Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    Related subject matter is disclosed in a U.S. Patent Application of Stevens et al. entitled “Cartridge Having An Integrated Collection Element For Point Of Care System”, Attorney Docket No. 43699, filed concurrently and the entire contents of which being incorporated herein by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to a system for capturing and testing fluid samples at a patient point of care location. In particular, the present invention relates to a system for collecting a fluid sample such as blood, directly into a sealed cartridge containing testing mechanisms for evaluation of the collected sample immediately upon collection. The cartridge contains an array of electrical contacts, electrochemical sensors (i.e., biosensor chips) and circuitry configured to electrically couple with a remote analytical device, such as a hand-held personal digital assistant (PDA), or a stand-alone computer workstation, which controls testing of the fluid sample within the cartridge and provides a rapid indication of test results at the point of care.  
         BACKGROUND OF THE INVENTION  
         [0003]    In a typical healthcare environment, clinical laboratories often perform numerous tests for doctors and healthcare professionals. Such laboratories perform these tests on various fluid samples, such as human blood, urine, plasma, serum or other fluids in order to measure chemical or physical properties of the samples. The results of these tests are used by doctors and healthcare professionals to make clinical decisions related to patient care and treatment. Because such results are used to make decisions for patient care, dependable test results are of the utmost importance. However, in addition to dependability considerations, many situations may require immediate determination of test results for effective care and treatment. In such cases, remote laboratory facilities are often unable to provide test results in a useful manner. As pointed out in U.S. Pat. No. 5,096,669 issued to Lauks et al., the entire content of which is incorporated herein by reference, many situations require test results immediately, such as in the physicians office, hospital emergency room or at the patient&#39;s bedside.  
           [0004]    In any sample testing scenario, the first consideration typically concerns sample collection and thereafter, sample transfer to a testing facility or apparatus. As discussed in U.S. Pat. No. 6,074,383 issued to Grippi et al., the entire content of which is incorporated herein by reference, the taking of samples such as blood, is considered a necessary part of the process of diagnosing and controlling many forms of disease. As described in the Grippi patent, blood samples are obtained by puncturing the skin of a patient&#39;s finger with a sharp object such as a syringe or pointed blade, which are typically disposable, such that once used, each may be discarded. Details of syringe construction and use in sample collection are described in U.S. Pat. No. 6,196,998 issued to Jansen et al., the entire content of which is incorporated herein by reference. Such conventional syringes described in the Jansen Patent include a barrel having an open distal end, typically engaged to a needle assembly with a needle cannula, and an opposed proximal end with a cylindrical wall extending between ends and defining a substance retaining chamber. As may be appreciated by those skilled in the art, collection of a sample within the retaining chamber of the syringe merely requires needle insertion at the distal end, and a sliding movement of a plunger within the chamber from the proximal end.  
           [0005]    One alternative to the syringe as a blood sample collection device is discussed in the Grippi patent referenced above. Lasers, commonly known as laser lancets, may be used as a substitute for a needle or pointed blade for obtaining blood samples from patients. A laser lancet, as with a mechanical lancet, can be used to puncture the surface of the skin for exposing blood samples where the blood may then be collected for analysis.  
           [0006]    As pointed out in U.S. Pat. No. 6,221,307 issued to Norman J. Hutton, the entire content of which is incorporated herein by reference, the collected blood samples may be taken and analyzed in hospital or clinical situations for various medical purposes. Sample analysis may include detection of pH, pCO 2 , pO 2 , Na + , Ca ++ , K + , hematocrit and glucose levels in the sample, in addition to sample temperature measurements through the use of real time sensors such as those described in U.S. Pat. No. 5,212,050 issued to Mier et al., and in U.S. Pat. No. 5,200,051 issued to Cozzette et al., the entire content of each being incorporated herein by reference.  
           [0007]    Collection, handling and testing of these samples typically requires the use of various medical testing instruments and, as pointed out in the Hutton patent referenced above, collection ideally occurs using standard sized collection devices. The use of standard sized collection devices allows the design and use of testing instruments which are configured to process samples without removal from the collection device. One such form of testing instrument currently available is a hand-held analyzer, which may be configured to accept samples contained within a standard collection device. Hand-held analyzers for sample testing are extensively discussed in U.S. Pat. No. 6,066,243 issued to Anderson et al., and in U.S. patent application Ser. No. 2002/0002326 issued to Causey et al., the entire content of each being incorporated herein by reference. Many such analyzers are configured to accept samples for testing via access ports adapted to receive small containment cartridges containing the sample for evaluation. Analyzers such as PDA-based devices are very cost effective, easily upgraded and allow on the spot analysis. Additional details regarding such configurations are discussed in U.S. Pat. No. 5,096,669, referenced above, in an article by Jason Thibeault entitled “Move Toward PDA-Based Devices Gets Boost from FDA”,  Medical Device &amp; Diagnostic Industry , August 2002, in an article by Ian Austin entitled “Palmtops In The Operating Room”,  New York Times , Aug. 22, 2002, and in an article by Stephanie De Ritis entitled “Expanding Exceeding POCT Boundaries”,  Advance/Laboratory , August 2002, the entire content of each being incorporated herein by reference.  
           [0008]    The containment cartridge method of sample collection and testing has proved successful in many applications. Containment cartridges include a small containment chamber into which a fluid sample is placed for testing, typically via a capillary tube placed into contact with an exposed fluid sample source. The chamber includes an extensive sensor array, such that numerous tests and evaluations may be performed on the contained sample. The cartridge is built as a standardized package which is configured to fit within an access port on a testing device that electrically couples to the sensor array of the cartridge, and directly collects information from the sensors regarding the contained sample. The move to standardize devices for interfacing between workstations and clinical systems is discussed further in the article entitled “Expanding Exceeding POCT Boundaries”, referenced above. One such containment cartridge compatible with a hand-held analyzer is discussed in U.S. Pat. No. 5,638,828 issued to Lauks et al., the entire content of which is incorporated herein by reference, and in U.S. Pat. No. 5,096,669 also issued to Lauks et al. and referenced above. The Lauks patents disclose a collection device for collecting a volume of blood or other fluids in a capillary tube housed within a sealed cartridge for diagnostic testing using a hand-held analytical device. As discussed in the Lauks patents, a fluid sample is introduced into a disposable cartridge through an orifice at one end of the cartridge. The sample enters the cartridge by putting the orifice in contact with an exposed source and a sample is drawn by capillary action into a conduit within the cartridge.  
           [0009]    However, the cartridge disclosed in the Lauks patents requires that a medical professional first prick the patient&#39;s finger with a finger stick to draw a small amount of blood through a dermal puncture. The medical professional is then required to place the orifice of the cartridge in contact with the blood sample formed on the dermal puncture in the patient&#39;s finger to draw the blood into the conduit of the collection cartridge. This method requires an exposed fluid sample f 6 r collection by the collection cartridge. An alternative collection method is also described in the Lauks patents wherein a syringe device is used to collect a sample then transfer the sample to the orifice of the cartridge or a reservoir chamber within the cartridge. This method requires additional steps to transfer the collected sample from a syringe to the cartridge which, depending on cartridge size and construction, may be difficult, time consuming and prone to contamination. In addition, as pointed out in the Lauks patents, transfer of exposed blood samples includes the risk of spills, contamination and transmission of infectious diseases such as human immunodeficiency virus or hepatitis.  
           [0010]    Therefore, a need exists to provide a cartridge assembly for directly collecting, containing and testing fluid samples such as blood, in association with hand-held analytical devices or stand-alone computer workstations, without requiring exposed sample sources or difficult sample transfers from a collection device to a cartridge reservoir.  
         SUMMARY OF THE INVENTION  
         [0011]    An object of the present invention is to provide a cartridge assembly and a sample collection device, such as a syringe, which may be used in combination for directly collecting, containing and testing fluid samples such as blood, without sample transfers or sample exposure.  
           [0012]    This and other objects are substantially achieved by providing a system for collecting a fluid sample directly into a sealed cartridge containing testing mechanisms for evaluation of the collected sample immediately upon collection. The cartridge is removably connected to a sample collection device such as a syringe, and collects a fluid sample for testing from the collection device apparatus. Once a sample has been collected, the cartridge may be removed from the collection device and engaged with a remote analytical testing device. Where the collection device allows shielding or retraction of the collection needle, lancet or other piercing element, the cartridge may remain safely engaged with the collection device during testing. The cartridge contains an array of electrical contacts, electrochemical sensors and circuitry configured to electrically couple with a remote analytical device such as a hand-held personal digital assistant (PDA), which controls the testing of the fluid sample within the cartridge and provides a rapid indication of test results at the point of care. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    These and other objects, advantages and novel features of the invention will be more readily appreciated from the following detailed description when read in conjunction with the accompanying drawings, in which:  
         [0014]    [0014]FIG. 1 is a view of an example of a removable cartridge system in use with a collection device according to an embodiment of the present invention;  
         [0015]    [0015]FIG. 2 is a view of the removable cartridge of FIG. 1 engaged with a collection device according to an embodiment of the present invention;  
         [0016]    [0016]FIG. 3 is a view of the removable cartridge of FIG. 1 engaged with a hand-held analytical device according to an embodiment of the present invention;  
         [0017]    [0017]FIG. 4 is a view of an example of a removable cartridge system in use with a lancet collection device according to an embodiment of the present invention;  
         [0018]    [0018]FIG. 5 is a view of the removable cartridge of FIG. 4 according to an embodiment of the present invention;  
         [0019]    [0019]FIG. 6 is a view of the removable cartridge of FIG. 4 engaged with a collection device according to an embodiment of the present invention;  
         [0020]    [0020]FIG. 7 is a view of an example of an evacuated removable cartridge system in use with a collection device according to an embodiment of the present invention;  
         [0021]    [0021]FIG. 8A is a view of the distal end of the evacuated removable cartridge of FIG. 7 according to an embodiment of the present invention;  
         [0022]    [0022]FIG. 8B is a view of the proximal end of the evacuated removable cartridge of FIG. 7 according to an embodiment of the present invention and  
         [0023]    [0023]FIG. 9 is a view of the evacuated removable cartridge of FIG. 7 engaged with a collection device according to an embodiment of the present invention.  
         [0024]    In the drawing figures, it will be understood that like numerals refer to like structures. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0025]    A diagram of an exemplary system  100  in accordance with an embodiment of the present invention is shown in FIG. 1. For the following discussion, reference will be made to FIGS. 1, 2 and  3 , and as necessary, attention will be drawn to a particular figure. FIG. 1 is a view in partial section of a collection cartridge  102  disengaged from a collection device  104 . FIG. 2 is a view of the removable cartridge  102  engaged with the collection device  104  of FIG. 1, and FIG. 3 is a view of the removable cartridge  102  of FIG. 1 engaged with a hand-held analytical device  106 , each according to an embodiment of the present invention.  
         [0026]    The system  100  of FIG. 1 preferably includes a disposable cartridge  102  for providing a containment chamber  108  into which fluid samples are placed by a collection device for analysis. As known to those skilled in the art, a collection device  104  such as a syringe or lancet, may be used to safely collect a fluid sample into a device body cavity or passageway. The cartridge  102  is adapted to removably engage the collection device  104  and allow the collection device to collect a fluid sample directly into the containment chamber  108  of the cartridge  102 . Once a sample is collected into the cartridge  102 , the cartridge may be removed from the collection device  104  and engaged with a remote analytical device  106  for testing. Where the collection device  104  allows shielding or retraction of the collection element, such as a needle or lancet, the cartridge  102  may remain safely engaged with the collection device during testing. It will be noted that the embodiments below include needle and lancet assemblies, however, the apparatus of the present invention works just as well with other collection device assemblies.  
         [0027]    The containment chamber  108  of the cartridge  102  provides contact between collected fluid samples within the chamber and sensory apparatus, such as miniaturized electrodes and micro-sensors, for executing a series of calibration and diagnostic tests on the sample. The sensory apparatus (not shown) is distributed in and around the chamber  108  as known to those skilled in the art, and is electrically coupled to an exposed electrical contact  110  located within a port  112  along the containment chamber wall  114  of the cartridge  102 . The exposed electrical contact  110  is contained within a mechanical coupler  116  as known to those skilled in the art, which is adapted to allow direct physical and electrical coupling of the cartridge  102  and a remote analytical device such as a hand-held analyzer, personal digital assistant (PDA) or VISOR®. Alternatively, the cartridge  102  may be coupled with a stand-alone computer workstation, or with any number of existing analyzers, such as those manufactured by the I-Stat Corporation of Princeton, N.J.  
         [0028]    The electrical contact  110  of cartridge  102  allows the cartridge to engage an input port on a hand-held analytical device and electrically couple the sensory apparatus of the cartridge to a testing and analysis means within the analytical device. Once coupled to the cartridge  102 , the analytical device gathers and processes information regarding the contained sample via the sensory apparatus within the containment chamber  108 , and thereafter produces outputs which are displayed on an output mechanism, such as a liquid crystal display (LCD), analog display or light emitting diode (LED) indicator. Additional tests on the sample may be directed by activation of user interface mechanisms located on the analytical device. As the cartridge  102  is inexpensive and entirely disposable, upon completion of sample testing the cartridge is removed from the analytical device and disposed of.  
         [0029]    With reference to the drawings of FIGS. 1, 2 and  3 , the cartridge assembly  102  of the embodiment shown comprises a housing  118  having a top and bottom containment wall mechanically coupled to one another in a fashion creating a chamber  108  providing for the capture and containment of a sample substance such as blood, from a collection device  104 . The housing  118  has a distal end  120  with a contaimnent chamber inlet orifice  122  formed therein, the orifice  122  being adapted to engage an outlet port  124  on the sample collection device  104 .  
         [0030]    As used herein, the term “proximal” refers to a location on the housing  118  closest to the person using the device and farthest from the patient in connection with which the device is used. Conversely, the term “distal” refers to a location on the housing  118  farthest from the person using the device and closest to the patient in connection with which the device is used.  
         [0031]    The cartridge  102  may be removably coupled with a collection device  104  in a number of methods, such as through a press fit between the outlet port  124  of the collection device  104  and the inlet orifice  122  of the cartridge housing  118 . The press fit mechanism of the collection device  104  removably holds the cartridge  102  firmly in place opposite the inlet port, or proximate end of the collection device  104 , which may hold a collection element such as a needle assembly.  
         [0032]    The press fit mechanism includes the outlet port  124  having a cylindrical extension  126  and an outlet passageway  128 . The inlet orifice  122  of the housing  118  includes an opening  132 , the inside diameter of which is slightly greater than the outside diameter of the cylindrical extension  126 . To couple the cartridge  102  with the collection device  104 , the collection device cylindrical extension  126  is inserted into the cylindrical opening  132  until the shoulder  130  is brought into contact with the distal end  120  of the housing  118 , indicating a secure fit between collection device  104  and collection cartridge  102 . Once the cartridge  102  is properly coupled with the collection device  104  as described above, an inlet passageway  134  creates a path between the containment chamber  108  and the outlet passageway  128  contained within the sample collection device  104 . While engaged, a leak-proof seal is formed between the inlet passageway  134  and the outlet passageway  128 , and a fluid sample is drawn into the containment chamber  108 . The sample may be drawn into the containment chamber  108  in a number of ways, including vacuum created within the chamber  108  or capillary action of the inlet passageway  134 .  
         [0033]    The location of the press fit between collection device  104  and collection cartridge  102  at the proximal end of the collection device opposite the device needle allows easier and safer collection cartridge insertion and removal. All steps are performed opposite the sharp distal end of the collection device  104  preventing dangers to healthcare professionals who may accidentally or through negligent handling, stick themselves with needles. It will be noted that the embodiment above may use a number of press fit mechanisms to bring the inlet passageway  134  into contact with the outlet passageway  128  allowing sample collection.  
         [0034]    Additionally, an adapter may be used at the outlet port  124  of the collection device  104  to allow the use of a wider range of collection cartridges. For example, collection cartridges by manufacturers such as the I-Stat Corporation, may be used in place of the collection cartridge  102  described above. The adapter may be used to engage any number of various collection cartridges and allow access between outlet passageway  128  of the collection device  104  and various inlet means employed by each collection cartridge manufacturer.  
         [0035]    As known by those skilled in the art, a fluid sample may be easily collected by a sample collection device  104 , where the collection device may be a syringe or lancet. The collected fluid sample within the device  104  is placed into contact with the outlet passageway  128  and is communicated to the proximal end of the collection device  104  through the natural capillary action of the passageway. The cartridge  102 , once properly engaged with the collection device  104  as described above and shown in FIG. 2, allows the collection of a portion of the fluid sample from the outlet passageway  128  of the collection device  104  by the containment chamber  108  of the cartridge  102  via the inlet passageway  134 . Once the cartridge  102  and the collection device  104  are properly engaged through the press fit mechanism described above, the outlet passageway  128  is brought into alignment and contact with the inlet passageway  134 . The inlet passageway  134  creates a path between the containment chamber  108  and the outlet passageway  128  contained within the sample collection device  104 . While engaged, a leak-proof seal is formed between the inlet passageway  134  and the outlet passageway  128  which allows the capillary action of the passageway  134  to communicate a fluid sample from the outlet passageway  128 . The capillary action of the containment chamber  108  completes the capture of the fluid sample, which is then communicated throughout the chamber. Once a sufficient sample is captured and contained within the cartridge  102 , the cartridge may be disengaged from the sample collection device  104  or, where practical to do so as described below, the cartridge may remain coupled to the collection device during testing. The exposed electrical contact  110  is located opposite the distal end  120  of the cartridge  102  thereby allowing the cartridge to remain engaged with the collection device  104  during sample testing with a hand-held analytical device as described below. Allowing the cartridge  102  and collection device  104  to remain coupled during testing may require shielding the collection device sharp distal end for safety, needle protection and other reasons obvious to those skilled in the art. Existing safety-engineered sharps protection systems include shields that pivot over needles, needles that retract into shields, and shields that move forward relative tot he needle, in order to contain the point of the needle. Needle pivoting, shielding or retracting systems and methods for collection devices are widely practiced and are described in numerous documents, such as U.S. Pat. No. 6,368,303 issued to Richard Caizza, and in U.S. Pat. No. 6,319,232 James Kashmer, the entire contents of each being incorporated herein by reference.  
         [0036]    The cartridge assembly  102  further includes sensory apparatus which surrounds the collected sample within the containment chamber  108 . As can be appreciated by one skilled in the art, the sensory apparatus may consist of a number of miniaturized electrodes and micro-sensors adapted to detect and measure various chemical and physical properties of the sample contained within the chamber  108 . The sensory apparatus is distributed in and around the chamber  108  and inlet passageway  134  of the cartridge  102  and is electrically coupled to the exposed electrical contact  110  located externally along the containment chamber wall  114  opposite the distal end  120  of the cartridge  102 . The exposed electrical contact  110  is contained within a mechanical coupler  116  adapted to allow direct physical and electrical coupling of the cartridge  102  and a like electrical contact and mechanical coupler located on a remote analytical device, such as a hand-held analyzer, personal digital assistant (PDA) or VISOR®, or a stand-alone computer workstation. Once within the containment chamber  108 , the sample is subject to extensive analysis through direct and indirect contacts with the sensory apparatus, as directed by the remote analytical device.  
         [0037]    Specifically, sample testing is achieved by engaging the cartridge  102  with the collection device  104  as described above. As noted earlier, an adapter may first be engaged with the collection device to accommodate alternate cartridges where necessary. Once engaged with the collection device  104 , a sample is collected by the collection device into the cartridge  102 . The filled cartridge  102  may then be removed from the sample collection device  104 , or where practical to do so as described above, the cartridge may remain coupled to the collection device or adapter during testing. A remote analytical device  106  is then prepared to receive the filled cartridge  102  for testing. As known to those skilled in the art, many interface modules are provided to adapt hand-held devices to multiple uses, such as SPRINGBOARD® expansion modules for a personal digital assistant (PDA) or VISOR® as shown in FIG. 3. Where required, an interface module  134  is installed on the analytical device  106  which allows engagement with the exposed electrical contact  110  and mechanical coupler  116  of the cartridge  102 . As appreciated by those skilled in the art, the analytical device  106  includes hardware and software adapted to access the sensory apparatus within the cartridge  102  and gather information on the sample contained therein, such as pH, pCO 2 , pO 2  Na + , Ca ++ , K + , hematocrit and glucose levels in the sample, in addition to sample temperature measurements. The analytical device may then perform numerous tests, configured by the user, on the sample contained within the containment chamber  108  of the cartridge  102  and display results via an output mechanism, such as a liquid crystal display (LCD), analog display or light emitting diode (LED) indicator on the analytical device. Additional tests or property detection may be directed by activation of user interface mechanisms located on the analytical device  106 . Upon completion, the cartridge  102  and sample therein, are removed from the analytical device  106  and disposed. The cartridge  102  is fabricated as a sterile, disposable unit, preferably made of an inexpensive plastic, such as polyethylene, polypropylene, polyvinylidene chloride or the like. Additionally, sensory apparatus within the cartridge  102  are sufficiently inexpensive to allow single use and disposal.  
         [0038]    In another embodiment of the present invention, a diagram of an exemplary system  136  in accordance with an embodiment of the present invention is shown in FIG. 4. FIG. 4 is a view of a collection cartridge  138  disengaged from a collection device  140 . The system  136  preferably includes a disposable cartridge  138  for providing a containment chamber into which fluid samples are placed for analysis, substantially the same as discussed above for the collection cartridge  102 . The cartridge  138  is adapted to engage a collection device  140  which draws a fluid sample to the surface of a patient&#39;s skin for collection directly into the containment chamber of the cartridge  138 .  
         [0039]    For the following discussion, reference will be made to all of FIGS. 4, 5 and  6 , and as necessary, attention will be drawn to a particular figure. FIG. 5 is a view in partial section of the collection cartridge  138  disengaged from a collection device  140 , and FIG. 6 is a view of the collection cartridge  138  engaged with a collection device  140  of FIG. 5, each according to an embodiment of the present invention.  
         [0040]    With reference to the drawing of FIG. 4, a cartridge  138  may be mechanically coupled with a collection device  140 , such as a lancet device, through a press fit mechanism  142  located at the distal end of the device body. In the embodiment shown in FIG. 4, the collection device  140  may be comprised of a handle housing  144 , or a handle-lancet housing combination, including a press fit mechanism  142 . The press fit mechanism  142  holds the cartridge  138  firmly in place within a recessed cartridge chamber  146  formed at the distal end of the collection device housing  144 . The recessed cartridge chamber  146  is comprised of a locking slot or recess located within the handle housing  144  extending from the distal end of the housing to receive and secure the collection cartridge  138  to the collection device  140 . The recessed cartridge chamber  146  is open at the distal end of the collection device, allowing the collection cartridge to position a containment chamber inlet orifice array  148  described below, adjacent to a collection device piercing mechanism also located at the distal end of the collection device  140  (not shown).  
         [0041]    With reference to the drawings of FIGS. 4 and 5, the cartridge assembly  138  of the embodiment shown comprises a housing  150  having a top and bottom containment wall, mechanically coupled to one another in a fashion creating a containment chamber  152  providing for the capture and containment of a sample substance substantially the same as discussed above for the collection cartridge  102 . The housing  150  has a distal end  154  with a containment chamber inlet orifice array  148  formed therein. The orifice array  148  includes one, or any number of inlet passageways  156  extending through the flat surface  158  of the housing  150  allowing access between the surface  158  and the containment chamber  152  within the cartridge  138 .  
         [0042]    The containment chamber  152  of the cartridge provides contact between collected fluid samples within the chamber and sensory apparatus for executing a series of calibration and diagnostic tests on the sample substantially the same as discussed above for the collection cartridge  102 . The sensory apparatus (not shown) is distributed in and around the chamber  152  as known to those skilled in the art, and is electrically coupled to an exposed electrical contact  160  located within a port  162  along the containment chamber wall surface  164 . The exposed electrical contact  160  is contained within a mechanical coupler  166  as known to those skilled in the art, which is adapted to allow direct physical and electrical coupling of the cartridge  138  and a remote analytical device such as a hand-held analyzer, personal digital assistant (PDA) or VISOR®, or stand-alone computer workstation, adapted to direct the testing of a sample within the chamber.  
         [0043]    As known by those skilled in the art, the collection device  140 , in this case a lancet, may be used to draw a blood sample from a patient. Additional details of lancet use are described in U.S. Pat. No. 4,677,979 issued to James A. Burns, the entire content of which is incorporated herein by reference. Once properly engaged with the collection device  140  as described above and shown in FIG. 6, the cartridge  138  allows the collection of a portion of the drawn fluid sample to the containment chamber  152  of the cartridge  138  via the inlet orifice array  148  using methods such as the capillary action of the inlet passageways  156  substantially as described with the first embodiment above. The fluid sample is placed into contact with the orifice array  148  and is communicated to the containment chamber  152  through the natural capillary action of the inlet passageways  156 . Once the cartridge  138  and the collection device  140  are properly engaged through the press fit mechanism described above, the orifice array  148  is brought into position adjacent to the lancet mechanism allowing the inlet passageways  156  to create a path between the containment chamber  152  and any exposed fluid. While engaged, the capillary action of the inlet passageways  156  can communicate a fluid sample from the orifice array, and the capillary action of the containment chamber  152  completes the capture of the fluid sample, which is then communicated throughout the chamber. Other methods, such as a vacuum may also be used to draw the sample into the containment chamber  152 .  
         [0044]    Once a sufficient sample is captured and contained within the cartridge  138 , the cartridge may be disengaged from the sample collection device  140  and placed in an analytical device for testing. Alternatively, the cartridge may remain engaged with the sample collection device and both may be placed in the analytical device for testing. Sample testing is achieved by removing the filled cartridge  138  from the sample collection device  140 , and engaging the exposed electrical contact  160  and mechanical coupler  166  with a like electrical contact and mechanical coupler located on a remote analytical device substantially the same as discussed above for the collection cartridge  102 . Sample testing may then be directed as described above.  
         [0045]    In another embodiment of the present invention, a diagram of an exemplary system  168  in accordance with an embodiment of the present invention is shown in FIG. 7. FIG. 7 is a view of a collection cartridge  170  disengaged from a collection device  172 . The system  168  preferably includes a disposable cartridge  170  for providing a containment chamber into which fluid samples are placed for analysis, substantially the same as discussed above for the collection cartridge  102 . The cartridge  170  is evacuated prior to use, and adapted to engage a collection device  172 , used to collect a fluid sample from a patient and transfer the sample directly into the containment chamber of the cartridge  170 .  
         [0046]    For the following discussion, reference will be made to all of FIGS. 7, 8 and  9 , and as necessary, attention will be drawn to a particular figure. FIG. 7 is a view in partial section of an example of an evacuated removable cartridge disengaged from a collection device, and FIGS. 8A and 8B are views of the evacuated removable cartridge. FIG. 9 is a view of the evacuated removable cartridge of FIG. 7 engaged with the collection device according to an embodiment of the present invention  
         [0047]    With reference to the drawing of FIG. 7, an evacuated cartridge  170  may be mechanically coupled with a collection device  172 , such as a syringe device, through a press fit mechanism located at the proximal end of the handle housing  172 . In the embodiment shown in FIG. 7, the collection device  172  may be comprised of a handle housing  178 , including a press fit mechanism and a shielded piercing member  180  at a distal end. The press fit mechanism holds the cartridge  170  firmly in place within a recessed cartridge slot  182  formed at the proximal end of the collection device housing  178 . The recessed cartridge slot  182  is comprised of first and second opposing tabs  184  and  186  extending as a partial housing wall about the circumference of the housing  178 , where the radius of the partial housing wall is defined by the slot  182 . The locking slot  182  is located between tabs  184  and  186  within the handle housing  178  and extends from the distal end of the housing to receive and secure the collection cartridge  170  to the collection device  172 . A piercing member, such as an intravenous needle  174 , in fluid communication with the shielded piercing member  180 , is positioned within the slot  182 , and is adapted to access the vacuum of the evacuated cartridge  170 , allowing a transfer of the sample from the collection device  172  to the cartridge  170 .  
         [0048]    With reference to the drawings of FIGS. 7, 8A and  8 B, the cartridge assembly  170  of the embodiment shown comprises a housing  188  having a top and bottom containment wall, mechanically coupled to one another in a fashion creating a containment chamber  190  providing for the capture and containment of a sample substance substantially the same as discussed above for the collection cartridge  102 . The housing  188  has a distal end  192  with a containment chamber inlet orifice  194  formed therein. The orifice  194  includes an inlet passageway  196  extending from the distal end  192  and the containment chamber  190  within the cartridge  170 , to mate with the intravenous needle  174  of the collection device.  
         [0049]    In this embodiment, or any embodiment described above in which a vacuum is required within the containment chamber to provide the mechanism for transferring a fluid sample, the vacuum can be provided as part of the manufactured cartridge, or created prior to use through various cartridge construction techniques.  
         [0050]    In the evacuated cartridge embodiment shown in FIG. 7, a vacuum can be created in the chamber  190  using a pliable cartridge body and a valve mechanism located at  198  to contain the vacuum within the chamber  190  until accessed by the intravenous needle  174  of the collection device  172  during engagement. The cartridge  170  can be manufactured having a contained vacuum for collection purposes, or, the cartridge can be manufactured having a pliable body for use with the valve mechanism for creating a contained vacuum in the field during use. The pliable body of the cartridge  170  can be manually compressed prior to use to evacuate the containment chamber  190  of the cartridge. The pliable body of the cartridge when released, returns to an original position, creating and capturing a vacuum within the containment chamber  190  via a valve mechanism located at  198 . The valve mechanism  198  allows single direction air flow for the purpose of vacuum creation. The mechanism can be constructed of a material that is resilient, yet easily penetrable by a cannula, such as the intravenous needle  174 .  
         [0051]    The containment chamber  190  of the cartridge  170  provides contact between collected fluid samples within the chamber and sensory apparatus for executing a series of calibration and diagnostic tests on the sample substantially the same as discussed above for the collection cartridge  102 . The sensory apparatus (not shown) is distributed in and around the chamber  190  as known to those skilled in the art, and is electrically coupled to an exposed electrical contact  202  located within a port  204  along the containment chamber wall surface  200 . The exposed electrical contact  202  is contained within a mechanical coupler  206  as known to those skilled in the art, which is adapted to allow direct physical and electrical coupling of the cartridge  170  and a remote analytical device such as a hand-held analyzer, personal digital assistant (PDA) or VISOR®, or stand-alone computer workstation, adapted to direct the testing of a sample within the chamber.  
         [0052]    As known by those skilled in the art, the collection device  172  may be used to draw a blood sample from a patient. Once properly engaged with the collection device  172  as described above and shown in FIG. 9, the cartridge  170  allows the collection of a portion of the drawn fluid sample to the containment chamber  190  of the cartridge  170  via the intravenous needle  174  of the collection device using methods such as capillary action or vacuum. The collected fluid sample within the collection device  172  is communicated to the proximal end of the collection device through the intravenous needle  174 . Once the evacuated cartridge  170  and the collection device  172  are properly engaged through the press fit mechanism described above, the intravenous needle  174  accesses the inlet passageway  196  and valve mechanism  198 , releasing the contained vacuum with in the evacuated cartridge  172 . The inlet passageway  196  and valve mechanism  198  create a path between the containment chamber  190  and the intravenous needle  174 , allowing the released vacuum to urge a fluid sample from the intravenous needle  174  into the containment chamber  190 . While engaged, a leak-proof seal is formed between the intravenous needle  174  and the valve mechanism  198 , which allows the vacuum of the evacuated cartridge  170  to communicate a fluid sample from the intravenous needle  174  throughout the chamber  190 .  
         [0053]    In another embodiment of the evacuated cartridge  170 , the valve mechanism can be replaced with a sealed membrane or a penetrable cartridge body. The evacuated cartridge  170  is manufactured including a contained vacuum within the containment chamber  190 , and requires no additional preparation steps prior to use. In this embodiment, the proper engagement through the press fit mechanism described above results in the intravenous needle  174  accessing the inlet passageway  196  and piercing the sealed membrane or cartridge body, and allowing fluid communication substantially as described above. Such embodiments of an evacuated cartridge based system therefore, also allows mating with existing sample access products available.  
         [0054]    Once a sufficient sample is captured and contained within the cartridge  170 , the cartridge may be disengaged from the sample collection device  172  and placed in an analytical device for testing. Sample testing is achieved by removing the filled cartridge  170  from the sample collection device, and engaging the exposed electrical contact  202  and mechanical coupler  206  with a like electrical contact and mechanical coupler located on a remote analytical device substantially the same as discussed above for the collection cartridge  102 . Sample testing may then be directed as described above. Alternatively, the cartridge may remain engaged with the sample collection device and, after shielding the piercing member  180 , both may be placed in the analytical device for testing.  
         [0055]    The collection cartridge disclosed in each embodiment provides the ability to obtain immediate, reliable and accurate testing of fluid samples without the processing delays associated with traditional laboratories. Moreover, the cartridge greatly reduces the quantity of fluid sample required from the patient to perform these tests.  
         [0056]    Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims.

Technology Category: 3