Medical device inserters and processes of inserting and using medical devices

• US 9,215,992 B2
• Filed: 03/24/2011
• Issued: 12/22/2015
• 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: Donnay, Manuel Luis, Nguyen, Tuan, Pace, Louis G, Robinson, Peter G
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/071,461
• Publication Number:
  US 20110319729A1
• Time in Patent Office: 1,734 Days
• Field of Search: 606/131, 606/185, 606/181, 606/1, 606/182, 600/309, 600/345, 600/365, 604/318
• 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 including a sheath defining a distal surface for placement on a skin surface, a device support movable between a proximal and distal position, and adapted to support a medical device, a sharp support movable between a proximal position and a distal position and adapted to support a sharp for inserting the medical device under the skin surface and extending through a portion of the device support, a handle movable between a proximal position and a distal position relative to the sheath and adapted to urge the device support and the sharp support from a proximal to a distal position to insert the sharp under the skin surface, and a driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position.

Claims

1. An apparatus, comprising:

a medical device;

a sheath defining a distal surface for placement on a skin surface;

a device support movable between a proximal position and a distal position that is closer to the skin surface, and adapted to support the medical device;

a sharp for inserting the medical device under the skin surface and extending through a portion of the device support;

a sharp support movable between the proximal position and the distal position that is closer to the skin surface and adapted to support the sharp;

a handle movable between a proximal position and a distal position relative to the sheath and adapted to urge the device support and the sharp support from the proximal position to the distal position to insert the sharp under the skin surface; and

a driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position;

wherein the device support includes a first engagement member for releasably coupling the device support to the sharp support and a second engagement member comprising one or more movable arms for engaging the medical device;

wherein the one or more movable arms are maintained in engagement with the medical device when the device support is in its proximal position; and

wherein a force applied to the handle moves the sheath into the handle and moves the medical device from the device support'"'"'s proximal position to the device support'"'"'s distal position and inserts the sharp under the skin surface.

2. The apparatus of claim 1, wherein the handle and the sheath comprise an interlocking configuration which prevents relative movement of the handle with respect to the sheath which is overcome by the force applied to the handle.

3. The apparatus of claim 1, wherein the one or more movable arms are normally biased in a position spaced apart from the medical device.

4. The apparatus of claim 3, wherein the one or more movable arms are permitted to return to the position spaced apart from the medical device when the device support is in the distal position.

5. The apparatus of claim 1, wherein the first engagement member is released from the sharp support when the device support reaches the distal position.

6. The apparatus of claim 5, wherein the first engagement member is maintained in engagement with the sharp support by a portion of the sheath.

7. The apparatus of claim 1, further comprising a stop to maintain the device support in the proximal position such that it protects a user from accessing the sharp.

8. The apparatus of claim 1, wherein the medical device is an analyte sensor comprising 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.

9. A method of using an apparatus, the method comprising:

holding an apparatus comprising a medical device, a sheath defining a distal surface, a device support comprising one or more arms adapted to support the medical device, a sharp extending through a portion of the device support, a sharp support adapted to support the sharp, a handle movable relative to the sheath, and a driver for displacing the sharp support;

disposing the distal surface of the sheath on a skin surface with the one or more arms of the device support maintained in a first position in engagement with the medical device;

displacing the handle in a first longitudinal direction such that the sheath moves into the handle;

displacing the sharp support in the first longitudinal direction, the sharp support displacing the sharp and the medical device;

inserting the sharp and the medical device under the skin surface;

releasing the driver; and

displacing the sharp in a second longitudinal direction by the driver;

wherein displacing the handle in the first longitudinal direction displaces the device support in the first longitudinal direction and inserts the sharp and the medical device under the skin surface.

10. The method of claim 9, wherein the first longitudinal direction is from a proximal position to a distal position, and the second longitudinal direction is from the distal position to the proximal position.

11. The method of claim 10, wherein the sharp is displaced towards the proximal position when the sharp support reaches the distal position.

12. The method of claim 11, wherein the handle is maintained in a distal position when the sharp support is displaced to the proximal position.

13. The method of claim 9, wherein displacing the handle in the first longitudinal direction comprises overcoming an interlocking configuration between the handle and the sheath by applying a predetermined force.

14. The method of claim 9, wherein inserting the medical device under the skin surface comprises releasing the medical device from the device support.

15. The method of claim 14, wherein releasing the medical device from the device support comprises allowing the one or more arms on the device support to displace radially outwardly.

16. The method of claim 9, wherein the medical device includes an analyte sensor comprising 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.

17. A system, comprising:

a medical device;

a sheath defining a distal surface for placement on a skin surface, the sheath having at least one biased retention feature;

a device support movable between a proximal position and a distal position, and comprising one or more movable arms adapted to support the medical device, wherein the one or more movable arms are maintained in engagement with the medical device when the device support is in its proximal position;

a sharp extending through a portion of the device support;

a sharp support movable between a proximal position and a distal position and adapted to support the sharp;

a handle movable between a proximal position and a distal position relative to the sheath and adapted to urge the device support and the sharp support from the proximal position to the distal position to insert the sharp under the skin surface, wherein advancing the handle from the proximal position to the distal position comprises applying a minimum force to overcome the at least one biased retention feature to allow distal movement of the handle relative to the sheath; and

a driver for advancing the sharp support towards the proximal position when the sharp support reaches the distal position;

wherein the device support includes at least one feature adapted to operatively engage the sharp support; and

further

wherein the minimum force applied to the handle moves the sheath into the handle and moves the medical device from the device support'"'"'s proximal position to the device support'"'"'s distal position and inserts the sharp under the skin surface.

18. The system of claim 17, wherein one of the sharp support and the device support includes at least one retention feature.

19. The system of claim 18, wherein the retention feature is disposed on the device support.

20. The system of claim 18, wherein the sheath maintains the retention feature operatively engaged between the device support and the sharp support until the device support is advanced to the distal position.

21. The system of claim 20, wherein advancement of the device support to the distal position releases the retention feature to allow proximal movement of the sharp support and the sharp relative to the device support.

22. The system of claim 18, wherein the handle is maintained in the distal position when the sharp support is advanced to the proximal position.

23. The system of claim 17, wherein the medical device includes an analyte sensor comprising 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.