Method for producing a pricking element

• US 8,087,141 B2
• Filed: 06/14/2007
• Issued: 01/03/2012
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Griss, Patrick, Zipfel, Marzellinus, Lopez, Angel
• Primary Examiner(s): COZART, JERMIE E
• Application Number:
  US11/763,266
• Publication Number:
  US 20080040919A1
• Time in Patent Office: 1,664 Days
• Field of Search: 294/24, 294/58, 295/57, 216/2, 216/41, 600/576, 604/272
• US Class Current: 29/424
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• 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
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: Y10T 29/302 Clad or other composite foil or thin metal making
• CPC Class Codes: Y10T 29/304 Using transitory solid cover material
• CPC Class Codes: Y10T 29/49812 Temporary protective coating, impregnation, or cast layer
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material
• CPC Class Codes: Y10T 29/53339 Hypodermic syringe
• CPC Class Codes: Y10T 428/12188 having marginal feature for indexing or weakened portion for severing

Abstract

The sheet metal or substrate material 22 is constructed by a photo-chemical machining or milling method. In this exemplary process, an etching mask 24 is applied to both sides of the substrate 22 and covers the structure of the flat-shaped member 12, which is to be uncovered in a subsequent etching step. The mask 24 is formed by coating the substrate 22 with a photoresist and is exposed through a photomask having the desired pattern that is arranged in front of the mask, whereby the photoresist is polymerized or hardened in the covered areas while the other areas are rinsed away after development.

Claims

1. A process for producing a lancing element having a sharp tip for piercing a body part of a test subject, comprising:

providing a mask having a shaping area to form the tip of the lancing element, a screening area which extends distally beyond the shaping area, and at least one side that is bent or concavely curved at the junction between the shaping area and the screening area;

placing the mask on a flat material; and

applying an etching agent to the mask and allowing the etching agent to act upon the flat material, wherein the screening area prevents the front of the tip from being etched off such that the etching produces a sharp tip by laterally undercutting side flanks of the shaping area and screening area.

2. The process of claim 1, further comprising providing the shaping area of the mask with a width that narrows in a direction toward the screening area.

3. The process of claim 1, further comprising providing the shaping area with at least one chamfered side.

4. The process of claim 1, further comprising providing the length of the screening area larger than a proximal undercutting width to offset the action of the etching agent.

5. The process of claim 1, further comprising providing a constriction in the mask that shapes the tip.

6. The process of claim 5, further comprising providing the width of the constriction as less than twice a lateral undercutting width.

7. The process of claim 5, further comprising providing the screening area with a width that widens in a distal direction away from the constriction.

8. The process of claim 1, further comprising providing the mask with a bridge section that widens in the distal direction relative to the tip to be formed.

9. The process of claim 1, further comprising etching the flat material such that an undercut is formed on an edge of the flat material.

10. The process of claim 1, further comprising applying the etching agent in a dipping bath or by spraying it onto the flat material.

11. The process of claim 10, further comprising applying the etching agent at an overpressure.

12. The process of claim 1, further comprising processing the flat material from roll to roll by photochemical mask etching.

13. The process of claim 1, further comprising selecting the thickness of the flat material from between 1 mm and 0.01 mm.

14. The process of claim 1, further comprising providing the mask with a channel slot and using the channel slot to form a semi-open capillary channel on the lancing element with walls whose distal ends are shaped as sharp tips.

15. The process of claim 14, further comprising providing the screening area as two screening areas for the tips of the two channel walls, each screening area being delimited on one side by the channel slot.

16. The process of claim 1, further comprising providing a second mask on a second side of the flat material and etching a pointed lancing shaft on one side of the flat material and a semi-open capillary channel with pointed channel walls on the other side of the flat material.

17. The process of claim 1, further comprising providing the mask with a compensation opening positioned laterally inward from an edge of the shaping area and etching away an edge contour of the flat shaped member from the edge through the compensation opening.

18. A process for producing a lancing element having a sharp tip for piercing a body part of a test subject, comprising:

providing a mask having a shaping area to form the tip of the lancing element, a screening area which extends distally beyond the shaping area, and a compensation opening disposed at a lateral distance to an undercut edge the shaping area;

placing the mask on a flat material; and

applying an etching agent to the mask and allowing the etching agent to act upon the flat material, wherein the screening area prevents the front of the tip from being etched off and the compensation opening prevents formation of a barb at or near the tip.

19. The process of claim 18, further comprising providing the compensation opening as a slot.

20. The process of claim 18, further comprising providing the compensation opening as a chain of holes.

21. The process of claim 18, further comprising providing the mask with an opening bordering the edge of the shaping area, wherein the compensation opening has a smaller width than the opening.

22. The process of claim 18, further comprising providing the mask with a bridge between the edge of the shaping area and the compensation opening.

23. The process of claim 18, further comprising positioning the compensation opening in at least one of the shaping area and the screening area.

24. The process of claim 18, further comprising providing the compensation opening laterally inward from a side edge of the mask that is bent or concavely curved.