Multi-site body fluid sampling and analysis cartridge

• US 9,380,974 B2
• Filed: 09/29/2006
• Issued: 07/05/2016
• 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): Cohen, Lee S
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US11/529,614
• Publication Number:
  US 20070179405A1
• Time in Patent Office: 3,567 Days
• Field of Search: 600/583
• US Class Current: 1/1
• 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;

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

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

a spring actuator configured to drive the skin-penetration member into skin of a user;

a hub, wherein the skin-penetration member and the spring actuator are attached to the hub;

a pin, wherein the hub is configured to rotate around the pin; and

an analyte quantification member disposed on or within the hub, wherein the analyte quantification member is in fluid communication with the inner lumen of the skin-penetration member.

2. The arrangement of claim 1, wherein the housing further comprises a plurality of footprints, wherein each footprint surrounds a respective aperture and is configured to be applied to a sampling site on the skin of the user, and wherein the spring actuator of at least one of the plurality of sampling and analysis sites is configured to drive the skin-penetration member of the same sampling and analysis site through at least one of the respective apertures.

3. The arrangement of claim 2, wherein each footprint has an opening, the opening having a diameter or major dimension of 3-8 mm.

4. The arrangement of claim 2, wherein each footprint comprises an elastomeric seal.

5. The arrangement of claim 1, wherein at least a portion of the housing is transparent and provides optical communication with each analyte quantification member.

6. The arrangement of claim 1, wherein the skin-penetration member of at least one of the sampling and analysis sites comprises a microneedle.

7. The arrangement of claim 1, wherein the spring actuator of at least one of the sampling and analysis sites comprises a torsional spring configured to urge the skin-penetration member along an arcuate path.

8. The arrangement of claim 7, wherein the skin penetration member of the at least one sampling and analysis site that comprises a torsional spring is configured to obstruct a wound opening in the skin of the user after the torsional spring moves from a compressed position to a relaxed position.

9. The arrangement of claim 7, wherein at least one of the sampling and analysis sites that comprises a torsional spring lacks a positive stop to limit the penetration depth of the skin-penetration member of the respective sampling and analysis site.

10. The arrangement of claim 1, wherein the hub of at least one of the sampling and analysis sites comprises at least one of a groove or projections, and wherein the at least one of the groove or projections is configured to releasably lock the hub against movement by the spring actuator.

11. The arrangement of claim 1 further comprising a trigger configured to release the hub of at least one of the sampling and analysis sites, and wherein the respective spring actuator of the at least one sampling and analysis site is configured to move the hub when the hub is released.

12. The arrangement of claim 11, wherein the trigger comprises a moveable arm, and wherein the hub of the at least one sampling and analysis site comprises a groove and the respective spring actuator of the at least one sampling and analysis site comprises a spring having a leg releasably mounted in the groove, and wherein the moveable arm is configured to displace the leg from the groove and the spring actuator of the at least one sampling and analysis site is configured to move the hub of the at least one sampling and analysis site when the moveable arm displaces the leg from the groove.

13. The arrangement of claim 12, wherein the moveable arm comprises an angular or arcuate ramp surface.

14. The arrangement of claim 12, wherein the housing comprises an opening for passage of the moveable arm, wherein the opening comprises a seal and wherein the seal comprises a solid flexible membrane, an apertured membrane in combination with a secondary seal, or a piercable membrane.

15. The arrangement of claim 11, wherein the trigger comprises a severable wire or fuse.

16. The arrangement of claim 1, wherein the arrangement is a disposable cartridge.

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

18. The arrangement of claim 17, wherein the readable information comprises at least one of:

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

19. The arrangement of claim 1, wherein at least one of the sampling and analysis sites comprises a control corresponding to a predetermined analyte concentration.

20. The arrangement of claim 1, 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.

21. The arrangement of claim 20, wherein the analyte quantification members 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.

22. The arrangement of claim 20, wherein the at least one light source and detector are configured to move to create 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.

23. The arrangement of claim 22, wherein the at least one light source and detector are mounted on a moveable indexing arm.

24. The arrangement of claim 20, the arrangement further comprising a plurality of light transmitting elements in optical communication with the at least one light source and the analyte quantification members, wherein the at least one light source and detector and the analyte quantification members are fixed relative to each other, wherein the detector is positioned to receive light reflected off each analyte quantification member, and wherein the detector comprises a plurality of sections, each section designated to receive light reflected off of a respective one of the analyte quantification members.

25. The arrangement of claim 20, wherein the at least one light source and detector, and the analyte quantification members, are fixed relative to each other, and further comprising a plurality of light transmitting elements in optical communication with the at least one light source and analyte quantification members, wherein the detector comprises a plurality of discrete detector elements, and wherein each of the plurality of discrete detector elements is positioned to receive light reflected off of a respective one of the analyte quantification members.

26. The arrangement of claim 1, wherein the spring actuator of at least one of the sampling and analysis sites is configured to move the hub and the skin-penetration member in an arcing movement toward the skin of the user.

27. The arrangement of claim 1, wherein the arrangement further comprises a cartridge and the cartridge comprises the plurality of sampling and analysis sites.

28. The arrangement of claim 1, wherein the arrangement has an annular shape.

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

30. The integrated device of claim 29, further comprising a detector in optical communication with at least one analyte quantification member.

31. The integrated device of claim 30, wherein the detector comprises at least one complementary metal oxide semiconductor (CMOS)-based detector element.

32. The integrated device of claim 30, wherein the detector comprises at least one linear or area array of CMOS-based detector elements.

33. The integrated device of claim 30, wherein the housing is configured to move to present a new skin-penetration member, spring actuator and analyte quantification member after the performance of a preceding sampling and analysis event.

34. The integrated device of claim 29, wherein the device is configured for one or more of hand-held operation and operation while being worn.

35. The integrated device of claim 29, wherein the device is configured for one or more of fingertip sampling and alternate site sampling.

36. An arrangement comprising:

a housing;

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

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

an actuator configured to drive the skin-penetration member into skin of a user;

a hub, wherein the skin-penetration member and the actuator are attached to the hub;

a pin, wherein the hub is configured to rotate around the pin; and

an analyte quantification member disposed on or within the hub, wherein the analyte quantification member is in fluid communication with the inner lumen of the skin-penetration member.

37. The arrangement of claim 36, wherein the arrangement further comprises a cartridge and the cartridge comprises the plurality of sampling and analysis sites.

38. The arrangement of claim 36, wherein the actuator of at least one of the sampling and analysis sites is configured to move the hub and the skin-penetration member in an arcing movement toward the skin of the user.

39. The arrangement of claim 36, wherein the arrangement has an annular shape.

40. The arrangement of claim 36, wherein the arrangement is a disposable cartridge.