Medical Device Inserters and Processes of Inserting and Using Medical Devices

• US 20120190943A1
• Filed: 03/30/2012
• Published: 07/26/2012
• Est. Priority Date: 03/24/2010
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Donnay, Manuel Luis, Nguyen, Tuan, Pace, Louis G., Robinson, Peter G.
• Application Number:
  US13/436,793
• Publication Number:
  US 20120190943A1
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 apparatus subassembly, comprising:

a sleeve;

a medical device carrier located within the sleeve and including a plurality of arms, each arm including an engagement boss; and

a disc-shaped medical device for on-body application including radially spaced recesses adapted to receive the engagement bosses;

wherein the arms are configured in an unstressed configuration to position the engagement bosses in engagement with the medical device in a proximal portion of the sleeve and to position the engagement bosses spaced apart from the medical device in a distal section of the sleeve.

2. The subassembly of claim 1, wherein the sleeve includes a plurality of ramped segments to control position of the arms.

3. The subassembly of claim 1, wherein the arms are arcuate-shaped.

4. The subassembly of claim 1, having only three arms, three bosses and corresponding recesses.

5. An inserter apparatus for advancing an analyte sensor through the skin of a subject with an introducer sharp, the inserter apparatus comprising:

a handle movable between a proximal position and distal position relative to a base;

a sharp carrier for holding the introducer sharp; and

an inserter apparatus subassembly, comprising;

a sleeve;

a medical device carrier located within the sleeve and including a plurality of arms, each arm including an engagement boss; and

a disc-shaped medical device for on-body application including radially spaced recesses adapted to receive the engagement bosses, wherein the arms are configured in an unstressed configuration to position the engagement bosses in engagement with the medical device in a proximal portion of the sleeve and to position the engagement bosses spaced apart from the medical device in a distal section of the sleeve.

6. The inserter apparatus of claim 5 further comprising a compression spring held in a preloaded condition between the sharp carrier and the medical device carrier within the inserter apparatus;

wherein the inserter apparatus is adapted to release the spring from the preloaded configuration to allow withdrawal of the introducer sharp by disengaging the sharp carrier only after the sharp carrier reaches a distal-most position by movement of the handle.

7. The inserter apparatus of claim 5, wherein the sleeve includes a plurality of ramped segments to control position of the arms.

8. The inserter apparatus of claim 5, wherein the arms are arcuate-shaped.

9. The inserter apparatus of claim 5, having only three arms, three bosses and corresponding recesses.