Medical device inserters and processes of inserting and using medical devices

• US 9,265,453 B2
• Filed: 03/24/2011
• Issued: 02/23/2016
• 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 Mason, Donnay, Manuel Luis, Nguyen, Tuan, Pace, Louis G, Robinson, Peter G, Yee, Philip
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/071,487
• Publication Number:
  US 20110288574A1
• Time in Patent Office: 1,797 Days
• Field of Search: 606/108, 606/131, 606/185, 606181-183, 600/309, 600/319, 600/320, 600/316, 600/322, 600345-347, 600/583, 604/174
• 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 inserter, comprising:

a housing;

a sheath coupled to and partially contained within the housing, wherein a distal end of the sheath defines a distal surface for placement on a skin surface and an entire width of a proximal end of the sheath is fully contained within the housing;

an analyte sensor;

an on-body housing;

a sharp;

a sharp holder coupled with the sharp, the sharp holder having at least one groove;

a spring;

a body having a projecting spring retention member with a plurality of tabs adapted to engage the at least one groove of the sharp holder, wherein the projecting spring retention member extends through a center of the spring;

an on-body housing feature within the sheath operative to releasably retain the on-body housing, the on-body housing coupled to the analyte sensor and including a sensor control unit;

a pusher coupled to and disposed within the housing and operative to translate the on-body housing and the sharp along a longitudinal axis of the inserter from a proximal position to a distal position in response to the housing being moved toward the distal surface relative to the sheath,

wherein the inserter is operative to allow the spring to expand and remove the sharp holder and sharp from the on-body housing when the pusher reaches the distal position.

2. The inserter of claim 1, wherein the sheath recedes into the housing as the housing is moved toward the distal surface.

3. The inserter of claim 1, wherein the sharp penetrates the skin surface in response to the housing being moved toward the distal surface.

4. The inserter of claim 1, wherein the analyte 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.

5. The inserter of claim 1, wherein the sharp holder has a tapered end.

6. The inserter of claim 1, comprising a removable cap.