Reusable ceramic skin-piercing device

• US 20010041904A1
• Filed: 04/05/2001
• Published: 11/15/2001
• Est. Priority Date: 04/05/2000
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Therasense Incorporated (Abbott Laboratories)
• Inventors: Heller, Adam, Funderburk, Jeffery V., Say, James L.
• Granted Patent: US 6,623,501 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15032 by heating
• CPC Class Codes: A61B 5/150328 by aseptic fluid
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices

Abstract

A reusable ceramic skin-piercing device. The skin-piercing device is capable of piercing the skin so as to make a sample of biological fluid available for an assay. In one embodiment, the skin-piercing device includes a skin-piercing element which is heated prior to use to a sufficiently high temperature to kill or deactivate pathogenic microorganisms. The device is heat-sterilized, being heated by passing an electrical current through a resistive element in thermal contact with the heat-conducting ceramic piercer. In another embodiment, the skin-piercing device includes a sleeve of elastomeric material with a sterilizing agent disposed in contact with the skin-piercing element. The sterilizing agent sterilizes the skin-piercing element after use.

The skin-piercing element is made of a hard refractory ceramic material. The ceramic material is optionally a composite, for example, a composite of a ceramic material and a metal, or multiple ceramic materials.

Claims

1. A skin-piercing device comprising:

a skin-piercing element comprising a ceramic blade and a resistive region; and

at least two conductors spaced apart from each other and configured and arranged for contact with the resistive region of the skin-piercing element to permit current flow between the conductors resulting in heating of the skin-piercing element to deactivate pathogenic microorganisms.

2. The skin-piercing device of

claim 1

, wherein the skin-piercing element of

claim 1

is reusable.

3. The skin-piercing device of

claim 2

, wherein the skin-piercing element comprises a conductive ceramic that forms the ceramic blade and resistive region.

4. The skin-piercing device of

claim 2

, wherein the skin-piercing element comprises a resistive film deposited over a portion of the ceramic blade and positioned for contact with the two conductors.

5. The skin-piercing device of

claim 4

, wherein the skin-piercing element is configured and arranged to heat the skin-piercing element, prior to piercing the skin, by passing the current through the resistive region via the conductors of the skin-piercing device.

6. The skin-piercing device of

claim 2

, wherein the skin-piercing element is monocrystalline or polycrystalline.

7. A method for sterilizing a skin-piercing device, the method comprising:

providing a skin-piercing element; and

delivering current to heat the skin-piercing element to deactivate pathogenic microorganisms.

8. The method of

claim 7

, wherein the skin-piercing element comprises:

a ceramic blade and a resistive region.

9. The method of

claim 8

, wherein the delivering operation comprises:

providing at least two conductors spaced apart from each other and configured and arranged for contact with the resistive region of the skin-piercing element; and

permitting the current to flow between the conductors resulting in heating of the skin-piercing element to deactivate pathogenic microorganisms.

10. The method of

claim 9

, wherein the skin-piercing element is reusable.

11. The method of

claim 9

, wherein the skin-piercing element comprises a conductive ceramic that forms the ceramic blade and resistive region.

12. The method of

claim 9

, wherein the skin-piercing element comprises a resistive film deposited over a portion of the ceramic blade.

13. The method of

claim 9

, wherein the skin-piercing element is monocrystalline or polycrystalline.

14. A skin-piercing device comprising:

a skin-piercing element comprising a blade; and

a sleeve disposed in contact with the skin-piercing element, the sleeve comprising an elastomeric material and at least one sterilizing agent.

15. The skin-piercing device of

claim 14

, wherein the sleeve comprises an opening through which the blade can extend.

16. The skin-piercing device of

claim 14

, where the elastomeric material is a crosslinked material.

17. The skin-piercing device of

claim 14

, wherein the sterilizing agent is selected from formaldehyde and glutaraldehyde.

18. The skin-piercing device of

claim 14

, wherein the sterilizing agent is selected from the group consisting of iodine-polyvinylpyridine, potassium triiodide, and tetraalkyl ammonium triiodide.

19. The skin-piercing device of

claim 14

, wherein the sterilizing agent is selected from epoxides and peroxides.

20. The skin-piercing device of

claim 14

, wherein the sterilizing agent comprises an alcohol.

21. The skin-piercing device of

claim 14

, wherein the sterilizing agent comprises a metal salt.

22. A method for sterilizing a skin-piercing device, the method comprising:

piercing skin using a skin-piercing element of a skin-piercing device;

after piercing skin, retracting the skin-piercing element to a position within the skin-piercing device and in contact with a sleeve disposed in the skin-piercing device, the sleeve comprising a elastomeric material and a sterilizing agent; and

sterilizing the skin-piercing element using the sterilizing agent of the sleeve.

23. The method of

claim 22

, wherein retracting the skin-piercing element comprises retracting the skin-piercing element to a position within the skin-piercing device and in contact with a sleeve comprising at least one sterilizing agent.

24. The method of

claim 22

, comprising:

contacting an enzyme disposed in a housing with an enzyme substrate also disposed in a housing to produce a sterilizing agent;

piercing skin using a skin-piercing element of a skin-piercing device;

after piercing skin, retracting the skin-piercing element to a position within the skin-piercing device and in contact with a sleeve disposed in the skin-piercing device, the sleeve comprising a pliant material and the sterilizing agent;

sterilizing the skin-piercing element using the sterilizing agent of the sleeve.

25. The method of

claim 24

, wherein the enzyme is thermostable.

26. The method of

claim 24

, wherein the enzyme is an oxidase.

27. The method of

claim 24

, wherein the enzyme substrate comprises glucose or lactate.