Integrated introducer and transmitter assembly and methods of use

• US 10,342,489 B2
• Filed: 09/25/2017
• Issued: 07/09/2019
• 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:
  US15/714,538
• Publication Number:
  US 20180028118A1
• Time in Patent Office: 652 Days
• Field of Search: 600345-366, 600373, 600309, 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 sensor introducer assembly, comprising:

a housing comprising a base portion configured to be placed on a skin surface of a patient;

an analyte sensor; and

an insertion unit disposed on the base portion and operatively coupled to the analyte sensor;

wherein the insertion unit includes a compressible introducer mechanism coupled to an introducer, wherein the compressible introducer mechanism is configured to displace at least a portion of the analyte sensor and the introducer to an insertion position under the skin surface, and wherein the introducer includes a sharp portion configured to releasably couple with the at least the portion of the analyte sensor;

wherein the compressible introducer mechanism moves from a non-compressed state to a compressed state in response to a manual force being directly applied to a surface of the compressible introducer mechanism, wherein when the compressible introducer mechanism moves from the non-compressed state to the compressed state the at least the portion of the analyte sensor and the introducer are displaced to the insertion position;

wherein the compressible introducer mechanism is configured to automatically withdraw the sharp portion of the introducer from under the skin surface while retaining the at least the portion of the analyte sensor at the insertion position; and

wherein the introducer is contained within the housing when the compressible introducer mechanism is in the non-compressed state.

2. The sensor introducer assembly of claim 1, wherein the analyte sensor is a glucose sensor.

3. The sensor introducer assembly of claim 1, wherein at the insertion position, the at least the portion of the analyte sensor is in fluid contact with a biological fluid under the skin surface.

4. The sensor introducer assembly of claim 1, wherein the analyte sensor is operatively coupled to sensor electronics.

5. The sensor introducer assembly of claim 4, wherein the sensor electronics include an opening portion, the opening portion configured to selectively provide access to the introducer.

6. The sensor introducer assembly of claim 4, wherein the sensor electronics are configured to communicate one or more signals corresponding to an analyte level monitored by the analyte sensor.

7. The sensor introducer assembly of claim 6, 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.

8. The sensor introducer assembly of claim 1, wherein the compressible introducer mechanism is configured to move from the compressed state to the non-compressed state when the manual force is removed therefrom.

9. The sensor introducer assembly of claim 1, wherein the at least the portion of the analyte sensor is substantially retained within the sharp portion of the introducer prior to displacement of the at least the portion of the analyte sensor to the insertion position under the skin surface.

10. An apparatus, comprising:

a housing;

an analyte sensor;

an introducer coupled to a compressible introducer mechanism, wherein the introducer includes a sharp portion configured to releasably couple with at least a portion of the analyte sensor;

wherein the compressible introducer mechanism is configured to move from a non-compressed state to a compressed state in response to a manual force being directly applied to a surface of the compressible introducer mechanism;

wherein the compressible introducer mechanism is further configured to displace the at least the portion of the analyte sensor and the sharp portion of the introducer to an insertion position under the skin surface when the compressible introducer mechanism moves from the non-compressed state to the compressed state;

wherein the compressible introducer mechanism is further configured to move from a compressed state to a non-compressed state in response to removal of the manual force and automatically withdraw the sharp portion of the introducer from under the skin surface while retaining the at least the portion of the analyte sensor at the insertion position; and

wherein the introducer is contained within the housing when the compressible introducer mechanism is in the non-compressed state.

11. The apparatus of claim 10, wherein the analyte sensor is a glucose sensor.

12. The apparatus of claim 10, wherein at the insertion position, the at least the portion of the analyte sensor is in fluid contact with a biological fluid under the skin surface.

13. The apparatus of claim 10, wherein the analyte sensor is operatively coupled to sensor electronics.

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

15. The apparatus of claim 13, wherein the sensor electronics are configured to communicate one or more signals corresponding to an analyte level monitored by the analyte sensor.

16. The apparatus of claim 15, 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.

17. The apparatus of claim 10, wherein the housing further comprises a base unit having an adhesive layer.

18. The apparatus of claim 10, wherein the at least the portion of the analyte sensor is substantially retained within the sharp portion of the introducer prior to displacement of the at least the portion of the analyte sensor to the insertion position under the skin surface.