Gateway System

• US 20080215003A1
• Filed: 02/22/2006
• Published: 09/04/2008
• Est. Priority Date: 03/17/2005
• Status: Active Grant

• Current Assignee: Unomedical A/S
• Original Assignee: Unomedical A/S
• Inventors: Mogensen, Lasse W., Mathiasen, Orla, Kornerup, Grete, Nielsen, Jens E.
• Granted Patent: US 7,985,199 B2
• Time in Patent Office: Days
• US Class Current: 604/116
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 39/02 Access sites
• 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

This invention relates to an injection site or gateway or a system comprising such an injection site or gateway. In one form the invention concerns a system comprising an inserter device and a gateway for subcutaneous injection of fluid where comprises a distal surface (1a) corresponding to a proximal surface (1b) integrated with the inserter device. In another form the invention concerns a gateway for subcutaneous injection of fluid, which gateway comprises—a body (1) with at least one through-going opening (6) with an entrance and an outlet, and at least one cannula (3) and having a proximal end protruding from the lower side of the body; —and at the entrance of the through-going opening medication can be injected by a delivery device (20) which delivery device has protruding parts (22) which form an inner opening with a diameter di; wherein the surface of the entrance is shaped in such a way that the cross-section of the top part of entrance, i.e. from the top of the entrance to a position di/3 below the top, do not exceed di.

Claims

1. A system comprising an inserter device and a gateway for subcutaneous injection of fluid where the gateway comprises a body (1) with at least one through-going opening (6), at least one cannula (3) and a restriction (4) for microorganisms placed at the distal end of the at least one cannula (3) or in the at least one through-going opening (6);

and which system comprises at least one penetrating member having a proximal end protruding from the lower side of the body (1);

drugs to be injected is delivered to the gateway by a drug delivery device (20) being able to pass the restriction (4) for microorganisms, the gateway is releasably connected to a biasing unit (15) in the inserter device (10, 13) which unit (15) can bring the gateway from a retracted to a forward position when released, characterized in that the gateway comprises a distal surface (1a) corresponding to a proximal surface (1b) integrated with the inserter device.

2. A system according to claim 1 characterized in that the proximal surface (1b) integrated with the delivery device (20) belongs to a separate interface (9, 30).

7. A system according to claim 1-6, wherein the distal surface (1a) of the gateway comprises a steering part (5) constituted of one or more parts inserted in the opening (6) which part or parts are made of a relatively hard material for example metal or hard plastic or the same material as the body (1) is made of.

8. A system according to claim 1-6, wherein the steering part (5) comprises tracks (5) which tracks are formed as protruding or recessing elements compared to the main part of the distal surface.

9. A system according to claim 8, wherein the tracks (5) have the form of one or more recesses.

10. A system according to claim 8, wherein at least a part of the steering part (5) can be separated from the body (1).

11. A system according to claim 10, wherein the steering part (5) is formed in a separate socket (36) which is being fastened to the body (1) of the gateway before use.

12. A system according to claim 11, wherein the part of the steering part (5) which can be separated from the body (1) functions as an adapter for a given drug delivery device (20).

13. A system according to claim 11, wherein the interface comprises an injection needle (31).

16. A system according to claim 1-14, wherein the gateway comprises means for releasably connecting a sensor device for measuring the glucose content of the blood.

18. A system according to claim 1-17, wherein a corresponding removable cover (19) can be positioned on top of the body (1) between injections.

19. A system according to claim 1-18, wherein the body (1) is made of a transparent material such as ABS, PP or PE.

3. A system comprising an inserter device, a gateway and an interface (9, 30), where the gateway comprises a body (1) with at least one through-going opening (6), at least one cannula (3) and a restriction (4) for microorganisms placed at the distal end of the at least one cannula (3) or in the at least one through-going opening (6);

and which system comprises at least one penetrating member having a proximal end protruding from the lower side of the body (1);

drugs to be injected is delivered to the gateway by a drug delivery device (20) being able to pass the restriction (4) for microorganisms, the gateway is releasably connected to a biasing unit (15) in the inserter device (10, 13) which unit (15) can bring the gateway from a retracted to a forward position when released, characterized in that the interface (9, 30) provides a distal surface corresponding to the inserter and a proximal surface corresponding to the gateway.

14. A system according to claim 3 or 5, wherein a separate interface (30) is secured to the delivery device (20).

15. A system according to claim 14, wherein the separate interface (30) can be moved from one position where it covers the injection needle (21) to a second position where the injection needle (21) is not covered.

4. A system comprising a drug delivery device (20) and a gateway for subcutaneous injection of fluid where the gateway comprises a body (1) with at least one through-going opening (6), at least one cannula (3) and a restriction (4) for microorganisms placed at the distal end of the at least one cannula (3) or in the at least one through-going opening (6);

and which system comprises at least one penetrating member having a proximal end protruding from the lower side of the body (1);

drugs to be injected is delivered to the gateway by the drug delivery device (20) being able to pass the restriction (4) for microorganisms, the gateway is releasably connected to a biasing unit (15) in an inserter device (10, 13) which unit (15) can bring the gateway from a retracted to a forward position when released, characterized in that the system also comprises a separate interface (9, 30) comprising a proximal surface (1c) corresponding to a distal surface (1a) of the gateway and a distal surface (1d) corresponding to a proximal surface (1b) of the delivery device (20).

5. A system comprising an inserter device (10, 13), a drug delivery device (20) and a gateway for subcutaneous injection of fluid where the gateway comprises a body (1) with at least one through-going opening (6), at least one cannula (3) and a restriction (4) for microorganisms placed at the distal end of the at least one cannula (3) or in the at least one through-going opening (6);

and which system comprises at least one penetrating member having a proximal end protruding from the lower side of the body (1);

drugs to be injected is delivered to the gateway by the drug delivery device (20) being able to pass the restriction (4) for microorganisms, the gateway is releasably connected to a biasing unit (15) in the inserter device (10, 13), which unit (15) can bring the gateway from a retracted to a forward position when released, characterized in that the gateway comprises a distal surface (1a) corresponding to a proximal surface (1b) integrated with the inserter device and to a proximal surface (1b) integrated with the delivery device (20).

6. A system according to claim 5, characterized in that the gateway comprises a distal surface (1a) corresponding to a proximal surface (1b) of an interface (9, 30) and the interface (9, 30) has a distal surface corresponding to a proximal surface (1b) of the delivery device (20).

17. A system according to claim 5, wherein the part of the inserter device (10, 13) being in contact with the body (1) of the gateway is shaped as the end of an injection pen.

20. A system comprising a drug delivery device (20) with an insertion needle (21) secured to an interface (30) characterized in that an end of the interface (30) which is not secured to the drug delivery device (20) is provided with at least one cover (4a) in order to provide a protected and sterile environment around the insertion needle (21).

21. A system according to claim 20, characterized in that the drug delivery device (20) is filled with a drug in a ready-to-use condition.

22. Gateway for subcutaneous injection of fluid, which gateway comprises

a body (1) with at least one through-going opening (6) with an entrance and an outlet, and at least one cannula (3) placed in fluid connection with the through-going opening (6) and having a proximal end protruding from the lower side of the body (1);

and at the entrance of the through-going opening (6) medication can be injected by a delivery device (20) which delivery device (20) has protruding parts (22) covering the entrance when delivering medication to the gateway and which protruding parts (22) form an inner opening with a diameter d_i;

characterized in that the surface of the entrance is shaped in such a way that the cross-section of the top part of entrance, i.e. from the top of the entrance to a position d_i/3 below the top, do not exceed d_i.

23. Gateway according to claim 22, wherein the surface of the top part is constructed as a part of a sphere.

24. Gateway according to claim 22, wherein the surface of the top part is constructed of several smaller plane surfaces connected to each other in angles above 90°

.

25. Gateway according to claim 22, having at least two through-going openings.

26. Gateway according to claim 25, wherein at least one of the through-going openings (6) has a wall which can not be penetrated by a pointy insertion needle (21) placed opposite the entrance for the insertion needle (21).

27. Gateway according to claim 25, wherein a septum (4) covers a shared entrance of at least two through-going openings (6).

28. Gateway according to claim 25, wherein the septum (4) can be either pushed away from the entrance of a through-going opening (6b) or penetrated in order to enter a through-going opening (6a).