Method for the mask-etching of a piercing element

• US 10,842,425 B2
• Filed: 12/14/2016
• Issued: 11/24/2020
• Est. Priority Date: 09/23/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Zipfel, Marzellinus, Lopez-Mras, Angel
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US15/378,434
• Publication Number:
  US 20170086726A1
• Time in Patent Office: 1,441 Days
• Field of Search: 600537, 600583, 606181, 606182, 216 11, 435 29
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150358 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01D 67/0034 by micromachining techniques, e.g. using masking and etching steps, photolithography
• CPC Class Codes: B01D 67/0058 by selective elimination of components, e.g. by leaching
• CPC Class Codes: B44C 1/227 by etching
• CPC Class Codes: C23F 1/02 Local etching

Abstract

A method is disclosed for the mask-etching of a piercing element having an elongate shaft, a distally protruding tip, a proximal holding part, and a laterally open collecting channel that collects bodily fluid and extends along the shaft as far as the area of the tip, wherein a side of a double-sided etching mask is applied respectively to the two sides of a substrate and, under the action of an etching agent, the piercing element is formed as a part made by chemical blanking, wherein a channel side of the etching mask is provided with a channel etching slit for unilateral etching of the collecting channel.

Claims

1. A piercing element during a chemical blanking process, comprising:

a substrate having opposing sides, wherein the substrate through the chemical blanking process is configured to form an elongate shaft, a distally protruding tip, a proximal holding part, and a laterally open collecting channel configured for collecting bodily fluid and extending along the elongate shaft as far as an area of the tip, wherein the collecting channel at least at one end portion extends with a continuously decreasing cross-sectional area; and

a double-sided etching mask covering the opposing sides of the substrate, wherein a channel side of the double-sided etching mask is provided with a channel etching slit for unilateral etching of the collecting channel, wherein the channel etching slit has a proximal end portion and a distal end portion located opposite the proximal end portion, wherein the proximal and/or distal end portion of the channel etching slit tapers toward an end of the channel etching slit, wherein the double-sided etching mask, on an opposite side directed away from the channel etching slit, comprises an auxiliary opening having a Y-shape which serves to avoid making of undercut edges in the area of the distally protruding tip, wherein the distally protruding tip has a wedge shape defined by edges that meet at a vertex on the opposite side, wherein the auxiliary opening with the Y-shape has a connection point, at least a pair of opening limbs tapering towards one another at the connection point, and an auxiliary opening slit extending from the connection point.

2. The piercing element of claim 1, wherein the double-sided etching mask is provided with a flange-forming area, which adjoins the channel etching slit in a proximal direction, and the flange-forming area is undercut to form a flange edge forming a mouth of the collecting channel.

3. The piercing element of claim 2, wherein the flange edge is configured for flanging a test element onto the proximal holding part.

4. The piercing element of claim 3, wherein the flange-forming area comprises a mask bridge extending transversely with respect to the channel etching slit.

5. The piercing element of claim 1, wherein the proximal and/or distal end portion of the channel etching slit tapers linearly, such that the etched collecting channel extends in the direction of the taper with a constant or continuously decreasing cross-sectional area.

6. The piercing element of claim 1, wherein the channel etching slit in a proximal region of the double-sided etching mask is positioned such that the etched collecting channel opens out at a front end of the proximal holding part.

7. The piercing element of claim 1, wherein the double-sided etching mask comprises a sacrificial continuation, which is arranged at the proximal end portion downstream of the channel etching slit and which is used to screen an etching agent effect in a mouth area of the collecting channel.

8. The piercing element of claim 7, wherein the sacrificial continuation protrudes freely on a mask edge and is defined by an arc shape in an edge area.

9. The piercing element of claim 7, wherein dimensions of the sacrificial continuation are adapted to an undercutting width of the substrate in response to the etching agent, such that the sacrificial continuation is completely etched off to a proximal base for the sacrificial continuation.

10. The piercing element of claim 1, wherein the double-sided etching mask comprises, on both sides of the substrate, a tip-forming area in order to form a tip contour, wherein the tip-forming area on the channel side is arranged distally in front of the tip-forming area lying on a side opposite the channel side.

11. The piercing element of claim 1, wherein the double-sided etching mask, on the opposite side directed away from the channel etching slit, comprises the auxiliary opening which serves to avoid making of undercut edges in the area of the distally protruding tip.

12. The piercing element of claim 11, wherein the auxiliary opening is arranged in a tip-forming area of the double-sided etching mask at a lateral distance from a mask edge.

13. The piercing element of claim 11, wherein the auxiliary opening limbs extend toward each other in a V shape in a distal direction.

14. The piercing element of claim 11, wherein the auxiliary opening has a distal auxiliary opening continuation which extends in a distal direction.

15. The piercing element of claim 14, wherein a proximal end of the auxiliary opening continuation, as viewed in a proximal direction, is arranged behind a distal end of the distally protruding tip to be formed.

16. The piercing element of claim 14, wherein the auxiliary opening is designed as a slit or series of holes.

17. The piercing element of claim 11, wherein the connection point of the opening limbs is arranged distally from a tip contour to be formed on a side opposite the channel-side.

18. The piercing element of claim 1, wherein the channel etching slit is extended so far into a distal tip-forming area of the etching mask that the collecting channel terminates at a distance of 150 to 400 μ

m before a distal end of the distally protruding tip.

19. The piercing element of claim 1, wherein the proximal and/or distal tapered end portion of the channel etching slit is reduced in width, by 0.4 to 0.6 times an initial width of the channel etching slit, toward a blunt end edge.

20. The piercing element of claim 1, wherein the channel etching slit, at the proximal and/or distal end portion, is tapered toward the slit end along a length in a range of between 100 and 300 μ

m.