MXPA05013490A - Cap for injection devices - Google Patents

Abstract

The invention relates to a cap that is suitable for use on an injection device that comprises an interchangeable needle assembly, said cap acting as an assembly and dismantling tool for the needle assembly.

Description

COVER FOR INJECTION DEVICES The present invention relates to a cap suitable for an injection device having an interchangeable needle assembly, which serves as a tool for assembling / disassembling the needle assembly. Injection devices having interchangeable needle assemblies of numerous patent publications are well known, such as: EP-A1-245312, EP-A1-268191, EP-A2-327910, EP-A1-594349. EP-A1-496141, EP-A1-450905, EP-A1-498737, WO 97/36625 A1, EP-A1-1003581, and WO200 / 3011371 A1. Some of these injection devices are referred to as "pen-type devices" or "pens", due to their essentially longitudinal shape, and to the fact that the device comprises a cartridge comprising the drug to be delivered. There are disposable and reusable pens. In general, both types of pen comprise a cartridge containing the drug or pharmaceutical composition to be administered. A particular feature of the reusable pen is that the drug cartridge can be removed when it is empty and the device can be reloaded with a new one. On the contrary, no exchange of the cartridge is intended in the case of the disposable pen, which will be discarded when the medicament deposit (essentially a cartridge) is empty.

This type of injection device is suitable for subcutaneous / transdermal administration of the pharmaceutical compositions, for example, in the field of diabetes (for example, for insulins, and insulin derivatives), for the treatment or prophylaxis of thrombotic diseases (for example, for heparins, and heparin derivatives), and for treatment by the use of hormones for growth or vaccines). The injection devices are designed so that the patient self-administers the drug as required, for example, for diabetic persons, or for the treatment of other diseases for which a long-term treatment with regular doses of a drug is required. administrable subcutaneously. However, similar or identical injection devices may also be suitable for health treatment or vaccination of animals. In general, this type of injection device comprises a housing consisting of one or more parts, a drug reservoir of a drug (liquid or in suspension) to be administered, a mechanism for dispensing and delivering the drug (eg, a plunger, a drive mechanism, a metering mechanism, and a delivery mechanism), which allows precise dosing and administration of a previously selected amount of medicament, a needle system for injection, and a cap. The drug reservoirs of the devices are essentially designed according to the main function of a cartridge, with which the drug is expelled by a movable plunger and applied to the patient through a needle for injection. In some cases, the injection needle system (needle assembly) may also contain a particular "needle cap" (which is different from the cap of the device). Those skilled in the art are well aware of many options and technologies to design or perform the specific design or construction of each of the required elements (optionally, mechanical, electrical, or electronically supported or equipped elements) of one such injection device ( such as a housing, drug reservoir, medication cartridge), drive mechanism, dosing mechanism, delivery mechanism, needle assembly, lid, etc.). In general, the dose of medication that is to be administered to the patient is fixed by an appropriate mechanism of fixation and delivery of the dose, and is expelled by the use of a needle for injection (for example, of needles of caliber 29 to 33). ). Injection needles suitable for administration by subcutaneous or hypodermic routes of pharmaceutical compositions are 3-18 mm, and essentially 5-13 mm in length. After preparation of the needle assembly in the device, the needle assembly should be changed regularly, preferably after each injection, in order to safeguard the sterility of the system and prevent infection. Consequently, the regular change of the needle is crucial for the patient. In fact, many patients (for example, the elderly or diabetic) may not be able to change the needle or the needle assembly as would be required by the aforementioned reasons. The reason may be, therefore, any disability that affects sight, fingers, and the like. This can lead to an increased risk of needle stick injury, for such people, or, alternatively, it can increase the risk of infection, if the needle / needle assembly is not regularly changed. Here, the present invention will reduce those risks and make it possible for the patient group to safely change the needle assembly without any assistance. In addition, other users of the invention, such as doctors or nurses, can also take advantage of the present invention. The aforementioned problem is solved by the technical elements of the present invention. Accordingly, a first aspect of the present invention is a lid for an injection device, wherein said injection device comprises an interchangeable needle assembly and wherein the lid can be attached to the device in order to cover the needle assembly interchangeable, and wherein the cap comprises a receiving bore, characterized in that the cap having the receiving bore is designed to receive the needle assembly. Accordingly, the present invention provides a means / tool for assembling / disassembling particularly easy to use by those comprised in the aforementioned groups of patients, and adapted for the particular geometric configuration of the needle assembly of such injection devices. According to the present invention, the terms which are mentioned in the following should be understood as having, in addition to the meanings which are generally known to those skilled in the art, the following preferred meanings: An "injection device" means any device of injection comprising a cover, for example, the injection devices of the type of pen known from EP-A1-828527, EP-A1-581924, EP-A1-498737, WO2003 / 011371, EP-A1-1074273, or other types of injection devices comprising a cover, for example, those known from WO2002 / 05147 A1, or WO2002 / 076535 A1. An "interchangeable needle assembly" means any needle assembly, respectively, the needle holder of a needle. injection device comprising an injection needle, which is designed to be removed by the user (as would be necessary to ensure that a clean needle is used by the user or the patient). Usually, said needle assembly must be screwed or otherwise fixed on the housing containing the cartridge. Therefore, the needle assembly can be designed so that it is easy to assemble / disassemble (or lock / unlock), for example by having a structured surface, or by designing a hexagonal bolt / screw or multiple faces . Preferably, the needle and / or injection device is designed to administer transdermal or subcutaneously pharmaceutical compositions for application to humans or animals. With particular preference, the needle and / or injection device is designed for the administration of insulin, insulin derivatives, or the like, heparin, heparin derivatives or the like, growth hormones, and the like. A "cap" according to the present invention can be any suitable cover of at least the needle assembly of an injection device, optionally comprising a clip and / or a fixation (see, for example, Figs. 1 to 4). In addition, a "cap" according to the present invention can be the original cap of an injection device, or a fixation or coupling that can be attached to the original cap of the injection device so that it fits and / or Forced locking with the original cover. A "lid, which can be fixed on the body of the device", means any lid that can be screwed (twisted or unscrewed), pinched or otherwise fixed on the body of an injection device. A "receiving bore" of the cap means any receiving bore that fits the needle assembly in order to allow assembly / removal of the interchangeable needle assembly on the injection device. The receiving bore is formed / designed by the lid, by the optional caliper, by any accessory of the lid, or by any combination of said lid, clip and accessory. The receiving bore can be designed as a nut-tightening wrench (male hexagon for Alien, tube, ring or closed-mouth, hexagonal, multi-sided nuts), or spanner, which is optionally adjustable to the diameter size of the needle set. Alternatively, the inner surface of the receiving core may be covered by, or consist of, any material having a suitable coefficient of friction, for example, by increasing the roughness of the surface and / or the elastic properties of the material used ( such as rubber, suitable plastics, or treated surfaces) and that is suitable for assembling / assembling the needle assembly of the injection device. A second aspect of the present invention is an injection device comprising a cover of the invention. A third aspect of the present invention is an interchangeable needle assembly having the geometric configuration of a hexagonal bolt or bolt, or of multiple faces, and which is adapted to the receiving bore of the cover of the invention. A fourth aspect of the present invention is the use of a cover of the invention for mounting / dismounting a needle assembly in / from an injection device. A fifth aspect of the present invention is the use of a needle assembly of the invention in an injection device comprising a cover of the invention. A sixth aspect of the present invention is a device comprising a cover of the invention, an interchangeable needle assembly of the invention, and / or an injection device of the invention.

EXAMPLES Some particular embodiments of the present invention have been represented as examples in Figs. 1 to 4, without limiting the invention to them. Fig. 1 shows side views of caps having a clip, in which: A is a cap having a clip designed as a ring nut or hexagonal closed wrench, B is a cap having a clip designed as a spanner comprising a rubber ring, which adjusts its shape to the needle assembly and blocks it with force. C is a lid that has a flexible clamp designed as a ring nut wrench or closed; and D is a cap having a flexible clip designed as a spanner comprising a partial ring of rubber. Fig. 2 shows an upper view of the lid, in which the front side of the lid comprises the receiving bore designed as, and having the function of, a pipe nut wrench. In Fig. 2A the receiving bore is hexagonal in design, while in Fig. 2B the receiving bore is designed as a ring wrench or closed wrench. Fig. 3 shows a side view of the lid having the receiving bore on the front side. Fig. 3A represents a side view of a form fitting and forcefully locking the lid, which serves as a reception core for the needle assembly. Fig. 3B depicts a side view of the lid, which serves as a receiving core for the needle assembly. Fig. 4 represents a side view of a lid having the receiving bore in an elongation of the distal end of the lid. Fig. 4A represents an elongation having a receiving bore corresponding to Fig. 1A. Fig. 4B depicts an elongation having a receiving bore corresponding to Fig. 1B. Fig. 4C depicts a sectional view of Fig. 4A, Fig. 4D depicts a sectional view of Fig. 1B. Fig. 4E represents an elongation having a receiving bore according to a ring wrench or closed wrench.

Claims (6)

1. - A cover for an injection device, in which the injection device comprises an interchangeable needle assembly, and in which the cover can be fixed on the device in order to cover the interchangeable needle assembly, and in which the cover comprises a receiving bore, characterized in that the cover having the receiving bore is designed to receive the needle assembly.

2. - An injection device comprising a lid according to claim 1.

3. - An interchangeable needle assembly having the geometrical configuration of a hexagonal or multi-face screw or bolt, and which coincides with the receiving bore of the lid according to claim 1.

4. - The use of a cap according to claim 1, for mounting / dismounting a needle assembly in / from an injection device.

5. - The use of a needle assembly according to claim 3, in an injection device comprising a lid according to claim 1.

6. - A device comprising a lid according to claim 1, an interchangeable needle assembly according to claim 3, and / or an injection device according to claim 2.