[go: up one dir, main page]

WO2010023564A2 - Dispositif et procédé pour le transfert d'une substance d'un système donneur fermé dans un système cible - Google Patents

Dispositif et procédé pour le transfert d'une substance d'un système donneur fermé dans un système cible Download PDF

Info

Publication number
WO2010023564A2
WO2010023564A2 PCT/IB2009/007798 IB2009007798W WO2010023564A2 WO 2010023564 A2 WO2010023564 A2 WO 2010023564A2 IB 2009007798 W IB2009007798 W IB 2009007798W WO 2010023564 A2 WO2010023564 A2 WO 2010023564A2
Authority
WO
WIPO (PCT)
Prior art keywords
substance
connection
enveloping body
infusion set
target system
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.)
Ceased
Application number
PCT/IB2009/007798
Other languages
German (de)
English (en)
Other versions
WO2010023564A3 (fr
Inventor
Walter Pobitschka
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2010023564A2 publication Critical patent/WO2010023564A2/fr
Publication of WO2010023564A3 publication Critical patent/WO2010023564A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61J1/2096—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
    • A61J1/20—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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61J1/20—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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • the present invention relates to a device for transferring a substance from a closed donor system into a target system with an enveloping body, within which the substance is contained, wherein the enveloping body has at least one connection to at least one target system.
  • the present invention relates to a method for transferring a substance from a closed donor system into a target system, wherein substance reaches at least one target system from an enveloping body and its at least one connection.
  • Background of the invention is the practice practiced in the medical field of transferring liquids or suspensions into the human organism, which substance communicates with the environment during preparation and measurement. The same applies to supply lines and containers in which the substances are filled. In any case, there is an exchange with the unsterile atmosphere. This, of course, involves contamination risks. Especially with regard to the addition of an infusion within a hospital room with several patients, the bacteria and viruses contained in the hospital room come into direct contact with the liquid or suspension which is to be injected or infused into the patient.
  • a device with which a substance is transferred under closed conditions from a donor system to a target system results from DE 101 51 343 A1.
  • This document is about a bag system for the cryopreservation of body fluids.
  • a predetermined number of bags are interconnected by conduits and substance is transferred within the closed systems. Due to the integration of all bags within a system, it is not possible to use the bags shown there in individual applications. The connections are part of a piping system and do not allow a different application.
  • the object of the invention is to provide a device and a method, wherein the target system can be selected and a substance transfer can be achieved while reducing the risk of contamination.
  • the substance should be transferred without contamination, in an open system as a target system, the substance should be transferred low contamination.
  • the method is intended to reduce the risk of contamination during the transfer of the substance to a living organism.
  • a device of the type in question is designed such that the terminal has a free end which protrudes freely from the envelope body and is connected to this sterile.
  • a sterile connection to an infusion set can take place, which is then coupled for the transfer of the substance into the last target system here, namely to the vascular access of a patient.
  • the substance is not contained in the envelope itself, but in a container.
  • the envelope body could surround the container at a distance or encase.
  • the container could be in the form of an ampoule with puncture stopper or vial.
  • the coated ampoule with sterile connectable connection forms a closed donor system.
  • the pressure equalization could be completely relocated to the target system and the resulting pressure difference in the donor system can be accepted, since the empty ampoule is disposed of after sterile separation from the target system.
  • the target system could be present as an injection device, by means of which the substance is removable from the donor system in the form of the sheathed ampoule.
  • the injection device could in turn be part of a closed system and comprise a connection which is already connected to the connection of the encoder system in the factory sterile.
  • the cannula of the injection device could puncture the elastomeric stopper, air or inert gas could be injected into the ampoule, so that the contents of the ampoule are under pressure and thus a fine metering is possible during removal or suction of the substance, without the negative pressure
  • the target system could be a closed system with two ports according to a variant of the fourth embodiment.
  • a connection is used for sterile connection with the encoder system according to In the first exemplary embodiment, another connection is suitable for direct injection if the injection device itself becomes the transmitter system after being filled with the substance itself.
  • the container within the enveloping body could also be an infusion bottle or another vessel which is preferably resealable and whose opening and closing can be realized from outside via the enveloping body.
  • the contents of which is poured into the envelope and from there - after appropriate sterile connection with the target system - can be sucked.
  • the closure could be in the form of a puncture stopper.
  • the piercing plug could be made of elastomer and teflonized.
  • containers in the form of an evacuated storage vessel with piercing stoppers it is also possible to use commercial airtight containers which can be closed airtight with screw cap or snap closure.
  • containers made of rososilicate glass could be used, which are suitable for aggressive substances that attack plastic.
  • An aggressive substance could be, for example, dimethyl sulfoxide (DMSO). It was a substance that preserves a patient's stem cells and supplies them under sterile conditions. It is advantageous that the storage stability of the substance DMSO in a container made of borosilicate glass is two years. A connection made of PVC, is contacted only briefly during the transfer of the DMSO, so that dissolution processes are not set in motion.
  • another substance can also be contained in the container which, for example, is incompatible with another component. Closed systems, which are pure target systems, could be hose and bag systems.
  • the enveloping body could directly contain the substance and be present as a collapsible, flexible pouch.
  • This embodiment enables cost-effective production and storage of substances, such as preparation solutions, at the point of use while maintaining the integrity of the system.
  • the enveloping body can have a volume of between 30 ml and 1000 ml in larger pack sizes. In small quantities, so-called “minibags” reach a volume of between 10 ml and 30 ml. These "minibags" are intended for individual use and may each contain the maximum amount of substance required for the intended preparation.
  • the port could open into the container with one end and protrude minimally into the substance and be there provided with a resealable closure.
  • the projecting free end of the connection according to the invention could be welded to another system in a sterile manner or already be sterile.
  • the reclosability of the end of the connection projecting into the substance makes possible the partial removal of substances, such as, for example, preparation solutions, of course taking into account the sterile connection and disconnection.
  • substances such as, for example, preparation solutions
  • the second embodiment is the formation of the closure as a snap closure of sealing material, which is equipped with a mounting bridge and can be actuated via the flexible wall of the container.
  • the attachment bridge serves for the captivity of the closure.
  • the closure ensures that the substance is not introduced into the connection before the sterile connection has taken place and is possibly contaminated.
  • the material of the bagged container is soft but strong enough not to be damaged during manipulation of the closure.
  • the enveloping body in bag form could comprise a base plate through which the connection is guided in a sealed manner.
  • a pressure compensation device could be provided which opens into the area of the container filled with air or inert gas, which always points upwards in the operating position, while the substance, according to the gravitational force, fills the lower part of the bag and the connection with its outlet to the outlet Ground points.
  • connection could be welded into a base plate of the enveloping body in a sterile manner and comprise a short cannula.
  • the opening of the ampoule closed with the piercing plug and the connection protruding from the enveloping body could face the bottom.
  • a suction device could also be used.
  • it is particularly important to the formation of the envelope since the short cannula in the operating position to pierce the puncture stopper of the ampoule, but should maintain a safe distance in the rest position.
  • the wall of the enveloping body could be formed so flexible that the short cannula enters the container in the operating position, or is manipulated therefrom from the outside.
  • the flexible wall is designed in the form of a bellows. This bellows could be strongly deformed in all directions due to the extremely tear-resistant and thin material, which could also be stretchable beyond. This deformation is reversible. Due to the low material thickness, objects located inside the container can be grasped, connected or positioned or otherwise manipulated. Because of the gripping movement, it is particularly important that the wall comprises at least two opposite flexible areas.
  • the bellows could be welded or glued sealingly to a base plate, possibly to a cover plate of the enveloping body.
  • a long cannula for supplying air or inert gas could be provided. Both cannulas could pierce the closure of the container in the operating position and protrude into this.
  • the bellows is extended and takes up the two cannulas.
  • the cannulas are prevented by a holding device from puncturing the closure of the container.
  • the holding device can be supported on the base plate of the envelope.
  • the holding device could be in the form of a flexible slotted sleeve according to a preferred structural embodiment, which is particularly easy to handle. As long as the cannulas are not used, they are arranged in the holding device, which protects the bellows of the enveloping body before piercing.
  • the sleeve is supported in the resting state on the one hand against the base plate of the enveloping body, on the other hand against the shoulders of the container in the enveloping body.
  • the sleeve In the operating position, the sleeve is manipulated from the outside via the bellows, now lies around the container and the Cannulas pierce the closure. The bellows of the envelope is thereby moved together.
  • the long cannula could open with its end facing away from the container in the enveloping body, which is connected to a pressure compensation device. In this way, the long cannula in the operating position for the pressure equalization in the container. Since the material of the enveloping body could be stretchable, it is also possible to form a pressure compensation device from this property. The pressure compensation device would then be that escaping intrinsic air that passes from the container into the enveloping body, expands and fills the Hül emotions. If substance is removed from the container, system-internal air reaches the container via the long cannula from the stretched enveloping body.
  • the closed encoder system is already prefabricated with further closed systems and is sterile connected.
  • the further closed system has indispensably not only a target function but also a donor function.
  • the above-described total donor system could include next to an infusion bottle or ampoule within an envelope as a pure donor system also a preferably calibrated drip chamber as another closed system.
  • the overall system could alternatively or additionally have an infusion set as another closed system with donor as well as target function.
  • Particularly preferred is the embodiment of the total donor system with calibrated drip chamber for volume-accurate transfer and with the infusion set for connection to the actual target system, namely the living organism, with the vascular connection of the connection of Infusionsbe- plug or the entire system is connectable.
  • the metering system, the drip chamber and the infusion set could be assigned a dosing shut-off.
  • connection of the infusion set could initially be connected to a vent syringe, via which the substance is sucked from the drip chamber into the infusion set until the ambient air largely displaced from the infusion set.
  • the venting syringe could also be associated with a dosing barrier and it itself could be contained in an enveloping body.
  • a pressure equalization should take place via a pressure compensation device. Since the material of the enveloping body could be stretchable, it is possible to form a pressure compensation device from this property. The pressure compensation device would then be that escaping system-internal air, the envelope body expands and fills, especially in the bellows area.
  • a pressure equalization container could be sterile connected to the enveloping body and fluidly connected.
  • connection means between the venting syringe and the infusion set could be detachable, so that the connection means of the infusion set can be connected to the vascular access of an organism as the last target system after the removal of the venting syringe.
  • a filter device could be provided between the venting syringe and the infusion set.
  • a bacterial filter with a pore size of about 0.2 microns could be used in an advantageous manner.
  • the filter device may be necessary that the filter device must be removed before connecting the infusion set to the vascular access, so as not to obstruct flow.
  • capillary forces prevent the substance or infusion solution from escaping from the infusion set.
  • the allocation of the filter device to the connection means of the infusion set is recognized as being particularly advantageous. When the solution is removed from the breather, the filter device protects the substance from contamination until it is removed just prior to connection to the vascular access.
  • the connection could be in the form of a flexible plastic tube. It could be a thermoplastic which is suitable for known sterile bonding techniques such as “sterile docking” and “sterile welding". "DOCKING” is about creating cuts under the influence of temperature and directly fusing both ends of two plastic hoses. "WELDING” involves the separation of the joint, whereby compression under temperature leads to the formation of a homogeneous cross-sectional area and cutting that two closed cut surfaces arise.
  • the sterile connection can also be carried out independently of the aforementioned connection steps. As the “Sterile Docking” and “Sterile Welding” are manufactured in a known manner by mounting and welding of plastic containers and hoses under clean room conditions and sterilization measures.
  • the pressure equalization could take place wherever volume changes of the substance occur. As a rule, this could occur both with the encoder system and with the target system as well as with an overall system and its integrated closed systems with target and encoder function.
  • the container could be part of an injection device and have a connection made of easily penetrable material.
  • the connection could be designed as a transparent flexible hose, for example as latex hose or latex corrugated hose. This allows for direct injection into a target system as an organism.
  • the substance within the injection device is sealed off from the environment until puncture into the organism and only enters the atmosphere after piercing the connection by means of the cannula of the injection device. Thus, the substance is only minimally exposed to a contamination risk.
  • the enveloping body may have a flexible wall in regions, so that the injection device can be actuated from the outside.
  • the enveloping body according to the fourth exemplary embodiment could also comprise a pressure compensation device.
  • generous foil envelopes could also be used as enveloping bodies. These could contain intrinsic gas / air and allow pressure equalization.
  • the injection device is pre-filled. This could be done at the factory under clean room conditions.
  • the injection equipment However, tion could also be filled on site by substance is removed from a device according to the invention according to the first embodiment.
  • the injection device could be assigned a protective sleeve which engages over the free connection projecting from the enveloping body and is removed in the operating position.
  • This protective sleeve could, for example, be screwed onto the baseplate of the enveloping body or else on the wrapper body additionally surrounding the throwing barrel of a carpule.
  • the fourth embodiment offers various applications. On the one hand can be injected with a cannula directly under perforation of the connection in the organism. On the other hand, however, the connection can first be perforated, then pushed up to the envelope body and finally the exposed cannula can be used normally. In the latter case, it is advantageous if the pushed-up connection does not hinder the injection and moves unintentionally in the direction of the needle tip. Therefore, fastening means could be provided on the enveloping body in the region of the connection, at which the perforated and pushed back connection can be fixed in the operating position.
  • the injection device could have two ports, one of which is sterile connectable and the other consists of the easily perforable material.
  • the user is free to transfer the substance contained in the injection device into another closed system after he has carried out a sterile connection or to inject the substance directly into a target system at the risk of a very low risk Kontaminati- ons.
  • the target system may be a living organism but may also be a conduit system, a laboratory instrument or a measuring instrument.
  • the device according to the invention described in the fourth embodiment could contain a syringe and the container for the substance could be in the form of the syringe part, namely the ampoule cannula.
  • the use of a calibrated syringe with an ampoule flask and an ampoule body allows an active metered transfer of the substance.
  • the syringe can be manually operated on the envelope body, but also be introduced into a known per se electromotive pumping system in which the dosage can be programmed time and volume precision. However, tion could also be filled on site by substance is removed from a device according to the invention according to the first embodiment.
  • a protective sleeve be associated with that overlaps the protruding from the envelope body free port and is removed in the operating position.
  • This protective sleeve could, for example, be screwed onto the baseplate of the enveloping body or else on the wrapper body additionally surrounding the throwing barrel of a carpule.
  • the fourth embodiment offers various applications. On the one hand can be injected with a cannula directly under perforation of the connection in the organism. On the other hand, however, the connection can first be perforated, then pushed up to the envelope body and finally the exposed cannula can be used normally. In the latter case, it is advantageous if the pushed-up connection does not hinder the injection and moves unintentionally in the direction of the needle tip. Therefore, fastening means could be provided on the enveloping body in the region of the connection, at which the perforated and pushed back connection can be fixed in the operating position.
  • the injection device could have two ports, one of which is sterile connectable and the other consists of the easily perforable material.
  • the user is free to transfer the substance contained in the injection device into another closed system after he has carried out a sterile connection or to inject the substance directly into a target system at the risk of a very low risk Kontaminati- ons.
  • the target system may be a living organism but may also be a conduit system, a laboratory instrument or a measuring instrument. It is also conceivable variant, with only a latex connection could be provided in pre-filled syringes.
  • the device according to the invention described in the fourth embodiment could contain a syringe and the container for the substance could be in the form of the syringe component, namely the cannula cartridge.
  • the use of a calibrated syringe with an ampoule flask and an ampoule body allows an active metered transfer of the substance.
  • the syringe can be manually operated via the enveloping body, but also in a known per se electromotive pumping system are introduced, in which the dosage can be programmed time and volume precision.
  • the prefilled ampule body of the syringe could be mounted in a holding device on the base plate of the enveloping body and protrude with the cannula into the connection in the form of a latex tube.
  • a stopcock could be provided at the end of the ampoule body facing away from the stopper.
  • the sleeve-shaped holding device could have a recess through which an opening and closing of the stopcock can take place from outside via the bellows.
  • a variant of the present as a syringe embodiment provides the ampoule body to assign a cannula with a cannula closure, which can be opened and closed via the flexible wall of the envelope.
  • a faster emptying and filling of the pressure compensation device according to the variable gas volume in Hüll- body is achieved if the enveloping body comprises two chambers with two connecting pieces for preferably a pressure compensation device or two smaller separate pressure compensation devices.
  • the first chamber could contain the ampoule flask and the second chamber could contain the ampoule body with the cannula and the closure.
  • connection in which the connection is welded into a base plate of the enveloping body, the second chamber of the enveloping body could here at the end facing away from the first chamber for the ampoule flask at least the connection for the sterile connection with the connection of another closed system itself form.
  • a connection could also be arranged on the enveloping body of the variant in question, which can easily be perforated.
  • the space-saving design of the envelope either from a single full-length bellows between the base and cover plate or a combination of enclosure in the area of the vial body and a bellows in the area of the vial.
  • the device according to the invention can be clamped better in a syringe pump known per se, since the enveloping body is reduced to a minimum.
  • the device according to the invention could contain a cartridge.
  • the container in which the substance is contained in the form of Karpullen feelsteils, namely the Karpullenkörpes be present.
  • the carpule body could be calibrated for metered delivery of the substance.
  • the Karpulle includes a Karpullen redesign displaceable Karpullenkolben.
  • the envelope body could be constructed of two chambers, wherein a pressure compensation device is provided per chamber.
  • a cannula could be provided, which points with its tip to the body of the carcass, or its piercing plug and protrudes with its opposite end into the port.
  • the connection could also be present here as a sterile connectable plastic tube for connection to a closed target system.
  • an easily penetrable connection could also be provided, in particular if direct injection is to be undertaken.
  • the second chamber of the enveloping body could consist of a cylindrical portion and a bellows, wherein within a cylindrical portion of the Karpullen redesign is included and a part of the Karpullenkolbens and wherein contained within the bellows the rest of the Karpullenkolbens.
  • this chamber and a transfer barrel of the first chamber could be movable relative to one another relative to one another and preferably fixable to one another in a predetermined position.
  • an external thread could be provided, on which a protective sleeve to protect the terminal and the cannula with a corresponding internal thread can be screwed.
  • the transfer of the substance takes place after production of the flow connection from the container to the connection in that the Karpullenkolben shifts a Gleitstopfen within the Karpullen stresses.
  • the Karpulle allows the portionwise and volume accurate delivery of the substance from the carpule body and could be particularly useful as disposable items.
  • a particular advantage of the device according to the invention is that in itself inexpensive containers, such as ampoules, bottles, syringes, carpules and connections, which are otherwise used in open systems, applied by the enveloping body with the freely projecting connection to fully closed systems can be.
  • the arrangement of the low-cost donor systems in a corresponding envelope a closed system can be produced, which can interact with other closed or open systems.
  • low-cost sensor systems can be used in the device according to the invention and made accessible to medical and scientific work. Basically, it is desirable to store each substance for complex preparation steps within a container within a closed system.
  • the method according to the invention could be designed so that the end face of the easily perforable connection contacts the target system before it is perforated by means of the injection device, in particular the cannula, and the substance is administered into the target system.
  • the front side could preferably consist of a disc-shaped latex foil.
  • This end-face latex film could be bordered by a latex ring, which can be fixed as required on the outside of the enveloping body in the region of the connection if the end face is already pierced.
  • the piercing of the end face of the perforable connection could also be done without making contact between the connection and the target system.
  • a device according to the invention can advantageously be used with an injection device according to the fourth embodiment.
  • the inventive method could be designed according to the second alternative so that the substance does not enter directly into the infusion set, but first into a drip chamber and from there into the infusion set.
  • the substance could be sucked via a vent syringe from the drip chamber into the infusion set until the gas, for example. Inert gas or air is largely displaced from the infusion set. The connection between the vent syringe and the infusion set is then released and the infusion set is connected to a vascular access of an organism.
  • a possibly existing filter device could be removed with a for the substance to fine-pore filter before the connection of the infusion set takes place with the vascular access of the organism.
  • an apparatus according to the second and third embodiments of the device according to the invention can be used to carry out this method.
  • FIG. 1 is a schematic representation of a front view of a device according to the invention according to a first embodiment
  • Fig. 2 is a schematic representation of a front view of an inventive
  • Fig. 3 is a schematic representation of a front view of an inventive
  • FIG. 5 is a schematic representation of a variant of the fourth embodiment of the device according to the invention with syringe and sterile connectable connection
  • FIG. 5B the device in a blister pack
  • FIG. 5B the device during the connection of the closed system with a donor system
  • FIG. 5C the device in operating position - here piercing an ampoule of the donor system
  • Fig. 5D the device in the operating position - here emptying of air into the ampoule of the encoder system
  • Fig. 5E the device in the operating position - here sucking the substance from the ampoule of the donor system
  • Fig. 5F the device in the operating position - here sterile
  • FIG. 5G Separating the connection from the connection of the donor system, in FIG. 5G the device as a donor system in rest position - readiness for transfer of the filled substance into a target system, in FIG. 5H the unfilled device, prefabricated with a donor system,
  • FIG. 6 is a schematic diagram of a detail of an enveloping body with two, different terminals according to a further variant of the fourth embodiment
  • FIG. 7 is a schematic representation of the subject of FIG. 6 with a sterile connected encoder system according to FIG. 1, FIG.
  • FIG. 8 is a schematic representation of a variant of the fourth embodiment of the device according to the invention with syringe and perforable connection and
  • FIG. 9 is a schematic representation of a variant of the fourth exemplary embodiment of the device according to the invention with cartridge and perforable attachment.
  • the figures show a device for transferring a substance from a closed donor system G into a target system Z with an enveloping body 1, within which the substance is contained, wherein the enveloping body 1 has at least one connection 2, 3 to at least one target system Z.
  • FIGS. 1, 5, 6, 7 and 9 it is illustrated that the connection 2, 3 protrudes freely from the enveloping body 1 according to the invention and is connected to it in a sterile manner.
  • a container 4 is provided for the substance within the enveloping body 1.
  • the container 4 is an ampoule with puncture plugs 5.
  • 6 denotes a metal seal.
  • This donor system G according to FIG. 1 plays a role in connection with FIGS. 5B to 5F and FIG. 5H.
  • the target system Z is an injection device within an enveloping body 1 with two chambers 7, 8 and a connection 2, by means of which the donor system G, the substance can be removed. While FIGS.
  • FIG. 5B to 5F show the coupling, the substance transfer and the decoupling between the donor system G and the target system Z
  • FIG. 5H shows a factory-prefabricated unit from the injection device as a component of a closed system and donor system, the two connections 2 already connected sterile.
  • the enveloping body 1 is a collapsible bag, in which the substance is directly contained.
  • the local connection 2 is already factory sterile connected to the cover plate 9 of a calibrated drip chamber 10 and this again sterile over its base plate 11 with an infusion set 12.
  • the terminal 2 is welded into the base plate 11 of the envelope 1 and protrudes minimally with its hülligen lakeen end the substance in the enveloping body 1, so that when emptying a minimal amount of substance remains in the enveloping body.
  • the terminal 2 has a snap closure 13 of sealing material with a mounting bridge 14. The snap closure 13 can be actuated via the flexible wall of the enveloping body 1.
  • an eyelet 15 is provided for suspending the device.
  • Figs. 3 and 4 the third embodiment of the device according to the invention is shown, which has many similarities with the second embodiment. Differences are that a present as an infusion bottle container 4 is provided within the specially designed envelope 1.
  • the port 2 comprises a short cannula 16.
  • a long cannula 17 is provided.
  • the eyelet 15 is arranged on the cover plate 9 of the enveloping body 1.
  • Fig. 3 shows that the short cannula 16 and the long cannula 17 are arranged in the rest position in a holding device 18 in the form of a slotted sleeve, which is supported on the one hand against the base plate 11 of the enveloping body 1, on the other hand against the container 4.
  • the holding device 18 engages around the container 4, while the cannulas 16, 17 pierce the puncture stopper 5 of the container 4.
  • the terminal 2 the base plate 11 of the enveloping body 1 is sterile welded and has in the operating position to the ground, so that the gravitational force can be exploited.
  • the port 2 is already factory sterile connected to the cover plate 9 a calibrated drip chamber 10 and this in turn sterile over its base plate 11 with an infusion set 12th
  • FIGS. 2 to 4 show that the enveloping body 1 and the drip chamber 10 each have a pressure compensation device 20.
  • the long cannula 17 opens with one end in enveloping body 1 and provides in the operating position for pressure equalization in the container 4, since it projects into the air or inert gas region of the container 4 and not into the substance.
  • the pressure compensation device 20 is filled, since gas has been displaced by the compression of the bellows 19.
  • the encoder systems G are part of a total encoder system G total, which in each case comprises two further closed systems G / Z, which have both donor and target function. A sterile connection with each other is guaranteed.
  • the overall donor system G total includes the infusion set 12 and the calibrated drip chamber 10 as further closed systems G / Z, which are both donor and target G / Z systems.
  • the infusion set 12 interacts with its free end with a venting syringe 21, which is likewise arranged in an enveloping body 1 with a bellows 19 in the piston area and a connection 2.
  • the port 2 the infusion set 12, the venting syringe 21 and the pressure compensation device 20 of the drip chamber 10 are each a Dosierabsperrung 25 assigned. The procedure is carried out that in the devices according to the second and third embodiment of FIG. 2, 3, 4
  • the substance is sucked out of the drip chamber 10 - G / Z into the infusion set 12 - G / Z via the venting syringe 21 until the gas has largely been expelled from the infusion set 12,
  • connection 2 described so far is a flexible plastic tube which can be connected in a sterile manner with a closed system G / Z, Z.
  • a container 4 is also provided within the enveloping body 1. There, the container 4 is part of an injection device.
  • the enveloping body 1 has a bellows 19, via which the injection device can be actuated.
  • a pressure compensation device 20 is also provided here.
  • a pressure compensation device 20 is connected to two chambers 7, 8.
  • Fig. 9 per chamber 7, 8 each a pressure compensation device 20 is provided.
  • the injection devices namely two syringes according to FIGS. 5G and 8, and a cartridge according to FIG. 9 are filled.
  • the filling is realized by the user
  • Figs. 8 and 9 are factory-filled containers 4 in the form of ampoules bodies 26 of the two syringes and the Karpullen stressess 27 of the carpal.
  • the device according to FIG. 5G has in this state achieved its function as a donor system G and is ready for sterile connection to a target system Z and for subsequent substance transfer. Beforehand, the following process steps take place:
  • FIG. 5F The suction of the substance from the donor system G in the vial body 26 is completed, it takes place the sterile Diskonnektieren the terminal 2 of the closed target system Z of the Connection 2 of the donor system G, in FIG. 5G: From the target system Z according to FIGS. 5A to 5F, a closed donor system G has become. There is readiness for the sterile connection with another closed target system Z 1 to transfer the stored substance.
  • FIGS. 5A to 5H the enveloping body 1 or its chamber 8 itself forms the connection 2, which can be connected in a sterile manner.
  • FIGS. 6 and 7 show an alternative enveloping body 1 with two ports 2 and 3, wherein port 3 consists of easily penetratable material and allows direct injection into a target system Z, which is present here as an organism. Both terminals 2, 3 are welded into the base plate 11 of the enveloping body 1 sterile.
  • FIG. 7 shows that the connection 2 is connected in a sterile manner to another enveloping body 1 which contains a container 4.
  • the rest position is shown, in which case the terminal 3 is overlapped by a protective sleeve 32.
  • the protective sleeve 32 is screwed with its internal thread, not shown in more detail on the likewise unspecified Asked external thread of the base plate 11 of the enveloping body 1 and is removed if necessary.
  • the cover plate 9 is glued to the end of the ampoule piston 31.
  • the filled with substance ampoule body 26 is seated in a holding device 33 which has a passage opening 34 through which a stopcock 35 at the end of the ampoule body 26 via the bellows 19 can be actuated.
  • the existing bellows bellows-shaped terminal 3 is welded in accordance with FIGS. 8 and 9 on the base plate 11 of the enveloping body sterile.
  • the latex sheet 36 is perforated by the cannula 30, 40, which is movable from the outside via the piston 31, 39 to the front.
  • the latex ring 37 can be fixed to fastening means 38, which are arranged on the base plate 11 of the enveloping body, in the region of the connection 3.
  • the fastening means 38 are in the form of a projection or a nose, on which the ring is secured after release of the cannula 30, 40.
  • the rest position is also shown.
  • This is a container 4 in the form of the Karpullen stressess 27 a calibrated carpal.
  • the enveloping body 1 here is constructed somewhat more complicated and comprises two chambers 7, 8. Each chamber 7, 8 is fluid-connected to one pressure-equalizing device 20 each.
  • the chamber 7 contains the Karpullenanalysis 27 and a Karpullenkolben 39.
  • the chamber 8 contains at least partially a cannula 40.
  • the cannula 40 has with a tip to the body of the cartilage 27 and protrudes in the rest position with its opposite tip into the port 3 inside.
  • the Karpullen emotions 27 is closed with a puncture plug 5.
  • a sliding plug 41 is displaceable.
  • the Karpullenkolben 39 is disposed in the chamber 7, which includes a bellows 19 and a cylindrical portion in the form of a stable sleeve 42.
  • the end of the Karpullenkolbens 39 is bonded to the cover plate 9, on which the bellows 19 is arranged.
  • the bellows 19 then goes into the stable sleeve 42, which also receives the Karpullen endeavor 27.
  • a radially inwardly facing annular shoulder 43 is provided, against which the Karpullen stresses 27 is supported.
  • the sleeve 42 also has a radially inwardly facing annular shoulder 44, which counteracts an axial movement of the Karpullenkolbens 39. While the annular shoulder 43 is already formed on the sleeve 42, the annular shoulder 44 is formed by the fact that after insertion of the Karpullen stressess 27 into the sleeve 42, a ring is inserted into the sleeve 42, which is welded to the sleeve 42 and so the annular shoulder 44 trains.
  • the chamber 8 is welded to the annular shoulder 43 of the sleeve 42.
  • the chambers 7, 8 are fluidly connected in the slightest extent, at least not sufficient to use only one pressure compensation device 1.
  • the chamber 8 a Studentsschtubus 45 and therein a welded to the base plate 11 bellows 19.
  • the transfer tube 45 engages over the free end of the stable sleeve 42, both components are movable relative to each other and include locking means in the form of a recess 46 and a projection 47, which engage in the operating position and fix the position of the cannula 40 in the Karpullen emotions 27.
  • Puncture stopper 5 of the substance filled Karpullen stressess 27 pierces and immersed in the substance and the projection 47 engages in the recess 46;
  • the volume reduction of the chamber 8 the local pressure compensation device 20 is filled with air, the bellows 19 of the chamber 7 and the Karpullenkolben 39 are moved to Gleitstopfen 41, this is filled by the reduction in volume of the chamber 7, the pressure equalization device 20 there with gas, the slide plug 41 is moved in the Karpullenanalysis 27 in the direction of cannula 40 and so substance in the cannula 40 displaces and the desired amount of
  • a device according to the two variants of the fourth embodiment shown in FIGS. 8 and 9 can be used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif et un procédé pour le transfert d'une substance d'un système donneur fermé (G) dans un système cible (Z), le dispositif comprenant une enveloppe (1) qui contient la substance et qui présente au moins un raccord (2, 3) à au moins un système cible (Z). L'invention doit permettre le choix du système cible et un mode de transfert de la substance qui réduise le risque de contamination. Selon deux modes de réalisation, le procédé doit réduire le risque de contamination lors du transfert de la substance à un organisme vivant. A cet effet, le dispositif selon l'invention est caractérisé en ce que le raccord (2, 3) fait saillie librement de l'enveloppe (1) et y est relié de manière stérile. Quant au procédé, il est caractérisé, d'une part, en ce qu'on perfore l'extrémité libre du raccord juste avant l'injection dans le système cible et, d'autre part, en ce que la substance parvient par le biais du raccord du système donneur dans un système de perfusion qui est raccordé de manière stérile et qui est à la fois un système cible et donneur fermé et en ce que la substance parvient de là dans le système cible.
PCT/IB2009/007798 2008-08-02 2009-07-30 Dispositif et procédé pour le transfert d'une substance d'un système donneur fermé dans un système cible Ceased WO2010023564A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200810035837 DE102008035837B4 (de) 2008-08-02 2008-08-02 Vorrichtung und Verfahren zum Transfer einer Substanz aus einem geschlossenen Gebersystem in ein Zielsystem
DE102008035837.1 2008-08-02

Publications (2)

Publication Number Publication Date
WO2010023564A2 true WO2010023564A2 (fr) 2010-03-04
WO2010023564A3 WO2010023564A3 (fr) 2010-10-28

Family

ID=41461567

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/007798 Ceased WO2010023564A2 (fr) 2008-08-02 2009-07-30 Dispositif et procédé pour le transfert d'une substance d'un système donneur fermé dans un système cible

Country Status (2)

Country Link
DE (1) DE102008035837B4 (fr)
WO (1) WO2010023564A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102008046685A1 (de) 2008-09-10 2010-04-15 Pobitschka, Walter, Dr. Verfahren und Vorrichtung zur Entnahme einer Substanz aus einem offenen System
DE102008047068B4 (de) 2008-09-12 2015-02-26 Walter Pobitschka Verfahren und Vorrichtung zur Trennung von Blut unter Einsatz einer Zentrifuge

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10151343A1 (de) 2001-10-22 2003-05-08 Vita 34 Ag Beutelsystem für die Kryokonservierung von Körperflüssigkeiten

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4411662A (en) * 1982-04-06 1983-10-25 Baxter Travenol Laboratories, Inc. Sterile coupling
FI852454A0 (fi) * 1983-05-20 1985-06-20 Bengt Gustavsson Anordning foer transportering av ett aemne.
US5289858A (en) * 1991-12-18 1994-03-01 Abbott Laboratories System for accommodating withdrawal of liquid from a bulk supply
US5647849A (en) * 1995-09-27 1997-07-15 Becton, Dickinson And Company Self-contained safety syringe
DE19613678C1 (de) * 1996-04-05 1998-01-08 Fresenius Ag Anordnung zum Verabreichen einer medizinischen Flüssigkeit
FR2749169B1 (fr) * 1996-06-04 1998-08-21 Delab Procede pour constituer une preparation injectable et dispositif pour la mise en oeuvre de ce procede
US6127430A (en) * 1998-12-16 2000-10-03 3M Innovative Properties Company Microemulsions containing water and hydrofluroethers
DE29920664U1 (de) * 1999-11-25 2000-01-20 Centeon Pharma GmbH, 35037 Marburg Sterilhülle für eine Injektionsspritze
DE19960667A1 (de) * 1999-12-15 2001-06-28 Norbert Ostendorf Sterile Umhüllung zur Flüssigkeitsentnahme
FR2880533B1 (fr) * 2005-01-07 2012-06-15 Sophrone Ranguin Dispositif de protection sur l'ensemble piston, plongeur et seringue
FR2907769B1 (fr) * 2006-10-31 2009-02-06 Maco Pharma Sa Recipient equipe d'un systeme de transfert aseptique

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10151343A1 (de) 2001-10-22 2003-05-08 Vita 34 Ag Beutelsystem für die Kryokonservierung von Körperflüssigkeiten

Also Published As

Publication number Publication date
DE102008035837B4 (de) 2015-04-09
DE102008035837A1 (de) 2010-02-04
WO2010023564A3 (fr) 2010-10-28

Similar Documents

Publication Publication Date Title
DE68909402T2 (de) Aufbewahrungs- und umfüllflasche zum aufbewahren von zwei bestandteilen einer heilkräftigen substanz.
DE68908700T2 (de) Aufbewahrungs- und umfüllflasche zum aufbewahren von zwei bestandteilen einer heilkräftigen substanz.
DE69203543T2 (de) Medizinische Spritze mit geschlossenem abdichtbarem Schlauch.
DE60315003T2 (de) Flüssigkeitstransfer-anordnung
EP2320851B1 (fr) Procédé et dispositif pour le transfert d'une substance entre des systèmes fermés
EP2841125B1 (fr) Poche munie d'une pièce en plastique soudée rigide en flexion
EP2467117B1 (fr) Système de mélange de médicaments à flacons multiples
DE19982614B4 (de) Aufnahmevorrichtung zum dichten Aufnehmen von Substanzen
EP0757553B1 (fr) Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques)
EP0390898B1 (fr) Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange
DE69808205T2 (de) Vorrichtung zum Befüllen und zum Verabreichen von Spritzen
DE3143329A1 (de) "schutzvorrichtung fuer einen verbindungsstoepsel"
WO2011054755A1 (fr) Dispositif pour l'administration stérile d'un milieu fluide
EP0584396A1 (fr) Raccord pour disconnecter et reconnecter l'écoulement d'un fluide
US12274671B2 (en) 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
DE3311490A1 (de) Mischverfahren und mischeinrichtung fuer eine sterilisierte fluessigkeit
WO2020249738A2 (fr) Système de transfert de liquide et composants dédiés
DE102008035837B4 (de) Vorrichtung und Verfahren zum Transfer einer Substanz aus einem geschlossenen Gebersystem in ein Zielsystem
DE10028829A1 (de) Behältnis zum Aufbewahren, Vermischen und Verabreichen von Lösungen
DE69203774T2 (de) Mischbehälter zum Verbinden einer Spritze und Verfahren.
DE19604113C2 (de) Einkammer-Transfersystem für Wirksubstanzen, und der daraus fertig montierte Transferbehälter
DE9300177U1 (de) Behälter, insbesondere Arzneimittel-Behälter
EP4458343B1 (fr) Dispositif de préparation et de distribution de solution antiseptique pour le lavage des plaies
WO2024246149A1 (fr) Unité de remplissage pour remplir un milieu, en particulier de manière aseptique
JP2025501217A (ja) バイアルまたは他の減圧容器から、薬物を再構成、回収、及び移動させるための圧力補償デバイス、ならびにこのデバイスを備えた装置

Legal Events

Date Code Title Description
DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 09805816

Country of ref document: EP

Kind code of ref document: A2

122 Ep: pct application non-entry in european phase

Ref document number: 09805816

Country of ref document: EP

Kind code of ref document: A2