Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing

• US 7,713,214 B2
• Filed: 12/18/2002
• Issued: 05/11/2010
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M.
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/324,053
• Publication Number:
  US 20030199894A1
• Time in Patent Office: 2,701 Days
• Field of Search: 606/167, 606/172, 606/173, 606/181, 606/182, 606/183, 606/180, 600/573, 600/583, 600/575
• US Class Current: 600/583
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15113 : 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 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single 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 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

A device for use with a penetrating member driver to penetrate tissue is provided. The device includes a single cartridge coupled to a plurality of penetrating members and operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of optical analyte sensors are coupled to the single cartridge and positioned to receive body fluid from a wound in the tissue created by the penetrating member.

Claims

1. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single disposable;

an electronic drive force generator;

a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth;

a plurality of penetrating members coupled to said single disposable and operatively couplable to the electronic drive force generator, said penetrating members movable to extend radially outward from the disposable to penetrate tissue, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract;

a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and

a plurality of optical analyte sensors, each of an optical analyte sensor being positioned in a sample chamber to receive body fluid from the wound in the tissue created by the penetrating member, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and

an optical illumination system to provide illumination of at least a portion of the sample chamber.

2. The device of claim 1 wherein the disposable includes a plurality of transparent windows aligned with said optical analyte sensors.

3. The device of claim 1 wherein said penetrating members are slidably coupled to said disposable.

4. The device of claim 1 wherein at least one optical analyte sensor is associated with at least one of said penetrating members.

5. The device of claim 1 wherein said disposable is a flat radial disc.

6. The device of claim 1 wherein said disposable has a diameter of less than 6 cm.

7. The device of claim 1 wherein said disposable is a unitary body.

8. The device of claim 1 wherein said penetrating members are not attached by a resilient member to the disposable.

9. The device of claim 1 wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

10. The device of claim 1 wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

11. The device of claim 1 wherein said optical analyte sensors are mounted on said cartridge disposable.

12. The device of claim 1 wherein each of said optical analyte sensors comprises an array of sensors.

13. The device of claim 1 wherein each of said optical analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity.

14. The device of claim 1 wherein each of said penetrating members are elongate members without molded attachments.

15. The device of claim 1 wherein each of said penetrating members is made of only one material selected from the following:

a metal or a metal alloy.

16. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single disposable having a plurality of cavities;

an electronic drive force generator;

a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth;

a plurality of penetrating members coupled to said single disposable and couplable to the electronic drive force generator, said penetrating members movable to extend outward to penetrate tissue, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract;

a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and

a plurality of optical analyte sensors each of an analyte sensor positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and

an optical illumination system to provide illumination of at least a portion of the sample chamber.

17. The device of claim 16 wherein the disposable includes a plurality of transparent windows aligned with said optical analyte sensors.

18. The device of claim 16, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

19. The device of claim 16, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 n a no liters.

20. The device of claim 16, wherein at least some of said optical analyte sensors are positioned on a bottom surface of said cavities.

21. The device of claim 16, wherein at least some of said optical analyte sensors are positioned on a side surface of said cavities.

22. The device of claim 16, wherein at least some of said optical analyte sensors are positioned on a top surface of said cavities.

23. The device of claim 16, wherein at least some of said optical analyte sensors are positioned on a curved surface of said cavities.

24. A device for use with a penetrating member driver to penetrate tissue, the device comprising:

a single disposable having a plurality of openings and a plurality of penetrating member cavities;

an electronic drive force generator;

a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth;

a plurality of penetrating members at least partially contained in said cavities, each of a penetrating member being couplable to the electronic drive force generator, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract;

a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and

a plurality of optical sensors attached to a substrate, said substrate couplable to said single disposable in manner positioning at least one of said optical sensors with each of said plurality of cavities, each of a sensor being positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and

an optical illumination system to provide illumination of at least a portion of the sample chamber.

25. The device of claim 24, wherein disposable includes a plurality of optically transparent portions aligned with said optical analyte sensors.

26. The device of claim 24, wherein said substrate comprises a material selected from:

polymer, metallic foil, or paper.

27. The device of claim 24, wherein said substrate comprises a laminate made from combinations of any of the following:

polymer, metallic foil, or paper.

28. The device of claim 24, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

29. The device of claim 24, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

30. A body fluid sampling system comprising:

a disposable;

an electronic drive force generator;

a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth;

a plurality of penetrating members coupled to said disposable and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue, each of a penetrating member being couplable to the electronic drive force generator, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract;

a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and

a plurality of optical analyte sensors coupled to said disposable, each of an optical analyte sensor being positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and

an optical illumination system to provide illumination of at least a portion of the sample chamber.

31. The system of claim 30, wherein disposable includes a plurality of optically transparent portions aligned with said optical analyte sensors.

32. The system of claim 30, further comprising a light source for providing excitation energy to one of said analyte sensors.

33. The system of claim 30, further comprising a dichroic mirror.

34. The system of claim 30, further comprising an optical sensor receiving reflected energy from one of said optical analyte sensors.

35. A system as in claim 30, wherein said drive force generator is configured to sequentially drive said penetrating members, each of said members moved from said launch position along a path into and out of the tissue site.

36. The system of claim 30, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter.

37. The system of claim 30, wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters.

38. The system of claim 30, wherein said optical analyte sensors are mounted on said disposable.

39. The system of claim 30, wherein each of said optical analyte sensors comprises an array of sensors.

40. The system of claim 30, wherein each of said optical analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity.

41. The system of claim 30, wherein each of said penetrating members are elongate members without molded attachments.

42. The system of claim 30, wherein each of said penetrating members is made of only one material selected from the following:

a metal or a metal alloy.