Multi-site body fluid sampling and analysis cartridge

• US 10,441,205 B2
• Filed: 06/23/2016
• Issued: 10/15/2019
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Litherland, Craig M., Emery, Jeffrey L., Escutia, Raul, Pfeiffer, James W., Jones, Jeffrey M.
• Primary Examiner(s): Cerioni, Daniel L
• Application Number:
  US15/191,434
• Publication Number:
  US 20160367178A1
• Time in Patent Office: 1,209 Days
• Field of Search: 600583
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150076 by heating
• 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 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150969 : Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15121 : comprising piezos
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15148 : Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
• 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 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/155 : Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices
• CPC Class Codes: A61B 5/6824 : Arm or wrist
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: G01N 1/14 : Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 21/0303 : Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/77 : by observing the effect on a chemical indicator
• CPC Class Codes: G01N 27/416 : Systems G01N27/27 takes precedence

Abstract

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

Claims

1. An arrangement comprising:

a housing comprising a plurality of chambers;

a plurality of sampling and analysis sites, each of the plurality of sampling and analysis sites contained within a respective chamber of the housing and comprising;

a skin-penetration member having a first end configured to pierce skin, wherein the skin-penetration member comprises an inner lumen in communication with the first end;

an actuator configured to drive the skin penetration member; and

an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member; and

at least one seal configured to protect the skin-penetration member, actuator, and analyte quantification member from contamination, wherein each chamber is enclosed and completely sealed.

2. The arrangement of claim 1, wherein the housing comprises an inner frame.

3. The arrangement of claim 2, wherein the inner frame partially encloses each of the plurality of chambers.

4. The arrangement of claim 1, wherein the housing comprises an opening for passage of one of the plurality of skin-penetration members and the at least one seal covers the opening.

5. The arrangement of claim 4, wherein the at least one seal is puncturable.

6. The arrangement of claim 5, wherein one of the skin-penetration members punctures the at least one seal.

7. The arrangement of claim 4, wherein the at least one seal is removeable.

8. The arrangement of claim 1, wherein the housing comprises an opening for passage of a triggering mechanism configured to trigger at least one of the sampling and analysis sites, and wherein the at least one seal covers the opening.

9. The arrangement of claim 8, wherein the at least seal comprises:

a solid flexible membrane;

an aperture membrane in combination with a secondary seal;

or

a pierceable membrane.

10. The arrangement of claim 8, wherein the at least one seal is configured to maintain sealing after passage of the triggering mechanism therethrough.

11. The arrangement of claim 1, wherein the housing comprises a first opening for passage of one of the plurality of skin-penetration members and a second opening for passage of a triggering mechanism.

12. The arrangement of claim 11, wherein the at least one seal comprises a first seal covering the first opening and a second seal covering the second opening.

13. The arrangement of claim 1, wherein the housing comprises a plurality of openings positioned to correspond with the location of the plurality of skin penetration members, and wherein the at least one seal covers the openings.

14. The arrangement of claim 13, wherein the at least one seal comprises a sealing film.

15. The arrangement of claim 1, wherein at least one of the plurality of skin-penetration members comprises a needle.

16. The arrangement of claim 1, wherein at least one of the plurality of actuators comprises a spring.

17. The arrangement of claim 16, wherein the spring comprises a torsional spring configured to urge at least one of the skin-penetration members along an arcuate path.

18. The arrangement of claim 17, wherein the at least one skin-penetration member of the at least one sampling and analysis site that comprises the torsional spring is configured to obstruct a wound opening in skin of a user after the torsional spring moves to a neutral position.

19. The arrangement of claim 1, wherein each analysis site further comprises a hub and each skin-penetration member is attached to a respective hub.

20. The arrangement of claim 19, wherein at least one of the hubs is configured to be released by a triggering mechanism, and wherein the respective actuator is configured to move the hub when the hub is released.

21. An integrated body fluid sampling and analysis device comprising the arrangement of claim 1.

22. The integrated device of claim 21 further comprising a detector in optical communication with at least one analyte quantification member through a transparent portion of the housing.

23. The integrated device of claim 22, wherein the detector comprises at least one complementary metal oxide semiconductor (CMOS)-based detector element.

24. The integrated device of claim 22, wherein the detector comprises at least one of a linear or area array of CMOS-based detector elements.

25. The integrated device of claim 21, wherein the arrangement is provided as a disposable cartridge.

26. The integrated device of claim 21, wherein the integrated device moves the housing in order to present a new sampling and analysis site for use after the performance of a preceding sampling and analysis event.

27. The integrated device of claim 21 further comprising at least one light source and detector, wherein the at least one light source and detector are configured to interrogate each analyte quantification member.

28. The integrated device of claim 27, wherein the analyte quantification members are moveable to index and come into registry with the at least one light source and detector for analysis.

29. The integrated device of claim 27, wherein the at least one light source and detector are configured to move to facilitate the creation of a list of unused analyte quantification members or to align an analyte quantification member with the at least one light source and detector for analysis.

30. The integrated device of claim 21, wherein the integrated device is configured for one or more of hand-held operation and operation while being worn.

31. The arrangement of claim 1, wherein the arrangement is provided as a disposable cartridge.

32. The arrangement of claim 1, wherein at least a portion of the housing is transparent.

33. The arrangement of claim 1, wherein the at least one seal is further configured to facilitate the creation of vacuum pressure at one of the plurality of the sampling and analysis sites.

34. The arrangement of claim 33, wherein the at least one seal is configured to maintain vacuum pressure after passage of a triggering mechanism therethrough.

35. The arrangement of claim 1 further comprising a barcode or a chip contained on or within the housing, wherein the barcode or chip comprises readable information.

36. The arrangement of claim 35, where in the readable information comprises at least one of:

calibration information, algorithm information, software code, and accuracy verification information.