Reagent-less whole-blood glucose meter

• US 20030086073A1
• Filed: 07/19/2002
• Published: 05/08/2003
• Est. Priority Date: 11/08/2001
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: Hercules Technology Growth Capital, Inc.
• Inventors: Braig, James R., Zheng, Peng, Li, Kenneth I., Sterling, Bernhard B., Hartstein, Philip C., Rule, Peter, Goldberger, Daniel S., Hall, W. Dale, Witte, Kenneth G., Gaffney, Robert D., Cortella, Julian M., Agostino, Mark D.
• Granted Patent: US 7,050,157 B2
• Time in Patent Office: Days
• US Class Current: 356/39
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence

Abstract

A reagentless whole-blood analyte detection system that is capable of being deployed near a patient has a source capable of emitting a beam of radiation that includes a spectral band. The whole-blood system also has a detector in an optical path of the beam. The whole-blood system also has a housing that is configured to house the source and the detector. The whole-blood system also has a sample element that is situated in the optical path of the beam. The sample element has a sample cell and a sample cell wall that does not eliminate transmittance of the beam of radiation in the spectral band.

Claims

1. A method of manufacturing a sample element with a sample element forming material, the method comprising:

(a) providing a molding chamber configured to receive a first molding insert and configured to receive a second molding insert, the first molding insert having a generally planar shape and having a first molding insert longitudinal axis, the second molding insert having a second molding insert longitudinal axis,

(b) selecting a molding condition within the molding chamber;

(c) positioning the first molding insert in the molding chamber, and positioning the second molding insert in the molding chamber such that the second molding insert longitudinal axis forms an angle with the first molding insert longitudinal axis;

(d) flowing the sample element forming material into the molding chamber; and

(e) removing the first molding insert and the second molding insert from the molding chamber.

2. The method of claim 1, wherein the selecting further comprises selecting the volume of the molding chamber.

3. The method of claim 2, further comprises changing the volume of the molding chamber between step (b) and step (e).

4. The method of claim 1, wherein the selecting further comprises selecting the pressure of the molding chamber.

5. The method of claim 4, further comprising changing the pressures of the molding chamber between step (b) and step (e).

6. The method of claim 1, wherein the selecting comprises selecting a low temperature molding process.

7. A sample element comprising:

a pierceable portion;

a sample cell defined by a first window and a second window;

a sample supply passage extending between the sample cell and the pierceable portion; and

a sample extractor.

8. The sample element of claim 7, wherein the sample cell is configured to hold a sample of tissue.

9. The sample element of claim 7, wherein the sample cell is configured to hold a sample of fluid.

10. The sample element of claim 9, wherein the sample cell is configured to hold a sample of whole-blood.

11. The sample element of claim 7, wherein the sample cell is configured to hold a mixture of bodily fluids comprising at least one of interstitial fluid, intracellular fluid, and whole-blood.

12. The sample element of claim 7, wherein the sample cell is configured to hold a sample of organic material.

13. The sample element of claim 7, wherein the sample cell is configured to hold a sample of inorganic material.

14. The sample element of claim 7, further comprising a mechanical intervention blood acquisition system.

15. The sample element of claim 14, wherein the mechanical intervention blood acquisition system further comprises a source of negative pressure.

16. The sample element of claim 15, wherein the negative pressure is induced by at least one of an ultrasonic system and a mechanical system.

17. The sample element of claim 7, further comprising a means for enhancing sample flow in the sample element.

18. The sample element of claim 17, wherein the means for enhancing sample flow comprises a surfactant.

19. The sample element of claim 17, wherein the means for enhancing sample flow comprises a physical treatment of at least a portion of the sample element.

20. The sample element of claim 17, wherein the means for enhancing sample flow comprises a chemical treatment of at least a portion of the sample element.

21. The sample element of claim 17, wherein the means for enhancing sample flow comprises a topological feature on at least one surface of the sample element.

22. A sample element comprising:

an opening;

a first sample cell wall, the first sample cell wall having a first inner side and a first outer side;

a sample cell at least partially defined by the first sample cell wall; and

a sample supply passage extending between the opening and the sample cell.

23. The sample element of claim 22, further comprising

a second sample cell wall having a second inner side and a second outer side;

an aperture; and

a auxiliary passage extending between the sample cell and the aperture.

24. The sample element of claim 23, further comprising an optical pathlength defined by the perpendicular distance between the first inner side and the second inner side.

25. The sample element of claim 24, wherein the optical pathlength is between about 1 μ

m and about 1.22 mm.

26. The sample element of claim 24, wherein the optical pathlength is between about 1 μ

m and about 100 μ

m.

27. The sample element of claim 24, wherein the optical pathlength is between about 24 μ

m and about 60 μ

m.

28. The sample element of claim 24, wherein the optical pathlength is about 25 μ

m.

29. The sample element of claim 24, wherein the optical pathlength is about 35 μ

m.

30. The sample element of claim 24, wherein the optical pathlength is about 45 μ

m.

31. The sample element of claim 24, wherein the optical pathlength is about 50 μ

m.

32. The sample element of claim 24, wherein the optical pathlength is about 55 μ

m.

33. The sample element of claim 22, further comprising a flow enhancer to increase the flow of the sample in the sample supply passage to the sample cell.

34. The sample element of claim 33, wherein the flow enhancer comprises at least one depression.

35. The sample element of claim 34, wherein the depression is formed by at least one of:

heating and applying pressure.

36. The sample element of claim 33, wherein the flow enhancer comprises a surfactant.

37. The sample element of claim 33, wherein the flow enhancer comprises a physical treatment of at least a portion of the sample element.

38. The sample element of claim 33, wherein the flow enhancer comprises a chemical treatment of at least a portion of the sample element.

39. The sample element of claim 33, wherein the flow enhancer comprises a topological feature on at least one surface of the sample element.

40. The sample element of claim 33, wherein at least one surface of the sample supply passage has a low surface tension.

41. The sample element of claim 22, wherein at least one surface of the sample supply passage has a surface tension, the surface tension being reduced by at least one of:

a deposition of a granulated detergent, a deposition of a surfactant, dipping the sample supply passage in a surfactant, a discharge of an electrical voltage, an application of an electrical current, or a corona discharge.

42. The sample element of claim 22, wherein the sample element is configured so that most of the sample that enters the sample supply passage is drawn out of the sample supply passage into the sample cell.

43. The sample element of claim 42, wherein the sample supply passage has a sample supply passage surface tension and the sample cell has a sample cell surface tension, the sample cell surface tension and the sample supply passage surface tension being selected so that most of the sample that enters the sample supply passage is drawn out of the sample supply passage into the sample cell.

44. The sample element of claim 22, wherein at least a portion of the sample supply passage comprises a shape configured to urge a sample toward the sample cell.

45. The sample element of claim 44, wherein the shape comprises a sawtooth configuration.

46. A sample element handling system comprising:

at least two sample elements;

an unused sample element portion; and

a used sample element portion connected to the unused sample element portion;

wherein prior to deployment of the sample element handling system, each of the sample elements are housed within the unused sample element portion, the sample elements being advanceable from the unused sample element portion to the used sample element portion.

47. The sample element handling system of claim 46, wherein the used sample element portion is configured to isolate the samples so that the sample element handling system can be discarded with non-biohazardous waste.

48. The sample element handling system of claim 46, wherein the sample element handling system further comprises an arcuate sample element carrier, the sample elements arranged around the outer perimeter of the sample element carrier.

49. A method of filling a sample element with a sample, the method comprising:

providing a sample element handler that includes at least two sample elements, an unused sample element portion, and a used sample element portion connected to the unused sample element portion;

(a) advancing a first sample element from the unused portion to a sample taking location;

(b) taking a sample so as to at least partially fill the sample element;

(c) advancing the first sample element from the sample taking location to the used sample element portion;

wherein the sample element handler is configured to be insertable into a whole-blood system so that the filled sample element is presented to an energy source.

50. The method of claim 49, wherein the steps (a)-(c) are all performed without intervention by the user.

51. A sample element cartridge comprising:

a first sample element;

a second sample element detachably attached to the first sample element; and

a sample element handler having a stored sample element portion, a deployed sample element portion, and a sample element advancer configured to transfer the first sample element from the stored sample element portion to the deployed sample element portion, and to transfer the second sample element from the stored sample element portion to the deployed sample element portion;

wherein the first sample element is configured to be detached from the second sample element after it has been transferred to the deployed sample element portion.

52. The sample element cartridge of claim 51, wherein the sample element handler has an arcuate outer perimeter, the first sample element and the second sample element arranged around the outer perimeter of the sample element handler.

53. A sample element comprising:

a calibration portion; and

a sample portion.

54. The sample element of claim 53, wherein the calibration portion further comprises a first calibration portion wall formed of a first material, the sample portion comprises a sample cell having a first sample cell wall formed of a second material, the first material and the second material having equivalent electromagnetic transmissive properties.

55. The sample element of claim 53, wherein the first material and the second material are the same material.

56. The sample element of claim 53, wherein the calibration portion comprises a necked-down portion.

57. The sample element of claim 53, wherein the thickness of the first calibration portion wall and the first sample cell wall are about the same.

58. The sample element of claim 53, wherein the calibration portion further comprises a second calibration portion wall, a calibration pathlength defined between the first calibration portion wall and the second calibration portion wall, the same cell comprises a second sample cell wall, an optical pathlength defined between the first sample cell wall and the second sample cell wall.

59. The sample element of claim 58, wherein the optical pathlength is about equal to the calibration pathlength.

60. The sample element of claim 58, wherein the calibration pathlength is about zero.

61. A method of handling a sample element comprising:

providing a sample element having a calibration portion and a sample portion;

filling at least a portion of the sample portion with a sample;

inserting the sample element into a whole-blood analysis system; and

performing optical analysis in at least one of the sample portion and the calibration portion; and

removing the sample element from the whole-blood analysis system.

62. The method of claim 61, wherein the step of performing optical analysis further comprises transmitting a first beam of electromagnetic radiation through the calibration portion of the sample element to determine an optical property of the sample element.

63. The method of claim 62, wherein the step of performing optical analysis further comprises transmitting a second beam of electromagnetic radiation through the sample portion of the sample element to determine an optical property of the sample and the sample element.

64. A sample element assembly for collecting a sample from a laceration in an appendage of a user, the sample element assembly comprising:

a sample element having a sample cell, an opening, and a sample supply passage providing fluid communication between the opening and the sample cell; and

a single motion sample extractor;

wherein a single motion of the sample cell assembly creates the laceration in the appendage also places the opening at the laceration so that the sample can be drawn into the sample element.

65. The sample cell assembly of claim 64, wherein the laceration is formed as a slice, an incision, or a microlaceration.

66. The sample cell assembly of claim 64, wherein the sample extractor comprises a lance made of a material selected from the group consisting of:

metal, plastic, or any other suitable rigid material.

67. The sample cell assembly of claim 64, wherein the sample extractor further comprises an appendage piercing end that includes a first cutting implement and a second cutting implement, the first cutting implement and the second cutting implement converging at a distal end, the appendage piercing end having a divergence disposed between the distal end of the appendage piercing end and the opening of the sample element.

68. The sample cell assembly of claim 64, wherein the sample extractor further comprises an appendage piercing end that includes a first cutting implement and a second cutting implement, the first cutting implement extending to a first distal end and the second cutting implement extending to a second distal end, the first distal end and the second distal end being spaced from each other.

69. The sample cell assembly of claim 64, wherein the sample extractor comprises an elongate piercing member that extends from a side of the sample element that has the opening, the longitudinal axis of the sample extractor being laterally offset from but generally parallel to the longitudinal axis of the sample supply passage, the elongate piercing member being small compared to the size of the opening.