal from said container, apt to allow the repeated withdrawal of the solution received into said container by temporarily and/or partially inserting a needle and by inserting, in the diluted solution, an anaesthetic and/or additional drug.
  • connection element and the collection element of the medical package are defined by, preferably flexible, tubular elements.
  • a self-sealing element at one end of the, preferably flexible, collection element is fundamental to allow an operator to perform in an easy and quick way, and in total safety, the procedures for preparing the pharmacological solution.
  • connection element of the medical package carries a connector of Luer Lock type complementary to the connector of the pharmacological package of the invention and connectable thereto.
  • the self-sealing element of the medical package can be associated removably to the end of the corresponding collection element.
  • the self-sealing element of the medical package can comprise, or consist of, a removable plug provided with one or more elastomeric membranes, in case arranged in sequence.
  • the present invention provides some relevant advantages.
  • the main advantage consists in that the connection between the connector of the bag containing the drug with the complementary connector of the bag containing the physiological solution allows to pour easily the content of a bag inside the other one. This advantageously allows to modify, in whole microbiological safety, the dosage of the drug of interest directly inside the container of the pharmacological package of the invention as well as by pouring inside the container of the medical package of the invention, without requiring extemporary preparation of the drug solution at the wished concentration by an operator under controlled conditions.
  • the presence of the removable self-sealing element whether it refers to the pharmacological or to the medical package, has the advantage that it can be replaced in a quick and simple way in case of malfunctions, or losses, by preventing or limiting possible contaminations of the pharmaceutical solution.
  • the packages, the invention relates to, can be packed under the shape of a kit, comprising, for example, bags containing different volumes of physiological solution, each one suitable to implement a predefined drug dilution.
  • a kit comprising, for example, bags containing different volumes of physiological solution, each one suitable to implement a predefined drug dilution.
  • the present invention then allows to wide significantly the concentrations for using drugs, especially alkalinized local anaesthetics, in the hospital compartment, by reducing for example the costs for purchasing and storing local anaesthetic solutions at different concentrations which in practice become necessary for the interventions.
  • a pharmacological package according to a preferred embodiment of the invention is designated as a whole with 1.
  • the pharmacological package 1 comprises a substantially bag-shaped container body 2 made of biocompatible material, which defines an internal containment compartment 21 which receives inside thereof a pharmacological fluid consisting in a solution of a drug.
  • the solution includes a local anaesthetic with an alkalinizing agent, in particular sodium bicarbonate (NaHCOs).
  • an alkalinizing agent in particular sodium bicarbonate (NaHCOs).
  • the local anaesthetic can be any amide local anaesthetic known to a person skilled in the art, preferably it can be selected in a group of amide local anaesthetics comprising, but not limited to, mepivacaine, bupivacaine and lidocaine.
  • Other embodiments can have even concentration equal for example to 0.08%, 0.12%, 0.25%, 1%, 1.5% by weight with respect to the total volume of the solution or other and different volumes (10, 20, 60, 100 ml).
  • the solution of local anaesthetic with alkalinizing agent is preferably saturated.
  • the pH value of the saturated solution depends upon viscosity, the surrounding environmental conditions and the material of the container 2.
  • the pH of the drug solution in particular the pH of the solution of local anaesthetic with alkalinizing agent, is comprised between 6.5 and 7.5.
  • the container 2 can receive 10, 20, 40, 60, 80, 100 ml of solution or other volumes.
  • the container 2 is preferably externally and internally sterile and transparent.
  • the container 2 is preferably made of a bi-coupled material bearing an internal layer, that is in contact with the solution, made of polypropylene and an external layer made of polyvinyl chloride (PVC). In this way, the container 2 has the plastic quality of PVC upon contact and keeps the optimum properties of compatibility with the solution of polypropylene.
  • PVC polyvinyl chloride
  • the container 2 has a connection element 4 which extends from the container 2 and puts said internal containment compartment 21 in communication with the outside of the container 2.
  • the connection element 4 of the package 1 is in tubular or channel shape which puts the internal compartment 21 of the container 2 itself in communication with the outside.
  • connection element 4 in particular carries an opening 4a, distal from the container 2, for inserting a diluent fluid into the container 2 or for the extraction of the solution containing the drug from the container 2.
  • connection element 4 is provided with joining means 5 of Luer type at the opening 4a, configured for coupling to means for introducing the diluent fluid in the container 2 and/or for extracting the drug solution from the container 2, in particular with connecting means of a medical package according to any one of the embodiments described in the present description.
  • the joining means 5 can comprise or consist of a connector of Luer cone-like type or of Luer-Lock type.
  • the joining means 5 of the connection element 4 is in shape of connector of, male or female, Luer lock type configured for coupling with a complementary Luer Lock connector.
  • a female Luer lock connector is provided.
  • the container 2 has a collection element 6 in tubular shape which extends from the container 2 and puts said internal containment compartment 21 in communication with the outside of the container 2.
  • the collection element 6 is provided with a pierceable and self-sealing element or septum 61, also denominated as point-needle, at one end 6a of the same element 6 distal from the container 2, apt to allow the repeated withdrawal of the solution of local anaesthetic by temporarily and/or partially inserting a needle or the like.
  • Said point-needle can also be used for inserting, in the solution containing the drug received in the containment compartment, an anaesthetic and/or additional drug.
  • the self-sealing element 61 can be associated removably to the end 6a of the collection element 6.
  • the self-sealing element 61 can comprises, or consist of, a removable plug provided with one or more elastomeric membranes, in case arranged in sequence.
  • a medical package according to a preferred embodiment of the invention is designated as a whole with 10.
  • the medical package 10 is configured to allow the dilution or dosage of a solution containing a drug contained in the pharmacological package 1 according to any one of the embodiments described in the present description.
  • the medical package 10 comprises a substantially bag-shaped container body 20 made of biocompatible material, which defines an internal containment compartment 210 which receives inside thereof a pharmacological fluid consisting in a physiological solution.
  • the physiological solution comprises 0.9% by weight of NaCl with respect to the total volume of the solution (w/v).
  • the physiological solution is an alkalinized physiological solution.
  • the physiological solution is an alkalinized physiological solution comprising 0.9% by weight of NaCl with respect to the total volume of the solution (w/v) and sodium bicarbonate.
  • the alkalinized physiological solution is saturated, having a pH comprised in a range of about 6.5-7.5.
  • the container 20 can receive 20, 60, 140, 230, 480, 780 800, 1000 ml of physiological solution or other volumes.
  • the container 20 is preferably externally and internally sterile and transparent.
  • the container 20 is preferably made of bi-coupled material carrying an internal layer, that is in contact with the physiological solution, made of polypropylene and an external layer made of polyvinyl chloride (PVC).
  • PVC polyvinyl chloride
  • the container 20 of the medical package 10 has a connection element 40 which extends from the container 20 and puts the internal containment compartment 210 in communication with the outside of the container.
  • the connection element 40 of the package 10 is in tubular or channel shape which puts the internal compartment 210 of the container 20 itself in communication with the outside.
  • connection element 40 in particular carries an opening 40a, distal from the container 20, for the extraction of the physiological solution from the container 20 or the insertion or pouring, within the above-mentioned container 20, of the drug solution of a pharmacological package 1 according to any one of the embodiments described in the present description.
  • connection element 40 of the medical package 10 is provided with connection means 50 of Luer type at the opening 40a, which is configured for coupling to the joining means 5 of the pharmacological package 1.
  • connection means 50 of the connection element 40 of the medical package is in shape of connector of Luer lock type, complementary with respect to the Luer Lock connector of the pharmacological package 1 and connectable thereto.
  • Luer lock connector is provided.
  • the container 20 of the medical package has a collection element 60 in tubular shape which extends from the container 20 and puts the internal containment compartment 210 in communication with the outside of the container 20.
  • the collection element 60 at one end 60a distal from the container 20, carries a pierceable and self-sealing element or septum 610, also denominated as point-needle, apt to allow the repeated withdrawal of the solution received into said container 20, by temporarily and/or partially inserting a needle or the like.
  • said self-sealing element 610 can be then used to withdraw the so-diluted drug solution received into the container 20, as well as for inserting, in the diluted solution, an anaesthetic and/or additional drug.
  • the self-sealing element 610 can be associated removably to the end 60a of the collection element 60.
  • the self-sealing element 610 can comprise, or consist of, a removable plug provided with one or more elastomeric membranes, in case arranged in sequence.
  • kit of parts according to a preferred embodiment of the invention is designated as a whole with 100.
  • the kit of parts 100 comprises at least a pharmacological package 1 and a medical package 10 according to any one of the embodiments described in the present description. Such kit is configured to allow the dosage or dilution of the drug solution received in the pharmacological package 1 at a wished concentration.
  • the joining means 5 of the pharmacological package 1 according to the invention is complementary to the connection means 50 of the medical package 10 and connectable thereto, by allowing to pour the drug solution from the container 2 of the pharmacological package 1 into the container 20 of the medical package 10 or vice versa.
  • the kit of parts 100 comprises at least a pharmacological package 1 according to any one of the variants defined in the present description and claims, and a plurality of medical packages 10 according to any one of the variants defined in the present description and claims, wherein each one of the above-mentioned medical packages 10 includes a different volume of physiological solution within the corresponding container 20.
  • the container 2 of the pharmacological package 1 containing the drug can be connected - through the connection element - to one to be selected from the containers carrying a predefined volume of physiological solution, so as to allow - by pouring the drug solution into the container 20 or vice versa - the preparation of a final solution of the drug having the wished concentration.
  • the kit of parts 100 comprises at least a pharmacological package 1 carrying within the container 2 a solution of alkalinized local anaesthetic according to any one of the variants defined in the present description and claims.
  • the kit 100 further comprises at least a medical package 10 containing an alkalinized physiological solution, preferably it comprises a plurality of medical packages 10, wherein each one of the above-mentioned medical packages 10 includes a different volume of alkalinized physiological solution within the corresponding container 20.
  • the kit of parts 100 comprises a pharmacological package 1 carrying within the container 2 a volume equal to 20 mL of solution of 2% (w/v) alkalinized local anaesthetic.
  • the kit 100 further comprises a plurality of medical packages 10, wherein each one of the above-mentioned medical packages 10 includes a different volume of alkalinized physiological solution within the corresponding container 20.
  • the container 2 of the pharmacological package 1 containing 20 ml of 2% (w/v) alkalinized local anaesthetic can be connected with the above-described modes to a corresponding container of the medical package 10 carrying a predefined volume of alkalinized physiological solution, by guaranteeing the concentrations of local anaesthetic as shown in the table below: Volume of the bag of alkalinized physiological solution Concentration of alkalinized local anaesthetic at the end of pouring (w/v) Final volume of alkalinized local anaesthetic at the end of pouring 20ml 1% 40ml 60ml 0.5% 80ml 140ml 0.25% 160ml 230ml 0.16% 250ml 480ml 0.08% 500ml 780ml 0.05% 800ml
  • the invention allows to widen significantly the use concentrations of the local anaesthetic alkalinized by simple procedures, which can be performed in the department, and capable of reducing to negligible levels the risks for safety, quality and sterility.

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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)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP24203621.8A 2023-10-02 2024-09-30 Beutel mit pharmakologischen fluid und entsprechenden kit Pending EP4534064A1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT102023000020301A IT202300020301A1 (it) 2023-10-02 2023-10-02 Sacca comprendente un fluido farmacologico e relativo kit

Publications (1)

Publication Number Publication Date
EP4534064A1 true EP4534064A1 (de) 2025-04-09

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EP24203621.8A Pending EP4534064A1 (de) 2023-10-02 2024-09-30 Beutel mit pharmakologischen fluid und entsprechenden kit

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EP (1) EP4534064A1 (de)
IT (1) IT202300020301A1 (de)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0092528A1 (de) 1982-04-16 1983-10-26 SIS-TER S.p.A. Vorrichtung für die Peritonealdialyse
EP0495330A1 (de) 1991-01-17 1992-07-22 Instituto De Biologia Y Sueroterapia, S.A. Zugangsvorrichtung für flexible Behälter
US6179822B1 (en) 1998-01-20 2001-01-30 Bracco Research Usa Single use universal access device/medical container assembly
US20150306288A1 (en) 2012-10-10 2015-10-29 Etablissement Francais Du Sang Method for preserving placental blood
WO2017140824A1 (de) 2016-02-17 2017-08-24 Sandoz Ag Gebinde, dessen verwendung, verfahren zu dessen herstellung und das gebinde umfassendes kit
US20190038887A1 (en) 2016-10-05 2019-02-07 Hyun Woo Lee Medical drain unit having luer-lock connection structure
US20230270102A1 (en) * 2020-07-21 2023-08-31 W.L. Gore & Associates, Inc. Bag for easy drainage and manipulation
US20230302456A1 (en) 2022-03-24 2023-09-28 Evolution Design & Development LLC Configurable assembly for retaining and dispensing liquids

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0092528A1 (de) 1982-04-16 1983-10-26 SIS-TER S.p.A. Vorrichtung für die Peritonealdialyse
EP0495330A1 (de) 1991-01-17 1992-07-22 Instituto De Biologia Y Sueroterapia, S.A. Zugangsvorrichtung für flexible Behälter
US6179822B1 (en) 1998-01-20 2001-01-30 Bracco Research Usa Single use universal access device/medical container assembly
US20150306288A1 (en) 2012-10-10 2015-10-29 Etablissement Francais Du Sang Method for preserving placental blood
WO2017140824A1 (de) 2016-02-17 2017-08-24 Sandoz Ag Gebinde, dessen verwendung, verfahren zu dessen herstellung und das gebinde umfassendes kit
US20190038887A1 (en) 2016-10-05 2019-02-07 Hyun Woo Lee Medical drain unit having luer-lock connection structure
US20230270102A1 (en) * 2020-07-21 2023-08-31 W.L. Gore & Associates, Inc. Bag for easy drainage and manipulation
US20230302456A1 (en) 2022-03-24 2023-09-28 Evolution Design & Development LLC Configurable assembly for retaining and dispensing liquids

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Publication number Publication date
IT202300020301A1 (it) 2025-04-02

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