Reusable ceramic skin-piercing device

• US 6,623,501 B2
• Filed: 04/05/2001
• Issued: 09/23/2003
• Est. Priority Date: 04/05/2000
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Therasense Incorporated (Abbott Laboratories)
• Inventors: Say, James L., Heller, Adam, Funderburk, Jeffery V.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US09/827,109
• Publication Number:
  US 20010041904A1
• Time in Patent Office: 901 Days
• Field of Search: 606/45, 606/49, 606/1, 606/181-185, 606/167, 606/171, 606/172, 600/583, 600/573, 600/584, 600/576, 600/578
• 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 method of collecting a blood sample, the method comprising:

providing a skin-piercing device comprising a housing, a ceramic blade movable into and out from the housing, and a resistive region in thermal contact with the blade;

sterilizing the skin-piercing device by;

(a) passing a current through the resistive region, and

(b) heating the blade;

piercing a skin of a patient, and

collecting a blood sample after piercing the skin.

2. The method of claim 1, wherein the step of collecting a blood sample comprises:

collecting a blood sample of less than 5 μ

L.

3. The method of claim 1, wherein the method further comprises:

after collecting the blood sample, again sterilizing the skin-piercing device.

4. A method of collecting a blood sample, the method comprising:

providing a skin-piercing device comprising;

(a) a ceramic blade, and

(b) a resistive region in thermal contact with the blade;

sterilizing the skin-piercing device by;

(a) passing a current through the resistive region,

(b) heating the blade, and

(c) then cooling the blade;

piercing a skin of a patient with the cooled blade, and

collecting a blood sample after piercing the skin.

5. The method of claim 4, wherein the step of collecting a blood sample comprises:

collecting a blood sample of less than 5 μ

L.

6. The method of claim 4, the method further comprises:

after collecting the blood sample, again sterilizing the skin-piercing device.

7. The method of claim 4, wherein the method comprises:

providing a skin-piercing device comprising at least two conductors spaced apart from each other and configured and arranged for contact with the resistive region.