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WO2006048114A1 - Remplissage premier ou subsequent d'un contenant pour liquide d'injection ou de perfusion - Google Patents

Remplissage premier ou subsequent d'un contenant pour liquide d'injection ou de perfusion Download PDF

Info

Publication number
WO2006048114A1
WO2006048114A1 PCT/EP2005/011168 EP2005011168W WO2006048114A1 WO 2006048114 A1 WO2006048114 A1 WO 2006048114A1 EP 2005011168 W EP2005011168 W EP 2005011168W WO 2006048114 A1 WO2006048114 A1 WO 2006048114A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
fluid
filling
injection
suction
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/EP2005/011168
Other languages
German (de)
English (en)
Inventor
Christoph Bally
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.)
Tecpharma Licensing AG
Original Assignee
Disetronic Licensing AG
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 Disetronic Licensing AG filed Critical Disetronic Licensing AG
Publication of WO2006048114A1 publication Critical patent/WO2006048114A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2209/00Ancillary equipment
    • A61M2209/04Tools for specific apparatus
    • A61M2209/045Tools for specific apparatus for filling, e.g. for filling reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body

Definitions

  • the invention relates to the filling or refilling of an injection or infusion fluid receiving container.
  • Such containers generally contain drugs in fluid form, in particular liquid form, for example insulin, and they are used in portable injection and / or infusion devices.
  • the drug fluid is finely dosed displaced by means of a piston from the container and administered.
  • Administration devices in which the aforementioned containers are used for the administration of fluid medicaments.
  • the containers are provided as refillable ampoules to allow users to fill and use the most appropriate fluid (drug) for them.
  • a refilling or refilling device for an injection or infusion fluid receiving container having a receptacle for the receptacle and a suction device for sucking an injection or infusion fluid into the receptacle
  • Suction has a controlled motor actuation.
  • This filling or refilling device can be provided alone. It helps the user to refill the container in a simple manner and without cumbersome handling, he just has to insert the container into the receptacle and start the motor operation when he has previously connected the container with a fluid reservoir.
  • the power to the motor may suitably be provided by batteries. Since a complicated handling is eliminated, a loss of fluid due to leakage can be avoided, as well as possibly occurring Sterilization problems.
  • the refilling means of the invention can be provided as a compact and inexpensive part to be manufactured.
  • the motor actuation may comprise a controller which automatically switches on the suction device after a command input and shuts off again after a predetermined filling.
  • the suction device generates a negative pressure in this from one end of the container in order to suck the fluid into the container from the other end of the container.
  • the container has a connection piece for a suction line, such a connection piece can be present in various designs, it can only consist of a passage through a container lid, through which a suction line is laid
  • the connection piece it is possible to design the connection piece as an attachment or adapter for the container lid or the head of the container, to or in which the suction line is then attached.
  • this fitting should be designed to fit as many as possible or all containers used in this field.
  • the filling or refilling device comprises a vibrating device for shaking the container. If such a vibrator is provided, it may be used to shake the container after filling until all bubbles in an aspirated liquid are at the suction end. Then, the suction can then be operated in the reverse manner as in the suction to deploy the bubbles through the Einsaugende from the container. If an embodiment with the ability to dispense bubbles is selected, a sensor could also be installed to check for any remaining bubbles. In such a case, the user may be prompted to redo the blister removal. Furthermore, it could be checked via the same or a different sensor if the container contains sufficient injection or infusion fluid when the suction process has been carried out. If this is not the case, a corresponding message could also be issued, or one Request for further refilling. All of these operations can be handled by means for menu control and input / output device requiring only a single input button.
  • the suction device has the following components: a piston which can be arranged displaceably in the longitudinal direction of the container in this; a displacement drive for the piston; and an electric motor for actuating the displacement drive.
  • the aforesaid shift actuator may include a reduction gear to convert the rotational speed of the engine to a suitable advance speed for the piston.
  • the displacement drive can have a piston engagement member, which is fixedly connected to the piston, so that the piston is axially secured in its two directions of movement on its adjusting device and can not be detached in particular during suction.
  • an injection or infusion fluid delivery device which may include a refill device as described above.
  • a refill device as described above.
  • This advantage has a particularly strong effect, especially when one considers that many of the components already present in such devices can also be used in the administration device to fill up the fluid container.
  • the delivery device may be an infusion pump, wherein the container receptacle is the ampoule receiving the pump, the piston is the displacement piston of the pump and wherein the motor is the propulsion motor for the displacement piston of the pump.
  • the controlled motor actuation takes on the task of either administering fluid or filling the container in different operating modes.
  • the motor for displacing fluid from the containers for sucking fluid into the container is designed so that it can rotate or be reversed in two different output and rotational directions.
  • a motor with only one direction of rotation is conceivable if the displacement drive is set up so that different piston movement directions can be generated, for example, by adding and switching off a direction reversing gear.
  • the vibrating device already mentioned above may also be a component of the administering device, for example a vibrating alarm device of the pump, which would then be coupled to the receptacle in such a way that it shakes the receptacle.
  • control of the engine can have different control options, namely for example a control for displacing the fluid out of the container, and on the other hand also a control for the aspiration of fluid into the container. It is advantageous if a menu-guided input is provided, by means of which the controls can be operated, in particular in the different operating mode.
  • the invention relates to the use of a fluid displacement or ejection unit of an injection or Lnfusionsfluid- administration device, in particular an infusion pump, as a suction unit for the fluid.
  • a fluid displacement or ejection unit of an injection or Lnfusionsfluid- administration device in particular an infusion pump
  • the administering device may be one as described above
  • the aspiration unit may be a refilling device, as also discussed above.
  • a shaker alarm device mounted on the apparatus or on the pump is used to agitate the container after aspirating the fluid to collect bubbles in the fluid at the aspirating end of the container.
  • the fluid displacement unit may also be used to expel bubbles in the fluid from the aspirating end of the container.
  • FIG. 1 is a sectional view an infusion pump shown, by means of which the filling or refilling according to the invention can be implemented.
  • the reference numeral 3 designates an infusion pump in FIG. 1, the parts important for the invention being shown, partly in schematic simplification.
  • the insulin pump has a housing, wherein in the drawing, the lower part of the housing is provided with the reference numeral 14, while the ampoule holder of the housing carries the reference numeral 1.
  • the ampoule 2 Inserted into the ampoule holder 1, the ampoule 2 is shown, which is a container which can receive injection or infusion fluid.
  • a suction line 12 is shown schematically, which leads through the unnamed lid of the ampoule into the interior of the ampoule.
  • both, the suction line 12 and the tip 13 are here schematically representative of any device that can be attached to the ampoule and to a reservoir and can be used and transported fluid from the reservoir into the ampoule.
  • Displacement axis is movable in the ampoule.
  • fluid such as insulin
  • the piston is fixedly connected to a piston-engaging member 7a (glued, welded, mechanically by form or frictional engagement, etc.) and the piston-engaging member is seated on a threaded rod 7; it is moved with this and together with the piston 6 in the ampoule 2 up and down.
  • This up and down movement is powered on the other side by an electric motor 11 which is connected to a controller 4, which in turn can be operated by an input / output unit 8 with input buttons 9 and an output 10, for example a small LCD display ,
  • a controller 4 which in turn can be operated by an input / output unit 8 with input buttons 9 and an output 10, for example a small LCD display ,
  • an input / output unit 8 with input buttons 9 and an output 10, for example a small LCD display
  • Control 4 the motor 11 to drive, in a manner which will be explained later.
  • the engine is one which has two output directions of rotation.
  • Motion transmission takes place by a displacement drive with a
  • Reduction gear 5 (5a to f, 31) with spur gears, and by a feed unit for longitudinal displacement of the threaded rod 7.
  • the reduction gear has in the illustrated case, the spur gears 5a to 5f and 31;
  • a small gear could be sufficient directly on the engine, which transmits its rotary motion to a large gear, which then actuates the threaded rod feed with the slow rotation.
  • the feed device is shown here as a telescopic device. It comprises, as a first displacement stage, the threaded rods 7.
  • the second displacement stage is formed by a threaded sleeve 20, in which the threaded rod 7 runs by means of a first spindle drive.
  • the threaded sleeve 20 is in turn surrounded by a drive sleeve 30, with which it forms a second spindle drive for its displacement along the axis V.
  • the drive sleeve 30 is mounted on the two other sleeves 40 and 50 in the housing.
  • the piston 6 is moved axially in the ampoule 2 to suck fluid or apply for administration.
  • the controller 4, the motor 11, the reduction gear 5 and the previously discussed feed device, together with the piston 6 and a possibly slightly shortened vial holder 1 form a separate refilling or refilling device according to the invention. If it is housed in the housing of an insulin pump, as shown in Figure 1, which also has a schematically illustrated Hinttelalarmvoriques 15, an operation when filling the ampoule 2 proceed as follows. If the ampoule 2 is empty, the piston 6 would either already be in the vicinity of the head of the ampoule 2 or be moved along the displacement axis V upwards.
  • the patient could be prompted via the display 10 to insert a new, empty ampoule if he had previously set the operating mode with the aid of the input / output unit 8 to "ampoule filling". Thereafter, the display is prompted to provide the new, empty ampoule with an adapter at the head end and pierce the needle 13 into a reservoir with an infusion fluid (insulin) to be administered.
  • Needle 13 is a short needle that is just long enough to penetrate the membrane of standard insulin storage containers.
  • the controller 4 (which also controls the motor and is connected to the input / output unit 8) actuates the jarging device 15 to shake the bubbles up toward the head of the ampoule. Then, the piston 6 can be pushed back up and then back again with the threaded rod 7, and thereafter, or after the necessary number of repetitions, one would have a bubble-free filled ampule 2.
  • a sensor (not shown) could check if there are any bubbles left , and the application of the bubbles could be automatically as long as shown above, until the ampoule is vesicle-free. Of course, this could also be done on demand by the user after a visual inspection, or could such a "bubble removal" by input (button 9) are requested.

Landscapes

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

Abstract

L'invention concerne le remplissage premier ou subséquent d'un contenant pour liquide d'injection ou de perfusion, ainsi qu'un dispositif pour le remplissage premier ou subséquent d'un contenant (2) pour liquide d'injection ou de perfusion, ce dispositif comportant un logement (1) pour le contenant (2) et un dispositif d'aspiration (4-7) qui aspire le liquide d'injection ou de perfusion dans le contenant, ce dispositif d'aspiration (4-7) étant actionné par un moteur (5, 11). La présente invention porte également sur un appareil pour administrer un liquide d'injection ou de perfusion, cet appareil étant pourvu d'un dispositif de remplissage premier ou subséquent, et sur l'utilisation d'une unité de refoulement ou d'éjection de liquide d'un appareil destiné à administrer un liquide d'injection ou de perfusion (3), notamment d'une pompe à perfusion, en tant qu'unité d'aspiration de liquide.
PCT/EP2005/011168 2004-10-29 2005-10-18 Remplissage premier ou subsequent d'un contenant pour liquide d'injection ou de perfusion Ceased WO2006048114A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004052628.1 2004-10-29
DE200410052628 DE102004052628A1 (de) 2004-10-29 2004-10-29 Füllung bzw. Wiederauffüllung eines Injektions- oder Infusionsfluid aufnehmenden Behältnisses

Publications (1)

Publication Number Publication Date
WO2006048114A1 true WO2006048114A1 (fr) 2006-05-11

Family

ID=35594695

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/011168 Ceased WO2006048114A1 (fr) 2004-10-29 2005-10-18 Remplissage premier ou subsequent d'un contenant pour liquide d'injection ou de perfusion

Country Status (2)

Country Link
DE (1) DE102004052628A1 (fr)
WO (1) WO2006048114A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112377A1 (fr) * 2009-03-31 2010-10-07 Sanofi-Aventis Deutschland Gmbh Améliorations concernant des dispositifs d'administration de médicament
WO2013135275A1 (fr) 2012-03-13 2013-09-19 F. Hoffmann-La Roche Ag Dispositif de remplissage et dispositif de commande pour remplir un récipient servant à administrer un liquide
US8673823B2 (en) 2010-03-18 2014-03-18 Sanofi Methods and uses relating to the identification of compound involved in pain as well as methods of diagnosing algesia
WO2015044102A1 (fr) * 2013-09-24 2015-04-02 Biocorp Recherche Et Developpement Stylo injecteur avec fonction de vibration pour sa cartouche pour decoller des bulles d'air
EP3354301A1 (fr) 2017-01-31 2018-08-01 Roche Diabetes Care GmbH Procédé et dispositif auxiliaire permettant de retirer le gaz et/ou des bulles de gaz d'un médicament liquide stocké dans un réservoir

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1392547B1 (it) * 2008-10-09 2012-03-09 Cane Srl Dispositivo per l'infusione di farmaci
EP2453956A1 (fr) 2009-07-15 2012-05-23 Sanofi-Aventis Deutschland GmbH Ensemble d'entraînement pour injecteur de type stylo et injecteur de type stylo avec ensemble d'entraînement

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3771694A (en) * 1972-07-07 1973-11-13 A Kaminski Infusion pump
US5322511A (en) * 1992-04-21 1994-06-21 Sterling Winthrop Inc. Portable hand-held power injector
US20010047153A1 (en) * 2000-02-07 2001-11-29 Mark Trocki Front-loading medical injector and syringes, syringe interfaces, syringe adapters and syringe plungers for use therewith
US20020107476A1 (en) * 1998-08-18 2002-08-08 Minimed Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5470759A (en) * 1992-06-10 1995-11-28 Fujirebio, Inc. Anti-glycated hemoglobin monoclonal antibody and method for measuring glycated hemoglobin
DE19717107B4 (de) * 1997-04-23 2005-06-23 Disetronic Licensing Ag System aus Behältnis und Antriebsvorrichtung für einen Kolben, der in dem ein Medikamentfluid enthaltenden Behältnis gehalten ist
DE19840992A1 (de) * 1998-09-08 2000-03-09 Disetronic Licensing Ag Drucküberwachung eines bei einer Infusion oder Injektion dosiert zu verabreichenden Produktfluids

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3771694A (en) * 1972-07-07 1973-11-13 A Kaminski Infusion pump
US5322511A (en) * 1992-04-21 1994-06-21 Sterling Winthrop Inc. Portable hand-held power injector
US20020107476A1 (en) * 1998-08-18 2002-08-08 Minimed Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US20010047153A1 (en) * 2000-02-07 2001-11-29 Mark Trocki Front-loading medical injector and syringes, syringe interfaces, syringe adapters and syringe plungers for use therewith

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112377A1 (fr) * 2009-03-31 2010-10-07 Sanofi-Aventis Deutschland Gmbh Améliorations concernant des dispositifs d'administration de médicament
US8673823B2 (en) 2010-03-18 2014-03-18 Sanofi Methods and uses relating to the identification of compound involved in pain as well as methods of diagnosing algesia
WO2013135275A1 (fr) 2012-03-13 2013-09-19 F. Hoffmann-La Roche Ag Dispositif de remplissage et dispositif de commande pour remplir un récipient servant à administrer un liquide
US9611058B2 (en) 2012-03-13 2017-04-04 Roche Diabetes Care, Inc. Filling device and controller for filling an administration container
WO2015044102A1 (fr) * 2013-09-24 2015-04-02 Biocorp Recherche Et Developpement Stylo injecteur avec fonction de vibration pour sa cartouche pour decoller des bulles d'air
EP3354301A1 (fr) 2017-01-31 2018-08-01 Roche Diabetes Care GmbH Procédé et dispositif auxiliaire permettant de retirer le gaz et/ou des bulles de gaz d'un médicament liquide stocké dans un réservoir
US10967135B2 (en) 2017-01-31 2021-04-06 Roche Diabetes Care, Inc. Method and device for removing gas and/or gas bubbles from a liquid medicament stored in a reservoir
EP4039292A1 (fr) 2017-01-31 2022-08-10 Roche Diabetes Care GmbH Procédé et dispositif auxiliaire permettant de retirer le gaz et/ou des bulles de gaz d'un médicament liquide stocké dans un réservoir

Also Published As

Publication number Publication date
DE102004052628A1 (de) 2006-05-04

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