Medical device inserters and processes of inserting and using medical devices

• US 9,186,098 B2
• Filed: 03/24/2011
• Issued: 11/17/2015
• 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, Pace, Louis G, Yee, Philip
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/071,497
• Publication Number:
  US 20120010642A1
• Time in Patent Office: 1,699 Days
• Field of Search: 600/309, 600/341, 600/583, 604/57, 604/59, 606181-183
• US Class Current: 1/1
• 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 apparatus, comprising:

a housing;

a handle coupled to and at least partially surrounding the housing;

a medical device including a sensor moveably and releasably held within the housing, the medical device moveable between a retracted position and a distal position; and

a sharp releasably coupled to the medical device and supporting the sensor;

wherein a force applied to the handle moves the housing into the handle and the medical device from the retracted position to the distal position;

wherein the sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

2. The apparatus of claim 1, further comprising a carrier for moveably holding the sharp in the housing wherein the carrier remains holding the sharp while the medical device moves from the retracted position to the distal position.

3. The apparatus of claim 1, wherein the medical device includes an on-body housing including a sensor control unit, and wherein the sensor is coupled to the sensor control unit.

4. The apparatus of claim 3, wherein the sharp is positioned through the sensor control unit prior to the force being applied to the handle to move the housing into the handle and the sharp from the retracted position to the partially exposed position.

5. The apparatus of claim 4, wherein the sensor control unit includes sensor electronics and the sharp is positioned through the sensor electronics.

6. The apparatus of claim 1, wherein the housing is configured to recede into the handle when the force is applied to the handle.

7. The apparatus of claim 1, wherein the sharp is configured to penetrate a skin surface when the force is applied to the handle.

8. The apparatus of claim 1, wherein a distal end of the housing is configured for placement on a skin surface and an entire width of a proximal end of the housing is fully contained within the handle.

9. An apparatus, comprising:

a housing;

a handle coupled to and at least partially surrounding the housing;

a sharp moveable within the housing from a retracted position to a partially exposed position;

an electrochemical sensor releasable coupled to the sharp for movement with the sharp and for insertion under a skin surface; and

a carrier for moveably supporting the sharp within the housing;

wherein a force applied to the handle moves the housing into the handle and the sharp from the refracted position to the partially exposed position;

wherein the electrochemical sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

10. The apparatus of claim 9, wherein the housing comprises a distal opening for release of the electrochemical sensor therefrom.

11. The apparatus of claim 9, wherein the housing contains a desiccant.

12. The apparatus of claim 9, wherein the housing defines one or more longitudinal ridges for aligning one of the sharp and the sensor.

13. The apparatus of claim 9, further comprising a medical device including an on-body housing including a sensor control unit, wherein the sensor is coupled to the sensor control unit.

14. The apparatus of claim 13, wherein the sharp is positioned through the sensor control unit prior to the force being applied to the handle to move the housing into the handle and the sharp from the retracted position to the partially exposed position.

15. The apparatus of claim 14, wherein the sensor control unit includes sensor electronics and the sharp is positioned through the sensor electronics.

16. The apparatus of claim 9, wherein the housing is configured to recede into the handle when the force is applied to the handle.

17. The apparatus of claim 9, wherein the sharp is configured to penetrate the skin surface when the force is applied to the handle.

18. The apparatus of claim 9, wherein a distal end of the housing is configured for placement on the skin surface and an entire width of a proximal end of the housing is fully contained within the handle.