Electrochemical sensor module

• US 10,278,632 B2
• Filed: 09/19/2016
• Issued: 05/07/2019
• 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): Jang, Christian
• Assistant Examiner(s): Toth, Karen
• Application Number:
  US15/269,204
• Publication Number:
  US 20170065214A1
• Time in Patent Office: 960 Days
• 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 cartridge stack comprising a plurality of cartridges stacked together so that adjacent ones of the cartridges contact each other, each cartridge extending along a length between opposite first and second ends so that the lengths of the cartridges in the cartridge stack extend parallel to each other, each cartridge comprising:

a sensor module comprising a skin piercing element that extends along the length of the cartridge, an analysis cell housing defining a sample passage way and an analysis cell in fluid communication with the piercing element, the analysis cell comprising at least first and second electrodes adapted for analyzing the amount of an 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 carried with the sensor module; and

a delivery arrangement carried with the sensor module, the delivery arrangement comprising a piston chamber, a piston rod disposed within the piston chamber coaxially with the skin piercing element, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber,

wherein each cartridge is slidable along an axis that extends along the length of the cartridge relative to an adjacent one of the cartridges in the stack.

2. The cartridge stack of claim 1, wherein each cartridge comprises a slot extending along a side of the cartridge and a rail extending parallel to the slot.

3. The cartridge stack of claim 2, wherein the rail of the cartridge is slidably coupled with the slot of an adjacent cartridge.

4. The cartridge stack of claim 2, wherein each cartridge comprises a first slot and a first rail on one side of the cartridge and a second slot and a second rail on an opposite side of the cartridge.

5. The cartridge stack of claim 2, wherein the slot extends along the side of the cartridge parallel to the skin piercing element.

6. The cartridge stack of claim 1, wherein each cartridge can be slidably decoupled from the stack.

7. A cartridge assembly comprising a device housing, a cartridge stack with a plurality of cartridges loadable within the device housing, and a drive assembly coupled to the device housing, wherein the cartridge stack is operatively mounted on the drive assembly,

each cartridge being removably coupled with an adjacent cartridge, each cartridge defining an axis extending from a proximal end of the cartridge to a distal end of the cartridge, and each cartridge comprising:

a sensor module comprising a skin piercing element that extends along the axis and an analysis cell in fluid communication with the skin piercing element, the analysis cell comprising at least first and second electrodes adapted for analyzing the amount of an 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 carried with the sensor module;

a delivery arrangement carried with the sensor module, the delivery arrangement comprising a piston chamber, a piston rod disposed within the piston chamber coaxially with the skin piercing element, and a valve arrangement providing selective fluid communication between the drug reservoir and the piston chamber; and

the drive assembly comprising;

a first drive mechanism configured to drive a cartridge of the cartridge stack along the axis; and

a second drive mechanism configured to drive the piston rod of the cartridge along the axis.

8. The cartridge assembly of claim 7, wherein each cartridge comprises a slot extending along a side of the cartridge and a rail extending parallel to the slot.

9. The cartridge stack of claim 8, wherein the rail of the cartridge is slidably coupled with the slot of an adjacent cartridge.

10. The cartridge stack of claim 8, wherein each cartridge comprises a first slot and a first rail on one side of the cartridge and a second slot and a second rail on an opposite side of the cartridge.

11. The cartridge stack of claim 8, wherein the slot extends along the side of the cartridge parallel to the skin piercing element.

12. The cartridge stack of claim 7, wherein the first and second drive mechanisms are configured to execute a sampling and delivery sequence on an end cartridge of the cartridge stack.

13. The cartridge stack of claim 7, wherein the drive assembly comprises a third drive mechanism configured to decouple and eject an end cartridge from the cartridge stack.

14. The cartridge assembly of claim 7, wherein the first drive mechanism is driven by a first motor and the second drive mechanism is driven by a second motor.