Assembly Comprising Skin-Mountable Device and Packaging Therefore

• US 20090254041A1
• Filed: 06/01/2007
• Published: 10/08/2009
• Est. Priority Date: 06/06/2006
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Petersen, Martin Majdall, Preuthun, Jan Harald, Hansen, Ib, Krag, Christian Røge
• Granted Patent: US 9,399,094 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

The present invention provides an assembly comprising a skin-mountable device with a mounting surface, the device being arranged in a packaging releasably attached to the device and having an opening through which the device can be moved when detached from the packaging. The device and the packaging comprises cooperating attachment means, whereby the attachment means allows the packaging to be moved in parallel with a skin surface for a predetermined distance when a force in parallel with the skin is applied to the packaging in the first direction, yet prevents movement of the packaging away from the general plane. The attachment means between the packaging and the skin-mountable device, allows the packaging to be used as a handling tool to place the device on a skin surface, the attachment means preventing that the device inadvertently falls out during handling, yet allows for easy and safe removal.

Claims

1. An assembly comprising:

a) a skin-mountable device comprising;

a mounting surface for mounting the skin-mountable device to the skin of a subject, the mounting surface defining a general first plane,

b) a packaging adapted to accommodate the skin-mountable device in an interior thereof and being releasably attached to the skin-mountable device, the packaging comprising;

an opening through which the skin-mountable device can be moved when detached from the packaging, the opening defining a second plane,

wherein the skin-mountable device and the packaging comprise cooperating attachment means, the attachment means allowing the packaging to be moved relative to the skin-mountable device in a first direction in parallel with the general plane for a predetermined distance when a force is applied to the packaging in the first direction, yet prevents, corresponding to the attachment means, movement of the packaging away from the general plane until the packaging has been moved a given distance in the first direction.

2. An assembly as in claim 1, wherein the opening is arranged substantially corresponding to the general plane.

3. An assembly as in claim 1, wherein further application of a force to the packaging in the first direction results in disengagement of the attachment means, this allowing the packaging to be moved away from the general plane.

4. An assembly as in claim 3, wherein further application of a force to the packaging in the first direction results in engagement between an inner inclined surface of the packaging and an upper surface of the skin-mountable device.

5. An assembly as in claim 1, wherein the packaging comprises gripping means associated with the attachment means, whereby application of a force to the gripping means forces the cooperating attachment means into engagement with each other.

6. An assembly as in claim 1, wherein the packaging comprises release means associated with the attachment means, whereby application of a force to the release means forces the cooperating attachment means from engagement with each other.

7. An assembly as in claim 1, wherein the cooperating attachment means comprises a pair of opposed protrusions on either the packaging or the skin-mountable device, and a pair of opposed cooperating structures arranged on the other of the packaging and the skin-mountable device.

8. An assembly as in claim 1, comprising releasable locking means for securing an initial position in which the packaging and the skin-mountable device is attached to each other.

9. An assembly as in claim 8, wherein the locking means is released when the packaging is moved relative to the skin-mountable device in the first direction.

10. An assembly as in claim 1,

wherein the packaging comprises a portion surrounding the opening, and a seal member releasably attached to the surrounding portion, thereby providing a sealed space for the skin-mountable device.

11. An assembly as in claim 1,

wherein the mounting surface comprises adhesive means for adhering the skin-mountable device to the skin of the subject, the adhesive means being covered by thereto releasably attached protective means, and

wherein the packaging comprises a portion surrounding the opening, and a seal member releasably attached to the surrounding portion, thereby providing a sealed space for the skin-mountable device.

12. An assembly as in claim 10, wherein removal of the seal member results in the protective means being removed from the adhesive means.

13. An assembly as in claim 10, wherein the seal member has an inner surface releasably attached to the adhesive means, the seal member thereby providing the protective means.

14. An assembly as in claim 10, wherein the seal is penetratable by a sterilizing gas, and wherein the inner surface is partially coated with a material allowing the seal member to be peeled from the adhesive means, yet allows the sterilizing gas to penetrate the seal member.

15. An assembly as in claim 1 any of the previous claims, the skin-mountable device further comprising a transcutaneous device comprising a distal end adapted to be inserted through the skin of a subject, the distal end being moveable between an initial position in which the distal end is retracted relative to the mounting surface, and an extended position in which the distal end projects relative to the mounting surface.

16. An assembly as in claim 15, wherein the transcutaneous device is provided in combination with a pointed insertion needle being retractable relative to the transcutaneous device.

17. An assembly as in claim 1, wherein the skin-mountable device comprises actuation means for moving the distal end of the transcutaneous device between the initial and the extended position when the actuation means is actuated.

18. An assembly as in claim 1, wherein the skin-mountable device is actuatable between an initial state and an actuated state, and wherein the skin-mountable device and the packaging comprises cooperating actuation means such that the skin-mountable device is actuated when the packaging is removed from the skin-mountable device.

19. A system comprising two assemblies as in claim 1, wherein the upper portion of the packaging has a outer generally inclined surface, the generally inclined surface being configured so as to allow two assemblies to be arranged on top of each other yin-yang wise.

20. A system comprising an assembly as in claim 1, in combination with a second device, wherein the second device and the skin-mountable device comprises cooperating attachment means.

21. A system as in claim 20, wherein the skin-mountable device comprises a transcutaneous device is in the form of a transcutaneous sensor device, and the second device comprises a processor adapted to transmit and/or process data acquired via the sensor device.

22. A system as in claim 20, wherein the skin-mountable device comprises a transcutaneous device is in the form of a transcutaneous access device, and the second device comprises a reservoir adapted to contain a fluid drug, an expelling assembly adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the transcutaneous access device, and processor means for controlling the expelling assembly.

23. A system as in claim 20, wherein the transcutaneous device comprises a distal end adapted to be inserted through the skin of a subject, the distal end being moveable between an initial position in which the distal end is retracted relative to the mounting surface, and an extended position in which the distal end projects relative to the mounting surface.

24. An assembly comprising:

a) a skin-mountable device comprising;

a mounting surface comprising adhesive means for adhering the device to the skin of a subject and defining a general plane,

b) a packaging releasably attached to the skin-mountable device in an initial position and comprising;

an interior space at least partially accommodating the skin-mountable device and having an opening through which the device can be moved when detached from the packaging, and

a circumferential portion surrounding the opening and defining a second plane, wherein;

the second plane is arranged substantially corresponding to the general plane,

the device and the packaging comprise cooperating attachment means, and

the attachment means allows the packaging to be moved relative to the skin-mountable device in a first direction in parallel with the general plane for a predetermined distance when a force is applied to the packaging in the first direction, yet prevents movement of the packaging away from the general plane corresponding to the attachment means.

25. An assembly comprising:

a) a skin-mountable device comprising;

a mounting surface for mounting the skin-mountable device to the skin of a subject, the mounting surface defining a first general plane,

b) a blister packaging adapted to accommodate the skin-mountable device in an interior thereof and being releasably attached to the skin-mountable device, the blister packaging comprising;

an opening through which the skin-mountable device can be moved when detached from the packaging, the opening defining a second plane,

wherein;

the skin-mountable device and the packaging comprises cooperating attachment means, the attachment means allowing the packaging to be rotated relative to the skin-mountable device in a first direction generally perpendicular relative to the general plane for a predetermined angle, and

further rotation of the packaging in the first direction results in disengagement of the attachment means, this allowing the packaging to be moved away from the general plane.

26. A method for mounting a skin-mountable device to the skin of a subject, comprising:

(a) providing an assembly comprising;

(i) a skin-mountable device having a lower adhesive mounting surface defining a general plane,

(ii) a blister packaging releasably attached to the skin-mountable device and comprising an opening through which the skin-mountable device can be moved when detached from the packaging, and

(iii) cooperating attachment means arranged between the skin-mountable device and the packaging, the attachment means allowing the packaging to be moved relative to the skin-mountable device in a first direction in parallel with the general plane for a predetermined distance when a force is applied to the packaging in the first direction,

(b) applying the assembly towards the skin thereby attaching the mounting surface to the skin,

(c) applying a force to the packaging in the first direction such that the packaging is moved in the first direction in parallel with the general plane for the predetermined distance, and

(d) applying further force to the packaging in the first direction, this resulting in disengagement of the attachment means, whereby the packaging can be moved away from the general plane.