Insertion device and method for inserting a subcutaneously insertable element into body

• US 8,696,570 B2
• Filed: 11/26/2007
• Issued: 04/15/2014
• Est. Priority Date: 11/28/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel J., Neta, Avraham, Kaidar, Ruthy
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US11/989,684
• Publication Number:
  US 20100217105A1
• Time in Patent Office: 2,332 Days
• Field of Search: 600/309, 600/369, 600/365, 600/316, 600/345, 600/347, 604/48, 604/164.01, 604/187
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/004 Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• 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 a fluid delivery device for delivering a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte is disclosed. The insertion device includes a housing and accommodated therein at least one penetrating cartridge provided with a penetrating member and with a subcutaneously insertable element; The insertion device is provided with a displacement mechanism which upon actuation is capable of protracting the penetrating cartridge towards the said device for delivery and/or sensing, wherein said protracting results in inserting of the penetrating cartridge into subcutaneous compartment of the body via an opening provided at the said device for delivery and/or sensing and said insertion device allows evacuation of the penetrating member from the subcutaneous compartment via the said opening.

Claims

1. An insertion device for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte, the insertion device comprising:

a housing having accommodated therein;

at least one penetrating cartridge provided with a penetrating member and a subcutaneously insertable element;

a displacement mechanism which upon actuation is capable of protracting said penetrating cartridge towards the device for delivery and/or sensing and inserting the subcutaneously insertable element into a subcutaneous compartment of the body, the displacement mechanism being movable from a first position in which the displacement mechanism is prevented from actuation to a second position in which the displacement mechanism can be actuated; and

a safety means for allowing the displacement mechanism to move from the first position to the second position for actuation only when the insertion device has been placed in an appropriate position on the device for delivery and/or sensing;

wherein said insertion device is suitable for inserting the subcutaneously insertable element into the subcutaneous compartment of the body via an opening provided in the device for delivery and/or sensing and said insertion device allows evacuation of the penetrating member from the subcutaneous compartment via the opening.

2. The insertion device as defined in claim 1, wherein the device for delivery and/or for sensing is skin adherable;

and said opening is configured as a well.

3. The insertion device as defined in claim 2, wherein said subcutaneously insertable element is a cannula for delivery of the therapeutic fluid.

4. The insertion device as defined in claim 3, wherein the delivery and/or sensing device is fitted with a reservoir for storing the therapeutic fluid and said well provides fluid communication between the cannula and the reservoir.

5. The insertion device as defined in claim 2, wherein said subcutaneously insertable element is a sensor for sensing the bodily analyte.

6. The insertion device as defined in claim 2, wherein said well is pivotable.

7. The insertion device as defined in claim 2, wherein said housing is provided with at least one protrusion;

and said device for delivery and/or for sensing is provided with at least one corresponding depression surrounding the well, such that upon insertion of the at least one protrusion into the at least one depression, the penetrating cartridge can be aligned with the well and disable the safety means to allow actuation of the displacement mechanism.

8. The insertion device as defined in claim 2, wherein said penetrating cartridge further comprises a sealing cap, which is receivable in the well upon inserting the penetrating cartridge;

and said cap is adapted to seal the well after the penetrating cartridge has been inserted and after the said penetrating member has been evacuated.

9. A method for inserting a subcutaneously insertable element within a subcutaneous compartment of a body of a patient using an insertion device according to claim 8, the method comprising the steps of:

inserting the penetrating member and the subcutaneously insertable element into the subcutaneous compartment via the well; and

removing the penetrating member from the subcutaneous compartment while retaining the subcutaneously insertable element in the subcutaneous compartment and while sealing an upper opening of the well.

10. The insertion device as defined in claim 1, wherein said displacement mechanism is manually actuatable.

11. The insertion device as defined in claim 10, further comprising a manually actuatable knob for actuation of the displacement mechanism;

wherein the safety means is configured to prevent inadvertent actuation of the knob.

12. The insertion device of claim 11, wherein the safety means includes a safety rod configured to move from a first position in which the knob is locked to a second position to allow actuation of the knob thereby allowing actuation of the displacement mechanism.

13. The insertion device as defined in claim 1, further comprising a retracting means operatively coupled with the penetrating cartridge and capable of automatically retracting the penetrating member from the subcutaneous compartment, while enabling the subcutaneously insertable element to retain within the subcutaneous compartment.

14. The insertion device as defined in claim 13, wherein the penetrating member includes an insertion end for penetrating the subcutaneous tissue;

and a grip portion located opposite the insertion end;

wherein the grip portion enables the penetrating member to be protracted and retracted.

15. The insertion device as defined in claim 13, wherein the penetrating member is a needle.

16. The insertion device as defined in claim 13, wherein said displacement mechanism is fitted with a coiled spring for protracting the penetrating cartridge;

and said retracting means further comprises a coiled spring for retracting the penetrating member.

17. The insertion device as defined in claim 13, wherein said displacement mechanism further comprises a crank actuatable by a cock-wheel.

18. The insertion device as defined in claim 17, further comprising a misfiring safety mechanism.

19. The insertion device as defined in claim 1, wherein said safety means includes a safety rod which enables protracting of the penetrating cartridge only when the penetrating cartridge is aligned with the well.

20. The insertion device of claim 19, wherein the safety rod is configured to move from a first position in which the displacement mechanism is locked to a second position to allow actuation of the displacement mechanism when the penetrating cartridge is aligned with the well.

21. The insertion device as defined in claim 1, wherein the therapeutic fluid is insulin.

22. The insertion device as defined in claim 1, wherein the bodily analyte is glucose.

23. The insertion device as defined in claim 1, wherein the insertion device is reusable.

24. The insertion device as defined in claim 1, wherein the insertion device is disposable.

25. The insertion device as defined in claim 1, further comprising a drum which is preloadable with a plurality of penetrating cartridges;

said drum is provided with a plurality of chambers for receiving the plurality of penetrating cartridges and said drum is displaceable with respect to the housing so as to align a chamber with a longitudinal axis of the insertion device and to enable protracting of the penetrating cartridge received in the chamber.

26. The insertion device of claim 1, wherein the insertion device is pivotable with the opening of the device for delivery and/or sensing to insert the subcutaneously insertable element into the body at a penetrating angle.

27. The insertion device according to claim 1, wherein the displacement mechanism comprises a trigger knob rotatable to move from the first position to the second position.

28. A method for delivering a therapeutic fluid to a subcutaneous compartment in a body of a patient and/or for sensing of a bodily analyte, said method comprising the steps of:

providing a device for delivery of the therapeutic fluid and/or for sensing the bodily analyte;

providing an insertion device comprising;

at least one penetrating cartridge having a penetrating member and a subcutaneously insertable element;

said insertion device further comprising a displacement mechanism and a safety means for allowing the displacement mechanism to actuate only when the insertion device has been placed in an appropriate position on the device and the displacement mechanism has been moved from a first position in which the displacement mechanism is prevented from actuation to a second position in which the displacement mechanism can be actuated;

placing the insertion device on the device for delivery and/or sensing in the appropriate position to disable the safety means;

after the insertion device has been placed on the device for delivery and/or sensing in the appropriate position, moving the displacement mechanism of the insertion device from the first position to the second position;

actuating the displacement mechanism at the second position thereby protracting the penetrating cartridge by the displacement mechanism towards the body of the patient so as to insert the subcutaneously insertable element into the subcutaneous compartment via an opening provided at the device for delivery and/or for sensing;

removing the penetrating member from the subcutaneous compartment while allowing the subcutaneously insertable element to remain in the subcutaneous compartment; and

delivering the therapeutic fluid to the subcutaneous compartment through the subcutaneously insertable element and/or sensing the bodily analyte.

29. The method according to claim 28, wherein the protracting step is performed automatically.

30. The method according to claim 28, wherein the removing step is performed manually.

31. The method according to claim 28, wherein the removing step is performed automatically.

32. The method according to claim 28, wherein said therapeutic fluid is insulin and said subcutaneously insertable element is a cannula.

33. The method according to claim 28, wherein said bodily analyte is glucose and said subcutaneously insertable element is a sensor.

34. The method of claim 28, further comprising pivoting the insertion device with the opening of the device for delivery and/or sensing at an angle with respect to the body of the patient.

35. The method according to claim 28, wherein the moving the displacement mechanism of the insertion device comprises rotating a trigger knob of the displacement mechanism from the first position to the second position.