Integrated package

• US 20080009805A1
• Filed: 11/04/2005
• Published: 01/10/2008
• Est. Priority Date: 05/08/2003
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Ethelfeld, Erik
• Application Number:
  US11/266,904
• Publication Number:
  US 20080009805A1
• Time in Patent Office: Days
• US Class Current: 604/180
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

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.

Claims

1. A device comprising:

a skin-mountable unit having a mounting surface comprising adhesive means for adhering the unit to the skin of a subject, the adhesive means being covered by thereto releasably attached protective means,

a handling unit releasably attached to the skin-mountable unit and comprising an interior space at least partially accommodating the skin-mountable unit and having 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, and

a seal member releasably attached to the surrounding portion, thereby providing a sealed space for the skin-mountable unit,

wherein removal of the seal member results in the protective means being removed from the adhesive means.

2. A device as defined in claim 1, wherein the handling unit comprises a circumferential portion surrounding the opening.

3. A device as defined in claim 2, wherein the circumferential portion defines a general plane.

4. A device as defined in claim 3, wherein the mounting surface is generally planar and arranged substantially corresponding to the general plane defined by the surrounding portion of the handling unit

5. A device as defined in claim 4, wherein the seal member is releasably attached to the adhesive means, the seal member thereby providing the protective means.

6. A device as defined in claim 4, wherein the mounting surface is arranged in a retracted position relative to the general plane.

7. A device as defined in any of the previous claims, the skin-mountable unit further comprising a transcutaneous device having a distal pointed end adapted to penetrate the skin of the subject, the transcutaneous device having a first position in which the distal end is retracted relative to the mounting surface, and a second position in which the distal end projects relative to the mounting surface.

8. A device as defined in claim 7, further comprising actuatable driving means associated with the handling unit and adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated with the handling unit attached to the skin-mountable unit.

9. A device as defined in claim 8, wherein the driving means comprises spring means, the handling unit further comprising:

actuation means actuatable from a first condition through an intermediate condition to a second condition in which the transcutaneous device is moved to its second position,

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 transcutaneous device from the first position to the second position.

10. A device as defined in claim 9, wherein the actuation means comprises an actuating element which is moved from a first position through an intermediate position to a second position, preferably corresponding to a substantially non-composite movement.

11. A device as defined in claim 9, wherein actuation of the actuation means from the first through the intermediate to the second condition is accomplished by moving two actuation elements against each other.

12. A device as defined in claims 8, wherein the driving means can be locked in its activated state.

13. A device as defined in claim 8, wherein the driving means comprises spring means (540) which is or can be arranged in an activated state, the second unit comprising trigger means (542) for releasably retaining the spring means in the actuated state, the trigger means being operable to release the spring means for moving the transcutaneous device from the first position to the second position.

14. A device as defined in claim 8, wherein the handling unit comprises a housing defining the interior space, the skin-mountable unit comprising an upper portion facing towards the interior space, the driving means being arranged within the interior space between the upper portion and the housing.

15. A device as defined in claim 7 in combination with an inserter (610), the inserter comprising:

means (611) for releasably receive and support the handling unit,

actuatable driving means (640),

the handling unit comprising a portion (657) moveable by the driving means when the latter is actuated, the moveable portion of the handling unit being arranged to engage the skin-mountable unit to thereby move the transcutaneous device from its first to its second position.

16. A device as defined in claim 7, wherein the transcutaneous device is a hollow infusion needle, the skin-mountable unit further comprising:

a reservoir adapted to contain a liquid drug and comprising in a situation of use an outlet in fluid communication with the infusion needle, and

expelling means for expelling a drug out of the reservoir and through the skin of the subject via the infusion needle.

17. A medical device as defined in claim 8, wherein the transcutaneous device is a cannula (860) in combination with a pointed insertion needle (880) accommodated at least partially within the cannula, the cannula having a distal opening,

the cannula and insertion needle being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated,

wherein the insertion needle is arranged to be moveable away from the distal opening when the cannula and the insertion needle have been moved to their second position.

18. A medical device as defined in claim 17, wherein the cannula comprises a needle-penetratable septum (861) through which the insertion needle is arranged when the cannula and the insertion needle is moved from their respective first position to their

19. A medical device as defined claim 8, wherein the transcutaneous device is a longitudinal sensor device (760) in combination with a pointed insertion needle (770) arranged to support a distal portion of the sensor device,

the sensor device and insertion needle being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated,

wherein the insertion needle is arranged to be moveable away from the distal portion when the sensor device and the insertion needle have been moved to their second position.

20. A medical device as defined claim 17, wherein the insertion needle in its second position is attached to the second unit, whereby removal of the second unit from the first unit withdraws the insertion needle therefrom.

23. A device as defined in claim 1, wherein the protecting means is provided by a peelable sheet member (351) attached to the adhesive means, the sheet member being connected to the seal member.

21. A method of applying a device to a skin surface of a subject, comprising the steps:

a) providing a device having a first unit and a releasably attached second unit, the first unit comprising;

a generally planar mounting surface comprising adhesive means for adhering the first unit to the skin of the subject, the adhesive means being covered by thereto releasably attached protective means, the second unit comprising;

an interior space accommodating the first unit and having an opening through which the first unit can be moved when detached from the second unit, the second unit having a circumferential portion defining a general plane and surrounding the opening, the mounting surface being arranged interiorly in respect of the general plane or substantially corresponding to the general plane,

a seal member releasably attached to the circumferential portion, thereby providing a sealed space for the first unit, wherein removal of the seal member results in the protective means being removed from the adhesive means,

b) removing the seal member thereby exposing the adhesive means,

c) arranging the adhesive means in contact with the skin of the subject and

d) removing the second unit from the first unit.

22. A method as defined in claim 21, wherein the seal member is releasably attached to the adhesive means, the seal member thereby providing the protective means,