(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`17 February 2011 (17.02.2011) (10) International Publication Number
`
`(43) International Publication Date
`
`WO 2011/019656 A1
`
`
`(51)
`
`(21)
`
`International Patent Classification:
`A613 5/15 (2006.01)
`
`International Application Number:
`PCT/US2010/044888
`
`(74)
`
`(81)
`
`(22)
`
`International Filing Date:
`
`9 August 2010 (09.08.2010)
`
`(25)
`
`(26)
`
`(30)
`
`(71)
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`(72)
`(75)
`
`Filing Language:
`
`Publication Language:
`
`English
`
`English
`
`Priority Data:
`12/539,483
`
`11 August 2009 (11.08.2009)
`
`US
`
`Applicant (for all designated States except US): AB-
`BOTT DIABETES CARE INC. [US/US]; 1360 South
`Loop Road, Alameda, California 94502 (US).
`
`(84)
`
`Inventors; and
`Inventors/Applicants (for US only): MCMINN, Daniel,
`R. [US/US]; 317 Mountain Ridge Drive, Danville, Cali-
`fornia 94506 (US). YAHNKE, Mark, S. [US/US]; 2065
`Eagle Avenue, Apt B, Alameda, California 94501 (US).
`
`Agent: BABA, Edward, J.; 1900 University Avenue,
`Suite 200, East Palo Alto, California 94303 (US).
`
`Designated States (unless otherwise indicated, for every
`kind ofnational protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP,
`KR, KZ, LA, LC, LK, LR, Ls, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
`TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`Designated States (unless otherwise indicated, for every
`kind ofregional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG,
`ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`
`[Continued on nextpage/
`
`(54) Title: INTEGRATED LANCET AND TEST STRIP AND METHODS OF MAKING AND USING SAME
`
`(57) Abstract: An integrated lancet and test strip for mea—
`surin g an analyte level is provided. The test strip includes a
`protrusion at a sample receiving end of the test strip, and a
`notch at a body receiving end of the test strip. Further, a
`method of measuring an analyte level in a sample of bodily
`fluid using the integrated lancing and testing meter is also
`provided. Still further, a method of making a plurality of
`test strips for use in an integrated lancet and test strip is
`also provided.
`
` II/
`
`\
`
`\ \
`
`3029
`
`soaabflry
`
`[— 3000c:
`
`32020
`
`f 30020
`
`30360 J
`
`FIG. SB
`
`
`
`W02011/019656A1|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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`

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`WO 2011/019656 A1 ||||||||||||||||||||||||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||||||||||||||||
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`Published:
`
`— with international search report (Art. 21(3))
`
`

`

`WO 2011/019656
`
`PCT/U82010/044888
`
`INTEGRATED LANCET AND TEST STRIP AND METHODS OF
`
`MAKING AND USING SAME
`
`CROSS REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This application claims the benefit of US. Patent Application No. 12/539,483,
`
`filed August ll, 2009, which application is incorporated herein by reference in its
`
`entirety.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The prevalence of diabetes is increasing markedly in the world. At this time,
`
`diagnosed diabetics represent about 3% of the population of the United States. It is
`
`believed that the actual number of diabetics in the United States is much higher.
`
`Diabetes can lead to numerous complications, such as, for example, retinopathy,
`
`nephropathy, and neuropathy.
`
`[0003]
`
`The most important factor for reducing diabetes—associated complications is the
`
`maintenance of an appropriate level of glucose in the blood stream. The maintenance of
`
`the appropriate level of glucose in the blood stream may prevent and even reverse some
`
`of the effects of diabetes.
`
`[0004]
`
`Analyte, e. g., glucose, monitoring devices known in the art have operated on the
`
`principle of taking blood from an individual by a variety of methods, such as by means
`
`of a needle or a lancet. The individual then coats a plastic strip carrying reagents with
`
`the blood, and finally inserts the blood coated strip into a blood glucose meter for
`
`measurement of glucose concentration by optical or electrochemical techniques. Or,
`
`alternatively, the plastic strip is inserted into the meter and then blood is applied to the
`
`strip.
`
`[0005]
`
`Medical devices of the prior art have begun to use integrated lancet and test
`
`strips. The integrated lancet and test strips are formed from various layers and comprise
`
`a channel between layers. The channel can become occluded when the test strip (the
`
`sensor containing portion) contacts the sample site. Occlusion of the channel may result
`
`in less success for a reading, slower fill times, and more times necessary to re—apply the
`
`sample.
`
`

`

`WO 2011/019656
`
`PCT/U82010/044888
`
`[0006]
`
`An integrated lancet and test strip for measuring an analyte level as well as
`
`SUMMARY OF THE INVENTION
`
`methods of making and using the same are provided. The integrated lancet and test strip
`
`includes a body, and the body includes a test strip receiving end and a lancet end. The
`
`integrated lancet and test strip also includes a lancet needle coupled to the lancet end of
`
`the body, and a test strip coupled to the test strip receiving end of the body. The test strip
`
`includes multiple electrodes and assay chemistry for determining an analyte level in a
`
`sample, a protrusion at a sample receiving end of the test strip, and a notch at a body
`
`receiving end of the test strip. The test strip and lancet needle are also configured such
`
`that the test strip is not in fluid communication with the lancet needle.
`
`[0007]
`
`These and other objects, advantages, and features of the invention will become
`
`apparent to those persons skilled in the art upon reading the details of the embodiments
`
`as more fully described below.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0008]
`
`The invention is best understood from the following detailed description when
`
`read in conjunction with the accompanying drawings. It is emphasized that, according to
`
`common practice, the various features of the drawings are not to—scale. On the contrary,
`
`the dimensions of the various features are arbitrarily expanded or reduced for clarity.
`
`Included in the drawings are the following figures:
`
`[0009]
`
`FIG. 1 illustrates a perspective view of an integrated lancing and testing meter
`
`and exploded perspective view of the assembly for storing and dispensing integrated
`
`lancet and test strips, according to certain embodiments.
`
`[0010]
`
`FIG. 2 illustrates a perspective view of selected components of a
`
`lancing/collecting assembly of a medical diagnostic apparatus and integrated lancet and
`
`test strip, according to certain embodiments.
`
`[0011]
`
`FIGS. 3A-B illustrate an exploded perspective view and perspective view,
`
`respectively, of an integrated lancct and test strip, according to certain embodiments.
`
`[0012]
`
`FIGS. 4A—B illustrate an exploded perspective view and perspective view,
`
`respectively, of an integrated lancet and test strip, according to certain embodiments.
`
`[0013]
`
`FIG. 5 illustrates a perspective view of a test strip, according to certain
`
`embodiments.
`
`[0014]
`
`FIG. 6 illustrates an exploded perspective view of a test strip, according to certain
`
`embodiments.
`
`

`

`WO 2011/019656
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`PCT/U82010/044888
`
`[0015]
`
`FIGS. 7A-F illustrate top planar Views of a test strip having various shapes of
`
`protrusions and notches, according to certain embodiments.
`
`[0016]
`
`FIGS. SA-C illustrate top planar views of a test strip having protrusions and
`
`notches in various locations, according to certain embodiments.
`
`[0017]
`
`FIG. 9 is a flow diagram of a method of measuring an analyte level in a sample of
`
`bodily fluid using an integrated lancing and testing meter, according to certain
`
`embodiments.
`
`[0018]
`
`FIGS. lOA—B illustrate top planar views of a layered structure being separated
`
`into test strips, according to certain embodiments.
`
`[0019]
`
`FIGS. llA—l 1B illustrate top planar views of a layered structure being separated
`
`into test strips, according to certain embodiments.
`
`[0020]
`
`FIGS. 12A—12B illustrate top planar views of a layered structure being separated
`
`into test strips, according to certain embodiments.
`
`[0021]
`
`FIG. 13 illustrates a flow diagram for measuring an analyte level in a sample of
`
`bodily fluid using an integrated lancing and testing meter, according to certain
`
`embodiments.
`
`[0022]
`
`FIG. 14A-14M illustrate in schematic form a method of measuring an analyte
`
`level in a sample of bodily fluid using an integrated lancet and testing meter, according
`
`to certain embodiments.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0023]
`
`Before the present invention is described, it is to be understood that this invention
`
`is not limited to particular embodiments described, as such may, of course, vary. It is
`
`also to be understood that the terminology used herein is for the purpose of describing
`
`particular embodiments only, and is not intended to be limiting, since the scope of the
`
`present invention will be limited only by the appended claims.
`
`[0024]
`
`Where a range of values is provided, it is understood that each intervening value,
`
`to the tenth of the unit of the lower limit unless the context clearly dictates otherwise,
`
`between the upper and lower limits of that range is also specifically disclosed. Each
`
`smaller range between any stated value or intervening value in a stated range and any
`
`other stated or intervening value in that stated range is encompassed within the
`
`invention. The upper and lower limits of these smaller ranges may independently be
`
`included or excluded in the range, and each range where either, neither or both limits are
`
`included in the smaller ranges is also encompassed within the invention, subject to any
`
`3
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`

`

`WO 2011/019656
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`PCT/U82010/044888
`
`specifically excluded limit in the stated range. Where the stated range includes one or
`
`both of the limits, ranges excluding either or both of those included limits are also
`
`included in the invention.
`
`[0025]
`
`Unless defined otherwise, all technical and scientific terms used herein have the
`
`same meaning as commonly understood by one of ordinary skill in the art to which this
`
`invention belongs. Although any methods and materials similar or equivalent to those
`
`described herein can be used in the practice or testing of the present invention, some
`
`potential and preferred methods and materials are now described. All publications
`
`mentioned herein are incorporated herein by reference to disclose and describe the
`
`methods and/or materials in connection with which the publications are cited. It is
`
`understood that the present disclosure supercedes any disclosure of an incorporated
`
`publication to the extent there is a contradiction.
`
`[0026]
`
`It must be noted that as used herein and in the appended claims, the singular
`
`forms "a", "an", and "the" include plural referents unless the context clearly dictates
`
`otherwise. Thus, for example, reference to "an electrode" includes a plurality of such
`
`electrodes and reference to ”the electrode” includes reference to one or more electrodes
`
`and equivalents thereof known to those skilled in the art, and so forth.
`
`[0027]
`
`The publications discussed herein are provided solely for their disclosure prior to
`
`the filing date of the present application. Nothing herein is to be construed as an
`
`admission that the present invention is not entitled to antedate such publication by virtue
`
`of prior invention. Further, the dates of publication provided may be different from the
`
`actual publication dates which may need to be independently confirmed.
`
`
`MEDICAL DIAGNOSTIC DEVICE AND ASSEMBLY
`
`[0028]
`
`FIG. 1 illustrates a medical diagnostic device 1300 and an assembly 1110 for
`
`storing and dispensing integrated lancet and test strips (shown removed from device
`
`1300), according to an embodiment. The example device shown is a point and shoot
`
`medical diagnostic dcvicc. By point and shoot, it is meant that a user places the meter on
`
`the skin location chosen for fluid/blood extraction, and is merely required to push a
`
`button to activate the device and then simply wait for the meter to make the measurement
`
`and report blood glucose level. Device 1300 includes a cartridge door 1306 which opens
`
`to allow assembly 1110 to be inserted and removed. Device 1300 is also referred to
`
`herein as “meter” and “integrated lancet and testing meter”.
`
`

`

`WO 2011/019656
`
`PCT/US2010/044888
`
`[0029]
`
`As shown in FIG. 1, the assembly 1110 for storing and dispensing integrated
`
`lancet and test strips includes a magazine 1118 including a plurality of integrated lancet
`
`and test strips 1005, each integrated lancet and test strip comprising a lancet—containing
`
`portion and a sensor—containing portion (also referred to herein as “test strip”).
`
`Integrated lancet and test strips that are suitable for use with a medical diagnostic device
`
`(also referred to herein as an “integrated lancet and testing meter”) are provided for in
`
`the sections to follow. Detailed description of test strips, and embodiments thereof, that
`
`may be integrated with the lancet are also provided for in sections to follow. The
`
`magazine 1118 has an exterior cover 1120. The purpose of the exterior cover 1120 is to
`
`maintain the test strips in a substantially moisture—tight, air—tight condition. Materials
`
`that are suitable for forming the exterior cover 1120 include rubber and other polymeric
`
`materials.
`
`[0030]
`
`Inside the exterior cover 1120 may be an interior cover (not shown), which
`
`contains a desiccant. The purpose of the interior cover is to provide a second barrier to
`
`maintain the integrated lancet and test strips in a substantially moisture-tight, air-tight
`
`condition. Materials that are suitable for forming the interior cover include polymeric
`
`materials impregnated with a desiccant, e. g., plastic impregnated with desiccant. The
`
`structure of the interior cover is substantially congruent with the structure of the exterior
`
`cover 1120. The desiccant absorbs moisture that evades the exterior cover 1120. Inside
`
`the interior cover 1122 is a platform 1124 for containing a biasing element 1125, e. g., a
`
`constant force spring, for urging test strips toward the location in the magazine 1 118
`
`from which test strips are fed to a lancing/collecting assembly 112 within the device
`
`1300. Also inside the interior cover is an insert 1126 for securing the biasing element
`
`1125. The platform 1124 can be filled with a desiccant, in order to enhance moisture
`
`resistance of the test strips stored within the assembly 1110.
`
`[0031]
`
`Medical diagnostic device 1300 comprises subsystems and assemblies (not
`
`shown) which facilitate the operations of the device. For example, device 1300 may
`
`include in addition to the assembly 11 10 for storing and dispensing test strips, a
`
`lancing/collecting assembly, an assembly for removing a protective cover from the tip of
`
`a lancet and re—attaching the protective cover to the tip of a used lancet, and an analyzer.
`
`An end cap having an opening, through which a lancet can be projected for forming an
`
`opening in the skin of a patient, and through which a sensor can be projected for
`
`collecting a sample of biological liquid emerging from the opening in the skin of the
`
`U1
`
`

`

`WO 2011/019656
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`PCT/U82010/044888
`
`patient. Device 1300 may also comprise one or more ports (e. g., ejection port and/or a
`
`lancing and/or testing port).
`
`[0032]
`
`A method of measuring an analyte level in a sample of bodily fluid using an
`
`integrated lancing and testing meter is provided. The method comprises piercing a
`
`lancing site on a subject With a lancet portion of an integrated lancet and test strip
`
`comprising a lancet and a test strip. The test strip comprises multiple electrodes and
`
`assay chemistry for determining the analyte level in the sample, a protrusion at a sample
`
`receiving end of the test strip, and a notch at a body receiving end of the test strip. The
`
`method further comprises automatically re—orienting the integrated lancet and test strip
`
`Within the meter, and automatically advancing and contacting the integrated lancet and
`
`test strip at the lancing site to measure an analyte level in a sample of bodily fluid, the
`
`integrated lancet and test strip first contacting a protrusion at the receiving end of the test
`
`strip to the lancing site.
`
`[0033]
`
`Referring for a moment to FIG. 13, a flow diagram is illustrated for measuring an
`
`analyte level in a sample of bodily fluid using an integrated lancing and testing meter,
`
`according to an embodiment. At block 13005, a lancet cap is removed from a lancet on
`
`an integrated lancet and test strip.
`
`[0034]
`
`At block 13010, the integrated lancet and test strip is advanced to pierce a lancing
`
`site on a subject With a lancet portion of the integrated lancet and test strip. If an ejection
`
`port and separate lancing/testing port are implemented, then the lancet is advanced out
`
`the lancing/testing port. The test strip may comprise, for example, multiple electrodes
`
`and assay chemistry for determining the analyte level in the sample; a protrusion at a
`
`sample receiving end of the test strip (as described in further detail later); and, a notch at
`
`a body receiving end of the test strip (as described in further detail later). In some
`
`embodiments, the test strip does not comprise a notch at the body receiving end of the
`
`test strip.
`
`[0035]
`
`At block 13015, the integrated lancet and test strip is automatically retracted
`
`Within the meter. At block 13020, the integrated lancet and test strip are automatically
`
`re-oriented Within the meter. At block 13025, the integrated lancet and test strip is
`
`automatically advanced to contact the test strip at the lancing site to measure an analyte
`
`level in a sample of the bodily fluid, the advancing of the integrated lancet and test strip
`
`first contacting the protrusion at the receiving end of the test strip to the lancing site.
`
`The integrated lancet and test strip first contacts a protrusion at the receiving end of the
`
`test strip to the lancing site. At block 13030, the integrated lancet and test strip is
`
`6
`
`

`

`WO 2011/019656
`
`PCT/USZOlO/044888
`
`retracted back into the device. At block 13035, the integrated lancet and test strip is
`
`automatically re—oriented within the device. At block 13040, the lancet is re-capped for
`
`safety. And at block 13045, the integrated lancet and test strip is ejected. If an ejection
`
`port and separate lancing/testing port are implemented; and then the test strip is ejected
`
`through the ejection port.
`
`[0036]
`
`FIG. 14A through FIG. 14M, inclusive, illustrate in schematic form one way of
`
`carrying out a method of measuring an analyte level in a sample of bodily fluid using an
`
`integrated lancet and testing meter, according to embodiments herein. FIG. 14A shows
`
`an integrated lancet and test strip 14000 in the cartridge 14118. FIG. 14B shows the
`
`integrated lancet and test strip 14000 advanced from the cartridge 14118 and inserted
`
`into the lancing/collecting assembly 14112, which is represented schematically by two
`
`parallel upright elements, each element having a slot formed therein. FIG. 14C shows
`
`the protective cover 14204 being removed from the lancet 14200 of the integrated lancet
`
`and test strip 14000. It should be noted that the protective cover 14204 could be
`
`removed before the integrated lancet and test strip 14000 is inserted into the
`
`lancing/collecting assembly 14112. FIG. 14D shows the integrated lancet and test strip
`
`14000 rotated 90° so that the lancet 14200 is in position for lancing the skin of the
`
`patient. FIG. 14E shows that the lancet 14200 has entered the skin of the patient. FIG.
`
`14F shows that the lancet 14200 has been retracted from the skin of the patient. FIG.
`
`14G shows that the integrated lancet and test strip 14000 is being rotated 180° so that the
`
`test strip 14002 can collect biological liquid emerging from the opening formed in the
`
`skin of the patient. FIG. 14H shows that the test strip 14002 of the integrated lancet and
`
`test strip 14000 is ready to be indexed so that the test strip 14002 can collect biological
`
`liquid emerging from the opening formed in the skin of the patient. FIG. 141 shows the
`
`test strip 14002 of the integrated lancet and test strip 14000 contacting the biological
`
`liquid emerging from the skin of the patient, first contacting a protrusion at the receiving
`
`end of the test strip to the lancing site. FIG. 14] shows that the integrated lancet and test
`
`strip 14000 is being rotated 90° so that the integrated lancet and test strip 14000 will
`
`come into the proper in position for being ejected from the medical diagnostic device.
`
`FIG. 14K shows the integrated lancet and test strip 14000 in position for ejection from
`
`the medical diagnostic device. FIG. 14L shows the protective cover 14204 being
`
`reattached to the lancet 14200. FIG. 14M shows the integrated lancet and test strip
`
`14000 being ejected from the medical diagnostic device.
`
`

`

`WO 2011/019656
`
`PCT/U82010/044888
`
`[0037]
`
`Referring to FIG. 2, a turret and integrated lancet and test strip are illustrated,
`
`according to an embodiment. Turret 2002 is a sub-assembly within device 1300 and
`
`works in conjunction with other components (not shown) within device 1300 to re-orient
`
`and advance the integrated lancet and test strip 2005 during use. For example, in an
`
`embodiment, turret 2002 receives the integrated lancet and test strip 2005; automatically
`
`re-orients the integrated lancet and test strip 2005 for piercing a lancing site;
`
`automatically advances and contacts the lancing tip at the lancing site; automatically re—
`
`orients the integrated lancet and test strip 2005 within device 1300; automatically
`
`advances and contacts the test strip at the lancing site, first contacting the protrusion at
`
`the receiving end of the test strip to the lancing site; and automatically re-orients the
`
`integrated lancet and test strip 2005 for re—capping and removal from device 1300.
`
`[0038]
`
`Details regarding device 1300, its subsystems and assemblies, and operations
`
`thereof, are described in US. Patent Application Nos. 11/535,985, 11/535,986,
`
`12/488,181 , the entireties of which are incorporated herein by reference.
`
`INTEGRATED LANCET AND TEST STRIP
`
`[0039]
`
`As shown in FIGS. 3A-3B, integrated lancet and test strip 3000 has a sensor-
`
`containing portion 3002 and a lancet—containing portion 3004. Referring specifically to
`
`FIGS. 3A-3B, an integrated lancet and testing 3000 is provided for measuring a body
`
`analyte, e. g., glucose, level in a diabetes care regimen. A lancet body 3202 includes a
`
`test strip receiving end 3036 and a lancet end. A lancet needle 3200 is coupled with and
`
`protruding from the lancet end and secured by a lancet cap 3204. A test strip 3002 is
`
`coupled to the test strip receiving end 3036 of the lancet body 3202 having multiple
`
`electrodes and assay chemistry for testing an analyte, e.g., glucose, level of an applied
`
`body fluid. The test strip comprises at least one protrusion on a sample receiving end.
`
`The test strip may further comprise at least one notch at a body receiving end of the test
`
`strip. The test strip 3002 and lancet 3200 are relatively disposed at different ends of the
`
`integrated lancet and test strip 3000 for providing both lancing and application of body
`
`fluid at a lancing site by reorienting and advancing the integrated lancet and test strip
`
`3000 within the meter 1300 after lancing to contact a sample receiving portion of the test
`
`strip precisely at the lancing site. In some embodiments, the test strip and lancet needle
`
`are configured such that the test strip is not in fluid communication with the lancet
`
`needle.
`
`

`

`WO 2011/019656
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`PCT/U82010/044888
`
`[0040]
`
`The reorienting may include rotating the integrated lancet and test strip 3000
`
`when the lancing site remains approximately at the predetermined location relative to the
`
`meter for application of body fluid to the sample receiving portion of the test strip 3002.
`
`The test strip 3002 and lancet 3200 may be symmetrically disposed at opposite ends of
`
`the lancet body 3202. The reorienting may include rotating and/or flipping the integrated
`
`lancet and test strip 3000 when the lancing site remains approximately at the
`
`predetermined location relative to the meter for application of body fluid to the sample
`
`receiving portion 3010a of the test strip 3002.
`
`[0041]
`
`The lancet body 3202 may include a pair of relatively disposed recesses 3028a,
`
`3028b for respectively positioning the test strip. For example, a spring-loaded ball and
`
`detent mechanism (not shown) may be implemented for lancing and application of body
`
`fluid at a same lancing/testing site. The recesses 3028a, 3028b may be a variety of
`
`shapes—e.g., rectangular, semi—circular, trapezoidal (as shown in FIG. 3B), irregular,
`
`etc.
`
`[0042]
`
`The lancet cap 3204 of FIG. 3B includes two elastomeric arms 3029, although
`
`there may be one or more than two, that couple with defined cutouts in the lancet body
`
`3202 for snapping the cap 3204 into and out of mating relationship with the lancet body
`
`3202 by respective application of sufficient coupling and separation force.
`
`[0043]
`
`Referring for a moment to FIG. 5, an integrated lancet and test strip 3000 is
`
`shown including a lancet body 3202, test strip 3002 coupled with the lancet body 3202,
`
`and a lancet cap 3204 protecting a lancet 3200 which is also coupled to the lancet body
`
`3202. Meter 1300 may include a pusher P, which pushes the integrated lancet and test
`
`strip 3000 into a turret (e.g., turret 2002 shown in FIG. 2). Pusher P is shown in FIG. 5
`
`coupled with the integrated lancet and test strip 3000, and having a U-shape. Pusher P,
`
`however, may have any of a variety of shapes that fit somewhat snugly such as to
`
`overlap the lancct cap 3204 at least through the plane of a mating contour 3201 of thc
`
`lancet cap 3204. Although not shown in FIG. 5, the pusher may have a corresponding
`
`contour to the mating contour 3201 of the lancet cap 3204. Meter 1300 may also include
`
`a blade or decapping lever that moves down to engage the lancet cap 3204 and uncap it
`
`from the integrated lancet and test strip 3000. When the blade is disposed in mating
`
`relation with the mating contour 3201 of the lancet cap 3204, the pusher P is also
`
`coupled, via its own corresponding contour or sufficient friction, with the blade and/or
`
`with the lancet cap 3204. This permits a retreating motion of the pusher P to bring the
`
`lancet cap 3204 with it away from the lancet body 3202 of the integrated lancet and test
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`WO 2011/019656
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`PCT/U82010/044888
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`strip 3000 for arming the lancet 3200 while the integrated lancet and test strip 3000 is
`
`disposed in the turret 2002 shown in FIG. 2. Although not shown, a chain or other
`
`flexible component may be attached to the pusher P for advancing and retreating the
`
`pusher P.
`
`[0044]
`
`FIG. 6 illustrates an exploded perspective view of an integrated lancet and test
`
`strip, according to another embodiment. Integrated lancet and test strip 3000 is shown
`
`including a lancet body 3202, test strip 3002 coupled with the lancet body 3202, and a
`
`lancet cap 3204 protecting a lancet 3200 which is also coupled to the lancet body 3202.
`
`Shown in this embodiment, integrated lancet and test strip 3000 further comprises at
`
`least two teeth 3136, 3138 in lancet body 3202; and, corresponding slots 3122, 3124 in
`
`test strip 3002 for coupling the lancet body 3202 and test strip 3002 together.
`
`TEST STRIPS
`
`[0045]
`
`FIGS. 4A-B illustrate test strips which can be integrated within an integrated
`
`lancet and test strip, according to certain embodiments. FIG. 4A is an exploded
`
`perspective view of a test strip, according to an embodiment; and, FIG. 4B is a
`
`perspective view of a test strip, according to another embodiment.
`
`[0046]
`
`Test strip 4002 is shown comprising a base 4006 and a cover 4008. As shown in
`
`FIGS. 4A-B, both the base 4006 and the cover 4008 are substantially rectangular in
`
`shape, although other shapes may be used. In this substantially rectangular embodiment,
`
`base 4006 has two major surfaces and four edges. Cover 4008 also has two major
`
`surfaces and four edges. Base 4006 has a protrusion 4010 formed in one edge 4910
`
`thereof, and the cover 4008 has a protrusion 4012 formed in one edge 4912 thereof.
`
`Base 4006 has a notch 4820 formed in one edge 4920 thereof, and the cover 4008 has a
`
`notch 4813 formed in one edge 4913 thereof. In FIGS. 4A—B, protrusions 4010 and 4012
`
`are located at an cdgcs 4910 and 4912, respectively, that forms the sample rccciving
`
`portion of the test strip, and notches 4813 and 4820 are shown at an edges 4913 and
`
`4920, respectively, opposite the edges of the protrusion. However, the notches may be at
`
`a different edge depending on design. The term notch is used herein interchangeably
`
`with recess, and can similarly be referred to as a groove, indentation, etc. When
`
`integrated to a lancet, the lancet may be positioned approximately 1800 from the
`
`protrusions 4010 and 4012.
`
`[0047]
`
`The surfaces of these protrusions 4010 and 4012 may bear a hydrophilic material
`
`in order to enable the sample of biological liquid to have greater affinity for the
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`protrusions 4010 and 4012 than if the protrusions were not bearing a hydrophilic
`
`material. The base 4006 may be made from an electrically non-conducting material, e. g.,
`
`an insulating material that is not capable of carrying substantial electric charge or
`
`current. Examples of materials usable include polyesters, polyethylene (both high
`
`density and low density), polyethylene terephthalate, polycarbonate, vinyls, and the like.
`
`The material may be treated with a primer or other such coating to improve the adhesion
`
`of the electrodes thereon. In certain embodiments, the base and/or cover is made from a
`
`hydrophobic polymeric material, e.g., "MELINFX" polymer, or the like. Cover 4008 is
`
`made from an electrically conducting material. In certain alternative embodiments,
`
`cover 4008 is made from an electrically non—conducting material such as those described
`
`above for base 4006.
`
`[0048]
`
`On the major surface of the base 4006 facing the cover 4008 is a layer of
`
`electrically conductive material 4822 in a first area and a layer of electrically conductive
`
`material 4014 in a second area. The first area constitutes the fill indication electrode and
`
`the second area constitutes the working electrode. Conductive material that may be used
`
`include gold, carbon, platinum, ruthenium dioxide, palladium, and conductive epoxies,
`
`such as, for example, ECCOCOAT CT5079—3 Carbon-Filled Conductive Epoxy Coating
`
`(available from W. R. Grace Company, Woburn, Mass), Ag/AgCl, Ag/AgBr, as well as
`
`other materials known to those skilled in the art.
`
`[0049]
`
`The cover 4008 is spaced from the base 4006 by layers 4022, 4020 of non—
`
`conductive adhesive in such a manner that a channel 4024 forming a sample flow path.
`
`This channel 4024 runs along the center of the test strip 4002. The non-conductive
`
`adhesive 4020 in a first area and layer of non-conductive adhesive 4022 in a second area
`
`also bond the cover 4008 to the base 4006. The cover 4008 is made of an electrically
`
`conductive material (such as, for example, vinyl having an electrically conductive
`
`material, e.g., Ag/AgCl, thereon) and functions as a dual purpose reference/counter
`
`electrode. When a sample of biological liquid is introduced at the hydrophilic protrusion
`
`(i.e., protrusions 4010 and 4012), the sample is easily drawn up into the channel 4024,
`
`along which the sample flows by means of capillary attraction. The protrusion in the
`
`sample receiving end contributes to breaking the surface tension of the fluid sample and
`
`to assist it in filling faster. Portions of the electrically conductive material of the base
`
`4006 function as electrical contact pads.
`
`[0050]
`
`While not critical, it is advantageous that the dimensions of the test strip 4002 be
`
`as small as possible in order to reduce the size of the assembly 1110 and reduce the
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`volume of sample required to carry out a test. Typical dimensions of the base 4006 and
`
`cover 4008 are approximately 6 mm x 6 mm x < 2 mm. Typical dimensions of the
`
`electrodes and typical dimensions of a sample flow channel 4024 are described in U. S