Insertion device for an insertion head, in particular for an infusion set

• US 7,771,393 B2
• Filed: 03/13/2008
• Issued: 08/10/2010
• Est. Priority Date: 03/14/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Collins, James, Rutti, Pascal, Liniger, Jurg
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MATNEY, BROOKE MARIE
• Application Number:
  US12/047,551
• Publication Number:
  US 20080249472A1
• Time in Patent Office: 880 Days
• Field of Search: 604/157, 604/164.08, 604/164.12, 604/890.1
• US Class Current: 604/157
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• 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 insertion device for an infusion set, the insertion device including a two-part housing and a retainer or a retention means by which the infusion set can be temporarily held on the device, and a driver or a drive means including a pretensionable spring for providing the drive energy for an insertion movement of the infusion set, wherein one of the housing parts can be pivoted relative to the other to engage the infusion set and, after engagement of the infusion set, they can be pivoted again, as a result of which the spring is pretensioned and the insertion device is brought to a ready-to-use state. After the insertion movement has been triggered, the infusion set is separated from the device, such that it can execute the greatest part of the insertion movement free of the retainer.

Claims

1. An insertion device for an infusion set, the insertion device comprising a two-part housing, a retainer which temporarily receives and holds the infusion set within the device, and a driver including a pretensionable spring for providing the drive energy for an insertion movement of the infusion set, wherein one of the housing parts can be moved relative to the other to engage the infusion set and, after engagement of the infusion set, can be moved again, as a result of which the spring is pretensioned and the insertion device is brought to a ready-to-use state, and wherein, after the insertion movement is initiated, the infusion set moves through at least part of the insertion movement free of the retainer.

2. An insertion device for an insertion head with at least one infusion cannula and/or at least one puncturing tip for introduction into the body of a patient, comprising:

a) a housing having at least one contact face for placing the insertion device onto an application site on the body of the patient for application of the insertion head;

b) a retention device which temporarily receives and holds the insertion head within the insertion device; and

c) a drive for effecting an insertion movement of the insertion head relative to the contact face in the longitudinal direction of an infusion cannula or puncturing tip of the insertion head from a first position, in which the insertion head is held ready for application by the retention device in such a way that the infusion cannulas and puncturing tips of the insertion head are set back relative to the contact face, to a second position, in which the infusion cannulas and puncturing tips of the insertion head protrude beyond the contact face to permit introduction of the infusion cannulas and puncturing tips into the body of the patient when the insertion movement is executed with the contact face of the insertion device placed on the body, wherein the housing has a first housing part, which carries the retention device and at least some of the at least one contact face, and a second housing part, which is movable relative to the first housing part from an operating position, in which the two housing parts are arranged in a position relative to one another that they adopt during the application of an insertion head with the insertion device, to a loading position, in which the retention device is accessible for correct engagement of the insertion head that is to be applied, wherein, after the insertion head has been engaged into the retention device, the second housing part can be moved back to the operating position, and the insertion device is designed in such a way that, after the insertion head has been engaged into the retention device and the second housing part has been moved back to the operating position, the insertion head is held with the retention device in the first position ready for application such that, at the start of the insertion movement the insertion head is separated from the retention device such that the insertion head executes at least the greatest part of the insertion movement free of the retention device.

3. The insertion device according to claim 2, wherein when the retention device is in the operating position, the insertion head is held by the retention device in the first position purely with a force fit, purely with a form fit, or with a combination of a force fit and form fit.

4. The insertion device according to claim 3, wherein when the retention device is in the loading position, the insertion head is held by the retention device purely with a form fit or with a combination of a force fit and form fit, said form fit cancelled during the movement of the second housing part from the loading position to the operating position.

5. The insertion device according to claim 3, wherein when the retention device is in the loading position, the insertion head is held by the retention device purely with a force fit, said force fit reduced during the movement of the second housing part from the loading position to the operating position.

6. The insertion device according to claim 2, wherein at least during most of the insertion movement or during the entire insertion movement of the insertion head, the retention device remains unmoved relative to the contact face.

7. The insertion device according to claim 6, wherein the retention device is immovable relative to those contact faces that are carried by the first housing part.

8. The insertion device according to claim 2, wherein the retention device is designed for holding the insertion head with a force-fit in the first position.

9. The insertion device according to claim 2, wherein the drive device comprises at least one pretensionable energy-storing element for providing the drive energy for the insertion movement, said energy-storing element being one of a helical spring, leg spring or leaf spring made of metal or plastic, a pneumatic compression spring, or a rubber spring element.

10. The insertion device according to claim 9, wherein the energy-storing element is pretensioned by the movement of the second housing part from the operating position to the loading position.

11. The insertion device according to claim 9, wherein the energy-storing element is pretensioned by the movement of the second housing part from the loading position to the operating position.

12. The insertion device according to claim 9, wherein, with the insertion head located in the first position, the energy-storing element is made ready in the pretensioned state, and the insertion movement is triggered by actuation of an actuation member, with increasing relaxation of the energy-storing element.

13. The insertion device according to claim 12, wherein the drive device comprises a thrust element for transmitting the drive energy to the insertion head to be applied and wherein, by displacing the thrust element counter to the direction of the insertion movement and subsequently locking it with a locking means that can be released by the actuation members, the energy-storing element is pretensioned and made ready in the pretensioned state.

14. The insertion device according to claim 2, wherein the second housing part can be pivoted relative to the first housing part for the movement from the operating position to the loading position.

15. The insertion device according to claim 2, wherein the second housing part is displaceable relative to the first housing part for the movement from the operating position to the loading position, the displacement being transverse to the direction of the insertion movement.

16. The insertion device according to claim 2, wherein the second housing part carries some of the contact faces.

17. The insertion device according to claim 2, wherein the insertion head can be engaged with the retention device by being pushed relative thereto in a direction transverse to the direction of the insertion movement.

18. The insertion device according to claim 2, the insertion device further comprising at least two actuation members, which have to be actuated simultaneously to trigger the insertion movement, a first of the actuation members being actuated by the contact face of the insertion device being pressed onto the body of the patient in the direction of the insertion movement of the insertion head.

19. The insertion device according to claim 18, wherein the first actuation member is one of a slide-shaped or button-shaped element which forms all the contact faces.

20. The insertion device according to claim 18, wherein a second actuation member is a button-shaped element which, when a user presses it with a finger tip, can be actuated in a direction transverse to the intended direction in which the insertion device is pressed onto the body of the patient.

21. The insertion device according to claim 18, wherein the at least two actuation members are operatively connected to one another such that by actuating one actuation member, a blocking of the other actuation member can be cancelled.

22. The insertion device according to claim 2, further comprising at least one actuation member for triggering the insertion movement, wherein the at least one actuation member can be actuated with one hand to permit one-handed triggering of the insertion movement.

23. The insertion device according to claim 2, further comprising at least one actuation member for triggering the insertion movement, wherein the at least one actuation member is designed such that, when an actuating force ceases, it automatically goes back to an unactuated state.

24. The insertion device according to claim 2, further comprising displacement means for effecting a transverse displacement of a displaceable actuation member of an insertion head to be held in the retention device, with at least one deployable infusion cannula and/or at least one deployable puncturing tip, during the movement of the second housing part from the loading position to the operating position, to permit automatic deployment of all the deployable infusion cannulas and puncturing tips of the insertion head during the movement of the second housing part from the loading position to the operating position.

25. The insertion device according to claim 24, wherein the displacement means for effecting a displacement of a displaceable actuation member comprises a run-on surface formed by the second housing part, by which an actuation member, displaceable transversely to the direction of the insertion movement, of an insertion head to be held in the retention device, with at least one deployable infusion cannula and/or at least one deployable puncturing tip, can be displaced during the movement of the second housing part from the loading position to the operating position, to ensure automatic deployment of all the deployable infusion cannulas and puncturing tips of the insertion head during the movement of the second housing part from the loading position to the operating position.

26. The insertion device according to claim 25, wherein the displacement means for effecting a displacement of a displaceable actuation member comprises a lever mechanism with which an actuation member, which is displaceable transverse to the direction of the insertion movement, of an insertion head to be held in the retention device, with at least one deployable infusion cannula and/or at least one deployable puncturing tip, can be displaced, during the movement of the second housing part from the loading position to the operating position, to ensure automatic deployment of all the deployable infusion cannulas and puncturing tips of the insertion head during the movement of the second housing part from the loading position to the operating position.

27. The insertion device according to claim 2, wherein the insertion device can be used several times to apply an insertion head.

28. The insertion device according to claim 2 and an insertion head which can be received in the insertion device and which comprises at least one infusion cannula and/or at least one puncturing tip.

29. The insertion head according to claim 28, wherein the insertion head comprises at least one deployable infusion cannula and/or at least one deployable puncturing tip, all the deployable infusion cannulas and puncturing tips of the insertion head being folded inwardly in the unactuated state, in which the insertion head, with the second housing part located in the loading position, is intended to be received in the retention device or is already received in the retention device, and the insertion device and the insertion head are designed such that all the deployable infusion cannulas and puncturing tips of the insertion head are automatically deployed during the movement of the second housing part from the loading position to the operating position.

30. The insertion device according to claim 2, wherein the insertion head is one of an infusion set, port and/or sensor arrangement and comprises at least one infusion cannula and/or at least one puncturing tip.

31. A method for applying an insertion head to the body of a patient, the insertion head comprising one of an infusion set, port and/or sensor arrangement and having at least one infusion cannula and/or at least one puncturing tip, said method involving using an insertion device comprising a housing having at least one contact face for placing the insertion device onto an application site on the body of the patient for application of the insertion head, a retention means with which the insertion head that is to be applied is temporarily held on the insertion device, and a drive means for effecting an insertion movement of the insertion head relative to the contact face, in the longitudinal direction of an infusion cannula or puncturing tip of the insertion head, from a first position, in which the insertion head is held ready for application by the retention means such that the infusion cannulas and puncturing tips are set back relative to the contact face, to a second position, in which the infusion cannulas and puncturing tips protrude substantially completely beyond the contact face, to permit introduction of the infusion cannulas and puncturing tips of the insertion head into the body of the patient when the insertion movement is executed with the contact face of the insertion device placed on the body, wherein the housing has a first housing part, which carries the retention means and at least some of the at least one contact face, and a second housing part, which is movable relative to the first housing part, from an operating position, in which the two housing parts are arranged in a position relative to one another that they adopt during the application of an insertion head, to a loading position, in which the retention device are accessible for engagement of the insertion head, wherein, after the insertion head has been engaged by the retention means, the second housing part can be moved back to the operating position, the insertion head then being held by the retention device ready for use, and wherein at the start of the insertion movement, the insertion head is separated from the retention means such that it executes the greatest part of the insertion movement free of the retention means, said method comprising the steps of:

a) making ready the insertion device;

b) moving the second housing part to the loading position;

c) engaging the insertion head with the retention device such that the insertion head is held by the retention means;

d) moving the second housing part from the loading position;

e) arranging the insertion device with the contact face on the desired application site on the body of the patient such that the infusion cannulas and puncturing tips can penetrate correctly into the body during the insertion movement; and

f) triggering the insertion movement, whereby the insertion head is separated from the retention means at the start of the insertion movement such that the insertion head executes at least the greatest part of the insertion movement free of the retention means.

32. The method according to claim 31, wherein the insertion head is held in the operating position by the retention means purely with a force fit, purely with a form fit, or with a combination of a force fit and form fit.

33. The method according to claim 32, wherein in the loading position the insertion head is held by the retention means purely with a form fit or with a combination of a force fit and form fit and the form fit is cancelled during the movement of the second housing part from the loading position to the operating position.

34. The method according to claim 32, wherein in the loading position the insertion head is held by the retention means purely with a force fit and the force fit is reduced during the movement of the second housing part from the loading position to the operating position.

35. The method according to claim 31, wherein the insertion device comprises a drive means comprising at least one pretensionable energy-storing element for providing the drive energy for the insertion movement, the energy-storing element being pretensioned by the movement of the second housing part from the operating position to the loading position and/or by the movement of the second housing part from the loading position to the operating position.

36. The method according to claim 31, wherein the second housing part is pivoted during the movement relative to the first housing part.

37. The method according to claim 31, wherein the insertion head is held in the retention means with a force fit, and the retention means is held immovably relative to the contact face during the insertion movement of the insertion head.

38. The method according to claim 31, wherein the insertion device further comprises a drive means having at least one pretensionable energy-storing element for providing the drive energy for the insertion movement, and the energy-storing element is made ready in the pretensioned state, and the insertion movement is then triggered by actuating an actuation member.

39. The method according to claim 38, wherein arranging the insertion device on the body of the patient and triggering the insertion movement is done with one hand.

40. The method according to claim 39, wherein the insertion head comprises at least one deployable infusion cannula and/or at least one deployable puncturing tip and, in a state in which all the deployable infusion cannulas and puncturing tips of the insertion head are folded inwardly is fitted into the retention means, all the deployable infusion cannulas and puncturing tips of the insertion head being deployed during the movement of the second housing part from the loading position to the operating position.