Method of determining the concentration of an analyte in a body fluid and system in therefor

• US 7,896,819 B2
• Filed: 10/20/2005
• Issued: 03/01/2011
• Est. Priority Date: 10/21/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rebec, Mihailo V., Smous, James E., Burson, Pamela J., Melle, Bryan S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/665,118
• Publication Number:
  US 20080097240A1
• Time in Patent Office: 1,958 Days
• Field of Search: 600/573, 600/583
• US Class Current: 600/573
• 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser

Abstract

A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample comprises applying pressure to the skin of the user. The skin is stretched so as to create a tear in the skin such that the applied pressure causes the body fluid to flow from the tear. The body fluid flowing from the tear is collected. Disclosed is also a pressure member for applying pressure to and stretching skin in preparation for forming a tear in the skin.

Claims

1. A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample, the method comprising the acts of:

applying pressure to skin of a user with a pressure member, the pressure member including a film;

directing electromagnetic radiation onto at least a portion of the film to heat the skin of the user at a site of the pressure, which softens the skin of the user at the site of the pressure;

stretching the skin by use of the applied pressure member, the stretching creating a tear in the skin such that the applied pressure causes the body fluid sample to flow from the tear.

2. The method of claim 1, further comprising collecting the body fluid sample flowing from the tear.

3. The method of claim 2, wherein the pressure member includes a skin-contacting area, the skin-contacting area forming an aperture therethrough.

4. The method of claim 1, wherein the body fluid sample is interstitial fluid.

5. The method of claim 3, further comprising the act of applying a film to the skin, the film including a mediation layer, and further comprising the acts of pressing the film against the skin with the skin-contacting area of the pressure member, and directing electromagnetic radiation onto at least a portion of the film to form an aperture in the film and to assist in creating the tear in the skin.

6. The method of claim 4, wherein the mediation layer includes gelatin and mediation material, the mediation material being located within the gelatin.

7. The method of claim 3, further comprising the act of applying a multilayer film to the skin, the multilayer film including a collection layer and a mediation layer, the collection layer and the mediation layer being adjacent to each other, further comprising the acts of pressing the multilayer film against the skin with the skin-contacting area of the pressure member, and directing electromagnetic radiation onto at least a portion of the multilayer film to form an aperture in the multilayer film and to assist in creating the tear in the skin.

8. The method of claim 3, further comprising the acts of applying a multilayer film to the skin, the multilayer film includes a collection layer, a gelatin layer having a mediation material, and a support layer, the gelatin layer being located between the collection and the support layers, and pressing the multilayer film against the skin with the skin-contacting area of the pressure member, and further comprising the act of directing electromagnetic radiation onto at least a portion of the multilayer film to form an aperture in the multilayer film and to assist in creating the tear in the skin.

9. The method of claim 5, wherein the pressure member has a first end adapted to hold the film, the mediation layer including mediation material;

wherein the stretching of the skin comprises contacting the skin with the first end of the pressure member;

wherein the directing of electromagnetic radiation causes the mediation material to convert the radiation to thermal energy to form the aperture in the film and the tear in the skin;

wherein the applying of pressure to the skin causes body fluid to flow from the tear and through the aperture in the skin-contacting area of the pressure member to an upper surface of the film; and

further including collecting the body fluid sample on the upper surface of the film while the pressure member remains in contact with the skin of the user.

10. A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample, the method comprising the acts of:

applying pressure to skin of a user with a pressure member, the pressure member including a skin-contacting area, the skin-contacting area forming an aperture therethrough in which the body fluid sample is collected;

applying a film to the skin with the skin-contacting area, the film including a mediation material;

directing electromagnetic radiation onto at least a portion of the film to cause the mediation material to convert the radiation to thermal energy which forms an aperture in the film and assists in creating a tear in the skin; and

stretching the skin by use of the applied pressure member, the stretching creating the tear in the skin such that the applied pressure causes the body fluid sample to flow from the tear.

11. The method of claim 10, further comprising collecting the body fluid sample flowing from the tear.

12. The method of claim 10, wherein the film comprises at least a gelatin layer that includes the mediation material.

13. The method of claim 12, wherein the film is a multilayer film, the multilayer film comprising a collection layer and the gelatin layer, the collection layer and the gelatin layer being adjacent to each other.

14. The method of claim 13, wherein the multilayer film further comprises a support layer, the gelatin layer being located between the collection layer and the support layer.

15. The method of claim 10, wherein the pressure member further includes a body and the film, the body including the skin-contacting area.

16. The method of claim 15, wherein the body further includes a sidewall encompassing and extending from the skin-contacting area of the body, the sidewall including an exterior surface, the skin-contacting area being configured to receive the film such that the film completely covers the aperture formed in the skin-contacting area.

17. The method of claim 16, wherein the film is detachably connected to the skin-contacting area.

18. The method of claim 16, wherein the sidewall is a conical-shaped cup.

19. A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample, the method comprising the acts of:

applying pressure to skin of a user with a pressure member, the pressure member including a film, the film comprising a gelatin layer having high electromagnetic energy absorbent particles suspended therein, the high electromagnetic energy absorbent particles being configured to produce heat when excited by high electromagnetic energy;

transferring the produced heat to the skin of the user at a site of the applied pressure, which softens the skin of the user at the site; and

stretching the skin by use of the applied pressure member, the stretching creating a tear in the skin such that the applied pressure causes the body fluid sample to flow from the tear.

20. The method of claim 19, further comprising collecting the body fluid sample flowing from the tear.

21. The method of claim 19, wherein the gelatin layer further includes a patterned coating of reflective material.

22. A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample, the method comprising the acts of:

applying pressure to skin of a user with a pressure member, the pressure member including a body and a film, the body having a sidewall encompassing and extending from a top portion of the body, the top portion forming a recess that receives an insert, the insert having an aperture therein;

directing electromagnetic radiation onto at least a portion of the film to heat the skin of the user at a site of the pressure, which softens the skin of the user at the site of the pressure;

stretching the skin by use of the applied pressure member, the stretching creating a tear in the skin such that the applied pressure causes the body fluid sample to flow from the tear; and

collecting the body fluid sample flowing from the tear.

23. The method of claim 22, wherein the aperture is a narrowing aperture.

24. The method of claim 22, wherein the aperture defines an interior surface that maintains a seal with the skin of the user in response to the applying.

25. The method of claim 24, wherein the interior surface forms a conically shaped aperture prior to and during the act of applying pressure.

26. A method of obtaining a body fluid sample for determining the concentration of an analyte in the body fluid sample, the method comprising the acts of:

applying pressure to skin of a user with a pressure member, the pressure member including a film, the film comprising at least a gelatin layer having high electromagnetic energy absorbent particles suspended therein, the high electromagnetic energy absorbent particles being dye particles or carbon black;

heating the skin at the site of the pressure to soften the skin;

stretching the skin by use of the applied pressure member, the stretching creating a tear in the skin such that the applied pressure causes the body fluid sample to flow from the tear; and

collecting the body fluid sample flowing from the tear.