DEVICES AND METHODS FOR BODY FLUID SAMPLING AND ANALYSIS

• US 20130172698A1
• Filed: 08/03/2012
• Published: 07/04/2013
• Est. Priority Date: 08/03/2011
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Escutia, Raul, Larkin, John F., Tomasco, Michael F., Vivolo, Joseph A., Reynolds, Paul D., Hu, Charles, Bloom, Daniel R., Wiard, Richard M.
• Granted Patent: US 9,782,114 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150809 : by audible feedback
• CPC Class Codes: A61B 5/150816 : by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 : by visual feedback
• CPC Class Codes: A61B 5/1509 : by disrupting a seal, e.g. puncturing a piston seal
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15111 : Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: G01N 15/0612 : Optical scan of the deposits G01N15/0625 takes precedence
• CPC Class Codes: G01N 21/00 : Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light G01N3/00 - G01N19/00 take precedence
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/78 : producing a change of colour
• CPC Class Codes: G01N 33/487 : of liquid biological material

Abstract

Described here are meters and methods for sampling, transporting, and/or analyzing a fluid sample. The meters may include a meter housing and a cartridge. In some instances, the meter may include a tower which may engage one or more portions of a cartridge. The meter housing may include an imaging system, which may or may not be included in the tower. The cartridge may include one or more sampling arrangements, which may be configured to collect a fluid sample from a sampling site. A sampling arrangement may include a skin-penetration member, a hub, and a quantification member.

Claims

1. An integrated body fluid sampling meter comprising:

a meter housing comprising a light source and a first detector; and

a disposable cartridge insertable into the meter housing and comprising a plurality of cells, wherein each cell has a first wall comprising a viewing window and a second wall comprising a light-blocking covering,

wherein one of the plurality of cells is positionable between the light source and the first detector.

2. The meter of claim 1 wherein the disposable cartridge is rotatable within the meter housing.

3. The meter of claim 2 wherein the meter is configured to initiate an indexing protocol upon insertion of the disposable cartridge into the meter housing, wherein the integrity of each cell is checked.

4. The meter of claim 3 further comprising a processor, and wherein the processor is configured to index each cell as either available or used during the indexing protocol.

5. The meter of claim 4 wherein the meter housing comprises a contact pad and wherein the disposable cartridge is movable between a testing position, where an available cell is aligned with the contact pad, and a standby position, where each of the plurality of cells is out of alignment with the contact pad.

6. The meter of claim 5 wherein the light-blocking covering is a foil seal.

7. The meter of claim 6 wherein the meter housing comprises a punch for puncturing the foil seal.

8. The meter of claim 1 wherein the disposable cartridge is substantially cylindrical.

9. The meter of claim 1 wherein the disposable cartridge has a barcode thereon.

10. The meter of claim 1 wherein the light source is a LED.

11. The meter of claim 1 comprising a second detector.

12. The meter of claim 1 wherein each cell comprises a sampling arrangement, wherein the sampling arrangement comprises a needle and an assay pad.

13. An integrated body fluid sampling meter comprising:

a meter housing comprising a contact pad, the contact pad moveable upon application of force to the meter;

a tower held inside the meter housing, wherein the tower is configured to hold a disposable cartridge, the disposable cartridge comprising a plurality of sampling arrangements; and

an activation element within the meter housing, wherein the activation element is actuatable to initiate a fluid sampling protocol, and wherein application of a predetermined force to the disposable cartridge via the contact pad may actuate the activation element.

14. The meter of claim 13 wherein the tower is fixed relative to the meter housing.

15. The meter of claim 14 wherein the activation element comprises a strain gauge coupled to the tower.

16. The meter of claim 15 wherein application of the predetermined force to the disposable cartridge causes a deflection in the tower, and wherein the strain gauge measures the deflection in the tower.

17. The meter of claim 13 wherein the tower is moveable relative to the meter housing

18. The meter of claim 17 wherein the activation element is a switch, and wherein movement of the tower triggers the switch.

19. The meter of claim 13 wherein the activation element is a force sensor.

20. The meter of claim 17 wherein the tower is attached to the meter housing via a pin.

21. The meter of claim 20 wherein the pin is slidable relative to the meter housing.

22. The meter of claim 20 wherein the tower is rotatable around the pin.

23. The meter of claim 13 further comprising a detector held within the tower.

24. The meter of claim 23 further comprising an optical system, wherein the disposable cartridge comprises a plurality of viewing windows, and wherein the optical system optically connects the detector to one of the plurality of viewing windows.

25. The meter of claim 13 wherein the tower is configured to fit at least partially within a recess of the disposable cartridge.

26. The meter of claim 25 further comprising a rotation element for rotating the disposable cartridge around the tower.

27. An integrated body fluid sampling meter comprising:

a meter housing comprising a tower and an activation element; and

a cartridge engaging the tower, wherein the cartridge comprises a plurality of sampling arrangements, and wherein the tower is configured to actuate the activation element to initiate a sampling protocol.

28. A method for sampling a body fluid comprising:

positioning a body fluid sampling meter adjacent to a sampling site, wherein the body fluid sampling meter comprises a meter housing having a contact pad, an activation element, and a tower within the meter housing, and configured to hold a disposable cartridge having a plurality of sampling arrangements; and

automatically sampling the sampling site with one of the plurality of sampling arrangements when the contact pad applies a force to the disposable cartridge to actuate the activation element.