EP3193970A1 - Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif - Google Patents

Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif

Info

Publication number
EP3193970A1
EP3193970A1 EP15763017.9A EP15763017A EP3193970A1 EP 3193970 A1 EP3193970 A1 EP 3193970A1 EP 15763017 A EP15763017 A EP 15763017A EP 3193970 A1 EP3193970 A1 EP 3193970A1
Authority
EP
European Patent Office
Prior art keywords
vial
connecting device
holder
container
fluid line
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Withdrawn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
EP15763017.9A
Other languages
German (de)
English (en)
Inventor
Winfried Brehm
Martin Kaiser
Massimo Fini
Alain Veneroni
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.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
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 Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP3193970A1 publication Critical patent/EP3193970A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M5/1414—Hanging-up devices
    • A61M5/1417—Holders or handles for hanging up infusion 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
    • 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
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve means
    • 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
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae
    • 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
    • A61M5/1414—Hanging-up devices
    • A61M5/1415—Stands, brackets or the like for supporting infusion accessories
    • 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
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • A61M5/1689—Drip counters
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36225—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with blood pumping means or components thereof
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362262—Details of incorporated reservoirs
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362265—Details of valves
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362266—Means for adding solutions or substances to the blood
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems

Definitions

  • the invention relates to the field of transfer of fluids from a container into another container or into a fluid line via a connecting device.
  • the invention relates to a device for connecting a vial to a container or a fluid line via a suitable connection device and a method for this purpose.
  • the invention further relates to the use of a device for connecting a vial to another container or a fluid line via a connecting device.
  • the device is mainly used in the medical field in the application of drugs in extracorporeal circuits.
  • this reference does not imply a limitation, an application in non-medical areas is also conceivable.
  • Commercially available vials also referred to as injection vials, vials or vials, are small containers of glass, more rarely plastic, with a capacity of 1 ml to 200 ml, which are used in medicine and in chemical laboratories.
  • the filling with a dry substance is used when substances have too low a stability.
  • the solution of the dry substance takes place shortly before administration by adding sterile water or another solvent.
  • Vials are closed with a stopper or a membrane of elastic material, such as rubber or polytetrafluoroethylene.
  • An aluminum bead attaches the injection plug or piercing membrane to the bottle head. At the center, the plug or membrane has the smallest thickness, at which point they can easily be pierced with the aid of a spike or cannula.
  • the transfer of a drug contained in the vial into a container, for example, carried out for dilution, the transfer into a fluid line is used in therapeutic treatments by means of infusions or extracorporeal circuits.
  • the medicament drawn up in the syringe is then transferred to another container.
  • the medicament drawn up into the syringe is administered via injection sites, usually designed as tees, into the fluid line provided for this purpose with the patient.
  • injection sites usually designed as tees
  • Disadvantages of administering the medicament from the vial by means of a syringe are the time-consuming double transfer of the medicament and the expensive use of additional disposable materials such as syringes and cannulas.
  • administration via a syringe fitted with a cannula carries the risk of injury to the clinician and associated disposal issues.
  • vials from vials are given as a bolus.
  • some therapeutic substances including anticoagulants (e.g., heparin, citrate), vitamins, antibiotics, erythropoietin, or iron preparations (e.g., Venofer) are preferably administered over a prolonged period of time.
  • anticoagulants e.g., heparin, citrate
  • vitamins e.g., antibiotics, erythropoietin, or iron preparations
  • iron preparations e.g., Venofer
  • connection means allows the direct connection of a commercially available vial to the extracorporeal circuit while avoiding the introduction of air into it.
  • the connection means comprises two conduit paths, the drug delivery conduit path having a gas barrier member and the second conduit path being connected to an external gas reservoir, which may be air, a gas-filled container or a gas-filled conduit, and which serves to ventilate the vial.
  • the document WO 01/91693 describes a device for coupling a connection device to a vial.
  • the device has a holding device for a vial of different sizes, a holding device for a connecting device in different sizes and an actuating means for coupling the connecting device to the vial.
  • the connecting device is pressed onto the neck of the vial, wherein the piercing device of the connecting device penetrates the septum of the vial.
  • the documents EP 2 319 553 and WO 2011/141200 disclose a hose set with a connection device for coupling a vial.
  • the connecting device comprises a supply lumen for the supply of a therapeutic substance and a vent lumen for the delivery of a fluid, such as air or liquid, into the interior of the vial to displace the therapeutic substance.
  • the connecting device described in the document EP 2 319 553 has a flow regulator, by means of which the delivery rate of the therapeutic substance from the vial can be adjusted and ends in a drip chamber, the air of which penetrates into the vial.
  • connection device described in document WO 2011/141200 can likewise open into a drip chamber and has at least one one-way valve, which is placed inside the supply lumen or within the ventilation lumen and opens or closes under the influence of a pressure difference generated by a pump.
  • connection device of the known type. This consists of a base body and a piercing device with two parallel cable paths, which are continued in the main body of the connection device. Bulges at the blunt end of the puncture seal the tubing when no vial is connected. When connecting a vial in a vertical plane X slidingly mounted piercing device is moved and combines the conduction paths of the piercing device and the body together.
  • the document EP 2 462 913 proposes a system for dispensing liquid, which contains a vial and a suitable connection device with a piercing device for opening the septum of the vial.
  • a cover Prior to the connection, a cover is placed on the vial, which is capable of fitting it with the connection device and has an engagement surface by means of which the cover can be rotated in the connection device for opening the flow paths.
  • a connecting device is known, which has a housing and a receiving part with a piercing device. The flow path of the connecting device is opened by rotation of the receiving part in the housing.
  • the invention has for its object to provide a device and a method of o.g. To develop a way so that a safe, time and labor-saving transfer of the contents of a vial into a container or a fluid line directly from a standard vial without the use of additional aids, such as disposable syringes or pumps, is possible.
  • the invention is further based on the object to ensure aseptic handling to avoid contamination of the contents of the vial during the transfer into a container or in a fluid line.
  • Connection device and vial should be easy to insert and the individual steps to transfer the contents of the vial into a container or fluid line (combining vial and connection device, opening the vial septum, opening and closing the flow paths) with the least possible effort and without risk of injury to the vial Personnel be feasible.
  • connection device and the vial are brought together in a defined position and held firmly and securely for the duration of the application.
  • the device should be inexpensive and easy to produce.
  • the device for connecting a vial to a container or to a fluid line and transferring the content of a vial into a container or a fluid line a first holder adapted to receive a connecting means, a second holder adapted to receive a vial, an actuating means and a connecting means.
  • the latter consists of an annular housing and an inner part with a piercing device, wherein the annular housing of the connecting device is installed rotatable about the inner part, so that by rotation of the housing, the flow paths of the connecting device can be opened and closed.
  • connection device can also be referred to as an adapter or connector.
  • Claim 12 relates to a medical treatment unit with the device according to the invention.
  • Claim 14 relates to an evaluation unit for the device according to the invention which, via the detection of the position of the vial and / or connection unit with the aid of at least one sensor, provides information about the opening or closing of the connection device.
  • the device according to the invention makes it possible to transfer the contents of a commercially available vial directly into a container or a fluid line without having to use additional disposable parts such as syringes or cannulas. This eliminates the problem of disposal, the time required for this is less and the risk of injury to the staff is not given. Since the puncture of the membrane of the vial by the mandrel is done automatically via the activation of the actuator, a risk of injury to the staff is excluded even in this process. In addition, in this way a secure connection of the vial over the duration of the application and a transfer of the contents under aseptic conditions.
  • the device according to the invention also guarantees easy applicability.
  • the vial and the connection device can be inserted into the device without any problems; the rotation of the housing around the inner part reduces the force required to open the flow paths.
  • the device according to the invention is simple and inexpensive to produce.
  • the elimination of additional disposable parts leads to an additional cost reduction.
  • FIG. 1 shows a simplified schematic representation of the structure of an infusion device with the device according to the invention
  • FIG. 2 shows a simplified schematic representation of the structure of an extracorporeal treatment device with the device according to the invention using the example of a hemodialysis device;
  • Fiq.3 a three-dimensional representation of the device according to the invention.
  • Fig. 4a a three-dimensional representation of the connection device with closed flow paths
  • Fig. 4b a three-dimensional representation of the connecting device with closed flow paths in longitudinal section
  • Fig. 5a a three-dimensional representation of the connection device with opened flow paths
  • Fiq.5b a three-dimensional representation of the connecting device with opened flow paths in longitudinal section
  • Fiq.6 a three-dimensional representation of the inner part of the connecting device
  • Fig. 7 is a three-dimensional view of the seal of the connector
  • Figures 7a and b a three-dimensional representation of the two halves of the seal of the connecting device
  • Fig. 8a a schematic representation of the inner part of the connecting device with attached seal in the closed state
  • Fig. 8b a schematic representation of the inner part of the connecting device with attached seal in the opened state
  • FIG. 9 a schematic view of the housing with hose connection
  • FIG. Fig. 10 a schematic representation of the double lumen tube
  • 1 a-d a three-dimensional representation of the (commissioning of the device according to the invention) method steps from the insertion of a commercially available vial and the connecting device until the opening of the flow paths of the connecting device;
  • Fiq.12a a representation of the device according to the invention in longitudinal section with dekonnektierter vial;
  • Fiq.12b a representation of the device according to the invention in longitudinal section with attached vial;
  • Fiq.13a-c an illustration of the mechanics of the device according to the invention in section during the connection of the vial;
  • Fiq.14 a three-dimensional representation of a section of the device according to the invention.
  • Fig. 1 shows a simplified schematic representation of the structure of an infusion device, in which the device according to the invention can be integrated.
  • a tube set [23] is used, which is connected to a patient via a venous vascular access.
  • the content of an infusion container [25] flows by gravity into the patient via a drip chamber [24] or is supplied to it via a pump [26].
  • Injection sites [28] for medicines can be integrated into the tube set. These are suitable for the connection of the device according to the invention [2]. It is also possible to connect the device according to the invention to the drip chamber [24].
  • the device according to the invention can moreover be designed as an integral part of an infusion tube set.
  • Fiq.2 shows a simplified schematic representation of the structure of an extracorporeal treatment device using the example of a Hemodialysis apparatus in which the device according to the invention can be integrated.
  • the patient In hemodialysis, the patient is usually bled from an arterial-venous fistula.
  • the part of the extracorporeal circuit in front of the dialyzer is referred to as arterial and after the dialyzer as venous part.
  • the extracorporeal circulation in hemodialysis, as in other extracorporeal treatment procedures usually completely within a hose or cassette set instead [23].
  • a drip chamber [24] is integrated into the venous part of the circuit in order to eliminate any air bubbles that may have occurred.
  • there are usually injection sites [28] for drugs that are suitable for the connection of the device according to the invention [2]. As can be seen from FIG.
  • the device according to the invention can moreover be designed as an integral part of a tube or cassette set for extracorporeal treatment and preferably a hemodialysis tube or cassette set.
  • Fiq.3 shows a three-dimensional representation of the device according to the invention [2]. This consists of a first holder [4] for receiving a connecting device [8], a second holder [5] for receiving a vial [1], an actuating means [7] and a connecting device [8].
  • An actuating means [7] is connected to a lifting rod [9], to which the second holder [5] is attached.
  • the actuating means [7] serves to move the lifting rod [9] and the second holder [5] in an axis X.
  • a turntable is integrated [6].
  • the connecting device [8] via an undercut [6 '] in the vertical and locking lugs [6 "] fixed in the horizontal direction.
  • the device according to the invention can be permanently integrated or detachably attached to a medical treatment unit, preferably into an infusion device or an extracorporeal treatment unit, in particular into a hemodialysis machine, via a machine holder [3].
  • the device can thus be used in a medical technology method, in particular in a method for infusion or extracorporeal treatment, preferably a hemodialysis method.
  • the rigid material is preferably made of a polymer suitable for this use, such as polycarbonate (PC), polypropylene (PP), polyethylene (PE), polystyrene (PS), polyvinyl chloride (PVC), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), acrylonitrile-butadiene-styrene (ABS), and co-polyester.
  • PC polycarbonate
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PVC polyvinyl chloride
  • PET polyethylene terephthalate
  • PBT polybutylene terephthalate
  • ABS acrylonitrile-butadiene-styrene
  • the soft material consists of a suitable elastic material, preferably an elastomer, such as silicone rubber, styrene-ethylene-butylene-styrene (SEBS), styrene-ethylene-propylene-styrene (SEPS), styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), poly-urethane (PU), polyisoprene, thermoplastic elastomer (TPE), natural rubber (NR) and latex.
  • elastomer such as silicone rubber, styrene-ethylene-butylene-styrene (SEBS), styrene-ethylene-propylene-styrene (SEPS), styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), poly-urethane (PU), poly
  • FIGS. 4a and 5a respectively show a three-dimensional representation of the connection device [8] with closed or opened flow paths.
  • FIGS. 4b and 5b respectively show a three-dimensional representation of the connection device [8] with closed or opened flow paths in longitudinal section. It can be seen from FIGS. 4a / b and 5a / b that the connecting device [8] consists of an annular housing [13] with an engaging surface [15], a likewise annular inner part [12], a piercing device [14], a seal [17] and a hose connection [1 6].
  • the housing [13] of the connecting device [8] is rotatably installed around the inner part [12] in the function of a valve. At the engagement surface [15], the housing [13] can be safely and easily rotated during rotation about the inner part [12]. without much effort.
  • vials [1] are predominantly made of a material that is rigid, when transferring the contents of a vial [1] into a container or into a fluid line so that the flow does not end, the volume of the transferred contents must be replaced.
  • the piercing device [14] of the device [2] according to the invention must therefore have two conduit paths.
  • a first conduit path [14 '] is used to transfer the contents of the vial [1] into a container or into a fluid conduit, via a second conduit [14 "] a fluid, preferably gas, can flow into the vial [1] Substitutes the outflowing content of the vial [1] and prevents the formation of a negative pressure that would allow the flow to dry off
  • the piercing device [14] can be designed in the form of two separate hollow needles, cannulas or spikes, preferably in the form of a double-lobed spike.
  • the connecting device [8] is further equipped such that a cover [29] can be placed tightly on the piercing device [14].
  • This may preferably be made of elastic material so that it is compressed in the connection of a vial [1] and the piercing device [14] is released, slides back to its original position during the deconnection and again covers the piercing device [14].
  • Fiq.6 are in a three-dimensional representation of the inner part [12] of the connecting device [8] of the device according to the invention [2] the first flow path [1 6 '] for the contents of the vial [1] and the second flow path [1 6 "] for a fluid flowing into the vial [1] and the contours of the seal [22]
  • the sealing contours [22] are used for the defined sealing of the flow paths, so that during rotation of the housing [13] around the inner part [12] opened and closed state of the connecting device [8] the flow paths are completely enclosed and in this way a tightness is ensured.
  • Figure 7 shows a three-dimensional representation of the seal [17] of the connection device [8].
  • the seal [17] serves a liquid-tight connection between inner part [12] and housing [13].
  • the seal [17] consists of a first [17 '] and a second half [17 "], which are designed to correspond to each other, so that Each half has a center hole [18], a centering pin [19] and, in a particularly preferred embodiment, a valve seat [20] and a valve flap [21]
  • the type of valves and different possibilities with regard to embodiment or mode of operation are not known known in the art and in particular for use in a device for transferring liquids from vials, for example in the international application WO 2011/141200 A1, the contents of which are hereby incorporated into the description, described in detail and therefore will not be explained in detail here.
  • Fiq.8a shows a schematic representation of the inner part [12] of the connecting device [8] with attached seal [17] in a closed position Condition
  • Fiq.8b is a schematic representation of the inner part [12] of the connecting device [8] with attached seal [17] in the open state.
  • connection contours [30] in order to guide the fluids flowing in and out through the connection device [8] in such a way that the connection of a double-lumen hose regardless of its angular position can be done.
  • the connecting device [8] Before putting the device according to the invention into operation [2], the connecting device [8], to which a fluid line or a container is connected, is inserted into the turntable [6] integrated in the first holder [4].
  • the connecting device [8] by the undercut of the turntable [6 '] in the vertical and by locking lugs [6 "] fixed in the horizontal direction.
  • Fiq.1 1 a shows the device according to the invention [2] with inserted connecting device [8] and a commercially available vial [1] before insertion.
  • a commercially available vial [1] consists of a body [1 '], a neck [1 "] and a head [1"'].
  • the head [1 "'] includes a closure, which may be formed as a plug or membrane and is secured by a bead on the neck [1"].
  • the vial [1] is inserted into the device [2] according to the invention, in which it is inserted with the neck [1 "] into the second holder [5] such that the head [1" '] of the vial [1] of FIG Connecting device [8] is directly opposite. This can be seen from Fiq.1 1 b.
  • the vial [1] in an axis X to connecting means [8] moves.
  • the septum of the vial [1] is perforated by the piercing device [14], which in the second position [34] of the actuating means [7] completely enters the vial [1], so that the first [14 '] and the second [14 "] Open the lead into the interior of the vial [1].
  • Fiq.1d shows the opening of the connecting device [8] by rotation of the housing [13] around the inner part [12].
  • the rotation is preferably carried out by 90 ° to one side of the device according to the invention [2].
  • the rotation of the turntable [6] has two effects: on the one hand, removal of the opened connecting device [8] is reliably prevented and, on the other hand, the connecting device [8] is fixed in its vertical position.
  • the actuating means [7] is moved back from the second [35] to the first position [34].
  • the lifting rod [9] of the device [2] according to the invention, to which the second holder [5] is attached, moves with and separates the vial [1] and the connecting device [8] from one another. Both parts can now be removed.
  • vial [1] and connecting device [8] are removed in the connected state when the connecting device [8] is closed. In this way, a faster and more comfortable disarming of the device according to the invention [2] after use is possible.
  • the insertion of vial [1] and connecting device [8] in the inventive device [2], the merger of all parts on the activation of the actuating means [7] and the opening or closing of the connecting device [8] can be done with one hand.
  • the device according to the invention is shown in longitudinal section with dekonnektierter vial [1] and closed connection means [8]. If the actuating means [7] is in its first position [34], an adjusting element [10] fixes the turntable [6]. An unintentional rotation of the turntable [6] and thus of the housing [13] of the connecting device [8] is prevented.
  • the device according to the invention is shown in longitudinal section with attached vial and opened connection device [8]. If the actuating means [7] is in its second position [35], an adjusting element [10] fixes the lifting rod [9]. In this way, unintentional separation of vial [1] and connecting device [8] is prevented.
  • the actuator thus supports a firm, secure and accurate mounting of the vial and connection device.
  • FIGS. 13a-c show, in individual steps, the mechanics of the device according to the invention in section during the connection of a vial.
  • a mechanical translation for example in the form of a toggle lever [1 1] or a gear, which is used for power transmission.
  • the force to be used by the staff to merge the vial [1] and the connector [8] will thus be significantly reduced, i. in individual cases up to 50 N, reduced and facilitates handling.
  • the device according to the invention has an evaluation unit [32] as an external additional device or integrated into the dialysis machine which has at least one sensor [31] the position of the vial [1] and / or the connecting device [8] and / or the opening of the connecting device [ 8] and, if necessary, can provide feedback to the dialysis machine or the user.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif et un procédé pour relier une bouteille perforée [1] à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée [1] dans un récipient ou un conduit de fluide, lequel dispositif comporte un premier support [4] qui est adapté pour recevoir un moyen de liaison [8], un second support [5] qui est adapté pour recevoir une bouteille perforée [1], un moyen d'actionnement [7] et un moyen de liaison [8] qui se compose d'un boîtier annulaire [13], d'une partie intérieure [12], pourvue d'au moins un dispositif de perçage [14], et d'un raccord de tuyau [16] ; le boîtier annulaire [13] du moyen de liaison [8] est élaboré de façon à pouvoir tourner autour de la partie intérieure [12] à la manière d'une vanne de telle sorte que la rotation du boîtier [13] permet d'ouvrir et de fermer les chemins d'écoulement du moyen de liaison [8].
EP15763017.9A 2014-09-18 2015-09-15 Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif Withdrawn EP3193970A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014013892.5A DE102014013892A1 (de) 2014-09-18 2014-09-18 Vorrichtung zum Anschluss einer Durchstechflasche an einen Behälter oder an eine Fluidleitung und Überführung des Inhaltes einer Durchstechflasche in einen Behälter oder in eine Fluidleitung, sowie Verfahren hierzu und Verwendung einer solchen Vorichtung
PCT/EP2015/071074 WO2016041948A1 (fr) 2014-09-18 2015-09-15 Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif

Publications (1)

Publication Number Publication Date
EP3193970A1 true EP3193970A1 (fr) 2017-07-26

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Application Number Title Priority Date Filing Date
EP15763017.9A Withdrawn EP3193970A1 (fr) 2014-09-18 2015-09-15 Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif

Country Status (6)

Country Link
US (1) US10441711B2 (fr)
EP (1) EP3193970A1 (fr)
JP (1) JP6711818B2 (fr)
CN (1) CN106714765B (fr)
DE (1) DE102014013892A1 (fr)
WO (1) WO2016041948A1 (fr)

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EP3600213A1 (fr) 2017-03-24 2020-02-05 CareFusion 303, Inc. Transformateur automatique de médicament pourvu d'un élément hydroscopique
US10595761B2 (en) 2017-11-01 2020-03-24 Edwards Lifesciences Corporation Adapter for use with a multi-port control valve used in blood sampling, blood pressure measurement systems
US20190125232A1 (en) 2017-11-01 2019-05-02 Edwards Lifesciences Corporation Multi-port control valve for use in blood sampling, blood pressure measurement systems
MX2020010471A (es) * 2018-04-05 2021-01-08 Becton Dickinson & Co Ltd Dispositivo de fijacion de montaje para unir el adaptador de un frasco a un frasco con medicamento.
CN110302407B (zh) * 2019-06-26 2023-11-28 温州维科生物实验设备有限公司 便携式空间除菌器
US11547632B2 (en) 2019-08-01 2023-01-10 Tbm Medical Solutions, Inc. Medical vial holder apparatus and method
USD933255S1 (en) 2019-08-01 2021-10-12 Tbm Medical Solutions, Inc. Medical vial holder

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Also Published As

Publication number Publication date
CN106714765A (zh) 2017-05-24
US10441711B2 (en) 2019-10-15
US20170304531A1 (en) 2017-10-26
JP2017532107A (ja) 2017-11-02
JP6711818B2 (ja) 2020-06-17
CN106714765B (zh) 2020-11-10
DE102014013892A1 (de) 2016-03-24
WO2016041948A1 (fr) 2016-03-24

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