Medical Device Inserters and Processes of Inserting and Using Medical Devices

• US 20150025338A1
• Filed: 10/08/2014
• Published: 01/22/2015
• Est. Priority Date: 03/24/2010
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Lee, Daniel H., Love, Michael, Yee, Phillip, Pace, Louis George
• Application Number:
  US14/509,985
• Publication Number:
  US 20150025338A1
• 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

1-10. -10. (canceled)

11. A device for applying an on-skin sensor assembly to skin of a host, the device comprising:

a base configured to secure a housing, wherein the housing is configured to receive an electronics unit, wherein the electronics unit is configured to generate analyte information based on a signal from a sensor;

a sensor insertion mechanism configured to insert the sensor into the host; and

a trigger configured, in response to being activated, to cause the sensor insertion mechanism to insert the sensor into the host, to secure the electronics unit to the housing such that the sensor electrically contacts the electronics unit, and to cause the housing to detach from the base.

12. The device of claim 11, wherein the electronics unit is configured, in response to the trigger being activated and/or the electrical connection of the sensor to the electronics unit, to generate analyte information.

13. The device of claim 11, wherein the housing is configured such that the electronics unit cannot be removed from the housing while the housing is adhered to the skin of the host.

14. The device of claim 11, wherein, in use, a time between sensor insertion into the host and the electronics unit securing to the housing is less than about 1 second.

15. The device of claim 11, wherein the device is configured to disengage from the housing and from the electronics unit in response to the electronics unit being released from a lock.

16. The device of claim 11, further comprising a trigger lock configured to prevent activation of the trigger.

17. The device of claim 11, wherein the sensor insertion mechanism is configured to insert the sensor into the host at a maximum velocity influenced by a centrifugal brake.

18. The device of claim 17, wherein the sensor insertion mechanism comprises a tab protruding in an axial direction from a wheel and configured to rotate about a fixed point, wherein rotational movement of the tab translates into a linear movement of a needle carrier to insert the sensor into the host.

19. The device of claim 11, further comprising a protective cover configured to cover the electronics unit and the housing after sensor insertion and to secure the electronics unit to the housing.

20. A device for applying an on-skin sensor assembly to skin of a host, the device comprising:

a base configured to secure a housing, wherein the housing is configured to receive a transmitter, and the transmitter is configured to generate analyte information based on a signal from a sensor; and

a mechanism configured to, in response to a single action by a user, cause the sensor to be inserted into the host, to secure the electronics unit to the housing such that the sensor electrically contacts the electronics unit, and to cause the housing to detach from the base.

21. The device of claim 20, wherein the mechanism includes a trigger, and the single action comprises activating the trigger to release stored energy and set components within the device in motion.

22. The device of claim 21, wherein the stored energy is stored in a torsion spring that, when released, is configured to cause a wheel to rotate.

23. The device of claim 22, wherein rotation of the wheel is configured to induce linear motion in a needle carrier.

24. A device for applying an on-skin sensor assembly to skin of a host, the device comprising:

a base configured to secure a housing, wherein the housing is configured to receive an electronics unit, wherein the electronics unit is configured to generate analyte information based on a signal from a sensor;

a sensor insertion mechanism configured to insert the sensor into the host, and including a needle carrying the sensor, a rotatable wheel, and a linearly translatable needle carrier; and

a trigger configured, in response to being activated, to cause the rotatable wheel to rotate, which in turn causes the linearly translatable needle carrier to translate toward the host to implant the sensor, and subsequently to translate away from the host to withdraw the needle from the host.

25. The device of claim 24, further comprising a torsion spring that stores energy, wherein the device is configured such that when the trigger is activated, the energy stored in the torsion spring is released, causing the wheel to rotate.

26. The device of claim 25, wherein the wheel includes a flange, and the trigger bears against the flange to retain the energy stored within the torsion spring.

27. The device of claim 24, further comprising a pushrod and a needle, and when the trigger is activated the pushrod ejects the sensor from a lumen of the needle and subsequently retracts into the needle lumen.