Body fluid monitoring and sampling devices and methods

• US 20080077048A1
• Filed: 08/28/2006
• Published: 03/27/2008
• Est. Priority Date: 08/28/2006
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Tomasco, Michael F., Jones, Jeffrey M., Escutia, Raul, Emery, Jeffrey L., Litherland, Craig M., Loney, Gregory C.
• Granted Patent: US 8,372,015 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150099 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 5/150358 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• 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 5/15113 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An integrated monitoring and body fluid sampling device constructed to permit digital as well as alternate-site body fluid sampling and analysis, the device comprising: a housing; at least one skin-penetration member; and a member constructed for the application of circumferential or vacuum pressure to an appendage; wherein the member is detachably or retractably connected to the housing in a manner such that the integrated monitoring and body fluid sampling device can perform digital or alternate-site body fluid sampling and analysis. Additional arrangements and techniques are also described.

Claims

1. An integrated device, the device comprising:

a housing;

at least one skin-penetration member; and

a member constructed for the application of circumferential or vacuum pressure to a sampling site;

wherein the member is detachably or moveably connected to the housing in a manner such that the integrated device can perform digital or alternate-site body fluid sampling and analysis.

2. The device of claim 1, wherein the housing contains the at least one skin-penetration member, a mechanism for transporting a sample of body fluid to an analysis site, and an arrangement for quantifying the amount of analyte contained the sample of body fluid, and a device for communicating the amount of analyte contained in the sample.

3. The device of claim 2, wherein the housing further contains a pump.

4. The device of claim 1, further comprising a footprint disposed on the housing or the attachment constructed to be applied to the sampling site on the skin of a user.

5. The device of claim 1, wherein the member comprises a cuff constructed to apply circumferential pressure to a digit placed therein.

6. The device of claim 5, wherein the cuff is inflated by a pump contained in the housing or in the member.

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

8. The device of claim 5, wherein the footprint comprises a elastomeric seal.

9. The device of claim 3, wherein the member comprises a connection with the housing such that the pump applies a negative pressure to the sampling site.

10. The device of claim 2, wherein the arrangement for quantifying the amount of analyte contained the sample of body fluid comprises at least one CMOS-based detector element.

12. The device of claim 1, comprising a connection between the housing and the member that indicates whether the device is to be used for digital or alternate-site sampling.

13. The device of claim 12, wherein the connection comprises electrical connectors.

14. The device of claim 12, wherein the connection provides for a positive pressure feedback when a digital member is attached to the housing, and a negative pressure feedback when an alternative-site sampling member is attached to the housing, and a pressure transducer capable of detecting the positive or negative pressure.

15. The device of claim 1, further comprising a footprint disposed on the housing constructed to be applied to the sampling site on the skin of a user during body fluid sampling, wherein the member comprises a member for applying circumferential pressure to a digit disposed therein, and the member is retractably connected to the housing in a manner that permits alternative-site sampling by application of the footprint to the skin of a user.

16. The device of claim 15, wherein the member is pivotably connected to the housing.

17. The device of claim 15, wherein the member is connected to the housing by a retractable tube/cord assembly.

18. The device of claim 1, wherein the housing contains a disposable cartridge comprising a plurality of skin-penetration elements and analysis sites, such that multiple tests can be performed without replacing the cartridge.

19. The device of claim 18, wherein the cartridge is moveable in order to present a new skin-penetration element and analysis site for use after the performance of a preceding sampling event.

20. The device of claim 19, wherein the device of constructed such that a plurality of skin-penetration members and analysis sites are presented for possible body fluid sampling in a manner that permits either digital or alternate-site sampling, at the election of the user.

11. The device of claim 11, wherein the arrangement for quantifying the amount of analyte contained the sample of body fluid comprises a linear array of CMOS-based detector elements.

21. An integrated device, the device comprising:

a housing;

a first footprint and a second footprint disposed on the housing, the first and second footprints constructed to be applied to a sampling site on the skin of a user during body fluid sampling;

a plurality of skin-penetration members contained within the housing, a first and second of the plurality of skin penetration members being in registry with the first and second footprint, respectively; and

a member constructed for the application of circumferential pressure to the sampling site;

wherein the first footprint is constructed and arranged for sampling body fluid from a digit, and the second footprint is constructed and arranged for sampling body fluid from an alternate site on the body of the user.

22. An integrated device constructed to permit digital as well as alternate-site body fluid sampling and analysis, the device comprising:

a housing;

at least one skin-penetration member; and

a member constructed for the application of circumferential pressure to a digit of the user;

wherein the member is movably or retractably connected to the housing in a manner such that the integrated monitoring and body fluid sampling device can perform digital or alternate-site body fluid sampling and analysis.

23. An arrangement for body fluid sampling, the arrangement comprising:

a housing;

at least one skin penetration member; and

a member constructed to apply circumferential or substantially circumferential pressure to a digit placed therein;

wherein the at least one skin penetration member is constructed and arranged to pierce a surface of the skin of the digit at a location proximate to the member constructed to apply circumferential pressure.

24. The arrangement of claim 23, wherein the housing is shaped and contoured to conform to a palm and fingers of a user when grasped by a hand of a user.

25. The arrangement of claim 23, wherein the at least one skin-penetration member comprises a lancet.

26. The arrangement of claim 25, wherein the at least one skin-penetration member forms part of a disposable cartridge comprising a plurality of skin-penetration members.

27. The arrangement of claim 26, wherein the cartridge is circular.

28. The arrangement of claim 23, wherein the member comprises an inflatable cuff.

29. The arrangement of claim 23, wherein the member comprises a cinchable strap.

30. The arrangement of claim 23, wherein the member comprises spring loaded arms adapted to encircle a digit disposed therein.

31. The arrangement of claim 23, wherein the member comprises a wound cable or strap.

32. The arrangement of claim 23, wherein the member comprises a biased pusher arm.

33. The arrangement of claim 23, wherein the member comprises an open jaw, the open jaw comprising an inflatable pillow disposed on an interior surface thereof.

34. The arrangement of claim 23, wherein the member comprises a closed jaw comprising a frame and a movable arm, the moveable arm comprising an inflatable pillow on an interior surface thereof.

35. The arrangement of claim 23, wherein the member comprises a U-shaped channel comprising first and second arms defining a distance therebetween, the distance selected such that interference is produced with a digit when said therethrough.

36. The arrangement of claim 35, wherein the U-shaped channel is fixedly mounted to the housing.

37. The arrangement of claim 35, wherein the U-shaped channel is movably connected to a driving mechanism.

38. An integrated body fluid sampling and analysis device comprising the arrangement of claim 23.