Medical device inserters and processes of inserting and using medical devices

• US 10,881,340 B2
• Filed: 01/15/2016
• Issued: 01/05/2021
• 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: Curry, Samuel M., Donnay, Manuel L., Nguyen, Tuan, Pace, Louis G., Robinson, Peter G., Yee, Phillip
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US14/996,751
• Publication Number:
  US 20160128615A1
• Time in Patent Office: 1,817 Days
• Field of Search: 606181-183, 600309, 600583
• 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. A method of inserting an analyte sensor into a subject, the method comprising:

positioning a distal surface of an insertion assembly on skin of the subject such that an adhesive layer adheres to the skin, the insertion assembly comprising a spring in a loaded position and an interior; and

pressing a button of the insertion assembly in a first lateral direction toward the interior of the insertion assembly,

wherein pressing the button releases the spring from the loaded position such that the spring moves a sliding member lengthwise along a length of a track in the insertion assembly, wherein the length of the track is oriented in a second lateral direction different from the first lateral direction,

wherein movement of the sliding member along the length of the track causes an actuator to advance in a distal longitudinal direction, wherein advancement of the actuator causes advancement of a sharp and the analyte sensor in the distal longitudinal direction,

wherein the sliding member applies a force on the actuator in a proximal longitudinal direction after the sharp and the analyte sensor have been advanced in the distal longitudinal direction, and

wherein the distal longitudinal direction and the proximal longitudinal direction are defined along an insertion axis.

2. The method of claim 1, wherein the spring is a first spring, the method further comprising retracting the sharp with a second spring of the insertion assembly.

3. The method of claim 2, wherein the length of the track is a first length of the track, and

wherein further movement of the sliding member along a second length of the track causes retraction of the sharp with the second spring, wherein the second length of the track is oriented in the second lateral direction.

4. The method of claim 3, wherein the sliding member is connected to a rotatable member such that the sliding member remains in contact with the rotatable member after the movement of the sliding member along the first and the second lengths of the track.

5. The method of claim 2, wherein the second spring is a compression spring.

6. The method of claim 1, wherein the second lateral direction is perpendicular to the insertion axis.

7. The method of claim 1, wherein the sliding member is restrained to motion along the track.

8. The method of claim 1, wherein the analyte sensor is a glucose sensor.

9. The method of claim 1, wherein at least a portion of the analyte sensor is housed within the sharp.

10. The method of claim 1, wherein the insertion assembly comprises an on-body device.

11. The method of claim 1, further comprising installing on-body electronics, without use of the insertion assembly, after the advancement of the analyte sensor into the subject.

12. The method of claim 11, further comprising wirelessly communicating, by the on-body electronics, analyte related data.

13. The method of claim 1, wherein the first lateral direction is perpendicular to the second lateral direction.

14. An insertion assembly for inserting an analyte sensor into a subject, the insertion assembly comprising:

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

an interior of the insertion assembly including a spring, a sliding member, an actuator, and a track; and

a button configured to be pressed in a first lateral direction toward the interior of the insertion assembly,

wherein the button is further configured to release the spring from a loaded position upon being pressed, such that the spring moves the sliding member lengthwise along a length of the track,

wherein the length of the track is oriented in a second lateral direction different from the first lateral direction,

wherein the sliding member is configured to move along the length of the track and cause the actuator to advance in a distal longitudinal direction, wherein advancement of the actuator causes advancement of a sharp and the analyte sensor in the distal longitudinal direction,

wherein the sliding member is further configured to apply a force on the actuator in a proximal longitudinal direction after the sharp and the analyte sensor have been advanced in the distal longitudinal direction, and

wherein the distal longitudinal direction and the proximal longitudinal direction are defined along an insertion axis.

15. The insertion assembly of claim 14, wherein the spring is a first spring, the insertion assembly further comprising a second spring configured to retract the sharp.

16. The insertion assembly of claim 15, wherein the length of the track is a first length of the track, wherein the sliding member is further configured to move along a second length of the track and cause retraction of the sharp with the second spring, and wherein the second length of the track is oriented in the second lateral direction.

17. The insertion assembly of claim 16, wherein the sliding member is connected to a rotatable member such that the slidable member remains in contact with the rotatable member after the movement of the sliding member along the first and the second lengths of the track.

18. The insertion assembly of claim 15, wherein the second spring is a compression spring.

19. The insertion assembly of claim 14, wherein the second lateral direction is perpendicular to the insertion axis.

20. The insertion assembly of claim 14, wherein the track is configured to restrain the sliding member to movement along the track.

21. The insertion assembly of claim 14, wherein the analyte sensor is a glucose sensor.

22. The insertion assembly of claim 14, wherein at least a portion of the analyte sensor is housed within the sharp.

23. The insertion assembly of claim 14, further comprising an on-body device.

24. The insertion assembly of claim 14, wherein the adhesive layer is configured to be coupled with on-body electronics.

25. The insertion assembly of claim 24, wherein the on-body electronics are configured to wirelessly communicate analyte related data.

26. The insertion assembly of claim 14, wherein the first lateral direction is perpendicular to the second lateral direction.

27. The insertion assembly of claim 23, wherein the on-body device comprises a cavity configured to hold on-body electronics.

28. The insertion assembly of claim 14, further comprising a hub coupled to the sharp.