Lancet protective cap

• US 7,479,118 B2
• Filed: 02/07/2005
• Issued: 01/20/2009
• 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.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/052,610
• Publication Number:
  US 20060174592A1
• Time in Patent Office: 1,443 Days
• Field of Search: 600/583, 600/577, 600/576, 600/574, 606/167, 606/181
• US Class Current: 600/583
• 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 and a second web, each of the webs includes a multi-layered material having a first material resistant to melting at a specific temperature and a second material meltable at the specific temperature;

melting the second material 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 material remains in an unmelted state to form a protective shell to protect integrity of at least the lancing tip; and

cutting the protective shell to a desired shape to form a removable cap, wherein there movable cap covers at least the lancing tip.

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

3. 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 cutting the protective shell to a desired shape includes forming a plurality of removable caps;

wherein each of the removable caps protect the integrity of at least the plurality of lancing tips; and

storing the plurality of lancing tips and the plurality of removable caps in a cartridge.

4. The method of claim 1, further comprising:

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

5. A method for covering a plurality of lancing tips, comprising:

sandwiching a plurality of lancing tips between a first web of multi-layered material and a second web of the multi-layered material, the multi-layered material including a first layer resistant to melting at a specific temperature and a second layer meltable at the specific temperature, wherein the plurality of lancing tips contact the second layers;

heating the first and second webs to the specific temperature to melt the second layers of the first and the second webs;

encapsulating the plurality of lancing tips with the melted material of the second layers;

wherein during the heating the first layers of the first and the second webs remain in an unmelted state to form an exterior protective shell configured to surround the plurality of lancing tips to protect integrity of the plurality of lancing tips and to contain the melted material of the second layers.

6. The method of claim 5, further comprising:

attaching the plurality of lancing tips to a plurality of test strips configured to analyze body fluid to form a plurality of integrated lancing test strips, wherein the plurality of integrated lancing test strips are disposed in a cartridge.

7. The method of claim 5, further comprising:

wherein the first layers of the first and second webs are made of a transparent material and the second layers of the first and second webs are made of an opaque material.

8. The method of claim 7, further comprising:

wherein the heating includes applying laser energy to the first web and the second web, the laser energy passing through the first layers to the second layers wherein the second layers absorb the laser energy.

9. The method of claim 5, further comprising:

cutting the protective shell to a desired shape to form a plurality of pull-off tabs; and

providing an indicator on each of the pull-off tabs to show a direction for removing each of the pull-off tabs to expose a lancing tip.

12. The method of claim 9, further comprising:

storing the plurality of lancet tips and the rigid shell in a cartridge.

10. A method, comprising:

unrolling a first web of multi-layered material from a first spindle;

unrolling a second web of multi-layered material from a second spindle, the first and the second webs each including a first layer resistant to melting at a specific temperature and a second layer meltable at the specific temperature;

positioning a plurality of lancet tips between the first web and the second web in a side by side relationship wherein a first lancet tip is substantially parallel to a second lancet tip;

heating the first and second webs to at least the specific temperature to melt the second layers of the first and the second webs;

encapsulating the plurality of lancet tips between the first web and the second web as the second layers of the first and the second webs melt; and

wherein the first layers of the first and the second webs form a rigid shell around the plurality of lancet tips and the second layers of the first and the second webs.

11. The method of claim 10, further comprising:

cutting the rigid shell to a desired shape to form a plurality of pull-off tabs.

13. A method for covering a lancet tip, comprising:

placing a first web over a lancet tip, the first web including a multi-layered material having a first layer resistant to melting at a specific temperature and a second layer meltable at the specific temperature, wherein the lancet tip contacts the second layer;

heating a second web to a specific temperature, the second web including the multi-layered material having the first layer resistant to melting at a specific temperature and the second layer meltable at the specific temperature;

covering the lancing tip with the second web, wherein the lancet tip contacts the second layer; and

melting the second layers of the first web and the second web as the second web contacts the first web in order to encapsulate the lancet tip.

14. The method of claim 13, further comprising:

forming a protective shell around the lancet tip as the first layers of the first web and the second web remain in an unmelted state to protect integrity of the lancet tip.

15. The method of claim 14, further comprising:

cutting the protective shell to a desired shape to form a removable cap, wherein the removable cap covers the lancet tip.

16. The method of claim 15, further comprising:

sterilizing the lancet tip.

17. The method of claim 13, wherein said heating the second web includes applying a thermal plate or a thermal roller to the second web, the thermal plate or the thermal roller being heated to a range between approximately 95 to 130 degrees Celsius.