Medical device inserters and processes of inserting and using medical devices

• US 10,010,280 B2
• Filed: 03/30/2012
• Issued: 07/03/2018
• 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: Donnay, Manuel Luis, Nguyen, Tuan, Pace, Louis G., Robinson, Peter G.
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/436,768
• Publication Number:
  US 20120197222A1
• Time in Patent Office: 2,286 Days
• Field of Search: 606181, 606182, 606185, 606131, 606 1, 604318, 600365, 600309, 600345
• 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. Embodiments include removing a substantially cylindrical cap from an inserter to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding sensor components, and fitting the sensor components into the inserter.

Claims

1. A method of assembly for an analyte monitoring system, the method comprising:

removing a substantially cylindrical cap from an inserter to expose an opening in a substantially cylindrical sleeve of the inserter;

removing a cover from a substantially cylindrical container holding a component of an on body electronics unit, the substantially cylindrical container being separate and apart from the inserter, wherein, prior to removal of the cover, the cover seals the component of the on body electronics unit in a compartment of the substantially cylindrical container; and

fitting the component of the on body electronics unit from within the substantially cylindrical container through the opening and into the substantially cylindrical sleeve of the inserter, wherein the inserter is adapted for insertion of an analyte sensor into a subject.

2. The method of claim 1, further comprising fitting together the analyte sensor and a sensor mount, wherein the component of the on body electronics unit in the substantially cylindrical container includes the sensor mount.

3. The method of claim 1, wherein the component of the on body electronics unit includes on body electronics configured to electrically couple with the analyte sensor.

4. The method of claim 1, further comprising using the inserter to insert the analyte sensor into the subject, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

5. The method of claim 4, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

6. The method of claim 5, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

7. The method of claim 1, further comprising using the inserter to insert the analyte sensor into the subject, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme crosslinked with a polymer disposed on the working electrode.

8. The method of claim 7, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

9. The method of claim 1, further comprising using the inserter, while the substantially cylindrical cap is in a detached state relative to the inserter, to pierce a skin surface of a subject.

11. The method of claim 6, wherein the component of the on body electronics unit includes on body electronics configured to electrically couple with an analyte sensor.

10. A method of assembly for an analyte monitoring system, the method comprising:

removing a substantially cylindrical cap from an inserter to expose an opening in a substantially cylindrical sleeve of the inserter;

removing a cover from a substantially cylindrical container holding a component of an on body electronics unit, the substantially cylindrical container being separate and apart from the inserter, wherein, prior to removal of the cover, the cover seals the component of the on body electronics unit in a compartment of the substantially cylindrical container;

fitting the component of the on body electronics unit from the substantially cylindrical container into the substantially cylindrical sleeve of the inserter; and

using the inserter, while the substantially cylindrical cap is in a detached state relative to the inserter, to pierce a skin surface of a subject.

12. The method of claim 10, wherein using the inserter includes positioning the analyte sensor in the subject, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

13. The method of claim 12, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

14. The method of claim 10, wherein using the inserter includes positioning the analyte sensor in the subject, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme crosslinked with a polymer disposed on the working electrode.

15. The method of claim 14, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

16. The method of claim 14, wherein the working electrode comprises a mediator crosslinked to the polymer disposed on the working electrode.