IP Library Granted Patent US 11,058,334
Granted Patent B1
US 11,058,334 · App. 17/206,013 · Granted Jul 13, 2021

Medical device inserters and processes of inserting and using medical devices

Inventors: Samuel M. Curry (Oakland, CA); Manuel L. Donnay (San Francisco, CA); Tuan Nguyen (Dublin, CA); Louis G. Pace (San Carlos, CA); Peter G. Robinson (Alamo, CA); Phillip Yee (San Francisco, CA)
Assignee: ABBOTT DIABETES CARE INC.
A61B5/150022A61B5/1411A61B5/14503A61B5/14532A61B5/14542A61B5/14546A61B5/157A61B5/1513A61B5/1519A61B5/15087A61B5/15107A61B5/15113A61B5/15117A61B5/15186A61B5/15194A61B5/150259A61B5/150282A61B5/150396A61B5/150419A61B5/150427A61B5/150511A61B5/6865A61B17/34A61M5/158A61B5/0002A61B5/01A61B5/15016A61B5/150732A61M2005/1585
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Quick Facts
Patent No.
US 11,058,334
App. No.
17/206,013
Granted
Jul 13, 2021
Kind
B1
Abstract

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Claims (55)

1. An insertion assembly for inserting a glucose sensor into a subject, the insertion assembly comprising:

the glucose sensor, wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;

a distal surface comprising an adhesive layer, wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;

an interior of the insertion assembly comprising a first spring in a loaded position, a second spring, a rotatable element, a sliding element, and a straight track having a length, wherein the sliding element is configured to move only within the straight track; and

a button configured to be pressed along a depression axis toward the interior of the insertion assembly,

wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding element to move within the straight track,

wherein movement of the sliding element within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the depression axis such that the distal end of the glucose sensor is inserted under the skin of the subject,

wherein the sliding element is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,

wherein the second spring is configured to expand and retract the sharp in the proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject,

wherein the sharp is configured to be retracted fully within the interior of the insertion assembly,

wherein the insertion assembly comprises a maximum height parallel with the insertion axis and a maximum width parallel with the length of the straight track, and wherein the maximum height is greater than the maximum width,

wherein the second spring is a compression spring, and

wherein the glucose sensor is configured to operate for a period of about seven days or more.

2. The insertion assembly of claim 1 , wherein the sharp is further configured to be inserted under the skin of the subject at an oblique angle with respect to the skin of the subject.

3. The insertion assembly of claim 1 , wherein the depression axis is perpendicular to the insertion axis.

4. The insertion assembly of claim 1 , wherein at least a part of the glucose sensor is housed within the sharp.

5. The insertion assembly of claim 1 , wherein, after the release of the first spring from the loaded position, the first spring is configured to cause the rotatable element to rotate less than a full rotation.

6. The insertion assembly of claim 5 , further comprising a stopping surface, wherein the stopping surface is configured to stop the rotation of the rotatable element.

7. The insertion assembly of claim 6 , wherein the sliding element is configured to move along a path that is different from the depression axis and the insertion axis.

8. The insertion assembly of claim 1 , wherein the glucose sensor is configured to operate for a period of about ten days.

9. The insertion assembly of claim 1 , further comprising a mount, wherein the mount is configured to be secured to the skin of the subject before the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis.

10. The insertion assembly of claim 1 , wherein the glucose sensor comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween, and wherein the glucose sensor is further configured to be coupled with on body electronics.

11. The insertion assembly of claim 10 , wherein the bendable portion of the glucose sensor is configured to bend prior to coupling of the glucose sensor with the on body electronics.

12. The insertion assembly of claim 10 , wherein the bendable portion of the glucose sensor is configured to bend during coupling of the glucose sensor with the on body electronics.

13. The insertion assembly of claim 1 , wherein the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis and the retraction of the sharp in the proximal direction along the insertion axis occur automatically after the button is pressed.

14. The insertion assembly of claim 1 , wherein an end section of the glucose sensor is configured to be in contact with interstitial fluid of the subject after the distal end of the glucose sensor is inserted under the skin of the subject.

15. The insertion assembly of claim 1 , wherein the glucose sensor comprises two or more electrodes.

16. The insertion assembly of claim 1 , further comprising a needle hub coupled with the sharp.

17. The insertion assembly of claim 1 , wherein the adhesive layer comprises an aperture.

18. The insertion assembly of claim 1 , wherein the sliding element is configured to move along a path that is different from the depression axis and the insertion axis.

19. An insertion assembly for inserting a glucose sensor into a subject, the insertion assembly comprising:

the glucose sensor, wherein the glucose sensor comprises two or more electrodes, and wherein a distal end of the glucose sensor is configured to be inserted under skin of the subject;

a distal surface comprising an adhesive layer, wherein the adhesive layer comprises an aperture, and wherein the distal surface is configured to be positioned on the skin of the subject such that the adhesive layer adheres to the skin of the subject;

an interior of the insertion assembly comprising a first spring in a loaded position, a second spring, a rotatable element, a sliding element, and a straight track having a length, wherein the sliding element is configured to move only within the straight track; and

a button configured to be pressed along a depression axis toward the interior of the insertion assembly,

wherein the button is further configured to release the first spring from the loaded position upon being pressed, such that the first spring causes the sliding element to move within the straight track,

wherein movement of the sliding element within the straight track causes advancement of a sharp and the glucose sensor in a distal direction along an insertion axis different from the depression axis such that the distal end of the glucose sensor is inserted under the skin of the subject,

wherein the sliding element is further configured to continue moving within the straight track after the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis,

wherein the second spring is configured to expand and retract the sharp in the proximal direction along the insertion axis while the distal end of the glucose sensor remains under the skin of the subject,

wherein the sharp is configured to be retracted fully within the interior of the insertion assembly,

wherein the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis and the retraction of the sharp in the proximal direction along the insertion axis occur automatically after the button is pressed,

wherein the insertion assembly comprises a maximum height parallel with the insertion axis and a maximum width parallel with the length of the straight track, and wherein the maximum height is greater than the maximum width,

wherein the second spring is a compression spring, and

wherein the glucose sensor is configured to operate for a period of about seven days or more.

20. The insertion assembly of claim 19 , wherein the glucose sensor further comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween, and wherein the glucose sensor is further configured to be coupled with on body electronics.

21. The insertion assembly of claim 20 , further comprising a needle hub coupled with the sharp and wherein at least a part of the glucose sensor is housed within the sharp.

22. The insertion assembly of claim 21 , wherein, after the release of the first spring from the loaded position, the first spring is configured to cause the rotatable element to rotate less than a full rotation.

23. The insertion assembly of claim 22 , wherein the sharp is further configured to be inserted under the skin of the subject at an oblique angle with respect to the skin of the subject.

24. The insertion assembly of claim 23 , wherein the bendable portion of the glucose sensor is configured to bend prior to coupling of the glucose sensor with the on body electronics.

25. The insertion assembly of claim 23 , wherein the bendable portion of the glucose sensor is configured to bend during coupling of the glucose sensor with the on body electronics.

26. The insertion assembly of claim 23 , further comprising a mount, wherein the mount is configured to be secured to the skin of the subject before the advancement of the sharp and the glucose sensor in the distal direction along the insertion axis.

27. The insertion assembly of claim 23 , further comprising a stopping surface, wherein the stopping surface is configured to stop the rotation of the rotatable element.

28. The insertion assembly of claim 23 , wherein the depression axis is perpendicular to the insertion axis.

29. The insertion assembly of claim 23 , wherein the sliding element is configured to move along a path that is different from the depression axis and the insertion axis.

30. The insertion assembly of claim 19 , wherein the sliding element is configured to move along a path that is different from the depression axis and the insertion axis.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2021
From: CURRY, SAMUEL M.; DONNAY, MANUEL L.; NGUYEN, TUAN; PACE, LOUIS G.; ROBINSON, PETER G.; YEE, PHILLIP
To: ABBOTT DIABETES CARE INC.
Reel/Frame 055669/0808 →
Continuity (7)
Continuation 17077445 · Oct 22, 2020
Continuation 14996751 · Jan 15, 2016
Continuation 13071487 · Mar 24, 2011
Provisional Application 61411262 · Nov 8, 2010
Provisional Application 61361374 · Jul 2, 2010
Provisional Application 61345562 · May 17, 2010
Provisional Application 61317243 · Mar 24, 2010
Cited By (2)
US 12,315,630 US 12,562,273