CA2592310C - Method for producing a pricking element - Google Patents
Method for producing a pricking element Download PDFInfo
- Publication number
- CA2592310C CA2592310C CA2592310A CA2592310A CA2592310C CA 2592310 C CA2592310 C CA 2592310C CA 2592310 A CA2592310 A CA 2592310A CA 2592310 A CA2592310 A CA 2592310A CA 2592310 C CA2592310 C CA 2592310C
- Authority
- CA
- Canada
- Prior art keywords
- mask
- process according
- tip
- area
- etching
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 238000004519 manufacturing process Methods 0.000 title description 8
- 238000005530 etching Methods 0.000 claims abstract description 60
- 238000000034 method Methods 0.000 claims abstract description 41
- 238000012216 screening Methods 0.000 claims abstract description 36
- 238000007493 shaping process Methods 0.000 claims abstract description 31
- 239000000463 material Substances 0.000 claims abstract description 25
- 210000001124 body fluid Anatomy 0.000 claims description 8
- 239000010839 body fluid Substances 0.000 claims description 8
- 238000012360 testing method Methods 0.000 claims description 6
- 239000002184 metal Substances 0.000 claims description 4
- 230000000717 retained effect Effects 0.000 claims description 3
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- 239000010935 stainless steel Substances 0.000 claims description 3
- 238000007598 dipping method Methods 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 description 15
- 239000008280 blood Substances 0.000 description 8
- 210000004369 blood Anatomy 0.000 description 8
- 239000000758 substrate Substances 0.000 description 8
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 238000001259 photo etching Methods 0.000 description 2
- 229920002120 photoresistant polymer Polymers 0.000 description 2
- 239000004065 semiconductor Substances 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000000835 electrochemical detection Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000003801 milling Methods 0.000 description 1
- 238000000206 photolithography Methods 0.000 description 1
- 238000012805 post-processing Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
- A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/30—Foil or other thin sheet-metal making or treating
- Y10T29/301—Method
- Y10T29/302—Clad or other composite foil or thin metal making
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/30—Foil or other thin sheet-metal making or treating
- Y10T29/301—Method
- Y10T29/303—Method with assembling or disassembling of a pack
- Y10T29/304—Using transitory solid cover material
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/4981—Utilizing transitory attached element or associated separate material
- Y10T29/49812—Temporary protective coating, impregnation, or cast layer
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49995—Shaping one-piece blank by removing material
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/53—Means to assemble or disassemble
- Y10T29/53313—Means to interrelatedly feed plural work parts from plural sources without manual intervention
- Y10T29/53322—Means to assemble container
- Y10T29/53339—Hypodermic syringe
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/12—All metal or with adjacent metals
- Y10T428/12188—All metal or with adjacent metals having marginal feature for indexing or weakened portion for severing
Abstract
The invention concerns a process for producing a lancing element in which a flat shaped member (12) is formed from a flat material (22) by applying a mask (24) and allowing an etching agent to act upon it wherein at least a part of the flat shaped member (12) is shaped as a tip (16, 16'). According to the invention it is proposed that the mask (24) is provided with a shaping area (30) for the tip to be formed (16, 16') and with a screening area (32) which extends distally beyond this shaping area to prevent the tip from being etched off at the front (16, 16') and that a sharp tip (16, 16') is exposed by laterally undercutting the side flanks (34, 36) of the shaping area and screening area (32).
Description
Method for Producing a Pricking Element The invention concerns a process for producing a lancing element in particular for withdrawing a body fluid in which a flat shaped member is formed from a flat material by applying a mask and allowing an etching agent to act upon it wherein at least a part of the flat shaped member is shaped as a tip for piercing into a body part of a test subject.
Lancing elements of this type allow the analysis of very small amounts of fluid especially in bioanalytics, such as for example those which are withdrawn in situ as capillary blood for blood glucose determinations. Such microfluidic systems, in addition to the microscopic volumes (microliters and less) are also characterized by structural elements of increasingly smaller dimensions which allow capillary forces to be utilized and can be implemented in so-called disposables in a suitable manner for mass production. Although manufacturing processes especially in the form of mask etching (photochemical etching) are known from the field of semiconductor technology for highly integrated systems; the materials used can hardly be used for mechanically stressed structures especially because of their brittleness. When biocompatible materials such as steel are etched, a problem occurs with conventional shaped-complementary etch masking that the generated lancing structures are rounded off and thus do not allow a particularly optimal puncture.
An etching process for producing surgical needles is known from US 4 777 096 A, in which the etch mask extends beyond the tip to be formed in a distally blunted shaping area which should prevent rounding. However, this mask overhang is shorter than the undercutting range of the etching agent so that the tip is shaped by a combined lateral and frontal etching action which only slightly reduces the problem of blunting.
Lancing elements of this type allow the analysis of very small amounts of fluid especially in bioanalytics, such as for example those which are withdrawn in situ as capillary blood for blood glucose determinations. Such microfluidic systems, in addition to the microscopic volumes (microliters and less) are also characterized by structural elements of increasingly smaller dimensions which allow capillary forces to be utilized and can be implemented in so-called disposables in a suitable manner for mass production. Although manufacturing processes especially in the form of mask etching (photochemical etching) are known from the field of semiconductor technology for highly integrated systems; the materials used can hardly be used for mechanically stressed structures especially because of their brittleness. When biocompatible materials such as steel are etched, a problem occurs with conventional shaped-complementary etch masking that the generated lancing structures are rounded off and thus do not allow a particularly optimal puncture.
An etching process for producing surgical needles is known from US 4 777 096 A, in which the etch mask extends beyond the tip to be formed in a distally blunted shaping area which should prevent rounding. However, this mask overhang is shorter than the undercutting range of the etching agent so that the tip is shaped by a combined lateral and frontal etching action which only slightly reduces the problem of blunting.
From this starting point, the object of the invention was to avoid the disadvantages occurring in the prior art and to improve a production process of the type mentioned above such that sharp lancing structures for optimal lancing into a body part are created in a process sequence suitable for mass production without requiring complicated post-processing steps.
In one aspect of the invention, there is provided a process for producing a lancing element, in particular, for withdrawing a body fluid, in which a flat shaped member is formed from a flat material by applying a mask and allowing an etching agent to act upon it wherein at least a part of the flat shaped member is shaped as a tip for piercing into a body part of a test subject, wherein the mask is provided with a shaping area for the tip to be shaped and with a screening area which extends distally beyond this shaping area to prevent the tip from being etched off at the front, wherein at least one side flank is bent or concavely curved in the junction between the shaping area and screening area so that the screening area has a constant or increasing width over a given screening length where it connects with the shaping area and a sharp tip is exposed only by laterally undercutting the side flanks of the shaping area and screening area.
In another aspect of the invention, there is provided a process for producing a lancing element in particular, for withdrawing a body fluid, in which a flat shaped member is formed from a flat material by applying a mask and allowing an etching agent to act upon it wherein at least a part of the flat shaped member is shaped as a tip for piercing into a body part of a test subject, wherein the mask is provided with a compensation opening at a lateral distance from an undercut edge section, and an edge contour of the flat shaped member is etched away from the edge through the compensation opening under the action of the etching agent, wherein the compensation opening is positioned only at the side of a central axis running towards the tip that is to be shaped so that a strip of the mask is retained in front of the tip along the central axis and the tip is screened from being etched off at the front.
The idea behind the invention is to produce a sharp tip solely by means of lateral mutually converging etching agent fronts. Accordingly it is proposed according to the invention that the mask is provided with a shaping area for the tip to be formed and with a screening area which extends distally beyond this shaping area to prevent the tip from being etched off at the front, and that a sharp tip is exposed by laterally undercutting the side flanks of the shaping and screening area. This can prevent the contour in the area of the tip from being rounded off whereby the etching process is terminated as soon as the bridge of material located between the side flanks of the etching mask is broken through. This allows optimized tips to be created in order to reduce the lancing pain and to enable body fluid to be picked up with the smallest possible dimensions. Moreover, the required propulsion forces for the lancing can be minimized and traumatization of the body tissue can be substantially avoided.
The shaping area of the etching mask advantageously narrows towards the screening area to produce a lancing shaft that tapers towards the tip. For this it is advantageous when the shaping area is linearly chamfered at least on one side.
Another advantageous embodiment provides that at least one side flank is bent or concavely curved in the junction between the shaping area and screening area so that the substrate material in the area of the tip to be produced only has to be removed from the side.
In any case, it should be ensured that the screening area has a constant or increasing width over a given screening length where it connects with the shaping area.
The screening length should be larger than the proximal undercutting width due to the action of the etching agent. This reliably prevents the tip from being centrally etched off.
The tip is preferably shaped as a result of a constriction in the mask where the width of the constriction should be less than twice the lateral undercutting width so that the substrate material under the constriction is completely etched away.
The screening area is advantageously widened again after the constriction.
Also in order to improve the stability of the etching mask, it is advantageous when the screening area has a widening bridge section distal to the tip that is to be formed.
Whereas etching processes in steel mainly proceed isotropically, it is also conceivable that the lateral undercutting width is larger or smaller than the etching depth.
Anisotropy for example occurs when the etching agent is applied at an overpressure relative to the surroundings in order to ensure a particularly effective action. The etching agent can be applied in a dipping bath or by being sprayed onto the flat material.
For a high throughput it is advantageous when the flat material that is preferably formed from stainless steel sheet metal is processed from roll to roll by photo-chemical mask etching. However, it is also possible to use a semiconductor wafer as a flat material.
The thickness of the flat material is advantageously between 1 mm and 0.01 mm.
According to a further preferred embodiment the lancing element is provided with a semi-open capillary channel to transport the body fluid that is formed by a channel slot in the mask where the distal ends of the channel walls form a sharp tip.
In this connection the screening areas for the tips of the channel walls are delimited on one side by the channel slot.
For a special design of the shaped member the flat material is provided on both sides with a mask wherein a pointed lancing shaft is etched free on one side and a semi-open capillary channel with pointed channel walls that extends towards the lancing shaft is etched free on the other side.
According to another aspect of the invention the etching mask is provided with a compensation opening at a lateral distance from an undercut edge section, and an edge contour of the flat shaped member is etched away from the edge through the compensation opening under the action of the etching agent. This allows undesired undercuts on the shaped member to be chemically milled off without additional manufacturing effort.
In order to remove the edges it is advantageous when the compensation opening preferably runs as a slot or chain of holes in the mask along the edge section. The compensation opening should have a smaller inner width than a cut-away in the mask adjoining the edge section.
In order to achieve a combined undercutting effect on a bridge of material extending between the edge of the mask and the compensation cut-out, the width of the overlying mask bridge should be less than the undercutting width of the etching agent measured from the edge of the mask.
Depending on the desired shape of the contour the invention provides that the compensation opening is arranged in a shaping area and optionally in a screening area of the mask for the tip to be formed. In particular it is advantageous when the compensation opening is laterally spaced apart from a bent or concavely curved side flank of the mask.
In order to also in this case protect the tip from being etched away at the front, it is of special advantage when the compensation opening is introduced at the side of a central axis running towards the tip that is to be formed so that a strip of the mask is retained in front of the tip along the central axis and at least beyond the undercutting width. In principle the same considerations apply here with regard to avoiding a frontal action of the etching agent as already setforth with regard to the edge of the mask. In any case a V-shaped contour of the compensation opening should be avoided.
The invention is elucidated in more detail in the following on the basis of the embodiment examples shown schematically in the diagram.
Fig. I shows a lancing element with a tip and a capillary channel for withdrawing blood in a top-view.
Fig. 2 shows the rear-side of an etching mask for producing the tip of the lancing element in a top-view.
Fig. 3 shows the front face of an etching mask for producing the capillary channel in the area of the tip in a top-view.
Fig. 4 shows an enlarged section of the etching mask in the distal end region of the capillary channel in a top-view.
Fig. 5 shows a section along the line 5 - 5 of fig. 4.
In one aspect of the invention, there is provided a process for producing a lancing element, in particular, for withdrawing a body fluid, in which a flat shaped member is formed from a flat material by applying a mask and allowing an etching agent to act upon it wherein at least a part of the flat shaped member is shaped as a tip for piercing into a body part of a test subject, wherein the mask is provided with a shaping area for the tip to be shaped and with a screening area which extends distally beyond this shaping area to prevent the tip from being etched off at the front, wherein at least one side flank is bent or concavely curved in the junction between the shaping area and screening area so that the screening area has a constant or increasing width over a given screening length where it connects with the shaping area and a sharp tip is exposed only by laterally undercutting the side flanks of the shaping area and screening area.
In another aspect of the invention, there is provided a process for producing a lancing element in particular, for withdrawing a body fluid, in which a flat shaped member is formed from a flat material by applying a mask and allowing an etching agent to act upon it wherein at least a part of the flat shaped member is shaped as a tip for piercing into a body part of a test subject, wherein the mask is provided with a compensation opening at a lateral distance from an undercut edge section, and an edge contour of the flat shaped member is etched away from the edge through the compensation opening under the action of the etching agent, wherein the compensation opening is positioned only at the side of a central axis running towards the tip that is to be shaped so that a strip of the mask is retained in front of the tip along the central axis and the tip is screened from being etched off at the front.
The idea behind the invention is to produce a sharp tip solely by means of lateral mutually converging etching agent fronts. Accordingly it is proposed according to the invention that the mask is provided with a shaping area for the tip to be formed and with a screening area which extends distally beyond this shaping area to prevent the tip from being etched off at the front, and that a sharp tip is exposed by laterally undercutting the side flanks of the shaping and screening area. This can prevent the contour in the area of the tip from being rounded off whereby the etching process is terminated as soon as the bridge of material located between the side flanks of the etching mask is broken through. This allows optimized tips to be created in order to reduce the lancing pain and to enable body fluid to be picked up with the smallest possible dimensions. Moreover, the required propulsion forces for the lancing can be minimized and traumatization of the body tissue can be substantially avoided.
The shaping area of the etching mask advantageously narrows towards the screening area to produce a lancing shaft that tapers towards the tip. For this it is advantageous when the shaping area is linearly chamfered at least on one side.
Another advantageous embodiment provides that at least one side flank is bent or concavely curved in the junction between the shaping area and screening area so that the substrate material in the area of the tip to be produced only has to be removed from the side.
In any case, it should be ensured that the screening area has a constant or increasing width over a given screening length where it connects with the shaping area.
The screening length should be larger than the proximal undercutting width due to the action of the etching agent. This reliably prevents the tip from being centrally etched off.
The tip is preferably shaped as a result of a constriction in the mask where the width of the constriction should be less than twice the lateral undercutting width so that the substrate material under the constriction is completely etched away.
The screening area is advantageously widened again after the constriction.
Also in order to improve the stability of the etching mask, it is advantageous when the screening area has a widening bridge section distal to the tip that is to be formed.
Whereas etching processes in steel mainly proceed isotropically, it is also conceivable that the lateral undercutting width is larger or smaller than the etching depth.
Anisotropy for example occurs when the etching agent is applied at an overpressure relative to the surroundings in order to ensure a particularly effective action. The etching agent can be applied in a dipping bath or by being sprayed onto the flat material.
For a high throughput it is advantageous when the flat material that is preferably formed from stainless steel sheet metal is processed from roll to roll by photo-chemical mask etching. However, it is also possible to use a semiconductor wafer as a flat material.
The thickness of the flat material is advantageously between 1 mm and 0.01 mm.
According to a further preferred embodiment the lancing element is provided with a semi-open capillary channel to transport the body fluid that is formed by a channel slot in the mask where the distal ends of the channel walls form a sharp tip.
In this connection the screening areas for the tips of the channel walls are delimited on one side by the channel slot.
For a special design of the shaped member the flat material is provided on both sides with a mask wherein a pointed lancing shaft is etched free on one side and a semi-open capillary channel with pointed channel walls that extends towards the lancing shaft is etched free on the other side.
According to another aspect of the invention the etching mask is provided with a compensation opening at a lateral distance from an undercut edge section, and an edge contour of the flat shaped member is etched away from the edge through the compensation opening under the action of the etching agent. This allows undesired undercuts on the shaped member to be chemically milled off without additional manufacturing effort.
In order to remove the edges it is advantageous when the compensation opening preferably runs as a slot or chain of holes in the mask along the edge section. The compensation opening should have a smaller inner width than a cut-away in the mask adjoining the edge section.
In order to achieve a combined undercutting effect on a bridge of material extending between the edge of the mask and the compensation cut-out, the width of the overlying mask bridge should be less than the undercutting width of the etching agent measured from the edge of the mask.
Depending on the desired shape of the contour the invention provides that the compensation opening is arranged in a shaping area and optionally in a screening area of the mask for the tip to be formed. In particular it is advantageous when the compensation opening is laterally spaced apart from a bent or concavely curved side flank of the mask.
In order to also in this case protect the tip from being etched away at the front, it is of special advantage when the compensation opening is introduced at the side of a central axis running towards the tip that is to be formed so that a strip of the mask is retained in front of the tip along the central axis and at least beyond the undercutting width. In principle the same considerations apply here with regard to avoiding a frontal action of the etching agent as already setforth with regard to the edge of the mask. In any case a V-shaped contour of the compensation opening should be avoided.
The invention is elucidated in more detail in the following on the basis of the embodiment examples shown schematically in the diagram.
Fig. I shows a lancing element with a tip and a capillary channel for withdrawing blood in a top-view.
Fig. 2 shows the rear-side of an etching mask for producing the tip of the lancing element in a top-view.
Fig. 3 shows the front face of an etching mask for producing the capillary channel in the area of the tip in a top-view.
Fig. 4 shows an enlarged section of the etching mask in the distal end region of the capillary channel in a top-view.
Fig. 5 shows a section along the line 5 - 5 of fig. 4.
Fig. 6 shows a section along the line 6 - 6 of fig. 4.
Figs. 7 to 9 show another embodiment example with a compensation slot in the etching mask in representations corresponding to figs. 4 to 6; and Fig. 10 shows a top-view of an etching mask for producing a tip according to the prior art.
The lancing and sampling element 10 shown in the drawing is used as a disposable article to withdraw and to capillary transport a small amount of blood from a body part of a test subject especially in order to carry out blood glucose measurements. For this purpose it comprises a flat shaped member 12, a lancing member 14 shaped thereon having a tip 16 and a semi-open capillary channel 18 for capillary blood transport from the tip 16 to an analytical site 20.
The flat shaped member 12 is made of a stainless steel metal sheet 22 having a thickness of about 100 to 300 m. Its proximal end section forms a holding area for handling during the lancing process whereas the lancing member 14 which is shaped as one piece at the distal end, generates a small wound in the skin of the user in order to remove microscopic volumes of blood. In this connection the capillary channel 18 has a groove shape or is semi-open over its length so that, as described below, it can be produced by photolithography. The withdrawn blood sample can for example be analysed by reflection spectroscopic or electrochemical detection methods in a known manner.
The material of the sheet metal or substrate is structured by means of the photo-chemical machining or milling method. In this process an etching mask 24 is applied, preferably to both sides, of the substrate 22 which covers the structure of the shaped member that is to be uncovered in a subsequent etching step. The mask is formed by coating the substrate 22 with a photoresist and it 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.
An etching agent to the substrate 22 is subsequently applied over the (double-sided) etching mask 24 generated in this manner so that the masked areas are etched away according to the basic shape. In the case of an isotropic etching action, the depth of the removed material corresponds to the lateral etching rate for the undercutting of edge contours of the mask 24. The etching process can also take place anisotropically due to external influencing parameters or material properties of the substrate i.e. the lateral undercutting rate is then larger or smaller than the depth etching rate.
Manufacture of the tip 16 is particularly critical for the function of the lancing element 10. According to fig. 10 an obvious approach according to the prior art would be to provide an appropriate etching mask with a pointed or triangular shaping area corresponding to the desired contour of the finished part. However, it was observed in this case that the tip 28 formed in this manner is not sharp but is rounded off due to the etching agent that flows in from all sides during undercutting of the triangular mask 26.
In order to avoid this the etching mask 24 according to the invention has a shaping area 30 for the tip 16 to be formed and a distal - with regard to the lancing direction -adjoining screening area 32 preventing the front of the tip 16 from being etched off.
The shaping area 30 narrows towards the screening area 32 and the side flanks 34, 36 of the mask 24 are bevelled with a linear slope. Starting at a constriction 38 the screening area 32 widens while forming a bridge section 40 towards the other areas of the mask so that the etching mask 24 remains overall more stable.
Hence, a sharp tip 16 is etched free by lateral undercutting of the side flanks 34, 36 of the shaping area and screening area 30, 32, the contour of which is shown by the dashed line in fig. 2. In this connection the screening area 32 has a larger screening length than the undercutting width viewed in the proximal direction whereas the width of the constriction 38 is less than twice the lateral undercutting width. In this manner the etched away material fronts converge at the constriction 38 until finally the tip 16 is uncovered when the etching process is completed.
The front side section of the mask 24 shown in fig. 3 is designed to be complementary to the desired capillary structure 18 in the area of the lancing member 14.
Accordingly the mask 24 has a capillary slot 42 through which the channel 18 is etched in to form the channel walls 44. In order to also facilitate the lancing in this case the distal ends of the channel walls 44 are chamfered as sharp tips 16'. This is achieved in the manner described above by screening areas 32 positioned in front where in fig. 3 functionally identical parts have the same reference numerals so that reference can be made to the previous embodiments. In contrast to fig. 2 the side flanks 34, 36 in the area of the constriction 38 are not concavely curved on both sides but are rather bluntly angled on one side and on the opposite side thereto they are linearly delimited by the capillary gap 42 so that a wedge-shaped tip 16' is formed as shown by the dashed line.
The basic geometric effects of the etching process in the area of the channel tips 16' are illustrated in figs. 4 to 6. Figs 5 and 6 only show the upper substrate area after a certain etching time where the lateral etching contours 46 only describe a circular line in the case of an isotropic etching action. Thus lateral undercutting of the mask edges and side flanks 34, 36 of the mask 24 result in undercut edges of the shaped member 48, 50 as shown best in fig. 5. Such undercuts are indeed desirable in the area of the capillary channel 18 because they further improve the capillarity. However, the undercut 52 results in a barb (fig. 6) at the tip 16, 16' which can impair the lancing into the skin.
In order to rectify this, a compensation slot 54 can be kept free in the mask according to figs. 7 and 8. This slot extends at a lateral distance to an undercut edge section 56 in the shaping area 30 of the mask 24 and ensures that the edges of the undercut 48 that would otherwise be formed are etched away. Hence, the etching agent which penetrates near to the edge via the compensation slot 54 results in a rounding of the edge 58 while avoiding a barb. The width of the mask strip 60 between the mask edge 56 and the compensation slot 54 is advantageously less than the lateral undercut width. This should ensure that the compensation slot 54 has a substantially smaller inner width compared to the neighbouring mask cut-out 62 so that the rounded edges 58 have a correspondingly smaller etching radius.
Figs. 7 to 9 show another embodiment example with a compensation slot in the etching mask in representations corresponding to figs. 4 to 6; and Fig. 10 shows a top-view of an etching mask for producing a tip according to the prior art.
The lancing and sampling element 10 shown in the drawing is used as a disposable article to withdraw and to capillary transport a small amount of blood from a body part of a test subject especially in order to carry out blood glucose measurements. For this purpose it comprises a flat shaped member 12, a lancing member 14 shaped thereon having a tip 16 and a semi-open capillary channel 18 for capillary blood transport from the tip 16 to an analytical site 20.
The flat shaped member 12 is made of a stainless steel metal sheet 22 having a thickness of about 100 to 300 m. Its proximal end section forms a holding area for handling during the lancing process whereas the lancing member 14 which is shaped as one piece at the distal end, generates a small wound in the skin of the user in order to remove microscopic volumes of blood. In this connection the capillary channel 18 has a groove shape or is semi-open over its length so that, as described below, it can be produced by photolithography. The withdrawn blood sample can for example be analysed by reflection spectroscopic or electrochemical detection methods in a known manner.
The material of the sheet metal or substrate is structured by means of the photo-chemical machining or milling method. In this process an etching mask 24 is applied, preferably to both sides, of the substrate 22 which covers the structure of the shaped member that is to be uncovered in a subsequent etching step. The mask is formed by coating the substrate 22 with a photoresist and it 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.
An etching agent to the substrate 22 is subsequently applied over the (double-sided) etching mask 24 generated in this manner so that the masked areas are etched away according to the basic shape. In the case of an isotropic etching action, the depth of the removed material corresponds to the lateral etching rate for the undercutting of edge contours of the mask 24. The etching process can also take place anisotropically due to external influencing parameters or material properties of the substrate i.e. the lateral undercutting rate is then larger or smaller than the depth etching rate.
Manufacture of the tip 16 is particularly critical for the function of the lancing element 10. According to fig. 10 an obvious approach according to the prior art would be to provide an appropriate etching mask with a pointed or triangular shaping area corresponding to the desired contour of the finished part. However, it was observed in this case that the tip 28 formed in this manner is not sharp but is rounded off due to the etching agent that flows in from all sides during undercutting of the triangular mask 26.
In order to avoid this the etching mask 24 according to the invention has a shaping area 30 for the tip 16 to be formed and a distal - with regard to the lancing direction -adjoining screening area 32 preventing the front of the tip 16 from being etched off.
The shaping area 30 narrows towards the screening area 32 and the side flanks 34, 36 of the mask 24 are bevelled with a linear slope. Starting at a constriction 38 the screening area 32 widens while forming a bridge section 40 towards the other areas of the mask so that the etching mask 24 remains overall more stable.
Hence, a sharp tip 16 is etched free by lateral undercutting of the side flanks 34, 36 of the shaping area and screening area 30, 32, the contour of which is shown by the dashed line in fig. 2. In this connection the screening area 32 has a larger screening length than the undercutting width viewed in the proximal direction whereas the width of the constriction 38 is less than twice the lateral undercutting width. In this manner the etched away material fronts converge at the constriction 38 until finally the tip 16 is uncovered when the etching process is completed.
The front side section of the mask 24 shown in fig. 3 is designed to be complementary to the desired capillary structure 18 in the area of the lancing member 14.
Accordingly the mask 24 has a capillary slot 42 through which the channel 18 is etched in to form the channel walls 44. In order to also facilitate the lancing in this case the distal ends of the channel walls 44 are chamfered as sharp tips 16'. This is achieved in the manner described above by screening areas 32 positioned in front where in fig. 3 functionally identical parts have the same reference numerals so that reference can be made to the previous embodiments. In contrast to fig. 2 the side flanks 34, 36 in the area of the constriction 38 are not concavely curved on both sides but are rather bluntly angled on one side and on the opposite side thereto they are linearly delimited by the capillary gap 42 so that a wedge-shaped tip 16' is formed as shown by the dashed line.
The basic geometric effects of the etching process in the area of the channel tips 16' are illustrated in figs. 4 to 6. Figs 5 and 6 only show the upper substrate area after a certain etching time where the lateral etching contours 46 only describe a circular line in the case of an isotropic etching action. Thus lateral undercutting of the mask edges and side flanks 34, 36 of the mask 24 result in undercut edges of the shaped member 48, 50 as shown best in fig. 5. Such undercuts are indeed desirable in the area of the capillary channel 18 because they further improve the capillarity. However, the undercut 52 results in a barb (fig. 6) at the tip 16, 16' which can impair the lancing into the skin.
In order to rectify this, a compensation slot 54 can be kept free in the mask according to figs. 7 and 8. This slot extends at a lateral distance to an undercut edge section 56 in the shaping area 30 of the mask 24 and ensures that the edges of the undercut 48 that would otherwise be formed are etched away. Hence, the etching agent which penetrates near to the edge via the compensation slot 54 results in a rounding of the edge 58 while avoiding a barb. The width of the mask strip 60 between the mask edge 56 and the compensation slot 54 is advantageously less than the lateral undercut width. This should ensure that the compensation slot 54 has a substantially smaller inner width compared to the neighbouring mask cut-out 62 so that the rounded edges 58 have a correspondingly smaller etching radius.
Claims (27)
1. Process for producing a lancing element in which a flat shaped member (12) is formed from a flat material (22) by applying a mask (24) and allowing an etching agent to act upon it wherein at least a part of the flat shaped member (12) is shaped as a tip (16, 16') for piercing into a body part of a test subject, wherein the mask (24) is provided with a shaping area (30) for the tip (16, 16') to be shaped and with a screening area (32) which extends distally beyond this shaping area to prevent the tip (16, 16') from being etched off at the front, characterized in that at least one side flank (34) is bent or concavely curved in the junction between the shaping area (30) and screening area (32) so that the screening area (32) has a constant or increasing width over a given screening length where it connects with the shaping area (30) and a sharp tip (16, 16') is exposed only by laterally undercutting the side flanks (34, 36) of the shaping area and screening area (32).
2. Process according to claim 1, characterized in that the shaping area (30) of the etching mask narrows towards the screening area (32).
3. Process according to claim 1 or 2, characterized in that the shaping area (30) is linearly chamfered at least on one side.
4. Process according to claim 1, characterized in that the screening length is larger than the proximal undercutting width due to the action of the etching agent.
5. Process according to any one of claims 1 to 4, characterized in that the tip (16, 16') is shaped by a constriction (38) in the mask (24).
6. Process according to claim 5, characterized in that the width of the constriction (38) should be less than twice the lateral undercutting width.
7. Process according to claim 5 or 6, characterized in that the screening area (32) is widened again after the constriction (38).
8. Process according to any one of claims 1 to 7, characterized in that the screening area (32) has a bridge section (40) that widens in the distal direction relative to the tip (16, 16') that is to be formed.
9. Process according to any one of claims 1 to 8, characterized in that the undercutting etching width is larger or smaller than the etching depth.
10. Process according to any one of claims 1 to 9, characterized in that the etching agent is applied in a dipping bath or by being sprayed onto the flat material.
11. Process according to any one of claims 1 to 10, characterized in that the etching agent is applied at an overpressure relative to the surroundings.
12. Process according to any one of claims 1 to 11, characterized in that the flat material (22) is processed from roll to roll by photochemical mask etching.
13. Process according to claim 12, characterized in that the flat material (22) is formed from stainless steel sheet metal.
14. Process according to any one of claims 1 to 13, characterized in that the thickness of the flat material (22) is selected to be between 1 mm and 0.01 mm.
15. Process according to any one of claims 1 to 14, characterized in that the lancing element is provided with a capillary channel (18) to transport the body fluid that is formed by a channel slot (42) in the mask (24), and that the distal ends of the channel walls (44) are shaped as a sharp tip (16').
16. Process according to claim 15, characterized in that the screening areas (32) for the tips (16') of the channel walls (44) are delimited on one side by the channel slot (42).
17. Process according to any one of claims 1 to 14, characterized in that the flat material (22) is provided on both sides with the mask (24) wherein a pointed lancing shaft (14) is etched free on one side and a capillary channel (18) with pointed channel walls (44) that extends towards the lancing shaft (14) is etched free on the other side.
18. Process according to any one of claims 1 to 17, characterized in that the mask (24) is provided with a compensation opening (54) at a lateral distance from an undercut edge section (56), and that an edge contour (48) of the flat shaped member (12) is etched away from the edge through the compensation opening (54) under the action of the etching agent.
19 Process according to any one of claims 1 to 17, characterized in that said lancing element is for withdrawing a body fluid.
20. Process for producing a lancing element in which a flat shaped member (12) is formed from a flat material (22) by applying a mask (24) and allowing an etching agent to act upon it wherein at least a part of the flat shaped member (12) is shaped as a tip (16, 16') for piercing into a body part of a test subject, wherein the mask (24) is provided with a compensation opening (54) at a lateral distance from an undercut edge section (56), and an edge contour (48) of the flat shaped member (12) is etched away from the edge through the compensation opening (54) under the action of the etching agent, characterized in that the compensation opening (54) is positioned only at the side of a central axis running towards the tip (16, 16') that is to be shaped so that a strip of the mask is retained in front of the tip (16, 16') along the central axis and the tip (16, 16') is screened from being etched off at the front.
21. Process according to claim 18 or 20, characterized in that the compensation opening (54) runs as a slot or chain of holes in the mask (24) along the edge section (56).
22. Process according to any one of claims 18, 20 or 21, characterized in that the compensation opening (54) has a smaller inner width than a cut-away in the mask (62) adjoining the edge section (56).
23. Process according to any one of claims 18 or 20 to 22, characterized in that a mask bridge (60) runs between the mask edge and the compensation opening (54), and that the width of the mask bridge (60) is less than the undercutting width of the etching agent measured form the edge of the mask.
24. Process according to any one of claims 18 or 20 to 23, characterized in that the compensation opening (54) is arranged in a shaping area (30) of the mask (24) for the tip (16, 16) to be shaped.
25. Process according to claim 24, characterized in that the compensation opening (54) is arranged in said shaping area (30) and in a screening area (32) of the mask (24) for the tip (16, 16) to be shaped.
26. Process according to any one of claims 18 or 20 to 25, characterized in that the compensation opening (54) is laterally spaced apart from a side flank (34) of the mask (24) that is bent or concavely curved distally beyond the tip (16, 16') to be shaped.
27. Process according to any one of claims 18 or 20 to 26, characterized in that said lancing element is for withdrawing a body fluid.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04029926.5 | 2004-12-17 | ||
EP04029926A EP1671585A1 (en) | 2004-12-17 | 2004-12-17 | Method of manufacturing a lancet element |
PCT/EP2005/013266 WO2006066744A1 (en) | 2004-12-17 | 2005-12-10 | Method for producing a pricking element |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2592310A1 CA2592310A1 (en) | 2006-06-29 |
CA2592310C true CA2592310C (en) | 2011-10-18 |
Family
ID=34927820
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2592310A Expired - Fee Related CA2592310C (en) | 2004-12-17 | 2005-12-10 | Method for producing a pricking element |
Country Status (14)
Country | Link |
---|---|
US (1) | US8087141B2 (en) |
EP (2) | EP1671585A1 (en) |
JP (1) | JP4838264B2 (en) |
KR (1) | KR101055237B1 (en) |
CN (1) | CN101080199B (en) |
AT (1) | ATE508689T1 (en) |
AU (1) | AU2005318594B2 (en) |
BR (1) | BRPI0515789B8 (en) |
CA (1) | CA2592310C (en) |
ES (1) | ES2363437T3 (en) |
HK (1) | HK1116377A1 (en) |
MX (1) | MX2007007020A (en) |
PL (1) | PL1830707T3 (en) |
WO (1) | WO2006066744A1 (en) |
Families Citing this family (59)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6391005B1 (en) | 1998-03-30 | 2002-05-21 | Agilent Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US8641644B2 (en) | 2000-11-21 | 2014-02-04 | Sanofi-Aventis Deutschland Gmbh | Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means |
US9795747B2 (en) | 2010-06-02 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Methods and apparatus for lancet actuation |
US9427532B2 (en) | 2001-06-12 | 2016-08-30 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7316700B2 (en) | 2001-06-12 | 2008-01-08 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
US9226699B2 (en) | 2002-04-19 | 2016-01-05 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling module with a continuous compression tissue interface surface |
WO2002100254A2 (en) | 2001-06-12 | 2002-12-19 | Pelikan Technologies, Inc. | Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge |
WO2002100460A2 (en) | 2001-06-12 | 2002-12-19 | Pelikan Technologies, Inc. | Electric lancet actuator |
US8337419B2 (en) | 2002-04-19 | 2012-12-25 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US7981056B2 (en) | 2002-04-19 | 2011-07-19 | Pelikan Technologies, Inc. | Methods and apparatus for lancet actuation |
US7041068B2 (en) | 2001-06-12 | 2006-05-09 | Pelikan Technologies, Inc. | Sampling module device and method |
US7344507B2 (en) | 2002-04-19 | 2008-03-18 | Pelikan Technologies, Inc. | Method and apparatus for lancet actuation |
US9314194B2 (en) | 2002-04-19 | 2016-04-19 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
US8784335B2 (en) | 2002-04-19 | 2014-07-22 | Sanofi-Aventis Deutschland Gmbh | Body fluid sampling device with a capacitive sensor |
US7892185B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US7297122B2 (en) | 2002-04-19 | 2007-11-20 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7229458B2 (en) | 2002-04-19 | 2007-06-12 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
US9795334B2 (en) | 2002-04-19 | 2017-10-24 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7892183B2 (en) | 2002-04-19 | 2011-02-22 | Pelikan Technologies, Inc. | Method and apparatus for body fluid sampling and analyte sensing |
US7232451B2 (en) | 2002-04-19 | 2007-06-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8267870B2 (en) | 2002-04-19 | 2012-09-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling with hybrid actuation |
US7226461B2 (en) | 2002-04-19 | 2007-06-05 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with sterility barrier release |
US7901362B2 (en) | 2002-04-19 | 2011-03-08 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7331931B2 (en) | 2002-04-19 | 2008-02-19 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8579831B2 (en) | 2002-04-19 | 2013-11-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US9248267B2 (en) | 2002-04-19 | 2016-02-02 | Sanofi-Aventis Deustchland Gmbh | Tissue penetration device |
US7976476B2 (en) | 2002-04-19 | 2011-07-12 | Pelikan Technologies, Inc. | Device and method for variable speed lancet |
US8221334B2 (en) | 2002-04-19 | 2012-07-17 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7674232B2 (en) | 2002-04-19 | 2010-03-09 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7547287B2 (en) | 2002-04-19 | 2009-06-16 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US7491178B2 (en) | 2002-04-19 | 2009-02-17 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US7909778B2 (en) | 2002-04-19 | 2011-03-22 | Pelikan Technologies, Inc. | Method and apparatus for penetrating tissue |
US8574895B2 (en) | 2002-12-30 | 2013-11-05 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus using optical techniques to measure analyte levels |
ES2347248T3 (en) | 2003-05-30 | 2010-10-27 | Pelikan Technologies Inc. | PROCEDURE AND APPLIANCE FOR FLUID INJECTION. |
DK1633235T3 (en) | 2003-06-06 | 2014-08-18 | Sanofi Aventis Deutschland | Apparatus for sampling body fluid and detecting analyte |
WO2006001797A1 (en) | 2004-06-14 | 2006-01-05 | Pelikan Technologies, Inc. | Low pain penetrating |
US8282576B2 (en) | 2003-09-29 | 2012-10-09 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for an improved sample capture device |
WO2005037095A1 (en) | 2003-10-14 | 2005-04-28 | Pelikan Technologies, Inc. | Method and apparatus for a variable user interface |
US7822454B1 (en) | 2005-01-03 | 2010-10-26 | Pelikan Technologies, Inc. | Fluid sampling device with improved analyte detecting member configuration |
EP1706026B1 (en) | 2003-12-31 | 2017-03-01 | Sanofi-Aventis Deutschland GmbH | Method and apparatus for improving fluidic flow and sample capture |
EP1751546A2 (en) | 2004-05-20 | 2007-02-14 | Albatros Technologies GmbH & Co. KG | Printable hydrogel for biosensors |
US9775553B2 (en) | 2004-06-03 | 2017-10-03 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for a fluid sampling device |
WO2005120365A1 (en) | 2004-06-03 | 2005-12-22 | Pelikan Technologies, Inc. | Method and apparatus for a fluid sampling device |
US8652831B2 (en) * | 2004-12-30 | 2014-02-18 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for analyte measurement test time |
EP1835848A4 (en) * | 2004-12-30 | 2009-07-29 | Pelikan Technologies Inc | Method and apparatus for analyte measurement test time |
WO2009126900A1 (en) | 2008-04-11 | 2009-10-15 | Pelikan Technologies, Inc. | Method and apparatus for analyte detecting device |
EP2210558A1 (en) | 2009-01-21 | 2010-07-28 | Roche Diagnostics GmbH | Lancet with capillary canal and sterile protection and method for producing such a lancet |
US9375169B2 (en) | 2009-01-30 | 2016-06-28 | Sanofi-Aventis Deutschland Gmbh | Cam drive for managing disposable penetrating member actions with a single motor and motor and control system |
EP2226007A1 (en) * | 2009-02-19 | 2010-09-08 | Roche Diagnostics GmbH | Test element magazine with covered test fields |
EP2226008A1 (en) | 2009-02-19 | 2010-09-08 | Roche Diagnostics GmbH | Method for producing an analytical magazine |
CN102325496B (en) | 2009-02-19 | 2015-10-07 | 霍夫曼-拉罗奇有限公司 | The joint space-efficient analyzing aid stores |
US8965476B2 (en) | 2010-04-16 | 2015-02-24 | Sanofi-Aventis Deutschland Gmbh | Tissue penetration device |
WO2013041557A1 (en) | 2011-09-23 | 2013-03-28 | Roche Diagnostics Gmbh | Method for the mask-etching of a piercing element |
EP2591724A1 (en) | 2011-11-10 | 2013-05-15 | Roche Diagnostics GmbH | Method for producing analytical aids |
JP6273827B2 (en) * | 2012-12-28 | 2018-02-07 | 大日本印刷株式会社 | Puncture device and method for manufacturing the same |
KR101620837B1 (en) * | 2014-06-02 | 2016-05-13 | 주식회사 고운세상코스메틱 | Manufacturing method of niddle for medical skin care |
EP3300663B1 (en) | 2016-09-28 | 2019-11-20 | Roche Diabetes Care GmbH | Sampling device and system for collecting a sample of a body fluid |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4777096A (en) * | 1984-12-14 | 1988-10-11 | Ethicon, Inc. | Sheet containing a plurality of surgical needles |
US5057401A (en) * | 1990-03-07 | 1991-10-15 | Ethicon, Inc. | Process for making a device with a three-dimensionally tapered point |
US5591139A (en) * | 1994-06-06 | 1997-01-07 | The Regents Of The University Of California | IC-processed microneedles |
US5476575A (en) * | 1994-08-03 | 1995-12-19 | International Business Machines Corporation | Fabrication of moly masks by electroetching |
US6610235B1 (en) * | 1997-06-30 | 2003-08-26 | The Regents Of The University Of California | Method of fabricating epidermal abrasion device |
GB9815820D0 (en) * | 1998-07-22 | 1998-09-16 | Secr Defence | Improvements relating to micro-machining |
US6406638B1 (en) * | 2000-01-06 | 2002-06-18 | The Regents Of The University Of California | Method of forming vertical, hollow needles within a semiconductor substrate, and needles formed thereby |
US7310543B2 (en) | 2001-03-26 | 2007-12-18 | Kumetrix, Inc. | Silicon microprobe with integrated biosensor |
US6767341B2 (en) * | 2001-06-13 | 2004-07-27 | Abbott Laboratories | Microneedles for minimally invasive drug delivery |
CA2419200C (en) | 2002-03-05 | 2015-06-30 | Bayer Healthcare Llc | Fluid collection apparatus having an integrated lance and reaction area |
US7343188B2 (en) * | 2002-05-09 | 2008-03-11 | Lifescan, Inc. | Devices and methods for accessing and analyzing physiological fluid |
WO2004008203A1 (en) * | 2002-07-11 | 2004-01-22 | Redfern Integrated Optics Pty Ltd | Planar waveguide with tapered region |
US7097776B2 (en) * | 2004-10-22 | 2006-08-29 | Hewlett-Packard Development Company, L.P. | Method of fabricating microneedles |
-
2004
- 2004-12-17 EP EP04029926A patent/EP1671585A1/en not_active Withdrawn
-
2005
- 2005-12-10 BR BRPI0515789A patent/BRPI0515789B8/en not_active IP Right Cessation
- 2005-12-10 PL PL05824859T patent/PL1830707T3/en unknown
- 2005-12-10 JP JP2007545909A patent/JP4838264B2/en not_active Expired - Fee Related
- 2005-12-10 AT AT05824859T patent/ATE508689T1/en active
- 2005-12-10 CA CA2592310A patent/CA2592310C/en not_active Expired - Fee Related
- 2005-12-10 KR KR1020077013616A patent/KR101055237B1/en active IP Right Grant
- 2005-12-10 WO PCT/EP2005/013266 patent/WO2006066744A1/en active Application Filing
- 2005-12-10 ES ES05824859T patent/ES2363437T3/en active Active
- 2005-12-10 EP EP05824859A patent/EP1830707B1/en not_active Not-in-force
- 2005-12-10 MX MX2007007020A patent/MX2007007020A/en active IP Right Grant
- 2005-12-10 AU AU2005318594A patent/AU2005318594B2/en active Active
- 2005-12-10 CN CN2005800433505A patent/CN101080199B/en not_active Expired - Fee Related
-
2007
- 2007-06-14 US US11/763,266 patent/US8087141B2/en not_active Expired - Fee Related
-
2008
- 2008-05-19 HK HK08105514.8A patent/HK1116377A1/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
BRPI0515789A (en) | 2008-08-05 |
US20080040919A1 (en) | 2008-02-21 |
EP1830707B1 (en) | 2011-05-11 |
CN101080199B (en) | 2010-06-16 |
EP1830707A1 (en) | 2007-09-12 |
PL1830707T3 (en) | 2011-10-31 |
JP2008523855A (en) | 2008-07-10 |
MX2007007020A (en) | 2007-07-04 |
US8087141B2 (en) | 2012-01-03 |
BRPI0515789B1 (en) | 2018-11-06 |
ATE508689T1 (en) | 2011-05-15 |
KR101055237B1 (en) | 2011-08-08 |
BRPI0515789B8 (en) | 2021-06-22 |
EP1671585A1 (en) | 2006-06-21 |
CA2592310A1 (en) | 2006-06-29 |
AU2005318594B2 (en) | 2011-03-17 |
AU2005318594A1 (en) | 2006-06-29 |
KR20070087611A (en) | 2007-08-28 |
WO2006066744A1 (en) | 2006-06-29 |
HK1116377A1 (en) | 2008-12-24 |
CN101080199A (en) | 2007-11-28 |
JP4838264B2 (en) | 2011-12-14 |
ES2363437T3 (en) | 2011-08-04 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA2592310C (en) | Method for producing a pricking element | |
US7976477B2 (en) | Precision depth control lancing tip | |
US7211052B2 (en) | Flexible test strip lancet device | |
US5318542A (en) | Split cannula and process for the production thereof | |
EP2866660B1 (en) | A microfabricated sensor and a method of sensing the level of a component in bodily fluid | |
US20070197937A1 (en) | Microfluid system and method for production thereof | |
MXPA01006710A (en) | Photolithographic process for the formation of a one-piece needle. | |
US20180325428A1 (en) | Medical device and process for manufacturing | |
US10245060B2 (en) | Edged medical cutting tool | |
KR101651809B1 (en) | Method for the mask-etching of a piercing element | |
US20190366068A1 (en) | Microneedle for biosensing and method of fabrication | |
KR20200028170A (en) | Needle set for biopsy | |
KR102384813B1 (en) | Needle set for biopsy | |
EP2520225A1 (en) | Lancet |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKLA | Lapsed |
Effective date: 20211210 |