Disposable inserter for use with a medical device

• US 9,333,296 B2
• Filed: 12/08/2014
• Issued: 05/10/2016
• Est. Priority Date: 06/09/2012
• Status: Active Grant

• Current Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Arnold, Ofer, Gescheit, Illai J, Neta, Avraham
• Primary Examiner(s): Gray, Phillip
• Application Number:
  US14/562,881
• Publication Number:
  US 20150094688A1
• Time in Patent Office: 519 Days
• Field of Search: 604/506, 604/198, 604/192, 604/272, 604/180
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1416 placed on the body of the patient
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 5/1415 Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

An inserter and methods of using embodiments of the inserter are described. The inserter includes a housing having a cannula assembly and an insertion mechanism. Two buttons are located on the inserter and are concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well that is disposed on the cradle. The inserter also includes a first parts and second part, whereby the first part includes a handle and the second part comprises the entire insertion mechanism, whereby the first and second part are connected via an indentation.

Claims

1. A disposable inserter configured to be received by a skin adherable cradle for supporting an insulin pump, the disposable inserter comprising:

a housing comprising a cannula assembly and an insertion mechanism;

two buttons concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well disposed on the skin adherable cradle; and

an inserter base having a first part and second part, whereby the first part includes a handle and the second part comprises the insertion mechanism, whereby the first and second part are connected via an indentation, and the first part and second part fold about the indentation when the handle is pulled to release the inserter base from the skin adherable cradle.

2. The disposable inserter of claim 1, wherein the insertion mechanism comprises insertion and retraction springs, the springs being maintained in the housing by two latches aligned with holes disposed in the housing.

3. The disposable inserter of claim 1, further comprising a protective ring which is put on a cylindrical portion of the insertion mechanism, the protective ring configured to cover the entire surface area of the two buttons.

4. The disposable inserter of claim 1, wherein the two buttons are designed as torsion snap fit, whereby a torsion bar is a part of the housing.

5. The disposable inserter of claim 2, wherein upon actuation of the two buttons the buttons are tilted and the insertion spring is allowed to expand and to push the insertion mechanism downwards to insert the cannula into the skin and the cannula assembly into the cradle well.

6. The disposable inserter of claim 2, wherein the springs are preloaded.

7. The disposable inserter of claim 1, comprising feedback elements indicating the status of the insertion mechanism whereby a visible green protective ring indicates the insertion mechanism is unused and a visible red slider or parts of it indicate the insertion mechanism is used.

16. The disposable inserter of claim 1, wherein the handle protrudes from the first part.

17. The disposable inserter of claim 1, wherein ends of inserter base are configured to engage snaps of the cradle.

18. The disposable inserter of claim 1, wherein the inserter base has four points of contact by which to engage the skin adherable cradle.

19. The disposable inserter of claim 1, wherein the indentation is geometrically designed to allow the inserter to release from the cradle only when the handle is pulled away from the cradle to both deflect upwards and fold the first and second parts of the inserter base.

20. The disposable inserter of claim 1, wherein the indentation is geometrically designed to allow the inserter to release from the cradle only when the handle is pulled away from the cradle to both deflect upwards and fold the first and second parts of the inserter base which releases both ends of the inserter base from snaps of the cradle.

8. A method of inserting a cannula into a body, comprising:

placing an inserter base of an inserter on a skin adherable cradle adapted to receive a micropump, the inserter comprising a cannula assembly having a cannula and the inserter base having a first part and second part, whereby the first part includes a handle and the second part comprises an insertion mechanism, whereby the first and second part are connected via an indentation;

removing a protective ring preventing unintentional pressing of buttons on the inserter, the buttons configured to trigger the insertion mechanism;

triggering the insertion mechanism by pressing concomitantly the buttons, the buttons being located on the two sides of a cylindrical portion of the inserter, the insertion mechanism inserting the cannula assembly into a well located in the cradle and further inserting the cannula of the cannula assembly into the body; and

disconnecting the inserter from the cradle after insertion of the cannula via pulling the handle and causing the first part and second part to fold about the indentation which releases the inserter base from the skin adherable cradle.

9. The method of claim 8, further comprising connecting the micropump to the cradle, the connecting step comprising pricking a septum of the cannula assembly with a connecting lumen provided with the micropump.

10. The method of claim 8, wherein inserting the cannula assembly into the well located in the cradle places a septum of the cannula assembly parallel to an upper plane of the well.

11. The method of claim 8, wherein placing the inserter base of the inserter on the skin adherable cradle further comprises engaging ends of the inserter base in snaps of the cradle.

12. The method of claim 8, wherein disconnecting the inserter from the cradle is via pulling the handle away from the cradle to both deflect upwards and fold the first and second parts of the inserter base, thereby releasing ends of the inserter base from snaps of the cradle.

13. The method of claim 8, further comprising indicating the status of the insertion mechanism via feedback elements of the inserter.

14. The method of claim 8, wherein triggering of the two buttons tilts the buttons which causes an insertion spring to expand and push the insertion mechanism downwards to insert the cannula into the body and the cannula assembly into the cradle well.

15. The method of claim 8, further comprising automatically retracting a needle assembly of the insertion mechanism into the cylindrical portion of the inserter after inserting the cannula assembly into a well located in the cradle and further inserting the cannula of the cannula assembly into the body.