Medical device inserters and processes of inserting and using medical devices

• US 10,959,654 B2
• Filed: 10/22/2020
• Issued: 03/30/2021
• 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:
  US17/077,445
• Publication Number:
  US 20210038137A1
• Time in Patent Office: 159 Days
• Field of Search: 606181-183, 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. 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 including 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 including a first spring in a loaded position, a second spring, a sliding member, an actuator, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and

a button configured to be pressed along a first 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 member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,

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

wherein the sliding member is further configured to apply a force on the actuator in a proximal direction along the insertion axis after the sharp and the glucose sensor have been advanced 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 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 second axis is perpendicular to the insertion axis.

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

4. The insertion assembly of claim 1, wherein the second axis is perpendicular to the first axis and the insertion axis.

5. The insertion assembly of claim 1, wherein the first axis is perpendicular to the insertion axis.

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

7. 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 a rotatable member to rotate less than a full rotation.

8. The insertion assembly of claim 7, further comprising a stopping surface, wherein the stopping surface is configured to stop the rotation of the rotatable member.

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

10. 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 advancement of the sharp and the glucose sensor in the distal direction along the insertion axis.

11. 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.

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

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

14. The insertion assembly of claim 11, wherein the proximal retention portion of the glucose sensor is configured to be substantially perpendicular to the distal insertion portion of the glucose sensor after coupling of the glucose sensor with the on body electronics.

15. 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.

16. 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.

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

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

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

20. 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 including 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 including a first spring in a loaded position, a second spring, a sliding member, an actuator, and a straight track having a length, wherein the sliding member is configured to move only within the straight track; and

a button configured to be pressed along a first 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 member to move within the straight track along a second axis different from the first axis, wherein the second axis is defined by the length of the straight track,

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

wherein the sliding member is further configured to apply a force on the actuator in a proximal direction along the insertion axis after the sharp and the glucose sensor have been advanced in the distal direction along an insertion axis,

wherein, after the sharp and the glucose sensor have been advanced in the distal direction along the insertion axis, 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 second axis is perpendicular to the insertion axis,

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.

21. The insertion assembly of claim 20, 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.

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

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

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 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 member.

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