Body fluid sampling device with pivotable catalyst member

• US 8,372,015 B2
• Filed: 08/28/2006
• Issued: 02/12/2013
• Est. Priority Date: 08/28/2006
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Escutia, Raul, Emery, Jeffrey L., Litherland, Craig M., Jones, Jeffrey M., Loney, Gregory C., Tomasco, Michael F.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US11/510,784
• Publication Number:
  US 20080077048A1
• Time in Patent Office: 2,360 Days
• Field of Search: 600/573, 600/575, 600/583, 600/576, 600/578, 600/579, 606181-183, 606201-202
• 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 device housing;

at least one skin-penetration member in the device housing;

a catalyst member constructed for application of circumferential pressure proximate to a sampling site; and

a pump;

wherein the catalyst member is pivotably connected to the device housing in a manner such that the catalyst member can pivot relative to and away from the device housing between a first position and a second position; and

wherein the catalyst member comprises a connection with the device housing such that the pump applies a positive pressure to the catalyst member when the catalyst member is in the second position, wherein the device is configured to perform a first fluid sampling procedure when the catalyst member is in the first position and is further configured to perform a second fluid sampling procedure when the catalyst member is in the second position, wherein the catalyst member applies circumferential pressure to the sampling site during the second fluid sampling procedure, wherein the pump is configured to supply positive pressure to the catalyst member during the second fluid sampling procedure, and wherein the pump can be switched to alternatively supply negative pressure to the sampling site during the first fluid sampling procedure.

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 an amount of analyte contained in the sample of body fluid, and a device for communicating the amount of analyte contained in the sample of body fluid.

3. The device of claim 2, wherein the arrangement for quantifying the amount of analyte contained in the sample of body fluid comprises at least one complementary metal oxide semiconductor (CMOS)-based detector element.

4. The device of claim 3, wherein the arrangement for quantifying the amount of analyte contained in the sample of body fluid comprises a linear array of complementary metal oxide semiconductor (CMOS)-based detector elements.

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

6. The device of claim 5, wherein the footprint comprises an elastomer.

7. The device of claim 5, wherein the catalyst member and the footprint are separate elements.

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

9. The device of claim 8, wherein the cuff is inflated by the pump.

10. The device of claim 8, wherein the cuff is circumferentially continuous.

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

12. 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.

13. 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.

14. The device of claim 13, wherein the cartridge is moveable in order to present a new skin-penetration element and analysis site for use after performance of a preceding sampling event.

15. The device of claim 14, wherein the device is 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, as elected by a user.

16. The device of claim 1, wherein the catalyst member is connected to the housing via a hinge.

17. The device of claim 1, further comprising at least one sensor configured and arranged to detect a presence of the skin of the user, wherein upon said detection the device automatically activates the catalyst member, and drives the at least one skin-penetration member into the skin of the user.

18. The device of claim 1, wherein the catalyst member is connected to the housing such that in the first position the catalyst member is disposed a first distance from the housing, and when pivoted away from the housing is disposed in the second position at a second distance away from the housing, wherein the second distance is greater than the first distance.

19. The device of claim 18, further comprising a recess disposed in the housing, and wherein in the first position the catalyst member is disposed within the recess, and in the second position the catalyst member is located outside of the recess.

20. The device of claim 1, wherein the catalyst member comprises a passage therethrough constructed and arranged to receive an outer periphery of a digit therein, while leaving a tip of the digit exposed.

21. The device of claim 1, further comprising a cartridge received within the housing, the cartridge comprising a plurality of skin penetration members and a plurality of analysis sites.

22. An integrated device, the integrated device comprising:

a housing;

at least one skin-penetrating member in the housing;

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

a pump constructed and arranged to supply positive pressure to the catalyst member and negative pressure to the sampling site;

wherein the catalyst member is pivotably connected to the housing in a manner such that the catalyst member can pivot relative to and away from the housing between a first position and a second position,

wherein the device is configured to perform a first fluid sampling procedure when the catalyst member is in the first position and is further configured to perform a second fluid sampling procedure when the catalyst member is in the second position, wherein the catalyst member applies circumferential pressure to the sampling site during the fluid second sampling procedure, wherein the pump is configured to supply positive pressure to the catalyst member during the second fluid sampling procedure, and wherein the pump can be switched to alternatively supply negative pressure to the sampling site during the first fluid sampling procedure.

23. An integrated device, the device comprising:

a housing;

a footprint disposed on the housing or as an attachment to the housing;

a cartridge received within the housing, the cartridge comprising a plurality of skin-penetration members and a plurality of analysis sites;

a catalyst member pivotably connected to the housing and constructed for application of pressure proximate to a sampling site, wherein the catalyst member is pivotable relative to the housing between a first position and a second position, the second position allowing a tip of a digit received within the catalyst member to be placed upon the footprint; and

a pump constructed and arranged to supply positive pressure to the catalyst member and negative pressure to the sampling site,

wherein the device is configured to perform a first fluid sampling procedure when the catalyst member is in the first position and is further configured to perform a second fluid sampling procedure when the catalyst member is in the second position, wherein the catalyst member applies circumferential pressure to the sampling site during the second fluid sampling procedure, wherein the pump is configured to supply positive pressure to the catalyst member during the second fluid sampling procedure, and wherein the pump can be switched to alternatively supply negative pressure to the sampling site during the first fluid sampling procedure.

24. The device of claim 23, wherein the catalyst member comprises a cuff constructed to apply circumferential pressure to a digit placed therein.

25. The device of claim 24, wherein the cuff is inflated by the pump contained in the housing or in the catalyst member.

26. The device of claim 23, wherein the cartridge is moveable in order to present a new skin-penetration element and analysis site for use after performance of a preceding sampling event.

27. The device of claim 23, wherein the catalyst member is connected to the housing via a hinge.

28. The device of claim 23, further comprising a recess disposed in the housing, and wherein in the first position the catalyst member is disposed within the recess, and in the second position the catalyst member is located outside of the recess.

29. The device of claim 23, wherein the catalyst member is circumferentially continuous.

30. The device of claim 23, wherein the catalyst member comprises a passage therethrough constructed and arranged to receive an outer periphery of a digit therein, while leaving a tip of the digit exposed.

31. The device of claim 23, wherein the catalyst member and the footprint are separate elements.

32. An integrated device for body fluid sampling and analysis of alternative sites and digital sites, at election of a user, the device comprising:

a housing;

a footprint disposed on the housing or as an attachment to the housing;

a cartridge received within the housing, the cartridge comprising a plurality of skin-penetration members and a plurality of analysis sites;

a catalyst member pivotably connected to the housing and constructed for application of pressure proximate to a sampling site, wherein the catalyst member is movable relative to the housing between a first position and a second position, the first position allowing placement of the footprint on an alternative site, and the second position allowing a tip of a digit received within the catalyst member to be placed upon the footprint; and

a pump constructed and arranged to supply positive pressure to the catalyst member and negative pressure to the sampling site,

wherein the device is configured to perform a first fluid sampling procedure when the catalyst member is in the first position and is further configured to perform a second fluid sampling procedure when the catalyst member is in the second position, wherein the catalyst member applies circumferential pressure to the sampling site during the second fluid sampling procedure, wherein the pump is configured to supply positive pressure to the catalyst member during the second fluid sampling procedure, and wherein the pump can be switched to alternatively supply negative pressure to the sampling site during the first fluid sampling procedure.

33. The integrated device of claim 32 wherein the housing comprises a recess, and wherein the catalyst member is received within the recess in the first position.

34. The integrated device of claim 33, wherein the catalyst member is outside the recess when in the second position.

35. The integrated device of claim 34, wherein the housing comprises a top surface and at least one side surface, and wherein the recess is disposed in the at least one side surface of the housing.

36. The integrated device of claim 35, wherein the catalyst member comprises an inflatable cuff.

37. The integrated device of claim 32, further comprising a positive pressure feed line between the pump and a member, and a negative pressure feed line between the pump and the footprint.

38. The integrated device of claim 32, wherein each of the plurality of skin-penetration members is attached to a hub, and the hub is operably associated with a spring for driving the skin-penetration member into a skin surface of a user.

39. The integrated device of claim 38, wherein the spring comprises a torsional spring.