Patent Application
20090299296
The present invention relates to devices for injecting, infusing, administering, delivering or dispensing a substance, and to methods of making and using such devices. More particularly, it relates to devices for administering or dosing medical, medicinal and/or therapeutic substances or liquids, and to a container for selectively receiving substances or liquids that alternately or selectively contain different concentrations of a substance that is to be dosed or administered.
For treatment of diabetes mellitus, devices of this kind are available, for example, in the form of insulin pumps, injection devices and insulin pens, with which patients can provide themselves with a therapeutic amount of insulin from a storage container associated with the device. The container, for example an ampoule, in which a plunger or stopper is received in a displaceable manner, is fixed in a receiving compartment of the administration device. When the stopper is displaced in an advancing, injection or delivery direction by a drive member of the injection pen or infusion pump, a dose or amount of the substance or liquid is conveyed out of the container through the outlet due to the displacement effect provided by the plunger. To permit individual therapy, such administration appliances generally permit the use of insulin solutions with different insulin concentrations.
The therapeutic or active substance concentrations are generally defined according to international standards. For the insulin concentration, an international unit (IU) corresponds per millimetre to pure human insulin of 26 U/mg (6.00 mmol/U). An insulin unit thus always has the same effect. The insulin concentrations U40 (40 IU/ml=1.5 mg/ml) and U100 (100 IE/ml=3.75 mg/ml) are widely used, while U200 and higher concentrations are increasingly being employed. When using a higher concentration, a smaller amount of liquid has to be delivered to administer the same amount of active substance or the same international units.
Changing from one insulin concentration to another requires adapting or reprogramming the pump or pen. If the reprogramming is not carried out, or is done incorrectly, the wrong amount of active substance enters the human body, which can lead to serious harm or injury to the patient. To ensure patient safety in the medical sector, it is necessary to ensure that no error occurs in the reading of a coding feature that indicates the concentration, something that can never be achieved with absolute certainty, despite considerable outlay in terms of effort and/or construction. Given the serious consequences of a wrongly identified or wrongly programmed insulin concentration, an extremely high safety level must be attained.
In the prior art, injection or infusion devices are known which can identify certain identification means applied to the container, for example bar codes, RFID tags or mechanically acting devices, with the coded insulin concentration and which can automatically adapt the dosing device to the corresponding concentrations. A precondition for this is that the ampoules used are equipped with characteristic identification means or features.
An ampoule or container designed for U200 insulin is disclosed in patent document WO 03/017914. To satisfy the stringent precision requirements regarding the precise amount delivered, a preferred diameter range of the container is disclosed. The preferred dimensions, however, only apply to the U200 insulin concentration.
In patent application WO 05/004954, an adjusting element for adjusting a liquid concentration is described which can be coupled to an ampoule and communicates with an injection device provided for the purpose. The adjustment of the concentration present in the container is to be carried out by the user and can be shown on a display.
An object of the present invention is to make available a container from which active substance solutions for different active substance concentrations can be expelled safely and in accordance with a particular or selected therapy, and which does not require adjusting or reprogramming of the active substance concentration on an administration device.
In one embodiment, the present invention comprises a container for receiving liquids with different concentrations of an active substance that is to be dosed, the container comprising a hollow body and a displaceable element for expelling the liquid, the displaceable element located for longitudinal movement in the hollow body, wherein the cross-sectional surface area of the hollow body is inversely proportional to the concentration of the active substance, such that, with identical longitudinal movements of the displaceable element, the dosed amount of active substance remains independent of the concentration.
In one embodiment, the present invention comprises a container for receiving liquids having different concentrations of an active substance that is to be administered or dosed, wherein the container comprises a hollow body and a displaceable element for expelling the liquid is located for longitudinal movement in the hollow body, and wherein the interior cross-sectional surface area of the hollow body is inversely proportional to the concentration of the substance, such that, with identical strokes or longitudinal movements of the displaceable element, the discharged amount of active substance remains independent of the concentration of the substance in the container.
In one embodiment, the present invention comprises a container for receiving medical liquids with different concentrations, which container can be received by an administration device. To permit individual therapy, different insulin concentrations can selectively or alternately be used. In some embodiments, the invention is suitable for use in an infusion or injection device in which a drive member acts on a plunger or stopper that is displaceable in the container. Of course, the cylinder can also be designed to be displaceable relative to the stationary plunger. The substance received in the container can contain a liquid medicament, for example an insulin solution, analgesic agent, nutrient solution or growth hormone, in different concentrations. In some embodiments, the container is arranged releasably in the administration device and can be exchanged when necessary, for example by the physician or patient.
In some embodiments, the container has an axially symmetrical body which has a substantially constant internal cross section and is designed to receive a displaceable element for expelling the liquid. Usually, a displacing body is fitted on or pushed into a front face. The liquid situated in the direction of displacement is expelled by a relative axial movement of the displacing body. Assuming uninterrupted flow conditions between the liquid reservoir and the outlet opening, this results in an expelled liquid volume which is calculated from the product of the cross-sectional surface area and the translational displacement of the displacing body.
If the cross-sectional surface area is chosen to be inversely proportional to the concentration of the substance, then, according to the table below, the delivered amount in insulin units (IU) is constant for identical displacement units (Δx). Each insulin concentration therefore has a so-called characteristic internal diameter. The characteristic internal diameter shown in the table for U100, which represents the most common insulin concentration, corresponds to the ISO standard 13926-1 for pen ampoules.
Since only the inner cross-sectional surface area or internal diameter influences the amount of active substance delivered, the outer geometry and length dimensions can be chosen freely, within the limits imposed by construction and/or practicality.
In some embodiments, the configuration of the inner cross section has a geometry that is axially symmetrical with respect to the direction of advance, for example a circular, polygonal or elliptic cross section.
In one embodiment, the liquid received by the container selectively includes medical or therapeutic liquids such as insulin for treatment of diabetes mellitus, growth hormones, nutrient solutions or analgesic agents.
In another embodiment, the container is designed for an active substance concentration of a medical liquid of between U10 and U1000.
In one preferred embodiment, the container is formed by an ampoule, carpoule, syringe reservoir or syringe ampoule for containing the substance that is to be dosed. A stopper which is displaceable in the longitudinal direction, and which has a seal or sealing means, for example sealing lips, forming a seal on the cross-sectional surfaces, forms a displacing body with a diameter and cross section. The displaceable stopper is driven by a drive member which ensures that the liquid is delivered at a constant stroke. In other words, each translation of the drive element by one displacement unit effects an expulsion of an identical amount of active substance or international units from the container, independently of the concentration contained in the container.
In one preferred embodiment, the container is a prefilled insulin ampoule in which the insulin concentration contained therein agrees with the characteristic internal diameter and cooperates with a suitable administration device.
In other preferred embodiments, the administration device is an injection pen or an insulin pump permitting self-medication for treatment of diabetes mellitus.
In one embodiment of an administration device, a drive member that can be coupled to the stopper is present. To ensure coupling with different diameter series, the drive member may be adjusted, in some embodiments automatically, to the stopper diameter.
In a preferred embodiment of an administration device, the seal is effected by a stopper which is axially displaceable and can be coupled mechanically to a drive member, wherein the drive member is designed such that it adapts to the diameter of the stopper. With stoppers of large diameter, the stopper may be flexurally rigid to ensure the dimensional stability of the seal and/or to prevent bulging, which may compromise dispensing accuracy.
If the configuration according to the present invention is used in an injection pen, the active substance solution is administered through a cannula or needle mounted or carried on the injection pen. A front end of the cannula protrudes from the injection pen and is able to penetrate the skin. In pump appliances, administration takes place through a catheter line mounted or carried on the outlet. To administer the active substance solution, the drive device initiates a translational movement of the drive member in an advancing or delivery direction. The dispensing procedure is such that, upon actuation of the dispensing mechanism, the plunger is pushed forward by a certain distance in the direction of the outlet of the container, as a result of which the active substance solution is forced into the catheter or into the cannula.
In another preferred embodiment, the internal diameter or the coding on the outer contour of a container to be inserted in an admistration device, e.g. and injection device or insulin pump, is detected by an identification device and the characteristic insulin concentration is calculated. In this way, in addition to the container imprint, the contained concentration can be shown to the user on a reading unit. The determined insulin concentration can be used to optimize the operation and/or performance of the administration device, for example to optimize the response threshold of occlusion detection, which has the purpose of warning the user if the flow in the delivery channel is impeded.
In one preferred embodiment, the drive member is a ram with a releasable connection to the stopper, which is connected with a force fit to the ram before insertion of the active substance container.
With regard to fastening, mounting, attaching or connecting components of the present invention, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the invention, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making the invention and/or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc.
Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.
| Number | Date | Country | Kind |
|---|---|---|---|
| 01774/06 | Nov 2006 | CH | national |
This application is a continuation of International Application No. PCT/EP2007/009710, filed on Nov. 9, 2007, which claims priority to Swiss Application No. 01774/061, filed on Nov. 10, 2006, the contents of both of which are incorporated in their entirety herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/EP2007/009710 | Nov 2007 | US |
| Child | 12437637 | US |
