SYSTEM CONSISTING OF AN INSERTION HEAD AND AN INSERTER

• US 20080275407A1
• Filed: 03/14/2008
• Published: 11/06/2008
• Est. Priority Date: 09/15/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Disetronic Licensing Ag
• Inventors: Scheurer, Simon
• Granted Patent: US 8,262,618 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• 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 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• 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: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base

Abstract

A system for positioning and inserting insertion means into tissue includes an insertion head and an inserter. The insertion head includes a base with a lower side positionable on tissue; and an insertion means movably mounted by the base, which is movable from a protective position where a free end of the insertion means is short of the lower side, into an insertion position where the free end protrudes beyond the lower side of the base. The inserter includes an inserter casing having a lower side with an opening for the insertion head; a holding means, coupled to the inserter casing for holding the insertion head in an initial position; a drive configured to move the insertion head out of the initial position in an advancing direction; and an activating member movable relative to the holding means and operable such that the insertion means is moved into the insertion position.

Claims

1. A system consisting of an insertion head and an inserter for positioning the insertion head on organic tissue, said insertion head comprising:

a base comprising a lower side which can be positioned on the tissue;

and an insertion means movably mounted by the base;

wherein the insertion means is movable relative to the base from a protective position in which a free end of the insertion means is short of the lower side, into an insertion position in which the free end protrudes beyond the lower side of the base;

said inserter comprising;

an inserter casing, a lower side of which comprises an opening for the insertion head;

a holding means, coupled to the inserter casing, for holding the insertion head in an initial position;

a drive, by means of which the insertion head can be moved out of the initial position in an advancing direction which points through the opening in the inserter casing;

and an activating member which can be moved relative to the holding means and can be operated, and by means of which it is possible to act on the insertion means, such that the insertion means is moved into the insertion position.

2. The system according to claim 1, wherein a coupling couples the activating member to the insertion means, the coupling comprising a joint with two joint elements, wherein the joint elements are coupleable.

3. The system according to claim 2, further comprising an effector associated with the inserter, wherein the effector member comprises a joint element.

4. The system according to claim 2, wherein the activating member is configured as one of the joint elements.

5. The system according to claim 4, wherein the effector and the activating member are configured as joint elements, said effector and activating member comprising the joint.

6. The system according to claim 2, wherein the joint elements comprise a guiding cam and an engaging element guided on the guiding cam.

7. The system according to claim 6, wherein the guiding cam and the engaging element are movable relative to the other in or counter to the advancing direction.

8. The system according to claim 6, wherein the guiding cam and the engaging element are movable relative to the inserter casing.

9. The system according to claim 6, wherein the guiding cam is configured as a tapering structure such that it tapers with respect to the advancing direction.

10. The system according to claim 9, wherein the guiding cam tapering structures tapers in the direction of the insertion means situated in its insertion position.

11. The system according to claim 6, wherein the guiding cam and the engaging element are movable relative to the other transverse to the advancing direction.

12. The system according to claim 2, wherein the inserter comprises the joint.

13. The system according to claim 2, wherein the insertion head comprises a receiving member movably mounted by the base coupled to the insertion means rigidly or in a joint, such that when the receiving member moves, the insertion means is moved into the insertion position and the activating member acts on the receiving member via the joint.

14. The system according to claim 1, further comprising a coupling which couples the activating member to the insertion means, wherein the coupling comprises a pressing contact via which the activating member acts on the insertion means.

15. The system according to claim 14, wherein the receiving member comprises a contact area for the pressing contact.

16. The system according to claim 15, wherein the receiving member comprises a joint element.

17. The system according to claim 14, further comprising an effector member associated with the inserter, wherein the effector member comprises a contact area for the pressing contact.

18. The system according to claim 17, wherein the activating member and the effector member are arranged as a first and a second joint, said first and second joints arranged in the inserter casing to be movable, wherein the effector member is movable in one direction by the first joint and in the counter direction by the second joint.

19. The system according to claim 1, wherein the inserter casing comprising the activating member is configured such that the activating member is movable in or counter to the advancing direction into a retracted or extended position.

20. The system according to claim 19, wherein the inserter casing slidingly guides the activating member.

21. The system according to claim 20, wherein the activating member comprises a lower side of the inserter positionable on the tissue, said lower side comprising a passage opening for the insertion head.

22. The system according to claim 21, wherein the activating member lengthens the inserter casing in the advancing direction in the extended position.

23. The system according to claim 1, wherein the inserter comprises a trigger for the drive and a blocking member arranged as a blocking engagement with the inserter casing in order to block the drive in a holding position, wherein said blocking engagement is releasable by operating the trigger.

24. The system according to claim 1, wherein the holding means comprises a holding spring which holds the insertion head in the initial position in a holding engagement, and in that the holding engagement can be released, against an elasticity force of the holding spring, by a drive force of the drive.

25. The system according to claim 1, wherein the drive comprises an advancing element which acts on the insertion head when the insertion head is in its initial position, and a force generator which acts on the advancing element in the advancing direction.

26. The system according to claim 1, wherein the insertion means is elongated in a longitudinal direction, wherein the lower side of the base encloses the insertion means when said insertion means is arranged in its initial position up to an acute angle of less than 50°

, and wherein the free end of the insertion means protrudes beyond the lower side as it moves into the insertion position.

27. The system according to claim 1, wherein base mounts the insertion means such that it can pivot about a rotational axis, and the insertion means comprises a longitudinal axis which intersects the rotational axis or crosses it at a distance of at most half the length of the insertion means.

28. The system according to claim 1, wherein insertion head further comprises a handle which projects from the base and comprises a first handle component and a second handle component which can be moved relative to the base and the first handle component, and a coupling which transmits a movement of the second handle component into a movement of the insertion means.

29. The system according to claim 28, wherein the handle is detachably coupled to the base.

30. The system according to claim 29, wherein the handle is releasable when the second handle component is moved.

31. The system according to claim 28, wherein the handle comprises a receptacle which accommodates the insertion means in its protective position.

32. An inserter for positioning an insertion head on organic tissue, said inserter comprising:

a) an inserter casing having a lower side comprising an opening for the insertion head;

b) a holding means coupled to the inserter casing for holding the insertion head in an initial position;

c) a drive for moving the insertion head out of the initial position in an advancing direction;

d) and an activating member movable relative to the holding means, wherein when said activating member is actuated, the insertion means is moved from a protective position into an insertion position.

33. The inserter according to claim 32, further comprising a coupling which couples the activating member to the insertion means, the coupling comprising a joint with two joint elements, wherein the joint elements are coupleable.

34. The system according to claim 33, further comprising an effector associated with the inserter, wherein the effector member comprises a joint element.

35. The system according to claim 34, wherein the activating member and the effector member are arranged as a first and a second joint, said first and second joints arranged in the inserter casing to be movable, wherein the effector member is movable in one direction by the first joint and in the counter direction by the second joint.

36. The system according to claim 33, wherein the activating member is configured as one of the joint elements.

37. The system according to claim 36, wherein the effector and the activating member are configured as joint elements, and wherein and the effector and the activating member comprise the joint.

38. The system according to claim 33, wherein the joint elements comprise a guiding cam and an engaging element guided on the guiding cam.

39. The system according to claim 38, wherein the guiding cam and the engaging element are movable relative to the other in or counter to the advancing direction.

40. The system according to claim 38, wherein the guiding cam and the engaging element are movable relative to the inserter casing.

41. The system according to claim 38, wherein the guiding cam is configured as a tapering structure such that it tapers with respect to the advancing direction.

42. The system according to claim 41, wherein the guiding cam tapering structures tapers in the direction of the insertion means situated in its insertion position.

43. The system according to claim 38, wherein the guiding cam and the engaging element are movable relative to the other transverse to the advancing direction.

44. The system according to claim 32, wherein the inserter casing mounts the activating member such that it can be moved in or counter to the advancing direction into a retracted or extended position, and preferably guides it in a sliding movement.

45. The system according to claim 44, wherein the activating member comprises a lower side of the inserter positionable on the tissue, said lower side comprising a passage opening for the insertion head.

46. The system according to claim 45, wherein the activating member lengthens the inserter casing in the advancing direction in the extended position.

47. The system according to claim 32, wherein the inserter comprises a trigger for the drive and a blocking member arranged as a blocking engagement with the inserter casing in order to block the drive in a holding position, wherein said blocking engagement is releasable by operating the trigger.

48. The system according to claim 32, wherein the holding means comprises a holding spring which holds the insertion head in the initial position in a holding engagement, and in that the holding engagement can be released, against an elasticity force of the holding spring, by a drive force of the drive.

49. The system according to claim 32, wherein the drive comprises an advancing element which acts on the insertion head when the insertion head is in its initial position, and a force generator which acts on the advancing element in the advancing direction.