Removal of stratum corneum by means of light

• US 6,027,496 A
• Filed: 03/25/1997
• Issued: 02/22/2000
• Est. Priority Date: 03/25/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Henning, Timothy P., Muetterties, Andrew J., Loomis, Neil W., Pope, Mark R., Bojan, Peter M.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US08/823,940
• Time in Patent Office: 1,064 Days
• Field of Search: 606/2-3, 606/9-12
• US Class Current: 606/9
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents

Abstract

A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of:

(a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and

(b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum.

Preferably, exposure of the region of the stratum corneum to the source of light is ceased when an amount of interstitial fluid fills the opening in the stratum corneum, which amount is sufficient to cause the scatter intensity of the light reflected from the surface of the interstitial fluid occupying the opening in the stratum corneum to differ from the scatter intensity of the light reflected from a region of the stratum corneum that is substantially free of interstitial fluid. The invention also involves an apparatus for carrying out the foregoing method.

Claims

1. A method for forming an opening in a region of the stratum corneum of a patient comprising the steps of:

(a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and

(b) exposing said region of the stratum corneum of said patient to said source of light for a period of time sufficient to form an opening in the stratum corneum, wherein exposure of said region of the stratum corneum to said source of light is ceased when an amount of interstitial fluid occupies said opening in the stratum corneum, said amount of interstitial fluid having a surface that causes light from said source of light to scatter, said scattered light having a scatter intensity, said amount of interstitial fluid being sufficient to cause said scatter intensity of light reflected from said surface of said interstitial fluid occupying said opening in the stratum corneum to differ from the scatter intensity of light reflected from a region of the stratum corneum that is substantially free of interstitial fluid.

2. The method of claim 1, wherein said source of light provides a pulse of light that results in a scatter intensity and at least one pulse of light subsequent to said first pulse of light, each of said at least one pulse of light subsequent to said first pulse of light resulting in a scatter intensity.

3. The method of claim 2, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 5%.

4. The method of claim 2, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 10%.

5. The method of claim 2, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 20%.

6. The method of claim 1, wherein said region of the stratum corneum exposed to said source of light is elliptical in shape.

7. The method of claim 1, wherein said source of light exposes the stratum corneum at an angle of from about 18°

to about 46°

, as measured from said surface of the stratum corneum to said source of light.

8. The method of claim 1, wherein said source of light is a laser.

9. The method of claim 1, wherein said source of light is a pulsed laser.

10. The method of claim 1, further including the step of analyzing the interstitial fluid collected from said opening in the stratum corneum.

11. The method of claim 1, wherein said source of light has a wavelength of from about 950 nm to about 1010 nm.

12. The method of claim 1, wherein said source of light has a wavelength of from about 970 nm to about 990 nm.

13. A method for collecting interstitial fluid from an opening in a region of the stratum corneum of a patient comprising the steps of:

(a) exposing said region of the stratum corneum of said patient to a source of light for a period of time sufficient to form an opening in the stratum corneum, wherein exposure of said region of the stratum corneum to said source of light is ceased when an amount of interstitial fluid occupies said opening in the stratum corneum, said amount of interstitial fluid having a surface that cause light from said source of light to scatter, said scatter light having a scatter intensity, said amount of interstitial fluid being sufficient to cause said scatter intensity of light reflected from said surface of said interstitial fluid occupying said opening in the stratum corneum to differ from the scatter intensity of light reflected from a region of the stratum corneum that is substantially free of interstitial fluid; and

(b) collecting interstitial fluid from said opening in the stratum corneum.

14. The method of claim 13, wherein said source of light provides a pulse of light that results in a scatter intensity and at least one pulse of light subsequent to said first pulse of light, each of said at least one pulse of light subsequent to said first pulse of light resulting in a scatter intensity.

15. The method of claim 13, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 5%.

16. The method of claim 13, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 10%.

17. The method of claim 13, wherein exposure is ceased when the scatter intensity resulting from a pulse of light provided subsequent to said first pulse of light differs from the scatter intensity resulting from said first pulse of light by at least about 20%.

18. The method of claim 13, wherein said region of the stratum corneum exposed to said source of light is elliptical in shape.

19. The method of claim 13, wherein said source of light exposes the stratum corneum at an angle of from about 18°

to about 46°

, as measured from the surface of the stratum corneum to said source of light.

20. The method of claim 13, wherein said source of light is a laser.

21. The method of claim 13, wherein said source of light is a pulsed laser.

22. The method of claim 13, further including the step of analyzing the biological fluid collected from the stratum corneum.