MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

• US 20110319729A1
• Filed: 03/24/2011
• Published: 12/29/2011
• 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.
• Granted Patent: US 9,215,992 B2
• 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 apparatus for inserting a medical device into the skin of a subject, which comprises:

a sheath defining a distal surface for placement on the skin of the subject;

a device support movable between a proximal and distal position, and adapted to support the medical device, the device support comprising a first engagement member for releasably coupling the device support to the sharp support and a second engagement member for engaging the medical device;

a sharp support movable between a proximal and a distal position and adapted to support a sharp for inserting the medical device into the skin of the subject and extending through a portion of said 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 into the skin of the subject; and

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

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

3. The apparatus of claim 1, wherein the second engagement member comprises one or more movable arms for engaging the device.

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

5. The apparatus of claim 4, wherein the one or more movable arms are maintained in engagement with the medical device when the device support is in the proximal position.

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

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

8. The apparatus of claim 7, wherein the engagement member is maintained in engagement with the sharp support by a portion of the sheath.

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

10. The apparatus of claim 1, wherein the handle comprises a button disposed within an outer housing.

11. The apparatus of claim 10, wherein the handle is flush with the top of the outer housing in an initial configuration when the medical device is supported in the device support, and the handle protrudes above the outer housing when the medical device is released from the device support.

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

13. A method for using a medical device comprising:

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

disposing the distal surface of the sheath on the skin of the subject; and

displacing the handle in a first longitudinal direction;

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

inserting the sharp into the skin of the subject;

delivering the medical device to the subject;

releasing the driver; and

displacing the sharp in the second longitudinal direction by the driver.

14. The method of claim 13, wherein the first longitudinal direction is from a proximal to distal position, and the second longitudinal direction is from a distal to proximal position.

15. The method of claim 13, wherein the sharp is displaced towards the proximal direction when the sharp support reaches the distal position.

16. The method of claim 13, wherein the handle is maintained in a distal position when the sharp support is displaced to the proximal position.

17. The method of claim 13, 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.

18. The method of claim 13, wherein delivering the medical device to the subject comprises releasing the medical device from the device support.

19. The method claim 18, wherein releasing the medical device from the device support comprises allowing on or more movable arms on the device support to displace radially outwardly.

20. A medical device insertion system comprising:

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

a device support movable between a proximal and distal position, and adapted to support the medical device, the device support including at least one feature adapted to operatively engage the sharp support;

a sharp support movable between a proximal and a distal position and adapted to support a sharp extending through a portion of said 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 into the skin of the subject,

wherein advancing the handle distally comprises applying a minimum force to overcome the at least one biased retention feature to allow distal movement of the handle relative to the detent; and

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

21. The system of claim 20, wherein one of the sharp support and the device support includes at least one retention feature.

22. The system of claim 21, wherein the retention feature is disposed on the device support.

23. The system of claim 21, wherein the sheath maintains the retention feature operatively engaged between the device support and the sharp support until advancement of the device support to the distal position.

24. The system of claim 23, wherein advancement of the device support to the distal position releases the retention feature to allow proximal movement of sharp support and sharp relative to the device support.

25. The system of claim 21, wherein the handle is maintained in a distal position when the sharp support is advanced to the proximal position.