Microsampling device and method of construction

• US 5,801,057 A
• Filed: 03/22/1996
• Issued: 09/01/1998
• Est. Priority Date: 03/22/1996
• Status: Expired due to Term

• Current Assignee: Kumetrix Incorporated
• Original Assignee: Kumetrix Incorporated
• Inventors: Subramanian, Kumar, Smart, Wilson H.
• Primary Examiner(s): Houtteman, Scott W.
• Application Number:
  US08/620,994
• Time in Patent Office: 893 Days
• Field of Search: 436/68, 436/95, 128/632
• US Class Current: 436/68
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A minimally intrusive and less painful, self-use microsampling device and method for the measurement of glucose and other analytes in blood are provided. The device of the invention may have one or two optical windows for measuring the concentration of an absorbent reaction product or no windows if methods other than optical absorbance is used. The sampling chamber of the device can contain analytical reagents and other additives to facilitate the sampling and analytical steps. Also provided is a fabrication method for the microsampling device.

Claims

1. A microsampler comprising:

a wafer of material defining therein a microsampler chamber;

a needle formed integrally with and extending from said microsampler chamber; and

a vent channel communicating with said microsampler chamber.

2. The microsampler of claim 1 wherein said chamber is formed in a wafer of a material chosen from the group consisting of silicon, ceramic and sapphire.

3. The microsampler of claim 2 wherein said chamber is formed in a silicon wafer.

4. The microsampler of claim 3 additionally including at least one optical window formed in said microsampler chamber.

5. The microsampler of claim 4 wherein said chamber has a volume of less than one microliter.

6. The microsampler of claim 5 wherein said needle has an outer diameter of less than 300 microns and a bore diameter of less than 250 microns.

7. The microsampler of claim 6 wherein the outer diameter of said needle is 100 microns and the bore diameter is 50 microns.

8. The microsampler of claim 6 wherein said chamber has two optical windows.

9. The microsampler of claim 8 wherein said chamber includes a mixture of reagents.

10. The microsampler of claim 9 wherein said needle is coated with sampling aids.

11. The microsampler of claim 10 wherein said sampling aids include anticoagulants, lubricants, detergents, analgesics and aniti-inflammatories.

12. A method of measuring glucose in blood comprising:

a. providing a microsampling device according to claim 7;

b. providing in said chamber of said device a mixture of reagents comprising glucose dehydrogenase, NAD⁺, a pH buffer, a tetrazolium salt, detergent and diaphorase to form a formazan dye when mixed with blood;

c. pricking the finger of a user with said needle to draw blood of said user into said chamber of said device and mix with said reagents; and

d. measuring the concentration of the glucose in the blood from the absorbance of the formazan dye.

13. The method of claim 12 further comprising coating the needle with sampling aids.

14. The method of claim 13 wherein said sampling aids include heparin, silicone, Triton, lidocaine and hydrocortisone.

15. The method of claim 14 where in said hydrocortisone is at the tip of the needle and said silicone is on the outside of the needle.

16. A method of making a microsampler with two optical windows comprising:

a. providing a silicon wafer having a top surface and a bottom surface;

b. etching out first and second depressions in the bottom surface of said wafer;

c. forming an optical window in the first and second depressions;

d. etching a patterned depression in the top surface aligned with the optical window in the bottom surface of said wafer and defining therein a microsampler chamber, a needle bore, and a vent channel;

e. covering said patterned depression in said top surface with a cover glass;

f. etching out the needle by removing silicon and cover glass; and

g. forming a point on the needle.

17. A method of making a microsampler with one window comprising:

a. providing a silicon wafer having a top surface and a bottom surface;

b. etching a patterned depression in the top surface of said wafer and defining therein a microsampler chamber, a needle bore, and a vent channel;

c. covering said patterned depression in said top surface with a cover glass;

d. etching out the needle by removing silicon and cover glass; and

e. forming a point on the needle.

18. A method of making a microsampler comprising:

a. providing a silicon wafer having a top surface and a bottom surface;

b. etching a patterned depression in the top surface of said wafer and defining therein a microsampler chamber, a needle bore, and a vent channel;

c. covering said patterned depression in said top surface with a cover of silicon material;

d. etching out the needle by removing silicon and silicon cover; and

e. forming a point on the needle.