Method of lancing skin for the extraction of blood

• US 20050049522A1
• Filed: 10/29/2003
• Published: 03/03/2005
• Est. Priority Date: 10/30/2002
• Status: Abandoned Application

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Allen, John J
• Application Number:
  US10/495,668
• Publication Number:
  US 20050049522A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

The present invention relates to a method of lancing skin through an outer surface of said skin to obtain a sample of blood, the method providing a lancing instrument having a sharpened end and a channel extending from said sharpened end to a sensor attached to a proximal end of said lancing instrument, forcing said sharpened tip into said skin to a first predetermined depth below said outer surface, wherein said sharpened tip creates an incision in said skin surface; then completely withdrawing said sharpened tip from the incision, forcing the sharpened tip back into said incision to a second predetermined depth, wherein said second predetermined depth is not as deep as the first predetermined dept; and drawing blood through said channel to the sensor.

Claims

1. A method of lancing skin through an outer surface of said skin to obtain a sample of blood, the method comprising the steps of:

providing a lancing instrument having a sharpened tip and a channel adjacent said sharpened tip to a sensor attached to a proximal end of said lancing instrument;

forcing said sharpened tip into said skin to a first predetermined depth below said outer surface, wherein said sharpened tip creates an incision in said skin surface;

completely withdrawing said sharpened tip from said incision;

forcing said sharpened tip back into said incision to a second predetermined depth, wherein said second predetermined depth is not as deep as said first predetermined depth; and

drawing blood through said channel to said sensor.

2. A method of lancing skin as set forth in claim 1 wherein said second predetermined depth is sufficient to insure that a distal end of said channel is positioned below said surface of said skin.

3. A method of lancing skin as set forth in claim 1 wherein said first predetermined depth is in the range of approximately 0.25 to 1.5 mm.

4. A method of lancing skin as set forth in claim 3 wherein said second predetermined depth is in the range of approximately 0.05 to 0.25 mm.

5. A method of lancing skin as set forth in claim 1, further comprising the step of providing pressure on said skin in a region surrounding said incision.

6. A method of lancing skin as set forth in claim 5 wherein said pressure is exerted by a milking ring positioned on said skin prior to said step of forcing said sharpened tip into said skin.

7. A method of lancing skin as set forth in claim 6 wherein said milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into said channel.

8. A method of lancing skin as set forth in claim 7 wherein said milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds.

9. A method of lancing skin as set forth in claim 1 wherein said second predetermined depth is sufficient to insure that a distal end of said channel is positioned adjacent said surface of said skin.

10. A method according to claim 5 where in said pressure is applied for a predetermined time period prior to lancing said skin, said predetermined time period being approximately three seconds or more.

11. A method of lancing skin through an outer surface of said skin to obtain a sample of blood, the method comprising the steps of:

providing a lancing instrument having an opening and a lancing element having a sharpened tip and a channel extending from adjacent said sharpened tip to a sensor attached to a proximal end of said lancing element;

forcing said sharpened tip into said skin by extending said sharpened tip to a first extension length beyond said opening, wherein said sharpened tip creates an incision in said skin surface;

completely withdrawing said sharpened tip from said incision;

forcing said sharpened tip back into said incision by extending said sharpened tip to a second extension length beyond said opening, wherein said second extension length is less than said first extension length; and

drawing blood through said channel to said sensor.

12. A method of lancing skin as set forth in claim 11 wherein said second extension length is sufficient to insure that a distal end of said channel is positioned below said surface of said skin.

13. A method of lancing skin as set forth in claim 11 wherein said first extension length is in the range of approximately 0.25 to 1.5 mm.

14. A method of lancing skin as set forth in claim 13 wherein said second extension length is in the range of approximately 0.05 to 0.25 mm.

15. A method of lancing skin as set forth in claim 11, further comprising the step of providing pressure on said skin in a region surrounding said incision.

16. A method of lancing skin as set forth in claim 15 wherein said pressure is exerted by a milking ring positioned on said skin prior to said step of forcing said sharpened tip into said skin.

17. A method of lancing skin as set forth in claim 16 wherein said milking ring provides a pressure sufficient to facilitate the flow of bodily fluids into said channel.

18. A method of lancing skin as set forth in claim 17 wherein said milking ring provides a pressure in a range of approximately 0.5 to 1.5 pounds.

19. A method of lancing skin as set forth in claim 11 wherein said second predetermined depth is sufficient to insure that a distal end of said channel is positioned adjacent said surface of said skin.

20. A method of lancing skin as set forth in claim 15 where in said pressure is applied for a predetermined time period prior to lancing said skin, said predetermined time period being approximately three seconds or more.