PHYSIOLOGICAL SAMPLE COLLECTION DEVICES AND METHODS OF USING THE SAME
First Claim
1. What is claimed is:
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1.A skin-piercing element for piercing the skin and accessing body fluid therein, said skin-piercing element comprising;
an opening within said skin-piercing element wherein said opening occupies a substantial portion of a width, diameter or length dimension of said skin-piercing element; and
a fluid pathway in fluid communication with said opening, wherein a pooling area is created within the skin by said opening upon insertion of said skin-piercing element into the skin.
1 Assignment
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Accused Products
Abstract
Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. At least one fluid pathway resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter for making analyte concentration measurements. Methods for using the devices and systems are also provided.
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Citations
68 Claims
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1. What is claimed is:
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1.A skin-piercing element for piercing the skin and accessing body fluid therein, said skin-piercing element comprising; an opening within said skin-piercing element wherein said opening occupies a substantial portion of a width, diameter or length dimension of said skin-piercing element; and a fluid pathway in fluid communication with said opening, wherein a pooling area is created within the skin by said opening upon insertion of said skin-piercing element into the skin. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A test strip device comprising:
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a biosensor for determining a characteristic of a physiological fluid; at least one microneedle integral with and extending from said biosensor;
said microneedle comprising an opening which occupies a substantial portion of a width, diameter or length dimension of said microneedle; anda fluid pathway extending from said biosensor to said microneedle wherein said fluid pathway is in fluid communication with said opening and said biosensor. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68)
at least one test strip device according to claim 8, and a meter for automatically determining the concentration of analyte in the physiological sample, wherein said meter is configured for receiving said test strip device.
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28. The system according to claim 27, further comprising a test strip cartridge for containing a plurality of said test strip devices, said cartridge configured for releasable engagement with said meter.
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29. The system according to claim 28, wherein said cartridge comprises a compartment for holding test strips devices which have been used.
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30. The system according to claim 27, wherein said meter is hand-held.
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31. The system of according to claim 27, wherein said meter comprises a housing, an aperture at a distal end of said housing and a test strip-receiving mechanism within said housing for operatively receiving said at least one test strip device.
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32. The system according to claim 31, wherein said meter further comprises means for spring-loading said test strip device in a retracted position within said distal end of said housing and means for releasing said at least one test strip from said spring-load wherein said at least one test strip is rapidly extended from said aperture.
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33. The system according to claim 31, wherein said distal end of said housing is made of transparent or semi-transparent material.
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34. The system according to claim 31, wherein said meter further comprises a pressure sensor for detecting and measuring pressure against said aperture.
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35. The system according to claim 34, wherein said meter further comprises a pressure sensor indicator for indicating the pressure measured by said pressure sensor.
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36. The system according to claim 27 wherein said meter further comprises a data display.
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37. The system according to claim 27 wherein said meter further comprises a source of negative pressure for applying a vacuum through said fluid pathway for facilitating the transfer of physiological sample exposed to said pathway to within said test strip.
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54. A method for determining the concentration of at least one analyte within a physiological fluid sample, said method comprising the steps of:
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(a) providing the system of claim 27 wherein said test strip device is operatively received within a distal end of said meter; (b) spring-loading said test strip device within said meter; (c) operatively contacting said distal end of said meter with a targeted skin surface; (d) releasing said spring-loaded test strip device, wherein said targeted skin surface is pierced by said microneedle; (f) creating a pooling area within the skin adjacent said microneedle whereby said physiological fluid pools within said pooling area; and (g) collecting said pooled physiological fluid from within the skin by means of said fluid pathway.
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55. The method according to claim 54 further comprising the step of applying optimal pressure against said target skin surface with said distal end of said meter.
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56. The method according to claim 55 wherein said step of applying optimal pressure comprises the steps of:
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sensing the pressure applied; indicating the amount of said sensed pressure; and adjusting said applied pressure if necessary according to said indicated amount of pressure.
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57. The method according to claim 54 wherein said step of collecting said pooled physiological fluid comprises exerting a capillary force on said pooled physiological fluid by means of said fluid pathway.
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58. The method according to claim 54 wherein said step of collecting further comprises applying pressure about the microneedle piercing site.
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59. The method according to claim 54 wherein said step of collecting further comprises applying a negative pressure to said pooled physiological fluid.
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60. The method according to claim 54 wherein said test strip device is visualized during one or more steps of said method.
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61. The method according to claim 60 wherein said one or more steps include steps (a), (b), (c) or (d).
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62. The method according to claim 54 wherein said step of providing comprises the step of inserting said test strip into said distal end of said meter.
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63. The method according to claim 54 wherein said step of inserting comprises inserting said test strip through said aperture.
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64. The method according to claim 54 wherein said step of providing comprises removing a distal portion of said meter and inserting said test strip into said receiving means within said distal end of said meter.
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65. A kit for determining at least one target analyte concentration of a physiological sample, said kit comprising a system according to claim 27.
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66. The kit according to claim 65, wherein said meter is disposable.
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67. A kit according to claim 65 further comprising instructions for using said system.
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68. A kit for determining at least one target analyte concentration of a physiological sample, said kit comprising a plurality of test strips according to claim 8.
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38. A method for collecting physiological fluid sample from skin, said method comprising:
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providing at least one skin-piercing element comprising; (i) an opening which occupies a substantial portion of a width, diameter or length dimension of said skin-piercing element and (ii) a fluid pathway in fluid communication with said opening; inserting said at least one skin-piercing element into the skin, wherein a pooling area is created within the skin by said opening and said physiological fluid pools within the pooling area; and collecting by means of said fluid pathway said pooled physiological fluid from within the skin. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
transferring said collected physiological fluid through said at least one fluid pathway to said biosensor; and determining the concentration of said at least one analyte.
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44. The method according to claim 43, wherein said step of determining the analyte concentration further comprises employing a meter.
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45. The method according to claim 43, wherein said step of determining the analyte concentration is performed by electrochemical means.
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46. The method according to claim 43, wherein said step of determining the analyte concentration is performed by colorimetric means.
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47. The method according to claim 46, wherein said step of determining is performed by fluorescent measuring means.
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48. The method according to claim 38, wherein said physiological fluid is blood and said analyte is glucose.
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49. The method according to claim 38 wherein said pooling area has a volume which is about 50% to 99% of the volume occupied by said skin piercing element.
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50. The method according to claim 49 wherein said pooling area has a volume which is about 50% to 75% of the volume occupied by said skin piercing element.
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51. A method for collecting a sample of physiological fluid, said method comprising the steps of:
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penetrating the skin to access said physiological fluid; creating a pooling area within said skin, wherein said pooling has a volume within the range from about 10 to 1,000 nL; allowing said access physiological fluid to pool within said pooling area; and exerting a capillary force on said pooled physiological fluid. - View Dependent Claims (52, 53)
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Specification