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

• US 7,815,607 B2
• Filed: 03/13/2008
• Issued: 10/19/2010
• 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: Pearson, Allen, Kelsey, Tom, Rutti, Pascal, Liniger, Jurg
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MATNEY, BROOKE MARIE
• Application Number:
  US12/047,643
• Publication Number:
  US 20080249473A1
• Time in Patent Office: 950 Days
• Field of Search: 604/890.1, 604/164.12, 604/157, 604/164.08
• 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 device including a retention means by which the infusion set can be temporarily held on the device and drive means including a pretensionable spring for providing drive energy for an insertion movement of the infusion set, wherein the infusion set is secured by the retention means by clamping when the retention means is in an engage position and can then be moved, with simultaneous pretensioning of the spring, to an insertion movement starting position, wherein the infusion set is already separated from the retention means at the start of the insertion movement, and wherein the infusion set moves through at least part of the insertion movement free of the retention means.

Claims

1. An insertion device for an infusion set, the device comprising a retainer by which the infusion set can be temporarily held on the device and a driver comprising a pretensionable spring for providing drive energy for an insertion movement of the infusion set, wherein the infusion set is secured by the retainer by clamping when the retainer is in an engage position and can then be moved, with simultaneous pretensioning of the spring, to an insertion movement starting position, wherein the infusion set is already separated from the retainer at the start of the insertion movement, and wherein 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 with at least one puncturing tip for introduction into the body of a patient, comprising:

a) 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) retention means with which the insertion head that is to be applied is temporarily held on the insertion device,

c) drive means for effecting an insertion movement of the insertion head relative to the contact face, in the longitudinal direction of the at least one infusion cannula or puncturing tip of the insertion head ready for application, from a first position, in which the insertion head ready for application is held by the retention means such that the at least one infusion cannula and puncturing tip are set back relative to the contact face, to a second position, in which the at least one infusion cannula and puncturing tip protrude beyond the contact face to permit introduction of the at least one infusion cannula and puncturing tip 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 drive means has at least one pretensionable energy-storing element for providing the drive energy, and the retention means are able to be positioned relative to the contact face in an engage position and in a standby position and are able to hold the insertion head in the engage position, and wherein the retention means, starting from the engage position, can then be brought to the standby position with the insertion head held on them, and, on reaching the standby position, the retention means hold the insertion head in the first position ready for application, whereby, at the start of the insertion movement, the insertion head is separated from the retention means such that it can execute at least a greater part of the insertion movement free of the retention means, and wherein the pretensionable energy-storing element is pretensioned upon the movement of the retention means from the engage position to the standby position.

3. The insertion device according to claim 2, wherein in the standby position the insertion head is held by the retention means 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 in the engage 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 retention means, with the insertion head held therein, from the engage position to the standby position.

5. The insertion device according to claim 3, wherein in the engage 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 retention means, with the insertion head held therein, from the engage position to the standby position.

6. The insertion device according to claim 2, wherein during one of most or all of the insertion movement the retention means remain unmoved relative to the contact face.

7. The insertion device according to claim 2, further comprising a manually activatable actuation means comprising one of a slide element, a rotary knob or a push button, by which the retention means, with the insertion head held thereon, can be brought manually from the engage position to the standby position, with pretensioning of the energy-storing element.

8. The insertion device according to claim 7, further comprising a housing, the retention means being connected to a slide element which can be gripped by hand and can be moved relative to the housing to move the retention means from the engage position to the standby position, with pretensioning of the energy-storing element.

9. The insertion device according to claim 2, wherein the overall dimensions of the device remain unchanged during the movement of the retention means from the engage position to the standby position.

10. The insertion device according to claim 2, wherein the pretensionable energy-storing element can be pretensioned repeatedly to permit repeated use of the insertion device for application of an insertion head.

11. The insertion device according to claim 2, wherein with the insertion head located in the first position, the energy-storing element can be made ready in the pretensioned state, and the insertion movement can then be triggered by actuation of at least one actuation member, with increasing relaxation of the energy-storing element.

12. The insertion device according to claim 11, wherein the drive means comprises a thrust element for transmitting the drive energy to the insertion head to be applied and, 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 can be pretensioned and made ready in the pretensioned state.

13. The insertion device according to claim 12, 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.

14. The insertion device according to claim 13, wherein the first actuation member is a slide-shaped or button-shaped element which forms all the contact faces.

15. The insertion device according to claim 13, wherein a second actuation member is a button-shaped element which can be pressed in a direction transverse to the direction in which the insertion device is pressed onto the body of the patient.

16. The insertion device according to claim 15, 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.

17. The insertion device according to claim 16, wherein the actuation member or the actuation members can be actuated with one hand to permit one-handed triggering of the insertion movement.

18. The insertion device according to claim 17, wherein when an actuating force ceases the actuation members automatically go back to an unactuated state.

19. The insertion device according to claim 2, wherein the energy-storing element is one of a helical spring, leg spring or leaf spring made of metal or plastic, a rubber spring element, or a pneumatic compression spring.

20. The insertion device according to claim 2, further comprising a displacement means for effecting a transverse displacement of a displaceable actuation member associated with the insertion head to permit automatic deployment of all the deployable infusion cannulas and puncturing tips of the insertion head during the movement of the retention means from the engage position to the standby position.

21. The insertion device according to claim 20, wherein the displacement means for effecting a displacement of a displaceable actuation member comprises a ramp surface on which the transversely displaceable actuation member can run during the movement of the retention means, with the insertion head held therein, from the engage position to the standby position and in so doing can be displaced transverse to the direction of movement of the retention means and of the insertion head.

22. The insertion device according to claim 21, wherein the displacement means for effecting a displacement of a displaceable actuation member comprises a lever mechanism.

23. An arrangement comprising an insertion device and an insertion head, the insertion device comprising a retainer by which the insertion head can be temporarily held on the device and driver comprising a pretensionable spring for providing drive energy for an insertion movement of the insertion head, wherein the insertion head is secured by the retainer by clamping when the retainer is in an engage position and can then be moved, with simultaneous pretensioning of the spring, to an insertion movement starting position, wherein the insertion head is already separated from the retainer at the start of the insertion movement, and wherein the insertion head moves through at least part of the insertion movement free of the retainer, the insertion head comprising at least one infusion cannula and/or at least one puncturing tip.

24. The arrangement according to claim 23, wherein the at least one infusion cannula and/or puncturing tip are deployable and folded inwardly in the unactuated state, in which the insertion head is intended to be received in the retainer arranged in the engage position or is already received in the retainer arranged in the engage position, and wherein the at least one deployable infusion cannula and/or puncturing tip are deployed during the movement of the retainer, with the insertion head held correctly therein, from the engage position to the standby position.

25. The arrangement according to claim 24, wherein the insertion head comprises at least one of an infusion set, port and sensor arrangement.

26. A method for applying an insertion head to the body of a patient, in particular an insertion head designed as an infusion set, port and/or sensor arrangement and having at least one infusion cannula and/or at least one puncturing tip, using an insertion device comprising:

a) 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) retention means with which the insertion head that is to be applied is temporarily held on the insertion device;

c) 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 ready for application, from a first position, in which the insertion head ready for application is held by the retention means such that all the infusion cannulas and puncturing tips of the insertion head are set back relative to the contact face, to a second position, in which all the infusion cannulas and puncturing tips of the insertion head protrude substantially completely beyond the contact face, in order to permit introduction of all 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 drive means has at least one pretensionable energy-storing element for providing the drive energy, and the retention means is able to be positioned relative to the contact face in an engage position and in a standby position and is designed such that the insertion head to be applied can be arranged on the retention means in the engage position such that it is held, and the retention means, starting from the engage position, can then be brought to the standby position with the insertion head held, and, on reaching the standby position, the retention means holds the insertion head in the first position ready for application, and wherein, at the start of the insertion movement, the insertion head is separated from the retention means, such that it can execute at least the greatest part of the insertion movement free of the retention means, and the pretensionable energy-storing element is pretensioned upon the movement of the retention means from the engage position to the standby position, said method comprising the steps of;

a) making ready the insertion device, with the retention means arranged in the engage position;

b) engaging the insertion head with the retention means such that the insertion head is held thereby;

c) moving the retention means from the engage position, with the insertion head held thereon, and with pretensioning of the pretensionable energy-storing element, to the standby position in which the insertion head is held ready for application in the first position by the retention means;

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

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

27. The method according to claim 26, wherein the insertion head is held in the first 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.

28. The method according to claim 27, wherein the insertion head in the engage position is held by the retention means purely with a form fit or with a combination of a force fit and form fit and, in particular, the form fit is cancelled during the movement of the retention means from the engage position to the standby position.

29. The method according to claim 27, wherein the insertion head in the engage position is held by the retention means purely with a force fit and, in particular, the force fit is reduced during the movement of the retention means from the engage position to the standby position.

30. The method according to claim 29, wherein the retention means is held unmoved relative to the contact face, at least during a large part of the insertion movement or during the entire insertion movement of the insertion head.

31. The method according to claim 30, wherein the retention means, with the insertion head held thereon, can be brought manually by muscle force from the engage position to the standby position by one of displacing a slide element, turning a rotary knob or pressing a push button.

32. The method according to claim 31, wherein the energy-storing element is made ready in the pretensioned state, and the insertion movement is then triggered by actuating an actuation member.

33. The method according to claim 32, wherein arranging the insertion device on the body of the patient and triggering the insertion movement is done with one hand.

34. The method according to claim 33, wherein an insertion head with 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, and all the deployable infusion cannulas and puncturing tips of the insertion head are deployed during the movement of the retention means, with the insertion head held therein, from the engage position to the standby position.