Integrated package

• US 8,740,851 B2
• Filed: 09/08/2010
• Issued: 06/03/2014
• Est. Priority Date: 05/08/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Ethelfeld, Erik Winkel
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/877,568
• Publication Number:
  US 20110060289A1
• Time in Patent Office: 1,364 Days
• Field of Search: 604/93.01, 604/131, 604/134, 604/141, 604/890.1, 604/264, 604/174, 604/180, 604/136, 604/164.01, 604/167.01, 206/438, 206/365, 206/524.1, 206/440
• 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 skin-mountable unit having a mounting surface comprising adhesive for adhering the unit to the skin of a subject, and a 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 unit can be moved when detached from the handling unit, the handling unit having a portion surrounding the opening. A seal member is releasably attached to the circumferential portion, providing a closed space for the skin-mountable unit. The device allows for easy handling. The user can grip the handling unit and handle the combined device during operation. The handling 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 an adhesive for adhering the unit to the skin of a subject, the adhesive being covered by a releasably attached seal member,

a handling unit releasably attached to the skin-mountable unit in a manner that allows the handling unit to be released from the skin mountable unit after the skin-mountable unit is attached to the skin of the subject and wherein the handling unit comprises an interior space at least partially accommodating the skin-mountable unit and having an opening through which the skin-mountable unit can be moved when detached from the handling unit, the handling unit having a portion surrounding the opening, and

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

wherein the handling unit and skin-mountable unit are arranged in a releasably attached manner that allows the device to be handled and initially applied against the skin as a unitary device and wherein in situation of use the handling unit is used to aid in attaching the device to the skin.

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 mounting surface is arranged in a retracted position relative to the general plane.

6. A device as defined in claim 1, further comprising a protective cover disposed between the seal member and the adhesive, wherein the seal member is connected to the protective cover.

7. A device as defined in claim 6 wherein removal of the seal member results in automatic removal of the protective cover.

8. A device as defined in claim 1, wherein the skin-mountable unit further comprising a transcutaneous device having a distal pointed end configured 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.

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

10. A device as defined in claim 9, wherein the driver comprises a spring, the handling unit further comprising:

an actuator that is 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 actuator from the first to the intermediate condition causes activation of the driver, and actuation of the actuator from the intermediate to the second condition causes release of the activated spring, moving the transcutaneous device from the first position to the second position.

11. A device as defined in claim 10, wherein the actuator 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.

12. A device as defined in claim 10, wherein actuation of the actuator from the first through the intermediate to the second condition is accomplished by moving two actuation elements against each other.

13. A device as defined in claim 9, wherein the driver can be locked in its activated state.

14. A device as defined in claim 9, wherein the driver comprises a spring which is or can be arranged in an activated state, the second unit comprising a trigger for releasably retaining the spring in the actuated state, the trigger being operable to release the spring for moving the transcutaneous device from the first position to the second position.

15. A device as defined in claim 9, 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 driver being arranged within the interior space between the upper portion and the housing.

16. A medical device as defined in claim 9, wherein the transcutaneous device is a cannula in combination with a pointed insertion needle 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 driver from their respective first position to their respective second position when the driver 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.

17. A medical device as defined in claim 16, wherein the cannula comprises a needle-penetratable septum through which the insertion needle is arranged when the cannula and the insertion needle is moved from their respective first position to their respective second position.

18. A medical device as defined claim 16, 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.

19. A medical device as defined claim 9, wherein the transcutaneous device is a longitudinal sensor device in combination with a pointed insertion needle arranged to support a distal portion of the sensor device,

the sensor device and insertion needle being arranged to be simultaneously moved by the driver from their respective first position to their respective second position when the driver 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 device as defined in claim 8 in combination with an inserter, the inserter comprising:

a housing configured to releasably receive and support the handling unit,

an actuatable driver,

the handling unit comprising a portion moveable by the driver 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.

21. A device as defined in claim 8, wherein the transcutaneous device is a hollow infusion needle, the skin-mountable unit further comprising:

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

an expelling unit configured to expel a drug out of the reservoir and through the skin of the subject via the infusion needle.