Electrochemical sensor module

• US 9,445,755 B2
• Filed: 11/12/2009
• Issued: 09/20/2016
• Est. Priority Date: 11/14/2008
• Status: Active Grant

• Current Assignee: Pepex Biomedical, Inc.
• Original Assignee: Pepex Biomedical, LLC
• Inventors: Say, James L.
• Primary Examiner(s): Berhanu, Etsub
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US13/129,343
• Publication Number:
  US 20110270061A1
• Time in Patent Office: 2,504 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/5438 : Electrodes
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Certain embodiments of a sensor cartridge element include a sensor module, an electrode arrangement installed on the sensor module, and a delivery arrangement securely coupled to the sensor module. The sensor module includes an analysis cell and a skin piercing member. The electrode arrangement generates an electrical signal when exposed to a fluid sample collected in the analysis cell. The delivery arrangement includes a drug reservoir, a piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber. Metering electronics and an actuator can manage collection of fluid samples and/or dispensing of drug doses.

Claims

1. A sensor cartridge element comprising:

a sensor module extending from a proximal end to a distal end, the sensor module including an analysis cell housing, a skin piercing member, and a skin piercing member anchor to which the skin piercing member is secured, the analysis cell housing defining an analysis cell and a sample passageway leading from the distal end of the sensor module to the analysis cell;

an electrode arrangement installed on the sensor module and arranged at least partially within the analysis cell of the sensor module, the electrode arrangement being configured to generate an electrical signal when exposed to a fluid sample collected in the analysis cell;

a delivery arrangement securely coupled to the sensor module, the delivery arrangement including a drug reservoir, a piston chamber, a piston rod disposed within the piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber, the piston rod being disposed external of the drug reservoir, and the piston rod being coaxial with the skin piercing member, wherein the sensor cartridge is part of a sensor cartridge stack, and wherein the sensor cartridge is configured to couple to a second sensor cartridge element in the stack and a third sensor cartridge element in the stack.

2. The sensor cartridge element of claim 1, wherein the electrode arrangement includes a working electrode and a counter electrode.

3. The cartridge element of claim 1, wherein the sensor cartridge element includes a first rail that fits within a slot defined in the second sensor cartridge element, and wherein the sensor cartridge element includes a second rail that fits within a slot defined in the third sensor cartridge element.

4. The sensor cartridge element of claim 1, wherein the valve arrangement includes a flapper valve.

5. The sensor cartridge element of claim 1, wherein the valve arrangement provides fluid communication between the drug reservoir and the piston chamber when a piston rod is drawn in a first direction within the piston chamber sufficient to release the valve arrangement.

6. The sensor cartridge element of claim 1, further comprising a flexible linkage mechanically connecting the analysis cell housing to the skin piercing member anchor.

7. The sensor cartridge element of claim 1, wherein the piston chamber extends generally parallel to the drug reservoir.

8. The sensor cartridge element of claim 1, wherein the delivery arrangement includes an inner wall defining a port that provides fluid communication between the drug reservoir and the piston chamber.

9. The sensor cartridge element of claim 1, wherein the sensor cartridge element is one of a plurality of sensor cartridge elements disposed within an interior of a housing.

10. The sensor cartridge element of claim 9, wherein a controller is arranged within the interior of the housing, the controller including metering electronics.

11. The sensor cartridge element of claim 9, wherein the controller determines a portion of a drug dosage to be dispensed based on the electrical signal.

12. The sensor cartridge element of claim 9, wherein the controller determines when to inject a dosage based on the electrical signal.

13. The monitoring and delivery device of claim 9, wherein the controller determines a dosage size of insulin to be dispensed by the delivery arrangement.

14. The sensor cartridge element of claim 1, wherein the delivery arrangement includes a piston rod configured to move in a first direction to release the valve arrangement to provide fluid communication between the drug reservoir and the piston chamber to enable the portion of a drug to enter the piston chamber from the drug reservoir;

and wherein the piston rod is further configured to move the piston rod in a second direction to expel the portion of the drug.

15. A device for sampling and dispensing, the device comprising

a housing, and a plurality of disposable cartridges, an actuator, and a controller disposed in the housing;

each cartridge comprising;

a sensor module extending from a proximal end to a distal end, the sensor module comprising a skin contact portion, a skin piercing element, an analysis cell housing defining a sample passageway, and an analysis cell in fluid communication with the piercing element, the analysis cell comprising at least first and second electrodes and adapted for analyzing the amount of analyte in a fluid sample, wherein the electrodes generate an electrical signal when exposed to a fluid sample collected in the analysis cell;

a drug reservoir; and

a delivery mechanism fluidly connecting the drug reservoir with the piercing element, the delivery mechanism comprising a piston chamber, a piston rod disposed within the piston chamber, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber, the piston rod being disposed external of the drug reservoir, and the piston rod being coaxial with the skin piercing element;

wherein the actuator is constructed to actuate the delivery mechanism;

and wherein the controller is operatively coupled with the actuator and capable of receiving signals from the analysis cell.

16. The device of claim 15, wherein each delivery mechanism is capable of delivering a selectively variable amount of drug from the drug reservoir.

17. The device of claim 15, wherein the controller is adapted to determine the amount of drug to be delivered by the delivery mechanism based on the signal from the analysis cell.

18. The device of claim 15, wherein each cartridge is slidably removable from the housing.

19. The device of claim 15, wherein the plurality of cartridges is disposed in the housing in a stacked arrangement.

20. The device of claim 19, wherein the stacked arrangement comprises an active end cartridge.

21. The device of claim 20, wherein the active end cartridge is slidably removable from the stacked arrangement.

22. The device of claim 20, wherein removing the active end cartridge exposes a next active end cartridge on the stacked arrangement until a last cartridge of the stacked arrangement is reached.

23. The device of claim 15, wherein each cartridge of the plurality of cartridges is a single use cartridge providing a single analysis of the analyte and a single delivery action.