Fluid delivery system with electrochemical sensing of analyte concentration levels

• US 8,603,075 B2
• Filed: 09/25/2007
• Issued: 12/10/2013
• Est. Priority Date: 09/29/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel J., Kaidar, Ruthy, Shapira, Gali
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US11/989,665
• Publication Number:
  US 20100241086A1
• Time in Patent Office: 2,268 Days
• Field of Search: 604/890.1
• US Class Current: 604/890.1
• CPC Class Codes: A61B 5/14525 using microdialysis
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A system and a method for delivering fluid to and sensing analyte levels in the body of the patient are disclosed. The system includes a dispensing apparatus configured to infuse fluid into the body of the patient and a sensing apparatus configured to be in communication with the dispensing apparatus and further configured to detect a level of analyte concentration in the body of the patient upon diffusion of the analyte into the fluid to be dispensed by the dispensing apparatus.

Claims

1. A system for delivering fluid to and sensing concentration levels of an analyte in a body of a patient, comprising:

a dispensing apparatus configured to infuse fluid into the body of the patient; and

a sensing apparatus configured to be in communication with said dispensing apparatus and further configured to detect a concentration level of the analyte in the body of the patient;

wherein the dispensing apparatus and the sensing apparatus share a single fluid reservoir, a single pump, and a single cannula with one single exit port; and

wherein the system further comprises a processor-controller apparatus configured to receive input data from the sensing apparatus and, after processing the input data, authorize the dispensing apparatus to dispense fluid based on the detected level of the analyte in the body of the patient and an external input.

2. The system according to claim 1, further comprising:

a remote-controlled unit configured to control said dispensing apparatus; and

another remote-controlled unit configured to control said sensing apparatus;

wherein said another remote-controlled unit is configured to transmit information to said remote-controlled unit to adjust dispensing of fluid to the body of the patient.

3. The system according to claim 1, wherein said analyte is glucose and said fluid is insulin.

4. The system according to claim 1, further comprising:

a reusable part; and

a disposable part configured to be coupled to said reusable part;

wherein said reusable part is configured to include electronics and a driving mechanism of said dispensing and sensing apparatuses, and said disposable part is configured to include a fluid reservoir and a needle assembly of said dispensing and sensing apparatuses;

whereby upon coupling of said reusable part and said disposable part, said dispensing and said sensing apparatuses become operable.

5. The system according to claim 4, wherein said sensing apparatus is a skin patch configured to include a cannula insertable into a subcutaneous tissue.

6. The system according to claim 1, further comprising:

a needle assembly having a cannula and a penetrating member;

wherein the sensing apparatus is an electrochemical sensing apparatus, and the processor-controller apparatus includes a processor; and

wherein said processor and said pump are configured to control flow of fluid from said reservoir into said cannula.

7. The system according to claim 6, wherein at least a portion of said cannula is permeable to said analyte to enable diffusion of the analyte into said cannula.

8. The system according to claim 1, wherein said pump is a peristaltic pump.

9. The system according to claim 1, wherein said pump is a syringe.

10. The system according to claim 1, wherein said sensing apparatus is configured to include an electrochemical detection mechanism having a sensor.

11. The system according to claim 10, wherein said sensor is selected from a group consisting of:

an enzymatic assays sensor, a non-enzymatic analyte sensor.

12. The system according to claim 10, wherein said electrochemical detection mechanism includes

a working electrode;

a counter electrode;

a measurement cell unit configured to include an analyte-saturated fluid configured to contact said working electrode;

wherein said measurement cell unit is configured to generate a flow of current between said working electrode and said counter electrode; and

wherein said electrochemical detection mechanism, based on said flow of said current, is configured to determine said level of concentration of analyte in the body of the patient.

13. The system according to claim 12, wherein said measurement cell unit is located in a portion of the cannula which in use is located within the body of the patient.

14. The system according to claim 12, wherein said measurement cell unit is located in a portion of the cannula which in use is located outside the body of the patient.

15. The system according to claim 14, wherein the sensing unit is configured to be located in use outside the body, above the skin.

16. The system according to claim 15, wherein the pump is configured to transport analyte-rich solution from the cannula to the measurement cell unit for analysis.

17. The system according to claim 4, further comprising an electrical circuit configured and arranged such that a signal representing the concentration level of the analyte detected by the sensing apparatus cannot be generated without the coupling of the reusable and disposable parts.

18. The system according to claim 17, wherein the electrical circuit is an amperometric circuit comprising an amperometer.

19. The system according to claim 18, wherein the electrical circuit further comprises a switch configured to close the circuit only when measurements are being carried out by the sensing apparatus.