Integrated introducer and transmitter assembly and methods of use

• US 9,775,563 B2
• Filed: 09/21/2016
• Issued: 10/03/2017
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US15/271,991
• Publication Number:
  US 20170027518A1
• Time in Patent Office: 377 Days
• Field of Search: 600345-366, 600373, 606181-189
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/1451 for interstitial fluid
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

Claims

1. A method of using a sensor introducer assembly, the sensor introducer assembly comprising an insertion unit operatively coupled to an analyte sensor, wherein the insertion unit includes a compressible introducer mechanism coupled to a sensor introducer, the method comprising:

placing a base portion of the sensor introducer assembly on a skin surface of a patient;

applying a manual force on a surface of the compressible introducer mechanism to cause the compressible introducer mechanism to move from a non-compressed state to a compressed state;

inserting, by the compressible introducer mechanism, at least a portion of the analyte sensor and the sensor introducer through a skin layer to an insertion position under the skin layer; and

automatically withdrawing the at least the portion of the sensor introducer from under the skin layer while retaining the at least the portion of the analyte sensor at the insertion position,

wherein the insertion unit and compressible introducer mechanism are contained within a housing when the compressible introducer mechanism is in the non-compressed state and the compressed state, and wherein the sensor introducer includes a sharp portion configured to releasably couple with the at least the portion of the analyte sensor.

2. The method of claim 1, further comprising driving the sharp portion, by the manual force, to pierce through the skin layer and to position the at least the portion of the analyte sensor in fluid contact with a biological fluid under the skin layer at the insertion position.

3. The method of claim 2, wherein the biological fluid includes one of interstitial fluid or blood.

4. The method of claim 1, wherein the analyte sensor is a glucose sensor.

5. The method of claim 1, wherein the analyte sensor is operatively coupled to sensor electronics.

6. The method of claim 5, wherein the sensor electronics include an opening portion, the opening portion configured to selectively provide access to the sensor introducer.

7. The method of claim 5, further comprising communicating, by the sensor electronics, one or more signals corresponding to an analyte level monitored by the analyte sensor.

8. The method of claim 7, wherein the sensor electronics further comprise a wireless communication unit configured to wirelessly transmit signals according to at least one of a radio frequency (RF), a Bluetooth protocol, an infrared protocol, an 802.11x communication protocol, and a Zigbee communication protocol.

9. The method of claim 1, further comprising removing the manual force from the compressible introducer mechanism to cause the compressible introducer mechanism to move from the compressed state to the non-compressed state.

10. The method of claim 1, wherein the compressible introducer mechanism includes a substantially dome-shaped outer surface.

11. A method, comprising:

applying a manual force on a surface of a compressible introducer mechanism coupled to a sensor introducer to cause the compressible introducer mechanism to move from a non-compressed state to a compressed state;

driving a sharp portion of the sensor introducer to pierce through a skin layer of a patient;

inserting, by the compressible introducer mechanism, at least a portion of the analyte sensor and the sensor introducer to an insertion position under the skin layer; and

automatically withdrawing the at least the portion of the sensor introducer from under the skin layer while retaining the at least the portion of the analyte sensor at the insertion position,

wherein the at least the portion of the analyte sensor is substantially retained within the least the portion of the sensor introducer prior to insertion of the at least the portion of the analyte sensor and the sensor introducer through the skin layer.

12. The method of claim 11, wherein the insertion unit and compressible introducer mechanism are contained within a housing when the compressible introducer mechanism is in the non-compressed state and the compressed state.

13. The method of claim 11, wherein the analyte sensor is operatively coupled to sensor electronics.

14. The method of claim 13, wherein the sensor electronics include an opening portion, the opening portion configured to selectively provide access to the sensor introducer.

15. The method of claim 14, wherein the opening portion comprises an aperture positioned through a relatively center portion of the sensor electronics.

16. The method of claim 13, further comprising communicating, by the sensor electronics, one or more signals corresponding to an analyte level monitored by the analyte sensor.

17. The method of claim 16, wherein the sensor electronics further comprise a wireless communication unit configured to wirelessly transmit signals according to at least one of a radio frequency (RF), a Bluetooth protocol, an infrared protocol, an 802.11x communication protocol, and a Zigbee communication protocol.

18. The method of claim 11, wherein the compressible introducer mechanism includes a substantially dome-shaped outer surface.

19. The method of claim 11, further comprising removing the manual force from the compressible introducer mechanism to cause the compressible introducer mechanism to move from the compressed state to the non-compressed state.

20. The method of claim 11, wherein the manual force comprises a pressure force in a direction toward the skin surface of the patient.