WO2006048114A1 - Filling or re-filling of a container for an injection or infusion fluid - Google Patents

Filling or re-filling of a container for an injection or infusion fluid Download PDF

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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
according
Prior art date
Application number
PCT/EP2005/011168
Other languages
German (de)
French (fr)
Inventor
Christoph Bally
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
Priority to DE200410052628 priority Critical patent/DE102004052628A1/en
Priority to DE102004052628.1 priority
Application filed by Disetronic Licensing Ag filed Critical Disetronic Licensing Ag
Publication of WO2006048114A1 publication Critical patent/WO2006048114A1/en

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

Abstract

The invention relates to the filling or re-filling of a container for an injection or infusion fluid, in addition to a device (2) for filling or re-filling a container for an injection or infusion fluid. Said device comprises a receptacle (1) for the container (2) and a suction device (4-7), which sucks an injection or infusion fluid into the container, the suction device (4-7) being actuated by a motor (5, 11). The invention also relates to an administration unit for the injection or infusion fluid comprising a filling or re-filling device and to the use of a fluid displacement or evacuation unit of an administration unit (3) for the injection or infusion fluid, in particular an infusion pump, as a suction unit for the fluid.

Description

Filling or refilling an injection or infusion fluid receiving container

The invention relates to the filling or refilling of injection or infusion fluid receiving container. Such containers usually contain medicines in fluid form, in particular liquid form, such as insulin, and they come in portable injection and / or infusion devices are used. In this case, the drug fluid is precisely metered by a piston displaced from the container and administered. DE 197 17 107 Al and DE 198 40 992 Al describe

Delivery devices, in which the aforementioned containers come for administering fluid medications used.

In most cases, the containers are provided as a fillable or refillable ampoules, to enable users to fill the best for them suitable fluid (medication) and use.

The manual filling of the containers, as has been necessary and was carried out, but becomes quite cumbersome. Older patients come up against difficulties.

It is the object of the present invention, the filling or refilling of injection or infusion fluid receiving container as simple and user-friendly to make.

For this purpose, a filling or Wiederauffülleinrichtung for an injection or infusion fluid receiving container provided in accordance with a first aspect of the present invention, with a receptacle for the container and a suction suckling an injection or infusion fluid into the container, wherein the has a controlled suction motor actuation. These fillers or Wiederauffülleinrichtung can be provided stand-alone available. It helps the user about to fill the container in a simple manner and without complicated handling, it needs to simply insert the container into the receptacle and set the Motor activity in gear when he has the container previously connected to a fluid supply. The power for the motor may suitably be provided by rechargeable or disposable batteries. Since a complicated handling is omitted, a fluid loss can be avoided by leaks, as any possible sterilization problems. When implemented alone, the filling or Wiederauffülleinrichtung the invention may be provided as a compact and inexpensive to manufacture part.

Motor activity may comprise a controller, according to a command input automatically turns on the suction device on and off again after a predetermined filling. By this measure, the fill-up is very simple.

In a preferred embodiment, the suction generated by one end of the container establishes a negative pressure in this to draw in from the other end of the container forth the fluid in the container. At one end, which can be called "intake end", the container comprises a connector for a suction line. Such a connector may be present in various versions, it may consist of only one pass through a container lid, then placed through which a suction line can be. on the other hand, there is the possibility of designing the connecting piece as an attachment or adapter for the container covers or the top of the container, on or in the then the suction pipe is attached.

By the aforementioned suction duct, the fluid is sucked into the container from a reservoir. When this happens by means of the above-mentioned connecting piece or of an adapter piece, this connection piece should be designed so that it fits on as many or all containers used in this field.

Advantageously, the filling or Wiederauffülleinrichtung according to the invention, a vibrating means for vibrating the container. If such a vibrating device is provided, it can be used to shake the container after filling until all bubbles are in a sucked fluid at the intake end. Then, the suction device may be operated in the reverse manner as the suction then to discharge the bubbles through the intake end of the container. If an embodiment with the possibility to apply bubbles is selected, a sensor could be installed, which checks whether any bubbles are left. In such a case, the user would be prompted to perform the bubble removing again. Further or other sensor could be checked whether the container contains sufficient injection or infusion fluid when the suction operation has been carried out over the same. If this is not so, another message could be issued, or a request for additional padding. All these operations can be handled funds for a menu control and an input / output device, for which only a single input button is required.

According to a preferred embodiment of the filling or Wiederauffülleinrichtung invention, the suction means following components: a piston which can be arranged in the longitudinal direction of the container displaceable in the latter; a shift actuator for the piston; and an electric motor for actuating the displacement adjustment drive.

The above-mentioned shifting actuator may include a gear reduction drive to convert the motor speed in a suitable feed speed for the piston. Further, the shift actuator may comprise a piston engaging member which is fixedly connected to the piston so that the piston is axially secured in both directions on its adjustment and can not peel off, in particular during suction.

According to a further aspect of the present invention, a Injektions¬ and Inf is provided usionsfluid- administration device that can have a filling or Wiederauffülleinrichtung, as described above. Here comes another great advantage of the present invention for supporting, which is used for administration of the fluid namely, the fact that it is possible for the filling or Wiederauffülleinrichtung integrated in a single unit provide. This advantage in particular has a particularly strong when you consider that many of the already present in such equipment components can be used in the administration set also to fill the fluid container.

In particular, the administration device may be an infusion pump, wherein the container receiving the ampoule holder of the pump, the piston is the displacer piston of the pump and the motor of the propulsion motor for the displacement pistons of the pump. So here's a way is inventively created to use the already existing in an administration set components so that a filling of the container can be achieved with them. The controlled motor actuation takes over the task to be administered in different modes of operation either fluid or to be able to fill the container. In one embodiment, the motor for displacing fluid from the containers for the intake of fluid in the container is in this case designed so that it rotate in two different directions of rotation or stripping and can be reversed. In principle, it should be noted here that also a motor with only one direction of rotation is possible if the shift actuator is set up so that different piston movement directions can be generated, for example, by the addition circuit and limit a rotation direction-reversing gear wheel.

The above already mentioned vibrating device may also be a part of the administration device, such as a Rüttelalarmvorrichtung the pump, which would then be coupled to the container so as to shake the container.

As regards the control of the engine, these various control options may include, namely, for example, a drive for displacing the fluid from the container, and on the other hand, a drive for the intake of fluid into the container. It is advantageous when a menu-driven input is provided by means of the controls can be actuated, in particular in the different operating mode.

The invention relates in a further aspect the use of a fluid-displacement or discharge unit of an injection or Lnfusionsfluid- administration device, in particular an infusion pump as a suction unit for the fluid. the synergistic effects already described above which relate to the use of existing components for both the administration and for the filling of the container or the suction of the fluid formed in this use. The administration device may be one as described above, and the suction unit may be a filling and Wiederauffülleinrichtung, as was also discussed above. In a preferred embodiment, arranged at the device or at the pump Rüttelalarmvorrichtung is used for vibrating the container after the suction of the fluid to collect bubbles in the fluid at the intake end of the container. The fluid displacement and ejection unit can also be used to discharge bubbles in the fluid from the intake end of the container.

The invention will be explained in more detail with reference to a preferred embodiment. It may comprise in any combination individually all the herein described features or. In the single attached figure 1 is a sectional view of an infusion pump is shown, by means of the filling or refilling of the invention may be implemented.

The reference numeral 3 in Figure 1, an infusion pump is referred to, the important for the invention, parts shown partially in schematic simplification. The insulin pump has a housing, wherein the lower part of the housing is provided with the reference numeral 14 in the drawing, while the ampoule holder of the housing bears the reference numeral. 1 inserted into the ampule holder 1, the ampule 2 is shown which is a container which can accommodate injection or infusion fluid. At the upper end of the ampoule 2, a suction pipe 12 is shown schematically, which passes through the non-designated lid of the vial into the interior of the ampoule. At its peak 13 is shown, and both the suction line 12 and tip 13 are schematically representative of any device, the arrival of the vial and a reservoir and can be used and fluid transported into the vial from the supply container here. In the ampoule, there is a piston 6 along the designated with V

Displacement axis is movable in the ampoule. During the upward movement of the piston 6 is in the ampoule 2 befindliches fluid, such as insulin, applied; during the downward movement of fluid may be sucked. The piston is fixed (glued, welded, mechanically by molding or friction fit, etc.) with a piston engaging member 7a is connected and the piston engaging member is seated on a threaded rod 7; it is moved with the latter and together with the piston 6 in the ampoule 2 up and down.

This up and down motion receives its drive 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 , On the unit 8 can be by means of the

Controller 4 to drive the motor 11, in a manner which will be explained later.

The engine is one which has two output directions of rotation. The

Movement is transmitted by a shift actuator having a

Reduction gear 5 (5a to f, 31) with cylindrical gears, and 7 by a feed unit for the longitudinal displacement of the threaded rod, the reduction gear, the spur gears 5a to 5f and 31 in the illustrated case; in principle, also a small gear might suffice directly to the motor which transmits its rotational movement to a large gear, which is then operated at the slow rotation of the threaded rod feed. The feed device is shown here as a telescopic device. as a first shifting stage it comprises the threaded rods 7. The second shifting 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 their displacement along the axis V. The drive sleeve 30 is mounted on the two further sleeves 40 and 50 in the housing. This feeding device, the piston is moved axially 6 in the ampoule 2 to draw in fluid or deploy for administration. As to the exact function of the feeding device, reference is also made here to DE 197 17 107 Al, especially to the embodiments of Figures 1 to 10 and in addition to other possible drive mechanisms according to the figures 19 to 22 of this document.

The controller 4, the motor 11, the reduction gear 5 and the previously discussed feed device can together with the piston 6 and a possibly somewhat shortened ampoule holder 1 form a separate filling or Wiederauffülleinrichtung according to the invention. When, as shown in Figure 1, housed in the case of an insulin pump, which also has a Rüttelalarmvorrichtung 15, shown schematically, an operation when filling the ampoule 2 may proceed as follows. If the vial 2 is empty, the plunger would have been located either in close to the head 6 of the ampoule 2 or be driven along the shifting axis V upwards. If no vial in the receptacle 1 is present, the patient could be prompted via the display 10 to set up a new, empty vial, if he has made the operation mode using the input / output unit 8 in advance to "ampoule filling". Thereafter, it is prompted by the display to provide the new, empty ampoule with an adapter at the head end and the needle stab 13 in a reservoir with a fluid to be administered infusion (insulin). The needle 13 is a short needle, which is just long enough to penetrate the membrane of the commercially available insulin reservoir.

When the piston 6 is located at the time where the new cartridge 2 is inserted, at the lower position of the ampoule (as shown in Figure 1) would be placed after a prompt on the display 10 an input, and the engine would via the transmission and the feeder insert threaded rod 7 to the top. Oklusionssensoren would, if present, is switched off, and a special, faster and more powerful motor would be used to move the piston downward and to fill the cartridge with insulin.

If the vial 2 is filled, still bubbles could be in it. To discharge this is determined by the controller 4 (which also controls the motor and is connected to the input / output unit 8) Rüttelalarmvorrichtung 15 operated to shake the bubbles up to the head of the ampoule out. Then, the plunger 6 can again with the threaded rod 7 upwards and are then pushed back again, and thereafter, or after the necessary number of repetitions to a sensor would have a bubble-free filled ampoule 2. (not shown) could check whether or bubbles are present and the output of the bubbles could be done automatically displayed as long as above until the ampoule is bubble-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.

With the present invention, users or patients can fill the containers in a simple manner and without handling difficulties and stay free in their choice of medication.

Claims

claims
1. filling or re-filling means receiving container (2), having a) a housing (1) for the container (2) for an injection or infusion fluid; and b) a suction device (4-7) that sucks a fluid injection or infusion into the container, wherein c) the suction device (4-7) has a controlled actuating motor (5, 11).
2. filling or Wiederauffülleinrichtung according to claim 1, characterized in that the motor actuating means (5, 11) comprises a controller (4), according to a command input automatically the suction device (4-7) turns on and off again after a predetermined filling ,
3. filling or Wiederauffülleinrichtung according to claim 1 or 2, characterized in that the suction from one end of the container (2) creates a negative pressure forth in this order from the other end of the container (2) fro the fluid into the container suck (2).
4. fillers or Wiederauffülleinrichtung according to any one of claims 1 to 3, characterized in that comprises the container (2) at one end, its intake end, a connection piece for a suction line (12).
5. filling or Wiederauffülleinrichtung according to one of claims 1 to 4, characterized in that it comprises a vibrating means for vibrating the container (2).
6. filling or Wiederauffülleinrichtung according to one of claims 1 to 5, characterized in that said aspiration means:
- a piston (6) in the longitudinal direction of the container (2) can be slidably disposed therein;
- a shift actuator (7, 20, 30, 40, 50) for the piston (6); and - an electric motor (11) for operating the displacement adjusting drive (7, 20, 30, 40, 50).
7 comprises filling or Wiederauffülleinrichtung according to claim 6, characterized in that the displacement actuator a reduction gear (5).
8. filling or Wiederauffülleinrichtung according to claim 6 or 7, characterized in that the shift actuator includes a piston engagement member (7a), wherein the piston engagement member (7a) and the piston (6) are fixedly connected together.
9. injection or Infusionsfluid- administering apparatus having a filling or
Wiederauffülleinrichtung according to any one of claims 1 to. 8
is 10. injection or infusion fluid administration device according to claim 9, characterized in that it is an infusion pump (3), wherein the container receiving the ampoule holder (2) of the pump, the piston of the displacement piston (6) of the pump (3) and wherein the motor of the propulsion motor (11) for the displacement piston (6) of the pump (3).
11. Infusionsfluid- injection or administration device according to claim 9 or 10, characterized in that the motor (11) for displacing fluid from the
may be the container (2) and for drawing fluid into the container (2) rotate in two different directions of rotation or output reversed.
12. injection or infusion fluid administration device according to one of claims 10 or 11, characterized in that one of the Rüttelalarmvorrichtung
Pump to the receptacle (2) is coupled such that it shakes the container (2).
13. injection or infusion fluid administration device according to one of claims 9 to 12, characterized in that the controller (4) of the engine, both a drive for displacing the fluid from the container (2) as well as a control for the intake of fluid in comprises the container.
14. injection or infusion fluid administration device according to claim 13, characterized in that it is a menu-driven input (8, 9, 15), by means of the controls can be actuated, in particular in different operation modes.
15. Use of a fluid-displacement or discharge unit of a
Injection or infusion fluid administration set (3), in particular an infusion pump as a suction unit for the fluid.
16. Use according to claim 15, wherein the injection or Infusionsfluid- administration set of one of the claims, according to a 9 to 15.
17. Use according to claim 15 or 16, wherein the means disposed on the device or on the pump Rüttelalarmvorrichtung for vibrating the container is used after the suction of the fluid to collect bubbles in the fluid at the intake end of the container.
18. Use according to any one claims 15 to 17, wherein the fluid displacement or discharge unit is used to discharge bubbles in the fluid from intake end of the container.
PCT/EP2005/011168 2004-10-29 2005-10-18 Filling or re-filling of a container for an injection or infusion fluid WO2006048114A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE200410052628 DE102004052628A1 (en) 2004-10-29 2004-10-29 Filling or refilling an injection or infusion fluid receiving container
DE102004052628.1 2004-10-29

Publications (1)

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

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/011168 WO2006048114A1 (en) 2004-10-29 2005-10-18 Filling or re-filling of a container for an injection or infusion fluid

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DE (1) DE102004052628A1 (en)
WO (1) WO2006048114A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112377A1 (en) * 2009-03-31 2010-10-07 Sanofi-Aventis Deutschland Gmbh Improvements in and relating to a medicament delivery devices
WO2013135275A1 (en) 2012-03-13 2013-09-19 F. Hoffmann-La Roche Ag Filling device and controller for filling an administration container
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 (en) * 2013-09-24 2015-04-02 Biocorp Recherche Et Developpement Injection pen with vibration function for cartridge of same for removing air bubbles

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1392547B1 (en) * 2008-10-09 2012-03-09 Cane Srl Device for the infusion of drugs
US20120209200A1 (en) 2009-07-15 2012-08-16 Sanofi-Aventis Deutschland Gmbh Drive Assembly for a Pen-Type Injector and Pen-Type Injector with a Drive Assembly

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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

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US5470759A (en) * 1992-06-10 1995-11-28 Fujirebio, Inc. Anti-glycated hemoglobin monoclonal antibody and method for measuring glycated hemoglobin
DE19717107B4 (en) * 1997-04-23 2005-06-23 Disetronic Licensing Ag System of container and driving apparatus for a piston which is held in the fluid containing a drug container
DE19840992A1 (en) * 1998-09-08 2000-03-09 Disetronic Licensing Ag Pressure monitoring a dosed with an infusion or injection fluid product to be administered

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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112377A1 (en) * 2009-03-31 2010-10-07 Sanofi-Aventis Deutschland Gmbh Improvements in and relating to a medicament delivery devices
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 (en) 2012-03-13 2013-09-19 F. Hoffmann-La Roche Ag Filling device and controller for filling an administration container
US9611058B2 (en) 2012-03-13 2017-04-04 Roche Diabetes Care, Inc. Filling device and controller for filling an administration container
WO2015044102A1 (en) * 2013-09-24 2015-04-02 Biocorp Recherche Et Developpement Injection pen with vibration function for cartridge of same for removing air bubbles

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