WO2006048114A1

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

Info

Publication number: WO2006048114A1
Application number: PCT/EP2005/011168
Authority: WO
Inventors: Christoph Bally
Original assignee: Disetronic Licensing Ag
Priority date: 2004-10-29
Filing date: 2005-10-18
Publication date: 2006-05-11
Also published as: DE102004052628A1

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 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. In this case, the drug fluid is finely dosed displaced by means of a piston from the container and administered. DE 197 17 107 A1 and DE 198 40 992 A1 describe

Administration devices in which the aforementioned containers are used for the administration of fluid medicaments.

In most cases, the containers are provided as refillable ampoules to allow users to fill and use the most appropriate fluid (drug) for them.

The manual filling of the containers, as it was previously necessary and was carried out, but quite cumbersome. Especially older patients encounter difficulties.

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

To this end, according to a first aspect of the present invention, there is provided 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. When realized by itself, 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. By this measure, the refilling process is very simple.

In a preferred embodiment, 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. At one end, which may also be called "sucking in", 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 On the other hand, 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.

Through the aforementioned suction line, the fluid is sucked into the container from a supply. If this is done by means of the above-mentioned fitting or an adapter, this fitting should be designed to fit as many as possible or all containers used in this field.

Advantageously, the filling or refilling device according to the invention 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.

According to a preferred embodiment of the filling or refilling device according to the invention, 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. Furthermore, 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.

According to another aspect of the present invention, an injection or infusion fluid delivery device is provided which may include a refill device as described above. Here comes another great advantage of the present invention, namely the fact that it is possible to provide the refilling device integrated in a single device used for the administration of the fluid. 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.

In particular, 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. Here, according to the invention, a possibility is created of using the components already present in an administering device in such a way that filling of the container can be achieved with them. The controlled motor actuation takes on the task of either administering fluid or filling the container in different operating modes. In one embodiment, in this case 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. Basically, it should be noted here that 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.

As far as the control of the engine is concerned, it 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.

According to a further aspect, 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. In this use, the synergetic effects already described above arise, which relate to the use of existing components both for the administration and for the filling of the container or the suction of the fluid. The administering device may be one as described above, and the aspiration unit may be a refilling device, as also discussed above. In a preferred embodiment, 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.

The invention will be explained in more detail below with reference to a preferred embodiment. It may have all the features described herein individually or in any combination. In the only accompanying figure 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. Inserted into the ampoule holder 1, the ampoule 2 is shown, which is a container which can receive injection or infusion fluid. At the upper end of the ampoule 2, a suction line 12 is shown schematically, which leads through the unnamed lid of the ampoule into the interior of the ampoule. At her a tip 13 is shown, and 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. In the ampoule is a piston 6, along the designated V

Displacement axis is movable in the ampoule. During the upward movement of the piston 6 in the ampoule 2 befindliches fluid, such as insulin, applied; during the downward movement, fluid can be sucked in. 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 , About the unit 8 can be by means of

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. The

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; In principle, 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. About this feed device, the piston 6 is moved axially in the ampoule 2 to suck fluid or apply for administration. As far as the exact function of the feed device is concerned, reference is additionally made here to DE 197 17 107 A1, specifically to the exemplary embodiments of FIGS. 1 to 10 and additionally to further possible drive devices according to FIGS. 19 to 22 in this document.

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 Rüttelalarmvorrichtung 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. If there is no ampoule in the receptacle 1, 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.

If the piston 6 at the time when the new ampoule 2 is used, located at the bottom of the ampoule (as shown in Figure 1) would be made after a prompt on the display 10 an input, and the engine via the transmission and the feed device push the threaded rod 7 all the way up. Oklusionssensoren would, if available, switched off and a special, faster and more a powerful motor would be used to move the piston down, filling the ampule with insulin.

If the ampoule 2 is filled, there may still be bubbles in it. To deploy them, 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.

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

Claims

claims

1. filling or re-filling device for an injection or infusion fluid receiving container (2), with a) a receptacle (1) for the container (2); and b) an aspirator (4-7) which draws an injection or infusion fluid into the container, wherein c) the aspirator (4-7) has a controlled motor actuation (5, 11).

2. filling or refilling device according to claim 1, characterized in that the motorized operation (5, 11) comprises a controller (4) which automatically switches on the suction device (4-7) after a command input and switches off again after a predetermined filling ,

3. filling and refilling device according to claim 1 or 2, characterized in that the suction device from one end of the container (2) produces a negative pressure in this, from the other end of the container (2) ago the fluid in the container (2) aspirate.

4. filling and refilling device according to one of claims 1 to 3, characterized in that the container (2) at one end, its suction end, a connecting piece for a suction line (12).

5. filling or refilling device according to one of claims 1 to 4, characterized in that it comprises a vibrating device for shaking the container (2).

6. filling or refilling device according to one of claims 1 to 5, characterized in that the suction device comprises:

- A piston (6) which can be arranged in the longitudinal direction of the container (2) slidably in this;

- A displacement drive (7, 20, 30, 40, 50) for the piston (6); and - An electric motor (11) for actuating the Verschiebestelltriebs (7, 20, 30, 40, 50).

7. filling and refilling device according to claim 6, characterized in that the displacement drive a reduction gear (5).

8. filling and refilling device according to claim 6 or 7, characterized in that the displacement drive a piston engaging member (7a), wherein the piston engaging member (7a) and the piston (6) are firmly connected.

9. Injection or infusion fluid administration device with a filling or

Refilling device according to one of claims 1 to 8.

10. Injection or infusion fluid delivery device according to claim 9, characterized in that it is an infusion pump (3), wherein the container receptacle is the ampoule receptacle (2) of the pump, the piston of the displacer (6) of the pump (3) and wherein the motor is the propulsion motor (11) for the displacer (6) of the pump (3).

11. Injection or infusion fluid administration device according to claim 9 or 10, characterized in that the motor (11) for displacing fluid from the

Container (2) and for sucking fluid in the container (2) in two different output rotational directions to turn or can be reversed.

12. Injection or infusion fluid administration device according to one of claims 10 or 11, characterized in that a Rüttelalarmvorrichtung the

Pump is coupled to the container (2) so 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 motor both a drive for displacing the fluid from the container (2) and a control for the suction of fluid in has the container.

14. Injection or infusion fluid administration device according to claim 13, characterized in that it comprises a menu-guided input (8, 9, 15) by means of which the actuators can be actuated, in particular in different operating modes.

15. Use of a fluid displacement or ejection unit of a

Injection or infusion fluid delivery device (3), in particular an infusion pump, as a suction unit for the fluid.

16. Use according to claim 15, wherein the injection or infusion fluid administration device is one according to one of claims 9 to 15.

17. Use according to claim 15 or 16, wherein a device arranged on the pump or Rüttelalarmvorrichtung for shaking the container after the suction of the fluid is used to collect bubbles in the fluid at the suction end of the container.

Use according to any of claims 15 to 17, wherein the fluid displacement unit is used to expel bubbles in the fluid from the suction end of the container.