Devices and methods for body fluid sampling and analysis

• US 11,051,734 B2
• Filed: 09/06/2017
• Issued: 07/06/2021
• Est. Priority Date: 08/03/2011
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Escutia, Raul, Bloom, Daniel R., Hu, Charles, Reynolds, Paul D., Vivolo, Joseph A., Tomasco, Michael F.
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/697,311
• Publication Number:
  US 20180008178A1
• Time in Patent Office: 1,399 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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. A body fluid sampling arrangement comprising:

a hub comprising a patterned surface on a first side of the hub, wherein the patterned surface comprises a plurality of fluid channels and defines a volume;

a skin penetration member extending from a second, opposite side of the hub and configured to pierce skin, wherein the skin penetration member comprises a bore therethrough, wherein the bore is in fluid communication with the patterned surface; and

a quantification member configured to react with a body fluid sample,

wherein the hub is configured to collect the body fluid sample in the volume, and when the volume is filled, deliver the body fluid sample to the quantification member.

2. The arrangement of claim 1, wherein the volume is a volume sufficient to provide a measurable result indicative of a property of the body fluid sample.

3. The arrangement of claim 2, wherein the body fluid sample is blood and the property of the body fluid sample is a concentration of glucose.

4. The arrangement of claim 1, wherein the patterned surface is configured to spread the body fluid sample so that it is positioned across a surface of the quantification member prior to contacting the quantification member.

5. The arrangement of claim 1, wherein the bore is centrally positioned relative to the patterned surface and the patterned surface is configured to promote spread of the body fluid sample radially across the patterned surface.

6. The arrangement of claim 1, wherein the patterned surface is configured to draw the body fluid sample from the bore across the patterned surface.

7. The arrangement of claim 6, wherein the patterned surface is configured to draw the body fluid sample across the patterned surface using capillary action.

8. The arrangement of claim 1, wherein the patterned surface further comprises a plurality of flow diverters.

9. The arrangement of claim 8, wherein each of the fluid channels is positioned between two adjacent flow diverters.

10. The arrangement of claim 8, wherein each of the fluid channels comprises a ramped surface.

11. The arrangement of claim 10, wherein each of the fluid channels increases in width as the fluid channel becomes shallower.

12. The arrangement of claim 8, wherein the plurality of flow diverters comprises a first flow diverter comprising an upper surface that is parallel with an upper surface of the hub, and a second flow diverter comprising an upper surface that is angled toward the bore.

13. The arrangement of claim 12, wherein the quantification member is positioned on the upper surface of the first flow diverter.

14. The arrangement of claim 12, wherein the second flow diverter allows the body fluid sample to reach a larger area of the quantification member.

15. The arrangement of claim 1, wherein the quantification member is positioned over the patterned surface.

16. The arrangement of claim 1, wherein the skin penetration member comprises an inner diameter of about 25-250 micrometers.

17. The arrangement of claim 1, wherein the patterned surface comprises a heparin coating, a surfactant coating, a wetting agent, or a combination thereof.

18. The arrangement of claim 1, wherein the hub further comprises a bore, and wherein the bore in the hub holds the skin penetration member.

19. The arrangement of claim 18, wherein each of the fluid channels comprises a ramped surface extending between the bore in the hub and an upper surface of the hub.

20. The arrangement of claim 1, wherein the arrangement is configured such that a reaction does not occur until the volume is filled.