Device for administration

• US 9,278,173 B2
• Filed: 12/22/2006
• Issued: 03/08/2016
• Est. Priority Date: 12/23/2005
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Mejlhede, Signe Thorning, Mogensen, Lasse W., Gyrn, Steffen, Hrdum, Elo
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/158,520
• Publication Number:
  US 20090076453A1
• Time in Patent Office: 3,364 Days
• Field of Search: 604/890.1, 604/151
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• 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 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 application relates to a device for an intermittent or continuous administration of a therapeutical substance, such as insulin, comprising an injection part and a fluid delivery part (3,4). The fluid delivery part normally comprises a reservoir (4), transferal means e.g. in form of a pump and a house (3), and the injection part normally comprises a base plate (10), a cannula part (1,16) comprising a cannula (9) extending past the proximal side of the base plate and means for fixation of the base plate to the skin of the user. According to the application the device comprises a base plate (10), a cannula part (1, 1b) comprising a body providing a through-going opening leading liquid to a cannula (9) which cannula (9) extends past the proximal side of the base plate (10) and means (21) for fixation of the base plate to the skin of the user wherein a flexible part is arranged in an area between the subcutaneously positioned section of the cannula (9) and the fluid delivery part (3, 4).

Claims

1. A device for delivering fluid which before injection comprises three separate parts:

an injection part, a cannula part and a fluid delivery part and after injection the device comprises two separable parts;

an injection part and a fluid delivery part as the cannula part is attached to the injection part when inserted into a subcutaneous position;

the fluid delivery part comprising a reservoir, a pump and a housing,

the injection part further comprises a base plate, the base plate comprises an adhesive portion for fixation of the base plate to the skin of the user, the base plate further comprising a connector for releasably connecting the fluid delivery part to the base plate such that the fluid delivery part is separable from the base plate during use, the connector extending from a distal side of the base plate, the base plate further comprising a surface on the distal side corresponding to an inserter device for the cannula part for attaching the cannula part to the injection part; and

the cannula part is before injection placed in a separate inserter device and comprises a body and a cannula, the cannula is made of a soft material and configured to be inserted by an injection needle of the inserter device, the body providing a through-going opening configured to lead liquid to the cannula, the cannula part configured to be inserted into and attached to the base plate after the base plate has been positioned on the skin of the patient, the cannula part comprising a cannula part locking mechanism configured to attach the cannula part to the base plate independent of the fluid delivery part, the cannula extending past a proximal side of the base plate after injection of the cannula into a use position,

wherein the device further comprises a flexible tube connecting the connector of the injection part at one end and the body of the cannula part at a second end to provide fluid communication between the reservoir and cannula.

2. A device according to claim 1, wherein the base plate is constructed either partially or completely from a flexible material.

3. A device according to claim 1, wherein the body of the cannula part is constructed either partially or completely from a flexible material.

4. A device according to claim 1, wherein the housing of the fluid delivery part also provides a housing for the injection part.

5. A device according to claim 1, wherein the cannula and the delivery part are not interconnected by non-flexible areas.

6. A device according to claim 1, wherein a fluid tight connection leading fluid from the reservoir to the cannula is formed when the delivery part and the injection part are joined together.

7. A device according to claim 6, comprising a sealing member configured to seal an opening of the reservoir to prevent access of micro organisms to the reservoir of the fluid delivery part during periods when the fluid delivery part and the injection part are separated.

8. A device according to claim 7, wherein the reservoir has two positions, a first position wherein an outlet from the reservoir is blocked with a first barrier which is not permeable for microorganisms and an inlet of the through-going opening in the cannula part is blocked with a second barrier which is not permeable for microorganisms, and a second position wherein an open fluid connection is formed between the reservoir and the through-going opening in the cannula part.

9. A device according to claim 8, wherein one or both of the barriers comprise a material which can be penetrated by a needle-like object where an opening formed in the material re-closes on retraction of the needle-like object.

10. A device according to claim 9, characterized in that the needle-like object is blunt.

11. A device according to claim 9, characterized in that the needle-like object is sharp-pointed.

12. A device according to claim 8, wherein one or both of the barriers comprise a hard surface which is moved forming an opening in an area positioned between an outlet of an outlet pipe and the inlet of the through-going fluid path.

13. A device according to claim 1, wherein the adhesive portion for fixation of the base plate to the skin of the user comprises a mounting pad adhered to the proximal side of the base plate or to a proximal side of the cannula part.

14. A device according to claim 1, wherein the base plate comprises a lattice with a peripheral coherent part and one or more bars interconnecting the peripheral part.

15. A device according to claim 14, wherein the base plate has a round or oval peripheral part and the bars have one end attached to the peripheral area and a second end attached to a central area.

16. A device according to claim 14 wherein the base plate has three or more bars.

17. A device according to claim 1, wherein the cannula comprises a cannula housing having a first end including solid walls and a protective seal protecting the entrance to the cannula.

18. A device according to claim 1, wherein the base plate comprises a first part of a cannula part configured to position a second part comprising the cannula.

19. A device according to claim 18, wherein the first part of the cannula part comprises the locking mechanism and the locking mechanism is configured to releasably lock the second part to the base plate in a desired position.

20. The device according to claim 1, wherein the base plate comprises a through opening, the cannula part comprising the cannula is insertable into the opening and allows for the injection needle of the inserter device to be removed from the injection part.

21. The device according to claim 1, wherein the cannula is inserted with the inserter device provided with a surface corresponding to the surface of the base plate and an inserter device connector, wherein connection of the inserter device connector to the base plate connector positions the inserter device so that the cannula including a body providing a fluid pathway to the cannula is inserted in correct relation to the base plate.

22. The device according to claim 1, wherein the base plate comprises a connector needle, the connector needle configured to penetrate a protective seal covering an entrance of a connector hub and a septum covering an entrance of a reservoir of the delivery part.

23. The device according to claim 22, wherein the protective seal comprises a deformable bubble-shaped membrane.

24. The device according to claim 23, wherein the reservoir and the deformable membrane are configured to be pushed together so that the deformable membrane is deformed and the connector needle penetrates the membrane and forms a fluid connection.