Sampling devices and methods utilizing a horizontal capillary test strip

• US 20040116829A1
• Filed: 12/05/2003
• Published: 06/17/2004
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Steven N., Roe, Jeffrey N., Raney, Charles C., Wiegel, Chris, Perez, Edward P., Fisher, David S., Donnay, Rafael C., Jung, A. Michael, Munson, Ian M.
• Granted Patent: US 7,476,202 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

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.

Claims

1. A test strip for collecting bodily fluid from an incision in the skin, comprising:

a body having a first end, a second end, a top surface, a bottom surface, and an aperture between the first and second ends and extending from the top surface to the bottom surface, said body defining a sampling passageway including an inlet opening communicating with the aperture; and

a sealing member on the bottom surface surrounding the aperture and positioned to contact and seal with the skin when said body is pressed against the skin.

2. The test strip of claim 1 in which said sealing member includes a hydrophobic surface.

3. The test strip of claim 1 in which said sealing member is deformable upon pressing against the skin.

4. The test strip of claim 1 in which said body further includes a recessed surface extending between the inlet opening and the bottom surface.

5. The test strip of claim 4 in which the recessed surface extends at an obtuse angle from the bottom surface to the inlet opening.

6. The test strip of claim 5 in which the obtuse angle is from about 100 degrees to about 150 degrees.

7. A test strip for collecting bodily fluid from an incision in the skin, comprising:

a body having a first end, a second end, a top surface, a bottom surface, and an end edge, said body defining a sampling passageway including an inlet opening communicating with the end edge at a location spaced from the bottom surface; and

a sealing member on the bottom surface aligned with the inlet opening and positioned to contact and seal with the skin when said body is pressed against the skin.

8. The test strip of claim 7 in which said body further includes first and second side edges extending from the first end to the second end, said sealing member extending from the first side edge to the second side edge.

9. The test strip of claim 7 in which said sealing member includes a hydrophobic surface.

10. The test strip of claim 7 in which said sealing member is deformable upon pressing against the skin.

11. The test strip of claim 7 in which said body further includes a recessed surface extending between the inlet opening and the bottom surface.

12. The test strip of claim 11 in which the recessed surface extends at an obtuse angle from the bottom surface to the inlet opening.

13. The test strip of claim 12 in which the obtuse angle is from about 100 degrees to about 150 degrees.

14. A test strip for collecting bodily fluid from an incision in the skin, comprising:

a body having a first end, a second end, a top surface, a bottom surface, and an aperture between the first and second ends and extending from the top surface to the bottom surface, said body defining a sampling passageway including an inlet opening communicating with the aperture, said body further including a recessed surface extending between the inlet opening and the bottom surface.

15. The test strip of claim 14 in which the recessed surface extends at an obtuse angle from the bottom surface to the inlet opening.

16. The test strip of claim 15 in which the obtuse angle is from about 100 degrees to about 150 degrees.

17. The test strip of claim 14 in which the inlet opening is spaced from the top surface.

18. A test strip for collecting bodily fluid from an incision in the skin, comprising:

a body having a first end, a second end, a top surface, a bottom surface, an end edge, and a recessed surface, said body defining a sampling passageway including an inlet opening communicating with at least one of the end edge and the recessed surface, the recessed surface extending between the inlet opening and the bottom surface.

19. The test strip of claim 18 in which the sampling surface extends at an obtuse angle from the bottom surface to the inlet opening.

20. The test strip of claim 19 in which the obtuse angle is from about 100 degrees to about 150 degrees.

21. The test strip of claim 18 in which the portion of the bottom surface adjacent to the sampling surface is hydrophobic.

22. The test strip of claim 18 and which further includes a sealing member on the bottom surface aligned with the inlet opening and positioned to contact and seal with the skin when said body is pressed against the skin.

23. The test strip of claim 22 in which said body further includes first and second side edges extending from the first end to the second end, said sealing member extending from the first side edge to the second side edge.

24. A test strip for collecting bodily fluid from an incision in the skin, comprising:

a body having a top surface, a bottom surface, a sampling surface extending from the bottom surface, and a first end, said body defining a sampling passageway including an inlet opening communicating with the sampling surface at a location spaced from the bottom surface, the sampling passageway extending in the direction of the first end from the inlet opening, the portion of the bottom surface adjacent to the sampling surface being hydrophobic.

25. The test strip of claim 24 in which said body includes a second end and defines an aperture located between the first and second ends and extending from the top surface to the bottom surface, the inlet opening communicating with the aperture, the bottom surface including a hydrophobic portion surrounding the aperture.

26. A method for collecting bodily fluid from an incision in the skin, comprising:

placing adjacent to the incision a test strip including a body having a first end, a second end, a top surface, a bottom surface, and an aperture between the first and second ends and extending from the top surface to the bottom surface, the body defining a sampling passageway including an inlet opening communicating with the aperture, the test strip further including a sealing member on the bottom surface surrounding the aperture and positioned to contact and seal with the skin; and

maintaining the test strip in position against the skin to draw bodily fluid from the incision into the sampling passageway.

27. A method for collecting bodily fluid from an incision in the skin, comprising:

placing adjacent to the incision a test strip including a body having a first end, a second end, a top surface, a bottom surface, and an end edge, the body defining a sampling passageway including an inlet opening communicating with the end edge at a location spaced from the bottom surface, the test strip further including a sealing member on the bottom surface aligned with the inlet opening and positioned to contact and seal with the skin; and

maintaining the test strip in position against the skin to draw bodily fluid from the incision into the sampling passageway.

28. A method for collecting bodily fluid from an incision in the skin, comprising:

placing adjacent to the incision a test strip including a body having a first end, a second end, a top surface, a bottom surface, and an aperture between the first and second ends and extending from the top surface to the bottom surface, the body defining a sampling passageway including an inlet opening communicating with the aperture, the body further including a recessed surface extending between the inlet opening and the bottom surface; and

maintaining the test strip in position against the skin to draw bodily fluid from the incision into the sampling passageway.

29. A method for collecting bodily fluid from an incision in the skin, comprising:

placing adjacent to the incision a test strip including a body having a first end, a second end, a top surface, a bottom surface, an end edge, and a recessed surface, the body defining a sampling passageway including an inlet opening communicating with at least one of the end edge and the recessed surface, the recessed surface extending between the inlet opening and the bottom surface; and

maintaining the test strip in position against the skin to draw bodily fluid from the incision into the sampling passageway.

30. A method for collecting bodily fluid from an incision in the skin, comprising:

placing adjacent to the incision a test strip including a body having a top surface, a bottom surface, a sampling surface extending from the bottom surface, and a first end, the body defining a sampling passageway including an inlet opening communicating with the sampling surface at a location spaced from the bottom surface, the sampling passageway extending in the direction of the first end from the inlet opening, the portion of the bottom surface adjacent to the sampling surface being hydrophobic; and

maintaining the test strip in position against the skin to draw bodily fluid from the incision into the sampling passageway.