Medical device inserters and processes of inserting and using medical devices

• US 10,945,649 B2
• Filed: 08/31/2020
• Issued: 03/16/2021
• Est. Priority Date: 03/24/2010
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lee, Daniel H., Love, Michael R., Pace, Louis G., Yee, Phillip
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US17/008,630
• Publication Number:
  US 20200397358A1
• Time in Patent Office: 197 Days
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00384 Actuation of one tool by pushing two buttons simultaneously
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150732 : Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6865 : Access ports
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• 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

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

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

an inserter housing;

the glucose sensor disposed within the inserter housing, wherein a part of the glucose sensor is configured to be inserted under a skin surface of the subject;

a rotor disposed within the inserter housing, the rotor comprising a rotor follower projection;

a torsion spring received within the rotor, wherein the torsion spring is configured to cause rotation of the rotor and the rotor follower projection;

a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a linear direction towards an insertion site on the skin surface of the subject;

the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; and

a compression spring configured to expand and to retract the second slidable body and the needle in a linear direction away from the insertion site while the glucose sensor remains at the insertion site.

2. The inserter assembly of claim 1, wherein the rotation of the rotor and the rotor follower projection causes the first slidable body and the second slidable body to advance simultaneously.

3. The inserter assembly of claim 1, wherein at least a portion of the glucose sensor is disposed within the needle during advancement of the first slidable body in the linear direction towards the insertion site.

4. The inserter assembly of claim 1, wherein the torsion spring comprises a winding, a first end extending from the winding, and a second end extending from the winding.

5. The inserter assembly of claim 4, wherein the first end of the torsion spring engages with the inserter housing and the second end of the torsion spring engages with the rotor.

6. The inserter assembly of claim 1, wherein the slot comprises a straight portion.

7. The inserter assembly of claim 1, wherein the housing comprises a recess in which the rotor is received.

8. The inserter assembly of claim 1, wherein a force applied by the rotor follower projection against a wall of the slot advances the first slidable body.

9. The inserter assembly of claim 1, wherein the slot in the first slidable body with the rotor follower projection received within the slot allows the first slidable body to advance towards the skin surface of the subject.

10. The inserter assembly of claim 1, wherein the rotor follower projection is configured to rotate in a circular path.

11. The inserter assembly of claim 1, wherein the rotor comprises a cylindrical shape.

12. The inserter assembly of claim 1, wherein the torsion spring comprises a center aperture that receives a second projection of the inserter assembly, wherein the torsion spring is configured to rotate around the second projection.

13. The inserter assembly of claim 1, further comprising a button configured to release the torsion spring when the button is depressed.

14. The inserter assembly of claim 1, wherein the glucose sensor comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween.

15. The inserter assembly of claim 14, wherein the bendable portion of the glucose sensor is configured to bend prior to coupling of on body electronics to the glucose sensor.

16. The inserter assembly of claim 14, wherein the bendable portion of the glucose sensor is configured to bend during coupling of on body electronics to the glucose sensor.

17. The inserter assembly of claim 1, wherein the torsion spring is provided in a pre-loaded state.

18. An inserter assembly for inserting a glucose sensor into a subject, the inserter assembly comprising:

an inserter housing comprising a recess;

the glucose sensor disposed within the inserter housing, wherein a part of the glucose sensor is configured to be inserted under a skin surface of the subject;

a rotor comprising a cylindrical shape, wherein the rotor is disposed within the recess of the inserter housing, and wherein the rotor comprises a rotor follower projection;

a torsion spring received within the rotor, wherein the torsion spring is configured to cause rotation of the rotor and the rotor follower projection, wherein the torsion spring comprises a center aperture configured to receive a second projection of the inserter assembly, and wherein the torsion spring is configured to rotate around the second projection;

a first slidable body disposed within the inserter housing, the first slidable body comprising a slot, wherein the rotor follower projection is received within the slot, and wherein the rotation of the rotor and the rotor follower projection causes the first slidable body, a second slidable body, and the glucose sensor to advance within the inserter housing in a linear direction towards an insertion site on the skin surface of the subject;

a button configured to release the torsion spring when the button is depressed;

the second slidable body disposed within the inserter housing, wherein the second slidable body is coupled with a needle; and

a compression spring configured to expand and to retract the second slidable body and the needle in a linear direction away from the insertion site while the glucose sensor remains at the insertion site, wherein a first end of the compression spring is in contact with the first slidable body and a second end of the compression spring is in contact with the second slidable body, and

wherein the rotation of the rotor and the rotor follower projection causes the first slidable body and the second slidable body to advance simultaneously towards the insertion site.

19. The inserter assembly of claim 18, wherein the torsion spring comprises a winding, a first end extending from the winding, and a second end extending from the winding, and wherein the first end of the torsion spring engages with the inserter housing and the second end of the torsion spring engages with the rotor.

20. The inserter assembly of claim 18, wherein the slot comprises a straight portion.

21. The inserter assembly of claim 18, wherein a force applied by the rotor follower projection against a wall of the slot advances the first slidable body.

22. The inserter assembly of claim 18, wherein the slot in the first slidable body with the rotor follower projection received within the slot allows the first slidable body to advance towards the skin surface of the subject.

23. The inserter assembly of claim 18, wherein the rotor follower projection is configured to rotate in a circular path.

24. The inserter assembly of claim 18, wherein the glucose sensor comprises a proximal retention portion, a distal insertion portion, and a bendable portion located therebetween.

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

26. The inserter assembly of claim 24, wherein the bendable portion of the glucose sensor is configured to bend during coupling of on body electronics to the glucose sensor.

27. The inserter assembly of claim 18, wherein at least a portion of the glucose sensor is disposed within the needle during advancement of the first slidable body in the linear direction towards the insertion site.

28. The inserter assembly of claim 18, wherein the torsion spring is provided in a pre-loaded state.