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Methods and Apparatus for Sampling and Analyzing Body Fluid

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Methods and Apparatus for Sampling and Analyzing Body Fluid 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 body fluid (57) A sampling device (10) for sampling body fluid includes a lancet (12) for making an incision, a capillary 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 blood glucose 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.
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