Lancing devices are well known in the medical health-care products industry for piercing the skin to produce blood for analysis. Biochemical analysis of blood samples is a diagnostic tool for determining clinical information. Many point-of-care tests are performed using capillary whole blood, the most common being monitoring blood glucose level in diabetics. Typically, a drop of blood is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.
Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancet drivers that contain a multitude of spring, cam and mass actuators to drive the lancet. These include cantilever springs, diaphragms, coil springs, as well as gravity plumbs to actuate the lancet. Typically, the device is pre-cocked, or the user cocks the device. The device is held against the skin and the user mechanically triggers the ballistic launch of the lancet.
The problem with current devices is that they require two hands to operate, one to hold the device and push a button which activates the device, and the other hand to provide a finger for lancing. After lancing, the finger needs to be free to move to another device for collection of the blood droplet and subsequent analysis.
Generally, known methods of blood sampling require several steps. First, a measurement session is set up by gathering various paraphernalia such as lancets, launchers, test strips, instrument, etc. Second, the patient must assemble the paraphernalia by loading a sterile lancet, loading a test strip, and arming the launcher.
Third, the patient must place their finger against the lancet launcher and using the other hand activate the launcher. Fourth, the patient must put down the launcher and place the bleeding finger against a test strip, which may or may not have been loaded into the instrument. The patient must insure blood has been loaded onto the test strip and the instrument has been calibrated prior to such loading. Finally, the patient must dispose of all the blood contaminated paraphernalia including the lancet. What has been needed is a blood sampling device and method that simplifies the blood sampling procedure.
Embodiments of the present invention are related to medical health-care products and to methods for obtaining blood for chemical analysis. More particularly, embodiments of the invention relate to devices and methods for piercing the skin (lancing) with a sensor to detect the presence of a patient's finger and activate the lancet automatically. In some embodiments, the cartridge and lancet are disposable.
In accordance with embodiments of the invention, a patient will be able to obtain a sample of blood in an ergonomic, convenient way using a method and apparatus which integrates lancing, sample collection, and analysis. The presence of patients finger on the ergonomic sampling area is sensed by monitoring the pressure applied by the finger on the cartridge which houses the lancet. The application of a predetermined pressure is measured by a piezoelectric or electrical circuit.
Advantages can be achieved in a blood sampling device by integrating the lancing and blood sample collection procedure so that the device can capture and transport the capillary blood from the wound created by the lancet to a desired active area, such as a strip for analyzing glucose. This can be done in embodiments of the invention by integrating the lancet, conduit and reservoir into a disposable cartridge which can be inserted into a hand-held sampling device with instrumentation for analyzing the blood sample.
In the use of an embodiment of the invention, a finger is placed over an ergonomically contoured sampling area and pressure is applied with the finger so that a sensor will activate the lancet, which will, in turn, lance the finger and allow the blood sample to be collected in the conduit and transported to the reservoir for analysis in a single step from the patient's perspective.
The objects, advantages and features of this invention will be more readily appreciated from the following detailed description, when read in conjunction with the accompanying drawing, in which:
Reference will now be made to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
Disposable means that the cartridge is used for one lancing cycle and is then discarded.
The lancet (12) has a distal end (16) which connects to the driver (40) and a proximal end (14) which lances the skin. The proximal end (14) is embedded within the conduit (18). Embedded means completely shielded by the cartridge when it is not lancing. The distal end (16) extends into the cavity (20). The reservoir (22) has a narrow opening (24) on the ergonomically contoured surface (26) which is adjacent to the proximal end (14) of the lancet (12). The term ergonomically contoured is generally defined to mean shaped to snugly fit a finger placed on the surface. The term reservoir is generally defined to mean an area which allows pooling of the blood sample. The term narrow is generally defined to mean a reduction in diameter of the reservoir so as to exploit capillary forces to better channel the blood into the rest of the reservoir. The term adjacent, as used in the context of the proximity of the proximal end (16) and narrow opening (24), is generally defined to mean that the proximal end (16) and the narrow opening (24) are located in the same general area. The cartridge (10) is capable of channeling the blood sample, which means transporting through small passages (not shown), to an active area (28) which corresponds to the device's system for analyzing the blood. This system can consist of a chemical, physical, optical, electrical or other means of analyzing the blood sample. The lancet and reservoir embodiment illustrated are integrated into the cartridge in a single packaged unit.
As the socket (32) is pushed downward it compresses the springs (34). The sensor (46) makes contact with the distal end (42) of the launcher (38) and thereby detects the presence of the finger on the ergonomically contoured surface. Detection means sensing using electrical means. The sensor is a piezoelectric device which detects this pressure and sends a signal to circuit (56) which actuates the launcher (38) and advances and then retracts the lancet (12) lancing the finger (50). In another embodiment, the sensor (46) is an electric contact which closes a circuit when it contacts the launcher (38) activating the launcher (38) to advance and retract the lancet (12) lancing the finger (50).
Activating means beginning the lancing event, which consists of advancing, stopping, and retracting the lancet.
An embodiment of the invention is a method of sampling which reduces the number of steps that must be taken by a patient to obtain a sample and analysis of the sample. First, the patient loads a cartridge with an embedded sterile lancet into the device. Second, the patient initiates a lancing cycle by turning on the power to the device or by placing the finger to be lanced on the ergonomically contoured surface and pressing down. Initiation means arming the device. This initiation prompts the sensor.
Prompting means that the sensor is made operational and given control to activate the launcher. Prompting is a safety precaution to avoid unintentionally launching the lancet.
The sensor is unprompted when the lancet is retracted after its lancing cycle to avoid multiple lancing events that would cause unnecessary pain and obstruct the collection of the blood sample. The lancing cycle consists of arming, advancing, stopping and retracting the lancet, and collecting the blood sample in the reservoir. The cycle is complete once the blood sample has been collected in the reservoir. Third, the patient presses down on the cartridge which forces the launcher to make contact with the sensor and activates the launcher. The lancet then pierces the skin and the reservoir collects the blood sample. The patient is then optionally informed to remove the finger by an audible signal such as a buzzer or a beeper, and/or a visual signal such as an LED or a display screen. The patient can then dispose of all the contaminated parts by removing the cartridge and disposing of it. In another embodiment, multiple cartridges may be loaded into the sampling device in the form of a cassette. The patient is informed by the device as to when to dispose of the entire cassette after the analysis is complete.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein.
It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application is a divisional of U.S. Ser. No. 10/363,510 filed Sep. 29, 2003 (now U.S. Pat. No. 7,749,174, which is a §3.71 filing of PCT/US02/19060 filed Jun. 12, 2002, which in turn claims the benefit of U.S. Ser. No. 60/297,860 filed Jun. 12, 2001. All applications above are fully incorporated herein by reference.
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| 2206674 | Aug 1972 | DE |
| 3538313 | Apr 1986 | DE |
| 4212315 | Oct 1993 | DE |
| 4320347 | Dec 1994 | DE |
| 4344452 | Jun 1995 | DE |
| 4420232 | Dec 1995 | DE |
| 29800611 | Jul 1998 | DE |
| 19819407 | Nov 1999 | DE |
| 200 09 475 | Sep 2000 | DE |
| 20009475 | Oct 2000 | DE |
| 29824204 | Oct 2000 | DE |
| 10032042 | Jan 2002 | DE |
| 10057832 | Feb 2002 | DE |
| 10057832 | Feb 2002 | DE |
| 10142232 | Mar 2003 | DE |
| 10208575 | Aug 2003 | DE |
| 10245721 | Dec 2003 | DE |
| 10361560 | Jul 2005 | DE |
| 0112498 | Jul 1984 | EP |
| 137975 | Apr 1985 | EP |
| 0160768 | Nov 1985 | EP |
| 0199484 | Oct 1986 | EP |
| 0254246 | Jan 1988 | EP |
| 0289 269 | Nov 1988 | EP |
| 0317847 | May 1989 | EP |
| 0320109 | Jun 1989 | EP |
| 0 364 208 | Apr 1990 | EP |
| 0170375 | May 1990 | EP |
| 0136362 | Dec 1990 | EP |
| 0449525 | Oct 1991 | EP |
| 0453283 | Oct 1991 | EP |
| 0263948 | Feb 1992 | EP |
| 0449147 | Aug 1992 | EP |
| 0530994 | Mar 1993 | EP |
| 0374355 | Jun 1993 | EP |
| 0351891 | Sep 1993 | EP |
| 0593096 | Apr 1994 | EP |
| 0630609 | Dec 1994 | EP |
| 0415388 | May 1995 | EP |
| 0654659 | May 1995 | EP |
| 0505494 | Jul 1995 | EP |
| 0662367 | Jul 1995 | EP |
| 0359831 | Aug 1995 | EP |
| 0471986 | Oct 1995 | EP |
| 0368474 | Dec 1995 | EP |
| 0461601 | Dec 1995 | EP |
| 0429076 | Jan 1996 | EP |
| 0552223 | Jul 1996 | EP |
| 0735363 | Oct 1996 | EP |
| 0505504 | Mar 1997 | EP |
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| 0537761 | Aug 1997 | EP |
| 0795601 | Sep 1997 | EP |
| 0562370 | Nov 1997 | EP |
| 0415393 | Dec 1997 | EP |
| 0823239 | Feb 1998 | EP |
| 0560336 | May 1998 | EP |
| 0878 708 | Nov 1998 | EP |
| 0 898 936 | Mar 1999 | EP |
| 0505475 | Mar 1999 | EP |
| 0901018 | Mar 1999 | EP |
| 0470649 | Jun 1999 | EP |
| 0 951 939 | Oct 1999 | EP |
| 0 951 939 | Oct 1999 | EP |
| 0847447 | Nov 1999 | EP |
| 0964059 | Dec 1999 | EP |
| 0964060 | Dec 1999 | EP |
| 0969097 | Jan 2000 | EP |
| 0 985 376 | May 2000 | EP |
| 1021950 | Jul 2000 | EP |
| 0894869 | Feb 2001 | EP |
| 1074832 | Feb 2001 | EP |
| 1093854 | Apr 2001 | EP |
| 1 101 443 | May 2001 | EP |
| 1101443 | May 2001 | EP |
| 1114995 | Jul 2001 | EP |
| 0736607 | Aug 2001 | EP |
| 1 157 660 | Nov 2001 | EP |
| 0874984 | Nov 2001 | EP |
| 1157660 | Nov 2001 | EP |
| 0730037 | Dec 2001 | EP |
| 0636879 | Jan 2002 | EP |
| 01174083 | Jan 2002 | EP |
| 0851224 | Mar 2002 | EP |
| 0759553 | May 2002 | EP |
| 0856586 | May 2002 | EP |
| 0817809 | Jul 2002 | EP |
| 0872728 | Jul 2002 | EP |
| 0795748 | Aug 2002 | EP |
| 0685737 | Sep 2002 | EP |
| 0958495 | Nov 2002 | EP |
| 0937249 | Dec 2002 | EP |
| 1337182 | Aug 2003 | EP |
| 0880692 | Jan 2004 | EP |
| 01374770 | Jan 2004 | EP |
| 1404232 | Apr 2004 | EP |
| 1404233 | Apr 2004 | EP |
| 1246688 | May 2004 | EP |
| 1502614 | Feb 2005 | EP |
| 1643908 | Apr 2006 | EP |
| 1790288 | May 2007 | EP |
| 1790288 | May 2007 | EP |
| 1921992 | May 2008 | EP |
| 2039294 | Mar 2009 | EP |
| 2039294 | Mar 2009 | EP |
| 2 555 432 | May 1985 | FR |
| 2622457 | Nov 1987 | FR |
| 1558111 | Dec 1979 | GB |
| 2168815 | Jun 1986 | GB |
| 233936 | Jun 1999 | GB |
| 2335860 | Oct 1999 | GB |
| 2335990 | Oct 1999 | GB |
| HEI 4 194660 | Jul 1992 | JP |
| 1996010208 | Dec 1992 | JP |
| 1014906 | Jan 1998 | JP |
| 2000-116768 | Apr 2000 | JP |
| WO 8001389 | Jul 1980 | WO |
| WO 8504089 | Sep 1985 | WO |
| WO8605966 | Oct 1986 | WO |
| WO 8607632 | Dec 1986 | WO |
| WO 9109139 | Jun 1991 | WO |
| WO9203099 | Mar 1992 | WO |
| WO9206971 | Apr 1992 | WO |
| WO9207263 | Apr 1992 | WO |
| WO9207468 | May 1992 | WO |
| WO9300044 | Jan 1993 | WO |
| WO 9306979 | Apr 1993 | WO |
| WO9309723 | May 1993 | WO |
| WO 9325898 | Dec 1993 | WO |
| WO 9427140 | Nov 1994 | WO |
| WO 9429703 | Dec 1994 | WO |
| WO 9429704 | Dec 1994 | WO |
| WO 9429731 | Dec 1994 | WO |
| WO 9500662 | Jan 1995 | WO |
| WO 9506240 | Mar 1995 | WO |
| WO 9510223 | Apr 1995 | WO |
| WO9512583 | May 1995 | WO |
| WO 9522597 | Aug 1995 | WO |
| WO9614799 | May 1996 | WO |
| WO 9630431 | Oct 1996 | WO |
| WO9637148 | Nov 1996 | WO |
| WO 9702359 | Jan 1997 | WO |
| WO 9702487 | Jan 1997 | WO |
| WO 9711883 | Apr 1997 | WO |
| WO 9711883 | Apr 1997 | WO |
| WO 9718464 | May 1997 | WO |
| WO9728741 | Aug 1997 | WO |
| WO 9730344 | Aug 1997 | WO |
| WO 9742882 | Nov 1997 | WO |
| WO 9742888 | Nov 1997 | WO |
| WO 9745720 | Dec 1997 | WO |
| WO 9803431 | Jan 1998 | WO |
| WO9814436 | Apr 1998 | WO |
| WO 9819159 | May 1998 | WO |
| WO9819609 | May 1998 | WO |
| WO 9820332 | May 1998 | WO |
| WO 9820348 | May 1998 | WO |
| WO9820867 | May 1998 | WO |
| WO 9824366 | Jun 1998 | WO |
| WO 9824373 | Jun 1998 | WO |
| WO 9835225 | Aug 1998 | WO |
| WO9845276 | Oct 1998 | WO |
| WO 9903584 | Jan 1999 | WO |
| WO 9905966 | Feb 1999 | WO |
| WO9907295 | Feb 1999 | WO |
| WO 9907431 | Feb 1999 | WO |
| WO 9913100 | Mar 1999 | WO |
| WO 9917854 | Apr 1999 | WO |
| WO 9918532 | Apr 1999 | WO |
| WO 9919507 | Apr 1999 | WO |
| WO 9919717 | Apr 1999 | WO |
| WO 9927483 | Jun 1999 | WO |
| WO 9927852 | Jun 1999 | WO |
| WO 9962576 | Dec 1999 | WO |
| WO 9964580 | Dec 1999 | WO |
| WO 0006024 | Feb 2000 | WO |
| WO 0009184 | Feb 2000 | WO |
| WO 0011578 | Mar 2000 | WO |
| WO 0015103 | Mar 2000 | WO |
| WO 0017799 | Mar 2000 | WO |
| WO 0017800 | Mar 2000 | WO |
| WO 0018293 | Apr 2000 | WO |
| WO 0019346 | Apr 2000 | WO |
| WO 0020626 | Apr 2000 | WO |
| WO0029577 | May 2000 | WO |
| WO 0030186 | May 2000 | WO |
| WO 0032097 | Jun 2000 | WO |
| WO 0032098 | Jun 2000 | WO |
| WO 0033236 | Jun 2000 | WO |
| WO 0039914 | Jul 2000 | WO |
| WO 0042422 | Jul 2000 | WO |
| WO 0044084 | Jul 2000 | WO |
| WO0046854 | Aug 2000 | WO |
| WO 0050771 | Aug 2000 | WO |
| WO0055915 | Sep 2000 | WO |
| WO 0060340 | Oct 2000 | WO |
| WO 0064022 | Oct 2000 | WO |
| WO 0067245 | Nov 2000 | WO |
| WO 0067268 | Nov 2000 | WO |
| WO 0072452 | Nov 2000 | WO |
| WO 0100090 | Jan 2001 | WO |
| WO 0115807 | Mar 2001 | WO |
| WO 0116578 | Mar 2001 | WO |
| WO 0175433 | Mar 2001 | WO |
| WO 0123885 | Apr 2001 | WO |
| WO 0125775 | Apr 2001 | WO |
| WO 0126813 | Apr 2001 | WO |
| WO0129037 | Apr 2001 | WO |
| WO 0133216 | May 2001 | WO |
| WO 0134029 | May 2001 | WO |
| WO 0136955 | May 2001 | WO |
| WO 0137174 | May 2001 | WO |
| WO 0145014 | Jun 2001 | WO |
| WO 0140788 | Jul 2001 | WO |
| WO 0157510 | Aug 2001 | WO |
| WO 0163271 | Aug 2001 | WO |
| WO 0164105 | Sep 2001 | WO |
| WO 0166010 | Sep 2001 | WO |
| WO 0169505 | Sep 2001 | WO |
| WO 0172220 | Oct 2001 | WO |
| WO 0172225 | Oct 2001 | WO |
| WO 0173124 | Oct 2001 | WO |
| WO 0173395 | Oct 2001 | WO |
| WO 0189691 | Nov 2001 | WO |
| WO 0195806 | Dec 2001 | WO |
| WO 0200101 | Jan 2002 | WO |
| WO 0202796 | Jan 2002 | WO |
| WO 0208750 | Jan 2002 | WO |
| WO 0208753 | Jan 2002 | WO |
| WO 0208950 | Jan 2002 | WO |
| WO 0218940 | Mar 2002 | WO |
| WO 0221317 | Mar 2002 | WO |
| WO 0225551 | Mar 2002 | WO |
| WO 0232559 | Apr 2002 | WO |
| WO 0241227 | May 2002 | WO |
| WO 0241779 | May 2002 | WO |
| WO 0244948 | Jun 2002 | WO |
| WO 0249507 | Jun 2002 | WO |
| WO0249507 | Jun 2002 | WO |
| WO 02056769 | Jul 2002 | WO |
| WO 02059734 | Aug 2002 | WO |
| WO 02069791 | Sep 2002 | WO |
| WO 02077638 | Oct 2002 | WO |
| WO 02100251 | Dec 2002 | WO |
| WO 02100252 | Dec 2002 | WO |
| WO 02100253 | Dec 2002 | WO |
| WO 02100254 | Dec 2002 | WO |
| WO 02100460 | Dec 2002 | WO |
| WO 02100461 | Dec 2002 | WO |
| WO 02101343 | Dec 2002 | WO |
| WO 02101359 | Dec 2002 | WO |
| WO 03000321 | Jan 2003 | WO |
| WO 03023389 | Mar 2003 | WO |
| WO 03042691 | May 2003 | WO |
| WO 03039369 | May 2003 | WO |
| WO 03045557 | Jun 2003 | WO |
| WO 03046542 | Jun 2003 | WO |
| WO 03049609 | Jun 2003 | WO |
| WO 03050534 | Jun 2003 | WO |
| WO 03066128 | Aug 2003 | WO |
| WO 03070099 | Aug 2003 | WO |
| WO 03071940 | Sep 2003 | WO |
| WO 03082091 | Oct 2003 | WO |
| WO 03082091 | Oct 2003 | WO |
| WO 03088824 | Oct 2003 | WO |
| WO 03088834 | Oct 2003 | WO |
| WO 03088835 | Oct 2003 | WO |
| WO 03088851 | Oct 2003 | WO |
| WO03088834 | Oct 2003 | WO |
| WO 03094752 | Nov 2003 | WO |
| WO 03101297 | Dec 2003 | WO |
| WO 2004008130 | Jan 2004 | WO |
| WO 2004022133 | Mar 2004 | WO |
| WO 2004026130 | Apr 2004 | WO |
| WO 2004040285 | May 2004 | WO |
| WO 2004040287 | May 2004 | WO |
| WO 2004040948 | May 2004 | WO |
| WO 2004041082 | May 2004 | WO |
| WO 2004045375 | Jun 2004 | WO |
| WO 2004054455 | Jul 2004 | WO |
| WO 2004060174 | Jul 2004 | WO |
| WO 2004060446 | Jul 2004 | WO |
| WO 2004091693 | Oct 2004 | WO |
| WO 2004098405 | Nov 2004 | WO |
| WO 2004003147 | Dec 2004 | WO |
| WO 2004107964 | Dec 2004 | WO |
| WO 2004107975 | Dec 2004 | WO |
| WO 2004112602 | Dec 2004 | WO |
| WO 2004112612 | Dec 2004 | WO |
| WO 2004112612 | Dec 2004 | WO |
| WO 2005001418 | Jan 2005 | WO |
| WO 2005006939 | Jan 2005 | WO |
| WO 2005011774 | Feb 2005 | WO |
| WO 2005013824 | Feb 2005 | WO |
| WO 2005016125 | Feb 2005 | WO |
| WO 2005018425 | Mar 2005 | WO |
| WO 2005018430 | Mar 2005 | WO |
| WO 2005018454 | Mar 2005 | WO |
| WO 2005018709 | Mar 2005 | WO |
| WO 2005018710 | Mar 2005 | WO |
| WO 2005018711 | Mar 2005 | WO |
| WO 2005022143 | Mar 2005 | WO |
| WO 2005023088 | Mar 2005 | WO |
| WO 2005033659 | Apr 2005 | WO |
| WO 2005034720 | Apr 2005 | WO |
| WO 2005034721 | Apr 2005 | WO |
| WO 2005034741 | Apr 2005 | WO |
| WO 2005034778 | Apr 2005 | WO |
| WO 2005035017 | Apr 2005 | WO |
| WO 2005035018 | Apr 2005 | WO |
| WO 2005037095 | Apr 2005 | WO |
| WO 2005046477 | May 2005 | WO |
| WO 2005065399 | Jul 2005 | WO |
| WO 2005065414 | Jul 2005 | WO |
| WO 2005065415 | Jul 2005 | WO |
| WO 2005065545 | Jul 2005 | WO |
| WO 2005072604 | Aug 2005 | WO |
| WO2005084546 | Sep 2005 | WO |
| WO 2005084557 | Sep 2005 | WO |
| WO 2005104948 | Nov 2005 | WO |
| WO 2005104948 | Nov 2005 | WO |
| WO 2005114185 | Dec 2005 | WO |
| WO 2005116622 | Dec 2005 | WO |
| WO 2005119234 | Dec 2005 | WO |
| WO 2005120197 | Dec 2005 | WO |
| WO 2005120199 | Dec 2005 | WO |
| WO 2005120365 | Dec 2005 | WO |
| WO 2005120365 | Dec 2005 | WO |
| WO 2005121759 | Dec 2005 | WO |
| WO 2006001797 | Jan 2006 | WO |
| WO 2006001973 | Jan 2006 | WO |
| WO 2006011062 | Feb 2006 | WO |
| WO 2006013045 | Feb 2006 | WO |
| WO 2006015615 | Feb 2006 | WO |
| WO 2006027702 | Mar 2006 | WO |
| WO 2006031920 | Mar 2006 | WO |
| WO 2006032391 | Mar 2006 | WO |
| WO 2006072004 | Jul 2006 | WO |
| WO 2006105146 | Oct 2006 | WO |
| WO 2006116441 | Nov 2006 | WO |
| WO 2007025635 | Mar 2007 | WO |
| WO 2007044834 | Apr 2007 | WO |
| WO 2007054335 | May 2007 | WO |
| WO 2007070719 | Jun 2007 | WO |
| WO 2007084367 | Jul 2007 | WO |
| WO 2007106470 | Sep 2007 | WO |
| WO 2007119900 | Oct 2007 | WO |
| WO 2008112268 | Sep 2008 | WO |
| WO 2008112279 | Sep 2008 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 20070249962 A1 | Oct 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60297860 | Jun 2001 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10363510 | US | |
| Child | 11768633 | US |