Multi-site body fluid sampling and analysis cartridge

• US 20070179405A1
• Filed: 09/29/2006
• Published: 08/02/2007
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Escutia, Raul, Jones, Jeffrey, Litherland, Craig, Emery, Jeffrey, Pfeiffer, James
• Granted Patent: US 9,380,974 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 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.

2. The arrangement of claim 1, wherein the housing comprises a plurality of apertures positioned to correspond with the location of each of the plurality skin-penetration members at each of the analysis sites.

3. The arrangement of claim 1, further comprising a plurality of footprints, each footprint disposed on the housing and surrounding a respective aperture, each footprint constructed to be applied to a sampling site on the skin of a user.

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

5. The arrangement of claim 3, wherein each footprint comprises an elastomeric seal.

6. The arrangement of claim 1, wherein at least a portion of the housing is transparent, thereby providing optical communication with each analyte quantification member.

7. The arrangement of claim 1, wherein the at least one skin-penetration member comprises a needle.

8. The arrangement of claim 1, wherein each actuator comprises a spring.

9. The arrangement of claim 8, wherein the spring comprises a torsional spring.

10. The arrangement of claim 9, wherein the torsional spring comprises a neutral position that causes the first end of the at least one skin penetration member to obstruct a wound opening created upon piercing the skin of the user.

11. The arrangement of claim 9, wherein the arrangement lacks a positive stop to limit the penetration depth of the at least one skin-penetration member.

12. The arrangement of claim 1, wherein each analysis site further comprises a hub, each skin-penetration member being attached to a respective hub, and a respective analyte quantification member being disposed on or within the hub.

13. The arrangement of claim 12, wherein each hub comprises at least one feature permitting attachment of a respective actuator thereto.

14. The arrangement of claim 12, wherein the hub comprises at least one of a groove or projections which releasably locks the hub against movement by the actuator.

15. The arrangement of claim 14, further comprising a triggering mechanism for releasing the hub thereby allowing movement of the hub by the actuator.

16. The arrangement of claim 15, wherein the actuator comprises a spring having a leg, the hub comprises a groove with the leg releasably mounted therein, and the triggering mechanism comprises a moveable actuator arm which displaces the leg from the groove thereby allowing movement of the hub by the actuator.

17. The arrangement of claim 16, wherein the moveable actuator comprises an angular or arcuate ramp surface.

18. The arrangement of claim 16, wherein the housing comprises an opening for passage of the moveable actuator, and the opening comprises a seal.

19. The arrangement of claim 18, wherein the seal comprises:

a solid flexible membrane;

an apertured membrane in combination with a secondary seal;

or

a piercable membrane.

20. The arrangement of claim 14, wherein the hub comprises a projection and the housing comprises a groove for releasably receiving the projection.

21. The arrangement of claim 15, wherein the triggering mechanism comprises a severable wire or fuse.

22. The arrangement of claim 1, wherein the arrangement is provided in the form of a disposable cartridge.

23. The arrangement of claim 1, further comprising readable information.

24. The arrangement of claim 23, wherein the readable information is contained on or within the housing.

25. The arrangement of claim 23, wherein the readable information comprises at least one of:

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

26. The arrangement of claim 23, wherein the readable information is contained on a barcode or a chip comprising a readable memory.

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

28. The arrangement of claim 1, further comprising at least one light source and detector configured and arranged to interrogate each analyte quantification member.

29. The arrangement of claim 28, wherein the analyte quantification members are moveable to index and come into registry with the at least one light source and detector.

30. The arrangement of claim 28, wherein the at least one light source and detector are movable to index and come into registry with each analyte quantification member.

31. The arrangement of claim 30, wherein the at least one light source and detector are mounted on a moveable indexing arm.

32. The arrangement of claim 28, 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 light source and analyte quantification members, wherein the detector is positioned to receive light reflected off each analyte quantification member and the detector comprises a plurality of sections, each section designated to receive light reflected off of a respective one of the analyte quantification members.

33. The arrangement of claim 28, 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 light source and analyte quantification members, wherein the detector comprises a plurality of discrete detector elements each of which is positioned to receive light reflected off of a respective one of the analyte quantification members.

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

35. The integrated device of claim 34, further comprising a detector in optical communication with at least one analyte quantification member.

36. The integrated device of claim 35, wherein the detector comprises at least one CMOS-based detector element.

37. The integrated device of claim 35, wherein the detector comprises at least one linear or area array of CMOS-based detector elements.

38. The integrated device of claim 35, wherein the cartridge is moveable in order to present a new skin-penetration member, actuator and analyte quantification member for use after the performance of a preceding sampling and analysis event.

39. The integrated device of claim 34, wherein the device is configured for hand-held operation, operation while being worn, or for alternative hand-held or wearable operation at the election of the user.

40. The integrated device of claim 34, wherein device is configured for fingertip sampling, alternate site sampling, or alternative fingertip/alternate site sampling at the election of the user.