Europäisches Patentamt *EP001579814A2* (19) European Patent Office

Office européen des brevets (11) EP 1 579 814 A2

(12) EUROPEAN PATENT APPLICATION

(43) Date of publication: (51) Int Cl.7: A61B 17/32 28.09.2005 Bulletin 2005/39

(21) Application number: 05005734.8

(22) Date of filing: 16.05.1997

(84) Designated Contracting States: (72) Inventors: AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC • Douglas, Joel S. NL PT SE Los Altos Hills, CA 94022 (US) • Roe, Jeffrey N. (30) Priority: 17.05.1996 US 17133 P San Ramon, CA 94583 (US) 14.06.1996 US 19918 P • Radwanski, Ryszard 01.08.1996 US 23658 P Morgan Hill, CA 95037 (US) 03.09.1996 US 25340 P • Duchon, Brent G. 16.09.1996 US 714548 Garden Grove, CA 92845 (US) 17.09.1996 US 710456 08.10.1996 US 727074 (74) Representative: Vossius & Partner Siebertstrasse 4 (62) Document number(s) of the earlier application(s) in 81675 München (DE) accordance with Art. 76 EPC: 97929682.9 / 0 955 909 Remarks: This application was filed on 16 - 03 - 2005 as a (71) Applicant: Roche Diagnostics Operations, Inc. divisional application to the application mentioned Indianapolis, Indiana 46250 (US) under INID code 62.

(54) Methods and apparatus for sampling and analyzing

(57) A sampling device (10) for sampling body fluid includes a lancet (12) for making an incision, a tube (18) for drawing up body fluid from the incision, and a test strip (30) affixed to an upper end of the capillary tube (18) for receiving the fluid. An absorbent pad (60) can be disposed between the test strip (30) and capillary tube (18) for spreading out the fluid being transferred to the test strip (30). An on site analyzer such as an optical analyzer (44) and/or an electrochemical analyzer (50) can be mounted in the device for analyzing the fluid. Al- ternatively, a test strip (30) can be slid through a slot formed in the bottom end of the device so that by pass- ing the device against the skin after an incision has been formed. The test strip (30) will directly contact body fluid emanating from the incision. EP 1 579 814 A2

Printed by Jouve, 75001 PARIS (FR) 1 EP 1 579 814 A2 2

Description the device. [0008] In institutional settings, it is often desirable to Field of the Invention collect the sample from the patient and then introduce the sample to a test device in a controlled fashion. Some [0001] The present invention relates to lancing devic- 5 monitoring systems, for example, require es and methods for obtaining samples of blood and oth- that the blood sample be applied to a test device which er fluids from the body for analysis or processing. is in contact with a test instrument. In such situations, bringing the finger of a patient directly to the test device Background of the Invention poses some risk of contamination from blood of a pre- 10 vious patient. With such systems, particularly in hospital [0002] Many medical procedures in use today require settings, it is common to lance a patient, collect a sample a relatively small sample of blood, in the range of 5-50 in a micropipette via capillary action and then deliver the µL. It is more cost effective and less traumatic to the sample from the pipette to the test device. patient to obtain such a sample by lancing or piercing [0009] Haynes U.S. Patent No. 4,920,977 describes the skin at a selected location, such as the finger, to en- 15 a blood collection assembly with lancet and microcol- able the collection of 1 or 2 drops of blood, than by using lection tube. This device incorporates a lancet and col- a phlebotomist to draw a tube of venous blood. With the lection container in a single device. The lancing and col- advent of home use tests such as self monitoring of lection are two separate activities, but the device is a blood glucose, there is a requirement for a simple pro- convenient single disposable unit for situations when cedure which can be performed in any setting by a per- 20 sample collection prior to use is desirable. Similar de- son needing to test. vices are disclosed in Sarrine U.S. Patent No. [0003] Lancets in conventional use generally have a 4,360,016, and O'Brien U.S. Patent No. 4,924,879. Jor- rigid body and a sterile needle which protrudes from one dan et al. U.S. Patents No. 4,850,973 and No. end. The lancet may be used to pierce the skin, thereby 4,858,607, disclose a combination device which may be enabling the collection of a blood sample from the open- 25 alternatively used as a syringe-type injection device and ing created. The blood is transferred to a test device or a lancing device with disposable solid needle lancet, de- collection device. Blood is most commonly taken from pending on configuration. Lange et al. U.S. Patent No. the fingertips, where the supply is generally excellent. 5,318,584 describes a blood lancet device for withdraw- However, the nerve density in this region causes signif- ing blood for diagnostic purposes. This invention uses icant pain in many patients. Sampling of alternate site, 30 a rotary/sliding transmission system to reduce the pain such as earlobes and limbs, is sometimes practiced to of lancing. The puncture depth is easily and precisely access sites which are less sensitive. These sites are adjustable by the user. also less likely to provide excellent blood samples and [0010] Suzuki et al. U.S. Patent No. 5,368,047, Dom- make blood transfer directly to test devices difficult. browski U.S. Patent No. 4,654,513 and Ishibashi et al. [0004] Repeated lancing in limited surface areas 35 U.S. Patent No. 5,320,607 each describe suction-type (such as fingertips) results in callous formation. This blood samplers. These devices develop suction be- leads to increased difficulty in drawing blood and in- tween the lancing site and the end of the device when creased pain. the lancet holding mechanism withdraws after piercing [0005] To reduce the anxiety of piercing the skin and the skin. A flexible gasket around the end of the device the associated pain, many spring loaded devices have 40 helps seal the end around the puncture site until ade- been developed. The following two patents are repre- quate sample is drawn from the puncture site or the user sentative of the devices which were developed in the pulls back on the device. 1980's for use with home diagnostic test products. [0011] Garcia et al. U.S. Patent No. 4,637,403 dis- [0006] U.S. Patent No. 4,503,856, Cornell et al., de- closes a combination lancing and blood collection de- scribes a spring loaded lancet injector. The reusable de- 45 vice which uses a capillary passage to conduct body flu- vice interfaces with a disposable lancet. The lancet hold- id to a separate test strip in the form of a microporous er may be latched in a retracted position. When the user membrane. It is necessary to achieve a precise posi- contacts a release, a spring causes the lancet to pierce tioning of the upper end of the capillary passage with the skin at high speed and then retract. The speed is respect to the membrane in order to ensure that body important to reduce the pain associated with the punc- 50 fluid from the passage is transferred to the membrane. ture. If an appreciable gap exists therebetween, no transfer [0007] Levin et al. U.S. Patent No. 4,517,978 de- may occur. scribes a blood sampling instrument. This device, which [0012] Also, the diameter of the capillary passage is is also spring loaded, uses a standard disposable lan- relatively small, so the width of a sample transferred to cet. The design enables easy and accurate positioning 55 the membrane may be-too small to be measured by on- against a fingertip so the impact site can be readily de- site measuring devices such as an optical measuring termined. After the lancet pierces the skin, a bounce system or an electrochemical meter. back spring retracts the lancet to a safe position within [0013] It is difficult for a user to determine whether a

2 3 EP 1 579 814 A2 4 sufficiently large drop of body fluid has been developed direct results displayed for the patient. at the incision for providing a large enough sample. [0024] A further object is to provide an on-site test [0014] International Publication Number strip with a relatively wide sample which can be ana- WO95/10223, Erickson et al., describes a means of col- lyzed by on-site analyzers such as optical and electro- lecting and measuring body fluids. This system uses a 5 chemical analyzers. disposable lancing and suction device with a spacer [0025] It is a further object of the invention is to pro- member which compresses the skin around the lance/ vide a device for minimally invasive sampling compris- needle. ing a reusable sampler and disposable sample collec- [0015] Single use devices have also been developed tion. for single use tests, i.e. home cholesterol testing, and 10 for institutional use to eliminate cross-patient contami- Summary of the Invention nation multi-patient use. Crossman et al. U.S. Patent No. 4,869,249, and Swierczek U.S. Patent No. [0026] One aspect of the present invention relates to 5,402,798, also disclose disposable, single use lancing a sampling device for sampling body fluid. The device devices. 15 includes a housing and a lancet carrier mounted in the [0016] The disclosures of the above patents are in- housing for supporting a disposable lancet. The device corporated herein by reference. also includes a mechanism for displacing the lancet car- [0017] An object of the present invention is to ensure rier toward a lower end of the housing for forming an that a sufficiently large drop of body fluid is developed incision in a user. A body fluid sampling member is at an incision, and that the body fluid reaches a test strip. 20 mounted in the housing for conducting body fluid from [0018] Another object is to ensure that the sample ap- the incision. That sampling member comprises a capil- plied to the test strip creates a measurement area that lary member, and a test strip. The capillary member in- is sufficiently wide to be properly analyzed. cludes an elongated stem having a capillary passage [0019] An additional object is to provide a novel elec- extending longitudinally therethrough for conducting trochemical analyzing system for analyzing a sample in 25 body fluid upwardly by capillary action. The test strip is the lancing device. affixed to the capillary member at an upper end- thereof [0020] A further object is to enable a sample of body and in communication with the capillary passage for re- fluid to be applied to a test strip which is mounted in a ceiving a sample of body fluid. lancing device. [0027] Preferably, the test strip comprises a micropo- [0021] Another object of this invention is to provide a 30 rous membrane, and an absorbent pad is preferably dis- method which can result in a sample of either blood or posed between the test strip and the upper end of the interstitial fluid, depending on the sample site and the capillary passage for wicking body fluid from the pas- penetration depth utilized. While there are no commer- sage to the test strip. cially available devices utilizing interstitial fluid (ISF) at [0028] The present invention also relates to the cap- this time, there are active efforts to establish the corre- 35 illary member per se. lation of analytes, such as glucose, in ISF compared to [0029] Another embodiment of the sampling device whole blood. If ISF could be readily obtained and corre- includes a housing, a lancet carrier mounted in the hous- lation is established, ISF may be preferable as a sample ing for supporting a disposable lancet, a mechanism for since there is no interference of red blood cells or he- displacing the lancet carrier toward a lower end of the matocrit adjustment required. 40 housing for forming an incision in a user, and a strip- [0022] Another object of this invention is to provide a holding mechanism mounted at a lower end of the hous- method which can draw a small but adjustable sample, ing for supporting a test strip across the lower end of the i.e. 3 µL for one test device and 8 µL for another test housing to enable the test strip to pick up body fluid from device, as appropriate. the incision. [0023] Another object of this invention is to provide a 45 [0030] The strip holding mechanism preferably com- method by which the drawn sample is collected and may prises a sleeve disposed in surrounding relationship to be easily presented to a testing device, regardless of the lancet carrier and includes radially aligned slots for the location of the sample site on the body. This ap- receiving a test strip. proach helps with infection control in that multiple pa- [0031] Preferably, the sleeve constitutes a first tients are not brought in contact with a single test instru- 50 sleeve, and the holding mechanism further includes a ment; only the sampling device with a disposable pa- second sleeve surrounding the first sleeve and including tient-contact portion is brought to the test instrument. slots that are radially aligned with the slots of the first Alternatively, the disposable portion of a test device may sleeve. The second sleeve is slidable longitudinally rel- be physically coupled with the sampler so the sample ative to both the housing and the first sleeve and is can be brought directly into the test device during sam- 55 spring biased downwardly. The slots which are formed pling. The test device may then be read in a test instru- in the second sleeve are elongated in a direction parallel ment if appropriate or the testing system can be inte- to a longitudinal axis of the housing to enable the second grated into the sampler and the test device can provide sleeve to move longitudinally relative to a test strip

3 5 EP 1 579 814 A2 6 mounted in the first sleeve. Detailed Description of Preferred Embodiments of the [0032] The present invention also relates to a method Invention of sampling body fluid which comprises the steps of po- sitioning a lower end of a sampling device against a skin [0035] Depicted in Figs. 1 and 2 is a lancing device surface, and displacing a lancet carrier toward the lower 5 10 for making an incision through a skin surface S, end of the sampling device to form an incision through wherein a disposable lancet 12 (hereinafter referred to the skin. A test strip is positioned in the sampling device as a "disposable") which carries a skin-lancing member to extend across the lower end thereof. The sampling in the form of a needle 14 can be displaced toward the device is moved toward the incision to bring the test strip skin surface by a cocked spring and then rapidly retract- into contact with body fluid emerging from the incision. 10 ed by another spring. Devices of this general type are The test strip is preferably positioned in the sampling known, and one preferred device is disclosed in com- device prior to the displacement of the lancet toward the monly assigned, concurrently filed U.S. application Se- lower end of the sampling device, whereby the lancet rial No. (Attorney Docket pierces the test strip. 018176-039), the disclosure of which is incorporated [0033] Another aspect of the invention involves the 15 herein by reference. provision of a drop-detecting mechanism on the lancing [0036] As disclosed in that application, the disposable device adjacent a lower end thereof for detecting a drop 12 includes a body 16 which carries not only the needle of body fluid on the user's skin. The mechanism can be 14, but also a capillary tube 18. The capillary tube is in the form of electrodes which contact the drop, or an mounted by friction fit between holding elements 15 that optical system including a light emitter and a light sen- 20 are integral with the body 16 and is downwardly slidable sor. The drop-detecting mechanism automatically deter- relative to the body 16 in response to manual downward mines whether a drop of sufficient size has been devel- displacement of a pusher 20 which possesses an ex- oped at the incision for providing a proper sample. posed actuator knob 22. [0037] The disposable 12 is situated telescopingly Brief Description of the Drawing 25 within a cylindrical stimulator sleeve 24 which is slidable longitudinally relative to a housing 26 of the device. The [0034] The objects and advantages of the invention sleeve 24 is biased downwardly, or forwardly, by a spring will become apparent from the following detailed de- 28. Following the cutting of an incision I in the skin and scription of preferred embodiments thereof in connec- the retraction of the lancet, the housing can be repeat- tion with the accompanying drawing in which like numer- 30 edly pushed downwardly against the skin as required to als designate like elements and in which: express the appropriate sample from the incision, whereupon the sleeve depresses a ring of body tissue Fig. 1 is a side elevational view, partially broken in surrounding relationship to the incision, causing the away, of a blood sampling device according to the incision to bulge while spreading apart the sides of the present invention, with a capillary tube thereof dis- 35 incision. Consequently, a drop D of body fluid such as posed in a retracted state; blood or interstitial fluid is formed at the open end of the Fig. 2 is a view similar to Fig. 1 after an incision has incision, even if the incision I has been made in a region been made, and the capillary tube has been extend- of the body where the supply of body fluid is relatively ed; low as compared to, say, the fingertip region. Fig. 3 is a longitudinal sectional view through one 40 [0038] Once the drop D has been created, the pusher embodiment of the capillary tube according to the 22 is displaced to push the capillary tube downwardly to present invention; a state where the lower end of the capillary tube can be Fig. 4 is a longitudinal sectional view taken through dipped into the body fluid drop to obtain a sample. The another embodiment of a capillary tube according pusher is then released for return to an upper position to the present invention; 45 by a return spring (not shown). As disclosed in the afore- Fig. 5 is view similar to Fig. 2 of a sampling device mentioned application, the fluid can then be transferred having an alternative form of analyzing instrument; from the capillary tube to a test strip, thereby making the Fig. 6 is a fragmentary view of a lower end of a lanc- overall sampling procedure more convenient. ing device, depicting a drop-detecting mechanism [0039] In accordance with the present invention, the according to the present invention; 50 sampling procedure is made even more convenient by Fig. 7 is a side elevational view, partially broken eliminating the need to transfer the body fluid from the away of another embodiment of the sampling de- capillary tube. vice, with a test strip mounted at a lower end there- [0040] In a first embodiment, the capillary tube carries of; and its own test strip. Depicted in Fig. 3 is a test strip 30 in Fig. 8 is a fragmentary view of the device depicted 55 the form of a microporous membrane (preferably of the in Fig. 6 in a sampling-taking state. type disclosed in commonly assigned U.S. application Serial No. 08/628,489, filed April 5, 1996, the disclosure of which is incorporated by reference herein).

4 7 EP 1 579 814 A2 8

[0041] The membrane 30 is bonded, e.g. by a suitable to the absorbent pad, or to a ring 62 which extends adhesive, to an enlarged head or flange portion 32 of around a circumferential outer edge face of the absorb- the capillary tube 18 which projects laterally with respect ent pad 60. That ring, together with the flange 32, forms to a stem portion 34 of the capillary tube. The head 32, a cover which covers portions of the absorbent pad not when viewed from the top, can be of any shape, such 5 covered by the membrane 30 to prevent the escape of as circular or rectangular (e.g., square). A capillary pas- the body fluid sample. When the capillary tube draws- sage 36 extends longitudinally through the stem 34 and up body fluid by capillary action, that fluid is wicked by head 32 to conduct body fluid into contact with the mem- the absorbent pad and supplied to the test strip 30.- An brane by capillary action. advantage of the capillary tube 18' is that the absorbent [0042] As is known in the art of capillary tubes, the 10 pad will spread-out the fluid so that a wider sample is amount of body fluid which is drawn up by capillary ac- applied to the test strip to facilitate analysis. tion can be regulated by a suitable selection of diameter [0047] A backpressure may occur which opposes a and length of the passage 36, thereby ensuring that a flow of body fluid through the absorbent pad 60. To deal proper dosing of the membrane is achieved. with that potential problem, the head 32' is provided with [0043] Fluid analyzing instruments can be mounted 15 air vent openings 64 to relieve the backpressure and fa- within the housing. For example, a conventional optical cilitate the flow of fluid through the pad 60. The air vents analyzing mechanism can be provided which includes are spaced laterally from the passage 36 and commu- a light source 40 and a light sensor 42 such as a pho- nicate with the pad. The diameter of the vent openings totransistor, which are electrically connected to a con- is smaller than that of the capillary tube and small ventional electronics unit 44 for monitoring a color 20 enough to prevent the passage of body fluid there- change of the sample as the sample reacts with chem- through. icals in the test strip. The electronics unit 44 displays [0048] Instead of being bonded directly to the absorb- the results on a display panel 90. In that way, for exam- ent pad 60, the membrane 30 could be bonded to the ple, the glucose level in blood can be measured. The cover 62. In that case, the absorbent pad 60 could be unit 44 is electrically connected to a battery 45 that is 25 bonded to the membrane, or to the cover, or to the cap- mounted in the housing. illary tube. [0044] In lieu of an optical analyzing mechanism, an [0049] In any event it will be appreciated that the test electrochemical mechanism can be provided in a device strip is affixed, either directly or indirectly, to the capillary 10' (Fig. 5), the mechanism including an electrochemical tube to constitute an integral part thereof. meter 50 which measures glucose levels. The meter 50 30 [0050] One problem faced by a user is being able to is electrically connected to a battery 51 mounted in the determine whether a drop of body fluid expressed from housing. The test strip 52 in this case would be provided an incision is of sufficient size to provide a proper sam- with a printed electrical circuit, and the pusher 24' would ple. That determination can be made automatically by possess electrical leads 54 positioned so as to contact a sampling device 10" in accordance with an embodi- respective portions of the printed circuit electrical paths 35 ment of the invention depicted in Fig. 6 wherein a drop on the test strip when the pusher 24' is in its lower po- sensing mechanism 65 is mounted on an inner sleeve sition (after having pushed the capillary tube down). 66. The drop sensing mechanism comprises a pair of Thus, the sample conducted to the test strip 52 by the diametrically opposed elements 67, 68. In one embod- capillary tube will contact the electrical circuit for con- iment, those elements comprise a pair of electrodes ducting a current therebetween when the leads 54 are 40 connected by wires 69 to the battery 45 or 51 and posi- brought into contact with the circuit. The leads are con- tioned such that when the outer sleeve 24 is retracted nected to the meter 50 which measures the current. in response to a pressing down of the housing, the elec- Since the level of current is proportional to the glucose trodes will make contact with the drop of body fluid only concentration, the- meter 50 is able to measure that con- if the drop is of sufficient height to provide an adequate centration. 45 sample. If such contact is made, the drop will close a [0045] When the disposable 12 is discarded after a circuit, enabling a sensor to determine that the drop is testing operation, the capillary tube 18 and test strip 30 of ample size. An indicator, such as a lamp 71 can be will be discarded therewith. A fresh disposable is then energized to advise the user. installed to present a new lancet 14, capillary tube 18 [0051] Alternatively, the elements 67, 68 of the mech- and test strip 30. Thus, the user never has to touch or 50 anism 65 could comprise a light emitter and light receiv- otherwise maneuver a test strip separately from the cap- er, respectively. When the drop of body fluid is of suffi- illary tube, since the test strip is attached thereto. cient height, it will block the transmission of light to the [0046] An alternate embodiment of a capillary tube 18' receiver, thus indicating that the drop is of sufficient size, is depicted in Fig. 4 wherein an absorbent pad 60 is dis- and triggering the energization of the lamp 71. posed between the test strip 30 and the head 32' of the 55 [0052] The drop-detecting mechanism 65 can be capillary tube 18'. That is, the absorbent pad, which can used with either of the embodiments disclosed in con- be formed of cellulose or suitable membrane, is bonded nection with Figs. 1-2 and 5. However, it is not necessary to the capillary tube 18', and the membrane 30 is bonded that the incision be.formed by a lancet. Other incision

5 9 EP 1 579 814 A2 10 forming devices could be used such as a laser beam or Claims pressurized fluid. That is, known pneumatic or hydraulic injectors of the type which inject pressurized gas or liq- 1. A sampling device for sampling body fluid, compris- uid against the skin could be used. such auto injectors ing: are sold by Becton-Dickinson, for example, to inject in- 5 sulin. By eliminating the insulin and merely injecting the a housing; gas (e.g., air or nitrogen) or liquid (e.g., water) at pres- sures about 30 psi. an incision could be formed in the means in the housing for forming an incision skin for taking samples of body fluid. Advantageously, through the skin of a user; and small particles could be mixed with the gas to promote 10 the tissue-cutting action. The particles could comprise a drop-detecting mechanism disposed adja- carbon particles of from 1 micron to 0.010 inches in di- cent a lower end of the device for detecting a ameter. drop of body fluid disposed on the user's skin. [0053] Another embodiment of a sampling device 10" according to the invention is depicted in Figs. 7 and 8. 15 2. The sampling device according to claim 1, further In that embodiment, the stimulator sleeve 24" is provid- including an indicator mounted on the housing and ed with a through-slot 70, and an inner sleeve 72 (which connected to the drop-detecting mechanism for supports the disposable), is provided with a through-slot providing an indication to a user when a detected 74 that is aligned with the through-slot 70. Those aligned drop is of predetermined size. through-slots 70, 74 are adapted to receive a test strip 20 30" which, if desired, includes an absorbent pad 60". 3. The sampling device according to claim 1 or 2, The test strip 30", which may comprise a porous mem- wherein the drop detecting mechanism includes a brane 30A" and an absorbent pad 30B" attached there- pair of spaced apart electrodes arranged to contact to, is manually inserted through the slots 70, 74 by the the drop. user. 25 [0054] When a lancing procedure is performed, the 4. The sampling device according to claim 1, 2 or 3, lancet pierces the test strip 30" en route to the skin sur- wherein the drop detecting mechanism comprises face. Then, as the housing is repeatedly pushed down a light emitter and light receiver disposed adjacent to pump body fluid to the open end of the incision as a lower end of the device. described earlier, the stimulator sleeve 24" will be re- 30 peatedly retracted, and simultaneously the inner sleeve 5. A sampling device for sampling body fluid, compris- 72, along with the test strip 30", will approach and con- ing: tact the drop of body fluid as shown in Fig. 8, whereby a sample of the fluid is collected on the test strip. Then, a housing; the user removes the test strip for testing at an off-site 35 analyzer. a lancet carrier mounted in the housing and [0055] It will be appreciated that the present invention adapted for supporting a disposable lancet; enables a test strip to be easily installed into and re- moved from a lancing device, thereby minimizing any a mechanism for displacing the lancet carrier risk of contamination of the sample. In the examples ac- 40 toward a lower end of the housing for forming cording to Figs. 1-5 the test strip is installed along with an incision through the skin of a user; and the disposable lancet, thereby being automatically po- sitioned in proper relationship to receive a sample and a strip-holding mechanism mounted at a lower to permit the sample to be analyzed by an on-side ana- end of the housing for supporting a test strip lyzing instrument. If desired, however, the analysis 45 across the lower end of the housing to enable could be performed by an off-site instrument by remov- the test strip to pick-up body fluid from the inci- ing the disposable from the device and taking it to the sion. off-site instrument. In the example of Figs. 7-8, the test strip is easily installed/removed by being passed 6. The sampling device according to claim 5, wherein through readily accessible slots. 50 the strip-holding mechanism comprises a sleeve [0056] Although the present invention has been de- surrounding the lancet carrier and including slots for scribed in connection with preferred embodiments receiving the test strip. thereof, it will be appreciated by those skilled in the art that additions, modifications, substitutions and deletions 7. The sampling device according to claim 6, wherein not specifically described may be made without depart- 55 the sleeve constitutes a first sleeve, the strip-hold- ing from the spirit and scope of the invention as defined ing mechanism further including a second sleeve in the appended claims. surrounding the first sleeve and including slots ra- dially aligned with the slots of the first sleeve, the

6 11 EP 1 579 814 A2 12

second sleeve being slidable longitudinally relative flange. to both the housing and the first sleeve and being spring biased downwardly, the slots formed in the second sleeve being elongated in a direction paral- lel to a longitudinal axis of the housing to enable the 5 second sleeve to move longitudinally relative to a test strip mounted in the first sleeve.

8. A body fluid sampling member adapted to be mounted in a device for sampling body fluid, com- 10 prising:

a capillary member including an elongated stem having a capillary passage extending lon- gitudinally therethrough for conducting body 15 fluid upwardly by capillary action; and

a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of 20 body fluid.

9. The body fluid sampling member according to claim 8 wherein the test strip comprises a microporous membrane. 25

10. The body fluid sampling member according to claim 9 further comprising an absorbent pad disposed be- tween the test strip and the upper end of the capil- lary member and arranged over the capillary pas- 30 sage for wicking body fluid from the passage to the test strip.

11. The body fluid sampling member according to claim 10 wherein the absorbent pad is affixed directly to 35 the capillary member, and the test strip is affixed directly to the absorbent pad.

12. The body fluid sampling member according to claim 10 or 11 further including a covering structure cov- 40 ering portions of the absorbent pad not covered by the membrane; the covering structure being vented by at least one air vent opening having a smaller cross section than the passage. 45 13. The body fluid sampling member according to claim 12 wherein the covering structure includes a flange projecting laterally outwardly from an upper end of the stem, a lower surface of the pad being seated on the flange. 50

14. The body fluid sampling member according to claim 13 wherein the covering structure further includes a side cover extending around a side surface of the pad. 55

15. the body fluid sampling member according to claim 14 wherein the.air vent opening is disposed in the

7 EP 1 579 814 A2

8 EP 1 579 814 A2

9 EP 1 579 814 A2

10