Sampling devices and methods utilizing a horizontal capillary test strip
First Claim
1. A sampling system, comprising:
- a test strip configured for loading into a lancing device to analyze body fluid from an incision created by the lancing device, wherein the test strip has a strip shape, wherein the test strip has a first end and a second end opposite the first end, the test strip includes an end edge at the second end, the test strip includinga test area configured to analyze the body fluid,a sampling passageway with an inlet opening that is remotely located from the test area, the inlet opening being defined in the end edge at the second end, the sampling passageway being sized and configured to draw the body fluid via capillary action, the sampling passageway extending from the inlet opening to the test area for transporting the body fluid from the incision to the test area via capillary action,a bottom surface that faces a skin when the test strip is received in the lancing device, anda sealing member projecting outwardly from the bottom surface of the test strip proximal the inlet opening and positioned to seal with the skin when the test strip is pressed against the skin to retain the body fluid at the inlet opening, wherein the sealing member is located on the bottom surface between the first end and the end edge at the second end, wherein the sealing member is made of a deformable material that deforms upon pressing against the skin, wherein the sealing member extends along the bottom surface at a location where the sealing member is sandwiched between the bottom surface of the test strip and the skin when the test strip is pressed against the skin, wherein the sealing member is configured to inhibit flow of the body fluid between the bottom surface of the test strip and the skin;
wherein the test strip with the sealing member is configured to be unloaded from the lancing device as a single disposable unit; and
wherein the sealing member has a surface that is hydrophobic.
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0 Petitions
Accused Products
Abstract
Systems and methods for the sampling of bodily fluid from an incision in the skin include test strips which are positioned adjacent to the skin and which include features to inhibit the passage of the bodily fluid between the skin and the underside of the test strip. One system utilizes a sealing member located on the bottom surface of the test strip and positioned to provide a fluid tight seal with the skin. A second system includes a recessed surface aligned with the inlet opening of the test strip to preclude contact of the bodily fluid directly with the bottom surface of the test strip. A third system involves the use of a hydrophobic surface on the underside of the test strip to inhibit wicking of the bodily fluid along the test strip. The present invention further encompasses the combination of the foregoing sampling systems with each other, and with incising, expressing and/or testing systems and methods, particularly in a single, integrated device.
53 Citations
26 Claims
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1. A sampling system, comprising:
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a test strip configured for loading into a lancing device to analyze body fluid from an incision created by the lancing device, wherein the test strip has a strip shape, wherein the test strip has a first end and a second end opposite the first end, the test strip includes an end edge at the second end, the test strip including a test area configured to analyze the body fluid, a sampling passageway with an inlet opening that is remotely located from the test area, the inlet opening being defined in the end edge at the second end, the sampling passageway being sized and configured to draw the body fluid via capillary action, the sampling passageway extending from the inlet opening to the test area for transporting the body fluid from the incision to the test area via capillary action, a bottom surface that faces a skin when the test strip is received in the lancing device, and a sealing member projecting outwardly from the bottom surface of the test strip proximal the inlet opening and positioned to seal with the skin when the test strip is pressed against the skin to retain the body fluid at the inlet opening, wherein the sealing member is located on the bottom surface between the first end and the end edge at the second end, wherein the sealing member is made of a deformable material that deforms upon pressing against the skin, wherein the sealing member extends along the bottom surface at a location where the sealing member is sandwiched between the bottom surface of the test strip and the skin when the test strip is pressed against the skin, wherein the sealing member is configured to inhibit flow of the body fluid between the bottom surface of the test strip and the skin; wherein the test strip with the sealing member is configured to be unloaded from the lancing device as a single disposable unit; and wherein the sealing member has a surface that is hydrophobic. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A sampling system, comprising:
a test strip configured for loading into a lancing device to analyze body fluid from an incision created by the lancing device, wherein the test strip has strip shape, wherein the test strip has a first end and a second end opposite the first end, the test strip includes an end edge at the second end, the test strip including a test area configured to analyze the body fluid, a sampling passageway with an inlet opening that is remotely located from the test area, the inlet opening being defined in the end edge at the second end, the sampling passageway being sized and configured to draw the body fluid via capillary action, the sampling passageway extending from the inlet opening to the test area for transporting the body fluid from the incision to the test area via capillary action, a bottom surface that faces a skin when the test strip is received in the lancing device, a sealing member projecting outwardly from the bottom surface of the test strip, wherein the sealing member is made of a deformable material that deforms upon pressing against the skin, and the test strip having a recessed surface extending between the inlet opening and the bottom surface to inhibit contact of the body fluid on the skin with the bottom surface of the test strip, wherein the recessed surface tapers away from the inlet opening at the end edge to the bottom surface, wherein the recessed surface extends from the end edge at the second end to the sealing member, wherein the recessed surface at the end edge with the inlet opening is located farther away from the skin than the recessed surface at the bottom surface during drawing of the body fluid from the incision; and wherein the test strip with the recessed surface is configured to be unloaded from the lancing device as a single disposable unit. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
Specification