Flluid deliver system with electrochemical sensing of analyte concentration levels

• US 20100241086A1
• Filed: 09/25/2007
• Published: 09/23/2010
• Est. Priority Date: 09/29/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Iddan, Gavriel J., Shapira, Gali, Yodfat, Ofer, Kaidar, Ruthy
• Granted Patent: US 8,603,075 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• 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 analyte levels in the body of the 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 level of analyte concentration in the body of the patient, upon diffusion of said analyte into the fluid to be dispensed by the dispensing apparatus.

2. The system according to claim 1, wherein said dispensing apparatus and said sensing apparatus are configured as a closed-loop system, wherein said closed-loop system includes

a processor-controller configured to regulate dispensing of fluid into the body of the patient based on a sensed level of analyte concentration in the body of the patient.

3. The system according to claim 1, wherein said dispensing apparatus and said sensing apparatus are configured as a semi-closed-loop system, wherein said semi-closed-loop system includes

a processor-controller configured to regulate dispensing of fluid into the body of the patient based on a sensed level of analyte concentration in the body of the patient and an external input.

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

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

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.

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

6. The system according to claim 1, further comprising

a reusable part;

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.

7. The system according to claim 6, wherein said sensing apparatus is a skin patch configured to include a cannula insertable into the subcutaneous tissue.

8. The system according to claim 1, further comprising

a fluid reservoir;

a needle assembly having a cannula and a penetrating member;

a pumping apparatus;

a processor; and

an electrochemical sensing apparatus;

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

9. The system according to claim 8, wherein at least a portion of said cannula is permeable to said analyte to enable diffusion of the analyte into said cannula.

10. The system according to claim 8, wherein said dispensing and sensing apparatuses are configured to share at least one of said cannula, said fluid reservoir, and said pumping apparatus.

11. The system according to claim 8, further comprising another cannula, wherein said dispensing apparatus is configured to dispense fluid into the body of the patient through said another cannula.

12. The system according to claim 8, further comprising another pumping mechanism;

wherein said pumping mechanism is configured to control delivery of fluid into the body of the patient, and said another pumping mechanism is configured to control flow of analyte for sensing of level of concentration of analyte in the body of the patient.

13. The system according to claim 12, wherein at least one of said pumping mechanism and said another pumping mechanism is a peristaltic pump.

14. The system according to claim 12, wherein at least one of said pumping mechanism and said another pumping mechanism is a syringe.

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

16. The system according to claim 15, wherein said sensor is selected from a group consisting of:

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

17. The system according to claim 15, 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;

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.

18. An apparatus for monitoring and sensing of concentration of analyte in the body of the patient, comprising:

an electrochemical sensing unit having at least one working electrode, wherein said at least one of working electrode is configured to be coated with an enzymatic sensing layer;

a counter electrode;

a measurement cell unit configured to include an analyte-saturated fluid; and

electronic processing unit;

said measurement cell unit is further configured to enable said analyte-saturated fluid to contact said at least one working electrode.

19. A method for monitoring concentration of analyte in the body of the patient, the method comprising steps of:

detecting level of analyte concentration in the body of the patient;

infusing fluid into the body of the patient based on the detected level of analyte concentration in the body of the patient; and

adjusting level of analyte concentration.

20. The method according claim 19, wherein said analyte is glucose and said fluid is insulin.