Lancet protective cap

• US 20060174592A1
• Filed: 02/07/2005
• Published: 08/10/2006
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Chan, Frank A.
• Granted Patent: US 7,479,118 B2
• Time in Patent Office: Days
• US Class Current: 53/442
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/15061 by material engagement, e.g. welding, bonding
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback

Abstract

A unique technique for maintaining the sterility and integrity of a lancet tip. One or more lancet tips are sandwiched between a first web and a second web of material to protect the sterility of the lancet tips. The first and second webs are heat fused together to form a structure that covers and encapsulates the lancet tips to protect the integrity of the lancet tips. The structure is cut to form individual protective caps to detachably cover each of the lancet tips.

Claims

1. A method for covering a lancing tip, comprising:

sandwiching at least a lancing tip between a first web of material resistant to melting at a specific temperature and a second web of material meltable at the specific temperature; and

melting the second web by heating both the first web and the second web to at least the specific temperature in order to encapsulate at least the lancing tip in a sterile enclosure;

wherein during the melting the first web remains in an unmelted state to form a ribbon to protect integrity of at least the lancing tip.

2. The method of claim 1, further comprising:

cooling the second web to form a removable cap covering at least the lancing tip.

3. The method of claim 1, further comprising:

cutting the first web and the second web to a desired shape to form a pull-off tab.

4. The method of claim 1, wherein:

the first web includes a multi-layered material having a first material resistant to melting at the specific temperature and a second material meltable at the specific temperature; and

said melting the second web includes melting the second material of the first web while the first material remains in an unmelted state.

5. The method of claim 1, wherein:

the second web includes a multi-layered material having a first material resistant to melting at the specific temperature and a second material meltable at the specific temperature; and

said melting the second web includes melting the second material of the second web while the first material remains in an unmelted state.

6. The method of claim 1, wherein said sandwiching at least the lancing tip includes sandwiching a plurality of the lancing tips between the first web and the second web.

7. The method of claim 1, further comprising:

wherein said sandwiching at least the lancing tip includes sandwiching a plurality of the lancing tips between the first web and the second web;

wherein the ribbon protects the integrity of at least the plurality of lancing tips; and

storing the plurality of lancing tips and the ribbon in a cartridge.

8. The method of claim 1, further comprising:

attaching the lancing tip to a test strip configured to analyze body fluid to form an integrated lancing test strip.

9. The method of claim 8, further comprising:

sterilizing the lancing tip before attaching the lancing tip to the test strip to form the integrated lancing test strip.

10. The method of claim 8, further comprising:

sterilizing the lancing tip after attaching the lancing tip to the test strip to form the integrated lancing test strip; and

calibrating the integrated lancing test strip wherein the test strip is configured to analyze a bodily fluid sample.

11. The method of claim 1, further comprising:

providing an indicator on the ribbon to show a direction for removing the ribbon to expose the lancing tip.

12. A device, comprising:

a lancet having a lancet tip configured to form an incision in skin;

a first web of a multi-layered material, wherein the multi-layered material has a heat-resistant first layer and a heat-sensitive second layer; and

a second web of the multi-layered material, the second layer of the second web contacting the second layer of the first web and sandwiching the lancet tip between the first web and the second web to protect sterility of the lancet tip;

wherein the second layer of the first web and the second layer of the second web are melted together to form a structure to encapsulate the lancet tip.

13. The device of claim 12, wherein:

the first layer includes polystyrene; and

the second layer includes polyethylene.

14. The device of claim 12, further comprising:

a plurality of the lancet tips sandwiched between the first web and the second web.

15. The device of claim 12, further comprising:

a plurality of the lancet tips sandwiched between the first web and the second web;

a plurality of the structures configured to encapsulate said plurality of the lancet tips; and

a cartridge for storing the plurality of the structures and the plurality of the lancet tips.

16. The device of claim 12, wherein the structure is severable to form a protective cap to cover the lancet tip.

17. The device of claim 12, wherein the first layer is rigid to form a protective outer surface of the structure.

18. The device of claim 12, further comprising:

a test strip attached to the lancet and adapted to analyze bodily fluid from the incision.

19. An apparatus, comprising:

means for forming an incision;

means for encapsulating said means for forming an incision in a sterile environment that is meltable at a temperature; and

means for strengthening said means for encapsulating that is resistant to melting at the temperature, wherein said means for strengthening protects integrity of said means for forming an incision.

20. The apparatus of claim 19, further comprising:

means for analyzing a body fluid from the incision.

21. The apparatus of claim 19, wherein:

said means for forming the incision includes a lancet;

said means for encapsulating includes a first web of a multi-layered material and a second web of the multi-layered material, wherein the multi-layered material has a heat-resistant first layer and a heat-sensitive second layer; and

said means for strengthening includes the first layer that is rigid.