Source: http://www.google.com/patents/US20060196031?dq=6819670
Timestamp: 2015-03-07 00:36:00
Document Index: 159995173

Matched Legal Cases: ['art 7', 'art 8', 'art 7', 'art 8', 'art 7', 'art 8', 'art 7', 'art 8', 'art 8', 'art 9']

Patent US20060196031 - Method for producing a puncturing and measuring device - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe invention relates to a method for producing combined puncturing and measuring devices for detection of an analyte in liquid. The combined puncturing and measuring devices generally comprise a support and a detection element. Recesses which define puncturing points are formed on one face of the band-shaped...http://www.google.com/patents/US20060196031?utm_source=gb-gplus-sharePatent US20060196031 - Method for producing a puncturing and measuring deviceAdvanced Patent SearchPublication numberUS20060196031 A1Publication typeApplicationApplication numberUS 10/552,089PCT numberPCT/EP2004/003441Publication dateSep 7, 2006Filing dateApr 1, 2004Priority dateApr 4, 2003Also published asDE10315544A1, DE10315544B4, US8015685, WO2004086970A1Publication number10552089, 552089, PCT/2004/3441, PCT/EP/2004/003441, PCT/EP/2004/03441, PCT/EP/4/003441, PCT/EP/4/03441, PCT/EP2004/003441, PCT/EP2004/03441, PCT/EP2004003441, PCT/EP200403441, PCT/EP4/003441, PCT/EP4/03441, PCT/EP4003441, PCT/EP403441, US 2006/0196031 A1, US 2006/196031 A1, US 20060196031 A1, US 20060196031A1, US 2006196031 A1, US 2006196031A1, US-A1-20060196031, US-A1-2006196031, US2006/0196031A1, US2006/196031A1, US20060196031 A1, US20060196031A1, US2006196031 A1, US2006196031A1InventorsJoachim Hoenes, Volker ZimmerOriginal AssigneeJoachim Hoenes, Volker ZimmerExport CitationBiBTeX, EndNote, RefManReferenced by (2), Classifications (21), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetMethod for producing a puncturing and measuring device
EMBODIMENTS FIG. 1 shows a band-shaped support material serving as an inert support body. A band-shaped support material 1, which is preferably designed as a thin metal film with a thickness of between 0.1 and 0.3 mm, has a height h, and a length designated by 1. The band-shaped support material 1 configured as a thin metal film can be received on a winding reel and is unwound continuously from a store of material during the production of individual lancets. The height h of the band-shaped support material 1 is chosen such that it corresponds at least to the later overall height of an individual puncturing/measuring disposable body 6 to be produced (cf. FIGS. 6 and 7). The view according to FIG. 2 shows that depressions 2 can be embossed in the band-shaped support material 1 conveyed continuously in direction of advance 39. Depending on the geometry of the tool embossing the depressions 2 in the band-shaped support material 1, the depressions obtained are groove-shaped or notch-shaped and have a depression width 3. Depending on the geometry of the punch tool, a base 4 of the depression can be made round or triangular. In order to ensure that liquid is transported by capillary action through the depression 2 introduced into the band-shaped support material 1, other geometries of the punch tool or embossing tool can also be used. The depressions 2 embossed in the band-shaped support material 1 extend continuously from a first face 9 to a second face 10 of the band-shaped support material 1. Depending on the geometry of individual puncturing/measuring disposable bodies 6 which are to be separated from the band-shaped support material 1 in a subsequent method step, virtual separating lines 5 are provided which each extend between two depressions 2 embossed from the first face 9 and to the second face 10 of the band-shaped support material 1. The individual puncturing/measuring disposable body 6 which is later obtained, and which is separated from the band-shaped support material 1 along the separating lines 5 shown in FIG. 2, comprises a first lancet part 7 and a second lancet part 8 between which the depression 2 extends, preferably in the axis of symmetry of the individual puncturing/measuring disposable body 6. FIG. 3 shows the production of recesses which delimit puncturing points on a first face of the band-shaped support material. If necessary, the height h of the test band can at the same time be shortened in this method step. It will be seen from the view in FIG. 3 that recesses 11 are produced on the first face 9 of the band-shaped support material 1. The recesses 11 can, as is shown in FIG. 3, be made triangular, for example. The point of the recesses 11 directed away from the first face 9 preferably coincides with the separating line 5 according to the view in FIG. 2. The recesses 11 are delimited by a first edge 14 and a second edge 15. With reference to the depressions 2 which are produced transversely with respect to the direction of advance 39 in the band-shaped support material 1, the intersection of edges 14, 15 defines a puncturing point 16. This expediently lies in the embossed depression 2, which can be configured as a groove or notch, for example. The puncturing point 16 can further be ground so that it is able to pierce human skin in order to collect a volume of blood. According to the view in FIG. 3, the separating lines 5, along which the individual puncturing/measuring disposable bodies 6 are later separated from the band-shaped support material 1, are provided in a division 12. The division 12 and the spacing of the depressions 2, seen in the direction of advance 39 of the band-shaped support material 1, is dependent on the later width of the individual puncturing/measuring disposable bodies 6 to be produced and can be chosen freely. After the production, shown in FIG. 3, of recesses 11 on the first face 9 of the band-shaped support material 1, a further processing of the band-shaped support material 1 takes place. It can be seen from the view according to FIG. 4 that the band-shaped support material 1, which is transported in direction of advance 39, is surrounded, in the area of the first face 9, by a soft plastic cover 18, for example of silicone material. The soft plastic cover 18 can have a U-shaped profile so that the puncturing tips 16 ground and sharpened at the first face 9 of the band-shaped support material 1 are protected from damage in the area of the depressions 2. Moreover, the silicone material cover 18 provides for a permanent sterility of the points 16 at the first face 9 of the band-shaped support material 1. The sterility is produced by irradiation with β or γ radiation or by heat and is maintained by surrounding the band-shaped support material with the soft plastic cover (silicone material cover) 18. At the second face 10 of the band-shaped support material 1 lying opposite the soft plastic cover 18, a plastic cover 19 is likewise applied. This can be made of a plastic material other than silicone material and serves for easier handling of the band-shaped support material 1. Accordingly, harder materials are preferably used. The plastic cover 19 can be used as a grip area. The plan view according to FIG. 4 shows the areas of the depressions 2 which extend between the soft plastic cover 18 at the first face 9 and the plastic cover 19 at the second face 10 of the band-shaped support material 1. The separating line 5, along which individual puncturing/measuring disposable bodies 6 are separated from the band-shaped support material 1, is flush with the tip of the recesses 11 which were produced at the first face 9 of the band-shaped support material 1, which define the puncturing points 16 on both sides of the depressions 2 (see view according to FIG. 3). It will be seen from FIG. 5 that the depressions of the band-shaped support material are provided with a cover and a detection element. In the view according to FIG. 5, the band-shaped support material 1 is provided at the first face 9 with the soft plastic cover 18 for protecting against damage. The plastic cover 19 is arranged lying opposite this at the second face 10 of the band-shaped support material 1. A cover film 21 is applied between the soft plastic cover 18 and the plastic cover 19. At the same time, or separately from this, a detection element 22 narrower than the cover film 21 is applied to the band-shaped support material 1. The detection element 22 is configured in the manner described in German patent application DE 196 29 656 A1, for example, and can be used for the detection of glucose in human blood. The detection element 22 is applied to the band-shaped support material 1 only after the latter has been sterilized by β or γ irradiation. Applying the detection element 22 afterwards has the advantage that the radiation-sensitive detection element 22 is not exposed to the sterilizing β or γ radiation, since such irradiation could greatly impair the functioning or efficacy of the detection element 22. According to the production method proposed according to the invention, the process steps of sterilization and of application of a radiation-sensitive detection element 22 are distinct from one another, so that the detection element 22 is not impaired by the process step of sterilization by β or γ radiation. As can be seen from the view according to FIG. 5, the areas of the depressions 2 still open in the band-shaped support material I in FIG. 4 are covered both by the cover film 21 and also by the detection element 22 and are no longer visible in the view according to FIG. 5. The depressions extend from the first face 9 to the second face 10 of the band-shaped support material 1 underneath the cover film 21 and underneath the detection element 22. The view according to FIG. 6 shows an individual puncturing/measuring disposable body with covered puncturing point and with a grip area. In the production method proposed according to the invention for combined measuring and puncturing devices for detection of an analyte in liquid, the individual puncturing/measuring disposable bodies 6 are separated from the band-shaped support material 1 along the separating lines 5 shown in FIGS. 2, 3 and 4. These bodies comprise, on both sides of the depression 2, which serves as capillary channel 23, a first lancet part 7 and a second lancet part 8. The separation of the individual puncturing/measuring disposable bodies 6 from the band-shaped support material 1 transported in the direction of advance 39 forms a first separating site 24 on the first lancet part 7 and a second separating site 25 on the second lancet part 8. The depression 2 suitable for capillary liquid transport lies underneath the cover film 21 and underneath the detection element 22. In the lower area of the individual puncturing/measuring disposable body 6, the latter is provided with a portion of the plastic cover 19, which can function as a grip area. The first face 9 of the individual puncturing/measuring disposable body 6 shown here is covered by the silicone material cover 18. FIG. 7 shows an individual puncturing/measuring disposable body with the silicone material cover portion removed. The depression 2, which can be formed like a groove or notch in the band-shaped support material 1, ends directly at the puncturing point 16. The puncturing point 16 can have a ground front part similar to an injection needle. A capillary channel mouth 27 of the depression 2 opens out in the puncture point 16. The depression 2, which serves as capillary channel 23 for capillary liquid transport, is formed with a capillary channel length 38. The width of the depression is indicated by reference number 37 and depends on the configuration of the punching or embossing tool with which the depressions 2 are produced in the band-shaped support material 1. The individual puncturing/measuring disposable body 6 comprises a first lancet part 7 and a second lancet part 8, at whose lines of separation 5 from the band-shaped support material 1 a separating side is in each case formed, designated by reference number 24 or 25. The depression 2, which forms the channel 23 suitable for capillary liquid transport, extends continuously from the capillary channel mouth 27 on the first face 9 of the individual puncturing/measuring disposable body 6 to the second face 10 of the band-shaped support material 1, here covered by the plastic cover portion 19. Cross sections through the individual puncturing/measuring disposable body 6 are indicated by VIII-VIII and IX-IX and are shown more clearly in FIGS. 8 and 9, respectively. FIG. 8 shows a cross section, according to the cross section line VIII-VIII in FIG. 7, through a capillary channel designed with a rounded depression base and suitable for liquid transport. The band-shaped support material 1 is covered by the detection element 22 in the cross-sectional plane. The detection element 22 has a thickness 28; the thickness of the band-shaped support material 1, preferably configured as a thin metal film with a thickness of 0.1 to 0.3 mm, is indicated by reference number 30. In the view according to FIG. 8, the base 4 of the depression 2 is designed with a rounded shape 34. A supply of liquid, for example human blood, is taken up by the capillary channel 23 extending perpendicular to the plane of the drawing in FIG. 8 and suitable for capillary liquid transport This channel merges into the detection element 22 and forms, in the latter, a saturated zone 33. The supply of liquid 32 that can be taken up in the depression 2 and the capillary channel 23 depends on the depth of the depression 2, i.e. on the depth of embossing into the band-shaped support material 1. With a capillary channel length 38 of approximately 15 mm and a capillary channel width 37 of approximately 0.25 mm, ca. 100 nl of human blood can be taken up in the capillary channel, on condition that the base 4 of the depression 2 has a rounded shape 34. The time needed for a sufficient volume of liquid to pass into the depression 2 functioning as capillary channel 23 and located underneath the cover film 21 and the detection element 22 depends on the configuration of that surface of the band-shaped support material 1 forming the capillary base and on the materials used for cover film 21 and detection element 22. If aluminium is chosen, its oxidized surface can be made highly hydrophilic. FIG. 9 shows the formation of a depression of triangular cross section in the band-shaped support material. In this embodiment variant too, the band-shaped support material 1 is covered on its top face by a detection element 22. A supply of liquid 32, for example human blood, passes into the depression 2 designed with a triangular shape 35 and forms a saturated area 33 in the detection element 22. According to the view in FIG. 9 too, the material thickness of the detection element is identified by reference number 28, while the material thickness of the band-shaped support material 1 is identified by reference number 30. Depending on the geometry of the depression 2 forming the capillary channel 23, whether its base 4 has a rounded shape 34 or a triangular shape 35, a corresponding supply of liquid can pass by capillary action under the cover film 21 and detection element 22 and wet the detection element portion 22 on the individual puncturing/measuring disposable body 6. In the method proposed according to the invention, the individual puncturing/measuring disposable body 6 shown in FIGS. 6 and 7 can be separated singly from the band-shaped support material 1; in addition to this, it is also possible, by batchwise perforation, to separate groups of 5 or 10 individual puncturing/measuring disposable bodies 6 from the band-shaped support material 1. If the individual puncturing/measuring disposable bodies 6 are separated in batches or groups, individual perforations can be produced along the virtual separating line 5, said perforations permitting easy separation of the outer-lying individual puncturing/measuring disposable body 6 from the respective batch. The individual puncturing/measuring disposable body 6 obtained by the production method proposed according to the invention represents a combined puncturing and measuring device whose puncturing point 16 is formed in the band-shaped support material 1 by embossing and whose measuring function is produced in the same production method by applying the detection element 22, with a cover film 21 covering the depressions 2. In the method according to the invention, the band-shaped support material 1 can also be coated with a cover film 21 containing the detection element 22, so that the detection element 22 is situated near the puncturing point 16 formed at one face of the band-shaped support material. In a method variant of this kind, it is possible to dispense with the depressions 2, 23 which are embossed into the band-shaped support material 1 and provide for capillary liquid transport to the detection element 22. If the detection element 22 is applied in the area of the sharpened or ground puncturing point 16, the detection element 22 is wetted directly after insertion of the individual puncturing/measuring disposable body 6 into the human skin. At the time of use of the combined puncturing and measuring device according to the invention, the soft plastic cover 18 surrounding the puncturing points 16 and preferably made of a silicone material is removed manually from the puncturing point 16 without leaving any residues. Removing the soft plastic material cover 18 from the puncturing point 16 without leaving any resides ensures wetting of a detection element 22 applied in the area of the puncturing point 16 or, on the other hand, unimpeded entry of a liquid into the depression 2, 23 which allows capillary liquid transport and can be embossed into the individual puncturing/measuring disposable body 6. Alternatively, instead of the soft plastic material cover 18, a hydrophilic plastic can be selected for covering the puncturing points 16, so that any residues possibly remaining in the area of the puncturing points 16 do not interfere with the wetting behaviour of the sample. The removal of the soft plastic material cover 18, which can be made of silicone material or of a hydrophilic plastic, can also be automated using a measurement system, for example if the measurement system comprises an apparatus with a magazine for receiving the combined puncturing and measuring devices proposed according to the invention for detection of an analyte in liquid. As regards the wetting of the combined puncturing and measuring device, it should be noted that the wetting of the combined puncturing and measuring device takes place in a separate step following the production of a skin incision, by guiding the puncturing point 16 to a drop of blood formed on the skin surface. The puncturing point 16 of the combined puncturing and measuring device can also be guided repeatedly to the drop of blood and inserted repeatedly into the skin incision, in order to achieve contact between the emerging body fluid, for example blood, and the depression 2, 23 forming a capillary channel or the detection element 22 or the combined puncturing and measuring device. It is now possible to dispense with producing lancets and test strips individually in separate work steps and subsequently joining the individual elements together, so that the method proposed according to the invention is particularly advantageous for industrial scale manufacture and makes production of individual puncturing/measuring disposable bodies 6, representing a combined puncturing and measuring device, very economical and affordable. LIST OF REFERENCE NUMBERS 1 band-shaped support material 2 depression (embossed) 3 depression width 4 depression base 5 separating line 6 individual puncturing/measuring disposable body 7 1st lancet part 8 2nd lancet part 9 1st face 10 2nd face 11 recess 12 division 14 1st edge 15 2nd edge 16 puncturing point 18 soft plastic cover 19 plastic cover 20 grip area 21 cover film 22 detection element 23 capillary channel 24 1st separating side 25 2nd separating side 26 attachment surface for mechanical components 27 capillary channel mouth 28 detection element�thickness 29 capillary channel base 30 material thickness of non-deformed band-shaped support material 1 31 material thickness in depression base 4 32 liquid supply 33 saturated zone of detection element 34 rounded shape 35 triangular shape 36 attachment area of suction device 37 capillary channel width 38 capillary channel length 39 direction of advance of band-shaped support material Referenced byCiting PatentFiling datePublication dateApplicantTitleUS7976479Sep 22, 2007Jul 12, 2011Roche Diagnostics Operations, Inc.Analytical aidUS20110137205 *Dec 7, 2010Jun 9, 2011Stephan-Michael FreyAnalysis system and method for determining an analyte in a body fluid* Cited by examinerClassifications U.S. Classification29/432International ClassificationA61B5/15, B23P11/00, A61L2/08, B01L3/00Cooperative ClassificationA61B5/1411, B01L2300/0812, B01L2300/0663, A61B2562/0295, A61L2/08, B01L2300/0825, B01L2400/0406, B01L3/502707, A61B5/15146, B01L3/5023, B01L2200/10European ClassificationB01L3/5027A, B01L3/5023, A61L2/08, A61B5/14B2, A61B5/151MLegal EventsDateCodeEventDescriptionDec 22, 2006ASAssignmentOwner name: ROCHE DIAGNOSTICS GMBH, GERMANYFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HOENES, JOACHIM;ZIMMER, VOLKER;REEL/FRAME:018672/0691;SIGNING DATES FROM 20060109 TO 20060110Owner name: ROCHE DIAGNOSTICS OPERATIONS, INC., INDIANAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ROCHE DIAGNOSTICS GMBH;REEL/FRAME:018672/0726Effective date: 20060109Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HOENES, JOACHIM;ZIMMER, VOLKER;SIGNING DATES FROM 20060109 TO 20060110;REEL/FRAME:018672/0691RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services