Analyte monitoring and fluid dispensing system

• US 9,248,232 B2
• Filed: 11/30/2010
• Issued: 02/02/2016
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Znati, Eli, Gescheit, Illai, Neta, Avraham, Levy, Offer
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US13/511,578
• Publication Number:
  US 20120277667A1
• Time in Patent Office: 1,890 Days
• Field of Search: 604 65- 67, 600/300, 600/309
• US Class Current: 1/1
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• 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 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments of the present disclosure are directed to a skin adherable device for delivering therapeutic fluid into a body of a patient. In some embodiments, the device includes a monitoring apparatus, a pump, 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 pump 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 skin securable medical device comprising:

a tip configured for insertion and for delivering therapeutic fluid into the body of a patient;

a pump for delivering the therapeutic fluid into the body of the patient via the tip;

a sensor provided at the tip and configured for sensing a level of one or more analytes within the body of the patient and configured for providing at least one sensor signal indicative of the level of one or more sensed analytes;

a processor housed within a patch unit for processing the at least one sensor signal and for controlling the therapeutic fluid delivery;

at least one first connector provided on the tip for enabling an electrical communication between the sensor and the processor; and

an adherable housing portion comprising a cradle for securing at least part of the device to the skin of the patient, the adherable housing portion including a well for receiving the tip within an opening, and at least one second connector located on at least one protrusion extending laterally inward within the opening of the well;

wherein;

upon insertion of the tip through the well, the at least one first connector is coupled to the at least one second connector establishing the electrical communication therebetween and enabling transfer of the at least one sensor signal from sensor to the processor; and

the patch unit comprises at least one third connector extending away from the underside of the patch unit, and electrical currents are also sent to the processor from the well when the at least one third connector of the patch unit is pressed against a conductive protrusion extending upward and away from the cradle toward the patch unit, the pressing causing contacting pads in the conductive protrusion to contact wires extending from the well to the conductive protrusion.

2. The device according to claim 1, wherein the cradle includes at least one latch for connecting the cradle and the patch unit.

3. The device according to claim 2, wherein the cradle includes a power source enabling continuous or periodic operation of the electrodes or probe.

4. The device according to claim 3, wherein the continuous or periodic operation of the electrodes or probe occurs when the pump is disconnected.

5. The device according to claim 2 wherein the cradle includes an amplifier for amplifying the signals conveyed from the sensor.

6. The device according to claim 1, wherein the tip includes a first lumen for delivering the therapeutic fluid and one or more second lumens for providing at least a portion of the sensor.

7. The device, according to claim 6, wherein the one or more second lumens includes three lumens.

8. The device according to claim 6, wherein the one or more second lumens includes one or more windows enabling exposure of at least a portion of the sensor to the surrounding.

9. The device according to claim 6, wherein the one or more second lumens is substantially shorter than the first lumen.

10. The device according to claim 6, wherein the first lumen has a substantially circular cross section and the one or more second lumens has a substantially arched cross section.

11. The device according to claim 1, wherein the sensor comprises a plurality of electrodes for sensing the level of one or more analytes.

12. The device according to claim 11, wherein each electrode resides in a separate one or more second lumens of the tip.

13. The device according to claim 1, wherein the tip comprises a cannula for delivering the therapeutic fluid therethrough.

14. The device of claim 1 wherein the conductive protrusion is configured to remain sealed by a sealed cap when the patch unit is disconnected from the cradle.

15. The device according to claim 1, wherein at least a portion of the sensor is bent for enabling physical contact between the at least one first and second connectors upon insertion of the tip through the well.

16. The device according to claim 1, wherein the device operates in a mode selected from the group consisting of:

a closed loop mode, a semi-closed loop mode, and an open loop mode.

17. The device according to claim 1, wherein the adherable housing portion comprises a latch including the at least one second connector for establishing the electrical communication with the at least one first connector.

18. The device according to claim 1, wherein the well is configured to enable tip insertion in an angle with respect to the adherable housing portion.

19. The device according to claim 1, further comprising:

a cannula cartridge unit;

a penetrating member for piercing the skin of the patient during insertion of the tip;

and an inserter;

wherein the cannula cartridge unit and the penetrating member are configured to align the tip, such that upon insertion of the tip through the well of the adherable housing portion, the at least one first connector contacts the at least one second connector.

20. The device according to claim 1, wherein the adherable housing portion includes an adhesive tape, the adhesive tape having at least one connector and at least one wire.