Device for inserting an insertion member, or a soft member, into body tissue

• US 9,522,228 B2
• Filed: 12/13/2012
• Issued: 12/20/2016
• Est. Priority Date: 06/21/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Teutsch, David, Huwiler, Christoph, Michel, Philipp, Kaufmann, Heiner
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Stiles, Amber
• Application Number:
  US13/714,227
• Publication Number:
  US 20130102965A1
• Time in Patent Office: 1,468 Days
• Field of Search: 604/164.01, 604/164.04, 604/164.08, 604/164.12, 604/174, 604/192, 604/198, 604/508, 604/157
• US Class Current: 1/1
• 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

A soft cannula is inserted into tissue and affixed to skin. A cannula arrangement moves within a housing and provides the soft cannula and a guiding needle extending through the cannula to temporarily stiffen it. A drive effects an insertion movement of the cannula arrangement from a first position, where a puncturing tip is pulled back relative to a face of the housing, into a second position, where the puncturing tip protrudes beyond the face, and automatically effects a retracting movement of the guiding needle into a third position, where the puncturing tip is pulled back relative to the face. The face is formed by a base plate affixed to the housing so that when the cannula arrangement is in the second position, the face detaches from the housing. A holder element is connected to the soft cannula and couples to the base plate in the cannula arrangement'"'"'s second position.

Claims

1. A device for inserting at least one insertion member having a puncturing tip into tissue of a patient and for affixing the at least one insertion member to the patient'"'"'s skin, the device comprising:

a housing having at least one contact face for affixing the device onto the patient'"'"'s skin;

an insertion arrangement movably arranged within the housing comprising the at least one insertion member to be inserted into the tissue and a holder element fixedly connected with at least a part of the at least one insertion member which is intended to remain for a long period inside the tissue; and

a drive arranged within the housing for effecting an insertion movement of the insertion arrangement from a first position, in which the puncturing tip of the at least one insertion member is pulled back relative to the contact face, into a second position, in which the puncturing tip of the at least one insertion member protrudes beyond the contact face, so that the at least one insertion member is inserted into the tissue when the device is placed with its contact face on the patient during the insertion movement of the insertion arrangement, the insertion movement being a linear movement along an axis perpendicular to a plane formed by the at least one contact face,

wherein the contact face is formed by a base plate affixed so that, after the insertion movement has been performed, the base plate detaches from the housing and wherein the holder element of the insertion arrangement is coupled to the base plate when the insertion arrangement by the insertion movement is brought into the second position,

wherein in an initial position, the insertion arrangement is oriented substantially parallel to said plane formed by the at least one contact face and before the insertion movement can be performed is pivoted from the initial position into a first position, in which the insertion arrangement is oriented substantially perpendicular to said plane formed by the at least one contact face, by tilting a drive unit housing, the tilting being effected by a pivot formed at a drive unit housing travelling in a guide slot of a first housing element;

wherein the at least one insertion member of the insertion arrangement comprises at least one soft member for insertion into the tissue and at least one guiding member for temporarily stiffening the at least one soft member during insertion into the tissue, wherein the guiding member forms the puncturing tip for puncturing the skin when inserting the at least one insertion member into the tissue, wherein the holder element is fixedly connected with the at least one soft member and wherein, after the insertion movement of the insertion arrangement the at least one soft member is coupled to the base plate by the holder element, the at least one guiding member is coupled to the housing so that, when the housing is removed from the base plate, the at least one guiding member is retained in the housing and is removed with the housing; and

wherein the drive further effects, after the insertion movement of the insertion arrangement, a retracting movement of the at least one guiding member from the second position into a third position, in which the puncturing tip of the at least one guiding member is pulled back relative to the contact face, so that, when the at least one soft member is held in the second position by the holder element coupled to the base plate, the at least one guiding member is separated from the at least one soft member.

2. The device according to claim 1, wherein the at least one insertion member having a puncturing tip is an infusion cannula and/or sensor tip.

3. The device according to claim 1, wherein the contact face has a skin compatible glue layer for affixing to the skin.

4. The device according to claim 3, wherein the skin compatible glue layer is covered by a removable protecting layer.

5. The device according to claim 1, wherein the base plate automatically separates from the housing when the insertion arrangement is brought into the second position.

6. The device according to claim 1, wherein the device, after the insertion movement of the insertion arrangement is performed, automatically performs the retracting movement of the at least one guiding member.

7. The device according to claim 1, wherein when the at least one guiding member after the retracting movement is arranged in the housing in the third position and the housing has been removed from the at least one soft member, the at least one guiding member cannot be separated from the housing or can be separated from the housing without contacting it or the holder element fixedly connected with the at least one guiding member.

8. The device according to claim 1, wherein the at least one soft member comprises at least one soft cannula with a fluid channel and the at least one guiding member comprises at least one guiding needle extending through the fluid channel of the soft cannula for temporarily stiffening the soft cannula during introduction into the tissue.

9. The device according to claim 1, wherein the device further comprises an activator for activating the drive, wherein the activator is actuated by a user with one hand.

10. The device according to claim 9, wherein upon an activating of the activator, the insertion arrangement is automatically moved from the initial position into the first position.

11. The device according to claim 1, wherein the device is formed by an inserting device providing the housing and the drive, by an insertion head providing the insertion arrangement and by a base plate provided by the insertion head or provided separately, wherein the insertion head is received within the inserting device for being applied to the body by the inserting device and the base plate is fixed to the housing in order to be pressed with the housing against the skin, and wherein, after the application of the insertion head and its removal from the base plate, the inserting device can receive another insertion head for applying to the body.

20. The device according to claim 10, wherein when the guiding member after the retracting movement is held in the housing in the third position and the housing has been removed from the soft member, the guiding member is contained within the housing in such a manner that its puncturing tip does not protrude out of the housing.

12. A device for inserting a soft member into a body tissue of a patient, the device comprising:

a housing having at least one contact face for placing the device onto the skin of the patient;

an insertion arrangement movably arranged within the housing comprising the soft member to be inserted into the tissue and a guiding member for temporarily stiffening the soft member during introduction into the tissue, wherein the guiding member forms a puncturing tip for puncturing the skin when inserting the stiffened soft member with the guiding member into the tissue; and

a drive for effecting an insertion movement of the insertion arrangement from a first position into a second position,

wherein in the first position, the insertion arrangement is oriented substantially perpendicular to a plane formed by the at least one contact face and insertion movement is a linear movement along an axis perpendicular to the plane, and the puncturing tip is pulled back relative to the contact face in the first position and protrudes beyond the contact face in the second position, so that, when during the insertion movement the device is placed with its contact face on the body of a patient, the soft member together with the guiding member is inserted into the tissue of the body of the patient and for effecting, after the insertion movement of the insertion arrangement, a retracting movement of the guiding member from the second position into a third position, in which its puncturing tip is pulled back relative to the contact face, so that, when the soft member is held in the second position, the guiding member is separated from the soft member,

wherein, after the insertion movement of the insertion arrangement has been performed, the retraction movement of the guiding member is automatically performed, and

wherein in an initial position, the insertion arrangement is oriented substantially parallel to said plane formed by the at least one contact face and, before the insertion movement can be performed, must be pivoted from the initial position into the first position, by tilting a drive unit housing, the tilting being effected by a pivot formed at a drive unit housing traveling in a guiding slot of a first housing element.

13. The device according to claim 12, wherein the soft member is a soft cannula and the guiding member is a guiding needle extending through a fluid channel of the soft cannula for temporarily stiffening the soft cannula during introduction into the tissue, wherein the guiding needle at one end protrudes out of the soft cannula thereby forming the puncturing tip for puncturing the skin of the body of the patient when inserting the soft cannula into the tissue, and wherein the drive is designed in such a manner that when during the retracting movement of the guiding needle from the second position into a third position the soft cannula is held in the second position, the guiding needle is pulled out of the fluid channel of the soft cannula.

14. The device according to claim 12, further comprising, an activator for activating the drive and wherein the activator is configured to be actuated by the user with one hand.

15. The device according to claim 12, wherein the drive comprises separate first and second drives, the first drive effecting the insertion movement and the second drive effecting the retracting movement.

16. The device according to claim 12 further comprising an activator for activating the drive, wherein upon an actuating of the activator, the insertion arrangement is automatically moved from the initial position into the first position.

17. The device according to claim 16, wherein the insertion arrangement further comprises a base plate coupled to the soft member, which carries a layer of skin compatible glue for affixing the soft member to the skin when inserting it into the tissue.

18. The device according to claim 16, wherein the contact face of the housing carries a layer of skin compatible glue for fixing it to the skin and is formed by a base plate which in a releasable manner is fixed to the housing and wherein the insertion arrangement comprises coupling means connected with the soft member by which the soft member is coupled to the base plate when the insertion arrangement is moved into the second position.

19. The device according to claim 18, wherein the base plate is automatically separated from the housing when the insertion arrangement is brought into the second position or when the guiding member is brought into the third position so that rest of the housing together with the guiding member can be removed from the base plate.

21. The device according claim 12, wherein when the guiding member after the retracting movement is held in the housing in the third position and the housing has been removed from the soft member, the guiding member cannot be separated from the housing or can be separated from the housing without contacting the guiding member or a holder element fixedly connected with the guiding member.

22. The device according to claim 21, wherein the device is formed by an inserting device providing the housing and the drive and an insertion head, in particular an infusion set, providing the insertion arrangement, which insertion head is received within the inserting device for being applied to the body of the patient by the inserting device, and wherein after the application of the insertion head and the removal of the guiding member from the housing of the inserting device, the inserting device can receive another insertion head for applying the another insertion head to the body of a patient.

23. A method of inserting a soft member into the tissue of the body of a patient by using the device according to claim 12, comprising:

placing the device with the at least one contact face onto the skin of the body at the desired application site;

activating the drive, thereby effecting subsequently the insertion movement of the insertion arrangement and the retracting movement of the guiding member; and

separating the housing with the guiding member from the soft member which remains inserted in the tissue of the body of the patient.

24. The method according to claim 23, wherein the soft member is a soft cannula and the guiding member is a guiding needle which during the insertion movement is extending through the fluid channel of the soft cannula.