Integrated package

Abstract

The present invention generally relates to skin-mountable devices. A device in accordance with the invention comprises a first skin-mountable unit having a mounting surface comprising adhesive means for adhering the unit to the skin of a subject, and a second handling unit releasably attached to the skin-mountable unit. The handling unit comprises an interior space at least partially accommodating the skin-mountable unit and has an opening through which the skin-mountable member can be moved when detached from the handling unit, the handling unit having a portion surrounding the opening. The device further comprises a seal member releasably attached to the circumferential portion, thereby providing a closed space for the skin-mountable unit. In this way a device is provided allowing for easy handling as a user can use the handling unit to grip and handle the combined device during operation thereof, just as the second unit can be designed and optimized for ease of use during manipulation of the skin-mountable unit.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of international application no. PCT / DK2004 / 000334 filed May 10, 2004 and claims priority of Danish application no. PA 2003 00698 filed May 8, 2003 and U.S. provisional application Ser. No. 60 / 471,196 filed May 16, 2003, all of which are hereby incorporated by reference. [0002] The present invention generally relates to skin-mountable devices. Especially, the invention relates to such devices which are supplied to the user in a package from which the device has to be removed prior to use.BACKGROUND OF THE INVENTION [0003] In the disclosure and discussion of the present invention reference is mostly made to the treatment of diabetes by injection or infusion of insulin, however, this is only an exemplary use of the present invention. [0004] Portable drug delivery devices for delivering a drug to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug and having an out...

AI Technical Summary

Benefits of technology

[0021] Having regard to the above-identified problems, it is an object of the present invention to provide a skin-mountable device which can be supplied to the user in a sealed enclosure, which is convenient to handle and use, and which can be manufactured cost effectively.

[0023] In this way a device is provided allowing for easy handling as a user can use the handling unit to grip and handle the combined device during operation thereof, just as the second unit may be designed and optimized for ease of use during manipulation (e.g. activation) of the skin-mountable unit.

[0024] In exemplary embodiments the handling unit comprises a circumferential portion surrounding the opening. Advantageously, the circumferential portion defines a general plane, this allowing e.g. foil-, film- or paper-like materials to be used as sealing members. In exemplary embodiments when it is desirable to sterilize the entire first unit, the seal member may be penetratable for sterilizing gases (e.g. ethylene oxide or dry steam), yet being non-penetratable for germs. By this arrangement the first unit can serve as a packaging for the second unit, this further reducing costs as well as overall size.

[0026] In a further aspect a device is provided, comprising a first unit and a releasably attached second unit. The first unit comprises a mounting surface adapted for application to the skin of a subject, and a transcutaneous access device (in the following also termed a transcutaneous device) comprising a distal pointed end adapted to penetrate the skin of the subject, and the second unit comprises a portion (e.g. a flange defining the general plane) adapted to engage the skin of the subject. The transcutaneous device has a first position in which the distal end is retracted relative to the skin-engaging portion and a second position in which the distal end projects relative to the skin-engaging portion. The second unit comprises actuatable driving means adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated with the second unit attached to the first unit. By this arrangement the second unit can be brought in engagement with the skin of the subject where after the driving means can be actuated for insertion of the transcutaneous device. In an exemplary embodiment of this arrangement the transcutaneous device is fixedly attached to the first unit, the first unit having a first position in which the mounting surface is retracted relative to the skin-engaging portion, and a second position in which the mounting surface has been moved to a plane defined by the skin-engaging portion, whereby the mounting surface engages the skin of the user and the transcutaneous device penetrates the skin when the driving means is actuated. The first unit may be arranged in an inclined position, this allowing the infusion device to be pivoted into its second skin-contacting position in a well controlled way.

[0031] When the driving means comprises spring means, the second unit may comprise actuation means actuatable from a first condition through an intermediate condition to a second condition, whereby actuation of the actuation means from the first to the intermediate condition causes activation of the driving means, and actuation of the actuation means from the intermediate to the second condition causes release of the activated spring means thereby moving the needle from the first position to the second position. By this arrangement the actuation means may serve as a user interface such that the user will not have to directly engage the spring means just as the user input may be transformed, e.g. from one type of movement to another.

Problems solved by technology

The first class comprises durable infusion pumps which are relatively expensive pumps intended for 3-4 years use, for which reason the initial cost for such a pump often is a barrier to this type of therapy.

Although this configuration provides a simple and cost-effective solution, the actual user-performed piercing of the tissue with the needle is often problematic as people who are not experts in medicine are usually insufficiently practised to place such a needle correctly and they often suffer from a fear of the likely pain.

Although the automatic needle insertion means adds convenience for the user and may serve to overcome needle fear, such means also adds to the complexity and bulkiness of the device, the first issue adding to the cost of the device, the latter issue making the device less attractive and convenient to wear.

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