Infusion set and injector device for infusion set

• US 20050215979A1
• Filed: 03/21/2005
• Published: 09/29/2005
• Est. Priority Date: 03/26/2004
• Status: Active Grant

• Current Assignee: Unomedical AS (ConvaTec Group Plc)
• Original Assignee: Unomedical AS (ConvaTec Group Plc)
• Inventors: Mogensen, Lasse Wesseltoft, Kornerup, Grete, Goransson, Magnus Walter
• Granted Patent: US 7,648,494 B2
• Time in Patent Office: Days
• US Class Current: 604/539
• 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 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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

An infusion set having an infusion part for insertion into a patient and a connector for connecting the infusion part with a medical device through a tube is provided. The connector is axially displaceable relative to the infusion part. The infusion part includes an adhesive support, a base part with a first set of guiding means and at least two retention devices for locking the connector to the infusion part, a cannula extending from the base part and being in fluid communication with a cavity. The cavity is further adapted to receive a second cannula extending from the connector where the second cannula is in fluid communication with the tube. The infusion set further includes a second set of guiding means that are adapted to fit with the first set of guiding means and at least two arms. The retention devices extend from an upper surface of a main surface of the base part and the arms include means corresponding to the retention members.

Claims

1. An infusion set comprising an infusion part (0B) for insertion into a patient and a connector (0A) for connecting the infusion part (0B) with a medical device through a tube (7), the connector being axially displaceable relative to the infusion part, said infusion part comprising an adhesive support (1), a base part (2) with a first set of guiding means (13) and at least two retention devices (4) for locking the connector (0A) to the infusion part (0B), a cannula (5) extending from said base part (2) and being in fluid communication with a cavity (3), said cavity being further adapted to receive a second cannula (6) extending from the connector, which second cannula (6) is in fluid communication with the tube (7), a second set of guiding means (8) adapted to fit with the first set of guiding means (13) and at least two arms (9), characterized in that the retention devices (4) are extending from an upper surface of a main surface of the base part (2) and that the arms (9) comprise means (10) corresponding to the retention means (4).

2. An infusion set according to claim 1, characterized in that the connector is symmetrical around a main plane of the connector and around a plane perpendicular to the main plane and parallel to a central axis.

3. An infusion set according to claim 1, characterized in that the connection between each arm (9) and the second set of guiding means (8) is made flexible in order for the arms (9) to be able to move in the direction perpendicular to the base part (2).

4. An infusion set according to claim 3, characterized in that the connection between each arm (9) and the second set of guiding means (8) comprises at least one groove.

5. An infusion set according to claim 1, characterized in that the retention devices (4) are positioned at flexible parts of the base part (2).

6. An infusion set according to claim 5, characterized in that the base part (2) has at least two cuttings (12) creating at least two flaps on which the retention devices (4) are positioned.

7. An infusion set according to claim 1, characterized in that the cannula (5) passes through the adhesive support (1).

8. An infusion set according to claim 1, characterized in that the adhesive support (1) is a plaster.

9. An infusion set according to claim 1, characterized in that the infusion part (0B) and the connector (0A) are made from two different plastics materials.

10. An infusion set according to claim 1, characterized in that there is a visual difference in the toning of the connector (0A) and the base part (2) of the infusion part (0B).

11. An infusion set according to claim 1, characterized in that the retention devices (4) are in form of a step.

12. An infusion set according to claim 1, characterized in that the retention devices (4) have a triangular shape.

13. An infusion set according to claim 1, characterized in that the tube is fastened by means of glue.

14. An infusion set according to claim 1, characterized in that the medical device is an insulin pump.

15. An infusion set according to claim 1, characterized in that the cannula (5) is a soft cannula made of thermoplastic elastomers (TPE).

16. An infusion set according to claim 15, characterized in that the thermoplastic elastomer is selected from the group consisting of polyester ethers, ECDEL, styrene based TPE, olefin based TPE, urethane based TPE, ester based TPE, amid based TPE, polyolefins and silicone rubbers.

17. An infusion set according to claim 15, characterized in that the thermoplastic elastomer is selected from the group consisting of polypropylene, C-FLEX™

, mixtures of C-FLEX™ and

polypropylene, LUPOLEN™

1840H, LUPOLEN™

3020D, PELLETHANE™

2363-75D, PELLETHANE™

2363-55D, TECOTHANE™ and

CARBOTHANE™

18. An infusion set according to claim 1, characterized in that the infusion part (0B) and/or the connector (0A) essentially is made of polypropylene.

19. An infusion set according to claim 1, characterized in that the second cannula (6) is extending from a central part of the connector and is placed in a withdrawn position relative to the front of the central part and that at least one of the first set of guiding means (13) comprises at least two stabilizing fins.

20. An infusion set according to claim 1, comprising an injector device for the subcutaneous introduction of the cannula (5) of the infusion part (0B) into the skin of a patient.

21. An infusion set according to claim 20, characterized in that the injector device comprises a housing (30), a back (33) and longitudinally extending guiding means (31), a member (32) which is longitudinally slidable within the housing (30) and comprising a needle (35) for insertion in the cavity of the cannula (5), a spring (34) located between the back of the housing and the longitudinally slidable member, locking means for maintaining the spring in a compressed state and release means (39) for disengaging the locking means, which device comprises a pivoting member (36) which can be swung from a position in which it allows for insertion of the needle into a position in which it embraces the needle.

43. The infusion set of claim 1 wherein said cavity is covered with a membrane.

22. An injector device for the subcutaneous introduction of the cannula (5) of an infusion part (0B) into the skin of a patient said device comprising a housing (30), a back (33) and longitudinally extending guiding means (31), a member (32) which is longitudinally slidable within the housing (30), an insertion needle (35) for insertion of said cannula, a spring (34) located between the back of the housing and the longitudinally slidable member, locking means for maintaining the spring in a compressed state and release means (39) for disengaging the locking means, characterized in that the device further comprises a pivoting member (36) which can be swung from a position in which the pivoting member (36) allows for insertion of the needle (35) into a position in which it embraces the needle.

23. An injector device according to claim 22, characterized in that the pivoting member (36) is fastened to the slidable member (32).

24. An injector device according to claim 23, characterized in that the position where the pivoting member (36) allows for insertion of the needle (5) is in an angle v where 45°

≦

v≦

180°

.

25. An injector device according to claim 23, characterized in that the position where the pivoting member (36) allows for insertion of the needle (5) is in an angle v where 80°

v≦

180°

.

26. An injector device according to claim 23, characterized in that the position where the pivoting member (36) allows for insertion of the needle (5) is in an angle v where v is approximately 90°

.

27. An injector device according to claim 22, characterized in that when the pivoting member (36) is in the position where it embraces the needle, the pivoting member is placed approximately parallel to the housing.

28. An injector device according to claim 22, characterized in that when the pivoting member (36) is in the position where it embraces the needle, the pivoting member is placed in an angle w to the housing where 0°

<

w≦

180°

.

29. An injector device according to claim 22, characterized in that when the pivoting member (36) is in the position where it embraces the needle, the pivoting member is placed in an angle w to the housing where 90°

≦

w≦

180°

.

30. An injector device according to claim 22, characterized in that the pivoting member (36) can embrace the needle when the slidable member (32) is in a forward position and the spring (34) in a released state, and preferably also the pivoting member (36) can embrace the needle when the slidable member (32) is in a retracted position and the spring (34) in a tightened state.

31. An injector device according to claim 22, characterized in that the pivoting member is swung from the position essentially orthogonally to a main axis of the application device, 180 degrees to another position embracing the needle and being secured in this position said position also being essentially orthogonal to said main axis.

32. An injector device according to claim 22, characterized in that the needle is destroyed and secured in the pivoting member when the pivoting member is brought to finally embrace the insertion needle.

33. An injector device according to claim 22, characterized in that the device further comprises locking means (45) for maintaining the pivoting member in the embracing position.

34. An injector device according to claim 22, characterized in that the infusion part (0B) is unreleasably fastened to an adhesive support (1) having an adhesive surface which adhesive surface is provided with a release liner (9).

35. An injector device according to claim 34, characterized in that the pivoting member (36) has fixing means (44) for releasably fastening a part of the adhesive support (1) to the pivoting member.

36. An injector device according to claim 34, characterized in that a projecting part of the release liner of the adhesive support (1) is fastened unreleasably to the housing (30).

37. An injector device according to claim 34, characterized in that the release liner of the adhesive support comprises at least two separate pieces (41, 42).

38. An injector device according to claim 37, characterized in that each piece of release liner has at least one projecting part.

39. An injector device according to claim 38, characterized in that the projecting part of a first piece of release liner (41) is attached to the pivoting member (36) during insertion and the projecting part of a second piece (42) of release liner is attached to the housing (30) during insertion.

40. An injector device according to claim 22, characterized in that the housing has stopping means (43), preferably a stopping tab.

41. An injector device according to claim 22, characterized in that the slidable member (32) is constructed of a lattice structure.

42. An injector device according to claim 22, characterized in that the release means (39) for disengaging the locking means comprises two positions placed on opposite sides of the housing (30).