Method and device for sampling and analyzing interstitial fluid and whole blood samples
First Claim
1. A fluid sampling device comprising a body, the body comprising a dermal layer penetration probe having a penetrating end and a communicating end, an analysis chamber having a proximal and distal end, the analysis chamber having a volume, and a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber, and wherein a capillary force exerted by the analysis chamber is greater than a capillary force exerted by the pre-chamber.
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Abstract
The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.
110 Citations
54 Claims
- 1. A fluid sampling device comprising a body, the body comprising a dermal layer penetration probe having a penetrating end and a communicating end, an analysis chamber having a proximal and distal end, the analysis chamber having a volume, and a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber, wherein the penetration probe is in fluid communication with the analysis chamber such that fluid can flow from the penetration probe toward the analysis chamber, and wherein a capillary force exerted by the analysis chamber is greater than a capillary force exerted by the pre-chamber.
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29. A method for determining a presence or an absence of an analyte in a fluid sample comprising the steps of:
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providing a fluid sampling device comprising a dermal layer penetration probe having a penetrating end and a communicating end, an analysis chamber having a proximal and distal end, the analysis chamber having a volume, and a pre-chamber having a volume and a first and second end, wherein the pre-chamber is interposed between the penetration probe and the analysis chamber such that the first end of the pre-chamber is adjacent the communicating end of the penetration probe and the second end of the pre-chamber is adjacent the proximal end of the analysis chamber;
penetrating a dermal layer with the penetration probe;
substantially filling the pre-chamber with a fluid sample by allowing the sample to flow from the penetration probe toward the pre-chamber;
substantially filling the analysis chamber with a fluid sample by allowing the sample to flow from the pre-chamber toward the analysis chamber, wherein a capillary force exerted by the analysis chamber is greater than a capillary force exerted by the pre-chamber; and
detecting a presence or an absence of the analyte within the analysis chamber.
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Specification