Analyte monitoring and fluid dispensing system

• US 10,258,737 B2
• Filed: 09/08/2015
• Issued: 04/16/2019
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Kaidar, Ruthy
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US14/847,101
• Publication Number:
  US 20150374905A1
• Time in Patent Office: 1,316 Days
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2210/04 Skin
• 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

Disclosed is a skin adherable device for delivering therapeutic fluid into a body of a patient. The device includes a monitoring apparatus, a dispensing apparatus, and a tip for delivering the therapeutic fluid into the body of the patient and for monitoring bodily analyte in the body of the patient. The dispensing apparatus may continuously deliver the therapeutic fluid to the body of the patient and the monitoring apparatus may continuously monitor bodily analytes of the patient.

Claims

1. A two-part patch unit comprising:

a disposable part comprising;

a first housing containing therewithin;

a reservoir containing therapeutic fluid for delivery, and

an energy supply; and

a connecting lumen fluidly connected to the reservoir and fixed to the first housing; and

a reusable part comprising a second housing containing therewithin;

a driving mechanism;

a monitoring apparatus for monitoring an analyte level and comprising an electrochemical sensing mechanism; and

a processor-controller; and

a cradle unit comprising;

a first surface receiving the disposable part and the reusable part;

a second surface comprising an adhesive for coupling to a skin surface; and

a well defining an opening between the first and second surfaces;

a cannula comprising;

an outer periphery along a longitudinal length which extends down from the second surface of the cradle unit; and

an open end distal from a proximal end adjacent to the reusable part and the disposable part;

a self-sealable septum coupled to the proximal end of the cannula, the reservoir being fluidically connectable to the cannula through the self-sealable septum via the connecting lumen which is configured to pierce the septum directly and immediately upon connection of the disposable part and reusable part to the cradle unit to deliver the therapeutic fluid out the open end, the cannula and septum are insertable together into the well with the cradle unit coupled to the skin surface, and wherein the well of the cradle anchors the septum and cannula upon insertion therein; and

a plurality of electrodes coupled to the outer periphery adjacent the open end of the cannula.

2. The two-part patch unit of claim 1 wherein the energy supply comprises one or more batteries within the disposable part.

3. The two-part patch unit of claim 1 wherein the cannula is configured to function as a probe for monitoring the analyte level within an interstitial fluid via the plurality of electrodes and at the same time is configured for delivery of the therapeutic fluid from the reservoir to a site under the skin surface.

4. The two-part patch unit of claim 1 further comprising a penetrating member comprising a sharpened piece used for pricking of the skin during cannula insertion, and that is removable upon insertion of the cannula through the skin surface.

5. The two-part patch unit of claim 1 wherein the cannula is a soft cannula.

6. The two-part patch unit of claim 1 further comprising an outlet port through which the therapeutic fluid passes in moving out of the reservoir for the delivery under the skin surface.

7. The two-part patch unit of claim 1 wherein the cannula comprises a substantially circular cross-sectional shape.

8. The two-part patch unit of claim 1 wherein the cannula extends through the cradle unit via the well, the well comprising protrusions extending upwardly away from the skin surface for anchoring the cannula to the cradle unit.

9. The two-part patch unit of claim 1 wherein the plurality of electrodes comprise concentric, ring-like, electrodes located transversally on the outer periphery of the cannula and each is separated from one another along the longitudinal length of the cannula.

10. The two-part patch unit of claim 1 wherein the plurality of electrodes comprises a working electrode, a counter electrode and a reference electrode.

11. The two-part patch unit of claim 10 wherein the working electrode comprises an enzyme-coated sensing layer.

12. The two-part patch unit of claim 1 further comprising connectors that close the electrical circuit after coupling with the disposable part such that upon such coupling, power is supplied to the reusable part via one or more batteries within the disposable part.

13. The two-part patch unit of claim 1 wherein the opening of the well between the first and second surfaces is bigger on the second surface than on the first surface.

14. The two-part patch unit of claim 1 wherein the disposable part and the reusable part each contact the first surface.

15. The two-part patch unit of claim 1 wherein the opening of the well between the first and second surfaces is bigger on the second surface than on the first surface, and the disposable part and the reusable part each contact the first surface.

16. A method of using a two-part patch unit comprising:

providing the two-part patch unit comprising;

a disposable part comprising;

a first housing containing therewithin;

a reservoir containing therapeutic fluid for delivery, and

an energy supply; and

a connecting lumen fluidly connected to the reservoir and fixed to the first housing; and

a reusable part comprising a second housing containing therewithin;

a driving mechanism;

a monitoring apparatus for monitoring an analyte level and comprising an electrochemical sensing mechanism; and

a processor-controller; and

a cradle unit comprising;

a first surface receiving the disposable part and the reusable part;

a second surface comprising an adhesive for coupling to a skin surface; and

a well defining an opening between the first and second surfaces; and

a cannula comprising;

an outer periphery along a longitudinal length which extends down from the second surface of the cradle unit; and

an open end distal from a proximal end adjacent to the reusable part and the disposable part;

a self-sealable septum coupled to the proximal end of the cannula, the reservoir being fluidically connectable to the cannula through the self-sealable septum via the connecting lumen which is configured to pierce the septum directly and immediately upon connection of the disposable part and reusable part to the cradle unit to deliver the therapeutic fluid out the open end, the cannula and septum are insertable together into the well with the cradle unit coupled to the skin surface, and wherein the well of the cradle anchors the septum and cannula upon insertion therein; and

a plurality of electrodes coupled to the outer periphery adjacent the open end of the cannula; and

coupling the cradle unit to the skin surface; and

monitoring the analyte level within an interstitial fluid via the plurality of electrodes on the cannula and at the same time delivering fluid from the reservoir to a site under the skin surface via the cannula of the two-part patch unit.

17. The method of claim 16 wherein the plurality of electrodes comprises concentric, ring-like, electrodes located transversally on the outer periphery of the cannula and each is separated from one another along the longitudinal length of the cannula.

18. The method of claim 16 wherein the plurality of electrodes comprises a working electrode, a counter electrode and a reference electrode.

19. The method of claim 18 further comprising sensing, via an enzyme-coated sensing layer on the working electrode, a glucose level in the interstitial fluid.

20. The method of claim 19 further comprising continuously sensing the glucose.