Integrated introducer and transmitter assembly and methods of use

• US 20070078322A1
• Filed: 09/30/2005
• Published: 04/05/2007
• 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
• Granted Patent: US 8,512,243 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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. An apparatus including an integrated sensor insertion unit, comprising:

a base unit;

a sensor coupled to the base unit; and

an insertion unit disposed on the base unit, the insertion unit operatively coupled to the sensor and configured to place at least a portion of the sensor under a skin of a patient, wherein the insertion unit is configured to remain disposed on the base unit after sensor placement.

2. The apparatus of claim 1 further including a transmitter unit disposed on said base unit, the transmitter unit configured to operatively couple to the sensor.

3. The apparatus of claim 2 wherein the transmitter unit includes an opening portion configured to substantially cover the insertion unit when the transmitter unit is disposed on the base unit.

4. The apparatus of claim 3. wherein the opening portion is slidably disposed on the transmitter unit to selectively expose the insertion unit.

5. The apparatus of claim 3 wherein the opening portion is pivotally mounted to the transmitter unit to selectively expose the insertion unit.

6. The apparatus of claim 1 wherein the base unit, the sensor and the insertion unit form an integrated disposable unit.

8. The apparatus of claim 1 wherein the insertion unit includes a sharp portion, the sharp portion configured to couple to a portion of the sensor, the sharp portion further configured to pierce through a skin of the patient to position at least the portion of the sensor in the patient.

9. The apparatus of claim 1 wherein at least the portion of the sensor is configured to be in fluid contact with a biological fluid of a patient.

10. The apparatus of claim 9 wherein the biological fluid includes one of interstitial fluid or blood.

11. The apparatus of claim 1 wherein the sensor is an analyte sensor.

12. The apparatus of claim 11 wherein the sensor is a glucose sensor.

13. An apparatus, comprising:

a transmitter mount;

a sensor coupled to the transmitter mount, the sensor configured to be in fluid contact with a biological fluid of a patient; and

a sensor introducer coupled to the sensor and configured to place at least a portion of the sensor under the skin of the patient, the sensor introducer integrated with the transmitter mount such that the sensor introducer is retained with the transmitter mount after sensor placement.

14. The apparatus of claim 13 further including an adhesive layer, the transmitter mount disposed on the adhesive layer, and a transmitter unit coupled to the transmitter mount on the adhesive layer, the transmitter unit further configured to be in electrical communication with the sensor.

15. The apparatus of claim 14 wherein the adhesive layer is positioned substantially around a sensor insertion location on a skin of the patient.

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

17. The apparatus of claim 14 wherein the transmitter unit is configured to transmit one or more signals corresponding to a respective one or more sensor signals.

18. The apparatus of claim 17 wherein the one or more sensor signals correspond to a respective one or more of analyte levels detected by the sensor.

19. The apparatus of claim 18 wherein the one or more analyte levels include one of a glucose level, a lactate level, or an oxygen level.

20. The apparatus of claim 17 further including a receiver unit configured to receive the one or more signals from the transmitter unit.

21. The apparatus of claim 13 wherein the biological fluid of the patient includes one of an interstitial fluid or blood.

21-1. A method, comprising the steps of:

placing at least a portion of a sensor under the skin of a patient;

substantially covering the sensor introducer mechanism; and

discarding the sensor introducer mechanism with the sensor.

22. An analyte detection apparatus for use with an analyte sensor, the apparatus comprising:

a transmitter; and

an analyte sensor insertion unit operatively coupled to the transmitter.

23. A system, comprising:

a transmitter mount;

a sensor coupled to the transmitter mount, the sensor configured to be in fluid contact with a biological fluid of a patient;

a sensor introducer coupled to the sensor and configured to place at least a portion of the sensor under the skin of the patient, the sensor introducer integrated with the transmitter mount such that the sensor introducer is retained with the transmitter mount after sensor placement; and

a transmitter unit coupled to the transmitter mount, the transmitter unit electrically coupled to the sensor, and configured to transmit one or more signals associated with the biological fluid levels of the patient.

24. An insertion kit, comprising:

a base unit;

a sensor coupled to the base unit; and

an insertion unit disposed on the base unit, the insertion unit operatively coupled to the sensor and configured to place at least a portion of the sensor under a skin of a patient, the insertion unit including a sensor introducer, wherein the sensor introducer is retained substantially disposed on the base unit after sensor placement.