Fluid delivery system with electrochemical sensing of analyte concentration levels

• US 9,056,161 B2
• Filed: 12/05/2013
• Issued: 06/16/2015
• Est. Priority Date: 09/29/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodat, Ofer, Iddan, Gavriel J., Kaidar, Ruthy, Shapira, Gali
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/098,091
• Publication Number:
  US 20140094746A1
• Time in Patent Office: 558 Days
• Field of Search: 604/890.1
• US Class Current: 1/1
• 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.

Claims

1. A system for delivering fluid to, and sensing concentration levels of an analyte in a body of a patient, the system 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, with the dispensing apparatus and the sensing apparatus sharing a single fluid reservoir, a single pump and a single cannula with one single exit port;

wherein the sensing apparatus is configured to detect the concentration level of the analyte upon diffusion of the analyte in the body of the patient into the fluid to be dispensed to the body of the patient by the dispensing apparatus prior to dispensing; 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 either the detected level of the analyte in the body of the patient, or the detected level of the analyte in the body of the patient and an external input;

wherein the sensing apparatus comprises an electrochemical detection mechanism having a sensor selected from a group consisting of an enzymatic assays sensor and a non-enzymatic analyte sensor;

wherein the electrochemical detection mechanism further comprises;

a working electrode;

a counter electrode; and

a measurement cell unit configured to include an analyte-saturated fluid configured to contact the working electrode, the measurement cell unit being located in a portion of the cannula which in use is located within the body of the patient;

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

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

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

a first remote-control unit configured to control the dispensing apparatus; and

a second remote-control unit configured to control the sensing apparatus;

wherein the second remote-control unit is configured to transmit information to the first remote-control unit to adjust dispensing of the fluid to the body of the patient.

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

a reusable part;

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

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

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

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

a needle assembly including the cannula and a penetrating member;

wherein the sensing apparatus comprises an electrochemical sensor and the processor-controller apparatus comprises a processor configured to control the pump to control a flow of the fluid from the fluid reservoir to the cannula.

5. The system according to claim 4, wherein at least a portion of the cannula is permeable to the analyte to enable diffusion of the analyte into the cannula.

6. The system according to claim 1, wherein the pump is a peristaltic pump.

7. The system according to claim 1, wherein the pump comprises a syringe.

8. The system according to claim 1, wherein the measurement cell unit is located in a portion of the cannula which in use is located outside the body of the patient.

9. The system according to claim 8, wherein the sensing unit is configured to be located in use outside the body, above the skin.

10. The system according to claim 9, wherein the pump is configured to transport analyte-rich solution from the cannula to the measurement cell unit for analysis.

11. A medical fluid-delivery and sensing system, comprising:

a housing comprising a first housing part, and a housing second part coupleable to the first housing part;

an electrical circuit comprising a first circuit part in the first housing part, and a second circuit part in the second housing part, the electronic circuit being configured and arranged to become operable only when the first housing part is coupled to the second housing part;

a dispensing apparatus for delivering fluid into a body of a patient, wherein at least part of the dispensing apparatus is enclosed within the first housing part; and

a sensing apparatus in communication with the dispensing apparatus, the sensing apparatus being 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, control the dispensing apparatus to deliver fluid based on either the detected level of the analyte in the body of the patient, or the detected level of the analyte in the body of the patient and an external input.

12. The system according to claim 11, wherein the electrical circuit is an amperometric circuit that is closed when the first housing part is coupled to the second housing part.

13. The system according to claim 11, wherein the sensing apparatus comprises an electrochemical detection mechanism.

14. The system according to claim 13, wherein the electrochemical detection mechanism comprises:

a working electrode;

a counter electrode;

a measurement cell unit configured to include an analyte-saturated fluid for contacting the working electrode;

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

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

15. The system according to claim 14, wherein at least one of the electrodes comprises a plurality of protruding nanostructures.

16. The system according to claim 14, wherein at least one of the electrodes defines a plurality of grooves or holes.