Physiological sample collection devices and methods of using the same
First Claim
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.
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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.
469 Citations
68 Claims
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1. A skin-piercing element for piercing the skin and accessing body fluid therein, said skin-piercing element comprising:
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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; and
a 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, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68)
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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.
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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