Medical device inserters and processes of inserting and using medical devices

• US 9,687,183 B2
• Filed: 03/30/2012
• Issued: 06/27/2017
• 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: Robinson, Peter G., Donnay, Manuel Luis, Nguyen, Tuan, Pace, Louis G.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/436,777
• Publication Number:
  US 20120190941A1
• Time in Patent Office: 1,915 Days
• Field of Search: 606181, 606182, 606185, 606131, 606 1, 600309, 600345, 600365, 600347, 604318
• 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. A method, comprising:

positioning a distal end of an inserter on a skin surface; and

applying a force on a proximal end of the inserter to displace a sharp carrier, a device carrier and an analyte monitoring assembly from a first position within the inserter in spaced relation with the skin surface to a second position adjacent to the skin surface, and to position a portion of an analyte sensor under the skin surface and in contact with interstitial fluid, wherein a spring is positioned within the inserter in a compressed, preloaded state when the sharp carrier, the device carrier and the analyte monitoring assembly are in the first position, and wherein the spring is retained in the compressed, preloaded state without a change in state as the sharp carrier, the device carrier and the analyte monitoring assembly move from the first position to the second position;

wherein the preloaded spring is biased to advance the sharp carrier from a retracted position with an introducer sharp extending through the device carrier and the analyte monitoring assembly to an extended position in spaced relation with the device carrier, wherein a plurality of carrier arms retain the sharp carrier in the retracted position, and wherein the sharp carrier is disengaged from the plurality of carrier arms permitting expansion of the preloaded spring to advance the sharp carrier to the extended position and withdraw the introducer sharp from the analyte monitoring assembly and the skin surface when the sharp carrier reaches the second position.

2. The method of claim 1, wherein the sharp carrier is disengaged by releasing compression from a support wall maintaining the plurality of carrier arms in an interference relationship with the sharp carrier until the sharp carrier reaches the second position.

3. The method of claim 2, wherein the support wall is configured to engage the sharp carrier by preventing the plurality of carrier arms from bending outwardly until the sharp carrier reaches the second position.

4. The method of claim 3, wherein the plurality of carrier arms are configured to clear the support wall when the sharp carrier reaches the second position.

5. The method of claim 4, wherein the plurality of carrier arms are configured to bend outwardly when the plurality of carrier arms clear the support wall.

6. The method of claim 5, wherein the plurality of carrier arms are configured to disengage from the sharp carrier when the plurality of carrier arms bend outwardly.

7. The method of claim 6, wherein when the plurality of carrier arms are configured to no longer be in an interference relationship with the sharp carrier when the plurality of carrier arms disengage from the sharp carrier.

8. The method of claim 1, wherein no springs are axially compressed during inserter actuation.

9. The method of claim 8, wherein no coil springs are compressed during the inserter actuation.

10. The method of claim 1, wherein the analyte sensor is operatively coupled to the analyte monitoring assembly.

11. The method of claim 10, wherein the analyte monitoring assembly is configured to receive the introducer sharp.

12. The method of claim 11, wherein when the analyte monitoring assembly reaches the second position, the analyte monitoring assembly is configured to adhere to the skin surface.

13. The method of claim 10, wherein the preloaded spring is configured to withdraw the introducer sharp to a proximal position within the inserter during expansion.

14. The method 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.

15. The method of claim 1, wherein the inserter includes a handle and a sheath.

16. The method of claim 15, wherein the introducer sharp is withdrawn into the handle and the sheath when the preloaded spring is released from the preloaded condition.

17. The method of claim 16, further comprising maintaining the handle in a fixed position relative to the sheath using a locking mechanism after the withdrawal of the introducer sharp from the analyte monitoring assembly and the skin surface.

18. The method of claim 1, wherein the analyte monitoring assembly includes sensor electronics operatively coupled to a housing.

19. The method of claim 18, wherein an adhesive layer is formed on a surface of the housing.

20. The method of claim 1, wherein the spring is coupled to the sharp carrier and the device carrier, and further wherein the spring is configured to move while in the compressed, preloaded state, with the sharp carrier, the device carrier and the analyte monitoring assembly from the first position to the second position.