Medical device inserters and processes of inserting and using medical devices

• US 10,772,547 B1
• Filed: 06/19/2020
• Issued: 09/15/2020
• 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:
  US16/906,811
• Time in Patent Office: 88 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. A method of inserting a medical device into a subject, the method comprising:

positioning an insertion assembly on skin of the subject such that an adhesive layer adheres to the skin, the insertion assembly comprising a housing, a torsion spring in a loaded position, a first slidable body having a slot, a second slidable body, a needle coupled with the second slidable body, the medical device, and a rotor having a projection received within the slot; and

depressing a button of the insertion assembly,

wherein depression of the button releases the torsion spring from the loaded position such that the torsion spring causes rotation of the rotor and projection, and

wherein rotation of the rotor and projection causes advancement of the first slidable body and the second slidable body within the housing and advancement of the needle and the medical device through an aperture in the adhesive layer and into the subject, followed by expansion of a compression spring that causes retraction of the needle.

2. The method of claim 1, 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.

3. The method of claim 2, wherein the rotation of the rotor and projection advances the first slidable body and the second slidable body simultaneously.

4. The method of claim 2, wherein movement of the second slidable body away from the skin of the subject retracts the needle from the subject.

5. The method of claim 2, wherein rotation of the rotor and projection causes advancement of the first slidable body and the second slidable body towards the skin of the subject.

6. The method of claim 2, wherein the second slidable body comprises a slot, wherein the projection is received within the slot of the second slidable body.

7. The method of claim 1, wherein the medical device is a sensor.

8. The method 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.

9. The method of claim 8, wherein the first end of the torsion spring engages with the housing and the second end of the torsion spring engages with the rotor.

10. The method of claim 8, wherein the torsion spring winding is helical.

11. The method of claim 1, wherein the slot comprises a straight portion.

12. The method of claim 1, wherein the slot comprises a straight portion and a curved portion.

13. The method of claim 1, wherein the housing comprises a recess in which the rotor is received.

14. The method of claim 1, wherein a force applied by the projection against a wall of the slot causes advancement of the first slidable body.

15. The method of claim 1, wherein the slot in the first slidable body with the projection received within the slot allows the first slidable body to advance towards the skin of the subject.

16. The method of claim 1, further comprising coupling on-body electronics to the adhesive layer.

17. The method of claim 16, further comprising wirelessly communicating, by the on-body electronics, data from the medical device.

18. The method of claim 1, wherein the projection rotates in a circular path.

19. The method of claim 1, wherein the rotor has a cylindrical shape.

20. The method of claim 1, wherein the torsion spring has a center aperture that receives a second projection of the insertion assembly, further wherein the torsion spring rotates around the second projection.