Insertion device for insertion heads and infusion sets

• US 8,870,822 B2
• Filed: 02/24/2009
• Issued: 10/28/2014
• Est. Priority Date: 08/24/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Thalmann, Christian, Scheurer, Simon, Wyss, Martin
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US12/391,513
• Publication Number:
  US 20090216215A1
• Time in Patent Office: 2,072 Days
• Field of Search: 604/136, 604/137, 60416411-16412, 604/156, 604/157, 604/164.01, 604/164.02, 604/164.04, 60416406-1641, 604/171
• US Class Current: 604/137
• 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 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

An insertion device for applying an infusion set to the body of a patient, wherein the device has two actuation members which have to be actuated simultaneously to trigger an insertion movement by which a cannula of the infusion set is introduced into the body and wherein, in some embodiments, one of the actuation members is a securing slide including a contact face to be placed on the body of the patient, the securing slide being actuated by the insertion device being pressed, via the contact face, against the body of the patient.

Claims

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

a housing;

at least one contact face for placing on an application site on the body of the patient for application of the insertion head;

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

a drive mechanism configured to supply a drive force for effecting an insertion movement of the insertion head relative to the contact face from a first position in which the insertion head is held by the retention means such that the infusion cannula or the puncturing tip is set back relative to the contact face to a second position in which the infusion cannula or the puncturing tip protrudes beyond the contact face to permit introduction of the infusion cannula or of the 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;

a first actuation member slidably coupled to the housing, wherein the contact face forms a distal end of the first actuation member; and

a second actuation member;

wherein the first and second actuation members have to be actuated sequentially to trigger the insertion movement, wherein the first actuation member has at least one opening adjacent an end opposite the distal end, and the second actuation member can only be actuated while the first actuation member is actuated by the contact face being pressed against the body of the patient such that it is slid relative to the housing so as to bring the at least one opening into alignment with the second actuation member and permit the second actuation member to move radially inward through the opening to be actuated.

2. The insertion device according to claim 1, wherein, when the pressing actuating force ceases, the actuation members automatically go back to an unactuated state.

3. The insertion device according to claim 1, wherein the first actuation member is one of a slide-shaped or button-shaped element, which comprises the contact face.

4. The insertion device according to claim 3, wherein the second actuation member is a button-shaped element which, when a user presses it with a finger tip is actuated transversely to the direction in which the insertion device is pressed onto the body of the patient.

5. The insertion device according to claim 1, wherein the actuation members are actuable with one hand to permit one-handed triggering of the insertion movement.

6. The insertion device according to claim 1, wherein the drive mechanism comprises at least one energy-storing element for providing the drive energy for the insertion movement.

7. The insertion device according to claim 6, wherein the at least one energy storing element is selected from a group consisting of a helical spring, leg spring or leaf spring made of metal or rubber.

8. The insertion device according to claim 6, wherein the at least one energy-storing element can be tensioned repeatedly by a user.

9. The insertion device according to claim 8, wherein the drive mechanism comprises a thrust element for transmitting the drive energy to the insertion head and wherein by displacing the thrust element counter to the direction of the insertion movement and subsequently locking it with locking means that can be released by the actuation members the energy-storing element is tensioned.

10. The insertion device according to claim 9, wherein the insertion the thrust element is connected to a grip part which can be grasped by hand and which is movable relative to the housing for tensioning the energy-storing element.

11. The arrangement according to claim 1, wherein the insertion device is configured such that the second actuation member is blocked from performing an actuating movement until the first actuation element is slid relative to the housing in a direction counter to the insertion movement.

12. An arrangement comprising an insertion device and an insertion head receiveable in said insertion device, the insertion device comprising:

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

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

c) a drive for automatically effecting an insertion movement of the insertion head relative to the contact face from a first position in which the insertion head is held by the retainer such that an infusion cannula or a puncturing tip is set back relative to the contact face to a second position in which the infusion cannula or the puncturing tip protrudes beyond the contact face to permit introduction of the infusion cannula or of the 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; and

d) at least two actuation members which have to be actuated sequentially to trigger the insertion movement, wherein a first of the actuation members is actuated by the contact face being pressed onto the body of the patient and a second of the actuation members is actuated by a movement that is independent of said pressing onto the body of the patient, and wherein the first of the actuation members has at least one opening adjacent an end opposite the contact face, and the second of the actuation members can only be actuated while the first of the actuation members is actuated by the contact face being pressed against the body of the patient so as to bring the at least one opening into alignment with the second of the actuation members and permit the second of the actuation members to move radially inward through the opening to be actuated.

13. The arrangement according to claim 12, wherein the second actuation member is actuated by the user applying a force to the second actuation member with a finger tip in a direction substantially transverse to the direction in which the insertion device is pressed onto the body of the patient.

14. The arrangement according to claim 12, wherein the drive comprises an energy-storing element.

15. An insertion device for applying an infusion set to the body of a patient, the device comprising two actuation members which have to be actuated sequentially to trigger an insertion movement of the infusion set, wherein a first one of the actuation members is a securing slide including a contact face to be placed on the body of the patient, the securing slide being actuated by the insertion device being pressed, via the contact face, against the body of the patient, and wherein the first of the actuation members has at least one opening adjacent an end opposite the contact face, and a second one of the actuation members can only be actuated while the first one of the actuation members is actuated by the contact face being pressed against the body of the patient so as to bring the at least one opening into alignment with the second of the actuation members and permit the second of the actuation members to move radially inward through the opening to be actuated.

16. A method for applying an insertion head to the body of a patient using an insertion device, wherein the insertion head is one of an infusion set, port or sensor arrangement and the insertion device comprises at least one contact face for placing the insertion device on an application site on the body of the patient for application of the insertion head, a retainer with which the insertion head that is to be applied is temporarily held on the insertion device, a drive for effecting an insertion movement of the insertion head relative to the contact face from a first position in which the insertion head is held by the retainer such that an infusion cannula or a puncturing tip is set back relative to the contact face to a second position in which the infusion cannula or the puncturing tip protrudes beyond the contact face to permit introduction of the infusion cannula or of the 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;

and at least two actuation members which have to be actuated sequentially to trigger the insertion movement, wherein a first of the actuation members is designed such that it can be actuated by the contact face being pressed onto the body of the patient, wherein the first of the actuation members has at least one opening adjacent an end opposite the contact face, and the second of the actuation members can only be actuated while the first of the actuation members is actuated by the contact face being pressed against the body of the patient so as to bring the at least one opening into alignment with the second of the actuation members and permit the second of the actuation members to move radially inward through the opening to be actuated, the method comprising the following steps;

a) placing an insertion head with an infusion cannula or a puncturing tip into the retainer in the first position;

b) arranging and pressing the insertion device via the contact face onto the desired application site on the body of the patient such that the infusion cannula or the puncturing tip of the insertion head can penetrate into the body during the insertion movement and actuating the first actuation member; and

c) while pressing the contact face against the body of the patient sufficiently to slide the contact face relative to the housing such to bring the at least one opening into alignment with the second of the actuation members to permit the second of the actuation members to move radially inward through the opening to be actuated, and actuating the second and, if present, any further actuation members for triggering the insertion movement.

17. The method according to claim 16, wherein the arranging and pressing of the insertion device and the actuating of the second and, if present, also any further actuation members is done with one hand.

18. The method according to claim 17, wherein the insertion device is pressed onto the desired application site in the direction of the insertion movement.

19. The method according to claim 18, wherein the second and, if present, any further actuation members are each actuated by the user pressing with a finger tip in a direction transverse to the direction in which the insertion device is pressed onto the body of the patient.