Packing for infusion set and method of applying an infusion set

• US 20070021729A1
• Filed: 06/08/2006
• Published: 01/25/2007
• Est. Priority Date: 06/28/2005
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Gyrn, Steffen, Olsen, Jesper, Ahman, Carl, Svendstrup, May, Mogensen, Lasse
• Granted Patent: US 7,621,395 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present invention relates to a packing for an infusion set. The infusion set for intermittent or continuous administration of a therapeutic substance, such as insulin, includes an infusion part having a cannula penetrating the skin of a patient and a connector which connects the infusion part with a medical device such as an adaptor for a syringe or an insulin pump. The insertion of the infusion part will be performed with an insertion needle which is delivered together with the infusion part under sterile conditions. The packaging includes an impenetrable part protecting the surroundings from the insertion needle and a removal part which is to be removed by the user before applying the infusion part. The inner surface of the impenetrable part is provided with a retainer for releasable retaining at least a part of the infusion set.

Claims

1. Packaging for an infusion set comprising an infusion part and a needle hub, the needle hub being combined with an insertion needle, the packaging comprising:

an impenetrable part including an inner part, the inner part comprising retaining members for releasably retaining at least a portion of the infusion set in the impenetrable part, the impenetrable part covering the insertion needle; and

a removable part releasably connected to the impenetrable part;

wherein the removable part is configured for removal from the impenetrable part prior to applying the infusion part to a patient'"'"'s skin.

2. Packaging according to claim 1, wherein the retaining members are an integrated part of the impenetrable part.

3. Packaging according to claim 1, wherein the retaining members are a separate part.

4. Packaging according to claim 3, wherein the separate part is maintained in the impenetrable part when the infusion set is released from the packaging.

5. Packaging according to claim 1, wherein a proximal side of the infusion set is provided with an adhesive.

6. Packaging according to claim 5, wherein the adhesive is covered with a release layer.

7. Packaging according to claim 6, wherein the release layer covering the adhesive is partly fastened to the impenetrable part or fastened to a part being connected to the impenetrable part.

8. Packaging according to claim 7, wherein the release layer comprises a band wherein one end of the band is fastened to the impenetrable part or fastened to a part being connected to the impenetrable part.

9. Packaging according to claim 7, wherein the release layer comprises at least two bands where one end of each band is fastened to the impenetrable part or fastened to a part being connected to the impenetrable part.

10. Packaging according to claim 1, wherein the impenetrable part comprises a hard material.

11. Packaging according to claim 10, wherein the impenetrable part comprises polypropylene (PP), polyethylene (PE HD) or polyvinyl chloride (PVC).

12. Packaging according to claim 1, wherein the needle hub is provided with means for retaining a device.

13. Packaging according to claim 1, wherein the needle hub comprises a retainer for retaining an inserter.

14. Packaging according to claim 1, wherein the needle hub comprises a retainer for retaining an inserter when the inserter is pushed towards the needle hub from a distal side of the inserter.

15. Packaging according to claim 1, wherein the infusion set is releasably retained by the retainer and wherein the retainer is formed as an integrated part of the impenetrable part of the packaging.

16. Packaging according to claim 15, wherein the infusion part comprises a connector that is releasably connected to the retainer of the impenetrable part.

17. Packaging according to claim 15, wherein the retainer comprises walls upstanding from the impenetrable part in an angle between −

45° and

45°

where 0°

is orthogonal to a proximal surface of the impenetrable part.

18. Packaging according to claim 17, wherein the connector comprises a cylinder or a truncated cone integrated with the infusion part.

19. Packaging according to claim 18, wherein the connector comprises a cylinder or a truncated cone formed by a groove in the infusion part such that a proximal end of the connector to be aligned to a proximal surface of the infusion part.

20. Packaging according to claim 15, wherein the retainer comprises a material wherein the material can be penetrated by the insertion needle and wherein the material is unreleasably connected to the impenetrable part of the packaging.

21. Packaging according to claim 1, wherein a support part parallel to a proximal surface of the infusion set is fastened to the impenetrable part or formed as an integrated part of the impenetrable part.

22. Packaging according to claim 1, wherein the retainer comprises an opening for the needle and a support part parallel to a proximal surface of the infusion set.

23. Packaging according to claim 22, wherein the connector comprises a cylinder or a truncated cone protruding from the proximal surface of the infusion part.

24. A method of applying an infusion set comprising an infusion part and a needle hub, the needle hub being combined with an insertion needle, the method comprising:

removing a removable part of a packaging;

fastening a device to the needle hub;

removing the infusion set from an impenetrable part of the packaging by pulling the device;

directing a proximal portion of the infusion set toward the skin of the user;

penetrating the skin of the user with the insertion needle, positioning the infusion part, and securing the infusion set to the skin of the patient; and

removing the device and the needle hub leaving the infusion set in position.

25. The method according to claim 24, comprising fastening the device to the needle hub, the device comprising an inserter and activating the inserter for penetrating the skin of the user with the insertion needle.

26. The method according to claim 24, further comprising removing a release liner covering an adhesive on the proximal portion the infusion set by pulling in the device.

27. The method according to claim 24, comprising tightening the device before removing the infusion set from the impenetrable part of the packaging.

28. The method according to claim 24 comprising tightening the device after removing the infusion set from the impenetrable part of the packaging.